infusion solution, emulsion<\/p>\n\n\n\n
Olimel N12E is an infusion solution . It is provided in a bag with three sections.<\/p>\n\n\n\n
One section contains a glucose solution with\u00a0calcium, the other contains a lipid emulsion and the third contains an amino acid solution with\u00a0electrolytes\u00a0.<\/p>\n\n\n\n
Olimel N12E is used to provide nutrition to adults and children over the age of two through a tube in a vein ( infusion ) when normal oral intake is not appropriate.<\/p>\n\n\n\n
Olimel N12E should only be used under medical supervision.<\/p>\n\n\n\n
In all cases, the doctor will base his decision on whether you should receive this medicine on factors such as age, weight, and medical condition, along with the results of any tests performed.<\/p>\n\n\n\n
Talk to your doctor or nurse before giving you Olimel N12E.<\/p>\n\n\n\n
If you receive nutritional solutions via infusion (TPN) too quickly, it can lead to injury or death.<\/p>\n\n\n\n
The infusion\u00a0must be stopped immediately if any abnormal signs or symptoms of\u00a0an allergic reaction\u00a0(such as sweating, fever, chills, headache, rash, or difficulty breathing) develop.\u00a0This medicine contains soybean oil and egg phospholipids.\u00a0Soybeans and egg protein can cause\u00a0hypersensitivity reactions.\u00a0Cross-allergic reactions between soybeans and peanut protein have been observed.<\/p>\n\n\n\n
Olimel N12E contains glucose made from maize. It may cause hypersensitivity (allergic reactions) if you are allergic to maize or maize products (see section \u201cOlimel N12E should not be given\u201d above).<\/p>\n\n\n\n
Breathing difficulties can also be a sign that small particles have formed that block blood vessel in the lungs (precipitation in the pulmonary vessels).\u00a0If you experience difficulty breathing, talk to a doctor or nurse.\u00a0They will decide on appropriate measures.<\/p>\n\n\n\n
Ceftriaxone (an antibiotic ) must not be mixed or co-administered with solutions containing calcium (including Olimel N12E) by drip into a vein.<\/p>\n\n\n\n
These medicines must not be given together, even if different infusion lines or infusion sites are used.\u00a0Your doctor may give you Olimel N12E and ceftriaxone one after the other if infusion tubes are used at different infusion sites or if the infusion tubing is replaced or rinsed thoroughly with a physiological saline solution between the\u00a0infusions\u00a0to avoid precipitation (particles formed by ceftriaxone calcium salt).<\/p>\n\n\n\n
Some medications and conditions can increase the risk of developing an\u00a0infection\u00a0or\u00a0sepsis\u00a0(bacteria in the blood).\u00a0The risk of\u00a0infection\u00a0or\u00a0sepsis\u00a0is particularly high when a tube (\u00a0intravenous\u00a0catheter\u00a0) is inserted into the vein.\u00a0Your doctor will monitor you closely and pay attention to any signs of\u00a0infection.\u00a0Patients who need\u00a0parenteral\u00a0nutrition\u00a0(nutrition through a tube in the vein) may be at greater risk of developing\u00a0infection\u00a0due to their disease state.\u00a0The risk of\u00a0infection can be reduced by using “aseptic technology” (“bacteria-free technology”) when placing and caring for the catheter and when preparing the nutrient solution (TPN).<\/p>\n\n\n\n
If you are severely malnourished so that you need to be nourished by a vein, your doctor will start treatment slowly.\u00a0Your doctor will also monitor you closely to avoid sudden changes in fluid,\u00a0vitamin,\u00a0electrolyte,\u00a0and mineral levels.<\/p>\n\n\n\n
The balance between water and salt in the body and metabolic disorders will be corrected before the\u00a0infusion\u00a0begins.\u00a0Your doctor will monitor your condition while you are receiving the medicine and may change your\u00a0dose\u00a0or give you additional nutrients, e.g.\u00a0vitamins,\u00a0electrolytes\u00a0and trace elements if he\/she deems it appropriate.<\/p>\n\n\n\n
