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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

MIOCHOL-E Powder and solvent for instillation solution (2014)

Αναφορές

Βιβλιογραφική αναφορά

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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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