10 mg / ml or 20 mg / ml solution for injection / infusion in pre-filled syringe
Propofol
What Propolipid is and what it is used for
Propolipid belongs to a group of medicines called general anesthetics. General anesthetics are used to induce unconsciousness (sleep) so that surgery or other procedures can be performed. They can also be used to sedate you (so that you become sleepy, but do not sleep completely).
Propolipid 10 mg / ml is used for:
- to induce and maintain general anesthesia in adults, adolescents, and children older than 1 month.
- to sedate patients older than 16 years who receive artificial respiration in intensive care
- to sedate adults, adolescents, and children over 1 month of age in examinations and surgical procedures, alone or in combination with local anesthesia or anesthesia of nerve pathways ( conduction anesthesia ).
Propolipid 20 mg / ml is used for:
- to induce and maintain general anesthesia in adults, adolescents, and children older than 3 years.
- to sedate patients older than 16 years who receive artificial respiration in intensive care
- to sedate adults, adolescents, and children over the age of 3 in examinations or surgical procedures, alone or in combination with local anesthesia or anesthesia of nerve pathways ( conduction anesthesia ).
What you need to know before you use Propolipid
Do not use Propolipid
- if you are allergic to propofol, soy, peanut, or any of the other ingredients of this medicine (listed in section 6).
- in the sedation of patients 16 years or younger in intensive care.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before receiving Propolipid and if any of the following applies to you or applies to you in the past.
You should not receive Propolipid, or only with extreme caution and under intensive supervision if you:
- has advanced heart failure
- have any other serious heart disease
- receive electric shock treatment (ECT, treatment for psychiatric problems).
In general, Propolipid should be given with caution to elderly or debilitated patients.
Before you receive Propolipid, tell your anesthetist or intensive care physician if you have:
- heart disease
- lung disease
- kidney disease
- liver disease
- seizures ( epilepsy )
- elevated pressure inside the skull (elevated intracranial pressure ). In combination with low blood pressure, the amount of blood that reaches the brain can decrease.
- altered fat levels in the blood. The levels of fat in the blood must be checked in case you receive total parenteral nutrition (food through a vein).
If you have any of the following conditions, they must be treated before you receive Propolipid:
- heart failure
- when not enough blood reaches the tissues ( circulatory failure )
- severe respiratory problems (respiratory failure)
- dehydration ( hypovolemia )
- cramps ( epilepsy ).
Propolipid may increase the risk of
- epileptic seizures
- a nerve reflex that lowers the heart rate (vagotonia, bradycardia )
- altered blood flow to the body’s organs (hemodynamic effects on the cardiovascular system) if you are overweight and receive high doses of Propolipid.
- if your body has lost a lot of water (you have hypovolemia )
Involuntary movements may occur during sedation with Propolipid. Physicians will take into account how this may affect the surgical procedures performed during sedation and take the necessary precautions.
Occasionally, after anesthesia, there may be a period of unconsciousness with stiffness in the muscles. This requires observation by medical staff, but no other treatment. It disappears by itself.
Injection of one Propolipid can be painful. A local anesthetic can be used to reduce this pain, but it can have side effects.
You must not leave the hospital until you are fully awake.
If you can go home shortly after receiving propofol, do not go home without company.
Children and adolescents (Propolipid 10 mg / ml)
Propolipid 10 mg/ml is not recommended for use in neonates or infants less than 1 month of age.
Administration with TCI (Target Controlled Infusion ) system is not recommended for children under 2 years of age as only limited data are available.
Propolipid 10 mg/ml must not be given to children and adolescents under 16 years of age as sedation in intensive care as safety has not been established in this patient group for this indication.
Children and adolescents (Propolipid 20 mg / ml)
Propolipid 20 mg/ml is not recommended for use in children under 3 years of age.
Propolipid 20 mg/ml must not be given to children and adolescents under 16 years of age as sedation in intensive care as safety has not been established in this patient group for this indication.
