Salipraneb 0.5mg/2.5mg nebuliser solution 2.5ml ampoules

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Ipratropium bromide; Salbutamol sulfate

Disponibbli minn:

Actavis UK Ltd

Kodiċi ATC:

R03AL02

INN (Isem Internazzjonali):

Ipratropium bromide; Salbutamol sulfate

Dożaġġ:

200microgram/1ml ; 1mg/1ml

Għamla farmaċewtika:

Nebuliser liquid

Rotta amministrattiva:

Inhalation

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 03010400; GTIN: 5012617025807

Fuljett ta 'informazzjoni

Ipratropium Salbutamol 0,5 2,5mg Nebuliser Solution PIL UK
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TECHNICAL APPROVAL
black
AAAJ0147
3
9.5.16
db
16.5.16
db
Laboratoire Unither
200 x 280
9 pt
9.5.16
10.5.16
* Please note that only Actavis Global Artwork Studios are permitted
to make changes to the above
artwork. No changes are permitted by any 3rd party other than added
notes and mark ups for
required changes.
WHAT IS IN THIS LEAFLET:
1. What Salipraneb Nebuliser Solution is and what it is used for
2. What you need to know before you use Salipraneb Nebuliser Solution
3. How to use Salipraneb Nebuliser Solution
4. Possible side effects
5. How to store Salipraneb Nebuliser Solution
6. Contents of the pack and other information
1. WHAT SALIPRANEB NEBULISER SOLUTION IS AND WHAT IT IS USED FOR
Salipraneb Nebuliser Solution belongs to a group of medicines called
“bronchodilators” which help to open up the air passages in your
lungs so
that you can breathe more easily.
Salipraneb Nebuliser Solution helps to make breathing easier in
patients
who have long-standing breathing difficulties.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE SALIPRANEB NEBULISER
SOLUTION
DO NOT USE SALIPRANEB NEBULISER SOLUTION:
•
If you are allergic (hypersensitive) to ipratropium bromide,
salbutamol
sulfate, atropine or any of the other ingredients of Salipraneb
Nebuliser
Solution (see section 6)
•
If you have a heart condition called cardiomyopathy (this is when your
heart does not work properly due to inflammation of the heart muscles)
•
If you have a fast and irregular heartbeat (known as tachyarrhythmia)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist if any of the following apply to
you:
•
If you are pregnant, thinking of becoming pregnant or if you are
breast-
feeding
•
If you have diabetes
•
If you have a heart condition

Karatteristiċi tal-prodott

OBJECT 1
SALIPRANEB 0.5MG / 2.5MG PER 2.5 ML NEBULISER
SOLUTION
Summary of Product Characteristics Updated 24-Aug-2016 | Accord-UK Ltd
1. Name of the medicinal product
Salipraneb 0.5mg / 2.5mg per 2.5 ml Nebuliser Solution
2. Qualitative and quantitative composition
Each 2.5 ml single dose ampoule contains 0.5mg of ipratropium bromide
(as monohydrate) and 2.5mg of
salbutamol (as sulfate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Nebuliser Solution.
A 2.5ml ampoule containing 2.5ml of colourless nebuliser solution.
4. Clinical particulars
4.1 Therapeutic indications
Salipraneb is indicated for the management of bronchospasm in patients
suffering from chronic
obstructive pulmonary diseases (COPD) who require regular treatment
with both ipratropium bromide
and salbutamol.
4.2 Posology and method of administration
Posology
For inhalation use.
The recommended dose is:
_Adults (including elderly patients and children over 12 years):_ 1
ampoule three or four times daily.
_Paediatric population_
_Children under 12 years: _There is no experience of the use of
Salipraneb in children under 12 years.
Method of Administration
Salipraneb may be administered from a suitable nebuliser or an
intermittent positive pressure ventilator
after the single dose ampoule has been opened and its contents
transferred to the nebuliser chamber.
Administration should be in accordance with the manufacturer's
instructions for the device. The solution
in the single dose ampoules is intended for inhalation use only and
should not be taken orally or
administered parenterally.
1. Prepare the nebuliser by following the manufacturer's instructions
and the advice of your doctor.
2. Carefully separate a new ampoule from the strip. Never use an
ampoule that has been opened already.
3. Open the ampoule by simply twisting off the top, always taking care
to hold it in an upright position.
4. Unless otherwise instructed by your doctor, squeeze all the
contents of the plastic ampoule into the
nebuliser chamber.
5. Assemble the