10 mg / ml, 20 mg / ml solution for injection / infusion, emulsion
propofol
What Profast is and what it is used for
Profast is a short-acting anesthetic drug that is injected into a vein.
Profast belongs to a group of medicines called general anesthetics. General anesthetics are used to induce unconsciousness (a type of sleep) so that surgeries and other treatments can be performed. They can also be used as sedatives, so-called sedation (so that you become sleepy but do not fall asleep completely.
Profast 10 mg / ml is used:
- to induce and maintain anesthesia (unconsciousness) in adults and children over 1 month of age
- as sedation (sedation) to patients over the age of 16 who are on a respirator during intensive care
- as sedation of adults and children over 1 month of age during surgeries and diagnostic procedures, alone or in combination with local or regional anesthesia ( local anesthetics ).
Profast 20 mg / ml is used:
- to induce and maintain anesthesia (unconsciousness) in adults and children over 3 years of age
- as sedation (sedation) to patients over the age of 16 who are on a respirator during intensive care
- as sedation of adults and children over 3 years of age during surgeries and diagnostic procedures, alone or in combination with local or regional anesthesia ( local anesthetics ).
Propofol contained in Profast may also be approved for the treatment of other diseases not mentioned in this leaflet. 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 using Profast
Do not use Profast
Profast 10 mg / ml:
Do not use Profast
- if you are allergic to propofol, soybeans, peanuts, or any of the other ingredients of this medicine (listed in section 6)
- for sedation of patients aged 16 years or younger during intensive care.
Profast 20 mg / ml:
Do not use Profast
- if you are allergic to propofol, soybeans, peanuts, or any of the other ingredients of this medicine (listed in section 6)
- for sedation of patients aged 16 years or younger during intensive care
- as anesthesia for children under 3 years.
Warnings and cautions
Talk to your doctor before using Profast.
Special care is required if Profast is used
- when the patient has an error in fat metabolism
- in diseases that lead to the use of fat-containing emulsions with caution. (See notes on intensive care.)
Profast should be given more slowly than usual to patients
- with poor general condition
- who have a heart, lung, kidney, or liver disease
- with fluid loss ( hypovolemia ).
Impaired cardiac, circulatory and pulmonary function, as well as hypovolemia, should be treated if possible before administration of the drug.
In the event of a sharp drop in blood pressure, you may need to give plasma replacement, possibly also vasoconstrictors, and give Profast at a slower rate. The risk of a sharp drop in blood pressure should be taken into account for patients with impaired coronary or cerebral hemorrhage, or with hypovolemia. The breakdown of propofol is dependent on blood flow. If other drugs that reduce the amount of blood pumped out of the heart are given at the same time, it also reduces the breakdown of propofol.
Profast must be given with caution and under close supervision to patients with severe heart disease.
When Profast is given to people with epilepsy, a seizure can be induced.
If Profast is given in combination with lidocaine, it must be known that lidocaine must not be given to patients with hereditary acute porphyria.
Profast has no vagolytic effect. Use has been associated with bradycardia (slow heart rate ), sometimes with severe outcomes (cardiac arrest). If the patient already has a high vagal tone or if Profast is given with other medicines that can reduce the heart rate, intravenous anticholinergics should be considered before or during anesthesia with Profast.
When Profast is used for sedation before surgery or diagnostic procedures, the patient must be constantly monitored for the first signs of hypotension, respiratory obstruction, and hypoxia.
As with other sedative drugs, the patient may move spontaneously during surgery even when Profast is used for sedation. If a procedure requires the patient to be completely still, these movements may jeopardize the surgical outcome.
Abuse and dependence on Profast have been reported mainly among health care professionals. As with all medicines for general anesthesia, Profast must not be used without ensuring a clear airway. Otherwise, there is a risk of respiratory complications that could lead to death.
Once Profast has been used, make sure that the patient has fully recovered from anesthesia before discharge.
