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Stabilis

Fluorouracil
Tradename

Fluorouracil

Austria, Belgium, Brazil, Canada, Czech


Republic, Denmark, Finland, Great
Britain, Greece, Netherlands, Hungary,
Italy, Norway, Poland, Portugal,
Republic of South Africa, Serbia, Spain,
Switzerland, Turkey, United States of
America
France
Denmark, Finland, Norway
Belgium
Republic of South Africa
Belgium

Fluorouracile
Flurablastin
Fluracedyl
Fluroblastin
Fluroblastine
Stability in solutions

1,44 mg/ml

23C

72

1501

1,44 mg/ml

4C

72

1501

1,5 mg/ml

25C

56

840

5 mg/ml

2-8C

91

110

0,5 & 5 mg/ml

25C

13

39

0,5 & 5 mg/ml

4C

13

39

1 & 10 mg/ml

21C

14

1475

1 & 10 mg/ml

4C

14

1475

1,44 mg/ml

23C

72

1501

1,44 mg/ml

4C

72

1501

1,5 mg/ml

25C

56

840

10 mg/ml

4C

30

40

5 mg/ml

2-8C

91

110

8 mg/ml

-20C

79

2323

8 mg/ml

5C

28

2323

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1 & 10 mg/ml

25C

72

842

1 & 10 mg/ml

4C

72

842

10 mg/ml

25C

112

1040

10 mg/ml

5C

112

1040

25 mg/ml

37C

14

484

25 mg/ml

4C

14

484

50 mg/ml

25C

415

50 mg/ml

33C

14

1475

50 mg/ml

37C

415

12 & 40 mg/ml

25C

33

0,1 mg/ml

-10C

1812

0,1 mg/ml

25C

1812

0,1 mg/ml

40C

1812

0,1 mg/ml

5C

1812

50 mg/ml

25C

28

1523

50 mg/ml

30C

21

1,44 mg/ml

21-22C

48

1520

1,44 mg/ml

23C

72

1501

1,44 mg/ml

4C

72

1501

1,44 mg/ml

4C

48

1520

25 mg/ml

25C

21

1817

25 mg/ml

31C

21

1817

25 mg/ml

4C

14

1817

5 mg/ml

25C

24

133

8,3 mg/ml

5C

112

1040

50 mg/ml

25C

56

447

50 mg/ml

25C

21

1817

50 mg/ml

31C

21

1817

10 mg/ml

22C

28

142

10 mg/ml

25C

28

844

10 mg/ml

35C

28

142

10 mg/ml

35C

28

844

10 mg/ml

4C

28

844

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15 & 45 mg/ml

25C

33

50 mg/ml

22C

28

142

50 mg/ml

25C

28

844

50 mg/ml

33C

14

1475

50 mg/ml

35C

28

142

50 mg/ml

35C

28

844

50 mg/ml

37C

56

1842

Stability of mixtures

1 mg/ml

20C-23C

Granisetron hydrochloride : 0,5 mg/ml

57

0,08 mg/ml

25C

Palonosetron hydrochloride : 26 g/ml

2009

1 & 16 mg/ml

-20C

Hydromorphone hydrochloride : 0,5 mg/ml

35

513

16 mg/ml

23C

Hydromorphone hydrochloride : 0,5 mg/ml

513

1 mg/ml

23C

Hydromorphone hydrochloride : 0,5 mg/ml

35

513

16 mg/ml

32C

Hydromorphone hydrochloride : 0,5 mg/ml

513

1 mg/ml

32C

Hydromorphone hydrochloride : 0,5 mg/ml

513

1 & 16 mg/ml

4C

Hydromorphone hydrochloride : 0,5 mg/ml

35

513

1 & 2 mg/ml

25C

Mannitol : 200 mg/ml

24

411

24 mg/ml

37C

Heparin sodium : 960 UI/ml

163

24 mg/ml

4C

Heparin sodium : 960 UI/ml

14

163

24 mg/ml

32C

Folinate sodium : 3,12 mg/ml

14

2331

Factors which affect stability


138
1998

Incompatibilities

Fluorouracil : 16 mg/ml

1415

Fluorouracil : 16 mg/ml

301

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Fluorouracil
