AMX 10 mg/ml concentrate for solution for fish treatment

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Deltamethrin

Commercializzato da:

PHARMAQ AS

Codice ATC:

QP53AC11

INN (Nome Internazionale):

Deltamethrin

Dosaggio:

10 milligram(s)/millilitre

Forma farmaceutica:

Concentrate for solution for fish treatment

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Gruppo terapeutico:

Atlantic salmon, Trout

Area terapeutica:

deltamethrin

Indicazioni terapeutiche:

Ectoparasiticide

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2009-02-06

Scheda tecnica

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alpha Max 10 mg/ml Concentrate for solution for fish treatment (in NO)
AMX 10 mg/ml Concentrate for solution for fish treatment (in IE & UK)
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).
Alpha Max 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 treatment.
At water temperatures below 6°C the product’s safety