Alimta ® (pemetrexed)

För fullständig produktresumé för Alimta® se FASS.

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Alimta® (pemetrexed): Densitet, pH och andra fysikaliska och kemiska egenskaper

Relevanta fysikaliska och kemiska egenskaper hos Alimta tillhandahålls, inklusive osmolalitet, densitet, pH och känslighet för syre, fukt eller ljus.

Product Characteristics

Alimta is a powder for concentrate for solution for infusion.1

Alimta is a white to either light yellow or green-yellow lyophilised powder.1

For precautions to be taken before handling or administering Alimta and for instructions on reconstitution and dilution of Alimta before administration, see summary of product characteristics section 6.6.1 

Further relevant characteristics of Alimta is provided in Table 1.

Table 1. Alimta Characteristics2

 

Details

Osmolality

The osmolality of Alimta 500 mg solution reconstituted with 20 mL 0.9 % sodium chloride at 25°C is 514 mOsm/kg of water

Density

The density of Alimta is approximately 1.02 g/mL at 25°C if Alimta is reconstituted with 0.9 % Sodium Chloride aqueous solution as directed

pH

The pH of Alimta is between 6.6 & 7.8 when reconstituted in 0.9 % Sodium Chloride Injection

Oxygen

Alimta (pemetrexed disodium) degrades by oxidation. Alimta is oxygen sensitive and exposure to air will affect the stability. The manufacturing process was developed to minimize oxidative degradation by reducing exposure of pemetrexed solution to oxygen and upon completion of lyophilization cycle the vacuum is neutralized with sterile filtered nitrogen thus controlling the oxygen level in the drug product vial headspace.

Moisture

Moisture does not impact the stability of intact vials of Alimta.  (The lyophilized powder in the intact vials of Alimta contains residual moisture).

Light sensitivity

Alimta is not sensitive to light exposure.

References

1. Alimta [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Datum fӧr senaste ӧversyn 2021 M05 20


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