Fertility<\/em><\/p>\n\n\n\nNo studies have been performed. This medicine may affect your fertility . Talk to your doctor about the possible risks of this medicine and what your options are for preserving your chances of having children.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
In some cases, Irinotecan Accord may cause side effects that affect the ability to drive and use machines.<\/p>\n\n\n\n
During the first 24 hours after receiving Irinotecan Accord, you may feel dizzy or have visual disturbances. If this happens, do not drive or use any tools or machines.<\/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. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and \/ or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor if you are unsure.<\/p>\n\n\n\n
Irinotecan Accord contains excipients<\/h2>\n\n\n\n
This medicine contains 45 mg sorbitol per ml. Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance , a rare, inherited disease, you (or your child) should not use this medicine. Patients with hereditary fructose intolerance cannot break down fructose, which can cause serious side effects .<\/p>\n\n\n\n
Talk to your doctor before using this medicine if you (or your child) have hereditary fructose intolerance , or if your child can no longer eat sweet food or drink without feeling sick, vomiting or feeling uncomfortable such as bloating, stomach cramps or diarrhea.<\/p>\n\n\n\n
This medicine contains less than 1 mmol sodium per dose , ie essentially ‘ sodium – free’ . is next to “sodium-free”.<\/p>\n\n\n\n
3. How to use Irinotecan Accord<\/h2>\n\n\n\n
Always use this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.<\/p>\n\n\n\n
Irinotecan Accord will be given to you by healthcare professionals.<\/p>\n\n\n\n
Your doctor may recommend a DNA test before the first dose of Irinotecan Accord.<\/p>\n\n\n\n
Some people are genetically more likely to get certain side effects from this drug.<\/p>\n\n\n\n
You may be given other medicines to prevent nausea, vomiting, diarrhea and other side effects when you receive Irinotecan Accord. You may need to continue using these medicines for at least one day after injecting one with Irinotecan Accord.<\/p>\n\n\n\n
Tell your healthcare provider if you experience burning sensation, pain or swelling around the infusion needle when you receive Irinotecan Accord. If drugs end up outside the vein, it can cause tissue damage. If you experience pain or notice redness or swelling at the infusion site when you receive Irinotecan Accord, inform your healthcare professional immediately.<\/p>\n\n\n\n
Irinotecan Accord will be given as an infusion (drip) into a vein over a period of 30 to 90 minutes. The amount of infusion given to you depends on your age, size and your general medical condition. It also depends on any other treatment you may have received for your cancer. The doctor calculates your body area in square meters (m 2<\/sup> ).<\/p>\n\n\n\n- If you have previously been treated with 5-fluorouracil, you will usually be treated with Irinotecan Accord alone and start with a dose of 350 mg \/ m 2<\/sup> once every three weeks.<\/li>
- If you have not received chemotherapy before, you will normally receive 180 mg \/ m 2<\/sup> Irinotecan Accord once every two weeks. This will then be followed by folic acid and 5-fluorouracil.<\/li>
- If you are being treated with irinotecan in combination with cetuximab, you will normally receive the same dose of irinotecan given in the last previous treatment cycles that contained irinotecan. Irinotecan Accord must not be given earlier than 1 hour after the end of the infusion of cetuximab.<\/li><\/ul>\n\n\n\n
The doses can be adjusted by your doctor depending on your general condition and any side effects .<\/p>\n\n\n\n
If you use more Irinotecan Accord than you should <\/h2>\n\n\n\n
