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SODIUM CHLORIDE injection, solution
[Fresenius Kabi USA, LLC]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Unapproved drug for use in drug shortage
Drug Label Sections

HEALTH CARE PROVIDER LETTER

 

 0.9% SODIUM CHLORIDE INJECTION SOLUTION AVAILABILITY

Subject: Importation of European Drug Product

March 3, 2014

Dear Healthcare Professional,

 

Due to the current critical shortage of 0.9% Sodium Chloride Injection in the U.S. market, Fresenius Kabi USA, LLC (Fresenius Kabi USA) is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of the drug. Fresenius Kabi USA has initiated temporary importation of a European Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion into the U.S. market. The European product contains the same active ingredient in the same concentration as the 0.9% Sodium Chloride Injection products approved in the United States. The Sodium Chloride 0.9% Freeflex Injection Solution product is manufactured near Halden, Norway, at Fresenius Kabi Norge AS, an FDA inspected facility. At its most recent FDA inspection, this facility was found to be in compliance with current good manufacturing practices.

At this time, FDA is not objecting to the importation and distribution of Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion, by Fresenius Kabi USA, to address the critical shortage of 0.9% Sodium Chloride Injection. Importation or distribution of Fresenius Kabi’s Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion by any entity other than Fresenius Kabi USA, is not within the scope of this decision and may be subject to enforcement action by the FDA. FDA has not approved Fresenius Kabi’s Sodium Chloride 0.9% Freeflex Injection Solution products in the United States.

Effective immediately, and during this temporary period, Fresenius Kabi USA will offer the following presentations of Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion:

 

Fresenius Kabi’s Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

Product Name

Volume

Ingredients

Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

50 mL

Each 50 mL contains:

Sodium Chloride 450 mg, Water for Injections to 50 mL

 

Total Electrolytes per 50 mL approx:

Sodium 7.7 mmol*, Chloride 7.7 mmol*

Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

100 mL

Each 100 mL contains:

Sodium Chloride 900 mg, Water for Injections to 100 mL

 

Total Electrolytes per 100 mL approx:

Sodium 15.4 mmol*, Chloride 15.4 mmol*

Sodium Chloride 0.9% w/v for

Intravenous Infusion

500 mL

Each 500 mL contains:

Sodium Chloride 4.5 g, Water for Injections to 500 mL

 

Total Electrolytes per 500 mL approx:

Sodium 77 mmol*, Chloride 77 mmol*

Sodium Chloride 0.9% w/v for Intravenous Infusion

1000 mL

Each 1000 mL contains:

Sodium Chloride 9 g, Water for Injections to 1000 mL

 

Total Electrolytes per 1000 mL approx:

Sodium 154 mmol*, Chloride 154 mmol*

* For monovalent ions, such as sodium and chloride, the numeric value of the millimole and milliequivalent are identical.

 

Fresenius Kabi’s Sodium Chloride 0.9% Injection Solution for Intravenous Infusion is packaged in freeflex®, a flexible bag with self-sealing ports and made of multilayer Polyolefin film that is PVC-free, plasticizer-free, latex-free and non-DEHP.

  

scfigure1                                                    scfigure2

 

It is important to note that there are differences in the formatting and content of the labeling between the U.S. marketed 0.9% Sodium Chloride solutions, and Fresenius Kabi’s Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion. Refer to comparison table attached.

 

Differences Between U.S. Prescribing Information and Fresenius Kabi’s Prescribing Information

Property

0.9% Sodium Chloride U.S. Products

Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

Active Ingredients

Sodium 154 mEq/L*

Sodium 154 mmol/L*

Chloride 154 mEq/L*

Chloride 154 mmol/L*

Osmolarity 308 mOsmol/L (calc.)

Osmolality 308 mOsmol/kg water** (calc.)

Indications for Use

See manufacturer’s package insert

Normal saline can be used as the vehicle for many parenteral drugs and as a sterile irrigation medium.