In some cases, a period of unconsciousness may occur after surgery when Profast has been used, which may be accompanied by increased muscle tone (muscle tension). Whether this occurs depends on whether the patient has previously been awake or not. Even if the patient spontaneously regains consciousness, an unconscious patient should always be closely monitored.
The loss of function caused by Profast usually lasts no longer than 12 hours. When explaining the effects of Profast to the patient, the doctor should take into account the type of procedure, other medicines taken at the same time, as well as the patient’s age and general condition. The patient should be informed of the following:
- that he/she may not return home without the company of another person
- when risky manual activities (such as driving) can be performed again
- that other sedatives (eg benzodiazepines, opiates, alcohol) may prolong or aggravate impaired function.
Studies in young animals and also clinical data show that repeated or prolonged use of anesthetics or sedatives in children under 3 years and pregnant women during the last three months of pregnancy can have negative effects on brain development in the child. Parents/guardians should discuss with the doctor the benefits, risks, timing, and duration of surgeries and other procedures that require anesthesia or sedatives.
Information regarding intensive care
Infusion of Profast emulsion for sedation given during intensive care can be associated with several different metabolic disorders and organ failure, which can lead to death.
In addition, there are reports that the following side effects may occur concomitantly: metabolic acidosis, rhabdomyolysis, hyperkalemia, hepatic enlargement, renal failure, hyperlipidemia, cardiac arrhythmia, Brugada-like ECG (saddle or tent-shaped ST elevation in right precordial electrodes V1-V3] and concave T -wave or) and rapidly worsening heart failure, which usually could not be treated with supportive inotropic treatments.
These side effects in combination are also called “propofol in fusion syndrome”.
These events were most commonly seen in patients with severe head injuries and in children with respiratory infections, who had received a higher dose than intended for adults as sedative treatment ( sedation ) during intensive care.
The following factors are considered important risk factors for the development of this complication:
Low oxygen saturation in the tissues, severe neurological damage and/or sepsis, high doses of one or more of the following drugs: vasoconstrictors, steroids, inotropic drugs, and/or propofol (usually at doses exceeding 4 mg propofol per kg body weight in more than 48 hours).
Prescribing physicians should be aware of the risk of these adverse effects in patients who have the risk factors described above, and immediately discontinue the use of propofol if the symptoms described above develop. All sedatives and all drugs used during intensive care should be titrated in such a way that optimal oxygen supply is guaranteed and the hemodynamic parameters remain optimal. If such changes in treatment occur, patients with elevated intracranial pressure should receive appropriate treatment that contributes to cerebral hemorrhage. The treating physician should ensure that the recommended dose of 4 mg propofol/kg body weight per hour is not exceeded, as far as possible.
Particular caution should be exercised in patients with fat metabolism (lipid metabolism) disorders or other disorders that require fat emulsions to be used with caution.
Control of fat metabolism is recommended if Profast is used in patients who are suspected of having elevated lipid levels in the blood. Infusion one by Profast should be adjusted appropriately if the analysis indicates a disturbance in fat metabolism. If the patient simultaneously receives parenteral nutrition, e.g. tube feeding, the amount of lipid you have given in Profast should be included. 1.0 ml Profast contains 0.1 grams of fat.
More information
Caution should be exercised when treating patients with mitochondrial disease. The disease can flare up in these patients if anesthesia is used, or during surgery or intensive care. In these patients, it is recommended that normal body temperature be maintained, carbohydrates are given and the patient is given enough fluids. The early signs of an outbreak of mitochondrial disease and the propofol in fusion syndrome may be similar.
Profast does not contain any antimicrobial preservatives and the growth of microorganisms is facilitated due to its composition.
Profast 10 mg / ml:
a) Children
Profast is not recommended for neonates as this patient group has not been adequately studied. Pharmacokinetic data indicate that the degradation of propofol is significantly lower in neonates and is highly variable in different individuals. If the dose is used that is recommended for older children, overdose can occur and lead to serious problems with the heart, blood circulation, and respiration.
