ZOLEDRONIC ACID injection, solution, concentrate

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Hikma Pharmaceuticals USA Inc.

INN (Διεθνής Όνομα):

ZOLEDRONIC ACID

Σύνθεση:

ZOLEDRONIC ACID ANHYDROUS 4 mg in 5 mL

Οδός χορήγησης:

INTRAVENOUS

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 nontumor-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 Advers

Περίληψη προϊόντος:

Zoledronic acid injection, 4 mg per 5 mL  single-dose vial of concentrate Carton of 1 vial………………..NDC 0143-9642-01 Store at 25°C (77°F); excursions permitted to 15º to 30°C (59º to 86°F) [see USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE
HIKMA PHARMACEUTICALS USA INC.
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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
RECENT MAJOR CHANGES
Warnings and Precautions, Embryo-Fetal Toxicity (5.10) 01/2019
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)
Limitations of use: The safety and efficacy of zoledronic acid
injection has not been established for use in
hyperparathyroidism or nontumor-related hypercalcemia.
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 to 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 international
units 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
Injection: 4 mg per 5 mL (0.8 mg/mL) single-dose vial of concentrate
(3)
CONTRAINDICATIONS
Hypersensitivity to any component of zoledronic acid (4)
WARNINGS AND PRECAUTIONS
Patients being treated with zoledronic acid should not be treated with
Reclast
. (5.1)
Adequately