Contraindications

See manufacturer’s package insert

Sodium Chloride 0.9% is contraindicated in patients with congestive heart failure, severe renal impairment, conditions of sodium retention, edema, liver cirrhosis and irrigation during electrosurgical procedures.

Warnings

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions to patients receiving corticosteroids or corticotropin.

Refer to Fresenius Kabi’s package insert or visit www.fresenius-kabi.us

Adverse Reactions

See manufacturer’s package insert

Excessive amounts of sodium chloride may cause hypernatremia, hypokalemia and acidosis. Proper use of normal saline as a vehicle for parenteral drugs or as an electrolyte replacement therapy is unlikely to result in adverse effects.

 

Hypernatremia rarely occurs with therapeutic doses of sodium chloride, but may occur in excessive administration. A serious complication of this is dehydration of the brain causing somnolence and confusion, which may progress to convulsions, coma and ultimately respiratory failure and death. Pulmonary embolism or pneumonia may also result. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, weakness and irritability.

 

Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may result in distension or disruption of tissues. Inadvertent contamination from careless technique may transmit infection. Adverse effects resulting from irrigation of body cavities, tissues or indwelling catheters and tubes are usually avoidable when appropriate procedures are followed.

Drug Interactions

See manufacturer’s package insert

Co-medication of drugs inducing sodium retention may exacerbate any systemic effects.

Overdose and Treatment

See manufacturer’s package insert

Overdose 

Infusion of excess intravenous fluid may cause hypervolemia and electrolyte imbalances. Excess sodium chloride in the body produces general gastrointestinal effects of nausea, vomiting, diarrhea and cramps. Salivation and lacrimation are reduced, while thirst and sweating are increased. Hypotension, tachycardia, renal failure, peripheral and pulmonary edema and respiratory arrest may occur. CNS symptoms include headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death. If any adverse effects are observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.

 

Treatment

Normal plasma sodium concentrations should be carefully restored at a rate not greater than 10-15 mmol/day using I.V. hypotonic saline. Dialysis may be necessary if there is significant renal impairment, the patient is moribund or plasma sodium levels are greater than 200 mmol/L. Convulsions may require diazepam or other appropriate treatment.

Container Type

See manufacturer’s package insert

Packaged in freeflex® bag. Made of multilayer polyolefin film. Non-DEHP, non-PVC, and latex-free.

Barcode

Readable U.S. barcodes

Any barcodes on Fresenius Kabi’s Sodium Chloride 0.9% freeflex® solution will not be appropriately recognized by scanning systems used in the United States and should not be used.

Institutions should manually input the product into their systems and confirm that barcode systems do not provide incorrect information when the product is scanned.

* For monovalent ions, such as sodium and chloride, the numeric value of the millimole and milliequivalent are identical

** 1 kilogram of water is equal to 1 liter of water

 

Refer to the package insert for Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion for full prescribing information

This communication and product information is available on the Fresenius Kabi USA web site www.fresenius-kabi.us as well as on the FDA Drug Shortage web site. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.

REPORTING ADVERSE EVENTS:

To report adverse events or quality problems experienced with the use of this product, call Fresenius Kabi USA Vigilance and Medical Affairs at 1-800-551-7176, Monday - Friday, between the hours of 8 a.m. and 5 p.m. (CST), or e-mail appmedicalinfo@APPpharma.com.

Fresenius Kabi USA CONTACT NUMBERS: Please use the following contact numbers as appropriate:

Reason To Call

Department

Number

ADE Reporting/Clinical/Technical Info.

Vigilance and Medical Affairs Dept.

