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Instruction for use: Recofol

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Dosage form: emulsion for intravenous administration

Active substance: Propofol*

ATX

N01AX10 Propofol

Pharmacological group:

Anesthetic means

The nosological classification (ICD-10)

R52.1 Persistent non-recurrent pain: Pain syndrome in oncology practice; Pain syndrome pronounced; Pain syndrome in malignant neoplasms; Pain syndrome in cancer; Pain syndrome with tumors; Pain syndrome in cancer patients; Pain in malignant neoplasms; Pain in malignant tumors; Pain in tumors; Pain in cancer patients; Pain in bone metastases; Pain in cancer; Malignant pain syndrome; Intensive chronic pain; Intensive pain syndrome; Intensive non-curable pain syndrome; Intensive chronic pain syndrome; Unrestrained pain; Tumor pain; Post-traumatic pain syndrome; Severe pain; Chronic pain; Chronic Pain Syndrome

Z100.0 * Anesthesiology and premedication: Abdominal surgery; Adenomectomy; Amputation; Angioplasty of the coronary arteries; Carotid artery angioplasty; Antiseptic treatment of skin in wounds; Antiseptic treatment of hands; Appendectomy; Atheroctomy; Balloon coronary angioplasty; Vaginal hysterectomy; Venous bypass; Interventions on the vagina and cervix; Interventions on the bladder; Interference in the oral cavity; Reconstructive-reconstructive operations; Hand hygiene of medical personnel; Gynecological Surgery; Gynecological interventions; Gynecological operations; Hypovolemic shock during surgery; Disinfection of purulent wounds; Disinfection of the edges of wounds; Diagnostic Interventions; Diagnostic procedures; Diathermocoagulation of the cervix; Long-term surgeries; Replacement of fistulous catheters; Infection in orthopedic surgical interventions; Artificial heart valve; Kistectomy; Short-term outpatient surgery; Short-term operations; Short-term surgical procedures; Cryotyreotomy; Blood loss during surgical interventions; Bleeding during surgery and in the postoperative period; Kuldotsentez; Laser coagulation; Laserocoagulation; Laser retinopathy of the retina; Laparoscopy; Laparoscopy in gynecology; Likvornaya fistula; Small gynecological operations; Small surgical interventions; Mastectomy and subsequent plastic surgery; Mediastinotomy; Microsurgical operations on the ear; Mukinging operations; Suturing; Minor surgery; Neurosurgical operation; Eclipse of the eyeball in ophthalmic surgery Orchiectomy; Pancreatectomy; Pericardectomy; The rehabilitation period after surgical operations; Reconvalence after surgical intervention; Percutaneous transluminal coronary angioplasty; Pleural Thoracocentesis; Pneumonia postoperative and post traumatic; Preparing for surgical procedures; Preparing for a surgical operation; Preparation of the surgeon's arms before surgery; Preparation of the colon for surgical interventions; Postoperative aspiration pneumonia in neurosurgical and thoracic operations; Postoperative nausea; Postoperative hemorrhage; Postoperative granuloma; Postoperative shock; Early postoperative period; Myocardial revascularization; Resection of the apex of the tooth root; Resection of the stomach; Bowel resection; Resection of the uterus; Liver resection; Small bowel resection; Resection of a part of the stomach; Reocclusion of the operated vessel; Gluing of tissues during surgical interventions; Suture removal; Condition after eye surgery; Condition after surgery; Condition after surgery in the nasal cavity;Condition after gastrectomy; Condition after resection of the small intestine; Condition after tonsillectomy; Condition after removal of duodenum; Condition after phlebectomy; Vascular Surgery; Splenectomy; Sterilization of surgical instrument; Sterilization of surgical instruments; Sternotomy; Dental surgery; Dental intervention on periodontal tissues; Strumectomy; Tonsillectomy; Thoracic surgery; Total gastrectomy; Transdermal intravascular coronary angioplasty; Transurethral resection; Turbinectomy; Removal of a tooth; Cataract removal; Removing Cysts; Removal of tonsils; Removal of myoma; Removal of mobile milk teeth; Removal of polyps; Removal of a broken tooth; Removal of the uterus; Removal of seams; Urethrotomy; Fistula of the luminal ducts; Frontoetmoidohaimorotomy; Surgical infection; Surgical treatment of chronic ulcers of extremities; Surgery; Surgery in the anus; Surgery on the large intestine; Surgical practice; Surgical procedure; Surgical interventions; Surgical interventions on the digestive tract; Surgical interventions on the urinary tract;Surgical interventions on the urinary system; Surgical interventions on the genitourinary system; Surgical intervention on the heart; Surgical procedures; Surgical operations; Surgical operations on veins; Surgical intervention; Vascular; Cholecystectomy; Partial resection of the stomach; Extraperitoneal hysterectomy; Percutaneous transluminal coronary angioplasty; Percutaneous transluminal angioplasty; Coronary artery bypass grafting; Extirpation of the tooth; Extirpation of infant teeth; Extirpation of pulp; Extracorporeal circulation; Extraction of the tooth; Extraction of teeth; Extraction of cataracts; Electrocoagulation; Endourological interventions; Episiotomy; Ethmoidotomy; Complications after tooth extraction

