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

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Metamizole sodium monohydrate; Hyoscine butylbromide

Beschikbaar vanaf:

VetViva Richter GmbH

ATC-code:

QA03DB04

INN (Algemene Internationale Benaming):

Metamizole sodium monohydrate; Hyoscine butylbromide

farmaceutische vorm:

Solution for injection

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutisch gebied:

butylscopolamine and analgesics

Autorisatie datum:

2015-09-18

Productkenmerken

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_[Version 8.1,01/2017] _
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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
3
-
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