Butasal 100 mg/ml + 0.05 mg/ml solution for injection for horses, cattle, dogs and cats

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Cyanocobalamin; Butaphosphan (Butafosfan)

Disponible depuis:

Interchemie Werken De Adelaar Eesti AS.

Code ATC:

QA12CX99

DCI (Dénomination commune internationale):

Cyanocobalamin; Butaphosphan (Butafosfan)

Dosage:

100.0 + 0.05 milligram(s)/millilitre

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Domaine thérapeutique:

other mineral products, combinations

Statut de autorisation:

Authorised

Date de l'autorisation:

2021-07-23

Résumé des caractéristiques du produit

Health Products Regulatory Authority
23 July 2021
CRN00C1TH
Page 1 of 4
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.
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
Health Products Regulatory Authority
23 July