Composition and release form

Emulsion for intravenous administration 1 ml

propofol 10 mg; 20 mg

auxiliary substances: soybean oil; egg phosphatides; glycerol; sodium hydroxide; water for injections

in ampoules of 20 ml; in the box there are 5 ampoules; or in bottles of 50 ml; in the box 1 bottle.

Description of dosage form

Almost white homogeneous emulsion.

Characteristic

Rapid intravenous anesthetic for introduction into anesthesia and maintenance of general anesthesia, as well as for sedation of patients during intensive therapy.

Pharmachologic effect

Pharmacological action - anesthesia.

Pharmacodynamics

Has a nonspecific effect at the level of lipid membranes of the central nervous system. Does not have an initial stimulating effect. The exit from anesthesia is usually not accompanied by headache, postoperative nausea and vomiting.

Pharmacokinetics

Propofol is 97% bound to plasma proteins. T1 / 2 after IV infusion - from 277 to 403 minutes. The propofol kinetics after IV bolus infusion can be represented as a three-part model: the rapid phase of the distribution (T1 / 2 - 2-4 min), the β-elimination phase (T1 / 2 - 30-60 min) and the γ-elimination phase ( T1 / 2 - 200-300 min). In the course of the γ-phase, a decrease in the concentration of the drug in the blood occurs slowly as a result of a prolonged redistribution from adipose tissue. In clinical settings, this phase does not affect the time of awakening. Propofol is metabolized predominantly by conjugation in the liver at a clearance of about 2 l / min, as well as outside the liver. Inactive metabolites are mostly excreted by the kidneys (about 88%). With maintenance of anesthesia in the usual regime, there was no significant cumulation of propofol after surgical procedures lasting up to 5 hours.

Clinical Pharmacology

In most patients, general anesthesia occurs 30-60 s later. The duration of anesthesia, depending on the dose and concomitant drugs, ranges from 10 minutes to 1 hour. From anesthesia, the patient wakes up quickly and with clear consciousness, the ability to open eyes appears after 10 minutes.

Indication for the drug Rekofol

introduction to anesthesia and maintenance of general anesthesia;

sedation of patients who are on artificial respiration during intensive therapy;

sedation during surgical or diagnostic procedures with regional or local anesthesia.

Contraindications

hypersensitivity;

Children's age: up to 1 month - for anesthesia and anesthesia, up to 16 years - to provide a sedative effect during intensive care.

Application in pregnancy and lactation

Propofol passes through the placental barrier and can exert a depressing effect on the fetus. Contraindicated during pregnancy, as well as in high doses for anesthesia during delivery (except for termination of pregnancy).

Data from studies conducted in nursing mothers show that a small amount of propofol enters the breast milk. It is believed that this does not pose a danger to the baby if the mother starts breastfeeding a few hours after the administration of propofol.

