10 mg / ml, 20 mg / ml solution for injection / infusion, emulsion
propofol
What Propofol Sandoz is and what it is used for
Propofol Sandoz 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 Sandoz is given as an injection by a doctor.
Propofol Sandoz 10 mg / ml solution for injection / infusion is used to:
- start and maintain general anesthesia in adults and children> 1 month
- then ventilated patients> 16 years in the intensive care unit
- then adults and children> 1 month during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.
Propofol Sandoz 20 mg / ml solution for injection / infusion is used to:
- start and maintain general anesthesia in adults and children> 3 years
- then ventilated patients> 16 years in the intensive care unit
- then adults and children> 3 years under diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.
Propofol contained in Propofol Sandoz 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 Sandoz
Do not use Propofol Sandoz
- if you are allergic to propofol or any of the other ingredients of this medicine (listed in section 6).
- to patients who are allergic to peanuts or soy. This is because Propofol Sandoz contains soybean oil.
- to patients who are 16 years or younger for sedation in the intensive care unit.
Warnings and cautions
Propofol Sandoz is not recommended for newborns.
Propofol Sandoz 20 mg / ml solution for injection / infusion
Propofol Sandoz 20 mg/ml is not recommended for use in children <3 years.
Propofol Sandoz must not be used in patients 16 years of age or younger for sedation in intensive care.
Talk to your doctor, anesthesiologist, or nurse before receiving Propofol Sandoz
- if you have any other health problems, such as heart, breathing, kidney, or liver problems
- if you have lost a lot of water (you are dehydrated)
- if you have ever had a seizure
- if you have been told that you have very high levels of fat in your blood. In these cases, your doctor may need to determine your blood fat levels
- if you have been told that your body has problems using fat. In these cases, your doctor may need to determine your blood fat levels
- if you have a condition called hereditary predisposition to acute porphyria
- or if you have mitochondrial disease (a disease that affects energy metabolism).
If you have any of the following conditions, you may experience very rare side effects. These conditions are:
- decreased blood flow in the tissues
- severe nerve damage
- sepsis. _
If you can go home shortly after receiving propofol, do not go home alone.
If you are not sure if the above applies to you, talk to your doctor or nurse before giving Propofol Sandoz.
Other medicines and Propofol Sandoz
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Special care is required when taking/receiving the following medicines:
- certain medicines you are given before the operation (the anesthetist knows which medicines can be affected)
- other anesthetics (eg general, local, or transient anesthetics)
- painkillers ( analgesics )
- strong painkillers ( fentanyl or opioids )
- parasympathetic acolytes (medicines used to treat eg painful cramps in certain organs, asthma, or Parkinson’s disease )
- benzodiazepines (medicines used to treat anxiety)
- suxamethon (muscle relaxant)
- neostigmine (a medicine used to treat a condition called myasthenia gravis )
- ciclosporin (a medicine used to prevent transplant rejection )
- rifampicin ( antibiotic )
- valproic acid (used to treat epilepsy ).
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 nurse for advice before taking this medicine.
Propofol Sandoz should not be used during pregnancy unless necessary.
You should not breastfeed when you are given Propofol Sandoz and the breast milk must be discarded 24 hours after receiving Propofol Sandoz.
Driving and using machines
Once you have received Propofol Sandoz, 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 Propofol Sandoz, do not drive. 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.
Propofol Sandoz contains soybean oil
If you are allergic to peanuts or soy, do not take this medicine (see above “Do not use Propofol Sandoz”).
Propofol Sandoz contains purified egg phospholipids.
It can cause problems if you are hypersensitive to them.
Propofol Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per 100 ml, ie essentially ‘sodium-free’.
How to use Propofol Sandoz
Propofol Sandoz is only given by anesthesiologists or by specially trained doctors in an intensive care unit. You get it as an injection or infusion (drip) in a friend. It is usually given on the back of the hand or the forearm.
- Your doctor will give you an injection with a thin needle or thin plastic tube called a cannula.
- To maintain anesthesia (sedation) or sedation, you can receive the drug as an intravenous infusion (drip) with an electric pump that automatically controls the rate at which you receive the infusion. This can happen if you are going to undergo a long operation or if you are in an intensive care unit.
The dose you are given varies depending on your age, your body weight, and your state of health. The doctor gives the right dose to start and then maintain anesthesia (anesthesia) or to achieve the desired lowering of the level of consciousness by carefully observing your reactions and your bodily functions ( pulse, blood pressure, breathing, etc.).
