Atrovent 500micrograms/2ml nebuliser liquid UDVs

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

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07-06-2018

Virkt innihaldsefni:

Ipratropium bromide

Fáanlegur frá:

Boehringer Ingelheim Ltd

ATC númer:

R03BB01

INN (Alþjóðlegt nafn):

Ipratropium bromide

Skammtar:

250microgram/1ml

Lyfjaform:

Nebuliser liquid

Stjórnsýsluleið:

Inhalation

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 03010200; GTIN: 5012816012219 5012816012110

Upplýsingar fylgiseðill

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects gets troublesome
or serious, or if you notice any side effects
not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1. What ATROVENT UDVs, 2 ml are and what
they are used for
2. Before you use ATROVENT UDVs, 2ml
3. How to use ATROVENT UDVs, 2 ml
4. Possible side effects
5. How to store ATROVENT UDVs, 2 ml
6. Further information
1. WHAT ATROVENT UDVS, 2 ML ARE AND
WHAT THEY ARE USED FOR
The name of your medicine is ATROVENT
UDVs, 2 ml (called ATROVENT in the rest of
this leaflet). You use it with a device called a
‘nebuliser’. This changes your medicine into
a mist for you to breathe in.
ATROVENT contains a medicine called
ipratropium bromide. This belongs to a group
of medicines called anticholinergics which
act as bronchodilators. It is used to make
breathing easier for people who have
breathing difficulties, such as in chronic
asthma or chronic obstructive pulmonary
disease (COPD).
ATROVENT can be taken at the same time as
medicines called ‘beta
2
-agonist
bronchodilators’ such as salbutamol.
ATROVENT works by opening up your
airways.
2. BEFORE YOU USE ATROVENT UDVS, 2 ML
DO NOT USE ATROVENT IF:
• You are allergic (hypersensitive) to
ipratropium bromide or any of the other
ingredients in ATROVENT (listed in Section
6 below)
• You are allergic (hypersensitive) to
medicines that are similar to ATROVENT,
such as atropine
Do not use this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before using
ATROVENT.
TAKE SPECIAL CARE WITH ATROVENT
Check with your doctor or pharmacist before
using your medicine if:
• You have cyst
                                
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Vara einkenni

                                OBJECT 1
ATROVENT 250 UDVS, 1 ML
Summary of Product Characteristics Updated 01-Mar-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Atrovent
®
250 UDVs
®
, 1 ml
Atrovent
®
UDVs
®
, 2 ml
2. Qualitative and quantitative composition
Each single dose unit contains 0.025 % w/v ipratropium bromide i.e.
250 micrograms in 1 ml and 500
micrograms in 2 ml.
For excipients, see 6.1.
3. Pharmaceutical form
Nebuliser solution.
4. Clinical particulars
4.1 Therapeutic indications
ATROVENT UDVs are indicated for treatment of reversible bronchospasm
associated with chronic
obstructive pulmonary disease (COPD).
ATROVENT UDVs are indicated, when used concomitantly with inhaled beta
2
-agonists, for treatment of
reversible airways obstruction as in acute and chronic asthma.
4.2 Posology and method of administration
The dosage should be adapted to the individual needs of the patient.
In children aged 12 years and under,
only ATROVENT 250 UDVs, 1 ml should be used. The following doses are
recommended:
Adults (including the elderly) and adolescents > 12 years of age:
250 - 500 micrograms (i.e. one vial of 250 micrograms in 1 ml or 1
vial of 500 micrograms in 2 ml) 3 to 4
times daily.
For treatment of acute bronchospasm, 500 micrograms.
Repeated doses can be administered until the patient is stable. The
time interval between the doses may
be determined by the physician.
It is advisable not to exceed the recommended daily dose during either
acute or maintenance treatment.
Daily doses exceeding 2 mg in adults and adolescents > 12 years of age
should only be given under
medical supervision.
Children 6 - 12 years of age:
250 micrograms (i.e. one vial of 250 micrograms in 1ml) up to a total
daily dose of 1mg (4 vials).
The time interval between doses may be determined by the physician.
Children 0 – 5 years of age (for treatment of acute asthma only):
125 – 250 micrograms (i.e. half to one vial of 250 micrograms in 1
ml) up to a total daily dose of 1 mg (4
vials).
Ipratropium bromide should be administered no more f
                                
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