Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ZOLEDRONIC ACID (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)
Heritage Pharmaceuticals Inc.
ZOLEDRONIC ACID
ZOLEDRONIC ACID ANHYDROUS 5 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Zoledronic acid injection is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see Clinical Studies (14.5) ]. Zoledronic acid injection is contraindicated in patients with the following conditions: - Hypocalcemia [see Warnings and Precautions (5.2) ] - Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see Warnings and Precautions (5.3) ]. - Known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. Hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Post-Marketing Experience (6.2) ]. Pregnancy Category D [see Warnings and Precautio
Each bottle contains a clear, colorless solution of Zoledronic Acid Injection 5 mg/100 mL and is packed individually in a carton. NDC 23155-525-31. Handling After opening the solution, it is stable for 24 hours at 2°C to 8°C (36°F to 46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION HERITAGE PHARMACEUTICALS INC. ---------- 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 INITIAL U.S. APPROVAL: 2001 RECENT MAJOR CHANGES Warnings and Precautions (5.4) 01/2015 INDICATIONS AND USAGE Zoledronic acid injection is a bisphosphonate indicated for: Treatment of Paget's disease of bone in men and women(1.5) DOSAGE AND ADMINISTRATION Infusion given intravenously over no less than 15 minutes: Treatment of Paget's disease of bone: a single 5 mg infusion. Patients should receive 1500 mg elemental calcium and 800 international units vitamin D daily (2.6) DOSAGE FORMS AND STRENGTHS 5 mg in a 100 mL ready-to-infuse solution (3) CONTRAINDICATIONS Hypocalcemia (4) Patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment (4, 5.3) Hypersensitivity to any component of zoledronic acid injection (4, 6.2) WARNINGS AND PRECAUTIONS _Products Containing Same Active Ingredient: _Patients receiving Zometa should not receive zoledronic acid injection (5.1) _Hypocalcemia_ may worsen during treatment. Patients must be adequately supplemented with calcium and vitamin D (5.2) _Renal Impairment: _A single dose should not exceed 5 mg and the duration of infusion should be no less than 15 minutes. Renal toxicity may be greater in patients with underlying renal impairment or with other risk factors, including advanced age or dehydration.Monitor creatinine clearance before each dose (2.7, 5.3) _Osteonecrosis of the Jaw_ _(ONJ)_ has been reported. All patients should have a routine oral exam by the prescriber prior to treatment(5.4) _Atypical Femur Fractures_ have been reported. Patients with thigh or groin pain should be evaluated to rule out a femoral fracture (5.5). _Pregnancy:_ Zoledronic acid injection can cause fetal harm. Women of c Prečítajte si celý dokument