Propentofylline 100 mg Film Coated Tablets for Dogs

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Propentofylline

Commercializzato da:

Norbrook Laboratories Limited

Codice ATC:

QC04AD90

INN (Nome Internazionale):

Propentofylline

Forma farmaceutica:

Film-coated tablet

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Dogs

Area terapeutica:

Cardio Vascular

Stato dell'autorizzazione:

Expired

Data dell'autorizzazione:

2011-11-14

Scheda tecnica

Issued: November 2011
AN: 02607/2008
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Propentofylline 100mg Film Coated Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Propentofylline
100.00mg/tablet
EXCIPIENTS:
Opadry II Blue 85G30552
8.00mg/tablet
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film coated tablet.
A light blue oblong tablet, with a central score line on both faces
which can be
divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For improvement in dullness, lethargy and overall demeanour in dogs.
Is
particularly useful in older dogs, where it may increase willingness
to exercise
and exercise tolerance.
4.3
CONTRAINDICATIONS
Do not administer to pregnant bitches or breeding animals.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
(I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Specific diseases (e.g. kidney disease) should be treated accordingly.
Issued: November 2011
AN: 02607/2008
Page 2 of 4
Consideration should be given to rationalising the medication of dogs
already
receiving treatment for congestive heart failure or bronchial disease.
(II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental ingestion. In the event of
accidental
ingestion, seek immediate medical advice and show the package leaflet
to the
doctor. Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In the rare event of allergic reactions, treatment with the product
should be
stopped.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Do not use in pregnant bitches as the product has not been evaluated
in
these animals.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Half tablet per 10kg body weight twice a day.
The tablets should