SURAMOX 15% LA
Pays: France
Langue: anglais
Source: HMA (Heads of Medicines Agencies)
Résumé des caractéristiques du produit
(SPC)
21-08-2013
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Ingrédients actifs:
amoxicillin trihydrate 150 mg/ml
Disponible depuis:
Virbac S.A.
Code ATC:
QJ01CA04
forme pharmaceutique:
Suspension for injection
Groupe thérapeutique:
amoxicillin
Domaine thérapeutique:
Cattle, Pigs
Date de l'autorisation:
2010-10-20
Résumé des caractéristiques du produit
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Suramox 15% LA, 150 mg/ml suspension for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Micronised amoxicillin (as trihydrate)
150.0 mg
(equivalent to 172.2 mg amoxicillin trihydrate)
EXCIPIENT:
Benzyl alcohol (E1519)
35.0 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection
Creamy to yellowish beige suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle: Treatment of respiratory infections due to _Pasteurella multocida_ and _Mannheimia haemolytica._
Pigs: Treatment of respiratory infections due to _Pasteurella multocida_.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillin or other substances of the
-lactam
group.
Do not use in rabbits, guinea pigs, hamsters or gerbils.
Do not use in case resistance to penicillins or cephalosporins occurs.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Strict aseptic precautions should be observed.
In case of the occurrence of allergic reaction, the treatment should be immediately withdrawn.
In animals with hepatic and renal failure, the dosage regimen should be carefully evaluated.
Inappropriate use of the product may increase the prevalence of bacteria resistant to amoxicillin.
Use of the product should be based
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