Vitofyllin 50 mg Film-coated Tablets for Dogs

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Propentofylline

Tilgængelig fra:

WDT-Wirtschaftsgenossenschaft deutscher Tieraerzte eG

ATC-kode:

QC04AD90

INN (International Name):

Propentofylline

Lægemiddelform:

Film-coated tablet

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Dogs

Terapeutisk område:

Cardio Vascular

Autorisation status:

Authorized

Autorisation dato:

2012-05-02

Produktets egenskaber

Revised: January 2023
AN: 02735/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Vitofyllin 50 mg film-coated tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
ACTIVE SUBSTANCE:
Propentofylline
50.00 mg/tablet
EXCIPIENTS:
Ferric Oxide, yellow, (E 172)
0.075 mg/tablet
Titanium Dioxide, (E171)
0.215 mg/tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Yellow, round, convex tablets with cross breakline on one side and
imprinting “50” on
the other side.
The tablet can be divided into 2 or 4 equal parts.
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 2.5 kg.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: January 2023
AN: 02735/2022
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
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.
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 case of accidental ingestion, seek medical advice immediately and
show the
package leaflet or the label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Dogs:
Rare
(1 to 10 animals / 10,000
animals treated)
Allergic skin reactions*,