Patient leaflet - PROPOFOL 2% FRESENIUS EMULSION FOR INJECTION OR INFUSION
1. what propofol fresenius is and what it is used for
Propofol Fresenius 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 2 % (20 mg/1 ml) Fresenius is used to:
- induce and maintain general anaesthesia in adults and children > 3 years.
- sedate patients > 16 years of age receiving artificial respiration in intensive care.
- sedate adults and children > 3 years during diagnostic and surgical procedures, alone or in combination with local or regional anaesthesia.
2. what you need to know before you are given propofol fresenius
Do not use Propofol Fresenius
if you are allergic to propofol or any of the other ingredients of this medicine (listed in section 6). -if you are allergic to soya or peanut (see “Propofol Fresenius contains soya-bean oil and sodium” at the end of section 2). -in patients of 16 years of age or younger for sedation in intensive care.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given Propofol Fresenius and if any of the subsequent mentioned applies to you or applied to you in the past.
You should not receive Propofol Fresenius, or only under extreme caution and intensive monitoring, if you: -have advanced heart failure -have any other serious disease of the heart -are receiving electroconvulsive therapy (ECT, a treatment for psychiatric problems)
In general, Propofol Fresenius should be given with caution to elderly or weak patients.
Before receiving Propofol Fresenius, tell your anaesthetist or intensive care doctor if you have: -heart disease -lung disease -kidney disease -liver disease -seizures (epilepsy) -a raised pressure inside the skull (raised intracranial pressure). In combination with low blood pressure the amount of blood reaching the brain may be decreased. -altered levels of fat in the blood. If you receiving total parenteral nutrition (feeding through a vein), the levels of fat in your blood must be monitored. -if your body has lost lots of water (you are hypovolaemic).
If you have any of the following conditions, they must be treated before you receive Propofol Fresenius:
- heart failure
- when there is insufficient blood reaching the tissues (circulatory failure)
- severe breathing problems (respiratory failure)
- dehydration (hypovolaemia)
- seizures (epilepsy) Propofol Fresenius may increase the risk of -epileptic seizures
- a nervous reflex that slows the heart rate (vagotonia, bradycardia)
- changes in the blood flow to the organs of the body (haemodynamic effects on the cardiovascular system)
If you are overweight and receive high doses of Propofol Fresenius.
- involuntary movements can occur during sedation with Propofol Fresenius. The doctors will take into account how this might affect surgical procedures being performed under sedation and will take the necessary precautions.
Very occasionally, after anaesthesia, there may be a period of unconsciousness associated with stiffness of the muscles. This requires observation by the medical staff but no other treatment. It will resolve spontaneously.
The injection of Propofol Fresenius can be painful. A local anaesthetic can be used to reduce this pain but can have its own side effects.
You will not be allowed to leave the hospital until you are fully awake. If you are able to go home shortly after receiving propofol you should not go home unaccompanied.
Children and adolescents
The use of Propofol 2 % (20 mg/1 ml) Fresenius is not recommended in children younger than 3 years of age. Propofol 2 % (20 mg/1 ml) Fresenius must not be given to children and adolescents younger than 16 years of age for sedation in the intensive care unit, since its safety has not been demonstrated in this patient group for this indication.
Other medicines and Propofol Fresenius
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You must take special care if you are also taking/receiving any of the following medicines:
- Premedications (your anaesthetist will know which medicines can be influenced by Propofol Fresenius)
- Other anaesthetics, including general, regional, local and inhalational anaesthetics (Lower doses of Propofol Fresenius may be required. Your anaesthetist will know this.)
- Painkillers (analgesics)
- Strong painkillers (fentanyl or opioids)
- Parasympatholytic agents (medicines used to treat e.g. painful cramps of organs, asthma or Parkinson's disease)
- Benzodiazepines (medicines used to treat anxiety)
- Suxamethonium (muscle relaxant) -Drugs that affect many of the internal body functions such as the heart rate, e.g. atropine
Alcohol containing medicines or beverages
Neostigmine (medicine used to treat a disease called myasthenia gravis) -Cyclosporine (medicine used to prevent transplant rejections) -Valproate (medicine used to treat epilepsy or mental disorders)
Propofol Fresenius with food and drink
After you have been given Propofol Fresenius, you should not eat, drink or consume alcohol until fully recovered.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Propofol Fresenius should not be given to pregnant women unless necessary. You should stop breast-feeding and discard any breast milk for 24 hours after receiving Propofol Fresenius.
Driving and using machines
After having Propofol 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 receiving Propofol, do not drive a car or go home unaccompanied. Ask your doctor when you can start doing these activities again and when you can go back to work.
Propofol Fresenius contains soya-bean oil and sodium
Propofol Fresenius contains soya-bean oil. This can rarely cause severe allergic reactions (see “Do not use Propofol Fresenius”).
Tell your doctor if you know that you have allergic reactions to soya-bean oil or peanut.
This medicinal product contains less than 1 mmol (23 mg) sodium per 100 ml, i.e. essentially ‚sodiumfree‘.
3. how to use propofol fresenius
Propofol Fresenius will only be given to you in hospitals or suitable therapy units by, or under the direct supervision of your anaesthetist or intensive care doctor.
Dosage
The dose you are given will vary depending on your age, body weight and physical condition. The doctor will give 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.
Adults
Most people need 1.5 –2.5 mg propofol per kg body weight to make them go to sleep (induction of anaesthesia), and then 4 to 12 mg propofol per kg body weight per hour after this to keep them asleep (maintenance of anaesthesia). For sedation, doses of 0.3 to 4.0 mg propofol per kg body weight per hour are usually sufficient.
