NOROMECTIN 1.0% W/V SOLUTION FOR INJECTION FOR SHEEP
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
03-09-2015
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Ingredient activ:
IVERMECTIN
Disponibil de la:
Norbrook Laboratories Limited
Codul ATC:
QP54AA01
INN (nume internaţional):
IVERMECTIN
Dozare:
1.0 %w/v
Forma farmaceutică:
Solution for Injection
Tip de prescriptie medicala:
LM-Licensed Merchant
Grupul Terapeutică:
Ovine
Zonă Terapeutică:
Ivermectin
Indicații terapeutice:
Endectoparasiticides
Statutul autorizaţiei:
Authorised
Data de autorizare:
2001-06-29
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin 1.0% w/v Solution for Injection for Sheep.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Each ml:
Ivermectin
10.0 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for the treatment of infections by the following species of gastrointestinal roundworms, lungworms, nasal bots
and psoroptic mange (sheep scab).
GASTROINTESTINAL ROUNDWORMS (ADULTS AND FOURTH STAGE LARVAE):
_Ostertagia circumcincta _(including inhibited larvae_), Haemonchus contortus _(including inhibited larvae), _Trichostrongylus_
_axei _(adults_), Trichostrongylus colubriformis _(adults)_, Trichostrongylus vitrinus _(adults_), Cooperia curticei, Nematodirus_
_filicollis_.
LUNGWORMS:
_Dictyocaulus filaria _(adults and fourth stage larvae)
NASAL BOTS:
_Oestrus ovis _(all larval stages)
MANGE MITES:
_Psoroptes ovis_
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to ivermectin.
Do not administer by the intravenous or intramuscular route.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 19/08/2015_
_CRN 7021379_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of psoroptic mange (sheep scab) with one injection is not recommended, because although clinical improvement
may be seen elimination of all mites may not occur.
Sheep scab (_Psoroptes ovis_) is an extremely contagious external parasite of sheep. Following treatment of infected sheep
great care must be taken to avoid re-infestation, as mites may be vi
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