Doramax 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:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP54AA03

INN (International Name):

Doramectin

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

doramectin

Authorization date:

2022-08-26

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Doramax 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs
(BE, IE)
Dorimec 10 mg/ml Solution for Injection for Cattle, Sheep and Pigs
(AT, DE, FR, HU, IT, NL, PL,
PT, ES)
Dorimec Vet, Solution for Injection (DK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Doramectin
10.0 mg
EXCIPIENTS
Butylhydroxyanisole (E320)
0.1 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, yellowish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, Sheep and Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
For treatment of gastrointestinal roundworms, lungworms, eyeworms,
warbles, lice, mange mites and
ticks.
Gastrointestinal roundworms (adults and fourth stage larvae unless
otherwise indicated):
_Ostertagia ostertagi _
(including inhibited larvae)
_O.lyrata _
(adults only)
_Haemonchus placei _
_Trichostrongylus axei _
_T.colubriformis _
_Cooperia oncophora _
_C.pectinata _
(adults only)
_C.punctata _
_C.surnabada _
(syn
_. mcmasteri) _
_N.spathiger _
(adults only)
_Bunostomum phlebotomum _
(adults only)
_Strongyloides papillosus _
(adults only)
_Oesophagostomum radiatum _
_Trichuris _
spp
_. _
(adults only)
Lungworms: (adults and fourth stage larvae)
_Dictyocaulus viviparus _
2
Eyeworms: (adults only)
_Thelazia _
spp.
Warbles: (parasitic stages)
_Hypoderma bovis _
_H.lineatum _
Sucking lice:
_Haematopinus eurysternus _
_Linognathus vituli _
_Solenopotes capillatus _
Mange mites:
_Psoroptes bovis _
_Sarcoptes scabiei _
_ _
The product may also be used as an aid in the treatment of
_Nematodirus helvetianus_
, biting lice
(
_Damalinia bovis_
), the tick
_Ixodes ricinus _
and the mange mite
_Chorioptes bovis_
.
Following product administration, efficacy against re-infection with
the following parasites persists for
the period indicated:
SPECIES
_Bunostomum phlebotomum _
DAYS
22
_Cooperia oncophora _
21
_Dictyocaulus viviparous _
35
_Haemonchus placei _
(adults only)
2