CALCITONIN SALMON spray, metered

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Par Pharmaceutical, Inc.

Designació comuna internacional (DCI):

CALCITONIN SALMON

Composición:

CALCITONIN SALMON 200 [iU] in 0.09 mL

Vía de administración:

NASAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Calcitonin Salmon Nasal Solution 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 Solution 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 Solution 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)]. Risk Summary Calcitonin Salmon Nasal Solution is not i

Resumen del producto:

HOW SUPPLIED     Available as a metered dose clear solution in a 3.7 mL fill clear glass bottle. It is available in a dosage strength of 200 International Units per activation (0.09 mL/spray). A screw-on pump is provided. The pump, following priming, will deliver 0.09 mL of solution. Calcitonin Salmon Nasal Solution contains 2200 International Units/mL calcitonin-salmon and is provided in an individual box containing one glass bottle and one screw-on pump (NDC 49884-161-11). Storage and Handling Store unopened bottle in refrigerator between 2°C to 8°C (36°F to 46°F). Freezing is to be avoided. 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. Each bottle contains at least 30 doses. Discard bottle after 30 doses.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CALCITONIN SALMON- CALCITONIN SALMON SPRAY, METERED
PAR PHARMACEUTICAL, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCITONIN SALMON
NASAL SOLUTION (CALCITONIN SALMON NASAL SPRAY) SAFELY AND EFFECTIVELY.
SEE FULL
PRESCRIBING INFORMATION FOR CALCITONIN SALMON NASAL SOLUTION
(CALCITONIN SALMON NASAL
SPRAY), FOR INTRANASAL USE ONLY (_SYNTHETIC ORIGIN_).
INITIAL U.S. APPROVAL: 1975
RECENT MAJOR CHANGES
Indications and Usage (1.2) 03/2014
Warnings and Precautions (5.4) 03/2014
INDICATIONS AND USAGE
Calcitonin Salmon Nasal Solution 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 Solution 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, inc