TRODAX 340 MG/ML SOLUTION FOR INJECTION
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
03-05-2024
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Virkt innihaldsefni:
NITROXINIL
Fáanlegur frá:
Merial Animal Health Limited
ATC númer:
QP52AG08
INN (Alþjóðlegt nafn):
NITROXINIL
Skammtar:
340 Mg/Ml
Lyfjaform:
Solution for Injection
Gerð lyfseðils:
LM-Licensed Merchant
Meðferðarhópur:
Bovine, Ovine
Lækningarsvæði:
Nitroxinil
Ábendingar:
Endoparasiticide
Leyfisstaða:
Authorised
Leyfisdagur:
1999-10-01
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Trodax 340 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Nitroxynil
340 mg/ml
as N-ethylglucamine salt.
EXCIPIENTS:
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Bright orange-red solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep and Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Trodax 34% is indicated for the treatment of fascioliasis (infestation of mature and immature Fasciola hepatica) in cattle
and sheep. It is also effective, at the recommended dose rate, against adult and larval infestations of Haemonchus contortus
in cattle and sheep and Haemonchus placei, Oesophagostomum radiatum and Bunostomum phlebotomum in cattle.
However, Trodax should not be regarded or used as a broad spectrum anthelmintic.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active ingredient.
Do not exceed the stated dose.
Do not use in dogs as fatalities have been reported.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 10/07/2013_
_CRN 7014909_
_page number: 1_
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
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