{"id":13416,"date":"2021-09-16T07:33:39","date_gmt":"2021-09-16T07:33:39","guid":{"rendered":"https:\/\/zeepedia.com\/?p=13416"},"modified":"2021-11-06T11:33:29","modified_gmt":"2021-11-06T11:33:29","slug":"gitrabin","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/gitrabin\/","title":{"rendered":"Gitrabin &#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 Gitrabin is and what it is used for<\/h2>\n\n\n\n<p>Gitrabin 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>Gitrabin can be given alone or in combination with other anticancer medicines, depending on the type of cancer.<\/p>\n\n\n\n<p>Gitrabin is used to treat the following types of cancer:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>a type of lung cancer (non-&nbsp;small cell lung cancer&nbsp;), as a single drug or in combination with cisplatin<\/li><li>pancreatic cancer<\/li><li>breast cancer, along with paclitaxel<\/li><li>ovarian cancer, along with carboplatin<\/li><li>bladder cancer, together with cisplatin.<\/li><\/ul>\n\n\n\n<p>Gemcitabine contained in Gitrabin may also be approved for the treatment of other conditions not mentioned in this leaflet.&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 Gitrabin<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Gitrabin<\/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>Talk to your doctor or pharmacist before using Gitrabin.<\/p>\n\n\n\n<p>Before the first&nbsp;infusion,&nbsp;a blood sample will be taken to determine if your kidney and liver function is adequate.&nbsp;Before each&nbsp;infusion, blood samples will be taken to check that you have enough&nbsp;blood cells&nbsp;to receive Gitrabin.&nbsp;Your doctor may decide to change&nbsp;your&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 your kidney and liver function.<\/p>\n\n\n\n<p>Talk to your doctor before using Gitrabin if:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>you have or have previously had any liver disease, heart disease, vascular disease or problems with your kidneys<\/li><li>you have previously received radiation treatment or if such treatment is planned<\/li><li>you have recently been vaccinated<\/li><li>you have difficulty breathing or feel very weak and are very pale (may be a sign of&nbsp;kidney failure&nbsp;or lung problems).<\/li><li>If you experience symptoms such as headache with confusion, seizures or changes in vision during treatment with this medicine, you should contact your doctor immediately.&nbsp;This can be a very rare&nbsp;side effect&nbsp;in the nervous system called posterior reversible encephalopathy syndrome.<\/li><li>If you have swelling in your body, shortness of breath or gain weight, you should consult your doctor, as this may be a sign that fluid is leaking from small blood vessels into the&nbsp;tissue&nbsp;.<\/li><\/ul>\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 under 18 years of age due to insufficient data on safety and efficacy.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Other drugs and Gitrabin<\/h2>\n\n\n\n<p>Tell your doctor or pharmacist if you are taking or have recently taken or might be taking any other medicines, including vaccines and over-the-counter medicines, or if you have recently been or will be having radiation therapy before using this medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n<p><strong>Pregnancy<\/strong><\/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.&nbsp;Treatment with Gitrabin should be avoided during pregnancy.&nbsp;Your doctor can inform you about the possible risk of Gitrabin when it is 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>You should stop breastfeeding during treatment with Gitrabin.<\/p>\n\n\n\n<p><strong>Fertility<\/strong><\/p>\n\n\n\n<p>Men are advised not to have children during treatment and up to 6 months after treatment with Gitrabin.&nbsp;If you wish to have children during treatment or during the 6 months following treatment, you should seek advice from your doctor or healthcare professional regarding freezing semen before treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Gitrabin can make you sleepy.<\/p>\n\n\n\n<p>Do not drive or use machines until you are sure that Gitrabin treatment does not affect your attention.<\/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 increased 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 Gitrabin<\/h2>\n\n\n\n<p>Always use this medicine exactly as your doctor or pharmacist has told you.&nbsp;Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;of Gitrabin is 1000-1250 mg per square meter of body surface area.&nbsp;Your height and weight are used to calculate your 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;The dose&nbsp;may need to be changed or the treatment may need to 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 Gitrabin depends on the type of cancer you are being treated for.<\/p>\n\n\n\n<p>Pharmacy or healthcare professionals will dilute the Gitrabin concentrate before giving it to you.