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Kinlytic

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Kinlytic

Kinlytic™
(urokinase) for Injection

Kinlytic

DRUG DESCRIPTION

Kinlytic™ (urokinase for injection) is a thrombolytic agent obtained from human neonatal kidney cells grown in tissue culture. The principal active ingredient of Kinlytic™ is the low molecular weight form of urokinase, and consists of an A chain of 2,000 daltons linked by a sulfhydryl bond to a B chain of 30,400 daltons. Kinlytic™ (urokinase injection) is supplied as a sterile lyophilized white powder containing 250,000 international units urokinase per vial, mannitol (25 mg/vial), Albumin (Human) (250 mg/vial), and sodium chloride (50 mg/vial).

Following reconstitution with 5 mL of Sterile Water for Injection, USP, Kinlytic™ (urokinase injection) is a clear, slightly straw-colored solution; each mL contains 50,000 international units of urokinase activity, 0.5% mannitol, 5% Albumin (Human), and 1% sodium chloride (pH range 6.0 to 7.5).

Thin translucent filaments may occasionally occur in reconstituted Kinlytic™ vials (see DOSAGE AND ADMINISTRATION).

Kinlytic™ (urokinase injection) is for intravenous infusion only.

Kinlytic™ (urokinase injection) is produced from human neonatal kidney cells (see WARNINGS). No fetal tissue is used in the production of Kinlytic™ (urokinase injection) . Kidney donations are obtained exclusively in the United States from neonates (birth to 28 days) for whom death has not been attributed to infectious causes and that have exhibited no evidence of an infectious disease based in part, on an examination of the maternal and neonatal donor medical records. The maternal and neonatal donor screening process also identifies specific risk factors for known infectious diseases and includes testing of sera for HBV, HCV, HIV-1, HIV-2, HTLV-I, HTLV-II, CMV, and EBV. Donors with sera testing positive or associated with other risk factors are excluded. During the manufacturing process, cells are tested at multiple stages for the presence of viruses using in vitro and in vivo tests that are capable of detecting a wide range of viruses. Cells are also screened for HPV using a DNA detection-based test and for reovirus using a polymerase chain reaction-based test. The manufacturing process used for this product has been validated in laboratory studies to inactivate and/or remove a diverse panel of spiked model enveloped and nonenveloped viruses, and includes purification steps and a heat treatment step (10 hours at 60°C in 2% sodium chloride). A single vial of Kinlytic™ contains urokinase produced using cells derived from one or two donors.

What are the possible side effects of urokinase (Abbokinase, Kinlytic)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

  • easy bruising or bleeding (nosebleeds, bleeding gums, bleeding from a wound, incision, catheter, or needle injection );
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill...

Read All Potential Side Effects and See Pictures of Kinlytic »

Last reviewed on RxList: 8/7/2008
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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