Side effects

Are common. Sometimes there may be hypotension and temporary respiratory arrest (may occur severely, especially in patients with a general worsened condition); in rare cases - epileptiform movements, including convulsions and opisthotonus (sometimes within a few hours or days), pulmonary edema; on waking up (in rare cases) - short-term impairment of consciousness (sometimes), very rarely - nausea, vomiting, headache, postoperative fever; in very rare cases - allergic reactions associated with anaphylactic symptoms (severe hypotension, bronchospasm, angioedema, facial erythema); bradycardia and a few cases of cardiac arrest (asystole); in very rare cases, using propofol for sedation during intensive therapy at doses higher than 4 mg / kg / h, rhabdomyolysis, metabolic acidosis, hyperkalemia or heart failure, sometimes fatal (see "Precautions"); very rarely after the introduction of propofol developed pancreatitis (the cause-effect relationship is not established); postoperative chills, fever, sensation of cold, euphoria were noted; change of color of urine to green or red-brown, violation of sexual behavior (after prolonged use); After repeated administration of propofol, mild thrombocytopenia was observed.

Local. Usually the drug is well tolerated. The most common undesirable effect is pain at the injection site, which can be reduced by injecting the drug into one of the larger veins on the forearm or in the ulnar fossa. Rarely, phlebitis and vein thrombosis are noted. In some cases, heavy tissue reactions can occur after paravenosis.

Interaction

The combined use of propofol with premedication products, inhalants or analgesics may increase anesthesia, as well as adverse cardiovascular reactions. The simultaneous use of opioids can exacerbate the depressant effect of propofol on respiration (respiratory arrest may occur more often and be longer).

The concentration of propofol in the blood may temporarily increase after the administration of fentanyl (there is no need to adjust the maintenance dose). In patients receiving cyclosporine, lipoencephalopathy was observed in some cases when lipid-containing emulsions like Recofol® were administered. When using Recofol®, lower doses of propofol may be sufficient to supplement local anesthetic agents.

Dosing and Administration

IV.

Recofol® 10 mg / ml

Recofol® 10 mg / mL is given only IV. In order to reduce the pain of injection, the initial dose of Recofol® immediately before administration can be mixed in a plastic syringe with lidocaine (10 mg / ml) at the rate of 1 part of injection of lidocaine into 20 parts of Rekofol®.

All actions with Rekofol® 10 mg / ml and the equipment necessary for its administration should be carried out under the strictest sterility conditions, since Recofol® does not contain any antimicrobial preservatives and, like any lipid emulsion, promotes the growth of bacteria and other microorganisms. Recofol is recruited in a sterile syringe under sterile conditions immediately after opening the ampoule or vial, and then immediately injected. Any fluids prescribed with Rekofol® should be administered as close as possible to the catheter. Rekofol® is not administered via a microbiological filter.

Recofol® 10 mg / ml can be administered either undiluted or diluted for infusion. Each ampoule or vial before injection or dilution should be carefully inspected for abnormalities. If any changes are found, the drug should not be used. Shake well before use. The remains of any solutions should be destroyed.

To ensure the required infusion rate, it is necessary to use the proper equipment. For this purpose, drop counters, metered infusion or syringe pumps are quite suitable. Using a conventional infusion set does not allow to prevent accidental overdose with a sufficient degree of reliability. When determining the maximum volume of propofol in the burette, the risk of uncontrolled infusion should be considered. Simultaneously with Recofol® 10 mg / ml, it is permitted to administer sodium chloride or a dextrose solution through the Y-shaped connector.

Rekofol® 10 mg / ml can be diluted with 0.9% sodium chloride solution or 5% dextrose solution for infusion. Dilute should be no more than 5 times (the minimum content of propofol 2 mg / ml), and use for this purpose a packet of PVC or a glass bottle for infusions. If an infusion bag of PVC is used, it is necessary to take a complete package and prepare the solution by casting a part of the infusion liquid and replacing it with an equal volume of propofol. Particular attention should be paid to preparing the solution under sterile conditions immediately before administration. Any dilute solutions should be used within 6 hours after preparation. The remains of any solutions must be destroyed. The dilution method is indicated in the table.

