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Alimta ® (pemetrexed for injection)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information:
Alimta Summary of Product Characteristics (SmPC)
Alimta® (pemetrexed): Association between spikes and particles
The use of a spike (large bore needles) to prepare the dose may produce stopper fragments. Lilly does NOT recommend the use of spikes with Alimta. If particulate matter is observed, do not administer.
for particles in the solution
primary contributor of particulate matter in vial presentations
originates from the rubber closure (stopper). Therefore, particles
observed after reconstitution might originate from puncturing the
stopper with the needle.1
elements can influence the production of stopper fragments during
type: Blunt needle tips have a much greater tendency to produce
fragments than sharp tips.
gauge: Needles larger than 21-gauge tend to promote
of puncture: Lower needle insertion forces reduce the tendency
to produce fragments.
of puncture: Needle insertion at a 45° angle to the plane of
the stopper reduces the likelihood of fragments.
use: Using a spike on a stopper design that was not intended to
receive a spike will produce fragments.
particles may arise during the manufacturing process Alimta is
produced using the stringent manufacturing controls and undergoing
inspection and sorting procedures to reduce the potential presence of
any atypical vials as low as possible. Other sources of particles can
also include the diluent, needle, tubing or administration sets used
during the infusion.1
particles are observed
medicinal products must be inspected visually for particulate matter
and discolouration prior to administration. If particulate matter is
observed, do not administer.2
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Alimta [summary of product characteristics]. Eli Lilly Nederland
B.V., The Netherlands
Date of Last Review:May 20, 2021
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