资料单张
1/6
LABELLING AND PACKAGE LEAFLET
2/6
A. LABELLING
3/6
LABEL - PACKAGE LEAFLET
SULFAPREX PREMIX FOR MEDICATED FEEDING STUFF FOR PIGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION
HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER
RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer:
LABORATORIOS CALIER, S.A.
C/ Barcelonès, 26 (Pla del Ramassà)
LES FRANQUESES DEL VALLÈS, (Barcelona)
SPAIN
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Sulfaprex Premix for medicated feeding stuff for pigs
(sulfadiazine + trimethoprim)
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER
INGREDIENT(S)
Each gram contains:
Sulfadiazine................................................................ 250 mg
Trimethoprim ................................................................ 50 mg
EXCIPIENTS:
Calcium carbonate
Yellowish-white granulated powder
4.
INDICATION(S)
For the treatment of mastitis, metritis and agalaxia syndrome (MMA), atrophic
rhinitis (when associated with _Bordetella bronchiseptica)_ and diarrhoeas caused
by strains of _E. coli _sensitive to sulfadiazine and trimethoprim_._
5.
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active ingredients.
Do not use in animals with renal or hepatic insufficiency.
Do not use in animals with blood dyscrasias.
6.
ADVERSE REACTIONS
Not known.
If you notice any serious effects or other effects not mentioned in this leaflet,
please inform your veterinary surgeon.
7.
TARGET SPECIES
Pigs
阅读完整的文件
产品特点
1/6
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT:
Sulfaprex Premix for medicated feeding stuff for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each gram contains:
ACTIVE SUBSTANCES:
Sulfadiazine................................................................ 250 mg
Trimethoprim ................................................................ 50 mg
EXCIPIENTS:
Calcium carbonate
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM:
Premix for medicated feeding stuff.
Yellowish-white granulated powder
4. CLINICAL PARTICULARS:
4.1 TARGET SPECIES:
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES:
For the treatment of mastitis, metritis and agalactia syndrome (MMA), atrophic
rhinitis (when associated with _Bordetella bronchiseptica_) and diarrhoeas caused
by strains of _E. coli_ sensitive to sulfadiazine and trimethoprim_._
4.3 CONTRAINDICATIONS:
Do not use in animals with known hypersensitivity to the active ingredients.
Do not use in animals with renal or hepatic insufficiency.
Do not use in animals with blood dyscrasias.
2/6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Bacteriological aetiology should be confirmed. Whenever possible sulfadiazine
and trimethoprim association should only be used based on susceptibility
testing.
The intake of medicated feed depends on the clinical condition of the animals.
In order to obtain the correct dosage the concentration of antimicrobial should
be adjusted accordingly and water consume should be guaranteed.
In case the correct dosage could not be ensured
阅读完整的文件