GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Heparin Sodium Injection USP 1000 IU/ml
B. Heparin Sodium Injection USP 5000 IU/ml
C. Heparin Sodium Injection USP 10,000 IU/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Heparin Sodium Injection USP 1000 IU/ml
Each ml contains:
Heparin Sodium USP………………...1000IU
(Derived From Bovine Intestinal Mucosa)
Benzyl Alcohol USP…………………0.95%w/v
Water for Injection USP…………..q.s


2. Heparin Sodium Injection USP 5000 IU/ml
Each ml contains:
Heparin Sodium USP ………………5000IU
(Derived From Bovine Intestinal Mucosa)
Benzyl Alcohol USP…………………0.95%w/v
Water for Injection USP ………….q.s

3. Heparin Sodium Injection USP 10,000 IU/ml
Each ml contains:
Heparin Sodium USP ………………10,000IU
(Derived From Bovine Intestinal Mucosa)
Benzyl Alcohol USP…………………0.95%w/v
Water for Injection USP ……………q.s

THERAPEUTIC INDICATIONS:

Heparin is used to prevent or treat certain blood vessel, heart, and lung conditions. Heparin is also used to prevent blood clotting during open-heart surgery, bypass surgery, kidney dialysis, and blood transfusions.

DIRECTION OF USE:

For Intravenous, Intramuscular or Subcutaneous use only.
Refer insert for full prescribing information.

CAUTION & WARNING:

CAUTION:
Do not use if the solution is discolored or contains a precipitate.
This product contains benzyl alcohol and is not recommended for use in neonates.
Use only if seal is intact and undamaged.
Warning:
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
NOT FOR LOCK FLUSH.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Should be protected from freezing.
Protect from light.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Heparin Sodium Injection USP 1000 IU/ml Technical Specification:

Product Name:Heparin Sodium Injection USP
Brand Name:BEPRIN
Strength:(1000 IU/ml) (5000 IU/ml), (10,000 IU/ml)
Dosage Form:Liquid Injection (Sterile and Nonpyrogenic)
Packing:1000 IU/ml (Packing: 1ml, 2ml, 5ml, 10ml, 30ml Ampoule/Vial)
5000 IU /ml (Packing: 1ml, 5ml, 10ml Ampoule/Vial)
10,000 IU/ml (Packing: 4ml Ampoule/Vial)
Derived from:Bovine Intestinal Mucosa
Route of Administration:For I.M./I.V. or S.C. 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:Anti-Coagulant
Indication: Heparin is used to prevent or treat certain blood vessel, heart, and lung conditions. Heparin is also used to prevent blood clotting during open-heart surgery, bypass surgery, kidney dialysis, and blood transfusions.
Storage:Store at 20°C to 25°C (68°F to 77°F). Do not freeze. Should be protected from freezing.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Heparin Sodium Injection USP 1000 IU/ml (Beprin)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Heparin Sodium Injection USP 1000 IU/ml
    Each ml contains:
    Heparin Sodium USP…………………1000IU
    (Derived From Bovine Intestinal Mucosa)
    Benzyl Alcohol USP…………………0.95%w/v
    Water for Injection USP…………..q.s

THERAPEUTIC INDICATIONS:

Heparin is used to prevent or treat certain blood vessel, heart, and lung conditions. Heparin is also used to prevent blood clotting during open-heart surgery, bypass surgery, kidney dialysis, and blood transfusions.

DIRECTION OF USE:

For Intravenous, Intramuscular or Subcutaneous use only.
Refer insert for full prescribing information.

CAUTION & WARNING:

CAUTION:
Do not use if the solution is discolored or contains a precipitate.
This product contains benzyl alcohol and is not recommended for use in neonates.
Use only if seal is intact and undamaged.

Warning:
Not to be sold by retail without the prescription of a Registered Medical Practitioner.
NOT FOR LOCK FLUSH.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Protect from light.
Should be protected from freezing.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.

