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

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Ketoprofen

Disponible depuis:

Richter Pharma AG

Code ATC:

QM01AE03

DCI (Dénomination commune internationale):

Ketoprofen

Dosage:

100 milligram(s)/millilitre

forme pharmaceutique:

Solution for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Cattle, Horses, Pigs

Domaine thérapeutique:

ketoprofen

indications thérapeutiques:

N.S.A.I.D.

Statut de autorisation:

Authorised

Date de l'autorisation:

2010-04-23

Résumé des caractéristiques du produit

Health Products Regulatory Authority
16 February 2022
CRN00CCS8
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rifen 100 mg/ml solution for injection for horses, cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Ketoprofen
100
mg
EXCIPIENTS:
Benzyl alcohol (E1519)
10
mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to brownish-yellowish solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horse, cattle, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Horse
Diseases affecting the osteoarticular and muscular-skeletal system
associated with acute pain and inflammation
-Lameness of traumatic origin
-Arthritis
-Osteitis, spavin
-Tendinitis, bursitis
-Naviculitis
-Laminitis
-Myositis
Ketoprofen is also indicated for post-surgical inflammation,
symptomatic therapy of colic and fever.
Cattle
Diseases associated with inflammation, pain or fever
-Respiratory diseases
-Mastitis
-Osteoarticular and muscular-skeletal disorders such as lameness,
arthritis and to ease uprise post parturition
-Injuries
For the relief of post-operative pain associated with dehorning in
calves.
Pigs
Diseases associated with inflammation, pain or fever
-Treatment associated with the Postpartum Dysgalactia
Syndrome/Mastitis Metritis Agalactia (MMA)
Health Products Regulatory Authority
16 February 2022
CRN00CCS8
Page 2 of 5
Syndrome
-Respiratory tract infections
-Symptomatic treatment of fever
For the short-term relief of post operative pain associated with minor
soft tissue surgery such as castration in piglets.
Where necessary ketoprofen should be combined with appropriate
antimicrobial therapy.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, or to
any of the excipients. Do not use in animals suffering from
gastro-intestinal lesions, haemorrhagic diathesis, impaired hepatic,
renal or cardiac function. Do not use with other NSAID
drugs concurrently or