QUELICIN CHLORIDE INJ 100MG/ML

Main information

  • Trade name:
  • QUELICIN CHLORIDE INJ 100MG/ML SOLUTION
  • Dosage:
  • 100MG
  • Pharmaceutical form:
  • SOLUTION
  • Composition:
  • SUCCINYLCHOLINE CHLORIDE 100MG
  • Administration route:
  • INTRAVENOUS
  • Units in package:
  • 5ML IN 10ML VIAL
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • QUELICIN CHLORIDE INJ 100MG/ML SOLUTION
    Canada
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • NEUROMUSCULAR BLOCKING AGENTS
  • Product summary:
  • Active ingredient group (AIG) number: 0105141002; AHFS: 12:20.20

Other information

Status

  • Source:
  • Health Canada
  • Authorization status:
  • MARKETED
  • Authorization number:
  • 00296163
  • Authorization date:
  • 31-12-1983
  • Last update:
  • 14-03-2019

Summary of Product characteristics: dosage,interactions,side effects

PRESCRIBING INFORMATION

QUELICIN

Succinylcholine Chloride Injection, USP

Neuromuscular Blocking Agent

Pfizer Canada Inc.

17300 Trans-Canada Highway

Kirkland, Québec

H9J 2M5

Control Number: 205275

DATE OF REVISION:

June 23, 2017

Prescribing Information - Quelicin Page 2 of 14

PRESCRIBING INFORMATION

NAME OF DRUG

QUELICIN

Succinylcholine Chloride Injection, USP

THERAPEUTIC CLASSIFICATION

Neuromuscular Blocking Agent

ACTION AND CLINICAL PHARMACOLOGY

Succinylcholine is an ultra short-acting, depolarizing-type, skeletal muscle relaxant. As does

acetylcholine, it combines with the cholinergic receptors of the motor end plate to produce depolarization.

This depolarization may be observed as fasciculations. Subsequent neuromuscular transmission is

inhibited so long as adequate concentration of succinylcholine remains at the receptor site. Onset of

flaccid paralysis is rapid (less than one minute after i.v. administration), and with single administration

lasts approximately 4 to 6 minutes.

Succinylcholine is rapidly hydrolysed by plasma cholinesterase to succinylmonocholine (which possesses

clinically insignificant depolarizing muscle relaxant properties) and then more slowly to succinic acid and

choline (see PRECAUTIONS). About 10% of the drug is excreted unchanged in the urine. The paralysis

following administration of succinylcholine chloride is progressive, initially involving consecutively the

levator muscles of the face, muscles of the glottis and finally the intercostals and the diaphragm and all

other skeletal muscles.

Succinylcholine has no direct action on the uterus or other smooth muscle structures. Because it is highly

ionized and has low fat solubility, it does not readily cross the placenta.

Tachyphylaxis occurs with repeated administration (see PRECAUTIONS).

Depending on the dose and duration of succinylcholine administration, the characteristic depolarizing

neuromuscular block (Phase I block) may change to a block with characteristics superficially resembling

a nondepolarizing block (Phase II block). This may be associated with prolonged respiratory muscle

paralysis or weakness in patients who manifest the transition to Phase II block. When this diagnosis is

confirmed by peripheral nerve stimulation, it may sometimes be reversed with anticholinesterase drugs

such as neostigmine (see PRECAUTIONS). Anticholinesterase drugs may not always be effective. If

given before succinylcholine is metabolized by cholinesterase, anticholinesterase drugs may prolong

rather than shorten paralysis.

Succinylcholine has no direct effect on the myocardium. Succinylcholine stimulates both autonomic

ganglia and muscarinic receptors which may cause changes in cardiac rhythm, predominantly bradycardia

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and occasional asystoles. Changes in rhythm including cardiac arrest, may also result from vagal

stimulation, which may occur during surgical procedures, or from hyperkalemia, particularly in children

(see PRECAUTIONS-Pediatric Use). These effects are enhanced by halogenated anesthetics.

Succinylcholine causes an increase in intraocular pressure immediately after its injection and during the

fasciculation phase, and causes slight increases which may persist after onset of complete paralysis

(see WARNINGS).

Succinylcholine may cause slight increases in intracranial pressure immediately after its injection and

during the fasciculation phase (see PRECAUTIONS).

As with other neuromuscular blocking agents, the potential for releasing histamine is present following

succinylcholine administration. Signs and symptoms of histamine-mediated release such as flushing,

hypotension and bronchoconstriction are, however, uncommon in normal clinical usage.

Succinylcholine has no effect on consciousness, pain threshold or cerebration. It should be used only with

adequate anesthesia (see WARNINGS).

