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Nicotinell

GlaxoSmithKline Consumer Healthcare

Depotplåster 7 mg/24 timmar
(Cirkelformat plåster som består av en beige yta, ett silverfärgat mellanskikt och ett genomskinligt skyddsskikt. Märkt med CWC)

Medel vid nikotinberoende

Aktiv substans:
ATC-kod: N07BA01
Utbytbarhet: Ej utbytbar
Läkemedel från GlaxoSmithKline Consumer Healthcare omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

Nikotin

Miljörisk: Användning av nikotin har bedömts medföra låg risk för miljöpåverkan.
Nedbrytning: Nikotin bryts ned i miljön.
Bioackumulering: Nikotin 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)

PEC = 0.17 μg/L


Where:

A = 5566.18 kg (total sold amount API in Sweden year 2016, derived from free base and tartate salt form, data from Quintiles IMS). Reduction of A may be justified based on metabolism data.

R = 80% removal rate based on Bueno et al 2012 (Reference 6)

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 (Desmodesmus subspicatus):

IC50 72h (growth) = 37,000 μg/L (OECD 201) (Reference 3)

NOEC = 3,200 μg/L


Water flea (Daphnia pulex):

Acute toxicity

EC50 48 h (immobility) = 242 μg/L (OECD 202) (Reference 3)


Water flea:

Chronic toxicity

No data


Rainbow Trout (Adult Onchorhynchus mykiss):

Acute toxicity

LC50 96 h (lethality) = 4,000 μg/L (OECD 203) (Reference 5)


Other ecotoxicity data:

Microorganisms in activated sludge

No data


PNEC = 242/1,000 = 0.242 μg/L

PNEC (μg/L) = lowest EC50/1,000, where 1,000 is the assessment factor applied for three acute EC50s. The EC50 for water flea (= 242 ug/L) has been used for this calculation since it is the most sensitive of the three tested species.


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.17/0.242 = 0.70, i.e. PEC/PNEC ≤ 1 which justifies the phrase “Use of nicotine has been considered to result in low environmental risk.”



Degradation

Biotic degradation

Ready degradability:

71% degradation in 28 days (OECD 301B) (Reference 3)

72% degradation within 10 day window


Abiotic degradation

Hydrolysis:

No data

Photolysis:

No Data

Justification of chosen degradation phrase:

Nicotine is readily biodegradable. The phrase “Nicotine is degraded in the environment” is thus chosen.



Bioaccumulation

Partitioning coefficient:

Log Dow = 0.28 at pH 7.4 (OECD 107) (Reference 3)


Justification of chosen bioaccumulation phrase:

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



Excretion (metabolism)

Nicotine is extensively metabolized to a number of metabolites, all of which are less active than the parent compound. The metabolism of nicotine primarily occurs in the liver, but also in the lung and kidney. Nicotine is metabolized primarily to cotinine but is also metabolized to nicotine N′-oxide. Cotinine has a half-life of 15-20 hours and its blood levels are 10 times higher than nicotine. Cotinine is further oxidized to trans-3′-hydroxycotinine, which is the most abundant metabolite of nicotine in the urine. Both nicotine and cotinine undergo glucuronidation.


The elimination half-life of nicotine is approximately 2 hours (range 1 - 4 hours). Total clearance for nicotine ranges from approximately 62 to 89 l/hr. Non-renal clearance for nicotine is estimated to be about 75% of total clearance. Nicotine and its metabolites are excreted almost exclusively in the urine. The renal excretion of unchanged nicotine is highly dependent on urinary pH, with greater excretion occurring at acidic pH. (Reference 2).



PBT/vPvB assessment

Nicotine 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). Nicotine does not fulfil the criteria for PBT and/or vBvP based on a log Dow < 4 and that it is not persistent.


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 Ziagen (Nicotine) 300mg Film Coated Tablets. ViiV Healthcare UK Ltd., March 2013.

  3. ECHA, European Chemicals Agency. January 2015.Nicotine registration joint submission.

  4. US National Library of Medicine. Toxicology Data Network HSDB:Nicotine.

  5. Edsall, C.C. Acute Toxicities to Larval Rainbow Trout of Representative Compounds Detected in Great Lakes Fish. Bull. Environ. Contam. Toxicol.46(2): 173-178, 1991.

  6. Bueno et al. Occurrence and persistence of organic emerging contaminants and priority pollutants in five sewage treatment plants of Spain: Two years pilot survey monitoring. Environmental Pollution, Volume 164, 2012, 267 – 273.