Menbutil 100 mg/ml solution for injection for cattle, pigs, horses, sheep and goats

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Menbutone

Available from:

aniMedica 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 area:

menbutone

Authorization status:

Authorised

Authorization date:

2018-12-14

Summary of Product characteristics

Health Products Regulatory Authority
20 March 2020
CRN0099JD
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Menbutil 100 mg/ml solution for injection for cattle, pigs, horses,
sheep and goats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml contains:
​
​
​
Active substance:
​
​
​
Menbutone
​100.0
​
mg
​
​
​
​
Excipients:
​
​
​
Chlorocresol
​2.0
​
mg
​
Sodium metabisulphite (E 223)
​2.0
​
mg
​
​
​
​
For the full list of excipients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs, horses, sheep and goats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Stimulation of hepato-digestive activity in case of digestive
disorders and hepatic insufficiency.
4.3 CONTRAINDICATIONS
Do not use in cases 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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Slow intravenous administration is advised (not less than 1 minute) to
avoid the side effects described in section 4.6.
It is recommended not to inject intramuscularly more than 20 ml on one
application site.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Do not eat, drink or smoke while handling the product.
People with known hypersensitivity to menbutone should avoid contact
with the veterinary medicinal product.
Accidental self-injection can induce irritation.
In case of accidental self-injection, seek medical advice immediately
and show the package leaflet or the label to the physician.
Health Products Regulatory Authority
20 March 2020
CRN0099JD
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
After intraveno