Active ingredients: Propofol
Propofol B. Braun 1% (10 mg / ml) emulsion for injection or infusion
Propofol package inserts are available for pack sizes:- Propofol B. Braun 1% (10 mg / ml) emulsion for injection or infusion
- Propofol B. Braun 2% (20mg / ml) emulsion for injection or infusion
- Propofol B. Braun 5 mg / ml emulsion for injection or infusion
Indications Why is Propofol used? What is it for?
Propofol B. Braun 1% (10 mg / ml) belongs to a group of medicines called general anesthetics. General anesthetics are used to induce unconsciousness (sleep) which allows for surgery or other procedures. They can also be used to sedate her (so that she is asleep but not completely).
Propofol B. Braun 1% (10 mg / ml) is used for:
- induce and maintain general anesthesia in adults and children over one month of age;
- sedate patients over 16 years of age with artificial respiration in intensive care;
- sedate adults and children over 1 month of age during diagnostic and surgical procedures, alone or in combination with local or regional anesthesia.
Contraindications When Propofol should not be used
Do not use Propofol B. Braun 1% (10 mg / ml)
- if you are allergic (hypersensitive) to propofol, soy, peanut or any of the other ingredients of this medicine (listed in section 6).
This medicine should not be used in patients up to 16 years or younger for sedation in intensive care.
Precautions for use What you need to know before taking Propofol
You need to be especially careful
- in case of lipid metabolism disorders,
- in case of pathologies that require particular caution in the use of lipid emulsions,
- in case of reduced blood volume (hypovolaemia),
- in case of severe weakness (debilitation) or heart, kidney or liver disease,
- in case of high cranial pressure
- in case of respiratory diseases,
- in case of epilepsy,
- if you are to undergo procedures where spontaneous movements are to be avoided.
Tell your doctor if you have any of these diseases or conditions.
If you are taking other lipids by infusion into a vein at the same time, your doctor will take into account the total daily amount of fat you are taking.
Propofol will be given to you by a doctor experienced in anesthesia or intensive care. Constant monitoring will be carried out during the anesthesia and awakening phase.
If you develop signs of the so-called "propofol infusion syndrome" (for a detailed list of symptoms see section 4, "Possible side effects"; in this case a doctor should be called) your doctor will reduce the dose of propofol or switch to a alternative drug.
See also the section "Driving and using machines" for the precautions to be taken after using propofol.
The use of Propofol B. Braun is not recommended in neonates.
Interactions Which drugs or foods can modify the effect of Propofol
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Propofol has been used successfully with various regional anesthesia techniques that numb only one part of the body (epidural and spinal anesthesia). Furthermore, the safety of use in combination with
- the drugs given before surgery
- other medicines such as muscle relaxants
- inhaled anesthetics
- painkillers.
However, your doctor may give you lower doses of propofol if general anesthesia or sedation is required in addition to regional anesthesia techniques.
Propofol B. Braun 10 mg / ml and alcohol
Your doctor will inform you about alcohol consumption before or after administration of Propofol B. Braun.
Warnings It is important to know that:
Pregnancy and breastfeeding
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 B. Braun should not be used during pregnancy unless clearly necessary. It crosses the placenta and may depress the vital functions of the newborn. However, propofol can be used during an induced abortion.
If you are breastfeeding you must stop breastfeeding and discard the milk for 24 hours after administration of Propofol B. Braun 1% (10 mg / ml). Studies in breastfeeding women have shown that propofol is excreted in small quantities in breast milk.
Driving and using machines
You should not drive or operate machinery after the injection or infusion of Propofol B. Braun 1% (10 mg / ml).
The doctor will explain to you
- if he will have to leave accompanied
- when you can start driving and using machines again
- what use to do with other tranquilizers (eg, tranquilizers, strong pain relievers, alcohol).
Propofol B. Braun 10 mg / ml contains sodium and soybean oil
This medicinal product contains less than 1 mmol sodium (23 mg) in 100 ml, ie essentially "sodium free". Propofol B. Braun contains soybean oil. If you are allergic to peanuts or soy, do not use this medicine.
Dosage and method of use How to use Propofol: Dosage
Propofol B. Braun 1% (10 mg / ml) should only be administered by anesthetists or medical specialists working in intensive care units.
