Excipients
Alimta
100 mg vials contain:1
Pemetrexed
disodium equivalent to 100 mg pemetrexed
active ingredient
106.4
mg Mannitol
bulking agent
Hydrochloric
acid and/or sodium hydroxide
may have been added to adjust pH
Water
for Injection
Removed during freeze drying/lyophilization
process
Alimta
500 mg Vials contain:1
Pemetrexed
disodium equivalent to 500 mg pemetrexed
active ingredient
500
mg Mannitol
bulking agent
Hydrochloric
acid and/or sodium hydroxide
may have been added to adjust pH
Water
for Injection
Removed during freeze drying/lyophilization
process
Overfill
When
reconstituted and used as directed, the vial will contain the
product’s labeled amount (e. g. 500 mg or 100 mg) of
usable/deliverable product.1
All
Alimta vials are overfilled to ensure that the container “delivers”
the label claim and to allow for any vial and syringe retention. The
appropriate volume of diluent has to be used to ensure the
usable/deliverable volume.1
The
following overages are added for vial and syringe retention:1
8.5
% for Alimta 100 mg vials
2 %
for Alimta 500 mg vials
Reconstitute
100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution
for injection, without preservative, resulting in a solution
containing 25 mg/ml pemetrexed.2
Reconstitute
500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution
for injection, without preservative, resulting in a solution
containing 25 mg/ml pemetrexed.2
Further
dilution is required.2
Pemetrexed
solutions are for single use only. Any unused medicinal product or
waste material must be disposed of in accordance with local
requirements.2
For
precautions to be taken before handling or administering Alimta and
for instructions on reconstitution and dilution of Alimta before
administration, see section summary of product characteristics,
section 6.6.2
References
1.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2.
Alimta [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands