Propofol 10 Mg/Ml (1%) Emulsion For Injection/Infusion
Package leaflet: Information for the user
Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion
propofol
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or nurse.
- If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Propofol 10 mg/ml (1%) is and what it is used for
2. What you need to know before you are given Propofol 10 mg/ml (1%)
3. How you will be given Propofol 10 mg/ml (1%)
4. Possible side effects
5. How to store Propofol 10 mg/ml (1%)
6. Contents of the pack and other information
1. What Propofol 10 mg/ml (1%) is and what it is used for
Propofol 10 mg/ml (1%) contains the active substance propofol. It belongs to a group of medicines called “general anaesthetics”. General anaesthetics are used to cause unconsciousness (sleep) so that surgical operations or other procedures can be performed. They can also be used to sedate you (so that you are sleepy but not completely asleep).
Propofol 10 mg/ml (1%) will be given to you as an injection by a doctor.
In adults and children over 1 month of age 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 during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia.
In people over 16 years of age it is also used to:
- Sedate you when receiving artificial respiration in an Intensive Care Unit (ICU).
2. What you need to know before you are given Propofol 10 mg/ml (1%)
You will not be given Propofol 10 mg/ml (1%) if:
- you are allergic to propofol or any of the other ingredients of this medicine (listed in section 6).
- you are allergic to peanut or soya. This is because Propofol 10 mg/ml (1%) contains soya oil.
- you are 16 years of age or younger for sedation in intensive care.
If any of the above applies to you, do not use Propofol 10 mg/ml (1%) and tell your doctor or nurse. If you are not sure, talk to one of these people before you are given Propofol 10 mg/ml (1%).
Warnings and precautions
Talk to your doctor or nurse before you are given Propofol 10 mg/ml (1%) 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.
Special care should be taken following use of Propofol 10 mg/ml (1%) and an adequate period is needed before you are discharged to ensure a full recovery. You must be accompanied by an adult when leaving the place of administration. Your doctor will advise you on when you can undertake skilled or hazardous tasks such as driving.
Children and adolescents
The use of Propofol 10 mg/ml (1%) is not recommended in newborn infants.
Other medicines and Propofol 10 mg/ml (1%)
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Propofol 10 mg/ml (1%) can affect the way some medicines work. Also some medicines can affect the way Propofol 10 mg/ml (1%) works.
After receiving this medicine, you are advised to avoid other substances that may make you drowsy such as alcohol, benzodiazepines and other sedatives.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
If you are pregnant you should receive Propofol 10 mg/ml (1%) only if absolutely necessary.
You should not breast-feed while receiving propofol and breast milk must be discarded for 24 hours after receiving propofol.
Driving and using machines
After being given Propofol 10 mg/ml (1%), 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 being given Propofol 10 mg/ml (1%), 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. Propofol 10 mg/ml (1%) contains Sodium and Soya oil
This medicinal product contains 0.016 mmol (0.4 mg) of sodium per ml of emulsion for injection/infusion. To be taken into consideration by patients on a controlled sodium diet.
Propofol 10 mg/ml (1%) contains soya oil. If you are allergic to peanut or soya, do not use this medicine.
3. How you will be given Propofol 10 mg/ml (1%)
You will be given Propofol 10 mg/ml (1%) 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 Propofol 10 mg/ml (1%) varies from one patient to another. The amount of Propofol 10 mg/ml (1%) that you need depends on your age, size, physical fitness and the level of sleepiness or sleep that you need. The doctor will give you the correct dose to start and to sustain anaesthesia or to achieve the required level of sedation, by carefully watching your responses and vital signs (pulse, blood pressure, breathing etc.).
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.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can 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: may affect 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: may affect up to 1 in 10 people
- Low blood pressure.
- Changes in your breathing pattern.
- Slow heart beat.
Rare: may affect up to 1 in 1,000 people
- Twitching, shaking and spasm of your body, which may cause your body to arch, or a fit (may also happen when you wake up).
Very rare: may affect up to 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).
