Drontal Cat XL Film-coated Tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Praziquantel; Pyrantel embonate

MAH:

Bayer Animal Health GmbH

ATC_code:

QP52AA51

INN:

Praziquantel; Pyrantel embonate

dosage:

30/345 mg/tablet

pharmaceutical_form:

Tablet

prescription_type:

CAM: Companion Animal Medicine as defined in relevant national legislation

therapeutic_area:

praziquantel, combinations

authorization_status:

Authorised

authorization_date:

2004-08-06

SPC

Health Products Regulatory Authority
22 June 2020
CRN009RDJ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
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.
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.
Health Products Regulatory Authority
22 June 2020
CRN009RDJ
Page 2 of 4
Any part-used tablets should be discarded.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Mild and transient digestive tract disorders such as hypersalivation
and