It is unlikely that you will get too much Irinotecan Accord. Should this still happen, you can get severe blood diseases and diarrhea. Maximum supportive care should be taken to prevent dehydration due to diarrhea and to treat any infectious complications. Talk to the doctor who gives you the medicine.<\/p>\n\n\n\n
If you forget to use Irinotecan Accord<\/h2>\n\n\n\n
It is very important that you get all the planned doses . If you miss a dose , contact your doctor immediately.<\/p>\n\n\n\n
4. Possible side effects<\/h2>\n\n\n\n
Like all medicines, Irinotecan Accord can cause side effects , although not everybody gets them. Your doctor will inform you about these side effects and explain the risks and benefits of treatment. Some of these side effects need to be treated immediately.<\/p>\n\n\n\n
See also the information in the section “Warnings and precautions”<\/strong> .<\/p>\n\n\n\nIf you get any of the following side effects after taking this medicine, contact your doctor immediately. If you are not in the hospital, you MUST SEEK a hospital immediately.<\/p>\n\n\n\n
- Allergic reactions. If you have wheezing, difficulty breathing, swelling, rash or itching (especially if your whole body is affected), contact a doctor or nurse immediately.<\/li>
- Severe allergic reactions (anaphylactic \/ anaphylactoid reactions) can occur, usually minutes after injection of the drug: rash including red, itchy skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may lead to difficulty swallowing) and it may feel like you are about to faint.<\/li>
- Diarrhea (see section 2).<\/li>
- Early diarrhea: Occurs within 24 hours of receiving this medicine, accompanied by symptoms such as runny nose, increased salivation, watery eyes, sweating, redness and stomach cramps. (This may occur while you are receiving an infusion . If this happens, tell your healthcare provider immediately. You may be given medicines that prevent and \/ or alleviate this early side effect ).<\/li>
- Late diarrhea: Occurs later than 24 hours after receiving this medicine. Due to the risk of dehydration and electrolyte disturbances in connection with diarrhea, it is important to be in contact with the healthcare staff for follow-up and advice regarding changes in medication and diet.<\/li><\/ul>\n\n\n\n
Very common (may affect more than 1 user in 10)<\/em><\/strong><\/p>\n\n\n\n- blood disease: neutropenia (decreased number of certain white blood cells ), thrombocytopenia (decreased number of platelets ), anemia (decreased number of red blood cells )<\/li>
- delayed diarrhea<\/li>
- nausea and vomiting<\/li>
- hair loss (hair grows back after treatment)<\/li>
- transient increase in liver enzymes or bilirubin during combination therapy.<\/li><\/ul>\n\n\n\n
Common (may affect up to 1 in 10 people)<\/em><\/strong><\/p>\n\n\n\n- acute cholinergic syndrome: the main symptoms consist of diarrhea and other symptoms such as abdominal pain; red, sore, itchy or watery eyes ( conjunctivitis ); rinnsnuva ( rhinitis ); low blood pressure; dilation of blood vessels; sweating; overindulge; general malaise and nausea; dizziness, visual disturbances; small pupils; watery eyes and increased salivation, occurring during or within 24 hours after infusion with Irinotecan Accord<\/li>
- fever, infection (including sepsis)<\/li>
- fever associated with a sharp decrease in white blood cells<\/li>
- dehydration, usually associated with diarrhea and \/ or vomiting<\/li>
- constipation<\/li>
- fatigue<\/li>
- elevated liver enzyme levels and creatinine levels in the blood.<\/li><\/ul>\n\n\n\n
Uncommon (may affect up to 1 in 100 people)<\/em><\/strong><\/p>\n\n\n\n- allergic reactions: if you have wheezing, difficulty breathing, swelling, rash or itching (especially if your whole body is affected), contact a doctor or nurse immediately<\/li>
- mild skin reactions; mild reactions at the infusion site<\/li>
- breathing difficulties<\/li>
- lung disease (interstitial lung disease)<\/li>
- stop in the intestine<\/li>
- abdominal pain and inflammation leading to diarrhea (a condition called pseudomembranous colitis )<\/li>
