Monographie - Gemtuzumab ozogamicin - Stabilis 4.0

Last update :
27/11/2024

Anticancer drug

Gemtuzumab ozogamicin

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

Mylotarg

Australia, Belgium, Chile, Colombia, Finland, France, Germany, Great Britain, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, United States of America, Venezuela

Stability in solutions

injection

Stability in solutions : Gemtuzumab ozogamicin

Container

Solvent

Concentration

Temperature

Storage

Duration of stability

References

Glass

Water for Injection

1 mg/ml

2-8°C

Protect from light

16

Hour

Manufacturer's stability data

Glass

Water for Injection

1 mg/ml

<30°C

Protect from light

3

Hour

Manufacturer's stability data

Polyvinyl chloride

Sodium chloride 0,9%

0,075 >>0,234 mg/ml

2-8°C

Protect from light

18

Hour

Manufacturer's stability data

Polyvinyl chloride

Sodium chloride 0,9%

0,075 >>0,234 mg/ml

<30°C

Protect from light

6

Hour

Manufacturer's stability data

Polyolefine

Sodium chloride 0,9%

0,075 >>0,234 mg/ml

2-8°C

Protect from light

18

Hour

Manufacturer's stability data

Polyolefine

Sodium chloride 0,9%

0,075 >>0,234 mg/ml

<30°C

Protect from light

6

Hour

Manufacturer's stability data

Ethylene vinyl acetate

Sodium chloride 0,9%

0,075 >>0,234 mg/ml

2-8°C

Protect from light

18

Hour

Manufacturer's stability data

Ethylene vinyl acetate

Sodium chloride 0,9%

0,075 >>0,234 mg/ml

<30°C

Protect from light

6

Hour

Manufacturer's stability data

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