ANTICHOLIUM Injection solution (2011)
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Περιεχόμενα
Name of the medicinal product
Anticholium.
Qualitative and quantitative composition
5 ml injection solution contains: 2.0 mg physostigmine salicylate (Ph. Eur.)
Pharmaceutical form
Injection solution.
Therapeutic indications
For the treatment of postoperative disorders: Central anticholinergic syndrome (CAS) Delayed postoperative awakening Shivering As antidote and/or antagonist in case of intoxication with and/or overdose ...
Posology and method of administration
In case of intoxication: Paediatric population Infants: Start with a low dose of 0.5 mg of physostigmine salicylate administered intravenously or intramuscularly, repeat this dose every 5 minutes up to ...
Contraindications
Anticholium must not be used in case of hypersensitivity to physostigmine salicylate (Ph. Eur.), sodium metabisulfite (Ph. Eur.) or to any of the excipients. Bronchial asthma, gangrene, coronary heart ...
Special warnings and precautions for use
Due to the content of sodium metabisulfite, hypersensitivity reactions may occur in individual cases, particularly in asthmatics, which are manifested in nausea, diarrhoea, wheezing, acute asthma attack, ...
Interaction with other medicinal products and other forms of interaction
Caution should be exercised in case of simultaneous administration of other cholinesterase inhibitors because of the potentiating effect. Anticholium is contraindicated in intoxication with depolarizing ...
Pregnancy and lactation
There is no experience of the use of Anticholium in pregnant women. Physostigmine, the active substance contained in Anticholium, passes to the placenta. Animal studies are insufficient with respect to ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Nausea, vomiting, change of heart rate (both bradycardia and tachycardia), sinoatrial block, hypotension, hypersalivation, sweating. In rare cases, sodium metabisulfite (Ph. Eur.) may cause hypersensitivity ...
Overdose
Overdose of Anticholium can cause bradycardia, hypersalivation, vomiting and generalized tonic-clonic seizures. Patients should be closely monitored by ECG. Intravenous administration of atropine up to ...
Pharmacodynamic properties
Pharmacotherapeutic group: Indirect parasympathomimetic ATC code: S01EB05 Like all medically used cholinesterase inhibitors, physostigmine is a carbamate, as far as its chemical structure is concerned. ...
Pharmacokinetic properties
In animals, the elimination half-life of physostigmine is between 20 and 30 minutes after intravenous administration, in human subjects it is between 18 and 30 minutes. This is in conformity with clinical ...
Preclinical safety data
Toxicology Toxicity studies with single administration have shown that the average lethal dose in rats is 1.28 mg/kg bodyweight after intramuscular administration, in rabbits it is 1.57 mg/kg bodyweight. ...
List of excipients
2.5 mg sodium metabisulfite (Ph. Eur., equivalent max. 1.7 mg SO2), sodium edetate (Ph. Eur.), water for injections, nitrogen
Incompatibilities
None known.
Shelf life
Shelf life in undamaged ampoules: 3 years. The infusion solution should be used immediately after preparation. Do not use the medicinal product after the expiry date stated on the pack.
Special precautions for storage
Do not store above 25°C, store in the outer packaging, protected from light.
Nature and contents of container
5 ml ampoules in packs containing 1 to 5 ampoules.
Marketing authorization holder
DR. FRANZ KÖHLER CHEMIE GMBH, Werner-von-Siemens-Str. 22-28, D-64625 Bensheim, Telephone 0 62 51/1083-0, Telefax 0 62 51 / 1083-146, E-Mail: info@koehler-chemie.de
Marketing authorization number(s)
6073341.00.00
Date of first authorization / renewal of the authorization
28.11.2005
Date of revision of the text
January 2011
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