Salbulin Novolizer 100micrograms/dose inhalation powder

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Salbutamol sulfate

Предлага се от:

Viatris UK Healthcare Ltd

АТС код:

R03AC02

INN (Международно Name):

Salbutamol sulfate

дозиране:

100microgram/1dose

Лекарствена форма:

Inhalation powder

Начин на приложение:

Inhalation

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 03010101; GTIN: 5060035241903

Листовка

T5008758
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 or pharmacist.
•
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 SALBULIN MDPI NOVOLIZER IS
AND WHAT IT IS USED FOR.
2. WHAT YOU NEED TO KNOW BEFORE
USING SALBULIN MDPI NOVOLIZER.
3. HOW TO USE SALBULIN MDPI
NOVOLIZER.
4.
POSSIBLE SIDE-EFFECTS.
5. HOW TO STORE SALBULIN MDPI
NOVOLIZER.
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION.
7. INSTRUCTIONS FOR USING THE
NOVOLIZER DEVICE.
1.
WHAT SALBULIN MDPI NOVOLIZER IS
AND WHAT IT IS USED FOR
Salbulin MDPI Novolizer is indicated in
adults, adolescents and children aged 6 to
12 years.
Salbulin MDPI Novolizer is a powder
for inhalation containing the active
substance salbutamol.
Salbutamol belongs to a group of
anti-asthmatic drugs known as
bronchodilators which are used to relieve
symptoms such as chest tightness,
wheezing or cough caused by asthma or
other conditions. Salbutamol can also be
used to prevent asthma symptoms
brought on by exercise and other
'triggers' such as pollen.
For instructions for using the Novolizer
Inhaler Device, see section 7 on the
reverse side of this leaflet.
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE SALBULIN MDPI
NOVOLIZER
DO NOT take Salbulin MDPI Novolizer
if:
• you are allergic (hypersensitive) to
salbutamol, lactose or milk protein
Warnings and precautions
Talk to your doctor before
using
Salbulin MDPI Novolizer if you
can
answer ‘yes’ to any of the
following questions:
• do you have any heart or circulatory
problems, particularly a recent heart
attack or angina?
• do you suffer from high blood
pressure?
• have

Данни за продукта

OBJECT 1
SALBULIN MDPI NOVOLIZER 100MCG INHALATION
POWDER
Summary of Product Characteristics Updated 02-Feb-2018 | Meda
Pharmaceuticals
1. Name of the medicinal product
Salbulin MDPI Novolizer
100 micrograms / dose inhalation powder
2. Qualitative and quantitative composition
One delivered dose contains 100 micrograms of salbutamol equivalent to
120 micrograms of salbutamol
sulphate.
The delivered dose is the dose which is available for the patient
after passing the mouthpiece.
Excipient:
11.42 milligrams mg of lactose monohydrate/delivered dose.
3. Pharmaceutical form
Inhalation powder
White powder
4. Clinical particulars
4.1 Therapeutic indications
Salbulin MDPI Novolizer 100 micrograms is indicated in adults,
adolescents and children aged 6 to 12
years.
Salbulin MDPI Novolizer 100 micrograms is recommended for use in
patients with reversible airways
obstruction such as asthma for relief and prevention of asthma
symptoms. It should be used to relieve
asthma symptoms when they occur and to prevent symptoms in
circumstances known by the patient to
precipitate symptoms, for example prior to exercise or allergen
exposure.
Salbulin MDPI Novolizer 100 micrograms is particularly useful for the
relief of symptoms of asthma,
providing it does not delay the introduction and regular use of
inhaled corticosteroid therapy.
4.2 Posology and method of administration
_Posology_
The dose depends on the type, severity, and course of the disorder.
Adults (including older people and adolescents)
For the relief of acute asthma symptoms including bronchospasm a
starting dose of one inhalation (100
micrograms) is recommended for adults; this dose may be increased to
two inhalations if necessary.
For prevention of exercise-induced or allergen induced symptoms two
inhalations (200 micrograms)
should be taken 10-15 minutes prior to challenge.
The maximum on-demand use in any 24 hours should not exceed 8
inhalations (equivalent to 800
micrograms).
Children (aged 6 to 12 years)
For the relief of acute asthma symptoms including bronchospas