ORAMEC Drench for Sheep 0.8 mg/ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Boehringer Ingelheim Vetmedica GmbH

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:

1994-10-01

Summary of Product characteristics

Health Products Regulatory Authority
27 July 2018
CRN008DDS
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
ORAMEC Drench for Sheep 0.8 mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Ivermectin
0.8 mg/ml
Excipients
Benzyl Alcohol
31.0 mg/ml
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
ORAMEC Drench for Sheep is highly effective for the treatment and
control of mixed
infections with the following gastrointestinal roundworms (including
benzimidazole-resistant strains of _Haemonchus contortus_, _Ostertagia
circumcincta_and
levamisole-resistant strains of _H. contortus, O. circumcincta_and _T.
colubriformis_):
GASTROINTESTINAL ROUNDWORMS(adult and fourth larval stage)
_Haemonchus contortus*_
_Ostertagia circumcincta*_
_Trichostrongylus _spp_._
_Cooperia _spp_._
_Nematodirus _spp_._
Including_N. battus_
_Strongyloides papillosus_
_Oesophagostomum _spp.
_Chabertia ovina_
Health Products Regulatory Authority
27 July 2018
CRN008DDS
Page 2 of 6
LUNGWORMS(adult and fourth larval stage)
_Dictyocaulus filaria_
NASAL BOT(all larval stages)
_Oestrus ovis_
* including benzimidazole resistant strains.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.
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 bodyweight,
misadministration of the product, or lack of calibration of the dosing
device.
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 tests s