Heparin Sodium

HEPARIN SODIUM- heparin sodium injection, solution
Fresenius Kabi Norge AS

1 INDICATIONS AND USAGE

Heparin Sodium Injection in Sodium Chloride at a concentration of 2 units/mL is indicated as an anticoagulant to maintain catheter patency.

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

Do not administer unless solution is clear and seal is intact. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Warning: Do not use plastic containers in series connection. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

Do not use Heparin Sodium in Sodium Chloride Injection as a “catheter lock flush” product.

Do not admix with other drugs. Discard unused portion.

INSTRUCTIONS FOR USE for the free flex ® Bag

Leave bag in the overwrap until time of use.

The intact port cap provides visual tamper evidence. Do not use if port cap is prematurely removed.

Maintain strict aseptic technique during handling.

To Open:

  1. Always inspect the bag before and after removal from the overwrap.
  2. Place the bag on a clean, flat surface. Starting in the bottom corner, peel the overwrap open and remove the bag.
  3. Check the bag for leaks by squeezing firmly. If leaks are found, discard the bag.
  4. Do not use if the solution is cloudy or a precipitate is present.

To Prepare for Administration:

  1. Immediately before connecting the infusion set, firmly grasp the BLUE infusion port cap with the arrow pointing away from the bag between index finger and thumb. Gently break off the port cap. The membrane of the infusion port is sterile, and disinfection before initial use is not necessary if proper aseptic handling technique is followed.
  2. Use a non-vented infusion set or close the air-inlet on a vented set. The BLUE infusion port is compatible with spike systems produced according to ISO 8536-4, with an external spike diameter of 5.5 to 5.7 mm.
  3. Close the roller clamp of the infusion set.
  4. Hold the base of the BLUE infusion port and insert the spike by rotating your wrist slightly until the spike is fully inserted.
  5. The port membrane contains a self-sealing septum that helps prevent leakage after removing the spike. The infusion port is not intended to be spiked more than once.
  6. Hang from the hole at the top of the bag.
  7. For Single Use Only. Discard unused portion.

2.2 Recommended Dosage for Maintenance of Catheter Patency

The recommended starting dose is 6 units per hour by intravenous infusion through an intravenous catheter to maintain catheter patency.

3 DOSAGE FORMS AND STRENGTHS

  • Injection: 1,000 USP units per 500 mL (2 units per mL) clear solution in a single-dose infusion bag
  • Injection: 2,000 USP units per 1,000 mL (2 units per mL) clear solution in a single-dose infusion bag

4 CONTRAINDICATIONS

The use of HEPARIN SODIUM IN SODIUM CHLORIDE is contraindicated in patients with the following conditions:

  • Uncontrollable active bleeding state, except when this is due to disseminated intravascular coagulation [see Warnings and Precautions (5.1)]
  • History of heparin-induced thrombocytopenia (HIT) and heparin-induced thrombocytopenia with thrombosis (HITT) [see Warnings and Precautions (5.2)]
  • Severe thrombocytopenia [see Warnings and Precautions (5.3)]
  • Known hypersensitivity to heparin or pork products (e.g., anaphylactoid reactions) [see Warnings and Precautions (5.5), Adverse Reactions (6.1)]

5 WARNINGS AND PRECAUTIONS

5.1 Hemorrhage

Avoid using heparin in the presence of major bleeding, except when the benefits of heparin therapy outweigh the potential risks.

Hemorrhage can occur at virtually any site in patients receiving heparin. Fatal hemorrhages have occurred. An unexplained fall in hematocrit or fall in blood pressure, or any other unexplained symptom should lead to serious consideration of a hemorrhagic event.

Use heparin sodium with caution in disease states in which there is increased risk of hemorrhage, including:

  • Cardiovascular — Subacute bacterial endocarditis. Severe hypertension.
  • Surgical — During and immediately following (a) spinal tap or spinal anesthesia or (b) major surgery, especially involving the brain, spinal cord or eye.
  • Hematologic — Conditions associated with increased bleeding tendencies, such as hemophilia, thrombocytopenia and some vascular purpuras.
  • Gastrointestinal — Ulcerative lesions and continuous tube drainage of the stomach or small intestine.
  • Patients with hereditary antithrombin III deficiency receiving concurrent antithrombin III therapy – The anticoagulant effect of heparin is enhanced by concurrent treatment with antithrombin III (human) in patients with hereditary antithrombin III deficiency. To reduce the risk of bleeding, reduce the heparin dose during concomitant treatment with antithrombin III (human).
  • Other — Menstruation, liver disease with impaired hemostasis.

5.2 Heparin-Induced Thrombocytopenia and Heparin-Induced Thrombocytopenia with Thrombosis

Heparin-induced thrombocytopenia (HIT) is a serious immune-mediated reaction. HIT occurs in patients treated with heparin and is due to the development of antibodies to a platelet Factor-4-heparin complex that induce in vivo platelet aggregation HIT may progress to the development of venous and arterial thromboses, a condition referred to as heparin-induced thrombocytopenia with thrombosis (HITT). Thrombotic events may also be the initial presentation for HITT. These serious thromboembolic events include deep vein thrombosis, pulmonary embolism, cerebral vein thrombosis, limb ischemia, stroke, myocardial infarction, mesenteric thrombosis, thrombus formation on a prosthetic cardiac valve, renal arterial thrombosis, skin necrosis, gangrene of the extremities that may lead to amputation, and possibly death.

If the platelet count falls below 100,000/mm3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant. HIT or HITT can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin sodium should be evaluated for HIT or HITT.

HIT can occur up to several weeks after the discontinuation of heparin therapy. Patients presenting with thrombocytopenia or thrombosis after discontinuation of heparin should be evaluated for HIT.

5.3 Thrombocytopenia

Thrombocytopenia in patients receiving heparin has been reported to occur in patients receiving heparin at frequencies up to 30%. It can occur 2 to 20 days (average 5 to 9) following the onset of heparin therapy. Obtain platelet counts before and periodically during heparin therapy. If the count falls below 100,000/mm3 or if recurrent thrombosis develops, promptly discontinue heparin, evaluate for HIT and HITT, and, if necessary, administer an alternative anticoagulant [see Warnings and Precautions (5.2)].

5.4 Heparin Resistance

Increased resistance to heparin is frequently encountered in fever, thrombosis, thrombophlebitis, infections with thrombosing tendencies, myocardial infarction, cancer and in postsurgical patients.

5.5 Hypersensitivity Reactions

Patients with documented hypersensitivity to heparin should be given the drug only in clearly life-threatening situations. Because Heparin Sodium in Sodium Chloride Injection is derived from animal tissue, it should be used with caution in patients with a history of allergy.

5.6 Increased Risk of Bleeding in Older Patients, Especially Women

A higher incidence of bleeding has been reported in patients, particularly women, over 60 years of age [see Use in Specific Populations (8.5)].

5.7 Laboratory Tests

Periodic platelet counts, hematocrits, and tests for occult blood in stool are recommended during the entire course of heparin therapy, regardless of the route of administration.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Hemorrhage [see Warnings and Precautions (5.1)]
  • Heparin-Induced Thrombocytopenia and Heparin-Induced thrombocytopenia with Thrombosis [see Warnings and Precautions (5.2)]
  • Thrombocytopenia [see Warnings and Precautions (5.3)]
  • Heparin Resistance [see Warnings and Precautions (5.4)]
  • Hypersensitivity [see Warnings and Precautions (5.5)]
  • Increased Risk of Bleeding in Older Patients, Especially Women [see Warnings and Precautions (5.6)]
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