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Relenza

MiljöinformationReceptstatusFörmånsstatus
GlaxoSmithKline

Inhalationspulver, avdelad dos 5 mg/dos
(vitt till benvitt pulver)

Antiviralt medel

Aktiv substans:
ATC-kod: J05AH01
Utbytbarhet: Ej utbytbar
Läkemedel från GlaxoSmithKline omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Zanamivir

Miljörisk: Risk för miljöpåverkan av zanamivir kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning: Zanamivir är potentiellt persistent.
Bioackumulering: Zanamivir har låg 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) = 1.5*10-6*A(100-R)

PEC = 0.0000021 μg/L


Where:

A = 0.0134 kg (total sold amount API in Sweden year 2016, data from QuintilesIMS). Reduction of A may be justified based on metabolism data.

R = 0% removal rate (conservatively, it has been assumed there is no loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Reference 1)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Reference 1)


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies


Green Algae:

No data


Water flea (Daphnia magna):

Acute toxicity

EC50 48 h (immobility) > 1,000,000 μg/L (OECD 202) (Reference 6)

NOEC > 1,000,000 μg/L


Water flea (Daphnia magna):

Chronic toxicity

EC50 21 days (reproduction) > 100,000 μg/L (OECD 211) (Reference 8)

NOEC = 100,000 μg/L


Fish:

Acute toxicity

No data


Other ecotoxicity data:

EC50 3 hours (Inhibition) =1,000,000 μg/L (OECD 209) (Reference 5)


PNEC cannot be calculated because data is not available for all three (algae, crustacean and fish) of the short-term toxicity endpoints.


Environmental risk classification (PEC/PNEC ratio)

Risk of environmental impact of zanamivir cannot be excluded, since there is not sufficient ecotoxicity data available.


Degradation


Biotic degradation

Ready degradability:

0.1% degradation in 28 days (OECD 301B) (Reference 7)


Inherent degradability:

No Data

50% primary (loss of parent) degradation in 3 days


Abiotic degradation

Hydrolysis:

Half-life, pH 7 > 1 year (OECD 111) (Reference 4)


Photolysis:

No data


Justification of chosen degradation phrase:

Zanamivir is not readily biodegradable nor inherently biodegradable. The phrase “Zanamivir is potentially persistent” is thus chosen.


Bioaccumulation


Partitioning coefficient:

Log Dow < 1 at pH 7 (OECD 107) (Reference 3)

Log Dow at pH 5 < 1

Log Dow at pH 7 < 1

Log Dow at pH 9 < 1


Justification of chosen bioaccumulation phrase:

Since log Dow < 4, the substance has low potential for bioaccumulation.


Excretion (metabolism)

Zanamivir has been shown to be renally excreted as unchanged drug, and does not undergo metabolism. In vitro studies demonstrated that zanamivir did not affect the activity of a range of probe substrates for cytochrome P450 isoenzymes (CYP1A/2, A6, 2C9, 2C18, 2D6, 2E1, 3A4) in human hepatic microsomes, nor did it induce cytochrome P450 expression in rats, suggesting that metabolic interactions between zanamivir and other drugs are unlikely in vivo.


The serum half-life of zanamivir following administration by oral inhalation ranges from 2.6 to 5.05 hours. It is entirely excreted unchanged in the urine. Total clearance ranges from 2.5 to 10.9 L/h as approximated by urinary clearance. Renal elimination is completed within 24 hours (Reference 2).


PBT/vPvB assessment

Zanamivir does not fulfil the criteria for PBT and/or vBvP.


All three properties, i.e. ‘P’, ‘B’ and ‘T’ are required in order to classify a compound as PBT (Reference 1). Zanamivir does not fulfil the criteria for PBT and/or vBvP based on a log Kow < 4.


Please, also see Safety data sheets on http://www.msds-gsk.com/ExtMSDSlist.asp.


References

  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.

  2. Pharmacokinetic properties: Metabolism and Elimination. Summary of Product Characteristics Relenza (Zanamivir) 5 mg dose Inhalation Powder. GlaxoSmithKline, May 2011.

  3. Croudace CP, Stanley RD and Cornish SK. GG167: Determination of Octanol-Water Partition Coefficient. Report No. BL5269/B. Brixham Environmental Laboratory, January 1996.

  4. Croudace CP, Stanley RD and Cornish SK. GG167: Hydrolysis as a Function of pH. Report No. BL5270/B. Brixham Environmental Laboratory, January 1996.

  5. Croudace CP and Latham M. GG167: Determination of Activated Sludge respiration Inhibition. Report No. BL5272/B. Brixham Environmental Laboratory, January 1996.

  6. Croudace CP, Banner AJ and Magor SE. GG167: Acute Toxicity to Daphnia magna. Report No. BL5271/B. Brixham Environmental Laboratory, January 1996.

  7. Long KWJ and Demsey M. GG167: Aerobic Biodegradation in Water. Report No. BL5375/B. Brixham Environmental Laboratory, January 1996.

  8. Goodband TJ. Zanamivir: Daphnid, Ceriodaphnia dubia Survival and Reproduction Test. Report No. 1127/1209. Safepharm Laboratories Limited, July 2006.