Other medicines and Propolipid
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor, anesthetist, or nurse if you are taking any of the following medicines:
- rifampicin (used to treat tuberculosis, TB)
- midazolam (used to induce sedation (a very relaxed state of calm, drowsiness, or sleep) and relieves anxiety and muscle tension)
Take special care with any of the following medicines:
Take special care with any of the following medicines:
- pre-medication (your anesthetist knows which drugs can be affected by Propolipid)
- other anesthetics, including general anesthesia, regional and local anesthetics, and inhalation anesthesia (low doses of Propolipid may be needed. Your anesthesiologist knows this.)
- analgesics ( analgesics )
- strong painkillers ( fentanyl or opioids )
- parasympatholytic (medicines used to treat eg painful cramps in certain organs, asthma, or Parkinson’s disease )
- benzodiazepines (medicines used to treat anxiety)
- suxamethon (muscle relaxant)
- drugs that affect many of the body’s internal functions such as heart rate, e.g. atropine
- alcoholic beverages or beverages
- neostigmine (a medicine used to treat myasthenia gravis )
- ciclosporin (a medicine used to prevent transplant rejection).
- valproate (a medicine used to treat epilepsy or mental disorders)
Use of Propolipid with food, drink, and alcohol
Once you have received Propolipid, do not eat, drink or drink alcohol until you have fully recovered.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Propolipid should only be used during pregnancy when necessary.
You should not breastfeed when you are given propofol and the breast milk must be discarded 24 hours after you have received Propolipid.
Driving and using machines
Once you have received Propolipid, you may feel drowsy for a while. Do not drive or use any tools or machines until you know the effects have disappeared.
If you can go home shortly after receiving Propolipidl, do not drive or go home without company.
Ask your doctor when you can start these activities again and when you can return to work.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Propolipid contains soybean oil and sodium
Propolipid contains soybean oil. Do not use this medicine if you are allergic to peanuts or soy.
This medicine contains less than 1 mmol (23 mg) sodium per 100 ml, ie essentially ‘sodium-free’.
How to use Propolipid
Propolipid is only given in hospitals or appropriate treatment units by or under the direct supervision of anesthesiologists or intensive care physicians.
Dosage
The amount of Propolipid you need depends on your age, body weight, and physical condition. Your doctor will give you the correct dose to initiate and maintain anesthesia or to achieve the degree of sedation (sedative effect and drowsiness) needed, by paying close attention to how you react and to vital signs ( pulse, blood pressure, breathing, etc).
You may need several different medications to keep you asleep or sleepy, pain-free, and keep your breathing normal and your blood pressure steady. Your doctor will decide which medicines you need and when you need them.
Adults
Most people need 1.5 to 2.5 mg propofol per kg body weight for them to fall asleep ( induction of anesthesia ), and then 4 to 12 mg propofol per kg body weight an hour for them to continue sleeping (maintenance of anesthesia ). When sedating, a dose of 0.3 to 4.0 mg propofol per kg body weight and hour is usually sufficient.
For sedation during surgery or examinations in adults, most patients need 0.5-1 mg of propofol per kg of body weight for 1-5 minutes to initiate sedation. Maintenance of sedation can be done by giving the infusion of Propolipid to the desired sedation level. Most patients need 1.5-4.5 mg of propofol per kg of body weight and hour. Infusion one can be supplemented by giving an additional 10-20 mg of propofol (1-2 ml of Propolipid 10 mg/ml or 0.5-1 ml of Propolipid 20 mg/ml) to be able to rapidly increase sedation if necessary.
When sedating patients over the age of 16 who receive artificial respiration during intensive care, the dose will be adjusted to the need for sedation depth. Satisfactory sedation is usually achieved with continuous feed at a rate of about 0.3-4.0 mg propofol/kg body weight/hour. Infusion rates over 4.0 mg propofol/kg body weight/hour are not recommended.
Use in children and adolescents over one month of age
Propolipid is not recommended for use in children younger than 1 month. Particular caution should also be exercised when administering Propolipid 10 mg/ml to children under 3 years of age. However, available data do not show that this would be less safe than in children older than 3 years.