Profast should not be used for sedation in patients aged 16 years or younger who are in intensive care, as the safety and efficacy of Propofol have not been established in this age group.
b) Elderly patients
Elderly patients need a lower dose of you when starting anesthesia with Profast. The patient’s general health condition and age must be taken into account. The lower dose should be given more slowly and titrated according to the patient’s reaction.
Even when Profast is used to maintain anesthesia and for sedation, the infusion rate and selected propofol concentration in the blood should be lower. Additional dose reduction and lower infusion rates are required for patients in risk groups ASA III and IV. Elderly patients should not receive a bolus injection (one or more) as it may lead to circulatory and respiratory failure.
Profast 20 mg / ml:
a) Children
Profast 20 mg/ml must not be used in children under 3 years of age as titration of Profast 20 mg/ml in young children can only be performed with difficulty due to the need for an extremely small volume.
Profast 20 mg/ml should not be used for sedation in patients 16 years of age or younger who are in intensive care, as the safety and efficacy of propofol have not been established in this age group.
b) Elderly patients
Elderly patients need a lower dose of you when starting anesthesia with Profast. The patient’s general health condition and age must be taken into account. The lower dose should be given more slowly and titrated according to the patient’s reaction.
Even when Profast is used to maintain anesthesia and for sedation, the infusion rate and selected propofol concentration in the blood should be lower. Additional dose reduction and lower infusion rates are required for patients in risk groups ASA III and IV. Elderly patients should not receive a bolus injection (one or more) as it may lead to circulatory and respiratory failure
Other medicines and Profast
Tell your doctor if you are taking/using, have recently taken/used, or might be taking/using other medicines.
Profast is well tolerated together with other agents used for anesthesia, e.g.
- drugs are given before anesthesia
- inhaled drugs to give anesthesia/anesthesia (inhalation anesthetics)
- painkillers
- muscle relaxants
- drugs for local anesthesia.
If it is used for local anesthesia, low-dose Profast may be needed. No signs of serious interaction have been observed.
Some of the drugs mentioned may reduce blood pressure or impair breathing and may have a combination effect with Profast. A sharp drop in blood pressure when anesthesia is initiated with propofol has been reported in patients treated with rifampicin. If opiates are given before anesthesia, respiratory arrest may occur more often and last longer.
Profast with food, drink, and alcohol
You must not drink any alcohol once you have received Profast.
Pregnancy and breastfeeding
Pregnancy
The safety of Profast during pregnancy has not been established. Animal studies have shown reproductive toxicological effects. Profast should therefore not be given during pregnancy unless necessary.
Profast passes through the placenta and can lead to respiratory failure and impaired circulation in newborns (impairment of vital functions). High doses should be avoided (ie more than 2.5 mg propofol per kg crush weight for initiating anesthesia, or 6 mg propofol per kg body weight for maintaining anesthesia ). Profast can be used as an anesthetic in terminating a pregnancy.
Breast-feeding
Studies in breastfeeding women have shown that propofol passes into breast milk in small amounts. The mother should therefore pause breastfeeding for up to 24 hours after receiving propofol, and discard all breast milk during this time.
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.
Driving and using machines
Once Profast has been given, the patient must be carefully observed for the appropriate amount of time. Patients should be informed that the ability to stay safe in traffic and to use machines may be impaired for some time after receiving Profast. The reduction in functional capacity caused by Profast usually lasts no longer than 12 hours. The patient must not go home alone but must be accompanied by another person.
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.
Profast contains soybean oil and sodium
Profast contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
How to use Profast
An approach
For intravenous injection/infusion
You should only receive Profast from a doctor trained in anesthesia or intensive care. Sedation or anesthesia with Profast must not be performed by the same person performing the operation or diagnostic procedure.
Cardiac function, blood circulation, and respiration should be monitored at all times (eg ECG and pulse oximetry). Usual equipment in the event of an emergency during anesthesia or sedation must always be available.
Dosage one should be adjusted individually and take into account pre-medication and the patient’s reaction.
In most cases, extra supplements of painkillers are needed to prevent pain when injecting one.
