12 ME \/ 0.2 ml, 30 ME \/ 0.5 ml, 48 ME \/ 0.5 ml solution for injection \/ infusion
filgrastim<\/p>\n\n\n\n
Nivestim is a\u00a0white blood cell\u00a0growth factor (granulocyte colony-stimulating factor) and belongs to a group of medicines called\u00a0cytokines.\u00a0Growth factors are\u00a0proteins\u00a0that are produced naturally in the body, but they can also be produced through biotechnology for use as medicines.\u00a0Nivestim works by stimulating the\u00a0bone marrow\u00a0to produce more\u00a0white blood cells.<\/p>\n\n\n\n
The number of\u00a0white blood cells\u00a0can be low (\u00a0neutropenia\u00a0) for various reasons and this makes it harder for the body to fight\u00a0infection.\u00a0Nivestim stimulates\u00a0the bone marrow\u00a0to rapidly produce new\u00a0white blood cells.<\/p>\n\n\n\n
Nivestim can be used for the following:<\/p>\n\n\n\n
Talk to your doctor, pharmacist, or nurse before using Nivestim.<\/p>\n\n\n\n
Tell your doctor before starting treatment if you have any<\/strong><\/p>\n\n\n\n Tell your doctor immediately during treatment with Nivestim, if you<\/p>\n\n\n\n Inflammation\u00a0of the aorta (the large blood vessel that transports blood from the heart to the body) has been reported with the frequency “rare” in cancer patients and healthy donors.\u00a0Symptoms may include fever, abdominal pain, malaise, back pain, and increased inflammatory markers.\u00a0Tell your doctor if you experience these symptoms.<\/p>\n\n\n\n Unsatisfactory treatment response<\/strong><\/p>\n\n\n\n If you respond less or stop responding to filgrastim treatment, your doctor will investigate what is causing this. Among other things, your doctor will check if you have developed antibodies that neutralize the activity of filgrastim.<\/p>\n\n\n\n Your doctor may want to monitor you closely, see section 4 of this leaflet.<\/p>\n\n\n\n If you are a patient and have severe\u00a0chronic\u00a0neutropenia, there may be a risk of developing blood cancer (\u00a0leukemia,\u00a0myelodysplastic syndrome\u00a0(MDS)).\u00a0Talk to your doctor about the risks of getting cancer in the blood and what tests should be done.\u00a0If you get cancer or there is a chance that you may get cancer in your blood, do not use Nivestim unless your doctor tells you to.<\/p>\n\n\n\n If you are a stem cell donor, you must be between 16 and 60 years old.<\/p>\n\n\n\n Take special care with other medicines that stimulate the white blood cells<\/strong><\/p>\n\n\n\n Nivestim belongs to a group of medicines that stimulate the production of\u00a0white blood cells.\u00a0The healthcare staff must always note in the medical record exactly which medicine you are using.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Nivestim has not been studied in pregnant or lactating women.<\/p>\n\n\n\n Nivestim is not recommended during pregnancy.<\/p>\n\n\n\n You must tell your doctor if you:<\/p>\n\n\n\n Tell your doctor if you become pregnant while you are being treated with Nivestim.<\/p>\n\n\n\n Unless your doctor tells you otherwise, stop breastfeeding if you are using Nivestim.<\/p>\n\n\n\n Nivestim may have less effect on the ability to drive and use machines. This medicine may cause dizziness. You should wait and see how you feel after taking Nivestim, before driving or using machines.<\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg) sodium per dose of 0,6 mg \/ ml or 0,96 mg \/ ml, ie essentially ‘sodium-free’.<\/p>\n\n\n\n Nivestim contains sorbitol<\/strong><\/p>\n\n\n\n This medicine contains 50 mg of sorbitol per ml.<\/p>\n\n\n\n Sorbitol is a source of fructose.\u00a0If you (or your child) have\u00a0hereditary\u00a0fructose intolerance, a rare, inherited disease, you (or your child) should not use this medicine.\u00a0Patients with\u00a0hereditary\u00a0fructose intolerance\u00a0can not break down fructose, which can cause serious\u00a0side effects.<\/p>\n\n\n\n Talk to your doctor before using this medicine if you (or your child) have\u00a0hereditary\u00a0fructose 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 Always take this medicine exactly as your doctor has told you.