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

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
22-11-2022
DSU DSU (DSU)
22-11-2022

ingredients actius:

Doramectin

Disponible des:

Chanelle Pharmaceuticals Manufacturing Limited

Codi ATC:

QP54AA03

Designació comuna internacional (DCI):

Doramectin

formulario farmacéutico:

Solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

doramectin

Data d'autorització:

2022-08-26

Fitxa tècnica

                                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
                                
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