{"id":13381,"date":"2021-09-07T06:04:03","date_gmt":"2021-09-07T06:04:03","guid":{"rendered":"https:\/\/zeepedia.com\/?p=13381"},"modified":"2021-11-08T10:42:57","modified_gmt":"2021-11-08T10:42:57","slug":"gemcitabine-accord","status":"publish","type":"post","link":"https:\/\/zeepedia.com\/medical\/medicines\/gemcitabine-accord\/","title":{"rendered":"Gemcitabine Accord &#8211; Gemcitabine uses, dose and side effects"},"content":{"rendered":"\n<p>100 mg \/ ml&nbsp;concentrate for&nbsp;infusion&nbsp;solution<br>gemcitabine<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1. What Gemcitabine Accord is and what it is used for<\/h2>\n\n\n\n<p>Gemcitabine Accord 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 Accord can be given alone or in combination with other anticancer medicines, depending on the type of cancer.<\/p>\n\n\n\n<p>Gemcitabine Accord is used to treat 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, along with paclitaxel<\/li><li>ovarian cancer&nbsp;(cancer of the ovaries), together with carboplatin<\/li><li>bladder cancer, together with cisplatin<\/li><\/ul>\n\n\n\n<p>Gemcitabine contained in Gemcitabine Accord may also be approved for the treatment of other conditions not mentioned in this product information.<\/p>\n\n\n\n<p>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 Gemcitabine Accord<\/h2>\n\n\n\n<h2 class=\"wp-block-heading\">Do not use Gemcitabine Accord<\/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) Gemcitabine Accord<\/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, pharmacist, or nurse before taking Gemcitabine Accord.<\/p>\n\n\n\n<p>Before the first&nbsp;infusion, blood samples will be taken to find out if your kidneys and liver are working well enough.&nbsp;In addition, blood samples will be taken before each&nbsp;infusion&nbsp;to check that you have enough&nbsp;blood cells&nbsp;to get Gemcitabine Accord.&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>Tell your doctor:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>if you have or have ever had any liver disease, heart disease, vascular disease or kidney problems.<\/li><li>if you have previously received radiation therapy or such treatment is planned because you may have an immediate or delayed radiation reaction with gemcitabine.<\/li><li>if you have recently been vaccinated as it may cause&nbsp;side effects&nbsp;along with gemcitabine.<\/li><li>If you get symptoms such as headache with confusion, seizures or vision changes during treatment with this medicine, 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 difficulty breathing or if you feel very weak and if you are very pale (may be a sign of lung problems or&nbsp;kidney failure&nbsp;)<\/li><li>if you suffer from alcoholism, as this medicine contains&nbsp;ethanol&nbsp;(alcohol)<\/li><li>if you suffer from&nbsp;epilepsy&nbsp;, then this medicine contains&nbsp;ethanol&nbsp;(alcohol).<\/li><li>if you suffer from capillary leakage syndrome, when fluid from the smaller blood vessels leaks into&nbsp;tissue&nbsp;one.&nbsp;Symptoms may include swelling of the legs, face and arms, weight gain, hypoalbuminemia (too little&nbsp;protein&nbsp;in the blood), severe&nbsp;hypotension&nbsp;(low&nbsp;blood pressure&nbsp;),&nbsp;acute&nbsp;renal impairment and&nbsp;pulmonary edema&nbsp;(fluid in the lungs)<\/li><li>if you suffer from posterior reversible encephalopathy syndrome.&nbsp;Symptoms include loss of consciousness, seizures, vision problems, focal neurological symptoms and&nbsp;acute&nbsp;high&nbsp;blood pressure&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 medicines and Gemcitabine Accord<\/h2>\n\n\n\n<p>Tell your doctor or 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><strong>Pregnancy and breastfeeding<\/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 for advice before using this medicine.&nbsp;Treatment with Gemcitabine Accord should be avoided during pregnancy.