Noromectin 1.0% w/v Solution for Injection for Pigs

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Ivermectin

Tillgänglig från:

Norbrook Laboratories (Ireland) Limited

ATC-kod:

QP54AA01

INN (International namn):

Ivermectin

Dos:

1 percent weight/volume

Läkemedelsform:

Solution for injection

Receptbelagda typ:

LM: Licensed Merchant as defined in relevant national legislation

Terapiområde:

ivermectin

Bemyndigande status:

Authorised

Tillstånd datum:

2002-09-27

Produktens egenskaper

Health Products Regulatory Authority
13 February 2019
CRN008WD8
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin 1.0% w/v Solution for Injection for Pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Ivermectin
1.0
% w/v
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A colourless to pale yellow, clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Noromectin Injection for Pigs is indicated for the treatment and
control of parasitic
diseases of pigs caused 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 and somatic larval stages)
Lungworms:
_Metastrongylus_ spp (adults)
Lice:
_Haematopinus suis_
Mange mites:
_Sarcoptes scabiei var suis_
Health Products Regulatory Authority
13 February 2019
CRN008WD8
Page 2 of 5
Noromectin Injection for Pigs may also be used as an aid in the
control of adult
whipworm (_Trichuris suis_).
4.3 CONTRAINDICATIONS
Noromectin Injection for Pigs is not for intravenous or intramuscular
use. Do not use
in animals known to be hypersensitive to the active substance
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Avermectins may not be well tolerated in all non-target species (cases
of intolerance
with fatal outcome are reported in dogs – especially collies, Old
English sheepdogs
and related breeds or crosses, and also in turtles and tortoises).
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT TO
ANIMALS
Do not smoke or eat while handling the product.
Direct contact of the product with the skin should be kept to a
minimum.Wash hands
after use
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7 USE DURING PREGNA