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:

Hikma Pharmaceuticals USA Inc.(dba Leucadia Pharmaceuticals)

Администрация маршрут:

INTRAMUSCULAR

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Calcitonin salmon injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. Calcitonin salmon injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). Calcitonin salmon injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furose

Обзор продуктов:

How Supplied Calcitonin Salmon Injection, USP, Synthetic is available as a sterile solution in individual 2 mL multi-dose vials containing 200 USP Units per mL. NDC 24201-400-02 carton containing 1 x 2 mL multi-dose vial Storage and Handling Store in a refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

CALCITONIN SALMON- CALCITONIN SALMON INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.(DBA LEUCADIA PHARMACEUTICALS)
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCITONIN SALMON
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CALCITONIN SALMON
INJECTION.
CALCITONIN SALMON INJECTION, SYNTHETIC, FOR SUBCUTANEOUS OR
INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
Calcitonin salmon 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 USP Units daily. Ensure
adequate calcium and vitamin D
intake ( 2.1, 2.5)
Hypercalcemia: start with 4 USP Units/kg body weight every 12 hours.
Increase to 8 USP Units/kg every
12 hours if no improvement in 1-2 days. Increase further to 8 USP
Units/kg every 6 hours if no
improvement after 2 more days ( 2.2)
Postmenopausal osteoporosis: 100 USP Units daily. Ensure adequate
calcium and vitamin D intake (
2.3, 2.5)
DOSAGE FORMS AND STRENGTHS
Injection: 200 USP 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)
Malignanc