Metaxol 20/100 mg/ml solution for use in drinking water for pigs and chickens

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Trimethoprim; Sulfamethoxazole

Disponible depuis:

Eurovet Animal Health B.V.

Code ATC:

QJ01EW11

DCI (Dénomination commune internationale):

Trimethoprim; Sulfamethoxazole

Dosage:

20, 100 milligram(s)/millilitre

forme pharmaceutique:

Oral solution

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Chickens, Pigs

Domaine thérapeutique:

sulfamethoxazole and trimethoprime

indications thérapeutiques:

Antibacterial

Statut de autorisation:

Authorised

Date de l'autorisation:

2016-07-08

Résumé des caractéristiques du produit

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:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION
IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
N-methyl pyrrolidone
690,8 mg
Propylene glycol
Sodium hydroxide (for pH adjustment)
Water, purified
A clear, pale yellow to brownish-yellow solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs (fattening pigs) and chickens (broilers).
3.2
INDICATIONS FOR USE FOR EACH 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 veterinary medicinal
product is used.
3.3
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 sulphonamides or
trimethoprim or any of the excipients.
3.4
SPECIAL WARNINGS
Severely diseased animals can have a decreased appetite and water
consumption. If necessary the
concentration of the veterinary medicinal in the drinking water should
be adjusted to make sure that
the recommended dosage is being consumed. However if the concentration
of