DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Doramectin

Available from:

Zoetis Belgium S.A.

ATC code:

QP54AA03

INN (International Name):

Doramectin

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs, Sheep

Therapeutic area:

doramectin

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2012-12-09

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DECTOMAX 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Doramectin
10.0 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Butylhydroxyanisole (E320)
0.1mg
Ethyl Oleate
Sesame oil
Clear colourless, to pale yellow solution.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle, sheep and pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
CATTLE :
For treatment and control of gastrointestinal nematodes, lungworms,
eyeworms, warbles, lice, mange
mites and ticks.
Gastrointestinal roundworms (adults and fourth stage larvae):
_Ostertagia ostertagi _
(including inhibited larvae)
_O.lyrata_
*
_Haemonchus placei _
_Trichostrongylus axei _
_T.colubriformis _
_Cooperia oncophora _
_C.pectinata_
*
_C.punctata_
_C.surnabada_
(syn
_. mcmasteri) _
_Nematodirus spathiger_
*
_Bunostomum phlebotomum_
*
_Strongyloides papillosus_
*
_ _
_Oesophagostomum radiatum _
_Trichuris _
spp
_._
*
*
adults
_ _
Lungworms: (adults and fourth stage larvae)
_Dictyocaulus viviparus_
Eyeworms: (adults)
_Thelazia _
spp.
Warbles: (parasitic stages)
_Hypoderma bovis _
_H.lineatum_
Sucking lice:
_Haematopinus eurysternus _
_Linognathus vituli _
_Solenopotes capillatus_
Mange mites:
_Psoroptes bovis _
_Sarcoptes scabiei _
_ _
The veterinary medicinal product may also be used as an aid in the
control of
_Nematodirus _
_helvetianus_
, biting lice (
_Damalinia bovis_
), the tick
_Ixodes ricinus_
and the mange mite
_Chorioptes _
_bovis_
.
Following veterinary medicinal product administration, efficacy
against re-infection with the
following parasites persists for the period indicated: SPECIES
DAYS
_ Bunostomum phlebotomum_
22
_Cooperia oncophora_
21
_Dictyocaulus viviparous_
35
_Haemonchus placei_
(adults only)
28
_Linognathus vituli_
28
_Oesophagostomum radiatum_
21
_Ostertagia