The onset and duration of action of succinylcholine may be altered by dehydration and electrolyte

imbalance, and by the use of other medications such as depolarizing or non-depolarizing muscle

relaxants.

INDICATIONS AND CLINICAL USE

Succinylcholine chloride is indicated as an adjunct to general anesthesia, to facilitate tracheal intubation,

and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

CONTRAINDICATIONS

Succinylcholine is contraindicated in persons with personal or familial history of malignant hyperthermia,

skeletal muscle myopathies, and known hypersensitivity to the drug.

It is also contraindicated in patients after the acute phase of injury following major burns, multiple trauma,

extensive denervation of skeletal muscle, or upper motor neuron injury, unless clinical circumstances

require immediate securing of the airway, because succinylcholine administered to such individuals may

result in severe hyperkalemia which may result in cardiac arrest (see WARNINGS). The risk of

hyperkalemia in these patients increases over time and usually peaks at 7 to 10 days after the injury. The

risk is dependent on the extent and location of the injury. The precise time of onset and the duration of

the risk period are not known.

Acute rhabdomyolysis with hyperkalemia can occur when used in individuals with a skeletal muscle

myopathy such as Duchenne's muscular dystrophy (see PRECAUTIONS-Pediatric Use).

Prescribing Information - Quelicin Page 4 of 14

WARNINGS

In infants and children, especially in boys under eight years of age, the rare possibility of inducing

life-threatening hyperkalemia in undiagnosed myopathies by the use of succinylcholine must be

balanced against the risk of alternative means of securing the airway.

Succinylcholine should be used only by those skilled in the management of artificial respiration and

only when facilities are instantly available for tracheal intubation and for providing adequate

ventilation of the patient, including the administration of oxygen under positive pressure and the

elimination of carbon dioxide. The clinician must be prepared to assist or control respiration.

To avoid distress to the patient, succinylcholine should not be administered before unconsciousness

has been induced. In emergency situations, however, it may be necessary to administer

succinylcholine before unconsciousness is induced.

Succinylcholine is metabolized by plasma cholinesterase and should be used with caution, if at all,

in patients known to be or suspected of being homozygous for the atypical plasma cholinesterase

gene.

Hyperkalemia

Succinylcholine should be administered with GREAT CAUTION to patients suffering from

hyperkalemia because in these circumstances succinylcholine may induce serious cardiac arrhythmias or

cardiac arrest due to hyperkalemia.

GREAT CAUTION should be observed if succinylcholine is administered to patients during the acute

phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or

upper motor neuron injury (see CONTRAINDICATIONS). The risk of hyperkalemia in these patients

increases over time and usually peaks at 7 to 10 days after the injury. The risk is dependent on the extent

and location of the injury. The precise time of onset and the duration of the risk period are undetermined.

Patients with chronic abdominal infection, subarachnoid hemorrhage, or conditions causing degeneration

of central and peripheral nervous systems should receive succinylcholine with GREAT CAUTION

because of the potential for developing severe hyperkalemia.

Immediate treatment of hyperkalemia should include hyperventilation, i.v. calcium, i.v. sodium

bicarbonate and I.V. glucose (with or without insulin).

Malignant Hyperthermia

Succinylcholine administration has been associated with acute onset of malignant hyperthermia, a

potentially fatal hypermetabolic state of skeletal muscle. The risk of developing malignant hyperthermia

following succinylcholine administration increases with the concomitant administration of volatile

anesthetics. Malignant hyperthermia frequently presents as intractable spasm of the jaw muscles (masseter

spasm) which may progress to generalized rigidity, increased oxygen demand, tachycardia, tachypnea and

profound hyperpyrexia.

Successful outcome depends on recognition of early signs, such as jaw muscle spasm, increase of

end-tidal carbon dioxide concentrations, or generalized rigidity to initial administration of succinylcholine

for tracheal intubation, or failure of tachycardia to respond to deepening anesthesia. Skin mottling, rising

temperature and coagulopathies may occur later in the course of the hypermetabolic process. In short

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procedures, these symptoms and signs may not appear until the patient is in the recovery room.

Recognition of the syndrome is a signal for discontinuance of anesthesia, attention to increased oxygen

consumption, requirement for a marked increase in minute ventilation to correct respiratory acidosis,

supplementary i.v. bicarbonate to control metabolic acidosis, support of circulation, assurance of adequate

urinary output and institution of measures to control rising temperature. Dantrolene sodium, intravenously,

is recommended as an adjunct to supportive measures in the management of this problem. Consult

literature references and the dantrolene prescribing information for additional information about the

management of malignant hyperthermic crisis. Continuous monitoring of temperature and expired CO

recommended as an aid to early recognition of malignant hyperthermia.