&nbsp;Your doctor may inform you about the possible risks of Gemcitabine Accord, as it is given during pregnancy.<\/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 Gemcitabine Accord.<\/p>\n\n\n\n<p><strong>Fertility<\/strong><\/p>\n\n\n\n<p>Men treated with Gemcitabine Accord are advised against having children during and up to 6 months after treatment.&nbsp;If you want to have children during and up to 6 months after treatment, you should seek advice from a doctor or pharmacist.&nbsp;You should also seek advice on saving semen before starting treatment.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Driving and using machines<\/h2>\n\n\n\n<p>Gemcitabine Accord can make you sleepy, especially if you have been drinking alcohol.&nbsp;The amount of alcohol in this medicine may affect your ability to drive or use machines.&nbsp;Do not drive or use machines until you are sure that treatment with Gemcitabine Accord will 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<p><strong>Gemcitabine Accord contains 44% (w \/ v)&nbsp;ethanol&nbsp;(alcohol), ie up to 9.9 g per maximum daily&nbsp;dose&nbsp;(2250 mg), equivalent to 250 ml beer or 100 ml wine per&nbsp;dose.<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Harmful to those suffering from alcoholism.<\/li><li>This should be considered in women who are pregnant or breastfeeding, children and high-risk patients, such as patients with liver disease or&nbsp;epilepsy&nbsp;.<\/li><li>The amount of alcohol in this medicine may affect the effect of other medicines.<\/li><li>The amount of alcohol in this medicine may affect your ability to drive or use machines.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\">Gemcitabine Accord contains 206 mg (9.0 mmol) sodium per maximum daily dose (2250 mg)<\/h2>\n\n\n\n<p>This should be considered by patients on a low-salt diet.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3. How to use Gemcitabine Accord<\/h2>\n\n\n\n<p>The recommended&nbsp;dose&nbsp;of Gemcitabine Accord is 1000-1250 mg for each square meter of body surface area.&nbsp;Your height and weight are measured to calculate the body surface area.&nbsp;Your doctor will then use your body surface area to calculate the right&nbsp;dose&nbsp;for you.&nbsp;Dose&nbsp;one may change or treatment may be delayed depending on your blood levels and your general condition.<\/p>\n\n\n\n<p>How often you receive Gemcitabine Accord depends on the type of cancer you are being treated for.<\/p>\n\n\n\n<p>Pharmacy or healthcare professionals will dilute the gemcitabine concentrate before giving it to you.<\/p>\n\n\n\n<p>You will always receive gemcitabine by&nbsp;infusion&nbsp;(drip) into a blood vessel (a vein).&nbsp;Infusion&nbsp;one will last 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<p>It is unlikely that you will receive too much of the medicine because it is given to you by healthcare professionals, but if you were to receive a larger&nbsp;dose&nbsp;than prescribed by your doctor, you may feel sleepy, dizzy, and feel your heart beating abnormally.<\/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>You must contact a doctor immediately if you experience any of the following:<\/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, feeling weak, easy to breathe or if you look pale (because you may have less&nbsp;hemoglobin&nbsp;than normal which is very common).