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

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Butafosfan, Cyanocobalamin

Available from:

CP Pharma Handelsgesellschaft mbH

ATC code:

QA12CX99

INN (International Name):

Butafosfan, Cyanocobalamin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Cattle, Dogs, Horses

Therapeutic area:

Vitamin; Mineral

Authorization status:

Authorized

Authorization date:

2023-08-14

Summary of Product characteristics

Issued: August 2023
AN: 02190/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
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.
Issued: August 2023
AN: 02190/2020
Page 2 of 5
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
hypersensitiv