Ipratropium bromide/Salbutamol Neutec 0.5/2.5 mg per 2.5 ml nebuliser solution

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Ipratropium bromide monohydrate; SALBUTAMOL SULFATE

Dostupno od:

Neutec Inhaler Ireland Limited

ATC koda:

R03AL02

INN (International ime):

Ipratropium bromide monohydrate; SALBUTAMOL SULFATE

Farmaceutski oblik:

Nebuliser solution

Područje terapije:

salbutamol and ipratropium bromide

Status autorizacije:

Not marketed

Datum autorizacije:

2023-09-30

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IPRATROPIUM BROMIDE/SALBUTAMOL NEUTEC 0.5 MG/2.5 MG PER 2.5 ML
NEBULISER SOLUTION
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ipratropium bromide/salbutamol Neutec is and what it is used for
2.
What you need to know before you use Ipratropium bromide/salbutamol
Neutec
3.
How to use Ipratropium bromide/salbutamol Neutec
4.
Possible side effects
5.
How to store Ipratropium bromide/salbutamol Neutec
6.
Contents of the pack and other information
1.
WHAT IPRATROPIUM BROMIDE/SALBUTAMOL NEUTEC IS AND WHAT IT IS USED FOR
Ipratropium bromide/salbutamol Neutec contains the active substances
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/salbutamol Neutec is used in adults, and
adolescents aged 12 years and above to
treat long-term breathing problems in an illness called ‘chronic
obstructive pulmonary disease’ or
COPD.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IPRATROPIUM BROMIDE/SALBUTAMOL
NEUTEC
DO NOT USE IPRATROPIUM BROMIDE/SALBUTAMOL NEUTEC, IF YOU:
•
are allergic to salbutamol, ipratropium bromide, atropine (including
medicines similar to
atropine) or any of the other ingredients of this medicine (listed in
section 6).
•
have a heart

Svojstava lijeka

Health Products Regulatory Authority
02 October 2023
CRN00C287
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ipratropium bromide/salbutamol Neutec 0.5/2.5 mg per 2.5 ml nebuliser
solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 mL single-dose container contains 0.5 mg ipratropium bromide
(as ipratropium bromide monohydrate) and 2.5 mg
salbutamol (as salbutamol sulphate), which is equivalent to 0.2 mg
ipratropium bromide and 1 mg of salbutamol per 1 mL.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
A clear, colourless or almost colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ipratropium bromide/salbutamol Neutec is indicated for the symptomatic
treatment of bronchospasm in adults and
adolescents over 12 years of age with chronic obstructive pulmonary
disease who require treatment with both ipratropium
bromide and salbutamol.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose for adults (including elderly patients) and
adolescents over 12 years:
1 single-dose container inhaled via nebuliser three or four times
daily.
_Special patient groups_
_Patients with hepatic or renal impairment_
Ipratropium bromide/salbutamol has not been studied in patients with
hepatic or renal insufficiency and must therefore be
administered with caution in these patient groups.
_Paediatric population_
The safety and efficacy of ipratropium bromide/salbutamol in children
under 12 years of age has not been established,
therefore Ipratropium bromide/salbutamol Neutec is not intended for
use in this group of patients.
_ _
If higher doses than those recommended are required to achieve a good
effect, the patient's overall treatment must be
reviewed by a doctor.
_ _
Method of administration
Inhalation use.
The use of Ipratropium bromide/salbutamol Neutec follows five simple
steps, which are outlined below:
1.
The nebuliser is prepared for use according to the manufacturer's
instructions.
2.
The pouch is opened a