MEGAPTH-G SOLUTION FOR INJECTION 20 MCG/80MCL CARTRIDGE PACK [SIN17051P]

Product Info

MEGAPTH-G SOLUTION FOR INJECTION 20 MCG/80MCL CARTRIDGE PACK

[SIN17051P]

INDICATIONS AND USAGE:
Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture:
Teriparatide is indicated for the treatment of postmenopausal women with osteoporosis who are at high risk for fracture. These include women with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant of previous osteoporosis therapy, based upon physician assessment. In postmenopausal women with osteoporosis, Teriparatide increases BMD and reduces the risk of vertebral and nonvertebral fractures.

Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture:
Teriparatide is indicated to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. These include men with a history of osteoporotic fracture, or who have multiple risk factors for fracture, or who have failed or are intolerant to previous osteoporosis therapy, based upon physician assessment. In men with primary or hypogonadal osteoporosis, Teriparatide increases BMD. The effects of Teriparatide on risk for fracture in men have not been studied.

Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture.

DOSAGE AND ADMINISTRATION:
Dosage:
The recommended dosage is 20 mcg given subcutaneously once a day.

Administration:
MEGAPTH-G should be administered as a subcutaneous injection into the thigh or abdominal wall. No data are available on the safety or efficacy of intravenous or intramuscular injection of MEGAPTH-G.
MEGAPTH-G should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration whenever solution and container permit. MEGAPTH-G is a clear and colorless liquid. Do not use if solid particles appear or if the solution is cloudy or colored.
Patients and caregivers who administer MEGAPTH-G should receive appropriate training and instruction on the proper use of the MEGAPTH-G delivery device from a qualified health professional.

Treatment Duration:
The safety and efficacy of Teriparatide have not been evaluated beyond 2 years of treatment.
Consequently, use of the drug for more than 2 years during a patients' lifetime is not recommended.

CONTRAINDICATIONS:
MEGAPTH-G should not be given to patients with hypersensitivity to Teriparatide or to any of its excipients.