Reproval 5% Small Animal Injection for Dogs and Cats
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
24-01-2013
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Active ingredient:
carprofen 50 mg
Available from:
Norbrook Laboratories Limited
ATC code:
QM01AE91
Pharmaceutical form:
Solution for injection
Therapeutic group:
carprofen
Therapeutic area:
Cats, Dogs
Authorization date:
2008-10-29
Summary of Product characteristics
Revised: November 2012
AN: 00800/2012
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Reproval 50mg/ml Solution for Injection for Dogs and Cats (RMS)
Norocarp 50mg/ml Solution for Injection for Dogs and Cats (all CMS except
France, Germany, Sweden and Denmark)
Carprieve 50mg/ml Solution for Injection for Dogs and Cats (France and
Germany)
Norocarp vet. 50mg/ml Solution for Injection for Dogs and Cats (Sweden)
Norodyl vet. 50mg/ml Solution for Injection for Dogs and Cats (Denmark)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Carprofen
50mg
Excipients:
Benzyl Alcohol
10mg
Sodium Formaldehyde Sulphoxylate
2.5mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for Injection
A clear colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
DOGS: For the control of post-operative pain and inflammation following
orthopaedic and soft tissue (including intra-ocular) surgery.
CATS: For the control of post operative pain following ovariohysterectomy
and soft tissue surgery.
Revised: November 2012
AN: 00800/2012
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in animals suffering from cardiac, hepatic or renal disease or
gastrointestinal problems, where there is a possibility of gastrointestinal
ulceration or bleeding, or hypersensitivity to carprofen or any other NSAIDs
or any
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