CYDECTIN 0.1 % W/V ORAL SOLUTION FOR SHEEP

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

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Download 제품 특성 요약 (SPC)
02-12-2016

유효 성분:

MOXIDECTIN

제공처:

Zoetis Ireland Limited

ATC 코드:

QP54AB02

INN (국제 이름):

MOXIDECTIN

복용량:

0.1 %w/v

약제 형태:

Oral Solution

처방전 유형:

LM-Licensed Merchant

치료 그룹:

Ovine

치료 영역:

Moxidectin

치료 징후:

Endectoparasiticides

승인 상태:

Authorised

승인 날짜:

2013-12-09

제품 특성 요약

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cydectin 0.1% w/v oral solution for sheep.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
Pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
Each ml contains
ACTIVE SUBSTANCE
Moxidectin Solid
1.00 mg
EXCIPIENTS
Benzyl Alcohol (E1519)
40.00 mg
Butylated Hydroxy Toluene 2.50 mg
Disodium Edetate
0.27 mg
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 17/11/2016_
_CRN 7024733_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Infections of sheep with parasites sensitive to moxidectin.
For the treatment and prevention of infections caused by:
Adult and immature gastro-intestinal nematodes:
- _Haemonchus contortus _(including inhibited larvae)
- _Ostertagia circumcincta _(including inhibited larvae)
- _Ostertagia trifurcata_
- _Trichostrongylus axei _(including inhibited larvae)
- _Trichostrongylus colubriformis_
- _Trichostrongylus vitrinus_
- _Nematodirus battus_
- _Nematodirus spathiger_
- _Nematodirus filicolis _(adults only)
- _Strongyloides papillosus _(larval stages only)
- _Cooperia curticei _(adults only)
- _Cooperia oncoaphora_
- _Oesophagostomum columbianum_
- _Oesophagostomum venulosym _(adults only)
- _Chabertia ovina_
- _Trichuris ovis _(adults only)
Adult respiratory tract nematode:
- _Dictyocaulus filaria_
The product has a persistent effect in preventing reinfection:
•
for 5 weeks by _Ostertagia circumcincta _and _Haemonchus contortus_
•
for 4 weeks by _Oesophagostomum columbianum_
Clinical trials, after experimental and natural infection, have shown that the product is effective against certain benzimidazole
resi
                                
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