Topimec Injection 10 mg/ml solution for injection

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Ivermectin

Dostupné z:

Chanelle Pharmaceuticals Manufacturing Limited

ATC kód:

QP54AA01

INN (Medzinárodný Name):

Ivermectin

Dávkovanie:

10 milligram(s)/millilitre

Forma lieku:

Solution for injection

Typ predpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické oblasti:

ivermectin

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2005-02-04

Súhrn charakteristických

Health Products Regulatory Authority
11 June 2021
CRN0093JR
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Topimec Injection 10 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCES:
Ivermectin 10 mg/ml
For a 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, Sheep and Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the treatment of the following parasites
of cattle,pigs and sheep:
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_.
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_
Health Products Regulatory Authority
11 June 2021
CRN0093JR
Page 2 of 7
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 stages)
LUNGWORMS:
_Metastrongylus spp_. (adult)
LICE:
_Haematopinus suis_
MANGE MITES:
_Sarcoptes scabiei_ var. _suis_
_ _
SHEEP:
GASTROINTESTINAL ROUNDWORMS (ADULT AND FOURTH-STAGE LARVAE):
_Teladorsagia circumcincta including inhibited larvae _
_T. trifurcata _
_Haemonchus contortus including inhibited larvae _
_Trichostrongyl