Several different medications may be needed to keep you anesthetized or drowsy, pain-free, maintain breathing, and keep blood pressure steady. Your doctor will decide which medicines you need and when you need them.
General anesthesia
Adults
- To start anesthesia, most adult patients under the age of 55 need between 1.5 and 2.5 mg/kg body weight.
- To maintain anesthesia, doses between 4 and 12 mg/kg/hour or repeated bolus injections (of Propofol Sandoz 10 mg/ml) are generally given with dose increases of 25-50 mg.
Doses may be lower in the elderly.
Sedation
Adults and young people over 16 years
- When sedating adults and young people over the age of 16 in the intensive care unit, the dose should be adjusted according to
- the level of sedation desired. When administered as a continuous infusion, doses of 0.3‑4.0 mg/kg/hour are usually given.
Adults
- When sedating for diagnostic and surgical procedures in adults, a dose of 0.5‑1 mg/kg body weight for 1‑5 minutes is generally required to start sedation. Maintaining sedation requires 1.5‑4.5 mg / kg body weight / hour. In addition, a single administration of 10-20 mg may be given if a rapid increase in sedation level (drowsiness) is required.
General anesthesia
Propofol Sandoz 10 mg / ml solution for injection / infusion
Children over 1 month
- To start anesthesia, most children over the age of 8 need about 2.5 mg/kg body weight Propofol Sandoz 10 mg/ml. In children younger than 8 years, the dosage may be higher (2.5‑4 mg/kg body weight).
- To maintain anesthesia with continuous infusion doses, doses between 9 and 15 mg/kg/hour usually provide satisfactory anesthesia. In younger children, especially between the ages of 1 month and 3 years, the dose requirements may be higher.
Propofol Sandoz 20 mg / ml solution for injection / infusion
Children under 3 years
- Propofol Sandoz 20 mg/ml is not recommended for initiating and maintaining anesthesia in children aged 1 month to 3 years, as the strength of 20 mg/ml is difficult to titrate in children due to the very small volumes required.
Children over 3 years
- To start anesthesia, most children over the age of 8 need about 2.5 mg/kg body weight Propofol Sandoz 20 mg/ml.
- In children younger than 8 years, the dosage may be higher (2.5‑4 mg/kg body weight).
- To maintain anesthesia with continuous infusion doses, doses between 9 and 15 mg/kg/hour usually provide satisfactory anesthesia. In younger children, the dose needs may be higher.
Sedation
Propofol Sandoz 10 mg / ml solution for injection / infusion
Children over 1 month
- When sedating children during diagnostic and surgical procedures, the dose should be adjusted to the required sedation level. Most children require a dose of 1-2 mg/kg body weight Propofol Sandoz 10 mg/ml for sedation to occur. Maintenance of sedation requires 1.5‑9 mg / kg / hour Propofol Sandoz 10 mg / ml. In addition, a single administration of up to 1 mg/kg body weight may be given if a rapid increase in sedation level is required.
- Propofol Sandoz 10 mg/ml must not be given to children aged 16 years or younger for the indication of sedation in the intensive care unit.
Propofol Sandoz 20 mg / ml solution for injection / infusion
Children over 3 years
- When sedating children during diagnostic and surgical procedures, the dose should be adjusted to the required sedation level. Most children require a dose of 1-2 mg/kg body weight Propofol Sandoz 20 mg/ml for sedation to occur. Maintenance of sedation requires 1.5‑9 mg / kg / hour Propofol Sandoz 20 mg / ml.
- Propofol Sandoz 20 mg/ml must not be given to children aged 16 years or younger for the indication of sedation in the intensive care unit.
Treatment time
When used for sedation, Propofol Sandoz must not be given for more than 7 days.
If you take more Propofol Sandoz than you should
Your doctor will make sure that you get the amount of Propofol Sandoz that suits you and the procedure you are going to undergo. However, different people need different doses and if you get too much, your anesthetist can take steps to check that your heart function and breathing are maintained. It is for this reason that anesthesia drugs are only given by anesthesiologists and by doctors in the intensive care unit.
If you have any further questions on the use of this product, ask your anesthetist or doctor in the intensive care unit.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects that can occur during anesthesia
The following side effects may occur during anesthesia (when an injection is given or when you are drowsy or asleep). The doctor will be observant of these. If they occur, you will receive appropriate treatment.
Very common (may affect more than 1 user in 10)
- Injection site pain (when the injection is given, before falling asleep).
