PMS-PROCHLORPERAZINE SUPPOSITOIRES 10MG

Main information

  • Trade name:
  • PMS-PROCHLORPERAZINE SUPPOSITOIRES 10MG SUPPOSITORY
  • Dosage:
  • 10MG
  • Pharmaceutical form:
  • SUPPOSITORY
  • Composition:
  • PROCHLORPERAZINE 10MG
  • Administration route:
  • RECTAL
  • Units in package:
  • 10
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • PMS-PROCHLORPERAZINE SUPPOSITOIRES 10MG SUPPOSITORY
    Canada
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • PHENOTHIAZINES
  • Product summary:
  • Active ingredient group (AIG) number: 0106181001; AHFS: 28:16.08.24

Other information

Status

  • Source:
  • Health Canada
  • Authorization status:
  • MARKETED
  • Authorization number:
  • 00753688
  • Authorization date:
  • 31-12-1989
  • Last update:
  • 27-11-2018

Summary of Product characteristics: dosage,interactions,side effects

PRESCRIBING INFORMATION

Pr

pms-PROCHLORPERAZINE

Prochlorperazine Maleate Tablets USP

5 mg and 10 mg

Prochlorperazine Suppositories USP

10 mg

Prochlorperazine Mesylate Injection BP

5 mg/mL

ANTIPSYCHOTIC/ANTIEMETIC

PHARMASCIENCE INC.

6111 Royalmount Ave., Suite 100

Montréal, Québec

H4P 2T4

Date of Revision :

January 10, 2013

Control Number: 161362

pms-PROCHLORPERAZINE Prescribing information

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Table of Contents

ACTIONS AND CLINICAL PHARMACOLOGY ....................................................................... 3

INDICATIONS AND CLINICAL USE ......................................................................................... 3

CONTRAINDICATIONS .............................................................................................................. 4

WARNINGS ................................................................................................................................... 4

PRECAUTIONS ............................................................................................................................. 5

ADVERSE EFFECTS .................................................................................................................... 7

SYMPTOMS AND TREATMENT OF OVERDOSAGE ........................................................... 10

DOSAGE AND ADMINISTRATION ......................................................................................... 10

AVAILABILITY OF DOSAGE FORMS .................................................................................... 11

Part III: CONSUMER INFORMATION ...................................................................................... 13

pms-PROCHLORPERAZINE Prescribing information

Page 3 of 20

PRESCRIBING INFORMATION

Pr

pms-PROCHLORPERAZINE

Prochlorperazine Maleate Tablets USP

5 mg and 10 mg

Prochlorperazine Suppositories USP

10 mg

Prochlorperazine Mesylate Injection BP

5 mg/mL

ACTIONS AND CLINICAL PHARMACOLOGY

Prochlorperazine is a piperazine phenothiazine derivative with antipsychotic, antiemetic and

weak sedative activity.

Prochlorperazine has actions similar to those of other phenothiazine derivatives but appears to be

less sedating and to have a weak propensity for causing hypotension or potentiating the effects of

Central Nervous System (CNS) depressants and anesthetics. However, it produces a high

incidence of extrapyramidal reactions.

Prochlorperazine is well absorbed from the gastrointestinal tract.

Onset of action following oral administration is 30 to 40 minutes; 60 minutes for suppositories

and 10 to 20 minutes after i.m. administration. Duration of action for all routes is 3 to 4 hours.

Prochlorperazine distributes to most body tissues with high concentrations being distributed into

liver and spleen. Prochlorperazine enters the enterohepatic circulation and is excreted chiefly in

the feces:

INDICATIONS AND CLINICAL USE

In the management of manifestations of psychotic disorders such as agitation, confusion,

delusion, tension and anxiety.

It is also effective in controlling nausea and vomiting due to stimulation of the chemoreceptor

trigger zone.

In selected patients, prochlorperazine may be of value for the relief of excessive anxiety,

accompanied by severe tension and agitation, associated with psychoneurotic or somatic

conditions.

pms-PROCHLORPERAZINE Prescribing information

Page 4 of 20

CONTRAINDICATIONS

Should not be administered in the presence of circulatory collapse, altered states of

consciousness or comatose states, particularly when these are due to intoxication with central

depressant drugs (alcohol, hypnotics, narcotics). It is contraindicated in severely depressed

patients, in the presence of blood dyscrasias, liver disease, renal insufficiency,

pheochromocytoma, or in patients with severe cardiovascular disorders or a history of

hypersensitivity to phenothiazine derivatives.

As with other phenothiazines, pms-PROCHLORPERAZINE is contraindicated in patients with

suspected or established subcortical brain damage, with or without hypothalamic damage, since a

hyperthermic reaction with temperatures above 40°C may occur, sometimes not until 14 to 16

hours after drug administration.

Phenothiazine compounds should not be used in patients receiving large doses of hypnotics, due

to the possibility of potentiation.

pms-PROCHLORPERAZINE is contraindicated in children undergoing surgery.

WARNINGS

The antiemetic action of prochlorperazine may mask the signs and symptoms of overdosage of,

other drugs and may obscure the diagnosis and treatment of other conditions such as brain

tumour or intestinal obstruction. Therefore the etiology of nausea and vomiting should be

established before using the drug.

Neutropenia, granulocytopenia and agranulocytosis have been reported during antipsychotic use.

Therefore, it is recommended that patients have their complete blood count (CBC) tested prior to

starting pms-PROCHLORPERAZINE and then periodically throughout treatment.

Occupational Hazards

The use of this drug may impair the mental and physical abilities required for the performance of

potentially hazardous tasks, such as driving a car or operating machinery.

Potentiation of the effects of alcohol may also occur.

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Special Populations:

Pregnant Women

Teratogenic Effects

Safety during pregnancy has not been established. Therefore, it is recommended that the drug be

given to pregnant patients only when, in the judgment of the physician, the potential benefit to

the patient outweighs the possible risk to the fetus.

Non-Teratogenic Effects

Neonates exposed to antipsychotic drugs (including pms-PROCHLORPERAZINE) during the

third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms

following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor,

somnolence, respiratory distress and feeding disorder in these neonates. These complications

have varied in severity; while in some cases symptoms have been self-limited, in other cases

neonates have required intensive care unit support and prolonged hospitalization.

pms-PROCHLORPERAZINE should not be used during pregnancy unless the expected benefits

to the mother markedly outweigh the potential risks to the fetus.

Children

The drug should not, be used in children under 2 years unless potentially life-saving.

The extrapyramidal symptoms which can occur secondary to prochlorperazine may be confused

with the CNS signs of an undiagnosed primary disease responsible for the vomiting, e.g. Reye's

syndrome or other encephalopathy. The use of pms-PROCHLORPERAZINE should be avoided

in children and adolescents whose signs and symptoms suggest Reye's syndrome.

PRECAUTIONS

The increased incidence of seizures, which occasionally occur in epileptics started on

antipsychotic medication may be controlled by increasing the dosage of their anticonvulsant.

Patients with a familial history of seizures or febrile convulsions are more likely to develop

seizures than those who have no-such history.

Phenothiazines may increase the effects of general anesthetics, opiates, barbiturates, and other

CNS depressants and the doses of these drugs should be reduced if administered concomitantly

with prochlorperazine.

On long-term therapy, particularly during the first 2 or 3 months it is advisable to perform

periodic liver function tests and blood counts as cholestatic jaundice and blood dyscrasias may

occur, necessitating discontinuation of treatment. Renal function should be monitored and, if

BUN becomes abnormal, treatment should be discontinued.

To lessen the likelihood of adverse reactions related to drug accumulation, patients on long-term

therapy, particularly on high doses, should be evaluated periodically to decide whether the

maintenance dosage could be lowered or drug therapy discontinued.

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Because of its anticholinergic action, pms-PROCHLORPERAZINE should be used with great

caution in patients with glaucoma or prostatic hypertrophy.

The effects of anticholinergic drugs may be potentiated by prochlorperazine. Paralytic ileus, even

resulting in death, may occur especially in the elderly. Caution should be observed if

constipation develops.

Retinal changes, lenticular and corneal deposits and abnormal skin pigmentation have been

observed with other phenothiazines and may occur after prolonged therapy. The possibility of

persistent tardive dyskinesia should, also be borne in mind when patients are under long term

treatment.

Patients receiving pms-PROCHLORPERAZINE should be cautioned against exposure to

extreme heat or organophosphorous insecticides.

