NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
Ventolin® Obstetric Injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Ventolin Obstetric Injection.It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits.Your doctor has weighed the risks of you taking Ventolin against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What is Ventolin Obstetric Injection is used for?
Ventolin Obstetric injection is used to stop contractions of premature labour between weeks 24 and 37 of pregnancy.Your medicine relaxes the muscles in the uterus and stops contractions due to labour during this stage of pregnancy.
Ventolin Obstetric injection may not be as effective if your ‘waters break’ or the neck of the uterus has widened.
Ventolin Obstetric Injection is not addictive.
Before you are given Ventolin Obstetric Injection
When you must not have it:
If you have ever had an allergic reaction to salbutamol sulphate or any of the ingredients listed toward the end of this leaflet. (See “Ingredients”)
Some of the symptoms of an allergic reaction may include:
Shortness of breath.
Wheezing or difficulty in breathing
Swelling of the face, lips, tongue or other parts of the body
Rash, itching or hives on the skin
you are less than 24 weeks pregnant
if you have any problem where it would not be safe to prolong the pregnancy
you have asthma
if you have a thyroid problem associated with pregnancy
you have been have or are having treatment for high blood pressure, including high blood pressure associated with pregnancy
you have pre-existing heart disease or rapid heart beats
if you have any problem with the bowels
you have a kidney problem
you have diabetes
you have eye problems due to the condition known as glaucoma
you have, or have had, bleeding from the vagina
your ‘waters break’ – you have had a ‘show’ or fluid leaking from the vagina
you are aware of any problem with your unborn child
you know you are having more than one baby
After the expiry date (EXP) printed on the pack or if the packaging is torn or shows signs of tampering.
Tell your doctor if:
You must tell your doctor if:
you are allergic to foods, dyes, preservatives or any other medicines
you are taking any other medicines, including medicines you buy without a prescription
you have had to stop taking this or any other asthma medicine for any reason
you have a thyroid problem
you have a heart problem
you are aware of any problem that may cause low blood potassium
you have a liver problem
you suffer from anxiety or panic attacks
you have had to stop taking this or any other medicine for treating labour in pregnancy
you have any other medical problem due to your pregnancy
How do I use Ventolin Obstetric Injection?
How to take it
Ventolin Obstetric injection must only be given by a doctor or physician who are experienced in giving tocolytic agents (which are used to treat premature labour).
The liquid in Ventolin Obstetric injection is diluted before use and is given by infusion (sometimes called a ‘drip’) into a vein.Often a special pump is used to deliver the medicine slowly into the vein.
Do not try to use Ventolin Obstetric Injection on your own.
How long you will be given it
Ventolin Obstetric Injection should not be given for more than 48 hours at a time.
What do I do if I have too much? (Overdose)
Immediately telephone your doctor or Poisons Information Centre (Incall 131126.In new Zealand call 0800 POISON or 0800 764 766) for advice, if you think you or anyone else may have been given too much Ventolin Obstetric Injection, even if there are no signs of discomfort or poisoning.
If you are not sure what to do, contact your doctor or pharmacist.
Symptoms of an overdose may include:
your heart beating significantly faster than normal
significant muscle tremors
an increased rate of breathing due to increased acid in the blood
Some side effects, for example changes in blood sugar (glucose) level or changes in blood potassium level can only be found when your doctor does tests from time to time to check your progress.
While you are given Ventolin Obstetric Injection
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are using Ventolin Obstetric Injection.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during the surgery.
Keep all of your doctor’s appointments so that your progress can be checked.
Tell your doctor if you become pregnant or are breast-feeding.
Your doctor will tell you which medicine you should take. It is important that asthma is managed well during pregnancy and you should not stop your medicine without asking your doctor.
Things you must not do
Do not use Ventolin Obstetric Injection to treat any other complaints unless your doctor tells you to.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
What are the side effects?
Like other medicines, Ventolin Obstetric Injection can cause some side effects.If they occur, they are most likely to be minor and temporary.However, some may be serious and need medical attention.Your doctor, pharmacist or nurse will be able to answer any questions you may have.
If you have any of the following side-effects, tell your doctor or nurse:
The most commonly reported side-effects are:
‘shakiness’ of the muscles
you are aware of your heartbeat
your heart beats faster than normal
your heartbeat does not feel regular
anxious or tense feeling
increased blood flow to the extremities (peripheral vasodilation)
high blood pressure
Rare side effects are:
nausea or sick feeling
Shortness of breath
Low blood pressure
The following side effects may also happen but the frequency of these is unknown:
Sweating / chills
Constipation or diarrhoea or other bowel trouble
Jaundice (yellow skin or eyes)
Drowsiness and weakness
Tell your doctor or nurse immediately if you notice any of the following:
angioedema (sudden swelling under the skin)
faint or dizzy feeling
wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting.These could be a symptom of an allergic reaction.
In a few cases, the medicine in Ventolin Obstetric injection may result in fluid collecting in the lungs.To prevent this, your doctor or nurse will carefully measure how much urine you pass and how much liquid you drink, and check your heart and lungs.If you feel breathless or start coughing when your medicine is given or just after, tell your doctor or nurse immediately.
Occasionally, the medicine in Ventolin Obstetric Injection may result in a loss of or reduction in blood flow (ischaemia) to the heart.Your doctor may do tests on your heart to check this.
Very rarely, in people receiving high dose treatment with this medicine and in patients with an acute exacerbation of asthma, a serious condition called acidosis, which affects the blood may occur because of build up of lactic acid.Your doctor may do tests to check this.
In a few people, the medicine in Ventolin Obstetric Injection may affect their blood sugar or potassium levels. Your doctor may do tests to check this.
If you have other problems after receiving Ventolin Obstetric Injection, tell your doctor or nurse.
Your unborn child may have an increased heartbeat. Very rarely, the unborn child may have low blood sugar or lack of bowel movement.
If you receive too high a dose of Ventolin Obstetric Injection, your heart will beat faster than normal and you will feel ‘shaky’.
This is not a complete list of all possible side effects.If you want more information, ask your doctor or nurse.
Do not be alarmed by this list of possible side effects.You may not experience any of them.
How do I store Ventolin Obstetric Injection?
Keep this medicine where children cannot reach it, such as in a locked cupboard.
A locked cupboard at least one-and-a-half metres above ground is a good place to store medicines
Keep Ventolin Obstetric Injection must be kept away from heat (store below 30°C) and protected from light.
Do not leave in a car, on a window sill or in a bathroom.
Heat and dampness can destroy some medicines.
What Ventolin Obstetric Injection looks like
Ventolin Obstetric Injection is stored in clear glass ampoules. Each ampoule of Ventolin Obstetric Injection contains 5 mL of liquid and provides 5 mg of salbutamol sulphate.
The liquid is either colourless or pale straw coloured.
Ventolin Obstetric Injection contains the active ingredient Salbutamol sulfate.
Ventolin Obstetric Injection also contains the inactive ingredients sodium chloride, water and dilute sulphuric acid for pH adjustment.
There are 5 ampoules in a box.
Ventolin Obstetric Injection is supplied in Australia by:
Allen & Hanburys
A division of GlaxoSmithKline Australia Pty Ltd
436 Johnston Street
Abbotsford Victoria 3067
This leaflet was prepared on 2 July 2014
The information provided applies only to: Ventolin® Obstetric Injection.
Ventolin is a registered trade mark of the GlaxoSmithKline group of companies.
Ventolin Obstetric Injection: AUST R 12528
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