Aerrane Inhalation Anaesthetic

Main information

  • Trade name:
  • Aerrane Inhalation Anaesthetic 100 % Volatile liquid for inhalation
  • Dosage:
  • 100 %
  • Pharmaceutical form:
  • Volatile liquid for inhalation
  • Units in package:
  • Bottle, glass, 1x100ml, 100 mL
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Baxter Healthcare of Puerto Rico

Documents

Localization

  • Available in:
  • Aerrane Inhalation Anaesthetic 100 % Volatile liquid for inhalation
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • AERRANE is a volatile halogenated anaesthetic for general inhalation anaesthesia.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 3904
  • Authorization date:
  • 24-12-1993
  • Last update:
  • 27-09-2017

Summary of Product characteristics: dosage,interactions,side effects

NEW ZEALAND DATA SHEET

AERRANE Data Sheet 4 July 2017

Page 1 of 13

Baxter Healthcare Ltd

1 AERRANE INHALATION ANAESTHETIC (100% inhalation, volatile liquid)

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Isoflurane 100% (USP).

Chemical structure: 1‐chloro‐2,2,2‐trifluoroethyl difluoromethyl ether.

3 PHARMACEUTICAL FORM

Inhalation, volatile liquid.

Isoflurane is a clear, colourless, stable volatile liquid containing no additives or chemical stabilisers; it

has a mildly pungent, musty, ethereal odour.

Physiochemical characteristics

Molecular weight

184.5

Boiling point at 760mmHg

48.5°C (uncorr.)

Refractive index

1.2990 – 1.3005

Specific gravity 25°/25°C

1.496

Vapour pressure (mm Hg)

20°C

25°C

30°C

35°C

Isoflurane does not decompose in the presence of soda lime, and does not attack aluminium, tin,

brass, iron or copper.

4 CLINICAL PARTICULARS

Therapeutic indications

Aerrane is a volatile halogenated anaesthetic for general inhalation anaesthesia.

Dose and method of administration

Isoflurane should be administered only by persons trained in the administration of general

anaesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment,

and circulatory resuscitation must be immediately available.

In order to be able to accurately control the precise concentration of Aerrane, vaporisers that have

been specially designed and calibrated for isoflurane should be used.

Dosage for induction and maintenance must be individualized and titrated to the desired effect

according to the patient’s age and clinical status.

With the

exception of neonates, the minimum alveolar concentration (MAC) of isoflurane decreases

with increasing patient age.

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Baxter Healthcare Ltd

Minimum alveolar concentration (MAC) of Aerrane in humans:

100%

Neonates

1.60

1 – 6 Months

1.87

7 – 11 Months

1.80

1 – 2 Years

1.60

3 – 5 Years

1.62

6 – 10 Years

1.40

0.58

10 – 15 Years

1.16

0.53

26 ± 4 Years

1.28

0.56

44 ± 7 Years

1.15

0.50

64 ± 5 Years

1.05

0.37

Induction of anaesthesia

When using isoflurane for induction, it should be considered that the risk of coughing, breath

holding, laryngospasm, and bronchospasm during induction increases with the concentration of

isoflurane.

If Aerrane is used for induction of anaesthesia, a starting concentration of 0.5% administered by

inhalation is recommended. Concentrations of 1.3 ‐ 3.0% usually

bring about surgical anaesthesia

within 7 to 10 minutes.

It is recommended that use be made of a hypnotic dose of a short acting barbiturate or another

product such as propofol, etomidate, or midazolam in order to avoid coughing or laryngospasm,

which can arise if induction is carried out with Aerrane alone or in combination with oxygen or with

an oxygen‐nitrous oxide mixture.

Maintenance of anaesthesia

Anaesthesia can be maintained during surgery using a concentration of 1.0 ‐ 2.5% administered by

inhalation, with the simultaneous administration of N

O and O

A higher concentration of 1.5 ‐ 3.5% of Aerrane is necessary if Aerrane is administered with pure

oxygen.

Recovery

The concentration of Aerrane administered by inhalation must be reduced to 0.5% at the end of the

operation, or to 0% during closure of the wound to allow prompt recovery.

If all

administration of anaesthetic agents has been stopped, the air passages of the patient should

be ventilated several times with 100% oxygen until complete awakening occurs.

If the vector gas is a mixture of 50% O

and 50% N

O, the volume of the minimum alveolar

concentration of Aerrane is approximately 0.65%.

NEW ZEALAND DATA SHEET

AERRANE Data Sheet 4 July 2017

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Baxter Healthcare Ltd

4.3

Contraindications

Aerrane is contraindicated in those patients:

with known hypersensitivity to isoflurane or to other halogenated anaesthetics

with known or suspected genetic disposition toward malignant hyperthermia

with a history of malignant hyperthermia, or

in whom liver dysfunction, jaundice or

unexplained fever, leucocytosis, and/or eosinophilia has occurred after a previous isoflurane

or other halogenated anaesthetic administration

with a history of confirmed hepatitis due to a halogenated inhalational anaesthetic

in whom general anaesthesia is contraindicated

undergoing an obstetric operation

with concomitant

nonselective MAOIs (see section 4.5).

Special warnings and precautions for use

Aerrane must only be used by a licenced anaesthetist. Since the depth of anaesthesia can change

easily and rapidly with Aerrane, only vaporisers that have been specially calibrated for this product

may be used. The extent of blood‐pressure reduction and respiratory depression can be an

indication of the extent or depth of anaesthesia; decreases may respond to reducing the inspired

concentration of isoflurane.

Spontaneous respiration must be carefully and continuously monitored and must be assisted if

necessary.

With the use of halogenated anaesthetics, disruption of the liver function,

icterus, and fatal liver

necrosis have been reported. Such reactions appear to indicate hypersensitivity reactions to

anaesthetics. Cirrhosis, viral hepatitis, or other pre‐existing liver disease can be a reason to select an

anaesthetic other than a halogenated anaesthetic.

