LARGACTIL Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Largactil 25mg/ml Solution for Injection.
Qualitative and quantitative composition
25mg/ml chlorpromazine hydrochloride. For full list of excipients see section 6.1
Pharmaceutical form
Sterile solution for injection. A clear, colourless or almost colourless solution.
Therapeutic indications
Largactil injection is a phenothiazine neuroleptic. It is indicated in the following conditions: Schizophrenia and other psychoses (especially paranoid) mania and hypomania. Anxiety, psychomotor agitation, ...
Posology and method of administration
Route of administration Deep intramuscular injection. Oral route administration should be used wherever possible. Parenteral formulations may be used in emergencies. They may only be administered by deep ...
Contraindications
Hypersensitivity to chlorpromazine or to any of the excipients Bone marrow depression Risk of angle-closure glaucoma Risk of urinary retention related to urethroprostatic disorders History of agranulocytosis ...
Special warnings and precautions for use
All patients must be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment will be discontinued ...
Interaction with other medicinal products and other forms of interaction
Adrenaline must not be used in patients overdosed with Largactil. Anticholinergic drugs may reduce the antipsychotic effect of Largactil and the mild anticholinergic effect of Largactil may be enhanced ...
Fertility, pregnancy and lactation
Pregnancy There is inadequate evidence of the safety of Largactil in human pregnancy. There is evidence of harmful effects in animals. Like other drugs it should be avoided in pregnancy unless the physician ...
Effects on ability to drive and use machines
Patients should be warned about drowsiness during the early days of treatment and advised not to drive or operate machinery.
Undesirable effects
Very common (≥1/10) Common (≥1/100 to <1/10) Not known (cannot be estimated from available data) Blood and lymphatic system disorders Not known: Agranulocytosis, Leucopenia Immune system disorders Not ...
Overdose
Toxicity and treatment of overdosage: Symptoms of chlorpromazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias, hypothermia, Parkinsonism, ...
Pharmacodynamic properties
Pharmacotherapeutic Group: Antipsychotics ATC Code: N05AA01 Largactil is a phenothiazine neuroleptic.
Pharmacokinetic properties
Chlorpromazine is rapidly absorbed and widely distributed in the body. It is metabolised in the liver and excreted in the urine and bile. Whilst plasma concentration of chlorpromazine itself rapidly declines ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Sodium sulphite anhydrous (E221) Sodium citrate Sodium metabisulphite (E223) Sodium chloride Water for injections
Incompatibilities
Largactil injection solutions have a pH of 5.0-6.5; they are incompatible with benzylpenicillin potassium, pentobarbital sodium and phenobarbital sodium.
Shelf life
The shelf life of the Largactil Injection is 36 months.
Special precautions for storage
Keep ampoules in outer carton in order to protect from light. Discoloured solution should not be used.
Nature and contents of container
Largactil Injection 2.5% w/v is supplied in boxes containing 10 1 ml or 10 2 ml in glass ampoules.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Aventis Pharma Ltd, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Marketing authorization number(s)
PL 04425/0582
Date of first authorization / renewal of the authorization
Date of First Authorisation: 24 April 2007
Date of revision of the text
09 October 2019
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