diarrhea.<\/li><\/ul>\n\n\n\nIf you get watery stools twice a day and\/or\u00a0inflammation\u00a0of the lining of the stomach (mild to moderate sores), you should contact your doctor immediately.<\/p>\n\n\n\n
You must not start combination therapy with 5 \u2011 fluorouracil and levofolinic acid, nor continue with combination therapy, if you get any side effects from the gastrointestinal tract, no matter how severe they are.<\/p>\n\n\n\n
Especially if you get diarrhea, your doctor will monitor you very closely, as your condition can quickly deteriorate and you can have serious\u00a0side effects.\u00a0Once the gastrointestinal symptoms have completely stopped, your doctor will tell you to start or continue a combination treatment with levofolinic acid and 5 \u2011 fluorouracil.<\/p>\n\n\n\n
Elderly or weak patients, or patients who have previously received radiotherapy, should be especially careful, as levofolinic acid may increase the risk of toxic effects of 5 \u2011 fluorouracil.<\/p>\n\n\n\n
Other medicines and Sodium levofolinate medac<\/h2>\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
The effects of the following medicines can be affected if they are taken with Sodium Levofolinate medac: phenobarbital, primidone,\u00a0phenytoin, succinimide (medicines used to\u00a0treat epilepsy\u00a0).\u00a0Your doctor may check the level of these medicines in your blood and change the\u00a0dose\u00a0to prevent an increase in seizures (cramps).<\/p>\n\n\n\n
Concomitant treatment with methotrexate may impair the effect of sodium levofolinate medac.<\/p>\n\n\n\n
Concomitant use of sodium levofolinate medac and 5 \u2011 fluorouracil increases the cytotoxic effect and side effects of 5 \u2011 fluorouracil.<\/p>\n\n\n\n
When Sodium Levofolinate medac is co-administered with folic acid antagonists (eg co-trimoxazole, pyrimethamine) the effect of the folic acid antagonist may be either reduced or completely neutralized.<\/p>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\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 using this medicine.<\/p>\n\n\n\n
It is unlikely that your doctor will ask you to take\/use a folic acid antagonist or 5 \u2011 fluorouracil when you are pregnant or breastfeeding.\u00a0However, if you have taken\/used a folic acid antagonist during pregnancy or breastfeeding, this medicine (Sodium Levofolinate medac) can be used to reduce its\u00a0side effects.<\/p>\n\n\n\n
Pregnancy<\/em><\/p>\n\n\n\nThere is no evidence that sodium levofolinate medac if given alone, would have harmful effects if given during pregnancy.<\/p>\n\n\n\n
If you are pregnant, you should only be given methotrexate if the benefits of your treatment outweigh the risks to your baby.<\/p>\n\n\n\n
If you are receiving methotrexate even though you are pregnant, you can use disodium levofolinate indefinitely to reduce or eliminate the effects of methotrexate.<\/p>\n\n\n\n
If you are pregnant, you must not be treated with a combination of Sodium Levofolinate medac and 5 \u2011 fluorouracil.<\/p>\n\n\n\n
Breast-feeding<\/em><\/p>\n\n\n\nYou must stop breastfeeding before starting treatment with methotrexate or 5-fluorouracil.<\/p>\n\n\n\n
Sodium levofolinate medac can be used alone during breastfeeding, when deemed necessary.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n It is unlikely that Sodium Levofolinate medac itself would affect your ability to drive or use machines. Your general condition is more important than the possible effects of Sodium Levofolinate medac.<\/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
Sodium levofolinate medac contains sodium<\/h2>\n\n\n\n This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per\u00a0vial, ie essentially ‘sodium-free’.<\/p>\n\n\n\n
How to use Sodium Levofolinate<\/h2>\n\n\n\n Sodium levofolinate medac should only be completed and given by trained healthcare professionals.<\/strong><\/p>\n\n\n\nSodium levofolinate medac should always be given in a blood vessel, either diluted as an injection or as an infusion (drip) after dilution.<\/p>\n\n\n\n
