DUPHALEVASOLE INJECTION 75 MG/ML

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LEVAMISOLE

Available from:

Zoetis Ireland Limited

ATC code:

QP52AE01

INN (International Name):

LEVAMISOLE

Dosage:

75 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Bovine, Ovine

Therapeutic area:

Levamisole

Therapeutic indications:

Endoparasiticide

Authorization status:

Authorised

Authorization date:

2013-08-23

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Duphalevasole Injection 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
Sodium Metabisulphite
1.5 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear colourless, solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
Sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Duphalevasole Injection 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 including the following:
LUNGWORMS (ADULT AND LARVAL STAGES): _Dictyocaulus _spp.
GASTRO-INTESTINAL WORMS (ADULT AND LARVAL STAGES):
_Trichostrongylus _spp.
_Cooperia _spp.
_Ostertagia _spp. (except inhibited _Ostertagia _larvae in cattle)
_Haemonchus _spp.
_Nematodirus _spp.
_Bunostomum _spp.
_Oesophagostomum _spp.
_Chabertia _spp.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/08/2013_
_CRN 7015614_
_page number: 1_
4.3 CONTRAINDICATIONS
Do not use in animals known to be hypersensitive to Levamisole.
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