Target species
Horses, cattle, pigs, dogs.
Indications for use
Horses, cattle, pigs, dogs: treatment of smooth muscle spasms and pain associated with underlying disorders of the gastro-intestinal tract, urogenital system and bile excretory organs.
Horses only: Spasmodic colics.
Cattle, pigs, dogs: Supportive therapy for acute diarrhoea and gastroenteritis.
Contraindications
Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Do not use in cases of:
- gastro-intestinal ulceration
- chronic gastro-intestinal disorders
- mechanic obstruction in the gastro-intestinal system
- paralytic ileus
- disorders of the haematopoietic system
- coagulopathies
- renal insufficiency
- tachyarrhythmia
- glaucoma
- prostate adenoma.
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 veterinary medicinal product to animals
In a very small number of people, metamizole can cause reversible, but potentially serious agranulocytosis and other reactions such as skin allergy. Take care to avoid self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Avoid skin and eye contact. People with known hypersensitivity to metamizole or hyoscine butylbromide should avoid contact with the veterinary medicinal product. Avoid use of the product if you are known to be sensitive to pyrazolones, or are sensitive to acetylsalicylic acid.
Wash splashes from skin and eyes immediately.
Adverse reactions
In very rare cases, anaphylactic reactions may occur and should be treated symptomatically.
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 dogs painful reactions at the injection site can occur immediately after injection, which abate rapidly and have no negative impact on the expected therapeutic benefit.
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 and lactation
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. Metabolites of metamizole cross the placental barrier and penetrate into milk. Therefore this product should be used only according to the benefit-risk assessment by the responsible veterinarian.
Interactions
The effects of metamizole and/or hyoscine butylbromide may be potentiated by concurrent use of other anticholinergic or analgesic substances.
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 antihistaminics as well as the tachycardic effects of β sympathomimetics may be enhanced by this veterinary medicinal product.
Amounts to be administered and administration route
Horse: slow intravenous use
Pig: slow intravenous use or intramuscular use
single injection of 20-25 mg metamizole sodium monohydrate/kg body weight and 0.16-0.2 mg hyoscine butylbromide/kg body weight i.e. once 4-5 ml per 100 kg.
For pigs, maximum injection volume is 5 ml per injection site.
Cattle: slow intravenous use or intramuscular use
Up to twice daily for three days, 20-25 mg metamizole sodium monohydrate/kg body weight and 0.16-0.2 mg hyoscine butylbromide/kg body weight i.e. 4-5 ml per 100 kg twice daily up to three days.
Dog: intravenous (slow) or intramuscular use,
single injection of 50 mg metamizole sodium monohydrate/kg body weight and 0.4 mg hyoscine butylbromide/kg body weight i.e. once 0.5 ml per 5 kg. Treatment can be repeated after 24 hours if necessary.
The stopper must not be punctured more than 25 times.
Overdose
In case of overdosage, the symptoms of atropine intoxication can be observed (dryness of the mucous membranes, mydriasis, tachycardia), due to the parasympatholytic activity of hyoscine butylbromide.
In case of overdosage, treatment should be discontinued. Parasympaticomimetics, such as physostigmine and neostigmine, are recommended as antidotes to hyoscine butylbromide. A specific antidote for metamizole sodium is not available. Therefore symptomatic treatment should be initiated in case of overdosage.
Withdrawal periods
Cattle:
Meat and offal: 18 days following intravenous administration
Meat and offal: 28 days following intramuscular administration
Not authorised for use in animals producing milk for human consumption.
Do not use in pregnant animals which are intended to produce milk for human consumption within 2 months of expected parturition.
Horses:
Meat and offal: 15 days
Not authorised for use in animals producing milk for human consumption.
Do not use in pregnant animals which are intended to produce milk for human consumption within 2 months of expected parturition.
Pigs:
Meat and offal: 15 days