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

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Menbutone

Sẵn có từ:

V.M.D. n.v.,

Mã ATC:

QA05AX90

INN (Tên quốc tế):

Menbutone

Liều dùng:

100 milligram(s)/millilitre

Dạng dược phẩm:

Solution for injection

Loại thuốc theo toa:

POM: Prescription Only Medicine as defined in relevant national legislation

Khu trị liệu:

menbutone

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2017-03-24

Đặc tính sản phẩm

Health Products Regulatory Authority
27 November 2020
CRN009TCW
Page 1 of 4
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 the 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, sheep, goats:
Stimulation of hepato-digestive activity in case of digestive
disorders and hepatic insufficiency.
4.3 CONTRAINDICATIONS
Do not use in known 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
For horses only slow intravenous administration.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Accidental self-injection can induce irritation.
People with known hypersensitivity to menbutone should avoid contact
with the veterinary medicinal product. In case of
accidental self-injection, seek medical advice immediately and show
the package leaflet or the label to the physician.
Do not eat, drink or smoke while handling this product.
Health Products Regulatory Authority
27 November 2020
CRN009TCW
Page 2 of 4
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
After intravenous administration, salivation, lacrimation, tremors,
spontaneous urination and defecation may occur.
After intramuscular administration, reaction at the injection site
(oedema, ha