\u00a0If you are not sure, talk to your doctor, nurse, or pharmacist.<\/p>\n\n\n\n How do I get Nivestim and how big is dose one?<\/strong><\/p>\n\n\n\n Nivestim is usually given as a daily\u00a0injection\u00a0into the tissue\u00a0just under the skin (a so-called\u00a0subcutaneous\u00a0injection\u00a0).\u00a0It can also be given as a daily, slow\u00a0injection\u00a0into a vein (a so-called\u00a0intravenous\u00a0infusion\u00a0).\u00a0How much\u00a0does\u00a0you get depends on your illness and your weight.\u00a0Your doctor will tell you how much Nivestim to take.<\/p>\n\n\n\n Patients undergoing bone marrow transplantation after chemotherapy:<\/p>\n\n\n\n In normal cases, you will receive the first dose of Nivestim at least 24 hours after chemotherapy and at least 24 hours after receiving your bone marrow transplant.<\/p>\n\n\n\n You, or people who take care of you, can teach you how to give your subcutaneous injection so that you can continue your treatment at home. However, you should not try this yourself if you have not received enough instruction first from your healthcare provider.<\/p>\n\n\n\n How long do I need to take Nivestim?<\/strong><\/p>\n\n\n\n You will need to take Nivestim until your white blood cell count is normal. Blood samples will be taken regularly to check the number of white blood cells in your body. Your doctor will tell you how long you need to take Nivestim.<\/p>\n\n\n\n Nivestim is used to treat children who are receiving chemotherapy or who have low white blood cell count ( neutropenia ). Dosage for children receiving chemotherapy is the same as for adults.<\/p>\n\n\n\n Do not increase the dose as prescribed by your doctor. If you think you have injected more Nivestim than you should, contact your doctor as soon as possible.<\/p>\n\n\n\n If you have missed an\u00a0injection, or have injected too little, contact your doctor as soon as possible.\u00a0Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor, nurse, or pharmacist\u00a0.<\/strong><\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Tell your doctor immediately<\/strong> during treatment:<\/p>\n\n\n\n – If you get an\u00a0allergic reaction\u00a0with weakness, drop in blood pressure, difficulty breathing, swelling of the face (\u00a0anaphylaxis\u00a0), skin rash, itchy rash (\u00a0hives\u00a0), swelling of the face, lips, mouth, tongue, or throat (\u00a0angioedema\u00a0) and shortness of breath (\u00a0dyspnoea\u00a0). A common\u00a0side effect\u00a0of filgrastim is a pain in muscles and bones (musculoskeletal pain), which can be relieved with common painkillers (\u00a0analgesics\u00a0).\u00a0Patients undergoing a stem cell or bone marrow transplant may suffer from a so-called\u00a0graft-versus-host disease (GvHD).\u00a0This is a reaction of the donated cells directed at the patient receiving the\u00a0transplant.\u00a0Signs and symptoms of this condition are rashes on the palms or soles of the feet, sores in the oral cavity, intestines, liver, skin, or the eyes, lungs,\u00a0vagina,\u00a0and joints.<\/p>\n\n\n\n In healthy stem cell donors, an increase in the number of white blood cells ( leukocytosis ) and a decrease in the number of platelets may occur. This impairs the blood’s ability to coagulate ( thrombocytopenia ). The doctor will check this.<\/p>\n\n\n\n Very common side effects (<\/strong> may affect more than 1 user in 10):<\/p>\n\n\n\n in cancer patients<\/strong><\/p>\n\n\n\n Common side effects (<\/strong> may affect up to 1 in 10 people):<\/p>\n\n\n\n Uncommon side effects (<\/strong> may affect up to 1 in 100 people):<\/p>\n\n\n\n Rare <\/strong>side effects<\/strong> (<\/strong> may affect up to 1 in 1,000 people):<\/strong><\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Use before the expiry date which is stated on the outer carton and the pre-filled syringe after EXP.\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store and transport cold (2 o<\/sup> C-8 o<\/sup> C). Do not freeze. Store the pre-filled syringe in the outer carton. Sensitive to light.