Other

In adults the incidence of bradycardia, which may progress to asystole, is greater after a second dose of

succinylcholine. In infants and young children, bradycardia and transient asystole may occur after one

dose of succinylcholine. The incidence and severity of bradycardia is greater in infants and children than

in adults. Pretreatment with anticholinergic agents (e.g. atropine), in most cases, will reduce the

occurrence of bradyarrhythmias.

Succinylcholine causes an increase in intraocular pressure. It should not be used in instances in which an

increase in intraocular pressure is undesirable (e.g. narrow angle glaucoma, penetrating eye injury) unless

the potential benefit of this use outweighs the potential risk.

Succinylcholine is acidic (pH = 3.5) and should not be mixed with alkaline solutions having a pH greater

than 8.5 (e.g. barbiturate solutions) (see PHARMACEUTICAL INFORMATION, Stability -

Compatibility).

PRECAUTIONS

General

When succinylcholine is given over a prolonged period of time, the characteristic depolarization block of

the myoneural junction (Phase I block) may change to a block with characteristics superficially

resembling a nondepolarizing block (Phase II block). Prolonged respiratory muscle paralysis or weakness

may be observed in patients manifesting this transition to Phase II block.

The transition from Phase I to Phase II block has been reported in 7 of 7 patients studied under halothane

anesthesia after an accumulated dose of 2 to 4 mg/kg succinylcholine (administered in repeated, divided

doses). The onset of Phase II block coincided with the onset of tachyphylaxis and prolongation of

spontaneous recovery. In another study, using balanced anesthesia (N

/narcotic-thiopental) and

succinylcholine infusion, the transition was less abrupt, with great individual variability in the dose of

succinylcholine required to produce Phase II block. Of 32 patients studied, 24 developed Phase II block.

Tachyphylaxis was not associated with the transition to Phase II block, and 50% of the patients who

developed Phase II block experienced prolonged recovery.

When Phase II block is suspected in cases of prolonged neuromuscular blockade, positive diagnosis

should be made by peripheral nerve stimulation, prior to administration of any anticholinesterase drug.

Reversal of Phase II block is a medical decision which must be made upon the basis of the individual

clinical pharmacology and the experience and judgment of the physician. The presence of Phase II block

is indicated by fade of responses to successive stimuli (preferably "train of four"). The use of an

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anticholinesterase drug to reverse Phase II block should be accompanied by appropriate doses of an

anticholinergic drug to prevent disturbances of cardiac rhythm. After adequate reversal of Phase II block

with an anticholinesterase agent, the patient should be continually observed for at least 1 hour for signs of

return of muscle relaxation. Reversal should not be attempted unless: (1) a peripheral nerve stimulator is

used to determine the presence of Phase II block (since anticholinesterase agents will potentiate

succinylcholine-induced Phase I block), and (2) spontaneous recovery of muscle twitch has been

observed for at least 20 minutes and has reached a plateau with further recovery proceeding slowly; this

delay is to ensure complete hydrolysis of succinylcholine by plasma cholinesterase prior to administration

of the anticholinesterase agent. Should the type of block be misdiagnosed, depolarization of the type

initially induced by succinylcholine (i.e. Phase I block), will be prolonged by an anticholinesterase agent.

Succinylcholine should be employed with caution in patients with fractures or muscle spasm because the

initial muscle fasciculations may cause additional trauma.

Succinylcholine may cause a transient increase in intracranial pressure; however, adequate anesthetic

induction prior to administration of succinylcholine will minimize this effect.

Succinylcholine may increase intragastric pressure, which could result in regurgitation and possible

aspiration of stomach contents.

Neuromuscular blockade may be prolonged in patients with hypokalemia or hypocalcemia.

The action of succinylcholine may be altered by some carcinomas or renal disease.

Reduced Plasma Cholinesterase Activity

Succinylcholine should be used carefully in patients with reduced plasma cholinesterase

(pseudocholinesterase) activity. The likelihood of prolonged neuromuscular block following

administration of succinylcholine must be considered in such patients (see DOSAGE AND

ADMINISTRATION).

Plasma cholinesterase activity may be diminished in the presence of genetic abnormalities of plasma

cholinesterase (e.g. patients heterozygous or homozygous for atypical plasma cholinesterase gene),

pregnancy, severe liver or kidney disease, malignant tumors, infections, burns, anemia, decompensated

heart disease, peptic ulcer, or myxedema. Plasma cholinesterase activity may also be diminished by

chronic administration of oral contraceptives, glucocorticoids, or certain monoamine oxidase inhibitors

and by irreversible inhibitors of plasma cholinesterase, (e.g. organophosphate insecticides, echothiophate,

and certain antineoplastic drugs).

