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Thiotepa products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

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 thiotepa 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.

ADIENNE (Tepadina®)

Strength

100mg vial
15mg vial

Excipients

None

Osmolarity / osmolality

No information

pH

No information

Endotoxin content

No information

Strength

400mg bag

Excipients

Solvent: Sodium chloride, water for injection

Osmolarity / osmolality

No information

pH

No information

Endotoxin content

No information

Esteve Pharmaceuticals (formerly Intrapharm Laboratories)

Strength

15mg vial

100mg vial

Excipients

None

Osmolarity / osmolality

No information

pH

5.5 – 7.5 (0.02% solution)

Endotoxin content

≤0.34 IU/mg

Fresenius Kabi

Strength

15mg vial

100mg vial

Excipients

Sodium carbonate

Osmolarity / osmolality

240 – 320 mOsm/kg (after dilution)

pH

7.5 – 8.5

Endotoxin content

<0.38 EU/mg

Seacross Pharmaceuticals Ltd

Strength

15mg vial

100mg vial

Excipients

None

Osmolarity / osmolality

No information

pH

No information

Endotoxin content

No information

MSN Laboratories Europe Limited

Strength

15mg vial

100mg vial

Excipients

None

Osmolarity / osmolality

256 mOsmol/kg (diluted with 0.9% NaCl to a concentration of 1mg/ml)

pH

5.5-7.5

Endotoxin content

<0.208 IU/mg

Strength

15mg vial

100mg vial

Excipients

None

Osmolarity / osmolality

No information

pH

No information

Endotoxin content

No information

Update history

  1. Republished
  2. Full monograph update
  1. Title and URL shortened.
  1. Advanz removed as discontinued by manufacturer
  1. Published