- Unusual colour of urine (may also happen when you wake up).
Not known: frequency cannot be estimated from the available data
- Passing large amounts of urine and being very thirsty (diabetes insipidus).
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: may affect up to 1 in 10 people
- Feeling sick (nausea).
- Being sick (vomiting).
- Headache.
Uncommon: may affect up to 1 in 100 people
- Swelling and redness along a vein or blood clots.
Very rare: may affect up to 1 in 10,000 people
- Inflamed pancreas (pancreatitis) which causes severe stomach pain.
- Feeling sexually aroused.
- High temperature (fever).
- If not injected properly, there may be pain, swelling and damaged skin where the injection was given.
- Being unconscious after the operation. (When this has happened, the patients have recovered without problems.)
Do not be concerned by this list of possible side effects. You may not get any of them.
Not known: frequency cannot be estimated from the available data
- Heart failure.
- Too much acid in your blood. This may make you breathe more quickly.
- Increased amount of potassium in your blood.
- High blood level of a type of fat called lipids.
- Euphoric mood.
- Involuntary movements.
- Drug abuse and dependence, mostly by healthcare professionals.
- Abnormal heart beat.
- Abnormal ECG.
- Enlargement of the liver.
- Breakdown of muscle cells (rhabdomyolysis).
- Kidney failure.
- Breathing difficulties.
- If not injected properly, there may be pain and swelling where the injection was given.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system for:
United Kingdom
Yellow Card Scheme
Website: http: //www .mhra.gov .uk/yellowcard or
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal or
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By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Propofol 10 mg/ml (1%)
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
The doctor and hospital pharmacist are responsible for storing, using and disposing of Propofol 10 mg/ml (1%) correctly.
Do not freeze.
After first opening: Since Propofol 10 mg/ml (1%) does not contain a preservative, the solution should be used immediately after opening the vial.
After dilution the chemical and physical in-use stability has been demonstrated for not more than 6 hours at 25°C.
From a microbiological point of view, unless the method of opening/ dilution preludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Propofol 10 mg/ml (1%) contains
- The active substance is propofol.
Each 20 ml vial contains 200 mg of propofol.
Each 50 ml vial contains 500 mg of propofol.
Each 100 ml vial contains 1000 mg of propofol.
- The other ingredients are glycerol, purified egg phospholipids, sodium hydroxide, soya bean oil-refined and water for injections.
What Propofol 10 mg/ml (1%) looks like and contents of the pack
Propofol 10 mg/ml (1%) is a white or slightly off-white emulsion, having a milk-like appearance with no evidence of oiling-out of the emulsion and free from visible particulate. It comes in glass vials of 20 ml, 50 ml or 100 ml.
Propofol 10 mg/ml (1%) is supplied in packs of 1, 5, 10 or 20 vials per carton or tray.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire
CV31 3RW
United Kingdom
Manufacturer
Hospira UK Limited
Queensway
Royal Leamington Spa
Warwickshire
CV31 3RW
United Kingdom
This leaflet was last revised in August 2015.
The following information is intended for healthcare professionals only:
Propofol 10 mg/ml (1%) Emulsion for Injection/Infusion propofol
Please refer to the Summary of Product Characteristics for full prescribing information.
Instructions for use
Propofol 10 mg/ml (1%) may be used as a slow bolus injection or infusion.
Containers should be shaken before use. If two layers can be seen after shaking, the emulsion should not be used. All contents that may be left over after a single use must be destroyed.
Prior to use, the rubber stopper should be disinfected using a medicinal alcohol (spray or dipped swab).
Propofol 10 mg/ml (1%) contains no antimicrobial preservatives and supports growth of micro-organisms.
When Propofol 10 mg/ml (1%) is to be aspirated, it must be drawn aseptically into a sterile syringe or giving set immediately after breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both Propofol 10 mg/ml (1%) and infusion equipment throughout the infusion period. Any infusion fluids added to the Propofol 10 mg/ml (1%) line must be administered close to the cannula site. Propofol 10 mg/ml (1%) must not be administered via a microbiological filter.