Patients homozygous for atypical plasma cholinesterase gene (1 in 2500 patients) are extremely sensitive

to the neuromuscular blocking effect of succinylcholine. In these patients, a 5 to 10 mg test dose of

succinylcholine may be administered, or neuromuscular blockade may be produced by the cautious

administration of a 1 mg/mL solution of succinylcholine by intravenous drip. Apnea or prolonged

muscle paralysis should be treated with controlled respiration.

Drug Interactions

Drugs which may enhance the neuromuscular blocking action of succinylcholine include: promazine,

oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide,

lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, diethylether,

Prescribing Information - Quelicin Page 7 of 14

isoflurane, desflurane, metoclopramide and terbutaline. The presence of an inhalational anesthetic may

exacerbate the side effects of succinylcholine in infants and children (see ADVERSE REACTIONS).

The neuromuscular blocking effect of succinylcholine may be enhanced by drugs that reduce plasma

cholinesterase activity (e.g. chronically administered oral contraceptives, glucocorticoids, or certain

monoamine oxidase inhibitors) or by drugs that irreversibly inhibit plasma cholinesterase (see

PRECAUTIONS).

Drugs which either inhibit plasma pseudocholinesterase (such as neostigmine) or compete with

succinylcholine for the enzyme (as does intravenous procaine) should not be given concurrently with

succinylcholine.

If other neuromuscular blocking agents are to be used during the same procedure, the possibility of a

synergistic or antagonistic effect should be considered.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There have been no long-term studies performed in animals to evaluate carcinogenic potential.

Pregnancy

Teratogenic Effects

Animal reproduction studies have not been conducted with succinylcholine chloride. It is also not known

whether succinylcholine can cause fetal harm when administered to a pregnant woman or can affect

reproduction capacity. Succinylcholine should be given to a pregnant woman only if clearly needed.

Nonteratogenic Effects

Plasma cholinesterase levels are decreased by approximately 24% during pregnancy and for several days

postpartum. Therefore, a higher proportion of patients may be expected to show increased sensitivity

(prolonged apnea) to succinylcholine when pregnant than when nonpregnant.

Labor and Delivery

Succinylcholine is commonly used to provide muscle relaxation during delivery by cesarean section.

While small amounts of succinylcholine are known to cross the placental barrier, under normal conditions

the quantity of drug that enters fetal circulation after a single dose of 1 mg/kg to the mother should not

endanger the fetus. However, since the amount of drug that crosses the placental barrier is dependent on

the concentration gradient between the maternal and fetal circulations, residual neuromuscular blockade

(apnea and flaccidity) may occur in the newborn after repeated high doses to, or in the presence of

atypical plasma cholinesterase in, the mother.

Nursing Mothers

It is not known whether succinylcholine is excreted in human milk. Because many drugs are excreted in

human milk, caution should be exercised following succinylcholine administration to a nursing woman.

Pediatric Use

There are rare reports of ventricular dysrhythmias, cardiac arrest and death secondary to acute

rhabdomyolysis with hyperkalemia in apparently healthy infants and children who receive

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succinylcholine (see WARNINGS). Several of these individuals were subsequently found to be

suffering from a myopathy such as Duchenne's muscular dystrophy whose clinical signs were not

obvious. When a healthy appearing infant or child suddenly develops cardiac arrest soon after

administration of succinylcholine, immediate treatment of hyperkalemia should include hyperventilation,

i.v. calcium, i.v. sodium bicarbonate and i.v. glucose (with or without insulin). Treatment for acute

rhabdomyolysis, including a single dose of dantrolene, should also be considered.

Unlike in adults, the incidence of bradycardia in infants and young children is common after one dose of

succinylcholine. The incidence and severity of bradycardia is greater in infants and children than in adults.

Pre-treatment with anticholinergic agents (e.g. atropine), in most cases, will reduce the occurrence of

bradyarrhythmias.

ADVERSE REACTIONS

Adverse reactions to succinylcholine consist primarily of an extension of its pharmacological actions.

Succinylcholine causes profound muscle relaxation resulting in respiratory depression to the point of

apnea; this effect may be prolonged. Hypersensitivity reactions, including anaphylaxis may occur in rare

instances. The following additional adverse reactions have been reported: cardiac arrest, malignant

hyperthermia, arrhythmias, bradycardia, tachycardia, hypertension, hypotension, hyperkalemia, prolonged

respiratory depression or apnea, increased intraocular pressure, muscle fasciculation, jaw rigidity,

postoperative muscle pain, rhabdomyolysis with possible myoglobinuric acute renal failure, excessive

salivation, and rash.

SYMPTOMS AND TREATMENT OF OVERDOSAGE

Symptoms

Overdosage with succinylcholine may result in neuromuscular block beyond the time needed for surgery

and anesthesia. This may be manifested by skeletal muscle weakness, decreased respiratory reserve, low

tidal volume, prolonged respiratory depression or apnea.

Treatment

The primary treatment is maintenance of a patent airway and respiratory support until recovery of normal

respiration is assured. Depending on the dose and duration of succinylcholine administration, the

characteristic depolarizing neuromuscular block (Phase I) may change to a block with characteristics

superficially resembling a nondepolarizing block (Phase II) (see PRECAUTIONS).

The decision to use neostigmine to reverse a Phase II succinylcholine-induced block depends on the

judgment of the clinician in the individual case. Valuable information in regard to this decision will be

gained by monitoring neuromuscular function. If neostigmine is used, its administration should be

accompanied by appropriate doses of an anticholinergic agent such as atropine.

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DOSAGE AND ADMINISTRATION

The dosage of succinylcholine should be individualized and should always be determined by the clinician

after careful assessment of the patient (see WARNINGS).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to

administration whenever solution and container permit. Solutions which are not clear and colourless

should not be used.

Adults

For Short Surgical Procedures

The average dose required to produce neuromuscular blockade and to facilitate tracheal intubation is

0.6 mg/kg QUELICIN

(succinylcholine chloride Injection USP) given intravenously. The optimum

dose will vary among individuals and may be from 0.3 to 1.1 mg/kg for adults.

Following administration of doses in this range, neuromuscular blockade develops in about 1 minute;

maximum blockade may persist for about 2 minutes, after which recovery takes place within 4 to 6

minutes. However, very large doses may result in more prolonged blockade. A 5 to 10 mg test dose may

be used to determine the sensitivity of the patient and the individual recovery time (see

PRECAUTIONS).

For Long Surgical Procedures

The dose of succinylcholine administered by infusion depends upon the duration of the surgical procedure

and the need for muscle relaxation. The average rate for an adult ranges between 2.5 and 4.3 mg per

minute.

Solutions containing from 1 to 2 mg per mL succinylcholine have commonly been used for continuous

infusion (see PHARMACEUTICAL INFORMATION, Stability-Compatibility). The more dilute

solution (1 mg per mL) is probably preferable from the standpoint of ease of control of the rate of

administration of the drug and, hence, of relaxation. This intravenous solution containing 1 mg per mL

may be administered at a rate of 0.5 mg (0.5 mL) to 10 mg (10 mL) per minute to obtain the required

amount of relaxation. The amount required per minute will depend upon the individual response as well

as the degree of relaxation required. Avoid overburdening the circulation with a large volume of fluid. It

is recommended that neuromuscular function be carefully monitored with a peripheral nerve stimulator

when using succinylcholine by infusion in order to avoid overdose, detect development of Phase II block,

follow its rate of recovery, and assess the effects of reversing agents (see PRECAUTIONS).

Children

The intravenous dose of succinylcholine is 2 mg/kg for infants and small children; for older children and

adolescents the dose is 1 mg/kg (see WARNINGS and PRECAUTIONS-Pediatric Use).

Rarely, I.V. bolus administration of succinylcholine in infants and children may result in malignant

ventricular arrhythmias and cardiac arrest secondary to acute rhabdomyolysis with hyperkalemia. In such

situations, an underlying myopathy should be suspected.

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Intravenous bolus administration of succinylcholine in infants and young children may result in profound

bradycardia or, rarely, asystole. Unlike in adults, the incidence of bradycardia in infants and children is

greater after a single dose of succinylcholine. The occurrence of bradyarrhythmias, in most cases, will be

reduced by pretreatment with an anticholinergic drug (e.g. atropine) (see PRECAUTIONS-Pediatric

Use).

Intramuscular Use

If necessary, succinylcholine may be given intramuscularly to infants, older children or adults when a suitable

vein is inaccessible. A dose of up to 3 or 4 mg/kg may be given, but not more than 150 mg total dose should

be administered by this route. The onset of effect of succinylcholine given intramuscularly is usually observed

in about 2 to 3 minutes.

Prescribing Information - Quelicin Page 11 of 14

PHARMACEUTICAL INFORMATION

Drug Substance

Trade Name

QUELICIN

Proper Name

Succinylcholine chloride

Chemical Name

2,2'-[1,4-dioxo-1,4-butanediyl)bis(oxy)]bis[N,N,N,-

trimethylethanaminium]dichloride

Structural Formula

Molecular Formula

Molecular Weight

361.31

Description

Succinylcholine chloride is a white, odorless, slightly bitter powder, that

is very soluble in water. It is unstable in alkaline solutions, but relatively

stable in acid solutions, depending upon the concentration of the solution

and the storage temperature.

Stability - Compatibility

Succinylcholine is acidic (pH=3.5) and should not be mixed with alkaline solutions having a pH greater than

8.5 (e.g., barbiturate solutions).

