Saiizen 6mg injection solution for slow growth treatment (1 tube box)

Dosage form 1 -tube box
Specifications Somatropin

Ingredient

Thành phần cho 1 ống

Composition information	Content
Somatropin	6mg

Uses

indications

Saiizen Liquid injection drug indicated in the following cases:

Children and adolescents:

Poor growth in children due to decreasing or not excreting endogenous growth hormones.

Poor growth in women with genital development disorders (Turner syndrome) has been confirmed by chromosomal analysis results.

growth cream in puberty children due to chronic kidney failure (CRF).

growth disorder (current height Adults:

Alternative treatment in adults with growth hormone deficiency on when young or when adults are diagnosed with a functional test for growth hormone deficiency.

Patients must also meet the following criteria:

If starting as a child: The patient is diagnosed with growth hormone deficiency as a child must be re -tested and confirms the deficiency of growth hormone before starting treatment with Saizen.

If the growth is in adulthood: Patients must have a growth hormone deficiency due to the disease of the hypothalam or pituitary area and at least a deficiency of another diagnosed hormone (except for prolactin) and have been properly replaced before starting a replacement therapy with growth hormones.

Pharmacokic

Pharmacological effects: Hormones of the anterior pituitary and pituitary lobes, ATC code: H01AC01.

Saiizen® contains growth hormone of human begins according to genetic technology from cells of mammals. It is a peptide with 191 amino acids with sequences, constituents, isotropic points, molecular weight, isomer structure and biological activity similar to growth hormone of the pituitary gland.

Saiizen® is an assimilation, anti -catabolic agent, not only works on growth but also works on the constituent of the body and metabolism. Saiizen® interacts with receptors on many types of cells including muscle cells, fat cells, liver cells, lymphocytes and hematopoietic cells. Some of the effects are not all, which are regulated through a group of other hormones called somatomedin (IGF-1, IGF-2).

Depending on the dose, treatment with Saiizen® may increase IGF-1, IGFBP-3, fatty acids that have not been estered and glycerol, blood urea, reduce nitrogen secretion, sodium, potassium in urine. The growth period of growth hormone plays an important decisive role in the effectiveness of the drug. There may be correlation saturation between the effect of Saizen and the high doses of the drug. This is not true in the case of hyperglycemia or c-peptide that increases significant after using high doses (20 mg).

Dynamic pharmacokinetics

The pharmacokinetics of the linear Saizen® up to the dose of 8 IU (2.67 mg). At higher doses (60 UI/20 mg) there is a certain level of linear, but there is no clinical confirmation.

After intravenous intravenous injection for healthy volunteers, the volume of distribution is stable about 7 l, the total clearance is about 15 l/hour while the renal clearance is negligible, the sale time of the drug is 20 - 30 minutes.

After subcutaneous injection and injection of the single dozen® dose, the cancellation time is noticeable about 2-4 hours. This is due to the limited absorption process.

Absolute bioavailability of both injections is 70 - 90%.

The highest growth hormone concentration in the serum is achieved after about 4 hours and the serum growth hormone level returns to normal after 24 hours. This proves that there is no growth of growth hormone during the injection process.

Saozen® subcutaneous injection solution (5.83 and 8.00 mg/ml) has a biological effect equivalent to 8 mg of dried freeze powder.

Before taking Saiizen 6mg injection solution for slow growth treatment (1 tube box)

How to use

Use Saiizen® injection solution as instructed in the sheet that comes with the drug box and in the instruction manual comes with
Easypod automatic injection tools or Aluetta injection pen.

Use only automatic syringes in children from 7 years old and older and adults. Using injection tools in children must always be supervised by adults.

Dosage

Saizen® is used for many times for a patient.

Should use Saiizen® when going to bed at the following dose:

Children and adolescents:

Saizen® dose should be calculated for each patient based on the body surface area (BSA) or body weight (BW).

In poor growth due to insufficient endogenous growth hormone excretion: subcutaneous injection 0.7 - 1mg/m2 of the body surface area (BSA) daily or 0.025 - 0.035 mg/kg body weight (BW) per day.

Poor growth in women due to genital gland development disorders (Turner syndrome): subcutaneous injection of 1.4 mg/m2 of body surface area (BSA) daily or 0.045 - 0.050 mg/kg body weight (BW) daily. Treatment in combination with non -masculine assimilated steroids in patients with Turner syndrome can increase growth response.

