Sympagesic 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:

Dechra Regulatory B.V.

Φαρμακολογική κατηγορία (ATC):

QA03DB04

INN (Διεθνής Όνομα):

Metamizole sodium monohydrate; Hyoscine butylbromide

Δοσολογία:

500, 4 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:

2019-06-26

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
03 April 2020
CRN009P51
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sympagesic 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
​500.0 mg
​
(equivalent to 443 mg metamizole)
​
​
​
​
Hyoscine butylbromide
​4.0 mg
​
(equivalent to 2.76 mg hyoscine)
​
​
​
​
EXCIPIENTS:
​
​
Phenol
​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 smooth muscle spasms and pain
associated with underlying disorders of the
gastro-intestinal tract, urogenital system and bile excretory organs.
Horses only: Spasmodic colics.
Cattle, pigs, dogs: Supportive therapy for acute diarrhoea and
gastroenteritis.
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 obstruction in the gastro-intestinal system
- paralytic ileus
- disorders of the haematopoietic system
- coagulopathies
- renal insufficiency
- tachyarrhythmia
- glaucoma
- prostate adenoma.
Health Products Regulatory Authority
03 April 2020
CRN009P51
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 rea