<\/li><li>Mild to moderate rash (very common) \/ itching (common), or fever (very common);&nbsp;(&nbsp;allergic reaction&nbsp;)<\/li><li>Temperature of 38\u00baC or more, sweating or having other signs of&nbsp;infection&nbsp;(because you may have fewer&nbsp;white blood cells&nbsp;than normal along with fever, which is also called febrile&nbsp;neutropenia&nbsp;) (common)<\/li><li>Pain,&nbsp;redness&nbsp;, swelling or soreness in the mouth (common)<\/li><li>Irregular heart rate (arrhythmia) (uncommon)<\/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 (less common)<\/li><li>Difficulty breathing (&nbsp;Mild&nbsp;breathing difficulties after&nbsp;infusion&nbsp;of Gemcitabine Accord&nbsp;are very common&nbsp;, but are transient. In less common or rare cases, however, severe lung problems occur)<\/li><li>Severe chest pain (heart attack) (rare)<\/li><li>Severe hypersensitivity \/ allergic reaction with severe skin 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 and possibly a feeling of that you will faint (&nbsp;anaphylactic reaction&nbsp;) (very rare)<\/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)<\/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)<\/li><li>Severe rash with&nbsp;itching&nbsp;, blistering or scaly skin (&nbsp;Stevens-Johnson&nbsp;syndrome,&nbsp;toxic epidermal necrolysis&nbsp;) (very rare).<\/li><\/ul>\n\n\n\n<p><strong>Other&nbsp;side effects&nbsp;of Gemcitabine Accord may include:<\/strong><\/p>\n\n\n\n<p><em>Very common (may affect more than 1 in 10 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Low&nbsp;white blood cell count<\/li><li>Low&nbsp;platelet count<\/li><li>Breathing difficulties<\/li><li>Vomiting<\/li><li>Nausea<\/li><li>Hair loss<\/li><li>Liver problems: Seen through abnormal blood test results<\/li><li>Blood in the urine<\/li><li>Abnormal urine samples: egg white in the urine<\/li><li>Flu-like symptoms&nbsp;including fever<\/li><li>Edema&nbsp;(swelling of the ankles, fingers, feet, face)<\/li><\/ul>\n\n\n\n<p><em>Common (may affect up to 1 in 10 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Poor appetite<\/li><li>Headache<\/li><li>Insomnia<\/li><li>Fatigue<\/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>Weakness<\/li><li>Overindulge<\/li><li>Infection&nbsp;is<\/li><\/ul>\n\n\n\n<p><em>Uncommon (may affect up to 1 in 100 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Interstitial&nbsp;pneumonitis&nbsp;(scarring of the lungs)<\/li><li>Respiratory cramps (hissing)<\/li><li>Abnormal lung X-ray (scarred lungs)<\/li><li>Heart failure<\/li><li>Stroke<\/li><li>Severe liver damage, including liver failure<\/li><li>Kidney failure<\/li><\/ul>\n\n\n\n<p><em>Rare (may affect up to 1 in 1,000 people)<\/em><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Low&nbsp;blood pressure<\/li><li>Skin peeling, ulceration or blistering<\/li><li>Injection site reactions<\/li><li>Cold sores in fingers and toes<\/li><li>Fluid in the lungs<\/li><li>Severe&nbsp;pneumonia&nbsp;that causes respiratory failure<\/li><li>Skin reaction caused by radiation (such as severe sunburn) on skin previously exposed to radiation<\/li><li>Radiation toxicity &#8211; scarring of the lung air sacs after radiation therapy<\/li><li>Inflammation&nbsp;of the blood vessels (&nbsp;peripheral&nbsp;vasculitis&nbsp;)<\/li><li>Skin flaking and severe blistering on the skin<\/li><\/ul>\n\n\n\n<p><em>Very rare (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 colon due to decreased blood flow)<\/li><li>Thrombotic microangiopathy: blood clots that form in small blood vessels<\/li><\/ul>\n\n\n\n<p><em>Has been reported<\/em>&nbsp;(may occur 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 levels (&nbsp;anemia&nbsp;), low&nbsp;white blood cell counts,&nbsp;and&nbsp;platelets&nbsp;can be detected with blood tests.<\/p>\n\n\n\n<p>You may get any of these symptoms and\/or conditions.&nbsp;You need to tell your doctor as soon as you notice any of these&nbsp;side effects.<\/p>\n\n\n\n<p>If you get&nbsp;any side effects, talk to your doctor, pharmacist, or nurse.&nbsp;This also applies to any&nbsp;side effects&nbsp;not mentioned in this information.<\/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 Gemcitabine Accord<\/h2>\n\n\n\n<p>Keep out of sight and reach of children.<\/p>\n\n\n\n<p>No special storage instructions.<\/p>\n\n\n\n<p><em>After first opening (before dilution):<\/em><\/p>\n\n\n\n<p>Each&nbsp;vial&nbsp;is for single use only and should be used immediately after opening.