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].
- 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
PRINCIPAL DISPLAY PANEL
4 mg/5 mL
CONCENTRATE FOR INTRAVENOUS INFUSIONRx ONLY
|ZOLEDRONIC ACID zoledronic acid injection, solution, concentrate|
|Labeler — West-Ward Pharmaceutical Corp (001230762)|
|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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