Saizen is a growth hormone whose main activity is to stimulate growth in children and adolescents and to treat adults with growth hormone deficiency.
The growth hormone (somatropin) contained in Saizen is almost identical to naturally secreted growth hormone in humans, except that it is manufactured outside the body by a process called “recombinant DNA technology”. ” (genetic engineering).
Saizen is used:
In children and adolescents:
· In the treatment of small children who have not grown up because their body produces little or no growth hormone,
· In the treatment of girls who have not grown up because of gonadal dysgenesis (also known as Turner syndrome) confirmed by a chromosome test,
· In the treatment of prepubertal children who have not grown up because of chronic renal failure, a disease in which the kidneys are damaged,
· In the treatment of growth problems in children who were born small and did not reach normal height at 4 years of age or older.
· In the treatment of adults with a pronounced lack of growth hormone (growth hormone deficiency). This treatment is prescribed in adults with severe growth hormone deficiency who has been diagnosed with a test.
Your doctor or pharmacist will explain why this medicine has been prescribed to you or your child.
Do not use SAIZEN 8 mg / ml solution for injection:
· If you (or your child) are allergic (hypersensitive) to somatropin or any of the other ingredients of this medicine given in section 6.
· If you have been informed that your child’s bones have stopped growing and that he / she has therefore reached its final size.
· If you have an active tumor (cancer). The tumors must be inactive and you must have finished your antitumor treatment before starting your Saizen treatment.
· If you (or your child) are diabetic and have an eye disease associated with this diabetes (proliferative or pre-proliferative diabetic retinopathy).
· If you or your child is critically ill, have complications secondary to open heart surgery, abdominal surgery, accidental poly trauma, acute respiratory failure, or similar situations.
In children with chronic renal failure, treatment with Saizen should be discontinued in renal transplantation.
Warnings and precautions:
Talk to your doctor before using Saizen.
· Treatment with Saizen should be performed and monitored by a physician experienced in the diagnosis and treatment of patients with growth hormone deficiency.
· Shortly after you have given Saizen, you (or your child) may experience feelings of weakness or dizziness due to low blood sugar. These sensations will disappear quickly. Your blood sugar level (or that of your child) can then rise above normal within 2 to 4 hours after administration. Since growth hormone treatment may alter how your body uses sugar, your blood sugar level (or your child’s blood sugar) will need to be checked regularly by your doctor. Somatropin can increase your blood sugar level (or your child’s).
· If you (or your child or a family member) have diabetes, your doctor will carefully monitor your blood sugar level and may need to make changes to your treatment for your diabetes during the Saizen concomitant treatment period. .
· Regular monitoring visits to an ophthalmologist may be necessary.
· Saizen can disrupt the functioning of your thyroid gland. Your doctor may need to check your blood levels of thyroid hormones and prescribe another hormone if you (or your child) have a deficiency of thyroid hormones.
· Saizen may cause fluid retention in adult patients. This is manifested by swelling and pain in the joints or muscles. If you experience these symptoms, talk to your doctor who may need to adjust your dose of Saizen.
If you have had a tumor in your childhood and have been treated with Saizen, the risk of developing a new tumor is increased. If you (or your child) have had a brain-related condition in the past, such as a tumor, your doctor will do a regular checkup to see if there is no recurrence of the disease.
· In rare cases, Saizen can cause inflammation of the pancreas
s causing severe abdominal and dorsal pain. Please consider this possibility especially if your child has a stomach ache and contact your doctor · Using Saizen, some patients may develop brain swelling. If you (or your child) have severe or frequent headaches, visual problems, vomiting or nausea, contact your doctor immediately. It may be necessary to discontinue growth hormone therapy and possibly resume it at a later date. If symptoms of brain swelling come back, treatment with Saizen should be stopped · When the drug is injected at the same place each time and for a long time, it may cause damage to the injection site. This is why it is important to systematically change the injection site. Your doctor or pharmacist can tell you the different parts of the body where the injections are possible (see section 3. How to use Saizen?) · Some children with growth hormone deficiency have developed leukemia (increased number of white blood cells) whether or not they have been treated with growth hormone. However, there is no evidence that the number of new cases of leukemia is higher in people treated with growth hormone without a predisposing factor. No causal link has been established with growth hormone therapy · Hip problems may occur more frequently in children with hormonal or renal problems. If your child has chronic kidney failure, a condition that can occur when the kidneys are damaged, it should be examined regularly for signs of bone disease. The influence of growth hormone therapy on bone disease or in children with hormonal or renal problems has not been established. A hip X-ray should be performed before starting treatment. If you have a complaint of hip or knee pain, or if your child limps while being treated with Saizen, tell your doctor. · In children with chronic renal failure, treatment with Saizen will be suspended if renal transplantation · Saizen is not indicated for the long-term treatment of children / adolescents with growth retardation secondary to genetically confirmed Prader-Willi syndrome, unless they also have a short-term growth hormone. Cases of sleep apnea and sudden death have been reported after initiation of growth hormone therapy in children / adolescents with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection · Growth hormone should generally be avoided in critically ill patients · If you do not respond to treatment with Saizen , you may have developed antibodies against growth hormone. Your doctor will perform the appropriate tests to determine if this is your case. · If you are over the age of 60 