Relatively little metabolism of Aerrane occurs in the human body. In the post operation period only

0.17% of the Aerrane taken up can be recovered as urinary metabolites. Peak serum inorganic

fluoride values usually average less than 5

mol/L and occur about four hours after anaesthesia,

returning to normal levels within 24 hours. No signs of renal injury have been reported after

Aerrane administration.

There is insufficient experience of use in repeated anaesthesia to make a definite recommendation

in this regard. As with all halogenated anaesthetics repeat anaesthesia within a short period of time

should be approached with caution.

It is recommended that ventilation be controlled in neurosurgery patients: cerebral blood flow

remains unchanged in the course of light anaesthesia; but tends to rise in the course of deeper

anaesthesia. An increase in intracranial pressure may be averted or abolished by hyperventilation of

the subject before or during anaesthesia. Aerrane should not be administered to patients who can

develop bronchoconstriction since bronchospasm can occur. In the case of neurosurgical

operations, respiration should be adequately checked. As with other halogenated anaesthetics,

Aerrane increases the flow of blood through the brain and is accompanied by a transient increase in

cerebrospinal fluid pressure. In most cases, this pressure increase can be prevented by

hyperventilation.

In light

of the fact that Aerrane acts in an irritating manner on the mucous membranes, the product

is difficult to use if inhalation anaesthesia is applied via mask. During the induction of anaesthesia in

children, saliva flow and tracheobronchial secretion can increase and can be the cause of

laryngospasm.

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Baxter Healthcare Ltd

In the case of patients who have undergone an abortion, an increased loss of blood has been found.

A transient increase in bromosulfthalein retention, blood glucose and serum creatinine with a

decrease in the serum urea level, serum cholesterol level and alkaline phosphatase level has been

observed.

Malignant hyperthermia

In susceptible individuals, isoflurane anaesthesia may trigger a skeletal muscle hypermetabolic state

in the skeletal muscle leading to high oxygen consumption and the clinical syndrome known as

malignant hyperthermia.

The clinical syndrome is signalled by hypercapnia and may include nonspecific

features such as

muscle rigidity, tachycardia, tachypnoea, cyanosis, arrhythmias, and/or unstable blood pressure. It

should also be noted that many of these nonspecific signs may appear with light anaesthesia: acute

hypoxia and hypovolaemia. An increase in overall metabolism may be reflected in an elevated

temperature, (which may rise rapidly early or late in the case, but usually is not the first sign of

augmented metabolism) and an increased usage of the CO

absorption system (hot canister). PaO

and pH may decrease, and hyperkalaemia and a base deficit may appear.

Treatment of malignant hyperthermia includes discontinuance of triggering agents (e.g. isoflurane),

administration of intravenous dantrolene sodium, and application of supportive therapy. Such

therapy includes vigorous efforts to decrease the patient’s body temperature, respiratory and

circulatory support as indicated,

and management of electrolyte‐fluid‐acid‐base derangements

(consult prescribing information for dantrolene sodium intravenous for additional information on

patient management). Renal failure may appear later, and urine flow should be monitored and

sustained if possible. Fatal outcome of malignant hyperthermia has been reported with isoflurane

(see section 4.3).

Perioperative hyperkalaemia

Use of inhaled anaesthetic agents has been associated with rare increases in serum potassium levels

that have resulted in cardiac arrhythmias and death in paediatric patients during the postoperative

period. Patients with latent as well as overt neuromuscular disease, particularly Duchenne muscular

dystrophy, appear to be most vulnerable. Concomitant use of succinylcholine has been associated

with most, but not all, of these cases. These patients also experienced significant elevations in

serum creatinine kinase levels and, in some cases, changes in urine consistent with myoglobinuria.

Despite the similarity in presentation to malignant hyperthermia, none of these patients exhibited

signs or symptoms of muscle rigidity or hypermetabolic state. Early and aggressive intervention to

treat the hyperkalaemia and resistant arrhythmias is recommended, as is subsequent evaluation for

latent neuromuscular disease.

Hepatic reactions

Cases of mild, moderate, and severe postoperative hepatic dysfunction or hepatitis with or without

jaundice, including fatal hepatic necrosis and hepatic failure, have been reported with isoflurane.

Such reactions can represent hypersensitivity hepatitis, a known risk of exposure to halogenated

anaesthetics, including isoflurane. Clinical judgment should be exercised when isoflurane is used in

patients with underlying hepatic conditions or under treatment with medicines known to cause

hepatic dysfunction (see section 4.3). As with all halogenated anaesthetics, repeated anaesthesia

within a short period of time should be approached with caution.

Hypersensitivity reactions

Allergic‐type hypersensitivity reactions, including anaphylaxis, have been reported with isoflurane.

Manifestations of such reactions have included hypotension, rash, difficulty breathing and

cardiovascular collapse.

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Baxter Healthcare Ltd

QT prolongation

Reports of QT prolongation, very rare associated with torsade de pointes, have been received.

Caution should be exercised when administering isoflurane to susceptible patients.

General monitoring

All patients anesthetized with isoflurane should be continuously monitored (eg. monitoring of the

electrocardiogram, blood pressure, oxygen saturation, and end tidal CO

Respiratory reactions

Isoflurane is a profound respiratory depressant whose effect is accentuated by narcotic

premedication or concurrent use of narcotics or other respiratory depressants. Excessive respiratory

depression may be related to depth of anaesthesia and respond to decreasing the inspired

concentration of isoflurane. The depressant effect is accentuated by concurrent use of narcotics and

other respiratory depressants. Respiration should be closely monitored and assisted or controlled

ventilation employed when necessary.

Patients with Myasthenia Gravis are extremely sensitive to medicines that produce respiratory

depression. These effects are potentiated with some general anaesthetics. Aerrane should be used

with caution in these patients.

Use in hypovolemic, hypotensive or haemodynamically compromised patients

Isoflurane

causes a dose‐dependent reduction in systemic vascular resistance and blood pressure.

