{"id":13389,"date":"2021-09-07T06:15:22","date_gmt":"2021-09-07T06:15:22","guid":{"rendered":"https:\/\/zeepedia.com\/?p=13389"},"modified":"2021-11-08T10:42:46","modified_gmt":"2021-11-08T10:42:46","slug":"gemcitabine-sandoz","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/gemcitabine-sandoz\/","title":{"rendered":"Gemcitabine Sandoz &#8211; Gemcitabine uses, dose and side effects"},"content":{"rendered":"\n<p>40 mg \/ mL&nbsp;concentrate for&nbsp;infusion&nbsp;solution<br>gemcitabine<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Gemcitabin Sandoz is and what it is used for<\/h2>\n\n\n\n<p>Gemcitabine Sandoz belongs to a group of medicines called&nbsp;cytostatics.&nbsp;This type of drug kills cells that divide, including cancer cells.<\/p>\n\n\n\n<p>Gemcitabine Sandoz can be given alone or in combination with other anticancer medicines, depending on the type of cancer.<\/p>\n\n\n\n<p>Gemcitabine Sandoz is used to treating the following cancers:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>non-&nbsp;small cell lung cancer&nbsp;(NSCLC), as a single drug or in combination with cisplatin.<\/li><li>pancreatic cancer (cancer of the pancreas).<\/li><li>breast cancer, in combination with paclitaxel.<\/li><li>ovarian cancer&nbsp;(cancer of the ovaries), in combination with carboplatin.<\/li><li>bladder cancer, in combination with cisplatin.<\/li><\/ul>\n\n\n\n<p>Gemcitabine contained in Gemcitabine Sandoz may also be approved for the treatment of other conditions not mentioned in this product information.&nbsp;Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">2. What you need to know before using Gemcitabin Sandoz<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Gemcitabine Sandoz<\/h2>\n\n\n\n<ul class=\"wp-block-list\"><li>if you are allergic to gemcitabine or any of the other ingredients of this medicine (listed in section 6).<\/li><li>if you are breast-feeding.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Warnings and cautions<\/h2>\n\n\n\n<p>Before the first&nbsp;infusion,&nbsp;a blood sample will be taken to check that your liver and kidneys are working well enough for you to receive this medicine.&nbsp;Before each&nbsp;infusion, blood samples will be taken to check that the amount of&nbsp;blood cells&nbsp;is sufficient to obtain Gemcitabine Sandoz.&nbsp;Your doctor may decide to change the&nbsp;dose&nbsp;or postpone treatment depending on your general condition or if your blood levels are too low.&nbsp;Blood tests will be taken regularly to check how well your kidneys and liver are working.<\/p>\n\n\n\n<p>Talk to your doctor or hospital pharmacist before using Gemcitabin Sandoz if:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>you have or have had liver disease, heart disease or vascular disease or problems with your lungs or kidneys, as you may not be able to get Gemcitabine Sandoz.<\/li><li>you have recently received radiation therapy or if such treatment is planned, as an early or delayed radiation reaction may occur with Gemcitabin Sandoz<\/li><li>you have recently been vaccinated (especially against yellow fever), as this may have a detrimental effect with Gemcitabine Sandoz<\/li><li>you have difficulty breathing or feel very weak and very pale (as this may be a sign of&nbsp;kidney failure&nbsp;or lung problems)<\/li><li>you swell in the body, become short of breath or gain weight (because this can be a sign that fluid is leaking from small blood vessels to&nbsp;tissue&nbsp;one).<\/li><\/ul>\n\n\n\n<p>Contact a doctor immediately if you experience symptoms such as headache with confusion, seizures, or changes in vision during treatment with this medicine.&nbsp;This can be a very rare&nbsp;side effect&nbsp;in the nervous system called posterior reversible encephalopathy syndrome.<\/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 children under 18 years of age as there are insufficient data on safety and efficacy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other medicines and Gemcitabine Sandoz<\/h2>\n\n\n\n<p>Tell your doctor or hospital pharmacist if you have recently taken or might take any other medicines, including vaccines and medicines obtained without a prescription.