Succinylcholine is rapidly hydrolyzed, quickly loses potency, and may cause a precipitate to form when

mixed with alkaline solutions of other drugs. Preferably, succinylcholine should be separately injected and

should not be mixed in the same syringe nor administered simultaneously through the same needle with

solutions of short-acting barbiturates, such as Pentothal* (sodium thiopental) or other drugs which have an

alkaline pH.

Admixtures containing 1 to 2 mg per mL of succinylcholine may be prepared dy diluting succinylcholine with

a sterile solution, such as 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. Such

admixtures should be used within 24 hours after preparation. Aseptic techniques should be used to prepare the

diluted product. Admixtures of succinylcholine should be prepared for single patient use only. The unused

portion of the diluted succinylcholine should be discarded.

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Storage Recommendations

All units must be kept refrigerated (2 to 8°C) to prevent loss of potency. These products are stable for up to

14 days at room temperature without significant loss of potency.

Availability

QUELICIN

(succinylcholine chloride injection USP) is supplied as a sterile solution in ampoules and fliptop

vials as follows:

List

Size (mL)

mg/mL

mg/total unit

06629

06970

List 06629: each mL contains succinylcholine chloride 20 mg, methylparaben 1.8 mg, propylparaben 0.2 mg

as preservatives, sodium chloride for tonicity; it may contain sodium hydroxide and/or hydrochloric acid to

adjust the pH at approximately 4.

List 06970: each mL contains succinylcholine chloride 100 mg; it may contain sodium hydroxide and/or

hydrochloric acid to adjust the pH at approximately 4.

This solution must be diluted for intravenous use: any unused reconstituted portion should be discarded.

Prescribing Information - Quelicin Page 13 of 14

SELECTED BIBLIOGRAPHY

Assem ESK. Anaphylactic reactions affecting the human heart. Agents and Actions 1989; 27:142.

Carrol JB. Increased incidence of masseter spasm in children with strabismus anesthetized with

halothane and succinylcholine. Anesthesiology 1987; 67:559-561.

Crespi G, Lualdi M, Restelli L, Pellerin I, Castiglioni C. Halothane and isoflurane:

succinylcholine-induced heart rate changes in pediatric anaesthesia. Minerva Anestesiol 1988; 54:1-4.

Delphin E, Jackson D, Rothstein P. Use of succinylcholine during elective pediatric anesthesia should

be reevaluated. Anesth Analg 1987; 66:1190-2.

Futter ME, Donati F, Bevan DR. Prolonged suxamethonium infusion during nitrous oxide anaesthesia

supplemented with halothane or fentanyl. Br J Anaesth 1983; 55:947-53.

Goudsouzian NG. Relaxants in paediatric anaesthesia. Clin Anaesthesiol 1985; 3(3):539-51.

Gronert GA. Malignant hyperthermia. Anesthesiology 1980; 53(5):395-423.

Gronert GA, Theye RA. Pathophysiology of hyperkalemia induced by succinylcholine.

Anesthesiology 1973; 43(1):89-99.

Gürgey A. Malignant hyperthermia in a patient with sickle cell anemia. Turk J Pediatr 1989;

31:245-247.

Illes IA, Defensor NC. Incidence and detection of cardiac arrhythmias during halothane anesthesia.

Anesth Analg 1965; 44:529-531.

Kashimoto S, Kanda F, Kumazawa T. Succinylcholine-induced ventricular arrythmia during

halothane anesthesia. Resuscitation 1985; 12:233-236.

Knight J, Mercader M, Bebak D. Anaphylaxis to succinylcholine. J Kans Med Soc 1982; 83:424.

List WFM. Succinylcholine-induced cardiac arrhythmias. Anesth Analg 1971; 50:361- 367.

Mehler J, Bachour H, Simons F, Wolpers K. Cardiac arrest during induction of anesthesia with

halothane and succinylcholine in an infant. Severe hyperkalemia and rhabdomyolysis due to a

suspected myopathy and/or malignant hyperthermia. Anaesthesist 1991; 40:497-501.

Nash CL, Haller R, Brown RH. Succinylcholine, paraplegia, and intra-operative cardiac arrest. A

Case Report. J Bone Joint Surg 1981; 63A(6):1010-2.

Rosenberg H, Gronert GA. Intractable cardiac arrest in children given succinylcholine.

Anesthesiology 1992; 77(5):1054.

Stoelting RK. Comparison of gallamine and atropine as pretreatment before anesthetic induction and

succinylcholine administration. Anesth Analg 1977; 56:493-495.

Prescribing Information - Quelicin Page 14 of 14

Warner LO, Beach TP, Garvin JP, Warner EJ. Halothane and children: The first quarter century.

