5.83 mg\/ml\u00a0solution for injection\u00a0in\u00a0cartridge\u00a0somatropin<\/p>\n\n\n\n
Somatropin is a\u00a0growth hormone.\u00a0Saizen’s most important function is to increase growth in children and adolescents and to treat adults with\u00a0growth hormone deficiency.<\/p>\n\n\n\n
The growth hormone\u00a0(somatropin) found in Saizen is almost identical to the natural human\u00a0growth hormone, except that it is produced outside the body through a process called “recombinant\u00a0DNA\u00a0technology” (genetic engineering).<\/p>\n\n\n\n
Saizen is used:<\/strong><\/p>\n\n\n\n Children and adolescents:<\/p>\n\n\n\n Adults:<\/p>\n\n\n\n This treatment is given to adults who have a severe growth hormone deficiency and who have been medically diagnosed with a test.<\/p>\n\n\n\n Doctors or pharmacists can explain why you or your child have been prescribed this treatment.<\/p>\n\n\n\n Somatropin contained in Saizen may also be approved for the treatment of other conditions not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n Saizen treatment must be stopped in children with chronic kidney disease before a kidney transplant.<\/p>\n\n\n\n Talk to your doctor before using Saizen.<\/p>\n\n\n\n Saizen treatment should be performed under regular supervision by a physician experienced in the diagnosis and treatment of patients with\u00a0growth hormone deficiency.<\/p>\n\n\n\n Shortly after you (or your child) have taken Saizen, you may feel shaky or dizzy due to low blood sugar. This feeling will quickly disappear. The blood sugar level can then rise above the normal level 2-4 hours after the administration. Because growth hormone therapy can alter the body’s sugar metabolism, blood sugar levels will be checked regularly by a doctor. Somatropin may cause the blood sugar level to rise.<\/p>\n\n\n\n If you (or your child) are diabetic or if someone in the family has\u00a0diabetes, your doctor will closely monitor your blood counts and possibly change your diabetes treatment while you are being treated with Saizen.<\/p>\n\n\n\n Regular eye check-ups may be necessary after receiving this medicine.<\/p>\n\n\n\n Saizen can affect your thyroid function. Your doctor may check the levels of thyroid hormone in your blood and prescribe another hormone if you (or your child) have developed a thyroid hormone deficiency.<\/p>\n\n\n\n If you (or your child) are taking\u00a0corticosteroids, you should contact your doctor regularly, as you may need to adjust your corticosteroid dose or your\u00a0dose\u00a0of Saizen.<\/p>\n\n\n\n Saizen can cause fluid retention in adult patients. This can manifest itself in the form of swelling and joint or muscle pain. If you get these symptoms, tell your doctor who may decide to change the dose of Saizen.<\/p>\n\n\n\n If you have had a\u00a0tumor\u00a0during your childhood and were treated with Saizen, there is an increased risk that a new\u00a0tumor will\u00a0develop.\u00a0If you (or your child) have previously had a disease that affects the brain, e.g.\u00a0a\u00a0tumor, your doctor will regularly examine you (or your child) to make sure it has not returned.<\/p>\n\n\n\n In rare cases, Saizen can cause inflammation of the pancreas, causing severe pain in the abdomen and back. Keep this in mind especially if your child has abdominal pain and contact your doctor.<\/p>\n\n\n\n Some patients may develop swelling in the brain during treatment with Saizen.\u00a0Contact a doctor immediately if you (or your child) have a severe or recurrent headache, vision problems, nausea, and\/or vomiting,\u00a0Then it may be necessary to discontinue growth hormone therapy.\u00a0The treatment can be started again later.\u00a0If the symptoms of swelling in the brain recur, treatment with Saizen should be stopped.<\/p>\n\n\n\n If the medicine is injected at the same site for a long time, damage to the injection site may occur. It is therefore important to vary the injection site. Your doctor or pharmacist may tell you which areas of your body to use for injection (see section 3 How to use Saizen).<\/p>\n\n\n\n Some children with\u00a0growth hormone deficiency\u00a0have developed\u00a0leukemia\u00a0(increased\u00a0white blood cell count\u00a0), whether or not they have been treated with\u00a0growth hormone.\u00a0However, there is no evidence that the incidence of\u00a0leukemia\u00a0is increased in growth hormone-treated patients without predisposition factors.\u00a0No causal relationship with growth hormone therapy has been demonstrated.<\/p>\n\n\n\n Hip problems sometimes occur in children with\u00a0hormone\u00a0or kidney problems.\u00a0If your child suffers from\u00a0chronic\u00a0kidney failure, which can occur when the kidneys are damaged, he or she should be examined regularly for signs of possible skeletal damage.