{"id":21272,"date":"2022-05-18T08:08:53","date_gmt":"2022-05-18T08:08:53","guid":{"rendered":"https:\/\/zeepedia.com\/?p=21272"},"modified":"2022-05-18T15:50:38","modified_gmt":"2022-05-18T15:50:38","slug":"profast","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/profast\/","title":{"rendered":"Profast &#8211; Propofol uses, dose and side effects"},"content":{"rendered":"\n<p>10 mg \/ ml, 20 mg \/ ml&nbsp;solution for injection \/ infusion,&nbsp;emulsion<br>propofol<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Profast is and what it is used for<\/h2>\n\n\n\n<p><strong>Profast is a short-acting anesthetic drug that is injected into a vein.<\/strong><\/p>\n\n\n\n<p>Profast belongs to a group of medicines called general anesthetics.\u00a0General anesthetics are used to induce unconsciousness (a type of sleep) so that surgeries and other treatments can be performed.\u00a0They can also be used as sedatives, so-called\u00a0sedation\u00a0(so that you become sleepy but do not fall asleep completely.<\/p>\n\n\n\n<p><strong>Profast 10 mg \/ ml is used:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>to induce and maintain\u00a0anesthesia\u00a0(unconsciousness) in adults and children over 1 month of age<\/li><li>as\u00a0sedation\u00a0(sedation) to patients over the age of 16 who are on a respirator during intensive care<\/li><li>as\u00a0sedation\u00a0of adults and children over 1 month of age during surgeries and\u00a0diagnostic procedures, alone or in combination with local or regional anesthesia (\u00a0local anesthetics\u00a0).<\/li><\/ul>\n\n\n\n<p><strong>Profast 20 mg \/ ml is used:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>to induce and maintain\u00a0anesthesia\u00a0(unconsciousness) in adults and children over 3 years of age<\/li><li>as\u00a0sedation\u00a0(sedation) to patients over the age of 16 who are on a respirator during intensive care<\/li><li>as\u00a0sedation\u00a0of adults and children over 3 years of age during surgeries and\u00a0diagnostic procedures, alone or in combination with local or regional anesthesia (\u00a0local anesthetics\u00a0).<br>Propofol contained in Profast may also be approved for the treatment of other diseases not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Profast<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Profast<\/h2>\n\n\n\n<p><strong>Profast 10 mg \/ ml:<\/strong><\/p>\n\n\n\n<p><strong>Do not&nbsp;<\/strong><strong>use Profast<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to propofol, soybeans, peanuts, or any of the other ingredients of this medicine (listed in section 6)<\/li><li>for\u00a0sedation\u00a0of patients aged 16 years or younger during intensive care.<\/li><\/ul>\n\n\n\n<p><strong>Profast 20 mg \/ ml:<\/strong><\/p>\n\n\n\n<p><strong>Do not use Profast<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to propofol, soybeans, peanuts, or any of the other ingredients of this medicine (listed in section 6)<\/li><li>for\u00a0sedation\u00a0of patients aged 16 years or younger during intensive care<\/li><li>as\u00a0anesthesia\u00a0for children under 3 years.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor before using Profast.<\/p>\n\n\n\n<p><strong>Special care is required if Profast is used<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>when the patient has an error in fat metabolism<\/li><li>in diseases that lead to the use of fat-containing\u00a0emulsions\u00a0with caution.\u00a0(See notes on intensive care.)<\/li><\/ul>\n\n\n\n<p>Profast should be given&nbsp;<em>more slowly<\/em>&nbsp;than usual to patients<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>with poor general condition<\/li><li>who have a heart, lung, kidney, or liver disease<\/li><li>with fluid loss (\u00a0hypovolemia\u00a0).<\/li><\/ul>\n\n\n\n<p>Impaired cardiac, circulatory and pulmonary function, as well as\u00a0hypovolemia,\u00a0should be treated if possible before administration of the drug.<\/p>\n\n\n\n<p>In the event of a sharp drop in blood pressure, you may need to give plasma replacement, possibly also vasoconstrictors, and give Profast at a slower rate.