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Posology: The recommended dose of teriparatide is 20 micrograms administered once daily.
Patients should receive supplemental calcium and vitamin D supplements if dietary intake is inadequate.
The maximum total duration of treatment with teriparatide should be 24 months (see Precautions).
The 24-month course of teriparatide should not be repeated over a patient's lifetime.
Following cessation of teriparatide therapy, patients may be continued on other osteoporosis therapies.
Special populations: Renal impairment: Teriparatide must not be used in patients with severe renal impairment (see Contraindications). In patients with moderate renal impairment, Teriparatide should be used with caution. No special caution is required for patients with mild renal impairment.
Patients with hepatic impairment: No data are available in patients with impaired hepatic function (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, teriparatide should be used with caution.
Paediatric population and young adults with open epiphyses: The safety and efficacy of teriparatide in children and adolescents less than 18 years has not been established. Teriparatide should not be used in paediatric patients (less than 18 years), or young adults with open epiphyses.
Elderly patients: Dosage adjustment based on age is not required (see Pharmacology: Pharmacokinetics under Actions)
Method of administration: TERROSA 20 μg/80 μL solution for injection should be administered once daily by subcutaneous injection in the thigh or abdomen.
It should be administered exclusively with the Terrosa Pen reusable, multidose medicine delivery system and the injection needles which are listed as compatible in the instructions which are provided with the pen. The pen and injection needles are not included with TERROSA 20 μg/80 μL solution for injection. However, for the treatment initiation a cartridge and pen pack should be used containing one carton of TERROSA 20 μg/80 μL solution for injection cartridge and one carton of Terrosa Pen.
TERROSA 20 μg/80 μL solution for injection must not be used with any other pen.
Patients must be trained to use the proper injection techniques (see Special precautions for disposal <and other handling> under Cautions for Usage). An instruction for use which is included in the carton of the delivery system is also available to instruct patients on the correct use of the pen.
The date of first injection should also be written on the outer carton of TERROSA 20 μg/80 μL solution for injection (see the provided space on the box: {First use}).