1-800-551-7176

Product Availability & Ordering

Customer Service Department

1-888-386-1300

Adverse events may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Online: www.fda.gov/medwatch/report.htm 
  • Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
  • Fax: 1-800-FDA-0178

 

Sincerely,

Melanie Power-Burns

Senior Director, U.S. Quality & Compliance

 

 

 

                                                   Comparison Table of U.S. 0.9% Sodium Chloride Injection to Fresenius Kabi’s Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

Fresenius Kabi                       

Hospira

Hospira

Hospira

Baxter

Baxter

Baxter

 

scfigure3 

 scfigure4

 scfigure5

 scfigure6

 scfigure7

  Product Image

                     Not  Available                   

 scfigure8

Product

Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

NDC #

63323-623-50

0409-7984-06

0409-7984-13

0409-7984-36

0338-0049-11

0338-0049-31

0338-0049-41

Volume

50 mL

50 mL

50 mL

50 mL

50 mL

50 mL

50 mL

Container Type

freeflex®

VisIV™ Flexible plastic container

Flexible plastic container

Flexible plastic container

VIAFLEX plastic container

VIAFLEX plastic container

VIAFLEX plastic container

Container Description

Made of multilayer polyolefin film.

Non-DEHP,

non-PVC, and latex free.

Fabricated from a clear mutilayer polyolefin plastic film. PVC, DEHP, and latex free.

PVC container. Contains DEHP, latex free.

PVC container. Contains DEHP, latex free.

PVC container. Contains DEHP, non-latex.

PVC container. Contains DEHP, non-latex.

PVC container. Contains DEHP, non-latex.

Preservative Free

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Case Size

60

60

48

80 (Quad Pack)

96 (Quad Pack)

96 (Multi Pack)

96

   

 

Fresenius Kabi

Hospira

Hospira

Hospira

Baxter

Baxter

Baxter

 

scfigure9 

 scfigure10

 scfigure11

scfigure12 

scfigure13 

 scfigure14

 scfigure15

Product

Sodium Chloride 0.9% Freeflex Injection Solution for Intravenous Infusion

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

NDC #

63323-623-00

0409-7984-11

0409-7984-23

0409-7984-37

0338-0049-18

0338-0049-38

0338-0049-48

Volume

100 mL

100 mL

100 mL

100 mL

100 mL

100 mL

100 mL

Container Type

freeflex®

VisIV™ Flexible plastic container

Flexible plastic container

Flexible plastic container

VIAFLEX plastic container

VIAFLEX plastic container

VIAFLEX plastic container

Preservative Free

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Container Description

Made of multilayer polyolefin film.

Non-DEHP,

non-PVC, and latex free.

Fabricated from a clear mutilayer polyolefin plastic film. PVC, DEHP, and latex free.

PVC container. Contains DEHP, latex free.

PVC container. Contains DEHP, latex free.

PVC container. Contains DEHP, non-latex.

PVC container. Contains DEHP, non-latex.

PVC container. Contains DEHP, non-latex.

Case Size

50

60

48

80 (Quad Pack)

96 (Quad Pack)

96 (Multi Pack)

96

  

 

Fresenius Kabi

Hospira

Hospira

Baxter

 

scfigure16 

scfigure17 

scfigure18 

scfigure19 

Product

Sodium Chloride 0.9% w/v for Intravenous Infusion

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

NDC #

63323-623-59

0409-7983-03

0409-7983-55

0338-0049-03

Volume

500 mL

500 mL

500 mL

500 mL

Container Type

freeflex®

Flexible plastic container

Flexible plastic container

VIAFLEX plastic container

Preservative Free

Yes

Yes

Yes

Yes

Container Description

Made of multilayer polyolefin film.

Non-DEHP,

non-PVC, and latex free.

PVC container. Contains DEHP, latex free.

PVC container. Contains DEHP, latex free.

PVC container. Contains DEHP, non-latex.

Case Size

20

24

18

24

    

 

Fresenius Kabi

Hospira

Baxter

 

scfigure20 

scfigure21 

scfigure22 

Product

Sodium Chloride 0.9% w/v for Intravenous Infusion

0.9% Sodium Chloride Injection, USP

0.9% Sodium Chloride Injection, USP

NDC #

63323-623-10

0409-7983-09

0338-0049-04

Volume

1000 mL

1000 mL

1000 mL

Container Type

freeflex®

Flexible plastic container

VIAFLEX plastic container

Preservative Free

Yes

Yes

Yes

Container Description

Made of multilayer polyolefin film.

