Delivering a safe, reliable, and convenient IV solution

0.9% Sodium Chloride Injection, USP, is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in the Fleboflex® plastic container for intravenous administration.

Product overview

  • Fleboflex® is a flexible container free of PVC, plasticizers, adhesives, and latex
  • The Fleboflex® container consists of a polypropylene multilayer film
  • Polypropylene is a highly compatible material. It is used for the preparation of intravenous mixtures with drugs that have shown their incompatibility with other plastics
  • Fleboflex® is totally collapsible, lightweight, and transparent
  • The Fleboflex® container meets the Class VI US Pharmacopeia (USP) testing for plastic containers. These tests confirm the biological safety of the container system
  • Available in 50, 100, 250, 500, and 1000 mL

Volume details

Fleboflex®

Max. additive volume in mL up to a pressure of 50 mL bar

50 mL

90

100 mL

8

250 mL

135

500 mL

288

1000 mL

176

Maximum removable volume (mL)

50 mL

145

100 mL

195

250 mL

397

500 mL

716

1000 mL

1207

Residual volume (mL)

50 mL

0-1

100 mL

0.3

250 mL

0.6 - 1.6

500 mL

0.6 - 7.1

1000 mL

0.6 - 5

Air volume (mL)

50 mL

4-10

100 mL

5-12

250 mL

5-15

500 mL

12-25

1000 mL

15-25

Fleboflex® 50 mL 100 mL 250 mL 500 mL 1000 mL

Max. additive volume in mL up to a pressure of 50 mL bar

90

8

135

288

176

Maximum removable volume (mL)

145

195

397

716

1207

Residual volume (mL)

0-1

0.3

0.6 - 1.6

0.6 - 7.1

0.6 - 5

Air volume (mL)

4-10

5-12

5-15

12-25

15-25

Drug

Cefotaxime

Composition

0.5 mg/mL in 0.9% SC

5 °C (41 °F)†

10 days

25 °C (77 °F)†

1 days

Cefuroxime

Composition

0.5 mg/mL in 0.9% SC

5 °C (41 °F)†

10 days

25 °C (77 °F)†

1 days

Cyclophosphamide

Composition

2 mL in 0.9% SC

5 °C (41 °F)†

6 days

25 °C (77 °F)†

5 days

Diazepam

Composition

50 μg/mL in 0.9% SC

5 °C (41 °F)†

10 days

25 °C (77 °F)†

4 days

Docetaxel

Composition

0.3 mg/mL in 0.9% SC

5 °C (41 °F)†

7 days

25 °C (77 °F)†

7 days

Doxorubicin

Composition

0.1 mg/mL in 0.9% SC

5 °C (41 °F)†

30 days

25 °C (77 °F)†

15 days

Etoposide

Composition

0.3 mg/mL in 0.9% SC

5 °C (41 °F)†

-

25 °C (77 °F)†

10 days

5-fluorouracil

Composition

3 mg/mL in 0.9% SC

5 °C (41 °F)†

28 days

25 °C (77 °F)†

28 days

Isosorbide Dinitrate

Composition

0.1 mg/mL in 0.9% SC

5 °C (41 °F)†

10 days

25 °C (77 °F)†

10 days

Methylprednisolone

Composition

5 mg/mL in 0.9% SC

5 °C (41 °F)†

10 days

25 °C (77 °F)†

Free Prednisolone >6.6 days

Morphine

Composition

0.1 mg/mL in 0.9% SC

5 °C (41 °F)†

10 days

25 °C (77 °F)†

10 days

Nitroglycerin

Composition

50 μg/mL in 0.9% SC

5 °C (41 °F)†

10 days

25 °C (77 °F)†

10 days

Ondansetron

Composition

1 mg/mL in 0.9% SC

5 °C (41 °F)†

10 days

25 °C (77 °F)†

10 days

Paclitaxel

Composition

0.6 mg/mL in 0.9% SC

5 °C (41 °F)†

7 days

25 °C (77 °F)†

7 days

1. Data on file.
* Internal studies elaborated by Grifols. Compatibility of additives with 0.9% Sodium Chloride must be checked before adding a medication.
† Please refer to the Prescribing Information of each individual drug additive for post-dilution storage and handling.

