10 mg \/ ml or 20 mg \/ ml solution for injection \/ infusion in pre-filled syringe
Propofol<\/p>\n\n\n\n
Propolipid belongs to a group of medicines called general anesthetics.\u00a0General anesthetics are used to induce unconsciousness (sleep) so that surgery or other procedures can be performed.\u00a0They can also be used to sedate you (so that you become sleepy, but do not sleep completely).<\/p>\n\n\n\n
Propolipid 10 mg \/ ml is used for:<\/strong><\/p>\n\n\n\n Propolipid 20 mg \/ ml is used for:<\/strong><\/p>\n\n\n\n Talk to your doctor, pharmacist, or nurse before receiving Propolipid and if any of the following applies to you or applies to you in the past.<\/p>\n\n\n\n You should not receive Propolipid, or only with extreme caution and under intensive supervision if you:<\/p>\n\n\n\n In general, Propolipid should be given with caution to elderly or debilitated patients.<\/p>\n\n\n\n Before you receive Propolipid, tell your anesthetist or intensive care physician if you have:<\/p>\n\n\n\n If you have any of the following conditions, they must be treated before you receive Propolipid:<\/p>\n\n\n\n Propolipid may increase the risk of<\/p>\n\n\n\n Involuntary movements may occur during sedation with Propolipid. Physicians will take into account how this may affect the surgical procedures performed during sedation and take the necessary precautions.<\/p>\n\n\n\n Occasionally, after\u00a0anesthesia, there may be a period of unconsciousness with stiffness in the muscles.\u00a0This requires observation by medical staff, but no other treatment.\u00a0It disappears by itself.<\/p>\n\n\n\n Injection\u00a0of one Propolipid can be painful.\u00a0A local anesthetic can be used to reduce this pain, but it can have side effects.<\/p>\n\n\n\n You must not leave the hospital until you are fully awake.<\/strong><\/p>\n\n\n\n If you can go home shortly after receiving propofol, do not go home without company.<\/p>\n\n\n\n Children and adolescents (Propolipid 10 mg \/ ml)<\/strong><\/p>\n\n\n\n Propolipid 10 mg\/ml is not recommended for use in neonates or infants less than 1 month of age.<\/p>\n\n\n\n Administration with TCI (Target Controlled Infusion ) system is not recommended for children under 2 years of age as only limited data are available.<\/p>\n\n\n\n Propolipid 10 mg\/ml must not be given to children and adolescents under 16 years of age as\u00a0sedation\u00a0in intensive care as safety has not been established in this patient group for this indication.<\/p>\n\n\n\n Children and adolescents (Propolipid 20 mg \/ ml)<\/strong><\/p>\n\n\n\n Propolipid 20 mg\/ml is not recommended for use in children under 3 years of age.<\/p>\n\n\n\n Propolipid 20 mg\/ml must not be given to children and adolescents under 16 years of age as\u00a0sedation\u00a0in intensive care as safety has not been established in this patient group for this indication.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n You must tell your doctor, anesthetist, or nurse if you are taking any of the following medicines:<\/p>\n\n\n\n Take special care with any of the following medicines:<\/p>\n\n\n\n Take special care with any of the following medicines:<\/p>\n\n\n\n Once you have received Propolipid, do not eat, drink or drink alcohol until you have fully recovered.<\/p>\n\n\n\n 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 Propolipid should only be used during pregnancy when necessary.<\/p>\n\n\n\n You should not breastfeed when you are given propofol and the breast milk must be discarded 24 hours after you have received Propolipid.<\/p>\n\n\n\n Once you have received Propolipid, you may feel drowsy for a while. Do not drive or use any tools or machines until you know the effects have disappeared.<\/p>\n\n\n\n If you can go home shortly after receiving Propolipidl, do not drive or go home without company.<\/p>\n\n\n\n Ask your doctor when you can start these activities again and when you can return to work.<\/p>\n\n\n\n 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 Propolipid contains soybean oil. Do not use this medicine if you are allergic to peanuts or soy.<\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg) sodium per 100 ml, ie essentially ‘sodium-free’.