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Download Leaflet View the Patient Leaflet in PDF Format Placeholder for barcode Placeholder for barcode Package leaflet: Information for the user 1. What Saizen is and what it is used for 2. What you need to know before you use Shortly after Saizen is given, you (or your child) may Rarely Saizen may cause an inflammation of the when kidneys are damaged, he or she should be Other medicines and Saizen Somatropin-containing products have no influence feel shaky or light-headed due to low blood sugar pancreas, which causes severe pain in the abdomen examined periodically for evidence of bone disease. Tell your doctor or pharmacist if you (or your child) on the ability to drive and use machines. Saizen is a growth hormone. Saizen's main action is Saizen levels. These feelings will quickly disappear. Your and back. Please consider this especially if your child It is uncertain whether the bone disease in children to increase growth in children and adolescents and are using, have recently used or might use any other (or your child’s) blood sugar levels may then rise suffers from stomach ache and contact your doctor. with hormone or kidney problems is affected by Important information about some of the to treat adults with growth hormone deficiency. Do not use Saizen medicines. above normal 2-4 hours after administration. Since An increase in sideways curvature of the spine growth hormone therapy. X-rays of the hip should ingredients of Saizen The growth hormone (somatropin) contained in • If you (or your child) are allergic (hypersensitive) If you (or your child) are using corticosteroids, it is treatment with growth hormone can alter how your (scoliosis) may progress in any child during rapid be obtained prior to initiating therapy. If your child This medicine contains less than 1 mmol sodium to somatropin or any of the other ingredients of important to tell the doctor or pharmacist. These Saizen is almost the same as human’s natural growth body handles sugar, your (or your child’s) sugar levels growth. During treatment with Saizen, your doctor develops a limp or complains of hip or knee pain hormone except that it is made outside the body by medicines could interact with Saizen and therefore (23 mg) per reconstituted solution, that is to say this medicine (listed in section 6). will be tested regularly by a doctor. Somatropin may will check you (or your child) for signs of scoliosis. while being treated with Saizen, tell your doctor. 8 mg/ml a process called “recombinant DNA technology” your doctor may need to adjust the dose of these essentially ‘sodium-free’. • If you have been told that your child’s bones have cause your (or your child’s) blood sugar to increase. Some patients may develop swelling of the brain, solution for injection in cartridge (genetic engineering). Treatment with Saizen will be stopped in children medicines or your Saizen dose. Corticosteroids are stopped growing and that he/she has therefore while taking Saizen. If you (or your child) suffer somatropin If you (or your child) are diabetic or a member of your with chronic kidney failure at the time of kidney used to treat several illnesses including asthma, 3. How to use Saizen Saizen is used: reached his/her final height. family has diabetes, your doctor will monitor closely from a bad or recurrent headache, problems with transplant. allergies, kidney rejection and rheumatoid arthritis. your eyesight, feel sick (nausea) and/or being sick Always use this medicine exactly as your doctor has In children and adolescents: • If you have an active tumour (cancer). Tumours your blood sugar level and may adjust the treatment Saizen is not indicated for the long-term treatment If you have a replacement therapy with oral Read all of this leaflet carefully before you start (vomiting), contact your doctor immediately. In told you. Check with your doctor or pharmacist if • in the treatment of children with short stature must be inactive and you must have finished for diabetes while you are being treated with Saizen. of paediatric patients who have growth failure due oestrogens, it may reduce the effect of Saizen on using this medicine because it contains important this case it may be necessary to stop the growth you are not sure. who have failed to grow because their body your anti-tumour treatment before you start your Please be aware that you may need regular eye tests to genetically confirmed Prader-Willi syndrome, growth. Therefore your doctor may need to adjust information for you. hormone treatment, although treatment may be produces no growth hormone or insufficient treatment with Saizen. after having this medicine. unless they also have a diagnosis of growth your Saizen dose. re-started at a later date. If the symptoms of brain Dosage • Keep this leaflet. You may need to read it again. levels of growth hormone • If you (or your child) have diabetes and are Saizen may affect how your thyroid works. Your hormone deficiency. There have been reports of swelling come back, treatment with Saizen should If you are treated with sex hormones, medicines to • If you have any further questions, ask your doctor sleep apnoea and sudden death after initiating The dose and frequency of administration of Saizen • in the treatment of girls who have failed to grow suffering from an associated eye disease doctor may test your blood for levels of thyroid be discontinued. control epilepsy (anticonvulsants) or cyclosporine or pharmacist. due to gonadal dysgenesis (also referred to as (proliferative or preproliferative diabetic hormones and prescribe another hormone if you (or therapy with growth hormone in paediatric patients will be decided by your doctor and will depend on When the medicine is injected into the same place (a medicine