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Företaget deltar inte i Fass, därför finns endast begränsad information om läkemedlet.

Forzaar Comp Forte

(Parallellimporterat)
MiljöinformationReceptstatusFörmånsstatus
Cross Pharma AB

Filmdragerad tablett 100 mg/25 mg
Avregistreringsdatum: 2011-01-31 (Tillhandahålls ej)

Blisterkartan är märkt både Forzaar och Forzaar Comp Forte.

Angiotensin II-antagonist och diuretikum.

Visa information om det parallellimporterade läkemedlet
Aktiva substanser:
ATC-kod: C09DA01
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
Läs mer om avregistrerade läkemedel

Miljöpåverkan (Läs mer om miljöpåverkan)

Miljöinformationen för hydroklortiazid är framtagen av företaget MSD för Cozaar® Comp, Cozaar® Comp Forte, Dichlotride, Dichlotride comp, Dichlotride-k, Fortzaar mite, Hydromet, Hydromet-k, Moduretic®, Moduretic® mite, Renitec® comp., Synerpril®

Miljörisk: Användning av hydroklortiazid har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Hydroklortiazid är potentiellt persistent.
Bioackumulering: Hydroklortiazid 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 = 0.41 μg/L


Where:

A = 2763 kg (total sold amount API in Sweden year 2015, data from IMS Health).

R = 0 % removal rate (worst case assumption)

P = number of inhabitants in Sweden = 9 *106

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

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


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies


Crustacean, water flea (Daphnia magna):

Acute toxicity (OECD 202) (Ref. III)

EC50 48 h (mortality) > 500 mg/L


Chronic toxicity (OECD 211) (Ref. VI)

LC50 21 d (reproduction, survival, length) > 100 mg/L

NOEC 21 d (reproduction, survival, length) = 100 mg

F
ish, fathead minnow (Pimephales promelas):

Acute toxicity (OECD 203) (Ref.IV)

LC50 96 h (mortality) > 500 mg/L


Chronic toxicity (OECD 210) (Ref VI)

NOEC 30 d (hatchability, survival, length, weight) = 10 mg/L

Algae (Pseudokirchneriella subcapitata) (OECD 201) (Ref VI)

EC50 72 h (growth rate, yield) > 100 mg/L

NOEC 72 h (growth rate, yield) = 100 mg/L

Bacteria (Pseudomonas.putida) (Method by Bringham and Kuhn, 1980, modified by Slabbert, 1986) (Ref. II):

EC50 48 h (growth rate) > 32 mg/L


PNEC = 1 mg/L = 1000 µg/L (10 mg/L / 10) based on the chronic NOEC for the fish early life stage and an assessment factor (AF) of 10)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.41/1000 = 4.1 x10-4, i.e. PEC/PNEC ≤ .1 which justifies the phrase "Use of hydrochlorothiazide has been considered to result in insignificant environmental risk."


Degradation


Abiotic degradation


Hydrolysis & Photolysis:


In laboratory studies performed to determine aqueous stability for aquatic toxicity tests, hydrolysis and/or photolysis effects were observed. A solution of 26 mg/L hydrochlorothiazide was prepared in Mullin's Spring Water (pH = 8.2) and incubated at 21oC under lighted conditions. The concentration of this solution was measured by HPLC at time 0 and 96 hours. A 53.8% recovery was noted, indicating that degradation of the compound was occurring (Ref. IV). Hydrochlorothiazide has been found to be degradable in the environment, however no data is available on metabolites. Therefore the phrase “Hydrochlorothiazde is potentially persistent” was chosen.


Bioaccumulation


Partitioning coefficient:

Log Kow = -0.07 at pH 7 (OECD 107) (Ref. V)


Justification of chosen bioaccumulation phrase:

Since log Kow < 4 at pH 7, the substance has low potential for bioaccumulation


.

References

  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. ICI Brixham Laboratory, 1988. “Hydrochlorothiazide: Bacterial growth inhibition Determination of the toxicity to Pseudomonas putida”, 12 July 1988.

  3. ICI Brixham Laboratory, 1989. “Hydrochlorothiazide: Determination of the acute toxicity to Daphnia magna”, 13 June 1988.

  4. Merck Internal Memo: Venkataramani to Bacher, MK-0152 (Hydrochlorothiazide) Ecotoxicological Characterization, March 30, 1994.

  5. Pubchem, 2017. http://pubchem.ncbi.nlm.nih.gov/compound/3639#section=Solubility

    accessed 20 April, 2017.

  6. Astra Zeneca, 2012. Environmental Risk Assessment Data Hydrochlorothiazide.

Miljöinformationen för losartan är framtagen av företaget MSD för Cozaar®, Cozaar® Comp, Cozaar® Comp Forte, Fortzaar mite

Miljörisk: Användning av losartan har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Losartan är potentiellt persistent.
Bioackumulering: Losartan 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 = 1.2 μg/L


Where:

A = 8161 kg (total sold amount API in Sweden year 2015, data from IMS Health).

