Human Coagulation Factor viii 500 IU Technical Specification:
Product Name: | Human Coagulation Factor viii (500 IU) |
Brand Name: | Generic |
Strength: | 250IU, 500IU |
Dosage Form: | Liquid Injection |
Packing: | 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: | Antihemorrhagic Drugs |
Indication: | Factor VIII is a medication used to treat and prevent bleeding in people with haemophilia A and other causes of low factor VIII. It is given by slow injection into a vein. Antibody formation to factor VIII can also be a major concern for patients receiving therapy against bleeding; the incidence of these inhibitors is dependent of various factors, including the factor VIII product itself. |
Storage: | Store at refrigerator at 2° to 8°C (36° to 46°F), or no more than 6 months at room temperature up to 25°C (77°F). At any time prior to the expiration date. |
Human Coagulation Factor viii 500IU Manufacturers, Suppliers in India:
Taj Pharmaceuticals is of the prominent Human Coagulation Factor viii 500IU Manufacturers in India that brings the best quality products. Our company Taj Pharma has rich experience in the niche manufacturing of Human Coagulation Factor viii 500IU.
Antihemophilic factor human, also known as Coagulation Factor VIII, is a non-recombinant, lyophilized concentrate of coagulation factor VIII, an endogenous protein and essential component of the coagulation cascade. Antihemophilic factor is manufactured with reduced amounts of von Willebrand Factor antigen (VWF:Ag) and purified from extraneous plasma-derived protein by affinity chromatography. A small amount of von Willebrand factor (vWF) antigen: Ag is used to purify the factor VIII complex and then removed from the final preparation. The final purified concentrate contains albumin as a stabilizer
Taj Pharma is a well-known Human Coagulation Factor viii 500IU Manufacturer in India that gives the assurance of high- quality and high standards. Strict quality control ensures that every batch of medicine brings a harmonious standard.
Taj Pharmaceuticals, one of the Human Coagulation Factor viii 500IU Manufacturers India brings the best quality products. The company carries a rich experience in the niche. Taj Pharmaceuticals is a reputed manufacturer and Human Coagulation Factor viii 500IU suppliers in India prefer Taj Pharmaceuticals due to the reliability and purity of its products. Taj Pharmaceuticals, the well-known Human Coagulation Factor viii 500IU Manufacturer in India gives the assurance of high quality and purity. The stringent quality control ensures that every batch of the drug brings a consistent standard. As Human Coagulation Factor viii 500IU Exporters
GENERIC NAME OF MEDICINAL PRODUCT:
- Human Coagulation Factor viii 250IU
- Human Coagulation Factor viii 500IU
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Human Coagulation Factor viii 250IU
Each vial contains:
Factor viii…………………………….250IU
Sodium Citrate (as Stabilizer) ……….29.0mg
Calcium Chloride (as Stabilizer) …….1.8mg
Aminoacetic Acid (as Stabilizer) ……. 128mg
Sodium Chloride (as isotonic agent) ……… 128mg
Protein ………………. NMT 80g/L
Fibrinogen……………. NMT 80% of total protein
Na+ …………………. NMT 200mM - Human Coagulation Factor viii 500IU
Each vial contains:
Factor viii…………………………….500IU
Sodium Citrate (as Stabilizer) ……….29.0mg
Calcium Chloride (as Stabilizer) …….1.8mg
Aminoacetic Acid (as Stabilizer) NMT 150mg
Sodium Chloride (as isotonic agent) ………NMT 128mg
Protein …………………………. NMT 40g/L
Fibrinogen……………………… NMT 80% of total Protein
Na+ ………………….…………. NMT 200mM
THERAPEUTIC INDICATION:
Factor VIII is a medication used to treat and prevent bleeding in people with haemophilia A and other causes of low factor VIII. It is given by slow injection into a vein. Antibody formation to factor VIII can also be a major concern for patients receiving therapy against bleeding; the incidence of these inhibitors is dependent of various factors, including the factor VIII product itself.
DOSAGE AND ADMINISTRATION:
Reconstitute with 10ml of WFI (Water for Injection)
Reconstitution may take up to 30 minutes
Use within 1 hour after reconstitution
Discard after 1 hour
Use syringe filter for administration
Do not use if the gel or precipitate is observed when reconstituted
CAUTION & WARNING:
CAUTION: Not to be sold by retail without the prescription of the registered medical practitioner
WARNING: Do not Freeze.
STORAGE & DOSAGE:
Storage: Store in refrigerator at 2° to 8°C in an airtight container, protected from light.
Direction for use: See package insert for further details.
Why Taj Pharmaceuticals?
When it comes to Human Coagulation Factor VIII 500IU, Taj Pharmaceuticals Limited stands as a trustworthy and reputable choice. Our commitment to delivering healthcare solutions of the highest quality sets us apart in the pharmaceutical industry. With extensive experience and a dedication to innovation, Taj Pharma has garnered a strong reputation for consistently providing effective and reliable medical products. Human Coagulation Factor VIII 500IU holds critical significance for individuals with hemophilia A, a genetic disorder characterized by deficient or defective clotting factor VIII. This essential clotting protein plays a pivotal role in preventing excessive bleeding and promoting blood clot formation. For patients dealing with hemophilia A, access to a dependable and potent source of Factor VIII is essential for managing their condition and improving their quality of life.
At Taj Pharmaceuticals Limited, we adhere to stringent quality control measures and manufacturing standards to ensure the purity, potency, and safety of our pharmaceutical products. Our Human Coagulation Factor VIII 500IU exemplifies our commitment to delivering treatments that healthcare professionals and patients can rely on. By choosing Taj Pharma for Human Coagulation Factor VIII 500IU, you are selecting a partner dedicated to advancing healthcare through quality-driven pharmaceuticals. Our mission is to make a positive impact on patient’s lives by providing them with treatments they can trust. Count on Taj Pharmaceuticals Limited for your medical needs, and experience the assurance of quality and efficacy in every product we offer.
What is Human Coagulation Factor VIII and its uses:
Human Coagulation Factor VIII, often simply referred to as Factor VIII, is a crucial protein involved in the blood clotting process. It is a fundamental component of the coagulation cascade, a complex series of reactions that work together to stop bleeding and promote wound healing. Factor VIII is synthesized in the liver and released into the bloodstream. It plays a key role in the intrinsic pathway of the coagulation cascade, which is activated when blood vessels are injured. Human Coagulation Factor VIII interacts with other clotting factors to convert inactive proenzymes into active enzymes, leading to the formation of a stable blood clot. In individuals with hemophilia A, a genetic disorder, there is a deficiency or dysfunction of Factor VIII. This deficiency impairs the blood clotting process, resulting in prolonged bleeding and an increased risk of spontaneous bleeding episodes, as well as difficulty in stopping bleeding after injuries or surgeries.
To manage hemophilia A, individuals often require replacement therapy with exogenous Factor VIII. This can be administered as a treatment to prevent bleeding or as a therapy during bleeding episodes. Human Coagulation Factor VIII, produced from human plasma or through recombinant technology, is administered by infusion into the bloodstream. It temporarily restores the missing or deficient Factor VIII, allowing the blood to clot effectively and preventing excessive bleeding. Human Coagulation Factor VIII is a lifeline for individuals with hemophilia A, enabling them to lead more normal lives by reducing the risk of bleeding complications and promoting better overall health. It is a cornerstone of hemophilia treatment and an essential therapy for those with this inherited bleeding disorder.
Uses of Human Coagulation Factor VIII:
- Hemophilia A Treatment: The primary and most vital use of Human Coagulation Factor VIII is in the treatment of hemophilia A, a genetic bleeding disorder. Hemophilia A is characterized by insufficient or defective Factor VIII, which results in impaired blood clotting. Patients with hemophilia A lack the ability to effectively control bleeding, making them susceptible to spontaneous and prolonged bleeding episodes, both externally and internally. Human Coagulation Factor VIII is administered intravenously to replace the missing or defective Factor VIII, effectively promoting clotting and preventing excessive bleeding. This treatment is essential for managing and preventing bleeding episodes, improving the overall quality of life for those with hemophilia A.
