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

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Metamizole sodium monohydrate; Hyoscine butylbromide

Διαθέσιμο από:

Richter Pharma AG

Φαρμακολογική κατηγορία (ATC):

QA03DB04

INN (Διεθνής Όνομα):

Metamizole sodium monohydrate; Hyoscine butylbromide

Δοσολογία:

500.0/4.0 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle, Dogs, Horses, Pigs

Θεραπευτική περιοχή:

butylscopolamine and analgesics

Θεραπευτικές ενδείξεις:

N.S.A.I.D.

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2015-09-18

Αρχείο Π.Χ.Π.

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