Norador 5 mg/ml Pour-on Solution for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Doramectin

Available from:

Norbrook Laboratories Limited

ATC code:

QP54AA

INN (International Name):

Doramectin

Pharmaceutical form:

Pour-on solution

Prescription type:

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

Therapeutic group:

Cattle

Therapeutic area:

Endectocide

Authorization status:

Expired

Authorization date:

2013-12-10

Summary of Product characteristics

Revised: January 2019
AN: 02490/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norador 5 mg/ml Pour-on Solution for Cattle [AT, BG, CY, CZ, DK, EE,
ES,
FR, EL, HU, IE, IT, LV, LT, MT, PL, PT, RO, SL, SI, UK]
Norador vet 5 mg/ml Pour-on Solution for Cattle [FI, SE]
Norador vet 5 mg/ml Solution for Cattle [NO]
Doratec 5 mg/ml Pour-on Solution for Cattle [BE, LU, NL]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Doramectin
5 mg
EXCIPIENT(S):
Brilliant blue FCF (E133)
0.007 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pour-on Solution
A pale blue, clear solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For
treatment
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_
Revised: January 2019
AN: 02490/2017
Page 2 of 7
_Oesophagostomum radiatum_
_Trichuris _spp
1
1
adults
Lungworms (adults and fourth stage larvae)
_Dictyocaulus viviparus_
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_
Duration of activity
The veterinary product protects cattle against infection or
re-infection with
the following parasites for the periods indicated.
Species
Days
_Ostertagia ostertagi_
_Cooperia oncophora_
35
28
_Dictyocaulus viviparus_
42
_Linognathis vituli_
49
_Oesophagostomum radiatum _
21
_Damalinia (Bovicola) bovis_
42
_Trichostrongy