p; 9.5 mL Vial 62856-102-01
1 Single-dose prefilled syringe, affixed with a 27-gauge x 1/2 inch needle and preassembled with UltraSafe Passive™ Needle Guard devices.
2 Single-dose graduated syringe, affixed with a 27-gauge x 1/2 inch needle and preassembled with UltraSafe Passive™ Needle Guard devices. UltraSafe Passive™ Needle Guard is a trademark of Safety Syringes, Inc.
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
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, inform the patients 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. Discontinue their use prior to dalteparin therapy whenever possible; if co-administration is essential, the patient's clinical and laboratory status should be closely monitored [see Drug Interactions (7)].
Inform patients:
of the instructions for injecting FRAGMIN 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 FRAGMIN.
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, 5.2)].
to tell their physicians and dentists they are taking FRAGMIN 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)].
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)].
FRAGMIN is a registered trademark of Pfizer Health AB and is licensed to Eisai Inc.
Manufactured for
Eisai Inc.
Woodcliff Lake, NJ 07677
Manufactured by
Pfizer Inc
New York, NY 10017
Made in Belgium
(multiple-dose vials)
Jointly manufactured by
Pfizer Inc, New York, NY 10017
and Vetter Pharma-Fertigung, GmbH & Co. KG
Ravensburg, Germany
(prefilled syringes)
PRINCIPAL DISPLAY PANEL - 2,500 IU / 0.2 mL
NDC 62856-250-10 (Single-dose prefilled syringes)
PRINCIPAL DISPLAY PANEL - 5,000 IU / 0.2 mL
NDC 62856-500-10 (Single-dose prefilled syringes)
PRINCIPAL DISPLAY PANEL - 7,500 IU / 0.3 mL
NDC 62856-750-10 (Single-dose prefilled syringes)
PRINCIPAL DISPLAY PANEL - 10,000 IU / 0.4 mL
NDC 62856-100-10 (Single-dose prefilled syringes)
PRINCIPAL DISPLAY PANEL - 10,000 IU / 1 mL
NDC 62856-101-10 (Single-dose graduated syringes)
PRINCIPAL DISPLAY PANEL - 12,500 IU / 0.5 mL
NDC 62856-125-10 (Single-dose prefilled syringes)
PRINCIPAL DISPLAY PANEL - 15,000 IU / 0.6 mL
NDC 62856-150-10 (Single-dose prefilled syringes
PRINCIPAL DISPLAY PANEL - 18,000 IU / 0.72 mL
NDC 62856-180-10 (Single-dose prefilled syringes)
PRINCIPAL DISPLAY PANEL - 95,000 IU / 3.8 mL
NDC 62856-251-01 (Multiple dose vial)
PRINCIPAL DISPLAY PANEL - 95,000 IU / 9.5 |
