SURAMOX 15% LA
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
amoxicillin trihydrate 150 mg/ml
Available from:
Virbac S.A.
ATC code:
QJ01CA04
Pharmaceutical form:
Suspension for injection
Therapeutic group:
amoxicillin
Therapeutic area:
Cattle, Pigs
Authorization date:
2010-10-20
Summary of Product characteristics
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In case of the occurrence of allergic reaction, the treatment should be immediately withdrawn.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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