Enoxaparin Sodium (Page 11 of 12)

16 HOW SUPPLIED/STORAGE AND HANDLING

Enoxaparin Sodium Injection USP is available in two concentrations (see Tables 26 and 27):

Table 26: 100 mg/mL Concentration

Dosage Unit/Strength*	Anti-Xa Activity †	Package Size (per carton)	Label Color	NDC Number
Prefilled Syringes ‡
30 mg/0.3 mL	3000 IU	10 syringes	Medium Blue	0703-8530-23
40 mg/0.4 mL	4000 IU	10 syringes	Yellow	0703-8540-23
Graduated Prefilled Syringes ‡
60 mg/0.6 mL	6000 IU	10 syringes	Orange	0703-8560-23
80 mg/0.8 mL	8000 IU	10 syringes	Brown	0703-8680-23
100 mg/1 mL	10,000 IU	10 syringes	Black	0703-8580-23
* Strength represents the number of milligrams of enoxaparin sodium, USP in Water for Injection. Enoxaparin Sodium Injection USP 30 and 40 mg prefilled syringes, and 60, 80, and 100 mg graduated prefilled syringes each contain 10 mg Enoxaparin Sodium, USP per 0.1 mL Water for Injection.
† Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard.
‡ Each enoxaparin sodium, USP prefilled syringe is for single, one-time use only and is affixed with a 27 gauge x 1/2 inch needle.

Table 27: 150 mg/mL Concentration

Dosage Unit/Strength*	Anti-Xa Activity †	Package Size (per carton)	Syringe Label Color	NDC Number
Graduated Prefilled Syringes ‡
120 mg/0.8 mL	12,000 IU	10 syringes	Purple	0703-8610-23
150 mg/1 mL	15,000 IU	10 syringes	Navy Blue	0703-8510-23
* Strength represents the number of milligrams of enoxaparin sodium, USP in Water for Injection. Enoxaparin Sodium Injection USP 120 and 150 mg graduated prefilled syringes contain 15 mg Enoxaparin sodium, USP per 0.1 mL Water for Injection.
† Approximate anti-Factor Xa activity based on reference to the W.H.O. First International Low Molecular Weight Heparin Reference Standard.
‡ Each Enoxaparin Sodium Injection, USP graduated prefilled syringe is for single, one-time use only and is affixed with a 27 gauge x 1/2 inch needle.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

KEEP OUT OF THE REACH OF CHILDREN.

17 PATIENT COUNSELING INFORMATION

If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, advise them to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness. Instruct the patient to seek immediate medical attention if any of these symptoms occur.

Inform patients:

• of the instructions for injecting enoxaparin sodium injection if they continue enoxaparin sodium injection therapy after discharge from the hospital.

• that it may take them longer than usual to stop bleeding.

• that they may bruise and/or bleed more easily when they use enoxaparin sodium injection.

• that they should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [see Warnings and Precautions ( 5.1, 5.5) ]..

• to tell their physicians and dentists they are taking enoxaparin sodium injection and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [see Warnings and Precautions (5.1, 5.3) ].

• to tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs [see Drug Interactions ( 7) ].

Manufactured In Italy By:
Italfarmaco S.p.A.
20126, Milano, Italy

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. B 1/2019