SERETIDE DISKUS 50500 MCG

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

FLUTICASONE PROPIONATE; SALMETEROL AS XINAFOATE

Dostupné s:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC kód:

R03AK06

Léková forma:

POWDER FOR INHALATION

Složení:

FLUTICASONE PROPIONATE 500 MCG; SALMETEROL AS XINAFOATE 50 MCG

Podání:

INHALATION

Druh předpisu:

Required

Výrobce:

GLAXO OPERATIONS UK LIMITED

Terapeutické skupiny:

SALMETEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Terapeutické oblasti:

SALMETEROL AND OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Terapeutické indikace:

Seretide is indicated in the regular treatment of asthma in children and adults, where use of a combination (bronchodilator and inhaled corticosteroid) has been found to be appropriate. Seretide (50/500 mcg) is indicated for the symptomatic treatment of patients with COPD, with a FEV1 <60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Datum autorizace:

2014-05-31

Informace pro uživatele

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a physician’s prescription only
SERETIDE DISKUS 50/100 MCG,
POWDER FOR INHALATION
Each dose contains 50 micrograms salmeterol (as Xinafoate)/
100 micrograms fluticasone propionate inhalation powder.
SERETIDE DISKUS 50/250 MCG,
POWDER FOR INHALATION
Each dose contains 50 micrograms salmeterol (as Xinafoate)/
250 micrograms fluticasone propionate inhalation powder.
SERETIDE DISKUS 50/500 MCG,
POWDER FOR INHALATION
Each dose contains 50 micrograms salmeterol (as Xinafoate)/
500 micrograms fluticasone propionate inhalation powder.
For
the
list
of
the
inactive
and
allergenic
ingredients
see
section
2
–
“Important information about some of the ingredients of the
medicine” and
section 6 – “Additional information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Seretide Diskus contains two active ingredients: salmeterol and
fluticasone
propionate:
•
Salmeterol is a long-acting bronchodilator. Bronchodilators help the
airways
in the lungs to stay open. This makes it easier for air to get in and
out. The
effect last for at least 12 hours.
•
Fluticasone propionate is a corticosteroid which reduces swelling and
irritation in the lungs.
The
physician
has
prescribed
this
medicine
to
help
prevent
breathing
problems such as:
•
Asthma
•
COPD – Seretide Diskus, at a dose of 50/250 and 50/500 micrograms,
is
also indicated to treat chronic obstructive pulmonary disease (COPD).
The
medicine reduces the number of flare-ups of COPD symptoms.
You must use Seretide Diskus every day as directed by your physician.
This
will make sure that it works proper

Charakteristika produktu

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_ _
SERETIDE DISKUS 50/100 MCG
SERETIDE DISKUS 50/250 MCG
SERETIDE DISKUS 50/500 MCG
1.
NAME OF THE MEDICINAL PRODUCT
Seretide Diskus 50/100 mcg.
Seretide Diskus 50/250 mcg.
Seretide Diskus 50 /500 mcg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 47
micrograms of salmeterol (as salmeterol xinafoate) and 92, 231 or 460
micrograms of
fluticasone propionate. This corresponds to a pre-dispensed dose of 50
micrograms of
salmeterol (as salmeterol xinafoate) and 100, 250 or 500 micrograms
fluticasone propionate.
Excipients with known effect:
Each delivered dose contains up to 12.5 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
_ _
Moulded plastic device containing a foil strip with 60 regularly
placed blisters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ASTHMA _
_ _
Seretide is indicated in the regular treatment of asthma in children
and adults, where use of a
combination (bronchodilator
_ _
and inhaled corticosteroid) has been found to be
_ _
appropriate.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) _
_ _
Seretide (50/250 & 50/500mcg) is indicated for the symptomatic
treatment of patients with
COPD, with a FEV
1
<60% predicted normal (pre-bronchodilator) and a history of repeated
exacerbations, who have significant symptoms despite regular
bronchodilator therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
Route of administration: Inhalation use.
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Patients should be made aware that Seretide Diskus must be used daily
for optimum benefit,
even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Seretide they are
receiving remains optimal
_ _
and is only changed on medical advice.
Patients should be given the strength of Seretide containing the
appropriate fluticasone
propionate dosage for the severity of their disease. If an individual
patient should require