Noromectin 1.0 % w/v Solution for Injection for Sheep

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ivermectin

Tilgjengelig fra:

Norbrook Laboratories (Ireland) Limited

ATC-kode:

QP54AA01

INN (International Name):

Ivermectin

Dosering :

1.0 percent weight/volume

Legemiddelform:

Solution for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

ivermectin

Autorisasjon status:

Authorised

Autorisasjon dato:

2001-06-29

Preparatomtale

Health Products Regulatory Authority
27 February 2019
CRN008TS7
Page 1 of 4
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.
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 viable for
up to 15 days off the sheep. It is important to ensure all
sheep which have been in contact with infected sheep are treated.
Contact between treated, infected and non-treated,
non-infected flocks must be avoided until at least 7 days after the
last treatment.
Health Products Regulatory Authority
27 February 2019
CRN008