DINALGEN 60 MG/ML SOLUTION FOR INJECTION FOR PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
KETOPROFEN
Available from:
Laboratorios Dr. Esteve, S.A.
ATC code:
QM01AE03
Dosage:
60 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
N.S.A.I.D
Therapeutic area:
Porcine
Authorization date:
2009-04-08
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dinalgen 60 mg/ml solution for injection for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
PIGS
Reduction of pyrexia in cases of respiratory disease and Postpartum Dysglactia Syndrome/Mastitis, Metritis, Agalactiae
(MMA syndrome) in sows, in combination with appropriate anti-infective therapy.
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 dehydrated or hypovolemic or hypotensive animals due to the potential risk of increased renal toxicity.
Do not use in animals that have previously shown signs of hypersensitivity to ketoprofen or aspirin or any of the
excipients.
Do not use where there is evidence of blood dyscrasia or blood coagulation disturbances
See also section 4.7
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Since gastric ulceration is a common finding in PMWS (Post-weaning Multisystemic Wasting Syndrome), the use of
ketoprofen in pigs affected by this pathology is not recommended, in order not to aggravate their situation.
Each 1 ml of the product contains:
Ketoprofen
60 mg
Benzyl alcohol (E1519)
10 mg
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/12/2011_
_CRN 7011501_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not exceed the recommended
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