Saizen 6 Mg/1.5 Ml Solution For Injection (Refrigerator)

Product Description:

• Please note that the doctor may have prescribed the medicine for a different use and/or with a different dosage than stated in the package insert.
• Always follow your doctor prescribing indicated on the pharmacy label.
• Saizen is a growth hormone.
• Saizen's main function is to increase growth in children and adolescents and to treat adults with growth hormone deficiency.
• The growth hormone (somatropin) found in Saizen is almost identical to natural human growth hormone, except that it is produced outside the body by a process called "recombinant DNA technology" (genetic technology).

Saizen is used:

In children and adolescents:

• For the treatment of short children who have stopped growing because their bodies do not produce growth hormones or produce insufficient amounts of growth hormones.
• For the treatment of girls who have stopped growing due to gonadal dysgenesis (also called Turner's syndrome ), confirmed by a chromosome test.
• For the treatment of children who have not yet reached puberty and who have stopped growing due to chronic renal failure, a condition where the kidneys are damaged.
• For the treatment of growth problems in children who were born small and who have not reached normal height by the age of four or later.

In adults:

• For the treatment of adults with pronounced growth hormone deficiency.
  This treatment is given to adults who have severe growth hormone deficiency and who have been medically diagnosed by a test.

• Your doctor or a pharmacist can explain why you or your child have been given this medicine.
• In children with chronic kidney disease, treatment with Saizen must be discontinued at the time of kidney transplantation.

How to use:

• Always use this medicine exactly as your doctor has told you. 
• Contact a doctor or pharmacist if you are unsure.

Dosage

• The dosage and frequency of administration (how often it is injected) of Saizen will be decided by your doctor and will depend on your (or your child's) body weight or body surface area.
• It is recommended that Saizen be taken at bedtime.

Children and youth:

Short height due to lack or insufficient levels of natural growth hormone:

• 7-1.0 mg/m² body surface each day or 0.025-0.035 mg/kg body weight each day, given subcutaneously (under the skin).

Reduced growth in girls due to gonadal dysgenesis ( Turner syndrome ):

• 4 mg/m² body surface area every day or 0.045-0.050 mg/kg body weight every day, given subcutaneously (under the skin).
  If your daughter is being treated for Turner syndrome and is also using non - androgenic anabolic steroids, the growth response may increase.
• Consult your doctor or a pharmacy if you are unsure whether she is using such medicines.

Growth failure in children who have not yet reached puberty due to chronic renal failure (a condition where the kidneys are damaged):

• 4 mg/m² body surface area per day, approximately equal to 0.045-0.050 mg/kg body weight each day, given subcutaneously ( under the skin).

Growth problems in children born small:

• 1 mg/m² body surface, approximately equal to 0.035 mg/kg body weight each day, given subcutaneously (under the skin).

Adults:

Growth hormone deficiency in adults:

• At the start of treatment, low doses of somatropin, 0.15-0.30 mg every day, given as a subcutaneous injection (under the skin) are recommended.
• The dose will be adjusted step by step by your doctor. 
• The recommended final dose of growth hormone will rarely exceed 1.0 mg/day.
• In general, the lowest effective dose that works for you should be given.
• If you are elderly or overweight, a lower dose may be needed.

Preparation and method of administration (how the injection is given):

• The dose and frequency of administration with Saizen will be determined by your doctor and will depend on your (or your child's) size or body weight. 
• Normally, Saizen should be given every day by subcutaneous injection (under the skin).

Duration of treatment:

• Your child should stop this treatment when he or she reaches a satisfactory adult height, or when his or her legs can no longer grow, as judged by his or her doctor. 
• Treatment with Saizen will be stopped in children with chronic renal failure at the time of kidney transplantation.
  In adults, growth hormone deficiency is a lifelong condition and should be treated accordingly by your doctor.

