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

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Ketoprofen

Dostępny od:

VetViva Richter GmbH

Kod ATC:

QM01AE03

INN (International Nazwa):

Ketoprofen

Forma farmaceutyczna:

Solution for injection

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Dziedzina terapeutyczna:

ketoprofen

Data autoryzacji:

2010-04-23

Charakterystyka produktu

1
_[Version 8.2,01/2021] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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) Syndrome
3
-
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 gastrointestinal lesions, haemorrhagic
diathesis, impaired hepatic, renal or
cardiac function. Do not use with other NSAID drugs concurrently or
within 24 hours of each other.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of pig