NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
BUPIVACAINE INJECTION BP
Bupivacaine hydrochloride monohydrate
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Bupivacaine Injection BP.
It does not contain all the available information.It does not take the place of talking to your doctor or pharmacist.
All medicines have benefits and risks.Your doctor has weighed the risks of you taking Bupivacaine Injection BP against the benefits this medicine is expected to have for you.
This medicine is likely to be used while you are at the clinic or in hospital.If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used.
If you have any concerns about receiving this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What Bupivacaine Injection BP is used for
Bupivacaine is used to prevent or relieve pain, but it will not put you to sleep. Bupivacaine Injection BP is used during or after surgery to relieve pain.It can also be used to make childbirth less painful.
Bupivacaine Injection BP belongs to a group of medicines known as local anaesthetics. It is injected into the body where it will either totally stop pain or will cause partial loss of feeling (numbness), depending on the amount used.
Your doctor will have explained why you are being treated with Bupivacaine Injection BP and what dose you will be given.
Follow all the directions and advice given to you by your doctor carefully.
They may differ from the information contained in this leaflet.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed it for another reason.
This product is available only on a doctor’s prescription.
Before you are given Bupivacaine Injection BP
When you must not be given it:
Do not use Bupivacaine Injection BP if you have an allergy to:
any medicine containing bupivacaine or other local anaesthetics e.g. lidocaine (lignocaine)
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
You should not be given Bupivacaine Injection BP if:
you have an infection or swelling (redness) where the injection will be given
you have uncorrected low blood pressure.
If you are not sure whether any of these apply to you, check with your doctor.
Before you are given it
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you are pregnant or intend to become pregnant.
It is not known if it is safe for you to receive bupivacaine while you are pregnant. It may affect your baby if you receive it early in pregnancy or in the last weeks before your baby is due.However, bupivacaine may be used during childbirth.Your doctor will discuss with you the benefits and risks of being given it during pregnancy.
Tell your doctor if you are breastfeeding or plan to breast feed.
Your baby can absorb bupivacaine in very small amounts from breast milk if you are breastfeeding.Your doctor will discuss with you the benefits and risks of being given it whilst you are breastfeeding.
Tell your doctor if you have or have had any medical conditions, especially the following:
problems with your blood pressure or circulation (especially low blood pressure)
problems with clotting of your blood
blood poisoning
acidosis, or too much acid in the blood
diseases of the brain, spine or nerves
muscle disease or weakness such as myasthenia gravis
kidney, liver, heart, or thyroid problems
epilepsy.
It may not be safe for you to be given Bupivacaine Injection BP if you have any of these conditions.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and bupivacaine may interfere with each other.These include:
medicines used to help control your heart beat, such as mexiletine
medicines to help prevent blood clots such as heparin
medicines for depression.
These medicines may affect the way bupivacaine works or be affected by bupivacaine. You may need different amounts of your medicine, or you may need to take a different medicine.
Your doctor will advise you about continuing to take other medicines while you are receiving Bupivacaine Injection BP.
If you have not told your doctor about any of these things, tell them before you are given any bupivacaine.
How Bupivacaine Injection BP is given
How it is given
Bupivacaine Injection BP must only be given by a doctor or nurse.
It is given by injection into the skin, near a single nerve, or into an area which contains a large number of nerves (e.g. if you are given an epidural injection which is an injection around the spinal cord).This causes an area of numbness at the site of injection or in an area that may seem unrelated to the site of injection.The last will be the case if you are given an epidural injection and will result in a feeling of numbness in your lower body.
If you are receiving an epidural infusion it will be injected by your doctor into the epidural space, near your spinal cord, through a space between vertebrae in your lower back.A thin tube will be inserted so a continuous dose can be given over a period of time.
Bupivacaine Injection BP should not be injected directly into the blood.
How much is given
Your doctor will decide what dose, how often and how long you will receive it.This depends on the type of pain relief required, your condition and other factors, such as your weight, age, how well your liver and kidneys are working, and whether or not other medicines are being given at the same time.
If you are given too much (overdose)
This rarely happens as Bupivacaine Injection BP is administered under the care of an experienced anaesthetist.Your condition will be carefully monitored following administration of bupivacaine.
However, if you are given too much bupivacaine, you may experience some of the effects listed under “Side Effects” below.Some side effects such as unconsciousness, low blood pressure and collapse will be monitored and detected by your doctor or nurse if it occurs.
Whenever you are given Bupivacaine Injection BP, equipment is available to treat you if you experience severe side effects.
If you think you have been given too much Bupivacaine Injection BP or if you experience severe side effects, tell your doctor or nurse immediately.
Side effects
Tell your doctor or nurse as soon as possible if you do not feel well while you are being treated with bupivacaine.
Like other medicines, bupivacaine can cause some side effects.If they occur, most are likely to be minor or temporary.However, some may be serious and need medical attention.
Ask your doctor or nurse to answer any questions that you may have.
Do not be alarmed by this list of possible side effects.You may not experience any of them.
Tell your doctor or nurse if you notice any of the following:
nervousness, agitation
dizziness
ringing in the ears
blurred vision
numbness
disorientation (feeling strange)
nausea
vomiting
difficulty swallowing, slurred speech
shakes (tremor), tingling sensation (pins and needles).
These are usually mild side effects and should only last a short time.
After an epidural injection of bupivacaine you may develop a headache or backache which is not always related to the medicine used.This may last for some months after the injection was given, although this is rare.
Tell your doctor or nurse immediately if notice any of the following:
fits
difficulty breathing
severe dizziness with slow or irregular heart beat
joint pain, stiffness or loss of motion.
If Bupivacaine Injection BP is given wrongly, or you are very sensitive to it, it may cause the above side effects.
These are all serious side effects.You may need urgent medical attention.Serious side effects are rare.
Other side effects not listed above, may occur in some patients.If you notice any other effects, check with your doctor.Some side effects may only be detected by your doctor.
Tell your doctor if you notice anything else that is making you feel unwell.
After being given Bupivacaine Injection BP
Be careful driving or operating machinery after you have been given Bupivacaine Injection BP.
You may be drowsy and feel light headed.Your reflexes may be made slower and you may feel nauseous.
Be careful when drinking alcohol following injection with bupivacaine.
It may cause your blood pressure to drop and cause you to feel dizzy and faint.
Disposal
Any Bupivacaine Injection BP which is not used will be disposed of in a safe manner by your doctor or pharmacist.
Bupivacaine Injection BP is for single use only.
Product description
What it looks like
Bupivacaine Injection BP is a clear, colourless solution in either a 20 mL glass theatre vial or a plastic 10 mL Steriamp® or Steriluer® ampoule.
Ingredients
Bupivacaine Injection BP contains Bupivacaine Hydrochloride (as monohydrate) (0.25% or 0.5%).
It also contains:
Sodium Chloride
Water for Injections.
This medicine does not contain a preservative.
Supplier
Pfizer Australia Pty Ltd
Sydney, NSW
Toll Free number: 1800 675 229
www.pfizer.com.au
Australian registration numbers
Bupivacaine Injection BP 0.25% (sterile) 50 mg in 20 mL Theatre Vial: AUST R 11314
Bupivacaine Injection BP 0.5% (sterile) 100 mg in 20 mL Theatre Vial: AUST R 12725
Bupivacaine Injection BP 0.5% (sterile) 50 mg in 10 mL Steriluer® or Steriamp® Ampoule: AUST R 11312
Date of preparation
This leaflet was prepared in November 2020.
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