Spasmium Comp. 500 mg/ml + 4 mg/ml Solution for Injection

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Hyoscine Butylbromide, Metamizole sodium monohydrate

Διαθέσιμο από:

Richter Pharma AG

Φαρμακολογική κατηγορία (ATC):

QA03DB04

INN (Διεθνής Όνομα):

Hyoscine Butylbromide, Metamizole sodium monohydrate

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Cattle, Dogs, Horses, Pigs

Θεραπευτική περιοχή:

Neurological Agent muscle relaxant

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2015-09-08

Αρχείο Π.Χ.Π.

Revised: January 2023
AN: 02966/2022
Page 1 of 6
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
Revised: January 2023
AN: 02966/2022
Page 2 of 6
-
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 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 self-injection, seek medical advi