Cangrelor

Back to results A-Z list

Reconstitution and dilutionFull monograph review pending

U.S. label preparation

Kengreal 50 mg IV vial · Reconstitution and dilution

Preparation: Reconstitute one 50 mg vial with 5 mL sterile water for injection. Swirl and allow foam to settle. For the 0.9% sodium chloride method, add the full vial contents to one 250 mL bag for 200 mcg/mL. The label also permits 5% dextrose.
Administration and handling: Use a dedicated line. Give the prescribed bolus from the diluted bag, followed immediately by the infusion. Patients weighing at least 100 kg require a minimum of two bags.

Product and source details

Chiesi USA, Inc. · NDA204958

Product NDC: 10122-620

SPL effective 2025-10-21 | SPL version 10. Checked 2026-11-13.

Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.

Reviewed product information

Applies to

Kengreal 50 mg lyophilized single-use vial for adult IV administration.

The institutional procedure corroborates the saline preparation. Consult the U.S. label for the PCI bolus from the diluted bag, dedicated line, and transition to an oral agent.

Preparation sources checked 2026-11-13.

Reconstitution

Add 5 mL sterile water for injection to the 50 mg vial. Swirl gently until dissolved.

Sources and exact locations

Claim ID: IVR-70-CANGRELOR-001

Review basis: Separately authored institutional guidance

Source 1
KENGREAL U.S. prescribing information (opens in a new tab)
Exact location: 2.3 Preparation and Administration (SPL section 5b710ffa-6f9d-4eb6-81dd-80e6ba91a6ba)
Publisher: DailyMed / Chiesi USA, Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:00.220251+00:00
Source 2
East Kent IV cangrelor procedure (opens in a new tab)
Exact location: Section 4.2, Reconstitution
Publisher: East Kent Hospitals University NHS Foundation Trust
Source family: East Kent Hospitals University NHS Foundation Trust
Retrieved: 2026-11-13T14:23:00.964264+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.

Dilution

For the saline preparation, transfer the entire reconstituted vial into a 250 mL bag of 0.9% sodium chloride. The labeled concentration is 200 mcg/mL.

Sources and exact locations

Claim ID: IVR-70-CANGRELOR-002

Review basis: Separately authored institutional guidance

Source 1
KENGREAL U.S. prescribing information (opens in a new tab)
Exact location: 2.3 Preparation and Administration (SPL section 5b710ffa-6f9d-4eb6-81dd-80e6ba91a6ba)
Publisher: DailyMed / Chiesi USA, Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:00.220251+00:00
Source 2
East Kent IV cangrelor procedure (opens in a new tab)
Exact location: Section 4.3, Dilution
Publisher: East Kent Hospitals University NHS Foundation Trust
Source family: East Kent Hospitals University NHS Foundation Trust
Retrieved: 2026-11-13T14:23:00.964264+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.

Product identifiers and clinical review status

U.S. label preparation available. Full monograph review pending.

Selected product identity

Matched to U.S. product NDC 10122-620 for the preparation statements shown.

View product identifiers and primary-label provenance

Selected product scope: Kengreal 50 mg lyophilized single-use vial for adult IV administration.
Field ID: IVR-70-CANGRELOR-META-PRODUCT_SCOPE
Primary source (opens in a new tab) | Product data elements and the claim-specific formulation described in the cited preparation sections
Complete product reconciliation: pending.
Labeler: Chiesi USA, Inc.
Field ID: IVR-70-CANGRELOR-META-LABELER
Primary source (opens in a new tab) | SPL author/assignedEntity/representedOrganization/name
Complete product reconciliation: pending.
Application number(s): NDA204958
Field ID: IVR-70-CANGRELOR-META-APPLICATION_NUMBERS
Primary source (opens in a new tab) | SPL subjectOf/approval/id/@extension
Complete product reconciliation: pending.
NDC(s): 10122-620-01; 10122-620-10
Field ID: IVR-70-CANGRELOR-META-NDCS
Primary source (opens in a new tab) | SPL manufacturedProduct/asContent/containerPackagedProduct/code/@code and How Supplied
Complete product reconciliation: pending.
DailyMed Set ID: 88b434fa-8891-4fd5-9d86-7ea64667c08f
Field ID: IVR-70-CANGRELOR-META-SETID
Primary source (opens in a new tab) | SPL document/setId/@root
Complete product reconciliation: pending.
SPL version: 10
Field ID: IVR-70-CANGRELOR-META-SPL_VERSION
Primary source (opens in a new tab) | SPL document/versionNumber/@value
Complete product reconciliation: pending.
Label printed revision date: Not established
SPL effective date: 2025-10-21
Field ID: IVR-70-CANGRELOR-META-REVISION_DATE
Primary source (opens in a new tab) | SPL document/effectiveTime/@value
Complete product reconciliation: pending.
Retrieved: 2026-11-13T14:23:00.220251+00:00
Field ID: IVR-70-CANGRELOR-META-RETRIEVED_AT
Primary source (opens in a new tab) | Timestamp recorded when source bytes were retrieved
Complete product reconciliation: pending.
Downloaded XML SHA-256: c98cbff596d951d395b22a77d246dc186e54b734fd78cc2eeeeec3f7d10caddd
Field ID: IVR-70-CANGRELOR-META-XML_SHA256
Primary source (opens in a new tab) | SHA-256 computed over the exact downloaded XML bytes
Complete product reconciliation: pending.

What remains to be completed

Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.

All medications Return to medication heading Application top