RELENZA- zanamivir powder

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

ZANAMIVIR (UNII: L6O3XI777I) (ZANAMIVIR - UNII:L6O3XI777I)

Dostupné z:

Physicians Total Care, Inc.

INN (Medzinárodný Name):

ZANAMIVIR

Zloženie:

ZANAMIVIR 5 mg

Spôsob podávania:

RESPIRATORY (INHALATION)

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

RELENZA® (zanamivir) Inhalation Powder is indicated for treatment of uncomplicated acute illness due to influenza A and B virus in adults and pediatric patients 7 years of age and older who have been symptomatic for no more than 2 days. RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients 5 years of age and older. - RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease) due to risk of serious bronchospasm [see Warnings and Precautions (5.1)] . RELENZA is not recommended for treatment or prophylaxis of influenza in individuals with underlying airways disease (such as asthma or chronic obstructive pulmonary disease) due to risk of serious bronchospasm [see Warnings and Precautions (5.1)] . - RELENZA has not been proven effective for treatment of influenza in individuals with underlying airways disease. - RELENZA has not been proven effective for prophylaxis of i

Prehľad produktov:

RELENZA is supplied in a circular double-foil pack (a ROTADISK) containing 4 blisters of the drug. Five ROTADISKs are packaged in a white polypropylene tube. The tube is packaged in a carton with 1 blue and gray DISKHALER inhalation device. They are supplied by Dispensing Solutions Inc. as follows: Store at 25 °C (77 °F); excursions permitted to 15 ° to 30 °C (59 ° to 86 °F) (see USP Controlled Room Temperature). Keep out of reach of children. Do not puncture any RELENZA ROTADISK blister until taking a dose using the DISKHALER. Manufactured By: GlaxoSmithKline Research Triangle Park, NC 27709 ©2010, GlaxoSmithKline. All rights reserved. Decembe 2010 RLZ:8PI Relabeling of "Additional" label by: Physicians Total Care, Inc. Tulsa, OK     74146

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

RELENZA - ZANAMIVIR POWDER
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RELENZA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR RELENZA.
RELENZA (ZANAMIVIR) INHALATION POWDER, FOR ORAL INHALATION
INITIAL U.S. APPROVAL: 1999
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 12/2010
INDICATIONS AND USAGE
RELENZA, an influenza neuraminidase inhibitor, is indicated for: (1)
TREATMENT OF INFLUENZA in patients 7 years of age and older who have
been symptomatic for no more than 2 days. (1.1)
(1)
PROPHYLAXIS OF INFLUENZA in patients 5 years of age and older. (1.2)
(1)
IMPORTANT LIMITATIONS ON USE OF RELENZA: (1)
NOT RECOMMENDED FOR TREATMENT OR PROPHYLAXIS OF INFLUENZA IN: (1)
Individuals with underlying airways disease. (5.1)
NOT PROVEN EFFECTIVE FOR: (1)
Treatment in individuals with underlying airways disease. (1.3)
Prophylaxis in nursing home residents. (1.3)
NOT A SUBSTITUTE FOR ANNUAL INFLUENZA VACCINATION. (1.3) (1)
CONSIDER AVAILABLE INFORMATION ON INFLUENZA DRUG SUSCEPTIBILITY
PATTERNS AND TREATMENT EFFECTS WHEN DECIDING
WHETHER TO USE RELENZA. (1.3) (1)
DOSAGE AND ADMINISTRATION
Indication
Dose
Treatment of Influenza (2.2) 10 mg twice daily for 5 days
Prophylaxis: (2.3)
Household Setting
10 mg once daily for 10 days
Community Outbreaks
10 mg once daily for 28 days
NOTE: The 10 mg dose is provided by 2 inhalations (one 5 mg blister
per inhalation). (2.1) (2)
DOSAGE FORMS AND STRENGTHS
Blister for oral inhalation: 5 mg. Four 5 mg blisters of powder on a
ROTADISK for oral inhalation via DISKHALER .
Packaged in carton containing 5 ROTADISKs (total of 10 doses) and 1
DISKHALER inhalation device. (3) (3)
CONTRAINDICATIONS
Do not use in patients with history of allergic reaction to any
ingredient of RELENZA, including lactose (which contains milk
proteins). (4) (4)
WARNINGS AND PRECAUTIONS
BRONCHOSPASM: Serious, sometimes fatal, cases have occurred. Not
recommended in individuals with underlying
airways dis