SLICE 2 mg/g premix for medicated feeding stuff for Atlantic salmon

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Emamectin benzoate

Commercializzato da:

Intervet Ireland Limited

Codice ATC:

QP54AA06

INN (Nome Internazionale):

Emamectin benzoate

Dosaggio:

2 milligram(s)/gram

Forma farmaceutica:

Premix for medicated feeding stuff

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Gruppo terapeutico:

Atlantic salmon

Area terapeutica:

emamectin

Indicazioni terapeutiche:

Ectoparasiticide

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2012-01-20

Scheda tecnica

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SLICE 2 mg/g premix for medicated feeding stuff for Atlantic salmon
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Emamectin benzoate
2.00 mg
(equivalent to 1.76 mg of Emamectin)
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Propylene glycol Ph. Eur.
25 mg
Butylhydroxyanisole
0.1 mg
Maize starch Ph.Eur
Maltodextrin M100
A white to off-white free flowing powder.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Atlantic salmon (
_Salmo salar_
).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment and prevention at group level of infestations of all
parasitic stages of sea lice
(
_Lepeophtheirus_
sp. and
_Caligus_
sp.) on Atlantic salmon (
_Salmo salar_
) ranging in size from smolts in
freshwater (just prior to transfer to seawater) to market weight fish
in seawater.
3.3
CONTRAINDICATIONS
Do not use in adult Atlantic salmon intended for broodstock.
Do not use for treatment of smolts in freshwater cages due to
potential environmental risks.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
2
Personal protective equipment, consisting of gloves, protective work
clothing, dust mask and safety
glasses with side shields should be worn when handling the veterinary
medicinal product in the
preparation of medicated fish feed.
Wash hands thoroughly with soap and water after handling the product
or medicated feed and before
eating or smoking.
Do not smoke or eat while handling the medicated feed.
Special precautions for the protection of the environment:
See section 5.5.
3.6
ADVERSE EVENTS
Atlantic salmon (
_Salmo salar_
):
Very common
(>1 animal / 10 animals treated):
Decreased appetite
1
1
A change in the sou