QUABIC-300- hemodialysis grade sodium bicarbonate solution solution, concentrate

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

Disponible desde:

AQUA MEDICA, S.A. DE C.V.

Vía de administración:

HEMODIALYSIS

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

For use only with 3-pump hemodialysis machines. Use oly with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water (standard ISO 13959:2014) IN A RATIO 1:1.23:32.77. - If cloudy or with broken seal.

Estado de Autorización:

unapproved drug other

Ficha técnica

QUABIC-300- HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION SOLUTION,
CONCENTRATE
AQUA MEDICA, S.A. DE C.V.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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This is a Hemodialysis-Grade Sodium Bicarbonate Solution.
This solution already diluted 1:27:57 with purified water (standard
13959:2014),
provides:
Sodium: 35.0 mEq/l
Bicarbonate: 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
ACTIVE INGREDIENT(S)
Sodium Bicarbonate: Antiseptic
PURPOSE
For use only with 3-pump hemodialysis machines.
USE
Use oly with 3-pump hemodialysis machines, together with acid
concentrate for
hemodialysis, diluting with purified water (standard ISO 13959:2014)
IN A RATIO
1:1.23:32.77.
WARNINGS
The 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.
DO NOT USE
If cloudy or with broken seal.
If not all of 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.
OTHER INFORMATION
Keep at room temperature.
INACTIVE INGREDIENTS
Purified water (standard ISO 13959:2014)
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
3785 mL NDC: 81943-502-01
QUABIC-300
hemodialysis grade sodium bicarbonate solution solution, concentrate
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:81943-502
AQUA MEDICA, S.A. DE C.V.
ROUTE OF ADMINISTRATION
HEMODIALYSIS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION -
UNII:HN1Z RA3Q20)
SODIUM
BICARBONATE
8.4 g
in 100 mL
INACTIVE INGREDIENTS