Table

Dilution and simultaneous administration of Rekofol® 10 mg / ml with other drugs

The method of simultaneous administration of drugs Excipient or solvent Preparation Precautionary measures
Pre-mixing 5% dextrose solution for IV infusion Mix 1 part of Rekofol® 10 mg / ml with 4 (or less) parts of 5% dextrose solution for IV infusion in a PVC bag or in a glass infusion bottle. It is recommended to take the complete package, pour out a part of the infusion fluid and replace it with an equal volume of RecoFol® 10 mg / ml Prepare in aseptic conditions immediately before administration. The mixture retains its properties for no more than 6 hours.
A solution of lidocaine hydrochloride (0.5% or 1%, without preservatives) for injection Mix 20 parts of Rekofol® 10 mg / ml with 1 (or less) part of a 0.5 or 1% solution of lidocaine hydrochloride for injection Prepare in aseptic conditions immediately before administration. Use only for anesthesia.
Simultaneous injection with a Y-shaped connector 5% dextrose solution for v / vinfusion or 0.9% sodium chloride solution for IV infusion Introduce simultaneously using the Y-shaped connector Place the Y-shaped connector near the injection site

Doses

The dose of Rekofol® 10 mg / ml is individually selected by an experienced anesthesiologist depending on the patient's body weight, sensitivity to propofol and other concomitant medications. Rekofol® is also used for sedation in surgical and diagnostic procedures, and there is experience in its use in combination with spinal epidural anesthesia. It is recommended to titrate propofol, depending on the patient's reaction, until the appearance of clinical signs of anesthesia.

Adults

Introductory anesthesia

The dose of Rekofol® 10 mg / ml should be titrated individually (20-40 mg of propofol every 10 seconds), depending on the patient's response. For introduction into anesthesia, Recofol® 10 mg / ml can be used as a slow bolus injection or infusion. Most adult patients under the age of 55 years will most likely need to administer propofol at a dose of 1.5-2.5 mg per 1 kg of body weight. Older patients and patients with an ASE level 3 and 4 ASE (American Society of Anaesthesiologists), especially with weakened cardiac function, will need smaller doses, and the total dose of Recofola 10 mg / ml can be reduced to a minimum: 1 mg propofol per 1 kg of body weight. For such patients, the drug should be administered at a lower rate - approximately 2 ml (or 20 mg) every 10 seconds. The total dose can be reduced at a lower rate of administration (20-50 mg / min).

Maintaining general anesthesia

Anesthesia is maintained by the administration of Recofola® 10 mg / ml by continuous infusion or repeated bolus injections to ensure sufficient anesthesia.

Permanent infusion. The required infusion rate varies markedly in different patients. To maintain general anesthesia, propofol should be administered at a dose of 4-12 mg / kg / h. More elderly, weakened patients, as well as patients with hypovolemia or with ASA 3 and 4 degrees, should reduce the dose to 4 mg / kg / h. With the onset of anesthesia (approximately during the first 10-20 minutes), some patients may be shown a slightly increased infusion rate (8-10 mg / kg / h).

Repeated bolus injections: bolus injections in a dose of 25-50 mg (2.5-5.0 ml), depending on the patient's reaction. Elderly patients should not be prescribed fast bolus injections (single or repeated), as this can lead to cardiopulmonary failure.

Providing a sedative effect for patients on artificial respiration during intensive care

For sedation during intensive therapy, it is recommended to administer propofol by continuous infusion. The rate of infusion is determined by the desired depth of sedation. Most patients can achieve a sufficient level of sedation with a dose of propofol 0.3-4 mg / kg / h. It is recommended that specialists who prescribe the drug not exceed the dose of 4 mg / kg / h (if possible) (see "Precautions"). The duration of permanent infusion of propofol should not exceed 7 days. To ensure sedation in intensive care units, it is not recommended to administer propofol using TCI (targeted controlled infusion).

Sedation for surgical and diagnostic procedures

The dose should be selected individually. Sufficient sedation for surgical and diagnostic procedures is usually achieved by first administering 0.5-1 mg / kg / h for 1-5 minutes, and then maintained at a constant infusion rate of 1-4.5 mg / kg / h. If there is a need to get a greater sedative effect, you can additionally administer a bolus dose of propofol in 10-20 mg. Patients with grade 3 and 4 ASA and elderly patients often have enough lower doses of propofol.

