Porcimec 10 mg/ml solution for injection for pigs

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Ivermectin

Dostępny od:

Cross Vetpharm Group Limited

Kod ATC:

QP54AA01

INN (International Nazwa):

Ivermectin

Dawkowanie:

10 milligram(s)/millilitre

Forma farmaceutyczna:

Solution for injection

Typ recepty:

LM: Licensed Merchant as defined in relevant national legislation

Grupa terapeutyczna:

Pigs

Dziedzina terapeutyczna:

ivermectin

Wskazania:

Endectoparasiticides

Status autoryzacji:

Authorised

Data autoryzacji:

2006-08-18

Charakterystyka produktu

Health Products Regulatory Authority
20 March 2018
CRN000WYW
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcimec 10 mg/ml solution for injection for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Ivermectin 1.0 % w/v (10 mg/ml)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
The product can be given to all ages of animals including piglets.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the effective treatment and control of
the following
harmful parasites of pigs:
GASTROINTESTINAL ROUNDWORMS:(Adults and fourth stage larvae):
_Ascaris suum _
_Hyostrongylus rubidus_
_Oesophagostomum _spp.
_Strongyloides ransomi (_adults and somatic larval stages)
LUNGWORMS:
_Metastrongylus _spp. (adult)
LICE:
_Haematopinus suis_
MANGE MITES:
_Sarcoptes scabiei _var. _suis_
Health Products Regulatory Authority
20 March 2018
CRN000WYW
Page 2 of 5
4.3 CONTRAINDICATIONS
Do not use in case of known hypersensitivity to the active ingredient.
Do not administer by the intravenous or intramuscular route.
Do not use in cats and dogs as severe adverse reactions may occur.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The product has been formulated specifically for use in pigs only. It
should not be
administered to other species as severe adverse reactions may occur.
Cases of
intolerance with fatal outcome are reported in dogs, especially
Collies, old English
Sheepdogs and related breeds or crosses, and also in
turtles/tortoises.
Parasite resistance to any particular class of anthelmintic may
develop following
frequent, repeated use of an anthelmintic of that class. It is
important that the correct
dose is given in order to minimise the risk of resistance. Assess
bodyweight as
accurately as possible before calculating the dosage.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTE