Dinalgen 150 mg/ml Solution for Injection for Cattle, Pigs and Horses

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

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Preparatomtale Preparatomtale (SPC)
17-11-2023

Aktiv ingrediens:

Ketoprofen

Tilgjengelig fra:

Ecuphar Veterinaria S.L.U.

ATC-kode:

QM01AE03

INN (International Name):

Ketoprofen

Legemiddelform:

Solution for injection

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cattle, Horses, Pigs

Terapeutisk område:

Anti Inflammatory NSAID

Autorisasjon status:

Authorized

Autorisasjon dato:

2010-09-23

Preparatomtale

                                Revised: April 2022
AN: 02927/2021
Page 1 of 7
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.
Revised: April 2022
AN: 02927/2021
Page 2 of 7
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.
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 or
acetyl-salcylic acid or
to any of the excipients.
Do not use in animals with evidence of blood dyscrasia or
coagulopathy. Do not
administer other non-steroidal anti-inflammatory drugs (NSAIDs)
concurrently or
within 24 hours of each other.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECA
                                
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