Hypotension and ECG changes, particularly non-specific and usually reversible Q and T wave

distortions, have been associated with the administration of phenothiazines. Therefore pms-

PROCHLORPERAZINE should be used with caution in patients with compensated

cardiovascular and cerebrovascular disorders.

Unexpected, sudden deaths have occurred in hospitalized patients treated with phenothiazines.

Previous brain damage or seizures may predispose. High doses should be avoided in known

seizure patients. Sudden exacerbations of psychotic behaviour patterns occurred in several

patients shortly before death. Acute fulminating pneumonia, or pneumonitis and aspiration of

gastric contents were also observed. Therefore, the physician also should keep in mind the

possible development of silent pneumonias.

Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration.

Tissue culture experiments indicate that approximately one-third of human breast cancers are

prolactin-dependent in vitro, a factor of potential importance if the prescription of these drugs is

contemplated in a patient with a previously detected breast cancer. Although disturbances such

as galactorrhea, amenorrhea, gynecomastia and impotence have been reported, the clinical

significance of elevated serum prolactin levels is unknown for most patients. An increase in

mammary neoplasms has been found in rodents after chronic administration of neuroleptic drugs.

Neither clinical studies, nor epidemiologic studies conducted to date, however, have shown an

association between chronic administration of these drugs and mammary tumorigenesis; the

available evidence is considered too limited to be conclusive at this time.

Hematologic

Venous Thromboembolism: Venous thromboembolism (VTE), including fatal pulmonary

embolism, has been reported with antipsychotic drugs, including prochlorperazine, in case

reports and/or observational studies. When prescribing pms-PROCHLORPERAZINE all

potential risk factors for VTE should be identified and preventative measures undertaken.

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Endocrine and Metabolism

Hyperglycemia: Diabetic ketoacidosis (DKA) has occurred in patients with no reported history

of hyperglycemia. Patients should have baseline and periodic monitoring of blood glucose and

body weight.

Hyperprolactinemia: Long-standing hyperprolactinemia when associated with hypogonadism

may lead to decreased bone mineral density in both female and male subjects.

Genitourinary: Rare cases of priapism have been reported with antipsychotic use, such as pms-

PROCHLORPERAZINE. This adverse reaction, as with other psychotropic drugs, did not appear

to be dose-dependent and did not correlate with the duration of treatment.

Withdrawal Emergent Neurological Signs

Abrupt withdrawal after short term administration of antipsychotic drugs does not generally pose

problems. However, transient dyskinetic signs are experienced by some patients on maintenance

therapy after abrupt withdrawal. The signs are very similar to those described under Tardive

Dyskinesia, except for duration. Although it is not known whether gradual withdrawal of

antipsychotic drugs will decrease the incidence of withdrawal emergent neurological signs,

gradual withdrawal would appear to be advisable.

Older Patients

The incidence of adverse reactions may be greater in patients over 55 years of age, since the half-

lives of antipsychotic drugs are often prolonged. To minimize this possibility, the maintenance

dosage should be reduced to the lowest effective level as soon as possible after initial titration

and-periodically reviewed.

Since psychiatric syndromes in the elderly can be caused by drugs or organic disease, withdrawal

of the precipitating drug or treatment of the medical condition should supersede initiation of

antipsychotic medication. These agents should not be used for non-psychiatric conditions for

which other drugs are available, since the elderly are especially prone to develop adverse effects

from antipsychotic drugs.

Children

Children with an acute febrile illness or suffering from dehydration seem to be much more

susceptible than adults to neuromuscular reactions, particularly dystonias. In such patients, the

drug should be used under close supervision and at low doses.

ADVERSE EFFECTS

Adverse reactions with different phenothiazines vary in type, frequency, and mechanism of

occurrence, i.e. some are dose-related while others involve individual patient sensitivity. Some

adverse reactions may be more likely to occur with greater intensity, in patients with special

medical problems.

pms-PROCHLORPERAZINE Prescribing information

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Not all of the following adverse reactions have been observed with every phenothiazine

derivative, but they have been reported with one or more and should be borne in mind when

drugs of this class are administered.

Patients should be advised of the risk of severe constipation during pms-

PROCHLORPERAZINE treatment, and that they should tell their doctor if constipation occurs

or worsens, as they may need laxatives.

Neurological

Extrapyramidal reactions including tremor, rigidity, akathisia, dystonia, dyskinesia, oculogyric

crises, opisthotonos, hyperreflexia and sialorrhea. EEG changes, disturbed temperature

regulation and seizures have also been encountered.

Persistent Tardive Dyskinesia

As with other antipsychotic agents, tardive dyskinesia may occur in patients on long term

therapy or may be observed after drug therapy has been discontinued. The risk seems to be

greater in elderly patients on high doses, especially females. The symptoms are persistent and in

some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary

movements of the tongue, face, mouth or jaw (e.g. protrusion of tongue, puffing of cheeks,

puckering of mouth chewing movements). Sometimes, these may be accompanied by

involuntary movements of the extremities.

There is no known effective treatment for tardive dyskinesia; antiparkinsonian agents usually do

not alleviate the symptoms of this syndrome.

It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it

be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different

antipsychotic agent, the syndrome may be masked. It has been reported that the fine vermicular

movements of the tongue may be an early sign of the syndrome and if the medication is stopped

at that time, the syndrome may not develop. The physician may be able to reduce the risk of this

syndrome by minimizing the unnecessary use of neuroleptic drugs and reducing the dose or

discontinuing the drug, if possible, when manifestations of this syndrome are recognized,

particularly in patients over the age of 50.

Behavioral

Sleep disturbances, drowsiness, fatigue, insomnia, and depression have been reported and may,

in severe cases, necessitate reduction in dosage. As with other phenothiazine derivatives

reactivation or aggravation of psychotic processes may be encountered. Paradoxical effects such

as agitation, anxiety, restlessness, excitement and bizarre dreams, have been observed,

Autonomic Nervous System

Dry mouth, nasal congestion, headache, nausea, constipation, tachycardia, hypotension, syncope,

dizziness, blurred vision, vomiting, sweating and urinary incontinence have been observed.

Patients with pheochromocytoma, cerebral vascular or renal insufficiency, or a severe cardiac

reserve deficiency such as mitral insufficiency appear to be particularly prone to hypotensive

pms-PROCHLORPERAZINE Prescribing information

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reactions with phenothiazine compounds, and should therefore be observed closely when the

drug is administered. Should hypotension occur in. Patients receiving prochlorperazine and a

vasopressor agent be required, i.v. levarterenol or phenylephrine should be used, and not

epinephrine, since phenothiazine derivatives can reverse the pressor effect of the latter drug.

Other autonomic reactions which have occurred with phenothiazines are salivation, polyuria,

glaucoma, bladder paralysis, adynamic ileus, and fecal compaction.

Metabolic and Endocrine

Anorexia, menstrual, irregularities, impotence, and increased thirst, weight changes, increased

appetite, peripheral edema, galactorrhea, gynecomastia, false positive pregnancy tests, and

changes in libido have also occurred in patients receiving phenothiazine therapy.

Allergic or Toxic

Pruritus, dermatitis, rash, erythema, urticaria, seborrhea, eczema, exfoliative dermatitis, and

photosensitivity. The possibility of an anaphylactoid reaction should be borne in mind.

Blood dyscrasias including leukopenia, agranulocytosis, pancytopenia, thrombocytopenic or

non-thrombocytopenic purpura, eosinophilia, and anemia, have been associated with,

phenothiazine therapy. Routine blood counts are therefore advisable during prolonged therapy. If

any soreness of the mouth gums or throat or any symptoms of upper respiratory infection occur

and confirmatory leukocyte count indicates cellular depression, therapy should be discontinued

and other appropriate measures instituted immediately.

Cholestatic jaundice and biliary stasis may be encountered, particularly during the first months of

therapy, and require immediate discontinuation of treatment.

Miscellaneous

The following adverse reactions have been reported in patients receiving phenothiazine

derivatives: headache, asthma laryngeal, cerebral and angioneurotic edema, altered cerebrospinal

fluid proteins, systemic lupus erythematosus-like syndrome, hyperpyrexia, ECG and EEG

changes and hypotension severe enough to cause fatal cardiac arrest. Skin pigmentation,

epithelial keratopathy, lenticular and corneal deposits have been associated with long-term

administration.

