Information on TEV-TROPIN

INDICATIONS
TEV-TROPIN® is indicated only for the long-term treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone.

DOSAGE AND ADMINISTRATION
A dosage of up to 0.1 mg/kg (0.3 IU/kg) of body weight administered 3 times per week by subcutaneous injection is recommended. The dosage schedule for TEV-TROPIN® should be individualized for each patient. Subcutaneous injection of greater than 1 mL of reconstituted solution is not recommended.
After the dose has been determined, each vial of TEV-TROPIN® should be reconstituted with 1 to 5 mL of bacteriostatic 0.9% sodium chloride for injection, USP (benzyl alcohol preserved).* The stream of normal saline should be aimed against the side of the vial to prevent foaming. Swirl the vial with a GENTLE rotary motion until the contents are completely dissolved and the solution is clear. DO NOT SHAKE. Since TEV-TROPIN® is a protein, shaking or vigorous mixing will cause the solution to be cloudy. If the resulting solution is cloudy or contains particulate matter, the contents MUST NOT be injected.
Occasionally, after refrigeration, some cloudiness may occur. This is not unusual for proteins like TEV-TROPIN® growth hormone. Allow the product to warm to room temperature. If cloudiness persists or particulate matter is noted, the contents MUST NOT be used.
Before and after injection, the septum of the vial should be wiped with rubbing alcohol or an alcoholic antiseptic solution to prevent contamination of the contents by repeated needle insertions. It is recommended that TEV-TROPIN® be administered using sterile disposable syringes and needles. The syringes should be of small enough volume that the prescribed dose can be drawn from the vial with reasonable accuracy.

Stability And Storage
Before Reconstitution – Vials of TEV-TROPIN® are stable when refrigerated at 36° to 46°F (2° to 8°C). Expiration dates are stated on the labels.
After Reconstitution – Vials of TEV-TROPIN® are stable for up to 14 days when reconstituted with bacteriostatic 0.9% sodium chloride (normal saline), USP, and stored in a refrigerator at 36° to 46°F (2° to 8°C). Do not freeze the reconstituted solution.

SIDE EFFECTS
Utilizing a double-antibody immunoassay, no antibodies to growth hormone could be detected in a group of 164 naïve and previously treated clinical trial patients after treatment with TEV-TROPIN® for up to 40 months. However, utilizing the less specific polyethelene glycol (PEG) precipitation immunoassay, 27 of the 164 patient group were tested after treatment with TEV-TROPIN® for 4 to 6 months and antibodies to growth hormone were detected in two patients (7.4%). The binding capacity of the antibodies from the two antibody positive patients was not determined.
None of the patients with anti-GH antibodies in the clinical studies experienced decreased linear growth response to TEV-TROPIN® or any other associated adverse event. Growth hormone antibody binding capacities below 2 mg/L have not been associated with growth attenuation. In some cases, when binding capacity exceeds 2 mg/L, growth attenuation has been observed.
In studies of growth hormone-deficient children, headaches occurred infrequently. Injection site reactions (e.g., pain, bruise) occurred in 8 of the 164 treated patients.
Leukemia has been reported in a small number of patients treated with other growth hormone products. It is uncertain whether this risk is related to the pathology of growth hormone deficiency itself, growth hormone therapy, or other associated treatments such as radiation therapy for intracranial tumors.

WARNINGS
See CONTRAINDICATIONS for information on increased mortality in patients with acute critical illnesses due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure. The safety of continuing somatropin treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. Therefore, the potential benefit of treatment continuation with somatropin in patients having acute critical illnesses should be weighed against the potential risk.

There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstructions or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. If during treatment with somatropin, patients show signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with somatropin should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively .

Unless patients with Prader-Willi syndrome also have a diagnosis of growth hormone deficiency, TEV-TROPIN® is not indicated for the long term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.

原产地英文商品名:	TEV-TROPIN 5MG VIAL 6X5MG VIALS
原产地英文药品名:	SOMATROPIN RECOMBINANT
中文参考商品译名:	TEV-TROPIN 5毫克/支 6支/盒
中文参考药品译名:	重组人生长激素
临床试验期:	完成
中文适应病症参考翻译1:	儿童生长激素分泌不足
生产厂家中文参考译名:	辉凌制药
生产厂家英文名:	FERRING

[通用药名]基因重组人生长激素　
[药品成分]本品是由191个氨基酸残基或N端有一甲硫氨酸的192个氨基酸残基组成的蛋白。　
[作用与用途]本品具有与人体生长激素同等的作用，即能促进骨骼、内脏和全身生长，促进蛋白质合成，影响脂肪和矿物质代谢，在人体生长发育中起着关键性作用。皮下注射约80％被吸收，5小时后达高峰血浓度，t1/2约4小时。主要用于内源性脑垂体生长激素分泌不足而引起的生长障碍、躯体矮小的侏儒症、短小病患儿。此外，尚可用于治疗烧伤、骨折、创伤、出血性溃疡、组织坏死、肌肉萎缩症、骨质疏松等疾病。
[用法与用量]本品给药剂量个体差异很大，采用肌内注射或皮下注射，一般用量为每周0．5—0．7单位／kg或每周12单位／m2，分6—7次给药。
[注意事项]偶可引进皮肤过敏、注射部位发红和皮下脂肪萎缩、氨基转移酶升高、呕吐及腹痛等。
1．肿瘤患者、糖尿病患者、颅内进行性损伤者禁用。
2. 对脑肿瘤的垂体抹儒病者、心脏或肾脏病者、孕妇和哺乳妇女等慎用。
3．使用前，需对脑垂体功能作详细检查，准确诊断后才能应用。
4．应临用时配制，用注射用水溶解，轻轻摇动，切勿振荡，以免变性。