Liver disease, including problems getting rid of bile (cholestasis),\u00a0fatty liver,\u00a0fibrosis, which can lead to liver failure, as well as gallbladder inflammation and\u00a0gallstones\u00a0in the gallbladder, have been reported in patients receiving\u00a0intravenous\u00a0nutrition.\u00a0The cause of these diseases is considered to be due to several factors and can vary between different patients.\u00a0If you get symptoms such as nausea, vomiting, abdominal pain, yellowing of the skin or eyes, contact your doctor to identify possible causes and contributing factors and possible treatments and preventive measures.<\/p>\n\n\n\n
The doctor should be aware of the following conditions:<\/p>\n\n\n\n
To monitor the effect and continuously monitor the safety of the\u00a0infusion, your doctor may perform clinical and laboratory tests while you are receiving this medicine.\u00a0If you are taking this medicine for several weeks, your blood status will be monitored regularly.<\/p>\n\n\n\n
If your body has a reduced ability to get rid of the fats in this medicine, “fat overload syndrome” may occur (see section 4 – Possible side effects ).<\/p>\n\n\n\n
If during\u00a0infusion\u00a0you notice pain, burning sensation, or swelling of the skin at the infusion site, or if the\u00a0infusion\u00a0is leaking, tell your doctor or nurse.\u00a0Infusion\u00a0one is stopped immediately and started in another vein.<\/p>\n\n\n\n
If your blood sugar gets too high, your doctor should adjust the rate of infusion one of Olimel N12E or give you medicines that control your blood sugar ( insulin ).<\/p>\n\n\n\n
Olimel N12E can only be given via a tube ( catheter ) into a large vein in the chest (central vein).<\/p>\n\n\n\n
If your child is under 18 years of age, special care will be taken to give the correct\u00a0dose.\u00a0More safety measures will also be taken, as children have a higher susceptibility to\u00a0infection.\u00a0Additions of\u00a0vitamins\u00a0and trace elements are always required.\u00a0Pharmaceutical forms adapted for children should be used.<\/p>\n\n\n\n
Tell your doctor if you are taking or using or have recently taken or used or might take or use any other medicines.<\/p>\n\n\n\n
In normal cases, it is not a problem to use other medicines at the same time as this medicine. Tell your doctor if you are taking any other medicines, including those without a prescription, to check that they are good to take at the same time.<\/p>\n\n\n\n
Tell your doctor if you are taking or receiving any of the following medicines:<\/p>\n\n\n\n
Olimel N12E must not be given at the same time as blood through the same tube.<\/p>\n\n\n\n
Olimel N12E contains\u00a0calcium.\u00a0It must not be given together with or through the same tube as ceftriaxone (an\u00a0antibiotic\u00a0) as particles can then form.\u00a0If the same tubing is used to give you these medicines one after the other, it should be rinsed thoroughly.<\/p>\n\n\n\n
Olimel N12E must not be given in the same infusion line or mixed with ampicillin (\u00a0antibiotic\u00a0) or fosphenytoin (\u00a0antiepileptic\u00a0) due to the risk of precipitation.<\/p>\n\n\n\n
The olive and soybean oil in Olimel N12E contains vitamin K. This does not normally affect blood thinners ( anticoagulants ) such as coumarin, but you should tell your doctor if you are taking blood thinners.<\/p>\n\n\n\n
The fats in this mixture may affect the results of some laboratory tests if blood samples are taken before the fats have disappeared from your bloodstream (usually they have disappeared 5 to 6 hours after the end of the infusion ).<\/p>\n\n\n\n
Olimel N12E contains\u00a0potassium.\u00a0Particular caution should be exercised in patients taking\u00a0diuretics, ACE inhibitors, or\u00a0angiotensin\u00a0II receptor antagonists (medicines for high\u00a0blood pressure\u00a0) or immunosuppressive medicines.\u00a0These types of drugs can increase potassium levels in the blood.<\/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 for advice before taking this medicine.<\/p>\n\n\n\n
