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

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Emamectin benzoate

MAH:

Intervet Ireland Limited

ATC_code:

QP54AA06

INN:

Emamectin benzoate

dosage:

2 milligram(s)/gram

pharmaceutical_form:

Premix for medicated feeding stuff

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_group:

Atlantic salmon

therapeutic_area:

emamectin

therapeutic_indication:

Ectoparasiticide

authorization_status:

Authorised

authorization_date:

2012-01-20

SPC

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