Vitofyllin 50 mg film-coated tablets for dogs

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Propentofylline

Inapatikana kutoka:

WDT - Wirtschaftsgenossenschaft deutscher Tierarzte eG,

ATC kanuni:

QC04AD90

INN (Jina la Kimataifa):

Propentofylline

Kipimo:

50 mg/tablet

Dawa fomu:

Film-coated tablet

Dawa ya aina:

POM: Prescription Only Medicine as defined in relevant national legislation

Eneo la matibabu:

propentofylline

Idhini hali ya:

Authorised

Idhini ya tarehe:

2012-05-11

Tabia za bidhaa

2 20220908-vitofyllin-50mg-vers-005
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
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
0.215 mg/tablet
Ferric Oxide, yellow, E 172
0.075 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 "50" 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.
3.3
CONTRAINDICATIONS
Refer to section 3.7.
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.
3.4
SPECIAL WARNINGS
None.
3 20220908-vitofyllin-50mg-vers-005
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 hands after use.
Special precautions for the protection of t