The following Structured Product Label (SPL) was submitted to the FDA by Aqua Medica, S.a. De C.v. for the product Aquacid-200 (NDC 81943-603). 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, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
This is a Hemodialysis Acid Concentrate, Pyrogen-Free.
By diluiting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014), each 1000 ml of this solucion provides:
Sodium: 100.00 mEq/l
Potassium: 0.00 mEq/l
Calcium: 3.00 mEq/l
Magnesium: 0.75 mEq/l
Chlorides: 103.75 mEq/l
Acetate: 4.00 mEq/l
Dextrose: 100.00 mEq/l
The final conductivity calculated at 25 C is 13.2 to 14.2 mS/cm.
Potassium Chloride
For use with 3-pump hemodialysis machines only.
For use with 3-pump hemodialysis machines only, using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.
For use with 3-pump hemodialysis machines only.
Using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
If you do not use the entire contents, discard the excess.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Sodium chloride, calcium chloride, acetic acid, dextrose, purified water USP
For use with 3-pump hemodialysis machines only, using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.
By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).
3785 mL NDC: 81943-603-03
* Please review the disclaimer below.