R = 0 % removal rate (worst case assumption)

P = number of inhabitants in Sweden = 9 *106

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

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


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies


Green Algae (Selenastrum capricornutum) (FDA 4.01) (Ref. II):

NOEC 10 day (cell growth) = 143 mg/L


Blue Green Algae (Microcystis aeruginosa)(FDA 4.01) (Ref. III): NOEC 10 day (cell growth) = 556 mg/L


Crustacean, water flea (Daphnia magna):

Acute toxicity

LC50 48 h (mortality) = 331 mg/L (OECD 202) (Ref.IV)

NOEC = 80 mg/L


Chronic toxicity

NOEC 21 day (survival, reproduction, growth) = 100 mg/L (OECD 211) (Ref V)

No effects noted up to the highest concentration tested


Fish, fathead minnow (Pimephales promelas):

Acute toxicity

LC50 48 h (mortality) > 1000 mg/L (U.S. EPA “Methods for Measuring the Acute Toxicity of Effluents to Fresh Water and Marine Organisms”, 1985) (Ref.IV)

NOEC = 100 mg/L


Chronic toxicity

NOEC 32-day (survival, hatching, growth) = 10 mg/L (OECD 210) (Ref VI)

No effects noted up to the highest concentration tested


Fish, rainbow trout (Oncorhynchus mykiss):

Acute toxicity

LC50 96 h (mortality) > 929 mg/L (FDA 4.11) (Ref.VII)

NOEC = 929 mg/L


PNEC = 1000 μg/L (10000 μg/L/ 10 based on the most sensitive chronic NOEC for the fish with an assessment factor (AF) of 10)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 1.2/1000 = 0.001, i.e. PEC/PNEC ≤ .1 which justifies the phrase “Use of losartan has been considered to result in insignificant environmental risk.”


Degradation


Biotic degradation


Bacteria > 90% of initial concentration remaining

Algal = 71% of initial concentration remaining after 28 days (FDA 3.11). (Ref VIII)


Abiotic degradation

Hydrolysis:

Hydrolytically stable between pH 5-9 (FDA 3.09). (Ref. IX)


Photolysis:

Susceptible to aqueous photolysis and rapidly degrades under clear sky conditions

Half-Lifemax < 18 hours (pH 9) over wavelength interval 290-800 nm

(FDA 3.10). (Ref. X)


Justification of chosen degradation phrase:

Losartan has been found to degrade under natural light conditions however no data are available on metabolites. Therefore the phrase “Losartan is potentially persistent” was thus chosen.


Bioaccumulation

Partitioning coefficient:

Log Kow = 1.2 (OECD 107). (Ref.XI)


Justification of chosen bioaccumulation phrase:

Since log Kow < 4 at pH 7, the substance has low potential for bioaccumulation


References


  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Toxicity to the Freshwater Green Alga, Selenastrum capricornutum, Under Static Test Conditions," Study No., J9209001f, TOX, Jupiter, FL, USA, 16 June 1993.

  3. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Toxicity to the Blue-Green Alga, Microcystis aeruginosa, Under Static Test Conditions," Study No., J9209001g, TOX, Jupiter, FL, USA, 16 June 1993.

  4. Merck, 1995. “ Environmental Quality Criteria Monograph for Losartan Potassium”, Merck & Co., Inc. Whitehouse Station, NJ, USA, 24 November 1995.

  5. Smithers Visicent, 2013. "Losartan – Full Life-Cycle Toxicity Test with Water Fleas, Daphnia magna, Under Static Renewal Conditions Following OECD Guideline #211" Smithers Viscient Study Number 359.6707" Wareham, MA, USA, 18 June 2013.

  6. Smithers Visicent, 2013. "Losartan – Early Life-Stage Toxicity Test with Fathead Minnow, Pimephales promelas, Following OECD Guideline #210" Smithers Viscient Study Number 359.6706" Wareham, MA, USA, 10 June 2013.

  7. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Acute Toxicity to Rainbow Trout, Oncorhynchus mykss, Under Static Test Conditions," Study No., J9209001i, TOX, Jupiter, FL, USA, 28 May 1993.

  8. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Biodegradation Inoculum Source Screening and Aerobic Biodegradation in Water," Study No., J9209001d, TOX, Jupiter, FL, USA, 06 August 1993.

  9. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Determination of the Rate of Hydrolysis as a Function of pH," Study No., J9209001b, TOX, Jupiter, FL, USA, 02 March 1993.

  10. Toxikon Environmental Sciences, 1993. "Losartan (MK-0954): Determination of Aqueous Photolysis," Study No., J9209001c, TOX, Jupiter, FL, USA, 02 July 1993.

  11. Merck & Co., Inc., 1995 “New Drug Application for Tablets Losartan Potassium, Environmental Assessment, Feb 1 1995”