Acomec 10 mg/ml Solution for Injection

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Ivermectin

Disponible des:

ECO Animal Health Europe Limited

Codi ATC:

QP54AA01

Designació comuna internacional (DCI):

Ivermectin

Dosis:

10.0 milligram(s)/millilitre

formulario farmacéutico:

Solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

ivermectin

Estat d'Autorització:

Authorised

Data d'autorització:

2004-11-26

Fitxa tècnica

PART III
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Acomec 10 mg/ml Solution for Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
ACTIVE SUBSTANCE(S):
Ivermectin…………………10 mg
EXCIPIENT(S):
Benzyl alcohol…………….10 mg
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
Cattle, sheep and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
For the treatment of gastrointestinal nematodes, lungworms, eyeworms,
warble flies, mites and lice (as shown
below) of beef and non-lactating dairy cattle:
Gastrointestinal worms (adults and 4
th
stage larvae):
_Ostertagia ostertagi _
_Ostertagia lyrata _
_Haemonchus placei _
_Trichostrongylus colubriformis _
_Cooperia oncophora_
(adults)
_Cooperia punctata_
(adults)
_Cooperia pectinata_
(adults)
_Bunostomum phlebotomum _
_Oesophagostomum radiatum _
Lungworms (adult and 4th stage larvae):
_Dictyocaulus viviparus _
Eyeworms (adult):
_Thelazia spp_
.
Warble flies (parasitic stages):
_Hypoderma bovis _
_H. lineatum _
Mites:
_Psoroptes ovis _
_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 _
but complete elimination may
not occur. Treatment with Acomec 10 mg/ml Solution for Injection at
the recommended dose rate prevents
re-infection with
_Haemonchus placei_
,
_Cooperia oncophora_
,
_Cooperia pectinata_
and
_Trichostrongylus axei_
for 7 days after treatment,
_Ostertagia ostertagi_
and
_Oesophagostomum radiatum_
for 14 days after treatment
and
_Dictyocaulus viviparus_
for 21 days after treatment.
SHEEP
For the treatment of psoroptic mange (sheep scab), gastrointestinal
nematodes, lungworms and nasal bots of
sheep:
Gastrointestinal roundworms (adults):
_Ostertagia circumcincta _
_Haemonchus contortus _
_Trichostr