RELENZA

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

ZANAMIVIR MICRONIZED

Fáanlegur frá:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC númer:

J05AH01

Lyfjaform:

POWDER FOR INHALATION

Samsetning:

ZANAMIVIR MICRONIZED 5 MG

Stjórnsýsluleið:

INHALATION

Gerð lyfseðils:

Required

Framleitt af:

GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND

Meðferðarhópur:

ZANAMIVIR

Lækningarsvæði:

ZANAMIVIR

Ábendingar:

Zanamivir is indicated for the treatment of both uncomplicated acute illness due to influenza A and B virus in adults and adolescents (> or = 12 years) who have been symptomatic for no more than 48 hours and pediatric patients 7 years and older who have been symptomatic for no more than 36 hours.

Leyfisdagur:

2022-02-28

Vara einkenni

_Page 1 of 14 _
_ _
_The format of this leaflet was determined by the Ministry of Health
and its content was checked and approved in March _
_2017_
_ _
RELENZA
TM
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-dispensed quantity of inhalation powder (one blister)
contains 5 mg zanamivir. Each
delivered inhalation (the amount that leaves the mouthpiece of the
Diskhaler) contains 4.0 mg
zanamivir.
Excipients with known effect:
Lactose monohydrate (approximately 20 mg which contains milk protein).
For the full list of excipients, see section 11.
1
INDICATIONS AND USAGE
1.1
TREATMENT OF INFLUENZA
RELENZA is indicated for treatment of both uncomplicated acute illness
due to
influenza A and B virus in adults and adolescents (> or = 12 years)
who have been symptomatic
for no more than 48 hours and pediatric patients 7 years and older who
have been symptomatic
for no more than 36 hours.
1.2
IMPORTANT LIMITATIONS ON USE OF RELENZA

RELENZA is not recommended for treatment 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.

Influenza viruses change over time. Emergence of resistance mutations
could decrease drug
effectiveness. Other factors (for example, changes in viral virulence)
might also diminish
clinical benefit of antiviral drugs. Prescribers should consider
available information on
influenza drug susceptibility patterns and treatment effects when
deciding whether to use
RELENZA.

There is no evidence for efficacy of zanamivir in any illness caused
by agents other than
influenza virus A and B.

Patients should be advised that the use of RELENZA for treatment of
influenza has not been
shown to reduce the risk of transmission of influenza to others.
2
DOSAGE AND ADMINISTRATION
2.1
DOSING CONSIDERATIONS
_Page 3 of 14 _
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
RELENZA is for admini