RELENZA ROTADISK 5 mgdose

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

ZANAMIVIR

זמין מ:

GLAXOSMITHKLINE PTE LTD

קוד ATC:

J05AH01

כמות:

5 mg/dose

טופס פרצבטיות:

POWDER, METERED

הרכב:

ZANAMIVIR 5 mg/dose

מסלול נתינה (של תרופות):

RESPIRATORY (INHALATION)

סוג מרשם:

Prescription Only

תוצרת:

GLAXO WELLCOME PRODUCTION

מצב אישור:

ACTIVE

תאריך אישור:

1999-10-21

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
5 mg per dose, inhalation powder, pre-dispensed
zanamivir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This medicine has been prescribed for you personally. Don’t pass it
to others-it may harm others, even if their
symptoms seem to be the same as yours.
Keep this leaflet. You may have to read it again.
If you have any questions, ask your doctor or pharmacist.
IF YOU HAVE SERIOUS SIDE EFFECTS, OR IF YOU NOTICE ANY SIDE EFFECTS
NOT LISTED IN THIS LEAFLET, TELL YOUR DOCTOR OR
PHARMACIST.
In this leaflet:
1.
What Relenza is and what it is used for
2.
Before you use Relenza
3.
How to use Relenza
4.
When to start using Relenza
5.
Possible side effects
6.
How to store Relenza
7.
Important things to take note
8.
Further information
9.
Step-by-step guide to using your Relenza Diskhaler
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 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. BEFORE YOU USE RELENZA
DON’T USE RELENZA:
•
IF YOU’RE ALLERGIC
(hypersensitive) to zanamivir
•
IF YOU’RE ALLERGIC
(hypersensitive) to lactose or milk protein
If you think this applies to you, don’t use Relenza until you have
checked with your doctor.
TAKE SPECIAL CARE WITH RELENZA.
DON’T GIVE RELENZA TO CHILDREN UNDER 5 YEARS OLD.
IF YOU HAVE ASTHMA, OR OTHER PROBLEMS WITH YOUR LUNGS OR YOUR
B

מאפייני מוצר

1
RELENZA
Zanamivir
PRESENTATION
Each Relenza Rotadisk consists of four regularly spaced double foil
blisters each containing a powder
mixture of zanamivir (5 mg) and lactose (20 mg).
INDICATIONS
Treatment of Influenza:
Relenza is indicated for treatment of infections due to influenza A
and B viruses in adults and children 5
years and older.
Prophylaxis:
Relenza is indicated for prophylaxis of both influenza A and B in
adults and juveniles 12 years and older.
DOSAGE AND METHOD OF ADMINISTRATION
Relenza is for administration to the respiratory tract by oral
inhalation only, using the Diskhaler device
provided.
Patients scheduled to take inhaled drugs, e.g. fast acting
bronchodilators, at the same time as Relenza
should be advised to administer that drug prior to administration of
Relenza.
Treatment of Influenza:
_Adults and children 5 years and older: _
The recommended dose of Relenza is two inhalations (2 x 5 mg) twice
daily for five days, providing a total
daily inhaled dose of 20 mg.
For maximum benefit, treatment should begin as soon as possible but no
later than 48 hours after onset of
symptoms.
Prophylaxis:
_Adults and juveniles 12 years and older: _
The recommended dose of Relenza is two inhalations (2 x 5 mg) once
daily for 10 days, providing a total
daily inhaled dose of 10 mg. The treatment can be prolonged for up to
one month at the most if the
exposure risk lasts more than 10 days.
The full course of prophylaxis therapy should be completed as
prescribed.
_Impaired Renal or Hepatic Function:_
No dose modification is required (see Pharmacokinetic properties).
_Elderly patients: _
No dose modification is required (see Pharmacokinetic properties).
_Paediatric patients:_
No dose modification is required (see Pharmacokinetic Properties).
CONTRA-INDICATIONS
Hypersensitivity to any ingredient of the preparation (see
Pharmaceutical Particulars – List of Excipients).
Contraindicated in patients with severe milk protein allergy.
2
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Zanamivir is a specific treatmen