Licensed for intrathecal use
Products licensed for intrathecal use are the first line option and should be used wherever suitable.
There are currently no known topotecan products licensed for intrathecal administration.
Not licensed for intrathecal use, limited information available
Products with partial information that are not licensed for intrathecal administration can still sometimes be used. Refer to the advice in our article and complete a risk assessment to enable you to interpret the details below and choose an appropriate product.
Accord concentrate
Topotecan Accord concentrate for solution for infusion
Strength
Excipients
Tartaric acid (E334), hydrochloric acid (for pH adjustment) (E507), sodium hydroxide (for pH adjustment), water for injection
Osmolarity
100 – 40 mOsmol/L
pH
1.5 – 2.5
Endotoxin content
No information
Accord powder for concentrate
Topotecan Accord powder for concentrate for solution for infusion
Strength
Excipients
Mannitol (E421), tartaric acid (E334), sodium hydroxide, hydrochloric acid (E507)
Osmolarity
No information
pH
No information
Endotoxin content
No information
Medac
Topotecan Medac concentrate for solution for infusion
Strength
1mg/mL in 1mg, 2mg or 4mg vials
Excipients
Water for injection, hydrochloric acid for pH adjustment, sodium hydroxide for pH adjustment
Osmolarity
No information
pH
No information
Endotoxin content
No information
Pfizer
Topotecan Hospira concentrate for solution for infusion
Strength
Excipients
Tartaric acid (E334), hydrochloric acid (for pH adjustment) (E507), sodium hydroxide (for pH adjustment), water for injection
Osmolarity
No information
pH
No information
Endotoxin content
No information
Sandoz
Topotecan Sandoz concentrate for solution for infusion
Strength
1mg/mL in 1mg, 2mg or 4mg vials
Excipients
Tartaric acid, diluted hydrochloric acid, water for injection
Osmolarity
No information
pH
2.0 – 2.5
Endotoxin content
No information
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