Medimec Injection 10 mg/ml solution for injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Ivermectin

Tilgjengelig fra:

Chanelle Pharmaceuticals Manufacturing Limited

ATC-kode:

QP54AA01

INN (International Name):

Ivermectin

Dosering :

10 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk område:

ivermectin

Autorisasjon status:

Authorised

Autorisasjon dato:

2005-02-04

Preparatomtale

Health Products Regulatory Authority
12 November 2018
CRN008PW0
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Medimec Injection 10 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Ivermectin 10 mg/ml
EXCIPIENTS:
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
Clear, colourless to slightly yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Medimec Injection is indicated for the treatment of the following
parasites of cattle and pigs:
CATTLE:
GASTRO-INTESTINAL ROUNDWORMS (adult and fourth stage larvae):
_Ostertagia_ spp (including inhibited _O. ostertagi_),
_Haemonchus placei_,
_Trichostrongylus axei_,
_Trichostrongylus colubriformis_,
_Cooperia_ spp,
_Oesophagostomum radiatum_,
_Strongyloides papillosus_ (adult)
_Nematodirus helvetianus_ (adult),
_N. spathiger_ (adult)
_Toxocara vitulorum_,
_Trichuris_ spp. (adult).
LUNGWORMS (adult and fourth stage larvae):
_Dictyocaulus viviparus_.
Health Products Regulatory Authority
12 November 2018
CRN008PW0
Page 2 of 7
EYE WORMS (adult):
_Thelazia_ spp.
WARBLES (parasitic stages):
_Hypoderma bovis_ and _H. lineatum_.
MANGE MITES:
_Psoroptes communis _var. bovis,
_Sarcoptes scabiei_ var. _bovis_.
SUCKING LICE:
_Linognathus vituli_,
_Haematopinus eurysternus_
May also be used as an aid in the reduction of infestation of the
mange mite _Chorioptes bovis_
but complete elimination may not occur.
PIGS:
GASTROINTESTINAL WORMS (adult and fourth stage larvae):
_Ascaris suum,_
_Hyostrongylus rubidus_,
_Oesophagostomum spp_,
_Strongyloides ransomi_ (adult stage)
LUNGWORMS:
_Metastrongylus spp_. (adult)
LICE:
_Haematopinus suis_
MANGE MITES:
_Sarcoptes scabiei_ var. _suis_
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active
ingredient. Do not administer by
the intravenous or intramuscular route.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Care shou