GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Iron Sucrose Injection USP 50mg/2.5ml
B. Iron Sucrose Injection USP 100mg/5ml
C. Iron Sucrose Injection USP 200mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Iron Sucrose Injection USP 50mg/2.5ml
a) Each 2.5ml Contains:
Ferric Hydroxide in Complex with Sucrose
Eq. to elemental Iron……...……………….50mg
b) Water for Injection USP…………….………q. s

B. Iron Sucrose Injection USP 100mg/5ml
a) Each 5ml Contains:
Ferric Hydroxide in Complex with Sucrose
Eq. to elemental Iron……………………….100mg
b) Water for Injection USP…………….………q. s


C. Iron Sucrose Injection USP 200mg/10ml
a) Each 10ml Contains:
Ferric Hydroxide in Complex with Sucrose
Eq. to elemental Iron……………………….200mg
b) Water for Injection USP…………….………q. s

THERAPEUTIC INDICATIONS:

Iron sucrose injection is used treat iron-deficiency anemia (a lower-than-normal number of red blood cells due to too little iron) in people with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working).

DIRECTION OF USE:

Venotaj Injection is for Intravenous infusion, the injection must be diluted with 0.9% Sodium Chloride Injection to a concentration of 0.5 to 2.0 mg of elemental iron per ml.
Shake well before use.
Use Immediately after dilution.

CAUTION & WARNING:

CAUTION: Before using check for absence of sediments.
The Injection Should be discard if any visible particle appears.
For Deep Intramuscular Use.
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.
Any portion of the content remaining after use MUST be discard.
PRECAUTION: Strict aseptic administration technique must be followed.

STORAGE & DOSAGE:

Storage: Store at 25°C.
Store in a cool & dry place.
Protect from light.
Do not freeze.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Dosage: As directed by Physician.

Iron Sucrose Injection USP 100mg/5ml Technical Specification:

Product Name:Iron Sucrose Injection USP 100mg/5ml
Brand Name:Venotaj
Strength:50mg/2.5ml, 100mg/5ml, 200mg/10ml
Dosage Form:Liquid Injection (Ampule)
Packing:1 Ampule
Route of Administration:For I.V. use 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:Nutritional Supplements
Indication: Iron sucrose injection is used treat iron-deficiency anaemia in people with chronic kidney disease.
Storage:Store at 25°C. Store in a cool & dry place. Protect from light. Do not freeze.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Iron Sucrose Injection USP 100mg/5ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Iron Sucrose Injection USP 100mg/5ml
    Each 5ml Contains:
    Ferric Hydroxide in Complex with Sucrose
    Eq. to elemental Iron……………………….100mg
    Water for Injection USP…………….………q. s

THERAPEUTIC INDICATIONS:

Iron sucrose injection is used treat iron-deficiency anemia (a lower-than-normal number of red blood cells due to too little iron) in people with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working).

DIRECTION OF USE:

Venotaj Injection is for Intravenous infusion, the injection must be diluted with 0.9% Sodium Chloride Injection to a concentration of 0.5 to 2.0 mg of elemental iron per ml.
Shake well before use.
Use Immediately after dilution.

CAUTION & WARNING:

CAUTION: Before using check for absence of sediments. The Injection Should be discard if any visible particle appears.
For Deep Intramuscular Use.
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.
Any portion of the content remaining after use MUST be discard.
PRECAUTION: Strict aseptic administration technique must be followed.

STORAGE & DOSAGE:

Storage: Store at 25°C.
Store in a cool & dry place.
Protect from light.
Do not freeze.
KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.
Dosage: As directed by Physician.

Why Taj Pharamceuticals?

When it comes to addressing iron-deficiency anemia, Taj Pharma’s Iron Sucrose Injection USP is a name you can trust. With a strong commitment to quality, Taj Pharma ensures that this medication meets the highest industry standards, including stringent regulatory approvals. This means that healthcare providers and patients alike can have confidence in the safety and effectiveness of this essential treatment. In addition to its quality and safety, Taj Pharma’s Iron Sucrose Injection USP offers several advantages. Its competitive pricing makes it a cost-effective choice for healthcare institutions, helping them optimize their budgets while providing high-quality care. Taj Pharma’s reliable supply chain ensures a consistent availability of this crucial medication, preventing interruptions in patient treatment. Moreover, Taj Pharmaceuticals prioritizes exceptional customer support, timely deliveries, and effective communication. Their track record and reputation in the pharmaceutical industry reflect a commitment to ethical business practices and a dedication to improving patient outcomes. Choose Taj Pharma’s Iron Sucrose Injection USP to provide your patients with a trusted solution for iron-deficiency anemia. With Taj Pharmaceuticals, you’re not just selecting a product; you’re partnering with a pharmaceutical company that prioritizes quality, safety, and the well-being of patients.

What is Iron Sucrose Injection USP and its uses?

