FDA Label for Aquacid-220
View Indications, Usage & Precautions
Aquacid-220 Product Label
The following document was submitted to the FDA by the labeler of this product Aqua Medica, S.a. De C.v.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
This is a Hemodialysis Acid Concentrate, Pyrogen-Free.
By diluiting one part of this acid concentrate with 34 parts of purified water (ISO Standard 13959:2014), each 1000 ml of this solucion provides:
Sodium: 103.00 mEq/l
Potassium: 0.00 mEq/l
Calcium: 2.50 mEq/l
Magnesium: 1.00 mEq/l
Chlorides: 106.50 mEq/l
Acetate: 3.00 mEq/l
Dextrose: 100.00 mEq/l
The final conductivity calculated at 25 C is 13.2 to 14.2 mS/cm.
Active Ingredient(S)
Potassium Chloride
Purpose
For use with 3-pump hemodialysis machines only.
Use
For use with 3-pump hemodialysis machines only, using purified water (Standard 13959:2014) and in combination with sodium bicarbonate.
Warnings
For use with 3-pump hemodialysis machines only.
Do Not Use
If the warranty seal is damaged or broken and do not allow debris to fall into the concentrate.
Otc - When Using
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.
Otc - Stop Use
If you do not use the entire contents, discard the excess.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- By diluting one part of this acid concentrate with 34 parts of purified water (ISO Standard 13959:2014).
Other Information
- Store at room temperature.
- If you do not use the entire contents, discard the excess.
Inactive Ingredients
Sodium chloride, calcium chloride, magnesium chloride, acetic acid, dextrose, purified water USP
Recent Major Changes
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 34 parts of purified water (ISO Standard 13959:2014).
Package Label - Principal Display Panel
3785 mL NDC: 81943-602-04
* Please review the disclaimer below.