Fluorouracil : 16 mg/ml
Amphotericin B liposomale : 0.83 mg/ml
Fluorouracil
Carboplatin
Fluorouracil : 1 mg/ml
Cisplatin : 0,5 mg/ml
Fluorouracil : 1 mg/ml
Cisplatin : 0,2 mg/ml
Fluorouracil
Cisplatin
Fluorouracil
Cisplatin
Fluorouracil : 0.25 mg/ml
Cytarabine : 0.4 mg/ml
Fluorouracil
Cytarabine
Fluorouracil
Cytarabine
Fluorouracil
Daunorubicin hydrochloride
Fluorouracil
Diazepam
Fluorouracil
Doxorubicin hydrochloride
Fluorouracil
Doxorubicin hydrochloride
Fluorouracil
Doxorubicin hydrochloride
Fluorouracil : 50 mg/ml
Droperidol : 2.5 mg/ml
Fluorouracil
Droperidol
Fluorouracil : 1 & 16 mg/ml
Fentanyl citrate : 12.5 g/ml
Fluorouracil : 16 mg/ml
Filgrastim : 30 g/ml
Fluorouracil
Filgrastim
Fluorouracil : 25 mg/ml
Folinate calcium : 10 mg/ml
Fluorouracil : 46.2 mg/ml
Folinate calcium : 1.5 mg/ml
Fluorouracil : 44.4 mg/ml
Folinate calcium : 2.2 mg/ml
Fluorouracil : 40 mg/ml
Folinate calcium : 4 mg/ml
Fluorouracil : 16.7 mg/ml
Folinate calcium : 13.3 mg/ml
Fluorouracil
Folinate calcium

3474
921
3474
413
413
3578
3474
431
3474
3580
3474
3474
3645
3474
3690
763
3474
514
244
3474
155
155
155
155
155
2181

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Fluorouracil
Folinate calcium
Fluorouracil : 50 mg/ml
Folinate calcium
Fluorouracil : 33.3 mg/ml
Folinate calcium : 6.7 mg/ml
Fluorouracil
Gallium nitrate
Fluorouracil : 50 mg/ml
Gallium nitrate : 1 mg/ml
Fluorouracil
Idarubicin hydrochloride
Fluorouracil : 16 mg/ml
Lansoprazole : 0.55 mg/ml
Fluorouracil : 33.3 mg/ml
Levofolinate calcium : 6.7 mg/ml
Fluorouracil : 40 mg/ml
Levofolinate calcium : 4 mg/ml
Fluorouracil : 16.7 mg/ml
Levofolinate calcium : 13.3 mg/ml
Fluorouracil : 50 mg/ml
Levofolinate calcium
Fluorouracil : 44.4 mg/ml
Levofolinate calcium : 2.2 mg/ml
Fluorouracil : 46.2 mg/ml
Levofolinate calcium : 1.5 mg/ml
Fluorouracil : 25 mg/ml
Levofolinate calcium : 10 mg/ml
Fluorouracil : 0.25 mg/ml
Methotrexate sodium : 0.2 mg/ml
Fluorouracil
Methotrexate sodium
Fluorouracil
Methotrexate sodium
Fluorouracil
Metoclopramide hydrochloride
Fluorouracil
Morphine hydrochloride
Fluorouracil : 1 & 16 mg/ml
Morphine sulfate : 1 mg/ml
Fluorouracil
Morphine sulfate
Fluorouracil
Morphine sulfate
Fluorouracil
Ondansetron hydrochloride
Fluorouracil : 16 mg/ml
Ondansetron hydrochloride : 1 mg/ml
Fluorouracil
Oxaliplatin
Fluorouracil : 25 mg/ml
Topotecan : 0,056 mg/ml

3474
2130
155
3474
91
3474
1625
155
155
155
2130
155
155
155
431
3474
3637
3474
3474
513
3474
3531
3474
334
3634
1026

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Fluorouracil
Vinorelbine tartrate
Fluorouracil : 16 mg/ml
Vinorelbine tartrate : 1 mg/ml

3474
84

Route of administration

References

Type
5 Journal

Publication
Stiles ML, Allen LV Jr, Prince SJ.

Stability of deferoxamine mesylate, floxuridine, fluorouracil, hydromorphone hydrochloride, lorazepam, and


midazolam hydrochloride in polypropylene infusion-pump syringes.

