CALCITONIN SALMON spray, metered

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Bryant Ranch Prepack

Vía de administración:

NASAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Calcitonin Salmon (synthetic origin) Nasal Spray is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. Fracture reduction efficacy has not been demonstrated. Calcitonin Salmon (synthetic origin) Nasal Spray should be reserved for patients for whom alternative 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). - Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see Warnings and Precautions (5.4)] . - Calcitonin Salmon (synthetic origin) Nasal Spray has not been shown to increase spinal bone mineral density in early postmenopausal women. Hypersensitivity to calcitonin salmon or any of the excipients. Reactions have included anaphylactic shock, anaphylaxis, bronchospasm, and swelling of the tongue or throat [see Warnings and Precautions (5.1)] .

Resumen del producto:

How Supplied Calcitonin Salmon (synthetic origin) Nasal Spray is available as a metered dose clear solution in a 3.7 mL fill clear glass bottle that contains 2,200 USP Calcitonin Salmon Units calcitonin salmon per mL. A pump is attached to the bottle.After priming, the pump will deliver 200 USP Calcitonin Salmon Units per activation (0.09 mL per spray). NDC: 72162-2128-03: 3.7 mL (30 doses) in a BOTTLE, GLASS Storage and Handling Store unopened bottle in refrigerator between 2°C to 8°C (36°F to 46°F). Protect from freezing. Store bottle in use at room temperature between 20°C to 25°C (68°F to 77°F) in an upright position, for up to 35 days (3.7 mL fill). Each bottle contains at least 30 doses (3.7 mL fill). Discard bottle after 30 doses (3.7 mL fill). Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CALCITONIN SALMON- CALCITONIN SALMON SPRAY, METERED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCITONIN SALMON
NASAL SPRAY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR CALCITONIN
SALMON NASAL SPRAY.
CALCITONIN SALMON NASAL SPRAY
INITIAL U.S. APPROVAL: 1975
INDICATIONS AND USAGE
Calcitonin Salmon (synthetic origin) Nasal Spray is a calcitonin,
indicated for the treatment of
postmenopausal osteoporosis in women greater than 5 years
postmenopause when alternative
treatments are not suitable. Fracture reduction efficacy has not been
demonstrated (1.1)
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 (1.2, 5.4)
Calcitonin salmon nasal spray has not been shown to increase bone
mineral density in early
postmenopausal women (1.2)
DOSAGE AND ADMINISTRATION
For intranasal use only: one spray (200 USP Calcitonin Salmon Units)
per day, alternating nostrils daily
(2.1)
Prior to first use, allow the bottle to reach room temperature and
prime the pump (2.2)
Ensure adequate calcium and vitamin D intake (2.3)
DOSAGE FORMS AND STRENGTHS
Nasal Spray: 2200 USP Calcitonin Salmon Units per mL of calcitonin
salmon in a 2 mL or 3.7 mL fill glass
bottle with attached pump. Each actuation delivers 200 USP Calcitonin
Salmon Units of calcitonin salmon
(3)
CONTRAINDICATIONS
Hypersensitivity to calcitonin salmon or any of the excipients (4)
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions including anaphylactic shock 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)
Nasal adverse reactions, including severe ulceration can occur.
Periodic nasal examinations are
recommended (5.3)
Malignancy: A meta-analysis of 21 clinical trials suggests a