SPL v2
SPL
SPL Set ID 28152c9f-b15c-3707-e063-6394a90a70e9
Route
HEMODIALYSIS
Published
Effective Date 2024-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bicarbonate Ion (8.4 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2024-03-30
Description

This is a Hemodialyhsis-Grade Sodium Bicarbonate Solution. This solution already diluted 1.27:57 with purified water (standard 13959:2014), provides: Sodium: 35.0 mEq/L Each 1000 mL of this solution conteins: Sodium bicarbonate USP, hemodialysis grade: 84.0 g Purified water (standard iso 13959:2014), csp: 1000 mL

Medication Information

Warnings and Precautions

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.

Indications and 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

Dosage and Administration

For use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water.

Description

This is a Hemodialyhsis-Grade Sodium Bicarbonate Solution. This solution already diluted 1.27:57 with purified water (standard 13959:2014), provides: Sodium: 35.0 mEq/L Each 1000 mL of this solution conteins: Sodium bicarbonate USP, hemodialysis grade: 84.0 g Purified water (standard iso 13959:2014), csp: 1000 mL

Section 42229-5

This is a Hemodialyhsis-Grade Sodium Bicarbonate Solution.

This solution already diluted 1.27:57 with purified water (standard 13959:2014), provides:

Sodium: 35.0 mEq/L

Each 1000 mL of this solution conteins:

Sodium bicarbonate USP, hemodialysis grade: 84.0 g

Purified water (standard iso 13959:2014), csp: 1000 mL

Section 44425-7

Keep at room temperature.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

If not all the contents are used, discard the excess.

Section 50570-1

If cloudy or with borken seal.

Section 51727-6

Purified water (standard ISO 13959:2014)

Section 51945-4

81943-503-03

Section 55105-1

For use only with 3-pump hemodialysis machines.

Section 55106-9

Sodium Bicarbonate: Antiseptic

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

For use only with 3-pump hemodialysis machines, together with acid concentrate for hemodialysis, diluting with purified water.

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

This is a Hemodialyhsis-Grade Sodium Bicarbonate Solution.

This solution already diluted 1.27:57 with purified water (standard 13959:2014), provides:

Sodium: 35.0 mEq/L

Each 1000 mL of this solution conteins:

Sodium bicarbonate USP, hemodialysis grade: 84.0 g

Purified water (standard iso 13959:2014), csp: 1000 mL

Section 44425-7 (44425-7)

Keep at room temperature.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

If not all the contents are used, discard the excess.

Section 50570-1 (50570-1)

If cloudy or with borken seal.

Section 51727-6 (51727-6)

Purified water (standard ISO 13959:2014)

Section 51945-4 (51945-4)

81943-503-03

Section 55105-1 (55105-1)

For use only with 3-pump hemodialysis machines.

Section 55106-9 (55106-9)

Sodium Bicarbonate: Antiseptic

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:34.320422 · Updated: 2026-03-14T23:13:32.363247