Aclasta^®

Infusionsvätska, lösning  5 mg

(Klar, färglös lösning)

Läkemedel för behandling av bensjukdomar, bisfosfonater

Aktiv substans

ATC-kod

(visar liknande läkemedel)

Läkemedlet omfattas av Läkemedelsförsäkringen

Detaljerad miljöinformation

PEC/PNEC = 0.09 ng/L / 31000 ng/L = 0.0000029 for Zoledronic acid, which means that the phrase

"Use of the medicine has been considered to result in insignificant environmental risk." is used for Level 1 and 2.

The PEC is based on the following data:

A = 0.6 kg (use data for 2009 from Läkemedelsstatistik AB, LSAB)

Approximately 100% excretion of pharmacologically active substance.

Approximately 0% elimination in sewage works assumed

PEC = 1.5 × 10^–6 × 0.6 kg × 100 = 0.09 ng/L

Ecotoxicological studies:

Green algae: EbC50 = 5.1 mg/L NOEC = 2.2 mg/L Selenastrum capricornutum, 72h, 92/69/EC (L383) C.3

ErC50 = 15.0 mg/L

Daphnia acute toxicity: EC50 > 18.0 mg/L Water flee (Daphnia magna), 48h, 92/69/EEC (L383) C.2

Daphnia chronic toxicity: NOEC = 0.38 mg/L Water flee (Daphnia magna), 21 days, OECD211

Fish acute toxicity: LC50 = Not available NOEC = not available

Fish chronic toxicity: NOEC = 0.31 mg/L Fathead minnow (Pimephales promelas), 32 days, OECD210

Bacterial Respiration Inhibition: EC50 = 100.0 mg/L

(30min, Inhibition of Oxygen Consumption by activated sludge (87/302/EEC), Part C)

The PNEC is based on the following data:

PNEC (µg/l) = lowest chronic NOEC/10, where 10 is the assessment factor used if chronic data from three trophic levels is available.

The most sensitive species in the chronic tests is fathead minnow with a NOEC of 0.31 mg/l.

PNEC = 310 µg/L/10 = 31 µg/l

Biodegradation: 1.0 % (28 days, 20-22°C, Method: 92/69/EC (L383) C.4-C * Carbon dioxide (CO2) evolution)

not readily degradable

Transformation in aerobic water-sediment system: DT50 (water) = 2.8 - 4.0 days (100 d, OECD308)

DT50 (total system) = not applicable as radioactivity predominantly found in sediment as unextractable

Stability: Stable (in water and buffer solutions at pH 3.6 and 9)

Adsorption to sludge: Koc = 625 - 3267 mL/g (2 sludges, 20°C, OECD106)

Koc = 3941 - 163274 mL/g (3 soils, 20°C, OECD106)

Bioaccumulation: Not expected, based on low Kow (See trigger values for concern for bioaccumulation potential in EMEA, 2006 and TGD, 2003)

BCF calculated: 0,00398 (Veith et al, 1979)

Excretion/Metabolism: Between 10-65 % of zoledronic acid excreted in urine within 24 h post infusion in patients. (Novartis Clinical Pharmacological Studies)

Structure: CAS-Nr. 165800-06-6

Phys.-chem. Properties:

Water Solubility 7.0 g/L (25°C)

Partition Coefficient

(logKow) < -2.0 (25°C, experimentally determined)

Literature:

EMEA,2006DOC.REF:EMEA/CHMP/SWP/4447/00;Guideline on the environmental risk assessment of medicinal products for human use.

EC-JRC, IHCP-ECB, 2003: Technical guidance docuemnt on risk assessment Part II: Environmental risk assessment.

Veith, G:D:, DeFoe, D:L:and Bergstedt, B:V:,1979.MEsuring and estimating the bioconcentration factor of cehmicals on fish.Journal of Fischeries Research Board of Canada, 36, 1040-1048.

Miljöinformationen för zoledronsyra är framtagen av företaget Novartis för Zometa^®