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SPC, UK: CLOPIXOL ACUPHASE Solution for injection (2016)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Clopixol-Acuphase 50 mg/ml solution for injection.

Qualitative and quantitative composition

Zuclopenthixol acetate 50 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

For the initial treatment of acute psychoses including mania and exacerbation of chronic psychoses, particularly where a duration of effect of 2-3 days is desirable.

Posology and method of administration

Posology Adults Dosage should be adjusted according to the severity of the patients illness. The usual dosage is 50-150 mg (1-3 ml), repeated if necessary after 2 or 3 days. Some patients may need an additional ...

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 acetate 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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Neuropleptics (antipsychotics) ATC Code: N05AF05 Mechanism of action Zuclopenthixol is a potent neuroleptic of the thioxanthene series with a piperazine side-chain. The antipsychotic ...

Pharmacokinetic properties

By esterification of zuclopenthixol with acetic acid, zuclopenthixol has been converted to a more lipophilic substance, zuclopenthixol acetate. When dissolved in oil and injected intramuscularly this substance ...

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 (derived from coconuts).

Incompatibilities

This product may be mixed in the same syringe with other products in the Clopixol Injection range. It should not be mixed with any other injection fluids.

Shelf life

Shelf life: 2 years as packaged for sale.

Special precautions for storage

Store at or below 25°C. Protect from light.

Nature and contents of container

Clear glass ampoules containing 1 mL of zuclopenthixol acetate 5% w/v in thin vegetable oil. The ampoules are packed in boxes of 5.

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, 2nd floor, Building 3, Abbey View, Everard Close, St Albans, AL1 2PS, United Kingdom

Marketing authorization number(s)

PL 00458/0063

Date of first authorization / renewal of the authorization

Date of First Authorisation in the UK: 16 March 1990 Renewal of the Authorisation: 3 July 2008

Date of revision of the text

December 2016

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