ATROVENT

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

IPRATROPIUM BROMIDE

Dostopno od:

BOEHRINGER INGELHEIM ISRAEL LTD.

Koda artikla:

R03BB01

Farmacevtska oblika:

INHALER

Sestava:

IPRATROPIUM BROMIDE 0.02 MG

Pot uporabe:

INHALATION

Tip zastaranja:

Required

Izdeluje:

BOEHRINGER INGELHEIM PHARMA GMBH & CO.KG, GERMANY

Terapevtska skupina:

IPRATROPIUM BROMIDE

Terapevtsko območje:

IPRATROPIUM BROMIDE

Terapevtske indikacije:

For the relief of symptoms of reversible bronchospasm associated with asthma, chronic bronchitis and emphysema.

Datum dovoljenje:

2024-01-31

Navodilo za uporabo

Atrovent
Proposed patient information
Metered dose inhaler
November 2020
Boehringer Ingelheim Israel
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
ATROVENT
®
INHALER
EACH PUFF RELEASES: 0.02 MILLIGRAM IPRATROPIUM BROMIDE
Inactive ingredients and allergens: see section 2 under ‘Important
information about
some of this medicine’s ingredients’, and section 6 ‘Additional
information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Relieving symptoms of reversible bronchospam in cases of asthma,
chronic
bronchitis, and emphysema.
THERAPEUTIC GROUP: anticholinergic.
ATROVENT is an inhaler that dilates the airways in cases of
bronchospasm
(constriction of the bronchial walls), so that you can breathe freely
more easily.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient ipratropium
bromide, to
atropine or atropine derivatives (anticholinergic substances with
similar
structure) or to any of the other ingredients in this medicine (listed
in
section 6).
•
You are pregnant (particularly during the first three months) or are
breastfeeding, unless your doctor has recommended this treatment after
weighing the risks and benefit.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
•
Talk to your doctor or pharmacist before using this medicine.
•
Make sure that the solution or medicine mist does not get in your
eyes.
•
Use ATROVENT with caution if you have a tendency to narrow-angle
glaucoma.
If the medicine accidentally gets in your eyes during use, mild and
reversible
eye complications may occu

Lastnosti izdelka

Atrovent
Proposed prescribing information
Boehringer Ingelheim
November 2020
Boehringer Ingelheim Israel 2
ATROVENT
IPRATROPIUM BROMIDE 0.02 MG
Metered Dose Inhaler
1.
NAME OF THE MEDICINAL PRODUCT
Atrovent
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation delivers 0.02 mg Ipratropium bromide.
Excipient with known effect: Ethanol. For the full list of excipients,
see section 6.1.
3.
PHARMACEUTICAL FORM
Metered dose inhaler
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atrovent is indicated for the relief of symptoms of reversible
bronchospasm associated with asthma,
chronic bronchitis and emphysema.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage should be adapted to the individual requirements of the
patient; patients should also be
kept under medical supervision during treatment. It is advisable not
to greatly exceed the
recommended daily dose during both acute and maintenance treatment.
If therapy does not produce a significant improvement or if the
patient's condition worsens, medical
advice must be sought in order to determine a new regimen of therapy.
In the case of acute or rapidly
worsening dyspnea, a doctor should be consulted immediately.
The recommended dosage is as follows:
_Adults _
Usually 1 or 2 puffs four times daily, although some patients may need
up to 4 puffs at a time to obtain
maximum benefit during early treatment. However, the total number of
inhalations should not exceed
12 in 24 hours.
_Children _
6-12 years: Usually 1 or 2 puffs three times daily.
In order to ensure that the inhaler is used correctly, administration
should be supervised by an adult.
The dose recommendations are the same for children < 6 years of age.
As there is insufficient ex-
perience in this age group, inhalation of the product should be
medically supervised.
Atrovent
Proposed prescribing information
Boehringer Ingelheim
November 2020
Boehringer Ingelheim Israel
2
4.3
CONTRAINDICATIONS
Atrovent is contraindicated in patients with hypersensitivity to the
active substance, to atropine o