Sudden unexpected and unexplained deaths have been reported in hospitalized psychotic patients

receiving phenothiazines. Previous brain damage or seizures may be predisposing factors; high

doses should be avoided in known seizure patients. Several patients have shown flare-ups of

psychotic behaviour patterns shortly before deaths. Autopsy findings have usually revealed acute

fulminating pneumonia or pneumonitis, aspiration of gastric contents or intramyocardial lesions.

Potentiation of CNS depressants (barbiturates, narcotics, analgesics, alcohol, antihistamines)

may occur.

Neuroleptic Malignant Syndrome

As with other neuroleptic drugs, a symptom complex sometimes referred to as neuroleptic

malignant syndrome (NMS) may occur. Cardinal features of NMS are hyperpyrexia, muscle

rigidity, altered mental status (including catatonic signs), and evidence of autonomic instability

(irregular pulse or blood pressure). Additional signs may include elevated CPK, myoglobinuria

pms-PROCHLORPERAZINE Prescribing information

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(rhabdomyolysis), and acute renal failure. NMS is potentially fatal and requires symptomatic

treatment and immediate discontinuation of neuroleptic treatment.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

Symptoms

Primarily extrapyramidal reactions, CNS depression which may vary from simple lethargy to

coma. Agitation and restlessness may also occur. Other possible manifestations include

convulsions, fever and autonomic reactions such as hypotension, dry mouth and ileus.

Treatment

Essentially symptomatic and supportive. Early gastric lavage may be helpful.

Maintain an open airway. If hypotension occurs, the standard measures for managing circulatory

shock should be initiated; if a pressor agent is required give levarterenol or phenylephrine and

not epinephrine as it may further depress the blood pressure. Extrapyramidal reactions should be

treated with an antiparkinsonian agent.

Centrally acting emetics will be ineffective because of prochlorperazine's antiemetic action.

Limited experience indicates that phenothiazines are not dialyzable.

For management of a suspected drug overdose, contact your regional Poison Control

Centre immediately

DOSAGE AND ADMINISTRATION

Begin with the lowest recommended dosage. Adjust to response of the individual.

Adults:

Oral and rectal route: to control nausea, vomiting or excessive anxiety: usually 5 to 10 mg, 3 or 4

times daily; in mild cases, a single dose of 5 to 10 mg is often adequate.

In psychiatry for moderate to severe conditions, the usual starting dosage is 10 mg 3 or 4 times a

day. Increase dosage gradually by 5 to l0 mg every 2 or 3 days until symptoms are controlled or

adverse reactions intervene.

Some patients respond satisfactorily on 50 to 75 mg per day. In more severe disturbances it may

reach 100 to 150 mg a day. For maintenance therapy, the dosage should be reduced to the

minimum effective dose.

Parenteral route:

I.M.Dosage: The drug is given by deep i.m. injection.

pms-PROCHLORPERAZINE Prescribing information

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Total daily dosage rarely exceeds 40 mg, except in severe psychiatric cases. When control is

achieved, the oral route should be substituted.

To control nausea, vomiting or excessive anxiety: 5 to 10 mg, 2 or 3 times a day.

In psychiatry: for immediate control of severely disturbed patients, 10 to 20 mg initially,

repeated every 2 to 4 hours until control is obtained. More than 3 or 4 doses are seldom

necessary. The patients should be kept in bed and under medical supervision.

In surgery: 5 to 10 mg I.M., 1 to 2 hours before anesthesia. Repeat once during surgery if

necessary.

Post-operatively, the same dose of 5 to 10 mg I.M. may be given to control acute symptoms and

repeated, if necessary, every 3 to 4 hours (maximum, 40 mg daily).

I.V. infusion: during and after surgery, may be give i.v. in the infusion solution at a

concentration of 20 mg/L. Total daily dose rarely exceeds 30 mg.

Children:

Daily dosage, administered in divided doses, should be based on body weight rather than on age,

and should not be exceeded. Do not administer to children under 2 years of age or 9 kg of body

weight. Occasionally the patient may react to the drug with signs of restlessness and excitement;

if this occurs, treatment should be discontinued.

Oral and rectal routes:

From 9 to 14 kg; 2.5 mg, 1 or 2 times a day, maximum 7.5 mg/day.

From 14 to l8 kg; 2.5 mg, 2 or .3 times a day, maximum 10 mg/day.

From 18 to 39 kg: 2.5 mg, 3 times a day or 5 mg 2 times a day, maximum 15 mg/day.

Vomiting usually subsides after a single day of treatment. In psychiatry; on the first day of

treatment a dosage of 10 mg, in divided doses, should not be exceeded. The maximum total daily

dosage reached by gradual increments should not exceed 20 mg for children of 2 to 5 years, and

25 mg for children of 6 to 12 years.

Parenteral route:

For severe nausea and vomiting and in child psychiatry; calculate each dose on the basis of

0.14 mg/kg of body weight and give by deep I.M. injection. Control is usually obtained with one

dose. When further therapy is needed, transfer the patient to an oral form at an equal or higher

dose.

AVAILABILITY OF DOSAGE FORMS

Tablets

5mg:

Each round, biconvex, bisected, peach-coloured tablet debossed with “pms” above

bisect and “5” below. Plain on the other side. Clear film-coated tablet contains: 5 mg of

pms-PROCHLORPERAZINE Prescribing information

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prochlorperazine (as prochlorperazine maleate) and the following non-medicinal

ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C yellow # 10

Aluminum Lake, FD&C yellow # 6 lake, hydroxypropyl methylcellulose, lactose,

magnesium stearate, microcrystalline cellulose, polyethylene glycol. Available in

bottles of 100 and 500. Store between 15°C and 30°C.

10 mg:

Each round, biconvex, bisected, peach-coloured tablet debossed with “pms” above

bisect and “10” below. Plain on the other side. Clear film-coated tablet contains: 10 mg

of prochlorperazine (as prochlorperazine maleate). Also contains the following non-

medicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C yellow #

10 Aluminum Lake, FD&C yellow # 6 lake, hydroxypropyl methylcellulose, lactose,

magnesium stearate, microcrystalline cellulose, polyethylene glycol. Available in

bottles of 100 and 500. Store between 15°C and 30°C.

Suppositories

10 mg: Each rectal suppository contains prochlorperazine base 10 mg. Also contains the

following non-medicinal ingredient: wecobee. Available in boxes of 10 suppositories.

Store between 15°C and 30°C. Protect unwrapped suppository from light.

Injection

5 mg/mL:Each mL contains: 5 mg of prochlorperazine base (as prochlorperazine mesylate). Also

contains sodium sulfite.

Available in boxes of 10 ampoules of 2 mL. Store between 15°C and 30°C. Protect from

light or discoloration may occur. Solution should be inspected visually for clarify,

particulate matter, precipitation, discolouration, and leakage prior to administration

whenever solution and container permit. Do not use product if solution show haziness,

particulate matter, discoloration, or leakage.

IMPORTANT: PLEASE READ

pms-PROCHLORPERAZINE Prescribing information

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Part III: CONSUMER INFORMATION

Pr

pms-PROCHLORPERAZINE

Prochlorperazine Maleate Tablets USP

5 mg and 10 mg

Prochlorperazine Suppositories USP

10 mg

This leaflet is part III of a three-part “Product Monograph”

published when pms-PROCHLORPERAZINE was

approved for sale in Canada and is designed specifically for

Consumers. This leaflet is a summary and will not tell you

everything about pms-PROCHLORPERAZINE. Contact

your doctor or pharmacist if you have any questions about

the drug.

ABOUT THIS MEDICATION

What the medication is used for:

Prochlorperazine belongs to a group of medicines called

“phenothiazines”. It is used for the management of the

symptoms of psychotic disorders such as excessive anxiety,

tension, confusion, delusions,

and agitation.

It also can be used to control nausea and vomiting.

What it does:

pms-PROCHLORPERAZINE is an antipsychotic medication

which affects chemicals in the brain that allow communications

between nerve cells (neurotransmitters). These chemicals are

called dopamine and serotonin. Exactly how pms-

PROCHLORPERAZINE works is unknown. However, it seems

to readjust the balance of dopamine and serotonin.

