ACTIVASE Information ACTIVASE Prescriptions Information prices and sales

<body> <H1>ACTIVASE</H1> <P><B> <font color=red>ACTIVASE Information Prescriptions Prices and Sales.</font></B></P> <p><B>Where to purchase <font color=red>ACTIVASE </font>directly from a certified pharmacy.</B><BR><a href=http://www.rxusa.com/cgibin/db/db.cgi?ACTIVASE>Order ACTIVASE online from here.</a><BR><a href=http://www.rxusa.com/cgibin/db/db.cgi?ACTIVASE>Free price quote on ACTIVASE prescription</a><BR><BR><a href=index.shtml>Home</a> | <a href=page2.shtml>ACTIVASE description & patient information</a> | <a href=page3.shtml>ACTIVASE indications & dosage</a> | <a href=page4.shtml>ACTIVASE side effects</a> | <a href=page5.shtml>ACTIVASE warnings & precautions</a> </p> <P><A NAME="D"><B><FONT SIZE=+1>DESCRIPTION</FONT></B></P> <P>Activase<SUP><FONT SIZE=-1>®</FONT></SUP>, Alteplase, is a tissue plasminogen activator produced by recombinant DNA technology. It is a sterile, purified glycoprotein of 527 amino acids. It is synthesized using the complementary DNA (cDNA) for natural human tissue-type plasminogen activator obtained from a human melanoma cell line. The manufacturing process involves the secretion of the enzyme alteplase into the culture medium by an established mammalian cell line (Chinese Hamster Ovary cells) into which the cDNA for alteplase has been genetically inserted. Fermentation is carried out in a nutrient medium containing the antibiotic gentamycin, 100 mg/L. However, the presence of the antibiotic is not detectable in the final product. </P> <P><A NAME="I"><B><FONT SIZE=+1>INDICATIONS</FONT></B></P> <p> <b>Acute Myocardial Infarction</b> </p> <P>Activase<SUP><FONT SIZE=-1>®</FONT></SUP>, Alteplase, recombinant is indicated for use in the management of acute myocardial infarction in adults for the improvement of ventricular function following AMI the reduction of the incidence of congestive heart failure, and the reduction of mortality associated with AMI. Treatment should be initiated as soon as possible after the onset of AMI symptoms (see <B>acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see acute massive pulmonary embolism (PE) in adults for: </P> <BLOCKQUOTE> <P>the lysis of acute pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments of the lungs, and </P> <P>the lysis of pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to maintain blood pressure without supportive measures. </P> </BLOCKQUOTE> <P>The diagnosis should be confirmed by objective means, such as pulmonary angiography or noninvasive procedures such as lung scanning. </P> <P></b> <B><A NAME="D"><FONT SIZE=+1>DOSAGE AND ADMINISTRATION</FONT></P> <p>Activase®, Alteplase, recombinant is for intravenous administration only. Extravasation of Activase infusion can cause ecchymosis and/or inflammation. Management consists of terminating the infusion at that IV site and application of local therapy. </p> <p>Acute Myocardial Infarction </p> <P>Administer Activase as soon as possible after the onset of symptoms. </P> <P>There are two Activase dose regimens for use in the management of acute myocardial infarction; controlled studies to compare clinical outcomes with these regimens have not been conducted. </P> <p>A DOSE OF 150 mg OF ACTIVASE SHOULD NOT BE USED FOR THE TREATMENT OF ACUTE MYOCARDIAL INFARCTION BECAUSE IT HAS BEEN ASSOCIATED WITH AN INCREASE IN INTRACRANIAL BLEEDING. </p> <p>Accelerated Infusion </p> <P>The recommended total dose is based upon patient weight, not to exceed 100 mg. For patients weighing > 67 kg, the recommended dose administered is 100 mg as a 15 mg intravenous bolus, followed by 50 mg infused over the next 30 minutes, and then 35 mg infused over the next 60 minutes. </P> <P>For patients weighing ¾ 67 kg, the recommended dose is administered as a 15 mg intravenous bolus, followed by 0.75 mg/kg infused over the next 30 minutes not to exceed 50 mg, and then 0.50 mg/kg over the next 60 minutes not to exceed 35 mg. </P> <P>The safety and efficacy of this accelerated infusion of Alteplase regimen has only been investigated with concomitant administration of heparin and aspirin as described in bolus dose may be prepared in one of the following ways: </i></P> <OL> <LI>By removing 15 mL from the vial of reconstituted (1 mg/mL) Activase using a syringe and needle. If this method is used with the 50 mg vials, the syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. If the 100 mg vial is used, the syringe should not be primed with air and the needle should be inserted away from the puncture mark made by the transfer device. </LI> <LI>By removing 15 mL from a proof (second injection site) on the infusion line after the infusion set is primed. </LI> <LI>By programming an infusion pump to deliver a 15 mL (1 mg/mL) bolus at the initiation of the infusion. </LI> </OL> <p> <i>b. The remainder of the Activase®, Alteplase, recombinant dose may