Methoxasol 20/100 mg/ml solution for use in drinking water for pigs and broilers
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
04-05-2013
Summary of Product characteristics
(SPC)
04-05-2013
Active ingredient:
sulfamethoxazole 100 mg/ml, trimethoprim 20 mg/ml
Available from:
Eurovet Animal Health
ATC code:
QJ01EW11
Pharmaceutical form:
Oral solution
Therapeutic group:
Sulfamethoxazole and trimethoprime
Therapeutic area:
Chicken Broilers, Pigs Food
Authorization date:
2012-06-20
Patient Information leaflet
1/11
PART IB-2A
FULL
LABEL TEXT
1 LITRE BOTTLE / 5 LITRE CAN
METHOXASOL
SOLUTION FOR USE IN DRINKING WATER
FOR PIGS AND BROILERS
NL/V/0166/001/DC.
THE FULL TEXT WILL BE PRINTED ON THE BOTTLE/CAN
FORMAT USED IS ESPECIALLY FOR THIS TYPE OF LABELLING
2/11
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
=
IMMEDIATE PACKAGE
=
LEAFLET
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Methoxasol 20/100 mg/ml solution for use in drinking water for pigs and chickens.
_FI/DK: Methoxasol vet 20/100 mg/ml solution for use in drinking water for pigs and chickens. _
Trimethoprim/Sulfamethoxazole
2.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Each ml contains:
Active Substance:
Trimethoprim
Sulfamethoxazole
20 mg
100 mg_ _
3.
PHARMACEUTICAL FORM
Clear and yellow solution for use in drinking water
4.
PACKAGE SIZE
1 litre _(5 litre)_
5.
TARGET SPECIES
Pigs and chickens (broilers).
6.
INDICATION(S)
Pigs: Treatment and prevention of respiratory infections caused by _Actinobacillus pleuropneumoniae_
susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Broilers: Treatment and prevention of respiratory infections caused by _Escherichia coli_ susceptible to
trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
7.
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 sulfonamides or trimethoprim.
8.
ADVERSE REACTIONS
A diminished w
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Summary of Product characteristics
1/5
SUMMARY OF PRODUCT CHARACTERISTICS
METHOXASOL
SOLUTION FOR USE IN DRINKING WATER
FOR PIGS AND BROILERS
NL/V/0166/001/DC.
2/5
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Methoxasol 20/100 mg/ml solution for use in drinking water for pigs and chickens.
_FI/DK: Methoxasol vet 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
20.0 mg
Sulfamethoxazole
100.0 mg
EXCIPIENTS For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water.
Clear and yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs and chickens (broilers).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: Treatment and prevention of respiratory infections caused by _Actinobacillus pleuropneumoniae_
susceptible to trimethoprim and sulfamethoxazole where the disease has been diagnosed in the herd.
Broilers: Treatment and prevention of respiratory infections caused by _Escherichia coli_ susceptible to
trimethoprim and sulfamethoxazole where the disease has been diagnosed in the flock.
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 sulfonamides or trimethoprim.
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 adjus
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