When it should not be used:

You should not use pms-PROCHLORPERAZINE if you have:

An allergy to prochlorperazine, to any of its ingredients or

to phenothiazines

A medical condition known as pheochromocytoma (a tumor

of the adrenal gland)

A severe heart or blood vessel disorder

Severe kidney problems

Has brain damage

Liver disease

A blood cell disorder such as anemia, low white blood cell

counts, or low platelets

Drowsiness, slow breathing, weak pulse

Decreased alertness caused by taking certain medications or

drinking alcohol

You are going to receive anesthesia in the spine or for a

region (such as an arm, leg or the lower part of your body)

What the medicinal ingredient is:

Prochlorperazine

What the non-medicinal ingredients are:

Tablets:

colloidal silicon dioxide, croscarmellose sodium, D&C

yellow # 10 Aluminum Lake, FD&C yellow # 6 lake,

hydroxypropyl methylcellulose, lactose, magnesium stearate,

microcrystalline cellulose, polyethylene glycol.

Suppositories

: wecobee.

What dosage forms it comes in:

Tablet:

5 mg and 10 mg

Suppository:

10 mg

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Studies with various medicines of the group to which pms-

PROCHLORPERAZINE belongs, when used in the elderly

patients with dementia, have been associated with an increased

rate of death. pms-PROCHLORPERAZINE is not indicated in

elderly patients with dementia.

Before you use pms-PROCHLORPERAZINE talk to your

doctor or pharmacist if:

You have risk factors for developing blood clots such as: a

family history of blood clots, age over 65, smoking, obesity,

recent major surgery (such as hip or knee replacement),

immobility due to air travel or other reason, or take oral

contraceptives (“The Pill”).

You have heart disease, glaucoma or prostatic hypertrophy

You are addicted to alcohol. You should not take pms-

PROCHLORPERAZINE if you are under the effects of

alcohol.

You are pregnant. pms-PROCHLORPERAZINE should not

be used during pregnancy unless your doctor considers the

benefits to you markedly outweighs the potential risks to the

fetus

You are taking barbiturates, painkillers, narcotics or,

antihistamines or other drugs that make you drowsy.

You have any allergies to this drug or its ingredients

You have or ever had a blackout or seizure

You are breastfeeding.

pms-PROCHLORPERAZINE may impair the mental and/or

physical abilities required for the performance of potentially

hazardous tasks such as driving a car or operating machinery,

especially during the first few days of therapy. You should be

cautious when performing potentially hazardous tasks.

Effects on Newborns:

In some cases, babies born to a mother taking pms-

PROCHLORPERAZINE during pregnancy have experienced

symptoms that are severe and require the newborn to be

hospitalized. Sometimes, the symptoms may resolve on their

IMPORTANT: PLEASE READ

pms-PROCHLORPERAZINE Prescribing information

Page 14 of 20

own. Be prepared to seek immediate emergency medical

attention for your newborn if they have difficulty breathing, are

overly sleepy, have muscle stiffness, or floppy muscles (like a

rag doll), are shaking, or are having difficulty feeding.

People who take pms-PROCHLORPERAZINE are cautioned:

Against exposure to extreme heat

That drugs such as pms-PROCHLORPERAZINE increase

the toxicity of certain types of insecticides

("organophosphorous" insecticides) including insecticides

for agriculture (farming), treating animals (flea and tick

control) and for treating pests around the house and garden.

Be cautious if you must use these products while taking

pms-PROCHLORPERAZINE.

INTERACTIONS WITH THIS MEDICATION

pms-PROCHLORPERAZINE can add to the effects of alcohol.

You should avoid consuming alcoholic beverages while on pms-

PROCHLORPERAZINE therapy.

Tell your doctor about all your prescription and over-the-counter

medications, vitamins, minerals, herbal products (such as St.

John’s Wort), and drugs prescribed by other doctors. Do not start

a new medication without telling your doctor.

Before using pms-PROCHLORPERAZINE, tell your doctor if

you regularly use other medicines that make you sleepy (such as

cold or allergy medicine, narcotic pain medicine, sleeping pills,

muscle relaxants, and medicine for seizures, depression, or

anxiety). You should not take pms-PROCHLORPERAZINE if

you have drowsiness caused by other medications.

Drugs that may interact with pms-PROCHLORPERAZINE

include: anti-anxiety agents, antidepressants, muscle relaxants,

anti-seizure medicine, high blood pressure medicine,

cabergoline, metrizamide, guanethidine, guanadrel,

grepafloxacin, sparfloxacin, lithium, cisapride, atropine-like

drugs, narcotic pain relievers (e.g., codeine), drugs used to aid

sleep, drowsiness-causing antihistamines (e.g.,

diphenhydramine), other drugs that may make you drowsy.

Many cough-and-cold products contain ingredients that may add

a drowsiness effect. Before using cough-and-cold medications,

ask your doctor or pharmacist about the safe use of those

products. Do not start or stop any medicine without doctor or

pharmacist approval.

This list is not complete and there may be other drugs that can

interact with pms-PROCHLORPERAZINE.

PROPER USE OF THIS MEDICATION

Take this medication exactly as prescribed. During the first few

days your doctor may gradually increase your dose to allow your

body to adjust to the medication. Do not take this more often or

increase your dose without consulting your doctor. Your

condition will not improve any faster but the risk of serious side

effects will be increased. Do not stop taking this drug suddenly

without your doctor's approval.

Your doctor will decide which dose is best for you.

Usual dose:

For treatment of psychiatric illness:

Usual initial adult dose: 10 mg three or four times daily. Doses

vary according to individual condition, should be increased

gradually by your doctor until your condition is under control.

For treatment of nausea and vomiting:

Usual adult dose: 5 mg to 10 mg, three or four times daily. In

mild cases a single dose of 5 to 10 mg may be used.

Children's doses:

usually based on weight, and given in divided

doses. Not for children under 2 years of age or body weight less

than 9 kg.

Your dosage may be increased or decreased by your doctor

depending on your response to the treatment.

Overdose:

In case of drug overdose, contact a health care practitioner,

hospital emergency department or regional Poison Control

Centre immediately, even if there are no symptoms.

Overdose symptoms may include agitation, and confusion,

drowsiness, dizziness, muscle stiffness or twitching, increased

salivation, trouble swallowing, weakness, loss of balance or

coordination, and fainting.

Missed Dose:

Take the missed dose as soon as you remember. If it is almost

time for your next dose, wait until then to take the medicine and

skip the missed dose. Do not double your dose to make up the

missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like other medications, pms-PROCHLORPERAZINE may

cause some side effects. These side effects may be minor and

temporary. However, some may be serious and need medical

attention.

Side effects may include: sweating, urinary incontinence,

dizziness, drowsiness, dry mouth, nasal congestion, skin

changes, insomnia, depression, agitation, anxiety,

restlessness, excitement and bizarre dreams, decreased

appetite, swelling of the hands and/or feet, nausea and

vomiting, headache, menstrual changes, change in libido,

swelling of the breasts and milk production in both men and

women, weight changes and blurred vision.

IMPORTANT: PLEASE READ

pms-PROCHLORPERAZINE Prescribing information

Page 15 of 20

If any of these affects you severely, tell your doctor.

Your doctor should check your body weight before starting pms-

PROCHLORPERAZINE and continue to monitor it for as long

as you are being treated.

Your doctor should take blood tests before starting pms-

PROCHLORPERAZINE. They will monitor blood sugar, and

the number of infection fighting white blood cells. Your doctor

should continue to monitor your blood for as long as you are

being treated.

If you have high levels of prolactin (measured with a blood test)

and a condition called hypogonadism you may be at increased

risk of breaking a bone due to osteoporosis. This occurs in both

men and women.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and seek

immediate

emergency

medical

attention

Only if

severe

In all

cases

Unknown

Allergic Reaction:

rash,

hives, swelling of the face,

lips, tongue or throat,

difficulty swallowing or

breathing

Neuroleptic Malignant

Syndrome:

any group of

symptoms which may

include high fever,

sweating, stiff muscles, fast

heartbeat, fast breathing and

feeling confused, drowsy or

agitated

Extrapyramidal

Symptoms:

muscle stiffness, body

spasm, upward eye rolling,

exaggeration of reflexes,

drooling, difficulty moving

how and when you want.

Fast or irregular heartbeat

Seizures or fits

Long-lasting (greater than 4

hours in duration) and

painful erection of the

penis.

