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SPC: AKINETON Solution for injection

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Akineton 5 mg solution for injection.

Qualitative and quantitative composition

Active substance: Biperiden Lactate. 1 ampoule of 1 ml solution for injection contains 5 mg Biperiden Lactate equivalent to 3.9 mg Biperiden. Excipient with known effect: less than 1 mmol sodium (sodium ...

Pharmaceutical form

Clear, colourless solution for injection, free from suspended matter. pH 4.8-5.8

Therapeutic indications

All forms of parkinsonism. Drug-induced extrapyramidal symptoms excito-motor phenomena, parkinsonoid, akinesia, rigidity, akathisia, acute dystonia. Nicotine poisoning. Poisoning by organic phosphorous ...

Posology and method of administration

Biperiden has to be dosed individually. Posology Adults Parkinson syndrome At the beginning of treatment and in severe cases, 10-20 mg Biperiden Lactate (=2–4 ml solution for injection) can be administered ...

Contraindications

Akineton should not be used in case of: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1existing untreated narrow angle glaucoma. Mechanical stenoses in the gastro-intestinal ...

Special warnings and precautions for use

Anti-cholinergic drugs, such as Biperiden, with a central mode of action can lead to an increased tendency to cerebral seizures. In patients with an increased tendency to convulsions, Akineton is to be ...

Interaction with other medicinal products and other forms of interaction

Combination with other anti-cholinergic drugs, e.g. psycho-pharmaceuticals, antihistamines, antiParkinson drugs and spasmolytic, can lead to an increase in central and peripheral side-effects. Taking quinidine ...

Fertility, pregnancy and lactation

Pregnancy Akineton should be administered during pregnancy only after a careful risk-benefit analysis, as no experience is available with its use in pregnancy. Breastfeeding Anti-cholinergic drugs can ...

Effects on ability to drive and use machines

Due to central nervous and peripheral side-effects, such as e.g. tiredness, dizziness and drowsiness, even when used correctly this drug can also change the ability to react to such an extent that – independent ...

Undesirable effects

Summary of the safety profile Side-effects may occur particularly at the beginning of treatment and if the dosage is increased too quickly. Central excitation effects are frequently seen in patients with ...

Overdose

Symptoms of overdose Symptoms of an intoxication resemble in principle that of atropine poisoning with peripheral anticholinergic symptoms (wide, slow-reacting pupils; dryness of the membranes; redness ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-parkinson drugs, anticholinergic agents, biperiden ATC code: N04AA02 Biperiden is a predominantly centrally acting anti-cholinergic. It has a peripheral effect, which is ...

Pharmacokinetic properties

Distribution The plasma protein binding of Biperiden amounts to about 95%. An apparent distribution volume of 24 ± 4.1 l/kg was determined for Biperiden. Biperiden is easily accessible to the tissue with ...

Preclinical safety data

Chronic toxicity Investigations on the chronic toxicity in rats and dogs gave no indication of organ toxicity. Mutagenic and tumourigenic potential In-vivo and in-vitro investigations with Biperiden gave ...

List of excipients

Sodium-(RS)-lactate Water for injection

Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

Shelf life

Shelf life: 5 years. This drug should no longer be used after the expiry date.

Special precautions for storage

Do not store above 25°C. Store ampoules in their outer carton, in order to protect the contents from light. Residual amounts of solution are to be discarded, once the ampoule has been opened.

Nature and contents of container

5 white-glass ampoules (type I) of 1 mlsolution for injection. 50 (10x5) white-glass ampoules (type I) of 1 ml solution for injection. Not all pack sizes may be marketed.

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

Desma GmbH, Peter-Sander-Str. 41b, 55252, Mainz-Kastel, Germany, Tel: +49 (0) 6134 21079 0, Fax: +49 (0) 6134 21079 24

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