If you take too much Saizen:

• Contact a doctor, hospital or Poison Information if you have taken too much medicine or if a child has taken medicine by accident. 
• For other questions about the medicine, contact your doctor or pharmacist.
• If you inject too much Saizen you should inform your doctor about this as it may be necessary to adjust the dose to correct the error.
• Too much medicine can cause changes in blood sugar levels that can make you (or your child) shaky and dizzy.
• If this occurs, contact your doctor as soon as possible.

If you have forgotten to take Saizen:

• If you forget a dose of Saizen, it is important to inform your doctor about this as it may be necessary to adjust the dose to correct the error.

If you stop treatment with Saizen:

• Do not stop treatment with Saizen without talking to your doctor.
• Ask your doctor or pharmacist if you have any questions about the use of this medicine.

Warnings and precautions:

Do not use Saizen:

• If you (or your child) are allergic to somatropin or any of the other ingredients of this medicine (listed in section 6)
• If you have learned that your child's bones have stopped growing, and that he/she has therefore reached his/her final length
• If you have an active tumor ( cancer ). Tumors must be inactive and you must have finished cancer treatment before starting your treatment with Saizen
• If you (or your child) have diabetes and have an associated eye disease (proliferative or preproliferative diabetic retinopathy )
• if you or your child has an acute illness, suffers from complications after open heart surgery, stomach surgery, several accidents that have led to trauma, acute respiratory failure (shortness of breath) or similar conditions

Consult a doctor before using Saizen:

• Treatment with Saizen should be carried out under the regular supervision of a doctor who has experience in the diagnosis and treatment of growth disorders.
• Due to low blood sugar , you may feel shaky or dizzy immediately after Saizen is given, but this will pass quickly. Blood sugar may rise to above normal levels 2-4 hours after administration. As treatment with growth hormone can affect the body's way of regulating blood sugar, your (or your child's) blood sugar level will be checked regularly by a doctor. Somatropin can cause your (or your child's) blood sugar to rise.
• If you (or your child) or a family member have diabetes, your doctor will monitor your blood sugar levels closely and possibly make changes to your diabetes treatment while you are being treated with Saizen.
• Please note that regular eye tests may be required after taking this medicine.
• Saizen can affect how your thyroid gland works. 
• Your doctor can test your blood for thyroid hormone levels and prescribe treatment with another hormone if you (or your child) develop thyroid hormone deficiency.
• If you (or your child) use corticosteroids , you should be examined regularly by your doctor. Your dose of corticosteroid or your dose of Saizen may need to be adjusted .
• Saizen may cause fluid retention in adult patients. This occurs as swelling and joint or muscle pain. Contact your doctor if you recognize any of these symptoms.
• Your doctor may choose to adjust your dose of Saizen.
• If you have had a tumor in childhood and were treated with Saizen, there is an increased risk of developing a new tumor. If you (or your child) have previously had any kind of brain disease, for example a tumour, your doctor will examine you (or your child) regularly to check that it has not returned.
• In rare cases, Saizen can cause an inflammation of the thyroid gland, which causes severe pain in the abdomen and back. 
• Pay particular attention to this and contact a doctor if your child gets stomach aches.
• An increase in sideways curvature of the spine (scoliosis) can develop in children during rapid growth. During treatment with Saizen, your doctor will examine you (or your child) for signs of scoliosis.
• Some patients may develop a swelling of the brain during treatment with Saizen. If you (or your child) complain of severe or frequent headaches, have vision problems, nausea and/or vomiting, contact a doctor immediately. In such cases, it may be necessary to stop treatment with growth hormone, although it can be resumed at a later time.
• If the symptoms of swelling in the brain return, the treatment must be stopped.
• When the medicine is injected in the same place over a long period of time, the area can be damaged. It is therefore important to change the injection site regularly.
• A doctor or pharmacist can tell you which parts of the body can be used.
• Some children with growth hormone deficiency have developed leukemia (increased number of white blood cells), regardless of whether they have been treated with growth hormone or not. However, it has not been shown that the incidence of leukemia is higher in recipients of growth hormone without predisposing factors. 
• No causal relationship with growth hormone therapy has been shown.
• Problems with the hips may possibly occur somewhat more frequently in children with hormone or kidney problems.
• If your child suffers from chronic kidney failure, which can occur when the kidneys are damaged, he or she should be examined regularly for signs of bone disease. It is uncertain whether bone disease in children with hormone or kidney problems is affected by treatment with growth hormone. X-ray examinations of the hip should be carried out before starting the treatment. If your child starts limping or complains of hip or knee pain during treatment with Saizen, tell your doctor.
• In children suffering from chronic kidney failure, the treatment must end with a kidney transplant.
• Saizen is not indicated for the long-term treatment of children who have deficient growth due to genetically ascertained Prader-Willi syndrome , unless they are also diagnosed with growth hormone deficiency. 
• Sleep apnea and sudden death have been reported after initiation of growth hormone therapy in children with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, previous upper airway obstruction, sleep apnea (temporary cessation of breathing), or unidentified respiratory infection.
• Growth hormone should generally not be used for seriously ill people.
• If the treatment with Saizen does not work, it may be that you have developed antibodies against the growth hormone. 
• Your doctor will carry out appropriate tests to determine this.
• If you are over 60 years old or if you use Saizen for a long time, you should be examined more frequently by your doctor. 
• As both experience with the treatment of the elderly and experience with long-term treatment with Saizen is limited, extra monitoring is required.

