Rifen vet.

1 x 50 ml

Liquid for injection, solution

Active substance

Ketoprofen : 100 mg/ml

ATC code

QM01AE03 Ketoprofen

QM01AE Propionic acid derivatives

QM01A Antiinflammatory and antirheumatic products, non-steroids (NSAIDs)

QM01 Antiinflammatory and antirheumatic products

QM Musculo-skeletal system

Species

Horse, cattle, pigs

Indications

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) 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.

Dose to be administered and administration route

Horses: Intravenous use (i.v.)

Cattle: Intravenous or intramuscular use (i.v. or i.m.)

Pigs: Intramuscular use (i.m.)

To ensure a correct dosage, body weight should be determined as accurately as possible.

Horse:

2.2 mg ketoprofen/kg body weight/day intravenously once daily for up to 3 to 5 consecutive days, i.e. 1 ml per 45 kg body weight.

In order to treat colic one injection is normally sufficient. A second administration of ketoprofen requires a reassessment of the patient’s clinical status. See point 4.5, Special precautions for use.

Cattle:

3 mg ketoprofen/kg body weight/day intravenously or deep intramuscularly once daily for up to 3 consecutive days, i.e. 3 ml per 100 kg body weight.

For the relief of post-operative pain associated with dehorning the product should be administered as a single injection intravenously or deep intramuscularly 10 – 30 minutes before the procedure.

In cattle, the volume per injection site for IM injection should not exceed 9 ml. If the injection volume exceeds 9 ml, this volume should be divided into multiple doses, administered at different injection sites.

Pigs:

3 mg ketoprofen/kg body weight as a single deep intramuscular injection, i.e. 3 ml per 100 kg body weight (= 0.03 ml/kg).

For reduction of post-operative pain the product should be injected 10 - 30 minutes before surgical intervention. Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device (i.e.: low dose syringe) and proper determination of body weight.

Adverse reactions

Horses, cattle, pigs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Hypersensitivity reaction, Anaphylaxis¹ .
Undetermined frequency (cannot be estimated from the available data):	Gastrointestinal irritation² , Gastric ulceration² , Small intestine ulcer² ; Renal disorder² ; Injection site irritation³ ; Inappetence⁴ .

¹ Anaphylaxis may be life-threatening and should be treated symptomatically.

² Due to the mechanism of action of NSAIDs (inhibition of prostaglandin synthesis).

³ Transient, caused by intramuscular injections.

⁴ Only in pigs, due to repeated administration, reversible.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.