CALCITONIN SALMON- calcitonin salmon spray, metered

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Sandoz Inc

INN:

CALCITONIN SALMON

composition:

CALCITONIN SALMON 200 [iU]

administration_route:

NASAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Calcitonin-salmon 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 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 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)] . Pregnancy Category C: Risk Summary There are no adequate an

leaflet_short:

How Supplied Calcitonin-Salmon Nasal Spray is available as a metered dose clear solution in a 3.7 mL fill clear glass bottle that contains 2200 International Units calcitonin-salmon per mL. A screw-on pump is provided. After priming, the pump will deliver 200 International Units per activation (0.09 mL per spray)................................................................. NDC 0781-6320-79 Storage and Handling Store unopened bottle in refrigerator between 2°C–8°C (36°F–46°F). Protect from freezing. Store bottle in use at room temperature between 15°C–30°C (59°F–86°F) in an upright position, for up to 35 days. Each bottle contains at least 30 doses. Discard bottle after 30 doses.

authorization_status:

New Drug Application Authorized Generic

SPC

CALCITONIN SALMON- CALCITONIN SALMON SPRAY, METERED
SANDOZ INC
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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, FOR INTRANASAL USE
INITIAL U.S. APPROVAL: 1975
RECENT MAJOR CHANGES
Indications and Usage (1.2) 3/2014
Warnings and Precautions (5.4) 3/2014
INDICATIONS AND USAGE
Calcitonin-salmon 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 International 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 International Units per mL of calcitonin-salmon in a
3.7 mL fill glass bottle with screw-on pump. Each
actuation delivers 200 International 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)
Maligna