Vitofyllin 100 mg Film-coated Tablets for Dogs

Država: Velika Britanija

Jezik: engleski

Izvor: VMD (Veterinary Medicines Directorate)

Aktivni sastojci:

Propentofylline

Dostupno od:

WDT-Wirtschaftsgenossenschaft deutscher Tieraerzte eG

ATC koda:

QC04AD90

INN (International ime):

Propentofylline

Farmaceutski oblik:

Film-coated tablet

Tip recepta:

POM-V - Prescription Only Medicine – Veterinarian

Terapijska grupa:

Dogs

Područje terapije:

Cardio Vascular

Status autorizacije:

Authorized

Datum autorizacije:

2012-05-01

Svojstava lijeka

Revised: January 2023
AN: 02735/2022
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
Each film-coated tablet contains:
ACTIVE SUBSTANCE: Propentofylline
100.00 mg/tablet
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT
INFORMATION IS ESSENTIAL FOR PROPER
ADMINISTRATION OF THE VETERINARY
MEDICINAL PRODUCT
FILM COATING:
Titanium Dioxide, E 171
0.43 mg/tablet
Ferric Oxide, yellow, E 172
0.15 mg/tablet
Hypromellose
Macrogol 6000
Talc
CORE:
Lactose monohydrate
Maize Starch
Crospovidone
Talc
Silicia, Colloidal Anhydrous
Magnesium Stearate
Film-coated tablets.
Yellow, round, convex tablets with cross breakline tab on one side and
imprinting
"100" on the other side.
The tablet can be divided into 2 or 4 equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the improvement of peripheral and cerebral vascular blood
circulation. For
improvement in dullness, lethargy and overall demeanour in dogs.
Revised: January 2023
AN: 02735/2022
Page 2 of 5
3.3
CONTRAINDICATIONS
Refer to section 3.7.
Do not use in dogs weighing less than 5 kg.
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
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 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