(dalteparin sodium)

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How Supplied/Storage and Handling

16 HOW SUPPLIED/STORAGE AND HANDLING

FRAGMIN (dalteparin sodium) injection, USP, is a sterile, aqueous, clear, colorless or straw-colored solution available as follows:

*
Single-dose prefilled syringe, affixed with a 27-gauge × 1/2 inch needle and preassembled with UltraSafe Passive™ Needle Guard devices. Discard unused portion.
Single-dose graduated syringe, affixed with a 27-gauge × 1/2 inch needle and preassembled with UltraSafe Passive™ Needle Guard devices. UltraSafe Passive™ Needle Guard is a trademark of Safety Syringes, Inc. Discard unused portion.

Presentation

Strength

Package Size

NDC Number

Single-dose prefilled syringe*

2,500 units / 0.2 mL

10 Syringes

0069-0195-02

5,000 units / 0.2 mL

10 Syringes

0069-0196-02

7,500 units / 0.3 mL

10 Syringes

0069-0206-02

Single-dose graduated syringe

10,000 units / mL

10 Syringes

0069-0217-02

Single-dose prefilled syringe*

12,500 units / 0.5 mL

10 Syringes

0069-0220-02

15,000 units / 0.6 mL

10 Syringes

0069-0223-02

18,000 units / 0.72 mL

10 Syringes

0069-0228-02

Multiple-dose vial

95,000 units / 3.8 mL
(25,000 units / mL)

3.8 mL vial

0069-0232-01

Single-dose vial

10,000 units / 4 mL
(2,500 units / mL)

10 vials

0069-0253-10

Store at 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Latex Allergy: The needle shield of the prefilled syringe may contain natural rubber latex [see Dosage and Administration (2.7)].

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