\u00a0The risk of a sharp drop in blood pressure should be taken into account for patients with impaired coronary or cerebral hemorrhage, or with\u00a0hypovolemia.\u00a0The breakdown of propofol is dependent on blood flow.\u00a0If other drugs that reduce the amount of blood pumped out of the heart are given at the same time, it also reduces the breakdown of propofol.<\/p>\n\n\n\n<p>Profast must be given with caution and under close supervision to patients with severe heart disease.<\/p>\n\n\n\n<p>When Profast is given to people with epilepsy, a seizure can be induced.<\/p>\n\n\n\n<p>If Profast is given in combination with\u00a0lidocaine, it must be known that\u00a0lidocaine\u00a0must not be given to patients with hereditary\u00a0acute\u00a0porphyria.<\/p>\n\n\n\n<p>Profast has no vagolytic effect.\u00a0Use has been associated with\u00a0bradycardia\u00a0(slow\u00a0heart rate\u00a0), sometimes with severe outcomes (cardiac arrest).\u00a0If the patient already has a high\u00a0vagal\u00a0tone\u00a0or if Profast is given with other medicines that can reduce the heart rate, intravenous anticholinergics should be considered before or during\u00a0anesthesia\u00a0with Profast.<\/p>\n\n\n\n<p>When Profast is used for\u00a0sedation\u00a0before surgery or\u00a0diagnostic procedures, the patient must be constantly monitored for the first signs of hypotension,\u00a0respiratory\u00a0obstruction,\u00a0and hypoxia.<\/p>\n\n\n\n<p>As with other sedative drugs, the patient may move spontaneously during surgery even when Profast is used for\u00a0sedation.\u00a0If a procedure requires the patient to be completely still, these movements may jeopardize the surgical outcome.<\/p>\n\n\n\n<p>Abuse and dependence on Profast have been reported mainly among health care professionals.\u00a0As with all medicines for general\u00a0anesthesia, Profast must not be used without ensuring a clear airway.\u00a0Otherwise, there is a risk of respiratory complications that could lead to death.<\/p>\n\n\n\n<p>Once Profast has been used, make sure that the patient has fully recovered from anesthesia before discharge.<\/p>\n\n\n\n<p>In some cases, a period of unconsciousness may occur after surgery when Profast has been used, which may be accompanied by increased&nbsp;muscle tone&nbsp;(muscle tension).&nbsp;Whether this occurs depends on whether the patient has previously been awake or not.&nbsp;Even if the patient spontaneously regains consciousness, an unconscious patient should always be closely monitored.<\/p>\n\n\n\n<p>The loss of function caused by Profast usually lasts no longer than 12 hours.&nbsp;When explaining the effects of Profast to the patient, the doctor should take into account the type of procedure, other medicines taken at the same time, as well as the patient&#8217;s age and general condition.&nbsp;The patient should be informed of the following:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>that he\/she may not return home without the company of another person<\/li><li>when risky manual activities (such as driving) can be performed again<\/li><li>that other sedatives (eg\u00a0benzodiazepines, opiates, alcohol) may prolong or aggravate impaired function.<\/li><\/ul>\n\n\n\n<p>Studies in young animals and also clinical data show that repeated or prolonged use of\u00a0anesthetics\u00a0or sedatives in children under 3 years and pregnant women during the last three months of pregnancy can have negative effects on brain development in the child.\u00a0Parents\/guardians should discuss with the doctor the benefits, risks, timing, and duration of surgeries and other procedures that require anesthesia or sedatives.<\/p>\n\n\n\n<p><strong>Information regarding intensive care<\/strong><\/p>\n\n\n\n<p>Infusion&nbsp;of Profast&nbsp;emulsion&nbsp;for&nbsp;sedation&nbsp;given during intensive care can be associated with several different metabolic disorders and organ failure, which can lead to death.