Moxodex 5 mg/ml Pour-on solution for cattle

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

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Letöltés Termékjellemzők (SPC)
24-11-2022
Letöltés DSU (DSU)
08-11-2023

Aktív összetevők:

Moxidectin

Beszerezhető a:

Chanelle Pharmaceuticals Manufacturing Limited

ATC-kód:

QP54AB02

INN (nemzetközi neve):

Moxidectin

Adagolás:

5 milligram(s)/millilitre

Gyógyszerészeti forma:

Pour-on solution

Recept típusa:

POM: Prescription Only Medicine as defined in relevant national legislation

Terápiás terület:

moxidectin

Engedélyezési státusz:

Authorised

Engedély dátuma:

2020-01-24

Termékjellemzők

                                1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Moxodex 5 mg/ml Pour on solution for cattle
Ridamec 5 mg_ml solution pour-on pour bovins (FR)
Moxodex vet 5 mg/ml Pour on solution for cattle (FI, SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Moxidectin
5 mg
Excipients:
Butylhydroxyanisole E320
0.10 mg
Tert butyl hydroquinone E319
0.03 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pour-on solution.
A clear colourless to pale yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections of cattle with parasites sensitive to moxidectin.
For the treatment of infections caused by:
- ADULT AND LARVAL GASTRO-INTESTINAL NEMATODES:
_Haemonchus placei _
_Ostertagia ostertagi _
(including inhibited larvae)
_ _
_Trichostrongylus axei _
_Nematodirus helvetianus _
_Cooperia oncophora _
_Cooperia punctata _
(adults)
_ _
_Oesophagostomum radiatum _
(adults)
_ _
_Bunostomum phlebotomum _
(adults)
_ _
- ADULT RESPIRATORY TRACT NEMATODE
_Dictyocaulus viviparous _
_ _
- WARBLES (MIGRATING LARVAE)
_Hypoderma bovis _
_Hypoderma lineatum _
- LICE
_Linognathus vituli _
_Haematopinus eurysternus _
_Solenopotes capillatus _
_Bovicola bovis (Damalinia bovis) _
_ _
- MANGE MITES
_Sarcoptes scabiei _
_Psoroptes ovis _
_Chorioptes bovis _
_ _
-
HORN FLIES
_Haematobia irritans _
_ _
The product has a persistent effect in preventing against reinfection
by:
_Ostertagia ostertagi _
for 5 weeks
_Dictyocaulus viviparus _
for 6 weeks.
_ _
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
Not to be used in other species as severe adverse reactions, including
fatalities in dogs, may occur.
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 fr
                                
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