Drontal Cat XL Film-coated Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

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Productkenmerken Productkenmerken (SPC)
04-05-2018

Werkstoffen:

Pyrantel embonate ; Praziquantel

Beschikbaar vanaf:

Bayer Limited

ATC-code:

QP52AA51

INN (Algemene Internationale Benaming):

Pyrantel embonate ; Praziquantel

Dosering:

30/345 mg/tablet

farmaceutische vorm:

Tablet

Prescription-type:

CAM: Companion Animal Medicine as defined in relevant national legislation

Therapeutische categorie:

Cats

Therapeutisch gebied:

praziquantel, combinations

therapeutische indicaties:

Endoparasiticide

Autorisatie-status:

Authorised

Autorisatie datum:

2004-08-06

Productkenmerken

                                Health Products Regulatory Authority
03 May 2018
CRN000XNS
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Drontal Cat XL Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES
Pyrantel embonate
345
mg
Praziquantel
30
mg
EXCIPIENTS
Titanium dioxide E171 (colouring agent)
2.60
mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White to yellowish, ellipsoid, biconvex, unscored tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of gastrointestinal roundworms and tapeworms:
_Toxocara cati, _
_Toxascaris leonina, Dipylidium caninum, Taenia taeniaeformis._
4.3 CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
Not intended for use in kittens less than 6 weeks of age.Until
sufficient studies have
been performed with this combination, 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.
Health Products Regulatory Authority
03 May 2018
CRN000XNS
Page 2 of 5
As a precautionary measure to prevent the establishment of _E.
multilocularis_ in the
UK or Ireland, it is recommended that all cats entering the country be
treated with
praziquantel.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None known.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
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.
Any part-used tablets should be discarded.
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 
                                
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