Zoledronic Acid (Page 7 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Zoledronic acid injection, 4 mg/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].

17 PATIENT COUNSELING INFORMATION

  • Patients should be instructed to tell their doctor if they have kidney problems before being given zoledronic acid.
  • Patients should be informed of the importance of getting their blood tests (serum creatinine) during the course of their zoledronic acid therapy.
  • Zoledronic acid 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 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 IU 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.

Reclast® is a registered trademark of Novartis Pharmaceutical Corporation.

Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A.
Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL

Distributed by: WEST-WARD PHARMACEUTICAL CORP.
Eatontown, NJ 07724 USA

PIN307-WES/2

PRINCIPAL DISPLAY PANEL

NDC 0143-9642-01
ZOLEDRONIC ACID
INJECTION
4 mg/5 mL
(0.8 mg/mL)
STERILE CONCENTRATE
CONCENTRATE FOR INTRAVENOUS INFUSIONRx ONLY

NDC 0143-9642-01 ZOLEDRONIC ACID INJECTION 4 mg/5 mL (0.8 mg/mL) STERILE CONCENTRATE CONCENTRATE FOR INTRAVENOUS INFUSION Rx ONLY
(click image for full-size original)
ZOLEDRONIC ACID zoledronic acid injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9642
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:0143-9642-01 5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202182 06/03/2013
Labeler — West-Ward Pharmaceutical Corp (001230762)
Establishment
Name Address ID/FEI Operations
Hikma Farmaceutica 452742943 ANALYSIS (0143-9642), LABEL (0143-9642), MANUFACTURE (0143-9642), PACK (0143-9642)

Revised: 06/2013 West-Ward Pharmaceutical Corp

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