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VENTOLIN SOLUTION FOR INTRAVENOUS INFUSION

Active substance(s): SALBUTAMOL SULPHATE

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10000000124840

v3

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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.
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pharmacist.
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to others. It may harm them, even if their signs of illness are the
same as yours.
Ě ,I\RXJHWDQ\VLGHHIIHFWVWDONWR\RXUGRFWRUQXUVHRU
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 :KDW\RXQHHGWRNQRZEHIRUH\RXXVH9HQWROLQ,QIXVLRQ
3 How to use Ventolin Infusion
4 Possible side effects
5 How to store Ventolin Infusion
6 &RQWHQWVRIWKHSDFNDQGRWKHULQIRUPDWLRQ

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:
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for air to get in and out. It helps to relieve chest tightness,
wheezing and cough
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contractions associated with labour.
Ventolin Infusion is used:
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similar conditions
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(premature labour) between the 22nd and 37thZHHNRIJHVWDWLRQ
WRSURYLGHDVKRUWGHOD\LQWKHHDUO\GHOLYHU\RIWKHEDE\ receive Ventolin Infusion for a maximum of 48 hours. This will
JLYH\RXUGRFWRURUPLGZLIHWLPHWRWDNHH[WUDPHDVXUHVWKDWZLOO
improve the health of your baby.

2 What you need to know before you use
Ventolin Infusion
Do not use Ventolin Infusion if:
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ingredients of this medicine (listed in section 6)
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heart disease (disease characterized by reduced blood supply
to your heart muscle, causing symptoms such as chest pain
(angina))
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of your pregnancy
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when prolongation of your pregnancy would be dangerous (such
as severe high blood pressure, infection of the womb, bleeding,
placenta is covering the birth canal or is detaching, or your baby
has died inside the womb)
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heart valve disorder) or long-standing lung disease (for example
chronic bronchitis, emphysema) causing an increase of blood
pressure to your lungs (pulmonary hypertension).
Warnings and precautions
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Ě GXULQJSUHJQDQF\\RXUZDWHUVKDYHEURNHQ
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(pulmonary oedema)
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sugar tests when you are given Ventolin Infusion
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by breathlessness, palpitations or angina
(see Do not use Ventolin Infusion if).
If you are given Ventolin Infusion for a short
delay in the delivery of a baby, your doctor
will monitor your heart and your unborn baby.

your blood (see section 3).
Other medicines and Ventolin Infusion
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medicines obtained without a prescription. This includes herbal
medicines. Ventolin Infusion can have an effect on the way some
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including eye drops (such as timolol)
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(such as insulin, metformin or glibenclamide)
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Ventolin Infusion should not be administered in the same syringe
or infusion as any other medication.
If you are scheduled for surgery with general anaesthetics your
doctor will stop the administration of Ventolin Infusion 6 hours
before surgery whenever possible to protect you from adverse
effects (e.g. irregular heart beat or bleeding of your womb).
Using Ventolin Infusion with food and drink
without food.
Pregnancy, breast-feeding and fertility
,I\RXDUHSUHJQDQWRUEUHDVWIHHGLQJWKLQN\RXPD\EHSUHJQDQW
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WDNLQJWKLVPHGLFLQH
Driving and using machines
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use any tools or machines.

3 How to use Ventolin Infusion
always be given to you by a person who is qualified to do so.
Where Ventolin infusion is used to temporarily delay premature
labour, it will always be given to you by a person who is qualified
to do so after careful consideration of the balance of benefits of
Ventolin Infusion to your baby and the potential untoward effects
the treatment may have on you.
The Ventolin Infusion will be diluted before it is given to
you. the medicine in the Summary of Product Characteristics (SPC).
To treat severe breathing problems
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for as long as required.
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To temporarily delay premature labour
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until contractions stop.
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should be stopped.
Ventolin Infusion is not suitable for treating children under
12 years of age.
available to continually monitor your health and that of your baby
throughout administration.
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Ě %ORRGSUHVVXUHDQGKHDUWUDWH lowering of your dose or discontinuing Ventolin Infusion if your
heart rate exceeds 120 beats per minute.
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Tell your doctor immediately if you experience chest pain
during treatment. ,IWKHUHDUHFKDQJHVLQ(&*UHFRUGLQJDQG
you have chest pain your doctor will stop the administration of
Ventolin Infusion.

The following information is intended
for Medical or Healthcare Professionals only

Ventolin®
Solution for Intravenous Infusion
1 mg/ml
salbutamol sulfate
To treat severe bronchospasm
Dilute 5 ml of Ventolin Solution for Intravenous Infusion to 500 ml
with Sodium Chloride and Dextrose Injection, Water for Injections,
Sodium Chloride Injection or Dextrose Injection.
To treat premature labour
a) using a syringe pump. Dilute 10 ml of Ventolin Solution for
Intravenous Infusion with 40 ml of 5% dextrose solution and
administer at a rate of 0·05 to 0·225 ml/minute
b) other infusion methods. Dilute 10 ml of Ventolin Solution for
Intravenous Infusion with 490 ml of 5% dextrose solution and
administer at a rate of 0·5 to 2·25 ml/minute.
Please refer to the Summary of Product Characteristics for more
details.
The ampoules are equipped with the OPC (One Point Cut) opening
system and must be opened using the following instructions:
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thumb above the coloured point and press.