Non-DEHP,

non-PVC, and latex free.

Fabricated from a clear mutilayer polyolefin plastic film. PVC, DEHP, and latex free

PVC container. Contains DEHP, non-latex.

Case Size

10

12

14

 

 

 

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scdraw3                      scdraw4

  

    scdraw5                  scdraw6

  

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 warning

 

 

PATIENT LEAFLET:  INFORMATION FOR THE USER

DESCRIPTION

Sterile isotonic solution of sodium chloride 9g/L in Water for Injections, containing no preservatives (normal saline).

PHARMACOLOGY

Sodium Chloride Injection 0.9% provides a source of sodium ions (154 mmol/L), chloride ions (154 mmol/L) and water.

INDICATIONS

Normal saline can be used as the vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid.

It can also be used as a sterile irrigation medium.

CONTRAINDICATIONS

Sodium Chloride 0.9% is contraindicated in patients with congestive heart failure, severe renal impairment, conditions of sodium retention, oedema, liver cirrhosis and irrigation during electrosurgical procedures.

PRECAUTIONS

Do not use unless the solution is clear. The entire contents of the bag should be used promptly.

When used as a vehicle for intravenous drug delivery, the product information document of such drugs should be checked prior to use to ensure compatibility with the sodium chloride solution. Reconstitution instructions should be read carefully.

Excessive administration of sodium chloride causes hypernatraemia, resulting in dehydration of internal organs, hypokalaemia and acidosis. Monitoring of fluid, electrolyte and acid/base balance may be necessary. Congestive heart failure and pulmonary oedema may be precipitated, particularly in patients with cardiovascular disease or those receiving corticosteroids, corticotrophin or other drugs that may give rise to sodium retention. Sodium chloride should be administered with care to patients with congestive heart failure, hypertension, peripheral or pulmonary oedema, hypoproteinaemia, impaired renal function, urinary tract obstruction, pre-eclampsia and very young or elderly patients. Intravenous infusion during or immediately after surgery may result in sodium retention.

Given that there is a possibility of systemic absorption of irrigation solutions, the same precautions apply.

USE IN PREGNANCY

Safety in pregnancy has not been established. Use is recommended only when clearly indicated.

USE IN LACTATION

Safety in lactation has not yet been established. Use of this product while breastfeeding is recommended only when potential benefits outweigh potential risks to the newborn infant.

PAEDIATRIC USE

In paediatric use, the dose should be calculated for each patient based on clinical condition, including body weight and laboratory data.

USE IN ELDERLY

For use in elderly, the dose should be based on individual patient assessment, including weight, fluid and electrolyte status and renal and cardiac function.

INTERACTIONS

Additives may be incompatible with sodium chloride.

Co-medication of drugs inducing sodium retention may exacerbate any systemic effects.

ADVERSE REACTIONS

Excessive amounts of sodium chloride may cause hypernatraemia, hypokalaemia and acidosis. Proper use of normal saline as a vehicle for parenteral drugs or as an electrolyte replacement therapy is unlikely to result in adverse effects.

Hypernatraemia rarely occurs with therapeutic doses of sodium chloride, but may occur in excessive administration. A serious complication of this is dehydration of the brain causing somnolence and confusion, which may progress to convulsions, coma and ultimately respiratory failure and death. Pulmonary embolism or pneumonia may also result. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, weakness and irritability.

Infusion of excess sodium chloride 0.9% solution may cause fluid overload or electrolyte imbalance. Intravenous administration of solutions may cause local reactions including pain, vein irritation and thrombophlebitis. Extravasation of solution may cause tissue injury.

If any adverse effects are observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.

Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may result in distension or disruption of tissues. Inadvertent contamination from careless technique may transmit infection. Adverse effects resulting from irrigation of body cavities, tissues or indwelling catheters and tubes are usually avoidable when appropriate procedures are followed.

