Paramectin 1% Solution for Injection

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Ivermectin

Fáanlegur frá:

Norbrook Laboratories (Ireland) Limited

ATC númer:

QP54AA01

INN (Alþjóðlegt nafn):

Ivermectin

Skammtar:

1.0 percent weight/volume

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

ivermectin

Leyfisstaða:

Authorised

Leyfisdagur:

2001-06-29

Vara einkenni

Health Products Regulatory Authority
25 January 2019
CRN008VKL
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Paramectin 1% Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Active substance
​
​
​
Ivermectin
1.0​
% w/v​
​
Excipients
​
​
​
Non-aqueous excipients to
100​
% v/v​
​
For a full list of exciients, see section 6.1.
​
​
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (beef and non-lactating dairy cattle) and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_CATTLE_
In cattle, treatment of infections by the following parasites:
GASTROINTESTINAL ROUNDWORMS (ADULTS AND FOURTH STAGE LARVAE):
_Ostertagia ostertagi _(including inhibited _O ostertagi_),
_Ostertagia lyrata, Haemonchus _
_placei_, _Trichostrongylus axei_, _Trichostrongylus colubriformis_,
_Cooperia oncophora, _
_Cooperia punctata, Cooperia pectinata, Bunostomum phlebotomum, _
_Oesophagostomum radiatum, Nematodirus helvetianus _(adult)
LUNGWORMS(adult and fourth stage larvae):
_Dictyocaulus viviparus_
WARBLES (PARASITIC STAGES):
_Hypoderma bovis, Hypoderma lineatum_
Health Products Regulatory Authority
25 January 2019
CRN008VKL
Page 2 of 7
SUCKING LICE:
_Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus_
MANGE MITES:
_Psoroptes bovis, Sarcoptes scabiei _var _bovis_
Paramectin Injection may also be used to reduce infection of the mange
mite
_Chorioptes bovis_, but complete elimination may not occur
_PIGS_
In pigs: treatment of infections by the following parasites:
GASTROINTESTINAL ROUNDWORMS:
_Ascaris suum_(adults and fourth-stage larvae)
_Hyostrongylus rubidus_(adults and fourth-stage larvae)
_Oesophagostomum_spp (adults and fourth-stage larvae)
_Strongyloides ransomi_(adults)
LUNGWORMS:
_Metastrongylus_spp (adults)
LICE:
_Haematopinus suis_
MANGE MITES:
_Sarcoptes scabiei_var _suis_
4.3 CONTRAINDICATIONS
Not permitted for use in lactating cows produci