Spasmium comp. 500 mg/ml + 4 mg/ml solution for injection

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Metamizole sodium monohydrate; Hyoscine butylbromide

Beschikbaar vanaf:

Richter Pharma AG

ATC-code:

QA03DB04

INN (Algemene Internationale Benaming):

Metamizole sodium monohydrate; Hyoscine butylbromide

Dosering:

500.0/4.0 milligram(s)/millilitre

farmaceutische vorm:

Solution for injection

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutische categorie:

Cattle, Dogs, Horses, Pigs

Therapeutisch gebied:

butylscopolamine and analgesics

therapeutische indicaties:

N.S.A.I.D.

Autorisatie-status:

Authorised

Autorisatie datum:

2015-09-18

Productkenmerken

Health Products Regulatory Authority
20 July 2020
CRN009GP4
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Spasmium comp. 500 mg/ml + 4 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Metamizole sodium monohydrate 500.0 mg
(equivalent to 443 mg metamizole)
Hyoscine butylbromide 4.0 mg
(equivalent to 2.76 mg hyoscine)
EXCIPIENTS:
Phenol (as preservative) 5.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, cattle, pigs, dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Horses, cattle, pigs, dogs: Treatment of spasms or sustained increased
tonus of smooth muscles of the gastro-intestinal tract or
of the urine and bile excretory organs associated with pain.
Horses only: Spasmodic colics.
Cattle, pigs, dogs only: As supportive therapy for acute diarrhoea.
4.3 CONTRAINDICATIONS
Do not use in known 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.
Health Products Regulatory Authority
20 July 2020
CRN009GP4
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
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 s