ZOLEDRONIC (Page 6 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING


Zoledronic Acid Injection 4 mg/5 mL single-use vial of concentrate

Carton of 1 vial………………………………………………NDC 68083-116-01

Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

  • Patients should be instructed to tell their doctor if they have kidney problems before being given Zoledronic acid Injection.
  • Patients should be informed of the importance of getting their blood tests (serum creatinine) during the course of their Zoledronic acid Injection therapy.
  • Zoledronic acid Injection should not be given if the patient is pregnant or plans to become pregnant, or if she is breast-feeding.
  • Patients should be advised to have a dental examination prior to treatment with Zoledronic acid Injection and should avoid invasive dental procedures during treatment.
  • Patients should be informed of the importance of good dental hygiene and routine dental care.
  • Patients with multiple myeloma and bone metastasis of solid tumors should be advised to take an oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of Vitamin D daily.
  • Patients should be advised to report any thigh, hip or groin pain. It is unknown whether the risk of atypical femur fracture continues after stopping therapy.
  • Patients should be aware of the most common side effects including: anemia, nausea, vomiting, constipation, diarrhea, fatigue, fever, weakness, lower limb edema, anorexia, decreased weight, bone pain, myalgia, arthralgia, back pain, malignant neoplasm aggravated, headache, dizziness, insomnia, paresthesia, dyspnea, cough, and abdominal pain.
  • There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including Zoledronic acid. Before being given Zoledronic acid, patients should tell their doctor if they are aspirin-sensitive.

The brands listed are the registered trademarks of their respective owners and are not trademarks of Gland Pharma Limited.
Manufactured by:
Gland Pharma Limited
Hyderabad-500 043, INDIA
Revised: June 2014

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zoledronic acid Injection 4 mg/5 mL single-use vial
Vial NDC: 68083-116-01
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].
See package insert for Dosage and Administration and preparation of solution.
Do not mix with calcium-containing infusion solution.Discard unused portion.

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(click image for full-size original)
ZOLEDRONIC zoledronic acid injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68083-116
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLEDRONIC ACID (ZOLEDRONIC ACID ANHYDROUS) ZOLEDRONIC ACID ANHYDROUS 4 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 220 mg in 5 mL
SODIUM CITRATE 24 mg in 5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68083-116-01 1 VIAL in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON (68083-116-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202930 09/20/2013
Labeler — Gland Pharma Limited (918601238)
Registrant — Gland Pharma Limited (918601238)
Establishment
Name Address ID/FEI Operations
Gland Pharma Limited 918601238 ANALYSIS (68083-116), MANUFACTURE (68083-116)

Revised: 01/2015 Gland Pharma Limited

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