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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Triclabendazole; Ivermectin

Available from:

Elanco GmbH

ATC code:

QP54AA51

INN (International Name):

Triclabendazole; Ivermectin

Dosage:

50, 1 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin, combinations

Authorization status:

Authorised

Authorization date:

2016-06-17

Summary of Product characteristics

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