FDA label 6b61a6f9-0cc7-47bf-a600-ae8bb89a9501
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- b1e83fb1-7f51-41b7-a1eb-495414bbf1f2
- SPL ID
- 6b61a6f9-0cc7-47bf-a600-ae8bb89a9501
- Version
- 6
- Effective date
- 2012-08-22
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:50:43
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 6b61a6f9-0cc7-47bf-a600-ae8bb89a9501 | id | |
| spl set id | b1e83fb1-7f51-41b7-a1eb-495414bbf1f2 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Intrathecal administration of drugs such as methotrexate sodium and cytarabine should be performed by personnel skilled in the technique of lumbar puncture under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. The labeling for methotrexate sodium and cytarabine should be consulted.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Adverse reactions may occur with any given intrathecal injection due to the chemotherapy or the technique of intrathecal administration. (See product labeling for methotrexate sodium and cytarabine.) Preservative-free methotrexate sodium and cytarabine should be used to minimize adverse reactions due to preservatives. If an adverse reaction does occur, discontinue the administration, evaluate the patient, institute appropriate therapeutic countermeasures and, if possible, save the remainder of the unused solution(s) for examination.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.