KETOFEN TABLETS 20 mg

Pays: Afrique du Sud

Langue: anglais

Source: South African Health Products Regulatory Authority (SAHPRA)

Disponible depuis:

Ceva Animal Health (Pty) Ltd

Dosage:

See ingredients

forme pharmaceutique:

Tablet

Composition:

Each tablet contains KETOPROFEN 20 mg

Domaine thérapeutique:

C 0301. ANTI-INFLAMMATORY

Statut de autorisation:

Canceled

Date de l'autorisation:

2005-05-09

Résumé des caractéristiques du produit

1C.1
Amendment date: 28 February 2018
VETERINARY MEDICINE
S3 KETOFEN TABLETS
PROPRIETARY NAME AND DOSAGE FORM
Ketofen® 5 mg tablets
Ketofen® 10 mg tablets
Ketofen® 20 mg tablets
COMPOSITION
Each Ketofen® 5 mg tablet contains 5 mg ketoprofen
Each Ketofen® 10 mg tablet contains 10 mg ketoprofen
Each Ketofen® 20 mg tablet contains 20 mg ketoprofen
PHARMACOLOGICAL CLASSIFICATION
C 3.1 Anti-rheumatics (Anti-inflammatory) agents
PHARMACOLOGICAL ACTION
PHARMACOKINETICS AND PHARMACODYNAMICS
Ketoprofen is a non-steroidal anti-inflammatory agent with analgesic
and
antipyretic activity. It acts by inhibiting prostaglandin synthesis.
INDICATIONS
Anti-inflammatory and analgesic treatment of musculo-skeletal
disorders
in cats and dogs.
CONTRA-INDICATIONS
•
Do not administer to animals with gastro-duodenal ulcers.
•
Do not administer to animals with a bleeding tendency.
•
Do not administer to animals with severe renal insufficiency.
•
Do not use when previous allergy to ketoprofen has occurred.
WARNINGS
Interactions
•
Do not mix with other oral substances.
•
Do not use with other non-steroidal anti-inflammatories, diuretics or
anticoagulants.
Pregnancy and lactation
•
It is not recommended to administer the product during pregnancy.
.
DOSAGE AND DIRECTIONS FOR USE
1 mg/kg body mass daily for 3 to 5 consecutive days.
SIDE EFFECTS AND SPECIAL PRECAUTIONS
Digestive intolerance (vomiting) has been observed in some cases. Side
effects typical of non-steroidal anti-inflammatory agents such as
gastro-
intestinal ulceration and nephrotoxicity may occur.
1C.2
Amendment date: 28 February 2018
KNOWN CLINICAL SIGNS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Gastro-intestinal ulceration and nephrotoxicity is related to duration
of
treatment.
Treatment is supportive.
IDENTIFICATION
Ketofen® 5 mg tablets are solid white circular tablets weighing 0,125
g
with convex extremities, bevelled edges and scored on one side.
Ketofen® 10 mg tablets are solid white circular tablets weighing
0,250 g
with convex extremities, beve