5 mg / ml solution for injection / infusion, emulsion
propofol
What Propofol-Lipuro is and what it is used for
Propofol-Lipuro belongs to a group of medicines called general anesthetics. General anesthetics are used to achieve unconsciousness (sleep) so that surgical operations or other procedures can be performed. They can also be used to calm (sedate) you so that you are sleepy but not completely asleep.
Propofol is used to
- initiate general anesthesia in adults and children over 1 month of age
- and sedate adult patients for short-term diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.
- start sedation in adults and children over 1 month of age during diagnostic and surgical procedures.
Propofol contained in Propofol-Lipuro may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Propofol-Liquor
Do not use Propofol-Lipuro
- if you are allergic to propofol, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).
- to maintain general anesthesia or sedation in children during diagnostic and surgical procedures
- for sedation in connection with intensive care.
Warnings and cautions
Talk to your doctor or pharmacist before taking Propofol-Liquor.
Special care must be taken
- if you have severe head injuries
- if you have mitochondrial disease
- if you have any disturbance in the body’s metabolism of fats
- if you have any other health problems that require great caution when using fat emulsions
- if your blood volume is too small ( hypovolemia )
- if you have low protein concentration in your blood (hypoproteinemia)
- if you are very weak or have problems with your heart, kidneys, or liver
- if you have high pressure in your head
- if you have breathing problems
- if you have epilepsy
- if you are going to undergo any procedure where spontaneous movements are particularly undesirable.
Tell your doctor if you have any of the above diseases or conditions.
If you are getting other fats at the same time via a drip into a vein, your doctor will pay attention to your total daily fat intake.
Propofol is administered by a doctor trained in anesthesia or intensive care. You are constantly monitored during anesthesia and awakening.
If you show signs of so-called propofoline fusion syndrome, your doctor will immediately stop dosing one of propofol. (See section 4 Possible side effects for a detailed list of symptoms under the heading “Doctors should be called immediately
any of the following arises’.)
See also the section ‘Driving and using machines’ for precautions to be taken after using propofol.
Children and young people
The use of Propofol-Lipuro is not recommended in neonates.
Other medicines and Propofol-Lipuro
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Propofol has been used with good effect in connection with various anesthesia techniques that anesthetize only a part of the body ( epidural and spinal anesthesia ).
Safe use has also been demonstrated
- medicines you receive before surgery
- other drugs such as muscle relaxants
- anesthetics that can be inhaled (inhaled)
- painkillers.
However, your doctor may give you a lower dose of propofol in cases where general anesthesia or sedation is needed in addition to anesthesia techniques that only anesthetize part of the body.
Your doctor will take into account that other medicines with a depressant effect on the central nervous system may increase the effect of propofol when co-administered with propofol. Particular caution will also be exercised if you are being treated with a rifampicin-containing antibiotic at the same time, as it may lead to the development of very low blood pressure.
Your doctor may reduce your dose if you are also being treated with valproate (a medicine used to treat seizures).
Propofol-Lipuro with alcohol
Your doctor will inform you about alcohol consumption before and after using Propofol-Liquor.
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.
Propofol-Lipuro should not be used during pregnancy unless necessary. The drug passes through the placenta and can inhibit vital functions in the newborn baby.
Propofol can, however, be used during an induced abortion.
If you are breastfeeding, refrain from breastfeeding for 24 hours after receiving Propofol-Liquor. Breast milk pumped out during this time should be discarded. Studies in breastfeeding women have shown that small amounts of propofol are excreted in human milk.
Driving and using machines
You should avoid driving and using machines for a while after an injection or infusion of Propofol-Liquor.
Your doctor will inform you
- if you should have someone with you when you leave the hospital
- when you can drive and use machines again
- on the use of other sedatives (eg sleeping pills, strong painkillers, alcohol).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
Propofol-Lipuro contains sodium and soybean oil
This medicine contains less than 1 mmol (23 mg) sodium per 20 ml, ie essentially ‘sodium-free’.
Propofol-Lipuro contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
How to use Propofol-Lipuro
Propofol-Lipuro is only given by people trained in anesthesia or by specially trained doctors in a hospital or adequately equipped daycare department.
Dosage
The dose you receive depends on your age, weight, and your state of health. The doctor gives the right dose to start the anesthesia (= anesthesia) or to achieve the desired lowering of the level of consciousness by carefully observing your reactions and your body functions ( pulse, blood pressure, breathing, etc.). The doctor also observes the limitations of the administration time, if necessary.
Propofol-Lipuro is given for a maximum of 1 hour.
