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Retavase

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Overview

What is Retavase?

Reteplase is a non-glycosylated deletion mutein of tissue plasminogen activator (tPA), containing the kringle 2 and the protease domains of human tPA.  Reteplase contains 355 of the 527 amino acids of native tPA (amino acids 1-3 and 176-527).  Reteplase is produced by recombinant DNA technology in E. coli. The protein is isolated as inactive inclusion bodies from E. coli, converted into its active form by an folding process and purified by chromatographic separation. The molecular weight of Reteplase is 39,571 daltons.

Potency is expressed in units (U) using a reference standard which is specific for RETAVASE and is not comparable with units used for other thrombolytic agents.

RETAVASE (reteplase) for Injection is a sterile, white, lyophilized powder for intravenous injection after reconstitution with Sterile Water for Injection, USP (without preservatives). Following reconstitution with 10 mL of Sterile Water for Injection, the resulting concentration is 1 unit/mL to allow for delivery of 10 mL (10 units reteplase). The pH is 6.0 ± 0.3. RETAVASE is supplied with overfill to ensure sufficient drug for administration of each 10 unit injection.

Each single-use vial delivers:



What does Retavase look like?



What are the available doses of Retavase?

For Injection: 10 units as a lyophilized powder in single-use vials for reconstitution co-packaged with Sterile Water for Injection, USP in 10 mL prefilled syringe. ()

What should I talk to my health care provider before I take Retavase?

How should I use Retavase?

RETAVASE is indicated for use in acute ST-elevation myocardial infarction (STEMI) to reduce the risk of death and heart failure.

Limitation of Use:

As soon as possible after the onset of STEMI, administer 10 units intravenously over 2 minutes. Administer a second dose of 10 units 30 minutes after the first dose.


What interacts with Retavase?

Sorry No Records found


What are the warnings of Retavase?

Sorry No Records found


What are the precautions of Retavase?

Sorry No Records found


What are the side effects of Retavase?

Sorry No records found


What should I look out for while using Retavase?

Because thrombolytic therapy increases the risk of bleeding, RETAVASE is contraindicated in the following situations:


What might happen if I take too much Retavase?

Sorry No Records found


How should I store and handle Retavase?

RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1RETAVASE (reteplase) for Injection is supplied as a sterile, preservative-free, lyophilized powder in 10 unit vials without a vacuum, in the following packaging configurations:RETAVASE Kit (NDC 10122-141-02):RETAVASE Half-Kit (NDC 10122-143-01):Storage:Distributed by:Chiesi USA, Inc.                     Cary, NC  27518Manufactured by: EKR Therapeutics, Inc.Cary, NC 27518U.S. License No. 1814Retavase® manufactured at Actavis Italy, S.p.A. Nerviano, Italy 20014To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260.RETAVASE® is a registered trademark of EKR Therapeutics, Inc.The trademarks Streptase®, Activase®, and Actilyse® referenced herein are the property of their respective owners and are not affiliated with, connected to, or sponsored by Chiesi USA, Inc.CTR-001-0415-00-SPL-1


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

RETAVASE is a recombinant plasminogen activator which catalyzes the cleavage of endogenous plasminogen to generate plasmin. Plasmin in turn degrades the fibrin matrix of the thrombus, thereby exerting its thrombolytic action.

Non-Clinical Toxicology
Because thrombolytic therapy increases the risk of bleeding, RETAVASE is contraindicated in the following situations:

RETAVASE can cause significant and sometimes fatal bleeding. Avoid intramuscular injections and other trauma to a patient administered RETAVASE. Minimize venipunctures. Avoid puncturing noncompressible veins, such as the internal jugular and subclavian. If an arterial puncture is necessary, use an upper extremity vessel that is accessible to manual compression, apply pressure for at least 30 minutes, and monitor the puncture site closely. As fibrin is lysed during RETAVASE therapy, bleeding from recent puncture sites or other recent trauma may occur.

Should serious bleeding (not controllable by local pressure) occur, terminate concomitant anticoagulant therapy.  Withhold the second RETAVASE dose if serious bleeding occurs before it is administered.

The following adverse reactions are discussed in greater detail in the other sections of the label:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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