Ipratropium bromide 250micrograms/1ml nebuliser liquid unit dose vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ipratropium bromide

Available from:

Arrow Generics Ltd

ATC code:

R03BB01

INN (International Name):

Ipratropium bromide

Dosage:

250microgram/1ml

Pharmaceutical form:

Nebuliser liquid

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010200; GTIN: 5060034832980

Patient Information leaflet

THIS LEAFLET WAS LAST REVISED IN JANUARY 2018.
MANUFACTURING
MARKETING AUTHORISATION HOLDER
Laboratoire Unither, Espace Industriel Nord, 151 rue André Durouchez
-
CS 28028, 80084 AMIENS CEDEX 2, France.
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow,
Middlesex, HA1 4HF, United Kingdom.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. You can also
report side
effects directly via Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.
BBBA0952
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IPRATROPIUM BROMIDE 250MCG/1ML & 500MCG/2ML PIL - UK
3
Black
Profile
S.Anson
16.06.17
11.01.18
S.Anson
BBBA0952
200 x 280
9pt
Laboratoire Unither
16.06.17
12.07.17

Summary of Product characteristics

OBJECT 1
IPRATROPIUM BROMIDE 250 MICROGRAMS/1ML
NEBULISER SOLUTION
Summary of Product Characteristics Updated 23-Mar-2018 | Accord-UK Ltd
1. Name of the medicinal product
Ipratropium Bromide 250 micrograms/1ml Nebuliser Solution
Ipratropium Bromide 500 micrograms/2ml Nebuliser Solution.
2. Qualitative and quantitative composition
Each ampoule contains ipratropium bromide at 250 micrograms/1ml i.e.
250 micrograms in 1ml and 500
micrograms in 2ml.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Nebuliser Solution.
A clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Ipratropium bromide is indicated for the treatment of reversible
bronchospasm associated with chronic
obstructive pulmonary disease (COPD).
Ipratropium bromide is 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
This medicinal product is for inhalation use only.
The dosage should be adapted to the individual needs of the patient.
In children aged 12 years and under,
only Ipratropium Bromide Nebuliser Solution 1 ml should be used. The
following doses are
recommended:
Adults (including the elderly) and children over 12 years of age:
250 - 500 micrograms (i.e. one vial of 250 micrograms in 1 ml or one
vial of 500 micrograms in 2ml) 3 to
4 times daily. The exact starting dose may vary depending on local
guidelines.
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 children over 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