Maximec 10 mg/ml solution for injection for pigs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Ivermectin

Dostopno od:

Bimeda Animal Health Limited

Koda artikla:

QP54AA01

INN (mednarodno ime):

Ivermectin

Odmerek:

1 percent weight/volume

Farmacevtska oblika:

Solution for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtsko območje:

ivermectin

Status dovoljenje:

Authorised

Datum dovoljenje:

2004-10-19

Lastnosti izdelka

1
_[Version 9,03/2022] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Maximec 10 mg/ml solution for injection for pigs [IE]
Renomec 10 mg/ml solution for injection for pigs [ES]
Cevamec 10 mg/ml solution for injection for pigs [FR]
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, slightly viscous, non-aqueous solution
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of the infections by the following parasites:
Gastrointestinal roundworms (adult and fourth-stage larvae):
_Ascaris suum _
_Hyostrongylus rubidus _
_Oesophagostomum_
spp.
_Strongyloides ransomi_
(adult)
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 or 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 selective treatment).