CYDECTIN 0.1 % W/V ORAL SOLUTION FOR SHEEP

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MOXIDECTIN

Available from:

Zoetis Ireland Limited

ATC code:

QP54AB02

INN (International Name):

MOXIDECTIN

Dosage:

0.1 %w/v

Pharmaceutical form:

Oral Solution

Prescription type:

LM-Licensed Merchant

Therapeutic group:

Ovine

Therapeutic area:

Moxidectin

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2013-12-09

Summary of Product characteristics

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