Trimsulfasol 20/100 mg/ml Solution for Use in Drinking Water for Pigs and Chickens

Pays: Royaume-Uni

Langue: anglais

Source: VMD (Veterinary Medicines Directorate)

Ingrédients actifs:

Sulfamethoxazole, Trimethoprim

Disponible depuis:

Dopharma Research B.V.

Code ATC:

QJ01EW11

DCI (Dénomination commune internationale):

Sulfamethoxazole, Trimethoprim

forme pharmaceutique:

Solution for use in drinking water

Type d'ordonnance:

POM-V - Prescription Only Medicine – Veterinarian

Groupe thérapeutique:

Chickens, Pigs

Domaine thérapeutique:

Antimicrobial

Statut de autorisation:

Authorized

Date de l'autorisation:

2017-08-22

Résumé des caractéristiques du produit

Amended Pages: April 2024
AN: 00414/2023
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Trimsulfasol 20/100 mg/ml solution for use in drinking water for pigs
and chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCES:
Trimethoprim 20 mg
Sulfamethoxazole
100 mg
EXCIPIENTS:
N-methyl pyrrolidone
691 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (fattening pigs) and chickens (broilers).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Fattening pigs:
Treatment and metaphylaxis of:
- Post weaning diarrhoea caused by ß-haemolytic K-88positive, K99-
positive or 987P
_Escherichia coli_ strains.
- Secondary bacterial infections caused by _Pasteurella multocida_,
_Actinobacillus _
_pleuropneumoniae_, _Streptococcus spp._ and _Haemophilus parasuis_.
Broilers:
Treatment and metaphylaxis of:
- Colibacillosis caused by _Escherichia coli_.
- Coryza caused by _Avibacterium paragallinarum_.
The presence of the disease in the group/flock must be established
before the veterinary
medicinal product is used.
Amended Pages: April 2024
AN: 00414/2023
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not use in animals suffering from severe liver or kidney disease,
oliguria or anuria.
Do not use in animals with impaired haematopoietic systems.
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
Severely diseased animals can have a decreased appetite and water
consumption. If
necessary, the concentration of the veterinary medicinal product in
the drinking water
should be adjusted to make sure that the recommended dosage is being
consumed.
However, if the concentration of the veterinary medicinal product is
increased too much,
the intake of the medicated drinking water decreases for palatability
reasons. Therefore,
water intake should be monitored regularly, especially in broilers.
In