DOSAGE AND ADMINISTRATION

The dosage of sodium chloride as a vehicle for parenteral drugs and as an electrolyte replenisher must be calculated after consideration of clinical and laboratory data.

For use in one patient, on one occasion only. It does not contain antimicrobials. Any unused portion should be discarded. Care should be taken with intravenous technique to avoid injection site reactions and infections.

OVERDOSAGE

Infusion of excess intravenous fluid may cause hypervolaemia and electrolyte imbalances. Excess sodium chloride in the body produces general gastrointestinal effects of nausea, vomiting, diarrhoea and cramps. Salivation and lacrimation are reduced,  while thirst and sweating are increased. Hypotension, tachycardia, renal failure, peripheral and pulmonary oedema and respiratory arrest may occur. CNS symptoms include headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death. If any adverse effects are observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.

TREATMENT

Normal plasma sodium concentrations should be carefully restored at a rate not greater than 10-15 mmol/day using I.V. hypotonic saline. Dialysis may be necessary if there is significant renal impairment, the patient is moribund or plasma sodium levels are greater than 200 mmol/L. Convulsions may require diazepam or other appropriate treatment.

PRESENTATION AND STORAGE CONDITIONS

Freeflex bags - Store below 25°C.

50mL           AUST R 144596

100mL         AUST R 144609

250mL         AUST R 144632

500mL         AUST R 29745

1000mL       AUST R 47400

 

 

Poison schedule of the medicine

Australia: Nil

New Zealand: General Sales Medicine

 

 

Date of Approval: 9th May 2005

Date of Most Recent Amendment: 16 July 2010

 

Name and address of the sponsor Fresenius Kabi Australia Pty Limited

964 Pacific Highway

Pymble NSW 2073 Australia

Tel: (02) 9391 5555

 

Fresenius Kabi New Zealand Limited

60 Pavilion Drive

Airport Oaks, Auckland 2022

New Zealand

Freecall: 0800 144 892

PACKAGE LABEL - PRINCIPAL DISPLAY - Sodium Chloride - 50 mL Bag

50 mL              Code FAH3038

Sodium Chloride 0.9% Injection Solution

for Intravenous Infusion

 

50ml-bag 

 


PACKAGE LABEL - PRINCIPAL DISPLAY - Sodium Chloride - 100 mL Bag

100 mL              Code FAH3015

Sodium Chloride 0.9% Injection Solution

for Intravenous Infusion

 

100ml-bag 

 

PACKAGE LABEL - PRINCIPAL DISPLAY - Sodium Chloride - 500 mL Bag

500 mL              Code K690521

Sodium Chloride 0.9% w/v

for Intravenous Infusion

 

500ml-bag 

 

PACKAGE LABEL - PRINCIPAL DISPLAY - Sodium Chloride - 1000 mL Bag

1000 mL              FAH1324

Sodium Chloride 0.9% w/v

for Intravenous Infusion

 

 1000ml-bag

SODIUM CHLORIDE 
sodium chloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:63323-623
Route of AdministrationINTRAVENOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (CHLORIDE ION and SODIUM CATION) SODIUM CHLORIDE9 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-623-5060 in 1 BOX
150 mL in 1 BAG
2NDC:63323-623-5760 in 1 BOX
250 mL in 1 BAG
3NDC:63323-623-0050 in 1 BOX
3100 mL in 1 BAG
4NDC:63323-623-0950 in 1 BOX
4100 mL in 1 BAG
5NDC:63323-623-5920 in 1 BOX
5500 mL in 1 BAG
6NDC:63323-623-5120 in 1 BOX
6500 mL in 1 BAG
7NDC:63323-623-1010 in 1 BOX
71000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage02/18/2014
Labeler - Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Fresenius Kabi Norge AS731170932MANUFACTURE(63323-623)

Revised: 3/2014
 
Fresenius Kabi USA, LLC

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