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

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Triclabendazole, Ivermectin

MAH:

Elanco Europe Ltd

ATC_code:

QP54AA51

INN:

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_indication:

Endoparasiticide

authorization_status:

Authorised

authorization_date:

2016-06-17

SPC

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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