Particular care must be taken when selecting the dosage for patients who are hypovolemic,

hypotensive, or otherwise haemodynamically compromised e.g. due to concomitant medications.

Use in patients with coronary artery disease

In patients with coronary artery disease, maintenance of normal haemodynamics is important in

order

to avoid myocardial ischaemia. Isoflurane, like some other coronary arteriolar dilators, can

cause dose‐dependent coronary vasodilation and has been shown to divert blood at the arteriolar

level from collateral‐dependent myocardium to normally perfused areas in selected animal models

(“coronary steal”). The extent to which coronary steal occurs in patients with steal‐prone coronary

anatomy is unclear. Clinical studies to date evaluating myocardial ischaemia, infarction and death as

outcome parameters have not established that the coronary arteriolar dilation property of Aerrane

is associated with coronary steal or myocardial ischaemia in patients with coronary artery disease.

However, due to the phenomenon of coronary steal, isoflurane should be used with caution in

patients with coronary artery disease. In particular, patients with subendocardial ischaemia may be

considered to be more susceptible.

Use in patients with, or at risk of, elevations of intracranial pressure

In patients with or at risk for elevations of intracranial pressure (ICP), isoflurane should be

administered cautiously and in conjunction with ICP‐reducing measures.

Reaction with CO

2

absorbents

Aerrane, as with other halogenated anaesthetics, has been reported to interact with dry carbon

dioxide absorbents to form carbon monoxide. In order to minimise the risk of formation of carbon

monoxide in rebreathing circuits and the possibility of elevated carboxyhaemoglobin levels, fresh

(moist) carbon dioxide absorbents should be used. In

addition, consideration should be given to

direct measurement of carboxyhaemoglobin levels in patients on closed circuit anaesthesia with

isoflurane, if oxygen desaturation develops which does not respond to usual corrective steps.

Barium hydroxide lime and soda lime become desiccated when fresh gases are passed through the

absorber canister at high flow rates over many hours or days. When a clinician suspects that

absorbent may be desiccated, it should be replaced before the administration of isoflurane.

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Baxter Healthcare Ltd

The colour indicator of most CO

absorbents does not necessarily change as a result of desiccation.

Therefore, the lack of significant colour change should not be taken as an assurance of adequate

hydration. CO

absorbents should be replaced routinely regardless of the state of the colour

indicator, following current guidelines for use of anaesthesiology equipment.

Decrease in intellectual function

Isoflurane may cause a decrease in intellectual function as well as changes in mood for several days

after general anaesthesia.

General

The following reactions have been reported following occupational

exposure to isoflurane:

dyspnoea, bronchospasm, stridor, cough, dizziness, paresthesia, hepatic reactions, flushing, rash,

contact dermatitis, erythema, periorbital oedema, eye irritation, conjunctival hyperaemia, and

headache (see section 4.8).

Interaction with other medicines and other forms of interaction

The simultaneous administration of Aerrane and the following products requires strict supervision of

the clinical and biologic condition of the patient.

Opioids

Opioids decrease the Minimum Alveolar Concentration (MAC) of isoflurane. Opioids such as

fentanyl and its analogues, when combined with isoflurane, may lead to a synergistic fall in blood

pressure and respiratory rate.

Nitrous oxide

O decreases the MAC of isoflurane (see section 4.2).

Neuromuscular blocking agents

Isoflurane decreases the required doses of neuromuscular blocking agents. If added relaxation is

required, supplemental doses of muscle relaxants may be used.

St John’s Wort

Severe hypotension and delayed emergence from anaesthesia with halogenated inhalational

anaesthetics have been reported in patients treated long‐term with St John’s Wort.

Contraindicated combination

Nonselective Mono Amine Oxidase Inhibitors

(MAOIs): Risk of haemodynamic instability and crisis

during the operation or medical procedure. Treatment should be stopped 15 days prior to surgery.

Combinations advised against

Beta‐sympathomimetics (isoprenaline) and alpha‐ and beta‐sympathomimetics (adrenaline;

noradrenaline): risk of serious ventricular arrhythmia as a result of an increase in heart rate.

Combinations requiring precautions in using

In the majority

of cases where a drug treatment is indispensable, there is no reason to suspend it

before general anaesthesia. It suffices to inform the anaesthetist about it.

Beta‐blockers

Concomitant use may exaggerate the cardiovascular effects of inhalational anaesthetics as there is a

risk of blockage of the cardiovascular compensation mechanism, resulting in

intensified hypotension

and negative inotropic effects (see section 4.4). The action of beta‐blockers can be suppressed

during the operation with the use of beta‐sympathomimetic agents. In general, any medication with

a beta‐blocker need not be stopped but any abrupt reductions of the dosage should be avoided.

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Baxter Healthcare Ltd

Isoniazid

Risk of potentiating the hepatotoxic effect, with increased formation of toxic metabolites of

isoniazid. Treatment with isoniazid should be suspended one week before the operation and should

not be resumed until 15 days afterward.

Adrenaline utilised for its local haemostatic action, by subcutaneous or gingival injections

Risk of multiple and serious ventricular arrhythmia as a consequence of increased heart rate.

Isoflurane is similar to sevoflurane in myocardium sensitisation to the arrhythmogenic effect of

exogenous adrenaline, whereas myocardial sensitivity with adrenaline is lower with Aerrane than

with other halogenated anaesthetics. Doses of adrenaline greater than 5µg/kg, when administered

submucosally, may produce multiple ventricular arrhythmias. Thus, the dosage should be limited to,

for example, 0.1mg adrenaline within 10 minutes or 0.3mg within one hour in adults.

Indirect sympathomimetics (amphetamines and their derivatives; psychostimulants, appetite

suppressants, ephedrine and its derivatives)

Risk of intraoperative hypersensitivity episode. In the case of a planned operation, it is preferable to

interrupt the treatment a few days before the operation.