Children

Introduction to anesthesia

Propofol is not prescribed for children younger than 1 month.

To introduce an anesthesia dose of 10 mg / ml Recofola should be slowly titrated depending on the patient's reaction before the appearance of clinical signs of anesthesia. Dosage should be selected depending on the age and / or body weight. Most patients older than 8 years for the introduction of anesthesia are likely to have a dose of approximately 2.5 mg of Rekofol® 10 mg / ml per kg of body weight. The required dose for patients younger than this age may be higher (2.5-4 mg / kg). Due to the lack of clinical data for high-risk children (ASA 3 and 4), these patients are given lower doses of Recofola® 10 mg / mL.

Maintaining general anesthesia

Propofol is not prescribed for children younger than 1 month.

Anesthesia is supported by the introduction of Recofol® through continuous infusion or repeated bolus injections. Dosage should be selected individually, but to achieve the required anesthesia, a sufficient infusion rate is usually 9-15 mg / kg / h. For children with ASA grades 3 and 4, no data are available.

Patients under 3 years of age may need a higher dose from the recommended range compared with older children. The dose should be selected individually and special care should be taken to ensure proper analgesia (see also "Precautions").

According to studies supporting general anesthesia, in children younger than 3 years the duration of the drug was usually about 20 minutes at a maximum of 75 minutes. Therefore, do not exceed the maximum duration of about 60 minutes, except when longer-term use is indicated, for example in malignant hyperthermia, where the use of inhalational anesthetics should be avoided.

Sedation with intensive care, surgical and diagnostic procedures

Propofol for sedation with intensive care is not prescribed for patients under 16 years of age (see "Contraindications"). Using propofol without recommendations, serious side effects (including fatal outcomes) were observed, although the causal relationship between these phenomena and the use of propofol was not proven. Side effects were most commonly encountered in children with respiratory infections when doses were administered that exceeded recommended doses for adults.

Recofol® 20 mg / ml

Recofol® 20 mg / ml is administered un-diluted. Each ampoule or vial before injection should be carefully inspected for abnormalities. If any changes are found, the drug should not be used. Shake well before use. The remains of any solutions should be destroyed.

To ensure the required infusion rate, it is necessary to use the proper equipment. For this purpose, drop counters, metered infusion or syringe pumps are quite suitable. Using a conventional infusion set does not allow to prevent accidental overdose with a sufficient degree of reliability. When determining the maximum volume of propofol in the burette, the risk of uncontrolled infusion should be considered.

The dose of Rekofol® 20 mg / ml is individually selected by an experienced anesthesiologist depending on the patient's body weight, sensitivity to propofol and other concomitant medications. Rekofol® is also used for sedation in surgical and diagnostic procedures, and has experience in its use in combination with spinal and epidural anesthesia.

Adults

Introduction to anesthesia

Dose Rekofol® 20 mg / ml should be titrated individually (20-40 mg of propofol every 10 seconds), depending on the patient's reaction. Most adult patients under the age of 55 years will most likely need to administer propofol at a dose of 1.5-2.5 mg per 1 kg of body weight. Older patients and patients with ASA of grade 3 and 4, especially with weakened cardiac function, will need smaller dosages, and a total dose of 20 mg / ml of Rekofol® can be reduced to a minimum of 1 mg of propofol per 1 kg of body weight. In such patients, the drug should be administered at a lower rate - approximately 1 ml (corresponding to 20 mg) every 10 seconds. The total dose can be reduced at a lower rate of administration (20-50 mg / min).

Maintaining general anesthesia

Anesthesia is maintained by the introduction of 20 mg / ml of Recofol® through continuous infusion.

The required infusion rate varies markedly in different patients. To maintain general anesthesia, propofol should be administered at a dose of 4-12 mg / kg / h. More elderly, weakened patients, as well as patients with hypovolemia or with ASA 3 and 4 degrees, should reduce the dose to 4 mg / kg / h. With the onset of anesthesia (approximately during the first 10-20 minutes), some patients may be shown a slightly increased infusion rate (8-10 mg / kg / h).

