SPL v3
SPL
SPL Set ID 0404b5ce-f8a2-74ad-e063-6294a90a0337
Route
HEMODIALYSIS
Published
Effective Date 2023-08-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorate Ion (19.91 kg)
Inactive Ingredients
Sodium Chloride Calcium Chloride Anhydrous Magnesium Chloride Anhydrous Acetic Acid Anhydrous Dextrose Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-03-30

Description

By diluting the contents of this box to complete 20 gal (75.70 l), one part of this acid concentrate with 44 parts of purified water (UNE-EN ISO 23500-3:2019 standard) will have the following concentrations: Sodium Potassiu m Calcium Magnesium chlorides Acetate Dextrose The final conductivity calculated at 25°C It is 13,2 to 14,2 mS/cm NON STERILE PRODUCT 100,00 mEq/l 2,00 mEq/l 2,50 mEq/l 1,00 mEq/l 105,50 mEq/l 4,00 mEq/l 100,00 mg/dl


Medication Information

Warnings and Precautions

For use with 3-pump hemodialysis machines only.

Indications and Usage

For use with 3-pump hemodialysis machines only, using purified water (Standard 13959:2014) and in conbination with

Dosage and Administration

By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).

Description

By diluting the contents of this box to complete 20 gal (75.70 l), one part of this acid concentrate with 44 parts of purified water (UNE-EN ISO 23500-3:2019 standard) will have the following concentrations: Sodium Potassiu m Calcium Magnesium chlorides Acetate Dextrose The final conductivity calculated at 25°C It is 13,2 to 14,2 mS/cm NON STERILE PRODUCT 100,00 mEq/l 2,00 mEq/l 2,50 mEq/l 1,00 mEq/l 105,50 mEq/l 4,00 mEq/l 100,00 mg/dl

Section 42229-5

By diluting the contents of this box to complete 20

gal (75.70 l), one part of this acid concentrate with

44 parts of purified water (UNE-EN ISO

23500-3:2019 standard) will have the following

concentrations:

Sodium

Potassiu m

Calcium

Magnesium

chlorides

Acetate

Dextrose

The final conductivity calculated at 25°C It is 13,2 to 14,2 mS/cm

NON STERILE PRODUCT

100,00 mEq/l

2,00 mEq/l

2,50 mEq/l

1,00 mEq/l

105,50 mEq/l

4,00 mEq/l

100,00 mg/dl

Section 44425-7

Store at room temperature.

Keep container tightly closed when not in use.

Section 50565-1

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

Section 50566-9

If you do not use the entire contents, discard the excess.

Section 50567-7

Using purified water (Standard 13959:2014) and in conbination with sodium bicarbonate.

Section 50570-1

If the warranty seal is damaged or broken and do not allow debris to fall into the concentrate.

Section 51727-6

Sodium Chloride, Anhydrous Calcium Chloride, Anhydrous Magnesium Chloride, Acetic Acid, Dextrosa

Section 51945-4

81943-601-01

Section 55105-1

For use with 3-pump hemodialysis machines only.

Section 55106-9

Potassium Chlorate


Structured Label Content

Indications and Usage (34067-9)

For use with 3-pump hemodialysis machines only, using purified water (Standard 13959:2014) and in conbination with

Dosage and Administration (34068-7)

By diluting one part of this acid concentrate with 44 parts of purified water (ISO Standard 13959:2014).

Warnings and Precautions (34071-1)

For use with 3-pump hemodialysis machines only.

Section 42229-5 (42229-5)

By diluting the contents of this box to complete 20

gal (75.70 l), one part of this acid concentrate with

44 parts of purified water (UNE-EN ISO

23500-3:2019 standard) will have the following

concentrations:

Sodium

Potassiu m

Calcium

Magnesium

chlorides

Acetate

Dextrose

The final conductivity calculated at 25°C It is 13,2 to 14,2 mS/cm

NON STERILE PRODUCT

100,00 mEq/l

2,00 mEq/l

2,50 mEq/l

1,00 mEq/l

105,50 mEq/l

4,00 mEq/l

100,00 mg/dl

Section 44425-7 (44425-7)

Store at room temperature.

Keep container tightly closed when not in use.

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 50566-9 (50566-9)

If you do not use the entire contents, discard the excess.

Section 50567-7 (50567-7)

Using purified water (Standard 13959:2014) and in conbination with sodium bicarbonate.

Section 50570-1 (50570-1)

If the warranty seal is damaged or broken and do not allow debris to fall into the concentrate.

Section 51727-6 (51727-6)

Sodium Chloride, Anhydrous Calcium Chloride, Anhydrous Magnesium Chloride, Acetic Acid, Dextrosa

Section 51945-4 (51945-4)

81943-601-01

Section 55105-1 (55105-1)

For use with 3-pump hemodialysis machines only.

Section 55106-9 (55106-9)

Potassium Chlorate


Advanced Ingredient Data


Raw Label Data

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