Spasmium Comp 500mg/ml + 4mg/ml Solution for Injection 100ml

Spasmium Comp injection: metamizole with hyoscine butylbromide

Spasmium Comp contains two active substances. Metamizole is a pyrazolone derivative used as an analgesic, antipyretic and spasmolytic agent; it inhibits the synthesis of prostaglandins by blocking cyclooxygenase. Hyoscine butylbromide is a parasympatholytic agent that inhibits the contraction of smooth muscles of the gastrointestinal tract and of the urine and bile excretory organs.

In horses Spasmium Comp is licensed for spasmodic colics and is given as a single intravenous injection. In cattle, pigs and dogs it is also used as supportive therapy for acute diarrhoea.

Key features of Spasmium Comp 500mg/ml + 4mg/ml Solution for Injection:

• Two active substances per ml: metamizole sodium monohydrate 500mg and hyoscine butylbromide 4mg.
• Licensed for horses, cattle, pigs and dogs.
• Horses: 2.5ml per 50kg by intravenous injection, as a single injection.
• 100ml vial: the stopper must not be punctured more than 25 times; use within 28 days of first opening.
• Combination product: for hyoscine butylbromide on its own, Spasmipur 20mg/ml is the related product.

For use under veterinary direction

Spasmium Comp is a prescription-only veterinary medicine. When given intravenously it should be administered slowly. See our range of vet medicines and equine care products.

Always follow the directions and dosage given to you by your prescriber.

Administration routes

• Intravenous use (i.v.): horses, cattle, dogs
• Intramuscular use (i.m.): pigs, dogs

Dosage

Horses (i.v.): 25 mg metamizole sodium monohydrate/kg body weight and 0.2 mg hyoscine butylbromide/kg body weight (i.e. 2.5 ml per 50 kg)

Cattle (i.v.): 40 mg metamizole sodium monohydrate/kg body weight and 0.32 mg hyoscine butylbromide/kg body weight (i.e. 4 ml per 50 kg)

Calves (i.v.): 50 mg metamizole sodium monohydrate/kg body weight and 0.4 mg hyoscine butylbromide/kg body weight (i.e. 1 ml per 10 kg)

Pigs (i.m.): 50 mg metamizole sodium monohydrate/kg body weight and 0.4 mg hyoscine butylbromide/kg body weight (i.e. 1 ml per 10 kg)

Dogs (i.v. or i.m.): 50 mg metamizole sodium monohydrate/kg body weight and 0.4 mg hyoscine butylbromide/kg body weight (i.e. 0.1 ml per kg)

Treatment frequency

• Cattle and calves: up to twice daily for three days.
• Horses and pigs: single injection.
• Dogs: single injection. Treatment can be repeated after 24 hours if necessary.

The stopper must not be punctured more than 25 times.

Due to the risk of anaphylactic shock metamizole-containing solutions should be administered slowly when given intravenously.

Before use

Do not use in cases 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 stenoses in the gastro-intestinal system
• paralytic ileus in horses
• 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.

Precautions for the person giving the injection:

• 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.
• People with known hypersensitivity to metamizole or hyoscine butylbromide should avoid contact with the veterinary medicinal product. Avoid use of the veterinary medicinal product if you are known to be sensitive to pyrazolones or are sensitive to acetylsalicylic acid.
• Wash splashes from skin and eyes immediately.

Pregnancy and lactation: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies in rabbits and rats have not produced any evidence of teratogenic effects. An effect upon the smooth muscles of the birth canal can occur. Metabolites of metamizole cross the placental barrier and penetrate into milk. Use 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 chinidin and antihistaminics as well as the tachycardic effects of β-sympathomimetics may be enhanced by this veterinary medicinal product.

Withdrawal periods: Meat and offal: horses, cattle (i.v.) 12 days; pigs (i.m.) 15 days. Milk: cattle (i.v.) 96 hours. Not authorised for use in mares producing milk for human consumption.

Adverse events and overdose

Horses, cattle, pigs, dogs:

• Very rare (less than 1 animal in 10,000 animals treated, including isolated reports): anaphylactic-type reaction, which should be treated symptomatically.
• Undetermined frequency (cannot be estimated from the available data): increased heart rate (in horses and cattle; slightly; due to the parasympatholytic activity of hyoscine butylbromide); dry mucous membrane, paralytic ileus, constipation and urinary retention (based on pharmacological properties of hyoscine butylbromide); injection site pain (in dogs; can occur immediately after injection, which abate rapidly without negative impact on the expected therapeutic benefit).

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system.

Overdose: The acute toxicity of both active substances is very low. In studies with rats the symptoms were non-specific and included: ataxia, mydriasis, tachycardia, prostration, convulsions, unconsciousness and respiratory signs. In case of overdosage treatment should be discontinued. Physostigmin is recommended as an antidote to hyoscine butylbromide. A specific antidote for metamizole sodium is not available. Therefore, symptomatic treatment should be initiated in case of overdosage. Due to the parasympatholytic activity of hyoscine butylbromide a slight increase in the heart rate was observed in some cases in horses and cattle following administration of the double therapeutic dose.

Storage and disposal

• After first opening the immediate packaging do not store above 25°C.
• Shelf life after first opening the immediate packaging: 28 days.
• Medicines should not be disposed of via wastewater. Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

Active ingredients: Metamizole sodium monohydrate 500.0 mg per ml (equivalent to 443 mg metamizole), Hyoscine butylbromide 4.0 mg per ml (equivalent to 2.76 mg hyoscine).

Other ingredients: Phenol (as preservative) 5.0 mg per ml, Tartaric acid (E 334), Water for injections.

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