{"id":18791,"date":"2022-02-23T17:27:12","date_gmt":"2022-02-23T17:27:12","guid":{"rendered":"https:\/\/zeepedia.com\/?p=18791"},"modified":"2022-02-24T12:50:40","modified_gmt":"2022-02-24T12:50:40","slug":"navirel","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/navirel\/","title":{"rendered":"Navirel &#8211; Vinorelbine uses, dose and side effects"},"content":{"rendered":"\n<p>10 mg \/ ml&nbsp;concentrate for&nbsp;solution for&nbsp;infusion<br>vinorelbine<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What Navirel is and what it is used for<\/h2>\n\n\n\n<p>Navirel is a concentrated solution for\u00a0infusion.\u00a0The active substance vinorelbine belongs to a group of medicines used to treat cancer.\u00a0These drugs are called\u00a0cytostatics, or cell inhibitors because they delay or prevent the growth of cancer cells.\u00a0Navirel is used to treat certain types of lung cancer (so-called non-small cell lung cancer\u00a0) and breast cancer.<\/p>\n\n\n\n<p>Vinorelbine contained in Navirel may also be approved for the treatment of other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What you need to know before using Navirel<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Navirel if you:<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>is allergic to vinorelbine, any other similar medicine used to treat cancer called vinca&nbsp;alkaloids&nbsp;or any of the other ingredients of this medicine (listed in section 6).<\/li><li>have a low number of certain&nbsp;white blood cells&nbsp;or are currently or have recently had a serious&nbsp;infection&nbsp;(within the last 2 weeks).<\/li><li>has a low&nbsp;platelet count&nbsp;.<\/li><li>have a serious liver disease that has nothing to do with the cancer treated with vinorelbine.<\/li><li>get or have recently been vaccinated against yellow fever.<\/li><li>is pregnant.<\/li><li>ammar.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Talk to your doctor, pharmacist, or nurse before receiving Navirel<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>you have received radiation therapy where the treatment field includes the liver.<\/li><li>you have impaired liver function.<\/li><li>you are receiving or have recently received certain forms of vaccine with live virus particles (so-called live, attenuated vaccines).<\/li><li>you are also given an antiepileptic medicine&nbsp;called&nbsp;phenytoin or an&nbsp;antifungal&nbsp;medicine called itraconazole.<\/li><li>you have had a heart attack or severe chest pain.<\/li><li>you show signs or symptoms of&nbsp;infection&nbsp;(fever, chills, etc.).&nbsp;Inform your doctor immediately, so that he \/ she can take any necessary samples.<\/li><li>you belong to the Japanese population, because there is an increased risk of developing diseases of the lung connective tissue.<\/li><\/ul>\n\n\n\n<p>Carefully avoid all contact with the eyes.&nbsp;There is a risk of severe irritation and even sores on the eye (corneal ulcers).&nbsp;In case of contact with eyes, rinse immediately with sodium chloride solution.<\/p>\n\n\n\n<p>In case of a burning sensation in the infusion area during or after\u00a0infusion\u00a0one, inform a doctor immediately.\u00a0This may be a sign of an injection error.\u00a0Infusion\u00a0must be stopped immediately.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Children and young people<\/h2>\n\n\n\n<p>This medicine is not recommended for use in children as there are insufficient data on the safety and efficacy in children.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Navirel<\/h2>\n\n\n\n<p>Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n<p>Your doctor should pay special attention if you are taking the following medicines:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>medicines used to thin the blood (&nbsp;anticoagulants&nbsp;)<\/li><li>antiepileptic&nbsp;drugs&nbsp;, such as&nbsp;phenytoin&nbsp;, phenobarbital and carbamazepine<\/li><li>drugs against bacteria, such as rifampicin, clarithromycin, erythromycin<\/li><li>antiviral&nbsp;drugs&nbsp;, such as ritonavir<\/li><li>antifungal drugs, such as itraconazole and ketaconazole<\/li><li>a cancer drug called mitomycin C<\/li><li>drugs that weaken the immune system, such as ciclosporin and tacrolimus<\/li><li>drugs for the treatment of heart disease, such as verapamil and&nbsp;quinidine<\/li><li>a herbal remedy called&nbsp;St. John&#8217;s wort&nbsp;(&nbsp;<em>Hypericum perforatum)<\/em>&nbsp;.<\/li><\/ul>\n\n\n\n<p>Live attenuated vaccines (vaccines that contain live virus particles, such as measles vaccine, mumps vaccine, rubella vaccine) are not recommended with Navirel, as they may increase the risk of life-threatening vaccination disease.