Note:

Origin: Bovine intestinal mucosa is a natural animal source. It is used in the pharmaceutical industry for the manufacture of the drug heparin. Hydrolysed proteins are a coproduct of this pharmaceutical process.

Why Taj Pharmaceuticals?

Selecting a pharmaceutical supplier for medications like Heparin Sodium Injection USP is a critical decision for healthcare professionals and institutions. When evaluating a supplier, several key factors come into play. First and foremost is quality assurance. Ensuring that medications adhere to stringent quality standards, including compliance with good manufacturing practices (GMP), is paramount to patient safety and treatment efficacy. Regulatory approvals from health authorities like the FDA are essential, as they confirm that the medication meets rigorous safety and efficacy standards. Reliability in product availability is another crucial consideration. Healthcare providers require a steady supply of medications like Heparin Sodium Injection USP to avoid treatment interruptions. Competitive pricing is also significant, allowing healthcare institutions to optimize budgets. Effective customer support, timely deliveries, and strong communication channels are highly valued by healthcare professionals. A pharmaceutical company’s reputation within the industry, built on ethical practices and consistency, plays a vital role in supplier selection. Additionally, an emphasis on research and development demonstrates commitment to advancing patient care. Above all, patient safety remains paramount. Pharmaceutical suppliers that prioritize patient safety through robust adverse event monitoring and reporting mechanisms contribute to a safer healthcare environment. In summary, the choice of a pharmaceutical supplier like Taj Pharmaceuticals for Heparin Sodium Injection USP entails a comprehensive assessment of quality, regulatory compliance, reliability, cost-effectiveness, customer service, reputation, and commitment to patient well-being.

What is Heparin Sodium Injection USP and it uses?

Heparin Sodium Injection USP is a medication used in healthcare for its anticoagulant (blood-thinning) properties. It contains the active ingredient heparin sodium, a natural anticoagulant that is derived from animal tissues, typically the mucosal lining of porcine intestines or bovine lungs. Here are its primary uses:

  • Prevention and Treatment of Blood Clots: Heparin Sodium Injection USP is widely used to prevent and treat blood clots within the blood vessels. This is important for conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), and venous thromboembolism (VTE).
  • During Surgical Procedures: Heparin Sodium Injection USP is often administered during certain surgical procedures, especially those involving blood vessels or the heart. It helps prevent the formation of blood clots during and after surgery.
  • Dialysis: Patients undergoing hemodialysis, a process that filters waste and excess fluids from the blood in cases of kidney dysfunction, may receive Heparin Sodium Injection USP to prevent clotting in the dialysis machine and ensure a smooth procedure.
  • Catheter Maintenance: In some cases, heparin solutions are used to maintain the patency of catheters, such as central venous catheters and arterial lines, to prevent clot formation within these critical access points.
  • Coagulation Disorders: Heparin may also be used in the treatment of certain coagulation disorders, such as disseminated intravascular coagulation (DIC) or antiphospholipid syndrome.
  • Cardiac Conditions: For patients with certain cardiac conditions, such as atrial fibrillation or mechanical heart valves, heparin may be prescribed to reduce the risk of blood clot formation and associated complications like strokes or valve thrombosis.

Heparin works by inhibiting the activity of various clotting factors in the blood, particularly thrombin and factor Xa, which play pivotal roles in the formation of blood clots. By preventing the excessive formation of blood clots, heparin helps maintain normal blood flow and reduces the risk of life-threatening conditions caused by blood clots, such as pulmonary embolism and stroke. It’s important to note that Heparin Sodium Injection USP is typically administered under the supervision of healthcare professionals, often as an intravenous (IV) injection or as a continuous infusion. The dosage and duration of treatment depend on the specific condition being treated, the patient’s individual medical history, and other factors. Accurate dosing and careful monitoring are essential to ensure that the anticoagulant effect is within the desired therapeutic range while minimizing the risk of bleeding complications.