<\/p>\n\n\n\n Propolipid is only given in hospitals or appropriate treatment units by or under the direct supervision of anesthesiologists or intensive care physicians.<\/p>\n\n\n\n Dosage<\/strong><\/p>\n\n\n\n The amount of Propolipid you need depends on your age, body weight, and physical condition.\u00a0Your doctor will give you the correct\u00a0dose\u00a0to initiate and maintain anesthesia or to achieve the degree of\u00a0sedation\u00a0(sedative effect and drowsiness) needed, by paying close attention to how you react and to vital signs (\u00a0pulse,\u00a0blood pressure, breathing, etc).<\/p>\n\n\n\n You may need several different medications to keep you asleep or sleepy, pain-free, and keep your breathing normal and your\u00a0blood pressure\u00a0steady.\u00a0Your doctor will decide which medicines you need and when you need them.<\/p>\n\n\n\n Adults<\/strong><\/p>\n\n\n\n Most people need 1.5 to 2.5 mg propofol per kg body weight for them to fall asleep (\u00a0induction\u00a0of\u00a0anesthesia\u00a0), and then 4 to 12 mg propofol per kg body weight an hour for them to continue sleeping (maintenance of\u00a0anesthesia\u00a0).\u00a0When\u00a0sedating, a\u00a0dose\u00a0of 0.3 to 4.0 mg propofol per kg body weight and hour\u00a0is usually sufficient.<\/p>\n\n\n\n For\u00a0sedation\u00a0during surgery or examinations in adults, most patients need 0.5-1 mg of propofol per kg of body weight for 1-5 minutes to initiate\u00a0sedation.\u00a0Maintenance of\u00a0sedation\u00a0can be done by giving the\u00a0infusion\u00a0of Propolipid to the desired sedation level.\u00a0Most patients need 1.5-4.5 mg of propofol per kg of body weight and hour.\u00a0Infusion\u00a0one can be supplemented by giving an additional 10-20 mg of propofol (1-2 ml of Propolipid 10 mg\/ml or 0.5-1 ml of Propolipid 20 mg\/ml) to be able to rapidly increase\u00a0sedation\u00a0if necessary.<\/p>\n\n\n\n When\u00a0sedating\u00a0patients over the age of 16 who receive artificial respiration during intensive care, the\u00a0dose\u00a0will be adjusted to the need for sedation depth.\u00a0Satisfactory\u00a0sedation\u00a0is usually achieved with continuous feed at a rate of about 0.3-4.0 mg propofol\/kg body weight\/hour.\u00a0Infusion rates over 4.0 mg propofol\/kg body weight\/hour are not recommended.<\/p>\n\n\n\n Use in children and adolescents over one month of age<\/strong><\/p>\n\n\n\n Propolipid is not recommended for use in children younger than 1 month.\u00a0Particular caution should also be exercised when\u00a0administering\u00a0Propolipid 10 mg\/ml to children under 3 years of age.\u00a0However, available data do not show that this would be less safe than in children older than 3 years.<\/p>\n\n\n\n The dose\u00a0should be adjusted according to age and\/or bodyweight.\u00a0Most patients over the age of 8 need about 2.5 mg\/kg body weight of Propolipid to fall asleep (\u00a0induction\u00a0of\u00a0anesthesia\u00a0).\u00a0In younger children, especially between 1 month and 3 years of age, a higher\u00a0dose\u00a0may be needed (2.5-4 mg\/kg body weight).<\/p>\n\n\n\n Speeds of 9-15 mg\/kg\/hour usually achieve sufficient\u00a0anesthesia\u00a0for them to continue sleeping (maintenance of\u00a0anesthesia\u00a0).\u00a0In younger children, especially between 1 month and 3 years of age, a higher\u00a0dose\u00a0may be required.<\/p>\n\n\n\n For\u00a0sedation\u00a0with Propolipid 10 mg\/ml during surgical and diagnostic procedures in children over 1 month of age, most children need 1-2 mg of propofol per kg body weight to initiate\u00a0sedation.\u00a0Maintenance of\u00a0sedation\u00a0can be done by giving the\u00a0infusion\u00a0of Propolipid to the desired sedation level.\u00a0Most patients need 1.5-9 mg of propofol per kg of body weight and hour.\u00a0Infusion\u00a0one can be supplemented by giving an additional 1 mg\/kg body weight to be able to quickly increase\u00a0sedation\u00a0a<\/p>\n\n\n\n Propolipid 10 mg\/ml must not be given to children and adolescents under 16 years of age as\u00a0sedation\u00a0in intensive care as safety has not been established in this patient group for this indication.<\/p>\n\n\n\n Use in children and adolescents over three years of age<\/strong><\/p>\n\n\n\n Propolipid 20 mg\/ml is not recommended for use in children under 3 years of age.