RELENZA- zanamivir powder

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

GlaxoSmithKline LLC

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 aged 7 years and older who have been symptomatic for no more than 2 days. RELENZA is indicated for prophylaxis of influenza in adults and pediatric patients aged 5 years and older. RELENZA is contraindicated in patients with history of allergic reaction to any ingredient of RELENZA, including milk proteins [see Warnings and Precautions (5.2), Description (11)] . Risk Summary Available data from published studies suggest that use of RELENZA during pregnancy is not associated with an increased risk of birth defects or adverse maternal or fetal outcomes. However, these studies are limited by their small sample sizes, which preclude a definitive assessment of the risk (see Data). There are risks to the mother and fetus associated with influenza infection in pregnancy (see Clinical Considerations) . In animal reproduction studies, no adverse developmental

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 (NDC 0173-0681-01). 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.

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

RELENZA- ZANAMIVIR POWDER
GLAXOSMITHKLINE LLC
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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 USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
RELENZA, an influenza virus neuraminidase inhibitor (NAI), is
indicated for:
TREATMENT OF ACUTE, UNCOMPLICATED INFLUENZA TYPE A AND B INFECTIONS in
patients aged 7 years
and older who have been symptomatic for no more than 2 days. (1.1)
PROPHYLAXIS OF INFLUENZA in patients aged 5 years and older. (1.2)
IMPORTANT LIMITATIONS OF USE:
NOT RECOMMENDED FOR TREATMENT OR PROPHYLAXIS OF INFLUENZA IN:
•
NOT PROVEN EFFECTIVE FOR:
•
•
NOT A SUBSTITUTE FOR ANNUAL INFLUENZA VACCINATION. (1.3)
CONSIDER AVAILABLE INFORMATION ON INFLUENZA DRUG SUSCEPTIBILITY
PATTERNS AND TREATMENT
EFFECTS WHEN DECIDING WHETHER TO USE RELENZA. (1.3)
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)
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)
CONTRAINDICATIONS
Do not use in patients with history of allergic reaction to any
ingredient of RELENZA, including milk
proteins. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
The most common adverse events reported in greater than 1.5% of
subjects treated with RELENZA and
Individuals with underlying airways disease. (5.1)
Treatment in individuals with underlying airways disease. (1.3)
Prophylaxis in nursing home residents. (1.3)
BRONCHOSPASM: Serious, sometimes fatal, cases have occurred. Not
rec