5.83 mg/ml solution for injection in cartridge somatropin
What Saizen is and what it is used fo
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.
The growth hormone (somatropin) found in Saizen is almost identical to the natural human growth hormone, except that it is produced outside the body through a process called “recombinant DNA technology” (genetic engineering).
Saizen is used:
Children and adolescents:
- in the treatment of children who have not grown because their body does not produce any growth hormone or too low levels of growth hormone
- in the treatment of girls who have not grown up due to gonadal dysgenesis (also called Turner syndrome ), confirmed by chromosome test
- in the treatment of children before puberty who have not grown due to chronic renal failure, a condition in which the kidneys are damaged
- in the treatment of growth problems in children born small and who have not reached a normal size at 4 years of age or later
Adults:
- in the treatment of adults with a pronounced growth hormone deficiency
This treatment is given to adults who have a severe growth hormone deficiency and who have been medically diagnosed with a test.
Doctors or pharmacists can explain why you or your child have been prescribed this treatment.
Somatropin contained in Saizen may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Saizen
Do not use Saizen
- if you (or your child) are allergic (hypersensitive) to somatropin or any of the other ingredients of this medicine (listed in section 6).
- if you have been told that your child’s tubular bone has stopped growing and that he/she has therefore reached its final length.
- if you have an active tumor (cancer). Tumors must be inactive and you must have stopped your cancer treatment before starting treatment with Saizen.
- if you (or your child) have diabetes and suffer from diabetes-related eye disease ( proliferative or pre proliferative diabetic retinopathy).
- if you (or your child) have an acute critical illness, suffer from complications following open-heart surgery, abdominal surgery, extensive injuries following an accident, acute breathing problems, or similar conditions.
Saizen treatment must be stopped in children with chronic kidney disease before a kidney transplant.
Warnings and cautions
Talk to your doctor before using Saizen.
Saizen treatment should be performed under regular supervision by a physician experienced in the diagnosis and treatment of patients with growth hormone deficiency.
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.
If you (or your child) are diabetic or if someone in the family has diabetes, your doctor will closely monitor your blood counts and possibly change your diabetes treatment while you are being treated with Saizen.
Regular eye check-ups may be necessary after receiving this medicine.
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.
If you (or your child) are taking corticosteroids, you should contact your doctor regularly, as you may need to adjust your corticosteroid dose or your dose of Saizen.
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.
If you have had a tumor during your childhood and were treated with Saizen, there is an increased risk that a new tumor will develop. If you (or your child) have previously had a disease that affects the brain, e.g. a tumor, your doctor will regularly examine you (or your child) to make sure it has not returned.
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.
An increase in the oblique back (scoliosis) can develop in children who grow rapidly. During treatment with Saizen, your doctor will examine you (or your child) for signs of scoliosis.
Some patients may develop swelling in the brain during treatment with Saizen. Contact a doctor immediately if you (or your child) have a severe or recurrent headache, vision problems, nausea, and/or vomiting, Then it may be necessary to discontinue growth hormone therapy. The treatment can be started again later. If the symptoms of swelling in the brain recur, treatment with Saizen should be stopped.
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).
Some children with growth hormone deficiency have developed leukemia (increased white blood cell count ), whether or not they have been treated with growth hormone. However, there is no evidence that the incidence of leukemia is increased in growth hormone-treated patients without predisposition factors. No causal relationship with growth hormone therapy has been demonstrated.
Hip problems sometimes occur 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 possible skeletal damage. It is uncertain whether skeletal damage in children with hormone or kidney problems is affected by growth hormone treatment. X-ray examination of the hip should be done before starting treatment. If your child starts to limp or complains of pain in the hip or knee during treatment with Saizen, tell your doctor.
In children with chronic kidney failure, treatment should be stopped before a kidney transplant.
Saizen is not intended for long-term treatment of children with a growth disorder due to Prader-Willi syndrome, which has been genetically confirmed unless growth hormone deficiency has also been diagnosed. Sleep apnea (temporary pauses in breathing during sleep) and sudden death have been reported after initiating growth hormone therapy in children with Prader-Willi syndrome, who had one or more of the following risk factors: severe obesity, previously impaired lung function or sleep apnea, or unidentified respiratory infection.
Growth hormone should not be given to seriously ill people.
If you do not respond to treatment with Saizen, you may have developed antibodies to growth hormone. Your doctor will perform tests to determine this.
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. Due to less experienced in the treatment of the elderly and long-term treatment with Saizen, special care is required in these situations.
Other medicines and Saizen
Tell your doctor or pharmacist if you (or your child) are taking, have recently taken, or might take any other medicines.
