Ecomectin 10 mg/ml Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ivermectin

Available from:

ECO Animal Health Europe 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:

1900-01-01

Summary of Product characteristics

PART III
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ecomectin 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 the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
A 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 Ecomectin 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