be administered as follows:</i> </p> <BLOCKQUOTE> <p>50 mg vials--administer using either a polyvinyl chloride bag or glass vial and infusion set </p> <P>100 mg vial--insert the spike end of an infusion set through the same puncture site created by the transfer device in the stopper of the vial of reconstituted Activase. Hang the Activase vial from the plastic molded capping attached to the bottom of the vial. </P> </BLOCKQUOTE> <p>3-Hour Infusion </p> <P>The recommended dose is 100 mg administered as 60 mg (34.8 million IU) in the first hour (of which 6 to 10 mg is administered as a bolus), 20 mg (11.6 million IU) over the second hour, and 20 mg (11.6 million IU) over the third hour. For smaller patients (< 65 kg), a dose of 1.25 mg/kg administered over 3 hours, as described above, may be used.<SUP><FONT SIZE=-1>value of the use of anticoagulants during and following administration of Activase has not been fully studied, heparin has been administered concomitantly for 24 hours or longer in more than 90% of patients. </P> <P>Aspirin and/or dipyridamole have been given to patients receiving Alteplase during and/or following heparin treatment. </P> <P><i>a. The bolus dose may be prepared in one of the following ways:</i> </P> <OL> <LI>By removing 6 to 10 mL from the vial of reconstituted (1 mg/mL) Activase using a syringe and needle. If this method is used with the 50 mg vials, the syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. If the 100 mg vial is used, the syringe should not be primed with air and the needle should be inserted away from the puncture mark made by the transfer device. </LI> <LI>By removing 6 to 10 mL from a proof (second injection site) on the infusion line after the infusion set is primed. </LI> <LI>By programming an infusion pump to deliver a 6 to 10 mL (1 mg/mL) bolus at the initiation of the infusion. </LI> </OL> <P><i>b. The remainder of the Activase dose may be administered as follows:</i> </P> <BLOCKQUOTE> <P>50 mg vials--administer using either a polyvinyl chloride bag or glass vial and infusion set </P> <P>100 mg vial--insert the spike end of an infusion set through the same puncture site created by the transfer device in the stopper of the vial of reconstituted Activase. Hang the Activase vial from the plastic molded capping attached to the bottom of the vial. </P> </BLOCKQUOTE> <p>Acute Ischemic Stroke </p> <P>The recommended dose is 0.9 mg/kg (maximum of 90 mg) infused over 60 minutes with 10% of the total dose administered as an initial intravenous bolus over 1 minute. </P> <P>The safety and efficacy of this regimen with concomitant administration of heparin and aspirin during the first 24 hours after symptom onset has not been investigated. </P> <P>THE DOSE FOR TREATMENT OF ACUTE ISCHEMIC STROKE SHOULD NOT EXCEED 90 mg. </P> <P><i>a. The bolus dose may be prepared in one of the following ways: </i></P> <OL> <LI>By removing the appropriate volume from the vial of reconstituted (1 mg/mL) Activase using a syringe and needle. If this method is used with the 50 mg vials, the syringe should not be primed with air and the needle should be inserted into the Activase vial stopper. If the 100 mg vial is used, the syringe should not be primed with air and the needle should be inserted away from the puncture mark made by the transfer device. </LI> <LI>By removing the appropriate volume from a proof (second injection site) on the infusion line after the infusion set is primed. </LI> <LI>By programming an infusion pump to deliver the appropriate volume as a bolus at the initiation of the infusion. </LI> </OL> <P><i>b. The remainder of the Activase dose may be administered as follows:</i> </P> <BLOCKQUOTE> <P>50 mg vials--administer using either a polyvinyl chloride bag or glass vial and infusion set </P> <P>100 mg vial--remove from the vial any quantity of drug in excess of that specified for patient treatment. Insert the spike end of an infusion set through the same puncture site created by the transfer device in the stopper of the vial of reconstituted Activase. Hang the Activase vial from the plastic molded capping attached to the bottom of the vial. </P> </BLOCKQUOTE> <p>Pulmonary Embolism </p> <P>The recommended dose is 100 mg administered by intravenous infusion over 2 hours. Heparin therapy should be instituted or reinstituted near the end of or immediately following the Activase infusion when the partial thromboplastin time or thrombin time returns to twice normal or less. </P> <P><i>The Activase dose may be administered as follows:</i> </P> <P>50 mg vials--administer using either a polyvinyl chloride bag or glass vial and infusion set </P> <P>100 mg vial--insert the spike end of an infusion set through the same puncture site created by the transfer device in the stopper of the vial of reconstituted Activase. Hang the Activase vial from the plastic molded capping attached to the bottom of