or have been using Saizen for a long time, you should be examined more frequently by your doctor. Since the experience of treating people over 60 years of age and long-term treatment with Saizen is more limited, special attention is required.Other medicines and SAIZEN 8 mg / ml solution for injection: Inform your doctor or pharmacist if you (or your child) use, have recently used or could use any other medication.If you (or your child) are taking corticosteroids, it is important to tell your doctor or pharmacist. These medicines may interfere with Saizen, so your doctor may need to adjust the dose of these medications or Saizen’s. Corticosteroids are used to treat various diseases such as asthma, allergies, kidney transplant rejection and rheumatoid arthritis.If you take oral estrogen replacement therapy, this treatment may reduce the effect of Saizen on the growth. Your doctor may need to adjust your dose of Saizen.If you are being treated with sex hormones, medicines to control epilepsy (anticonvulsants), or cyclosporine (a medicine that weakens the immune system after transplantation). ), talk to your doctor as he may need to adjust the doses of these medicines.SAIZEN 8 mg / ml solution for injection with food and drinkNo object.Pregnancy and breastfeedingIf you are pregnant or breastfeeding, if you think to be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.The clinical studies currently available do not prove the safety of treatment with growth hormone in pregnant and lactating women. Saizen should be stopped if pregnancy occurs.Vehicle driving and use of machinesThe effects of Saizen on the ability to drive and use machines have not been studied. Drugs containing somatropin have no influence on the ability to drive and use machines.SAIZEN 8 mg / ml solution for injection containsNo object.3. HOW TO USE SAIZEN 8 mg / ml solution for injection Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.PosologyIt is recommended that you take Saizen at bedtime.Your doctor will determine the dose and frequency of administration of Saizen based on your body weight or body surface area (or of your child) .Use in children and adolescents · Small size due to lack or insufficient levels of natural growth hormone: 0.7 to 1.0 mg / m² body surface area or 0.025 to 0.035 mg / kg body weight administered daily subcutaneously (under the skin) · Growth retardation in girls with gonadal dysgenesis (Turner’s syndrome): 1.4 mg / m² body surface area or 0.045- 0.050 mg / kg body weight, administered daily subcutaneously (under the skin) .If your daughter is being treated for Turner syndrome and is also taking non-androgenic anabolic steroids, treatment response t by Saizen can be increased. Ask your doctor or pharmacist if you have any doubt about these medicines · Growth retardation in prepubertal children due to chronic renal failure, in which the kidneys are damaged: 1.4 mg / m² surface area body weight, equivalent to approximately 0.045 to 0.050 mg / kg body weight, administered daily subcutaneously (under the skin). · Growth problems in children born small: 1 mg / m² body surface area, equivalent to approximately 0.035 mg / kg body weight, administered daily subcutaneously (under the skin) .Use in Adults Growth hormone deficiency in adults: To begin, low doses of the order of 0.15 to 0.30 mg administered daily subcutaneously (under the skin) are recommended. Then your doctor will adjust the dose in steps. The maintenance dose of growth hormone rarely exceeds 1.0 mg / day. In general, the lowest possible dose should be administered based on your efficacy level. In elderly or overweight patients, it may be necessary to use a lower dose.Method and method of administrationYour doctor will determine the dose and frequency of administration of Saizen according to your size or body weight (or those of your child). Generally, Saizen should be administered daily by subcutaneous injection (under the skin). Important information For the administration of Saizen, carefully read the following instructions. When the drug is injected at the same place each time and for a long time, it can cause lesions. This is why it is important to systematically change the injection site. Your doctor or pharmacist can tell you the different parts of the body where the injections are feasible. Do not inject into areas where you feel bumps, hard knots, lows or painful areas; talk to your doctor or pharmacist about any abnormalities. Clean the skin at the injection site with soap and water. The cartridge containing the Saizen solution is ready to use with the cool.click auto-injectors (without needle) or easypod.Place all the necessary accessories to injecting the solution on a clean surface and wash your hands with soap and water. The solution should be clear to slightly opalescent, with no visible particles or signs of deterioration. If the solution contains particles, it should not be injected.How to perform your daily self-injection of SAIZEN 8 mg / ml, solution for injectionContaining the insertion of the cartridge in the needle-free autoinjector cool.click or the easypod auto-injector and injection of Saizen’s solution, refer to the instruction manual supplied with each auto-injector. The main users easypod is intended for are children from 7 years and up to adulthood. The use of injection devices by children should always be under the supervision of an adult.Duration of treatmentYour child will have to stop milking when he has reached a satisfactory adult size or if his bones can no longer grow, which will be left to the discretion of the doctor. In children with chronic renal failure, Saizen should be discontinued in case of kidney transplant.The growth hormone deficiency in adults is a long-term illness that should be treated as such by your doctor.If you used more than SAIZEN 8 mg / ml solution for injection you should: If you have injected more Saizen than you should, you should inform your doctor as it may be necessary to change the dosage slightly to make up for it. . Overdose can lead to blood sugar levels that can cause weakness or dizziness. If this occurs, contact your doctor as soon as possible.If you forget to use SAIZEN 8 mg / ml solution for injection: If you miss an injection, tell your doctor because it may be necessary to change the dosage slightly to make up for it. If you stop using SAIZEN 8 mg / ml solution for injection: Do not stop using Saizen without talking to your doctor.If you have further questions about using this medicine, ask more information to your doctor or pharmacist.
1 Vial, 2 Vials, 3 vials, 4 Vials, 5 Vials
5 mg, 8.8 mg