Tauramox 5 mg/ml Pour-On Solution for Cattle

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Moxidectin

Mevcut itibaren:

Norbrook Laboratories (Ireland) Limited

ATC kodu:

QP54AB02

INN (International Adı):

Moxidectin

Doz:

5 milligram(s)/millilitre

Farmasötik formu:

Pour-on solution

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik alanı:

moxidectin

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2017-03-01

Ürün özellikleri

Page 1 of 7
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Tauramox 5 mg/ml Pour-On Solution for Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Moxidectin
5 mg
EXCIPIENT(S):
Tertiary Butylhydroquinone (E319)
0.03
mg
Butylhydroxyanisole (E320)
0.1
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pour-on Solution
A translucent, colourless to pale yellow slightly viscous solution
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections of cattle with parasites sensitive to moxidectin. For the
treatment of infections caused by:
- ADULT AND LARVAL GASTRO-INTESTINAL NEMATODES:
_Haemonchus placei_
_Ostertagia ostertagi _
(including inhibited larvae)
_Trichostrongylus axei_
_Nematodirus helvetianus_
_Cooperia oncophora_
_Cooperia punctata _
(adults)
_Oesophagostomum radiatum _
(adults)
_Bunostomum phlebotomum _
(adults)
- ADULT RESPIRATORY TRACT NEMATODE
_Dictyocaulus viviparus _
_ _
_ _- WARBLES (MIGRATING LARVAE)
_Hypoderma bovis_
_Hypoderma lineatum_
- LICE
_Linognathus vituli_
_Haematopinus eurysternus_
Page 2 of 7
_Solenopotes capillatus_
_Bovicola bovis (Damalinia bovis)_
- MANGE MITES
_Sarcoptes scabiei_
_Psoroptes ovis_
_Chorioptes bovis_
- HORN FLIES
_Haematobia irritans_
THE PRODUCT HAS A PERSISTENT EFFECT IN PREVENTING AGAINST REINFECTION
BY:
_Ostertagia ostertagi _
for 5 weeks
_Dictyocaulus viviparus _
for 6 weeks.
4.3 CONTRAINDICATIONS
Do not use in other species as severe adverse reactions, including
fatalities in dogs, may occur.
Do not use in cases of hypersensitivity to the active substance or any
of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For cutaneous application only.
Care should be taken to avoid the following practices because they
increase the risk of development
of resistance and could ultimately result in ineffective therapy:
- too frequent and repeated use of anthelmintics from the same class,
over an extended period of time.
- under dosing, which may be