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Paricalcitol Accord

Accord Healthcare AB

Injektionsvätska, lösning 5 mikrog/ml
(Klar och färglös vattenlösning, fri från synliga partiklar.)

Antiparatyreoideamedel

Aktiv substans:
ATC-kod: H05BX02
Läkemedel från Accord Healthcare AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

Miljöinformationen för parikalcitol är framtagen av företaget AbbVie för Zemplar

Miljörisk: Risk för miljöpåverkan av parikalcitol kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att parikalcitol är persistent, då data saknas.
Bioackumulering: Parikalcitol har hög potential att bioackumuleras.


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Detaljerad miljöinformation


Environmental Risk Classification


Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:

PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100)

Where:

A (kg/yr)

0.00007215 kg

total API sold (kg) in Sweden in 2016 (Quintiles IMS

2016)

R

0 %

removal rate (due to loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation); use 0 if no data is available.

P

9*106

number of inhabitants in Sweden

V (L/day)

200

volume of wastewater per capita and day (200 L/day is the default value) (ECHA 2016)

D


factor for dilution of waste water by surface water flow (10 is the default value) (ECHA 2016); Note: The factor 109 converts the quantity distressed from kg to mcg.

PEC (μg/L) = (0.00007215*109 *(100-0))/(365 *9*106 * 200 * 10 * 100)

PEC = 0.00000001098 μg/L (1.098*10-8μg/L)


According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of paricalcitol is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit of 0.01 µg/L.


Predicted No Effect Concentration (PNEC)

Risk of environmental impact of paricalcitol cannot be excluded, since no ecotoxicity data are available.


Ecotoxicological studies

No ecotoxicity data are available. 


Environmental risk classification (PEC/PNEC ratio)

Risk of environmental impact of paricalcitol cannot be excluded, since no ecotoxicity data are available


Degradation

The potential for persistence of paricalcitol cannot be excluded, due to lack of data.


Bioaccumulation

Partitioning coefficient:

The HPLC method was used to determine Log Dow (pH 7.4). Log Dow was calculated as a function of pH using ACD/LogD software. The result was Log Dow = 5.83 at pH 7.4 (guideline e.g. OECD 107). (Abbott 2006)


Justification of chosen bioaccumulation phrase:

Since log Dow > 4 at pH 7.4, paricalcitol has high potential for bioaccumulation.


Excretion (metabolism)

After oral administration of 3H-paricalcitol, the parent drug was extensively metabolized with only 2% of parent compound excreted in feces (and no parent compound found in urine). Several metabolites have been detected in urine and feces. Two minor metabolites related to paricalcitol were detected in human plasma. One metabolite was identified as 24(R)-hydroxy paricalcitol, while the other metabolite was unidentified. The 24(R)-hydroxy paricalcitol is less active than paricalcitol in an in vivo rat model of PTH suppression. (PDR 2018, TOXNET 2018, AbbVie 2016)


References

Abbott. 2006. Physical and Chemical Properties of Paricalcitol. Pharmaceutical R&D Memo. Abbott Laboratories, Abbott Park, Illinois, USA. 17 February 2006.

AbbVie. 2016. ZEMPLAR (paricalcitol) capsules, for oral use: Highlights of Prescribing Information. FDA Reference ID: 4000456. Available URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021606s016s017lbl.pdf. Accessed 29 January 2018.

ECHA. 2016. Guidance on Information Requirements and Chemical Safety Assessment Chapter R.16: Environmental exposure assessment. Version 3.0. February 2016. (https://echa.europa.eu/documents/10162/13632/information_requirements_r16_en.pdf/b9f0f406-ff5f-4315-908e-e5f83115d6af)

Quintiles IMS. 2016. QuintilesIMS / LIF - kg consumption/2016.

Prescribers’ Digital Reference (PDR). 2018. Paricalcitol- Drug Summary. Available URL: http://www.pdr.net/drug-summary/Zemplar-Capsules-paricalcitol-37. Accessed 29 January 2018.

Statistics Sweden. 2017. Population and Population Changes 1749–2016. Available URL: http://www.scb.se/en/finding-statistics/statistics-by-subject-area/population/population-composition/population-statistics/pong/tables-and-graphs/yearly-statistics--the-whole-country/population-and-population-changes/. Accessed 30 January 2018.

TOXNET. 2018. Hazardous Substances Data Bank (HSDB): Paricalcitol. National Library of Medicine's TOXNET System. Available URL: http://toxnet.nlm.nih.gov. Accessed 29 January 2018.