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Boehringer Ingelheim

Injektionsvätska, lösning 150 mikrog/ml
(Klar, färglös lösning)

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ATC-kod: C02AC01
Läkemedel från Boehringer Ingelheim omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Klonidin

Miljörisk: Risk för miljöpåverkan av klonidin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning: Klonidin är potentiellt persistent.
Bioackumulering: Klonidin har låg potential att bioackumuleras.


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Detaljerad miljöinformation

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) = 4.0 * 10-6 μg/L


Where:

A = 0.0292 kg (total sold amount API in Sweden year 2017, data from IQVIA).

R = 0 % removal rate.

P = number of inhabitants in Sweden = 10 *106

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

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


Predicted No Effect Concentration (PNEC)

Enviromental assesment was based on toxicity data, however as only one and not three different trophic levels were avalaible, a valid PNEC could not be calculated.


The phrase "Risk of enviromental impact of klonidin cannot be excluded, since there is not sufficient ecotoxicity data available" is therefore used.


Degradation

Biotic degradation

Ready degradability:

Calculated data using EPIWIN suggest that Clonidine hydrochloride is not readily biodegradable (III).


Inherent degradability:

No data.


Simulation studies:

No data on simulation studies.


Abiotic degradation

Hydrolysis: Clonidine is not expected to undergo hydrolysis in the environment due to the lack of functional groups that hydrolyze under environmental conditions (IV).

Photolysis: Clonidine does not contain chromophores that absorb at wavelengths >290 nm, and therefore is not expected to be susceptible to direct photolysis by sunlight (V).


Justification of chosen degradation phrase:

Clonidine hydrochloride lacks data on biotic degradation however QSAR data suggest that Clonidine hydrochloride is not readily biodegradable. Data on abiotic degradation suggest that the substance does not undergo hydrolysis or photolysis. Based on these data Clonidine hydrochloride is considered “potentially persistent”.


Bioaccumulation

Partitioning coefficient:

A log Kow of 1.57 has been determined for Clonidine hydrochloride (method unknown)(V).


Bioconcentration:

An estimated BCF of 5 was calculated in fish for clonidine (V).


Justification of chosen bioaccumulation phrase:

Based on the data showing an n-octanol/water partition coefficient of < 4, and the QSAR calculations estimating a BCF of 5, Clonidine hydrochloride is considered to have “low potential for bioaccumulation”.


Excretion (metabolism)

About 70% of administered Clonidine hydrochloride is excreted with the urine, mainly in form of the unchanged parent drug (40-60% of the dose) (III). The main metabolite p-hydroxy-clonidine is pharmacologically inactive. Approximately 20% of the total amount is excreted with the faeces, of which 55% is excreted as unchanged parent compound.


PBT/vPvB assessment

Clonidine hydrochloride is considered not to fulfil the criteria for PBT or vPvB.


References

I. European Chemicals Agency (ECHA), 2008. Guidance on information requirements and chemical safety assessment. Chapter R.10: Characterization of dose[concentration]-response for environment.

http://echa.europa.eu/documents/10162/13632/information_requirements_r10_en.pdf

II. Boehringer Ingelheim GmbH internal report No U08-0057-01.

III. Boehringer Ingelheim Environmental Risk Assessment of Clonidine hydrochloride.

IV. Lyman WJ et al; Handbook of Chemical Property Estimation Methods. Washington, DC: Amer Chem Soc. (1990).

V. Hansch, C., Leo, A., D. Hoekman. Exploring QSAR - Hydrophobic, Electronic, and Steric Constants. Washington, DC: American Chemical Society., 1995., p. 54