RETAVASE- reteplase kit

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

RETEPLASE (UNII: DQA630RIE9) (RETEPLASE - UNII:DQA630RIE9)

Commercializzato da:

Chiesi USA, Inc.

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

RETAVASE is indicated for use in acute ST-elevation myocardial infarction (STEMI) to reduce the risk of death and heart failure. Limitation of Use: The risk of stroke may outweigh the benefit produced by thrombolytic therapy in patients whose STEMI puts them at low risk for death or heart failure. Because thrombolytic therapy increases the risk of bleeding, RETAVASE is contraindicated in the following situations: - Active internal bleeding - Recent stroke - Intracranial or intraspinal surgery or serious head trauma within 3 months - Intracranial conditions that increase the risk of bleeding (e.g. neoplasms, arteriovenous malformation, or aneurysms) - Bleeding diathesis - Current severe uncontrolled hypertension Risk Summary Limited published data with RETAVASE use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.  In animal reproduction studies, reteplase administered to pregnant rabbits resulted in hemorrhaging in the genital tract, leading to abortions i

Dettagli prodotto:

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): 2 single-use RETAVASE vials 10 units, 2 single-use prefilled syringes for reconstitution (10 mL Sterile Water for Injection, USP), 2 syringe plungers, 2 sterile 10 mL graduated syringes, 2 sterile reconstitution spikes, 1 quick reference guide and 1 package insert. RETAVASE Half-Kit (NDC 10122-143-01): 1 single-use RETAVASE vial 10 units, 1 single-use prefilled syringe for reconstitution (10 mL Sterile Water for Injection, USP), 1 syringe plunger, 1 sterile 10 mL graduated syringe, 1 sterile reconstitution spike, 1 quick reference guide and 1 package insert. Storage: Store RETAVASE at 2°C to 25°C (36°F to 77°F). The box should remain sealed until use to protect the lyophilisate from exposure to light. Manufactured by: Chiesi USA, Inc.                     Cary, NC  27518 U.S. License No. 2150 Retavase® manufactured at Patheon Italia, S.p.A., Monza, Italy 20900. To report an adverse event, record the lot number and call Medical Information at 1-888-661-9260. RETAVASE® is a registered trademark of Chiesi USA, 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-001-0422-03-SPL

Stato dell'autorizzazione:

Biologic Licensing Application

Scheda tecnica

RETAVASE- RETEPLASE
CHIESI USA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RETAVASE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RETAVASE.
RETAVASE (RETEPLASE) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
RETAVASE is a tissue plasminogen activator (tPA) indicated for
treatment of acute ST-elevation
myocardial infarction (STEMI) to reduce the risk of death and heart
failure. (1)
Limitation of Use: The risk of stroke may outweigh the benefit
produced by thrombolytic therapy in
patients whose STEMI puts them at low risk for death or heart failure.
(1)
DOSAGE AND ADMINISTRATION
Two 10 unit intravenous injections, each administered over 2 minutes,
30 minutes apart. (2.1)
No other medication should be injected or infused simultaneously via
the same intravenous line or
added to the injection solution. (2.1)
DOSAGE FORMS AND STRENGTHS
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. (3)
CONTRAINDICATIONS
Do not use in patients with: Active internal bleeding (4)
Recent stroke (4)
Recent intracranial or intraspinal surgery or serious head trauma (4)
Intracranial neoplasm, arteriovenous malformation, or aneurysm (4)
Known bleeding diathesis (4)
Severe uncontrolled hypertension (4)
WARNINGS AND PRECAUTIONS
Increases the risk of bleeding. Avoid intramuscular injections. (5.1)
Hypersensitivity (5.2)
Cholesterol embolism (5.3)
ADVERSE REACTIONS
The most common adverse reaction (>5%) is bleeding. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CHIESI USA, INC. AT
1-888-661-9260 OR
FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
USE IN SPECIFIC POPULATIONS
Pediatric Use: Safety and effectiveness have not been established.
(8.4)
REVISED: 4/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 DOSING INFORMATION AND ADMINISTRATION
2.2