MedLibrary.org

Prescription Medications

Enoxaparin Sodium (Page 14 of 14)

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

Do not store the multiple-dose vials for more than 28 days after the first use.

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, they should be informed to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness. If any of these symptoms occur the patient should contact his or her physician immediately.

Additionally, the use of aspirin and other NSAIDs may enhance the risk of hemorrhage. Their use should be discontinued prior to enoxaparin therapy whenever possible; if co-administration is essential, the patient’s clinical and laboratory status should be closely monitored [see Drug Interactions (7)].

Patients should also be informed:

  • of the instructions for injecting enoxaparin sodium if their therapy is to continue after discharge from the hospitals.
  • it may take them longer than usual to stop bleeding.
  • they may bruise and/or bleed more easily when they are treated with enoxaparin sodium.
  • 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 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 (5.3)].
  • 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 for:
Fresenius Kabi USA, LLC
Lake Zurich, IL 60047

© 2014 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL — 30 mg/0.3 mL Syringe Carton

NDC 63323-568-83
FK562883

Enoxaparin Sodium
Injection

30 mg / 0.3 mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.3 mL Syringes

FRESENIUS KABI

PRINCIPAL DISPLAY PANEL -- 30 mg/0.3 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg/0.4 mL Syringe Carton

NDC 63323-568-87 FK562887

Enoxaparin Sodium
Injection

40 mg / 0.4 mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.4 mL Syringes

FRESENIUS KABI

PRINCIPAL DISPLAY PANEL -- 40 mg/0.4 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 60 mg/0.6 mL Syringe Carton

NDC 63323-568-88 FK562888

Enoxaparin Sodium
Injection

60 mg / 0.6 mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.6 mL Syringes

FRESENIUS KABI

PRINCIPAL DISPLAY PANEL -- 60 mg/0.6 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 80 mg/0.8 mL Syringe Carton

NDC 63323-568-90 FK562890

Enoxaparin Sodium
Injection

80 mg / 0.8 mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

FRESENIUS KABI

PRINCIPAL DISPLAY PANEL -- 80 mg/0.8 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg/1 mL Syringe Carton

NDC 63323-568-84 FK562884

Enoxaparin Sodium
Injection

100 mg / 1 mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1 mL Syringes

FRESENIUS KABI

PRINCIPAL DISPLAY PANEL -- 100 mg/1 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 300 mg/3 mL Vial Carton

NDC 63323-565-86
FK562586

Enoxaparin Sodium
Injection

300 mg /3 mL
(100 mg/1 mL)

Rx ONLY

For Subcutaneous or
Intravenous Injection

Multiple Dose Vial

One 3 mL Vial

FRESENIUS KABI

PRINCIPAL DISPLAY PANEL -- 300 mg/3 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 120 mg/0.8 mL Syringe Carton

NDC 63323-569-90 FK562990

Enoxaparin Sodium
Injection

120 mg / 0.8 mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 0.8 mL Syringes

FRESENIUS KABI

PRINCIPAL DISPLAY PANEL -- 120 mg/0.8 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg/1 mL Syringe Carton

NDC 63323-569-84 FK562984

Enoxaparin Sodium
Injection

150 mg / 1 mL

Rx ONLY

SINGLE DOSE SYRINGES WITH AUTOMATIC SAFETY DEVICE

FOR SUBCUTANEOUS INJECTION

Ten 1 mL Syringes

FRESENIUS KABI

PRINCIPAL DISPLAY PANEL -- 150 mg/1 mL Syringe Carton
(click image for full-size original)
ENOXAPARIN SODIUM enoxaparin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-568
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
enoxaparin sodium (enoxaparin) enoxaparin sodium 100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-568-83 10 SYRINGE in 1 CARTON contains a SYRINGE
1 0.3 mL in 1 SYRINGE This package is contained within the CARTON (63323-568-83)
2 NDC:63323-568-87 10 SYRINGE in 1 CARTON contains a SYRINGE
2 0.4 mL in 1 SYRINGE This package is contained within the CARTON (63323-568-87)
3 NDC:63323-568-88 10 SYRINGE in 1 CARTON contains a SYRINGE
3 0.6 mL in 1 SYRINGE This package is contained within the CARTON (63323-568-88)
4 NDC:63323-568-90 10 SYRINGE in 1 CARTON contains a SYRINGE
4 0.8 mL in 1 SYRINGE This package is contained within the CARTON (63323-568-90)
5 NDC:63323-568-84 10 SYRINGE in 1 CARTON contains a SYRINGE
5 1 mL in 1 SYRINGE This package is contained within the CARTON (63323-568-84)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020164 02/20/2015
ENOXAPARIN SODIUM enoxaparin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-565
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
enoxaparin sodium (enoxaparin) enoxaparin sodium 300 mg in 3 mL
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-565-86 1 VIAL, MULTI-DOSE in 1 CARTON contains a VIAL, MULTI-DOSE
1 3 mL in 1 VIAL, MULTI-DOSE This package is contained within the CARTON (63323-565-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020164 02/20/2015
ENOXAPARIN SODIUM enoxaparin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-569
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
enoxaparin sodium (enoxaparin) enoxaparin sodium 150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-569-90 10 SYRINGE in 1 CARTON contains a SYRINGE
1 0.8 mL in 1 SYRINGE This package is contained within the CARTON (63323-569-90)
2 NDC:63323-569-84 10 SYRINGE in 1 CARTON contains a SYRINGE
2 1 mL in 1 SYRINGE This package is contained within the CARTON (63323-569-84)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020164 02/20/2015
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Sanofi Winthrop Industrie 297730488 MANUFACTURE (63323-568), ANALYSIS (63323-568), LABEL (63323-568), PACK (63323-568)
Establishment
Name Address ID/FEI Operations
Sanofi-Aventis Deutschland 313218430 MANUFACTURE (63323-565), ANALYSIS (63323-565), LABEL (63323-565), PACK (63323-565)
Establishment
Name Address ID/FEI Operations
Sanofi Winthrop Industrie 298045688 MANUFACTURE (63323-569), ANALYSIS (63323-569), LABEL (63323-569), PACK (63323-569)

Revised: 02/2015 Fresenius Kabi USA, LLC

Page 14 of 14 « First Page 5 « 10 11 12 13 14