Dosage
The dose that will be administered depends on age, body weight and physical condition. The doctor will administer the correct dose to induce and maintain anesthesia or to achieve the desired level of sedation, carefully monitoring the body's reactions and vital signs. (pulse, blood pressure, respiration, etc.) If necessary, the doctor will also observe the limits of the application time.
Propofol B. Braun 1% (10 mg / ml) is usually given by injection to induce general anesthesia and by continuous infusion (a longer, slower injection) when used to maintain general anesthesia. It can be given as a diluted or undiluted infusion If used as a sedative it is usually given by infusion.
The duration of administration of Propofol B. Braun 1% (10 mg / ml) should not exceed 7 days.
Method of administration
Propofol B. Braun 1% (10 mg / ml) will be given by intravenous injection or infusion, i.e. with a needle or tube inserted into a vein. Since Propofol B. Braun 1% (10 mg / ml) contains no preservatives, the infusion of one vial of Propofol B. Braun 1% (10 mg / ml) should not last more than 12 hours. The infusion from a container of diluted Propofol B. Braun 1% (10 mg / ml) should not last more than 6 hours.
Circulation and respiration will be monitored constantly during the injection or infusion.
Overdose What to do if you have taken too much Propofol
If you have received more Propofol B. Braun 1% (10 mg / ml) than you should
This is unlikely to happen as the doses that are administered are closely controlled. However, any accidental overdose may cause depression of heart function and breathing, in which case the doctor will take all necessary measures immediately.
If you have any further questions on the use of Propofol B. Braun 1% (10 mg / ml), ask your doctor or pharmacist.
Side Effects What are the side effects of Propofol
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Call a doctor immediately if the following side effects occur.
Common (may affect up to 1 in 10 people):
- Low blood pressure which in some cases may require the infusion of fluids and a reduction in the rate of administration of propofol.
- Heart rhythm too slow, serious event in rare cases.
Rare (may affect up to 1 in 1,000 people):
- Seizures of the epileptic type.
Very rare (may affect up to 1 in 10,000 people):
- Allergic reactions, including swelling of the face, tongue or throat, wheezing, red skin, and low blood pressure
- Cases of postoperative unconsciousness have been reported. Patients will therefore be closely monitored during the awakening period.
- Water in the lungs (pulmonary edema) after administration of propofol
- Inflammation of the pancreas.
Not known (frequency cannot be estimated from the available data):
- There have been isolated reports of serious adverse reactions characterized by a combination of the following symptoms: destruction of muscle tissue, accumulation of acidic substances in the blood, excessively high potassium levels, elevated levels of fat in the blood, changes in the electrocardiogram (ECG type Brugada ), liver enlargement, irregular heart rhythm, kidney failure and heart failure. This condition has been called "propofol infusion syndrome." Some affected patients have died. These effects have only been seen in ICU patients on doses of propofol. higher than 4 mg per kg of body weight per hour See also section 2, "Warnings and precautions".
Other side effects:
Very common (affects more than 1 in 10 patients treated):
- Pain at the injection site during the first injection. Pain can be reduced by injecting propofol into larger veins in the forearm. Simultaneous injection of lidocaine (a local anesthetic) and propofol also helps reduce pain at the injection site.
Common (may affect up to 1 in 10 people):
- Brief interruption of breathing
- Headache during the recovery period
- Nausea or vomiting during the recovery period
Uncommon (may affect up to 1 in 100 people):
- Blood clots in the veins or inflammation of the veins
Very rare (may affect up to 1 in 10,000 people):
- Loss of sexual control during the recovery period
- Changes in urine color following prolonged administration of propofol
- Cases of fever after surgery
Not known (frequency cannot be estimated from the available data):
- Involuntary movements
- Excessively cheerful mood
- Drug abuse
- Heart failure
- In very rare cases where propofol has been administered at doses higher than those recommended for sedation in intensive care units, a breakdown of muscle tissue has been reported.
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 at www.agenziafarmaco.gov. it / it / responsible. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
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 after "EXP". The expiry date refers to the last day of the month.
Do not store above 25 ° C. Do not freeze.
Propofol B. Braun 1% (10 mg / ml) should be used immediately after opening the vial or ampoule.
Diluted solutions of Propofol B. Braun 1% (10 mg / ml) should be used immediately after preparation.
