DRONTAL TABLETS CATS VETERINARY

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

PRAZIQUANTEL; PYRANTEL EMBONATE

Dostopno od:

LIDORR ELEMENTS LTD

Farmacevtska oblika:

TABLETS

Sestava:

PRAZIQUANTEL 20 MG; PYRANTEL EMBONATE 230 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

BAYER ANIMAL HEALTH GmbH, GERMANY

Terapevtske indikacije:

Tape worms and round worms in cats.

Datum dovoljenje:

2020-12-31

Navodilo za uporabo

Page 1 of
CONSUMER LEAFLET FOR A VETERINARY PRODUCT
This medicine is marketed according to a veterinarian’s prescription
only.
For animal use only
1.
NAME OF THE VETERINARY MEDICINE, FORM AND STRENGTH
Drontal Tablets Cats Veterinary
2.
ACTIVE INGREDIENTS and quantity in a single dose: Pyrantel Embonate 230 mg per tablet
Praziquantel 20 mg per tablet
EXCIPIENTS – each tablet contains: Titanium Dioxide 1.8 mg.
For a full list of excipients, see section 13: "additional
information".
3.
WHAT IS THE MEDICINE INTENDED FOR
For the treatment of tapeworms and roundworms in cats.
Therapeutic group: Anthelmintics.
Pyrantel Embonate- for the control of roundworms
Praziquantel- for the control of tapeworms.
.
4.
CONTRA-INDICATIONS
Do not use simultaneously with piperazine compounds.
Not intended for use in kittens less than 6 weeks of age.
Do not use during pregnancy.
5.
SIDE EFFECTS
Mild and transient digestive tract disorders such as hypersalivation
and/or vomiting
and mild and transient neurological disorders such as ataxia may occur
in extremely
rare cases.
Reporting of suspected adverse reactions
Side effects can be reported to the Ministry of Health by clicking on
the link
"Adverse Drug Reactions Repot" that appears on the home page of the
Ministry
of Health web site (www.health.gov.il), which leads to an online form
for reporting
side effects. Alternatively you can use the following link:
https://sideeffects.health.gov.il/
Side effects can also be reported to Lidorr Elements, by email to:
[e-mail]
6.
TARGET ANIMALS
Cats.
7.
DOSAGE AND ADMINISTRATION
Page 2 of
According to the veterinarian’s instructions. 1 tablet per 4 kg
bodyweight according
to the below:
The cat's bodyweight Number of tablets to administer:
2 kg
½ tablet
4 kg
1 tablet
6 kg 1 ½ tablets
8 kg 2 tablets
8.
HOW TO USE THE PRODUCT
Single oral administration. The tablet should be given directly to the
animal, but if
necessary can be disguised in food.
9.
WITHDRAWAL PERIOD
Not applicable.
10.
WARNINGS
•
SPECIAL WARNINGS FOR USE OF THE ME

Lastnosti izdelka

Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Tablets Cats Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE CONSTITUENTS
MG PER TABLET
Pyrantel Embonate
230.0
Praziquantel
20.0
RELEVANT CONSTITUENTS OF THE EXCIPIENTS
Titanium Dioxide
1.8 mg
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish scored coated tablet. The tablet can be divided
into equal
halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of tapeworms and roundworms in cats.
4.3
CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
Not intended for use in kittens less than 6 weeks of age.
Do not use during pregnancy.
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 re-occur
unless control
of intermediate hosts such as fleas, mice etc is undertaken.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Page 2 of 4
None.
ii.
Special
precautions
to
be
taken
by
the
person
administering
the
medicinal product to animals
In the interests of good hygiene, persons administering the tablets
directly
to a cat, or by adding them to the cat’s food, should wash their
hands
afterwards.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Mild and transient digestive tract disorders such as hypersalivation
and/or
vomiting and mild and transient neurological disorders such as ataxia
may
occur in extremely rare cases.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the
medicinal
product is important. It allows continued monitoring of the
benefit/risk
balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of
Health
according to the National Regulation by using an online form
https://sideeffects.health.gov.il/
Adverse events ca