SPASMIUM COMP. 500 MG/ML + 4 MG/ML SOLUTION FOR INJECTION

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

METAMIZOLE SODIUM MONOHYDRATE, HYOSCINE BUTYLBROMIDE

Dostupno od:

Richter Pharma AG

ATC koda:

QA03DB04

INN (International ime):

METAMIZOLE SODIUM MONOHYDRATE, HYOSCINE BUTYLBROMIDE

Doziranje:

500.0/4.0

Farmaceutski oblik:

Solution for Injection

Tip recepta:

POM

Terapijska grupa:

Bovine, Canine, Equine, Porcine

Područje terapije:

Butylscopolamine and analgesics

Terapijske indikacije:

N.S.A.I.D

Status autorizacije:

Authorised

Datum autorizacije:

2015-09-18

Svojstava lijeka

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