Levacide Pour-on 200 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:

200 milligram(s)/millilitre

Pharmaceutical form:

Pour-on solution

Prescription type:

LR: Licensed Retailer as defined in national legislation

Therapeutic area:

levamisole

Authorization status:

Authorised

Authorization date:

1997-12-12

Summary of Product characteristics

Health Products Regulatory Authority
03 May 2019
CRN0091QM
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Levacide Pour-on 200 mg/ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Levamisole (as lavamisole hydrochloride) 200 mg/ml
Excipients:
Patent Blue (E131) 1 mg/ml
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Pour-on Solution
A dark blue non-aqueous solution for external use.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Levacide Pour-on is a broad spectrum anthelmintic indicated for use in
cattle in the treatment and control of nematode
infections such as parasitic gastro-enteritis and lungworm disease
caused by the following mature and developing immature
gastro-intestinal and pulmonary nematodes :
Lungworms -Dictyocaulus viviparus
Gastro-intestinal worms - _Trichostrongylus_ spp; _Cooperia_ spp;
_Ostertagia ostertagi _(except inhibited _O. ostertagi _larvae);
_Haemonchus_ spp; _Nematodirus_ spp; _Bunostomum_ spp;
_Oesophagostomum _spp.
4.3 CONTRAINDICATIONS
Do not use in animals producing milk for human consumption.
Do not use in animals with known hypersensitivity to the active
ingredients.
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.”
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) strongly
suggest resistance to a particular anthelmintic, an anthelmintic
belonging to another pharmacological class and having a different mode