<\/p>\n\n\n\n<p>Gitrabin is always given as&nbsp;an infusion&nbsp;into a vein.&nbsp;Infusion&nbsp;one lasts for about 30 minutes.<\/p>\n\n\n\n<p>This medicine is not recommended for children under 18 years of age.<\/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,&nbsp;although not everybody gets them.<\/p>\n\n\n\n<p><em>You must contact your doctor immediately if you notice any of the following:<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Fever or&nbsp;infection&nbsp;(common (may affect up to 1 in 10 people)): if you have a temperature of 38\u00baC or more, sweat or have other signs of&nbsp;infection&nbsp;(because you may have fewer&nbsp;white blood cells&nbsp;, which is very common).<\/li><li>Irregular heartbeat (less common (may affect up to 1 in 100 people)).<\/li><li>Pain,&nbsp;redness&nbsp;, swelling or soreness in the mouth (common (may affect up to 1 in 10 people)).<\/li><li>Allergic reaction: if you get a rash (very common (may affect more than 1 in 10 people)) \/ itching (common (may affect up to 1 in 10 users)) or fever (very common (may affect more than 1 in 10 users) )).<\/li><li>Anaphylactic reaction&nbsp;(severe hypersensitivity \/ allergic reaction) with severe rash including red, itchy skin, swelling of hands, feet, ankles, face, lips, mouth and throat (which may cause difficulty swallowing or breathing), wheezing, rapid heartbeat (&nbsp;tachycardia&nbsp;) and possibly a feeling that you will faint (&nbsp;anaphylactic reaction&nbsp;) (very rare (may affect up to 1 in 10,000 users))<\/li><li>Myocardial infarction (rare (may affect up to 1 in 1,000 people))<\/li><li>Fatigue, feeling weak, easy to breathe or if you look pale (because you have less&nbsp;hemoglobin&nbsp;than normal, which is very common (may affect more than 1 in 10 users)).<\/li><li>Bleeding in the gums, nose or mouth as well as non-stop bleeding, reddish or pinkish urine, unexpected bruising (because you may have smaller&nbsp;platelets&nbsp;than normal, which is very common (may affect more than 1 in 10 users)).<\/li><li>Difficulty breathing (shortly after Gitrabin&nbsp;infusion&nbsp;, it is very common to have mild breathing difficulties, which pass quickly, but in less common or rare cases, more serious lung problems may occur).<\/li><li>Headache with vision changes, confusion, seizures or seizures (&nbsp;Reversible&nbsp;Posterior Leukoencephalopathy Syndrome (RPLS, also known as PRES, Posterior&nbsp;Reversible&nbsp;Encephalopathy&nbsp;Syndrome) (very rare (may affect up to 1 in 10,000 users))<\/li><li>General swelling, shortness of breath or weight gain, as you may have fluid leakage from small blood vessels to the&nbsp;tissues&nbsp;(capillary&nbsp;leakage syndrome&nbsp;) (very rare (may affect up to 1 in 10,000 users))<\/li><li>Severe rash with&nbsp;itching&nbsp;, blistering or scaly skin (&nbsp;Stevens-Johnson&nbsp;syndrome,&nbsp;toxic epidermal necrolysis&nbsp;) (very rare (may affect up to 1 in 10,000 users).<\/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><em>Other&nbsp;side effects&nbsp;with Gitrabin may include:<\/em><\/p>\n\n\n\n<p><em>Very common&nbsp;side effects&nbsp;(may affect more than 1 user in 10)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>low&nbsp;white blood cell count<\/li><li>breathing difficulties<\/li><li>vomiting<\/li><li>nausea<\/li><li>hair loss<\/li><li>liver problems detected by 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>edema&nbsp;(swelling of the ankles, fingers, feet, face)<\/li><\/ul>\n\n\n\n<p><em>Common&nbsp;side effects&nbsp;(may affect up to 1 in 10 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>anorexia&nbsp;(poor appetite)<\/li><li>headache<\/li><li>insomnia<\/li><li>somnolence<\/li><li>cough<\/li><li>Runny nose<\/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>infection&nbsp;is<\/li><\/ul>\n\n\n\n<p><em>Uncommon&nbsp;side effects&nbsp;(may affect up to 1 in 100 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>stroke (&nbsp;stroke&nbsp;)<\/li><li>heart failure<\/li><li>interstitial&nbsp;pneumonitis&nbsp;(scarring of the lungs)<\/li><li>respiratory cramps (wheezing when breathing)<\/li><li>abnormal X-ray of the breast (scarring of the lungs)<\/li><li>severe liver damage, including liver failure, which can be life-threatening<\/li><li>kidney failure<\/li><\/ul>\n\n\n\n<p><em>Rare&nbsp;side effects&nbsp;(may affect up to 1 in 1000 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>low&nbsp;blood pressure<\/li><li>tissue death in fingers or toes<\/li><li>fluid in the lungs<\/li><li>severe&nbsp;pneumonia causing&nbsp;respiratory failure (respiratory failure syndrome in adults)<\/li><li>peeling, sores on the skin or blistering<\/li><li>injection site reactions<\/li><li>scarring of the lung air sacs after radiation therapy (radiation damage)<\/li><li>skin rash, which is similar to severe sun damage, and which can occur on skin that has previously been exposed to radiation (radiation recall)<\/li><\/ul>\n\n\n\n<p><em>Very rare&nbsp;side effects&nbsp;(may affect up to 1 in 10,000 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>increased&nbsp;platelet count<\/li><li>ischemic&nbsp;colitis&nbsp;(&nbsp;inflammation&nbsp;of the wall of the colon caused by decreased blood supply)<\/li><li>thrombotic microangiopathy: blood clots that form in small blood vessels<\/li><\/ul>\n\n\n\n<p><em>Has been reported (occurs in an unknown number of users)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>sepsis: when bacteria and its&nbsp;toxins&nbsp;(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>If you have any of these symptoms and\/or conditions, or when you start to experience any of these&nbsp;side effects, you must tell your doctor immediately.<\/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 Gitrabin<\/h2>\n\n\n\n<p>Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n<p><em>Unopened&nbsp;vial<\/em><\/p>\n\n\n\n<p>Store in a refrigerator (2 \u00baC &#8211; 8 \u00baC).<\/p>\n\n\n\n<p><em>After the first opening<\/em><\/p>\n\n\n\n<p>Chemical and physical in-use stability has been demonstrated for 28 days at 25 \u00baC and at 2-8 \u00baC.<\/p>\n\n\n\n<p>From a&nbsp;microbiological&nbsp;point of view, the product should be used immediately, unless the method of opening excludes the risk of&nbsp;microbiological&nbsp;contamination.&nbsp;If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.<\/p>\n\n\n\n<p><em>Infusion&nbsp;solution<\/em><\/p>\n\n\n\n<p>Chemical and physical in-use stability has been demonstrated for 28 days at 2 till to 8 \u00baC and at approximately 25 \u00baC after dilution in 0.9% sodium chloride solution to a final concentration between 2-25 mg \/ ml (2.0 mg \/ ml, 12 mg \/ ml and 25 mg \/ ml).&nbsp;Diluted solutions are stable when packaged in either PVC or PE infusion bags.<\/p>\n\n\n\n<p>From a&nbsp;microbiological&nbsp;point of view, the infusion solution should be used immediately.&nbsp;If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 till to 8 \u00baC unless diluted under controlled and aseptically validated conditions.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the label and carton.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>Gitrabin should not be used if visible particles are present.<\/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<ul class=\"wp-block-list\"><li>The active substance is gemcitabine (as gemcitabine hydrochloride).&nbsp;Each ml of concentrate for solution for infusion contains 40 mg gemcitabine (as gemcitabine hydrochloride).&nbsp;Each 5 ml&nbsp;vial&nbsp;contains 200 mg of gemcitabine (as gemcitabine hydrochloride).&nbsp;Each 25 ml&nbsp;vial&nbsp;contains 1 g of gemcitabine (as gemcitabine hydrochloride).&nbsp;Each 50 ml&nbsp;vial&nbsp;contains 2 g of gemcitabine (as gemcitabine hydrochloride).<\/li><li>The other ingredients are&nbsp;hydrochloric acid&nbsp;(for&nbsp;pH&nbsp;adjustment), water for injections.<\/li><\/ul>\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>Gitrabin concentrate for solution for infusion is a clear colorless or slightly yellow solution.<\/p>\n\n\n\n<p>Gitrabin is supplied in stained glass vials with a rubber stopper and is sealed with polypropylene sheet aluminum caps.<\/p>\n\n\n\n<p>Each&nbsp;vial&nbsp;is packaged with or without a protective plastic cover.<\/p>\n\n\n\n<p><em>Pack sizes<\/em><\/p>\n\n\n\n<p>1 x 5 ml&nbsp;vial<\/p>\n\n\n\n<p>1 x 25 ml&nbsp;vial<\/p>\n\n\n\n<p>1 x 50 ml&nbsp;vial<\/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>Actavis Group PTC EHF.<\/p>\n\n\n\n<p>Reykjarv\u00edkurvegur 76-78<\/p>\n\n\n\n<p>220 Hafnarfjordur<\/p>\n\n\n\n<p>Iceland<\/p>\n\n\n\n<p><strong>Manufacturer<\/strong><\/p>\n\n\n\n<p>Actavis Italy SpA-Nerviano Plant<\/p>\n\n\n\n<p>Viale Pasteur 10<\/p>\n\n\n\n<p>20014 Nerviano (MI)<\/p>\n\n\n\n<p>Italy<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gitrabin 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":[14442,14447,14439,14443,14444,14448,14441,14446,14440,14445],"class_list":["post-13416","post","type-post","status-publish","format-standard","hentry","category-medicines","category-g","tag-benefits-of-gemcitabine","tag-benefits-of-gitrabin","tag-gemcitabine","tag-gemcitabine-side-effects","tag-gitrabin","tag-gitrabin-side-effects","tag-what-gemcitabine-is-used-for","tag-what-gitrabin-is-used-for","tag-what-is-gemcitabine","tag-what-is-gitrabin"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13416","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=13416"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13416\/revisions"}],"predecessor-version":[{"id":15513,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13416\/revisions\/15513"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=13416"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=13416"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=13416"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}