Introduction

Company name: Boehringer Ingelheim Limited

Address: Ellesfield Avenue

Bracknell

Berkshire RG12 8YS

Telephone: Sales & Marketing Enquiries 01344 746959

Telephone: Technical Enquiries 01344 746957

Fax: 01344 741349

Presentation

Solution for injection. Each ml contains 4 mg butylscopolamine bromide and 500 mg metamizole (INN) as active ingredients plus 5 mg phenol as preservative.

Uses

Actions: Butylscopolamine bromide is a spasmolytic and analgesic agent with particular activity on the smooth muscle of the digestive and urinary systems. Metamizole is a non-steroidal anti-inflammatory drug of the pyrazolone group and also has analgesic and anti-pyretic properties.

Indications

- As an aid in the control of pain associated with simple equine colic and as a diagnostic aid in more severe equine colics.

- For the control of diarrhoea in cattle, horses and dogs particularly when pain or abdominal discomfort is present.

- For the control of pain associated with urinary obstruction in horses and dogs.

Dosage and administration

Use aseptic techniques

Horses	5 ml per 100 kg bodyweight by intravenous route only
Adult Cattle	5 ml per 100 kg bodyweight by intravenous or intramuscular injection
Dogs	0.1 ml per kg bodyweight by intravenous or intramuscular injection

Contra-indications, warnings, etc

Due to a risk of local reactions, do not use the intramuscular route in horses.

Studies in laboratory animals (rabbit, rat) have not produced any evidence of a teratogenic effect. No information on use during pregnancy in the target species is available and therefore should not be used.

Withdrawal periods

Animals should not be slaughtered for human consumption during treatment. Horses - 12 days

Cattle - 9 days after intravenous injection, 28 days after intramuscular injection.

Do not use in cows producing milk for human consumption.

The effects of metamizole and/or butylscopolamine bromide may be potentiated by concurrent use of other anticholinergic or analgesic drugs.

The acute toxicity of both compounds is very low. In studies with rats, the symptoms were non-specific and included ataxia, mydriasis, tachycardia, prostration, convulsions, coma and respiratory signs.

Symptomatic treatment should be initiated in case of overdosage.

Take care to avoid self-injection. In a very small number of people, metamizole can cause reversible, but potentially serious agranulocytosis and other reactions such as skin allergy. Avoid use of the product if you are known to be sensitive to pyrazolones, or are sensitive to aspirin. Wash any splashes from the skin. If accidental self-injection occurs, seek medical advice and show the Doctor the product packaging.

Unused product and containers should be disposed of in accordance with national requirements.

Pharmaceutical precautions

Do not store above 25°C. Protect from light. Avoid introduction of contamination during use. Should any apparent growth or discolouration occur, discard the product.

Following withdrawal of the first dose use the product within 28 days after which discard unused material.

Keep out of the reach and sight of children.

For animal treatment only.

Legal category

POM-V

Packaging Quantities

100 ml multidose glass injection bottles.

Further information

In horses, a slight transient increase in heart rate may be observed due to the parasympatholytic activity of butylscopolamine bromide.

Marketing authorisation number

Vm 00015/4065.