Profast 20 mg / ml
Bolus doses of Profast 20 mg/ml are not recommended.
Dosage
Dosage one varies depending on age, body weight, general health, and pre-medication. The doctor uses an appropriate dose to initiate and maintain anesthesia or to reach the required sedation depth, while carefully observing your physical reactions and important bodily functions ( heart rate, blood pressure, respiration, etc.).
If you have received too much Profast,
the result may be decreased blood circulation and respiratory function. In case of respiratory arrest, some type of artificial respiration must be used and in case of low blood pressure, usual measures must be taken, e.g. place the head end of the bed lower, possibly providing plasma replacement (to restore the amount of blood) and also vasoconstrictors if needed.
If you have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor or hospitalfor risk assessment and advice.
Ask your doctor if you have any further questions on the use of this product.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Any side effects ar
Initiation and maintenance of anesthesia and sedation with propofol is usually a mild procedure with little excitation. The most commonly reported side effects are decreased blood pressure and respiratory depression (weaker reactions from the respiratory center). The type, severity, and frequency of adverse reactions observed with propofol depend on the patient’s state of health and the type of procedure performed and the treatment to be followed.
In particular, the following side effects have been observed:
Very common (more than 1 in 10 patients treated)
General disorders and administration site conditions
- Local pain at the first injection 4.
Common (1 to 10 out of 100 patients treated)
Central and peripheral nervous system
Spontaneous movements and muscle twitching at the onset of anesthesia, headache during awakening.
The heart
Slow pulse 1
Blood vessels
Lowered blood pressure 2
Respiratory, thoracic, and mediastinal disorders
Hyperventilation and cough during anesthesia, temporary respiratory arrest during anesthesia
The gastrointestinal tract
Hiccups during onset, nausea, and vomiting during the recovery phase
General disorders and administration site conditions
Hot flashes during the onset of anesthesia
Uncommon (1 in 10 of 1,000 patients treated)
Blood vessels
Thrombosis and venous inflammation
Respiratory, thoracic, and mediastinal disorders
Cough while maintaining anesthesia
Rare (1 to 10 patients in 10,000)
Central and peripheral nervous system
Dizziness chills, and chills during the recovery phase, episodes reminiscent of epilepsy with seizures and opisthotonic during the initial, maintenance, and the recovery phase (in very rare cases after a delay of a few hours to a few days)
Respiratory, thoracic, and mediastinal disorders
Cough during the recovery phase
Very rare (less than 1 in 10,000 patients treated)
The immune system
Severe hypersensitivity reactions ( anaphylaxis ), may include angioedema, shortness of breath due to bronchoconstriction, reddening of the skin, and decreased blood pressure.
Central and peripheral nervous system
Unconsciousness after surgery
The heart
Pulmonary edema
The gastrointestinal tract
Inflammation of the pancreas
Kidneys and urinary tract
Discolored urine after prolonged treatment with Profast
Reproductive system and mammary glands
Sexual disinhibition
General disorders and administration site conditions
Severe tissue reactions and tissue necrosis after improper administration outside the vessel.
Injuries and poisonings and treatment complications
Fever after surgery
No known frequency: can not be calculated from the available data
Metabolism and nutrition disorders
Excess acid in the blood caused by metabolic function (metabolic acidosis ) 5, elevated potassium levels in the blood 5, elevated lipid levels in the blood 5
Mental disorders
The euphoria during the recovery phase, drug abuse, and drug dependence 8
Central and peripheral nervous system
Involuntary movements
The heart
Irregular heartbeat 5, heart failure 5.7
Respiratory, thoracic, and mediastinal disorders
Respiratory failure (depending on dose one)
Liver and bile ducts
Enlarged liver 5
Musculoskeletal and connective tissue disorders
Degradation of striated muscles ( rhabdomyolysis ) 3.5
Kidneys and urinary tract
Kidney failure 5
General disorders and administration site conditions
Local pain, swelling after improper administration outside vessel one
Reproductive system
Prolonged, often painful erection (priapism)
Surveys
ECG changes (Brugada syndrome) 5.6
If Profast is given at the same time as lidocaine, the following side effects may occur in rare cases:
- dizziness
- vomiting
- drowsiness
- seizures
- slow heart rate ( bradycardia )
- irregular heartbeat ( arrhythmia ) and
- shock.