Drug Composition 5 °C (41 °F)† 25 °C (77 °F)†

Cefotaxime

0.5 mg/mL in 0.9% SC

10 days

1 days

Cefuroxime

0.5 mg/mL in 0.9% SC

10 days

1 days

Cyclophosphamide

2 mL in 0.9% SC

6 days

5 days

Diazepam

50 μg/mL in 0.9% SC

10 days

4 days

Docetaxel

0.3 mg/mL in 0.9% SC

7 days

7 days

Doxorubicin

0.1 mg/mL in 0.9% SC

30 days

15 days

Etoposide

0.3 mg/mL in 0.9% SC

-

10 days

5-fluorouracil

3 mg/mL in 0.9% SC

28 days

28 days

Isosorbide Dinitrate

0.1 mg/mL in 0.9% SC

10 days

10 days

Methylprednisolone

5 mg/mL in 0.9% SC

10 days

Free Prednisolone >6.6 days

Morphine

0.1 mg/mL in 0.9% SC

10 days

10 days

Nitroglycerin

50 μg/mL in 0.9% SC

10 days

10 days

Ondansetron

1 mg/mL in 0.9% SC

10 days

10 days

Paclitaxel

0.6 mg/mL in 0.9% SC

7 days

7 days

Bag features

1

Designed for safe and easy handling

  • Designed with rounded upper and lower corners that guarantee handling without accidental punctures
  • Integrated eyelet support for easy and safe handling of the container during the infusion
2

Highly compatible material

  • The solution is only in contact with polypropylene. Both the multilayer film and the inner membranes of the medication and outlet ports contain only polypropylene
  • Polypropylene can be sterilized at a higher temperature because it resists heat better than other olefins
3

High sealing resistance

High resistance to pressure cuffs, responding satisfactorily to 400 mmHg pressure for 72 hours.

4

Product information

  • Inclusion of the National Drug Code
  • Inclusion of lot and expiration date
5

Grifols port system

  • Medication and outlet ports designed with rigid and long tubes to avoid perforation due to needle insertion
  • Safe attachment of the infusion set due to its internal membrane
  • No parts of the cover have to be removed in order to access the outlet port

Individual overwrap of polypropylene protects and maintains the sterility of the container and limits evaporative moisture loss from the primary solution container. It is transparent to allow visual inspection and has a peelable opening system.

Product also available in Canada

Description

0.9% Sodium Chloride Injection,
USP 50 mL

NDC Number

76297-001-11

Case weight Kg

8

Bags/ box

115

Bags/ pallet

3680

Bags/ container*

169,280

0.9% Sodium Chloride Injection,
USP 100 mL

NDC Number

76297-001-21

Case weight Kg

8.5

Bags/ box

70

Bags/ pallet

2240

Bags/ container*

103,040

0.9% Sodium Chloride Injection,
USP 250 mL

NDC Number

76297-001-31

Case weight Kg

8.5

Bags/ box

28

Bags/ pallet

896

Bags/ container*

41,216

0.9% Sodium Chloride Injection,
USP 500 mL

NDC Number

76297-001-01

Case weight Kg

11.6

Bags/ box

20

Bags/ pallet

640

Bags/ container*

29,440

0.9% Sodium Chloride injection,
USP 1000 mL

NDC Number

76297-001-41

Case weight Kg

11

Bags/ box

10

Bags/ pallet

320

Bags/ container*

14,720

*Each container can be filled with a combination of all the bag sizes.

Description NDC Number Case weight Kg Bags/ box Bags/ pallet Bags/ container*

0.9% Sodium Chloride Injection,
USP 50 mL

76297-001-11

8

115

3680

169,280

0.9% Sodium Chloride Injection,
USP 100 mL

76297-001-21

8.5

70

2240

103,040

0.9% Sodium Chloride Injection,
USP 250 mL

76297-001-31

8.5

28

896

41,216

0.9% Sodium Chloride Injection,
USP 500 mL

76297-001-01

11.6

20

640

29,440

0.9% Sodium Chloride injection,
USP 1000 mL

76297-001-41

11

10

320

14,720

Guidelines for use of 0.9% Sodium Chloride solution in Fleboflex® container

Overwrap removal

  1. The overwrap is designed to be opened by pulling apart the 2 sheets of the overwrap.
  2. The recommended method to remove the overwrap is to peel off one sheet by the corner while holding the other sheet at one end to carefully remove the solution container.

The overwrap should not be removed until product is to be used.

To add medication

  1. Prepare the medication site. Using a syringe with a 19- to 22-gauge needle, securely hold the container and insert the needle through the center of the medication port and inject the medication. Insert the needle perpendicular to the point of addition.

The compatibility of the additives with Sodium Chloride 0.9% must be checked before adding a medication.

Attach administration set

  1. Suspend the container from the eyelet support and remove the protector from the outlet port at the bottom of the container.
  2. Hold the container properly and attach the administration set.
  3. While advancing through the tube, a slight resistance will gradually be felt.

Use non-vented administration sets

The Fleboflex® container has been designed to work without venting. No air is required to withdraw the solution.

Air entering through the administration set could slow or even stop the infusion due to air bubbles.

  1. After opening the container, the contents should be used immediately and should not be stored for a subsequent infusion. Do not reconnect any partially used containers. Discard any unused portion.

    Administration sets should come without air venting. If vented administration sets are used, be sure air venting inlet remains closed during the infusion.

Do not connect flexible plastic containers in a series in order to avoid air embolism due to possible residual air contained in the primary container. Using a vented intravenous administration set with the vent in the open position could result in air embolism. Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers.

More information

Do you have any questions or concerns?

Contact a Grifols representative for more information