For sedation during surgical and diagnostic procedures in adults, most patients will require 0.5 –1 mg propofol per kg body weight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol Fresenius infusion to the desired level of sedation. Most patients will require 1.5 –4.5 mg propofol per kg body weight per hour. The infusion may be supplemented by bolus administration of 10 –20 mg propofol (0.5 – 1 ml Propofol 2 % (20 mg/1 ml) Fresenius) if a rapid increase of the depth of sedation is required.
To provide sedation for ventilated patients older than 16 years of age under intensive care conditions the dose will be adjusted according to the depth of sedation required. Usually satisfactory sedation is achieved by continuous infusion with administration rates in the range of 0.3 to 4.0 mg propofol per kg body weight per hour. Rates of infusion greater than 4.0 mg propofol per kg bodyweight per hour are not recommended.
Use in children and adolescents over three years of age
The use of Propofol 2 % (20 mg/1 ml) Fresenius is not recommended in children younger than 3 years of age.
The dose should be adjusted according to age and/or body weight. Most patients over 8 years of age require approximately 2.5 mg/kg bodyweight Propofol Fresenius to make them go to sleep (induction of anaesthesia). In younger children dose requirements may be higher (2.5 –4 mg/kg bodyweight). Rates in the region of 9 –15 mg/kg/h usually achieve satisfactory anesthesia to keep them asleep (maintenance of anaesthesia). In younger children dose requirements may be higher.
For sedation during surgical and diagnostic procedures in children over 3 years of age with Propofol 2 % (20 mg/1 ml) Fresenius most paediatric patients require 1 –2 mg/kg bodyweight propofol for onset of sedation. Maintenance of sedation may be accomplished by titrating Propofol Fresenius infusion to the desired level of sedation. Most patients require 1.5 –9 mg/kg/h propofol.
Propofol 2 % (20 mg/1 ml) Fresenius must not be given to children and adolescents younger than 16 years of age for sedation in the intensive care unit, since its safety has not been demonstrated in this patient group for this indication.
Method of administration
Propofol Fresenius is for intravenous use, usually on the back of your hand or in the forearm. Your anaesthetist may use a needle or cannula (a fine plastic tube). Propofol Fresenius will be injected into a vein either manually or by electric pumps. An electric pump may be used to give the injection for long operations and for use in intensive care.
Elderly and weak patients
Elderly and weak patients may require lower doses.
Duration of treatment
When used for sedation, Propofol Fresenius must not be administered for more than 7 days.
If you received more Propofol than you should
Your doctor will ensure that you receive the right amount of Propofol for you and for the procedure you are undergoing. However, different people need different doses and if you do receive too much for you, your anaesthetist may need to take measures to make sure your heart and breathing are adequately supported. This is why anaesthetic drugs are only administered by doctors trained in anaesthesia or in the care of patients in intensive care.
If you have any further questions on the use of this medicine, ask your anaesthetist or intensive care doctor.
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)
Slow or fast heartbeat
Low blood pressure
Changes in your breathing pattern (low respiratory rate, breathing arrest)
Hiccups
Cough (may also happen when you wake up)
Uncommon (may affect up to 1 in 100 people)
Swelling and redness or blood clots at the vein along the injection site
Rare (may affect up to 1 in 1,000 people)
Twitching and shaking of your body, or fits (may also happen when you wake up).
Very rare (may affect up to 1 in 10, 000 people)
Serious allergic reaction which causes difficulty in breathing, swollen and reddened skin with hot flushes
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)
Involuntary movements
Severe skin and tissue reaction following accidental application beside the vein.
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)
Headache
Feeling sick (nausea), being sick (vomiting).
Cough.
Rare (may affect up to 1 in 1,000people)
Dizziness, chills and sensations of cold □ Excitations
Very rare (may affect up to 1 in 10,000 people)
Being unconscious after the operation (when this has happened, the patients have recovered without problems)
Inflamed pancreas (pancreatitis) which causes severe stomach pain (a causal relationship could not be shown)
Fever following surgery
Not known (frequency cannot be estimated from the available data)
Feeling euphoric
Feeling sexually aroused
Irregular heart beat
Changes in ECG (Brugada type ECG)
Increase in liver size
Kidney failure
Breakdown of muscle cells (rhabdomyolysis), increase in acidity of your blood, high potassium and fat levels in your blood, heart failure □
Drug abuse, mostly by healthcare professionals
When Propofol Fresenius is administered in combination with lidocaine (a local anaesthetic used to reduce the pain at the site of injection), certain side effects may occur rarely:
-dizziness
-vomiting
-sleepiness
-fits -a slowing of the heart rate (bradycardia)
-irregular heartbeat (cardiac arrhythmias)
-shock
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system below. By reporting side effects you can help provide more information on the safety of this medicine.
For the UK:
You can report side effects directly via the Yellow Card Scheme at:
For Ireland:
You can also report side effects directly via
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL – Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website:
E-mail:
5. how to store propofol fresenius
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 ampoule/vial and the outer packaging after EXP. The expiry date refers to the last day of that month.
Do not store above 25 °C. Do not freeze.
After opening the product must be used immediately. Administration systems with Propofol Fresenius should be replaced 12 hours after opening of the ampoule or vial.
Containers should be shaken before use. Do not use this medicine if you notice two layers after shaking the emulsion. Use only homogeneous preparations and undamaged containers.
For single use only. Any unused emulsion must be discarded.
Do not throw away any medicines via wastewater or household waste. 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 2 % (20 mg/1 ml) Fresenius contains
The active substance is propofol.
-
1 ml emulsion contains 20 mg propofol. Each 20 ml ampoule contains 400 mg propofol. Each 50 ml vial contains 1000 mg propofol. Each 100 ml vial contains 2000 mg propofol.