ZOLEDRONIC ACID injection, solution, concentrate

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Mylan Institutional LLC

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cCa) of greater than or equal to 12 mg/dL [3 mmol/L] using the formula: cCa in mg/dL = Ca in mg/dL + 0.8 (4 g/dL - patient albumin [g/dL]). Zoledronic acid injection is indicated for the treatment of 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. Limitations of Use The safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established. Hypersensitivity to Zoledronic Acid or Any Components of Zoledronic Acid Injection Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see Adverse R

পণ্য সারাংশ:

Zoledronic acid injection is a clear colorless solution and is available as follows: Zoledronic acid injection, 4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion Carton of 1 vial…………………….……….NDC 67457-920-05 Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Discard unused portion.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE
MYLAN INSTITUTIONAL LLC
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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, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Zoledronic acid injection is a bisphosphonate indicated for the
treatment of:
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Limitations of Use: The safety and efficacy of zoledronic acid
injection has not been established for use in
hyperparathyroidism or non-tumor-related hypercalcemia.
DOSAGE AND ADMINISTRATION
Hypercalcemia of malignancy (2.1)
•
•
Multiple myeloma and bone metastasis from solid tumors (2.2)
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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
Zoledronic Acid Injection: 4 mg/5 mL (0.8 mg/mL) single-dose vial for
dilution prior to intravenous infusion
(3)
CONTRAINDICATIONS
Hypersensitivity to any component of zoledronic acid injection (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse events (greater than 25%) were nausea,
fatigue, anemia, bone pain,
constipation, fever, vomiting, and dyspnea. (6.1)
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
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USE IN SPECIFIC POPULATIONS
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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)
4 mg as a single-dose intravenous infusion over no less than 15
minutes.
4 mg as retreatment after a minimum of 7 days.
4 mg as a single-dose intravenous infusion over