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Contra-indications, warnings, etc
Due to a risk of local reactions, do not use the intramuscular route in horses.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in horses suffering from paralytic ileus.
Special precautions for use in animals
Due to the risk of anaphylactic shock metamizole-containing solutions should be administered slowly when given intravenously.
Special Precautions to be taken by the person administering the product to animals
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.
Adverse Reactions
In horses, a slight transient increase in heart rate may be observed due to the parasympatholytic activity of butylscopolaminiumbromide (hyoscine butylbromide). In very rare cases, cardiovascular shock may occur if the intravenous injection is administered too fast. In horses, mild tachycardia may be observed occasionally due to the parasympatholytic activity of hyoscine butylbromide.
In very rare cases, anaphylactic reactions may occur and should be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy
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 this product should not be used.
Interaction with other medicinal products and other forms of interactions
The effects of metamizole and/or butylscopolamine bromide may be potentiated by concurrent use of other anticholinergic or analgesic drugs.
Concomitant use of inducers of hepatic microsomal enzymes (e.g., barbiturates, phenylbutazone) reduces the half-life period and hence the duration of action of metamizole. Simultaneous administration of neuroleptics, especially phenothiazine derivatives, may lead to severe hypothermia. Furthermore, the risk of gastro-intestinal bleeding is increased upon concurrent use of glucocorticoids. The diuretic effect of furosemide is attenuated.
Co-administration of other weak analgesics increases the effects and side-effects of metamizole.
The anticholinergic action of quinidine and antihistaminic as well as the tachycardic effects of β sympathomimetics may be enhanced by this veterinary medicinal product.
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.
Withdrawal periods
Animals should not be slaughtered for human consumption during treatment.
Meat and offal:
Horses - 12 days
Cattle - 9 days after intravenous injection, 28 days after intramuscular injection.
Do not use in cows producing milk for human consumption.