000/mm3. In patients receiving FRAGMIN who experience platelet counts < 50,000/mm3, discontinue FRAGMIN until the platelet count recovers above 50,000/mm3.
2.3 Dose Reductions for Renal Insufficiency in Extended Treatment of Acute Symptomatic Venous Thromboembolism in Patients with CancerIn patients with severely impaired renal function (CrCl < 30 mL/min), monitor anti-Xa levels to determine the appropriate FRAGMIN dose. Target anti-Xa range is 0.5-1.5 IU/mL. When monitoring anti-Xa in these patients, perform sampling 4-6 hrs after FRAGMIN dosing and only after the patient has received 3-4 doses.
2.4 Administration Subcutaneous injection technique: Patients should be sitting or lying down and FRAGMIN administered by deep subcutaneous injection. FRAGMIN may be injected in a U-shape area around the navel, the upper outer side of the thigh or the upper outer quadrangle of the buttock. The injection site should be varied daily. When the area around the navel or the thigh is used, using the thumb and forefinger, you must lift up a fold of skin while giving the injection. The entire length of the needle should be inserted at a 45 to 90 degree angle.
Inspect FRAGMIN prefilled syringes and vials visually for particulate matter and discoloration prior to administration
After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks. Discard any unused solution after 2 weeks.
Instructions for using the prefilled single-dose syringes preassembled with needle guard devices
Fixed dose syringes: To ensure delivery of the full dose, do not expel the air bubble from the prefilled syringe before injection. Hold the syringe assembly by the open sides of the device. Remove the needle shield. Insert the needle into the injection area as instructed above. Depress the plunger of the syringe while holding the finger flange until the entire dose has been given. The needle guard will not be activated unless the entire dose has been given. Remove needle from the patient. Let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded. Discard the syringe assembly in approved containers.
Gradated syringes: Hold the syringe assembly by the open sides of the device. Remove the needle shield. With the needle pointing up, prepare the syringe by expelling the air bubble and then continuing to push the plunger to the desired dose or volume, discarding the extra solution in an appropriate manner. Insert the needle into the injection area as instructed above. Depress the plunger of the syringe while holding the finger flange until the entire dose remaining in the syringe has been given. The needle guard will not be activated unless the entire dose has been given. Remove needle from the patient. Let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded. Discard the syringe assembly in approved containers.
3 DOSAGE FORMS AND STRENGTHS
2,50 IU / 0.2 mL single-dose prefilled syringe
5,000 IU / 0.2 mL single-dose prefilled syringe
7,500 IU / 0.3 mL single-dose prefilled syringe
10,000 IU / 0.4 mL single-dose prefilled syringe
10,000 IU / 1 mL single-dose graduated syringe
12,500 IU / 0.5 mL single-dose prefilled syringe
15,000 IU / 0.6 mL single-dose prefilled syringe
18,000 IU / 0.72 mL single-dose prefilled syringe
95,000 IU / 3.8 mL multiple-dose vial
95,000 IU / 9.5 mL multiple-dose vial
4 CONTRAINDICATIONS
Active major bleeding
H |
