Equibactin Vet. (333 mg/g + 67 mg/g) Oral Paste for Horses

País: Regne Unit

Idioma: anglès

Font: VMD (Veterinary Medicines Directorate)

ingredients actius:

Sulfadiazine, Trimethoprim

Disponible des:

Le Vet B.V.

Codi ATC:

QJ01EW10

Designació comuna internacional (DCI):

Sulfadiazine, Trimethoprim

formulario farmacéutico:

Oral paste

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Horses

Área terapéutica:

Antimicrobial

Estat d'Autorització:

Authorized

Data d'autorització:

2008-07-07

Fitxa tècnica

Revised: October 2015
AN: 00436/2015
Page
1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Equibactin vet. (333 mg/g + 67 mg/g) Oral Paste for
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains :
ACTIVE SUBSTANCES:
Trimethoprim
66.7 mg
Sulfadiazine
333.3 mg
EXCIPIENT(S):
Chlorocresol
2.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral paste.
White to almost white suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections in horses caused by bacteria sensitive to the
combination of
trimethoprim and sulfadiazine, particularly:
Respiratory tract infections associated with _Streptococcus_ spp. and
_Staphylococcus_
_aureus_;
Gastrointestinal infections associated with _E. coli_;
Urogenital infections associated with beta-hemolytic streptococci;
Wound infections and open or drained abscesses associated with _
Streptococcus_
spp. and
_Staphylococcus aureus_.
4.3
CONTRAINDICATIONS
Do not use in horses known to be hypersensitive to sulfonamides, with
serious
hepatic or renal insufficiency nor with blood dyscrasias,
Do not use this product to treat abscesses without proper drainage.
Do not use in case resistance to sulphonamides occurs.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: October 2015
AN: 00436/2015
Page
2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
During treatment with the product animals must have free and easy
access to
drinking water.
Do not use the same syringe in more than one animal.
Use of the product should be based on susceptibility testing and take
into account
official and local antimicrobial policies.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to the combination of Sulfadiazine
and Trimethoprim,
and
may
decrease
the
effectiveness
of
treatment
with
sulphonamides
and/or
trimethoprim due to the potential for cross-resista