Ventolin 500micrograms/1ml solution for injection ampoules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Salbutamol sulfate

Dostępny od:

GlaxoSmithKline UK Ltd

Kod ATC:

R03CC02

INN (International Nazwa):

Salbutamol sulfate

Dawkowanie:

500microgram/1ml

Forma farmaceutyczna:

Solution for injection

Droga podania:

Subcutaneous; Intramuscular; Intravenous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 03010101; GTIN: 5000124430030

Ulotka dla pacjenta

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN
®
INJECTION 500 micrograms/ml
SALBUTAMOL SULFATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, nurse 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, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Ventolin Injection is and what it is used for
2
What you need to know before you use Ventolin Injection
3
How to use Ventolin Injection
4
Possible side effects
5
How to store Ventolin Injection
6
Contents of the pack and other information
1
WHAT VENTOLIN INJECTION IS AND WHAT IT IS USED FOR
Ventolin Injection contains a medicine called salbutamol. This belongs
to a group of
medicines called bronchodilators.

Bronchodilators help the airways in your lungs to stay open. This
makes it easier for air
to get in and out.

They help to relieve chest tightness, wheezing and cough.
Ventolin Injection is used to treat severe breathing problems in
people with asthma
and similar conditions.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN INJECTION
DO NOT USE VENTOLIN INJECTION:

if you are allergic to salbutamol sulfate or any of the other
ingredients of this medicine
(listed in Section 6)

if you unexpectedly go into early labour (premature labour) or
threatened abortion
Do not take if the above applies to you. If you are not sure, talk to
your doctor or pharmacist
before taking Ventolin Injection.
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before taking your medicine
if:

you have high blood pressure

you are diabetic

you have an overactive thyroid gland

you have a history of heart p

Charakterystyka produktu

OBJECT 1
VENTOLIN INJECTION 500MCG
Summary of Product Characteristics Updated 13-Feb-2015 |
GlaxoSmithKline UK
1. Name of the medicinal product
Ventolin® Injection 500 micrograms (0.5mg) in 1ml
2. Qualitative and quantitative composition
Ventolin Injection 500 micrograms (0.5mg) in 1ml (500 micrograms/ml)
is presented as ampoules of 1ml,
each containing 500 micrograms salbutamol as salbutamol sulfate BP in
a sterile isotonic solution.
3. Pharmaceutical form
A colourless or faintly straw coloured solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Ventolin Injection is indicated in adults and adolescents.
Ventolin Injection provides short-acting (4-6 hour) bronchodilation
with a fast onset (within 5 minutes) in
reversible airways obstruction. It is indicated for the relief of
severe bronchospasm.
4.2 Posology and method of administration
Ventolin Injection may be administered by the subcutaneous,
intramuscular or intravenous route, under
the direction of a physician.
Adults:
_Subcutaneous route:_ 500 micrograms (8 micrograms/kg body weight) and
repeated every four hours as
required.
_Intramuscular route:_ 500 micrograms (8 micrograms/kg body weight)
and repeated every four hours as
required.
Slow intravenous injection:
250 micrograms (4 micrograms/kg bodyweight) injected slowly. If
necessary the dose may be repeated.
The use of Ventolin Injection 500 micrograms in 1ml (500
micrograms/ml, for intravenenous
administration may be facilitated by dilution to 10ml with Water for
Injection BP (final concentration of
50 micrograms/ml) and 5mls of the diluted preparation (250
micrograms/5ml) administered by slow
intravenous injection.
_Paediatric Population_
The safety and efficacy of Ventolin Injection in children under the
age of 12 has not been established.
From the available data no recommendation on posology can be made.
Children aged 12 years and over: Dose as per adult population
Instructions to open the ampoule
Ampoules are equipped with the OPC (One Point Cut) opening system and
must be op