MIOCHOL-E Powder and solvent for instillation solution (2014)
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Περιεχόμενα
Name of the medicinal product
Miochol-E, 20mg, Powder and Solvent for instillation solution for intraocular use.
Qualitative and quantitative composition
Each powder vial contains 20mg acetylcholine chloride. Miochol-E contains 10mg/ml of acetylcholine chloride, (20mg in 2ml) upon reconstitution. For excipients, see section 6.1.
Pharmaceutical form
Powder and solvent for instillation solution for intraocular use. Vial: white solid or powder Ampoule: clear, colourless solution Filter: syringe filter
Therapeutic indications
To obtain rapid and complete miosis after delivery of the lens in cataract surgery as well as in penetrating keratoplasty, iridectomy and other anterior segment surgery where rapid complete miosis is required. ...
Posology and method of administration
Miochol-E is for intraocular irrigation only. A freshly prepared 1% solution should be used in the anterior chamber of the eye during surgery. Adults and Elderly In most cases a satisfactory miosis, which ...
Contraindications
There are no known contra-indications to the use of Miochol-E in cataract or anterior segment surgery.
Special warnings and precautions for use
If miosis is to be obtained quickly and completely, obstructions to miosis such as anterior or posterior synechiae may require surgery prior to administration of Miochol-E. In cataract surgery Miochol-E ...
Interaction with other medicinal products and other forms of interaction
Although clinical studies with acetylcholine chloride and animal studies with acetylcholine or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there ...
Pregnancy and lactation
The safety and efficacy of Miochol-E in pregnancy and lactation have not been established. Miochol-E should not be used in pregnant or lactating patients.
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
Adverse reactions which are indicative of systemic absorption have been reported rarely in the literature. Symptoms include bradycardia, hypotension, flushing, breathing difficulties and sweating. Isolated ...
Overdose
The symptoms of overdosage are likely to be effects resulting from systemic absorption, ie bradycardia, hypotension, flushing, breathing difficulties and sweating. Atropine sulphate (0.5-1mg) should be ...
Pharmacodynamic properties
Acetylcholine is a physiological neuromediator of postganglionic parasympathetic nerve fibres (muscarinic action), skeletal muscles and ganglia of the sympathetic system (nicotinic action). The ocular ...
Pharmacokinetic properties
Topical: Not applicable.
Preclinical safety data
The active ingredient of Miochol-E is acetylcholine, a natural neurohormonal transmitter the pharmacological activity and toxicity of which have been clearly defined. The effect of Miochol has been demonstrated ...
List of excipients
Vial: Mannitol Ampoule: Sodium acetate trihydrate Magnesium chloride hexahydrate Potassium chloride Calcium chloride dihydrate Water for injections
Incompatibilities
None known. The filter hub is recommended only for use with Miochol-E.
Shelf life
Shelf life Unopened: 24 months. Opened: Use immediately after reconstitution.
Special precautions for storage
Do not store above 25°C. Do not freeze. Do not resterilise.
Nature and contents of container
Miochol-E is supplied as packs containing 1 blister and 1 filter hub. Packs are subjected to antimicrobial treatment with ethylene oxide. One blister contains: vial containing powder; clear, colourless ...
Special precautions for disposal and other handling
The reconstituted preparation is a clear, colourless solution. Warning: Do not use if blister or peelable backing is damaged or broken. Open under aseptic conditions only. The contents of the blister can ...
Marketing authorization holder
DR GERHARD MANN CHEM-PHARM FABRIK GMBH BRUNSBUTTELER DAMM 165-173 13581 BERLIN GERMANY
Marketing authorization number(s)
PL 13757/0017
Date of first authorization / renewal of the authorization
1 May 2001
Date of revision of the text
12/09/2014
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