Relenza powder for inhalation

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

zanamivir

Available from:

Glaxo Wellcome Production

ATC code:

J05AH01

INN (International Name):

zanamivir

Dosage:

5mg

Pharmaceutical form:

powder for inhalation

Units in package:

(1) rotadisk with (20mg/4x5/) powder in blister and diskhaler, (5) rotadisk with (100mg/4x5x5/) powder in blister and diskhaler

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-12-09

Patient Information leaflet

10000000145162
What is in this leaflet
1
WHAT RELENZA IS AND WHAT IT IS USED FOR
2
WHAT YOU NEED TO KNOW BEFORE YOU
USE RELENZA
3
HOW TO USE RELENZA
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE RELENZA
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
What Relenza is and what
it is used for
Relenza contains zanamivir, which belongs to
a group of medicines called _antivirals_.
RELENZA IS USED TO TREAT FLU _(influenza virus _
_infection)_. It reduces the symptoms of flu,
and helps you recover more quickly.
Relenza is also used to help prevent you from
getting flu, during a flu outbreak.
Adults and children aged 5 years or more can
be treated with Relenza.
Relenza needs to be inhaled (breathed in)
into the lungs, because it is poorly absorbed
into the body if it is swallowed. The flu virus
infects the lungs, and when you inhale
Relenza it works directly on the virus inside
your lungs.
RELENZA IS NOT A SUBSTITUTE FOR FLU
VACCINATION. You still need to talk to your
doctor about whether you need to be
vaccinated against flu.
2
What you need to know
before you use Relenza
Don’t use Relenza:
• IF YOU’RE ALLERGIC to zanamivir or any of the
other ingredients of this medicine (listed in
section 6).
DON’T GIVE RELENZA TO CHILDREN UNDER 5 YEARS OLD.
Take special care with Relenza
If you feel tightness in your throat or
chest when you use Relenza
In very rare cases, Relenza can cause a
reaction including:
• TIGHTNESS OF THE THROAT AND CHEST
• DIFFICULTY BREATHING.
If you get any of these symptoms when you
use Relenza:
➔ STOP USING RELENZA AND GET MEDICAL HELP
IMMEDIATELY. Contact your doctor or the
nearest hospital emergency department.
If you have asthma, or other problems
with your lungs or your breathing
Your doctor needs to know if you have:
• ASTHMA
• OTHER LUNG DISEASE THAT CAUSES BREATHING
PROBLEMS — FOR EXAMPLE, EMPHYSEMA,
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
(COPD), OR CHRONIC BRONCHITIS.
➔ TELL YOUR DOCTOR BEFORE YOU USE RELENZA,
so that he or she can supervise you more
closely to check that your condit

Summary of Product characteristics

1/7
RELENZA 5MG/DOSE INHALATION POWDER.
Summary of Product Characteristics Updated 14-Jul-2015 |
GlaxoSmithKline UK
1.
NAME OF THE MEDICINAL PRODUCT
Relenza 5mg/dose, inhalation powder, pre-dispensed.
2.
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 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed. White to off-white powder.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF INFLUENZA
Relenza is indicated for treatment of both influenza A and B in adults
and children (≥ 5 years) who present with
symptoms typical of influenza when influenza is circulating in the
community.
PREVENTION OF INFLUENZA
Relenza is indicated for post-exposure prophylaxis of influenza A and
B in adults and children (≥ 5 years) following
contact with a clinically diagnosed case in a household (see section
5.1 for children aged 5-11 years). In exceptional
circumstances, Relenza may be considered for seasonal prophylaxis of
influenza A and B during a community outbreak
(e.g. in case of a mismatch between circulating and vaccine strains
and a pandemic situation).
Relenza is not a substitute for influenza vaccination. The appropriate
use of Relenza for prevention of influenza should
be determined on a case-by-case basis depending on the circumstances
and the population requiring protection.
The use of antivirals for the treatment and prevention of influenza
should take into consideration official
recommendations, the variability of epidemiology, and the impact of
the disease in different geographical areas and
patient populations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Inhaled drugs, e.g. asthma medication, should be administered prior to
administration of Relenza (see section 4.