Alvebuton 100 mg/ml Solution for injection for cattle, pigs, horses, sheep, goats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Menbutone

Available from:

Alvetra u. Werfft GmbH

ATC code:

QA05AX90

INN (International Name):

Menbutone

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Goats, Horses, Pigs, Sheep

Therapeutic area:

menbutone

Therapeutic indications:

Alimentary Tract Preparation

Authorization status:

Authorised

Authorization date:

2017-03-24

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Alvebuton 100 mg/ml Solution for injection for cattle, pigs, horses,
sheep, goats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Menbutone ............................. 100.00 mg
EXCIPIENTS:
Chlorocresol................................ 2.00 mg
Sodium metabisulfite (E 223)..... 2.00 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, pale yellow to yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs, horses, sheep, goats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle, pigs, horses, sheeps, goats:
Stimulation of hepato-digestive activity in case of digestive
disorders and hepatic insufficiency.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
Do not use in animals with cardiac disease or in the late stages of
pregnancy.
Please refer to section 4.7 “Use during pregnancy, lactation or
lay”.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
For horses only intravenous administration.
The intravenous administration should be done slowly (not less than 1
minute) to avoid the side effects described in
section 4.6.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
In case of accidental self-injection,
seek medical advice immediately and show the package leaflet or the
label to the
physician. Accidental self-injection can induce irritation.
People with known hypersensitivity to menbutone should avoid contact
with the veterinary medicinal product.
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