Do not use Propofol B. Braun 1% (10 mg / ml) if two separate layers are visible after shaking the product.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other_information "> Other information
What Propofol B. Braun 1% (10 mg / ml) contains
The active ingredient is propofol
Each milliliter of Propofol B. Braun 1% (10 mg / ml) contains 10 mg of propofol.
1 vial of 20 ml contains 200 mg of propofol.
1 vial of 50 ml contains 500 mg of propofol.
1 vial of 100 ml contains 1,000 mg of propofol.
The other ingredients are: refined soybean oil, medium chain triglycerides, egg lecithin, glycerol, sodium oleate, water for injections.
Description of what Propofol B. Braun 1% (10 mg / ml) looks like and contents of the pack
It is an "emulsion for injection or infusion.
It is a milky white "oil-in-water emulsion."
It is available in
- 20 milliliter vials, in packs of 5 vials
- vials of 50 or 100 milliliters, in packs of 1 or 10 vials
- vials of 20 milliliters, in packs of 10 vials.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
PROPOFOL B. BRAUN 1% (10 MG / ML) EMULSION FOR INJECTION OR FOR INFUSION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Propofol B. Braun 1% (10 mg / ml) contains:
Excipients with known effects:
1 ml of emulsion for injection or infusion contains:
refined soybean oil 50 mg;
sodium 0.03 mg.
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM -
Emulsion for injection or infusion.
Milky white oil-in-water emulsion.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Propofol B. Braun 1% (10 mg / ml) is a fast-acting intravenous general anesthetic for:
• induction and maintenance of general anesthesia, in adults and children older than 1 month;
• sedation of ventilated patients over 16 years of age in the intensive care unit;
• sedation for diagnostic and surgical procedures, alone or in combination with local or regional anesthesia in adults and children over 1 month of age.
04.2 Posology and method of administration -
General instructions
Propofol B. Braun 1% (10 mg / ml) should only be administered in hospitals or day hospitals that are adequately equipped by physicians specializing in anesthesia or in the care of patients in intensive care. Circulatory and respiratory functions must be continuously monitored (eg ECG, pulse oximeter) and means must always be readily available for maintaining a patent airway, for artificial ventilation and other means of resuscitation. For sedation during surgery or diagnostic tests, Propofol B. Braun 1% (10 mg / ml) should not be administered by the same person who is performing the surgical or diagnostic procedure.
Generally, other analgesic medicines are needed in addition to Propofol B. Braun 1% (10 mg / ml).
Dosage
Propofol B. Braun 1% (10 mg / ml) is administered intravenously. Dosage is determined individually, based on the patient's response.
• General anesthesia in adults
Induction of anesthesia:
For the induction of anesthesia, Propofol B. Braun 1% (10 mg / ml) should be titrated (20-40 mg propofol every 10 seconds) according to the patient's response, until clinical signs of anesthesia appear. Doses between 1.5 and 2.5 mg / kg body weight are usually required for most adult patients under the age of 55.
In older patients and in patients of ASA class III and IV, especially those with impaired cardiac function, the required dosage will be lower and the total dose of Propofol B. Braun 1% (10 mg / ml) may be reduced. at 1 mg / kg body weight or less. Lower rates of administration (approximately 2 ml, corresponding to 20 mg every 10 seconds) should be applied in these patients.
Maintenance of anesthesia:
Anesthesia can be maintained by administering Propofol B. Braun 1% (10 mg / mL) via continuous infusion or repeated bolus injection. If a technique involving repeated bolus injection is used, additional doses between 25 can be given. mg (2.5 ml of Propofol B. Braun 1% (10 mg / ml)) and 50 mg (5.0 ml of Propofol B. Braun 1% (10 mg / ml)), depending on clinical needs. For maintenance of continuous infusion anesthesia, the required doses are usually between 4-12 mg / kg body weight / h.
In elderly patients, in patients in poor general conditions or in ASA class III and IV and in hypovolaemic patients, the dosage may be further reduced in relation to the severity of the patient's condition and the anesthetic technique used.
• General anesthesia in children over 1 month of age
Induction of anesthesia:
For induction of anesthesia, Propofol B. Braun 1% (10 mg / ml) should be titrated slowly, based on the patient's response, until clinical signs of anesthesia appear. Dosage should be adjusted according to the patient's response. "age and / or body weight.
