Ketofen 20 mg Tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Ketoprofen

Verfügbar ab:

Ceva Animal Health Ltd

ATC-Code:

QM01AE03

INN (Internationale Bezeichnung):

Ketoprofen

Darreichungsform:

Tablet

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Cats, Dogs

Therapiebereich:

Anti Inflammatory NSAID

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

1992-04-30

Fachinformation

Revised: October 2022
AN: 01667/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
KETOFEN 20mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoprofen 20 mg per tablet
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet:
White uncoated tablets with a break line on one side. The score line
is
intended to facilitate ease of swallowing and not divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
For the relief of acute pain and inflammation associated with musculo-
skeletal and other painful disorders in the dog and cat.
For the relief of pain in dogs associated with chronic osteoarthritic
conditions.
4.3
CONTRAINDICATIONS
Do not administer with diuretics or anti-coagulants.
Do not administer other non-steroidal anti-inflammatory drugs (NSAIDs)
concurrently or within 24 hours of each other.
Use is contraindicated in animals suffering from cardiac, hepatic or
renal
disease, where there is a possibility of gastro-intestinal ulceration
or
Revised: October 2022
AN: 01667/2022
Page 2 of 5
bleeding, where there is evidence of a blood dyscrasia or
hypersensitivity
to the product.
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
Avoid use in any dehydrated, hypovolaemic or hypotensive animals as
there is a potential risk of increased renal toxicity.
Use in any animal less than 6 weeks of age or in aged animals may
involve additional risk. If such use cannot be avoided animals may
require a reduced dosage and careful clinical management.
4.5
SPECIAL PRECAUTIONS FOR USE
(i) Special precautions for use in animals
When treating acute pain or inflammation, do not exceed the stated
dose
of 1mg/kg or 5 day duration of treatment.
(ii) Special precautions for use to be taken by the person
administering
the medicinal product to the animals
Wash hands after use. In the event of accidental ingestion, seek
medical
advice and show the doctor what has been taken.
4.6
ADVERSE REACTI