&nbsp;Because the yellow fever vaccine also contains live virus particles, you must not be given yellow fever vaccines in combination with Navirel.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n<p>You should not be treated with Navirel if you are pregnant unless it has been explicitly prescribed by your doctor.<\/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<p>You should not be treated with Navirel if you are breastfeeding.\u00a0If treatment is necessary, you must stop breastfeeding.<\/p>\n\n\n\n<p>Women should take measures to avoid pregnancy during treatment and for at least three months after stopping treatment by using an effective contraceptive.<\/p>\n\n\n\n<p>Men receiving treatment must ensure that their partner does not become pregnant during treatment and up to six months after treatment by using an effective contraceptive.<\/p>\n\n\n\n<p>Advice on sperm preservation should be sought before treatment due to the risk of\u00a0irreversible\u00a0sterility caused by treatment with vinorelbine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Side effects\u00a0that may impair your ability to drive and\/or use machines may occur after treatment with vinorelbine.\u00a0If you feel unwell, do not perform tasks that require mental concentration, such as driving or using machines.<\/p>\n\n\n\n<p>You are responsible for assessing whether you are fit to drive a vehicle or perform work that requires increased 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\">How to use Navirel<\/h2>\n\n\n\n<p><strong>The preparation&nbsp;and&nbsp;administration&nbsp;of Navirel should only be performed by trained healthcare professionals who specialize in cancer treatment.&nbsp;Navirel is for single use only.<\/strong><\/p>\n\n\n\n<p>Before each treatment, a blood sample will be taken to analyze its constituents to check that you have a sufficient number of\u00a0blood cells\u00a0to be treated with Navirel.\u00a0If the results of this analysis are not satisfactory, your treatment may be postponed and further samples were taken until these values \u200b\u200breturn to normal.<\/p>\n\n\n\n<p>Navirel is usually given once a week.&nbsp;The usual&nbsp;dose&nbsp;for adults is 25-30 mg \/ m\u00b2.&nbsp;Always follow your doctor&#8217;s instructions.<\/p>\n\n\n\n<p><strong><em>Dose adjustment<\/em><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>In case of significant hepatic impairment, the&nbsp;dose&nbsp;may be changed by your doctor.&nbsp;Follow your doctor&#8217;s instructions.<\/li><li>In case of impaired renal function, it is not necessary to adjust&nbsp;dose&nbsp;one.&nbsp;Follow your doctor&#8217;s instructions.<\/li><\/ul>\n\n\n\n<p><strong>Navirel should always be&nbsp;<\/strong><strong>injected&nbsp;<\/strong><strong>into a vein.<\/strong><\/p>\n\n\n\n<p>It can be given as an&nbsp;injection&nbsp;for 6 to 10 minutes or as a rapid&nbsp;infusion&nbsp;(drip) for 20 to 30 minutes.<\/p>\n\n\n\n<p>After\u00a0administration, sodium chloride solution will be given as a drip into the same vein so that the drug is distributed.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">If you receive more Navirel than you do in the package leaflet<\/h2>\n\n\n\n<p>Your doctor will check that you are getting the right\u00a0dose\u00a0for your illness.\u00a0However, if you are concerned or have symptoms of a possible overdose, such as fever, signs of\u00a0infection,\u00a0or constipation, you should contact a doctor, emergency doctor, or pharmacist.\u00a0<\/p>\n\n\n\n<p>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<p>If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.<\/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>Tell your doctor immediately<\/strong>&nbsp;if you get any of the following symptoms, as they may be signs of serious side effects:<\/p>\n\n\n\n<p><strong>Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Cough, fever and chills, which can be signs of a severe&nbsp;infection&nbsp;that can lead to organ failure and blood poisoning.<\/li><li>Difficulty breathing (&nbsp;dyspnoea&nbsp;), difficulty breathing caused by contractions of the airways (&nbsp;bronchospasm&nbsp;).<\/li><\/ul>\n\n\n\n<p><strong>Rare (&nbsp;<\/strong><strong>may affect up to 1 in 1,000 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Severe chest pain can spread to the neck and arms.&nbsp;Such pain can occur due to insufficient blood supply to the heart (angina or heart attack).<\/li><li>Signs of very low&nbsp;blood pressure&nbsp;, e.g.&nbsp;severe dizziness or dizziness, when getting up.<\/li><li>Severe constipation with abdominal pain when you have not had a bowel movement for several days (paralytic&nbsp;ileus&nbsp;).