Medicinal Products

DIPRIVAN 20 mg / mL

Generic drug of the therapeutic class: Anesthesia, resuscitation, analgesics
active ingredients: Propofol
laboratory: Astrazeneca

Injectable emulsion IV
Pre-filled syringe of 50 ml
All forms

Indication

a) ANESTHESIA

· Propofol is an intravenous, fast-acting anesthetic agent that can be used for the induction and maintenance of general anesthesia.

· Propofol can be given to adults and children over 3 years of age.

b) SEDATION

Propofol can be used:

· For sedation during surgical procedures or diagnostic procedures, alone or in combination with local or regional anesthesia in adults and children over 3 years of age.

· For sedation of patients over 16 years of age ventilated in surgical or medical resuscitation unit.

Dosage DIPRIVAN 20 mg / ml Emulsion for injection IV 50 ml pre-filled syringe

This product should be administered only by physicians specialized in anesthesia-resuscitation or emergency medicine and familiar with the use of anesthetics, or under their control, and having all necessary anesthesia and resuscitation equipment.

The recommendations of the scholarly societies concerned must be respected, especially when used in an out-of-hospital situation (emergency situation or medical transport).

Shake the pre-filled syringe before use.

How to administer propofol in pre-filled syringes only, specific to the use of the DIPRIFUSOR-TCI device for Intravenous Concentration Anesthesia (TCI), see section IV) . Can only be used for the induction and maintenance of anesthesia in adults; it is not recommended for sedation or in children since there is no validated pharmacokinetic model.

I) GENERAL ANESTHESIA

DIPRIVAN 20 mg / ml should be used as an infusion to induce anesthesia only in patients who will receive anesthesia for maintenance of anesthesia.

A) Induction

a) In the adult and the elderly (over 65 years old)

In patients, premedicated or not, it is recommended to administer the product by continuous infusion at an initial rate of 1 or 2 ml every 10 seconds until the narcosis is obtained.

Most patients younger than 55 years will require 1.5 to 2.5 mg / kg of propofol. The total dose required can be reduced by a lower rate of administration (20 to 50 mg / min, ie 1200 to 3000 mg / h).

In the elderly, the dose required for induction of anesthesia should be reduced. This dose should be administered slowly and titrated according to the response.

It is recommended not to exceed 1.5 mg / kg after 75 years.

b) In children over 3 years old

The administration of propofol with the device DIPRIFUSOR - TCI is not recommended in the child who is in general anesthesia or in sedation.

The dosage should be adjusted according to the weight and age of the child.

Most patients over 8 years of age will require approximately 2.5 mg / kg of DIPRIVAN 20 mg / ml for the induction of anesthesia. For children over 3 years, the required dose may be higher (2.5 to 4 mg / kg).

c) In patients whose general condition is impaired (ASA grade III or IV)

In patients whose general condition is impaired (ASA grade III or IV), lower rates of administration will be used: approximately 1 ml (20 mg) every 10 seconds.

In ASA IV patients, the induction dose should be less than 1.5 mg / kg (see Warnings and Precautions ).

Further reduction in dose and rate of administration will be required in elderly ASA grade III or IV patients.

B) MAINTENANCE

It will be performed by administering propofol on demand, depending on the depth of anesthesia desired.

DIPRIVAN 20 mg / ml is not suitable for repeated bolus injection, in this case use DIPRIVAN 10 mg / ml.

a) In the adult and the elderly (over 65 years old)

In adults, the average dosage varies from one patient to another, but is generally in the range of 0.1 to 0.2 mg / kg / min (6 to 12 mg / kg / h).

In the case of over 55 years the dosage will generally be lower. In the elderly, the infusion rate or target concentration should also be reduced.

Fast (simple) bolus administration should not be used in the elderly, as it may lead to cardiorespiratory depression.

b) In children over 3 years old

To maintain a satisfactory level of general anesthesia, DIPRIVAN 20 mg / ml should be administered by infusion.

The average infusion rate varies considerably among children but is generally between 9 and 15 mg / kg / h.

The required dose may be higher in younger children.

c) In patients whose general condition is impaired (ASA grade III or IV)

In the subject ASA grade III or IV, the dosage will generally be lower.

Further reduction in dose and rate of administration will be required in elderly ASA grade III or IV patients.

II) SEDATION

Intensive care sedation

The use of propofol for sedation Intensive Care Unit for children under 16 is contraindicated (see Contraindications section ).

Propofol administration with the DIPRIFUSOR - TCI device is not recommended for sedation.

Administration of DIPRIVAN 20 mg / ml in repeated injections is not recommended.

