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

Negara: Inggris

Bahasa: Inggris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Sulfamethoxazole, Trimethoprim

Tersedia dari:

Eurovet Animal Health B.V.

Kode ATC:

QJ01EW11

INN (Nama Internasional):

Sulfamethoxazole, Trimethoprim

Bentuk farmasi:

Oral solution

Jenis Resep:

POM-V - Prescription Only Medicine – Veterinarian

Kelompok Terapi:

Chickens, Pigs

Area terapi:

Antimicrobial

Status otorisasi:

Authorized

Tanggal Otorisasi:

2016-07-07

Karakteristik produk

Revised: February 2022
AN: 01447/2021 and 01448/2021
Page 1 of 6
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 solution 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.
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.
- 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.
Revised: February 2022
AN: 01447/2021 and 01448/2021
Page 2 of 6
Do not use in animals with impaired haematopoietic systems.
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 VMP in the drinking water should be
adjusted to
make sure that the recommended dosage is being consumed. However if
the
concentration of the pro