Poor growth in puberty children due to chronic renal failure (CRF): Injection under the skin 1.4 mg/m2 of the body surface (BSA) is equivalent to 0.045 - 0.05 mg/kg body weight (BW) per day.

Poor growth in babies born smaller than gestational age (SGA): The recommended dose is 0.035 mg/kg body weight (or 1 mg/m2/day) injected under the skin.

Stop treatment when the patient is satisfied with an adult height or when the bones are closed.

In case of growth disorders in children born smaller than gestational age, treatment should be continued until the final height is achieved. Stop treatment after the first year if the growth rate is 14 years old (girls) or> 16 years old (boys), corresponding to the closing of the bone tip.

Adults:

Deficiency of growth hormone in adults: When starting with somatropine treatment, low doses of 0.15 - 0.3 mg should be used daily. The dose should be adjusted gradually based on the value of the growth factor similar to insulin 1 (IGF-1). However, the last dose is recommended to exceed 1.0 mg/day. In general, the lowest dose should be effective.

Women may require higher doses than men, because in men shows an increase in IGF-1 sensitive over time. This shows that the risks in women, especially in patients who are treated for oral alternative oral estrogen, under the dose of treatment, while in men overdose.

Dosage needed may be lower in older or overweight patients.

The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when using overdose? Overdose can lead to hypoglycemia and then hyperglycemia. Moreover, Somatropine overdose can cause expressions of fluid.

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

About 10% of patients with erythema and rashes at the injection site.

There may be expressions of adult fluid fluid during the time of growth hormone treatment. Edema, joint swelling, joint pain, muscle pain and paresthesia may be the clinical manifestation of fluid stasis. However, these signs and symptoms are often transient and dependent on treatment.

Adult patients with growth hormone deficiency have been diagnosed since childhood less side effects than patients with growth hormone deficiency of growth. Somatropin antibodies can be formed at a small percentage of patients. So far antibodies have low combination and not related to the decrease in the vefiner except in patients with mutations loss of gene segment. In very rare cases, small stature related to the loss of growth hormone complex can lead to antibody formation to impair growth.

leukemia has been recorded in a small number of patients with growth hormone deficiency, some of them have been treated with somatropin. However, there is no evidence that the rate of leukemia increases in children treated with growth hormone without trend factors.

The side effects are listed according to the following frequency: Very common (≥1/10), common (≥1/100 to Nervous system disorders:

Common: headache (simple), Calon syndrome (adult).

Very rare: The femoral tip of the femoral head (separating the femur) or the femoral necrosis of the femoral head.

Unknown frequency: Hypersensitivity reactions on the spot and whole body.

Endocrine disorders:

Very rare: Hypothyroidism.

Nutrition and metabolic disorders:

common in adults, less common in children: fluid, peripheral edema, stiffness, muscle pain, joint pain and paresthesia.

Uncommon: female mammary glands.

common: reaction at the injection site, localized fat atrophy.

Disorder digestive system:

The unknown frequency: pancreatitis.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Saiizen Liquid injection is contraindicated in the following cases:

There is a history of hypersensitivity to somatropin or any ingredient of the drug. The intracranial tumors must be inactivated and must complete any anti -tumor therapy before starting the growth hormone treatment. Treatment should be discontinued if there is a sign of tumor development. Severe.

Be cautious when using

The treatment must be performed under the monitoring of doctors who have experience in the diagnosis and treatment of growth hormones.

Do not overdose maximum daily recommended daily (see the dose and usage section).

tumor

Patients with new or outer tumors when treated for growth hormone after tumor treatment must be carefully monitored and examined by a doctor regularly.

Patients with secondary growth hormone deficiency due to intracranial tumors should pay attention to regular examination to detect signs of the recurrence or bad progress of the disease.

In cancer survivors as a child, there is a report on the risk of the second tumor in patients who treated with Somatropin after the first tumor treatment. In patients with tumor radiation therapy at the top of the intracranial tumor, especially the meningeal tumor, is the most common tumor among these second tumors.

Prader - Willi syndrome

Somatropin is only indicated for prolonged treatment in underdeveloped children due to Prader - Willi syndrome when there is a deficiency of growth hormone. There are several reports on sleep apnea and sudden death in patients with Prader - Willi syndrome while treating growth hormone due to a number of attached risks such as severe obesity, a history of airway obstruction, sleep apnea or non -specific respiratory infections.

leukemia

Acute leukemia in a small number of patients lacking growth hormone, in which a few patients have been treated with somatropin. However, there is no evidence that the rate of leukemia increases in children treated with growth hormone without trend factors.