When used in sedation in patients requiring intensive care, it is recommended to administer propofol as a continuous infusion.

The dosage should be adjusted according to the depth required for sedation. For most patients, sufficient sedation is achieved with doses ranging from 1 mg / kg / h to 4 mg / kg / h. (see section Warnings and precautions for use ).

In the elderly, the dose and rate of infusion or target concentration should be reduced.

If the patient concomitantly receives other intravenous lipids, a reduction of the quantities administered must be made to take into account the amounts of lipids provided by DIPRIVAN 1 ml of DIPRIVAN 20 mg / ml (20 mg of propofol) contains 0, 1 g of lipids.

Anesthetic sedation for short-term acts and in addition to locoregional anesthesia

In the adult

When used in anesthetic sedation for diagnostic and / or therapeutic purposes, or in addition to locoregional anesthesia, it is recommended to administer propofol by slow injection or infusion for initiation and continuous infusion for 'interview.

In young and generally healthy subjects, the initial dose will be 0.5 to 1 mg / kg in slow injection or infusion over a period of 1 to 5 minutes. Maintenance will be by infusion at a dose of 1 to 4.5 mg / kg / h with adjustment depending on the desired clinical effect.

In elderly patients and / or grade ASA III and ASA IV, the initial dose should not exceed 0.5 mg / kg as a slow injection or as an infusion over a period of 1 to 5 minutes followed by a 1.5 mg infusion / kg / h to be adjusted according to the desired clinical effect.

In children over 3 years old

Doses and rate of administration should be adjusted to the depth required for desired sedation and the clinical response. In most pediatric patients, the dose required for the onset of sedation is between 1 and 2 mg / kg of propofol.

Maintenance of sedation can be obtained by titrated infusion of DIPRIVAN according to the desired sedation level. Most subjects require a dose of 1.5 to 9 mg / kg / h of propofol.

In ASA patients grades III and IV lower doses may be needed.

III) GENERAL RECOMMENDATIONS

Induction

Propofol can be administered in the terminal part of the tubing of a 5% isotonic glucose infusion, 0.9% saline or a 4% glucose and 0.18% saline mixture (see section Incompatibilities ).

Extended administration (maintenance of general anesthesia and / or sedation).

Analgesics are usually needed in combination with this medication.

This product has been used in combination with spinal and epidural anesthesia as well as most anesthesia products: premedications, muscle relaxants, inhalation anesthetics and analgesics. No pharmacological incompatibility was encountered. Under these conditions, lower dosages of propofol are needed.

If DIPRIVAN is administered pure, an electric syringe pump or volumetric flow controlled pump should be used.

DIPRIVAN 20 mg / ml should not be diluted.

IV) INTRAVENOUS ADMINISTRATION WITH CONCENTRATION TARGET ADMINISTRATION OF PROPOFOL WITH DIPRIFUSOR DEVICE - TCI (Target Controlled Infusion).

The use of the DIPRIFUSOR - TCI device for the administration of DIPRIVAN is reserved for the induction and maintenance of general anesthesia in adults. It is not recommended in sedation or in children.

This system allows the anesthetist to achieve and control the desired induction rate and depth of anesthesia by defining and adjusting a target (predicted concentration) of blood concentration in propofol.

Only the device DIPRIFUSOR - TCI including the software DIPRIFUSOR - TCI allows the administration of propofol by TCI.

This device works with syringes pre-filled with propofol 10 mg / ml (500 mg / 50 ml) and 20 mg / ml (1 g / 50 ml) with an electronic identification system.

The user should be familiar with the use of a syringe pump, TCI propofol administration, and syringe identification systems of 10 mg / ml 1% and 20 mg / ml. All of these elements are described in the training manual and use of DIPRIFUSOR available on request.

Guidance on propofol concentration objectives is provided below. Due to the interindividual variability, pharmacology, and pharmacokinetics of propofol (both in premedicated and non-premedicated patients), target propofol concentrations should be adjusted to the patient's response to achieve the desired anesthetic depth. .

Induction

In adult patients under 55 years, the induction of anesthesia can usually be achieved with a target blood concentration of propofol between 4 and 8 micrograms / ml. In premedicated patients, an initial target blood concentration of 4 micrograms / ml is recommended, in non-premedicated patients it is 6 micrograms / ml.

In this range of target concentrations, the induction time is generally between 60 and 120 seconds.

Higher target concentrations will result in faster induction but may result in greater hemodynamic and respiratory depression.