<\/li><\/ul>\n\n\n\n<p><strong>Has been reported (occurs in an unknown number of users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Signs of severe&nbsp;allergic reaction&nbsp;which may include wheezing, swelling of the lips, tongue and throat or body, difficulty swallowing, rash, dizziness and fainting (&nbsp;anaphylactic reaction&nbsp;or&nbsp;shock&nbsp;, anaphylactoid reaction).<\/li><\/ul>\n\n\n\n<p>The following is a list of other&nbsp;side effects&nbsp;that may occur:<\/p>\n\n\n\n<p><strong>Very common (may affect more than 1 user in 10)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Inhibition of bone marrow function with reduced number of&nbsp;red blood cells&nbsp;, which can make the skin pale and cause weakness or shortness of breath, and certain types of&nbsp;white blood cells&nbsp;(&nbsp;neutrophils&nbsp;), which are transient within 5 to 7 days.<\/li><li>Constipation, vomiting,&nbsp;inflammation&nbsp;of the oral mucosa,&nbsp;inflammation&nbsp;of the esophagus.<\/li><li>Loss of certain reflex reactions (deep tendon reflexes);&nbsp;weakness in the legs has been reported after long-term chemotherapy.<\/li><li>Transient elevations of blood tests that show changes in liver function without symptoms.<\/li><li>Hair loss, usually mild.<\/li><li>Injection site reactions such as reddening of the skin, burning pain, changes in the color of the vein and local&nbsp;inflammation&nbsp;of the vein (&nbsp;phlebitis&nbsp;).<\/li><li>Feeling weak, tired, fever, pain in various places including chest pain and pain at the tumor site.<\/li><\/ul>\n\n\n\n<p><strong>Common (may affect up to 1 in 10 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Decreased&nbsp;platelet count&nbsp;(particles in the blood, which help to stop bleeding), in rare cases severe.<\/li><li>Bacterial,&nbsp;viral&nbsp;or fungal infections in various parts of the body, such as the respiratory tract, urinary tract or gastrointestinal tract, are mild to moderate and usually transient with appropriate treatment.<\/li><li>Difficulty breathing or skin reactions as a result of a&nbsp;hypersensitivity reaction&nbsp;to vinorelbine.<\/li><li>Diarrhea, usually mild to moderate.<\/li><li>Muscle pain, joint pain, jaw pain.<\/li><li>Increased&nbsp;creatinine&nbsp;in the blood, a substance that reflects kidney function.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon (may affect up to 1 in 100 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Nerve problems such as tingling or tingling and increased or decreased muscle tension (&nbsp;paresthesia&nbsp;).<\/li><li>Low&nbsp;blood pressure&nbsp;.<\/li><li>High&nbsp;blood pressure&nbsp;.<\/li><li>Sudden feeling of heat and reddening of the face and neck (hot flashes).<\/li><li>Feeling of cold in hands and feet.<\/li><\/ul>\n\n\n\n<p><strong>Rare (may affect up to 1 in 1,000 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Severe low levels of&nbsp;sodium&nbsp;in the blood, which can cause fatigue and confusion, muscle twitching, cramps or&nbsp;coma&nbsp;.<\/li><li>Inflammation&nbsp;of the pancreas (an organ that regulates blood sugar) which causes severe pain in the stomach and back (&nbsp;pancreatitis&nbsp;).<\/li><li>Transient changes in a curve showing the electrical activity of the heart, including heartbeat (transient&nbsp;ECG&nbsp;changes).<\/li><li>Respiratory problems caused by diseases of the lung connective tissue (interstitial lung disease).<\/li><li>Fainting (collapse).<\/li><li>General skin reactions.<\/li><li>Severe skin conditions at the injection site, such as tissue death ( injection&nbsp;necrosis&nbsp;).<\/li><\/ul>\n\n\n\n<p><strong>Very rare (may affect up to 1 in 10,000 people)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Blood poisoning with complications and blood poisoning leading to death.<\/li><li>Heart diseases such as rapid heart rate (&nbsp;tachycardia&nbsp;), palpitations (palpitations) and irregular heartbeats (arrhythmias).<\/li><li>Impaired lung function (&nbsp;respiratory failure&nbsp;).<\/li><li>Guillain-Barr\u00e9 syndrome (symptoms of which may include weakness or paralysis of the arms and legs, difficulty breathing and&nbsp;blood pressure&nbsp;).<\/li><\/ul>\n\n\n\n<p><strong>Has been reported (occurs in an unknown number of users)<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Low levels of certain&nbsp;white blood cells&nbsp;accompanied by fever (febrile&nbsp;neutropenia&nbsp;).<\/li><li>Severe reduction of all&nbsp;blood cells&nbsp;, which can lead to weakness, bruising or greater risk of&nbsp;infection&nbsp;.<\/li><li>Systemic&nbsp;infection&nbsp;with fever and an unusually low number of certain&nbsp;white blood cells&nbsp;that can be potentially life-threatening (&nbsp;neutropenic&nbsp;sepsis&nbsp;).