Combiprasal 0.5 mg/2.5 mg per 2.5 ml nebuliser solution

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Ipratropium bromide; SALBUTAMOL SULFATE

可用日期:

Pharma Stulln GmbH

ATC代码:

R03AL; R03AL02

INN（国际名称）:

Ipratropium bromide; SALBUTAMOL SULFATE

剂量:

0.5 mg/2.5 milligram(s)

药物剂型:

Nebuliser solution

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Adrenergics in combination with anticholinergics; salbutamol and ipratropium bromide

授权状态:

Marketed

授权日期:

2014-01-10

资料单张

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
COMBIPRASAL 0.5 MG / 2.5 MG PER 2.5 ML
NEBULISER SOLUTION
IPRATROPIUM BROMIDE AND 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 COMBIPRASAL is and what it is used for
2. What you need to know before you use COMBIPRASAL
3. How to use COMBIPRASAL
4. Possible side effects
5.
How to store COMBIPRASAL
6. Contents of the pack and other information
1.
WHAT COMBIPRASAL IS AND WHAT IT IS USED FOR
The name of your medicine is COMBIPRASAL. You use it with a device
called a ‘nebuliser’. This changes
your medicine into a mist for you to breathe in.
The active substances are ipratropium bromide and salbutamol. Both
belong to a group of medicines called
bronchodilators. They work by opening up your airways and therefore
making breathing easier.
COMBIPRASAL is used in adults and children over 12 years to treat long
term breathing problems
(e.g. chronic bronchitis and emphysema).
COMBIPRASAL alleviates wheezing when breathing, shortness of breath
and tightness in the chest.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE COMBIPRASAL
DO NOT USE COMBIPRASAL
-
if you are allergic to salbutamol, ipratropium bromide or atropine
(including medicines similar to
atropine) or any of the other ingredients of this medicine (listed in
section 6).
-
if you have heart rhythm disorder including a very fast heart beat.
-
if you know that your heart is enlarged or if you have a heart problem
called ‘hypertrophic obstructive
cardiomyopathy’. This is where the wall bet

产品特点

Health Products Regulatory Authority
07 October 2021
CRN00CGHS
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Combiprasal 0.5 mg / 2.5 mg per 2.5 ml nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-dose container (2.5 ml) contains 0.5 mg ipratropium
bromide (as monohydrate) and 2.5 mg salbutamol (as
salbutamol sulfate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
A clear, colourless solution (pH approx. 3.5, osmolality approx. 300
mOsm/kg).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Combiprasal 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 patients and children over 12 years)_
The content of one single-dose container three or four times daily.
_Paediatric population (under 12 years)_
The safety and efficacy of Combiprasal in children aged under 12 years
have not been established. Combiprasal is not
recommended in children below 12 years of age.
Method of administration
Inhalation use.
Drug delivery characteristics were studied _in vitro_ using an eFlow
rapid electronic nebuliser and a PARI LC Sprint nebuliser:
NEBULISER
DROPLET SIZE
DISTRIBUTION
[micrometer]
DRUG DELIVERY RATE
[microgram/minute]
TOTAL DRUG DELIVERED
[microgram]
D10
D50*
D90
eFlow rapid electronic
nebuliser
2.5
4.7
10.4
Salbutamol: 361.2
Ipratropium: 73.6
Salbutamol: 1185.7
Ipratropium: 240.6
PARI LC Sprint nebuliser
(used with PARI Boy SX
compressor)
1.4
4.2
13.2
Salbutamol: 137.9
Ipratropium: 28.1
Salbutamol: 1031.7
Ipratropium: 206.7
*
Median Mass Diameter
Health Products Regulatory Authority
07 October 2021
CRN00CGHS
Page 2 of 10
No information is available in respect of pulmonary inhalation and
deposition patterns across nebuliser systems that have not
been studied.
The use of an al