DANIDOL 300 mg/ml oral solution for cattle and pigs
Land: Frankrig
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
Indlægsseddel
(PIL)
03-12-2013
Produktets egenskaber
(SPC)
03-12-2013
Aktiv bestanddel:
ketoprofen 300 mg/ml
Tilgængelig fra:
Laboratorios Dr. Esteve S.A.
ATC-kode:
QM01AE03
Lægemiddelform:
Oral solution
Terapeutisk gruppe:
ketoprofen
Terapeutisk område:
Cattle, Pigs
Autorisation dato:
2011-07-12
Indlægsseddel
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DANIDOL 300 mg/ml oral solution for cattle and
pigs (all countries except ES)
EDERAL 300 mg/ml oral solution for cattle and pigs (ES)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of the product contains:
Ketoprofen 300 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution for use in drinking water
Clear yellowish solution
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Fattening Cattle and Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Fattening Cattle and Pigs:
Treatment for the reduction of pyrexia and
dyspnoea associated with respiratory disease in combination
with appropriate anti-infective therapy.
4.3 CONTRAINDICATIONS
Do not administer to suckling calves.
Do not administer to fasting animals or animals with limited
access to feed.
Do not use in animals where there is the possibility of gastrointestinal alterations, ulceration or bleeding
in order not to aggravate their situation.
Do not use in dehydrated or hypovolemic or hypotensive animal due to the potential risk of increased
renal toxicity.
Do not administer to swine fattened at extensive or semi-extensive production farms with access to
soil
or foreign objects that may damage the gastric mucosa, or with a high parasite burden, or under a
severe stress situation.
Do not use in animals suffering from cardiac, hepatic,
or renal disease.
Do not use where there is evidence of blood dyscrasia.
Do not use in animals with a history of hypersensitivity to
ketoprofen, aspirin or any of the excipients.
See also section 4.7
4.4 SPECIAL WARNINGS FOR EACH
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Produktets egenskaber
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DANIDOL 300 mg/ml oral solution for cattle and
pigs (all countries except ES)
EDERAL 300 mg/ml oral solution for cattle and pigs (ES)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of the product contains:
Ketoprofen 300 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution for use in drinking water
Clear yellowish solution
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Fattening Cattle and Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Fattening Cattle and Pigs:
Treatment for the reduction of pyrexia and
dyspnoea associated with respiratory disease in combination
with appropriate anti-infective therapy.
4.3 CONTRAINDICATIONS
Do not administer to suckling calves.
Do not administer to fasting animals or animals with limited
access to feed.
Do not use in animals where there is the possibility of gastrointestinal alterations, ulceration or bleeding
in order not to aggravate their situation.
Do not use in dehydrated or hypovolemic or hypotensive animal due to the potential risk of increased
renal toxicity.
Do not administer to swine fattened at extensive or semi-extensive production farms with access to
soil
or foreign objects that may damage the gastric mucosa, or with a high parasite burden, or under a
severe stress situation.
Do not use in animals suffering from cardiac, hepatic,
or renal disease.
Do not use where there is evidence of blood dyscrasia.
Do not use in animals with a history of hypersensitivity to
ketoprofen, aspirin or any of the excipients.
See also section 4.7
4.4 SPECIAL WARNINGS FOR EACH
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