Butasal 100 mg/ml + 0.05 mg/ml Solution for Injection for Horses, Cattle, Dogs and Cats

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Butafosfan, Cyanocobalamin

Tilgængelig fra:

Interchemie Werken De Adelaar Eesti AS

ATC-kode:

QA12CX99

INN (International Name):

Butafosfan, Cyanocobalamin

Lægemiddelform:

Solution for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cats, Cattle, Dogs, Horses

Terapeutisk område:

Vitamin; Mineral

Autorisation status:

Authorized

Autorisation dato:

2021-05-06

Produktets egenskaber

Issued: May 2021
AN: 01302/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Butasal 100 mg/ml + 0.05 mg/ml solution for injection for horses,
cattle, dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of the solution for injection contains:
ACTIVE SUBSTANCES:
Butafosfan
100.0 mg
Cyanocobalamin (vitamin B12)
0.05 mg
EXCIPIENTS:
Benzyl alcohol (E1519)
10.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear red solution without visible particles.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Horses, cattle, dogs and cats.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As supportive treatment of metabolic or reproductive disorders, when
supplementation of phosphorous and cyanocobalamin is needed.
In case of peri-parturient metabolic disorders, tetany and paresis
(milk fever), the
product should be administered in addition to magnesium and calcium,
respectively.
4.3.
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substances
or to any of the
excipients.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
It is recommended to determine the cause(s) of the metabolic or
reproductive disorders
to define the most appropriate measures of prevention and treatment
and the need for
a therapy with supplemental phosphorus and vitamin B12.
Issued: May 2021
AN: 01302/2020
Page 2 of 5
4.5.
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Due to a deficiency in glucuronidating metabolic pathways in cats,
which are involved
in benzyl alcohol metabolism, this veterinary medicinal product should
be used with
caution and the recommended dose should be strictly observed in this
species.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Benzyl alcohol may cause hypersensitivity (allergic reactions). People
with known
hypersensitivity to benzyl alcohol should avoid contact with the
product.
The product can cause skin, eye o