Propentofylline 50 mg Film Coated Tablets for Dogs

Summary of Product characteristics

                                Issued: November 2011
AN: 02606/2008
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Propentofylline 50mg Film Coated Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Propentofylline
50.00mg/tablet
EXCIPIENTS:
Opadry II Blue 85G30552
4.00mg/tablet
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film coated tablet.
A light blue circular tablet, quarter scored on one side 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: 02606/2008
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
5kg
body
weight
twice
a
day
(equivalent
to
6-10
mg
propentofyl
                                
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