Zoledronic acid Injection 4mg Technical Specification:
| Product Name: | Zoledronic acid Injection 4mg |
| Brand Name: | Zoledronic |
| Strength: | 4mg |
| Dosage Form: | Lyophilized Dry Powder for Injection |
| Packing: | SINGLE USE VIAL |
| Route of Administration: | For I.V. infusion only. |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Anti-Cancer |
| Indication: | Zoledronic acid Injection is a medication used to treat a number of bone diseases. These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, Paget’s disease of bone and Duchenne muscular dystrophy. |
| Storage: | Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Zoledronic acid Injection 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Zoledronic acid Injection 4mg
Each combi pack contains
One vial of
Zoledronic acid Injection 4mg
Each vial contains:
Zoledronic Acid Monohydrate
Equivalent to Zoledronic acid……….4 mg
Mannitol………………………………………220 mg
Sodium Citrate……………………………..24mg
One ampoule of
Sterile Water for Injection contains
Water for Injection………………..……..5 ml
THERAPEUTIC INDICATION:
Zoledronic acid Injection is a medication used to treat a number of bone diseases. These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, Paget’s disease of bone and Duchenne muscular dystrophy.
DIRECTION OF USE:
For Intravenous infusion only.
Reconstitution: Reconstitute with 5 ml of Sterile Water for Injections USP provided with this pack.
Requires two dilution before administration.
The reconstituted solution should immediately be diluted in 100ml of calcium free sterile 0.9% w/v Sodium Chloride Injection or 0.5% w/v Dextrose Injection.
Reconstituted and diluted solution should be used immediately.
Please refer accompanying package inert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
Requires two dilution before administration.
Reconstituted injection to be administered within 24 hours of preparation when stored at temperature between 2°C to 8°C.
Do not mix with Calcium containing infusion solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light.
Dosage: As directed by an Oncologist.
Why Taj Pharmaceuticals?
Taj Pharma is the premier source for Zoledronic Acid Injection, and here’s why you should choose us for your healthcare needs. With a legacy of excellence in pharmaceuticals, we prioritize quality and safety above all else. Our Zoledronic Acid Injection is manufactured with stringent quality control measures, ensuring every dose meets the highest industry standards. What sets Taj Pharma apart is our dedication to affordability. We believe that access to life-saving medications should be within reach for everyone, which is why we offer competitive pricing on Zoledronic Acid Injection without compromising on quality. We understand the importance of this medication in treating conditions like osteoporosis and bone metastases, and we’re committed to making it accessible to patients worldwide. Taj Pharma’s commitment to patient well-being extends beyond the product itself. Our customer support team is here to assist you every step of the way, providing information, answering your questions, and ensuring a seamless experience from order to delivery. Trust Taj Pharma for your Zoledronic Acid Injection needs and experience pharmaceutical excellence with a human touch.
What is Zoledronic acid Injection and its use?
Zoledronic acid injection is a medication that belongs to a class of drugs known as bisphosphonates. It is used to treat a variety of conditions related to bone health. Here are some of its primary uses:
- Osteoporosis: Zoledronic acid is often prescribed to postmenopausal women and men at high risk of fractures due to osteoporosis. It helps increase bone density and reduce the risk of fractures.
- Cancer-Related Bone Problems: Zoledronic acid is used in the treatment of certain cancers that can spread to the bones, such as breast cancer, prostate cancer, and multiple myeloma. It helps to strengthen bones and reduce the risk of fractures, pain, and other complications caused by cancer metastasis to the bones.
- Hypercalcemia of Malignancy: This medication can also be used to treat hypercalcemia (elevated levels of calcium in the blood) that occurs as a result of cancer, as it helps lower calcium levels and relieve associated symptoms.
- Paget’s Disease of Bone: Zoledronic acid is sometimes used in the treatment of Paget’s disease, a condition characterized by abnormal bone growth and remodeling.
Zoledronic acid works by inhibiting the breakdown of bone, thereby increasing bone density and reducing the risk of fractures. It is typically administered as an intravenous (IV) infusion and is prescribed and monitored by healthcare professionals.
How does Zoledronic acid Injection Work?
Zoledronic acid injection works by inhibiting the breakdown of bone, a process known as bone resorption. It belongs to a class of medications called bisphosphonates, which have a high affinity for bone tissue. Here’s how Zoledronic acid works:
- Inhibition of Osteoclast Activity: Zoledronic acid primarily targets osteoclasts, which are cells responsible for breaking down and resorbing bone tissue. These cells play a crucial role in the natural process of bone remodeling. However, in conditions like osteoporosis, cancer-related bone problems, or Paget’s disease, excessive bone resorption can lead to weakened bones and an increased risk of fractures.
