Folenda Dosage/Direction for Use

Propofol (Folenda) 10 mg/mL may only be administered by doctors that have been trained in anesthesiology intensive care. Sedation or anesthesia with Propofol 10 mg/mL and the surgical or diagnostic procedure may not be performed by the same person.
The cardiac, circulatory and respiratory functions should be continuously monitored (e.g. ECG, pulse oxymetry). The customary equipment for possible accidents during anesthesia or sedation must be ready for use at all times.
The dosage should be adjusted individually while taking the premedication and the patient's reaction into consideration.
Normally, the additional administration of analgesics is necessary.
Anesthesia for Adult (including elderly): Induction of anesthesia: For the induction of anesthesia, Propofol (Folenda) 10 mg/mL is administered, titrated at a speed of 20-40 mg Propofol every 10 seconds, until unconsciousness occurs.
Most adults less than 55 years of age would normally require a total dose of 1.5 to 2.5 mg Propofol/kg of body weight.
For patients in risk groups ASA III and IV, especially in the case of prior cardiac damage and elderly patients, it may be necessary to reduce the total dosage of Propofol (Folenda) 10 mg/mL down to 1 mg Propofol/kg body of mass. Whereby Propofol (Folenda) 10 mg/mL is administered at slower infusion speed (approximately 20 mg of Propofol every 10 second).
Maintenance of anesthesia: The anesthesia can be maintained with a long-term infusion or repeated bolus injections of Propofol (Folenda) 10 mg/mL.
Continuous infusion: For maintenance of anesthesia by means of continuous infusion, the dosage and infusion speed must be adjusted for each individual. Normally, the dosage is 4-12 mg Propofol/kg of body mass per hour in order to maintain a satisfactory level of anesthesia.
In the case of elderly patients in a poor general state of health or with hypovolemia and patients in the risk groups ASA III and IV, the dosage of Propofol (Folenda) 10 mg/mL may be reduced down to 4 mg Propofol/kg of body mass per hour.
Repeated bolus injection: For maintenance of anesthesia by means of repeated bolus injection, generally 25-50 mg Propofol (2.5-5 mL Propofol 10 mg/mL) are subsequently injected.
Anesthesia in children from 1 month of age: Induction of anesthesia: For the induction of anesthesia, Propofol (Folenda) 10 mg/mL is titrated slowly until clinical signs can be seen that indicate the start of anesthesia. The dose should be adjusted based on the age and/or body weight. Most children over 8 years of age likely to require approximately 2.5 mg Propofol/kg of body mass for induction of anesthesia. In the case of younger children, especially those in the age range of 1 month to 3 years, the required dose may be higher (2.5-4 mg Propofol/kg of body mass). Lower doses are recommended for patients in the risk groups ASA III and IV.
Maintenance of anesthesia: Maintenance of the required depth of anesthesia can be achieved with the administration of Propofol (Folenda) 10 mg/mL by means of an infusion or repeated bolus administration. The required dosage rates vary considerably among patients, however a satisfactory state of anesthesia is normally achieved at doses in the range of 9-15 mg/kg of body mass per hour. In the case of younger children, especially those in the age range of 1 month to 3 years, the required dose may be higher.
Lower doses are recommended for patients in the risk groups ASA III and IV.
Sedation of patients over 16 years of age during intensive care: For the sedation of ventilated patients during intensive care, Propofol (Folenda) 10 mg/mL should be administered as a continuous infusion. The dosage is based on the required depth of sedation. Normally, the desired depths of sedation can be achieved with doses in the range of 0.3 to 4.0 mg Propofol/kg of body mass per hour.
Propofol (Folenda) 10 mg/mL may not be used for the sedation of children aged 16 years or younger as part of intensive care.
The administration of Propofol (Folenda) 10 mg/mL by means of a TCI system is not recommended for sedation as part of intensive care.
Sedation of adults for surgical and diagnostic procedures: During the administration of Propofol (Folenda) 10 mg/mL, the patient must be continually monitored for signs of a decrease in blood pressure, respiratory tract obstruction and oxygen deficiency and the customary emergency equipment for accidents must be kept ready.
For induction of anesthesia, generally 0.5-1.0 mg Propofol/kg of body mass are administered for 1-5 minutes. For the maintenance of anesthesia, the dosage is determined based on the desired depth of sedation and is generally in the range between 1.5-4.5 mg Propofol/kg of body mass per hour.
In addition to the infusion, 10-20 mg may be injected as a bolus if a quick increase in the depth of sedation is necessary.
