DINALGEN 300 MG/ML ORAL SOLUTION FOR USE IN DRINKING WATER FOR CATTLE AND PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-07-2016
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Active ingredient:
KETOPROFEN
Available from:
Laboratorios Dr. Esteve, S.A.
ATC code:
QM01AE03
INN (International Name):
KETOPROFEN
Dosage:
300 Mg/Ml
Pharmaceutical form:
Oral Solution
Prescription type:
POM
Therapeutic group:
Bovine, Porcine
Therapeutic area:
Ketoprofen
Therapeutic indications:
N.S.A.I.D
Authorization status:
Authorised
Authorization date:
2009-04-08
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DINALGEN 300 mg/ml oral solution for use in drinking water for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral solution.
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 anti-
infective therapy, as appropriate.
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 case of hypersensitivity to ketoprofen or aspirin or to any of the excipients.
Do not use other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other.
See also section 4.7
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each ml contains:
Active Substance:
Ketoprofen
300 mg
For a full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
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