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

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ketoprofen

Available from:

Labiana Life Sciences SA

ATC code:

QM01AE03

INN (International Name):

Ketoprofen

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Horses, Pigs

Therapeutic area:

Anti Inflammatory NSAID

Authorization status:

Authorized

Authorization date:

2021-02-24

Summary of Product characteristics

Revised: February 2022
AN: 01993/2021 & 01995/2021
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Labiprofen 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 in
combination with
antimicrobial therapy where appropriate.
-
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
SyndromePDS- (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.).
Revised: February 2022
AN: 01993/2021 & 01995/2021
Page 2 of 7
-
Reduction of postoperative pain and inflammation.
-
Reduction of visceral pain associated with colic.
4.3
CONTRAINDICATIONS
Do not use in cases of gastro-intestinal ulceration or bleeding, in
order not to aggravate
their situation.
Do not use in cases of 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 cases of blood dyscrasia, coagulopathy or haemorrhagic
diathesis. Do not
administer other non-steroidal anti-inflammatory drugs (NSAIDs)
concurrently or within
24 hours of each other.
4.4
SPECIAL W