<\/p>\n\n\n\n<p>In addition, there are reports that the following\u00a0side effects\u00a0may occur concomitantly: metabolic\u00a0acidosis,\u00a0rhabdomyolysis,\u00a0hyperkalemia, hepatic enlargement,\u00a0renal failure,\u00a0hyperlipidemia,\u00a0cardiac arrhythmia, Brugada-like\u00a0ECG\u00a0(saddle or tent-shaped ST elevation in right precordial electrodes V1-V3] and concave\u00a0T -wave\u00a0or) and rapidly worsening\u00a0heart failure, which usually could not be treated with supportive inotropic treatments.<\/p>\n\n\n\n<p>These\u00a0side effects\u00a0in combination are also called &#8220;propofol in fusion syndrome&#8221;.<\/p>\n\n\n\n<p>These events were most commonly seen in patients with severe head injuries and in children with respiratory infections, who had received a higher&nbsp;dose&nbsp;than intended for adults as sedative treatment (&nbsp;sedation&nbsp;) during intensive care.<\/p>\n\n\n\n<p>The following factors are considered important risk factors for the development of this complication:<\/p>\n\n\n\n<p>Low oxygen saturation in the\u00a0tissues, severe neurological damage and\/or\u00a0sepsis, high\u00a0doses\u00a0of one or more of the following drugs: vasoconstrictors,\u00a0steroids, inotropic drugs, and\/or propofol (usually at\u00a0doses\u00a0exceeding 4 mg propofol per kg body weight in more than 48 hours).<\/p>\n\n\n\n<p>Prescribing physicians should be aware of the risk of these adverse effects in patients who have the risk factors described above, and immediately discontinue the use of propofol if the symptoms described above develop.\u00a0All sedatives and all drugs used during intensive care should be titrated in such a way that optimal oxygen supply is guaranteed and the hemodynamic parameters remain optimal.\u00a0If such changes in treatment occur, patients with elevated\u00a0intracranial pressure\u00a0should receive appropriate treatment that contributes to cerebral hemorrhage.\u00a0The treating physician should ensure that the recommended\u00a0dose\u00a0of 4 mg propofol\/kg body weight per hour is not exceeded, as far as possible.<\/p>\n\n\n\n<p>Particular caution should be exercised in patients with fat metabolism (lipid metabolism) disorders or other disorders that require fat emulsions to be used with caution.<\/p>\n\n\n\n<p>Control of fat metabolism is recommended if Profast is used in patients who are suspected of having elevated lipid levels in the blood.\u00a0Infusion\u00a0one by Profast should be adjusted appropriately if the analysis indicates a disturbance in fat metabolism.\u00a0If the patient simultaneously receives\u00a0parenteral\u00a0nutrition, e.g.\u00a0tube feeding, the amount of\u00a0lipid\u00a0you have given in Profast should be included.\u00a01.0 ml Profast contains 0.1 grams of fat.<\/p>\n\n\n\n<p><em>More information<\/em><\/p>\n\n\n\n<p>Caution should be exercised when treating patients with mitochondrial disease.\u00a0The disease can flare up in these patients if\u00a0anesthesia\u00a0is used, or during surgery or intensive care.\u00a0In these patients, it is recommended that normal body temperature be maintained, carbohydrates are given and the patient is given enough fluids.\u00a0The early signs of an outbreak of mitochondrial disease and the propofol in fusion syndrome may be similar.<\/p>\n\n\n\n<p>Profast does not contain any antimicrobial&nbsp;preservatives&nbsp;and the growth of&nbsp;microorganisms&nbsp;is facilitated due to its composition.<\/p>\n\n\n\n<p><strong>Profast 10 mg \/ ml:<\/strong><\/p>\n\n\n\n<p><strong>a)&nbsp;<\/strong><em><strong>Children<\/strong><\/em><\/p>\n\n\n\n<p>Profast is not recommended for neonates as this patient group has not been adequately studied.\u00a0Pharmacokinetic\u00a0data indicate that the degradation of propofol is significantly lower in neonates and is highly variable in different individuals.\u00a0If the\u00a0dose\u00a0is used that is recommended for older children, overdose can occur and lead to serious problems with the heart, blood circulation, and respiration.<\/p>\n\n\n\n<p>Profast should not be used for&nbsp;sedation&nbsp;in patients aged 16 years or younger who are in intensive care, as the safety and efficacy of Propofol have not been established in this age group.