CLOPIXOL Solution for injection (2022)
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Περιεχόμενα
Name of the medicinal product
Clopixol 200 mg/ml solution for injection. Clopixol Conc. 500 mg/ml solution for injection.
Qualitative and quantitative composition
<u>Clopixol Injection:</u> Zuclopenthixol decanoate 200 mg/ml. <u>Clopixol Conc. Injection:</u> Zuclopenthixol decanoate 500 mg/ml. For the full list of excipients, see section 6.1.
Pharmaceutical form
Solution for injection. Clear, yellowish oil, practically free from particles.
Therapeutic indications
The maintenance treatment of schizophrenia and paranoid psychoses.
Posology and method of administration
Posology Adults Dosage and dosage interval should be adjusted according to the patients symptoms and response to treatment. The usual dosage range of zuclopenthixol decanoate is 200 500 mg every one to ...
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, zuclopenthixol enhances the response to alcohol, the effects of barbiturates and other CNS depressants. Zuclopenthixol may potentiate the effects of general anaesthetics ...
Fertility, pregnancy and lactation
Pregnancy Zuclopenthixol decanoate should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus. Neonates exposed to antipsychotics ...
Effects on ability to drive and use machines
Zuclopenthixol is a sedative drug. 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 ...
Undesirable effects
The majority of undesirable effects are dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment. Extrapyramidal reactions may ...
Overdose
Symptoms Somnolence, coma, extrapyramidal symptoms, convulsions, hypotension, shock, hyper or hypothermia. ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Neuropleptics (antipsychotics) <b>ATC Code:</b> N05AF05 Mechanism of action The action of zuclopenthixol, as with other antipsychotics is mediated through dopamine receptor ...
Pharmacokinetic properties
After deep intramuscular injection of Clopixol, serum levels of zuclopenthixol increase during the first week and decline slowly thereafter. A linear relationship has been observed between Clopixol dosage ...
Preclinical safety data
Reproductive toxicity Impaired mating performance and reduced conception rates were observed in rats treated with zuclopenthixol at doses equal to the maximum recommend human dose of 50 mg on a mg/m² basis. ...
List of excipients
Thin vegetable oil
Incompatibilities
This product may be mixed in the same syringe with other products in the Clopixol Injection range, including Clopixol-Acuphase Injection (zuclopenthixol acetate 50 mg/ml). It should not be mixed with any ...
Shelf life
<u>Clopixol Injection:</u> 1 ml ampoules: 36 months. 10 ml vials: 36 months (unopened), shelf life after opening vials: 1 day <u>Clopixol Conc. Injection:</u> 48 months.
Special precautions for storage
Keep the ampoules in the outer carton in order to protect from light.
Nature and contents of container
Clopixol Injection Ampoules containing 1 ml of 200 mg/ml zuclopenthixol decanoate in thin vegetable oil. <u>Pack size:</u> 10 ampoules per box. 10 ml clear glass vials with a rubber stopper secured with ...
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, United Kingdom
Marketing authorization number(s)
Clopixol Injection: PL 00458/0017 Clopixol Conc. Injection: PL 00458/0060
Date of first authorization / renewal of the authorization
Date of First Authorisation in the UK: Clopixol Injection: 15 May 1978 Clopixol Conc. Injection: 21 November 1988 Renewal of the Authorisation: Clopixol Injection: 3 July 2008 Clopixol Conc. Injection: ...
Date of revision of the text
10/2022
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