Indications: This product is indicated for the treatment of osteoporosis in postmenopausal women at high risk of fracture. This product may significantly reduce the risk of vertebral and non-vertebral fractures in postmenopausal women, but its effect on reducing the risk of hip fractures has not been demonstrated.
Usage and dosage:
1, The recommended dose of this product is 20 μg subcutaneously per day, and the injection site should be chosen as the thigh or abdomen.
2. Patients should be instructed to use the correct injection method. Patients can also refer to the instruction manual attached to this product to use the injection pen correctly.
3. The maximum total duration of treatment with this product is 24 months. Patients may receive only one 24-month treatment in their lifetime.
4. Patients should take calcium and vitamin D supplements if dietary needs are not met.
5、After stopping treatment with this product, patients can continue other osteoporosis treatments.
6、Patients with renal insufficiency: this product should not be used in patients with severe renal insufficiency. Patients with moderate renal insufficiency should use this product with caution.
7、Patients with hepatic insufficiency: No research has been conducted in patients with hepatic insufficiency, and should be used with caution under the guidance of a doctor.
8、Children and adolescents with open epiphyses: there is no experience with the use of this product in adolescents less than 18 years of age. This product should not be used in adolescents younger than 18 years of age and youth with open epiphyses.
9、Geriatric Use: No dosage adjustment is required based on age.
10, injection pen guide: injection pen detailed operation diagram and injection instructions, please refer to the “injection pen manual” attached to the box of this product.
11, Important Note: Before using the injection pen, please carefully read the “injection pen manual”, if you do not fully comply with the manual operation may lead to dosage errors, injection pen damage or infection.
12, this product is a pre-filled pen injector, each pen is limited to one patient. A new sterile injection needle is required for each injection. The instruction manual for the pen is included in the box. This product does not contain needles. Needles for insulin injection pens may be used. After each injection, the product should be stored back in the refrigerator.
13. Do not use if the solution is cloudy, colored or particulate.
14、Please refer to the injection pen manual for the use of injection pens.
15、Please follow local regulations for disposal of unused products and waste.
Contraindications:
1, Hypersensitivity to teriparatide or any excipients of this product.
2, Pregnant and lactating women.
3, Patients with hypercalcemia.
4, Patients with severe renal insufficiency.
5、Skeletal metabolic diseases other than primary osteoporosis and glucocorticoid-induced osteoporosis (including hyperparathyroidism and Paget's disease).
6. Unexplained elevation of alkaline phosphatase.
7、Patients who have previously received external irradiation or skeletal implant radiotherapy.
8, The therapeutic scope of this product should exclude patients with bone malignancy or with bone metastases.
Storage Methods:
1, The product should be stored under refrigeration at 2℃-8℃ and protected from light. The injection pen should be put back into the refrigerator immediately after use. It should not be frozen.
2, The injection pen shall not be stored with the needle installed.
3, The data from the chemical, physical and microbiological stability tests of this product during the period of use support the validity period of 28 days of use when stored at 2-8°C. Once used, the product can be stored at 2-8℃ for a maximum of 28 days. It is the responsibility of the user to use the product beyond these storage times and conditions.
The information is taken from the internet and is for reference only.