<\/p>\n\n\n\n<p><strong>b)&nbsp;<\/strong><strong><em>Elderly patients<\/em><\/strong><\/p>\n\n\n\n<p>Elderly patients need a lower&nbsp;dose of&nbsp;you when starting&nbsp;anesthesia&nbsp;with Profast.&nbsp;The patient&#8217;s general health condition and age must be taken into account.&nbsp;The lower&nbsp;dose&nbsp;should be given more slowly and titrated according to the patient&#8217;s reaction.<\/p>\n\n\n\n<p>Even when Profast is used to maintain anesthesia and for\u00a0sedation, the infusion rate and selected propofol concentration in the blood should be lower.\u00a0Additional dose reduction and lower infusion rates are required for patients in risk groups ASA III and IV.\u00a0Elderly patients should not receive a bolus injection (one or more) as it may lead to circulatory and respiratory failure.<\/p>\n\n\n\n<p><strong>Profast 20 mg \/ ml:<\/strong><\/p>\n\n\n\n<p><strong>a)&nbsp;<\/strong><strong><em>Children<\/em><\/strong><\/p>\n\n\n\n<p>Profast 20 mg\/ml must not be used in children under 3 years of age as titration of Profast 20 mg\/ml in young children can only be performed with difficulty due to the need for an extremely small volume.<\/p>\n\n\n\n<p>Profast 20 mg\/ml should not be used for\u00a0sedation\u00a0in patients 16 years of age or younger who are in intensive care, as the safety and efficacy of propofol have not been established in this age group.<\/p>\n\n\n\n<p><strong>b)&nbsp;<\/strong><strong><em>Elderly patients<\/em><\/strong><\/p>\n\n\n\n<p>Elderly patients need a lower&nbsp;dose of&nbsp;you when starting&nbsp;anesthesia&nbsp;with Profast.&nbsp;The patient&#8217;s general health condition and age must be taken into account.&nbsp;The lower&nbsp;dose&nbsp;should be given more slowly and titrated according to the patient&#8217;s reaction.<\/p>\n\n\n\n<p>Even when Profast is used to maintain anesthesia and for\u00a0sedation, the infusion rate and selected propofol concentration in the blood should be lower.\u00a0Additional dose reduction and lower infusion rates are required for patients in risk groups ASA III and IV.\u00a0Elderly patients should not receive a bolus injection (one or more) as it may lead to circulatory and respiratory failure<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Profast<\/h2>\n\n\n\n<p>Tell your doctor if you are taking\/using, have recently taken\/used, or might be taking\/using other medicines.<\/p>\n\n\n\n<p>Profast is well tolerated together with other agents used for\u00a0anesthesia, e.g.<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>drugs are given before anesthesia<\/li><li>inhaled drugs to give anesthesia\/anesthesia (inhalation anesthetics)<\/li><li>painkillers<\/li><li>muscle relaxants<\/li><li>drugs for\u00a0local anesthesia.<\/li><\/ul>\n\n\n\n<p>If it is used for\u00a0local anesthesia, low-dose\u00a0Profast may be needed.\u00a0No signs of serious\u00a0interaction\u00a0have been observed.<\/p>\n\n\n\n<p>Some of the drugs mentioned may reduce&nbsp;blood pressure&nbsp;or impair breathing and may have a combination effect with Profast.&nbsp;A sharp drop in blood pressure when&nbsp;anesthesia&nbsp;is initiated with propofol has been reported in patients treated with rifampicin.&nbsp;If opiates are given before anesthesia, respiratory arrest may occur more often and last longer.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Profast with food, drink, and alcohol<\/h2>\n\n\n\n<p>You must not drink any alcohol once you have received Profast.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy and breastfeeding<\/h2>\n\n\n\n<p><em>Pregnancy<\/em><\/p>\n\n\n\n<p>The safety of Profast during pregnancy has not been established.\u00a0Animal studies have shown reproductive toxicological effects.\u00a0Profast should therefore not be given during pregnancy unless necessary.<\/p>\n\n\n\n<p>Profast passes through the placenta and can lead to respiratory failure and impaired circulation in newborns (impairment of vital functions).\u00a0High\u00a0doses\u00a0should be avoided (ie more than 2.5 mg propofol per kg crush weight for initiating\u00a0anesthesia, or 6 mg propofol per kg body weight for maintaining\u00a0anesthesia\u00a0).