Anesth Analg 1984; 63:838-840.

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Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative

Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative

Stokes Healthcare Inc. is voluntarily recalling 1 lot of 81 units of Pilocarpine 0.1% Ophthalmic Solution, to the consumer and veterinarian office levels. The ophthalmic solution has been found to contain a higher level of the preservative benzalkonium chloride than is typical.

FDA - U.S. Food and Drug Administration

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

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

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

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

1-2-2019

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Safety of concentrated l‐lysine (base), l‐lysine monohydrochloride and l‐lysine sulfate produced using different strains of Corynebacterium glutamicum for all animal species based on a dossier submitted by FEFANA asbl

Published on: Thu, 31 Jan 2019 The EFSA FEEDAP Panel previously (2016) could not conclude on the safety of certain concentrated liquid l‐lysine (base), l‐lysine monohydrochloride (HCl) and l‐lysine sulfate products manufactured using different strains of Corynebacterium glutamicum. New information on the safety of these products was provided by the applicant. The recipient strain C. glutamicum KCTC 12307BP qualifies for qualified presumption of safety (QPS) approach for safety assessment, the genetic mo...

Europe - EFSA - European Food Safety Authority EFSA Journal

1-2-2019

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Safety and efficacy of l‐lysine monohydrochloride and concentrated liquid l‐lysine (base) produced by fermentation using Corynebacterium glutamicum strain NRRL B‐50775 for all animal species based on a dossier submitted by ADM

Published on: Thu, 31 Jan 2019 The European Commission asked EFSA for an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a l‐lysine monohydrochloride (HCl, minimum 98.5%) and of a concentrated liquid l‐lysine (base, minimum 50%) produced by a genetically modified strain of Corynebacterium glutamicum(NRRL B‐50775). They are intended to be used in feed or water for drinking for all animal species and categories. Neither the production strain C. gluta...

Europe - EFSA - European Food Safety Authority EFSA Journal

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

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

18-12-2018

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Enovachem Pharmaceuticals Issues Voluntary Nationwide Recall of Dyural-40 and Dyural-80 Convenience Kits Containing Recalled Sodium Chloride Injection, USP, 0.9% Due to Latex Hazard

Torrance, CA, Asclemed USA Inc is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, which has been recalled due to product labeling incorrectly stating stoppers do not contain latex.

FDA - U.S. Food and Drug Administration

6-12-2018

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma Issues Voluntary Nationwide Recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, Due to Potential Higher Concentrations of Ibuprofen

Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

FDA - U.S. Food and Drug Administration

28-11-2018

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Prenoxad 1 mg/mL solution for injection (naloxone hydrochloride)

Update - medicine shortage

Therapeutic Goods Administration - Australia

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

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi Issues Voluntary Nationwide Recall of Sodium Chloride Injection, USP, 0.9% Due to Product Labeling Incorrectly Stating Stoppers Do Not Contain Latex

Fresenius Kabi USA is voluntarily recalling 163 lots of Sodium Chloride Injection, USP, 0.9%, 10 mL fill in a 10 mL vial and Sodium Chloride Injection, USP, 0.9%, 20 mL fill in a 20 mL vial to the user level. The product insert states that stoppers for both the 10mL and the 20mL vials do not contain natural rubber latex; the tray label for the two vial sizes and the vial label for the 20mL vial also state that the stoppers do not contain latex. The product is being recalled because the stoppers contain n...

FDA - U.S. Food and Drug Administration

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

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

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

16-10-2018

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Modification of the existing maximum residue levels for mepiquat in cotton seeds and animal commodities

Published on: Mon, 15 Oct 2018 00:00:00 +0200 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant, BASF SE, submitted an application to the competent national authority in Greece to modify the existing maximum residue level (MRL) for the active substance mepiquat in cotton seeds. The data submitted in support of the application were found to be sufficient to derive a MRL proposal for cotton seeds and the previously derived MRL proposals for animal commodities were found to be stil...

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

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of primary myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-essential thrombocythaemia myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

18-3-2019


Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Orphan designation: N-(cyanomethyl)-4-(2-{[4-(morpholin-4-yl)phenyl]amino}pyrimidin-4-yl)benzamide, dihydrochloride salt, Treatment of post-polycythaemia vera myelofibrosis, 05/08/2011, Positive

Europe - EMA - European Medicines Agency

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

11-3-2019


Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Orphan designation: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1)), Treatment of C3 glomerulopathy, 14/12/2018, Positive

Europe - EMA - European Medicines Agency

20-2-2019


Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Glibenclamide / metformin hydrochloride: List of nationally authorised medicinal products - PSUSA/00002002/201806