For most patients over 8 years of age, approximately 2.5 mg / kg per body weight of propofol is required for induction of anesthesia. In younger children, especially between the ages of 1 month and 3 years, a higher dose (2.5-4 mg / kg / body weight) may be needed.
Maintenance of general anesthesia:
Anesthesia can be maintained by administering Propofol B. Braun 10 mg / ml by infusion or by repeated bolus injection to maintain the required intensity of anesthesia. The required rate of administration varies considerably between patients, but rates of 9-15 mg / kg / h usually allow satisfactory anesthesia to be achieved. In younger children, especially between the ages of 1 month and 3 years, a higher dose may be needed.
Lower dosages are recommended for patients of ASA grade III and IV (see section 4.4).
• Sedation of ventilated patients in intensive care units.
For sedation during intensive care it is recommended that propofol be administered by continuous infusion. The rate of infusion should be determined by the desired depth of sedation. Sufficient sedation can be achieved in most patients with a dose of 0.3-4 mg / kg / h of propofol (see also section 4.4). Propofol is not indicated for intensive care sedation of patients aged 16 years and younger (see section 4.3). Administration of propofol with the Target Controlled Infusion (TCI) system is not recommended for sedation in intensive care units.
• Sedation for diagnostic and surgical procedures in adults
To induce sedation during surgical and diagnostic procedures, the doses and rate of administration should be adjusted according to the clinical response. For most patients, 0.5-1 mg / kg body weight should be administered for 1-5 minutes for sedation to begin. Maintenance of sedation can be achieved by titrating the infusion of Propofol B. Braun 1% (10 mg / ml) according to the level of sedation required. For most patients, 1.5-4.5 mg / ml should be administered. kg body weight / h. The infusion can be supplemented with the administration of boluses of 10-20 mg (1-2 ml of Propofol B. Braun 1% (10 mg / ml)), if a rapid increase in depth of sedation. In patients over 55 years of age and in patients of ASA Class III and IV, lower doses of Propofol B. Braun 1% (10 mg / ml) may be required and the rate of administration may need to be reduced.
• Sedation for diagnostic and surgical procedures in children over one month of age
The doses and rate of administration should be adjusted according to the required sedation intensity and clinical response. Most pediatric patients require 1-2 mg per kg bodyweight of propofol for initiation of sedation. Maintenance of sedation can be accomplished by titrating Propofol B. Braun 1% (10 mg / mL) as an infusion to the desired level of sedation. Most patients require 1.5-9 mg / kg / h of propofol. The infusion can be supplemented by bolus administration up to 1 mg / kg body weight if a rapid increase in sedation intensity is required.
Lower dosages may be required in patients belonging to ASA grade III and IV.
Method and duration of administration
• Method of administration
Intravenous use
Propofol B. Braun 1% (10 mg / ml) is administered intravenously by continuous infusion or injection, either undiluted or diluted with 5% w / v glucose solution or 0.9% w / v sodium chloride solution, as well as in solution with 0.18% w / v sodium chloride and 4% w / v glucose solution (see also section 6.6).
Containers must be shaken before use.
Before use, the neck of the vial or the surface of the rubber stopper of the vial must be cleaned with medical alcohol (spray or soaked swab). After use, discard the closed empty containers.
Propofol B. Braun 1% (10 mg / ml) does not contain antimicrobial preservatives and may allow for possible bacterial growth. Therefore, Propofol B. Braun 1% (10 mg / ml) must be aspirated aseptically into a syringe or in a sterile infusion set immediately after opening the vial or breaking the seal of the vial.
Administration should take place immediately. The aseptic conditions relating to Propofol B. Braun 1% (10 mg / ml) and the infusion equipment must be ensured throughout the infusion period.
Any medications or fluids added to an ongoing infusion of Propofol B. Braun 1% (10 mg / ml) should be administered close to the cannula insertion site. Propofol B. Braun 1% (10 mg / ml) it must not be administered using infusion sets with microbiological filters.
The contents of one ampoule or vial of Propofol B. Braun 1% (10 mg / ml) and syringes containing Propofol B. Braun 1% (10 mg / ml) are intended for single patient use only. .
