MIACALCIN- calcitonin salmon injection, solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Mylan Institutional LLC

INN (Rahvusvaheline Nimetus):

CALCITONIN SALMON

Koostis:

CALCITONIN SALMON 200 [iU] in 1 mL

Manustamisviis:

INTRAMUSCULAR

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Miacalcin 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. Miacalcin 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). Miacalcin 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 furosemide, oral phosphate or

Toote kokkuvõte:

How Supplied Miacalcin (calcitonin salmon, USP) Injection, Synthetic is available as a sterile solution in individual 2 mL multi-dose vials containing 200 USP Units per mL. NDC 67457-675-02 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.

Volitamisolek:

New Drug Application

Toote omadused

MIACALCIN- CALCITONIN SALMON INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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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:
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•
•
Limitations of Use:
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
Hypersensitivity to calcitonin salmon or any of the excipients (4)
WARNINGS AND PRECAUTIONS
•
•
•
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ADVERSE REACTIONS
Most common adverse reactions are nausea with or without vomiting
(10%), injection site inflammation
(10%), and flushing of the face or hands (2% to 5%) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
USE IN SPECIFIC POPULATIONS
®
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)
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)
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)
Injection: 200 USP Units per mL