<\/li><li>SIADH syndrome (symptoms of this include eg weight gain, nausea, muscle cramps).<\/li><li>Loss of appetite \/ decreased appetite.<\/li><li>Palmoplants erythrodysesthesia (symptoms of this include, for example, numbness, tingling, burning or&nbsp;itching&nbsp;,&nbsp;redness&nbsp;[similar to sunburn], swelling, discomfort, tenderness, rash).<\/li><\/ul>\n\n\n\n<p>Burning pain and&nbsp;redness&nbsp;in the infusion area may occur during or after&nbsp;infusion&nbsp;one.&nbsp;As this may be a sign of an injection error, you should inform your doctor or nurse, and the&nbsp;infusion&nbsp;must be stopped immediately.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">How to store Navirel<\/h2>\n\n\n\n<p>Keep this medicine out of the 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 label after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00b0 C &#8211; 8 \u00b0 C).&nbsp;Do not freeze.&nbsp;Store in the original package.&nbsp;Sensitive to light.<\/p>\n\n\n\n<p>Medicines should not be disposed of via wastewater or household waste.&nbsp;Ask your pharmacist how to dispose of medicines no longer required.&nbsp;These measures will help to protect the environment.<\/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 vinorelbine (as tartrate), 10 mg\/ml.<\/p>\n\n\n\n<p>One 1 ml&nbsp;vial&nbsp;contains a total of 10 mg of vinorelbine (as tartrate).<\/p>\n\n\n\n<p>One 5 ml&nbsp;vial&nbsp;contains a total of 50 mg of vinorelbine (as tartrate).<\/p>\n\n\n\n<p>The other ingredient is water for injections.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">What the medicine looks like and contents of the pack<\/h2>\n\n\n\n<p>Navirel is a clear, colorless to pale yellow concentrate for solution for&nbsp;infusion&nbsp;(sterile concentrate) supplied in glass vials.<\/p>\n\n\n\n<p>Pack sizes: 1 ml or 5 ml concentrate in packs of 1 or 10 vials.\u00a0Also available as multi-pack with 10 packs, each containing 1\u00a0vial.<\/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>medac<\/p>\n\n\n\n<p>Society for clinical<\/p>\n\n\n\n<p>Special preparations mbH<\/p>\n\n\n\n<p>Theater.\u00a06<\/p>\n\n\n\n<p>22880 Wedel<\/p>\n\n\n\n<p>Germany<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table><thead><tr><th scope=\"col\"><strong>This medicinal product is authorized under the European Economic Area under the names:<\/strong><\/th><\/tr><\/thead><tbody><tr><td>Denmark<\/td><td>Navirel 10 mg \/ ml concentrate for solution for infusion<\/td><\/tr><tr><td>Finland<\/td><td>Navirel 10 mg \/ ml infusioconcentraatti, liuosta varten<\/td><\/tr><tr><td>Netherlands<\/td><td>Navirel 10 mg \/ ml concentrate for solution for infusion<\/td><\/tr><tr><td>Norway<\/td><td>Navirel 10 mg \/ ml concentrate for solution for infusion<\/td><\/tr><tr><td>Poland<\/td><td>Navirel<\/td><\/tr><tr><td>Portugal<\/td><td>Vinorelbina Navirel 10 mg \/ ml concentrated for perfusion solution<\/td><\/tr><tr><td>Slovakia<\/td><td>Navirel 10 mg \/ ml infusion concentrate<\/td><\/tr><tr><td>Sweden<\/td><td>Navirel 10 mg \/ ml concentrate for&nbsp;solution for&nbsp;infusion<\/td><\/tr><tr><td>Czech Republic<\/td><td>Navirel 10 mg \/ ml concentrate for solution for infusion<\/td><\/tr><tr><td>Germany<\/td><td>Navirel 10 mg\/ml concentrate for the preparation of an infusion solution<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>Navirel is a concentrate for solution for infusion . The active substance vinorelbine belongs to a group of medicines used to treat cancer. These drugs are called cytostatics , or cell inhibitors, because they delay or prevent the growth of cancer cells. Navirel is used to treat certain types of lung cancer (so-called non- small cell lung cancer ) and breast cancer.<\/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":[2200,15581],"tags":[18626,18621,18622,18625,18617,18620,18623,18618,18624,18619],"class_list":["post-18791","post","type-post","status-publish","format-standard","hentry","category-medicines","category-n","tag-benefits-of-navirel","tag-benefits-of-vinorelbine","tag-navirel","tag-navirel-side-effects","tag-vinorelbine","tag-vinorelbine-side-effects","tag-what-is-navirel","tag-what-is-vinorelbine","tag-what-navirel-is-used-for","tag-what-vinorelbine-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18791","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=18791"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18791\/revisions"}],"predecessor-version":[{"id":18839,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/18791\/revisions\/18839"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=18791"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=18791"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=18791"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}