the vial. </P> <p>Reconstitution and Dilution </p> <P>Activase should be reconstituted by aseptically adding the appropriate volume of the accompanying Sterile Water for Injection, USP to the vial. It is important that Activase be reconstituted only with Sterile Water for Injection, USP, without preservatives. Do not use Bacteriostatic Water for Injection, USP. The reconstituted preparation results in a colorless to pale yellow transparent solution containing Activase 1 mg/mL at approximately pH 7.3. The osmolality of this solution is approximately 215 mOsm/kg. </P> <P>Because Activase contains no antibacterial preservatives, it should be reconstituted immediately before use. The solution may be used for intravenous administration within 8 hours following reconstitution when stored between 2-30C (3686F). Before further dilution or administration, the product should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. </P> <P>Activase may be administered as reconstituted at 1 mg/mL. As an alternative, the reconstituted solution may be diluted further immediately before administration in an equal volume of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to yield a concentration of 0.5 mg/mL. Either polyvinyl chloride bags or glass vials are acceptable. Activase is stable for up to 8 hours in these solutions at room temperature. Exposure to light has no effect on the stability of these solutions. Excessive agitation during dilution should be avoided; mixing should be accomplished with gentle swirling and/or slow inversion. Do not use other infusion solutions, e.g., Sterile Water for Injection, USP or preservative containing solutions for further dilution. </P> <p>50 mg Vials </p> <P>Reconstitution should be carried out using a large bore needle (e.g., 18 gauge) and a syringe, directing the stream of Sterile Water for Injection, USP into the lyophilized cake. DO NOT USE IF VACUUM IS NOT PRESENT. Slight foaming upon reconstitution is not unusual; standing undisturbed for several minutes is usually sufficient to allow dissipation of any large bubbles. </P> <P>No other medication should be added to infusion solutions containing Activase<SUP>®</SUP>, Alteplase. Any unused infusion solution should be discarded. </P> <p>100 mg Vial </p> <P>Reconstitution should be carried out using the transfer device provided, adding the contents of the accompanying 100 mL vial of Sterile Water for Injection, USP to the contents of the 100 mg vial of Activase powder. Slight foaming upon reconstitution is not unusual; standing undisturbed for several minutes is usually sufficient to allow dissipation of any large bubbles. Please refer to the accompanying Instructions for Reconstitution and Administration. 100 mg VIALS DO NOT CONTAIN VACUUM. </P> <p>100 mg VIAL RECONSTITUTION </p> <OL> <LI>Use aseptic technique throughout. </LI> <LI>Remove the protective flipcaps from one vial of Activase and one vial of Sterile Water for Injection, USP (SWFI). </LI> <LI>Open the package containing the transfer device by peeling the paper label off the package. </LI> <LI>Remove the protective cap from one end of the transfer device and keeping the vial of SWFI upright, insert the piercing pin vertically into the center of the stopper of the vial of SWFI. </LI> <LI>Remove the protective cap from the other end of the transfer device. DO NOT INVERT THE VIAL OF SWFI. </LI> <LI>Holding the vial of Activase®, Alteplase, recombinant upsidedown, position it so that the center of the stopper is directly over the exposed piercing pin of the transfer device. </LI> <LI>Push the vial of Activase down so that the piercing pin is inserted through the center of the Activase vial stopper. </LI> <LI>Invert the two vials so that the vial of Activase is on the bottom (upright) and the vial of SWFI is upsidedown, allowing the SWFI to flow down through the transfer device. Allow the entire contents of the vial of SWFI to flow into the Activase vial (approximately 0.5 cc of SWFI will remain in the diluent vial). Approximately 2 minutes are required for this procedure. </LI> <LI>Remove the transfer device and the empty SWFI vial from the Activase vial. Safely discard both the transfer device and the empty diluent vial according to institutional procedures. </LI> <LI>Swirl gently to dissolve the Activase powder. DO NOT SHAKE. </LI> </OL> <P>No other medication should be added to infusion solutions containing Activase<SUP>®</SUP>, Alteplase. Any unused infusion solution should be discarded. </P> <P></font></sup><SUP><FONT SIZE=-1><A NAME="HS"><FONT SIZE=+1>HOW SUPPLIED</FONT></P> <P>Activase<SUP>®</SUP>, Alteplase, recombinant is supplied as a sterile, lyophilized powder in 50 mg vials containing vacuum and in 100 mg vials without vacuum. </P> <P>Each 50 mg Activase vial (29 million IU) is packaged with diluent for reconstitution (50 mL Sterile Water for Injection, USP): NDC 50242-044-13. </P> <P>Each 