MIACALCIN calcitonin salmon injection solution

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

CALCITONIN SALMON (UNII: 7SFC6U2VI5) (CALCITONIN SALMON - UNII:7SFC6U2VI5)

Доступна с:

Sebela Pharmaceuticals Inc.

ИНН (Международная Имя):

CALCITONIN SALMON

состав:

CALCITONIN SALMON 200 [iU] in 1 mL

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

New Drug Application

Характеристики продукта

MIACALCIN- CALCITONIN SALMON INJECTION, SOLUTION
SEBELA PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MIACALCIN INJECTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR MIACALCIN INJECTION.
MIACALCIN
(CALCITONIN-SALMON) INJECTION, SYNTHETIC, FOR SUBCUTANEOUS OR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
Miacalcin synthetic injection is a calcitonin, indicated for the
following conditions:
Treatment of symptomatic Paget’s disease of bone when alternative
treatments are not suitable ( 1.1)
Treatment of hypercalcemia ( 1.2)
Treatment of postmenopausal osteoporosis when alternative treatments
are not suitable. Fracture reduction efficacy
has not been demonstrated ( 1.3)
Limitations of Use:
Due to the possible association between malignancy and
calcitonin-salmon use, the need for continued therapy should
be re-evaluated on a periodic basis ( 1.4, 5.3)
DOSAGE AND ADMINISTRATION
Symptomatic Paget’s disease of bone: 100 International Units daily.
Ensure adequate calcium and vitamin D intake ( 2.1,
2.5)
Hypercalcemia: start with 4 International Units/kg body weight every
12 hours. Increase to 8 International Units/kg
every 12 hours if no improvement in 1-2 days. Increase further to 8
International Units/kg every 6 hours if no
improvement after 2 more days ( 2.2)
Postmenopausal osteoporosis: 100 International Units daily. Ensure
adequate calcium and vitamin D intake ( 2.3, 2.5)
DOSAGE FORMS AND STRENGTHS
Injection: 200 International Units per mL sterile solution in 2 mL
multi-dose vials ( 3)
CONTRAINDICATIONS
Hypersensitivity to calcitonin-salmon or any of the excipients ( 4)
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions, including reports of fatal
anaphylaxis have been reported. Consider skin testing
prior to treatment in patients with suspected hypersensitivity to
calcitonin-salmon ( 5.1)
Hypocalcemia has been reported. Ensure adequate intake of calcium and
vitamin D ( 5.2)
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