The following Structured Product Label (SPL) was submitted to the FDA by Aqua Medica, S.a. De C.v. for the product Quabic-100 (NDC 81943-503). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, otc - do not use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
This is a Hemodialysis-Grade Sodium Bicarbonate Solutio.
This solution already diluted 1.27:57 with purified wather (standard 13959:2014), provides:
Sodium: 35..0 mEq/l
Each 1000 mL of this solution contains:
Sodium bicarbonate USP, hemodialysis grade: 84.0 g
Purified water (standard iso 13959:2014), csp: 1000 mL
Sodium Bicarbonate: Antiseptic
For use only with 3-pump hemodialysis machines.
Use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standar ISO 13959:2014) IN A RATIO 1:1.
This solution should be transparent and colorless. Do not use if cloudy or with broken seal. If not all of the contents are used, discard the excess. Keep at room temperature.
For use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water.
If cloudy or with broken seal.
If not all the contents are used, discard the excess.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep at room temperature.
Purified water (standard ISO 13959:2014)
NDC: 81943-503-02
* Please review the disclaimer below.
