国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Deltamethrin
PHARMAQ AS
QP53AC11
Deltamethrin
10 milligram(s)/millilitre
Concentrate for solution for fish treatment
POM: Prescription Only Medicine as defined in relevant national legislation
Atlantic salmon, Trout
deltamethrin
Ectoparasiticide
Authorised
2009-02-06
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 阅读完整的文件