- Binding to Hydroxyapatite Crystals: Zoledronic acid molecules bind strongly to the surface of hydroxyapatite crystals in bone. Hydroxyapatite is a mineral component of bone tissue.
- Inhibition of Osteoclast Function: When Zoledronic acid is absorbed into the bone, it interferes with the normal function of osteoclasts. It reduces their ability to break down bone, slowing the bone resorption process.
- Increased Bone Density: By inhibiting bone resorption, Zoledronic acid helps to maintain or increase bone density. This is particularly important in conditions like osteoporosis, where bone density decreases, leading to a higher risk of fractures.
- Reduction in Complications: In the context of cancer-related bone problems, Zoledronic acid helps to strengthen bones and reduce complications associated with bone metastasis, such as fractures and pain. It can also lower elevated levels of calcium in the blood, a common issue in certain cancers.
Zoledronic acid is typically administered as an intravenous (IV) infusion and is prescribed by healthcare professionals. The treatment regimen and frequency of administration may vary depending on the specific medical condition being treated. Patients receiving Zoledronic acid therapy should be monitored by their healthcare provider to ensure the medication’s effectiveness and safety.
Benefits of Zoledronic Acid Injection:
- Improved Bone Health: Zoledronic acid injection is primarily used to treat conditions like osteoporosis and cancer-related bone problems. It can increase bone density, reduce the risk of fractures, and strengthen bones, leading to improved overall bone health.
- Pain Relief: For individuals with cancer-related bone pain or complications, Zoledronic acid can help alleviate pain and discomfort by stabilizing bone structure and reducing the risk of fractures.
- Hypercalcemia Treatment: Zoledronic acid is effective in lowering elevated levels of calcium in the blood due to cancer-related hypercalcemia, which can relieve symptoms such as fatigue, nausea, and confusion.
Common Side Effects of Zoledronic Acid Injection:
- Flu-like Symptoms: Some people may experience flu-like symptoms, such as fever, chills, fatigue, and muscle aches, shortly after receiving the injection. These symptoms are usually temporary and can be managed with over-the-counter pain relievers.
- Joint or Bone Pain: Mild to moderate joint or bone pain is a common side effect of Zoledronic acid. This discomfort typically improves over time and can be managed with pain relievers if needed.
- Nausea and Vomiting: Nausea and vomiting may occur in some individuals, but these side effects are usually mild and transient. Anti-nausea medications may be prescribed if necessary.
- Low Calcium Levels: In rare cases, Zoledronic acid can lead to low calcium levels in the blood (hypocalcemia). This can cause symptoms like muscle cramps, numbness, and tingling. Calcium supplements may be recommended to prevent or treat this side effect.
Serious Side Effects (Less Common):
- Kidney Problems: Zoledronic acid can affect kidney function, leading to a condition known as acute kidney injury (AKI). Your healthcare provider will monitor your kidney function during treatment.
- Osteonecrosis of the Jaw (ONJ): Although rare, Zoledronic acid has been associated with ONJ, a condition characterized by the death of jawbone tissue. This risk is higher in cancer patients receiving higher doses of the medication and undergoing dental procedures. Dental health should be assessed before starting treatment.
- Allergic Reactions: Severe allergic reactions are extremely rare but can occur. Seek immediate medical attention if you experience symptoms like difficulty breathing, swelling of the face, lips, tongue, or throat, or severe skin reactions.
It’s essential to discuss the potential benefits and risks of Zoledronic acid treatment with your healthcare provider. They will carefully consider your medical history and specific condition before recommending this medication. Regular monitoring and open communication with your healthcare team can help manage any side effects and optimize the benefits of the treatment.
Frequently asked questions (FAQs) about Zoledronic Acid Injection:
- What is Zoledronic Acid Injection used for?
Zoledronic Acid Injection is used to treat conditions such as osteoporosis, cancer related bone problems, hypercalcemia of malignancy, and Paget’s disease of bone. It helps improve bone health and reduce the risk of fractures.
- How is Zoledronic Acid Injection administered?
Zoledronic Acid is typically administered as an intravenous (IV) infusion. The frequency and dosage of the infusion depend on the specific medical condition being treated.
- Are there any common side effects of Zoledronic Acid Injection?
Common side effects may include flulike symptoms (fever, chills, fatigue), joint or bone pain, and mild nausea. These side effects are usually temporary and manageable.
- What precautions should I take before starting Zoledronic Acid treatment?