\u00a0It is uncertain whether skeletal damage in children with\u00a0hormone\u00a0or kidney problems is affected by\u00a0growth hormone\u00a0treatment.\u00a0X-ray examination of the hip should be done before starting treatment.\u00a0If your child starts to limp or complains of pain in the hip or knee during treatment with Saizen, tell your doctor.<\/p>\n\n\n\n In children with\u00a0chronic\u00a0kidney failure, treatment should be stopped before a kidney transplant.<\/p>\n\n\n\n Saizen is not intended for long-term treatment of children with a growth disorder due to\u00a0Prader-Willi syndrome, which has been genetically confirmed unless\u00a0growth hormone\u00a0deficiency has also been diagnosed.\u00a0Sleep apnea\u00a0(temporary pauses in breathing during sleep) and sudden death have been reported after initiating\u00a0growth hormone\u00a0therapy in children with\u00a0Prader-Willi syndrome, who had one or more of the following risk factors: severe obesity, previously impaired lung function or\u00a0sleep apnea, or unidentified respiratory infection.<\/p>\n\n\n\n Growth hormone should not be given to seriously ill people.<\/p>\n\n\n\n If you are over 60 years of age or if you are being treated with Saizen for a long time, you should be examined more often by your doctor.\u00a0Due to less experienced in the treatment of the elderly and long-term treatment with Saizen, special care is required in these situations.<\/p>\n\n\n\n Tell your doctor or pharmacist if you (or your child) are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n If you (or your child) use cortisone, it is important to tell your doctor or pharmacist.\u00a0These medicines can affect Saizen and therefore your doctor may need to adjust the\u00a0dosage\u00a0of one of these medicines or Saizen.\u00a0Cortisone preparations are used to treat many serious diseases such as\u00a0asthma,\u00a0allergies,\u00a0and\u00a0chronic\u00a0rheumatoid arthritis\u00a0(\u00a0rheumatoid arthritis\u00a0).<\/p>\n\n\n\n If you receive\u00a0substitution treatment\u00a0with oral\u00a0estrogen, it may affect Saizen’s effect on growth.\u00a0Your doctor may therefore need to adjust the\u00a0dose\u00a0of one of Saizen.<\/p>\n\n\n\n If you are being treated with sex hormones, medicines for\u00a0epilepsy,\u00a0or ciclosporin (a medicine that weakens the immune system after transplantation), tell your doctor as the\u00a0dose\u00a0of one of these medicines may need to be adjusted.<\/p>\n\n\n\n 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 There is insufficient information on the safety of growth hormone therapy during pregnancy and lactation. Saizen treatment should be discontinued during pregnancy.<\/p>\n\n\n\n Medicines containing somatropin have no known effect on the ability to drive and use machines.<\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per\u00a0cartridge, ie essentially ‘sodium-free’.<\/p>\n\n\n\n Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n Dosage<\/strong><\/p>\n\n\n\n The dose and frequency of Saizen are adjusted by your doctor depending on your (or your child’s) body weight or body surface area.<\/p>\n\n\n\n It is recommended that Saizen be given in the evening.<\/p>\n\n\n\n Children and adolescents:<\/p>\n\n\n\n Adults:<\/p>\n\n\n\n Method and method of injection<\/strong><\/p>\n\n\n\n The dose\u00a0and how often Saizen should be injected will be determined by your doctor and will depend on your (or your child’s) size or body weight.\u00a0Usually, Saizen should be administered daily by\u00a0subcutaneous\u00a0injection\u00a0(under the skin).<\/p>\n\n\n\n Important information<\/strong><\/p>\n\n\n\n Read the following instructions carefully before injecting Saizen.<\/p>\n\n\n\n When the drug is injected in the same place every time for a long time, it can cause injuries.\u00a0It is important to vary the injection site at all times.\u00a0Your doctor or pharmacist can tell you which area of \u200b\u200byour body you should use.\u00a0Do not use a place where you feel lumps, firm lumps, pits, or pain, talk to your doctor or pharmacist if you feel it.\u00a0Clean the skin at the injection site with soap and water.<\/p>\n\n\n\n Cylinder cartridge\u00a0one with the solution with Saizen is ready to use for\u00a0injection\u00a0with an easy pod auto-injector or aluetta pen-injector.<\/p>\n\n\n\n Each cartridge with\u00a0Saizen\u00a0is color-coded and can only be used with the aluetta pen injector that has a matching color code to give the correct\u00a0dose.\u00a0A cylinder\u00a0cartridge containing 6 mg somatropin (blue) may only be used with Aletta pen injector 6 (blue).<\/p>\n\n\n\n Put everything you need for\u00a0injection\u00a0of one of the solutions on a clean surface and wash your hands with soap and water.<\/p>\n\n\n\n The solution should be ready to be slightly opalescent without particles and visible signs of deterioration.