CYDECTIN 1 % W/V INJECTABLE SOLUTION FOR SHEEP
País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Fitxa tècnica
(SPC)
19-01-2017
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ingredients actius:
MOXIDECTIN
Disponible des:
Zoetis Ireland Limited
Codi ATC:
QP54AB02
Designació comuna internacional (DCI):
MOXIDECTIN
Dosis:
1 %w/v
formulario farmacéutico:
Solution for Injection
tipo de receta:
LM-Licensed Merchant
Grupo terapéutico:
Ovine
Área terapéutica:
Moxidectin
indicaciones terapéuticas:
Endectoparasiticides
Estat d'Autorització:
Authorised
Data d'autorització:
2013-12-09
Fitxa tècnica
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cydectin 1% w/v Injectable Solution for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for Injection
A clear to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep
Each ml contains
Moxidectin
10.00 mg
Excipients
Benzyl Alcohol
40.00 mg
Butylated hydroxytoluene
2.50 mg
Disodium edetate
0.27 mg
QSP
1.000 ml
For a full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 04/01/2017_
_CRN 7024723_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In sheep:
Moxidectin is indicated for treatment of infections caused by moxidectin sensitive strains of:
Gastro-intestinal nematodes:
_. Haemonchus contortus_
_. Ostertagia (Teladorsagia) circumcincta _(including inhibited larvae)
_. Trichostrongylus axei _(adults)
_. Trichostrongylus colubriformis _(adults and L3)
_. Nematodirus spathiger _(adults)
_. Cooperia curticei (macmasteri) _(adults)
_. Cooperia punctata _(adults)
_. Gaigeria pachyscelis _(L3)
_. Oesophagostomum columbianum _(L3)
_. Chabertia ovina _(adults)
Respiratory tract nematodes:
_Dictyocaulus filaria _(adults)
Larvae of Diptera:
. _Oestrus ovis_: L1, L2, L3
Mange mites:
_. Psoroptes ovis_
Moxidectin has a persistent effect of:
_. _5 weeks against _Ostertagia circumcincta, Haemonchus contortus, Psoroptes ovis_
_. _4 weeks against _Gaigeria pachyscelis, Oesophagostomum columbianum_
_. _2 weeks against _Trichostrongylus colubriformis_
Trials have shown that moxidectin is effective against strains of _Haemonchus. contortus _resistant to benzimidazoles,
ivermectin and doramectin.
4.3 CONTRAINDICATIONS
Not to be used in animals with a history of
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