Infusion of Propofol B. Braun 1% (10 mg / ml) undiluted
When administering Propofol B. Braun 1% (10 mg / mL) by continuous infusion, it is recommended to always use burettes, droppers, syringe pumps or volumetric infusion pumps to control the infusion rate. As established for parenteral administration of all types of lipid emulsions, the duration of continuous infusion of Propofol B. Braun 1% (10 mg / ml) from a single infusion system should not exceed 12 hours. of infusion and the container of Propofol B. Braun 1% (10 mg / ml) must be discarded and replaced after 12 hours at the latest. Any residues of Propofol B. Braun 1% (10 mg / ml) at the end of the infusion o after changing the infusion system must be discarded.
Infusion of Propofol B. Braun 1% (10 mg / ml) diluted
When administering infusions of diluted Propofol B. Braun 1% (10 mg / ml), it is recommended to always use burettes, droppers, syringe pumps or volumetric infusion pumps to control the rate of infusion and to avoid the risk of accidental infusion. controlled large volume of Propofol B. Braun 1% (10 mg / ml) diluted.
The maximum dilution should not exceed 1 part of Propofol B. Braun 1% (10 mg / ml) with 4 parts of 5% w / v glucose solution or 0.9% w / v sodium chloride solution, or 0.9% w / v sodium chloride solution. 0.18% w / v and 4% w / v glucose solution (minimum concentration 2 mg of propofol / ml). The mixture must be prepared under aseptic conditions immediately prior to administration and must be used within 6 hours of preparation.
To reduce the pain of the initial injection, Propofol B. Braun 1% (10 mg / ml) can be mixed with preservative-free 1% injectable lidocaine (mix 20 parts of Propofol B. Braun 1% (10 mg / ml) ) and up to a maximum of 1 part of 1% injectable lidocaine).
Before infusing muscle relaxants such as atracurium or mivacurium after Propofol B. Braun 1% (10 mg / ml) via the same intravenous line, it is recommended to flush the line prior to administration.
Propofol can also be used by TCI, controlled infusion devices. Due to the different algorithms available on the market in relation to dosage recommendations, it is recommended to follow the instructions for use booklet provided by the device manufacturer.
• Duration of administration
Propofol B. Braun 1% (10 mg / ml) can be administered for up to 7 days.
04.3 Contraindications -
Propofol B. Braun 1% (10 mg / ml) is contraindicated in patients with known hypersensitivity to propofol or to any of the excipients.
Propofol B. Braun 10 mg / ml contains soybean oil and must not be used in patients with hypersensitivity to peanut or soy.
Propofol B. Braun 10 mg / ml should not be used in patients aged 16 years or less, for intensive care sedation.
04.4 Special warnings and appropriate precautions for use -
Propofol must be administered by qualified anesthesia personnel (or, if necessary, by doctors qualified for the assistance of patients in intensive care).
Patients should be monitored constantly and equipment to maintain a patent airway, for artificial ventilation, for oxygen supplementation and other equipment for resuscitation should be available at all times. Propofol should not be administered by the person performing the diagnostic or surgical procedures.
Abuse of propofol, predominantly by healthcare professionals, has been reported. As with other general anesthetics, administration of propofol without airway support could result in fatal respiratory complications.
When administering propofol for conscious sedation, surgical and diagnostic procedures, patients should be continuously monitored for any initial signs of hypotension, airway obstruction, and oxygen desaturation.
As with other sedative agents, the use of propofol for sedation during surgical procedures may induce involuntary patient movements. During procedures requiring immobility, these movements can be hazardous to the site being operated on.
After the use of propofol it is necessary to wait for an adequate time before discharging the patient, in order to guarantee complete recovery. In very rare cases the use of propofol can be associated with the development of a period of postoperative unconsciousness, possibly accompanied by an increase in muscle tone.
This can be preceded, but not necessarily, by a supervisory phase. Recovery occurs spontaneously, but adequate care must be given to the unconscious patient.
Propofol-induced impairment is usually no longer detectable beyond 12 hours. In advising patients about:
• the opportunity to be accompanied when leaving the place where the administration took place
• the timing for resuming activities that are dangerous or require skill, such as driving
• The use of other potentially sedative agents (eg benzodiazepines, opioids, alcohol) should take into account the effects of propofol, the procedure, concomitant therapies, the age and condition of the patient.