In patients over 55 years old and those classified as ASA III or IV, the initial concentration will be decreased. The target concentration can then be increased in increments of 0.5 to 1.0 micrograms / ml every minute to achieve progressive induction of anesthesia.

In patients over 75 years of age, it is recommended not to exceed a target concentration of more than 2.5 micrograms / ml.

Interview

The combination of analgesics will usually be necessary. Their influence on the reduction of the target blood concentration of propofol during maintenance will depend on the amount of analgesic administered simultaneously.

Target blood concentrations of propofol between 3 and 6 micrograms / ml are generally sufficient to maintain satisfactory anesthesia.

Propofol blood concentration predicted to awaken is generally 1.0 to 2.0 micrograms / ml and will depend on the amount of analgesics administered during the maintenance phase.

Against indications

· Known hypersensitivity to propofol or to any of the components of this product.

· Due to the presence of soybean oil, this medicine is contraindicated in case of peanut or soy allergy.

o Propofol is contraindicated in children under 16 years of age by sedation in the Intensive Care Unit (see Warnings and Precautions section ).

· BREASTFEEDING:

o The use of propofol in breastfeeding women is not recommended.

Diprivan side effects

The adverse effects attributable to propofol are presented below by organ class and frequency.

Frequencies are defined as: very rare (≤ 1/10 000), rare (≥ 1/10 000, ≤ 1/1 000), frequent (≥ 1/100, ≤ 1/10), very common (≥ 1 / 10).

Class-Body

Frequency

Side effects

General disorders

Very frequent

Pain at the injection site (1) .

Very rare

Rhabdomyolysis (6), (8) .

Vascular system disorders

frequent

Hypotension may be severe (2) .

Uncommon

Thrombocytopenia (3) .

Very rare

Local venous complications at the place of injection of the product (4) .

Cardiovascular system disorders

frequent

Bradycardia (5) .

few

Asystole (5) .

Very rare

Pulmonary edema.

Not known (12)

Heart failure.

Cardiac arrhythmia (8), (10) .

Respiratory system disorders

frequent

Transient apnea during injection.

Gastrointestinal disorders

frequent

Nausea and vomiting upon waking.

Very rare

Pancreatitis.

Hepatobiliary disorders

Not known (12)

Hepatomegaly (8) .

Nervous system disorders

frequent

Headache upon waking.

few

Epileptiform-like motions including opisthotonos and convulsive seizures during induction, maintenance, and awakening.

Very rare

A non-watch phase can also be observed.

Not known (12)

Involuntary movements.

Injury, poisoning and complication related to an intervention

Very rare

Post-anesthetic fever.

Renal and urological disorders

Very rare

Modification of urine staining following prolonged administration of propofol.

Not known (12)

Renal insufficiency (8) .

Immune system disorders

Very rare

Anaphylactic shock may include angioedema, bronchospasm and erythema, with severe hypotension.

Sexual disorders

Very rare

Sexual disinhibition.

Skin disorders

Very rare

Urticaria (7) .

Metabolism and nutrition disorders

Not known (12)

Metabolic acidosis (8) .

Hyperkalemia (8) .

Hyperlipidemia (8) .

Psychiatric disorders

Not known (12)

Euphoric mood (9) .

Abuse (9) of propofol.

investigations

Not known (12)

Brugada syndrome (8), (11) .

(1) The pain can be greatly ameliorated by using the large veins of the forearm and the crease of the elbow. In children, the pain is even more common than in adults, especially when the injection is made in a small vein of the hand or wrist, it is less in a vein of the fold of the elbow or forearm .

(2) (See warnings and precautions for use ) section.

(3) In repeated administration, attributed to the lipid vector.

(4) Local venous complications at injection are exceptional. Accidental extravasations observed, as well as animal studies, showed only a minimal tissue reaction. Intra-arterial injection in animals did not cause tissue complications locally and downstream.

(5) Some cases of bradycardia, sometimes severe and asystole have been reported.

(6) When administering propofol for sedation in intensive care units at doses greater than 4 mg / kg / h.

(7) Due to the presence of refined soybean oil there is a risk of a hypersensitivity reaction.

(8) Associated effects characterizing propofol infusion syndrome that may occur in critically ill patients with multiple risk factors for these events (see Warnings and Precautions ) section.

(9) Propofol abuse, especially among health professionals.

(10) Rapidly evolving cardiac failure in adults (in some cases with fatal outcome). In these cases, heart failure generally did not respond to treatment with an inotropic agent.

(11) Brugada syndrome (ST segment elevation ECG with domed appearance).

(12) Frequency not known because it can not be estimated from the available data.

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