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding and fertility<\/h2>\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><strong>Pregnancy<\/strong><\/p>\n\n\n\n<p>If you are pregnant or planning to become pregnant, tell your doctor.&nbsp;Treatment with Gemcitabine Sandoz should be avoided during pregnancy.&nbsp;Your doctor may inform you about the possible risk of Gemcitabine Sandoz when given during pregnancy.<\/p>\n\n\n\n<p><strong>Breast-feeding<\/strong><\/p>\n\n\n\n<p>Tell your doctor if you are breastfeeding.<\/p>\n\n\n\n<p>Breast-feeding should be discontinued during treatment with Gemcitabine Sandoz.<\/p>\n\n\n\n<p><strong>Fertility<\/strong><\/p>\n\n\n\n<p>Men are advised against having children during treatment and up to 6 months after treatment with Gemcitabine Sandoz.&nbsp;If you wish to have children during treatment or during the 6 months following treatment, you should seek the advice of your doctor or pharmacist regarding the preservation of semen before treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Treatment with Gemcitabine Sandoz may make you feel sleepy, especially if you have been drinking alcohol.&nbsp;Do not drive or use machines until you are sure that treatment with Gemcitabin Sandoz does not make you sleepy.<\/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.&nbsp;One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or&nbsp;side effects.&nbsp;Descriptions of these effects and&nbsp;side effects&nbsp;can be found in other sections.&nbsp;Read all the information in this leaflet for guidance.&nbsp;If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Gemcitabine Sandoz<\/h2>\n\n\n\n<p>The usual&nbsp;dose&nbsp;of Gemcitabine Sandoz is 1000-1250 mg per square meter of body surface area.&nbsp;Your height and weight are used to calculate body surface area.&nbsp;Your doctor will use the measurement of your body surface area to calculate the correct&nbsp;dose&nbsp;for you.&nbsp;This&nbsp;dose&nbsp;can be adjusted or the treatment can be postponed depending on your blood levels and your general condition.<\/p>\n\n\n\n<p>How often you receive&nbsp;an infusion&nbsp;of Gemcitabine Sandoz depends on the type of cancer you are being treated for.<\/p>\n\n\n\n<p>Gemcitabine Sandoz is always given as&nbsp;an infusion&nbsp;(after dilution) into a vein.&nbsp;Infusion&nbsp;one lasts for about 30 minutes.<\/p>\n\n\n\n<p>If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4. Possible side effects<\/h2>\n\n\n\n<p>Like all medicines, this medicine can cause&nbsp;side effects, although not everybody gets them.<\/p>\n\n\n\n<p><strong>You should contact your doctor immediately if you notice any of the following:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Bleeding in the gums, nose or mouth or any non-stop bleeding, reddish or pinkish urine, unexpected bruising (because you may have smaller&nbsp;platelets&nbsp;than normal, which is very common)<\/li><li>Fatigue, fainting, shortness of breath or paleness (because your hemoglobin value may be lower than normal, which is very common)<\/li><li>Mild to moderate rash (very common) \/&nbsp;itching&nbsp;(common) or fever (very common) (allergic reactions)<\/li><li>Body temperature of 38 \u00b0 C or higher, sweating or other signs of&nbsp;infection&nbsp;(because you may have fewer&nbsp;white blood cells&nbsp;than normal along with fever, which is called febrile&nbsp;neutropenia&nbsp;) (common)<\/li><li>Pain,&nbsp;redness&nbsp;, swelling or sores in the mouth (inflammation of the mouth) (common)<\/li><li>Arrhythmia in the heart (less common)<\/li><li>Extreme fatigue and weakness, slight bleeding in the skin (bruising),&nbsp;acute&nbsp;renal failure&nbsp;(low or no urine output) and signs of&nbsp;infection&nbsp;(&nbsp;hemolytic uremic syndrome&nbsp;);&nbsp;the condition can be fatal (less common)<\/li><li>Difficulty breathing (it is very common to have mild breathing difficulties shortly after Gemcitabin Sandoz&nbsp;infusion,&nbsp;which passes quickly, but in less common or rare cases, more serious lung problems may occur)<\/li><li>Severe chest pain (heart attack) (rare)<\/li><li>Severe hypersensitivity \/ allergic reaction with severe rash (including red, itchy skin), swelling of