As with other intravenous anesthetic agents, caution should be exercised in patients with impaired cardiac, respiratory, renal or hepatic function, or in hypovolaemic or debilitated patients. The clearance of propofol is dependent on blood flow, therefore, concomitant treatments that reduce cardiac output will also reduce the clearance of propofol.
Propofol has no vagolytic activity and has been associated with reported cases of bradycardia (occasionally profound) and even asystole. Intravenous administration of an anticholinergic agent prior to induction of anesthesia should be considered, especially in situations where vagal tone is likely to predominate or when propofol is used in combination with other agents that can cause bradycardia.
When propofol is administered to an epileptic patient, there may be a risk of convulsions. Particular care should be taken in patients with lipid metabolism disorders and in other conditions where caution is required in the use of lipid emulsions.
Monitoring of lipid levels is recommended if propofol is administered to patients believed to be at particular risk of lipid overload. If monitoring indicates inadequate clearance of lipids from the body, appropriate correction of the administration of propofol should be made. If the patient takes other lipids intravenously at the same time, the quantity must be reduced to take into account the quantity of lipids infused in the propofol formulation: 1.0 ml of Propofol B. Braun 10 mg / ml contains 0, 1 g of lipids.
The use of propofol is not recommended in neonates as this patient population has not been fully studied. Pharmacokinetic data (see section 5.2) indicate that clearance is considerably reduced in neonates and exhibits very high inter-individual variability. Relative overdose may occur with administration of recommended doses for older children resulting in severe cardiovascular depression.
Recommendations for management in the intensive care unit
The safety and efficacy of propofol for (background) sedation in children under 16 years of age have not been demonstrated. Although no causal relationship has been established, serious side effects have been reported with (background) sedation in patients under 16 years of age (including cases with fatal outcome) during unauthorized use. In particular, these effects related to the occurrence of metabolic acidosis, hyperlipidaemia, rhabdomyolysis and / or heart failure. These effects were reported very frequently in children with respiratory tract infections who have been given doses higher than those recommended for adults for sedation in the intensive care unit.
There have been reports of associations of the following conditions: metabolic acidosis, rhabdomyolysis, hyperkalaemia, hepatomegaly, renal failure, hyperlipidemia, cardiac arrhythmia, Brugada-type ECG (elevated ST segment and convex T wave) and rapidly progressive heart failure usually unresponsive to treatment. supportive inotropic (in some cases with fatal outcome) in adults. The associations between these events have been referred to as propofol infusion syndrome.
The following appear to be the main risk factors for the development of such events: reduced release of oxygen at the tissue level; severe neurological injury and / or sepsis; high dosages of one or more of the following pharmacological agents: vasoconstrictors, steroids, inotropics and / or propofol (usually following prolonged administration at doses above 4 mg / kg / h).
Prescribers should be alert to such events and consider reducing the dosage of propofol or switching to an alternative anesthetic at the onset of symptoms. All sedative and therapeutic agents used in the Intensive Care Unit (ICU), including propofol, should be dosed to maintain optimal hemodynamic and oxygen release parameters. Patients with elevated intracranial pressure (PIC) should receive appropriate treatment to support cerebral perfusion pressure during these treatment changes. Physicians are advised not to exceed the dosage of 4 mg / kg / h if possible.
Additional precautions
Propofol B. Braun 10 mg / ml does not contain antimicrobial preservatives and promotes the growth of microorganisms.
Aseptically aspirating propofol into a sterile syringe or infusion set immediately after opening the vial or breaking the seal. Administration should commence immediately.
Asepsis should be maintained throughout the infusion for both propofol and infusion equipment. Any infusion fluids added to the propofol line should be administered in the vicinity of the cannula. Do not administer propofol through a microbiological filter.
Propofol and the syringes containing it are for single use only. In accordance with established guidelines for other lipid emulsions, a single propofol infusion should not exceed 12 hours. At the end of the procedure (or after 12 hours, whichever comes first) the propofol reservoir and infusion line must be properly disposed of and replaced.
This medicine contains less than 1 mmol (23 mg) sodium in 100 ml, so it is essentially 'sodium-free'.