Muscle relaxing agents

Concomitant use increases the risk of intensification of the action of depolarising relaxants and in

particular, nondepolarising relaxants. The disappearance of the myoneural effect takes longer with

Aerrane than with other conventional anaesthetics. If such combinations are used and additional

relaxation is required, supplemental doses of muscle relaxants

should be administered with caution.

Neuromuscular blocking agents

In general, isoflurane decreases the required doses of neuromuscular blocking agents; it is

recommended that approximately 1/3 to 1/2 of the usual dose of these substances is administered.

Anaesthetic concentrations of isoflurane at equilibrium reduce the ED95 of succinylcholine,

atracurium, pancuronium, rocuronium and vecuronium by

approximately 25 ‐ 40% or more

compared to N

O/opioid anaesthesia. Neostigmine has an effect on the non‐depolarising relaxants,

but has no effect on the relaxing action of Aerrane itself.

Morphine analgesics

These products potentiate the depressive action of Aerrane on respiration.

Calcium antagonists

Aerrane may lead to marked hypotension in patients treated with calcium antagonists, particularly

dihydropyridine derivatives.

Fertility, pregnancy and lactation

Carcinogenicity, genotoxicity, effects on fertility

Not stated.

Pregnancy (Category B3)

All general anaesthetics cross the placenta and carry the potential to produce central nervous

system and respiratory depression in the newborn infant. In routine practice this does not appear to

be a problem, however in the compromised foetus, careful consideration should be given to this

potential depression, and to the selection of anaesthetic medicines, doses and techniques.

Isoflurane exerts a relaxant effect on uterine smooth muscle. This can lead to increased blood loss

in situations where uterine muscle contraction aids haemostasis such as in obstetric surgery and in

patients undergoing abortions or uterine curettage.

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Concerning the use of this substance in pregnancy, in the case of humans, adequate data do not

exist in order to judge possible injuriousness. In regard to effects in animal tests, in published foetal

rhesus macaque studies, isoflurane exposed in utero, resulted in increased neuronal and

oligodendrocyte apoptosis in the developing brain of the offspring. Studies in juvenile animals

suggest neuroapoptosis correlates with long‐term cognitive deficits (see section 4.6: Pregnancy and

Lactation).

In light of the fact that it has not been established that Aerrane can be

used safely in pregnant

women, the use of this product must be avoided during pregnancy.

Insufficient information is available to recommend use in pregnancy or obstetrics.

Lactation

Breast feeding should not be given for up to 12 hours after the termination of anaesthesia. Because

there is insufficient information regarding the excretion of isoflurane in human milk, the potential

risks and benefits for each specific patient should be carefully considered before isoflurane is

administered to nursing women.

Effects on ability to drive and use machines

Following anaesthesia with Aerrane, patients should be advised that performance of activities

requiring mental alertness may be impaired for some time. Patients must not undertake hazardous

tasks such as driving or operating machinery for at least 24 hours following administration of a

general anaesthetic. The patient should only be sent home with an escort, and should not consume

any alcohol.

Undesirable effects

The following adverse

reactions were identified from controlled clinical studies of adult and

paediatric patients using a variety of premedications, other anaesthetics and surgical procedures of

varying lengths:

Cardiac disorders

Intraoperative arterial hypotension or hypertension: This was dependent on the dose; postoperative

hypotension (uncommon); postoperative hypertension (rare).

Increase in heart rate: This was intensified in case of the existence of hypercapnia. Serious

ventricular rhythm disorders, including arrhythmias (postoperatively) and atrial, ventricular or nodal

arrhythmias (intraoperatively), can arise commonly.

Respiratory, thoracic, and mediastinal disorders

The pungency of Aerrane can give rise to an irritating action on the mucous membranes during the

induction of anaesthesia, which can be accompanied by respiratory depression, coughing (very

common), secretions (uncommon), and a tendency toward laryngospasm (common) or

bronchospasm (rare). Breath‐holding was very commonly observed.

Hepatobiliary disorders

Disturbance of the liver function and liver damage (including blood bilirubin increased, alanine

aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase

increased, bromsulphthalein clearance decreased and blood lactate dehydrogenase increased),

jaundice were observed.

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Metabolism and nutrition disorders

Blood glucose increased.

General disorders and administration site conditions

Chills/shivering (very common); asthenia and fatigue; malignant hyperthermia (see section 4.4).

Psychiatric disorders

Delerium (common); mood changes and nightmares (uncommon); confusional state and

nervousness.

Nervous system disorders

Agitation during induction (very common); movements during maintenance (common); convulsive

pattern on ECG (uncommon); seizures (rare); ataxia, intellectual function decreased, dizziness and

drowsiness.

Gastrointestinal disorders

Nausea on recovery (very common); vomiting on induction (uncommon) or recovery (common); and

retching during induction (uncommon), maintenance (uncommon) or postoperatively.

Blood and lymphatic system disorders

The number of white blood cells increased very commonly (postoperatively), even in the absence of

surgical stress.

Skin and subcutaneous tissue disorders

Diaphoresis (uncommon); rash.

Musculoskeletal connective tissue and bone disorders

Myalgia.

The following adverse reactions have been reported in post‐marketing experience:

Blood and lymphatic system disorders

Carboxyhaemoglobin increased.

Immune system disorders

Anaphylactic reaction.

Metabolism and nutrition disorders

Hyperkalaemia.

Psychiatric disorders

Withdrawal syndrome (following multi‐day exposure; symptoms included seizure, hallucination,

ataxia, agitation, confusion).

Nervous system disorders

Brain oedema, intracranial pressure increased, migraine, myoclonus, nystagmus, pupils unequal,

headache.

Cardiac disorders

Cardiac arrest, ventricular fibrillation, torsade de pointes, myocardial infarction, myocardial

ischaemia, atrioventricular block complete, atrioventricular block second degree, atrial fibrillation,

ECG QT prolonged, atrioventricular block first degree, ventricular tachycardia, ventricular

extrasystoles, tachycardia, bradycardia, cardiac output decreased.

