Patient Information Leaflet

Diprivan 10 mg/ml (1%)

Emulsion for Injection or Infusion

propofol

What you should know about Diprivan 1%.

The information in this leaflet applies only to your anaesthetic agent, Diprivan 1%. Please read it carefully. It gives you important information but it can’t tell you everything. If you have any questions, or are not sure about anything, ask your anaesthetist or doctor.

This leaflet does not replace the advice from your anaesthetist or intensive care doctor, who are trained to look after you during your operation or while you are in intensive care.

What is your medicine?

Diprivan 1% is an injection containing 10 mg of propofol in each millilitre.

Diprivan 1% contains a number of inactive ingredients which allow it to be made. These are glycerol, purified egg phosphatide, sodium hydroxide, soya bean oil, water for injections and nitrogen.

Diprivan 1% is supplied in glass ampoules of 20 ml, glass vials of 50 ml or 100 ml or pre filled syringes of 20 ml or 50 ml.

 

Diprivan 1% belongs to a group of medicines called general anaesthetics. This means that it causes you to become unconscious (asleep) whilst surgical operations or other procedures are being conducted. It can also be used in certain circumstances to sedate you (make you sleepy without sending you to sleep).

What is your medicine for?

Diprivan 1% is used either to make you unconscious (asleep) or to sedate you (make you sleepy) while you are having an operation or other procedures, or you are undergoing intensive care.

When should Diprivan 1% not be used?

Before receiving your anaesthetic, the anaesthetist, surgeon or intensive care doctor will assess your medical condition and any current treatment. Please tell them if:

• you have ever received Diprivan 1% or 2% before and have experienced an allergic reaction to its use
• you are pregnant or are trying to become pregnant
• you are breast feeding.

Diprivan 1% should not be given to children aged under 1 month. It can be used to put children over this age to sleep, for surgical operations or other procedures.

If the child is under 3 years old, then a different anaesthetic should be used to keep the child asleep during the operation or procedure.

Diprivan 1% should not be used for the sedation in intensive care of children aged 16 years or younger.

Diprivan 1% contains soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

What precautions should be taken with Diprivan 1%?

Before receiving your anaesthetic, tell your anaesthetist or intensive care doctor if:

• you have ever had an epileptic fit or convulsion
• you have ever been told that either you have very high fat levels in your blood or you have problems in relation to your body being able to handle and use fat
• you have any other health problems such as problems with your heart, breathing, kidneys or liver, if you are dehydrated or if you have been generally unwell for some time
• you are taking any other medicines including those which you have bought.

Your anaesthetist or intensive care doctor will adjust the dose of Diprivan 1% to your age and physical fitness and will be continuously monitoring your condition. He or she may need to use several different medicines to keep you asleep or sleepy, free from pain, breathing in a healthy way and to keep your blood pressure steady. Your anaesthetist or intensive care doctor will decide which medicine to use, as and when the need arises. There have been very rare reports of patients who experience a period of unconsciousness after their operation. These patients have recovered without complications.

After receiving Diprivan 1% your ability to drive a car or to operate machinery may be affected for some time. Therefore, if you are able to go home shortly after receiving Diprivan 1% do not drive a car. Ask your anaesthetist when you can return to work particularly if you use machinery or heavy equipment.

Diprivan 1% contains 0.0018 mmol sodium per ml. To be taken into consideration by patients on a controlled sodium diet.

How will you receive your Diprivan 1%?

Diprivan 1% will be given to you by your anaesthetist or intensive care doctor.

Diprivan 1% will be given to you as an injection into a vein, usually in the back of the hand or in the forearm. Your anaesthetist may use a needle, or a fine plastic tube called a cannula. For long operations and for use in intensive care situations, an electric pump may be used to control the rate at which the injection is given.

The amount of Diprivan 1% you need will depend on your age, size, physical fitness and the level of sleepiness or sleep that is required. Your anaesthetist or intensive care doctor will closely control the amount of Diprivan 1% given to you. Most people need 0.5–2.5 mg per kg body weight to make them sleepy or to put them to sleep, and then from 0.3–15 mg/kg/hr to maintain the appropriate level of sleepiness or depth of sleep.

What undesirable events may be experienced with Diprivan 1%?

As with all medicines, undesirable events are sometimes experienced.

During anaesthesia these may include:

• a feeling of pain near the injection site before the injection makes you unconscious
• a fall in blood pressure
• changes in your breathing pattern
• some twitching and shaking
• allergic reactions which occur rarely
• slowing or stopping of your heart.

Your anaesthetist or intensive care doctor will be monitoring for these and if they occur you will be treated accordingly.

After anaesthesia these may include:

• nausea
• vomiting
• headache
• a feeling of sexual arousal
• fever or high temperature
• redness or soreness where the anaesthetic was given.

Rarely, other undesirable events such as twitching, shaking or convulsions, fluid retention in the lungs and discolouration of the urine may occur either during or after anaesthesia.

Do not be alarmed by this list of possible events. You may not have any of them. There have been very rare reports of rhabdomyolysis (breakdown of muscle cells) during intensive care use and also heart failure and pancreatitis (inflammation of a large gland situated close to the stomach). These rare cases have been seen when Diprivan 1% has been given in doses above those recommended for sedation in intensive care.

Tell your anaesthetist, hospital specialist or general practitioner if you think you have any of these or any other undesirable events.

How should Diprivan 1% be stored?

Diprivan 1% should be stored between 2°C and 25°C and should not be frozen. It should not be used after the expiry date shown on the carton. Your anaesthetist and hospital pharmacist are responsible for the correct storage, use and disposal of Diprivan 1%.