AMX 10 mg/ml Concentrate for Solution for Fish Treatment

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Deltamethrin

Available from:

Pharmaq AS

ATC code:

QP53AC11

INN (International Name):

Deltamethrin

Pharmaceutical form:

Concentrate for cutaneous solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Atlantic salmon, Trout - Golden/Rainbow/Redband/Steelhead

Therapeutic area:

Ectoparasiticide

Authorization status:

Authorized

Authorization date:

2008-12-17

Summary of Product characteristics

Revised: November 2023
AN: 00944/2023 & 01613/2023
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AMX 10 mg/ml Concentrate for solution for fish treatment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Deltamethrin 10 mg/ml
EXCIPIENT:
N-methyl pyrrolidone 648 mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for fish treatment
Slightly opaque, pale yellow liquid
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Atlantic salmon (_Salmo salar_) and rainbow trout (_Oncorhynchus
mykiss)._
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment of adult and preadult sea lice (_Lepeophtheirus
salmonis_) on Atlantic
salmon (_Salmo salar_) and rainbow trout (_Oncorhynchus mykiss)_.
4.3
CONTRAINDICATIONS
Do not use on fish with infectious diseases, as treatment against sea
lice may
aggravate the clinical signs and increase the mortality.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The efficacy of this medicinal product declines with water
temperatures below 6°C.
Avoid treatment if large amounts of organic material are present in
the sea water or if
the sea-cage is overgrown, as this may reduce the efficacy of the
treatment.
Dead sea lice may remain on the fish for a few days after treatment
(depending on
the water temperature).
Revised: November 2023
AN: 00944/2023 & 01613/2023
Page 2 of 7
AMX does not prevent reinfestation with sea lice after treatment.
Lack of efficacy and reduced sensitivity to deltamethrin has been
observed.
Suboptimal treatment regimen and frequent treatments as well as the
use of
pyrethroids only for sea lice treatment, can induce reduced
sensitivity in the sea lice
with lack of efficacy as a possible consequence.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
All fish should be oxygenated during treatment. Ensure that the oxygen
level is above
7 mg/l before the treatment is initiated and that it is kept above
7mg/l during the entire
duration of the treatme