Delivering an innovative, safe, and convenient IV solution

Fleboflex® Luer is an innovative container that combines safety and convenience when preparing and administering IV drugs

  • Made of polypropylene: free of PVC, plasticizers, adhesives, and latex
  • With a needle-free system that avoids the risk of accidental punctures
  • Comes partially filled: large additive volume

Fleboflex® Luer means safety

Prevention of accidental needle stick injuries

No dripping when connecting and disconnecting the syringe or vial adaptor

Avoids potential spike drops

No potential risk of microbiological contamination in the manipulation

Fleboflex® Luer means convenience

Large additive volume

Smooth and quick addition and removal of medication that prevents RSI (repetitive strain injury) syndrome

High flow rate of the solution

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

Volume details

Fleboflex® Luer

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

50/100 mL

136

100/250 mL

289

250/500 mL

422

500/1000 mL

639

Maximum removable volume (mL)

50/100 mL

187

100/250 mL

394

250/500 mL

677

500/1000 mL

1139

Residual volume (mL)

50/100 mL

0.3-1.8

100/250 mL

0.3-1.5

250/500 mL

0.2-1.9

500/1000 mL

0.2-2.6

Air volume (mL)

50/100 mL

4-5

100/250 mL

5-20

250/500 mL

12-30

500/1000 mL

15-30

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

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

136

289

422

639

Maximum removable volume (mL)

187

394

677

1139

Residual volume (mL)

0.3-1.8

0.3-1.5

0.2-1.9

0.2-2.6

Air volume (mL)

4-5

5-20

12-30

15-30

Drug

Bleomycin sulfate

Size

0.15 U/mL in 0.9% SC

25 °C (77 °F)

7 days

Carboplatin

Size

0.5 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Cisplatin

Size

0.5 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Cytarabine

Size

13 mg/mL in 0.9% SC

25 °C (77 °F)

1 day

Dacarbazine*‡§

Size

3.4 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Docetaxel

Size

0.3 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Etoposide

Size

0.3 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Epirubicin

Size

2 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Fludarabine

Size

6 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Gemcitabine

Size

4 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Idarubicin

Size

1 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Ifosfamide

Size

1 mg/mL in SC

25 °C (77 °F)

7 days

Irinotecan

Size

2.8 mg/mL in SC

25 °C (77 °F)

7 days

Methotrexate

Size

1 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Mitoxantrone

Size

0.2 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Oxaliplatin

Size

0.6 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Paclitaxel

Size

0.3 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Vinblastine

Size

0.2 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Vincristine

Size

0.04 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

Vinorelbine

Size

1 mg/mL in 0.9% SC

25 °C (77 °F)

7 days

1. Data on file. Internal studies elaborated by Grifols.
* Compatibility of additives with Sodium Chloride 0.9% must be checked before adding a medication.
† Dacarbazine solutions should be protected from light and used within 8 hours of reconstitution.§
‡ Please refer to the Prescribing Information of each individual drug additive for post-dilution storage and handling.
§ Dacarbazine - dacarbazine injection, powder, for solution. Fresenius Kabi USA, LLC.

Hypersensitivity/infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus have been reported with 0.9% Sodium Chloride Injection, USP.

Drug Size 25 °C (77 °F)

Bleomycin sulfate

0.15 U/mL in 0.9% SC

7 days

Carboplatin

0.5 mg/mL in 0.9% SC

7 days

Cisplatin

0.5 mg/mL in 0.9% SC

7 days

Cytarabine

13 mg/mL in 0.9% SC

1 day

Dacarbazine*‡§

3.4 mg/mL in 0.9% SC

7 days

Docetaxel

0.3 mg/mL in 0.9% SC

7 days

Etoposide

0.3 mg/mL in 0.9% SC

7 days

Epirubicin

2 mg/mL in 0.9% SC

7 days

Fludarabine

6 mg/mL in 0.9% SC

7 days

Gemcitabine

4 mg/mL in 0.9% SC

7 days

Idarubicin

1 mg/mL in 0.9% SC

7 days

Ifosfamide

1 mg/mL in SC

7 days

Irinotecan

2.8 mg/mL in SC

7 days

Methotrexate

1 mg/mL in 0.9% SC

7 days

Mitoxantrone

0.2 mg/mL in 0.9% SC

7 days

Oxaliplatin

0.6 mg/mL in 0.9% SC

7 days

Paclitaxel

0.3 mg/mL in 0.9% SC

7 days

Vinblastine

0.2 mg/mL in 0.9% SC

7 days

Vincristine

0.04 mg/mL in 0.9% SC

7 days

Vinorelbine

1 mg/mL in 0.9% SC

7 days

Bag features

1

Designed for safe and easy handling

Integrated eyelet support for easy and safe handling of the container during the infusion.

2

Product information

  • Inclusion of the National Drug Code
  • Inclusion of lot and expiration date
  • Sequential number

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.

4

Injection/extraction port

Luer-lock valve for automatic locking that allows easy, quick, and safe access to the interior of the bag through the connection of a needle-free syringe or a male vial adaptor.

5

Infusion port

Hermetic twist-off made of polypropylene for the connection of the infusion equipment. It maintains sterility until opened.

Description

0.9% Sodium Chloride Injection, USP 50/100 mL

NDC Number

76297-001-51

Case weight Kg

9

Bags/ box

90

Bags/ pallet

2880

Bags/ container*

132,480

0.9% Sodium Chloride Injection, USP 100/250 mL

NDC Number

76297-001-61

Case weight Kg

12

Bags/ box

50

Bags/ pallet

1600

Bags/ container*

73,600

0.9% Sodium Chloride Injection, USP 250/500 mL

NDC Number

76297-001-71

Case weight Kg

15

Bags/ box

32

Bags/ pallet

1024

Bags/ container*

47,104

0.9% Sodium Chloride Injection, USP 500/1000 mL

NDC Number

76297-001-81

Case weight Kg

19

Bags/ box

24

Bags/ pallet

768

Bags/ container*

35,328

*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 50/100 mL

76297-001-51

9

90

2880

132,480

0.9% Sodium Chloride Injection, USP 100/250 mL

76297-001-61

12

50

1600

73,600

0.9% Sodium Chloride Injection, USP 250/500 mL

76297-001-71

15

32

1024

47,104

0.9% Sodium Chloride Injection, USP 500/1000 mL

76297-001-81

19

24

768

35,328

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

Container inspection

  • Visually inspect the container for particulate matter and discoloration
  • Check for minute leaks by squeezing the inner container firmly. If leaks are found, discard the solution as sterility may be impaired
  • If the ports are damaged, detached, or not present, discard the container as solution path sterility may be impaired
  • Do not administer unless the solution is clear and the seal is intact

Adding medications and solution removal with a needle-free syringe

  1. Connect a syringe to the luer valve.
  2. Secure the connection with a small rotational movement.
  3. Add or remove solution.

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

Reconstitution of vials with a vial adaptor

  1. Remove the protective foil from the blister containing the vial adaptor. Do not remove the adaptor from the blister.
  2. Without removing the blister, connect the vial adaptor to the vial by pressing vertically on the surface until the adaptor is fixed and the awl has penetrated the surface of the vial.
  3. Remove the blister.
  4. The vial with the vial adaptor is ready to reconstitute once connected to the luer valve of the bag.

More information

Do you have any questions or concerns?

Contact a Grifols representative for more information