Levacide Low Volume Worm Drench 75 mg/ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Levamisole hydrochloride

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QP52AE01

INN (International Name):

Levamisole hydrochloride

Dosage:

75 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

levamisole

Authorization status:

Authorised

Authorization date:

1989-10-01

Summary of Product characteristics

Health Products Regulatory Authority
24 January 2019
CRN008TFG
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Levacide Low Volume Worm Drench 75 mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Levamisole (as levamisole hydrochloride)
75
mg
Excipients
Methyl Parahydroxybenzoate (E218)
1.5
mg
Tartrazine (E102)
0.11
mg
Sodium Metabisulphite
1.5
mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A yellow viscous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
Sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Levacide Low Volume is a broad spectrum anthelmintic for use in the
treatment and
control of nematode infections. It should be used in cases of
parasitic gastro-enteritis
and lungworm disease caused by mature and developing immature forms of
those
organisms sensitive to treatment with Levamisole Hydrochloride.
Lungworms:
Dictyocaulus spp.
Health Products Regulatory Authority
24 January 2019
CRN008TFG
Page 2 of 5
Gastrointestinal worms:
Trichostrongylus spp.
Cooperia spp.
Ostertagia spp. (except inhibited Ostertagia larvae)
Haemonchus spp.
Nematodirus spp.
Bunostomum spp.
Oesophagostomum spp.
Chabertia spp.
4.3 CONTRAINDICATIONS
Do not use in animals known to be hypersensitive to Levamisole.
Do not use in animals producing milk for human consumption.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care should be taken when treating heavily pregnant animals or animals
under stress
from adverse weather conditions, poor nutrition, penning, handling
etc.. Levacide
Low Volume Worm Drench is not effective against Type II Ostertagiasis
(winter
scours) in cattle. In cases of lungworm infections, coughing may
persist for a
considerable time following successful treatment with Levacide Low
Volume Worm
Drench. This is due to tissue damage caused by the parasites.
Care should be taken to avoid the following practices because they
increase the risk
of development of resistance and could ultimate