Triazole Fluke and Worm Drench

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Levamisole hydrochloride ; Rafoxanide

Διαθέσιμο από:

Pharvet (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

QP52AE51

INN (Διεθνής Όνομα):

Levamisole hydrochloride ; Rafoxanide

Δοσολογία:

15.0, 22.5 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Oral suspension

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική ομάδα:

Cattle, Sheep

Θεραπευτική περιοχή:

levamisole, combinations

Θεραπευτικές ενδείξεις:

Endoparasiticide

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1989-10-01

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Triazole Fluke and Worm Drench
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES
Levamisole Hydrochloride
15 mg
Rafoxanide
22.5 mg
EXCIPIENTS
Sodium Metabisulphite (E223)
0.5 mg
Propyl Parahydroxybenzoate(E216)
0.1 mg
Methyl Parahydroxybenzoate(E218)
1.0 mg
Quinoline Yellow (E104)
0.09 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
A yellow aqueous oral suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Triazole _
is a combination product for the treatment of the common nematode
parasites (including lung worm
-
_Dictyocaulus _
spp.) and liver fluke (
_Fasciola hepatica) _
of cattle and sheep.
Triazole is active against:
_Fasciola hepatica _
(mature and immature over 8 weeks of age)
_Nematodirus _
spp.
_Dictyocaulus _
spp.
_Ostertagia _
spp. (except inhibited ostertagia larvae)
4.3 CONTRAINDICATIONS
Do not use in concurrent treatment with organophosphates and / or
diethylcarbamazine.
Do not use in animals with known hypersensitivity to the active
ingredients.
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.
Suspected clinical cases of resistance to anthelmintics should be
further investigated using appropriate tests
(e.g. Faecal Egg Count Reduction Test). Where the results of the tests
strongly suggest resistance to a
particular anthelmintic, an anthelmintic belonging to another
pharmacological class and having a different
mode of action should be used.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIA