DEPIXOL Solution for injection (2021)
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Περιεχόμενα
Name of the medicinal product
Depixol Low Volume 200 mg/ml solution for injection.
Qualitative and quantitative composition
200 mg/ml flupentixol decanoate in thin vegetable oil. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection. Clear, yellowish oil, practically free from particles. Oily solution for deep intramuscular injection.
Therapeutic indications
The treatment of schizophrenia and other psychoses. Use of Depixol should be restricted to those stabilised on oral therapy.
Posology and method of administration
Posology Adults The usual dosage of flupentixol decanoate lies between 50 mg every 4 weeks and 300 mg every 2 weeks, but some patients may require up to 400 mg weekly. The maximum single dose at any one ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates ...
Special warnings and precautions for use
Caution should be exercised in patients having: liver disease; cardiac disease or arrhythmias; severe respiratory disease; renal failure; epilepsy (and conditions predisposing to epilepsy e.g. alcohol ...
Interaction with other medicinal products and other forms of interaction
In common with other antipsychotics, flupentixol enhances the response to alcohol, the effects of barbiturates and other CNS depressants. Flupentixol may potentiate the effects of general anaesthetics ...
Fertility, pregnancy and lactation
Pregnancy As the safety of this drug during pregnancy has not been established, use during pregnancy, especially the first and last trimesters, should be avoided, unless the expected benefit to the patient ...
Effects on ability to drive and use machines
Alertness may be impaired, especially at the start of treatment, or following the consumption of alcohol; patients should be warned of this risk and advised not to drive or operate machinery until their ...
Undesirable effects
Cases of suicidal ideation and suicidal behaviours have been reported during flupentixol therapy or early after treatment discontinuation (see section 4.4). The majority of undesirable effects are dose ...
Overdose
Overdosage may cause somnolence or even coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular ...
Pharmacodynamic properties
Pharmacotherapeutic group: Neuroleptics (antipsychotics) ATC code: N05AF01 Mechanism of action Flupentixol is a antipsychotic of the thioxanthene series. The antipsychotic effect of antipsychotics is related ...
Pharmacokinetic properties
Absorption By esterification of flupentixol with decanoic acid flupentixol has been converted to a highly lipophilic substance, flupentixol decanoate. When dissolved in oil and injected intramuscularly ...
Preclinical safety data
Reproductive toxicity In fertility studies in rats, flupentixol slightly affected the pregnancy rate of female rats. Animal reproduction studies in mice, rats and rabbits have not shown evidence of teratogenic ...
List of excipients
Thin vegetable oil Viscoleo (fractionated coconut oil)
Incompatibilities
This product may be mixed in the same syringe with other products in the Depixol Injection range. It should not be mixed with any other injection fluids.
Shelf life
<u>Ampoules 1 ml:</u> 2 years.
Special precautions for storage
Do not store above 25°C. Keep the ampoules in the outer carton in order to protect from light.
Nature and contents of container
Ampoules containing 1 ml of 200 mg/ml flupentixol decanoate in thin vegetable oil. <u>Pack size:</u> 5 ampoules per carton.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Lundbeck Limited, Iveco House, Station Road, Watford, Hertfordshire, WD17 1ET, UK
Marketing authorization number(s)
PL 0458/0065
Date of first authorization / renewal of the authorization
Date of First Authorisation in the UK: 23 October 1991 Renewal of the Authorisation: 09 November 2010
Date of revision of the text
01/2021
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