<\/p>\n\n\n\n The syringe can be taken out of the refrigerator and left at room temperature for a single period of a maximum of 15 days (but not above 25\u00baC).<\/p>\n\n\n\n Do not use this medicine if you notice that it is cloudy or if there are particles in it.<\/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 Nivestim is a clear, colorless solution for injection\/infusion into pre-filled syringes of glass with an injection needle (stainless steel) fitted with a needle guard.\u00a0The needle cover contains “epoxyprene”, a\u00a0derivative\u00a0of natural rubber latex that can come into contact with the needle.<\/p>\n\n\n\n There are 1, 5, 8, or 10 syringes in each pack.\u00a0Not all pack sizes may be marketed.<\/p>\n\n\n\n Marketing Authorisation Holder<\/strong><\/p>\n\n\n\n Pfizer Europe MA EEIG<\/p>\n\n\n\n Boulevard de la Plaine 17<\/p>\n\n\n\n 1050 Brussels<\/p>\n\n\n\n Belgium<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Hospira Zagreb doo Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n Nivestim is a white blood cell growth factor (granulocyte colony stimulating factor) and belongs to a group of medicines called cytokines . Growth factors are proteins that are produced naturally in the body, but they can also be produced through biotechnology for use as medicines. Nivestim works by stimulating the bone marrow to produce more white blood 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":[2200,15581],"tags":[18702,19088,4628,4627,19084,19087,18701,18700,19085,19086],"class_list":["post-19100","post","type-post","status-publish","format-standard","hentry","category-medicines","category-n","tag-benefits-of-filgrastim","tag-benefits-of-nivestim","tag-filgrastim","tag-filgrastim-side-effects","tag-nivestim","tag-nivestim-side-effects","tag-what-filgrastim-is-used-for","tag-what-is-filgrastim","tag-what-is-nivestim","tag-what-nivestim-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19100","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=19100"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19100\/revisions"}],"predecessor-version":[{"id":19158,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/19100\/revisions\/19158"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=19100"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=19100"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=19100"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Other medicines and Nivestim<\/h2>\n\n\n\n
Pregnancy, breastfeeding and fertility<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Nivestim contains sodium<\/h2>\n\n\n\n
How to use Nivestim<\/h2>\n\n\n\n
Use for children<\/h2>\n\n\n\n
If you use more Nivestim than you should <\/h2>\n\n\n\n
If you forget to use Nivestim<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
– If you get a cough, fever, and difficulty breathing (\u00a0dyspnoea\u00a0).\u00a0This may be a sign of\u00a0acute\u00a0respiratory distress syndrome (ARDS).
– If you get kidney damage (\u00a0glomerulonephritis).\u00a0Kidney damage has been observed in patients receiving filgrastim.\u00a0Contact your doctor immediately if you get swollen in the face or around the ankles, get blood in the urine or brown urine, or notice that you do not urinate as often as usual.<\/p>\n\n\n\n
– If you get any of the following side effects:<\/p>\n\n\n\n
These symptoms can be a sign of a side effect called “capillary leakage syndrome”, which causes fluid to leak from small blood vessels into the body. This condition must be treated immediately.<\/li><\/ul>\n\n\n\n
If you get two or more of any of the following symptoms at the same time:<\/p>\n\n\n\n
This can be a symptom of a condition called “sepsis” (or “blood poisoning”), a serious infection with inflammation throughout the body, which can be life-threatening and requires immediate medical attention.<\/li><\/ul>\n\n\n\n
– If you get pain in the upper left part of the abdomen (abdomen), pain under the ribs on the left side, or at the tip of the shoulder blade, as it may indicate problems with the spleen (enlarged spleen ( splenomegaly ) or ruptured spleen ).