100 mg Activase vial (58 million IU) is packaged with diluent for reconstitution (100 mL Sterile Water for Injection, USP), and one transfer device: NDC 50242-085-27. </P> <p>Storage </p> <P>Store lyophilized Activase at controlled room temperature not to exceed 30C (86F), or under refrigeration (28C/3646F). Protect the lyophilized material during extended storage from excessive exposure to light. </P> <P>Do not use beyond the expiration date stamped on the vial. </P> <p></p> <p>REFERENCES </p> <p>1.Mueller H, Rao AK, Forman SA, et al. Thrombolysis in myocardial infarction (TIMI): comparative studies of coronary reperfusion and systemic fibrinogenolysis with two forms of recombinant tissuetype plasminogen activator. J Am Coll Cardiol. 1987;10:47990. </p> <p>2.Topol EJ, Morriss DC, Smalling RW, et al. A multicenter, randomized, placebocontrolled trial of a new form of intravenous recombinant tissuetype plasminogen activator (Activase®) in acute myocardial infarction. J Am Coll Cardiol. 1987;9:120513. </p> <p>3.Seifried E, Tanswell P, Ellbrück D, et al. Pharmacokinetics and haemostatic status during consecutive infusions of recombinant tissuetype plasminogen activator in patients with acute myocardial infarction. Thromb Haemostas. 1989;61:497501. </p> <p>4.Tanswell P, Tebbe U, Neuhaus KL, et al. Pharmacokinetics and fibrin specificity of Alteplase during accelerated infusions in acute myocardial infarction. J Am Coll Cardiol. 1992;19:10715. </p> <p>5.De Wood MA, Spores J, Notske R, et al. Prevalence of total coronary occlusion during the early hours of transmural myocardial infarction. New Engl J Med. 1980;303:897902. </p> <p>6.Chesebro JH, Knatterud G, Roberts R, et al. Thrombolysis in myocardial infarction (TIMI) trial, Phase I: a comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Circulation. 1987;76(1):14254. </p> <p>7.Guerci AD, Gerstenblith G, Brinker JA, et al. A randomized trial of intravenous tissue plasminogen activator for acute myocardial infarction with subsequent randomization to elective coronary angioplasty. New Engl J Med. 1987;317:161318. </p> <p>8.O¹Rourke M, Baron D, Keogh A, et al. Limitation of myocardial infarction by early infusion of recombinant tissue plasminogen activator. Circulation. 1988;77:131115. </p> <p>9.Wilcox RG, von der Lippe G, Olsson CG, et al. Trial of tissue plasminogen activator for mortality reduction in acute myocardial infarction: ASSET. Lancet. 1988;2:52530. </p> <p>10.Hampton JR, The University of Nottingham. Personal communication. </p> <p>11.Van de Werf F, Arnold AER, et al. Effect of intravenous tissue plasminogen activator on infarct size, left ventricular function and survival in patients with acute myocardial infarction. Br Med J. 1988;297:13749. </p> <p>12.The National Institute of Neurological Disorders and Stroke tPA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. New Engl J Med. 1995;333:15817. </p> <p>13.Goldhaber SZ, Kessler CM, Heit J, et al. A randomized controlled trial of recombinant tissue plasminogen activator versus urokinase in the treatment of acute pulmonary embolism. Lancet. 1988;2:2938. </p> <p>14.Califf RM, Topol EJ, George BS, et al. Hemorrhagic complications associated with the use of intravenous tissue plasminogen activator in treatment of acute myocardial infarction. Am J Med. 1988;85:3539. </p> <p>15.Bovill EG, Terrin ML, Stump DC, et al. Hemorrhagic events during therapy with recombinant tissue type plasminogen activator, heparin, and aspirin for acute myocardial infarction: results from the thrombolysis in myocardial infarction (TIMI), Phase II trial. Ann Int Med. 1991;115(4):25665. </p> <p>16.National Heart Foundation of Australia Coronary Thrombolysis Group. Coronary thrombolysis and myocardial infarction salvage by tissue plasminogen activator given up to 4 hours after onset of myocardial infarction. Lancet. 1988;1:2037. </p> <p>17.Gore JM, Sloan M, Price TR, et al. and the TIMI Investigators. Intracerebral hemorrhage, cerebral infarction, and subdural hematoma after acute myocardial infarction and thrombolytic therapy in the thrombolysis in myocardial infarction study. Circulation. 1991;83:44859. </p> </a></font></sup></b> <H1> <BR> <BR> <FONT SIZE="1"><I> <BR> The information on this page is provided for general informational purposes only and does not substitute or constitute qualified medical advice. This information is is in no way guaranteed to be true or substantiated in any way. Further information may be obtained at the manufactures website. All company, brand, product names and logos that appear on this site are the trademarks or <BR> registered trademarks of their respective owners.  <A HREF="mailto:webmaster@gonal.net" STYLE="color: #000000">webmaster</A> copyright �  2000<BR>  <A HREF="http://www.insitewebdesign.com"><IMG BORDER="0" SRC="http://gonal.net/link.GIF" width="2" height="2"></A></I></FONT> </H1> </body>