How Does Heparin Sodium Injection USP work?

Heparin Sodium Injection USP is an anticoagulant medication that works by inhibiting the formation and growth of blood clots within the circulatory system. Its mechanism of action primarily involves interactions with various components of the blood coagulation cascade. Here’s how Heparin Sodium Injection USP works:

  • Binding to Antithrombin III: Heparin Sodium Injection USP binds to a natural anticoagulant protein in the blood called antithrombin III (ATIII). This binding significantly enhances the activity of ATIII. ATIII, when activated, inhibits several key enzymes involved in the blood clotting process.
  • Inhibition of Thrombin (Factor IIa): One of the primary targets of heparin is thrombin, also known as factor IIa. Thrombin plays a central role in converting fibrinogen into fibrin, which is essential for forming stable blood clots. Heparin enhances the inhibitory effect of ATIII on thrombin, preventing the conversion of fibrinogen to fibrin.
  • Inhibition of Factor Xa: Heparin also inhibits factor Xa, another crucial enzyme in the coagulation cascade. Factor Xa is responsible for converting prothrombin into thrombin. By blocking the activity of factor Xa, heparin further disrupts the coagulation process.
  • Preventing Clot Formation: By inhibiting thrombin and factor Xa, Heparin Sodium Injection USP effectively prevents the formation of new blood clots and inhibits the growth of existing clots. This helps maintain normal blood flow and reduces the risk of conditions like deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis.
  • Preventing Clot Propagation: Heparin’s anticoagulant effect also extends to preventing the propagation of clots. It stops small clots from growing into larger, more dangerous clots that could potentially cause blockages in blood vessels.
  • Immediate Onset of Action: Heparin Sodium Injection USP has a rapid onset of action when administered intravenously, making it useful in situations where the quick anticoagulation is needed, such as during certain surgical procedures or in acute thromboembolic events.

It’s important to note that the dosage and administration of Heparin Sodium Injection USP are carefully controlled to achieve the desired level of anticoagulation while minimizing the risk of bleeding complications. Monitoring of coagulation parameters, such as activated partial thromboplastin time (aPTT) or anti-Xa levels, is frequently performed to ensure that the anticoagulant effect is within the therapeutic range. Dosing adjustments are made as necessary based on the patient’s response to treatment and individual medical factors. Heparin therapy should always be administered under the supervision of healthcare professionals who are experienced in its use.

Benefits and Side Effects of Heparin Sodium Injection USP:

Heparin Sodium Injection USP offers several benefits in the prevention and treatment of blood clotting disorders but may also be associated with certain side effects. Here’s an overview of its benefits and potential side effects:

Benefits:

  • Effective Anticoagulation: Heparin Sodium Injection USP is a potent and rapidly acting anticoagulant. It is widely used to prevent and treat various conditions associated with abnormal blood clotting, including deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis.
  • Surgical and Medical Procedures: Heparin is commonly used during surgical procedures that involve blood vessels, such as open-heart surgery or vascular surgery. It helps prevent clot formation in surgical instruments and maintains blood flow during surgery. Additionally, it is used in medical situations where temporary anticoagulation is required, such as during dialysis.
  • Safe and Well-Established: Heparin has been used for many years and has a well-established safety profile when administered under appropriate medical supervision. It is considered a standard of care for certain medical conditions.
  • Rapid Onset of Action: When administered intravenously, Heparin Sodium Injection USP has a rapid onset of action, making it suitable for situations where quick anticoagulation is needed.

