VENTOLIN DISKUS

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

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Navodilo za uporabo Navodilo za uporabo (PIL)
18-12-2023
Lastnosti izdelka Lastnosti izdelka (SPC)
01-11-2023
Javno poročilo o oceni Javno poročilo o oceni (PAR)
17-08-2016

Aktivna sestavina:

SALBUTAMOL AS SULFATE

Dostopno od:

GLAXO SMITH KLINE (ISRAEL) LTD

Koda artikla:

R03AC02

Farmacevtska oblika:

POWDER FOR INHALATION

Sestava:

SALBUTAMOL AS SULFATE 200 MCG/DOSE

Pot uporabe:

INHALATION

Tip zastaranja:

Required

Izdeluje:

GLAXO SMITHKLINE TRADING SERVICES LIMITED, IRELAND

Terapevtska skupina:

SALBUTAMOL

Terapevtsko območje:

SALBUTAMOL

Terapevtske indikacije:

Relief of bronchospasm in broncial asthma of all types, chronic, bronchitis and emphysema.

Datum dovoljenje:

2022-11-30

Navodilo za uporabo

                                PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician's prescription only
Ventolin Diskus
Powder for Inhalation
Each metered dose contains:
salbutamol (as sulfate) 200 mcg
Ventolin Diskus contains 60 metered doses.
For the list of the inactive and allergenic ingredients in the
medicine, see
section 2 – Important information about some of the ingredients in
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 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?
Ventolin Diskus is used to treat breathing problems in people with
asthma and
similar conditions. This includes relieving and preventing asthma
brought on
by exercise or other triggers, such as dust, pollen, cats, dogs and
cigarette
smoke.
Therapeutic group:
Selective beta-2 adrenoceptor agonist.
Ventolin Diskus contains a medicine called salbutamol. It belongs to a
group
of medicines called fast-acting bronchodilators.
• Bronchodilators help the airways in your lungs to stay open. This
makes it
easier for air to get in and out.
• They help to relieve chest tightness, wheezing and cough.
2. BEFORE USING THE MEDICINE
Special warnings regarding use of the medicine
Before the treatment with Ventolin Diskus, tell the physician if:
• your asthma is active (for example, you have frequent symptoms or
flare ups
or limited physical ability). Your physician may start or increase a
medicine
to control your asthma such as an inhaled corticosteroid.
• you have high blood pressure.
• you have an overactive thyroid gland.
• you have a history of heart problems, such as an irregular or fast
heartbeat
or angina.
• you are taking xant
                                
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Lastnosti izdelka

                                Page 1 of 6
VENTOLIN DISKUS
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin Diskus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventolin Diskus is a plastic inhaler device containing a foil strip
with 60 regularly spaced blisters
each containing a mixture of 200 micrograms of microfine salbutamol
(as sulfate) and larger
particle lactose.
Excipients with known effect: Contains Lactose monohydrate (which
contains milk protein)
12.5 mg/blister (see section 4.4).
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Multi-dose dry powder inhalation device.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Ventolin Diskus is indicated in adults, adolescents and children.
Ventolin Diskus can be used for relief of bronchospasm in broncial
asthma of all types, chronic
bronchitis and emphysema.
Ventolin Diskus is particularly suitable for the relief of asthma
symptoms. It should be used to
relieve symptoms when they occur, and to prevent them in those
circumstances recognised by the
patient to precipitate an asthma attack (e.g. before exercise or
unavoidable allergen exposure).
Ventolin Diskus is particularly valuable as relief medication in mild,
moderate
or severe asthma, provided that reliance on it does not delay the
introduction and use of regular
inhaled corticosteroid therapy.
4.2
POSOLOGY AND
METHOD OF
ADMINISTRATION
Posology
Adults (including the elderly)_ _
For the relief of acute asthma symptoms including bronchospasm, 100
micrograms may be
administered (with Ventolin Inhaler CFC Free) as a single minimum
starting dose. This may be
increased to 200 mcg if necessary.
To prevent allergen or exercise-induced symptoms, 200 mcg should be
taken 10-15 minutes
before challenge.
For chronic therapy, 200 mcg up to four times a day.
Page 2 of 6
Children
For the relief_ of acute _asthma symptoms including _bronchospasm_, or
before _allergen _exposure _or _
_exercise_, 100 mcg (with Ventolin Inhaler CFC Free), or 200 mcg if
necessary._ _
For chronic_ therapy_, 200 mcg up to four times a day.
_ _
On-demand use o
                                
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