“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Zoledronic Acid (Zometa)

Trade Name : Zometa

Novartis Pharmaceuticals Corporation

INJECTION, SOLUTION, CONCENTRATE

Strength 4 mg/5mL

ZOLEDRONIC ACID Diphosphonates [CS],Bisphosphonate [EPC]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Zoledronic Acid (Zometa) which is also known as Zometa and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 4 mg/5mL per ml. Read more

Zoledronic Acid (Zometa) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • No data
  • Zometa is a bisphosphonate indicated for the treatment of:
  • Limitations of Use
  • Hypercalcemia of Malignancy ()n
  • 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. ()
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Hypercalcemia of Malignancy ()
  • Multiple myeloma and Bone Metastasis of Solid Tumors ()
  • Administer through a separate vented infusion line and do not allow to come in contact with any calcium or divalent cation-containing solutions. ()
  • Injection: 4 mg/100 mL (0.04 mg/mL) single-dose ready-to-use bottle.
  • Injection: 4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion.
  • Injection: 4 mg/100 mL (0.04 mg/mL) single-dose ready-to-use bottle ()
  • Injection: 4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion ()
  • Hypersensitivity to Zoledronicu00a0Acid or Any Components of Zometa
  • Hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported .
  • Hypersensitivity to any component of Zometa ()
  • No data
  • Patients being treated with Zometa should not be treated with Reclast. ()n
  • Adequately rehydrate patients with hypercalcemia of malignancy prior to administration of Zometa and monitor electrolytes during treatment. ()n
  • Renal toxicity may be greater in patients with renal impairment. Do not use doses greater than 4u00a0mg. Treatment in patients with severe renal impairment is not recommended. Monitor serum creatinine before each dose. ()n
  • Osteonecrosis of the jaw (ONJ) has been reported. Preventive dental exams should be performed before starting Zometa. Avoid invasive dental procedures. ()n
  • Severe incapacitating bone, joint, and/or muscle pain may occur. Discontinue Zometa if severe symptoms occur. ()u00a0n
  • Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy. These fractures may occur after minimal or no trauma. Evaluate patients with thigh or groin pain to rule out a femoral fracture. Consider drug discontinuation in patients suspected to have an atypical femur fracture. ()
  • Hypocalcemia:
  • Zometa can cause fetal harm. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception. (, , )
  • The most common adverse events (greater than 25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea. ()
  • No data
  • Aminoglycosides:
  • Loop Diuretics:
  • Nephrotoxic Drugs:
  • No data
  • Lactation:
  • Females and Males of Reproductive Potential:
  • Pediatric Use:
  • Geriatric Use:
  • Clinical experience with acute overdosage of Zometa is limited. Two patients received Zometa 32u00a0mg over 5u00a0minutes in clinical trials. Neither patient experienced any clinical or laboratory toxicity. Overdosage may cause clinically significant hypocalcemia, hypophosphatemia, and hypomagnesemia. Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively.
  • In an open-label study of zoledronicu00a0acid 4u00a0mg in breast cancer patients, a female patient received a single 48-mg dose of zoledronicu00a0acid in error. Two days after the overdose, the patient experienced a single episode of hyperthermia (38u00b0C), which resolved after treatment. All other evaluations were normal, and the patient was discharged seven days after the overdose.
  • A patient with non-Hodgkinu2019s lymphoma received zoledronicu00a0acid 4u00a0mg daily on four successive days for a total dose of 16u00a0mg. The patient developed paresthesia and abnormal liver function tests with increased GGT (nearly 100 unit/L, each value unknown). The outcome of this case is not known.
  • In controlled clinical trials, administration of Zometa 4u00a0mg as an intravenous infusion over 5u00a0minutes has been shown to increase the risk of renal toxicity compared to the same dose administered as a 15-minute intravenous infusion. In controlled clinical trials, Zometa 8u00a0mg has been shown to be associated with an increased risk of renal toxicity compared to Zometa 4u00a0mg, even when given as a 15-minute intravenous infusion, and was not associated with added benefit in patients with hypercalcemia of malignancy .
  • Zometa contains zoledronicu00a0acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronicu00a0acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:
  • Zoledronicu00a0acid is a white crystalline powder. Its molecular formula is CHNOPu2022HO and its molar mass is 290.1g/mol. Zoledronicu00a0acid is highly soluble in 0.1Nu00a0sodium hydroxide solution, sparingly soluble in water and 0.1Nu00a0hydrochloric acid, and practically insoluble in organic solvents. The pH of a 0.7% solution of zoledronicu00a0acid in water is approximatelyu00a02.0.