33 Journal

39 Journal

40 Journal

Am J Health-Syst Pharm 1996 ; 53: 1583-1588.

Baud-Camus F, Crauste-Manciet S, Klein E, Richard L, Brossard D.

Stability of fluorouracil in polypropylene syringes and ethylene vinyl acetate infusion-pump reservoirs.
Am J Health-Syst Pharm 1996 ; 53: 1457-1458.

Farhang-Asnafi S, Callaert S, Barre J, Tillement JP, Thebault A.

Influence of intravenous admixtures on the stability of the new solution of 5-fluorouracil.


J Pharm Clin 1997 ; 16: 45-48.

Dine T, Lebegue S, Benaji B, Gressier B, Segard V, Goudaliez F, Luyckx M, Brunet C, Mallevais ML, Kablan J,
Cazin M, Cazin JC.

Stability and compatibility studies of four cytostatic agents (fluorouracil, dacarbazine, cyclophosphamide and
ifosfamide) with PVC infusion bags.
57 Journal

Pharm Sci Communications 1994 ; 4: 97-101.


Mayron D, Gennaro AR.

Stability and compatibility of granisetron hydrochloride in IV solutions and oral liquids and during simulated Y-site
injection with selected drugs.

84 Journal

Am J Health-Syst Pharm 1996 ; 53: 294-304.


Trissel LA, Martinez JF.

Visual, turbidimetric, and particle-content assessment of compatibility of vinorelbine tartrate with selected drugs
during simulated Y-site injection.

91 Journal

110 Journal

133 Journal

138 Journal

Am J Hosp Pharm 1994 ; 51: 495-499.


Lober CA, Dollard PA.

Visual compatibility of gallium nitrate with selected drugs during Y-site injection.
Am J Hosp Pharm 1993 ; 50: 1208-1210.

Vincke BJ, Verstraeten AE, El Eini DID, Mc Carthy TM.

Extended stability of 5-fluorouracil and methotrexate solutions in PVC containers.


Int J Pharm 1989 ; 54: 181-189.

Allen LV Jr, Stiles ML, Prince SJ, Smeeding J.

Stability of 14 drugs in the latex reservoir of an elastomeric infusion device.


Am J Health-Syst Pharm 1996 ; 53: 2740-2743.

Corbrion V, Crauste-Manciet S, Allain P, Brossard D.

Precipitation of fluorouracil in elastomeric infusers with a polyisoprene reservoir and in polypropylene syringes with
an elastomeric joint.

Am J Health-Syst Pharm 1997 ; 54: 1845-1848.

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142 Journal

Rochard EB, Barthes DMC, Courtois PY.

Stability of fluorouracil, cytarabine, or doxorubicin hydrochloride in ethylene vinylacetate portable infusion-pump


reservoirs.

155 Journal

163 Journal

Am J Hosp Pharm 1992 ; 49: 619-623.


Trissel LA, Martinez JF, Xu QA.

Incompatibility of fluorouracil with leucovorin calcium or levoleucovorin calcium.


Am J Health-Syst Pharm 1995 ; 52: 710-715.

Sewell GJ, Allsopp M, Collinson MP, Tyrrell C, Prentice AJ, Copplestone JA.

Stability studies on admixtures of 5-fluorouracil with carboplatin and 5-fluorouracil with heparin for administration
in continuous infusion regimens.

244 Journal

301 Journal

334 Journal

411 Journal

413 Journal

415 Journal

431 Journal

447 Laboratory

J Clin Pharm Ther 1994 ; 19: 127-133.


Trissel LA, Martinez JF.

Compatibility of filgrastim with selected drugs during simulated Y-site administration.


Am J Hosp Pharm 1994 ; 51: 1907-1913.

Trissel LA, Gilbert DL, Martinez JF, Baker MB, Walter WV, Mirtallo JM.

Compatibility of parenteral nutrient solutions with selected drugs during simulated Y-site administration.
Am J Health-Syst Pharm 1997 ; 54: 1295-1300.
Trissel LA, Tramonte SM, Grilley BJ.

Visual compatibility of ondansetron hydrochloride with selected drugs during simulated Y-site injection.
Am J Hosp Pharm 1991 ; 48: 988-992.

Woloschuk DMM, Wermeling JR, Pruemer JM.

