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

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

4.1. Therapeutic indications

Acute spasm of the gastrointestinal tract, biliary tract, pancreas and urogenital tract.

As antispasmodic agent in radiology in different diagnostic procedures where spasm may be a problem.

4.2. Posology and method of administration

Posology

Adults

1-2 ampoules (20-40 mg) intramuscularly, subcutaneously or intravenously slowly.

Maximum daily dose: 100mg (5 vials).

Hyoscine butylbromide injection should not be taken on a continuous daily basis or for extended periods without investigating the cause of abdominal pain.

Elderly

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

Paediatric population

Not recommended for children.

Method of administration

For intramuscular, subcutaneous or slow intravenous injection.

4.9. Overdose

Symptoms

In the case of overdosage, anticholinergic symptoms such as urinary retention, dry mouth, reddening of the skin, tachycardia, inhibition of gastrointestinal motility and transient visual disturbances may occur, and Cheynes-Stokes respiration has been reported.

Treatment

Symptoms of hyoscine butylbromide overdosage respond to parasympathomimetics. For patients with glaucoma, an ophthalmologist should promptly be consulted, pilocarpine should be given locally. Cardiovascular complications should be treated according to usual therapeutic principles. In case of respiratory paralysis, intubation and artificial respiration.

Catheterisation may be required for urinary retention.

In addition, appropriate supportive measures should be used as required.

6.3. Shelf life

24 months.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

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.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

For single use only. Any unused solution should be discarded.

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