It’s essential to inform your healthcare provider about your medical history, including any kidney problems or dental issues. Dental health should be assessed before starting treatment to minimize the risk of osteonecrosis of the jaw (ONJ).
- How long will I need to take Zoledronic Acid Injection?
The duration of treatment varies depending on the underlying condition. Your healthcare provider will determine the appropriate treatment plan for your specific needs.
- Can Zoledronic Acid Injection be used during pregnancy or while breastfeeding?
Zoledronic Acid is not recommended during pregnancy or breastfeeding due to potential risks to the developing fetus or infant. Discuss alternative treatments with your healthcare provider.
- What should I do if I miss a scheduled Zoledronic Acid infusion?
It’s important to adhere to your scheduled infusions. If you miss an appointment, contact your healthcare provider to reschedule and discuss any potential consequences.
- Can I take other medications while on Zoledronic Acid treatment?
Inform your healthcare provider about all the medications, supplements, and herbal products you are taking, as some may interact with Zoledronic Acid. They will advise you on any necessary adjustments.
- Is Zoledronic Acid safe for long-term use?
Your healthcare provider will determine the appropriate duration of treatment based on your condition and individual factors. Long-term use may be recommended in some cases, but it requires careful monitoring.
- What should I do if I experience severe side effects or allergic reactions while on Zoledronic Acid treatment?
Seek immediate medical attention if you experience severe side effects, such as difficulty breathing, swelling, or signs of an allergic reaction. Contact your healthcare provider for guidance on managing any adverse reactions.
As Zoledronic Acid Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Zoledronic Acid Injection product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Zoledronic Acid Injection Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Zoledronic Acid Injection, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274
GENERIC NAME OF THE MEDICINAL PRODUCT:
Zoledronic acid Injection 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Zoledronic acid Injection 4mg
Each combi pack contains
One vial of
Zoledronic acid Injection 4mg
Each vial contains:
Zoledronic Acid Monohydrate
Equivalent to Zoledronic acid……….4 mg
Mannitol………………………………………220 mg
Sodium Citrate……………………………..24mg
One ampoule of
Sterile Water for Injection contains
Water for Injection………………..……..5 ml
Each combi pack contains
One vial of
Zoledronic acid Injection 4mg
Each vial contains:
Zoledronic Acid Monohydrate
Equivalent to Zoledronic acid……….4 mg
Mannitol………………………………………220 mg
Sodium Citrate……………………………..24mg
One ampoule of
Sterile Water for Injection contains
Water for Injection………………..……..5 ml
THERAPEUTIC INDICATION:
Zoledronic acid Injection is a medication used to treat a number of bone diseases. These include osteoporosis, high blood calcium due to cancer, bone breakdown due to cancer, Paget's disease of bone and Duchenne muscular dystrophy.
DIRECTION OF USE:
For Intravenous infusion only.
Reconstitution: Reconstitute with 5 ml of Sterile Water for Injections USP provided with this pack.
Requires two dilution before administration.
The reconstituted solution should immediately be diluted in 100ml of calcium free sterile 0.9% w/v Sodium Chloride Injection or 0.5% w/v Dextrose Injection.
Reconstituted and diluted solution should be used immediately.
Please refer accompanying package inert for detailed dosage, directions for use and precautions.
Reconstitution: Reconstitute with 5 ml of Sterile Water for Injections USP provided with this pack.
Requires two dilution before administration.
The reconstituted solution should immediately be diluted in 100ml of calcium free sterile 0.9% w/v Sodium Chloride Injection or 0.5% w/v Dextrose Injection.
Reconstituted and diluted solution should be used immediately.
Please refer accompanying package inert for detailed dosage, directions for use and precautions.
CAUTION & WARNING:
CAUTION: This injection should not be used if it contains visible particulate matter after reconstitution.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
Requires two dilution before administration.
Reconstituted injection to be administered within 24 hours of preparation when stored at temperature between 2°C to 8°C.
Do not mix with Calcium containing infusion solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
WARNING: Cytotoxic Agent: To be sold by retail on the prescription of an Oncologist/ Cancer Hospital only.
Cytotoxic special handling procedures see insert
Requires two dilution before administration.
Reconstituted injection to be administered within 24 hours of preparation when stored at temperature between 2°C to 8°C.
Do not mix with Calcium containing infusion solution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE.
Discard Unused portion.
Keep out of the reach of the children.
STORAGE & DOSAGE:
Storage: Store vials at 20°C to 25°C (68° to 77° F); excursions permitted between 15°C to 30°C (59° to 86° F) [See USP Controlled Room Temperature]. Protected from light.
Dosage: As directed by an Oncologist.
Dosage: As directed by an Oncologist.
