Rofectan Plus XL Tablets For Dogs

Country: United Kingdom

Bahasa: Inggeris

Sumber: VMD (Veterinary Medicines Directorate)

Bahan aktif:

Febantel, Praziquantel, Pyrantel Embonate

Boleh didapati daripada:

C&H Generics Ltd

Kod ATC:

QP52AA51

INN (Nama Antarabangsa):

Febantel, Praziquantel, Pyrantel Embonate

Borang farmaseutikal:

Tablet

Jenis preskripsi:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Kumpulan terapeutik:

Dogs

Kawasan terapeutik:

Anthelmintic anticestodal

Status kebenaran:

Authorized

Tarikh kebenaran:

2021-01-12

Ciri produk

Amended pages: February 2021
AN: 02194/2017
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rofectan Plus XL Tablets for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Praziquantel
175 mg
Pyrantel Embonate
504 mg (equivalent
to 175 mg pyrantel)
Febantel
525 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
A yellow coloured oblong tablet with a breakline on both sides.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In adult dogs:
For the treatment of mixed infections with roundworms, hookworms,
whipworms, and tapeworms of the following species:
ROUNDWORMS (NEMATODES):
Ascarids (adult and late immature forms): _Toxocara canis_,
_Toxascaris leonina_.
Hookworms (adults): _Uncinaria stenocephala_, _Ancylostoma caninum_.
Whipworms (adults): _Trichuris vulpis_.
Amended pages: February 2021
AN: 02194/2017
Page 2 of 8
TAPEWORMS (CESTODES):
Adult and immature forms of: _Echinococcus_ species _(E. granulosus,
E. _
_multilocularis), Taenia_ species_ (T. hydatigena, T. pisiformis, T.
taeniformis), _
_Dipylidium caninum_.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the
excipients
Do not use simultaneously with piperazine compounds as piperazine may
block
the action of pyrantel embonate contained in this product. Other
worming
products may contain piperazine.
Do not use simultaneously with other deworming products without
veterinary
advice.
Do not exceed the stated dose.
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.
Dogs should also be prevented from scavenging or hunting as part of
measures
to prevent tapeworm reinfestation.
If your