Spasmium comp.

1 x 100 ml

Liquid for injection, solution

Active substance

Metamizole (Metamizole sodium) : 500 mg/ml

Hyoscine / Scopolamine (Butylscopolaminebromide / Hyoscine butylbromide) : 4 mg/ml

ATC code

QA03DB04 Butylscopolamine and analgesics

QA03DB Belladonna and derivatives in comb. with analgesics

QA03D Antispasmodics in comb. with analgesics

QA03 Drugs for functional gastrointestinal disorders

QA Alimentary tract and metabolism

Species

Horses, cattle, pigs, dogs

Indications

Horses, cattle, pigs, dogs:

Treatment of spasms or sustained increased tonus of smooth muscles of the gastrointestinal tract or of the urine and bile excretory organs associated with pain.

Horses:

Spasmodic colics.

Cattle, pigs, dogs:

As supportive therapy for acute diarrhoea.

Dose to be administered and administration route

Horse, cattle:	intravenous use
Pig:	intramuscular use
Dog:	intravenous or intramuscular use

Dosage instruction:

Horse:	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:	40 mg metamizole sodium monohydrate/kg body weight and 0.32 mg hyoscine butylbromide/kg body weight (i.e. 4 ml per 50 kg)
Calf:	50 mg metamizole sodium monohydrate/kg body weight and 0.4 mg hyoscine butylbromide/kg body weight (i.e. 1 ml per 10 kg)
Pig:	50 mg metamizole sodium monohydrate/kg body weight and 0.4 mg hyoscine butylbromide/kg body weight (i.e. 1 ml per 10 kg)
Dog:	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.

Adverse reactions

Horses, cattle, pigs, dogs:

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Anaphylactic-type reaction¹

Undetermined frequency (cannot be estimated from the available data):

Increased heart rate²;

Dry mucous membrane³;

Paralytic ileus³, Constipation³;

Urinary retention³;

Injection site pain⁴

¹Should be treated symptomatically.

²In horses and cattle. Slightly. Due to the parasympatholytic activity of hyoscine butylbromide.

³Based on pharmacological properties of hyoscine butylbromide.

⁴In 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. See the package leaflet for respective contact details.