Sensitive insulin

Because somatropin can reduce insulin sensitivity, patients need to be monitored to detect glucose intolerance. For patients with diabetes, the insulin dose may be needed after starting treatment with somatropin. Patients with diabetes or glucose intolerance when treated with somatropin need to be closely monitored, (may need to adjust the appropriate treatment for diabetes).

Rnin disease

In the case of retinopathy, there is no need to stop Somatropin therapy instead. However, in the case of hyperactive retinopathy or expedious proliferation retinal disease, it is necessary to stop therapy to replace Somatropin.

thyroid function

growth hormone increases the reduction of T4 to T3 and therefore can reveal newly new hypothyroidism. Therefore, it is necessary to check the thyroid function in all patients. For patients with pituitary disability, standard replacement treatment must be closely monitored when treated with somatropin.

Hurry up the benign intracranial pressure

In case of severe headache, recurrence, visual disorders, nausea and/or vomiting, should illuminate the bottom of the eye to detect a thorn. If the thorny gai is determined to pay attention to the diagnosis of benign intracranial pressure (or fake brain tumor) and if true, should stop treating Saiizen®. Currently, there is no enough data to guide the clinical decision for patients with increased intracranial pressure. If the hormone treatments grow again, careful monitoring of symptoms of increased intracranial pressure.

Pancreatitis

Despite rare, pancreatitis should be considered in patients treated with somatropine, especially for children with abdominal pain.

Scoliosis

Scoliosis is known to have a more frequency occurring in some groups of patients treated with somatropin, such as Turner syndrome. In addition, rapid development in any children can cause scoliosis progression. There is no increase in the rate or severity of this disease when using somatropine. Signs of scoliosis should be monitored during treatment.

antibodies

As well as all products containing somatropin, a small number of patients can form anti -Somatropin antibodies.

However, the cohesion of these antibodies is low and does not affect the growth rate. Patients who lack growth hormones that do not respond to treatment require anti -Somatropine antibody tests.

The femoral bone transferred

The femoral tip of the femoral head is often combined with endocrine disorders such as growth hormone deficiency and hypothyroidism, and with growth stages. In children being treated for growth hormone, the femoral tip of the femur may be due to hidden endocrine disorders or due to increased growth rate due to treatment. Increasing growth may increase the risks related to joints, hip joints are over -bearing joints in the period of puberty growth. Doctors and parents must be alert when children appear lame or complain about pain in the hips or knees during the time of growth hormone treatment.

Poor growth due to chronic kidney failure

Patients with poor growth due to chronic renal failure must be regularly examined to detect signs of kidney dystrophy. The breast transferred to the femoral head or femoral necrosis may be seen in children with renal dysplasia due to progression of the kidneys and are not sure these problems are affected when treated with growth hormones. Need to take X-ray of the hip before the growth hormone treatment.

In children with chronic kidney failure, the kidney function should be adjusted to less than 50% compared to normal before starting growth hormone treatment. To identify growth disorders, it is advisable to monitor growth a year before starting treatment. Caution treatment for renal failure (including control of acidosis, hyperthyroidism and nutritional condition for a year before treatment) during treatment. Should stop treating growth hormone during kidney transplantation.

Children born smaller than gestational age

In children born smaller than gestational age, eliminating medical causes or other treatments may explain this growth disorder before starting treatment.

For babies born smaller than gestational age, blood and blood sugar levels are required to be hungry before they start treatment and then once a year. For patients at high risk of pesticide (for example, patients with a family history of diabetes, obesity, increased body mass index, to resist severe insulin, thick black thorns) need to conduct blood sugar tolerance (OGTT). If there is a clinical diabetes manifestation, do not use growth hormones.

For babies born smaller than the gestational age, quantify IGF-1 before starting treatment and then twice a year. If quantitative, IGF-1 concentration is higher +2SD compared to the standard values compared to the age of the child and puberty, must be based on the IGF-1/GFBD-3 ratio to adjust the dose.

There is no experience in treating children younger than gestational age began treatment at the time of puberty. Therefore, it is not recommended for starting treatment for these patients at puberty. There is also not much experience for patients with Silver - Russel syndrome.

Increasing height achieved in children born smaller than the age of gestational stature being treated with somatropin may be partially lost if stopped before these children reach the final height.