Method of administration
You will receive Propofol-Lipuro as an injection or infusion into a vein, ie through a needle or a small tube that is inserted into one of your veins. When used as an infusion, the drug can be diluted before use.
Your blood circulation and breathing are constantly monitored while injection or infusion is given.
If you take more Propofol-Lipuro than you should
This is unlikely to happen, as the dose you receive will be monitored very carefully.
However, if you accidentally overdose, this may result in impaired cardiac function and respiration. In this case, the doctor takes the necessary action immediately.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
A doctor must be called immediately if any of the following arises:
Common (may affect up to 1 in 10 people):
- low blood pressure which can sometimes require an infusion of fluids and that propofol is given more slowly
- too slow heartbeat, which in rare cases can be serious.
Rare (may affect up to 1 in 1,000 people):
- epilepsy-like seizures.
Very rare (may affect up to 1 in 10,000 people):
- allergic reactions up to allergic shock including swelling of the face, tongue, or throat, wheezing, reddening of the skin, and low blood pressure
- cases of unconsciousness after surgery has occurred. Therefore, you will be closely monitored during the awakening.
- fluid accumulation in the lungs ( pulmonary edema ) after administration of propofol
- inflammation of the pancreas.
No known frequency (can not be calculated from the available data):
- Reports of isolated cases of serious side effects manifested as a combination of the following symptoms has occurred: degradation of muscle tissue, accumulation of acidic substances in the blood, abnormally high potassium levels in the blood, elevated blood fat levels, abnormal electrocardiograms (Brugada-like ECG ), liver enlargement, irregular heartbeat, kidney failure, and heart failure. This has been called “propofol in fusion syndrome”. Some of the reported cases have been fatal. These side effects have only been observed in intensive care patients, mainly in patients with severe head injuries and in children with respiratory infections who have received propofol doses higher than 4 mg per kg body weight per hour. See also section 2, ‘Warnings and Precautions’.
Other side effects are:
Very common (may affect more than 1 in 10 people):
- injection site pain during the first injection. The pain can be reduced by giving propofol in the larger veins of the forearm. Concomitant injection of lidocaine (local anesthetic) and propofol also reduces the pain at the injection site.
Common (may affect up to 1 in 10 people):
- shortness of breath
- headache during awakening
- nausea or vomiting during waking.
Uncommon (may affect up to 1 in 100 people):
- blood clots in veins or inflammation of the vein at the injection site
Very rare (may affect up to 1 in 10,000 people):
- loss of control over sexual drive during awakening
- abnormal color of the urine after receiving propofol for a long time
- fever after surgery.
- tissue damage after accidental injection of the drug outside a vein.
No known frequency (can not be calculated from the available data):
- involuntary movements
- abnormally good mood
- drug abuse and drug addiction
- heart failure
- cardiac arrest
- shallow breathing
- prolonged and painful erection of the penis
- pain and/or swelling at the injection site following accidental injection of the drug outside a vein
- Rare cases of muscle tissue degradation have been reported when a higher dose than recommended was used for sedation in intensive care units.
How to store Propofol-Lipuro
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 label and carton. The expiration date is the last day of the specified month.
Do not store above 25 ° C. Do not freeze.
Propofol-Lipuro should be used immediately after opening or diluting the ampoule.
Do not use Propofol-Lipuro if two separate layers can be seen after shaking the product or if it is not milky white.
Contents of the pack and other information
Content declaration
- The active substance is propofol.
One milliliter of Propofol-Lipuro 5 mg / ml contains 5 mg of propofol.
1 ampoule of 20 ml contains 100 mg of propofol. - The other ingredients are:
soybean oil, refined
triglycerides , medium chain
egg phospholipids for injection
glycerol
sodium oleate
water for injections.
What the medicine looks like and the contents of the pack
Propofol-Lipuro is an emulsion for injection/infusion.
Emulsion One is a milky white oil-in-water emulsion.
The product is marketed in glass ampoules of 20 ml which are available in packs of 5 ampoules.
Marketing Authorization Holder and Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany
Postal address:
34209 Melsungen, Germany
Contact your local marketing authorization holder for more information on this medicine.
B. Braun Medical AB
Box 110
182 12 Danderyd
This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
| Propofol-Lipuro 0.5% (5 mg / ml): | Ireland, Slovakia, Spain, Great Britain (Northern Ireland), Portugal, Czech Republic |
| Propofol B. Braun 5 mg / ml: | Italy |
| Propofol “B.Braun” 5 mg / ml: | Denmark |
| Propofol-Lipuro 5 mg / ml: | Finland, France, Norway, Poland, Sweden, Hungary |
| Propofol-Lipuro 5 mg/ml emulsion for injection or infusion: | Austria, Germany, Luxembourg |