Levacide 7.5% Solution for Injection

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Levamisole Hydrochloride

Dostopno od:

Norbrook Laboratories Limited

Koda artikla:

amended)

INN (mednarodno ime):

Levamisole Hydrochloride

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

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

Terapevtska skupina:

Cattle, Sheep

Terapevtsko območje:

Anthelmintic

Status dovoljenje:

Authorized

Datum dovoljenje:

1983-04-27

Lastnosti izdelka

Revised: July 2010
(ATC vet code amended)
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Levacide 7.5% Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Levamisole Hydrochloride
7.500% w/v
EXCIPIENTS:
Methyl Hydroxybenzoate
0.150% w/v
Sodium Metabisulphite
0.150% w/v
Disodium Edetate Dihydrate
0.050% w/v
Quinoline Yellow (E104)
0.10% w/v
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear yellow solution, free from visible particles.
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.
4.3
CONTRAINDICATIONS
Animals must not be treated within a period of 14 days before or after
treatment with organophosphorus compounds.
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.
Revised: July 2010
(ATC vet code amended)
Page 2 of 5
•
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 of the test(s) strongly suggest resistance to a
particular
anthelmintic, an anthelmintic belonging to another pharmacological
class and
having a different mode of action should be used.
Resistance to levamisole has been reported in _ Teladorsagia_,