Tribamec 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:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP54AA51

INN (International Name):

Triclabendazole; Ivermectin

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin, combinations

Authorization date:

2023-01-20

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tribamec Duo 50 mg/ml + 1 mg/ml Oral Suspension for Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES
:
Triclabendazole
50 mg
Ivermectin
1 mg
EXCIPIENTS
:
Methyl parahydroxybenzoate (E218)
1.2 mg
Propyl parahydroxybenzoate
0.5 mg
Benzyl alcohol
27.0 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral suspension
A smooth white to off white uniform suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
For sheep over 3 months of age.
4.2
INDICATION FOR USE
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 cases of hypersensitivity to the active ingredients or
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 may be due to underestimation of bodyweight,
misadministration
of the product or lack of calibration of the dosing device (if any).
Suspected clinical cases of resistance to anthelmintics shou