PRAZITEL PLUS VETERINARY TABLETS

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

FEBANTEL; PRAZIQUANTEL; PYRANTEL

متاح من:

A.L. MEDI-MARKET LTD.

الشكل الصيدلاني:

TABLETS

تركيب:

FEBANTEL 150 MG; PYRANTEL 50 MG; PRAZIQUANTEL 50 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

CHANELLE PHARMACEUTICALS MANUFACTURING LTD., IRELAND

الخصائص العلاجية:

In dogs: Treatment of mixed infections by nematodes and cestodes of the following species:Nematodes:Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms).Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults).Whipworms: Trichuris vulpis (adults).Cestodes: Tapeworms: Tapeworms: Echinococcus species, (E. granulosus, E. multilocularis), Taenia species, (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum (adult and immature forms).

تاريخ الترخيص:

2021-10-31

نشرة المعلومات

CONSUMER PACKAGE INSERT FOR
A VETERINARY PREPARATION
The medicine is dispensed with
a veterinarian’s prescription only
For animal treatment only
1. NAME OF THE VETERINARY
MEDICINE,
ITS
FORM
AND
STRENGTH
PRAZITEL PLUS VETERINARY
TABLETS
2. ACTIVE INGREDIENTS
Each tablet contains:
Praziquantel 50 mg, pyrantel 50 mg
(equivalent
to
144
mg
pyrantel
embonate), Febantel 150 mg.
Inactive and allergenic ingredients: see
section 13 ”Further information“.
3. WHAT
IS THE
MEDICINE
INTENDED FOR?
For the treatment of nematodes and
cestodes in dogs, of the following
species:
NEMATODES:
ASCARIDS:
Toxocara canis, Toxascaris
leonina
(adult and late immature
forms).
HOOKWORMS:
Uncinaria stenocephala,
Ancylostoma caninum
(adults).
WHIPWORMS: Trichuris vulpis (adults).
CESTODES:
TAPEWORMS:
Echinococcus species,
(E. granulosus, E. multilocularis),
Taenia species, (T. hydatigena, T.
pisiformis, T. taeniformis) Dipylidium
caninum
(adult and immature forms).
THERAPEUTIC GROUP:
Anthelmintic.
4. CONTRAINDICATIONS
Do not use the product simultaneously
with preparations containing piperazine
as the anthelmintic activity of pyrantel
and piperazine may be contraindicated.
Do not use the product in animals
with a known sensitivity to the active
ingredients or to any of the inactive
ingredients.
5. SIDE EFFECTS
In very rare cases, gastrointestinal
disturbances (diarrhea, vomiting) have
been observed.
If you notice any serious adverse
reactions not mentioned in this leaflet,
please inform your veterinarian.
Side effects can be reported to the
Ministry of Health by clicking on the
link “Report Side Effects of Drug
Treatment“ found on the Ministry of
Health homepage (www.health.gov.il),
that directs you to the online form for
reporting side effects, or by entering
the link:
http://sideeffects.health.gov.il
6. TARGET SPECIES
Dogs
7. MODE OF ADMINISTRATION AND
DOSAGE
SINGLE DOSE: FOR ORAL ADMINISTRATION.
The recommended dosage are: 15
mg/kg bodyweight febantel, 5 mg/kg
pyrantel (equivalent to approximately
14.4 mg/kg pyrantel embonate) and
5

خصائص المنتج

Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prazitel Plus Veterinary Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Praziquantel
50 mg
Pyrantel
(equivalent to 144 mg pyrantel
embonate)
50 mg
Febantel
150 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
A pale yellow tablet with a cross breakline on one side.
The tablets 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
In dogs: Treatment of mixed infections by nematodes and cestodes of
the following
species
NEMATODES:
ASCARIDS: _Toxocara canis_, _Toxascaris leonina_ (adult and late
immature forms).
HOOKWORMS: _Uncinaria stenocephala_, _Ancylostoma caninum_ (adults).
WHIPWORMS: _Trichuris vulpis_ (adults).
CESTODES:
TAPEWORMS: _Echinococcus_ species, _(E. granulosus, E.
multilocularis), Taenia_
species, _(T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium
caninum_ (adult and
immature forms).
4.3
CONTRAINDICATIONS
Page 2 of 6
Do not use simultaneously with piperazine compounds.
Do not use in animals with a known sensitivity to the active
ingredients or to any of
the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Fleas serve as intermediate hosts for one common type of tapeworm –
_Dipylidium _
_caninum_. Tapeworm infestation is certain to reoccur unless control
of intermediate
hosts such as fleas, mice, etc. is undertaken.
Tapeworm infestation is unlikely in pups less than 6 weeks of age.
Parasite resistance to any particular class of anthelmintic may
develop following
frequent, repeated use of an anthelmintic of that class.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
In case of accidental ingestion, seek medical advice and show the
package leaflet to
the physician.
In the interests of