Spasmalgan compositum 500 mg/ml + 4 mg/ml Solution for injection for horses, cattle, pigs and dogs

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Metamizole sodium monohydrate; Hyoscine butylbromide

Διαθέσιμο από:

Veyx-Pharma GmbH

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 περιοχή:

butylscopolamine and analgesics

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2020-05-29

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
05 August 2021
CRN00CGMM
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Spasmalgan compositum 500 mg/ml + 4 mg/ml Solution for injection for
horses, cattle, pigs and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCES:
​
​
Metamizole sodium monohydrate
​500.00 mg
​
(equivalent to 443.00 mg metamizole)
​
​
Hyoscine butylbromide
​4.00 mg
​
(equivalent to 2.76 mg hyoscine)
​
​
​
​
EXCIPIENTS:
​
​
Benzyl alcohol (E1519)
​10.00 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, cattle, pigs and dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
Horse:
Spasmodic colics
Cattle/Calf, pig, dog:
As supportive therapy for acute diarrhoea.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
Due to the content of metamizole sodium, do not use in case of:
- disorders of the haematopoietic system
- gastrointestinal ulcers
- chronic gastro-intestinal disorders
- renal insufficiency
- coagulopathies
Due to the content of hyoscine butylbromide do not use in case of:
- mechanic stenoses in the gastro-intestinal system
- tachyarrhythmia
- glaucoma
- prostate adenoma.
Health Products Regulatory Authority
05 August 2021
CRN00CGMM
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 reve