Prazitel Plus XL Tablets For Dogs

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Preparatomtale Preparatomtale (SPC)
08-01-2023
DSU DSU (DSU)
21-04-2023

Aktiv ingrediens:

Praziquantel; Pyrantel embonate ; Febantel

Tilgjengelig fra:

Chanelle Pharmaceuticals Manufacturing Limited

ATC-kode:

QP52AA01; QP52AC05; QP52AF02

INN (International Name):

Praziquantel; Pyrantel embonate ; Febantel

Dosering :

175,504,525 mg/tablet

Legemiddelform:

Tablet

Resept typen:

CAM: Companion Animal Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Dogs

Terapeutisk område:

praziquantel; febantel; pyrantel

Indikasjoner:

Endectoparasiticides

Autorisasjon status:

Authorised

Autorisasjon dato:

2012-03-02

Preparatomtale

                                1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prazitel Plus XL Tablets For Dogs (AT, BG, CZ, EL, HU, IE, IS, LV, LT,
NL, PL, PT, SK &
UK)
Prazitel Tablets For Large Dogs (FI)
Prazitel Forte vet (NO & DK)
Prazitel Compresse per Cani di Taglia Grande (IT)
Prazitel comprimidos para perros grandes (ES)
Strantel XL Tablets For Dogs (DE)
Strantel vet Forte (SE)
Exitel Plus XL Tablets for Dogs (BE, LU)
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:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS
Lactose monohydrate
Microcrystalline cellulose
Magnesium stearate
Colloidal anhydrous silica
Croscarmellose sodium
Sodium laurilsulfate
Pork flavour
A yellow coloured oblong tablet with a breakline on both sides.
The tablets can be divided into two equal parts.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
In adult 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:
2
TAPEWORMS:
_Echinococcus_
species,
_(E. granulosus, E. multilocularis), Taenia_
species,
_(T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum_
(adult and immature forms).
3.3
CONTRAINDICATIONS
Do not use simultaneously with piperazine compounds.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
3.4
SPECIAL WARNINGS
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.
Care should be taken to avoid the following practices because they
increase the risk of
development of resistance and could ultimately res
                                
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