KetoProPig 100mg/ml Oral Solution for Pigs
Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
29-06-2013
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Active ingredient:
ketoprofen 10 g
Available from:
Fort Dodge Animal Health
ATC code:
QM01AE03
Pharmaceutical form:
Oral solution
Therapeutic group:
ketoprofen
Therapeutic area:
Pigs
Authorization date:
2011-07-10
Summary of Product characteristics
Revised: November 2011
AN: 01317/2011
Page 1 of 8
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
KetoProPig 100 mg/ml Oral Solution for use in drinking water for Pigs
KeProPig 100 mg/ml Oral Solution for use in drinking water for Pigs (ES and
PO)
2.
QUALITATIVE AND QUANITIATIVE COMPOSITION
Each ml contains:
Active substance
Ketoprofen:
100 mg
Excipients
Benzyl Alcohol:
20 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Transparent and colourless liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Fattening Pigs
4.2
INDICATIONS FOR USE
Symptomatic treatment for reduction of pyrexia in cases of acute infectious
respiratory disease in fattening pigs in combination with an appropriate anti -
infective therapy_._
4.3
CONTRA-INDICATIONS
Do not use in case of hypersensitivity to ketoprofen.
Do not use in animals known to be allergic to aspirin.
Do not use in pregnant animals.
Do not use in pigs already suffering from gastric ulcers, in order not to aggravate
their situation.
Revised: November 2011
AN: 01317/2011
Page 2 of 8
Revised: November 2011
AN: 01317/2011
Page 3 of 8
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Avoid use in dehydrated, hypovolaemic or hypotensive pigs as there is a
potential risk of increased renal toxicity.
Use in very young animals may involve additional risk: however, if used,
animals require careful clinical management.
As ketoprofen is ulcerogenic, the use is not recommended in case of PMWS
(Post-weaning multisystemic wasting syndrome) because ulcers are already
frequently associated with
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