Sedation of patients on artificial respiration during intensive care

For sedation during intensive therapy, it is recommended to administer propofol by continuous infusion. The rate of infusion is determined by the desired depth of sedation. Most patients can achieve a sufficient level of sedation with a dose of propofol 0.3-4 mg / kg / h. It is recommended that dose-setting specialists do not exceed the dose of 4 mg / kg / h, if possible (see "Precautions"). The duration of a continuous infusion of propofol should not exceed 7 days. To ensure sedation in intensive care units, it is not recommended to administer propofol using TCI (targeted controlled infusion).

Sedation for surgical and diagnostic procedures

The dose should be selected individually. Sufficient sedation for surgical and diagnostic procedures is usually achieved by first administering 0.5-1 mg / kg / h for 1-5 minutes, and then maintained at a constant infusion rate of 1-4.5 mg / kg / h. Patients with grade 3 and 4 ASA and elderly patients often have enough lower doses of propofol.

Children

Introduction to anesthesia

Propofol is not prescribed for children younger than 1 month.

To introduce an anesthetic dose of 20 mg / ml, Recofol® should be titrated slowly depending on the patient's response before the appearance of clinical signs of anesthesia. Dosage should be selected depending on the age and / or body weight. Most patients older than 8 years for the introduction of anesthesia are likely to have enough dose of Rekofol® 20 mg / ml at approximately 2.5 mg / kg body weight. The required dose for patients younger than this age may be higher (2.5-4 mg / kg). Due to the lack of clinical data for high-risk children (ASA 3 and 4), these patients are given lower doses of Recofola® 20 mg / mL. Recofol ® 20 mg / ml is not recommended for use in anesthesia in children from 1 month to 3 years, due to the difficulty of accurately introducing small amounts of the drug (see also "Precautions"). In such cases it is recommended to use Recofol® 10 mg / ml.

Maintaining general anesthesia

Propofol is not prescribed for children younger than 1 month.

Anesthesia is supported by the introduction of Recofol® through continuous infusion. Dosage should be selected individually, but to achieve the required anesthesia, a sufficient infusion rate is usually 9-15 mg / kg / h. For children with ASA grades 3 and 4, no data are available.

Patients younger (younger than 3 years) may need a higher dose from the recommended range compared with older children. The dose should be selected individually and special care should be taken to ensure proper analgesia (see also "Precautions").

According to the data on the maintenance of general anesthesia in children younger than 3 years, the duration of the drug was usually about 20 minutes at a maximum of 75 minutes. Therefore, do not exceed the maximum duration of about 60 minutes, except when longer-term use is indicated, for example, in malignant hyperthermia, where the use of inhalational anesthetics should be avoided.

Sedation with intensive care, surgical and diagnostic procedures

Propofol for sedation with intensive care is not prescribed for patients aged 16 years or younger (see Contraindications).

Using propofol without recommendations, serious side effects (including fatal outcomes) were observed, although the causal relationship between these phenomena and the use of propofol was not proven. Side effects were most commonly encountered in children with respiratory infections when doses were administered that exceeded recommended doses for adults.

Overdose

Symptoms: depression of the cardiovascular and respiratory systems.

Treatment: when respiratory system is depressed, ventilation (oxygen) is recommended, in case of oppression of cardiac activity, the patient's position should be changed so that his head is higher and his legs are lower. If necessary, the introduction of vasopressors and plasma-substituting agents or solutions of electrolytes (for example Ringer's solution) is possible.

Precautionary measures

The use of the drug is possible only by specialists-anaesthesiologists. During the administration of the drug, patients should be under constant observation to identify early signs of possible hypotension, airway obstruction, hypoventilation and insufficient oxygen saturation.

Use with caution in elderly or weakened patients, with diseases of the cardiovascular system, respiratory tract, kidney or liver, with concomitant hypovolemia, in children.

Propofol is not recommended for general anesthesia in children younger than 1 month. It is not recommended to apply for anesthesia in children from 1 month to 3 years due to the difficulty of accurately introducing small amounts of the drug. Particular care should be taken when using propofol for anesthesia of children under 3 years of age, although the currently available facts do not indicate significant differences, in terms of safety, compared with the administration of propofol to children over 3 years of age.

