For further copies of this leaflet, visit emc.medicines.org.uk or call AstraZeneca on 01582 836836.
P019954
Diprivan 10 mg/ml (1%)
Emulsion for Injection or Infusion
propofol
Read all of this leaflet carefully before you start having this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you think you have a side effect, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
- 1. What Diprivan is and what it is used for
- 2. Before you have Diprivan
- 3. How to have Diprivan
- 4. Possible side effects
- 5. How to store Diprivan
- 6. Further information
What Diprivan is and what it is used for
Diprivan contains a medicine called propofol. This belongs to a group of medicines called ‘general anaesthetics’.
Diprivan will be given to you as an injection by a doctor. It is used to:
- Help put you to sleep before an operation or other procedure.
- Keep you asleep during an operation or other procedure.
- Sedate you (make you feel sleepy) while you are in an Intensive Care Unit (ICU).
Before you have Diprivan
Do not have Diprivan if:
- You are allergic (hypersensitive) to propofol or any of the other ingredients of Diprivan (listed in Section 6:
Further information). - You are allergic to peanut or soya. This is because Diprivan contains soya oil.
- You are pregnant (see the section called ‘Pregnancy and breast-feeding’).
If any of the above apply to you, do not have Diprivan and tell your doctor, anaesthetist or nurse. If you are not sure,
talk to one of these people before having Diprivan.
Children and young people
- Diprivan should only be given to children aged 1 month and above.
- When Diprivan is used for sedation in an Intensive Care Unit, it should only be given to people aged 17 years
and above.
Take special care with Diprivan
Before you have this medicine, tell your doctor, anaesthetist or nurse if:
- You have ever had a fit or convulsion.
- You have ever been told that you have very high levels of fat in your blood.
- You have ever been told that your body has problems using fat.
- Your body has lost lots of water (you are dehydrated).
- You have any other health problems, such as problems with your heart, breathing, kidneys or liver.
- You have been generally unwell for some time.
If you are not sure if any of the above apply to you, talk to your doctor or nurse before having Diprivan.
Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines. This includes medicines that you buy
without a prescription and herbal medicines.
Pregnancy and breast-feeding
- Do not have Diprivan if you are pregnant.
- If you are trying to get pregnant or if you are breast-feeding, talk to your doctor or nurse before having this
medicine.
Driving and using machines
After having Diprivan, you may still feel sleepy for some time. Do not drive or use any tools or machines until you
are sure the effects have worn off.
- If you are able to go home shortly after having Diprivan, do not drive a car or use any tools or machines.
- Ask your doctor when you can start doing these activities again and when you can go back to work.
Important information about some of the ingredients of Diprivan
Diprivan contains sodium. If you are on a sodium controlled diet, you will need to take this into account.
Diprivan contains soya oil. If you are allergic to peanut or soya, do not use this medicine.
Diprivan contains disodium edetate. During prolonged use of Diprivan for intensive care, you may need to be given a
zinc (a mineral) supplement.
How to have Diprivan
You will be given Diprivan by a doctor. It will be given to you as an injection into a vein. This is usually in the back of your hand or in your forearm.
- The doctor will give you the injection using a needle or through a fine plastic tube called a ‘cannula’.
- The doctor can also use an electric pump to control how fast the injection is given. This may be done if you
are having a long operation or if you are in an Intensive Care Unit.
The dose of Diprivan varies from one patient to another.
The amount of Diprivan that you need depends on your
age, size, physical fitness and the level of sleepiness or sleep that you need. The doctor will work out how much to
give you.
You may need several different medicines to keep you asleep or sleepy, free from pain, breathing in a healthy
way and to keep your blood pressure steady. The doctor will decide which medicines you need and when you need
them.
Diprivan 1% Side Effects
Like all medicines, Diprivan may cause side effects although not everybody gets them.
Side effects that can happen during anaesthesia
The following side effects can happen during anaesthesia (while the injection is being given to you or when you
are sleepy or asleep). Your doctor will be looking out for these. If they happen, your doctor will give you appropriate
treatment.
Very common (affects more than 1 in 10 people)
- A feeling of pain at the site of the injection (while the injection is being given, before you fall asleep).
Common (affects less than 1 in 10 people)
- Low blood pressure.
- Changes in your breathing pattern.
- Slow heart beat.
Rare (affects less than 1 in 1,000 people)
- Twitching and shaking of your body, or a fit (may also happen when you wake up).
- Unusual colour of urine (may also happen when you wake up).
Very rare (affects less than 1 in 10,000 people)
- Allergic reactions.
- Stopping of your heart beat.
- Build up of fluid in the lungs which can make you very breathless (may also happen when you wake up).
Side effects that can happen after anaesthesia
The following side effects can happen after anaesthesia (when you are waking up or after you have woken up).
Common (affects less than 1 in 10 people)
- Feeling sick (nausea).
- Being sick (vomiting).
- Headache.
Uncommon (affects less than 1 in 100 people)
- Swelling and redness along a vein or blood clots.
Very rare (affects less than 1 in 10,000 people)
- Feeling sexually aroused.
- High temperature (fever).
- Redness or soreness where the injection was given.
- Being unconscious after the operation. (When this has happened, the patients have recovered without
problems.)
Other possible side effects
The following side effects have been seen when Diprivan is used in intensive care at higher doses than recommended.
Very rare (affects less than 1 in 10,000 people)
- Breakdown of muscle cells (rhabdomyolysis).
- Heart failure.
- Inflamed pancreas (pancreatitis) which causes severe stomach pain.
The following side effects have been seen in children in intensive care when Diprivan has been stopped suddenly.
Common (affects less than 1 in 10 people)
- ‘Withdrawal symptoms’. These include unusual behaviour, sweating, shaking and feeling anxious.
- Flushing of the skin.
Do not be concerned by this list of possible side effects.
You may not get any of them.
If you think you have a side effect or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
How to store Diprivan
- The doctor and hospital pharmacist are responsible for storing, using and disposing of Diprivan correctly.
- Store Diprivan between 2°C and 25°C. Do not freeze.
- Do not use Diprivan after the expiry date which is stated on the carton.
Further information
What Diprivan 1% contains
The active substance is propofol. There is 10 mg of propofol in each millilitre.
The other ingredients are glycerol, purified egg phosphatide, sodium hydroxide, soya bean oil, water for injections, nitrogen and disodium edetate.
What Diprivan 1% looks like and contents of the pack
Diprivan 1% is a milky, white liquid. It comes in glass ampoules of 20 ml, glass vials of 50 ml or 100 ml, or pre-filled syringes of 20 ml or 50 ml.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation for Diprivan 1% is held by
Diprivan 1% is manufactured by
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name Diprivan 1%
Reference number 17901/0007
This is a service provided by the Royal National Institute of the Blind.
Leaflet prepared: May 2008
Diprivan is a trade mark of the AstraZeneca group of companies.
© AstraZeneca 2008
UK PAI 08 0026
No comments:
Post a Comment