Fasimec Duo 50 mg/ml + 1 mg/ml Oral Suspension for Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ivermectin, Triclabendazole

Available from:

Elanco Europe Ltd

ATC code:

QP54AA51

INN (International Name):

Ivermectin, Triclabendazole

Pharmaceutical form:

Oral suspension

Prescription type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Sheep

Therapeutic area:

Anthelmintic flukicide

Authorization status:

Authorized

Authorization date:

2007-11-20

Summary of Product characteristics

Revised: December 2020
AN: 01398/2020
Page 1 of 7
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_
Revised: December 2020
AN: 01398/2020
Page 2 of 7
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.
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 period of time.
·
Underdosing which m