A lower dosage and slower administration may be necessary for patients in risk groups ASA III and IV. A lower dosage may also be necessary in patients over 55 years of age.
Note: In the case of elderly patients, smaller doses are required for the induction of anesthesia with Propofol (Folenda) 10 mg/mL. The patient's general state of health and age should be taken into account. The lowered dose should be administered more slowly and titrated according to the reaction.
Even when using Propofol (Folenda) 10 mg/mL for maintenance of anesthesia and for sedation, the infusion rate and the selected Propofol concentration in the blood should be decreased.
An additional lowering of the dosage and the infusion rate is necessary for patients in risk groups ASA III and IV. Elderly patients should not be given any bolus injections (individual or multiple), since circulatory and respiratory depression may result.
Sedation of children from 1 month of age for surgical and diagnostic procedures: The dosage and the periods between doses are selected based on the desired depth of sedation and the clinical response. For the induction of sedation, a dose of 1-2 mg Propofol/kg of body weight is necessary for most pediatric patients. Maintenance of the sedation is achieved with the titration of Propofol (Folenda) 10 mg/mL via an infusion until the desired depth of sedation is reached. For most patients, 1.5-9 mg Propofol/kg of body mass per hour is required. The infusion can be supplemented with bolus administration of up to 1 mg Propofol/kg of body mass, if a rapid increase in the depth of sedation is required.
Lower doses may be necessary for patients in the risk groups ASA III and IV.
Propofol 10 mg/mL may not be used for the sedation of children aged 16 years or younger as part of intensive care.
Method of use: Prior to use, the rubber stopper must be cleaned with alcohol spray or a swab dipped in alcohol. The rubber stopper does not contain latex. Opened containers should be destroyed after use. Propofol (Folenda) 10 mg/mL is administered intravenously, either undiluted from plastic syringes or glass vials or as a mixture with 5% glucose solution in PVC bags or glass vials.
Propofol (Folenda) 10 mg/mL does not contain any antimicrobial preservation media and the growth of microorganisms is facilitated due to its composition.
The emulsion must be drawn into a sterile syringe or a sterile administration device under aseptic conditions immediately after breaking the seal on the vial. The administration must be started immediately.
Strict asepsis must be adhered to both for Propofol 10 mg/mL and for the infusion equipment used during the period of the infusion. The addition of drugs or fluids into the ongoing infusion of Propofol 10 mg/mL must occur in close proximity to the cannula.
When using Propofol (Folenda) 10 mg/mL, no bacteria filters may be used.
The content of a vial and the respective infusion system are only intended for a single use in one patient.
Infusion of undiluted Propofol 10 mg/mL: For an infusion of undiluted Propofol (Folenda) 10 mg/mL, an infusion pump or volumetric pump should be employed.
The duration of an infusion of Propofol (Folenda) 10 mg/mL from one infusion system may not exceed 12 hours, as is customary for fat emulsions. At the end of the infusion, but after 12 hours at the latest, residual quantities of Propofol (Folenda) 10 mg/mL and the infusion system may not be further used; if necessary, the infusion system must be changed out.
Infusion of diluted Propofol 10 mg/mL: The infusion of diluted Propofol 10 mg/mL must occur by means of a controllable infusion system (burette or volumetric pump), in order to prevent the accidental administration of larger quantities of Propofol 10 mg/mL.
The maximum dilution must not exceed 1 part of Propofol with 4 parts of glucose 50 mg/mL (5%) solution for injection, sodium chloride 9 mg/mL (0.9%) solution for injection or sodium chloride 1.8 mg/mL (0.18%) and glucose 40 mg/mL (4%) solution for injection (minimum concentration 2 mg Propofol/mL). The mixture should be prepared aseptically (controlled and validated conditions preserved) immediately prior to administration and must be administered within 12 hours after preparation.
To reduce pain at the injection site Lidocaine may be injected immediately before the use of Propofol 10 mg/mL or Propofol 10 mg/mL may be mixed, immediately before use, with preservative free Lidocaine injection (20 parts of Propofol 10 mg/mL with up to 1 part of Lidocaine 10 mg/mL (1%) solution for injection) under controlled and validated aseptical conditions. The mixture has to be administered within 12 hours after preparation.
The muscle relaxants Atracurium and Mivacurium should not be administered through the same intravenous access as Propofol 10 mg/mL without first rinsing it out.
The vials should be shaken before use.
Duration of use: Propofol (Folenda) 10 mg/mL may only be used in a patient for a maximum of 7 days.