If you (or your child) use cortisone, it is important to tell your doctor or pharmacist. These medicines can affect Saizen and therefore your doctor may need to adjust the dosage of one of these medicines or Saizen. Cortisone preparations are used to treat many serious diseases such as asthma, allergies, and chronic rheumatoid arthritis ( rheumatoid arthritis ).
If you receive substitution treatment with oral estrogen, it may affect Saizen’s effect on growth. Your doctor may therefore need to adjust the dose of one of Saizen.
If you are being treated with sex hormones, medicines for epilepsy, or ciclosporin (a medicine that weakens the immune system after transplantation), tell your doctor as the dose of one of these medicines may need to be adjusted.
Pregnancy and breastfeeding
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.
There is insufficient information on the safety of growth hormone therapy during pregnancy and lactation. Saizen treatment should be discontinued during pregnancy.
Driving and using machines
Medicines containing somatropin have no known effect on the ability to drive and use machines.
Important information about some of the ingredients of Saizen
This medicine contains less than 1 mmol (23 mg) sodium per cartridge, ie essentially ‘sodium-free’.
How to use Saizen
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dosage
The dose and frequency of Saizen are adjusted by your doctor depending on your (or your child’s) body weight or body surface area.
It is recommended that Saizen be given in the evening.
Children and adolescents:
- Short body length caused by lack of or too little secretion of natural growth hormone:
0.7-1.0 mg / m 2 body surface area daily or 0.025-0.035 mg/kg body weight daily by injection under the skin. - Growth disorder in girls with gonadal dysgenesis ( Turner syndrome ):
1.4 mg / m 2 body surface area daily or 0.045-0.050 mg/kg body weight daily by injection under the skin. If your daughter is being treated for Turner syndrome and is receiving non-androgenic anabolic steroids at the same time, it may increase her growth rate. If you have any further questions on the use of this product, ask your doctor or pharmacist. - Growth disturbance in children before puberty due to chronic renal failure, a condition in which the kidneys are damaged:
1.4 mg / m 2 body surface area, corresponding to approximately 0.045-0.050 mg/kg body weight daily by injection under the skin. - Growth disorder in infants born small:
1 mg / m 2 body surface area, approximately equal to 0.035 mg/kg body weight daily by injection under the skin.
Adults:
- Growth hormone deficiency in adults:
At the start of treatment, low doses of 0.15–0.3 mg daily by injection under the skin are recommended. Dose one is gradually adjusted by your doctor. The recommended final dose of growth hormone rarely exceeds 1.0 mg per day. The lowest effective dose that works for you should be injected. If you are older or overweight, a lower dose may be necessary.
Method and method of injection
The dose and 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. Usually, Saizen should be administered daily by subcutaneous injection (under the skin).
Important information
Read the following instructions carefully before injecting Saizen.
When the drug is injected in the same place every time for a long time, it can cause injuries. It is important to vary the injection site at all times. Your doctor or pharmacist can tell you which area of your body you should use. Do not use a place where you feel lumps, firm lumps, pits, or pain, talk to your doctor or pharmacist if you feel it. Clean the skin at the injection site with soap and water.
Cylinder cartridge one with the solution with Saizen is ready to use for injection with an easy pod auto-injector or aluetta pen-injector.
Each cartridge with Saizen is color-coded and can only be used with the aluetta pen injector that has a matching color code to give the correct dose. A cylinder cartridge containing 6 mg somatropin (blue) may only be used with Aletta pen injector 6 (blue).
Put everything you need for injection of one of the solutions on a clean surface and wash your hands with soap and water.
The solution should be ready to be slightly opalescent without particles and visible signs of deterioration. If the solution contains particles, it should not be injected.
How to take your daily injection of Saizen yourself
Carefully read the instructions that come with each injector for a description of how to insert a cartridge into an easy pod auto-injector or aluetta pen injector and how to inject the solution with Saizen. Easypod is primarily intended for children from 7 years and up and adults. For children, the use of injectable drugs should always be done under the supervision of an adult.
Duration of treatment
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. Saizen treatment will be discontinued in children with chronic kidney disease before a kidney transplant.
In adults with a growth hormone deficiency, this is a condition that lasts a lifetime and should be treated accordingly by your doctor.
If you use more Saizen than you should
If you inject too much Saizen, tell your doctor, as one may need to be changed slightly to correct what happened. If you inject too much, there may be changes in your blood sugar levels. This can mean that you (or your child) feel shaky and dizzy. Contact your doctor immediately if this occurs.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Saizen
If you miss a dose, tell your doctor as it may be necessary to change the dose slightly to correct what happened.
If you stop taking Saizen
Do not stop taking Saizen without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience severe and recurrent headaches with nausea, vomiting, or visual disturbances. This is a symptom of a less common side effect called benign intracranial hypertension.