\u00a0Profast can be used as an anesthetic in terminating a pregnancy.<\/p>\n\n\n\n<p><em>Breast-feeding<\/em><\/p>\n\n\n\n<p>Studies in breastfeeding women have shown that propofol passes into breast milk in small amounts.\u00a0The mother should therefore pause breastfeeding for up to 24 hours after receiving propofol, and discard all breast milk during this time.<\/p>\n\n\n\n<p>If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Once Profast has been given, the patient must be carefully observed for the appropriate amount of time.\u00a0Patients should be informed that the ability to stay safe in traffic and to use machines may be impaired for some time after receiving Profast.\u00a0The reduction in functional capacity caused by Profast usually lasts no longer than 12 hours.\u00a0The patient must not go home alone but must be accompanied by another person.<\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Profast contains soybean oil and sodium<\/h2>\n\n\n\n<p>Profast contains soybean oil.&nbsp;If you are allergic to peanuts or soy, do not use this medicine.<\/p>\n\n\n\n<p>This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per\u00a0vial, ie essentially &#8216;sodium-free&#8217;.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to use Profast<\/h2>\n\n\n\n<p><strong>An&nbsp;<\/strong><strong>approach<\/strong><\/p>\n\n\n\n<p>For intravenous injection\/infusion<\/p>\n\n\n\n<p>You should only receive Profast from a doctor trained in\u00a0anesthesia\u00a0or intensive care.\u00a0Sedation\u00a0or anesthesia with Profast must not be performed by the same person performing the operation or\u00a0diagnostic procedure.<\/p>\n\n\n\n<p>Cardiac function, blood circulation, and respiration should be monitored at all times (eg\u00a0ECG\u00a0and pulse oximetry).\u00a0Usual equipment in the event of an emergency during\u00a0anesthesia\u00a0or\u00a0sedation\u00a0must always be available.<\/p>\n\n\n\n<p>Dosage\u00a0one should be adjusted individually and take into account pre-medication and the patient&#8217;s reaction.<\/p>\n\n\n\n<p>In most cases, extra supplements of painkillers are needed to prevent pain when&nbsp;injecting&nbsp;one.<\/p>\n\n\n\n<p><strong>Profast 20 mg \/ ml<\/strong><\/p>\n\n\n\n<p><strong>Bolus doses\u00a0of Profast 20 mg\/ml are not recommended.<\/strong><\/p>\n\n\n\n<p><strong>Dosage<\/strong><\/p>\n\n\n\n<p>Dosage\u00a0one varies depending on age, body weight, general health, and pre-medication.\u00a0The doctor uses an appropriate\u00a0dose\u00a0to initiate and maintain\u00a0anesthesia\u00a0or to reach the required sedation depth, while carefully observing your physical reactions and important bodily functions (\u00a0heart rate,\u00a0blood pressure, respiration, etc.).<\/p>\n\n\n\n<p><strong>If you have received too much Profast,<\/strong><\/p>\n\n\n\n<p>the result may be decreased blood circulation and respiratory function.\u00a0In case of respiratory arrest, some type of artificial respiration must be used and in case of low\u00a0blood pressure, usual measures must be taken, e.g.\u00a0place the head end of the bed lower, possibly providing plasma replacement (to restore the amount of blood) and also vasoconstrictors if needed.<\/p>\n\n\n\n<p>If you have ingested too much medicine or if e.g.\u00a0a child ingested the medicine accidentally contact a doctor or hospitalfor risk assessment and advice.<\/p>\n\n\n\n<p>Ask your doctor if you have any further questions on the use of this product.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n<p><strong>Any&nbsp;side effects&nbsp;ar<\/strong><\/p>\n\n\n\n<p>Initiation and maintenance of anesthesia and\u00a0sedation\u00a0with propofol is usually a mild procedure with little\u00a0excitation.\u00a0The most commonly reported\u00a0side effects\u00a0are decreased\u00a0blood pressure\u00a0and\u00a0respiratory depression\u00a0(weaker reactions from the respiratory center).\u00a0The type, severity, and frequency of\u00a0adverse reactions\u00a0observed with propofol depend on the patient&#8217;s state of health and the type of procedure performed and the treatment to be followed.