Soybean oil can in rare cases cause allergic reactions.
- Severe bradycardia (slow heart rate) is rare, and can sometimes lead to cardiac arrest.
- Drops in blood pressure can sometimes make it necessary to provide blood volume replacement and give Profast infusion at a slower rate.
- Rhabdomyolysis (muscle breakdown) has been reported in very rare cases when Profast has been given in high doses as 4 mg propofol per kg body weight per hour, for sedation during intensive care.
- This can in most cases be avoided by giving lidocaine at the same time, and by giving the medicine in larger veins in the forearm or armpit.
- A combination of these events, also known as “propofol infusion syndrome”, can occur in seriously ill patients who often have several risk factors for being affected.
- Brugada syndrome – ST elevation and concave T-waves on ECG.
- In adults, heart failure worsens rapidly (in some cases with fatal outcomes) and in most cases could not be treated with supportive inotropic treatment measures.
- Improper use and dependence on propofol, mainly by healthcare professionals.
- In cases where tissue status was impaired, necrosis (tissue death) has been reported.
How to store Profast
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label 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.
Profast 10 mg / ml
Dilution with glucose solution 50 mg / ml (5%) for injection , sodium chloride solution 9 mg / ml (0.9%) for injection or sodium chloride solution 1.8 mg / ml (0.18%) and 40 mg / ml glucose solution (4% ), and lidocaine solution for injection 10 mg / ml (1%) without preservatives . The mixtures must be prepared under aseptic conditions (always under controlled and validated conditions) immediately before administration and must be administered within 12 hours.
The packaging should be shaken before use.
Do not use if the contents are layered in two layers after emulsion one has been shaken.
Use only homogeneous preparations and undamaged packaging.
For single use only. Any remaining emulsion must be discarded.
Your anesthetist and hospital pharmacist are responsible for Prophast being stored, used, and disposed of properly
Contents of the pack and other information
Content declaration
The active substance is propofol.
Profast 10 mg / ml
1 ml solution for injection / infusion contains 10 mg propofol.
A 20 ml vial contains 200 mg of propofol.
A 50 ml vial contains 500 mg of propofol.
One 100 ml vial contains 1,000 mg of propofol.
Profast 20 mg / ml
1 ml solution for injection / infusion contains 20 mg propofol.
One vial of 50 ml contains 1000 mg of propofol.
Profast 10 mg / ml and 20 mg / ml:
The other ingredients are refined soybean oil, medium triglycerides, glycerol, egg lecithin, sodium oleate, sodium hydroxide (for pH adjustment), and water for injections.
What the medicine looks like and the contents of the pack
White oil-in-water emulsion for injection/infusion.
The drug is provided as:
Emulsion for injection/infusion in a colorless glass vial (type II) with a gray bromobutyl rubber stopper.
Pack sizes:
Profast 10 mg / ml
Colorless 20 ml glass vial (type II) with a gray bromobutyl rubber stopper. Packs of 1, 5, and 10 units.
Colorless 50 ml glass vial (type II) with a gray bromobutyl rubber stopper. Packs of 1 and 10 units.
Colorless glass vial (type II) of 100 ml with a gray bromobutyl rubber stopper. Packs of 1 and 10 units.
Profast 20 mg / ml
Colorless 50 ml glass vial (type II) with a gray bromobutyl rubber stopper. Packs of 1 and 10 units.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Baxter Holding BV
Kobaltweg 49
3542CE Utrecht
Netherlands
Manufacturer
UAB Norameda
Meister 8a, 02189 Vilnius
Lithuania
Bieffe Medical SpA,
Via Nuova Provinciale
23034 Grosotto (SO), Italy
SIA “UNIFARMA” Vangažu iela 23,
Riga, Latvia.