BYSIMIN Solution for injection Ref.[50419] Active ingredients: Butylscopolamine

Revision Year: 2017  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus

Product name and form

Bysimin 20mg/ml solution for injection.

Pharmaceutical Form

Solution for injection.

Clear, colourless or almost colourless solution free from visible particles.

Qualitative and quantitative composition

Each 1ml ampoule contains 20 mg hyoscine butylbromide.

Excipient with known effect: Contains less than 1 mmol of sodium (23 mg) per dose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Butylscopolamine

Butylscopolamine is an antispasmodic agent which relaxes smooth muscle of the organs of the abdominal and pelvic cavities. It is believed to act predominantly on the intramural parasympathetic ganglia of these organs.

List of Excipients

Sodium chloride
Sodium hydroxide (for pH adjustment)
Hydrochloric acid, concentrated (for pH adjustment)
Water for injection

Pack sizes and marketing

Box containing 5 × 1 ml or 10 × 1 ml type I clear glass ampoules in PVC trays sealed with PE transparent foil.

Not all pack sizes may be marketed.

Marketing authorization holder

Medochemie Ltd, 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus

Drugs

Drug Countries
BYSIMIN Cyprus, Estonia, Croatia, Malta, Romania

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