hands, feet, ankles, face, lips, mouth or throat (may cause difficulty swallowing or breathing), wheezing, palpitations and fainting. (&nbsp;anaphylactic reaction&nbsp;) (very rare)<\/li><li>General swelling, shortness of breath or weight gain, as fluid may leak from small blood vessels to&nbsp;tissues&nbsp;(capillary leakage syndrome) (very rare)<\/li><li>Headache with vision changes, confusion, seizures (posterior reversible encephalopathy syndrome) (very rare)<\/li><li>Severe rash with&nbsp;itching&nbsp;, blistering or scaly skin (Stevens-Johnson syndrome,&nbsp;toxic epidermal necrolysis&nbsp;) (very rare)<\/li><li>Extreme fatigue and weakness, purple or small areas with bleeding in the skin (bruising),&nbsp;acute&nbsp;renal failure&nbsp;(low urine output or no urine output) and signs of&nbsp;infection&nbsp;.&nbsp;These can be signs of thrombotic microangiopathy (blood clots that form in small blood vessels) and&nbsp;hemolytic uremic syndrome&nbsp;, which can be fatal.<\/li><\/ul>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;are&nbsp;<\/strong><strong>of Gemcitabine Sandoz may include:<\/strong><\/p>\n\n\n\n<p><strong>Very common<\/strong>&nbsp;(may affect more than 1 user in 10):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Low&nbsp;white blood cell count<\/li><li>Vomiting<\/li><li>Nausea<\/li><li>Hair loss<\/li><li>Liver problems detected using blood tests<\/li><li>Blood in the urine<\/li><li>Abnormal urine values: egg white in the urine<\/li><li>Flu-like symptoms&nbsp;that include fever<\/li><li>Swelling of the ankles, fingers, feet, face (&nbsp;edema&nbsp;).<\/li><\/ul>\n\n\n\n<p><strong>Common<\/strong>&nbsp;(may affect up to 1 in 10 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Poor appetite<\/li><li>Headache<\/li><li>Sleeping problems<\/li><li>Somnolence<\/li><li>Cough<\/li><li>Snuva<\/li><li>Constipation<\/li><li>Diarrhea<\/li><li>Itching<\/li><li>Sweating<\/li><li>Muscle pain<\/li><li>Back pain<\/li><li>Fever<\/li><li>Impotence<\/li><li>Overindulge<\/li><li>Elevated liver values \u200b\u200b(&nbsp;bilirubin&nbsp;)<\/li><li>Infection&nbsp;is.<\/li><\/ul>\n\n\n\n<p><strong>Uncommon<\/strong>&nbsp;(may affect up to 1 in 100 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Scarring of the lung air sacs (interstitial&nbsp;pneumonitis&nbsp;)<\/li><li>Wheezing (respiratory cramps)<\/li><li>Scarring of the lungs (abnormal X-ray of the chest)<\/li><li>Stroke<\/li><li>Heart failure<\/li><li>Kidney failure<\/li><li>Serious liver damage, including liver failure that can lead to death.<\/li><\/ul>\n\n\n\n<p><strong>Rare<\/strong>&nbsp;(may affect up to 1 in 1,000 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Low&nbsp;blood pressure<\/li><li>Skin peeling, skin sores or blistering<\/li><li>Flaky skin and severe blisters on the skin<\/li><li>Injection site reactions<\/li><li>Severe&nbsp;pneumonia&nbsp;causing respiratory failure (&nbsp;acute&nbsp;respiratory failure syndrome)<\/li><li>Skin rash that is similar to severe sun damage, which can occur on skin that has previously been subjected to radiation treatment (so-called radiation recall)<\/li><li>Fluid in the lungs<\/li><li>Scarring in the air bubbles of the lung in connection with radiation therapy (radiation toxicity)<\/li><li>Gangrene (cold sores) in fingers or toes<\/li><li>Inflammation&nbsp;of blood vessels<\/li><li>Elevated liver values \u200b\u200b(gamma-glutamyltransferase, GGT).<\/li><\/ul>\n\n\n\n<p><strong>Very rare<\/strong>&nbsp;(may affect up to 1 in 10,000 people):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Increased&nbsp;platelet count<\/li><li>Inflammation&nbsp;of the wall of the colon caused by decreased blood supply (ischemic&nbsp;colitis&nbsp;)<\/li><li>Thrombotic microangiopathy: blood clots that form in small blood vessels.<\/li><\/ul>\n\n\n\n<p><strong>Has been reported<\/strong>&nbsp;(occurs in an unknown number of users):<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Sepsis: when bacteria and its&nbsp;toxins&nbsp;er (toxins) circulate in the blood and begin to damage organs<\/li><li>Pseudocellulite: Reddening of the skin with swelling.<\/li><\/ul>\n\n\n\n<p>Low hemoglobin (&nbsp;anemia&nbsp;), low&nbsp;white blood cell count,&nbsp;and altered&nbsp;platelet count, as seen in blood samples.