The dose should be adjusted according to age and/or bodyweight. Most patients over the age of 8 need about 2.5 mg/kg body weight of Propolipid to fall asleep ( induction of anesthesia ). In younger children, especially between 1 month and 3 years of age, a higher dose may be needed (2.5-4 mg/kg body weight).
Speeds of 9-15 mg/kg/hour usually achieve sufficient anesthesia for them to continue sleeping (maintenance of anesthesia ). In younger children, especially between 1 month and 3 years of age, a higher dose may be required.
For sedation with Propolipid 10 mg/ml during surgical and diagnostic procedures in children over 1 month of age, most children need 1-2 mg of propofol per kg body weight to initiate sedation. Maintenance of sedation can be done by giving the infusion of Propolipid to the desired sedation level. Most patients need 1.5-9 mg of propofol per kg of body weight and hour. Infusion one can be supplemented by giving an additional 1 mg/kg body weight to be able to quickly increase sedation a
Propolipid 10 mg/ml must not be given to children and adolescents under 16 years of age as sedation in intensive care as safety has not been established in this patient group for this indication.
Use in children and adolescents over three years of age
Propolipid 20 mg/ml is not recommended for use in children under 3 years of age.
The dose should be adjusted according to age and/or bodyweight. Most patients over the age of 8 need about 2.5 mg/kg body weight of Propolipid to fall asleep ( induction of anesthesia ). In younger children, a higher dose may be needed (2.5-4 mg/kg body weight).
Speeds of 9-15 mg/kg/hour usually achieve sufficient anesthesia for them to continue sleeping (maintenance of anesthesia ). In younger children, a higher dose may be required.
For sedation with Propolipid 20 mg/ml during surgical and diagnostic procedures in children over 3 years of age, most children need 1-2 mg of propofol per kilogram of body weight to initiate sedation. Maintenance of sedation can be done by giving the infusion of Propolipid to the desired sedation level. Most patients need 1.5-9 mg of propofol per kg of body weight and hour.
Propolipid 20 mg/ml must not be given to children and adolescents under 16 years of age as sedation in intensive care as safety has not been established in this patient group for this indication.
Method of administration
Propolipid is used intravenously and is usually given on the top of the hand or in the armpit. Your anesthetist may use a needle or needle (a narrow plastic tube). Propolipid will be injected into a vein either manually or using an electric pump. Your doctor will make sure that the pump is compatible with the pre-filled syringes. 10 ml and 20 ml glass syringes and 10 ml plastic syringes are only suitable for manual use and must not be used with a pump.
Propolipid is for single use only. Leftover medicine must be discarded. The pre-filled syringe should be shaken before use. If two layers can be seen after shaking, emulsion one should not be used. Use only homogeneous drugs and undamaged syringes.
Installation of pre-filled syringes (for pre-assembled syringes, step 2 can be omitted):
Sterility must be ensured. The outside of the syringe and the plunger rod are not sterile!
- Take the syringe out of the package and shake it.
- Connect the piston rod by screwing it clockwise into the syringe.
- Remove the syringe tip cap and connect the infusion line or needle to the syringe. Remove gas bubbles (a small bubble may remain) and the ready-to-use syringe can be installed in the pump or given manually.
Duration of treatment
When Propolipid is used for sedation, it must not be given for more than 7 days.
If you take more Propolipid than you should
Your doctor will make sure that you get the correct amount of propofol for you and the procedure you are undergoing.
However, different people need different doses for you, and if you receive too high a dose, your anesthetist will need to take steps to ensure that your heart function and breathing function properly. This is the reason why anesthetics are only given by doctors who are trained in anesthesia and patients who are cared for in intensive care.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
The following side effects may occur during anesthesia (while an injection is given and you are drowsy or asleep). The doctor will pay attention to these. If they occur, the doctor will give appropriate treatment.
