DECTOMAX 5 MG/ML POUR-ON SOLUTION FOR CATTLE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-11-2016
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Active ingredient:
DORAMECTIN
Available from:
Zoetis Ireland Limited
ATC code:
QP54AA03
INN (International Name):
DORAMECTIN
Dosage:
5 Mg/Ml
Pharmaceutical form:
Pour-on Solution
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine
Therapeutic area:
Doramectin
Therapeutic indications:
Endectoparasiticides
Authorization status:
Authorised
Authorization date:
2013-12-09
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dectomax 5 mg/ml Pour-On Solution for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Pour-on solution
Clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
Each ml contains:
ACTIVE SUBSTANCE
Doramectin
5.0 mg
EXCIPIENTS
Trolamine (as an antioxidant)
0.5 mg
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 11/11/2016_
_CRN 7022237_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of infestations of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice,
mange mites and hornfly in cattle.
Gastrointestinal roundworms (adults and fourth stage larvae)
_Ostertagia ostertagi _(inc. inhibited larvae)
_O. lyrata_
_1_
_Haemonchus placei_
_Trichostrongylus axei_
_T. colubriformis_
_Cooperia oncophora_
_C. punctata_
_1_
_C. surnabada_
_1_
_(syn. mcmasteri)_
_Bunostomum phlebotomum_
_1_
_Oesophagostomum radiatum_
_Trichuris _spp
1
1
adults
Lungworms (adults and fourth stage larvae)
_Dictyocaulus viviparous_
Eyeworms (adults)
_Thelazia spp_
Warbles (parasitic stages)
_Hypoderma bovis, H. lineatum_
Biting lice
_Damalinia (Bovicola) bovis_
Sucking lice
_Haematopinus eurystemus_
_Linognathus vituli_
_Solenopotes capillatus_
Mange mites
_Psoroptes bovis_
_Sarcoptes scabiei_
_Chorioptes bovis_
Horn fly
_Haematobia irritans_
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 11/11/2016_
_CRN 7022237_
_page number: 2_
Duration of activity
Following product administration, efficacy against re-infection with the following parasites per
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