Medicinal Products

DIPRIVAN 500 mg / 50 ml 10 mg / mL

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

Injectable emulsion IV
Box of 1 bottle 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 may be given in adults and children over 1 month of age.

b) SEDATION

· Propofol can be used:

o for sedation during surgical procedures or diagnostic procedures, alone or in combination with local or regional anesthesia, in adults and children over 1 month of age,

o for sedation of patients over 16 years of age ventilated in surgical or medical resuscitation unit.

Dosage DIPRIVAN 500 mg / 50 ml 10 mg / ml Injectable Emulsion IV Box of 1 Bottle of 50 ml

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 bottle before use.

I) GENERAL 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 at a rate of about 4 ml (40 mg) every 10 seconds until the narcosis.

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 older than one month

For the induction of anesthesia, the dose of DIPRIVAN 10 mg / ml should be administered slowly until clinical signs of narcosis are obtained and titrated according to the response. The dosage should be adjusted according to the weight and the age of the child. Most patients over 8 years of age will require approximately 2.5 mg / kg of DIPRIVAN 10 mg / ml for the induction of anesthesia. In the youngest, especially between 1 month and 3 years, the necessary 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 2 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) Interview

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

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).

When used in repeated injections, 25 mg (2.5 ml) to 50 mg (5 ml) of propofol will be injected on demand.

In addition to the infusion, bolus administration of 25 mg (2.5 ml) 50 mg (5.0 ml) propofol may be performed if it is desired to rapidly increase the depth of anesthesia.

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

Fast bolus administration (single or repeated) should not be used in the elderly, which may lead to cardiorespiratory depression.

b) In children over 1 month old

Anesthesia can be maintained by administration of DIPRIVAN 10 mg / ml in continuous infusion or by repeated bolus injections to adjust the desired depth of anesthesia. Average doses of administration vary considerably depending on the subject, but they generally range between 9 and 15 mg / kg / h to obtain satisfactory anesthesia.

In younger children, especially between 1 month and 3 years, the required doses may be higher.

Lower doses are recommended for the subject ASA III and IV (see Warnings and Precautions for Use section ).

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

II A) SEDATION IN INTENSIVE CARE

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

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 required depth of 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 in the amounts administered must be made to take into account the amounts of lipids provided by DIPRIVAN: 1 ml of DIPRIVAN 10 mg / ml (10 mg of propofol) contains 0 1 g of lipids.

II B) ANESTHETIC SEDATION FOR SHORT-TERM ACTS AND IN SUPPLEMENT OF LOCO-REGIONAL 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 1 month old

Doses and rate of administration should be adjusted according to the required sedation depth and 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. An additional bolus of 1 mg / kg maximum may be given if it is necessary to rapidly increase the depth of sedation.

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.

If DIPRIVAN is to be diluted when used as an infusion (maintenance of anesthesia or sedation), it is recommended to use 5% isotonic glucose.

Dilutions should not exceed 1 in 5 (ie not less than 2 mg of propofol per ml).

In practice:

· Each 50 ml vial should not be diluted in more than 250 ml of 5% isotonic glucose solution.

· This dilution should be prepared with strict aseptic conditions.

· It must be performed immediately before administration and used within 6 hours after this preparation.

· The infusion can be performed with different techniques but a standard tubing used alone will not avoid the risk of accidental and uncontrolled infusion of large volumes of diluted propofol. A burette, a drop meter or a volumetric pump with controlled flow rate must be used.

· The risk of an uncontrolled infusion must be taken into account when deciding on the maximum amount of propofol in the burette.

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.

· CHILD:

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

· BREASTFEEDING:

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

Adverse effects Diprivan 500 MG / 50 ML

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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