Ventolin 5mg/5ml solution for infusion 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:

1mg/1ml

Forma farmaceutyczna:

Solution for infusion

Droga podania:

Intravenous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 03010101; GTIN: 5000124415709

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN
®
SOLUTION FOR INTRAVENOUS INFUSION 1 mg/ml
SALBUTAMOL SULFATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

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
Infusion is and what it is used for
2
What you need to know before you use Ventolin Infusion
3
How to use Ventolin
Infusion
4
Possible side effects
5
How to store Ventolin Infusion
6
Contents of the pack and other information
1
WHAT VENTOLIN INFUSION IS AND WHAT IT IS USED FOR
Ventolin Solution for Intravenous Infusion (called ‘Ventolin
Infusion’ in this leaflet) contains a
medicine called salbutamol. This belongs to a group of medicines
called ‘beta-agonists’. It
acts on special receptor sites in the lungs and in the uterus (in
women) to:

help the airways in your lungs to stay open. This makes it easier for
air to get in and out.
It helps to relieve chest tightness, wheezing and cough

relax the muscles in the walls of the uterus. This may stop the
contractions associated
with labour.
Ventolin Infusion is used:

to treat severe breathing problems in people with asthma and similar
conditions

in women who have unexpectedly gone into early labour (premature
labour) between the
22
nd
and 37
th
week of gestation, to provide a short delay in the early delivery of
the baby.
You will receive Ventolin Infusion for a maximum of 48 hours. This
will give your doctor
or midwife time to take extra measures that will improve the health of
your baby.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN INFUSION
DO NOT USE VENTOLIN INFUSION IF:

yo

Charakterystyka produktu

OBJECT 1
VENTOLIN SOLUTION FOR IV INFUSION
Summary of Product Characteristics Updated 13-Feb-2015 |
GlaxoSmithKline UK
1. Name of the medicinal product
Ventolin
®
Solution for Intravenous Infusion 5mg in 5ml (1mg/ml).
2. Qualitative and quantitative composition
Ventolin Solution for Intravenous Infusion 5mg in 5ml (1mg/ml) is
presented as ampoules of 5ml, each
containing 5mg salbutamol as Salbutamol Sulfate BP in a sterile
isotonic solution.
3. Pharmaceutical form
Clear, colourless or pale straw-coloured solution for intravenous
infusion.
4. Clinical particulars
4.1 Therapeutic indications
Ventolin Solution for Intravenous Infusion is indicated in adults and
adolescents.
Ventolin Solution for Intravenous Infusion should be administered
under the direction of a physician. It is
indicated for two distinct clinical situations:
a) For the relief of severe bronchospasm.
b) To arrest labour between 22 and 37 weeks of gestation in patients
with no medical or obstetric
contraindication to tocolytic therapy.
4.2 Posology and method of administration
Ventolin Solution for Intravenous Infusion is used to prepare an
infusion solution. It should not be
injected undiluted. Ventolin Solution for Intravenous Infusion should
not be administered in the same
syringe or infusion as any other medication.
1. In severe bronchospasm.
Adults: A suitable solution for infusion providing 10 micrograms
salbutamol/ml is prepared by diluting
5ml Ventolin Solution for Intravenous Infusion to 500ml with an
infusion solution such as Sodium
Chloride and Dextrose Injection BP. Other suitable diluents are Water
for Injections BP, Sodium Chloride
Injection BP or Dextrose Injection BP.
Infusion rates providing 3 to 20 micrograms salbutamol/minute (0.3 to
2ml/minute of the above infusion
solution) are usually adequate. Higher doses have been used with
success in patients with respiratory
failure.
_Paediatric Population_
The safety and efficacy of Ventolin Solution for Intravenous in
children under the age of 12 has not been
established. From the avail