SPASMIUM COMP. 500 MG/ML + 4 MG/ML SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-10-2015
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
METAMIZOLE SODIUM MONOHYDRATE, HYOSCINE BUTYLBROMIDE
Available from:
Richter Pharma AG
ATC code:
QA03DB04
INN (International Name):
METAMIZOLE SODIUM MONOHYDRATE, HYOSCINE BUTYLBROMIDE
Dosage:
500.0/4.0
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Canine, Equine, Porcine
Therapeutic area:
Butylscopolamine and analgesics
Therapeutic indications:
N.S.A.I.D
Authorization status:
Authorised
Authorization date:
2015-09-18
Summary of Product characteristics
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 18/09/2015_
_CRN 7018452_
_page number: 1_
4.3 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 stenoses in the gastro-intestinal system
-
paralytic ileus in horses
-
disorders of the haematopoietic system
-
coagulopathies
-
renal insufficiency
-
tachyarrhythmia
-
glaucoma
-
prostate adenoma.
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 adminis
Read the complete document