Sodium levofolinate medac must not be given in the spinal fluid (intrathecally).<\/strong><\/p>\n\n\n\nDose of sodium levofolinate medac to prevent toxic symptoms during methotrexate treatment<\/em><\/p>\n\n\n\nIf you receive a methotrexate dose of more than 500 mg \/ m\u00b2 body surface area in connection with cancer treatment, you must also receive levofolinic acid afterwards. At a dose of 100\u2011500 mg \/ m\u00b2 methotrexate, your doctor may consider giving you levofolinic acid.<\/p>\n\n\n\n
Your doctor will make sure that you get the dose that is appropriate for your illness.<\/p>\n\n\n\n
Dose of Sodium Levofolinate medac to increase the cytotoxic effects of 5-fluorouracil<\/em><\/p>\n\n\n\nThere are different treatment regimens for the combination therapy of Sodium Levofolinate medac and 5-fluorouracil (once a week, twice a month, or once a month).<\/p>\n\n\n\n
Your doctor will make sure that you receive the correct\u00a0dose\u00a0for your illness at appropriate intervals.<\/p>\n\n\n\n
If you receive more Sodium Levofolinate medac than you should<\/h2>\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
Very large amounts of sodium levofolinate medac may cancel out the effect of folic acid antagonists such as methotrexate. In the event of a possible overdose of the combination of 5 \u2011 fluorouracil and Sodium Levofolinate medac, the instructions for overdosing on 5 \u2011 fluorouracil should be followed.<\/p>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/p>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n
Stop taking Sodium Levofolinate medac and contact a doctor immediately or go to the nearest emergency room if you experience any of the following symptoms:<\/p>\n\n\n\n
Very rare (may affect up to 1 in 10,000 people):<\/em><\/p>\n\n\n\nsevere allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may lead to difficulty swallowing or breathing) and you may feel faint .Other side effects that may occur:<\/p>\n\n\n\n
Uncommon (may affect up to 1 in 100 people):<\/em><\/p>\n\n\n\nfever<\/li><\/ul>\n\n\n\nRare (may affect up to 1 in 1,000 people):<\/em><\/p>\n\n\n\nsleep problems (insomnia), anxiety and depression after high doses<\/li> problems with the digestive system (after high doses )<\/li> increased incidence of seizures in patients with epilepsy<\/li><\/ul>\n\n\n\nSodium levofolinate in combination with 5 \u2011 fluorouracil<\/strong><\/em><\/p>\n\n\n\nIf you are receiving levofolinic acid in combination with a cancer medicine that contains fluoropyrimidines, you are more likely to experience any of the following side effects from this other medicine.<\/p>\n\n\n\n
Very common (may affect more than 1 user in 10):<\/em><\/p>\n\n\n\ndecreased number of blood cells (including life-threatening conditions)<\/li> inflammation (painful swelling and redness ) in the lining of the gastrointestinal tract and mouth ( life-threatening condition has occurred)<\/li><\/ul>\n\n\n\nCommon (may affect up to 1 in 10 people)<\/em><\/p>\n\n\n\nredness and swelling of the palms or soles of the feet which may cause the skin to flake (hand \u2011 foot syndrome)<\/li><\/ul>\n\n\n\nHas been reported (occurs in an unknown number of users):<\/em><\/p>\n\n\n\nhigher than normal levels of ammonia (a breakdown product that the body produces) in the blood<\/li><\/ul>\n\n\n\nThe safety profile may be affected depending on the treatment regimen used for 5 \u2011 fluorouracil, as the cytotoxic effects of 5 \u2011 fluorouracil are potentiated.<\/p>\n\n\n\n
When the drugs are given once a month<\/strong><\/em><\/p>\n\n\n\nVery common (may affect more than 1 user in 10):<\/em><\/p>\n\n\n\nvomiting, nausea<\/li><\/ul>\n\n\n\nNo enhancement of other toxic effects caused by 5-fluorouracil (eg neurotoxicity which is harmful to the nervous system) has been observed.<\/p>\n\n\n\n
When the drugs are given once a week<\/strong><\/em><\/p>\n\n\n\nVery common (may affect more than 1 user in 10):<\/em><\/p>\n\n\n\nsevere diarrhea and dehydration that can be due to diarrhea and can lead to hospitalization and sometimes death<\/li><\/ul>\n\n\n\nHow to store Sodium Levofolinate medac<\/h2>\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 label after \u201cEXP\u201d and the carton after \u201cEXP\u201d.\u00a0that. \u201d.\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n
