Halofusol 0.5 mg/ml Oral Solution for Calves

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: VMD (Veterinary Medicines Directorate)

Thành phần hoạt chất:

Halofuginone

Sẵn có từ:

Laboratorios Karizoo S.A

Mã ATC:

QP51AX08

INN (Tên quốc tế):

Halofuginone

Dạng dược phẩm:

Oral solution

Loại thuốc theo toa:

POM-V - Prescription Only Medicine – Veterinarian

Nhóm trị liệu:

Cattle

Khu trị liệu:

Antiprotozoal

Tình trạng ủy quyền:

Authorized

Ngày ủy quyền:

2020-12-23

Đặc tính sản phẩm

Issued: December 2020
AN: 00029/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Halofusol 0.5 mg/ml oral solution for calves
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Halofuginone
0.50 mg
Equivalent to 0.6086 mg of halofuginone lactate
EXCIPIENTS:
Benzoic acid (E 210)
1.00 mg
Tartrazine (E 102)
0.03 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (newborn calves).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In new born calves:
•Prevention of diarrhoea due to diagnosed _ Cryptosporidium parvum_
in farms
with history of cryptosporidiosis.
Administration should start in the first 24 to 48 hours of life.
•Reduction of diarrhoea due to diagnosed _Cryptosporidium parvum_.
Administration should start within 24 hours after the onset of
diarrhoea.
In both cases, the reduction of oocysts excretion has been
demonstrated.
4.3
CONTRAINDICATIONS
Do not use on an empty stomach.
Do not use in cases of diarrhoea established for more than 24 hours
and in weak
animals.
Issued: December 2020
AN: 00029/2020
Page 2 of 6
Do not use in known cases of hypersensitivity to the active substance
or to any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Administer after colostrum feeding, or after milk or milk replacer
feeding only, using
either the metering pump included or any appropriate device for oral
administration.
Do not use on an empty stomach. For treatment of anorexic calves, the
product
should be administered in half a litre of an electrolyte solution. The
animals should
receive enough colostrum according to good breeding practice.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
People with known hypersensitivity to the active substance or any of
the excipients
should admi