<\/p>\n\n\n\n<p>In particular, the following&nbsp;side effects&nbsp;have been observed:<\/p>\n\n\n\n<p><strong>Very common<\/strong>&nbsp;(more than 1 in 10 patients treated)<\/p>\n\n\n\n<p><em>General disorders and administration site conditions<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Local pain at the first injection\u00a0<sup>4<\/sup>.<\/li><\/ul>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(1 to 10 out of 100 patients treated)<\/p>\n\n\n\n<p><em>Central and&nbsp;peripheral nervous system<\/em><\/p>\n\n\n\n<p>Spontaneous movements and muscle twitching at the onset of\u00a0anesthesia, headache during awakening.<\/p>\n\n\n\n<p><em>The heart<\/em><\/p>\n\n\n\n<p>Slow&nbsp;pulse&nbsp;<sup>1<\/sup><\/p>\n\n\n\n<p><em>Blood vessels<\/em><\/p>\n\n\n\n<p>Lowered blood pressure&nbsp;<sup>2<\/sup><\/p>\n\n\n\n<p><em>Respiratory, thoracic, and\u00a0mediastinal disorders<\/em><\/p>\n\n\n\n<p>Hyperventilation\u00a0and cough during\u00a0anesthesia, temporary respiratory arrest during\u00a0anesthesia<\/p>\n\n\n\n<p><em>The gastrointestinal tract<\/em><\/p>\n\n\n\n<p>Hiccups during onset, nausea, and vomiting during the recovery phase<\/p>\n\n\n\n<p><em>General disorders and administration site conditions<\/em><\/p>\n\n\n\n<p>Hot flashes during the onset of&nbsp;anesthesia<\/p>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(1 in 10 of 1,000 patients treated)<\/p>\n\n\n\n<p><em>Blood vessels<\/em><\/p>\n\n\n\n<p>Thrombosis&nbsp;and venous inflammation<\/p>\n\n\n\n<p><em>Respiratory, thoracic, and\u00a0mediastinal disorders<\/em><\/p>\n\n\n\n<p>Cough while maintaining&nbsp;anesthesia<\/p>\n\n\n\n<p><strong>Rare<\/strong>&nbsp;(1 to 10 patients in 10,000)<\/p>\n\n\n\n<p><em>Central and&nbsp;peripheral nervous system<\/em><\/p>\n\n\n\n<p>Dizziness chills, and chills during the recovery phase, episodes reminiscent of\u00a0epilepsy\u00a0with seizures and opisthotonic during the initial, maintenance, and the recovery phase (in very rare cases after a delay of a few hours to a few days)<\/p>\n\n\n\n<p><em>Respiratory, thoracic, and\u00a0mediastinal disorders<\/em><\/p>\n\n\n\n<p>Cough during the recovery phase<\/p>\n\n\n\n<p><strong>Very rare<\/strong>&nbsp;(less than 1 in 10,000 patients treated)<\/p>\n\n\n\n<p><em>The immune system<\/em><\/p>\n\n\n\n<p>Severe\u00a0hypersensitivity reactions\u00a0(\u00a0anaphylaxis\u00a0), may include\u00a0angioedema, shortness of breath due to bronchoconstriction, reddening of the skin, and decreased\u00a0blood pressure.<\/p>\n\n\n\n<p><em>Central and&nbsp;peripheral nervous system<\/em><\/p>\n\n\n\n<p>Unconsciousness after surgery<\/p>\n\n\n\n<p><em>The heart<\/em><\/p>\n\n\n\n<p>Pulmonary edema<\/p>\n\n\n\n<p><em>The gastrointestinal tract<\/em><\/p>\n\n\n\n<p>Inflammation&nbsp;of the pancreas<\/p>\n\n\n\n<p><em>Kidneys and urinary tract<\/em><\/p>\n\n\n\n<p>Discolored urine after prolonged treatment with Profast<\/p>\n\n\n\n<p><em>Reproductive system and mammary glands<\/em><\/p>\n\n\n\n<p>Sexual disinhibition<\/p>\n\n\n\n<p><em>General disorders and administration site conditions<\/em><\/p>\n\n\n\n<p>Severe tissue reactions and tissue necrosis after improper\u00a0administration\u00a0outside the\u00a0vessel.<\/p>\n\n\n\n<p><em>Injuries and poisonings and treatment complications<\/em><\/p>\n\n\n\n<p>Fever after surgery<\/p>\n\n\n\n<p><strong>No known frequency: can not be calculated from the available data<\/strong><\/p>\n\n\n\n<p><em>Metabolism&nbsp;and&nbsp;nutrition disorders<\/em><\/p>\n\n\n\n<p>Excess acid in the blood caused by metabolic function (metabolic\u00a0acidosis\u00a0)\u00a0<sup>5<\/sup>, elevated potassium levels in the blood\u00a05, elevated lipid levels in the blood\u00a0<sup>5<\/sup><\/p>\n\n\n\n<p><em>Mental disorders<\/em><\/p>\n\n\n\n<p>The euphoria\u00a0during the recovery phase, drug abuse, and drug dependence\u00a0<sup>8<\/sup><\/p>\n\n\n\n<p><em>Central and&nbsp;peripheral nervous system<\/em><\/p>\n\n\n\n<p>Involuntary movements<\/p>\n\n\n\n<p><em>The heart<\/em><\/p>\n\n\n\n<p>Irregular