Translation

During the treatment of growth hormone replacement therapy in adults, there may be fluid. However, these symptoms are usually fleeting and depends heavily on treatment.

In the case of prolonged or severe coherence, the treatment should be reduced to avoid progress to the wrist.

Acute disease

In patients with acute disease that can treat somatropin, the consideration of treatment benefits and the risks may occur.

Interaction with glucocorticoid

When starting to replace growth hormone can reveal secondary adrenal insufficiency in some patients due to reduced activity of 11B-hydroxysteroid dehydrogenase, type 1 (11-HSD1), a cortisone conversion enzyme into cortisol and may require glucocorticoid replacement treatment.

Somatropin initialization in patients with glucocorticoid replacement treatment may lead to cortisol deficiencies. Glucocorticoid dose may be adjusted (see interactive section).

Use oral estrogen

If the female patient is taking somatropin to start oral estrogen treatment, the Somatropin dose should be increased to maintain serum IGF-1 concentration in the normal range corresponding to age. On the contrary, if a female patient is using a somatropin to stop taking oral estrogen, the somatropine dose should be reduced to avoid overdose of growth hormones and/or unwanted effects (see the interaction).

General warning

Injecting location should change to avoid fat tissue atrophy.

The lack of growth hormone in adults is a lifetime -prolonged disease and needs appropriate treatment, but there is not much experience in treating patients over 60 years old and has no long -term experience in adults.

Special prudence when using and other operations:

Cartridge (Cartridge) 5.83 mg Saiizen® solution is only for Easypod automatic syringes or Aluetta injection pen.

Aluetta and tube injection pens (Cartridge) Saizen are available in many specifications. Each type of Aluetta pen has its own color code and is only used in accordance with the color code of the tube (Cartridge) Saizen to make the right dose. Aluetta 6 injection pen (blue) must be used with blue tube (cartridge) containing 6mg of somatropin.

Store the injection tools containing Saiizen in the refrigerator, see the special cautious part when preserved.

The injection solution must be transparent or mildly opaque without any signs of damage. If the solution is still still, must not be removed.

The product is not used or the removed tools after injection must be handled appropriately as prescribed.

Use drugs for women during pregnancy and lactation

Pregnant women

From animal reproductive studies using somatropin, there is no evidence to increase the risk of harmful to embryos and fetuses. There is no study on the use of this drug for animals during pregnancy. So do not use somatropin for pregnant women and women may be pregnant without using contraception.

Women in breastfeeding

There is no clinical studies on the use of somatropin in nursing women. It is not known whether Somatropin is excreted in milk or not. Therefore, it is necessary to be cautious when indicating Somatropin treatment for women in the breast -feeding period.

Reproduction

Clinical toxic toxicity studies show that the growth hormone of recombinant recombinants does not cause adverse effects on the fertility of men and women.

The effect of drugs on driving and operating machinery

somatropin does not affect the ability to drive and operate machinery.

Drug interaction

Concomitant treatment with glucocorticoid inhibits the effective treatment of somatropin. Patients with ACTH deficiency must be replaced with glucocorticoid need to adjust the dose carefully to avoid inhibiting the effects of growth hormones.

The growth hormone reduces the conversion of cortisone into cortisol and may reveal the central adrenal gland reduction that has previously been detected or caused low doses to replace glucocorticoids inefficiently.

may need higher growth hormone dose to achieve the treatment goals in women who are taking oral alternative oral alternative therapy.

Data from a study of interaction conducted on adults with growth hormone deficiency shows that using somatropin may increase the clearance of substances metabolized by Cytochrome P450. The clearance of metabolites through cytochrome P450 3A4 (for example, sex steroids, corticosteroids, anti -epileptic drugs and cyclosporine) may increase, leading to low blood in the blood, so it is necessary to monitor the clinical effect of these drugs.

Cavalry: Because there is no information about the Tuong Tuong, not mixed Saizen® with any other drug.

Storage

Store in the refrigerator at 2 ° C - 8 ° C. Do not freeze. Store in the original packaging to avoid light. After the first injection, the tube (Cartridge) Saizen®, Easypod automatic syringe or Aluetta injection pen containing the tube (Cartridge) Saiizen® must be stored in the refrigerator at 2 ° C - 8 ° C for up to 28 days.

When using Easypod automatic syringes or Aluetta injection pen, keeping the tube (Cartridge) Saizen® attached to the device, preserving to avoid light.

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