Monographie - Isatuximab - Stabilis 4.0

Last update :
14/08/2025

Anticancer drug

Isatuximab

injection

Stability in solutions

Stability of mixtures

Factors which affect stability

Compatibility

Route of administration

References

pdf

Tradename

Tradename

Trade names are indicative and excipients composition can be different depending on the country and manufacturers

Sarclisa

Argentina, Belgium, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Luxembourg, Mexico, Norway, Romania, Spain, Sweden, Switzerland

Stability in solutions

injection

Stability in solutions : Isatuximab

Container

Solvent

Concentration

Temperature

Storage

Duration of stability

References

partially used vials

None

20 mg/ml

2-8°C

Not specified

14

Day

Level of evidence A+

partially used vials

None

20 mg/ml

23-27°C

Not specified

72

Hour

Level of evidence A+

Polyvinyl chloride

NaCl 0,9% or Glucose 5%

? mg/ml

15-25°C

Not specified

8

Hour

Manufacturer's stability data

Polyvinyl chloride

NaCl 0,9% or Glucose 5%

? mg/ml

2-8°C

Not specified

48

Hour

Manufacturer's stability data

Polyethylene

NaCl 0,9% or Glucose 5%

? mg/ml

15-25°C

Not specified

8

Hour

Manufacturer's stability data

Polyethylene

NaCl 0,9% or Glucose 5%

? mg/ml

2-8°C

Not specified

48

Hour

Manufacturer's stability data

Polypropylene

NaCl 0,9% or Glucose 5%

? mg/ml

15-25°C

Not specified

8

Hour

Manufacturer's stability data

Polypropylene

NaCl 0,9% or Glucose 5%

? mg/ml

2-8°C

Not specified

48

Hour

Manufacturer's stability data

Polyolefine

NaCl 0,9% or Glucose 5%

? mg/ml

15-25°C

Not specified

8

Hour

Manufacturer's stability data

Polyolefine

NaCl 0,9% or Glucose 5%

? mg/ml

2-8°C

Not specified

48

Hour

Manufacturer's stability data

Polyolefine

Sodium chloride 0,9%

1 & 8 mg/ml

2-8°C

Not specified

14

Day

Level of evidence A+

Polyolefine

Sodium chloride 0,9%

1 & 8 mg/ml

23-27°C

Not specified

72

Hour

Level of evidence A+

Ethylene vinyl acetate

NaCl 0,9% or Glucose 5%

? mg/ml

15-25°C

Not specified

8

Hour

Manufacturer's stability data

Ethylene vinyl acetate

NaCl 0,9% or Glucose 5%

? mg/ml

2-8°C

Not specified

48

Hour

Manufacturer's stability data

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