that weakens the immune system after Turner syndrome), confirmed by a test on the your child) are found to have developed a lack of with Prader-Willi syndrome who had one or more your (or your child’s) body weight or body surface • This medicine has been prescribed for you only. retinopathy). over a long period of time, it can cause damage to transplantation), you should tell your doctor as the chromosomes thyroid hormone. of the following risk factors: severe obesity, history area. Do not pass it on to others. It may harm them, • If you or your child have an acute critical illness, this area. It is therefore important to keep changing dose of these medicines may need to be adjusted. of upper airway obstruction or sleep apnoea, or It is recommended that Saizen be administered at even if their symptoms are the same as yours. • in the treatment of pre-pubertal children who suffering complications following open heart If you (or your child) are using corticosteroids, you the injection site. Your doctor or pharmacist can have failed to grow due to chronic renal failure, a should consult your doctor regularly, as you may unidentified respiratory infection. Pregnancy and breast feeding bedtime. • If you get any side effects, talk to your doctor surgery, abdominal surgery, multiple accidental speak to you about which parts of the body should condition in which kidneys are damaged need adjustment of your corticosteroid or your Growth hormone should generally not be used by If you are pregnant or breast-feeding, think you may Children and adolescents: or pharmacist. This includes any possible side trauma, acute respiratory failure or similar be used (see section 3 How to use Saizen). • in the treatment of growth problems in children Saizen dose. people who are seriously ill. be pregnant or are planning to have a baby, ask your effects not listed in this leaflet. See Section 4. conditions. Some children with growth hormone deficiency • Short stature due to a lack of, or insufficient who were born small and who have not reached If you do not respond to the therapy with Saizen, doctor or pharmacist for advice before taking this Treatment with Saizen has to be stopped in children Saizen may cause fluid retention in adult patients. have developed leukaemia (increased number of levels of natural growth hormone: normal height by the age of 4 years or later. This may appear as swelling and joint or muscle pain. you may have developed antibodies to growth medicine. What is in this leaflet: with chronic kidney disease at time of kidney white blood cells), whether or not they have received 0.7-1.0 mg/m2 body surface area each day or In adults: If you feel these symptoms tell your doctor who may treatment with growth hormone. However there is hormone. Your doctor will conduct appropriate tests There is currently insufficient evidence from human 1. What Saizen is and what it is used for transplantation. 0.025-0.035 mg/kg body weight each day by • in the treatment of adults with a marked lack of decide to adjust your dose of Saizen. no evidence that leukaemia incidence is increased to determine this. studies on the safety of growth hormone treatment Warnings and precautions subcutaneous administration (under the skin) 2. What you need to know before you use Saizen growth hormone ( growth hormone deficiency). If you have had a tumour in your childhood and in growth hormone recipients without predisposing If you are over 60 years old or if you are taking during pregnancy and breast feeding. Saizen should Talk to your doctor before using Saizen. • Growth failure in girls due to gonadal dysgenesis 3. How to use Saizen This therapy is given to adults who have a serious were treated with Saizen, there is an increased risk factors. No cause and effect relationship with Saizen for a long time you should be examined be discontinued, if pregnancy occurs.
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    References I-9012 1. Saizen prescribing information. EMD Serono, Inc. February 2020. 2. Serostim prescribing information. EMD Serono, Inc. June 2019. 3. Zorbtive prescribing information. EMD Serono, Inc. September 2019. 4. Genotropin prescribing information. Pfizer, Inc./Pharmacia and Upjohn Co. April 2019. 5. Humatrope prescribing information. Eli Lilly and Company. October 2019. 6. Norditropin FlexPro prescribing information. Novo Nordisk Inc. March 2020. 7. Omnitrope prescribing information. Sandoz Inc. June 2019. 8. Nutropin AQ NuSpin prescribing information. December 2016. 9. Zomacton prescribing information. Ferring Pharmaceuticals Inc. July 2018. 10. Richmond EJ, Rogol AD, et al. Diagnosis of Growth Hormone Deficiency in Children. UptoDate. Literature review current through June 2020. Last updated March 2020. Accessed July 2020. 11. Grimberg A, DiVall SA, Polychronakos C, et al. Pediatric Endocrine Society Guidelines for Growth Hormone and Insulin-Like Growth Factor-1 Treatment in Children and Adolescents: Growth Hormone Deficiency, Idiopathic Short Stature, and Primary Insulin-Like Growth Factor-1 Deficiency. Horm Res Paediatr. 2016;86:361–397. 12. Collett-Solberg PF, Ambler G, Backeljauw PF, et al. Growth Hormone Research Society International Perspective Guidelines for Diagnosis, Genetics, and Therapy of Short Stature in Children. Horm Res Paediatr. 2019;92:1-14. 13. Growth Hormone Research Society (GRS) Consensus Guidelines for the Diagnosis and Treatment of Growth Hormone (GH) Deficiency in Childhood and Adolescence: Summary Statement. J Clin Endocrinol Metab. 2000;85(11):3990-3993. 14. Richmond EJ, Rogol AD, et al. Diagnostic Approach to Children and Adolescents with Short Stature. UptoDate. Literature review current through June 2020. Last updated January 2020. Accessed July 2020.
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