Azitromax

Pulver till koncentrat till infusionsvätska, lösning  500 mg

(Vitt till benvitt pulver)

Antibakteriella medel för systemiskt bruk, makrolider

Aktiv substans

ATC-kod

(visar liknande läkemedel)

Läkemedlet omfattas av Läkemedelsförsäkringen

Detaljerad miljöinformation

PEC-calculation based on sales of 68,24 kg azithromycin during 2008. Based on sediment binding studies 74,2% of azithromycin released to the environment will be inextricably bound to sediment and not bioavailable, therefore:

PEC = (1,5x10-4) (68,24) (0,258) = 0,00264

PNEC-calculation using safety factor of 100 based on availability of multiple end points including chronic ceriodaphnia: 0,94/100 = 0,0094

PEC/PNEC = 0,28

0.1 < PEC/PNEC < 1

Ecotoxicity:

Blue-green algae EC50 = 0,94 ug/L (OECD 201 & OPPTS 850.5400)

Green algae 72hr EC50 = 0,0037 mg/L= 3,7 ug/L (OECD 201)

Daphnia magna 48hr EC50 = 120 mg/L= 120,000 ug/L (OECD 202)

Ceriodaphnia dubia 7d NOEC = 0,0044 mg/L = 4,4 ug/L (US EPA 1002.0)

Rainbow Trout 96hr NOEC = 84 mg/L= 84,000 ug/L (OECD 203)

Ready Biodegradation: None after 28 days (OECD 301D)

Bioaccumulation: Log Kow at pH 7,0= 0,534 (FDA TAD 3.02)

Sediment binding: 74,2 – 96,3% sediment bound azithomycin was solvent non-extractable in an OECD 308 study. This means that a minimum of 74,2% of the substance volume cannot be stripped from sediment using solvents, it will not release in water, and hence not be bioavailable. The PEC-value is therefore decreased by a factor of 0,258.

Metabolism: Although approximately 40% of the ingested dose is metabolized, the pharmacological activity of the metabolites is not clearly documented, and hence it are not taken into account in the PEC-calculation.

Sales volume in Sweden 2008: 68,24 kg