Product Monograph - Sodium Acetate Injection, USP
PRECAUTIONS
Sodium replacement therapy should be guided primarily by the serum sodium level.
Caution should be exercised in administering sodium-containing solutions to patients with severe renal function impairment, cirrhosis, cardiac failure, or other edematous or sodium-retaining states, as well as in patients with oliguria or anuria.
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
Solutions containing acetate ions should be used with caution as excess administration may result in metabolic alkalosis.
Pregnancy
Teratogenic Effects: Animal reproduction studies have not been conducted with sodium acetate. It is also not known whether sodium acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium acetate should be given to a pregnant woman only if clearly needed.
Use in Children
Sodium Acetate is not intended for pediatric use.
ADVERSE REACTIONS
Sodium overload can occur with intravenous infusion of excessive amounts of sodium-containing solutions (see WARNINGS and PRECAUTIONS).
Reporting Side Effects You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
OVERDOSAGE
For management of a suspected drug overdose, contact your regional poison control centre.
In the event of overdosage, discontinue infusion containing sodium acetate immediately and institute corrective therapy as indicated to reduce elevated serum sodium levels, and restore acid-base balance if necessary (see WARNINGS, PRECAUTIONS and ADVERSE REACTIONS).
DOSAGE AND ADMINISTRATION
Sodium Acetate Injection, USP is administered intravenously only after dilution in a larger volume of intravenous fluids. The dose and rate of administration are dependent upon the individual needs of the patient.
Serum sodium should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of milliequivalents (mEq) of sodium with an equal number of acetate.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
50 mL Single-dose container is designed for use with a single patient as a single injection/infusion. Discard unused portion.
Directions for dispensing from MaxivialTM Pharmacy Bulk Package:
Sodium Acetate Injection, USP is available in a single use vial for pharmacy use only, referred to as a MaxivialTM. Like the single use vial, MaxivialTM is not for direct infusion. MaxivialTM comes with a hanging vial label and should be suspended as a unit in a laminar flow hood. Entry into the vial must be made with a sterile transfer set or other sterile dispensing device and contents dispensed in aliquots using aseptic technique (see DOSAGE AND ADMINISTRATION).
Use of syringe/needle is not recommended as it may cause leakage. Any unused portion should be discarded within 24 hours after initial entry when stored at room temperature.
AVAILABILITY OF DOSAGE FORMS
Sodium Acetate Injection, USP is supplied in USP type I glass clear vials, closed with Bromobutyl grey rubber closures and sealed with aluminum, flip-top seals, in boxes of 25, and MaxivialTM Pharmacy Bulk Packages.
| Single use vial | MaxivialTM Pharmacy Bulk Packages | |
|---|---|---|
| Sodium Acetate Content (%) | 32.8 | 32.8 |
Na+ mmol/mL or mEq/mL | 4 | 4 |
CH3COO– mmol/mL or mEq/mL | 4 | 4 |
| mOsmol/mL | 8 | 8 |
| Fill Volume (mL) | 50 | 100 |
STORAGE AND STABILITY RECOMMENDATIONS
Store at 15 °C to 30 °C. Do not freeze.
If you want more information about Sodium Acetate Injection, USP:
- Talk to your healthcare professional
- Find the full prescribing information that is prepared for healthcare professionals by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (https://www.fresenius-kabi.com/en-ca), or by calling 1-877-821-7724.
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Last Revised: NOV 20, 2024