Skip to Content

BUPIVACAINE 2.5 MG/ML SOLUTION FOR INJECTION

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Driving and using Machines
Do not drive or use any tools or machines because Bupivacaine may interfere with your ability to do so
safely. Ask your doctor when it would be safe to resume these activities.
Package Leaflet: Information for the User
Bupivacaine 2.5 mg/ml Solution for Injection
Bupivacaine 5 mg/ml Solution for Injection
Bupivacaine hydrochloride monohydrate
Read all of this leaflet carefully before you are given this medicine

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this Leaflet
1.
What Bupivacaine is and what it is used for
2.
Before you are given Bupivacaine
3.
How to use Bupivacaine
4.
Possible side effects
5.
How to store Bupivacaine
6.
Further information
1.

What Bupivacaine is and what it is used for

Bupivacaine is a local anaesthetic. It belongs to a group of medicines called amide- type local anaesthetics.
It produces a loss of feeling or sensation that is confined to one part of the body.
Bupivacaine is used for
-
surgical operations, including obstetric operations such as caesarean section
-
relief of acute pain including labour pain or pain after an operation
2.

Before you are given Bupivacaine

Do not use Bupivacaine:




If you are allergic (hypersensitive) to bupivacaine hydrochloride monohydrate or local anaesthetics
of the amide type or to any of the other ingredients in this medicine. An allergic reaction may be
recognised as a rash, itching, swollen face or lips, or shortness of breath.
To produce local anaesthesia by injecting it into a vein of a limb that has been isolated from the
circulation by means of a tourniquet (a technique called intravenous regional anaesthesia or Bier’sblock)
If you are having obstetrical paracervical block (a type of anaesthesia given during labour).

Important information about some of the ingredients of Bupivacaine.
This medicinal product contains 0.14 mmol (3.15 mg) sodium per ml. To be taken into consideration by
patients on a controlled sodium diet.
3.

How to use Bupivacaine

Bupivacaine will be given to you by your doctor who will have the necessary knowledge and experience in
the technique of epidural anaesthesia.
The medicinal product is for single use only.
Dosage:
Your doctor will decide what dose is right for you. This will normally between 15- 150mg of Bupivacaine
hydrochloride monohydrate. The dose will depend on your size, your state of health, the part of the body
that the medicine is injected into and what the medicine is being used for. Smaller doses are used for
elderly people, young children and people who are unwell.
You may be given this medicine before minor or major surgery, or during childbirth. For minor surgery,
the injection will usually be given near the part of the body to be operated on. The medicine will prevent
pain and cause numbness which will gradually wear off once the procedure is over. For major surgery or
childbirth, you may be given an injection in your back which will take a few minutes. This will prevent pain
and cause numbness in the lower half of your body which usually lasts for 3 to 4 hours.
For most procedures, one dose is enough but more doses may be needed if the procedure takes a long
time.
Route and method of administration:
The medicinal product is for epidural use, intraarticular use, subcutaneous use or intramuscular use only.
Epidural anaesthesia involves an injection into the spine that can cause both a loss of sensation (an
anaesthetic) as well as pain relief (an analgesic) by blocking the transmission of pain signals through nerves
in or near the spinal cord. It can be used as an anaesthetic, as a pain reliever (an analgesic) together with
general anaesthesia, and
for postoperative pain relief (analgesia) in procedures involving the lower limbs,
perineum, pelvis, abdomen and thorax.
If you have been given more Bupivacaine than you should
It is unlikely that you will be given too much Bupivacaine as it will be administered by a medical
professional. However, if you are concerned, contact your doctor or nurse
immediately.
If you forget to take Bupivacaine
If you think you have missed a dose, please tell your doctor or nurse.

Take special care with Bupivacaine and tell your doctor if you suffer from:

If you have any further questions on the use of this product, ask your doctor or pharmacist.









4.

any liver disorder
a blood infection (septicaemia)
very low or very high blood pressure
dehydration or any recent vomiting, diarrhoea or blood loss
heart disease
a tumour or an accumulation of fluid in the abdomen.
pleural effusions (fluid in the lungs) and septicaemia (blood poisoning) You should talk to your doctor
if you think this could apply to you.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Taking some medicines together can be harmful. Remember that the doctor at the hospital may not have
been informed if you have recently begun a course of treatment for another illness. In particular tell your
doctor if you are taking
-
other local anaesthetics
-
medicines to control your heartbeat (such as lidocaine, mexiletine, or amiodarone)
-
clonidine (used to treat high blood pressure or migraine)
-
ketamine (an anaesthetic)

Possible side effects

Like all medicines, Bupivacaine can cause side effects, although not everybody gets them.
Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing,
swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).
Serious side effects
If you develop any of the following side effects, contact your doctor immediately:

Fits

Heart attack - rare
Side effects can be listed according to how often they occur:
very common:
common:
uncommon:
rare:

very rare:
not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data

Pregnancy and Breastfeeding

The following side effects have also been reported:

If you are pregnant or you think you may be pregnant, you should inform your doctor who will decide
whether or not you should be given Bupivacaine.

