CYDECTINE 2% LA FOR SHEEP
Country: Greece
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
14-06-2013
Summary of Product characteristics
(SPC)
14-06-2013
Active ingredient:
moxidectin 20 mg/ml
Available from:
Fort Dodge Santé Animale
ATC code:
QP54AB02
Pharmaceutical form:
Solution for injection
Therapeutic group:
moxidectin
Therapeutic area:
Sheep
Authorization date:
2012-02-17
Patient Information leaflet
Page 1 of 5
PACKAGE LEAFLET
2
PACKAGE LEAFLET
CYDECTIN 2% w/v LA Solution for Injection for Sheep
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND
OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR
BATCH RELEASE, IF DIFFERENT
MARKETING AUTHORISATION HOLDER:
<_Pfizer/Fort Dodge subsidiaries in each Member State_>
MANUFACTURER FOR THE BATCH RELEASE :
Pfizer Olot, S.L.U.
Carretera Camprodon s/n – La Riba
17813 – Vall de Bianya
Gerona, Spain
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CYDECTIN 2% w/v LA Solution for Injection for Sheep
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
ACTIVE SUBSTANCES
Moxidectin
20 mg
EXCIPIENTS
Benzyl alcohol
For a full list of excipients, see section 6.1
70 mg
4.
INDICATION(S)
Treatment and prevention of mixed
infections of gastro-intestinal nematodes, respiratory nematodes
and certain anthropod parasites in sheep.
Moxidectin is indicated for treatment of infections caused by moxidectin sensitive strains of:
- Gastro-intestinal nematodes: _ _
_Haemonchus contortus _(adults and L3)_ _
_Ostertagia (Teladorsagia) circumcincta _(adults and L3, including inhibited larvae)_ _
_Trichostrongylus axei _(adults)_ _
_Trichostrongylus colubriformis _(adults and L3)_ _
_ Nematodirus spathiger _(adults)_ _
_Cooperia curticei (macmasteri) _(adults)_ _
_ Cooperia punctata _(adults)_ _
_ Oesophagostomum columbianum _(L3)_ _
_Chabertia ovina _(adults)_ _
- Respiratory tract nematodes
_Dictyocaulus filaria _(adults)
- Larvae of Diptera
_Oestrus ovis_: L1, L2, L3
3
- Mange mites_ _
_Psoroptes ovis _
Trials have shown that moxidectin is eff
Read the complete document
Summary of Product characteristics
Cydectin 2% LA for sheep
PART IB
Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CYDECTIN 2% w/v LA Solution for Injection for Sheep
Cydectin Larga Acción 20 mg/ml para ovino (Spain)
Cydectin LA 20
mg/ml solution for injection for sheep (Italy)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES
Moxidectin
20 mg
EXCIPIENTS
Benzyl alcohol
For a full list of excipients, see section 6.1
70 mg
3.
PHARMACEUTICAL FORM
Solution for injection
A clear yellow liquid solution for injection
4.
CLINICAL PARTICULARS
5.1
TARGET SPECIES
Sheep above 15kg bodyweight.
4.1
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and prevention of mixed infections of gastro-intestinal
nematodes, respiratory nematodes and certain anthropod parasites in
sheep.
Moxidectin is indicated for treatment of infections caused by
moxidectin sensitive strains of:
Cydectin 2% LA for sheep
PART IB
Summary of Product Characteristics
- Gastro-intestinal nematodes: _ _
_. Haemonchus contortus _(adults and L3)_ _
_. Ostertagia
(Teladorsagia) circumcincta _(adults and L3, including
inhibited larvae) _ _
_. Trichostrongylus axei _(adults)_ _
_. Trichostrongylus colubriformis _(adults and L3)_ _
_. Nematodirus spathiger _(adults)_ _
_. Cooperia curticei (macmasteri) _(adults)_ _
_. Cooperia punctata _(adults)_ _
_. Oesophagostomum columbianum _(L3)_ _
_. Chabertia ovina _(adults)_ _
- Respiratory tract nematodes
_Dictyocaulus filaria _(adults)
- Larvae of
Read the complete document
