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

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Sulfamethoxazole, Trimethoprim

Dostupné z:

Dopharma Research B.V.

ATC kód:

QJ01EW11

INN (Medzinárodný Name):

Sulfamethoxazole, Trimethoprim

Forma lieku:

Solution for use in drinking water

Typ predpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Chickens, Pigs

Terapeutické oblasti:

Antimicrobial

Stav Autorizácia:

Authorized

Dátum Autorizácia:

2017-08-22

Súhrn charakteristických

Revised: July 2022
AN: 02137/2021 & 02138/2021
Page 1 of 6
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:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water.
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 _susceptible to
trimethoprim-sulfamethoxazole.
- Coryza caused by _Avibacterium paragallinarum_ susceptible to
trimethoprim-
sulfamethoxazole.
The presence of the disease in the group/flock must be established
before the product is
used.
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.
Revised: July 2022
AN: 02137/2021 & 02138/2021
Page 2 of 6
Do not use in case of known hypersensitivity to sulphonamides or
trimethoprim or 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 product is increased too much, the
intake of the
medicated drinking water decreases for palatability reasons. Ther