Noromectin 0.08% w/v Drench Oral Solution

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Ivermectin

Available from:

Norbrook Laboratories Limited

ATC code:

QP54AA

INN (International Name):

Ivermectin

Pharmaceutical form:

Oral solution

Prescription type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Sheep

Therapeutic area:

Endectocide

Authorization status:

Authorized

Authorization date:

2000-05-25

Summary of Product characteristics

Revised: August 2010
(Amended pages)
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin 0.08% w/v Drench Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Ivermectin
0.08% w/v
EXCIPIENTS:
Benzyl Alcohol 3.0% v/v
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 treatment and control of gastrointestinal nematodes, and lungworms
and
nasal bots of sheep
GASTROINTESTINAL WORMS (ADULT AND IMMATURE):
_Haemonchus contortus, Ostertagia circumcincta,_ _Trichostrongylus
_spp, _Cooperia _
spp,
_Nematodirus _
spp
including
_N. _
_battus, _
_Strongyloides _
_papillosus_,_ _
_Oesophagostomum _spp, and adult _Chabertia ovina._
Inhibited larval stages and benzimidazole resistant strains of _ H.
contortus_ and
_Ostertagia circumcincta_ are also controlled.
LUNGWORMS_ _(ADULT AND IMMATURE):
_Dictyocaulus filaria_
NASAL BOT (ALL LARVAL STAGES):
_Oestrus ovis_
Revised: August 2010
(Amended pages)
Page 2 of 5
4.3
CONTRA-INDICATIONS
The product has been formulated specifically for use in sheep. It
should not be
used in other species, as adverse reactions, including fatalities in
dogs, may
occur.
The product is not for intravenous or intramuscular use.
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, which may be due to underestimation of body weight,
misadministration of the product, or lack of calibration of the dosing
device (if
any)
Suspected
clinical
cases
of
resistance
to
anthelmintics
should
be
further
investigated using appropriate tests (e.g. Faecal Egg Count Reduction
Test).
Where the results of the test(s) strongl