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Vascular disorders

Flushing.

Respiratory, thoracic, and mediastinal disorders

Apnoea, hypoxia, bronchospasm, airway obstruction, respiratory depression, hypercapnia, stridor,

hiccups.

Gastrointestinal disorders

Pancreatitis.

Hepatobiliary disorders

Hepatic failure, hepatic necrosis, hepatitis fulminant, cholestatic hepatitis, hepatitis, hepatic

steatosis, jaundice, gammaglutamyltransferase increased.

Skin and subcutaneous tissue disorders

Rash.

Musculoskeletal, connective tissue and bone disorders

Rhabdomyolysis.

Renal and urinary disorders

Acute renal failure**, oliguria**.

General disorders and administration site conditions

Malignant hyperthermia, hypothermia.

Injury, poisoning, and procedural complications*

Unwanted awareness during anaesthesia, dyspnoea, bronchospasm, stridor, cough, dizziness,

paresthesia, hepatic reactions, flushing, rash, contact dermatitis, erythema, periorbital oedema, eye

irritation, conjunctival hyperaemia, headache.

All reactions categorized in this section, with the exception of unwanted awareness during anaesthesia, were

from occupational exposure in non‐patients.

Cases of acute renal failure and oliguria have been reported after isoflurane anaesthesia.

These events may be secondary to hypotension or other effects of isoflurane.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows

continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are

asked to report any suspected adverse reactions: https://nzphvc.otago.ac.nz/reporting/

Overdose

In case of overdosage, stop administration of the anaesthetic agent, check whether air passages are

open, and depending on the circumstances, continue with assisted or controlled respiration using

pure oxygen. Support and maintain adequate haemodynamics.

For advice on the management of overdose please contact the National Poisons Centre on phone

number: 0800 764

766 [0800 POISON] in New Zealand (or 131126 in Australia).

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5 PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties

Pharmacotherapeutic group

Nervous system, Anaesthetics, Anaesthetics general,

Halogenated hydrocarbons

ATC code

N01AB06.

Aerrane is an inhalation‐type anaesthetic, belonging to the group of halogenated anaesthetics.

Induction and recovery from anaesthesia rapidly take place with Aerrane.

Aerrane has the slightly irritating odour of ether, which can limit the speed of induction.

Pharyngeal and laryngeal reflexes are rapidly diminished as a result of which tracheal intubation is

rendered easy.

Chemical structure

CAS registry number

26675‐46‐7

Molecular formula

Pharmacokinetic properties

Aerrane is metabolised minimally in comparison to other halogenated anaesthetics such as

enflurane or halothane. On average 95% of the Aerrane is recovered in the expired air; 0.2% of the

Aerrane that is taken up with the body is metabolised. The principal metabolite is trifluoroacetic

acid. The average serum level of inorganic fluoride in patients administered Aerrane anaesthesia is

between 3 and 4µmol/L.

In patients anaesthetised with Aerrane, the mean peak serum concentration of inorganic fluorides is

usually less than 5µmol/L and occurs about four hours after anaesthesia, returning to normal levels

within 24 hours. This should not alter renal function in a normal subject.

Preclinical safety data

Not stated.

6 PHARMACEUTICAL PARTICULARS

List of excipients

None.

Incompatibilities

Isoflurane has been reported to interact with dry carbon dioxide (CO

) absorbents to form carbon

monoxide that may result in elevated levels of carboxyhemoglobin in some patients.

In order to minimise the risk of formation of carbon monoxide in rebreathing circuits and the

possibility of elevated carboxyhaemoglobin levels, fresh (moist) carbon dioxide absorbents should be

used (see section 4.4).

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Shelf life

5 years.

Special precautions for storage

Store at or below 30°C.

Store bottle in an upright position. To avoid leakage, apply bottle cap firmly but not too tightly.

Aerrane must be kept in

the original container until immediately prior to use.

Nature and contents of container

AERRANE is available in amber coloured glass bottles containing 100mL or 250mL isoflurane.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Replace cap after use.

Any unused medicine or waste

material should be disposed of in accordance with local

requirements.

Aerrane should only be administered by persons trained in the administration of general

anaesthesia, using a vaporizer designed and calibrated for use with Aerrane (see section 4.4).

7 MEDICINE SCHEDULE

Prescription Medicine.

8 SPONSOR

Aerrane is distributed in New Zealand by:

Baxter Healthcare Ltd

33 Vestey Drive

Mt Wellington

Auckland 1060.

Baxter Healthcare Ltd

PO Box 14 062

Panmure

Auckland 1741

Phone (09) 574 2400.

Aerrane is distributed in Australia by:

Baxter Healthcare Pty Ltd

1 Baxter Drive

Old Toongabbie, NSW 2146.

Aerrane is manufactured by:

Baxter Healthcare of Puerto Rico

Route 3, km 142.5

Guayama 00784

Puerto Rico.

9 DATE OF FIRST APPROVAL

13 July 1995

10 DATE OF REVISION OF THE TEXT

4 July 2017

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SUMMARY TABLE OF CHANGES

Section changed

Summary of new information

Entire document reformatted to new standard format based on the European

Summary of Product Characteristics (SPC).

Replacement of ‘drugs’ with ‘medicines’.

Headings standardized.

Dose and method of administration. Clarification of use with vaporizers specially

designed and calibrated for use with isoflurane.

Table. O

O column, percentage removed.

Contraindications. Inclusion of “… and/or eosinophilia…”

Special warnings and precautions for use. Peak serum value corrected.

Special warnings and precautions for use/Malignant hyperthermia. Section

updated.

Fertility, pregnancy and lactation. Additional paragraph relating to foetal rhesus

macaque studies.

Pharmacodynamic properties. Pharmacotherapeutic group and ATC code

included. CAS registry number corrected.

Revision date updated.