Stability and compatibility of fluorouracil and mannitol during simulated Y-site administration.
Am J Hosp Pharm 1991 ; 48: 2158-2160.
Stewart CF, Fleming RA.

Compatibility of cisplatin and fluorouracil in 0.9% sodium chloride injection.


Am J Hosp Pharm 1990 ; 47: 1373-1377.
Stiles ML, Allen LV, Tu YH.

Stability of fluorouracil administered through four portable infusion pumps.


Am J Hosp Pharm 1989 ; 46: 2036-2040.
McRae MP, King JC.

Compatibility of antineoplastic, antibiotic and corticosteroid drugs in intravenous admixtures.


Am J Hosp Pharm 1975 ; 33: 1010-1013.
Zambon Biomedica

Guidelines for the administration of drugs using the Home Pump/Homepump Eclipse disposable elastomeric
infusion systems

484 Journal

1998

Northcott M, Allsopp MA, Powell H, Sewell GJ.

The stability of carboplatin, diamorphine, 5-fluorouracil and mitozantrone infusions in an ambulatory pump under
storage and prolonged in use conditions.

513 Journal

514 Journal

763 Journal

840 Journal

J Clin Pharm Ther 1991 ; 16: 123-129.


Xu QA, Trissel LA, Martinez JF.

Stability and compatibility of fluorouracil with morphine sulfate and hydromorphone hydrochloride.
Ann Pharmacotherapy 1996 ; 30: 756-761.
Xu QA, Trissel LA, Martinez JF.

Rapid loss of fentanyl citrate admixed with fluorouracil in polyvinyl chloride containers.
Ann Pharmacotherapy 1997 ; 31: 297-302.

Cohen MH, Jonhson-Early A, Hood MA, McKenzie M, Citron ML, Jaffe N, Krasnow SH.
Drug precipitation within IV tubing : A potential hazard of chemotherapy administration.
Cancer Treat Rep 1985 ; 69: 1325-1326.
Biondi L, Nairn JG.

Stability of 5-fluorouracil and flucytosine in parenteral solutions.


Can J Hosp Pharm 1986 ; 39: 60-66.

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842 Journal

844 Journal

921 Journal

Pinguet F, Favre G, Canal P, Pujol A, Soula G.


Stability of 5-fluorouracil to heat and light.
J Pharm Clin 1990 ; 9: 155-158.

Rochard E, Chapelle G, Bouquet S, Barthes D, Courtois PH.

Stability of fluorouracil and cytarabine in ethylvinylacetate containers.


J Pharm Clin 1989 ; 9: 31-35.

Trissel LA, Gilbert DL, Martinez JF.

Incompatibility and compatibility of amphotericin B cholesteryl sulfate complex with selected other drugs during
simulated Y-site administration.

1026 Journal

1040 Journal

1415 Journal

1475 Journal

1501 Journal

1520 Laboratory

1523 Laboratory

1625 Journal

1812 Journal

1817 Journal

1842 Journal

1998 Journal

2009 Journal

Hosp Pharm 1998 ; 33: 284-292.


Mayron D, Gennaro AR.

Stability and compatibility of topotecan hydrochloride with selected drugs.


Am J Health-Syst Pharm 1999 ; 56: 875-881.

Quebbeman EJ, Hamid AAR, Hoffman NE, Ausman RK.

Stability of fluorouracil in plastic containers used for continuous infusion at home.


Am J Hosp Pharm 1984 ; 41: 1153-1156.

Trissel L.A, Gilbert D.L, Martinez J.F, Baker M.B, Walter W.V, Mirtallo J.M.
Compatibility of medications with 3-in-1 parenteral nutrition admixtures.
JPEN 1999 ; 23: 67-74.

Martel P, Petit I, Pinguet F, Poujol S, Astre C, Fabbro M.

Long-term stability of 5-fluorouracil stored in PVC bags and in ambulatory pump reservoirs.
J Pharm Biomed Anal 1996 ; 14: 395-399.

Beitz C, Bertsch T, Hannak D, Schrammel W, Einberger C, Wehling M.

Compatibility of plastics with cytotoxic drug solutions - comparison of polyethylene with other container materials.
Int J Pharm 1999 ; 185: 113-121.
B Braun

Etude de stabilit des mdicaments en Ecoflac


2001

Fresenius Kabi

Dossier technique Freeflex


2003

Trissel LA, Saenz C, Williams YW, Ingram D.

