Noromectin Premix 6 mg/g Premix for Medicated Feeding Stuff for Swine

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

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Hent Produktets egenskaber (SPC)
20-07-2021

Aktiv bestanddel:

Ivermectin

Tilgængelig fra:

Norbrook Laboratories Limited

ATC-kode:

QP54AA01

INN (International Name):

Ivermectin

Lægemiddelform:

Premix for medicated feeding stuff

Recept type:

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

Terapeutisk gruppe:

Pigs

Terapeutisk område:

Anthelmintic

Autorisation status:

Expired

Autorisation dato:

2007-02-22

Produktets egenskaber

                                Revised: December 2011
AN. 00123/2011
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin Premix 6 mg/g Premix for Medicated Feeding Stuff for Swine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ACTIVE SUBSTANCE_
Ivermectin
6 mg/g
_EXCIPIENTS_
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Premix for medicated feedingstuff.
Free flowing yellow to light brown meal.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES:
Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES:
The product is indicated for the treatment of the following
gastrointestinal
roundworms, lungworms, lice and mange in adult and growing pigs:
Gastrointestinal worms:
_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_
The product given to pregnant sows before farrowing effectively
controls
transmission via the milk of _S. ransomi_ to piglets.
Revised: December 2011
AN. 00123/2011
Page 2 of 7
4.3
CONTRAINDICATIONS:
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
turtle
/
tortoises).
Do not use in animals known to be hypersensitive to the active
substance, or
to any of the excipients.
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.
Suspected
clinical
cases
of
resist
                                
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