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

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Cyanocobalamin; Butaphosphan (Butafosfan)

Tillgänglig från:

CP-Pharma Handelsgesellschaft mbH

ATC-kod:

QA12CX99

INN (International namn):

Cyanocobalamin; Butaphosphan (Butafosfan)

Läkemedelsform:

Solution for injection

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapiområde:

other mineral products, combinations

Tillstånd datum:

2023-09-01

Produktens egenskaper

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Catophos 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 prod