&nbsp;If the preparation is not used immediately, the storage conditions are the responsibility of the user.<\/p>\n\n\n\n<p><em>After dilution:<\/em><\/p>\n\n\n\n<p>After dilution in 0.9% sodium chloride solution, the solution is chemically and physically stable for 60 days at 2-8\u00baC, and at 25\u00baC.<\/p>\n\n\n\n<p>For microbiological reasons, the infusion solution should be used immediately.&nbsp;If the preparation is not used immediately, the storage conditions before use are the responsibility of the user.&nbsp;The storage time of reconstituted solution should not normally exceed 24 hours at 2-8\u00baC, unless dilution has taken place under controlled and validated aseptic conditions.<\/p>\n\n\n\n<p>Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.&nbsp;The expiration date is the last day of the specified month.<\/p>\n\n\n\n<p>The medicine will be prepared and given to you by a healthcare professional.<\/p>\n\n\n\n<p>Any unused product should be discarded by a healthcare professional.<\/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>&#8211; The active substance is gemcitabine.&nbsp;Each ml of concentrate for&nbsp;solution&nbsp;for&nbsp;infusion&nbsp;contains 100 mg of gemcitabine (as gemcitabine hydrochloride).&nbsp;Each&nbsp;vial&nbsp;contains either 200 mg, 1000 mg, 1500 mg or 2000 mg gemcitabine (as gemcitabine hydrochloride).<\/p>\n\n\n\n<p>The other ingredients are macrogol 300, propylene glycol, anhydrous&nbsp;ethanol&nbsp;, sodium hydroxide (&nbsp;pH&nbsp;adjuster),&nbsp;hydrochloric acid&nbsp;, concentrated (&nbsp;pH&nbsp;adjuster).<\/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>Gemcitabine Accord concentrate for&nbsp;solution&nbsp;for&nbsp;infusion&nbsp;is a clear, colorless or slightly yellow solution.<\/p>\n\n\n\n<p>Gemcitabine Accord is filled in colorless glass vials which are closed with a rubber stopper and an aluminum closure (flip-off).<\/p>\n\n\n\n<p><em>Pack sizes<\/em><\/p>\n\n\n\n<p>1 x 2 ml&nbsp;vial<\/p>\n\n\n\n<p>1 x 10 ml&nbsp;vial<\/p>\n\n\n\n<p>1 x 15 ml&nbsp;vial<\/p>\n\n\n\n<p>1 x 20 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><em>Marketing Authorisation Holder<\/em><\/p>\n\n\n\n<p>Accord Healthcare BV<\/p>\n\n\n\n<p>Winthontlaan 200<\/p>\n\n\n\n<p>3526 KV Utrecht<\/p>\n\n\n\n<p>Netherlands<\/p>\n\n\n\n<p><em>Manufacturer<\/em><\/p>\n\n\n\n<p>Accord Healthcare Limited<\/p>\n\n\n\n<p>Sage House<\/p>\n\n\n\n<p>319 Pinner Road<\/p>\n\n\n\n<p>North Harrow<\/p>\n\n\n\n<p>Middlesex, HA1 4HF<\/p>\n\n\n\n<p>UK<\/p>\n\n\n\n<p>Accord Healthcare Polska Sp.z oo,<\/p>\n\n\n\n<p>ul.&nbsp;Lutomierska 50,95-200 Pabianice, Poland<\/p>\n\n\n\n<p>Accord Healthcare BV,<\/p>\n\n\n\n<p>Winthontlaan 200,<\/p>\n\n\n\n<p>3526 KV Utrecht,<\/p>\n\n\n\n<p>Netherlands<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gemcitabine Accord 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":[14442,14537,14439,14534,14443,14441,14440,14535],"class_list":["post-13381","post","type-post","status-publish","format-standard","hentry","category-medicines","category-g","tag-benefits-of-gemcitabine","tag-benefits-of-gemcitabine-accord","tag-gemcitabine","tag-gemcitabine-accord","tag-gemcitabine-side-effects","tag-what-gemcitabine-is-used-for","tag-what-is-gemcitabine","tag-what-is-gemcitabine-accord"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13381","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=13381"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13381\/revisions"}],"predecessor-version":[{"id":15546,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/13381\/revisions\/15546"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=13381"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=13381"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=13381"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}