<\/p>\n\n\n\n<p>You may get any of these symptoms\/conditions.&nbsp;If you get any of these&nbsp;side effects, tell your doctor as soon as possible.<\/p>\n\n\n\n<p>If you are concerned about any&nbsp;side effects, talk to your doctor.<\/p>\n\n\n\n<p><em>Reporting of side effects<\/em><\/p>\n\n\n\n<p>If you get any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This also applies to any side effects not mentioned in this information.&nbsp;You can also report side effects directly to the Medical Products Agency.&nbsp;By reporting side effects, you can help increase drug safety information.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">5. How to store Gemcitabin Sandoz<\/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;or EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>The hospital pharmacy must store the Gemcitabine Sandoz bottles at 2 \u00b0 C \u2013 8 \u00b0 C.&nbsp;Do not freeze.<\/p>\n\n\n\n<p>If the solution is stored at temperatures below 2 \u00b0 C,&nbsp;the precipitate&nbsp;may&nbsp;form.<\/p>\n\n\n\n<p>If the solution looks discolored or contains visible particles, discard it.<\/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\">6. Contents of the packaging 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 gemcitabine (as hydrochloride).<\/p>\n\n\n\n<p>1 ml concentrate for&nbsp;solution&nbsp;for&nbsp;infusion&nbsp;contains 40 mg gemcitabine (as hydrochloride).<\/p>\n\n\n\n<p>One 5 ml bottle contains 200 mg gemcitabine (as hydrochloride).<\/p>\n\n\n\n<p>One 25 ml bottle contains 1000 mg of gemcitabine (as hydrochloride).<\/p>\n\n\n\n<p>One 50 ml bottle contains 2000 mg gemcitabine (as hydrochloride).<\/p>\n\n\n\n<p>The other ingredients are water for injections and dilute&nbsp;hydrochloric acid&nbsp;(for&nbsp;pH&nbsp;adjustment).<\/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>The drug is a concentrated solution&nbsp;for&nbsp;infusion.<\/p>\n\n\n\n<p>The concentrate for&nbsp;solution&nbsp;for&nbsp;infusion&nbsp;is a clear, colorless to light yellow solution in a colorless glass bottle (type I glass) closed with a gray rubber stopper (&nbsp;Ph.&nbsp;EUR, type I) with or without plastic protection (Onco \u2011 Safe or protective foil).&nbsp;&#8220;Onco \u2011 Safe&#8221; and protective foil are not in contact with the medicine and provide increased safety during transport, which increases the safety of pharmacy and medical staff during transport.<\/p>\n\n\n\n<p>Pack sizes:<\/p>\n\n\n\n<p>200 mg \/ 5 ml: 1&nbsp;vial&nbsp;, 5 vials, 10 vials.<\/p>\n\n\n\n<p>1,000 mg \/ 25 ml: 1&nbsp;vial&nbsp;.<\/p>\n\n\n\n<p>2,000 mg \/ 50 ml: 1&nbsp;vial&nbsp;.<\/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><strong>Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n<p>Sandoz A \/ S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>EBEWE Pharma Ges.mbH Nfg.&nbsp;KG, 4866 Unterach, Austria<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gemcitabine Sandoz belongs to a group of medicines called cytostatics. This type of drug kills cells that divide, including cancer cells.<\/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":[2200,2207],"tags":[14442,14528,14439,14524,14527,14443,14441,14526,14440,14525],"class_list":["post-13389","post","type-post","status-publish","format-standard","hentry","category-medicines","category-g","tag-benefits-of-gemcitabine","tag-benefits-of-gemcitabine-sandoz","tag-gemcitabine","tag-gemcitabine-sandoz","tag-gemcitabine-sandoz-side-effects","tag-gemcitabine-side-effects","tag-what-gemcitabine-is-used-for","tag-what-gemcitabine-sandoz-is-used-for","tag-what-is-gemcitabine","tag-what-is-gemcitabine-sandoz"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13389","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=13389"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13389\/revisions"}],"predecessor-version":[{"id":15544,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13389\/revisions\/15544"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=13389"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=13389"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=13389"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}