Footer

Revision of dates and versions of source documents.

Correction of trademark statement.

Based on Australian PI approved 19 June 2017; and CCSI 416 2017 0406.

Please refer to the Medsafe website (www.medsafe.govt.nz) for most recent data sheet.

Baxter is a trademark of Baxter International Inc. Aerrane is a registered trademark of Baxter

International Inc.

17-1-2019

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Safety of cassia gum as a feed additive for cats and dogs based on a dossier submitted by Glycomer GmbH

Published on: Wed, 16 Jan 2019 The additive cassia gum consists mainly of high-molecular weight polysaccharides composed primarily of a linear chain of 1,4-b-D-mannopyranose units with 1,6-linked a-D-galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum in cats and dogs. The Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semi-refined cassia...

Europe - EFSA - European Food Safety Authority EFSA Journal

17-1-2019

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Safety and efficacy of benzoic acid as a technological feed additive for weaned piglets and pigs for fattening

Published on: Wed, 16 Jan 2019 The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedings...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Safety and efficacy of 3‐phytase FSF10000 as a feed additive for chickens for fattening or reared for laying, laying hens and minor poultry species

Published on: Tue, 15 Jan 2019 The additive 3‐phytase FSF10000 is a solid product that contains a 3‐phytase produced by a genetically modified strain of Komagataella phaffii. A liquid formulation of the additive has been previously assessed by the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) and is currently authorised as a feed additive for poultry species. The applicant requested for the use of this new formulation of the additive in chickens for fattening or reared ...

Europe - EFSA - European Food Safety Authority EFSA Journal

16-1-2019

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Safety and efficacy of Deccox® (decoquinate) for chickens for fattening

Published on: Mon, 14 Jan 2019 Deccox®, containing decoquinate as the active substance, is a feed additive intended to be used for the prevention of coccidiosis in chickens for fattening at a dose range of 20–40 mg/kg complete feed. Decoquinate from Deccox® is safe for chickens for fattening at the highest applied concentration in complete feed of 40 mg/kg. No practically relevant interactions with other additives or veterinary drugs exist except with bentonite. Decoquinate does not have antibacterial a...

Europe - EFSA - European Food Safety Authority EFSA Journal

15-1-2019

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Safety assessment of the substance, montmorillonite clay modified with hexadecyltrimethylammonium bromide, for use in food contact materials

Published on: Mon, 14 Jan 2019 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of montmorillonite clay modified with hexadecyltrimethylammonium bromide (HDTA) when used as an additive at up to ■■■■■ in polylactic acid (PLA) bottles intended for contact with water for long‐term storage at ambient temperature or below. The modified clay, which 90% w/w of the particles have a dimension of 33.1 μm or less and the average size is 9 μm, has a layered structure w...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Assessment of the application for renewal of authorisation of selenomethionine produced by Saccharomyces cerevisiae NCYC R397 for all animal species

Published on: Fri, 11 Jan 2019 The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of organic form of selenium produced by Saccharomyces cerevisiae NCYC R397 (Alkosel®) for all animal species. The FEEDAP Panel has delivered two opinions (on 2007 and 2016) on the safety and efficacy of the additive. The additive is characterised as organic selenium mainly selenomethionine (63%); it was ini...

Europe - EFSA - European Food Safety Authority EFSA Journal

12-1-2019

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Assessment of the application for renewal of authorisation of Lantharenol® (lanthanum carbonate octahydrate) for cats

Published on: Fri, 11 Jan 2019 Lantharenol® is a feed additive consisting of lanthanum carbonate octahydrate. It is currently authorised as a zootechnical additive (decrease in phosphorous excretion via urine) for cats; this opinion concerns the renewal of the authorisation. In 2007, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Lantharenol® as a feed additive for cats. The applicant has provided data demonstrating th...

Europe - EFSA - European Food Safety Authority EFSA Journal

22-11-2018

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

Foreign Product Alert: Black Lion Pill, Help 100% & Pure Natural & Body Slim capsules, Herba Saraf, Horny Little Devil, Ja Dera Max capsules, Lida (Plus) capsules, Nutra Organics Green Tea Extract capsules, Papapa, Red Zone Xtreme 3000, Rhino 69 Extreme 5

These foreign health products have been found by regulators in other countries to contain undeclared drug ingredients and/or unacceptable contaminant(s).

Health Canada

22-11-2018

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Safety and efficacy of Monteban® G100 (narasin) for ducks for fattening

Published on: Wed, 21 Nov 2018 Following a request from the 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 Monteban® G100 for ducks. Monteban® G100, containing narasin, is intended for the prevention of coccidiosis in ducks for fattening at a dose range of 60–70 mg/kg of complete feed. Narasin from Monteban® G100 is safe for ducks for fattening at a level of 70 mg/kg complete feed...

Europe - EFSA - European Food Safety Authority Publications

21-11-2018

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

VaperBC recalls 100 mg Nicotine Base Liquid Nicotine

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

21-11-2018

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Safety and efficacy of Monteban® G100 (narasin) for chickens for fattening

Published on: Tue, 20 Nov 2018 The feed additive Monteban® G100, containing the active substance narasin, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening at a dose of 60–70 mg/kg complete feed. Narasin is produced by fermentation. Limited data on the taxonomic identification of the production strain did not allow the proper identification of strain NRRL 8092 as Streptomyces aureofaciens. The FEEDAP Panel cannot conclude on the absence of genetic determinants for ...

Europe - EFSA - European Food Safety Authority Publications

20-11-2018

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Vijf winnaars van energieneutrale sportprojecten kunnen aan de slag

Op 20 november zijn de vijf winnaars van de Innovation Challenge Energieneutrale Sportaccommodaties, vanuit het programma Sportinnovator, bekendgemaakt. De innovatieve ideeën voor energiebesparing bij sportaccommodaties hebben groen licht gekregen. Ze ontvangen hiervoor steun van het ministerie van Volksgezondheid, Welzijn en Sport om innovatie in de sport te bevorderen. Onderstaande initiatieven krijgen 100.000 euro om het idee in de praktijk door te voeren.

