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

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Triclabendazole; Ivermectin

Beschikbaar vanaf:

Elanco GmbH

ATC-code:

QP54AA51

INN (Algemene Internationale Benaming):

Triclabendazole; Ivermectin

Dosering:

50, 1 milligram(s)/millilitre

farmaceutische vorm:

Oral suspension

Prescription-type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutisch gebied:

ivermectin, combinations

Autorisatie-status:

Authorised

Autorisatie datum:

2016-06-17

Productkenmerken

Health Products Regulatory Authority
05 April 2019
CRN008WV9
Page 1 of 5
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
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 the full list of excipients, see section 6.1.
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.
Health Products Regulatory Authority
05 April 2019
CRN008WV9
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
I. SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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