Läs upp

Cookies

Den här webbplatsen använder så kallade cookies. Cookies är små textfiler som lagras i din dator och sparar information om olika val som du gjort på en webbsida – t ex språk, version och statistik – för att du inte ska behöva göra dessa val en gång till. Tekniken är etablerad sedan många år tillbaka och används idag på väldigt många webbplatser på Internet.

Du kan när som helst ändra cookieinställningarna för denna webbplats.

FASS logotyp
Receptbelagd

Peka på symbolerna och beteckningarna till vänster för en förklaring.

Kontakt

Sök apotek med läkemedlet i lager

Sök lagerstatus

AZARGA

MiljöinformationReceptstatusFörmånsstatus
Novartis

Ögondroppar, suspension 10 mg/ml + 5 mg/ml
(Vit till benvit homogen suspension, pH cirka 7,2)

Medel mot glaukom

Aktiva substanser:
ATC-kod: S01ED51
Läkemedel från Novartis omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Brinzolamid

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


Läs mer

Detaljerad miljöinformation

Environmental risk: Risk of environmental impact of brinzolamide cannot be excluded, since no ecotoxicity data are available. 

Degradation: The potential for persistence of brinzolamide cannot be excluded, due to lack of data.

Bioaccumulation: Brinzolamide has low potential for bioaccumulation.

Detailed background information

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) = 1.5*10-6 * 19.5117 kg * 100

PEC = 0.0029 μg/L

Where:

A = 19.5117 kg (total sold amount API in Sweden year 2015, data from IMS Health).

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

P = number of inhabitants in Sweden = 9 *106 

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (ECHA 2008)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (ECHA 2008)

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae: no data available

Crustacean (Daphnia magna): no data available

Fish: no data available

Other ecotoxicity data: No data available

PNEC derivation:

No PNEC can be calculated since there is no environmental toxicity data available 

Environmental risk classification (PEC/PNEC ratio)

Calculation of a risk ratio is not possible, due to the lack of environmental toxicity data. Therefore, the following phrase is used: Risk of environmental impact of brinzolamide cannot be excluded, since no ecotoxicity data are available.

Degradation 

Biotic degradation

Ready degradability: no data available

Justification of chosen degradation phrase:

As no data on biological degradation is available the following phrase is used: ‘The potential for persistence of brinzolamide cannot be excluded, due to lack of data.’

Bioaccumulation

Partitioning coefficient:

logKow = 0.817 (method unknown) (Alcon Technical Report No. 136:60:0900)

Justification of chosen bioaccumulation phrase:

As log Kow < 4, the following statement is used for Brinzolamide: ‘Brinzolamide has low potential for bioaccumulation.’  

Excretion (metabolism)

Following topical or systemic administration, brinzolamide undergoes metabolic reactions that include N-dealkylation, O-dealkylation and oxidation of the N-propyl side chain, all CYP-450 catalyzed reactions. N-desethyl brinzolamide is the major metabolite of brinzolamide in primates and human whole blood and is the only quantifiable metabolite in human whole blood. (Alcon Technical Report No. 025:38570:0596, Alcon Technical Report No. 027:38570:0596, Alcon Technical Report No. 029:38570:0596, Alcon Technical Report No. 037:38570:0796) Studies with radioactive 14C-brinzolamide revealed that after 24 hours following an IV does, that approximately 50-60% of brinzolamide was excreted unchanged from the body and that approximately 42% remained in the blood and the carcass. (Alcon Technical Report No. 014:38570:0496)

PBT/vPvB assessment

Based on screening information, brinzolamide cannot be considered a potential PBT substance as the octanol-water partition coefficient remains significantly below the trigger level for a bioaccumulative substance.

References


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

  • Alcon Technical Report No. 136:60:0900

  • Alcon Technical Report No. 025:38570:0596

  • Alcon Technical Report No. 027:38570:0596

  • Alcon Technical Report No. 029:38570:0596

  • Alcon Technical Report No. 037:38570:0796

  • Alcon Technical Report No. 014:38570:0496  

Timolol

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


Läs mer

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) = 1.5*10-6 * 24.62 kg * 100

PEC = 0.0037 μg/L

Where:

A = 24.62 kg (sum of 4.458 kg timolol and 27.5513 kg timolol maleat, equaling 20.16 kg timolol) (total sold amount API in Sweden year 2016, data from QuintilesIMS).

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

P = number of inhabitants in Sweden = 9 *106 

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (ECHA 2008)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (ECHA 2008)


Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae: no data available


Crustacean (Daphnia magna): no data available


Fish: no data available


Other ecotoxicity data: No data available


PNEC derivation:

No PNEC can be calculated since there is no environmental toxicity data available 


Environmental risk classification (PEC/PNEC ratio)

Calculation of a risk ratio is not possible, due to the lack of environmental toxicity data. Therefore, the following phrase is used: "Risk of environmental impact of timolol cannot be excluded, since no ecotoxicity data are available."


Degradation 

Biotic degradation

Ready degradability: no data available

Justification of chosen degradation phrase:

As no data on biological degradation is available the following phrase is used: ‘The potential for persistence of timolol cannot be excluded, due to lack of data.’


Bioaccumulation

Partitioning coefficient:

logKow = 1.8 (method unknown) (Clarkes’s Analysis of Drugs and Poisons, 2017)

Justification of chosen bioaccumulation phrase:

As the logKow remains below the trigger level for a bioaccumlative substance (logKow < 4.0), the following statement is used for timolol: ‘Timolol has low potential for bioaccumulation.’


Excretion (metabolism)

Approximately 80% of timolol is metabolized in the liver to inactive metabolites. The unchanged drug and its metabolites are excreted in urine. Only small amounts of the drug are removed by hemodialysis. (AHFS Drug Information, 2017)


PBT/vPvB assessment

Based on screening information, timolol cannot be considered a potential PBT substance as the octanol-water partition coefficient remains below the trigger level for a bioaccumulative substance.


References