BYSIMIN Solution for injection (2017)

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Περιεχόμενα

1. Name of the medicinal product

Bysimin 20mg/ml solution for injection.

2. 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.

3. Pharmaceutical form

Solution for injection. Clear, colourless or almost colourless solution free from visible particles.

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 ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hyoscine butylbromide injection should not be administered to patients with myasthenia gravis, megacolon, narrow ...

4.4. Special warnings and precautions for use

Hyoscine butylbromide injection should not be given by intramuscular injection to patients being treated with anticoagulant drugs since intramuscular haematoma may occur. These patients can receive slow ...

4.5. Interaction with other medicinal products and other forms of interaction

The anticholinergic effect of drugs such as tri- and tetracyclic antidepressants, antihistamines, antipsychotics, quinidine, amantadine, disopyramide and other anticholinergics (e.g. tiotropium, ipratropium, ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are limited data from the use of hyoscine butylbromide in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. As a precautionary measure hyoscine butylbromide ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as accommodation disorder or ...

4.8. Undesirable effects

Many of the listed undesirable effects can be assigned to the anticholinergic properties of hyoscine butylbromide. Anticholinergic side effects of hyoscine butylbromide are usually mild and transient. ...

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 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Belladonna alkaloids, semisynthetic, quaternary ammonium compounds ATC code: A03BB01 Hyoscine butylbromide is an antispasmodic agent which relaxes smooth muscle ...

5.2. Pharmacokinetic properties

Absorption and distribution After intravenous administration hyoscine butylbromide is rapidly distributed (t½α=4 min, t½β=29 min) into the tissues. The volume of distribution (Vss) is 128 L (corresponding ...

5.3. Preclinical safety data

In limited reproductive toxicity studies hyoscine butylbromide showed no evidence of teratogenicity in rats at 200 mg/kg in the diet or in rabbits at 200 mg/kg by oral gavage or 50 mg/kg by subcutaneous ...

6.1. List of excipients

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

6.2. Incompatibilities

None known.

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.

7. Marketing authorization holder

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

10. Date of revision of the text

2017-03-08

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