  • Zometa is available in 100 mL bottles as a sterile liquid ready-to-use solution for intravenous infusion and in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion.
  • Inactive Ingredients:
  • No data
  • Standard lifetime carcinogenicity bioassays were conducted in mice and rats. Mice were given oral doses of zoledronicu00a0acid of 0.1, 0.5, or 2.0u00a0mg/kg/day. There was an increased incidence of Harderian gland adenomas in males and females in all treatment groups (at doses greater than or equal to 0.002u00a0times a human intravenous dose of 4u00a0mg, based on a comparison of relative body surface areas). Rats were given oral doses of zoledronicu00a0acid of 0.1, 0.5, or 2.0u00a0mg/kg/day. No increased incidence of tumors was observed (at doses less than or equal to 0.2u00a0times the human intravenous dose of 4u00a0mg, based on a comparison of relative body surface areas).
  • Zoledronicu00a0acid was not genotoxic in the Ames bacterial mutagenicity assay, in the Chinese hamster ovary cell assay, or in the Chinese hamster gene mutation assay, with or without metabolic activation. Zoledronicu00a0acid was not genotoxic in the rat micronucleus assay.
  • Female rats were given subcutaneous doses of zoledronicu00a0acid of 0.01, 0.03, or 0.1u00a0mg/kg/day beginning 15u00a0days before mating and continuing through gestation. Effects observed in the high-dose group (with systemic exposure of 1.2u00a0times the human systemic exposure following an intravenous dose of 4u00a0mg, based on AUC comparison) included inhibition of ovulation and a decrease in the number of pregnant rats. Effects observed in both the mid-dose group (with systemic exposure of 0.2u00a0times the human systemic exposure following an intravenous dose of 4u00a0mg, based on an AUC comparison) and high-dose group included an increase in preimplantation losses and a decrease in the number of implantations and live fetuses.
  • No data
  • 4 mg/100 mL (0.04 mg/mL) single-dose ready-to-use bottle
  • Carton of 1 bottleu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026...NDCu00a00078-0590-61
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F-86u00b0F) [see USP Controlled Room Temperature]. Discard unused portion.
  • 4 mg/5 mL (0.8 mg/mL) single-dose vial for dilution prior to intravenous infusion
  • Carton of 1 vialu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026..NDCu00a00078-0387-25
  • Store at 25u00b0C (77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F-86u00b0F) [see USP Controlled Room Temperature]. Discard unused portion.
  • Drugs With Same Active Ingredient or in the Same Drug Class
  • ntttttttInform patients not to take Reclast or other bisphosphonates during the course of their Zometa therapy .ntttttt
  • Renal Impairment
  • Osteonecrosis of the Jaw (ONJ)
  • Musculoskeletal Pain
  • ntttttttAdvise patients to immediately tell their doctor about any severe bone, joint, and/or muscle pain .ntttttt
  • Atypical Subtrochanteric and Diaphyseal Femoral Fracture
  • ntttttttAdvise patients to report any thigh, hip, or groin pain. It is unknown whether the risk of atypical femur fracture continues after stopping therapy .
  • Patients With Asthma
  • There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including zoledronic acid. Before being given zoledronic acid, instruct patients to tell their doctor if they are aspirin-sensitive .
  • Hypocalcemia
  • Advise patients with multiple myeloma and bone metastasis of solid tumors to take an oral calcium supplement of 500 mg and a multiple vitamin containing 400 international units of vitamin D daily .
  • Embryo-Fetal Toxicity
  • Lactation
  • Advise lactating women not to breastfeed during and after treatment with Zometa .
  • Common Adverse Reactions
  • Advise patients that the most common side effects of ZOMETA are nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea.
  • Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
  • u00a9 Novartis
  • T2018-137December 2018
  • NDC 0078-0387-25
  • Zometan
  • (zoledronic acid)
  • Injection
  • 4 mg / 5 mL(0.8 mg / mL)
  • For Intravenous Infusion after Dilution
  • Single-dose
  • Discard unsed portion.
  • One 5 mL vial
  • Sterile
  • Not for direct injection. Dose must be diluted.
  • See package insert for Preparation of Solution.
  • Do not mix with calcium-containing infusion solutions.
  • Rx only
  • NOVARTIS
  • NDC 0078-0590-61
  • ZOMETAn
  • (zoledronic acid) Injection
  • Sterile Solution
  • 100 mL bottle
  • 4 mg/100 mL(0.04 mg/mL)
  • Solution for Intravenous Infusion
  • Single-dose
  • Discard unsed portion.
  • For more information visit
  • www.us.zometa.com
  • or call
  • 1-866-4-ZOMETA
  • (1-866-496-6382)
  • NOVARTIS
  • Rx only

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.