Store in a refrigerator (2 \u00b0 C \u2011 8 \u00b0 C).<\/p>\n\n\n\n
Keep the vial in the outer carton. Sensitive to light.<\/p>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n The active substance is levofolinic acid.<\/p>\n\n\n\n
1 ml solution contains 54.65 mg disodium levofolinate, equivalent to 50 mg levofolinic acid.<\/p>\n\n\n\n
One vial of 1 ml contains 54.65 mg of disodium levofolinate, equivalent to 50 mg of levofolinic acid.<\/p>\n\n\n\n
A 4 ml vial contains 218.6 mg disodium levofolinate, equivalent to 200 mg levofolinic acid.<\/p>\n\n\n\n
A 9 ml vial contains 491.85 mg disodium levofolinate, equivalent to 450 mg levofolinic acid.<\/p>\n\n\n\n
The other ingredients are sodium hydroxide,\u00a0hydrochloric acid, water for injections<\/p>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n Sodium levofolinate medac is a clear, colorless to slightly yellowish solution for injection\/infusion.\u00a0It is marketed in colorless I-type vials with bromobutyl rubber stoppers and aluminum flip-off caps.<\/p>\n\n\n\n
Pack sizes:<\/p>\n\n\n\n
Vials with 1 ml, 4 ml, or 9 ml solution for injection or infusion in packs of 1 or 5 vials.\u00a0Not all pack sizes may be marketed<\/p>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n medac<\/p>\n\n\n\n
Society for Clinical Specialties mbH<\/p>\n\n\n\n
Theater.\u00a06<\/p>\n\n\n\n
22880 Wedel<\/p>\n\n\n\n
Germany<\/p>\n\n\n\n
This medicinal product is authorized under the European Economic Area under the names:<\/strong><\/p>\n\n\n\nBelgium:<\/td> Levofolic 50 mg \/ ml solution injectable \/ for perfusionLevofolic 50 mg \/ ml solution for injection \/ infusionLevofolic 50 mg \/ ml Solution for injection \/ infusion<\/td><\/tr> Estonia:<\/td> Levofolinic acid medac 50 mg \/ ml s\u00fcste- \/ infusioonilahus<\/td><\/tr> Finland:<\/td> Levofolic 50 mg \/ ml injection \/ infusion test, liuosLevofolic 50 mg \/ ml solution for injection or infusion<\/td><\/tr> France:<\/td> Levofolinate sodium medac 50 mg \/ ml, injectable solution \/ for perfusion<\/td><\/tr> Italy:<\/td> Sodio Levofolinato medac 50 mg \/ ml infusible or infusion solution<\/td><\/tr> Latvia:<\/td> Levofolic 50 mg \/ ml injection \/ infusion solution<\/td><\/tr> Lithuania:<\/td> Levofolino r\u016bg\u0161tis medac 50 mg \/ ml injekcinis ar infuzinis tirpalas<\/td><\/tr> Poland:<\/td> Levofolic 50 mg \/ ml solution for infusion \/ infusion<\/td><\/tr> Portugal:<\/td> Levofolic 50 mg \/ ml injectable solution or for perfusion<\/td><\/tr> Slovakia:<\/td> Levofolic 50 mg \/ ml injectable \/ infused solution<\/td><\/tr> Slovenia:<\/td> Levofolic 50 mg \/ ml raztopina for injection \/ infusion<\/td><\/tr> UK: <\/td> Levofolinic acid 50 mg \/ ml solution for injection \/ infusion<\/td><\/tr> Sweden:<\/td> Sodium levofolinate medac<\/td><\/tr> Germany:<\/td> Levofolic 50 mg \/ ml Solution for injection \/ infusion<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"Levofolinic acid contained in Sodium Levofolinate medac may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.<\/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":[2200,18530],"tags":[18651,18646,18647,18650,18642,18645,18648,18643,18649,18644],"class_list":["post-18785","post","type-post","status-publish","format-standard","hentry","category-medicines","category-s","tag-benefits-of-levofolinic-acid","tag-benefits-of-sodium-levofolinate-medac","tag-levofolinic-acid","tag-levofolinic-acid-side-effects","tag-sodium-levofolinate-medac","tag-sodium-levofolinate-medac-side-effects","tag-what-is-levofolinic-acid","tag-what-is-sodium-levofolinate-medac","tag-what-levofolinic-acid-is-used-for","tag-what-sodium-levofolinate-medac-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18785","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=18785"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18785\/revisions"}],"predecessor-version":[{"id":18842,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18785\/revisions\/18842"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=18785"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=18785"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=18785"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}