SEREVENT INHALER CFC-FREE

Quốc gia: Nam Phi

Ngôn ngữ: Tiếng Anh

Nguồn: South African Health Products Regulatory Authority (SAHPRA)

Sẵn có từ:

GlaxoSmithKline South Africa (Pty) Limited

Liều dùng:

See ingredients

Dạng dược phẩm:

INHALER

Thành phần:

EACH METERED DOSE DELIVERS SALMETEROL 25,0 ug

Tình trạng ủy quyền:

Registered

Ngày ủy quyền:

2006-01-12

Tờ rơi thông tin

Page 1 of 10
GDS-30
SEREVENT INHALER CFC-FREE
PIL
SCHEDULING STATUS:
S4
SEREVENT INHALER CFC-FREE
Metered-dose inhaler
Salmeterol xinafoate 25 µg (micrograms)
READ ALL THIS LEAFLET CAREFULLY BEFORE YOU START USING SEREVENT
INHALER CFC-FREE.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
SEREVENT INHALER CFC-FREE has been prescribed for you personally and
you should
not share your medicine with other people. It may harm them, even if
their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET:
1. What SEREVENT INHALER CFC-FREE is and what it is used for
2. What you need to know before you use SEREVENT INHALER CFC-FREE
3. How to use SEREVENT INHALER CFC-FREE
4. Possible side effects
5. How to store SEREVENT INHALER CFC-FREE
6. Contents of the pack and other information.
1.
WHAT SEREVENT INHALER CFC-FREE IS USED FOR:
Page 2 of 10
GDS-30
Salmeterol xinafoate is a bronchodilator. It relaxes the muscles in
the walls of the small air
passages in the lungs. Your doctor has prescribed SEREVENT INHALER
CFC-FREE for you to
treat your asthma, chronic bronchitis or emphysema.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SEREVENT INHALER CFC-
FREE:
DO NOT USE SEREVENT INHALER CFC-FREE:
•
if you are allergic (hypersensitive) to salmeterol xinofoate, or to
the any of the other ingredients
in SEREVENT INHALER CFC-FREE
•
if you have asthma and do not use a cortisone inhaler or tablets.
•
if you are taking a medicine called ketoconazole, used to treat fungal
infections.
WARNINGS AND PRECAUTIONS:
TAKE SPECIAL CARE WITH SEREVENT INHALER CFC-FREE:
Special care should be taken with SEREVENT INHALER CFC-FREE:
•
if you are using SEREVENT INHALER CFC-FREE for your asthma, because
you must
always use and continue taking any other asthma medication (e.g. a
cortisone inhaler or
cortisone tablets). Continue taking the same doses as before, unless
your doctor tells you
otherwise. DO NOT STOP TAKING YOUR CORTISONE INHALER OR CORTISONE
TABLETS WHEN YOU

Đặc tính sản phẩm

Page
1
of
12
GDS-30
SEREVENT INHALER CFC-FREE
PROPOSED PI
SCHEDULING STATUS:
S4
1.
NAME OF THE MEDICINE
SEREVENT INHALER CFC-FREE
Salmeterol xinafoate 25 µg (micrograms)
Metered-dose inhaler
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Pressurised metered-dose inhaler delivering 25 micrograms salmeterol
(as xinafoate) with each
actuation.
3.
PHARMACUTICAL FORM:
Metered-dose inhaler.
SEREVENT
INHALER
CFC-FREE
is
a
metered-dose
aerosol
inhaler
comprising
of
a
suspension of salmeterol xinafoate in a non-CFC propellant Norflurane.
4.
CLINICAL PARTICULARS:
4.1
INDICATIONS:
ASTHMA:
_ADULTS: _
Page
2
of
12
GDS-30
Long-term
maintenance
treatment
of
reversible
airways
obstruction,
in
asthma,
chronic
bronchitis and emphysema.
_CHILDREN 4 YEARS AND OLDER: _
Maintenance treatment
of reversible airways obstruction
in asthma
including
long-lasting
prevention of exercise-induced bronchospasm.
SEREVENT INHALER CFC-FREE should be used only as an adjunct to
corticosteroids in the
management of asthma.
SEREVENT INHALER CFC-FREE is not intended for use in acute attacks of
asthma, in view of
the slow onset of action.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION:
SEREVENT INHALER CFC-FREE: administered by the inhaled route only.
As there may be adverse effects associated with excessive dosing, the
dosage or frequency of
administration should not be increased.
_Adults: _Two inhalations (2 x 25 micrograms of salmeterol) twice
daily.
_Children 4 years and older: _Two inhalations (2 x 25 micrograms of
salmeterol) twice daily.
There are insufficient clinical data to recommend the use of SEREVENT
INHALER CFC-FREE
in children below 4 years of age.
_Elderly: _There is no need to adjust the dose in the elderly.
In order to gain full therapeutic benefit, regular usage of SEREVENT
INHALER CFC-FREE is
recommended in the treatment of asthma. The onset of the
bronchodilator effect of SEREVENT
INHALER CFC-FREE usually occurs in approximately 10-30 minutes or
longer. The full
benefits will be apparent after the 1st or 2nd dose of the medicine.
If
sympt