Vitofyllin 100 mg film-coated tabletsfor dogs
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
09-07-2013
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Active ingredient:
propentofylline 100 mg
Available from:
Animalcare Limited
ATC code:
QC04A
Pharmaceutical form:
Tablet
Therapeutic group:
PERIPHERAL VASODILATORS
Therapeutic area:
Dogs
Authorization date:
2012-02-22
Summary of Product characteristics
Issued: May 2012
AN: 02115/2010
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vitofyllin 100 mg film-coated tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Propentofylline
100.00 mg/tablet
EXCIPIENTS:
Ferric Oxide, yellow, (E 172)
0.150 mg/tablet
Titanium Dioxide, (E171)
0.430 mg/tablet
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Yellow, round convex tablets with cross-snap-tab on one and imprinting "100" on the
other side.
The tablet can be divided into equal halves and quarters._ _
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the improvement of peripheral and cerebral vascular blood circulation. For
improvement in dullness, lethargy and overall demeanour in dogs_._
4.3 CONTRAINDICATIONS
Refer to section 4.7
Do not use in dogs weighing less than 5 kg.
Do not use in cases of hypersensitivity to the active substance and/or to any of the other
ingredients of the product.
4.4 SPECIAL WARNINGS
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Issued: May 2012
AN: 02115/2010
Page 2 of 5
Specific diseases (e.g. kidney disease) should be treated accordingly.
Consideration should be given to rationalising the medication of dogs already receiving
treatment for congestive heart failure or bronchial disease.
In the case of renal failure, the dose should be reduced.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Care should be ta
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