Porcimec 10 mg/ml solution for injection for pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Bimeda Animal Health Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

ivermectin

Authorization status:

Authorised

Authorization date:

2006-08-18

Summary of Product characteristics

1
_[Version 9,03/2022] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcimec 10 mg/ml solution for injection for pigs [IE]
Porcimec P 10 mg/ml solution for injection for pigs [BE]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCE:
Ivermectin 10 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER
CONSTITUENTS
Glycerol
Glycerol formal
A clear colourless solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
The veterinary medicinal product is indicated for the effective
treatment and control of the following
harmful parasites of pigs:
Gastrointestinal roundworms (adult and fourth-stage larvae):
_Ascaris suum _
_Hyostrongylus rubidus _
_Oesophagostomum_
spp.
_Strongyloides ransomi_
(adult and somatic larval stages)
Lungworms:
_Metastrongylus_
spp. (adult)
Lice:
_Haematopinus suis _
Mange mites:
_Sarcoptes scabiei _
var.
_ suis _
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
Do not use by intramuscular or intravenous administration.
Do not use in cats and dogs as severe adverse reactions may occur.
3.4
SPECIAL WARNINGS
3
Unnecessary use of antiparasitics or use deviating from the
instructions given in the SPC may increase
the resistance selection pressure and lead to reduced efficacy. The
decision to use the veterinary
medicinal product should be based on confirmation of the parasitic
species and burden, or of the risk
of infestation based on its epidemiological features, for each
individual animal or herd.
Repeated use for an extended period, particularly when using the same
class of substances, increases
the risk of resistance development. Within a herd, maintenance of
susceptible refugia is essential to
reduce that risk. Systematically applied interval-based treatment and
treatment of a whole herd should
be avoided. Instead, if feasible, only selected individual animals or
subgroups should be treated
(targeted s