ZOLEDRONIC ACID injection solution concentrate

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

קנה את זה

מאפייני מוצר מאפייני מוצר (SPC)
10-01-2018

מרכיב פעיל:

ZOLEDRONIC ACID (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)

זמין מ:

AGILA SPECIALTIES PRIVATE LIMITED

INN (שם בינלאומי):

ZOLEDRONIC ACID

הרכב:

ZOLEDRONIC ACID ANHYDROUS 4 mg in 5 mL

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

                                ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE
AGILA SPECIALTIES PRIVATE LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLEDRONIC ACID INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLEDRONIC ACID
INJECTION.
ZOLEDRONIC ACID INJECTION
READY-TO-USE SOLUTION FOR INTRAVENOUS INFUSION
(FOR SINGLE USE)
CONCENTRATE FOR INTRAVENOUS INFUSION
INITIAL U.S. APPROVAL: 2001
RECENT MAJOR CHANGES
Warnings and Precautions, addition of atypical subtrochanteric and
diaphyseal femoral fractures (5.6) 03/2012
INDICATIONS AND USAGE
Zoledronic acid injection is a bisphosphonate indicated for the
treatment of:
Hypercalcemia of malignancy (1.1)
Patients with multiple myeloma and patients with documented bone
metastases from solid tumors, in conjunction with
standard antineoplastic therapy. Prostate cancer should have
progressed after treatment with at least one hormonal
therapy (1.2)
Important limitation of use: The safety and efficacy of zoledronic
acid injection has not been established for use in
hyperparathyroidism or nontumor-related hypercalcemia (1.3)
DOSAGE AND ADMINISTRATION
Hypercalcemia of malignancy (2.1)
4 mg as a single-use intravenous infusion over no less than 15 minutes
4 mg as retreatment after a minimum of 7 days
Multiple myeloma and bone metastasis from solid tumors (2.2)
4 mg as a single-use intravenous infusion over no less than 15 minutes
every 3-4 weeks for patients with creatinine
clearance of greater than 60 mL/min
Reduce the dose for patients with renal impairment
Coadminister oral calcium supplements of 500 mg and a multiple vitamin
containing 400 IU of Vitamin D daily.
Administer through a separate vented infusion line and do not allow to
come in contact with any calcium or divalent cation-
containing solutions (2.3)
DOSAGE FORMS AND STRENGTHS
4 mg per 5 mL single-use vial of concentrate (3)
CONTRAINDICATIONS
Hypersensitivity to any component of zoledronic acid injection (4)
WARNINGS AND PR
                                
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