Combisyn Injection
Country: United Kingdom
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
13-03-2012
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Active ingredient:
amoxicillin (as trihydrate) 14 w/v, Clavulanic Acid (as potassium clavulate) 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: August 2011
AN: 00927/2010
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Combisyn Suspension for Injection (United Kingdom)
Noroclav Suspension for Injection (France)
Noroclav Suspension for Injection (Portugal)
Noroclav 175 mg Suspension for Injection (Spain)
Noroclav Injection (Belgium, Italy)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml 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:
Treatment of respiratory infections due to _Pasteurella multocida_ and
_Mannheimia haemolytica_.
In Dogs:
Respiratory tract infections, urinary tract infections, skin and soft tissue
infections (e.g. abscesses, pyoderma, anal sacculitis and gingivitis
Revised: August 2011
AN: 00927/2010
Page 2 of 7
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 contraindicated where resistance to the combination
of penicillins or other
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