Cydectin 1% w/v Injectable Solution for Sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Moxidectin

Available from:

Zoetis Belgium S.A.

ATC code:

QP54AB02

INN (International Name):

Moxidectin

Dosage:

1 percent weight/volume

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Sheep

Therapeutic area:

moxidectin

Therapeutic indications:

Endectoparasiticides

Authorization status:

Authorised

Authorization date:

2013-12-09

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cydectin 1% w/v Injectable Solution for Sheep
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Moxidectin
10.00 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS_ _
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Benzyl Alcohol (E1519)
40.00 mg
Butylated Hydroxytoluene (E321)
2.50 mg
Disodium Edetate (E385)
0.27 mg
Polysorbate 80
Sodium phosphate anhydrous
Sodium acid phosphate monohydrate
Propylene glycol
Water for injections
A clear to pale yellow solution
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Sheep.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
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 nematode:
•
_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 _
and
_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.
3.3
CONTRAINDICATIONS
Not to be used in animals with a history of previous vaccination
against footrot. Such use may result in
anaphylactic-type reactions, including dyspnoea, ataxia, depression,
deat