Very Common
Nausea (feeling sick), low blood pressure (your doctor can monitor this).

You must not have an obstetrical paracervical block (a type of anaesthesia during labour) if you are
receiving this medicine.

Common
Slow heartbeat, pins and needles, dizziness, vomiting, not being able to urinate, and high blood pressure
(your doctor can monitor this).

Bupivacaine may get into breast milk. If you are breast-feeding you should discuss options with your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Uncommon
Pins and needles around the mouth, numbness of the tongue, sensitivity to sound, visual disturbances, loss
of consciousness, tremor, light- headedness, ringing in the ears, and speech disorder.

Rare
Nerve disorders or injury, loss of movement, paralysis, double vision, and shallow breathing.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet,
please tell your doctor of pharmacist.
5.

How to store Bupivacaine

Keep out of the reach and sight of children.
Do not use Bupivacaine after the expiry date which is stated on the vial and the box after “EXP”. The expiry
date refers to the last day of the month.
Store below 30°C. Do not refrigerate or freeze. Shelf life after dilution:
Chemical and physical in use stability has been demonstrated for 36 hours at
25°C.
From a microbiological point of view the product should be used immediately. After first opening: to be used
immediately.
Only clear solutions practically free from particles should be used. Do not use if container is damaged.
Any unused solution should be discarded.
Medicines should not be disposed of via waste-water or with household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.

What Bupivacaine looks like and the content of the pack:
Bupivacaine is a clear, colourless, aqueous, sterile solution for injection supplied in 10ml and 20 ml glass
vial.
Pack sizes:
5 X 10ml solution for injection 1 X 20ml solution for injection
Not all packs sizes may be marketed.
Marketing Authorization Holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer:
Pfizer Service Company BVBA Hoge Wei 10, 1930, Zaventem Belgium
Pfizer PGM,
Zone industrielle, 29, route des Industries, 37530 Pocé -Sur-Cisse, France
This leaflet was last approved in 07/2013.

Further information

What Bupivacaine contains
The active substance is bupivacaine hydrochloride monohydrate.
For Bupivacaine 2.5mg/ml Solution for Injection
Each ml contains 2.5 mg of Bupivacaine hydrochloride monohydrate
Each 10 ml glass vial contains 25 mg of bupivacaine hydrochloride monohydrate. Each 20 ml glass vial
contains 50 mg of bupivacaine hydrochloride monohydrate.
For Bupivacaine 5 mg/ml Solution for Injection
Each ml contains 5 mg of bupivacaine hydrochloride monohydrate
Each vial with 10 ml contains 50 mg of bupivacaine hydrochloride monohydrate. Each vial with 20 ml
contains 100 mg of bupivacaine hydrochloride monohydrate.
Other ingredients – Sodium Chloride, 0.4% sodium hydroxide, 0.85% hydrochloric acid and
Water for injections.

---------------------------------------------------------------------------------------------------The following information is intended for medical or healthcare professionals only:
Any unused solution should be adequately disposed of, in accordance with local requirements.
1. Administration
Solution for injection.
The medicinal product is for epidural use, intraarticular use, subcutaneous use or
intramuscular use only.
The maximum dosage must be determined by evaluating the size and physical status of the patient and
considering the usual rate of systemic absorption from a particular injection site. A single dose of up to 150
mg bupivacaine hydrochloride monohydrate can be used. Doses of up to 50 mg 2-hourly may subsequently
be used. A total dose of up to 500 mg bupivacaine hydrochloride monohydrate over 24 hours, which does
not include the initial bolus dose, can be used routinely. For young, elderly or debilitated patients, the
doses should be reduced.
2.
Handling Instructions
For single use only.
Bupivacaine is compatible when mixed with sodium chloride 9 mg/ml (0.9%) solution for injection, Ringer
Lactate Solution and Sufentanil Citrate 50 μg/ml. However, this medicinal product must not be mixed with
any other medicinal products.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide