Growth disturbances due to lack of growth hormone secretion (growth hormone deficiency, GHD) and growth disorders associated with Turner syndrome or chronic kidney failure.
Growth disturbances [current standard deviation height (SDS) score <- 2.5 and adjusted height SDS <- 1] in short-term infants for gestational age (SGA), with weight severe at birth and / or length below - 2 SD, who failed to show catch-up growth [high speed (HV) SDS <0 in the last year] by 4 years of age or later.
Prader-Willi syndrome (PWS), to improve growth and body composition. The PWS diagnosis should be confirmed by appropriate genetic testing.
Specify the drug Genotropin for N prolific big
Alternative therapy in adults with a pronounced growth hormone deficiency.
Adult initiation: Patients with severe growth hormone Genotropin deficiency associated with multiple hormone deficiencies as a result of speech in the hypothalamus or pituitary pathology, and who have at least a lack of sound. of a pituitary hormone that is not prolactin. These patients should undergo an appropriate dynamic test to diagnose or rule out growth hormone deficiency.
Childhood Onset: The patient is deficient growth hormone in childhood as a result of congenital, genetic, acquired or spontaneous causes. Patients with childhood initiation of GHD should be re-evaluated for growth hormone secretion Genotropin following completion of longitudinal growth. In patients with a high probability for persistent GHD, i.e. a congenital cause or secondary GHD following a pituitary / hypothyroid disease or insult, an insulin-like growth factor-I (IGF-I) SDS <- 2 off growth hormone therapy for at least 4 weeks should be considered for sufficient evidence of profound GHD.
All other patients will require IGF-I assay and a growth hormone stimulation test.
Dosage and administration of Genotropin
Injections should be injected under the skin and at various sites to prevent fat atrophy.
Growth disturbance due to inadequate secretion of growth hormone in children: Generally a dose of 0.025 to 0.035 Genotropin mg / kg body weight per day or 0.7-1.0 mg / m 2 body surface area Every day is recommended. Higher doses have been used.
Where GHD childhood initiation persists through adolescence, treatment should be continued to achieve full somatic development (eg body composition, bone mass). For monitoring, the attainment of a mass-defined normal parietal bone is defined as a score of T> - 1 (i.e., the criterion for average adult parietal mass measured by dual X-ray energy absorption taking into account account sex and ethnicity) is one of the treatment goals during the transition period. For dosage instructions see most below.
Prader-Willi syndrome, for improvement of growth and body composition in children: Generally a dose of 0.035 mg / kg body weight per day or 1.0 mg / m 2 body surface area per Days are recommended. The daily dose of 2.7 mg should not be exceeded. Treatment should not be used in children with a growth rate of less than 1 cm per year and close to closure of epiphyses.
Growth disturbance due to Turner syndrome: Genotropin A dose of 0.045 to 0.050 mg / kg body weight per day or / m 1.4 mg 2 surface area of the body each day is recommended.
Growth disorders in chronic renal failure: Genotropin A dose of 0.045 to 0.050 mg / kg body weight per day (1.4 mg / m 2 body surface area per day) is recommended. Higher doses may be needed if the growth rate is too low. A dose adjustment may be needed after six months of treatment.
Growth disorders in children Short born small for gestational age: Genotropin A dose of 0.035 mg / kg body weight per day (1 mg / m 2 body surface area per day) is usually recommended until official gain (see section 5.1). The drug should be discontinued after the first year of treatment if the SDS velocity is less than 1.the drug should be discontinued if the high velocity is <2 cm / year, and if confirmed as necessary, the bone age is> 14 years (girls) or > 16 years (boys), which corresponds to the closure of the apical growth plate.
Growth hormone deficient adult patients: In patients who continue growth hormone therapy after childhood GHD, the recommended dose to restart is 0.2-0.5 mg per day. The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration.
In adult patients starting GHD, treatment should begin with a low dose, 0.15-0.3 mg per day. The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration.
In both cases the therapeutic target should have IGF-I concentrations within 2 SDS from the adjusted mean age. Patients with normal IGF-I levels at the start of therapy should be given growth hormone genotropin up to an IGF-I level into the upper range of normal, not more than 2 SDS. Clinical responses and side effects may also be used as guidelines for dose titration. Admittedly there are patients with GHD who do not normalize IGF-I levels despite a good clinical response, and therefore do not require an increase in dose.