There are no adequate data from the use of Olimel N12E in pregnant and lactating women. If necessary, Olimel N12E can be considered as treatment during pregnancy and lactation. Olimel N12E should only be given to pregnant and lactating women after careful consideration.<\/p>\n\n\n\n
Sufficient data are not available.<\/p>\n\n\n\n
Not relevant.<\/p>\n\n\n\n
Dosage<\/strong><\/p>\n\n\n\n Olimel N12E should only be given to adults and children over two years of age.<\/p>\n\n\n\n Olimel N12E is an\u00a0infusion solution, an\u00a0emulsion\u00a0given through a tube (\u00a0catheter\u00a0) into a vein in the breast.<\/p>\n\n\n\n Olimel N12E should reach room temperature before use.<\/p>\n\n\n\n Olimel N12E is for single use only.<\/p>\n\n\n\n Giving a bag via infusion usually takes between 12 and 24 hours.<\/p>\n\n\n\n Dosage – adults<\/em><\/strong><\/p>\n\n\n\n Your doctor will specify a flow rate that corresponds to your needs and your clinical condition.<\/p>\n\n\n\n Treatment can be continued for as long as needed, depending on your clinical condition.<\/p>\n\n\n\n Dosage – children over 2 years of age and adolescents<\/em><\/strong><\/p>\n\n\n\n The doctor decides the\u00a0dose\u00a0and for how long the medicine should be given.\u00a0It depends on the patient’s age, weight, height, medical condition, and the body’s ability to break down and assimilate the ingredients in Olimel N12E.<\/p>\n\n\n\n If you have ingested too much medicine or if e.g.\u00a0If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.<\/p>\n\n\n\n If the\u00a0dose\u00a0is too high or the\u00a0infusion\u00a0is too fast, the amino acids can make the blood too acidic, and signs of\u00a0hypervolemia\u00a0(increase in circulating blood volume) may occur.\u00a0Blood glucose levels in the blood and urine may increase, hyperosmolar syndrome (too high\u00a0viscosity\u00a0in the blood) may develop and the fat content may increase the number of triglycerides in the blood.\u00a0Excessive\u00a0infusion\u00a0or excessive volume of Olimel N12E may cause nausea, vomiting, chills, headache, hot flashes, excessive sweating (\u00a0hyperhidrosis\u00a0), and disturbances in the electrolyte balance.\u00a0If any of these occur, the\u00a0infusion\u00a0must be stopped immediately.<\/p>\n\n\n\n In some severe cases, the doctor may need to give temporary kidney dialysis to help the kidneys get rid of the excess product.<\/p>\n\n\n\n To prevent this, your doctor will monitor your condition and test your blood counts regularly.<\/p>\n\n\n\n Ask your doctor for further questions on how to use this product.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n If you notice any change in how you feel during or after treatment, contact a doctor or nurse immediately.<\/p>\n\n\n\n The tests that your doctor performs while you are taking this medicine should minimize the risk of\u00a0side effects.<\/p>\n\n\n\n If any abnormal signs or symptoms of\u00a0an allergic reaction\u00a0develop, e.g.\u00a0sweating, fever, chills, headache, rash, or difficulty breathing, the\u00a0infusion\u00a0should be stopped immediately.<\/p>\n\n\n\n The following side effects have been reported with Olimel:<\/p>\n\n\n\n Common: may affect up to 1 in 10 users<\/em><\/p>\n\n\n\n Has been reported: occurs an unknown number of users<\/em><\/p>\n\n\n\n The following side effects have been reported with similar parenteral nutrition drugs:<\/p>\n\n\n\n Very rare: may affect up to 1 in 10,000 people<\/em><\/p>\n\n\n\n Has been reported: occurs an unknown number of users<\/em><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Use this medicine before the expiry date which is stated on the bag and the outer carton after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Do not freeze.<\/p>\n\n\n\n Store in the outer bag.