CHANIMEC 0.8 MG/ML ORAL SOLUTION FOR SHEEP.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-05-2015
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Active ingredient:
IVERMECTIN
Available from:
Chanelle Pharmaceuticals Manufacturing Limited
ATC code:
QP54AA01
INN (International Name):
IVERMECTIN
Dosage:
0.8 Mg/Ml
Pharmaceutical form:
Oral Solution
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Ovine
Therapeutic area:
Ivermectin
Therapeutic indications:
Endectoparasiticides
Authorization status:
Authorised
Authorization date:
2009-07-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CHANIMEC 0.8 mg/ml Oral Solution for Sheep.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral Solution.
A transparent, yellow coloured solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
ACTIVE SUBSTANCE:
Each ml contains:
Ivermectin
0.8 mg
EXCIPIENTS:
Benzyl Alcohol (E1519)
28.6 mg
Butylhydroxyanisole (E320)
0.10 mg
Propyl Gallate (E310)
0.10 mg
For the full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 12/05/2015_
_CRN 7020669_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections with the following parasites:
NEMATODES
GASTROINTESTINAL ROUNDWORMS (adult and fourth larval stage)
_Haemonchus contortus_
_Teladorsagia circumcincta_
_Trichostrongylus _spp.
_Cooperia _spp.
_Nematodirus _spp.
Including _N. battus_
_Strongyloides papillosus_
_Chabertia ovina_
LUNGWORMS(adult and fourth larval stage)
_Dictyocaulus filaria_
ARTHROPODS
NASAL BOT (all larval stages)
_Oestrus ovis_
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active ingredient or any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
•
Underdosing, which may be due to underestimation of body weight or misadministration of the product.
Resistance to ivermectin (an avermectin) has been reported in _Teladorsagia _in sheep and goats within the EU and it
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