<\/p>\n\n\n\n The dose\u00a0should be adjusted according to age and\/or bodyweight.\u00a0Most patients over the age of 8 need about 2.5 mg\/kg body weight of Propolipid to fall asleep (\u00a0induction\u00a0of\u00a0anesthesia\u00a0).\u00a0In younger children, a higher\u00a0dose\u00a0may be needed (2.5-4 mg\/kg body weight).<\/p>\n\n\n\n Speeds of 9-15 mg\/kg\/hour usually achieve sufficient\u00a0anesthesia\u00a0for them to continue sleeping (maintenance of\u00a0anesthesia\u00a0).\u00a0In younger children, a higher\u00a0dose\u00a0may be required.<\/p>\n\n\n\n For\u00a0sedation\u00a0with Propolipid 20 mg\/ml during surgical and diagnostic procedures in children over 3 years of age, most children need 1-2 mg of propofol per kilogram of body weight to initiate\u00a0sedation.\u00a0Maintenance of\u00a0sedation\u00a0can be done by giving the\u00a0infusion\u00a0of Propolipid to the desired sedation level.\u00a0Most patients need 1.5-9 mg of propofol per kg of body weight and hour.<\/p>\n\n\n\n Propolipid 20 mg\/ml must not be given to children and adolescents under 16 years of age as\u00a0sedation\u00a0in intensive care as safety has not been established in this patient group for this indication.<\/p>\n\n\n\n Method of administration<\/strong><\/p>\n\n\n\n Propolipid is used intravenously and is usually given on the top of the hand or in the armpit. Your anesthetist may use a needle or needle (a narrow plastic tube). Propolipid will be injected into a vein either manually or using an electric pump. Your doctor will make sure that the pump is compatible with the pre-filled syringes. 10 ml and 20 ml glass syringes and 10 ml plastic syringes are only suitable for manual use and must not be used with a pump.<\/p>\n\n\n\n Propolipid is for single use only. Leftover medicine must be discarded. The pre-filled syringe should be shaken before use. If two layers can be seen after shaking, emulsion one should not be used. Use only homogeneous drugs and undamaged syringes.<\/p>\n\n\n\n Installation of pre-filled syringes (for pre-assembled syringes, step 2 can be omitted):<\/em><\/p>\n\n\n\n Sterility must be ensured. The outside of the syringe and the plunger rod are not sterile!<\/p>\n\n\n\n Duration of treatment<\/strong><\/p>\n\n\n\n When Propolipid is used for\u00a0sedation, it must not be given for more than 7 days.<\/p>\n\n\n\n If you take more Propolipid than you should<\/strong><\/p>\n\n\n\n Your doctor will make sure that you get the correct amount of propofol for you and the procedure you are undergoing.<\/p>\n\n\n\n However, different people need different\u00a0doses\u00a0for you, and if you receive too high a\u00a0dose, your anesthetist will need to take steps to ensure that your heart function and breathing function properly.\u00a0This is the reason why anesthetics are only given by doctors who are trained in anesthesia and patients who are cared for in intensive care.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n The following side effects may occur during anesthesia (while an injection is given and you are drowsy or asleep). The doctor will pay attention to these. If they occur, the doctor will give appropriate treatment.<\/p>\n\n\n\n Very common (may affect more than 1 user in 10):<\/em><\/strong><\/p>\n\n\n\n Common (may affect up to 1 in 10 people):<\/em><\/strong><\/p>\n\n\n\n Uncommon (may affect up to 1 in 100 people):<\/em><\/strong><\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 people)<\/em><\/strong> :<\/em><\/p>\n\n\n\n Very rare (may affect up to 1 in 10,000 people):<\/em><\/strong><\/p>\n\n\n\n Has been reported (occurs in an unknown number of users):<\/em><\/strong><\/p>\n\n\n\n Side effects that may occur after anesthesia<\/strong><\/p>\n\n\n\n These side effects may occur after anesthesia (on awakening or after awakening):<\/p>\n\n\n\n Common (may affect up to 1 in 10 people):<\/em><\/strong><\/p>\n\n\n\n Rare (may affect up to 1 in 1,000 people)<\/em><\/strong> :<\/em><\/p>\n\n\n\n Very rare (may affect up to 1 in 10,000 people):<\/em><\/strong><\/p>\n\n\n\n Has been reported (occurs in an unknown number of users):<\/em><\/strong><\/p>\n\n\n\n When Propofol Fresenius Kabi is given in combination with lidocaine (a local anesthetic used to reduce the pain at the injection site), in rare cases some side effects may occur:<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the syringe after EXP and on the outer carton after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Do not store above 25 \u00b0 C. Do not freeze.