Symbicort 400/12 Turbuhaler

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Budesonide 320ug equivalent to 400 µg metered dose;  ;  ;  ; Formoterol fumarate 9ug equivalent to 12 µg metered dose;  

Disponible des:

AstraZeneca Limited

Designació comuna internacional (DCI):

Budesonide 400 µg (equivalent to 320 µg delivered dose)

formulario farmacéutico:

Powder for inhalation

Composición:

Active: Budesonide 320ug equivalent to 400 µg metered dose       Formoterol fumarate 9ug equivalent to 12 µg metered dose   Excipient: Lactose monohydrate

Unidades en paquete:

Inhaler, metered, Turbuhaler, 60 dose units

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Minakem Dunkerque Production

indicaciones terapéuticas:

SYMBICORT TURBUHALER is indicated in the treatment of asthma to achieve overall asthma control, including the prevention and relief of symptoms as well as the reduction of the risk of exacerbations. SYMBICORT TURBUHALER is suitable for any asthma severity, where the use of inhaled corticosteroids is appropriate.

Resumen del producto:

Package - Contents - Shelf Life: Inhaler, metered, Turbuhaler - 60 dose units - 24 months from date of manufacture stored at or below 30°C

Data d'autorització:

2001-12-12

Informació per a l'usuari

Symbicort

Turbuhaler

CMI 200720
Copyright
1(8)
SYMBICORT
® TURBUHALER
®
Budesonide/formoterol
100/6, 200/6 or 400/12 micrograms per inhalation
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
SYMBICORT TURBUHALER. It does
not contain all the information that is known about SYMBICORT
TURBUHALER. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed
the risks of you taking SYMBICORT
TURBUHALER against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT SYMBICORT TURBUHALER IS USED FOR
SYMBICORT TURBUHALER is used to treat the inflammation caused by your
airway disease (asthma or
chronic obstructive pulmonary disease (COPD)). It also widens the
airways so that you find it easier to
breathe. To get the best effect, you should use SYMBICORT TURBUHALER
as prescribed by your doctor,
even when you have no symptoms._ _
SYMBICORT TURBUHALER contains both the medicines budesonide and
formoterol, which have different
ways of treating your airway disease (asthma or chronic obstructive
pulmonary disease). Your airway
disease is caused by an inflammation in the airways. Budesonide
reduces and prevents this
inflammation.
Formoterol works by widening your airways, making it easier for you to
breathe. This effect starts within
1-3 minutes after inhaling the medicine and lasts for up to 12 hours.
When you breathe in through the
mouthpiece of the inhaler, your breath carries the medicine to your
lungs. See the instructions on “HOW
TO USE TURBUHALER” in the pack.
SYMBICORT TURBUHALER is not addictive.
SYMBICORT TURBUHALER is only available with a doctor’s prescription.
BEFORE YOU USE SYMBICORT TURBUHALER
_WHEN YOU MUST NOT USE IT _
DO NOT USE SYMBICORT TURBUHALER IF YOU ARE PREGNANT OR BREAST FEEDING
UNLESS YOUR DOCT

Fitxa tècnica

S
YMBICORT
T
URBUHALER
Data Sheet 170223
Copyright
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
S
YMBICORT
®
100/6 T
URBUHALER
®
, inhalation powder
S
YMBICORT
®
200/6 T
URBUHALER
®
, inhalation powder
S
YMBICORT
®
400/12 T
URBUHALER
®
, inhalation powder
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SYMBICORT 100/6 TURBUHALER
S
YMBICORT
100/6 T
URBUHALER
delivers the same amount of budesonide and formoterol as
the corresponding Turbuhaler monoproducts, i.e. budesonide 100
micrograms/inhalation
(metered dose) and formoterol fumarate dihydrate 6
micrograms/inhalation (metered dose).
Each delivered dose (the dose that leaves the mouthpiece) contains as
active constituents:
budesonide
80
micrograms/inhalation
and
formoterol
fumarate
dihydrate
4.5
micrograms/inhalation.
Each inhaler contains 60 doses or 120 doses
SYMBICORT 200/6 TURBUHALER
S
YMBICORT
200/6 T
URBUHALER
delivers the same amount of budesonide and formoterol as
the corresponding Turbuhaler monoproducts, i.e. budesonide 200
micrograms/inhalation
(metered dose) and formoterol fumarate dihydrate 6
micrograms/inhalation (metered dose).
Each delivered dose (the dose that leaves the mouthpiece) contains as
active constituents:
budesonide
160
micrograms/inhalation
and
formoterol
fumarate
dihydrate
4.5
micrograms/inhalation.
Each inhaler contains 60 doses or 120 doses
SYMBICORT 400/12 TURBUHALER
S
YMBICORT
400/12 T
URBUHALER
delivers the same amount of budesonide and formoterol as
the corresponding Turbuhaler monoproducts, i.e. budesonide 400
micrograms/inhalation
(metered dose) and formoterol fumarate dihydrate 12
micrograms/inhalation (metered dose).
Each delivered dose (the dose that leaves the mouthpiece) contains as
active constituents:
budesonide
320
micrograms/inhalation
and
formoterol
fumarate
dihydrate
9
micrograms/inhalation.
Each inhaler contains 60 doses
Formoterol fumarate dihydrate is hereafter referred to as formoterol.
2
S
YMBICORT
T
URBUHALER
Data Sheet 170223
Copyright
3.
PHARMACEUTICAL FORM
Inhalation powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUT