Levacide Low Volume 7.5% Oral Solution

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Levamisole Hydrochloride

Verfügbar ab:

Norbrook Laboratories Limited

ATC-Code:

QP52AE01

INN (Internationale Bezeichnung):

Levamisole Hydrochloride

Darreichungsform:

Oral solution

Verschreibungstyp:

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

Therapiegruppe:

Cattle, Sheep

Therapiebereich:

Anthelmintic

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

1987-02-03

Fachinformation

Revised: 09 June 2010
AN: 00154/2010
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Levacide Low Volume 7.5% Oral Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
7.5% w/v Levamisole Hydrochloride
EXCIPIENTS:
0.15% w/v Methyl Hydroxybenzoate as antimicrobial preservative
0.011% w/v Tartrazine (E102) as dye
0.15% w/v Sodium Metabisulphite as an antioxidant
0.05% w/v Disodium Edetate Dihydrate as an antioxidant
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution
A clear yellow liquid
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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. These include:
_Haemonchus _spp, _Ostertagia _spp (except inhibited Ostertagia larvae
in
cattle), _Nematodirus_ spp, _Trichostrongylus_ spp, _Cooperia _spp,
_Oesophagostomum _spp, _Chabertia _spp, _Bunostomum _spp and
_Dictyocaulus _spp.
4.3
CONTRAINDICATIONS
Animals must not be treated within a period of 14 days before or after
treatment with organophosphorus compounds.
Revised: 09 June 2010
AN: 00154/2010
Page 2 of 5
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