AKINETON Solution for injection
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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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