Noromectin Drench 0.8 mg/ml Oral Solution for Sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

0.8 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin

Authorization status:

Authorised

Authorization date:

2000-06-14

Summary of Product characteristics

Health Products Regulatory Authority
15 January 2019
CRN008TFC
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin Drench 0.8 mg/ml Oral Solution for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Ivermectin 0.8 mg/ml
EXCIPIENT(S)
Benzyl alcohol 30 mg/ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Solution. A pale yellow clear liquid
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The medicinal product is indicated for the treatment and control of
gastrointestinal
nematodes, lungworms, and nasal bots of sheep.
GASTRO-INTESTINAL WORMS
_Haemonchus contortus _[Adult, L4 and inhibited L4]_, Ostertagia
(Teladorsagia) _
_circumcincta _[Adult, L4 and inhibited L4]_, Trichostrongylus axei_
[Adult and L4],
_Trichostrongylus colubriformis_ [Adult and L4], _Trichostrongylus
vitrinus_ [Adult and L4],
_Cooperiacurticei_ [Adult and L4], _Cooperia oncophora _[Adult and
L4], _Nematodirus _
_battus _[Adult and L4], _Nematodirus filicollis_ [Adult and L4],
_Nematodirusspathiger_
[Adult and L4]_, Strongyloides papillosus _[Adult and L4]_, _
_Oesophagostomumcolumbianum_ [Adult and L4], _Oesophagostomum
venulosum _
[Adult and L4] and adult _Chabertia ovina._
Inhibited larval stages and benzimidazole resistant strains of _H
contortus_ and
_Ostertagia (Teladorsagia) circumcincta_ are also controlled.
LUNGWORMS (ADULT AND IMMATURE):
Health Products Regulatory Authority
15 January 2019
CRN008TFC
Page 2 of 5
_Dictyocaulus filaria_
NASAL BOT (ALL LARVAL STAGES):_Oestrus ovis_
4.3 CONTRAINDICATIONS
Do not use in animals in which milk is intended for human consumption.
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,