Pregnancy and breastfeeding:

• Consult a doctor or pharmacist before taking this medicine if you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant.
  As of today, there are insufficient findings from studies conducted on humans regarding the safe use of growth hormones during pregnancy or breastfeeding. 
• Treatment with Saizen must be discontinued if pregnancy occurs.

Driving and using machines:

• You must only drive or carry out risky work when it is safe for you. 
• Medicines can affect your ability to drive or perform risky work.
• Read the information in this leaflet carefully. 
• If you are in doubt, you must talk to your doctor or pharmacist.
• No effect studies have been carried out on Saizen regarding the ability to drive and use machines.
  Medicines containing somatropin have no influence on the ability to drive and use machines.

How To Store Saizen:

• Keep out of reach of children.
• Do not use Saizen after the expiry date which is stated on the cartridge after EXP. 
• The expiration date refers to the last day of that month.
• Store unused cylinder ampoule with Saizen in a refrigerator (2-8ºc). Store in the original packaging to protect from light. 
• Do not freeze.
• Use within 28 days after the first injection.
• After the first injection, the Saizen cylinder ampoule, easypod autoinjector or alueta peninjector, which

Ingredients:

Composition of Saizen:

• The active ingredient is Somatropin (Recombinant Human Growth Hormone).
• Other ingredients are sucrose, poloxamer 188, phenol, citric acid (for ph adjustment), sodium hydroxide (for ph adjustment) and water for injections.

Saizen 5.83 mg/ml :

• Saizen 5.83 mg/ml is ready for slightly opalescent solution for injection in a pre-filled cylinder ampoule (type I) with a plunger stopper (rubber) and seal (aluminium cap and rubber), containing 1.03 ml solution (6 mg somatropin).
• The ampoule containing 6 mg of somatropin is marked with a blue label.
• Pack sizes of 1 and 5 cylinder ampoules.

Saizen 8 mg/ml :

• Saizen 8 mg/ml is a ready to weak opalescent solution for injection in a pre-filled cylinder ampoule (type I) with a plunger stopper (rubber) and seal (aluminium cap and rubber).
• The ampoule containing 12 mg of somatropin is marked with a red label.
• The ampoule containing 20 mg of somatropin is marked with a yellow label.
• Pack sizes of 1 and 5 cylinder ampoules containing 1.50 ml solution (12 mg somatropin) or 2.50 ml solution (20 mg somatropin).