heartbeat\u00a0<sup>5<\/sup>,\u00a0heart failure\u00a0<sup>5.7<\/sup><\/p>\n\n\n\n<p><em>Respiratory, thoracic, and\u00a0mediastinal disorders<\/em><\/p>\n\n\n\n<p>Respiratory failure (depending on&nbsp;dose&nbsp;one)<\/p>\n\n\n\n<p><em>Liver and bile ducts<\/em><\/p>\n\n\n\n<p>Enlarged liver&nbsp;<sup>5<\/sup><\/p>\n\n\n\n<p><em>Musculoskeletal and connective tissue disorders<\/em><\/p>\n\n\n\n<p>Degradation of striated muscles (&nbsp;rhabdomyolysis&nbsp;)&nbsp;<sup>3.5<\/sup><\/p>\n\n\n\n<p><em>Kidneys and urinary tract<\/em><\/p>\n\n\n\n<p>Kidney failure&nbsp;<sup>5<\/sup><\/p>\n\n\n\n<p><em>General disorders and administration site conditions<\/em><\/p>\n\n\n\n<p>Local pain, swelling after improper&nbsp;administration&nbsp;outside&nbsp;vessel&nbsp;one<\/p>\n\n\n\n<p><em>Reproductive system<\/em><\/p>\n\n\n\n<p>Prolonged, often painful&nbsp;erection&nbsp;(priapism)<\/p>\n\n\n\n<p><em>Surveys<\/em><\/p>\n\n\n\n<p>ECG&nbsp;changes (Brugada syndrome)&nbsp;<sup>5.6<\/sup><\/p>\n\n\n\n<p>If Profast is given at the same time as\u00a0lidocaine, the following\u00a0side effects\u00a0may occur in rare cases:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>dizziness<\/li><li>vomiting<\/li><li>drowsiness<\/li><li>seizures<\/li><li>slow heart rate (\u00a0bradycardia\u00a0)<\/li><li>irregular heartbeat (\u00a0arrhythmia\u00a0) and<\/li><li>shock.<\/li><\/ul>\n\n\n\n<p>Soybean oil can in rare cases cause allergic reactions.<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>Severe\u00a0bradycardia\u00a0(slow heart rate) is rare, and can sometimes lead to cardiac arrest.<\/li><li>Drops in blood pressure can sometimes make it necessary to provide blood volume replacement and give Profast\u00a0infusion\u00a0at a slower rate.<\/li><li>Rhabdomyolysis\u00a0(muscle breakdown) has been reported in very rare cases when Profast has been given in high\u00a0doses\u00a0as 4 mg propofol per kg body weight per hour, for\u00a0sedation\u00a0during intensive care.<\/li><li>This can in most cases be avoided by giving\u00a0lidocaine\u00a0at the same time, and by giving the medicine in larger veins in the forearm or armpit.<\/li><li>A combination of these events, also known as &#8220;propofol infusion syndrome&#8221;, can occur in seriously ill patients who often have several risk factors for being affected.<\/li><li>Brugada syndrome &#8211; ST elevation and concave\u00a0T-waves\u00a0on\u00a0ECG.<\/li><li>In adults,\u00a0heart failure\u00a0worsens rapidly (in some cases with fatal outcomes) and in most cases could not be treated with supportive inotropic treatment measures.<\/li><li>Improper use and dependence on propofol, mainly by healthcare professionals.<\/li><li>In cases where tissue status was impaired,\u00a0necrosis\u00a0(tissue death) has been reported.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Profast<\/h2>\n\n\n\n<p>Keep out of sight and reach of children.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Do not store above 25 \u00b0 C.<\/p>\n\n\n\n<p>Do not freeze.<\/p>\n\n\n\n<p>After opening, the product must be used immediately.<\/p>\n\n\n\n<p><strong>Profast 10 mg \/ ml<\/strong><\/p>\n\n\n\n<p>Dilution with glucose solution 50 mg \/ ml (5%) for&nbsp;injection&nbsp;, sodium chloride solution 9 mg \/ ml (0.9%) for&nbsp;injection&nbsp;or sodium chloride solution 1.8 mg \/ ml (0.18%) and 40 mg \/ ml glucose solution (4% ), and lidocaine solution for&nbsp;injection&nbsp;10 mg \/ ml (1%) without&nbsp;preservatives&nbsp;.&nbsp;The mixtures&nbsp;must be prepared under aseptic conditions (always under controlled and validated conditions) immediately before&nbsp;administration&nbsp;and must be administered within 12 hours.<\/p>\n\n\n\n<p>The packaging should be shaken before use.<\/p>\n\n\n\n<p>Do not use if the contents are layered in two layers after&nbsp;emulsion&nbsp;one has been shaken.<\/p>\n\n\n\n<p>Use only homogeneous&nbsp;preparations&nbsp;and undamaged packaging.<\/p>\n\n\n\n<p>For single use only.&nbsp;Any remaining&nbsp;emulsion&nbsp;must be discarded.