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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Butaphosphan (Butafosfan); Cyanocobalamin

Available from:

Veyx-Pharma GmbH

ATC code:

QA12CX99

INN (International Name):

Butaphosphan (Butafosfan); Cyanocobalamin

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

other mineral products, combinations

Authorization date:

2023-09-22

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vey Tosal 100 mg/ml + 0.05 mg/ml solution for injection for horses,
cattle, dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCES:
Butafosfan:
100.00 mg
Cyanocobalamin (vitamin B12):
0.05 mg
EXCIPIENT:
Benzyl alcohol (E 1519)
20.00 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
_ _
Solution for injection.
Clear, pink solution.
_ _
_ _
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, horses, 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.
Supporting muscle function in the presence of deficiencies of
phosphorous and/or cyanocobalamin.
4.3
CONTRAINDICATIONS
_ _
Do not use in cases of 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 B
12
.
_ _
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
This veterinary medicinal product contains benzyl alcohol which may
cause hypersensitivity (allergic)
reactions. People with known hypersensitivity to benzyl alcohol should
avoid contact with the veterinary
medicinal product.
This pro