<\/p>\n\n\n\n After opening, the product must be used immediately.<\/p>\n\n\n\n Propolipid 10 mg \/ ml<\/em><\/p>\n\n\n\n The diluted Propolipid 10 mg\/ml administration system should be replaced 12 hours after opening the syringe.<\/p>\n\n\n\n Dilutions with glucose solution 50 mg\/ml or sodium chloride solution 9 mg\/ml or\u00a0mixture\u00a0with unpreserved\u00a0injection solution\u00a0with\u00a0lidocaine\u00a010 mg\/ml (at least 2 mg propofol per ml) should be prepared aseptically (controlled and validated conditions assumed) immediately before\u00a0administration\u00a0and must be consumed within 6 hours.<\/p>\n\n\n\n Propolipid 20 mg \/ ml<\/em><\/p>\n\n\n\n The Propolipid 20 mg\/ml administration system should be replaced 12 hours after opening the syringe.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n Each ml of emulsion contains 10 mg of propofol.<\/p>\n\n\n\n Each 10 ml syringe contains 100 mg of propofol.<\/p>\n\n\n\n Each 20 ml syringe contains 200 mg of propofol.<\/p>\n\n\n\n Each 50 ml syringe contains 500 mg of propofol.<\/p>\n\n\n\n Each ml of emulsion contains 20 mg of propofol.<\/p>\n\n\n\n Each 50 ml syringe contains 1000 mg of propofol.<\/p>\n\n\n\n Propolipid is a white oil-in-water emulsion for\u00a0injection\u00a0or\u00a0infusion\u00a0into a pre-filled\u00a0syringe.<\/p>\n\n\n\n Propolipid is available in pre-filled plastic or glass syringes.<\/p>\n\n\n\n Pack sizes:<\/strong><\/p>\n\n\n\n A pack containing 5 pre-filled glass syringes with 10 ml\u00a0emulsion.<\/p>\n\n\n\n A pack containing 6 pre-filled plastic syringes with 10 ml\u00a0emulsion.<\/p>\n\n\n\n A pack containing 5 pre-filled glass syringes with 20 ml\u00a0emulsion.<\/p>\n\n\n\n A pack containing 6 pre-filled plastic syringes with 20 ml\u00a0emulsion.<\/p>\n\n\n\n A pack containing 1 pre-filled plastic syringe with 50 ml\u00a0emulsion.<\/p>\n\n\n\n Marketing Authorisation Holder:<\/em><\/p>\n\n\n\n Fresenius Kabi AB<\/p>\n\n\n\n 751 74 Uppsala<\/p>\n\n\n\n Manufacturer:<\/em><\/p>\n\n\n\n Fresenius Kabi Austria GmbH<\/p>\n\n\n\n Hafnerstrasse 36<\/p>\n\n\n\n A-8055 Graz<\/p>\n\n\n\n Austria<\/p>\n\n\n\n 2015-10-21<\/p>\n","protected":false},"excerpt":{"rendered":" Propolipid belongs to a group of medicines called general anesthetics. General aesthetics are used to induce unconsciousness (sleep), so that surgery or other procedures can be performed. They can also be used to sedate you (so that you become sleepy, but do not sleep 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":[21871,22034,5467,5469,22030,22033,5468,22031,21870,22032],"class_list":["post-21368","post","type-post","status-publish","format-standard","hentry","category-medicines","category-p","tag-benefits-of-propofol","tag-benefits-of-propolipid","tag-propofol","tag-propofol-side-effects","tag-propolipid","tag-propolipid-side-effects","tag-what-is-propofol","tag-what-is-propolipid","tag-what-propofol-is-used-for","tag-what-propolipid-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21368","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=21368"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21368\/revisions"}],"predecessor-version":[{"id":21400,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/21368\/revisions\/21400"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=21368"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=21368"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=21368"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What you need to know before you use Propolipid<\/h2>\n\n\n\n
Do not use Propolipid<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Other medicines and Propolipid<\/h2>\n\n\n\n
Use of Propolipid with food, drink, and alcohol<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Propolipid contains soybean oil and sodium<\/h2>\n\n\n\n
How to use Propolipid<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Propolipid<\/h2>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n