Iron Sucrose Injection USP is a medication used to treat iron-deficiency anemia in patients who cannot take iron orally or when oral iron supplements are ineffective. It provides a source of iron that can be directly administered into the bloodstream. Here are its primary uses and related information:

  • Iron-Deficiency Anemia: Iron Sucrose Injection USP is primarily used to treat iron-deficiency anemia. This type of anemia occurs when the body lacks sufficient iron to produce an adequate number of red blood cells or hemoglobin, leading to symptoms such as fatigue, weakness, and pallor.
  • Gastrointestinal Disorders: It is often prescribed for patients with gastrointestinal disorders, such as inflammatory bowel disease (IBD), celiac disease, or chronic gastrointestinal bleeding, where iron absorption from the gut is impaired.
  • Hemodialysis Patients: Iron Sucrose Injection USP is commonly used in hemodialysis patients. Chronic kidney disease and regular hemodialysis treatments can lead to iron loss, and this medication helps replenish iron stores.
  • Pregnancy and Lactation: Pregnant women with iron-deficiency anemia and those who cannot tolerate oral iron supplements may receive Iron Sucrose Injection USP. Ensuring proper iron levels during pregnancy is vital for the health of both the mother and the developing fetus.
  • Post-Surgery or Trauma: In some cases, patients recovering from major surgery or trauma may require iron supplementation to aid in the production of red blood cells and the healing process.
  • Cancer Patients: Cancer patients undergoing chemotherapy or radiation therapy may develop anemia as a side effect. Iron Sucrose Injection USP can be used as part of supportive care to manage anemia in cancer patients.

Iron Sucrose Injection USP works by providing a source of iron directly into the bloodstream. Iron is an essential component for the production of hemoglobin, which carries oxygen in red blood cells. When iron levels are low, the body cannot produce enough healthy red blood cells, leading to anemia. It’s important to note that Iron Sucrose Injection USP should be administered by healthcare professionals, typically through intravenous (IV) infusion, to ensure proper dosing and minimize the risk of adverse reactions. The dosage and frequency of administration depend on the severity of the anemia and the patient’s individual needs. As with any medication, its use should be determined and closely monitored by a qualified healthcare provider.

How Does Iron Sucrose Injection USP Work?

Iron Sucrose Injection USP is a medication used to treat iron-deficiency anemia by providing a source of iron directly into the bloodstream. Its mechanism of action is as follows:

  • Iron Replenishment: Iron is an essential element for the production of hemoglobin, a protein found in red blood cells that is responsible for carrying oxygen from the lungs to various tissues and organs throughout the body. When iron levels are low, the body cannot produce an adequate number of healthy red blood cells, leading to anemia.
  • Intravenous Administration: Iron Sucrose Injection USP is administered intravenously (IV) by healthcare professionals. This method allows for the controlled and efficient delivery of iron directly into the bloodstream.
  • Iron Absorption: Once in the bloodstream, the iron from Iron Sucrose Injection USP is readily available for uptake by the bone marrow, where red blood cells are produced. Iron is a critical component of hemoglobin, and its presence facilitates the synthesis of new hemoglobin molecules within developing red blood cells.
  • Red Blood Cell Production: As iron levels increase in the body, the bone marrow can produce a greater number of red blood cells. These newly formed red blood cells are rich in hemoglobin and are better equipped to transport oxygen.
  • Symptom Relief: With increased hemoglobin levels and improved oxygen-carrying capacity, the symptoms of iron-deficiency anemia begin to improve. Patients may experience increased energy, reduced fatigue, improved skin color, and enhanced overall well-being.

It’s important to note that the effectiveness of Iron Sucrose Injection USP in treating iron-deficiency anemia is based on its ability to provide a concentrated source of iron that can be rapidly absorbed into the bloodstream. This intravenous approach is particularly useful in cases where oral iron supplements are ineffective or not well-tolerated due to gastrointestinal issues or when rapid correction of iron deficiency is required. The dosage and frequency of Iron Sucrose Injection USP administration are determined by healthcare professionals based on the severity of the anemia, the patient’s weight, and individual needs. Close monitoring during treatment is essential to ensure that iron levels are adequately replenished while minimizing the risk of adverse effects.

Benefits and Side Effects of Iron Sucrose Injection USP:

Iron Sucrose Injection USP offers several benefits in the treatment of iron-deficiency anemia, but it may also be associated with certain side effects. Here’s an overview of its benefits and potential side effects:

Benefits:

  • Effective Iron Replenishment: Iron Sucrose Injection USP is highly effective in rapidly increasing iron levels in the body. It provides a concentrated source of iron that is readily absorbed into the bloodstream, allowing for the efficient production of hemoglobin and red blood cells.
  • Quick Symptom Relief: Patients with iron-deficiency anemia often experience symptoms such as fatigue, weakness, pale skin, and shortness of breath. Iron Sucrose Injection USP can lead to a swift improvement in these symptoms, enhancing the patient’s quality of life.
  • Tolerability: In cases where oral iron supplements are not well-tolerated due to gastrointestinal side effects or other reasons, intravenous iron administration can be a valuable alternative.
  • Suitable for Specific Populations: Iron Sucrose Injection USP is commonly used in various patient populations, including those with chronic kidney disease, patients undergoing hemodialysis, pregnant women with iron-deficiency anemia, and individuals recovering from major surgery or trauma.
  • Customized Treatment: Healthcare providers can tailor the dosage and frequency of Iron Sucrose Injection USP to meet the individual needs of patients, ensuring an optimal response to treatment.