Safety and efficacy of propofol for sedation of children younger than 16 years have not been proven. Despite the lack of evidence of a causal relationship, serious unintended side effects (including fatal outcomes) were recorded during sedation of patients under 16 years of age during unlicensed use of the drug. These side effects include, in particular, the development of metabolic acidosis, hyperlipidemia, skeletal muscle necrosis and / or heart failure. Such side effects were most often observed in children with respiratory infections receiving sediment medication in the intensive care unit at doses exceeding the recommended adult limits.

Very rarely reported cases of metabolic acidosis, rhabdomyolysis, hyperkalemia and / or rapidly progressive heart failure (sometimes fatal) among adults who received the drug for more than 58 hours at doses exceeding 5 mg / kg / h. This is more than the maximum dose of 4 mg / kg / h, currently recommended for sedation during intensive care. Heart failure in these cases is usually not treated inotropic therapy. It is recommended that specialists who prescribe the drug do not exceed the dose of 4 mg / kg / h, which is sufficient for sedation of patients with artificial ventilation during intensive therapy (with a duration of treatment more than 1 day). Specialists should be prepared to develop such undesirable effects, and at the first appearance of symptoms they need to reduce the dose or switch to another sedative.

Propofol does not have vagolytic activity, and its use was accompanied by cases of bradycardia, sometimes deep, as well as asystole. Consider the possibility of IV administration of an anticholinergic agent prior to anesthesia or during anesthesia, especially when using propofol together with other drugs that can cause a bradycardia, and in cases of a likely predominance of vagal tone.

As an emulsifier, Rekofol® contains egg lecithin. As a result of dissolution, a lysolecithin-compound is formed, in which hemolytic properties were detected in vitro. In clinical conditions, even with complete dissolution, the risk of hemolysis remains low if the recommended dosages are observed. In the presence of pathologies (hepatic and / or renal insufficiency) with a low concentration of albumin, this risk increases, and therefore it is necessary to regularly check the relevant indicators.

Special precautions should be observed when administering the drug to patients with high intracranial pressure and a low average BP; there is a risk of a significant decrease in intracranial perfusion pressure.

Given that the drug is a lipid emulsion, when administered to patients with metabolic disorders of lipids, incl. pathological hyperlipidemia, special care is needed. When appointing Rekofol® patients with a special risk of fat excess should observe the blood lipid concentration indices and, if necessary, reduce the dose. If the patient receives other parenteral lipid emulsions other than Recofol®, the amount of fat contained in Recofol® should be taken into account when calculating total fat intake. It is necessary to monitor the concentration of lipids in all patients on sedation for more than 3 days.

In patients with epilepsy, propofol can cause seizures. Before conducting anesthesia in patients with epilepsy, it is necessary to make sure that the patient has been given the necessary antiepileptic drugs. When treating electroshock, propofol is not recommended.

To ensure sufficient analgesia, analgesics should be used additionally (propofol does not possess its own analgesic effect). It is necessary to wait for the full awakening of the patient after general anesthesia before disconnecting it from the devices. It should be noted that the consequences of general anesthesia can worsen a patient's ability to perceive postoperative instructions.

After the introduction of the drug, the patient should be closely monitored for a sufficiently long period. The patient should refrain from managing the vehicles and mechanisms and work only under close supervision. When discharging from the hospital, the patient should be escorted home. The patient should be advised not to drink alcohol.

Special instructions

Since Recofol® does not contain preservatives that prevent the growth of pathogenic bacteria and other microorganisms, dilution and administration of the drug should be carried out under aseptic conditions. Any liquid solutions used concurrently with Rekofol® should be administered as close as possible to the location of the cannula. The drug should not be administered via a microbiological filter.

In accordance with general recommendations regarding the use of lipid emulsions, the infusion of undiluted propofol should not exceed 12 hours at a time.

Rekofol® 20 mg / ml should not be mixed with any other solutions or infusion liquids.

Storage conditions for Recofol

In the dark place at a temperature of 2-25 ° C. (do not freeze)

Keep out of the reach of children.

Shelf life of Recofol

3 years.

Do not use after the expiry date printed on the package.

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