DINALGEN 150 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND HORSES

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

KETOPROFEN

Commercializzato da:

Laboratorios Dr. Esteve, S.A.

Codice ATC:

QM01AE03

INN (Nome Internazionale):

KETOPROFEN

Dosaggio:

150 Mg/Ml

Forma farmaceutica:

Solution for Injection

Tipo di ricetta:

POM

Gruppo terapeutico:

Bovine, Equine - Food, Porcine

Area terapeutica:

Ketoprofen

Indicazioni terapeutiche:

N.S.A.I.D

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2010-09-24

Scheda tecnica

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