Posology : מינונים

4.2    Posology and Method of Administration

4.2.1 General instructions

RIPOL 10 MG/ML must only be given in hospitals or adequately equipped day therapy units by physicians trained in anaesthesia or in the care of patients in intensive care. Circulatory and respiratory functions should be constantly monitored (e.g. ECG, pulse-oxymeter) and facilities for maintenance of patent airways, artificial ventilation, and other resuscitation facilities should be immediately available at all times. For sedation during surgical or diagnostic procedures RIPOL 10 MG/ML should not be given by the same person that carries out the surgical or diagnostic procedure.

Supplementary analgesic medicinal products are generally required in addition to RIPOL 10 MG/ML 
4.2.2 Posology

RIPOL 10 MG/ML is given intravenously. The dosage is adjusted individually according to the patient’s response.



●    General anaesthesia in adults

Induction of anaesthesia:
For induction of anaesthesia RIPOL 10 MG/ML should be titrated (20 – 40 mg of propofol every 10 seconds) against the patient’s response until the clinical signs show the onset of anaesthesia. Most adult patients younger than 55 years are likely to require 1.5 to 2.5 mg/kg body weight.
In patients over this age and in patients of ASA grades III and IV, especially those with impaired cardiac function, the dosage requirements will be less and the total dose of RIPOL 10 MG/ML % may be reduced to a minimum of 1 mg/kg body weight. In these patients' lower rates of administration should be applied (approximately 2 ml, corresponding to 20 mg every 10 seconds).

Maintenance of anaesthesia:
Anaesthesia can be maintained by administering RIPOL 10 MG/ML either by continuous infusion or by repeat bolus injections. If a technique involving repeat bolus injections is used, increments of 25 mg (2.5 ml) RIPOL 10 MG/ML to 50 mg (5.0 ml) RIPOL 10 MG/ML may be given according to clinical requirements. For maintenance of anaesthesia by continuous infusion the dosage requirements usually are in the range of 4 – 12 mg/kg body weight/h.
In elderly patients, in patients of poor general condition, in patients of ASA grades III and IV and in hypovolaemic patients the dosage may be reduced further depending on the severity of the patient’s condition and on the performed anaesthetic technique.
Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

●    General anaesthesia in children over 1 month of age

Induction of anaesthesia:
For induction of anaesthesia RIPOL 10 MG/ML should be slowly titrated against the patient’s response until the clinical signs show the onset of anaesthesia. The dosage should be adjusted according to age and/or body weight.
Most patients over 8 years of age require approximately 2.5 mg/kg body weight of propofol for induction of anaesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher (2.5 – 4 mg/kg body weight).

Maintenance of general anaesthesia:
Anaesthesia can be maintained by administering RIPOL 10 MG/ML by infusion or repeated bolus injection to maintain the depth of anaesthesia required. The required rate of administration varies considerably between patients but rates in the region of 9 – 15 mg/kg/h usually achieve satisfactory anaesthesia. In younger children, especially between the age of 1 month and 3 years, dose requirements may be higher.

For ASA III and IV patients lower doses are recommended (see also section 4.4).

●    Sedation of ventilated patients in the Intensive Care Unit
For sedation during intensive care it is advised that propofol should be administered by continuous in- fusion. The infusion rate should be determined by the desired depth of sedation. In most patients sufficient sedation can be obtained with a dosage of 0.3 - 4 mg/kg/h of propofol (see also section 4.4).

Propofol is not indicated for sedation in intensive care of patients of 16 years of age or younger (see section 4.3). Administration of propofol by Target Controlled Infusion (TCI) system is not advised for sedation in the intensive care unit.
Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

●    Sedation for diagnostic and surgical procedures in adults

To provide sedation during surgical and diagnostic procedures, doses and administration rates should be adjusted according to the clinical response. Most patients will require 0.5 – 1 mg/kg body weight over 1 to 5 minutes for onset of sedation. Maintenance of sedation may be accomplished by titrating RIPOL 10 MG/ML infusion to the desired level of sedation. Most patients will require 1.5 –4.5 mg/kg body weight/h. The infusion may be supplemented by bolus administration of 10 – 20 mg (1 – 2 ml) RIPOL 10 MG/ML if a rapid increase of the depth of sedation is required.

In patients older than 55 years and in patients of ASA grades III and IV lower doses of RIPOL 10 MG/ML may be required and the rate of administration may need to be reduced.
Rapid bolus administration (single or repeated) should not be used in older people as this may lead to cardiorespiratory depression.