- Rare cases of renal failure , hypotension and cardiac \u2011 circulatory failure have been observed in patients suffering from dehydration associated with diarrhea and \/ or vomiting or blood poisoning.<\/li><\/ul>\n\n\n\n
Rare (may affect up to 1 in 1,000 people)<\/em><\/strong><\/p>\n\n\n\n- severe allergic reactions (anaphylactic \/ anaphylactoid reactions) may occur, usually minutes after injection of the drug: rash including red, itchy skin, swelling of hands, feet, ankles, face, lips, mouth or throat (which may lead to difficulty swallowing) and it may feel like you are about to faint. If this happens, consult a doctor immediately<\/li>
- early effects such as muscle contraction or cramping and numbness ( paresthesia )<\/li>
- bleeding in the gastrointestinal tract and inflammation of the colon including the appendix<\/li>
- intestinal perforation (hole in the intestinal wall), loss of appetite, abdominal pain, mucositis<\/li>
- pancreatitis<\/li>
- high blood pressure during and after the medicine is given<\/li>
- decreased levels of potassium or sodium in the blood, often associated with diarrhea and vomiting.<\/li><\/ul>\n\n\n\n
Very rare (may affect up to 1 in 10,000 people)<\/em><\/strong><\/p>\n\n\n\n- transient speech disorders<\/li>
- elevated levels of certain digestive enzymes, which break down sugar and fats.<\/li><\/ul>\n\n\n\n
Has been reported<\/strong> (may occur in an unknown number of users):<\/p>\n\n\n\n- severe, persistent or bloody diarrhea (which may be associated with abdominal pain or fever) caused by bacteria called Clostridium difficile<\/em><\/li>
- blood infection<\/li>
- dehydration (due to diarrhea and vomiting)<\/li>
- dizziness, rapid heartbeat and pale skin (a condition called hypovolemia )<\/li>
- allergic reaction<\/li>
- temporary speech disorders during or shortly after treatment<\/li>
- tingling and numbness<\/li>
- high blood pressure (during or after infusion )<\/li>
- heart problems *<\/li>
- lung disease that causes wheezing and shortness of breath (see section 2)<\/li>
- hiccup<\/li>
- intestinal blockage<\/li>
- enlarged colon<\/li>
- bleeding from the intestines<\/li>
- inflammation of the colon<\/li>
- deviating laboratory results<\/li>
- holes in the intestine<\/li>
- fatty liver disease<\/li>
- skin reactions<\/li>
- reactions at the site where the drug was administered<\/li>
- low levels of potassium in the blood<\/li>
- low levels of salt in the blood that are usually associated with diarrhea and vomiting<\/li>
- muscle cramps<\/li>
- kidney problems *<\/li>
- low blood pressure*<\/li>
- fungal infections<\/li>
- viral infections<\/li><\/ul>\n\n\n\n
* Rare cases of these events have been observed in patients who have experienced dehydration associated with diarrhea and \/ or vomiting or infection in the blood.<\/p>\n\n\n\n
If you receive Irinotecan Accord in combination with cetuximab<\/strong> , some of the side effects you may experience may also be related to this combination. Such side effects may include: acne-like rash. Thus, you must also read the package leaflet for cetuximab.<\/p>\n\n\n\nIf you receive Irinotecan Accord in combination with capecitabine<\/strong> , some of the side effects you may experience may also be related to this combination. Such side effects may include: very common: blood clots, common: allergic reactions, heart attack and fever in patients with low white blood cell count . You must therefore also read the package leaflet for capecitabine.<\/p>\n\n\n\nIf you are receiving Irinotecan Accord in combination with capecitabine<\/strong> and bevacizumab<\/strong> , some of the side effects you are experiencing may also be related to this combination. Such side effects may include: low white blood cell count , blood clots, high blood pressure and heart attack. You must therefore also read the package leaflet for capecitabine and bevacizumab.<\/p>\n\n\n\nReporting of side effects<\/em><\/p>\n\n\n\nIf you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.<\/p>\n\n\n\n