<\/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 The active substances in each bag of reconstituted emulsion are 14.2% (equivalent to 14.2 g \/ 100 ml) L-amino acid solution (alanine, arginine , glycine , histidine, isoleucine, leucine, lysine (as lysine acetate), methionine, phenylalanine, proline , serine , threonine, tryptophan, tyrosine, valine , aspartic acid, glutamic acid) with electrolytes ( sodium , potassium , magnesium , phosphate, acetate, chloride), 17.5% (equivalent to 17.5 g \/ 100 ml) lipid emulsion (refined olive oil and refined soybean oil) and 27.5% (equivalent to 27.5 g \/ 100 ml) glucose solution (as glucose monohydrate) with calcium .<\/p>\n\n\n\n Other ingredients are:<\/p>\n\n\n\n Olimel N12E is an infusion solution , emulsion packaged in a bag in three sections. One section contains a lipid emulsion (fat emulsion), the other an amino acid solution with electrolytes and the third a glucose solution with calcium . The sections are separated by non-permanent seals. Before administration , the contents of the sections should be mixed by rolling the bag starting from the upper end until the seals are open.<\/p>\n\n\n\n Appearance before mixing:<\/em><\/p>\n\n\n\n Appearance after mixing: homogeneous milky mixture .<\/em><\/p>\n\n\n\n The bag with three sections is made of multilayer plastic. The inner layer of the bag material (the contact layer) is designed so that it is compatible with the ingredients and the approved additives.<\/p>\n\n\n\n To avoid contact with oxygen from the air, the bag is packed in an outer bag as an oxygen barrier. It contains a small bag with an oxygen absorber.<\/p>\n\n\n\n Pack sizes<\/strong><\/p>\n\n\n\n 650 ml bag: 1 carton with 10 bags<\/p>\n\n\n\n 1000 ml bag: 1 carton with 6 bags<\/p>\n\n\n\n 1500 ml bag: 1 carton with 4 bags<\/p>\n\n\n\n 2000 ml bag: 1 carton with 4 bags<\/p>\n\n\n\n 1 bag of 650 ml, 1000 ml, 1500 ml and 2000 ml.<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n Baxter Medical AB<\/p>\n\n\n\n Box 63<\/p>\n\n\n\n 164 94 Kista<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Baxter SA<\/p>\n\n\n\n Boulevard Ren\u00e9 Branquart, 80<\/p>\n\n\n\n 7860 Lessines<\/p>\n\n\n\n Belgium<\/p>\n","protected":false},"excerpt":{"rendered":" Olimel N12E is an infusion solution . It is provided in a bag with three sections.<\/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":[2200,18526],"tags":[19768,19802,14201,19767,19798,19804,19801,19803,19799,19800],"class_list":["post-19616","post","type-post","status-publish","format-standard","hentry","category-medicines","category-o","tag-amino-acid","tag-benefits-of-olimel-n12e","tag-glucose","tag-lipid-emulsion","tag-olimel-n12e","tag-olimel-n12e-dosage","tag-olimel-n12e-side-effects","tag-olimel-n12e-usage","tag-what-is-olimel-n12e","tag-what-olimel-n12e-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19616","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=19616"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19616\/revisions"}],"predecessor-version":[{"id":19661,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19616\/revisions\/19661"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19616"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19616"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19616"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}If you take more Olimel N12E than you should<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Olimel N12E<\/h2>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
Section with lipid emulsion<\/td> Section with amino acid solution and electrolytes<\/td> Section with glucose solution and calcium<\/td><\/tr> Purified egg phospholipids,glycerol , sodium oleate,sodium hydroxide (for pH adjustment), water forinjections<\/td> Glacial acetic acid (for pH adjustment), water forinjections<\/td> Hydrochloric acid (for pH adjustment), water forinjections<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n