04.5 Interactions with other medicinal products and other forms of interaction -
Propofol has been used in conjunction with spinal and epidural anesthesia and with routinely used premedications, neuromuscular blocking drugs, inhalants and analgesics without finding any pharmacological incompatibilities. When general anesthesia or sedation are used reduced doses of propofol may be required in addition to regional anesthesia techniques.
04.6 Pregnancy and breastfeeding -
Pregnancy
The safety of propofol during pregnancy has not been established. Propofol should not be given to pregnant women except when absolutely necessary. Propofol crosses the placenta and can cause neonatal depression. However it is possible to use propofol during induced abortion.
Feeding time
Studies performed on nursing mothers show that small amounts of propofol are excreted in human milk. Therefore women should not breastfeed for 24 hours after administration of propofol. The milk produced in this time must be eliminated.
04.7 Effects on ability to drive and use machines -
Patients should be advised that for some time after the use of propofol there may be an impairment in the ability to perform proficient activities, such as driving or using machines.
Propofol-induced impairment is usually no longer detectable after 12 hours (see section 4.4).
04.8 Undesirable effects -
Induction and maintenance of anesthesia or sedation with propofol are usually uneventful, with minimal signs of agitation. The most commonly reported ADRs are pharmacologically predictable undesirable effects for an anesthetic / sedative agent, such as hypotension. The nature, severity and incidence of adverse events observed in patients taking propofol may be related to the recipient's condition and operative procedures. or therapeutic running.
Table of adverse drug reactions
Severe bradycardias are rare. There have been rare reports of progression to asystole.
Occasionally, hypotension may require the use of intravenous fluids and a reduction in the rate of administration of propofol.
There have been very rare reports of rhabdomyolysis following administration of propofol at doses above 4 mg / kg / h for ICU sedation.
It can be minimized by using larger diameter veins in the forearm and antecubital fossa.
With Propofol B. Braun 10 mg / ml local pain can also be minimized by administering lidocaine concomitantly.
The combination of these events, referred to as "propofol infusion syndrome", can be seen in seriously ill patients who often have multiple risk factors for the development of the events. See section 4.4.
Brugada type ECG: elevation of the ST segment and convex T wave in the ECG.
Rapidly progressive (in some cases fatal) heart failure in adults. Heart failure usually did not respond to supportive inotropic treatment in such cases.
Abuse of drugs, mainly by health personnel.
Not known as not estimable from available clinical trial data.
Reporting of suspected adverse reactions.
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
Accidental overdose can cause cardio-respiratory depression. Respiratory depression should be treated with artificial oxygen respiration. In case of cardiovascular depression, the patient's head should be lowered and, if severe, the use of plasma expanders and pressure agents.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: other general anesthetics.
ATC code: N01AX10.
Mechanism of action, pharmacodynamic effect
After the intravenous injection of Propofol B. Braun 1% (10 mg / ml), the hypnotic effect occurs rapidly. Depending on the injection speed, the induction time of anesthesia varies between 30 and 40 seconds. The duration of action after the administration of a single bolus is short, due to the rapid metabolism and excretion (4-6 minutes).
No clinically relevant accumulation of propofol was observed after repeated bolus injection or after infusion with the recommended dosing schedule.
Patients regain consciousness quickly.
Bradycardia and hypotension may occasionally occur during induction of anesthesia, possibly due to a lack of vagolytic activity. Usually the cardio-circulatory situation normalizes during the maintenance phase of the anesthesia.
Pediatric population
Limited studies on the duration of propofol-based anesthesia in children indicate that safety and efficacy remain unchanged for up to 4 hours. Literature evidence of use in children documents use in prolonged procedures with no changes in safety and efficacy.
05.2 "Pharmacokinetic properties -
Distribution
After intravenous administration, approximately 98% of propofol is bound to plasma proteins.
Following intravenous bolus administration, the initial level of propofol in the blood drops rapidly following rapid distribution to several compartments (step a). The distribution half-life was calculated to be around 2-4 minutes.
During elimination, the decrease in blood levels is slower. The elimination half-life during the β phase ranges from 30 to 60 minutes. Subsequently, a third deep compartment is highlighted which represents the redistribution of propofol from the more weakly perfused tissues.
The central volume of distribution is between 0.2 and 0.79 l / kg of body weight, the volume of homeostasis of distribution is between 1.8-5.3 l / kg of body weight.