Tardive Dyskinesia:

uncontrollable movements

or twitches of the body,

face, eyes or tongue,

stretching the neck and

body

Low Blood Pressure:

feeling of Lightheadedness

or fainting especially when

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and seek

immediate

getting up from a lying or

sitting position)

High Blood Pressure:

headaches, vision disorders,

nausea and vomiting

Decreased sweating

Jaundice:

yellow colour to

skin and eyes, dark urine

Respiratory Infection:

fever, flu-like symptoms,

coughing, difficult or fast

breathing

New or worsening

constipation

Akathisia:

a feeling of

restlessness, inability to

remain motionless

Vision Changes:

blurred

vision, glaucoma or other

eye disorder

Increased Blood Sugar:

frequent urination, thirst

and hunger

Uncommon

Blood clots:

swelling pain

and redness in an arm or leg

that can be warm to touch.

You may develop sudden

chest pain, difficulty

breathing and heart

palpitations.

This is not a complete list of side effects. For any unexpected

effects while taking pms-PROCHLORPERAZINE, contact

your doctor or pharmacist.

HOW TO STORE IT

Store between 15°C and 30°C.

Protect unwrapped suppository from light.

Do not use after the expiry date shown on the bottle/boxes.

Keep this and all medications out of the reach and sight of

children.

IMPORTANT: PLEASE READ

pms-PROCHLORPERAZINE Prescribing information

Page 16 of 20

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

For more information, please contact your doctor, pharmacist or

other healthcare professional.

This document plus the full product monograph, prepared for

health professionals, can be obtained by contacting the sponsor,

Pharmascience Inc. at, 1-888-550-6060.

This leaflet was prepared by

Pharmascience Inc.

Montreal Quebec

H4P 2T4

Last revised: December 20, 2012

REPORTING SUSPECTED SIDE-EFFECTS

You can report any suspected adverse reactions associated with

the use of health products to the Canada Vigilance Program by

one of the following 3 ways:

Report online at www.healthcanada.gc.ca/medeffect

Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and:

Fax toll-free to 1-866-678-6789, or

Mail to: Canada Vigilance Program

Health Canada

Postal Locator 0701E

Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the

adverse

reaction

reporting

guidelines

available

MedEffect

Canada

site

www.healthcanada.gc.ca/medeffect .

NOTE:

Should

you

require

information

related

to

the

management of side effects, contact your health professional.

The

Canada

Vigilance

Program

does

not

provide

medical

advice.

IMPORTANT: PLEASE READ

pms-PROCHLORPERAZINE Prescribing information

Page 17 of 20

Part III: CONSUMER INFORMATION

Pr

pms-PROCHLORPERAZINE

Prochlorperazine Mesylate Injection BP

5 mg/mL

This leaflet is part III of a three-part “Product Monograph”

published when pms-PROCHLORPERAZINE was

approved for sale in Canada and is designed specifically for

Consumers. This leaflet is a summary and will not tell you

everything about pms-PROCHLORPERAZINE. Contact

your doctor or pharmacist if you have any questions about

the drug.

ABOUT THIS MEDICATION

What the medication is used for:

Prochlorperazine belongs to a group of medicines called

“phenothiazines”. It is used for the management of the

symptoms of psychotic disorders such as excessive anxiety,

tension, confusion, delusions,

and agitation.

It also can be used to control nausea and vomiting.

What it does:

pms-PROCHLORPERAZINE is an antipsychotic medication

which affects chemicals in the brain that allow communications

between nerve cells (neurotransmitters). These chemicals are

called dopamine and serotonin. Exactly how pms-

PROCHLORPERAZINE works is unknown. However, it seems

to readjust the balance of dopamine and serotonin.

When it should not be used:

You should not use pms-PROCHLORPERAZINE if you have:

An allergy to prochlorperazine, to any of its ingredients or

to phenothiazines

A medical condition known as pheochromocytoma (a tumor

of the adrenal gland)

A severe heart or blood vessel disorder

Severe kidney problems

Has brain damage

Liver disease

A blood cell disorder such as anemia, low white blood cell

counts, or low platelets

Drowsiness, slow breathing, weak pulse

Decreased alertness caused by taking certain medications or

drinking alcohol

You are going to receive anesthesia in the spine or for a

region (such as an arm, leg or the lower part of your body)

What the medicinal ingredient is:

Prochlorperazine (as prochlorperazine mesylate)

Also contains the non medicinal ingredient: sodium sulfite

What dosage forms it comes in:

Injection:

5 mg/mL

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

Studies with various medicines of the group to which pms-

PROCHLORPERAZINE belongs, when used in the elderly

patients with dementia, have been associated with an increased

rate of death. pms-PROCHLORPERAZINE is not indicated in

elderly patients with dementia.

Before you use pms-PROCHLORPERAZINE talk to your

doctor or pharmacist if:

You have risk factors for developing blood clots such as: a

family history of blood clots, age over 65, smoking, obesity,

recent major surgery (such as hip or knee replacement),

immobility due to air travel or other reason, or take oral

contraceptives (“The Pill”).

You have heart disease, glaucoma or prostatic hypertrophy

You are addicted to alcohol. You should not take pms-

PROCHLORPERAZINE if you are under the effects of

alcohol.

You are pregnant. pms-PROCHLORPERAZINE should not

be used during pregnancy unless your doctor considers the

benefits to you markedly outweighs the potential risks to the

fetus

You are taking barbiturates, painkillers, narcotics or,

antihistamines or other drugs that make you drowsy.

You have any allergies to this drug or its ingredients

You have or ever had a blackout or seizure

You are breastfeeding.

pms-PROCHLORPERAZINE may impair the mental and/or

physical abilities required for the performance of potentially

hazardous tasks such as driving a car or operating machinery,

especially during the first few days of therapy. You should be

cautious when performing potentially hazardous tasks.

Effects on Newborns:

In some cases, babies born to a mother taking pms-

PROCHLORPERAZINE during pregnancy have experienced

symptoms that are severe and require the newborn to be

hospitalized. Sometimes, the symptoms may resolve on their

own. Be prepared to seek immediate emergency medical

attention for your newborn if they have difficulty breathing, are

overly sleepy, have muscle stiffness, or floppy muscles (like a

rag doll), are shaking, or are having difficulty feeding.

People who take pms-PROCHLORPERAZINE are cautioned:

Against exposure to extreme heat

That drugs such as pms-PROCHLORPERAZINE increase

the toxicity of certain types of insecticides

IMPORTANT: PLEASE READ

pms-PROCHLORPERAZINE Prescribing information

Page 18 of 20

("organophosphorous" insecticides) including insecticides

for agriculture (farming), treating animals (flea and tick

control) and for treating pests around the house and garden.

Be cautious if you must use these products while taking

pms-PROCHLORPERAZINE.

INTERACTIONS WITH THIS MEDICATION

pms-PROCHLORPERAZINE can add to the effects of alcohol.

You should avoid consuming alcoholic beverages while on pms-

PROCHLORPERAZINE therapy.

Tell your doctor about all your prescription and over-the-counter

medications, vitamins, minerals, herbal products (such as St.

John’s Wort), and drugs prescribed by other doctors. Do not start

a new medication without telling your doctor.

Before using pms-PROCHLORPERAZINE, tell your doctor if

you regularly use other medicines that make you sleepy (such as

cold or allergy medicine, narcotic pain medicine, sleeping pills,

muscle relaxants, and medicine for seizures, depression, or

anxiety). You should not take pms-PROCHLORPERAZINE if

you have drowsiness caused by other medications.

Drugs that may interact with pms-PROCHLORPERAZINE

include: anti-anxiety agents, antidepressants, muscle relaxants,

anti-seizure medicine, high blood pressure medicine,

cabergoline, metrizamide, guanethidine, guanadrel,

grepafloxacin, sparfloxacin, lithium, cisapride, atropine-like

drugs, narcotic pain relievers (e.g., codeine), drugs used to aid

sleep, drowsiness-causing antihistamines (e.g.,

diphenhydramine), other drugs that may make you drowsy.

Many cough-and-cold products contain ingredients that may add

a drowsiness effect. Before using cough-and-cold medications,

ask your doctor or pharmacist about the safe use of those

products. Do not start or stop any medicine without doctor or

pharmacist approval.

This list is not complete and there may be other drugs that can

interact with pms-PROCHLORPERAZINE.

PROPER USE OF THIS MEDICATION

Take this medication exactly as prescribed. During the first few

days your doctor may gradually increase your dose to allow your

body to adjust to the medication. Do not take this more often or

increase your dose without consulting your doctor. Your

condition will not improve any faster but the risk of serious side

effects will be increased. Do not stop taking this drug suddenly

without your doctor's approval.

