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

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Sulfamethoxazole, Trimethoprim

Dostupné s:

Eurovet Animal Health B.V.

ATC kód:

QJ01EW11

INN (Mezinárodní Name):

Sulfamethoxazole, Trimethoprim

Léková forma:

Oral solution

Druh předpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Chickens, Pigs

Terapeutické oblasti:

Antimicrobial

Stav Autorizace:

Authorized

Datum autorizace:

2016-07-07

Charakteristika produktu

Revised: May 2024
AN: 00300/2023 and 02321/2023
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Metaxol 20/100 mg/ml solution for use in drinking water for pigs and
chickens.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substances:
Trimethoprim
20 mg
Sulfamethoxazole
100 mg
Excipients:
N-methyl pyrrolidone
690,8 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water.
A clear, pale yellow to brownish-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 beta-haemolytic K88-positive, K99-
positive or 987P _Escherichia coli_ strains susceptible to
trimethoprim-
sulfamethoxazole.
-
Secondary bacterial infections caused by _Pasteurella multocida_,
_Actinobacillus pleuropneumoniae_, _Streptococcus spp_. and
_Haemophilus _
_parasuis_ susceptible to trimethoprim-sulfamethoxazole.
Broilers:
Treatment and metaphylaxis of:
-
Colibacillosis caused by _Escherichia coli_ susceptible to
trimethoprim-
sulfamethoxazole.
Revised: May 2024
AN: 00300/2023 and 02321/2023
Page 2 of 7
-
Coryza caused by _Avibacterium paragallinarum_ susceptible to
trimethoprim-sulfamethoxazole.
The presence of the disease in the group/flock must be established
before the
veterinary medicinal 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.
Do not use in cases ofhypersensitivity 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 be