Very common (may affect more than 1 user in 10):
- local pain at the injection site (while the injection is given, before going to sleep)
Common (may affect up to 1 in 10 people):
- slow or fast heartbeats
- low blood pressure
- changes in breathing patterns (slow breathing, pauses in breathing)
- hiccup
- cough (may also occur on waking)
Uncommon (may affect up to 1 in 100 people):
- swelling and redness or blood clots in the blood vessel at the injection site
Rare (may affect up to 1 in 1,000 people) :
- twitching and shaking in the body, or seizures (may also occur after waking up)
Very rare (may affect up to 1 in 10,000 people):
- the severe allergic reaction which causes difficulty breathing, swelling and redness of the skin, hot flashes
- fluid accumulation in the lungs which may cause shortness of breath (may also occur after waking up)
- discolored urine (may also occur after waking up)
Has been reported (occurs in an unknown number of users):
- involuntary movements
- severe reactions in the skin and tissues after unintentional administration outside the blood vessel
- Prolonged, often painful erection (priapism)
Side effects that may occur after anesthesia
These side effects may occur after anesthesia (on awakening or after awakening):
Common (may affect up to 1 in 10 people):
- headache
- nausea or vomiting
- cough
Rare (may affect up to 1 in 1,000 people) :
- dizziness, chills, and a feeling of cold
- excitement
Very rare (may affect up to 1 in 10,000 people):
- unconsciousness after surgery (when this has occurred, the patient has recovered without problems)
- inflammation of the pancreas ( pancreatitis ) which causes severe abdominal pain (a causal relationship could not be determined)
- fever after surgery
Has been reported (occurs in an unknown number of users):
- euphoria (feeling of happiness)
- sexual arousal
- irregular heartbeats
- ECG changes ( Brugada-type ECG )
- liver enlargement
- kidney failure
- degradation of muscle cells ( rhabdomyolysis ), altered acidity in the blood, high levels of potassium and fat in the blood, heart failure
- abuse of the drug, mainly among healthcare professionals
- Prolonged, often painful erection (priapism)
When Propofol Fresenius Kabi is given in combination with lidocaine (a local anesthetic used to reduce the pain at the injection site), in rare cases some side effects may occur:
- dizziness
- vomiting
- somnolence
- seizures
- slower heart rate ( bradycardia )
- irregular heartbeat ( cardiac arrhythmias )
- shock
How to store Propolipid
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 syringe after EXP and on the outer carton after EXP. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Do not freeze.
After opening, the product must be used immediately.
Propolipid 10 mg / ml
The diluted Propolipid 10 mg/ml administration system should be replaced 12 hours after opening the syringe.
Dilutions with glucose solution 50 mg/ml or sodium chloride solution 9 mg/ml or mixture with unpreserved injection solution with lidocaine 10 mg/ml (at least 2 mg propofol per ml) should be prepared aseptically (controlled and validated conditions assumed) immediately before administration and must be consumed within 6 hours.
Propolipid 20 mg / ml
The Propolipid 20 mg/ml administration system should be replaced 12 hours after opening the syringe.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is propofol.
Each ml of emulsion contains 10 mg of propofol.
Each 10 ml syringe contains 100 mg of propofol.
Each 20 ml syringe contains 200 mg of propofol.
Each 50 ml syringe contains 500 mg of propofol.
Each ml of emulsion contains 20 mg of propofol.
Each 50 ml syringe contains 1000 mg of propofol.
- The other ingredients are soybean oil, refined, medium-chain triglycerides, purified egg phospholipids, glycerol, oleic acid, sodium hydroxide, and water for injections.
What the medicine looks like and the contents of the pack
Propolipid is a white oil-in-water emulsion for injection or infusion into a pre-filled syringe.
Propolipid is available in pre-filled plastic or glass syringes.
Pack sizes:
A pack containing 5 pre-filled glass syringes with 10 ml emulsion.
A pack containing 6 pre-filled plastic syringes with 10 ml emulsion.
A pack containing 5 pre-filled glass syringes with 20 ml emulsion.
A pack containing 6 pre-filled plastic syringes with 20 ml emulsion.
A pack containing 1 pre-filled plastic syringe with 50 ml emulsion.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi AB
751 74 Uppsala
Manufacturer:
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
2015-10-21