FDA Label for Quabic-100
View Indications, Usage & Precautions
Quabic-100 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-Grade Sodium Bicarbonate Solution.
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
Otc - Active Ingredient
Sodium Bicarbonate: Antiseptic
Otc - Purpose
For use only with 3-pump hemodialysis machines.
Indications & Usage
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.
Warnings
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.
Dosage & Administration
For use only with 3-pump hemodialysis machines, together wit acid conentrate for hemodialysis, diluting with purified water.
Otc - Do Not Use
If cloudy or with broken seal.
Otc - When Using
If not all the contents are used, 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.
Storage And Handling
Keep at room temperature.
Inactive Ingredient
Purified water (standard ISO 13959:2014)
Package Label.Principal Display Panel
3785 mL NDC: 81943-503-01
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