Ketosol 100 mg/ml solution for injection for cattle, pigs and horses

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Ketoprofen

Fáanlegur frá:

Interchemie Werken De Adelaar Eesti AS.

ATC númer:

QM01AE03

INN (Alþjóðlegt nafn):

Ketoprofen

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

ketoprofen

Leyfisstaða:

Authorised

Leyfisdagur:

2022-04-29

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ketosol-100, 100 mg/ml solution for injection for cattle, pigs and
horses (EE, BG, HR, LV,
RO, SI and SK)
Ketoject, 100 mg/ml solution for injection for cattle, pigs and horses
(IT, PL and HU)
Ketoject 100 mg/ml solution for injection for cattle, pigs and horses
(CZ)
Ketosol, 100 mg/ml solution for injection for cattle, pigs and horses
(CY, DE, EL, ES, FR,
IE, LU, NL, PT)
Ketosol vet, 100 mg/ml solution for injection for cattle, pigs and
horses (SE)
Ketochemie, 100 mg/ml solution for injection for cattle, pigs and
horses (AT, BE, DK, FI)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each ml contains:
ACTIVE SUBSTANCE:
Ketoprofen.........................100.0 mg
EXCIPIENTS:
Benzyl alcohol (E1519)......10.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, slightly yellow solution, free from visible particles.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Cattle, pigs, horses.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
Diseases associated with inflammation, pain or fever:
-
respiratory tract infections.
-
mastitis.
-
osteoarticular and muscular-skeletal disorders such as lameness,
arthritis.
-
to ease uprise post parturition.
-
injuries.
Where necessary ketoprofen should be combined with appropriate
antimicrobial therapy.
Pigs:
Diseases associated with inflammation, pain or fever:
-
Postpartum
Dysgalactia
Syndrome
(PPDS)
(Mastitis
Metritis
Agalactia
(MMA)
syndrome).
-
respiratory tract infections.
Where necessary ketoprofen should be combined with appropriate
antimicrobial therapy.
Horses:
Diseases affecting the osteoarticular and muscular-skeletal system
associated with acute pain
and inflammation:
-
lameness of traumatic origin.
-
arthritis.
-
osteitis.
-
tendinitis, bursitis.
-
navicular syndrome.
-
laminitis.
-
myositis.
Ketoprofen is also indicated for post-surgical inflammation and
symptomatic therapy of
colic.
4.3.
CONTRAINDICATIONS
Do not use in cases o