●    Sedation for diagnostic and surgical procedures in children over 1 month of age 
Doses and administration rates should be adjusted according to the required depth of sedation and the clinical response. Most paediatric patients require 1 – 2 mg/kg body weight of propofol for onset of sedation. Maintenance of sedation may be accomplished by titrating RIPOL 10 MG/ML as infusion to the desired level of sedation. Most patients require 1.5 – 9 mg/kg/h of propofol. The infusion may be supplemented by bolus administration of up to 1 mg/kg b.w. if a rapid increase of depth of sedation is required.

In ASA III and IV patients lower doses may be required.

4.2.3 Duration of administration
RIPOL 10MG/ML can be administered for a maximum of 7 days.
4.2.4 Method of administration

Intravenous use
RIPOL 10MG/ML is administered intravenously by injection or continuous infusion either undiluted or diluted with 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution as well as preservative- free lidocaine injection 1% (see also section 6.6).

Containers should be shaken before use.

Before use, the neck of the ampoule or the surface of the rubber stopper of the vial should be cleaned with medicinal alcohol (spray or swabs). After use, tapped containers must be discarded.

RIPOL 10MG/ML contains no antimicrobial preservatives and supports growth of microorganisms.
Therefore, RIPOL 10MG/ML is to be drawn up aseptically into a sterile syringe or an infusion set immediately after opening the ampoule or breaking the vial seal. Administration must commence without delay. Asepsis must be maintained for both RIPOL 10MG/ML and the infusion equipment throughout the infusion period.

Any medicinal products or fluids added to a running RIPOL 10MG/ML infusion must be ad- ministered close to the cannula site. If infusion sets with filters are to be used, these must be lipid-per- meable. RIPOL 10MG/ML must not be administered via infusion sets with microbiological filters.

The contents of one ampoule or one vial of RIPOL 10MG/ML and any syringe containing RIPOL 10MG/ML are for single use in one patient.

Infusion of undiluted RIPOL 10MG/ML
When administering RIPOL 10MG/ML by continuous infusion, it is recommended that burettes, drop counters, syringe pumps or volumetric infusion pumps, should always be used to control the infusion rates. As established for the parenteral administration of all kinds of fat emulsions, the duration of continuous infusion of RIPOL 10MG/ML from one infusion system must not exceed 12 hours. The infusion line and the reservoir of RIPOL 10MG/ML must be discarded and replaced after 12 hours at the latest. Any portion of RIPOL 10MG/ML remaining after the end of infusion or after replacement of the infusion system must be discarded.

Infusion of diluted RIPOL 10MG/ML
For administering infusion of diluted RIPOL 10MG/ML burettes, drop counters, syringe pumps, or volumetric infusion pumps should always be used to control infusion rates and to avoid the risk of accidentally uncontrolled infusion of large volumes of diluted RIPOL 10MG/ML.
The maximum dilution must not exceed 1 part of RIPOL 10MG/ML mg/ml with 4 parts of 5 % w/v glucose solution or 0.9 % w/v sodium chloride solution, or 0.18 % w/v sodium chloride and 4 % w/v glucose solution (minimum concentration 2 mg propofol/ml). The mixture should be prepared aseptically immediately prior to administration and must be used within 7 hours of preparation.

In order to reduce pain on initial injection, RIPOL 10MG/ML may be mixed with preservative-free lidocaine injection 1 % (mix 20 parts of RIPOL 10MG/ML with up to 1 part of lidocaine injection 1%).

Before giving the muscle relaxants atracurium or mivacurium subsequent to RIPOL 10MG/ML through the same intravenous line, it is recommended that the line be rinsed prior to administration.

Propofol may also be used by Target Controlled Infusion. Due to the different algorithms available on the market for dosage recommendations please refer to the instructions for use leaflet of the device manufacturer.


Needle Size - It is recommended to use a 21 G-type needle or above, please note that the use of a needle thicker than 0.8 mm and an incorrect piercing method can cause the fragmentation of a stopper and even the collapse of the stopper into the vial.

Angle and method of insertion -To prevent Coring (the formation of particles inside the solution), the needle should be inserted at a 45o–60° angle with the opening of the needle tip facing up (i.e., away from the stopper). A small amount of pressure is applied, and the angle is gradually increased as the needle enters the vial. The needle should be at a 90° angle just as the needle bevel passes through the stopper.



Picture 1 -Instructions for correct insertion of a needle through a rubber stopper 
Avoid puncturing the same stopper several times. If it is necessary, the stabbing will be done each time in a new place in the center of the stopper by using a different needle.

Do not use the product if particles are observed in the solution.