Levacide Injection 75 mg/ml

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Levamisole hydrochloride

Διαθέσιμο από:

Norbrook Laboratories (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

QP52AE01

INN (Διεθνής Όνομα):

Levamisole hydrochloride

Δοσολογία:

75 milligram(s)/millilitre

Φαρμακοτεχνική μορφή:

Solution for injection

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

levamisole

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1989-10-01

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
25 January 2019
CRN008SVL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Levacide 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 sterile solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, Sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Levacide 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.
Health Products Regulatory Authority
25 January 2019
CRN008SVL
Page 2 of 5
_Ostertagia_ spp. (except inhibited _Ostertagia_ larvae in cattle)
_Haemonchus_ spp.
_Nematodirus_ spp.
_Bunostomum_ spp.
_Oesophagostomum_ spp._Chabertia_ spp.
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 bodyweight,
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