5. How to store Irinotecan Accord<\/h2>\n\n\n\n
Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n
Do not freeze.<\/p>\n\n\n\n
For single use only.<\/p>\n\n\n\n
No special storage instructions. Store in the original package. Sensitive to light. Used before the expiry date which is stated on the carton and vial after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n
6. Contents of the packaging and other information<\/h2>\n\n\n\nContent declaration<\/h2>\n\n\n\n- The active substance is irinotecan hydrochloride trihydrate.<\/li>
- 1 ml of concentrate contains 20 mg irinotecan hydrochloride trihydrate equivalent to 17.33 mg irinotecan.<\/li>
- One 2 ml vial contains 40 mg irinotecan hydrochloride trihydrate.<\/li>
- One 5 ml vial contains 100 mg irinotecan hydrochloride trihydrate.<\/li>
- One 15 ml vial contains 300 mg irinotecan hydrochloride trihydrate.<\/li>
- One 25 ml vial contains 500 mg irinotecan hydrochloride trihydrate.<\/li>
- One 50 ml vial contains 1,000 mg of irinotecan hydrochloride trihydrate.<\/li>
- The other ingredients are sorbitol (E420), lactic acid , sodium hydroxide, hydrochloric acid and water for injections.<\/li><\/ul>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Irinotecan Accord 20 mg \/ ml concentrate for solution for infusion is a clear, light yellow solution.<\/p>\n\n\n\n
Pack sizes:<\/p>\n\n\n\n
2 ml<\/p>\n\n\n\n
5 ml<\/p>\n\n\n\n
15 ml<\/p>\n\n\n\n
25 ml<\/p>\n\n\n\n
50 ml<\/p>\n\n\n\n
Not all pack sizes may be marketed<\/p>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/strong><\/p>\n\n\n\nAccord Healthcare BV<\/p>\n\n\n\n
Winthontlaan 200<\/p>\n\n\n\n
3526 KV Utrecht<\/p>\n\n\n\n
Netherlands<\/p>\n\n\n\n
Manufacturer<\/strong><\/p>\n\n\n\nAccord Healthcare Limited<\/p>\n\n\n\n
Sage House, 319, Pinner Road, North Harrow<\/p>\n\n\n\n
Middlesex HA1 4HF<\/p>\n\n\n\n
UK<\/p>\n\n\n\n
Accord Healthcare Polska Sp.z oo,<\/p>\n\n\n\n
ul. Lutomierska 50,95-200 Pabianice, Poland<\/p>\n\n\n\n
Accord Healthcare BV,<\/p>\n\n\n\n
Winthontlaan 200,<\/p>\n\n\n\n
3526 KV Utrecht,<\/p>\n\n\n\n
Netherlands<\/p>\n","protected":false},"excerpt":{"rendered":"
Irinotecan Accord belongs to a group of medicines called cytostatics (medicines for cancer). Irinotecan Accord is used for treating advanced cancer of the colon and rectum in adults, either in combination with other medicines or alone. Irinotecan Accord is a cancer medicine that contains the active substance irinotecan hydrochloride trihydrate. Irinotecan hydrochloride trihydrate prevents the growth and spread of cancer cells in the body.<\/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":[12116,2200],"tags":[12359,12355,12360,12358,12350,12353,12354,12357,12352,12356,12351],"class_list":["post-14544","post","type-post","status-publish","format-standard","hentry","category-i","category-medicines","tag-benefits-of-irinotecan-accord","tag-irinotecan-accord","tag-irinotecan-accord-side-effects","tag-irinotecan-accord-uses","tag-irinotecan-hydrochloride-trihydrate","tag-irinotecan-hydrochloride-trihydrate-uses","tag-side-effects-of-irinotecan-hydrochloride-trihydrate","tag-what-irinotecan-accord-is-used-for","tag-what-irinotecan-hydrochloride-trihydrate-is-used-for","tag-what-is-irinotecan-accord","tag-what-is-irinotecan-hydrochloride-trihydrate"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14544","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=14544"}],"version-history":[{"count":5,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14544\/revisions"}],"predecessor-version":[{"id":14779,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/14544\/revisions\/14779"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=14544"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=14544"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=14544"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}