Biotransformation
Propofol is metabolised predominantly in the liver with the formation of propofol glucuronides and glucuronides and sulphate conjugates of the related quinol. All metabolites are inactive.
Elimination
Propofol is rapidly cleared from the body (total clearance approximately 2 l / min). Clearance occurs through metabolism, predominantly in the liver, where it is blood flow dependent. Clearance is higher in children than in adults. 88% of the administered dose is excreted in the urine as metabolites. Only 0.3% is excreted unchanged in the urine.
Pediatric population
After a single intravenous dose of 3 mg / kg, the clearance per kg body weight of propofol increased with age as follows: the median clearance was significantly lower in infants less than 1 month of age (n = 25) (20 mL / kg / min) compared to older children (n = 36, age range 4 months-7 years). Furthermore, inter-individual variability was considerable in neonates (range 3.7-78 mL / kg / min Due to these limited experimental data indicating great variability, recommended doses cannot be given for this age group.
The median clearance of propofol in older children after a single bolus of 3 mg / kg was 37.5 ml / min / kg (4-24 months) (n = 8), 38.7 ml / min / kg (11-43 months) (n = 6), 48 mL / min / kg (1-3 years) (n = 12), 28.2 mL / min / kg (4-7 years) (n = 10) versus 23.6 ml / min / kg in adults (n = 6).
05.3 Preclinical safety data -
Non-clinical data reveal no specific hazard for humans based on conventional studies of repeated dose toxicity and genotoxicity. Carcinogenicity studies have not been conducted.
Reproductive toxicity studies have shown effects related to the pharmacodynamic properties of propofol only at high doses. No teratogenic effects were observed.
In local tolerance studies, intramuscular injection resulted in tissue damage around the injection site.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Refined soybean oil,
medium chain triglycerides,
glycerol,
egg lecithin,
sodium oleate,
water for injections.
06.2 Incompatibility "-
This medicinal product must not be mixed with other products except those mentioned in section 6.6.
06.3 Period of validity "-
Closed: 2 years.
After first opening: use immediately.
After dilution, as indicated: administration of the diluted product should commence immediately after preparation.
06.4 Special precautions for storage -
Do not store above 25 ° C.
Do not freeze.
06.5 Nature of the immediate packaging and contents of the package -
Type I colorless glass vials, containing 20 ml of emulsion.
Type II colorless glass vials, sealed with bromine butyl rubber closures containing 50 ml or 100 ml of emulsion.
Packaging:
• glass vials: 5x20 ml;
• glass vials: 1x50 ml, 10x20 ml, 10x50 ml, 1x100 ml, 10x100 ml.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
Containers must be shaken before use.
For single use only. Any unused residues must be eliminated, see section 4.2.
If two layers are noticed after the product has been shaken, it should not be used.
Propofol B. Braun 1% (10 mg / ml) can only be mixed with the following products: glucose solution 50 mg / ml (5% w / v), sodium chloride solution 9 mg / ml (0.9% w / v), or sodium chloride solution 1.8 mg / ml (0.18% w / v) and glucose solution 40 mg / ml (4% w / v), and injectable lidocaine 10 mg / ml (1% ) without preservatives (see section 4.2 Method and duration of administration, "Infusion of Propofol B. Braun 1% (10 mg / ml) diluted").
Co-administration of Propofol B. Braun 1% (10 mg / ml) together with a 50 mg / ml (5% w / v) glucose solution or a 9 mg / ml (0.9%) sodium chloride solution is possible. w / v), or a 1.8 mg / ml (0.18% w / v) sodium chloride solution and 40 mg / ml (4% w / v) glucose solution via a Y-connector near the site injection.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
B. Braun Melsungen AG
Carl-Braun Straβe 1
34212 Melsungen,
Germany
08.0 MARKETING AUTHORIZATION NUMBER -
5 vials of 20 ml A.I.C. n. 035911015
1 vial of 50 ml A.I.C. n. 035911027
1 vial of 100 ml A.I.C. n. 035911039
10 vials of 50 ml A.I.C. n. 035911041
10 vials of 100 ml A.I.C. n. 035911054
10 vials of 20 ml A.I.C. n. 035911092
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
23-11-2004 // - - -