\u00a0If the solution contains particles, it should not be injected.<\/p>\n\n\n\n How to take your daily injection of Saizen yourself<\/strong><\/p>\n\n\n\n Carefully read the instructions that come with each injector for a description of how\u00a0to insert a cartridge into an easy pod auto-injector or aluetta pen injector and how to inject the solution with Saizen.\u00a0Easypod is primarily intended for children from 7 years and up and adults.\u00a0For children, the use of injectable drugs should always be done under the supervision of an adult.<\/p>\n\n\n\n Duration of treatment<\/strong><\/p>\n\n\n\n Your child should stop using this treatment when he\/she reaches a satisfactory height or his \/ her legs can no longer grow, as judged by his \/ her doctor.\u00a0Saizen treatment will be discontinued in children with\u00a0chronic\u00a0kidney disease before a kidney transplant.<\/p>\n\n\n\n In adults with\u00a0a growth hormone deficiency, this is a condition that lasts a lifetime and should be treated accordingly by your doctor.<\/p>\n\n\n\n If you inject too much Saizen, tell your doctor, as\u00a0one may need to be changed slightly to correct what happened.\u00a0If you inject too much, there may be changes in your blood sugar levels.\u00a0This can mean that you (or your child) feel shaky and dizzy.\u00a0Contact your doctor immediately if this occurs.<\/p>\n\n\n\n If you have ingested too much medicine or if e.g.\u00a0If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.<\/p>\n\n\n\n If you miss a\u00a0dose, tell your doctor as it may be necessary to change the\u00a0dose\u00a0slightly to correct what happened.<\/p>\n\n\n\n Do not stop taking Saizen without talking to your doctor.<\/p>\n\n\n\n If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Contact your doctor immediately if you experience severe and recurrent headaches with nausea, vomiting,<\/strong> or visual disturbances.\u00a0This is a symptom of a less common side effect called benign\u00a0intracranial\u00a0hypertension.<\/strong><\/p>\n\n\n\n Side effects\u00a0can occur with a certain frequency, which is defined as follows:<\/strong><\/p>\n\n\n\n Common side effects:<\/strong><\/p>\n\n\n\n Uncommon side effects:<\/strong><\/p>\n\n\n\n Very rare side effects:<\/strong><\/p>\n\n\n\n Side effects with unknown frequency:<\/strong><\/p>\n\n\n\n You (or your child) may get allergic reactions from treatment with Saizen.<\/p>\n\n\n\n You (or your child) may have elevated insulin levels (hyperinsulinism) because muscle, fat, and liver cells do not respond properly to\u00a0insulin\u00a0during growth hormone therapy (insulin resistance).\u00a0This condition can result in high blood sugar (hyperglycemia).<\/p>\n\n\n\n In rare cases,\u00a0inflammation\u00a0of the pancreas has been reported in patients treated with\u00a0growth hormone.<\/p>\n\n\n\n A few isolated cases of\u00a0leukemia\u00a0have been reported in patients with\u00a0a growth hormone deficiency, some of whom have been treated with somatropin.\u00a0However, there is no evidence that the incidence of\u00a0leukemia\u00a0is increased in growth hormone-treated patients without predisposition factors.<\/p>\n\n\n\n In very rare cases, patients may develop\u00a0antibodies\u00a0(a type of\u00a0protein\u00a0that helps protect the body) against somatropin.\u00a0These usually do not cause any\u00a0side effects\u00a0and utypicallydo not affect growth.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the cartridge after EXP. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Store the unused cartridge with Saizen in a refrigerator (2 \u00b0 C – 8 \u00b0 C). Store in the original package. Sensitive to light. Do not freeze.<\/p>\n\n\n\n Use within 28 days after the first\u00a0injection.<\/p>\n\n\n\n After the first\u00a0injection, cartridge one\u00a0with Saizen, easy pod autoinjector containing cartridge\u00a0one\u00a0with\u00a0Saizen, or aluetta pen injector containing cartridge\u00a0one\u00a0with Saizen must be stored in a refrigerator (2 \u00b0 C-8 \u00b0 C) for a maximum of 28 days, of which up to 7 days may be outside refrigerator at a maximum of 25 \u00b0 C.\u00a0After storage outside the refrigerator for up to 7 days, the cartridge one with\u00a0Saizen\u00a0must be put back in the refrigerator and used within 28 days after the first\u00a0injection.<\/p>\n\n\n\n When using an easy pod auto-injector or aluetta pen-injector, the cartridge should be\u00a0stored\u00a0in the auto-injector.<\/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 The active substance is somatropin ( recombinant human growth hormone ) 6 mg.<\/p>\n\n\n\n The other ingredients are sucrose, poloxamer 188, phenol, citric acid (for\u00a0pH\u00a0adjustment), sodium hydroxide (for\u00a0pH\u00a0adjustment), and water for injections.