Common (may affect up to 1 in 10 people)
- Slow heartbeat
- Low blood pressure
- Transient changes in breathing pattern (respiratory arrest) (when an injection is given, before going to sleep)
- Hyperventilation and cough (when the injection is given, before going to bed)
- Hiccup
- Hemorrhoids.
Uncommon (may affect up to 1 in 100 people)
- Cough (during maintenance treatment).
Rare (may affect up to 1 in 1,000 people)
- Epilepsy-like seizures (may also occur when you wake up).
Very rare (may affect up to 1 in 10,000 people)
- Severe allergic reaction with difficulty breathing or dizziness
- Fluid buildup in the lungs can also make you short of breath (may also occur when you wake up)
- Abnormal color of the urine (may also occur when you wake up).
Has been reported (occurs in an unknown number of users)
- Involuntary movements
- Respiratory paralysis (dose-dependent)
- Prolonged, often painful erection (priapism).
Side effects that may occur after anesthesia
The following side effects may occur after anesthesia (when you wake up or after you wake up).
Common (may affect up to 1 in 10 people)
- Excitement, headache
- Nausea, vomiting.
Uncommon (may affect up to 1 in 100 people)
- Swelling and redness or blood clots in the vein used for injection.
Rare (may affect up to 1 in 1,000 people)
- Dizziness chills and feeling cold
- Cough (when you wake up).
Very rare (may affect up to 1 in 10,000 people)
- Unconsciousness after surgery (when this has occurred, patients have recovered without any problems)
- Inflammation of the pancreas ( pancreatitis ) leading to severe abdominal pain (no causal link has been identified)
- Sexual arousal
- Fever after surgery
- ECG ‑changes (Brugada ‑ similar ECG )
- Severe tissue damage and tissue death after accidental injection next to the blood vessel.
Has been reported (occurs in an unknown number of users)
- Feeling of euphoria
- Irregular heartbeat
- Increased liver size
- Kidney failure
- Degradation of muscle cells ( rhabdomyolysis ), increased acidity in the blood, high levels of potassium and fat in the blood, heart failure
- Local pain, swelling after accidental injection next to the blood vessel
- Drug abuse and drug addiction, mainly among healthcare professionals.
How to store Propofol Sandoz
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 after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Do not freeze.
Keep the vial/ampoule in the outer carton. Sensitive to light.
Shelf life after first opening / dilution:
Propofol Sandoz 10 mg / ml solution for injection / infusion
Mixture one should be reconstituted aseptically before administration and must be administered within 6 hours after reconstitution.
By established guidelines for other lipid emulsions, a single infusion of Propofol Sandoz 10 mg/ml should not exceed 12 hours. At the end of the procedure or after 12 hours, whichever occurs first, both the Propofol Sandoz 10 mg/ml container and the infusion line should be discarded and replaced as appropriate.
Propofol Sandoz 20 mg / ml solution for injection / infusion
Use immediately.
Do not dilute.
Propofol Sandoz 10 mg / ml and 20 mg / ml solution for injection / infusion
Chemical and physical in-use stability has been demonstrated for 24 hours at 25 ° C.
From a microbiological point of view, the solution should be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user.
Do not use this medicine if you notice particles.
Medicines should not be disposed of via wastewater. Your doctor or hospital pharmacist is responsible for proper storage and use and for disposing of the medicine correctly.
Contents of the pack and other information
Content declaration
Propofol Sandoz 10 mg / ml solution for injection / infusion
The active substance is propofol.
Each milliliter of solution for injection/infusion contains 10 mg of propofol.
Propofol Sandoz 20 mg / ml solution for injection / infusion
The active substance is propofol.
Each milliliter of solution for injection/infusion contains 20 mg of propofol.
The other ingredients are refined soybean oil, egg phospholipids, glycerol, sodium hydroxide (for pH adjustment), and water for injections.
What the medicine looks like and the contents of the pack
Propofol Sandoz 10 mg/ml and 20 mg/ml solution for injection/infusion is a white or almost white, aqueous isotonic oil-in-water‑ emulsion, practically free from external particle contamination and large drops of oil. Slight foaming can be seen with long-term storage. It is available in 20 ml ampoules of type 1 glass or 20, 50, and 100 ml vials of type I glass with a rubber stopper of bromobutyl.
Pack sizes
10 mg / ml:
5 x 20 ml ampoule is
5 x 20 ml vials
1 x 50 ml vial
5 x 50 ml vials
1 x 100 ml vial
20 mg / ml:
1 x 50 ml vial
5 x 50 ml vials
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
CORDEN PHARMA SpA, Viale dell’Industria 3, 20867 Caponago, Italy