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

13-11-2018

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

Alebrije Dist Wholesale Recalls Quesillo Queseria “La Milagrosa” and “Alebrije Cheese” Because of Possible Health Risk

ALEBRIJE DIST WHOLESALE is collaborating with health officials due to a positive finding of Salmonella in a sample of Quesillo “Queseria La Milagrosa”. ALEBRIJE DIST WHOLESALE is voluntarily recalling the amount of 100 kilos of Quesillo “Queseria La Milagrosa”. While “Alebrije Cheese” has not been found positive for Salmonella, ALEBRIJE DIST WHOLESALE has decided to voluntarily recall the specific 498 “Alebrije Cheese” pieces that were imported during the same period out of an abundance of caution.

FDA - U.S. Food and Drug Administration

9-11-2018

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Losartan Potassium and Hydrochlorothiazide Due to the Detection of Trace Amounts of NDEA (N-Nitrosodiethylamine) Impurity Found in the Active Pharmaceutical Ingredient (API)

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in ...

FDA - U.S. Food and Drug Administration

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

Published on: Wed, 07 Nov 2018 00:00:00 +0100 The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the additive Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials. It is a family of mixtures combining the four lanthanides lanthanum (La), europium (Eu), gadolinium (Gd) and/or terbium (Tb) in different proportions as their 1,4‐benzene dicarboxylate complexes, used as a taggant in plastics for authentication and ...

Europe - EFSA - European Food Safety Authority Publications

31-10-2018

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Efficacy of Bergazym® P100 (endo‐1,4‐β‐xylanase) as a feed additive for chickens for fattening and weaned piglets

Published on: Tue, 30 Oct 2018 00:00:00 +0100 The product Bergazym® P100 contains a xylanase which is produced by a non‐genetically modified strain of Trichoderma reesei. The additive is available in a coated granular form and it is intended to be used as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, and weaned piglets at the dose of 1,500 EPU/kg feed. The production strain and the additive were fully characterised in a previous assessment of the Panel o...

Europe - EFSA - European Food Safety Authority Publications

26-10-2018

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Safety and efficacy of l‐threonine produced by fermentation using Escherichia coli CGMCC 7.232 for all animal species

Published on: Thu, 25 Oct 2018 00:00:00 +0200 The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.232). It is intended to be used in feed and water for drinking for all animal species and categories. The production strain and its recombinant DNA were not detected in the additive. The product l‐threonine, manufactured by fermentation with E. coli CGMCC 7.232, does not raise any safety concern with regard to the gen...

Europe - EFSA - European Food Safety Authority Publications

24-10-2018

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Safety and efficacy of Hostazym® X (endo‐1,4‐beta‐xylanase) as a feed additive for sows in order to have benefit in piglets

Published on: Tue, 23 Oct 2018 00:00:00 +0200 Following a request from the 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 HOSTAZYM® X as a feed additive for sows in order to have benefit in piglets. The additive HOSTAZYM® X contains endo‐1,4‐beta‐xylanase and is available in liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, tu...

Europe - EFSA - European Food Safety Authority Publications

20-10-2018

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide from chemical group 30 (miscellaneous substances)

Published on: Fri, 19 Oct 2018 00:00:00 +0200 EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2‐(4‐methylphenoxy)‐N‐(1H‐pyrazol‐3‐yl)‐N‐(thiophen‐2‐ylmethyl)acetamide [FL‐no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intende...

Europe - EFSA - European Food Safety Authority Publications

28-9-2018

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo Pharmaceuticals Issues Voluntary Nationwide Recall for Two Lots of Robaxin® 750mg Tablets 100 Count Bottle Packs Due to Incorrect Daily Dosing Information on Label

Endo International plc (NASDAQ: ENDP) today announced that one of its operating companies, Endo Pharmaceuticals Inc., is voluntarily recalling two lots of Robaxin® (methocarbamol tablets, USP) 750mg Tablets 100 Count Bottle pack to the consumer level. The products have been found to have incorrect daily dosing information on the label due to a labeling error which misstates the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily." (see pic...

FDA - U.S. Food and Drug Administration

20-9-2018

Vacant position at IMA's Quality Assessment Team

Vacant position at IMA's Quality Assessment Team

The Agency advertises vacancy for expert in Quality Assessment Team in Assessment Division. The Agency is looking for strong candidate who are willing to work on challenging and interesting tasks. The vacancy is a full position (100%).

IMA - Icelandic Medicines Agency

7-9-2018

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

SCA Pharmaceuticals LLC. Issues Voluntary Nationwide Recall of Furosemide 100 mg in 0.9% Sodium Chloride due to Presence of Precipitate

, SCA Pharmaceuticals LLC (“SCA Pharma”) is voluntarily recalling 7 lots of the injectable product Furosemide 100 mg in 0.9% Sodium Chloride 100 mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate.

FDA - U.S. Food and Drug Administration

1-9-2018

Spodoptera frugiperda partial risk assessment

Spodoptera frugiperda partial risk assessment

Published on: Fri, 31 Aug 2018 00:00:00 +0200 EFSA was asked for a partial risk assessment of Spodoptera frugiperda for the territory of the EU focussing on the main pathways for entry, factors affecting establishment, risk reduction options and pest management. As a polyphagous pest, five commodity pathways were examined in detail. Aggregating across these and other pathways, we estimate that tens of thousands to over a million individual larvae could enter the EU annually on host commodities. Instigat...

Europe - EFSA - European Food Safety Authority Publications

29-8-2018

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Safety assessment of the process ‘General Plastic’, based on Starlinger Decon technology, used to recycle post‐consumer PET into food contact materials

Published on: Fri, 10 Aug 2018 00:00:00 +0200 This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety evaluation of the recycling process General Plastic (EU register No RECYC153), which is based on the Starlinger Decon technology. The decontamination efficiency of the process was demonstrated by a challenge test. The input of this process is hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes orig...