Side effects can occur with a certain frequency, which is defined as follows:
- very common: may affect more than 1 in 10 people
- common: may affect up to 1 in 10 people
- uncommon: may affect up to 1 in 100 people
- rare: may affect up to 1 in 1,000 people
- very rare: may affect up to 1 in 10,000 people
- has been reported (occurs in an unknown number of users)
Common side effects:
- Injection site reactions such as e.g. redness, itching, swelling, rash, hives, pain, inflammation, bleeding, and abnormal accumulation of blood outside a blood vessel (hematoma). If this becomes particularly difficult, consult your doctor.
- Local loss of fat under the skin, which can be avoided if you change the injection site.
- Carpal tunnel syndrome in adults, is characterized by a persistent stinging, burning sensation, pain, and/or numbness in the fingers that mainly affects the thumb, index finger, and sometimes even the middle and ring finger.
- Fluid retention: peripheral edema (swelling), muscle pain, numbness and tingling, joint pain, and joint problems in adult users. These side effects usually occur early in treatment and are transient and dose-dependent.
- Headache (occasional).
Uncommon side effects:
- Benign intracranial pressure increase (increased pressure inside the skull around the brain characterized by headache, nausea, vomiting, double vision, and other visual symptoms).
- Carpal tunnel syndrome in children is characterized by a persistent stinging, burning sensation, pain, and/or numbness in the fingers which mainly affects the thumb, forefinger, and sometimes also the middle and ring finger.
- Fluid retention: peripheral edema (swelling), muscle aches, numbness and tingling, joint pain, and joint problems in children. These side effects usually occur early in treatment and are transient and dose-dependent.
- Enlarged breasts (one or both sides may be affected).
Very rare side effects:
- Epiphysiolysis of the hip joint (a hip problem that occurs if the growing part of the femur slips out of the femur) and tissue death of the upper part of the femur, due to lack of blood supply. If your child starts to limp and has pain in the hip or knee, contact your doctor or pharmacist.
- Growth hormone treatment can reduce thyroid hormone levels. Your doctor may check this through blood sampling and, if necessary, take appropriate treatment.
Side effects with unknown frequency:
You (or your child) may get allergic reactions from treatment with Saizen.
You (or your child) may have elevated insulin levels (hyperinsulinism) because muscle, fat, and liver cells do not respond properly to insulin during growth hormone therapy (insulin resistance). This condition can result in high blood sugar (hyperglycemia).
In rare cases, inflammation of the pancreas has been reported in patients treated with growth hormone.
A few isolated cases of leukemia have been reported in patients with a growth hormone deficiency, some of whom have been treated with somatropin. However, there is no evidence that the incidence of leukemia is increased in growth hormone-treated patients without predisposition factors.
In very rare cases, patients may develop antibodies (a type of protein that helps protect the body) against somatropin. These usually do not cause any side effects and utypicallydo not affect growth.
How to store Saizen
Keep this medicine out of the sight and reach of children.
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.
Store the unused cartridge with Saizen in a refrigerator (2 ° C – 8 ° C). Store in the original package. Sensitive to light. Do not freeze.
Use within 28 days after the first injection.
After the first injection, cartridge one with Saizen, easy pod autoinjector containing cartridge one with Saizen, or aluetta pen injector containing cartridge one with Saizen must be stored in a refrigerator (2 ° C-8 ° C) for a maximum of 28 days, of which up to 7 days may be outside refrigerator at a maximum of 25 ° C. After storage outside the refrigerator for up to 7 days, the cartridge one with Saizen must be put back in the refrigerator and used within 28 days after the first injection.
When using an easy pod auto-injector or aluetta pen-injector, the cartridge should be stored in the auto-injector.
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.
Contents of the packaging and other information
Content declaration
The active substance is somatropin ( recombinant human growth hormone ) 6 mg.
The other ingredients are sucrose, poloxamer 188, phenol, citric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.
What the medicine looks like and the contents of the pack
Saizen 5.83 mg/ml is a clear to slightly opalescent solution for injection in a pre-filled cartridge (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). A cylinder cartridge containing 6 mg somatropin has a color-labeled label (blue).
Pack sizes of 1 and 5 cartridges.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck AB
Box 3033
169 03 Solna
Manufacturer
Merck Serono SpA, Modugno, Bari, Italy
This medicinal product is authorized under the European Economic Area under the names:
Size: Belgium, Estonia, Finland, France, Greece, Iceland, Ireland, Italy, Latvia, Luxembourg, Norway, Portugal, Romania, Slovakia, Spain, UK, Sweden, Czech Republic, Germany, Hungary, Austria