Ipratropiumbromide/Salbutamol Sandoz 0,5/2,5 mg per 2,5 ml, verneveloplossing

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

IPRATROPIUMBROMIDE 1-WATER 0,53 mg/flacon SAMENSTELLING overeenkomend met ; IPRATROPIUMBROMIDE 0-WATER 0,5 mg/flacon ; SALBUTAMOLSULFAAT 3 mg/flacon SAMENSTELLING overeenkomend met ; SALBUTAMOL 2,5 mg/flacon

Available from:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC code:

R03AL02

INN (International Name):

IPRATROPIUMBROMIDE 1-WATER 0,53 mg/flacon SAMENSTELLING overeenkomend met ; IPRATROPIUMBROMIDE 0-WATER 0,5 mg/flacon ; SALBUTAMOLSULFAAT 3 mg/flacon SAMENSTELLING overeenkomend met ; SALBUTAMOL 2,5 mg/flacon

Pharmaceutical form:

Verneveloplossing

Composition:

NATRIUMCHLORIDE ; STIKSTOF (HEAD SPACE) (E 941) ; WATER VOOR INJECTIE ; ZWAVELZUUR (E 513),

Administration route:

Inhalatie

Therapeutic area:

Salbutamol and ipratropium bromide

Product summary:

Hulpstoffen: NATRIUMCHLORIDE; STIKSTOF (HEAD SPACE) (E 941); WATER VOOR INJECTIE; ZWAVELZUUR (E 513);

Authorization date:

1900-01-01

Patient Information leaflet

Sandoz B.V.
Page 1/8
Ipratropiumbromide/Salbutamol Sandoz 0,5/2,5 mg
per 2,5 ml verneveloplossing
RVG 109136
1311-v8
1.3.1.3 Leaflet
Juli 2020
PACKAGE LEAFLET: INFORMATION FOR THE USER
IPRATROPIUMBROMIDE/SALBUTAMOL SANDOZ 0,5/2,5 MG PER 2,5 ML,
VERNEVELOPLOSSING
IPRATROPIUM BROMIDE/SALBUTAMOL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What [nationally completed name] is and what it is used for
2.
What you need to know before you use [nationally completed name]
3.
How to use [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
Your medicine is called [nationally completed name]. The active
ingredients are ipratropium bromide
and salbutamol. Ipratropium bromide and salbutamol both belong to a
group of medicines called
bronchodilators, which help to improve your breathing by opening up
your airways. This is achieved by
preventing the contraction of the smooth muscles surrounding the
airways, therefore allowing the
airways to remain open. Ipratropium bromide acts by blocking the nerve
signals that go to the muscles
surrounding the airways, and salbutamol acts by stimulating the beta
2
receptors in the muscles.
[Nationally completed name] is used to treat breathing problems in
people with long-standing
breathing difficulties (such as chronic bronchitis, emphysema).
[Nationally completed name] will
relieve wheezing, shortness of breath and ches

Summary of Product characteristics

Sandoz B.V.
Page 1/9
Ipratropiumbromide/Salbutamol Sandoz 0,5/2,5 mg per
2,5 ml verneveloplossing
RVG 109136
1311-v9
1.3.1.1 Samenvatting van de Productkenmerken
Juli 2020
1.
NAAM VAN HET GENEESMIDDEL
Ipratropiumbromide/Salbutamol Sandoz 0,5/2,5 mg per 2,5 ml,
verneveloplossing
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5ml ampoule contains 0.5 mg of ipratropium bromide (as 525
micrograms ipratropium
bromide monohydrate) and 2.5 mg of salbutamol (as sulphate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nebuliser Solution.
A polyethylene ampoule containing clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed name] is indicated for the management of
bronchospasm in patients suffering
from
chronic
obstructive
pulmonary disease
(COPD)
who
require
regular treatment with both
ipratropium bromide and salbutamol.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_The recommended dose is: _
_Adults (including elderly and children over 12 years)_
: The content of one ampoule three or four times
daily.
_Paediatric population_
: [nationally completed name] is not recommended in children below 12
years
of age due to lack of data on safety and efficacy
Method of administration
_ _
Inhalation use.
[nationally completed name] may be administered from a suitable
nebuliser, e.g. PARI LC PLUS
Nebuliser, jet nebulizer, or an intermittent positive pressure
ventilator after the single dose ampoule
has been opened and its contents transferred to the nebuliser chamber.
The use of the solution for
nebulization is not only limited to the given examples, but can also
be based on the experience of the
clinical professional. For full instructions on the use of the
nebuliser the patient should be instructed
to read the leaflet of the respective device carefully before starting
the inhalation.
Drug delivery characteristics were studied in vitro using the PARI LC
PLUS nebuliser device:
Sandoz B.V.
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Ipratropiumbromide/Salbutamol Sandoz 0,5/2,5 mg per