Usual dose:

Your doctor will decide which dose is best for you.

Your dosage may be increased or decreased by your doctor

depending on your response to the treatment.

Overdose:

In case of drug overdose, contact a health care practitioner,

hospital emergency department or regional Poison Control

Centre immediately, even if there are no symptoms.

Overdose symptoms may include agitation, and confusion,

drowsiness, dizziness, muscle stiffness or twitching, increased

salivation, trouble swallowing, weakness, loss of balance or

coordination, and fainting.

Missed Dose:

Take the missed dose as soon as you remember. If it is almost

time for your next dose, wait until then to take the medicine and

skip the missed dose. Do not double your dose to make up the

missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like other medications, pms-PROCHLORPERAZINE may

cause some side effects. These side effects may be minor and

temporary. However, some may be serious and need medical

attention.

Side effects may include: sweating, urinary incontinence,

dizziness, drowsiness, dry mouth, nasal congestion, skin

changes, insomnia, depression, agitation, anxiety,

restlessness, excitement and bizarre dreams, decreased

appetite, swelling of the hands and/or feet,

nausea and

vomiting, headache, menstrual changes, change in libido,

swelling of the breasts and milk production in both men and

women, weight changes and blurred vision.

If any of these affects you severely, tell your doctor.

Your doctor should check your body weight before starting pms-

PROCHLORPERAZINE and continue to monitor it for as long

as you are being treated.

Your doctor should take blood tests before starting pms-

PROCHLORPERAZINE. They will monitor blood sugar, and

the number of infection fighting white blood cells. Your doctor

should continue to monitor your blood for as long as you are

being treated.

If you have high levels of prolactin (measured with a blood test)

and a condition called hypogonadism you may be at increased

risk of breaking a bone due to osteoporosis. This occurs in both

men and women.

IMPORTANT: PLEASE READ

pms-PROCHLORPERAZINE Prescribing information

Page 19 of 20

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and seek

immediate

emergency

medical

attention

Only if

severe

In all

cases

Unknown

Allergic Reaction:

rash,

hives, swelling of the face,

lips, tongue or throat,

difficulty swallowing or

breathing

Neuroleptic Malignant

Syndrome:

any group of

symptoms which may

include high fever,

sweating, stiff muscles, fast

heartbeat, fast breathing and

feeling confused, drowsy or

agitated

Extrapyramidal

Symptoms:

muscle stiffness, body

spasm, upward eye rolling,

exaggeration of reflexes,

drooling, difficulty moving

how and when you want.

Fast or irregular heartbeat

Seizures or fits

Long-lasting (greater than 4

hours in duration) and

painful erection of the

penis.

Tardive Dyskinesia:

uncontrollable movements

or twitches of the body,

face, eyes or tongue,

stretching the neck and

body

Low Blood Pressure:

feeling of Lightheadedness

or fainting especially when

getting up from a lying or

sitting position)

High Blood Pressure:

headaches, vision disorders,

nausea and vomiting

Decreased sweating

Jaundice:

yellow colour to

skin and eyes, dark urine

Respiratory Infection:

fever, flu-like symptoms,

coughing, difficult or fast

breathing

New or worsening

constipation

Akathisia:

a feeling of

SERIOUS SIDE EFFECTS, HOW OFTEN THEY

HAPPEN AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

doctor or

pharmacist

Stop taking

drug and seek

immediate

emergency

medical

attention

Only if

severe

In all

cases

restlessness, inability to

remain motionless

Vision Changes:

blurred

vision, glaucoma or other

eye disorder

Increased Blood Sugar:

frequent urination, thirst

and hunger

Uncommon

Blood clots:

swelling pain

and redness in an arm or leg

that can be warm to touch.

You may develop sudden

chest pain, difficulty

breathing and heart

palpitations.

This is not a complete list of side effects. For any unexpected

effects while taking pms-PROCHLORPERAZINE, contact

your doctor or pharmacist.

HOW TO STORE IT

Store between 15°C and 30°C. Protect from light.

Discard if marked discoloration.

Do not use after the expiry date shown on the boxes.

Keep this and all medications out of the reach and sight of

children.

IMPORTANT: PLEASE READ

pms-PROCHLORPERAZINE Prescribing information

Page 20 of 20

REPORTING SUSPECTED SIDE EFFECTS

MORE INFORMATION

For more information, please contact your doctor, pharmacist or

other healthcare professional.

This document plus the full product monograph, prepared for

health professionals, can be obtained by contacting the sponsor,

Pharmascience Inc. at, 1-888-550-6060.

This leaflet was prepared by

Pharmascience Inc.

Montreal Quebec

H4P 2T4

Last revised: January 10, 2013

REPORTING SUSPECTED SIDE-EFFECTS

You can report any suspected adverse reactions associated with

the use of health products to the Canada Vigilance Program by

one of the following 3 ways:

Report online at www.healthcanada.gc.ca/medeffect

Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and:

Fax toll-free to 1-866-678-6789, or

Mail to: Canada Vigilance Program

Health Canada

Postal Locator 0701E

Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the

adverse

reaction

reporting

guidelines

available

MedEffect

Canada

site

www.healthcanada.gc.ca/medeffect .

NOTE:

Should

you

require

information

related

to

the

management of side effects, contact your health professional.

The

Canada

Vigilance

Program

does

not

provide

medical

advice.

21-3-2019

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Modification of the existing maximum residue levels for pyridaben in tomatoes and aubergines

Published on: Wed, 20 Mar 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue levels (MRLs) for the active substance pyridaben in tomatoes and aubergines. An MRL proposal of 0.15 mg/kg was derived for tomatoes and aubergines which reflects the intended use of the plant protection product containing pyridaben. Adequate analytical metho...

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Modification of the existing maximum residue level for cyprodinil in Florence fennel

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20-3-2019

Safety and efficacy of eight compounds belonging to different chemical groups when used as flavourings for cats and dogs

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Published on: Tue, 19 Mar 2019 Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 23 compounds belonging to different chemical groups. This opinion concerns eight out of the 23 compounds, which are currently authorised for use as flavours in food. The Panel concludes that the eight additives are safe for cats and dogs at the proposed use level: phenyl...

Europe - EFSA - European Food Safety Authority EFSA Journal

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Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

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Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019

Mylan Institutional LLC Initiates Voluntary Nationwide Recall of Levoleucovorin Injection Due to the Presence of Particulate Matter

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FDA - U.S. Food and Drug Administration

16-3-2019

Efficacy of sodium formate as a technological feed additive (hygiene condition enhancer) for all animal species

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Published on: Fri, 15 Mar 2019 In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maxim...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 50mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical Ingredient

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FDA - U.S. Food and Drug Administration

16-3-2019

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

Legacy Pharmaceutical Packaging, LLC Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25mg, 50mg, And 100mg Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmace

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FDA - U.S. Food and Drug Administration

15-3-2019

Modification of the existing maximum residue level for fluopyram in broccoli

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Europe - EFSA - European Food Safety Authority EFSA Journal

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Staatssecretaris Blokhuis: komende jaren krijgen alle dak- en thuisloze jongeren hulp

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Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

14-3-2019

Safety of annatto E and the exposure to the annatto colouring principles bixin and norbixin (E 160b) when used as a food additive

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14-3-2019

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Safety evaluation of the food enzyme β‐glucanase, xylanase and cellulase from Mycothermus thermophiloides (strain NZYM‐ST)

Published on: Fri, 08 Mar 2019 The food enzyme has three declared activities (endo‐1,3(4)‐β‐glucanase EC 3.2.1.6, endo‐1,4‐β‐xylanase EC 3.2.1.8 and cellulase (endo‐1,4‐β‐d‐glucanase EC 3.2.1.4)) and is produced with a non‐genetically modified Mycothermus thermophiloides strain by Novozymes A/S. It is intended to be used in baking and brewing processes. For the two intended uses, based on the maximum use levels recommended and individual data from the EFSA Comprehensive European Food Database, dietary e...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Safety evaluation of the food enzyme triacylglycerol lipase from Aspergillus niger (strain LFS)

Published on: Tue, 12 Mar 2019 The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with a genetically modified Aspergillus niger strain LFS by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The triacylglycerol lipase food enzyme is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the fo...