<\/p>\n\n\n\n Saizen 5.83 mg\/ml is a clear to slightly opalescent\u00a0solution for injection\u00a0in a pre-filled\u00a0cartridge\u00a0(type 1 glass) with a plunger, a stopper (rubber), and a shrink stopper (aluminum and rubber), containing a nominal 1.03 ml solution (6 mg somatropin).\u00a0A cylinder\u00a0cartridge containing 6 mg somatropin has a color-labeled label (blue).<\/p>\n\n\n\n Pack sizes of 1 and 5\u00a0cartridges.<\/p>\n\n\n\n Not all pack sizes may be marketed.<\/p>\n\n\n\n Merck AB<\/p>\n\n\n\n Box 3033<\/p>\n\n\n\n 169 03 Solna<\/p>\n\n\n\n Manufacturer<\/strong><\/p>\n\n\n\n Merck Serono SpA, Modugno, Bari, Italy<\/p>\n\n\n\n This medicinal product is authorized under the European Economic Area under the names:<\/strong><\/p>\n\n\n\n Size: Belgium, Estonia, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Luxembourg, Norway, Portugal, Romania, Slovakia, Spain, UK, Sweden, Czech Republic, Germany, Hungary, Austria<\/p>\n","protected":false},"excerpt":{"rendered":" Somatropin is a growth hormone . Saizen’s most important function is to increase growth in children and adolescents and to treat adults with growth hormone deficiency .<\/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":[2200,18530],"tags":[23522,13646,23518,23521,13643,13647,23519,13644,23520,13645],"class_list":["post-22565","post","type-post","status-publish","format-standard","hentry","category-medicines","category-s","tag-benefits-of-saizen","tag-benefits-of-somatropin","tag-saizen","tag-saizen-side-effects","tag-somatropin","tag-somatropin-side-effects","tag-what-is-saizen","tag-what-is-somatropin","tag-what-saizen-is-used-for","tag-what-somatropin-is-used-for"],"_links":{"self":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22565","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=22565"}],"version-history":[{"count":4,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22565\/revisions"}],"predecessor-version":[{"id":22584,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/posts\/22565\/revisions\/22584"}],"wp:attachment":[{"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/media?parent=22565"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/categories?post=22565"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zeepedia.com\/medical\/wp-json\/wp\/v2\/tags?post=22565"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}What you need to know before using Saizen<\/h2>\n\n\n\n
Do not use Saizen<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
An increase in the oblique back (scoliosis) can develop in children who grow rapidly.\u00a0During treatment with Saizen, your doctor will examine you (or your child) for signs of scoliosis.<\/p>\n\n\n\n
If you do not respond to treatment with Saizen, you may have developed\u00a0antibodies\u00a0to\u00a0growth hormone.\u00a0Your doctor will perform tests to determine this.<\/p>\n\n\n\nOther medicines and Saizen<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Important information about some of the ingredients of Saizen<\/h2>\n\n\n\n
How to use Saizen<\/h2>\n\n\n\n
0.7-1.0 mg \/ m\u00a02<\/sup>\u00a0body surface area daily or 0.025-0.035 mg\/kg body weight daily by\u00a0injection\u00a0under the skin.<\/li>
1.4 mg \/ m\u00a02\u00a0body surface area daily or 0.045-0.050 mg\/kg body weight daily by\u00a0injection\u00a0under the skin. If your daughter is being treated for\u00a0Turner syndrome\u00a0and is receiving non-androgenic anabolic steroids\u00a0at\u00a0the same time, it may increase her growth rate.\u00a0If you have any further questions on the use of this product, ask your doctor or pharmacist.<\/li>
1.4 mg \/ m\u00a02\u00a0body surface area, corresponding to approximately 0.045-0.050 mg\/kg body weight daily by\u00a0injection\u00a0under the skin.<\/li>
1 mg \/ m\u00a02\u00a0body surface area, approximately equal to 0.035 mg\/kg body weight daily by\u00a0injection\u00a0under the skin.<\/li><\/ul>\n\n\n\n
At the start of treatment, low\u00a0doses\u00a0of 0.15\u20130.3 mg daily by\u00a0injection\u00a0under the skin are recommended.\u00a0Dose\u00a0one is gradually adjusted by your doctor.\u00a0The recommended final dose of\u00a0growth hormone\u00a0rarely exceeds 1.0 mg per day.\u00a0The lowest effective\u00a0dose\u00a0that works for you should be injected.\u00a0If you are older or overweight, a lower dose\u00a0may be necessary.<\/li><\/ul>\n\n\n\nIf you use more Saizen than you should<\/h2>\n\n\n\n
If you forget to take Saizen<\/h2>\n\n\n\n
If you stop taking Saizen<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Saizen<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Content declaration<\/h2>\n\n\n\n
What the medicine looks like and the contents of the pack<\/h2>\n\n\n\n
Marketing Authorisation Holder<\/h2>\n\n\n\n