Side Effects:

  • Bleeding: The most significant side effect of heparin is the increased risk of bleeding. This can manifest as bleeding from the gums, nosebleeds, easy bruising, gastrointestinal bleeding, or more severe bleeding in internal organs. It is essential for healthcare professionals to carefully monitor patients receiving heparin to minimize the risk of excessive bleeding.
  • Heparin-Induced Thrombocytopenia (HIT): In some cases, heparin can lead to a condition called heparin-induced thrombocytopenia, where the platelet count in the blood drops, and there is an increased risk of abnormal clot formation. This is a serious complication that requires immediate medical attention.
  • Hypersensitivity Reactions: Allergic reactions to heparin are rare but can occur. Symptoms may include skin rash, itching, swelling, or more severe allergic reactions like anaphylaxis.
  • Osteoporosis: Prolonged use of heparin can lead to a condition known as heparin-induced osteoporosis, which is characterized by decreased bone density and an increased risk of fractures.
  • Hematoma Formation: Injection site reactions may occur, leading to the formation of hematomas (collections of blood) at the injection site.
  • Hair Loss: Some patients may experience hair loss (alopecia) as a rare side effect of heparin therapy.

It’s important to emphasize that heparin therapy should be administered and monitored by healthcare professionals with expertise in anticoagulation management. Patients receiving heparin should be closely monitored for signs of bleeding or adverse reactions. The dosage and duration of heparin treatment are tailored to the patient’s specific condition and needs, with adjustments made as necessary to maintain the desired level of anticoagulation while minimizing risks. In cases of any adverse effects or complications, healthcare providers should be promptly informed for appropriate management.

Frequently Asked Questions About Heparin Sodium Injection USP:

Certainly, here are some frequently asked questions (FAQs) about Heparin Sodium Injection USP:

  1. What is Heparin Sodium Injection USP?

Heparin Sodium Injection USP is a medication used as an anticoagulant to prevent and treat conditions associated with abnormal blood clotting. It works by inhibiting the formation of blood clots within blood vessels.

  1. What are the common uses of Heparin Sodium Injection USP?

Heparin Sodium Injection USP is used to prevent and treat conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), arterial thrombosis, and to maintain blood flow during surgical procedures involving blood vessels.

  1. How is Heparin Sodium Injection USP administered?

Heparin Sodium Injection USP is typically administered intravenously (IV) or subcutaneously (under the skin) by healthcare professionals. The dosage and administration method depend on the specific medical condition and patient’s needs.

  1. What is the mechanism of action of Heparin Sodium Injection USP?

Heparin works by enhancing the activity of antithrombin III (ATIII), which inhibits several key enzymes involved in the blood clotting process, including thrombin and factor Xa. This inhibition prevents the formation and growth of blood clots.

  1. What are the potential side effects of Heparin Sodium Injection USP?

Common side effects include bleeding (which can manifest as nosebleeds, gum bleeding, easy bruising, etc.), heparininduced thrombocytopenia (HIT), hypersensitivity reactions, hematoma formation at injection sites, and rarely, hair loss.

  1. How is the dosage of Heparin Sodium Injection USP determined?

The dosage of Heparin Sodium Injection USP is determined by healthcare professionals based on the patient’s medical condition, weight, and the desired level of anticoagulation. Frequent monitoring of coagulation parameters is essential to adjust the dosage as needed.

  1. Can Heparin Sodium Injection USP be used during pregnancy?

Heparin is often considered a safer option than some other anticoagulants during pregnancy, but its use should be carefully managed by a healthcare provider, especially if needed for medical reasons.

  1. What should I do if I experience bleeding while on Heparin Sodium Injection USP?

If you experience bleeding that is prolonged or severe, contact your healthcare provider immediately. They will assess the situation and may adjust your treatment as necessary.

  1. Can Heparin Sodium Injection USP interact with other medications?

Yes, Heparin Sodium Injection USP can interact with other medications, including other anticoagulants and drugs that affect blood clotting. It’s important to inform your healthcare provider about all the medications you are taking to avoid potential drug interactions.

  1. How long is Heparin Sodium Injection USP typically administered?

The duration of Heparin Sodium Injection USP treatment varies depending on the medical condition it is used to treat. It can be administered for short-term or long-term use, depending on the individual patient’s needs.

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

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

Heparin Sodium 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 Heparin Sodium 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