FLUKIVER 5% W/V ORAL SUSPENSION

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Compra

Scheda tecnica Scheda tecnica (SPC)
18-05-2024

Principio attivo:

CLOSANTEL

Commercializzato da:

Elanco Animal Health, Eli Lilly and Company Limited

Codice ATC:

QP52AG09

INN (Nome Internazionale):

CLOSANTEL

Dosaggio:

5 %w/v

Forma farmaceutica:

Oral Suspension

Tipo di ricetta:

LM-Licensed Merchant

Gruppo terapeutico:

Ovine

Area terapeutica:

Closantel

Indicazioni terapeutiche:

Endoparasiticide

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2013-01-18

Scheda tecnica

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flukiver 5% w/v Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Closantel (as Clostanel sodium)
50 mg/ml
Excipients:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension.
A white suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep and lambs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment and control of adult and immature liver fluke, haematophagous nematodes and larval stages of some
arthropods in sheep.
Liver fluke:
_Fasciola hepatica _(average efficacy against 6 week immature stages is 86%)
_Fasciola gigantica_
Haematophagous nematodes
_Haemonchus contortus _(including benzimidazole resistant strains)
_Chabertia ovina_
_Gaigeria pachyscelis_
Arthropods
_Oestrus ovis _(Sheep Nasal Bot Fly)
Ticks (_lxodes ricinus_) feeding on sheep at the time of treatment are likely to produce fewer viable eggs.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/03/2014_
_CRN 7017277_
_page number: 1_
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they increase the risk of development of resistance and could
ultimately result in ineffective therapy:
•
Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
•
Underdosing which may be due to underestimation of bodyweight, misadministration of the product, or lack of
calibration of the dosing device.
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests
                                
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