Spasmipur 20 mg/ml solution for injection

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Hyoscine butylbromide

Dostępny od:

Richter Pharma AG

Kod ATC:

QA03BB01

INN (International Nazwa):

Hyoscine butylbromide

Dawkowanie:

20 milligram(s)/millilitre

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Dziedzina terapeutyczna:

butylscopolamine

Status autoryzacji:

Authorised

Data autoryzacji:

2019-05-10

Charakterystyka produktu

Health Products Regulatory Authority
21 May 2019
CRN000Y7P
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Spasmipur 20 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains:
​
​
ACTIVE SUBSTANCE:
​
​
Hyoscine butylbromide
​20 mg
​
(equivalent to 13.8 mg hyoscine)
​
​
EXCIPIENTS:
​
​
Benzyl alcohol (E1519)
​20 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horses, cattle, sheep and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of acute spasms of the gastrointestinal tract (colic) and of
the urinary tract.
As an aid in procedures for which reduced peristaltic activity of the
gastrointestinal tract or reduced contractions in the urinary
tract are required.
4.3 CONTRAINDICATIONS
Do not use in case of paralytic ileus, mechanical obstruction, or
cardiac disorders.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use in horses with glaucoma.
Do not use in horses less than 6 weeks of age.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Horses should be monitored carefully following treatment.
The treatment is essentially symptomatic and an appropriate handling
of the underlying disorder is necessary.
Health Products Regulatory Authority
21 May 2019
CRN000Y7P
Page 2 of 4
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
People with known hypersensitivity to hyoscine butylbromide or benzyl
alcohol should avoid contact with the veterinary
medicinal product.
Accidental self-injection may result in cardiac and circulatory
effects. Avoid accidental self-injection. In case of accidental
self-injection, seek medical advice immediately and show the package
leaflet or the label to the physi