MOXIGRO 1 MG/ML ORAL SOLUTION FOR SHEEP
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
02-12-2016
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Ingredient activ:
MOXIDECTIN
Disponibil de la:
Zoetis Ireland Limited
Codul ATC:
QP54AB02
INN (nume internaţional):
MOXIDECTIN
Dozare:
1 Mg/Ml
Forma farmaceutică:
Oral Solution
Tip de prescriptie medicala:
LM-Licensed Merchant
Grupul Terapeutică:
Ovine
Zonă Terapeutică:
Moxidectin
Indicații terapeutice:
Endectoparasiticides
Statutul autorizaţiei:
Authorised
Data de autorizare:
2015-05-08
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
MOXIGRO 1 mg/ml Oral Solution for Sheep.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
Active substance
Moxidectin
1.00 mg
Excipients
Benzyl Alcohol (E1519)
40.00 mg
Butylated Hydroxytoluene
2.50 mg
Disodium Edetate
0.27 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution
Pale yellow solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 17/11/2016_
_CRN 7024733_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections of sheep with parasites sensitive to moxidectin.
For the treatment and prevention of infections caused by:
- Adult and immature gastro-intestinal nematodes
_Haemonchus contortus _(including inhibited larvae)
_Ostertagia circumcincta _(including inhibited larvae)
_Ostertagia trifurcata_
_Trichostrongylus axei _(including inhibited larvae)
_Trichostrongylus colubriformis_
_Trichostrongylus vitrinus_
_Nematodirus battus_
_Nematodirus spathiger_
_Nematodirus filicolis _(adults only)
_Strongyloides papillosus _(larval stages only)
_Cooperia curticei _(adults only)
_Cooperia oncoaphora_
_Oesophagostomum columbianum_
_Oesophagostomum venulosym _(adults only)
_Chabertia ovina_
_Trichuris ovis _(adults only)
- Adult respiratory tract nematode
_Dictyocaulus filaria_
The product has a persistent effect in preventing reinfection:
for 5 weeks by _Ostertagia circumcincta _and _Haemonchus contortus_
for 4 weeks by _Oesophagostomum columbianum_
Clinical trials, after experimental and natural infection, have shown that the product is effective against certain
benzimidazole resistant strains of:
_Haemonchus contortus_
_Ostertagia circumcinct
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