Aztreonam-avibactam

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Reconstitution and dilutionFull monograph review pending

U.S. label preparation

Emblaveo · Reconstitution and dilution

Preparation: Reconstitute the combination vial with 10 mL sterile water for injection. Further dilute the prescribed volume in 0.9% sodium chloride, 5% dextrose or lactated Ringer's.
Administration and handling: Use the dose-specific withdrawal volume. Storage limits depend on the diluent and the preparation stage.

Product and source details

AbbVie Inc. · NDA217906

Product NDC: 0074-3878

SPL effective 2026-06-24 | SPL version 7. 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

Emblaveo single-dose vial, aztreonam 1.5 g and avibactam 0.5 g, for adult IV infusion.

Use U.S. label section 2.3, Table 3 for withdrawal volumes. The international table uses different volumes for the same component doses. Its storage intervals also differ.

Preparation sources checked 2026-11-13.

Reconstitution

Add 10 mL sterile water for injection to each vial and gently mix until dissolved. Further dilution is required before IV infusion.

Sources and exact locations

Claim ID: IVR-70-AZTREONAM-AVIBACTAM-001

Review basis: Separately authored institutional guidance

Source 1
EMBLAVEO U.S. prescribing information (opens in a new tab)
Exact location: 2. 3 Preparation of EMBLAVEO Solution for Administration (SPL section 182a6794-9fdd-4465-994e-8a6089c4074d)
Publisher: DailyMed / AbbVie Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:00.322470+00:00
Source 2
Galway adult IV guide: Aztreonam-avibactam (opens in a new tab)
Exact location: Reconstitution
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:23:00.774829+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.

Infusion Fluids

0.9% sodium chloride and 5% dextrose are both labeled options for further dilution. Use the U.S. dose-specific preparation table to select the volume.

Sources and exact locations

Claim ID: IVR-70-AZTREONAM-AVIBACTAM-002

Review basis: Separately authored institutional guidance

Source 1
EMBLAVEO U.S. prescribing information (opens in a new tab)
Exact location: 2. 3 Preparation of EMBLAVEO Solution for Administration (SPL section 182a6794-9fdd-4465-994e-8a6089c4074d)
Publisher: DailyMed / AbbVie Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:00.322470+00:00
Source 2
Galway adult IV guide: Aztreonam-avibactam (opens in a new tab)
Exact location: Infusion fluids and Methods of intravenous administration
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:23:00.774829+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.

Infusion Time

Infuse the prepared adult dose over 3 hours.

Sources and exact locations

Claim ID: IVR-70-AZTREONAM-AVIBACTAM-003

Review basis: Separately authored institutional guidance

Source 1
EMBLAVEO U.S. prescribing information (opens in a new tab)
Exact location: 2.1 Recommended Dosage in Adults with Estimated Creatinine Clearance G reater than 50 mL/min (SPL section 8e93fc4e-0c43-4567-bc07-189993892851)
Publisher: DailyMed / AbbVie Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:23:00.322470+00:00
Source 2
Galway adult IV guide: Aztreonam-avibactam (opens in a new tab)
Exact location: Methods of intravenous administration
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:23:00.774829+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.

Stability research for elastomeric pumps

The study tested aztreonam 25 mg/mL and avibactam 8.33 mg/mL in normal saline in a 240 mL Baxter Infusor LV. It measured physical and chemical stability using a 90% potency threshold. Sterility and clinical outcomes need separate evaluation before assigning a beyond-use date.

Toro Blanch et al., Antibiotics, July 2026. Sections 2, 4.2 and 5. 2026 elastomeric pump stability study (opens in a new tab)

Assigning a compounding beyond-use date requires a separate assessment.

Product identifiers and clinical review status

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

Selected product identity

Matched to U.S. product NDC 0074-3878 for the preparation statements shown.

View product identifiers and primary-label provenance

Selected product scope: Emblaveo single-dose vial, aztreonam 1.5 g and avibactam 0.5 g, for adult IV infusion.
Field ID: IVR-70-AZTREONAM-AVIBACTAM-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: AbbVie Inc.
Field ID: IVR-70-AZTREONAM-AVIBACTAM-META-LABELER
Primary source (opens in a new tab) | SPL author/assignedEntity/representedOrganization/name
Complete product reconciliation: pending.
Application number(s): NDA217906
Field ID: IVR-70-AZTREONAM-AVIBACTAM-META-APPLICATION_NUMBERS
Primary source (opens in a new tab) | SPL subjectOf/approval/id/@extension
Complete product reconciliation: pending.
NDC(s): 0074-3878-01; 0074-3878-10
Field ID: IVR-70-AZTREONAM-AVIBACTAM-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: be1a6c99-d4b3-46d7-9e99-6e5f9fab556a
Field ID: IVR-70-AZTREONAM-AVIBACTAM-META-SETID
Primary source (opens in a new tab) | SPL document/setId/@root
Complete product reconciliation: pending.
SPL version: 7
Field ID: IVR-70-AZTREONAM-AVIBACTAM-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: 2026-06-24
Field ID: IVR-70-AZTREONAM-AVIBACTAM-META-REVISION_DATE
Primary source (opens in a new tab) | SPL document/effectiveTime/@value
Complete product reconciliation: pending.
Retrieved: 2026-11-13T14:23:00.322470+00:00
Field ID: IVR-70-AZTREONAM-AVIBACTAM-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: 3e04b674319f420f8ec31f27d873402e2ce8b40b65378b28dd715daf25b21a77
Field ID: IVR-70-AZTREONAM-AVIBACTAM-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.

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