Azasure 500 mg/g Powder for Suspension for Fish Treatment

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Azamethiphos

זמין מ:

Ground Animal Health Limited

קוד ATC:

QP53AF17

INN (שם בינלאומי):

Azamethiphos

טופס פרצבטיות:

Powder for suspension for fish treatment

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Atlantic salmon

איזור תרפויטי:

Ectoparasiticide

מצב אישור:

Authorized

תאריך אישור:

2013-12-04

מאפייני מוצר

Revised: August 2023
AN: 02209/2022 & 02211/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Azasure 500 mg/g Powder for Suspension for Fish Treatment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
1g of product contains azamethiphos 500mg
Excipients:
For full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Powder for suspension for fish treatment. Fine
beige powder in water soluble sachet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Farmed Atlantic salmon (Salmo salar)
4.2
INDICATIONS FOR USE (SPECIFYING THE TARGET SPECIES)
For the control of mature pre-adult to adult sea-lice (Lepeophtheirus
salmonis)
or (Caligus species) on farmed Atlantic salmon.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS (FOR EACH TARGET SPECIES)
Repeated use of the same class of chemotherapeutic agent may result in
the
development of resistance.
In order to reduce the risk of resistance to the product developing,
the product
should be used as part of a multi-tactic pest-management program.
Oxygenation must be provided during treatment.
Vigorous oxygenation is
recommended in the treatment cage. Where several cages are to be
treated a
large reservoir of oxygen bottles should be available.
Do not use the product prophylactically. Only use when infestation
with adult lice
has been diagnosed.
Revised: August 2023
AN: 02209/2022 & 02211/2022
Page 2 of 7
4.5
SPECIAL PRECAUTIONS FOR USE
I
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
At water temperatures above 10�C it is advisable to limit treatment
periods to
30 minutes.
Vigorous oxygenation of the water must be provided during
treatment.
For external use only.
During treatment, careful observation of fish behaviour must be
maintained. If
signs of distress, e.g., fish falling on their side, occur after 30
minutes of
treatment, remove the tarpaulin and ensure vigorous oxygenation of the
water.
The product should be applied to salmon suffering from infestation
with sea-
lice before the stage at which serious skin damage is evi