Animec 1 % Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP54AA01

INN (International Name):

Ivermectin

Dosage:

1 percent weight/volume

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:

2001-01-12

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Animec 1% Solution for Injection for Cattle, Sheep and 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
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, Sheep and Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Animec Injection is indicated for the effective treatment and control
of the following harmful parasites
of cattle, sheep and pigs:
CATTLE:
GASTRO-INTESTINAL ROUNDWORMS
(adult and fourth stage larvae):
_Ostertagia_
spp (including inhibited
_O. ostertagi_
)
_Haemonchus placei_
_Trichostrongylus axei_
_Trichostrongylus colubriformis_
_Cooperia_
spp
_Bunostomum phlebotomum_
_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 bovis_
,
_Sarcoptes scabiei_
var.
_bovis_
.
SUCKING LICE
:
_Linognathus vituli_
,
_Haematopinus eurysternus_
_Solenopotes capillatus_
.
May also be used as an aid in the control of the mange mite
_Chorioptes bovis_
and biting lice
(
_Damalinia bovis_
), but complete elimination may not occur.
PERSISTANT ACTIVITY
Treatment at the recommended dose rate controls re-infection with
_Haemonchus_
_placei_
and
_Cooperia _
_spp. _
acquired up to 14 days after treatment,
_Ostertagia ostertagi_
and
_Oesophagostomum radiatum_
acquired up to 21 days after treatment and
_Dictyocaulus viviparus_
acquired up to 28 days after
treatment.
To obtain optimal benefit from the persistent activity of Animec
injection for grazing animals it is
recommended that calves which are set-stocked in their first grazing
season should be treated 3, 8 and
13 weeks after the day of turn-out. This can protect the animals fro