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SIMBRINZA

MiljöinformationReceptstatusFörmånsstatus
Novartis

Ögondroppar, suspension 10 mg/ml + 2 mg/ml
(Vit till benvit homogen suspension, ögondroppar)

Medel mot glaukom

Aktiva substanser:
ATC-kod: S01EC54
Läkemedel från Novartis omfattas av Läkemedelsförsäkringen.
Läkemedlet distribueras också av företag som inte omfattas av Läkemedelsförsäkringen, se Förpackningar.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Brimonidin

Miljörisk: Risk för miljöpåverkan av brimonidin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att brimonidin är persistent, då data saknas.
Bioackumulering: Det kan inte uteslutas att brimonidin kan bioackumuleras, då data saknas.


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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) = 1.5*10-6 * 2.2 kg * 100

PEC = 0.00033 μg/L

Where:

A = 2.2 kg (total sold amount API in Sweden in 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 brimonidin 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 brimonidin cannot be excluded, due to lack of data.’


Bioaccumulation

Partitioning coefficient:

No data available

Justification of chosen bioaccumulation phrase:

As no information on the octanol-water partition coefficient is available, the following statement is used for fluorescein: ‘The potential for bioaccumulation of brimonidin cannot be excluded, due to lack of data.’


Excretion (metabolism

Following administration of brimonidine tartrate gel (1 g of gel containing 5 mg of brimonidine tartrate applied to the entire face) once daily for 29 days in patients with erythema associated with rosacea, peak plasma concentration and area under the concentration-time curve (AUC) were 40 and 20%, respectively, those observed following administration of brimonidine tartrate 0.2% ophthalmic solution (1 drop in each eye every 8 hours for 24 hours). Mean peak plasma concentration and AUC were highest on day 15 in patients receiving brimonidine gel. Systemic exposure was slightly lower on day 29, indicating no further drug accumulation with brimonidine gel application.

Brimonidine is extensively metabolized by the liver.1 Urinary excretion is the major route of elimination of brimonidine and its metabolites (Medicines Complete 2017).


References


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.


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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