Europe - EFSA - European Food Safety Authority EFSA Journal

13-3-2019

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Safety evaluation of the food enzyme glucose oxidase from Aspergillus niger (strain ZGL)

Published on: Tue, 12 Mar 2019 The food enzyme glucose oxidase (β‐d‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with a genetically modified Aspergillus niger strain ZGL by DSM Food Specialties B.V.. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The glucose oxidase is intended to be used in baking processes. Based on the maximum use levels, dietary exposure to the food enzyme‐total orga...

Europe - EFSA - European Food Safety Authority EFSA Journal

11-3-2019

PMS-Amoxicillin (2019-03-11)

PMS-Amoxicillin (2019-03-11)

Health Canada

9-3-2019

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Safety evaluation of the food enzyme 4‐α‐glucanotransferase from Aeribacillus pallidus (strain AE‐SAS)

Published on: Fri, 08 Mar 2019 The food enzyme 4‐α‐glucanotransferase (1,4‐α‐d‐glucan:1,4‐α‐d‐glucan 4‐α‐d‐glycosyltransferase, EC 2.4.1.25) is produced with a non‐genetically modified Aeribacillus pallidus (previously identified as Geobacillus pallidus) strain from Amano Enzyme Inc. The food enzyme is intended to be used in baking processes and in starch processing for the production of modified dextrins. For baking processes, based on the maximum use levels recommended and individual data from the EFS...

Europe - EFSA - European Food Safety Authority EFSA Journal

9-3-2019

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Safety of ethyl lauroyl arginate (E 243) as a food additive in the light of the new information provided and the proposed extension of use

Published on: Fri, 08 Mar 2019 The present scientific opinion deals with the evaluation of the safety of the food additive ethyl lauroyl arginate (E 243) in the light of a new interpretation of the available toxicological data and with respect to the proposed changes to the currently authorised conditions of use. Ethyl lauroyl arginate (E 243) is an already authorised food additive in the EU for use in heat‐treated meat products only, with some exceptions. The safety of ethyl lauroyl arginate (E 243) as...

Europe - EFSA - European Food Safety Authority EFSA Journal

8-3-2019


Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Draft Colchicine tablet 0.5 mg and 1 mg product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

7-3-2019

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging Issues Voluntary Nationwide Recall of Valsartan Tablets Due to the Detection of NDEA (N-Nitrosodiethylamine) Impurity

American Health Packaging is voluntarily recalling one lot of Valsartan Tablets, USP, 160 mg to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the finished drug product is N-Nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Resea...

FDA - U.S. Food and Drug Administration

7-3-2019

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Re‐evaluation of Quillaia extract (E 999) as a food additive and safety of the proposed extension of use

Published on: Wed, 06 Mar 2019 The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on Quillaia extract (E 999) when used as a food additive and the evaluation of the safety of its proposed extension of use as a food additive in flavourings. The Scientific Committee for Food (SCF) in 1978 established an acceptable daily intake (ADI) of 0–5 mg spray‐dried extract/kg body weight (bw) per day for E 999. The Joint FAO/WHO Expert Committee on Food Additives ...

Europe - EFSA - European Food Safety Authority EFSA Journal

7-3-2019

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Safety and efficacy of Robenz® 66G (robenidine hydrochloride) for chickens for fattening and turkeys for fattening

Published on: Tue, 05 Mar 2019 Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz® 66G (robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz®66G is considered safe for chickens for fattening at the highest proposed level of 36 mg robenidine HCl/kg complete feed with a ...

Europe - EFSA - European Food Safety Authority EFSA Journal

5-3-2019

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Morphine Sulfate Injection BP 30 mg in 1 mL ampoule

Safety advisory – Section 19A product not for epidural or intrathecal use

Therapeutic Goods Administration - Australia

5-3-2019

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Opinion on the follow‐up of the re‐evaluation of sorbic acid (E200) and potassium sorbate (E202) as food additives

Published on: Fri, 01 Mar 2019 In this opinion, the EFSA Panel on Food Additives and Flavourings (FAF Panel) was requested by the European Commission to carry out a scientific evaluation of an extended one‐generation reproductive toxicity study (EOGRTS) to determine whether it would allow reconsideration of the temporary group acceptable daily intake (ADI) for sorbic acid (E 200) and potassium sorbate (E 202), established by the Panel on Food Additives and Nutrient Sources added to Food (ANS Panel) in 2...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-3-2019

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP, 25 mg, 50 mg and 100 mg Due to the Detection of Trace Amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity found in the Active Pharmaceutical

Camber Pharmaceuticals, Inc. is recalling 87 lots of Losartan Tablets USP 25 mg, 50 mg, and 100 mg to consumer level. This recall was prompted due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) a possible process impurity or contaminant in an active pharmaceutical ingredient, manufactured by Hetero Labs Limited, Unit – I (API manufacturer).

FDA - U.S. Food and Drug Administration

26-2-2019

UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist

UTZ Quality Foods Issues Allergy Alert on Undeclared Milk in Bachman 10 Ounce Twist

Utz Quality Foods, LLC., is voluntarily recalling a specific expiration date code of Bachman 10 oz Twist Pretzel packages due to undeclared milk. This recall was initiated after reviewing production records which identified a small number of packages were mislabeled.

FDA - U.S. Food and Drug Administration

26-2-2019

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Safety and efficacy of TYFER™ (ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breading

Published on: Mon, 25 Feb 2019 Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFER™ (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFER™/kg complete feed; this conclusion can be extended to chickens reared for laying/breedin...

Europe - EFSA - European Food Safety Authority EFSA Journal

25-2-2019

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited Issues Voluntary Nationwide Consumer Level Recall of One Lot (BLM 715A) of Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Due to detection of NDEA (N-Nitrosodiethylamine) Impurity

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

25-2-2019

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients

FDA is alerting the public that a safety clinical trial found an increased risk of blood clots in the lungs and death when a 10 mg twice daily dose of tofacitinib (Xeljanz, Xeljanz XR) was used in patients with rheumatoid arthritis (RA). FDA has not approved this 10 mg twice daily dose for RA; this dose is only approved in the dosing regimen for patients with ulcerative colitis

FDA - U.S. Food and Drug Administration

21-2-2019


Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers, European Medicines Agency, London, UK, from 26/10/2018 to 26/10/2018

Europe - EMA - European Medicines Agency

15-2-2019

Toegang tot Wet langdurige zorg ook voor mensen met een psychische stoornis

Toegang tot Wet langdurige zorg ook voor mensen met een psychische stoornis

Mensen die hun leven lang intensieve geestelijke gezondheidszorg (GGZ) nodig hebben, kunnen vanaf 2021 toegang krijgen tot de Wet langdurige zorg (Wlz). Het gaat hierbij naar verwachting om 10.000 cliënten die permanent toezicht of 24 uur per dag zorg in de nabijheid nodig hebben en nu zorg en ondersteuning krijgen vanuit de Wet maatschappelijk ondersteuning of de Zorgverzekeringswet. De ministerraad heeft op voorstel van staatssecretaris Blokhuis van Volksgezondheid, Welzijn en Sport ingestemd met toeze...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

15-2-2019

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Published on: Thu, 14 Feb 2019 Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat‐killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently describ...

Europe - EFSA - European Food Safety Authority EFSA Journal

14-2-2019

Modification of the existing maximum residue levels for mandipropamid in various crops

Modification of the existing maximum residue levels for mandipropamid in various crops

Published on: Wed, 13 Feb 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Syngenta Crop Protection B.V. and Agriculture and Horticulture Development Board (AHDB) submitted, respectively, a request to the competent national authorities in the Netherlands and United Kingdom to modify the existing maximum residue levels (MRLs) for the active substance mandipropamid in various crops. The data submitted in support of the request were found to be sufficient to derive MRL propo...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-2-2019

Health Canada will be updating its safety review of breast implants

Health Canada will be updating its safety review of breast implants

OTTAWA - Health Canada will be updating its safety review of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) following an increase in reports of Canadian cases. As of January 1, 2019, Health Canada has received reports of 22 confirmed and 22 suspected Canadian cases of BIA-ALCL. In its initial safety review in 2017, Health Canada found that the rate of BIA-ALCL cases was low, with 5 confirmed Canadian cases of BIA-ALCL reported by Canadian manufacturers in the last 10 years. Increased...

