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:

VetViva Richter GmbH

Φαρμακολογική κατηγορία (ATC):

QA03DB04

INN (Διεθνής Όνομα):

Metamizole sodium monohydrate; Hyoscine butylbromide

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

butylscopolamine and analgesics

Ημερομηνία της άδειας:

2015-09-18

Αρχείο Π.Χ.Π.

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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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
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-
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 advice immediately
and show