Kilo-mec 1% 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:

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:

2000-06-14

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Kilo-mec 1% Solution for Injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Ivermectin
10 mg
Excipient
Benzyl alcohol (preservative)
10 mg
3
PHARMACEUTICAL FORM
Solution for injection.
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Sheep, cattle 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 4th stage larvae):
_Ostertagia ostertagi Ostertagia lyrata Haemonchus placei
Trichostrongylus colubriformis Cooperia _
_oncophora _
(adults)
_Cooperia punctata _
(adults)
_Cooperia pectinata _
(adults)
_Bunostomum phlebotonum _
_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 contortus Trichostrongylus axei _
_T. colubriformis _
and
_T. vitrinus Cooperia curticei Nematodirus filicollis _
Variable activity may be observed ag