<\/p>\n\n\n\n<p>Your anesthetist and hospital pharmacist are responsible for Prophast being stored, used, and disposed of properly<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Contents of the pack and other information<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Content declaration<\/h2>\n\n\n\n<p>The active substance is propofol.<\/p>\n\n\n\n<p><em>Profast 10 mg \/ ml<\/em><\/p>\n\n\n\n<p>1 ml solution for injection \/ infusion&nbsp;contains&nbsp;10 mg propofol.<\/p>\n\n\n\n<p>A 20 ml&nbsp;vial&nbsp;contains 200 mg of propofol.<\/p>\n\n\n\n<p>A\u00a050 ml vial contains 500 mg of propofol.<\/p>\n\n\n\n<p>One 100 ml&nbsp;vial&nbsp;contains 1,000 mg of propofol.<\/p>\n\n\n\n<p><em>Profast 20 mg \/ ml<\/em><\/p>\n\n\n\n<p>1 ml solution for injection \/ infusion&nbsp;contains&nbsp;20 mg propofol.<\/p>\n\n\n\n<p>One&nbsp;vial&nbsp;of 50 ml contains 1000 mg of propofol.<\/p>\n\n\n\n<p><em>Profast 10 mg \/ ml and 20 mg \/ ml:<\/em><\/p>\n\n\n\n<p>The other ingredients are refined soybean oil, medium\u00a0triglycerides,\u00a0glycerol, egg lecithin, sodium oleate, sodium hydroxide (for\u00a0pH\u00a0adjustment), and water for injections.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n<p>White oil-in-water\u00a0emulsion\u00a0for injection\/infusion.<\/p>\n\n\n\n<p>The drug is provided as:<\/p>\n\n\n\n<p>Emulsion\u00a0for injection\/infusion in a colorless glass\u00a0vial\u00a0(type II) with a gray bromobutyl rubber stopper.<\/p>\n\n\n\n<p>Pack sizes:<\/p>\n\n\n\n<p><em>Profast 10 mg \/ ml<\/em><\/p>\n\n\n\n<p>Colorless 20 ml glass\u00a0vial\u00a0(type II) with a gray bromobutyl rubber stopper.\u00a0Packs of 1, 5, and 10 units.<\/p>\n\n\n\n<p>Colorless 50 ml glass&nbsp;vial&nbsp;(type II) with a gray bromobutyl rubber stopper.&nbsp;Packs of 1 and 10 units.<\/p>\n\n\n\n<p>Colorless glass&nbsp;vial&nbsp;(type II) of 100 ml with a gray bromobutyl rubber stopper.&nbsp;Packs of 1 and 10 units.<\/p>\n\n\n\n<p><em>Profast 20 mg \/ ml<\/em><\/p>\n\n\n\n<p>Colorless 50 ml glass&nbsp;vial&nbsp;(type II) with a gray bromobutyl rubber stopper.&nbsp;Packs of 1 and 10 units.<\/p>\n\n\n\n<p>Not all pack sizes may be marketed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n<p>Baxter Holding BV<\/p>\n\n\n\n<p>Kobaltweg 49<\/p>\n\n\n\n<p>3542CE Utrecht<\/p>\n\n\n\n<p>Netherlands<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>UAB Norameda<\/p>\n\n\n\n<p>Meister 8a, 02189 Vilnius<\/p>\n\n\n\n<p>Lithuania<\/p>\n\n\n\n<p>Bieffe Medical SpA,<\/p>\n\n\n\n<p>Via Nuova Provinciale<\/p>\n\n\n\n<p>23034 Grosotto (SO), Italy<\/p>\n\n\n\n<p>SIA \u201cUNIFARMA\u201d Vanga\u017eu iela 23,<\/p>\n\n\n\n<p>Riga, Latvia.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Profast belongs to a group of medicines called general anesthetics. General aesthetics are used to induce unconsciousness (a type of sleep) so that surgeries and other treatments can be performed. They can also be used as sedatives, so-called sedation (so that you become sleepy but do not fall asleep completely.<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"cybocfi_hide_featured_image":"","footnotes":""},"categories":[2200,18527],"tags":[21876,21871,21872,21875,5467,5469,21873,5468,21874,21870],"class_list":["post-21272","post","type-post","status-publish","format-standard","hentry","category-medicines","category-p","tag-benefits-of-profast","tag-benefits-of-propofol","tag-profast","tag-profast-side-effects","tag-propofol","tag-propofol-side-effects","tag-what-is-profast","tag-what-is-propofol","tag-what-profast-is-used-for","tag-what-propofol-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21272","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/comments?post=21272"}],"version-history":[{"count":3,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21272\/revisions"}],"predecessor-version":[{"id":21304,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21272\/revisions\/21304"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=21272"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=21272"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=21272"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}