SERETIDE ACCUHALER 250/50 powder for inhalation blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

fluticasone propionate, Quantity: 250 microgram/actuation; salmeterol xinafoate, Quantity: 72.5 microgram/actuation (Equivalent: salmeterol, Qty 50 microgram/actuation)

Prieinama:

GlaxoSmithKline Australia Pty Ltd

Vaisto forma:

Inhalation, powder for

Sudėtis:

Excipient Ingredients: lactose monohydrate

Vartojimo būdas:

Oral

Vienetai pakuotėje:

28 dose (sample), 28 dose, 60 dose

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

For the regular treatment of asthma, where the use of a combination product is appropriate. This may include: Patients on effective maintenance doses of long-acting beta2-agonists and inhaled corticosteroids. Patients who are symptomatic on current inhaled corticosteroid therapy. Initiation of maintenance therapy in those patients with moderate persistent asthma not adequately controlled on as needed reliever medication, and who have moderate/severe airway limitation and daily symptoms requiring reliever medication every day (see CLINICAL TRIALS). For the symptomatic treatment of patients with severe COPD (FEV1<50% predicted normal) and a history of repeated exacerbations who have significant symptoms despite regular beta-2 agonist bronchodilator therapy. Seretide is not indicated for the initiation of bronchodilator therapy in COPD.

Produkto santrauka:

Visual Identification: A two-tone purple, circular device in moulded plastic, approximately 8.5cm in diameter and approximately 3cm high, with a dose counter indicating 28 or 60 doses.; Container Type: Blister Pack; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Autorizacija statusas:

Licence status A

Leidimo data:

2000-02-08

Pakuotės lapelis

SERETIDE
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SERETIDE?
SERETIDE contains the active ingredients fluticasone propionate and
salmeterol xinafoate. SERETIDE is used to help with asthma
and chronic obstructive pulmonary disease (COPD) in people who need
regular treatment.
For more information, see Section 1. Why am I using SERETIDE? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SERETIDE?
Do not use if you have ever had an allergic reaction to any medicine
containing fluticasone propionate or salmeterol xinafoate or
lactose monohydrate or milk proteins (this applies to ACCUHALER only)
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
SERETIDE? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SERETIDE and affect how it works. A
list of these medicines is in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE SERETIDE?
•
Follow dosage directions given to you by your doctor or pharmacist and
continue taking it for as long as your doctor tells you.
•
SERETIDE should be inhaled into your lungs through the mouth, through
one of two presentations; the ACCUHALER or the
Metered Dose Inhaler (MDI).
More instructions can be found in Section 4. How do I use SERETIDE? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SERETIDE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
SERETIDE.
•
If you are going to have surgery, tell the surgeon or anesthetist that
you are taking this medicine.
•
Tell your doctor if you become, or are trying to become, pregnant.
•
Tell your doctor if you are using SERETIDE, if you h

Prekės savybės

1
AUSTRALIAN PRODUCT INFORMATION
SERETIDE (FLUTICASONE PROPIONATE/ SALMETEROL XINAFOATE)
ACCUHALER AND MDI
1
NAME OF THE MEDICINE
Fluticasone propionate/ salmeterol xinafoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SERETIDE ACCUHALER:
Each a foil strip contains regularly placed blisters each containing
100, 250 or 500
micrograms of fluticasone propionate and 50 micrograms of salmeterol
(as xinafoate).
SERETIDE metered dose inhaler (MDI):
Each single actuation provides 50, 125 or 250 micrograms of
fluticasone propionate and 25
micrograms of salmeterol (as xinafoate).
LIST OF EXCIPIENTS WITH KNOWN EFFECT
SERETIDE ACCUHALER also contains the excipient lactose monohydrate
(which contains
milk protein) (see Section 4.3 CONTRAINDICATIONS).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SERETIDE ACCUHALER: Powder for inhalation
SERETIDE MDI: Pressurised inhalation
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the regular treatment of asthma, where the use of a combination
product is appropriate.
This may include:
•
Patients on effective maintenance doses of long-acting beta-2 agonists
and inhaled
corticosteroids
•
Patients who are symptomatic on current inhaled corticosteroid therapy
•
Initiation of maintenance therapy in those patients with moderate
persistent asthma
not adequately controlled on ‘as needed’ reliever medication, and
who have
moderate/severe airway limitation and daily symptoms requiring
reliever medication
every day (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical
trials).
For the symptomatic treatment of patients with severe COPD (FEV1<50%
predicted normal)
and a history of repeated exacerbations who have significant symptoms
despite regular
2
beta-2 agonist bronchodilator therapy. SERETIDE is not indicated for
the initiation of
bronchodilator therapy in COPD.
4.2
DOSE AND METHOD OF ADMINISTRATION
SERETIDE ACCUHALER and MDI are for inhalation only.
SERETIDE ACCUHALER and MDI must be used regularly for optimum benefit,
even when
asym