Fasimec Duo 50 mg/ml + 1 mg/ml oral suspension for sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

Triclabendazole, Ivermectin

Available from:

Elanco Europe Ltd

ATC code:

QP54AA51

INN (International Name):

Triclabendazole, Ivermectin

Dosage:

50/1 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

LM: Licensed Merchant as defined in relevant national legislation

Therapeutic group:

Sheep

Therapeutic area:

ivermectin, combinations

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2016-06-17

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fasimec Duo 50 mg/ml + 1 mg/ml oral suspension for sheep.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral suspension
Cream coloured aqueous oral suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
For sheep over 3 months of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mixed trematode (fluke) and nematode or arthropod
infections due to gastrointestinal roundworms,
lungworms, liver fluke and nasal bots.
GASTROINTESTINAL NEMATODES (ADULT AND IMMATURE):
_Haemonchus contortus, Teladorsagia (Ostertagia) circumcincta,
Trichostrongylus spp, Cooperia spp, Nematodirus spp_
including_ N. battus_,_ Strongyloides papillosus, Oesophagostomum
spp_, and adult_ Chabertia ovina._
Inhibited larval
stages and benzimidazole resistant
strains of_ Haemonchus contortus_ and_ Teladorsagia (Ostertagia)_
_circumcincta_ are also controlled.
LIVER FLUKE (MATURE, IMMATURE AND EARLY IMMATURE STAGES DOWN TO LESS
THAN 1 WEEK OF AGE):
_Fasciola hepatica_
LUNGWORMS (ADULT AND IMMATURE):
_Dictyocaulus filaria_
NASAL BOTS (ALL STAGES):
_Oestrus ovis_
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredients or any of the excipients.
ACTIVE INGREDIENTS:
Ivermectin
1
mg/ml
Triclabendazole
50
mg/ml
EXCIPIENTS:
Methyl parahydroxybenzoate (E218)
1.4 mg/ml
Propyl parahydroxybenzoate (E216)
0.5 mg/ml
Benzyl alcohol
5.0 mg/ml
For a full list of excipients, see section 6.1.
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