Incompatibilities of lansoprazole injection with other drugs during simulated Y-site coadministration.
Int J Pharm Compound 2001 ; 5: 314-321.
Fuhrman LC, Godwin DA, Davis RA.

Stability of 5-fluorouracil in an extemporaneously compounded ophtalmic solution.


Int J Pharm Compound 2000 ; 4, 4: 320-323.
Roberts S, Sewell GJ.

Stability and compatibility of 5-fluorouracil infusions in the Braun Easypump.


J Oncol Pharm Practice 2003 ; 9: 109-112.
Sadjack A, Wintersteiger R.

Compatibility of morphin, baclofen, floxuridine and fluorouracil in an implantable infusion pump.


Arzneimittel Forschung 1995 ; 45: 93-98.
Allwood MC.

Fluorouracil precipitate.

Am J Health-Syst Pharm 1998 55: 1315-1316.


Trissel LA, Zhang Y.

Physical and chemical stability of palonosetron hydrochloride with fluorouracil and with gemcitabine hydrochloride
during simulated Y-site administration.

Int J Pharm Compound 2005 ; 2005, 9, 4: 320-322.

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2130 Journal

Lokiec F, Amirault P, Bonnans H, Gauzan MF, Sauvage N, Santoni J.

Stabilit du mlange 5-fluoro-uracil-acide fonique : influence des concentrations, du contenant et de la forme de


lacide folinique.

2181 Journal

2323 Journal

Bull Cancer 1999 ; 86, 11: 946-954.


Milano G, Rene N.

Etude de compatibilit physicochimique 5- fluoro-uracile (nouvelle prparation franaise) - acide folinique.


Bull Cancer 1995 ; 82: 189-195.

Galanti L, Lebitasy M.P, Hecq J.D, Cadrobbi J, Vanbeckbergen D, Jamart J.

Long-Term Stability of 5-Fluorouracil in 0.9% Sodium Chloride after Freezing, Microwave Thawing, and
Refrigeration

2331 Journal

3474 Laboratory
3531 Laboratory
3578 Laboratory
3580 Laboratory
3634 Laboratory
3637 Laboratory
3645 Laboratory
3690 Laboratory

Can J Hosp Pharm 2009 ; 62, 1

Cadrobbi J, Hecq J.D, Vanbeckbergen D, Jamart J, Galanti L.


Stability of 5-fluorouracil and sodium folinate admixture.
Hospital Pharmacy Europe 2009 ; 42 : 30-31.

Fluorouracil 50 mg/mL solution for injection or infusion - Summary of Product Characteristics


Accord Healthcare Limited 2009

Morphine sulphate 10 mg/mL injection BP.


Wockhardt 2010

Cisplatin - Summary of Product Characteristics


Accord Healthcare 2011

Cytarabine Accord - Rsum des caractristiques du produit


Accord Healthare France 2013

Oxaliplatine (Oxaliplatine Accord) - Rsum des caractristiques du produit


Accord Healthcare 2011

Methotrexate (Methotrexate solution for injection) - Summary of Product Characteristics


Hameln Pharmaceuticals 2014

Doxorubicin concentrate for solution for infusion - Summary of Product Characteristics


Accord Healthcare 2014

Doxorubicine 2 mg/mL concentrate for solution for infusion - Summary of Product Caracteristics
Accord Healthcare 2014

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Dictionary
Cytostatic

Injection

Tradename

Stability in solutions

Container

Molecule

Concentration

Temperature

Storage

Length of time

References

Glass

NaCl 0,9% or Glucose 5%

Protect from light

Hour

With or without light

Day

Sodium chloride 0,9%

Polyvinyl chloride

Light

Glucose 5%

None

Polypropylene

Not specified

Polyethylene

Elastomer

Ethylene vinyl acetate

Not specified

Stability of mixtures

Solvent

Compound

Factors which affect stability

Induces

Precipitation

Incompatibilities

Parenteral nutrition (with lipids)

Parenteral nutrition (binary mixture)

Route of administration

Intravenous infusion

Continuous infusion

Intra-arterial

Intravesical

Intraperitoneal

Intravitreous

Sub-conjunctival

References

Dictionary

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