DINALGEN 150 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND HORSES
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
16-07-2015
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Active ingredient:
KETOPROFEN
Available from:
Laboratorios Dr. Esteve, S.A.
ATC code:
QM01AE03
INN (International Name):
KETOPROFEN
Dosage:
150 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Equine - Food, Porcine
Therapeutic area:
Ketoprofen
Therapeutic indications:
N.S.A.I.D
Authorization status:
Authorised
Authorization date:
2010-09-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
DINALGEN 150 mg/ml solution for injection for cattle, pigs and horses.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ketoprofen
150 mg
EXCIPIENTS:
Benzyl alcohol (E1519)
10 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless to yellowish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs and horses.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
- Reduction of inflammation and pain associated with post-partum, musculoskeletal disorders and lameness.
- Reduction of fever associated with bovine respiratory disease.
- Reduction of inflammation, fever and pain in acute clinical mastitis in combination with antimicrobial therapy where
appropriate.
Pigs:
- Reduction of pyrexia in cases of respiratory disease and Postpartum Dysglactia Syndrome-PDS-(Metritis Mastitis
Agalactia syndrome) in sows, in combination with antimicrobial therapy, where appropriate.
Horses:
- Reduction of inflammation and pain associated with osteoarticular and musculoskeletal disorders (lameness, laminitis,
osteoarthritis, synovitis, tendinitis, etc.).
- Reduction of postoperative pain and inflammation.
- Reduction of visceral pain associated with colic.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 01/07/2015_
_CRN 7021036_
_page number: 1_
4.3 CONTRAINDICATIONS
Do not use in animals where there is the possibility of gastro-intestinal ulceration or bleeding, in order not to aggravate
their situation.
Do not use in animals suffering from cardiac, hepatic, or renal disease.
Do not use in cases of known hypersensitivity to ketoprofen
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