Europe - EFSA - European Food Safety Authority Publications

28-8-2018

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

Accord Healthcare Inc. Issues Voluntary Nationwide Recall of Hydrochlorothiazide Tablets USP 12.5 Mg Due to Labeling Mix-up

A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market.

FDA - U.S. Food and Drug Administration

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

3-8-2018

Scientific guideline:  Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance, adopted

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

22-6-2018

Metronidazole intravenous infusion 500 mg/100 mL bag

Metronidazole intravenous infusion 500 mg/100 mL bag

Shortage and althernative supply of Metronidazole intravenous infusion 500 mg/100 mL bag

Therapeutic Goods Administration - Australia

15-6-2018

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections

At least 43 patient reported adverse event after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. FDA identified multiple substances in Guardian’s product, including poloxamer 407 and poloxamer 407 degradants. FDA prepared i...

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

3-5-2018

CVM eSubmitter Webinar 1 Agenda

CVM eSubmitter Webinar 1 Agenda

CVM will host the first of a three-part webinar series to provide information on the use of CVM’s electronic submission tool, eSubmitter, in the new animal drug application approval process. These webinars will support the use of eSubmitter as we move to 100% electronic submission.

FDA - U.S. Food and Drug Administration

28-2-2018

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim capsules

Help 100% & Pure Natural & Body Slim Capsules pose a serious risk to your health and should not be taken

Therapeutic Goods Administration - Australia

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

3-7-2017

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Icelandic Medicines Agency wishes to recruit experts to its Licencing Unit

The Agency advertises two vacancies for experts in its Quality Assessment Team. The Agency is looking for strong candidates who are willing to work on challenging and interesting tasks. Each vacancy is a full position (100%). Application deadline is up to and including 16 July 2017.

IMA - Icelandic Medicines Agency

12-12-2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

Therapeutic Goods (Microbiological Standards for Medicines) (TGO 100) Order 2018

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Therapeutic Goods Administration - Australia

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Opinion/decision on a Paediatric investigation plan (PIP): Bempedoic acid (ETC-1002), decision type: , therapeutic area: , PIP number: P/0185/2018

Europe - EMA - European Medicines Agency

21-11-2018

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Quality Regulatory Clinical Ireland Limited)

EU/3/18/2100 (Active substance: Propagermanium) - Orphan designation - Commission Decision (2018)7810 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/103/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

19-9-2018

Kadcyla (Roche Registration GmbH)

Kadcyla (Roche Registration GmbH)

Kadcyla (Active substance: Trastuzumab emtansine) - Centralised - Renewal - Commission Decision (2018)6100 of Wed, 19 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2389/R/39

Europe -DG Health and Food Safety

23-8-2018

 Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Minutes of the 100th meeting of the Management Board: 6-7 June 2018

Europe - EMA - European Medicines Agency

27-6-2018

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Takeda GmbH)

PANTOLOC Control (Active substance: pantoprazole) - PSUSA - Modification - Commission Decision (2018)4105 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1100/PSUSA/2285/201708

Europe -DG Health and Food Safety

6-6-2018

Agenda:  Agenda for the 100th meeting of the Management Board

Agenda: Agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

5-6-2018

Agenda:  Draft agenda for the 100th meeting of the Management Board

Agenda: Draft agenda for the 100th meeting of the Management Board

Europe - EMA - European Medicines Agency

24-5-2018

Tybost (Gilead Sciences International Limited)

Tybost (Gilead Sciences International Limited)

Tybost (Active substance: cobicistat) - PSUSA - Modification - Commission Decision (2018)3255 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10081/201708

Europe -DG Health and Food Safety

24-5-2018

Stribild (Gilead Sciences International Limited)

Stribild (Gilead Sciences International Limited)

Stribild (Active substance: elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil (as fumarate)) - PSUSA - Modification - Commission Decision (2018)3277 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2574/PSUSA/10082/201708

Europe -DG Health and Food Safety

18-5-2018

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Roche Registration GmbH)

EU/3/14/1328 (Active substance: 4-{[(2R,3S,4R,5S)-4-(4-chloro-2-fluoro-phenyl)-3-(3-chloro-2-fluoro-phenyl)-4-cyano-5-(2,2-dimethyl-propyl)-pyrrolidine-2-carbonyl]-amino}-3-methoxy-benzoic acid) - Transfer of orphan designation - Commission Decision (2018)3149 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/14/T/01

Europe -DG Health and Food Safety

18-5-2018

EU/3/04/204 (Gilead Sciences Ireland UC)

EU/3/04/204 (Gilead Sciences Ireland UC)

EU/3/04/204 (Active substance: Aztreonam lysinate (inhalation use)) - Transfer of orphan designation - Commission Decision (2018)3131 of Fri, 18 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/006/04/T/03

Europe -DG Health and Food Safety

16-5-2018

EU/3/06/391 (Novartis Europharm Limited)

EU/3/06/391 (Novartis Europharm Limited)

EU/3/06/391 (Active substance: Amphotericin B (for inhalation use)) - Transfer of orphan designation - Commission Decision (2018)3034 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/027/06/T/03

Europe -DG Health and Food Safety

16-5-2018

EU/3/03/140 (Novartis Europharm Limited)

EU/3/03/140 (Novartis Europharm Limited)

EU/3/03/140 (Active substance: Tobramycin (inhalation powder)) - Transfer of orphan designation - Commission Decision (2018)3031 of Wed, 16 May 2018 European Medicines Agency (EMA) procedure number: EMEA/OD/072/02/T/02

Europe -DG Health and Food Safety

10-5-2018

Inhalation and nasal spray registered medicines

Inhalation and nasal spray registered medicines

New information about application pathways and data requirements for inhalation and nasal spray registered medicines

Therapeutic Goods Administration - Australia