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Fortum®

MiljöinformationReceptstatusFörmånsstatus
GlaxoSmithKline

Pulver till injektions-/infusionsvätska, lösning 2 g
(Vitt till gräddvitt pulver)

Antibakteriella medel för systemiskt bruk, Cefalosporiner, tredje generationen.

ATC-kod: J01DD02
Läkemedel från GlaxoSmithKline omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Ceftazidim (vattenfritt)

Miljörisk: Användning av ceftazidim har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Ceftazidim är potentiellt persistent.
Bioackumulering: Ceftazidim 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 = 0.0088 μg/L


Where:

A =58,69 kg (total sold amount API in Sweden year 2016, data from Quintiles IMS).

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

Blue Green Algae (Anabena flos-aquae):

IC50 72h (inhibition of growth rate) = 25 μg/L (OECD 201) (Reference 6)

NOEC = 13 μg/L


Water flea (Daphnia magna):

Acute toxicity

EC50 48 h (immobility) > 106,000 μg/L (OECD 202) (Reference 5)

NOEC = 106,000 μg/L


Rainbow Trout (Oncorhyncus mykiss):

Acute toxicity

LC50 96 h (immobility) > 106,000 μg/L (OECD 203) (Reference 7)

NOEC = 106,000 μg/L


Other ecotoxicity data:

Microorganisms in activated sludge

EC50 3 hours (Inhibition) > 1,030,000 μg/L (OECD 209) (Reference 3)

NOEC = 1,030,00 μg/L


PNEC = 13/10 = 1.30 μg/L


PNEC (μg/L) = NOEC/10, where 10 is the assessment factor recommended for the anti-microbial study effect (NOEC) with cyanobacteria (Reference 9). The NOEC for blue green algae (= 13 µg/L) has been used for this calculation.


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.0088/1.30 = 0.0068, i.e. PEC/PNEC ≤ 1 which justifies the phrase “Use of ceftazidime has been considered to result in insignificant environmental risk.”


Degradation

Biotic degradation

Ready degradability:

No data

Inherent degradability:

34% primary (parent) degradation in 14 days (OECD 302B) (Reference 4)


Abiotic degradation

Hydrolysis:

No data

Photolysis:

No data


Justification of chosen degradation phrase:

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


Bioaccumulation

Partitioning coefficient:

Log Dow = -3.07 at pH 7.4 (TAD 3.02) (Reference 8)


Justification of chosen bioaccumulation phrase:

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


Excretion (metabolism)

Ceftazidime is not metabolised.


After parenteral administration plasma levels decrease with a half-life of about 2 h. Ceftazidime is excreted unchanged into the urine by glomerular filtration; approximately 80 to 90 % of the dose is recovered in the urine within 24 h. Less than 1 % is excreted via the bile. (Reference 2)


PBT/vPvB assessment

Ceftazidime 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). Ceftazidime does not fulfil the criteria for PBT and/or vBvP based on a log Dow < 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 Fortum (Ceftazidime) 1g Injection. GlaxoSmithKline, September 2012.

  3. Daniel M and Young BE. Ceftizidime hydrochloride: Effect on the Respiration Rate of Activated Sludge. Report No. BL7724/B. Brixham Environmental Laboratories, December 2004.

  4. Daniel M and Young BE. Ceftizidime hydrochloride: Determination of Inherent Biodegradability (Zahn-Wellens Test). Report No. BL7725/B. Brixham Environmental Laboratories, December 2004.

  5. Lillicrap AD. Ceftizidime hydrochloride: Acute Toxicity to Daphnia magna. Report No. BL7722/B. Brixham Environmental Laboratories, December 2004.

  6. Lillicrap AD. Ceftizidime hydrochloride: Toxicity to the blue green alga, Anabaena flos-aquae. Report No. BL7723/B . Brixham Environmental Laboratories, December 2004.

  7. Lillicrap AD. Ceftizidime hydrochloride: Acute Toxicity to Rainbow trout (Oncorhynchus mykiss. Report No. BL7722/B. Brixham Environmental Laboratories, December 2004.

  8. Material Safety Data Sheet for Fortaz (Ceftazidime for Injection). SDS number 110558. GlaxoSmithKline plc, July 2011.

  9. EMA Q&A for Environmental Risk Assessment

    http://www.ema.europa.eu/docs/en_GB/document_library/Other/2011/04/WC500105107.pdf