AMX 10 MG/ML CONCENTRATE FOR SOLUTION FOR FISH TREATMENT.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-06-2015
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Active ingredient:
DELTAMETHRIN
Available from:
PHARMAQ AS
ATC code:
QP53AC11
INN (International Name):
DELTAMETHRIN
Dosage:
10 Mg/Ml
Pharmaceutical form:
Concentrate for solution for fish treatment
Prescription type:
POM
Therapeutic group:
Fish - (Atlantic) Salmon, Fish - (Rainbow) Trout
Therapeutic area:
Deltamethrin
Therapeutic indications:
Ectoparasiticide
Authorization status:
Authorised
Authorization date:
2009-02-06
Summary of Product characteristics
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
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
o
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).
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 12/06/2015_
_CRN 7020998_
_page number: 1_
4.5 SPECIAL
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