.
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Ě %DODQFHRIZDWHUDQGVDOWVLQ\RXUERG\Tell your doctor
immediately if you experience coughing or shortness
of breath during treatment. If any signs indicate that there
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oedema) (e.g. coughing or shortness of breath), your doctor may
stop the administration of Ventolin Infusion.
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EXLOGXSRIODFWDWHLQ\RXUEORRG DOVRNQRZQDVODFWLFDFLGRVLV 
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If you receive more Ventolin Infusion than you should
Ventolin Infusion will always be given under carefully controlled
FRQGLWLRQV+RZHYHULI\RXWKLQNWKDW\RXKDYHEHHQJLYHQPRUH
than you should tell your doctor or nurse as soon as possible.
The following effects may happen:
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become faster
These effects usually wear off in a few hours.
If you stop taking Ventolin Infusion
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,I\RXKDYHDQ\IXUWKHUTXHVWLRQVRQWKHXVHRIWKLVPHGLFLQHDVN
your doctor, nurse or pharmacist.

4 Possible side effects
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not everybody gets them. The following side effects may happen
with this medicine:
Allergic reactions (may affect up to 1 in 10,000 people)
,I\RXKDYHDQDOOHUJLFUHDFWLRQVWRSWDNLQJ9HQWROLQ,QIXVLRQDQG
see a doctor straight away. Signs of an allergic reaction include:
swelling of the face, lips, mouth, tongue or throat which may cause
difficulty in swallowing or breathing, itchy rash, feeling faint and
light headed, and collapse.
Important side effects to look out for when treated
for premature labour:
Rare (may affect up to 1 in 1,000 people)
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happens to you, tell your doctor or nurse straight away.
Tell your doctor if you have any of the following side effects
which may also happen with this medicine:
Very common (may affect more than 1 in 10 people)
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Ě 1fast heart beats.
Common (may affect up to 1 in 10 people)
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Ě 1pounding heart beat (palpitations)
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dizziness
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PXVFOHZHDNQHVVWKLUVWRUĐSLQVDQGQHHGOHVđ
Uncommon (may affect up to 1 in 100 people)
Ě 1fluid accumulation in the lungs (pulmonary oedema)
which may cause difficulty breathing.

.
. .

Rare (may affect up to 1 in 1,000 people)
Ě 1unusual or irregular heartbeats

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Ě 1flushing (reddening) of the face
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Very rare (may affect up to 1 in 10,000 people)
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restlessness and excitability.
The following side effects can also happen but the
frequency of these are not known:
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(nausea and vomiting)
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pain, hyperventilation, shortness of breath, cold feet and hands,
irregular heartbeat or thirst.
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DOOEHWDDJRQLVWVOLNH9HQWROLQ,QIXVLRQZKHQXVHGWRGHOD\
premature labour.
1 The following side effects have also been observed when Ventolin
Infusion is used to treat severe breathing problems as well as
observed when used to delay premature labour.
If you think this medicine is not working well enough
for you
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WDONWR\RXUGRFWRUDVVRRQDVSRVVLEOH JHWWLQJZRUVHDQG\RXPD\QHHGDGLIIHUHQWPHGLFLQH'RQRWWDNH
extra Ventolin Infusion unless your doctor tells you to.
Reporting of side effects
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or nurse. This includes any possible side effects not listed in
WKLVOHDIOHW %\UHSRUWLQJVLGHHIIHFWV\RXFDQKHOSSURYLGHPRUHLQIRUPDWLRQRQ
the safety of this medicine.

5 How to store Ventolin Infusion
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refers to the last day of that month.
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Ventolin Infusion to your pharmacist to be destroyed.
Do not throw away any medicines via wastewater or household
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longer use. These measures will help protect the environment.

Other formats:
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large print or audio please call, free of charge:

 8.2QO\
Please be ready to give the following information:
Product name
Reference number

Ventolin Infusion
10949/0087

This is a service provided by the Royal National Institute
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This leaflet was last revised in March 2014
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group of companies. All rights reserved.
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6 Contents of the pack and other information
What Ventolin Infusion contains
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sodium hydroxide and sulfuric acid.
What Ventolin Infusion looks like and contents of the pack
Ventolin Infusion comes in a 5 ml glass ampoule.
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normal saline adjusted to pH 3.5.
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Marketing Authorisation Holder
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Manufacturer
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San Polo di Torrile
Parma
Italy

.
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v3

10000000124840

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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