Ovimectin 10 mg/ml Solution for Injection for Sheep

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Ivermectin

Boleh didapati daripada:

Bimeda Animal Health Limited

Kod ATC:

QP54AA01

INN (Nama Antarabangsa):

Ivermectin

Dos:

10 milligram(s)/millilitre

Borang farmaseutikal:

Solution for injection

Jenis preskripsi:

POM: Prescription Only Medicine as defined in relevant national legislation

Kawasan terapeutik:

ivermectin

Status kebenaran:

Authorised

Tarikh kebenaran:

2006-05-26

Ciri produk

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ovimectin 10 mg/ml Solution for Injection for Sheep
[IE]
Tizoval 10 mg/ml Solution for Injection for Sheep [ES]
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 to slightly yellow solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Sheep
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the effective treatment and control of the following species of
gastrointestinal roundworms,
lungworms, grubs and lice of sheep:
Gastrointestinal roundworms (adult and fourth-stage larvae):
_Teladorsagia (Ostertagia) circumcincta _
including inhibited larvae
_ _
_O. trifurcata _
_Haemonchus contortus_
including inhibited larvae
_Trichostrongylus axei_
(adult)
_T. colubriformis _
and
_ T. vitrinus _
(adult)
_Cooperia_
_curticei _
_Oesophagostomum columbianum _
_O. venulosum _
(adult)
_ _
_Nematodirus filicollis _
_Chabertia ovina _
_Trichuris_
ovis (adult)
Benzimidazole-resistant strains of
_Haemonchus contortus_
and
_Ostertagia_
_circumcincta_
are also
controlled.
Lungworms:
_Dictyocaulus filaria_
(adult and fourth-stage larvae)
_Protostrongylus rufescens _
(adult)
Nasal Bots (all larval stages):
_Oestrus ovis _
2
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.
3.4
SPECIAL WARNINGS
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 flock.
Repeated use for an extended period, particularly when using the same
class of substances, increases
the risk of resistance develo