Dectomax 10 mg/ml Solution for Injection for Cattle and Sheep

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Doramectin

Available from:

Elanco Europe Ltd

INN (International Name):

Doramectin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Therapeutic group:

Cattle, Sheep

Therapeutic area:

Endectocide

Authorization status:

Authorized

Authorization date:

1994-08-05

Summary of Product characteristics

Revised: December 2020
AN: 01355/2020
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dectomax 10 mg/ml Solution for Injection for Cattle and Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains:
Active ingredient
Doramectin
10.00 mg
(1)
Excipients
Butylhydroxyanisole (E320)
0.1 mg
(1)
Contains no overage and assumes a potency of 100 percent. The actual
amount of doramectin added will depend on the potency of the ingoing
drug
substance.
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, to pale yellow oily solution for parenteral
administration.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
For treatment and control of the following harmful species of
gastrointestinal
roundworms, lungworms, eyeworms, warbles, lice and mange mites.
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*_
Revised: December 2020
AN: 01355/2020
Page 2 of 8
_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_
May also be used as an aid in the control of _Nematodirus
helvetianus,_ biting
lice (_Damalinia bovis_) and the mange mite _Chorioptes bovis._
The pharmacokinetics of Dectomax Solution for Injection allows
protection
of cattle against infection or re-infection with the following
parasites for the
period indicated:
SPECIES
DAYS
_Ostertagia ostertag