QUABIC-100- hemodialysis grade sodium bicarbonate solution solution, concentrate

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

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

Indgivelsesvej:

HEMODIALYSIS

Recept type:

OTC DRUG

Terapeutiske indikationer:

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. If cloudy or with broken seal.

Autorisation status:

unapproved drug other

Produktets egenskaber

QUABIC-100- 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 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 wit acid
conentrate 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)
3785 mL NDC: 81943-503-01
QUABIC-100
hemodialysis grade sodium bicarbonate solution solution, concentrate
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:81943-503
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
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:81943-
503-01
3785 mL in 1 BOTTLE; Type 0: Not a Combin