– If you are being treated for severe chronic neutropenia and have blood in your urine ( haematuria ). Your doctor may need to check your urine regularly if you experience this side effect or if you have protein (egg white) in your urine ( proteinuria ).<\/p>\n\n\n\nHow to store Nivestim<\/h2>\n\n\n\n
Contents of the pack and other information<\/h2>\n\n\n\n
What Nivestim contains<\/h2>\n\n\n\n
What the medicine looks like and contents of the pack<\/h2>\n\n\n\n
Marketing Authorization Holder and Manufacturer<\/h2>\n\n\n\n
Prudni\u010dka Cesta 60
10291 Prigorje Brdove\u010dko
Croatia<\/p>\n\n\n\nBelgium \/ Belgique \/ Belgien<\/strong>Luxembourg \/ Luxemburg<\/strong>Pfizer NV \/ SATel: +32 (0) 2 554 62 11<\/td> Lithuania<\/strong>Pfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000<\/td><\/tr> Bulgaria<\/strong>Pfizer Luxembourg SARE, Clone of BulgariaTel: +359 2 970 4333<\/td> Hungary<\/strong>Pfizer Kft.Tel .: + 36 1 488 37 00<\/td><\/tr> Czech Republic<\/strong>Pfizer, spol. s roTel: + 420-283-004-111<\/td> Malta<\/strong>Drugsales LtdTel .: +356 21 419 070\/1\/2<\/td><\/tr> Denmark<\/strong>Pfizer ApSTel: + 45 44 20 11 00<\/td> The Netherlands<\/strong>Pfizer bvTel: +31 (0) 10 406 43 01<\/td><\/tr> Germany<\/strong>PFIZER PHARMA GmbHTel: + 49 (0) 30 550055-51000<\/td> Norway<\/strong>Pfizer ASTel: +47 67 52 61 00<\/td><\/tr> Eesti<\/strong>Pfizer Luxembourg SARL Eesti subsidiaryTel: +372 666 7500<\/td> Austria<\/strong>Pfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0<\/td><\/tr> Greece<\/strong>Aenorasis SA:\u0397\u03bb: + 30 210 6136332<\/td> Poland<\/strong>Pfizer Polska Sp. z ooTel .: +48 22 335 61 00<\/td><\/tr> Spain<\/strong>Pfizer, SLTel: +34 91 490 99 00<\/td> Portugal<\/strong>Pfizer Laboratories, Lda.Tel: +351 21 423 55 00<\/td><\/tr> France<\/strong>PfizerTel: + 33 (0) 1 58 07 34 40<\/td> Romania<\/strong>Pfizer Rom\u00e2nia SRLTel: +40 (0) 21 207 28 00<\/td><\/tr> Croatia<\/strong>Pfizer Croatia dooTel: +385 1 3908 777<\/td> Slovenia<\/strong>Pfizer Luxembourg SARLPfizer, a company in the field of pharmaceuticals, LjubljanaTel: +386 (0) 1 52 11 400<\/td><\/tr> Ireland<\/strong>Pfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161<\/td> Slovak Republic<\/strong>Pfizer Luxembourg SARL, organizerTel: + 421\u20132\u20133355 5500<\/td><\/tr> Iceland<\/strong>Icepharma hf.Phone: +354 540 8000<\/td> Finland \/ Finland<\/strong>Pfizer OyPuh \/ Tel: +358 (0) 9 430 040<\/td><\/tr> Italy<\/strong>Pfizer SrlTel: +39 06 33 18 21<\/td> Sweden<\/strong>Pfizer ABTel: +46 (0) 8 550 520 00<\/td><\/tr> .\u03a0\u03c1\u03bf\u03c2<\/strong>Pfizer \u0395\u039b\u039b\u0391\u03a3 \u0391.\u0395. (Cyprus Branch):\u0397\u03bb: +357 22 817690<\/td> United Kingdom (Northern Ireland)<\/strong>Pfizer LimitedTel: +44 (0) 1304 616161<\/td><\/tr> Latvia<\/strong>Pfizer Luxembourg SARL subsidiary Latvij\u0101Tel .: + 371 670 35 775<\/td> <\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"