Nisamox Injection
Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
03-03-2013
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Active ingredient:
amoxicillin trihydrate 14 %w/v, Potassium clavulanate 3.5 %w/v
Available from:
Norbrook Laboratories Limited
Pharmaceutical form:
Suspension for injection
Therapeutic area:
Cattle
Authorization date:
2011-08-17
Summary of Product characteristics
Revised: September 2012
AN: 00536/2012
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nisamox Suspension for Injection (Belgium & UK)
Nisamox Suspension for Injection (Portugal)
Nisamox 175 mg Suspension for Injection (Spain)
Nisinject Suspension for Injection (Italy)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml supplies:
ACTIVE SUBSTANCE:
Amoxicillin (as Amoxicillin trihydrate)
140 mg
Clavulanic acid (as Potassium clavulanate)
35 mg
EXCIPIENTS:
Butylated hydroxyanisole (E320) 0.08 mg
Butylated hydroxytoluene (E321) 0.08 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
An off-white to cream oily suspension.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
Respiratory infections
Soft tissue infections (e.g. joint/navel ill, abscesses etc.)
In Dogs:
Respiratory tract infections, urinary tract infections, skin and soft tissue
infections (e.g. abscesses, pyoderma, anal sacculitis and gingivitis.).
Revised: September 2012
AN: 00536/2012
Page 2 of 9
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillin or other
substances of the beta-lactam group.
Do not use in animals with serious dysfunction of kidneys accompanied by
anuria or oliguria.
Do not use in rabbits, guinea pigs, hamsters or gerbils.
The use of the product is contra-indicated where resistance to the
combination of penicillins or other substances of the beta-lactam group is
known to occur.
4.4 SPECIAL WARNINGS FOR
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