Propofol 10 mg/ml (1%) is for single use in an individual patient. In accordance with established guidelines for other lipid emulsions, a single infusion of propofol must not exceed 12 hours. At the end of the procedure or at 12 hours, whichever is the sooner; both the reservoir of propofol and the infusion line must be discarded and replaced as appropriate.
Propofol can be used for infusion undiluted from glass containers or diluted with 5% Dextrose (Intravenous Infusion BP) only, in glass infusion bottles. Dilutions, which must not exceed 1 in 5 (2 mg propofol per ml) should be prepared aseptically immediately before administration and must be used within 6 hours of preparation.
Propofol has no analgesic properties and therefore supplementary analgesic agents are generally required in addition to Propofol 10 mg/ml (1%).
A burette, drop counter or volumetric pump must be included in the infusion line. The risk of uncontrolled infusion must be taken into account when deciding the maximum amount of propofol in the burette.
When Propofol 10 mg/ml (1%) is used undiluted to maintain anaesthesia, it is recommended that equipment such as syringe pumps or volumetric infusion pumps should always be used to control infusion rates.
Propofol 10 mg/ml (1%) may be administered via a Y -piece close to the injection site into infusions of the following:
• Dextrose 5% Intravenous Infusion B.P.
• Sodium Chloride 0.9% Intravenous Infusion B.P.
• Dextrose 4% with Sodium Chloride 0.18% Intravenous Infusion B.P.
Propofol 10 mg/ml (1%) may be premixed with alfentanil injection containing 500 micrograms/ml alfentanil in the ratio of 20:1 to 50:1 w/w. Mixtures should be prepared using sterile technique and used within 6 hours of preparation.
In order to reduce pain on initial injection, Propofol 10 mg/ml (1%) may be mixed with preservative-free Lidocaine Injection 0.5 % or 1 %; (see "Dilution and Co-administration" table below).
The infusion system should be rinsed before administration of muscle relaxants like atracurium and mivacurium when using the same infusion system for Propofol 10 mg/ml (1%).
Parenteral products should be inspected visually for particulate matter prior to administration. If particulate matter is evident emulsion should not be used.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Dilution and Co-Administration of Propofol 10 mg/ml (1%) with Other Drugs or Infusion Fluids (see also 'Additional Precautions' section under “4.4 Special warnings and precautions for use” in the SmPC)
|
Co-administration Technique |
Additive or Diluent |
Preparation |
Precautions |
|
Pre-mixing. |
Dextrose 5% Intravenous Infusion |
Mix 1 part of Propofol 10 mg/ml (1%) with up to 4 parts of Dextrose 5% Intravenous Infusion B.P in glass infusion bottles. |
Prepare aseptically immediately before administration. The mixture is stable for up to 6 hours. |
|
Lidocaine hydrochloride injection (0.5% or 1% without preservatives). |
Mix 20 parts of Propofol 10 mg/ml (1%) with up to 1 part of either 0.5% or 1% lidocaine hydrochloride injection. |
Prepare mixture aseptically immediately prior to administration. Use for Induction only. | |
|
Alfentanil injection (500 microgram/ml). |
Mix Propofol 10 mg/ml (1%) with alfentanil injection in a ratio of 20:1 to 50:1 v/v. |
Prepare mixture aseptically; use within 6 hours of preparation. | |
|
Co-administration via a Y -piece connector. |
Dextrose 5% intravenous infusion |
Co-administer via a Y -piece connector. |
Place the Y-piece connector close to the injection site. |
|
Sodium chloride 0.9% intravenous infusion |
As above |
As above | |
|
Dextrose 4% with sodium chloride 0.18% intravenous infusion |
As above |
As above |
Incompatibilities
The neuromuscular blocking agents, atracurium and mivacurium should not be given through the same intravenous line as Propofol 10 mg/ml (1%) without prior flushing.
This medicinal product must not be mixed with other medicinal products except those mentioned in the table above.
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