METAXOL 20/100 MG/ML SOLUTION FOR USE IN DRINKING WATER FOR PIGS AND CHICKENS

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

SULFAMETHOXAZOLE, TRIMETHOPRIM

MAH:

Eurovet Animal Health B.V.

ATC_code:

QJ01EW11

INN:

SULFAMETHOXAZOLE, TRIMETHOPRIM

dosage:

20/100

pharmaceutical_form:

Oral Solution

prescription_type:

POM

therapeutic_group:

Fowl - Chicken, Porcine

therapeutic_area:

Sulfamethoxazole and trimethoprime

therapeutic_indication:

Antibacterial

authorization_status:

Authorised

authorization_date:

2016-07-08

SPC

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
1 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.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 08/07/2016_
_CRN 7020382_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Sever