Health Canada

9-2-2019

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

Birdseed Food Co. Issues Allergy Alert on Undeclared Cashews in Craft Granola Goldenola Turmeric & Ginger

BIRDSEED FOOD CO. of Bend, OR is recalling Craft Granola Goldenola Turmeric & Ginger that was sold between the dates of 10/03/18 - 02/07/19, because it contains undeclared cashews. People who have an allergy or severe sensitivity to cashews run the risk of serious or life-threatening allergic reaction if they consume this product.

FDA - U.S. Food and Drug Administration

4-2-2019

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy's Laboratories Continues its Voluntary Nationwide Recall of Levetiracetam in 0.54% Sodium Chloride Injection 1500mg/100mL Due to Mislabeling

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced that it’s wholly owned subsidiary, Dr Reddy’s Laboratories, Inc is continuing its voluntary nationwide recall of lot ABD807 of Levetiracetram in 0.54% Sodium Chloride Injection, 1,500 mg/100 mL (15 mg/mL) single-dose infusion bags to the hospital level in U.S.A.

FDA - U.S. Food and Drug Administration

30-1-2019

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Tris Pharma, Inc Expands Its Voluntary Nationwide Retail Recall of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, Due to Higher Concentration of Ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

FDA - U.S. Food and Drug Administration

26-1-2019

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β‐unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones

Published on: Fri, 25 Jan 2019 The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6‐methylcoumarin [FL‐no: 13.012] and 5‐ethyl‐3‐hydroxy‐4‐methylfuran‐2(5H)‐one [FL‐no: 10.023] the concern for genotoxicity was ruled out. 6‐Methylc...

Europe - EFSA - European Food Safety Authority EFSA Journal

26-1-2019

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Safety assessment of the substance poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) for use in food contact materials

Published on: Fri, 25 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of poly((R)‐3‐hydroxybutyrate‐co‐(R)‐3‐hydroxyhexanoate) (PHBH), CAS No 147398‐31‐0 and food contact material (FCM) substance No 1059. This biodegradable copolymer is produced by fermentation of palm oil using a genetically modified microorganism (Cupriavidus necator). Overall migration was up to 5.4 mg/kg. Oligomers are hydroxyl‐terminated or with crotyl‐ and hexenyl end‐...

Europe - EFSA - European Food Safety Authority EFSA Journal

23-1-2019

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Safety evaluation of the food enzyme lysophospholipase from Trichoderma reesei (strain RF7206)

Published on: Tue, 22 Jan 2019 The food enzyme lysophospholipase (EC 3.1.1.5) is produced with the genetically modified Trichoderma reesei strain RF7206 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and recombinant DNA. The lysophospholipase food enzyme is intended to be used in starch processing for the production of glucose syrups. Residual amounts of total organic solids (TOS) are removed by the ...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

UPDATED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP

Torrent Pharmaceuticals Limited is expanding its voluntary recall from 10 lots of Losartan potassium tablets USP to include 6 lots of Losartan potassium and hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

FDA - U.S. Food and Drug Administration

22-1-2019

PMS-Lactulose Syrup (2019-01-22)

PMS-Lactulose Syrup (2019-01-22)

Health Canada

22-1-2019

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Modification of the existing maximum residue level for trifloxystrobin in broccoli

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer Hellas AG submitted a request to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance trifloxystrobin in broccoli. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for broccoli. Adequate analytical methods for enforcement are available to control the residues of trifloxystrobin o...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-1-2019

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Modification of the existing maximum residue levels for aclonifen in celeriacs and certain fresh herbs

Published on: Mon, 21 Jan 2019 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Landesanstalt für Landwirtschaft und Gartenbau Sachsen‐Anhalt (LSA) and Dienstleistungszentrum Ländlicher Raum Rheinpfalz (DLR), respectively, submitted a request to the competent national authority in Germany to modify the existing maximum residue levels (MRL) for the active substance aclonifen in chives, parsley, celery leaves/dill leaves, thyme/savoury and in celeriacs/turnip‐rooted celery. The ...

Europe - EFSA - European Food Safety Authority EFSA Journal

18-3-2019


Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Orphan designation: Acebutolol hydrochloride, Treatment of Smith-Magenis syndrome, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

14-3-2019


Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Orphan designation: recombinant human interleukin-3 truncated diphtheria toxin fusion protein, Treatment of acute myeloid leukaemia, 09/10/2015, Positive

Europe - EMA - European Medicines Agency

13-3-2019

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (EUSA Pharma (Netherlands) B.V.)

Qarziba (Active substance: dinutuximab beta) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)2061 of Wed, 13 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/3918/T/10

Europe -DG Health and Food Safety

7-3-2019

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Accord Healthcare S.L.U.)

Pregabalin Accord (Active substance: pregabalin) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2019)1913 of Thu, 07 Mar 2019 European Medicines Agency (EMA) procedure number: EMEA/H/C/4024/T/10

Europe -DG Health and Food Safety

1-3-2019

ACV meeting statement, Meeting 10, 3 October 2018

ACV meeting statement, Meeting 10, 3 October 2018

Advisory Committee on Vaccines meeting statement is now available

Therapeutic Goods Administration - Australia

25-2-2019

EU/3/10/732 (Southwood Research Limited)

EU/3/10/732 (Southwood Research Limited)

EU/3/10/732 (Active substance: Entinostat) - Transfer of orphan designation - Commission Decision (2019)1631 of Mon, 25 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000004131

Europe -DG Health and Food Safety

21-2-2019


Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Orphan designation: Rilonacept, Treatment of cryopirin-associated periodic syndromes, 10/07/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Orphan designation: (3S)-3-{4-[7-(aminocarbonyl)-2H-indazol-2-yl] phenyl} piperidine tosylate monohydrate salt, Treatment of mantle-cell lymphoma, 01/10/2010, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Orphan designation: Iodine (131I) chlorotoxin, Treatment of glioma, 22/10/2007, Withdrawn

Europe - EMA - European Medicines Agency

21-2-2019


Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Orphan designation: Isofagomine tartrate, Treatment of Gaucher disease, 23/10/2007, Withdrawn

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Orphan designation: Rufinamide, Treatment of Lennox-Gastaut syndrome, 20/10/2004, Expired

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Orphan designation: Rucaparib, Treatment of ovarian cancer, 10/10/2012, Withdrawn

Europe - EMA - European Medicines Agency

14-2-2019

EU/3/10/798 (Diurnal Europe B.V.)

EU/3/10/798 (Diurnal Europe B.V.)

EU/3/10/798 (Active substance: Synthetic double-stranded short interfering RNA oligonucleotide directed against proopiomelanocortin) - Transfer of orphan designation - Commission Decision (2019)1360 of Thu, 14 Feb 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003061

Europe -DG Health and Food Safety

13-2-2019


Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Orphan designation: P-ethoxy growth factor receptor-bound protein 2 antisense oligonucleotide, Treatment of acute myeloid leukaemia, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

13-2-2019


Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Orphan designation: Seladelpar, Treatment of primary biliary cholangitis, 16/10/2017, Positive

Europe - EMA - European Medicines Agency

1-2-2019

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names

Diotop 75 mg / 20 mg modified-release capsules, hard and associated names (Active substance: diclofenac/omeprazole) - Community Referrals - Art 29 - Commission Decision (2019)845 of Fri, 01 Feb 2019 European Medicines Agency (EMA) procedure number: EMEA/H/A-29(4)/1474

Europe -DG Health and Food Safety

28-1-2019


Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Orphan designation: Mogamulizumab, Treatment of cutaneous T-cell lymphoma, 14/10/2016, Positive

Europe - EMA - European Medicines Agency

25-1-2019


Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Orphan designation: Glucagon, Treatment of congenital hyperinsulinism, 08/10/2009, Positive

Europe - EMA - European Medicines Agency

23-1-2019

EU/3/10/777 (Voisin Consulting S.A.R.L.)

EU/3/10/777 (Voisin Consulting S.A.R.L.)

EU/3/10/777 (Active substance: Cyclic pyranopterin monophosphate) - Transfer of orphan designation - Commission Decision (2019)574 of Wed, 23 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000003164

Europe -DG Health and Food Safety

22-1-2019

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Vanda Pharmaceuticals Germany GmbH)

EU/3/10/841 (Active substance: Tasimelteon) - Transfer of orphan designation - Commission Decision (2019)573 of Tue, 22 Jan 2019 European Medicines Agency (EMA) procedure number: EMA/OD/0000002557

Europe -DG Health and Food Safety