Maintenance dose rarely exceeds 1.0 mg per day. Women may require higher doses than men, whose IGF-I sensitivity increases over time. This means that there is a risk that women, especially those on oral estrogen replacement are being treated while men are over-treated.
The accuracy of the growth hormone genotropin doses should therefore be controlled every 6 months. As the normal physiological production of growth hormone genotropin decreases with age, the dose requirement is reduced. In patients over 60 years of age, treatment should begin with a dose of 0.1-0.2 mg per day and should be gradually increased according to individual patient requirements. The minimum effective dose should be used. Maintenance dose in patients rarely exceeds 0.5 mg per day.
Genotropin 12mg (Somatropin 36IU) hormone of growth (2)
Contraindications to the drug Genotropin
Hypersensitivity to the active substance or to any of the excipients.
Genotropin 12mg Somatropin must not be used when there is any evidence of tumor activity. Intracranial tumors must be inactive and antitumour therapy must be completed before starting growth hormone therapy. The drug should be discontinued if there is evidence of tumor growth
Genotropin should not be used for growth promotions in children with closed epiphyses.
Patients with acute critical distress complications after open-heart surgery, abdominal surgery, multiple accidental injuries, acute respiratory failure or similar conditions should not be treated with Genotropin.
Warnings before using Genotropin
Before you start using the medicine, be sure to tell your doctor about any medical conditions or allergies you may have:
a serious illness caused by lung failure, or complications from recent surgery, trauma or medical trauma;
Active cancer
eye problems caused by diabetes (diabetic retinopathy);
you are being treated for Prader-Willi syndrome and you are overweight or have serious breathing problems (including sleep apnea).
Tell your doctor if you have ever had:
Cancer: There may be an increased risk of developing tumors, both cancerous and non-cancerous, when growth hormones are used by childhood cancer survivors.
Diabetes: Genotropin 12mg Somatropin can cause an increase in blood sugar and variable glucose tolerance.
Scoliosis: People with scoliosis are at risk of worsening their condition while taking somatropin
tuyến giáp hoạt động kém: Nếu bạn bị suy giáp không kiểm soát được, điều trị bằng somatropin có thể không hiệu quả như nó có thể.
Trong một số trường hợp, không nên sử dụng Genotropin ở trẻ. Một số nhãn hiệu somatropin có chứa một thành phần có thể gây ra tác dụng phụ nghiêm trọng hoặc tử vong ở trẻ nhỏ hoặc trẻ sinh non. Đừng cho thuốc này cho trẻ mà không có lời khuyên y tế.
Một số nhãn hiệu somatropin dự kiến sẽ không gây hại cho thai nhi, bao gồm Genotropin, Onitrope, Saizen và Serostim.
Người ta không biết liệu một số nhãn hiệu somatropin khác sẽ gây hại cho thai nhi, bao gồm Humatrope, Norditropin, Nutropin, Zomacton và Zorbtive.
Hãy cho bác sĩ của bạn nếu bạn đang mang thai hoặc dự định có thai.
Có thể không an toàn khi cho con bú trong khi bạn đang sử dụng thuốc Genotropin. Hỏi bác sĩ về bất kỳ rủi ro.
Mang thai và cho con bú
Mang thai
Các nghiên cứu trên động vật không đủ liên quan đến ảnh hưởng đến mang thai, phát triển embryofoetal, quá trình sinh đẻ hoặc phát triển sau khi sinh với. Không có nghiên cứu lâm sàng trên thai tiếp xúc đều có sẵn. Do đó, Genotropin 12mg somatropin chứa sản phẩm không được khuyến khích trong khi mang thai và phụ nữ sinh đẻ tiềm năng không sử dụng biện pháp tránh thai.
cho con bú
Hiện vẫn chưa có nghiên cứu lâm sàng được tiến hành với các sản phẩm có chứa somatropin ở phụ nữ cho con bú. Người ta không biết liệu Genotropin 12mg somatropin được bài tiết vào sữa của con người, nhưng sự hấp thụ của protein nguyên vẹn từ đường tiêu hóa của trẻ sơ sinh là rất khó xảy ra. Do đó nên thận trọng khi somatropin chứa sản phẩm được dùng cho phụ nữ cho con bú.
Tương tác thuốc khác với Genotropin
Nói với bác sĩ của bạn về tất cả các loại thuốc khác của bạn, đặc biệt là:
thuốc tránh thai hoặc liệu pháp thay thế hormone
insulin hoặc thuốc trị tiểu đường đường uống;
một steroid (prednison, dexamethasone, methylprednisolone, và những thuốc khác).
Danh sách này không đầy đủ. Các loại thuốc khác có thể ảnh hưởng đến Genotropin, bao gồm thuốc kê đơn và thuốc không kê đơn, vitamin và các sản phẩm thảo dược. Không phải tất cả các tương tác thuốc có thể được liệt kê ở đây.
Tác dụng phụ của Genotropin
Nhận trợ giúp y tế khẩn cấp nếu bạn có dấu hiệu phản ứng dị ứng: nổi mề đay; khó thở; sưng mặt, môi, lưỡi hoặc cổ họng của bạn.
Vấn đề hô hấp nghiêm trọng có thể xảy ra ở những bệnh nhân mắc hội chứng Prader-Willi sử dụng Genotropin. Nếu bạn mắc hội chứng Prader-Willi, hãy gọi bác sĩ kịp thời nếu bạn có dấu hiệu của các vấn đề về phổi hoặc hô hấp như khó thở, ho, hoặc ngáy mới hoặc tăng.
Cũng gọi cho bác sĩ của bạn ngay lập tức nếu bạn có:
đau ở đầu gối hoặc hông của bạn, đi bằng chân;
đau tai, sưng, ấm hoặc thoát nước;
tê hoặc ngứa ran ở cổ tay, bàn tay hoặc ngón tay của bạn;
sưng nặng hoặc bọng mắt ở tay và chân của bạn;
đau hoặc sưng ở khớp của bạn;
viêm tụy: giảm đau ở dạ dày trên lan ra lưng, buồn nôn và nôn;
lượng đường trong máu cao: tăng khát nước, tăng đi tiểu, khô miệng, mùi hơi thở trái cây;
tăng áp lực bên trong hộp sọ: đau đầu dữ dội, ù tai, chóng mặt, buồn nôn, các vấn đề về thị lực, đau sau mắt; hoặc là
signs of an adrenal gland problem: extreme weakness, severe dizziness, weight loss, change in skin color, feeling very weak or tired.
Common Genotropin side effects may include:
pain, itching, or skin change where the medicine was injected;
swelling, rapid weight gain;
muscle or joint pain;
numbness or tingling;
stomach pain, flatulence;
headache, back pain;
cold or flu symptoms, stuffy nose, sneezing, sore throat, earache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
Shelf life of the drug Genotropin
3 years
Chemical and physical stability in use has been demonstrated for 4 weeks at 2 ° C - 8 ° C.
From the point of view of microbiology, once reconstituted, the product can be stored for 4 weeks at 2 ° C - 8 ° C. Other times during use store and this condition is the responsibility of the user. .
Genotropin drug storage
Before mixing:
Store in the refrigerator (2 ° C - 8 ° C), or up to 1 month equal to or lower than 25 ° C. Keep the two chamber / pre-filled ink pen in the outer carton to avoid light.
After mixing:
Store in a refrigerator (2 ° C - 8 ° C). Don't freeze. Keep the two chamber / pre-filled ink pen in the outer carton to avoid light. For the storage conditions of renewable medicinal products see section 6.3.
Special precautions for handling and other disposition of the drug Genotropin
Only reconstitute the powder with the solvent provided.
Two-chamber ink : The solutions are prepared by screwing the mixing device or the sprayer or the GoQuick the pen section pre-filled together so that the solvents will be mixed with the powder in the two-chamber cartridge. Gently dissolve the powder with a slow swirling motion. Do not shake vigorously, this can cause denaturation of the active ingredient. The reproducible solutions are almost colorless or slightly opaque. The reconstituted solution for injection is to be tested prior to use and only clear solution without particles should be used.
Comprehensive instructions for the preparation and administration of re-made Genotropin products are given in the package leaflet, section 3, “Injecting genotropin” and in the relevant instructions for use provided with the device. used.
When using a syringe injection device, the phase should be screwed first.
Handling Instructions : Any unused product or waste material must be disposed of in accordance with local requirements. Empty GoQuick pre-filled pens should never be refilled and must be disposed of properly.
Genotropin 12mg (Somatropin 36IU) hormone of growth (3)
Note: Information on the drug Genotropin 12mg Somatropin is intended to share knowledge for reference purposes, patients are not allowed to arbitrarily use drugs, all information on drug use must be specified by a specialist doctor.
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