Europe - EMA - European Medicines Agency

20-2-2019


Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/2018

Europe - EMA - European Medicines Agency

20-2-2019


Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Orphan designation: Histamine dihydrochloride, Treatment of acute myeloid leukaemia, 11/04/2005, Expired

Europe - EMA - European Medicines Agency

20-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0354/2018

Europe - EMA - European Medicines Agency

19-2-2019


Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Orphan designation: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride, Treatment of Kabuki syndrome, 19/11/2018, Positive

Europe - EMA - European Medicines Agency

19-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Opinion/decision on a Paediatric investigation plan (PIP): Phenylephrine hydrochloride,ketorolac trometamol (OMS302), decision type: , therapeutic area: , PIP number: P/0362/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Opinion/decision on a Paediatric investigation plan (PIP): Landiolol (hydrochloride), decision type: , therapeutic area: , PIP number: P/0273/2018

Europe - EMA - European Medicines Agency

5-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Opinion/decision on a Paediatric investigation plan (PIP): Eviplera,emtricitabine,Rilpivirine (hydrochloride),Tenofovir (disoproxil fumarate), decision type: , therapeutic area: , PIP number: P/0274/2018

Europe - EMA - European Medicines Agency

4-2-2019


Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Opinion/decision on a Paediatric investigation plan (PIP): Edurant,Rilpivirine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0322/2018

Europe - EMA - European Medicines Agency

1-2-2019


Summary of opinion: Doxolipad,doxorubicin hydrochloride,  31/01/2019,  Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Summary of opinion: Doxolipad,doxorubicin hydrochloride, 31/01/2019, Negative

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Opinion/decision on a Paediatric investigation plan (PIP): Macrogol 3350,sodium sulfate,sodium chloride,sodium ascorbate,potassium chloride (NER1006),Ascorbic acid, decision type: , therapeutic area: , PIP number: P/0315/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Opinion/decision on a Paediatric investigation plan (PIP): Ciprofloxacin (hydrochloride), decision type: , therapeutic area: , PIP number: P/0253/2018

Europe - EMA - European Medicines Agency

31-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Opinion/decision on a Paediatric investigation plan (PIP): Cariprazine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0301/2018

Europe - EMA - European Medicines Agency

29-1-2019


Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Chlorphenoxamine hydrochloride : List of nationally authorised medicinal products - PSUSA/00010361/201805

Europe - EMA - European Medicines Agency

28-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Opinion/decision on a Paediatric investigation plan (PIP): Sarizotan (hydrochloride), decision type: , therapeutic area: , PIP number: P/0287/2018

Europe - EMA - European Medicines Agency

23-1-2019


Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Orphan designation: 3-(5-Amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione hydrochloride-, Treatment of diffuse large B-cell lymphoma, 27/06/2016, Positive

Europe - EMA - European Medicines Agency

22-1-2019


Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Orphan designation: Doxorubicin hydrochloride (in heat-sensitive liposomes), Treatment of hepatocellular carcinoma, 23/02/2011, Positive

Europe - EMA - European Medicines Agency

11-1-2019


Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Opinion/decision on a Paediatric investigation plan (PIP): Octenidine (dihydrochloride), decision type: , therapeutic area: , PIP number: P/0240/2018

Europe - EMA - European Medicines Agency

18-12-2018


Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Calcium chloride / glutamic acid / glutathione / histidine / lactobionic acid / magnesium chloride / mannitol / potassium chloride / sodium hydroxide: List of nationally authorised medicinal products - PSUSA/00010390/201801

Europe - EMA - European Medicines Agency

18-12-2018

EU/3/18/2104 (Novartis Europharm Limited)

EU/3/18/2104 (Novartis Europharm Limited)

EU/3/18/2104 (Active substance: (4-{(2S,4S)-4-ethoxy-1-[(5-methoxy-7-methyl-1H-indol-4-yl)methyl]piperidin-2-yl}benzoic acid-hydrogen chloride(1/1))) - Orphan designation - Commission Decision (2018)9019 of Tue, 18 Dec 2018 European Medicines Agency (EMA) procedure number: EMA/OD/157/18

Europe -DG Health and Food Safety

13-12-2018


Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Overview of comments received on 'Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance' (EMA/CHMP/800775/2017)

Europe - EMA - European Medicines Agency

13-12-2018


Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Pegylated liposomal doxorubicin hydrochloride concentrate for solution 2 mg/ml product-specific bioequivalence guidance

Europe - EMA - European Medicines Agency

11-12-2018


Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Epinephrine mepivacaine hydrochloride, mepivacaine norepinephrine, mepivacaine: List of nationally authorised medicinal products - PSUSA/00001979/201803

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

22-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:

Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018

Europe - EMA - European Medicines Agency

24-9-2018

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (ITG Isotope Technologies Garching GmbH)

EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712

Europe -DG Health and Food Safety