Side Effects:

  • Hypersensitivity Reactions: Although rare, hypersensitivity reactions to Iron Sucrose Injection USP can occur. Symptoms may include skin rash, itching, swelling, or more severe allergic reactions like anaphylaxis. Patients should be closely monitored during administration.
  • Hypotension: Some patients may experience a drop in blood pressure (hypotension) during or shortly after receiving the injection. Healthcare providers typically administer the medication slowly and monitor vital signs to minimize this risk.
  • Nausea and Vomiting: Gastrointestinal side effects, such as nausea and vomiting, can occur in some patients, although they are generally mild and transient.
  • Pain or Discomfort at the Injection Site: Pain, discomfort, or local reactions at the injection site may occur. Healthcare providers can take measures to reduce these effects.
  • Dizziness: Some individuals may experience dizziness after receiving Iron Sucrose Injection USP. Patients should be advised to avoid activities that require alertness until any dizziness subsides.
  • Iron Overload: Excessive administration of iron can lead to iron overload in the body, a condition known as hemochromatosis. Careful dosing and monitoring are essential to prevent this complication.
  • Nausea and Metallic Taste: Patients may report a metallic taste in the mouth or ongoing nausea during or after iron infusion.
  • Headache: Headaches are a potential side effect, although they are generally mild and short-lived.

It’s crucial for healthcare providers to carefully assess the risk-benefit profile when prescribing Iron Sucrose Injection USP and to monitor patients closely during and after administration. Patient education about potential side effects and the importance of reporting any unusual symptoms is also essential. Overall, the benefits of treating iron-deficiency anemia with Iron Sucrose Injection USP often outweigh the potential risks, especially when administered under the supervision of qualified healthcare professionals.

Frequently Asked Questions About Iron Sucrose Injection USP:

Certainly, here are some frequently asked questions (FAQs) about Iron Sucrose Injection USP:

  1. What is Iron Sucrose Injection USP?

Iron Sucrose Injection USP is a medication used to treat irondeficiency anemia by providing a concentrated source of iron that can be administered intravenously (IV).

  1. Who is a candidate for Iron Sucrose Injection USP?

Iron Sucrose Injection USP is typically prescribed for individuals with irondeficiency anemia who cannot tolerate or do not respond well to oral iron supplements. It is commonly used in patients with chronic kidney disease, those undergoing hemodialysis, pregnant women with irondeficiency anemia, and others.

  1. How is Iron Sucrose Injection USP administered?

Iron Sucrose Injection USP is administered intravenously (IV) by healthcare professionals. The dosage and frequency of administration are determined based on the patient’s iron needs and the severity of their anemia.

  1. What are the common symptoms of irondeficiency anemia?

Common symptoms may include fatigue, weakness, pale skin, shortness of breath, cold hands and feet, brittle nails, and headaches. Irondeficiency anemia can also lead to cognitive and developmental issues in children.

  1. Are there any contraindications or situations where Iron Sucrose Injection USP should not be used?

Iron Sucrose Injection USP should be used with caution in patients with known hypersensitivity to iron or the components of the injection. It is generally avoided in patients with certain conditions, such as hemochromatosis or iron overload disorders.

  1. What are the potential side effects of Iron Sucrose Injection USP?

Common side effects can include hypersensitivity reactions, hypotension, nausea, vomiting, pain at the injection site, dizziness, metallic taste, headache, and others. Severe allergic reactions are rare but can occur.

  1. How long does it take to see improvements in iron levels and anemia symptoms with Iron Sucrose Injection USP?

The timing of improvements can vary among individuals. Some patients may experience symptom relief within a few days, while others may require several weeks of treatment to see significant changes in their iron levels and anemia symptoms.

  1. Can Iron Sucrose Injection USP be used during pregnancy and breastfeeding?

Iron Sucrose Injection USP is often used in pregnant women with irondeficiency anemia when the benefits outweigh potential risks. The decision should be made in consultation with a healthcare provider.

  1. Is routine monitoring required during Iron Sucrose Injection USP treatment?

Yes, routine monitoring of iron levels, hemoglobin, and vital signs is typically performed during and after treatment to ensure that iron levels are replenished effectively and that side effects are promptly addressed.

  1. Can Iron Sucrose Injection USP interact with other medications?

Iron Sucrose Injection USP may interact with certain medications. It’s important to inform your healthcare provider about all the medications you are taking to avoid potential drug interactions.

Always consult with a qualified healthcare provider for personalized information and guidance regarding Iron Sucrose Injection USP, as individual circumstances and medical needs may vary.

As Iron Sucrose Injection USP Exporters; We can cater to export business queries from the following geographies. We are exporting our Iron Sucrose Injection USP 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

Iron Sucrose Injection USP 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 Iron Sucrose Injection USP, 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