PAVTIDE MDI 250/25 fluticasone propionate 250 mcg/salmeterol (as xinafoate) 25 mcg inhalation pressurised aerosol can metered dose (with counter)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

20-10-2021

Summary of Product characteristics (SPC)

21-08-2021

Public Assessment Report (PAR)

27-11-2017

Active ingredient:

fluticasone propionate, Quantity: 250 microgram/actuation; salmeterol xinafoate, Quantity: 36.3 microgram/actuation (Equivalent: salmeterol, Qty 25 microgram/actuation)

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

fluticasone propionate,Salmeterol xinafoate

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: norflurane

Administration route:

Inhalation

Units in package:

Sample Pack, 120 doses

Prescription type:

(S4) Prescription Only Medicine

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 beta2-agonists and inhaled corticosteroids.,*Patients who are symptomatic on current inhaled corticosteroid therapy.,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. Pavtide is not indicated for the initiation of bronchodilator therapy in COPD.

Product summary:

Visual Identification: Actuator & metal can with concave base fitted with a metering valve and a plastic doese counter. The canister contains a white to off-white suspension. The internal surfaces of the can & the valve are free from obvious defects.; Container Type: Aerosol Can - Metered Dose; Container Material: Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-05-07

Patient Information leaflet

PAVTIDE MDI
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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 PAVTIDE MDI?
PAVTIDE MDI contains the active ingredients fluticasone propionate and
salmeterol xinafoate. PAVTIDE MDI 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 PAVTIDE MDI? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PAVTIDE MDI?
Do not use if you have ever had an allergic reaction to any medicine
containing fluticasone propionate or salmeterol xinafoate 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
PAVTIDE MDI? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PAVTIDE MDI 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 PAVTIDE MDI?
•
Follow dosage directions given to you by your doctor or pharmacist and
continue taking it for as long as your doctor tells you.
•
PAVTIDE MDI should be inhaled into your lungs through the mouth.
More instructions can be found in Section 4. How do I use PAVTIDE MDI?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PAVTIDE MDI?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
PAVTIDE MDI.
•
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 PAVTIDE MDI, if you have any blood
tests.
•
Contact your doctor if you experience a change in your vision.
•
Keep all of your d

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Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
PAVTIDE (FLUTICASONE PROPIONATE/ SALMETEROL XINAFOATE)
ACCUHALER AND MDI
1
NAME OF THE MEDICINE
Fluticasone propionate/ salmeterol xinafoate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PAVTIDE 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).
PAVTIDE 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
PAVTIDE 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
PAVTIDE ACCUHALER: Powder for inhalation
PAVTIDE 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. PAVTIDE is not indicated for
the initiation of
bronchodilator therapy in COPD.
4.2
DOSE AND METHOD OF ADMINISTRATION
PAVTIDE ACCUHALER and MDI are for inhalation only.
PAVTIDE ACCUHALER and MDI must be used regularly for optimum benefit,
even when
asymptomatic.

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