Levafluke Oral Drench

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Hent Produktets egenskaber (SPC)
12-06-2017

Aktiv bestanddel:

Levamisole hydrochloride ; Rafoxanide

Tilgængelig fra:

Biochem Ltd

ATC-kode:

QP52AE51

INN (International Name):

Levamisole hydrochloride ; Rafoxanide

Dosering:

15,22.5 milligram(s)/millilitre

Lægemiddelform:

Oral suspension

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cattle, Sheep

Terapeutisk område:

levamisole, combinations

Terapeutiske indikationer:

Endoparasiticide

Autorisation status:

Authorised

Autorisation dato:

1999-10-01

Produktets egenskaber

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Levafluke Oral Drench.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Oral Suspension.
A yellow aqueous suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_LEVAFLUKE_ is a combination product for the treatment of the common
nematode parasites (including lung worm -
_Dicytocaulus_ spp.) and liver fluke (_Fasciola hepatica_) in cattle
and sheep.
_Levafluke_ is active against
_Fasciola hepatica, (mature and immature over 8 weeks of age)_
_Nematodirus spp.,_
_Dictyocaulus spp.,_
_Ostertagia spp._ in cattle and sheep (except inhibited ostertagia
larvae)_._
4.3 CONTRAINDICATIONS
Do not use in concurrent treatment with organophosphates and/or
diethylcarbamazine.
Do not use in animals with known hypersensitivity to the active
ingredients.
ACTIVE SUBSTANCE
QUANTITY PER ML
Rafoxanide
22.5 mg
Levamisole Hydrochloride
15.0 mg
EXCIPIENTS
Methyl Parahydroxybenzoate (E218) 1.0 mg
Propyl Parahydroxybenzoate (E216)
0.1 mg
Sodium metabisulphite (E223)
0.2 mg
Quinoline yellow (E104)
0.09 mg
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken to avoid the following practices because they
increase the risk of developm
                                
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