- Surgical Procedures: Individuals with hemophilia A often require surgical interventions for various reasons, ranging from minor procedures to major surgeries. In such cases, Human Coagulation Factor VIII is administered before, during, and after surgery to ensure proper blood clotting and minimize bleeding risks. This is crucial to achieve successful surgical outcomes and prevent potentially life-threatening complications associated with excessive bleeding.
- Prophylactic Treatment: Some patients with severe hemophilia A may undergo prophylactic treatment, which involves regularly scheduled infusions of Human Coagulation Factor VIII to prevent bleeding episodes before they occur. This preventive approach aims to maintain stable Factor VIII levels in the blood, reducing the risk of spontaneous bleeding and joint damage over time.
It’s important to note that the administration of Human Coagulation Factor VIII should always be done under the guidance of a qualified healthcare professional. The dosage, frequency, and treatment plan will depend on the individual’s specific medical condition, severity of hemophilia A, and response to the treatment. Effective management of hemophilia A with Human Coagulation Factor VIII can significantly enhance the quality of life for those living with this bleeding disorder.
Benefits of Human Coagulation Factor VIII 500IU:
- Hemophilia A Management: Human Coagulation Factor VIII 500IU is a crucial treatment for individuals with hemophilia A, a genetic disorder characterized by deficiency or dysfunction of clotting Factor VIII. Administering this clotting factor helps restore the ability to form blood clots, reducing the risk of excessive bleeding and improving overall quality of life.
- Prevention of Bleeding Episodes: Regular infusion of Human Coagulation Factor VIII 500IU helps prevent and manage bleeding episodes in individuals with hemophilia A. It enables patients to engage in daily activities with reduced fear of bleeding complications.
- Enhanced Mobility: By providing effective clotting support, Human Coagulation Factor VIII 500IU allows patients to maintain greater mobility and participate in physical activities without the constant concern of potential bleeding.
- Surgical Interventions: For individuals with hemophilia A who require surgical procedures, Human Coagulation Factor VIII 500IU is essential to ensure proper clotting during and after surgery, minimizing bleeding risks and improving surgical outcomes.
Side Effects of Human Coagulation Factor VIII 500IU:
- Allergic Reactions: Like with any medical product, allergic reactions can occur. Symptoms may include rash, itching, hives, swelling, difficulty breathing, and low blood pressure. Seek medical attention immediately if any allergic reactions are experienced.
- Inhibitor Development: In some cases, the body may develop inhibitors, or antibodies, against the infused clotting factor. This can reduce the effectiveness of the treatment and require adjustments in dosages or alternative treatments.
- Localized Reactions: Injection-site reactions such as redness, pain, and swelling may occur. These reactions are usually mild and temporary.
- Thrombotic Events: There have been reports of blood clot formation, also known as thrombosis, in individuals receiving clotting factor products. The risk of thrombosis should be carefully assessed and monitored.
- Flu-Like Symptoms: Infusion of Human Coagulation Factor VIII 500IU can sometimes lead to flu-like symptoms, including fever, chills, and fatigue. These symptoms are typically transient.
- Headache: Mild headaches can occur as a side effect of treatment, but they usually subside without intervention.
Frequently Asked Questions about Human Coagulation Factor VIII 500IU:
What is Human Coagulation Factor VIII 500IU?
Human Coagulation Factor VIII 500IU is a medication used to treat bleeding disorders, specifically hemophilia A. It contains a concentrated form of factor VIII, a protein that is essential for blood clotting. This medication is used to replace or supplement the missing or deficient factor VIII in individuals with hemophilia A, a genetic disorder that impairs the blood’s ability to clot properly.
How is Human Coagulation Factor VIII 500IU administered?
This medication is typically administered via intravenous (IV) infusion. It’s important to follow the prescribed dosage and administration instructions provided by a healthcare professional. The exact dosage and frequency of administration can vary based on factors such as the severity of the bleeding disorder and the individual’s response to treatment.
What is the purpose of Human Coagulation Factor VIII 500IU?
The purpose of this medication is to restore the blood’s ability to clot properly in individuals with hemophilia A. People with hemophilia A lack sufficient factor VIII, which is necessary for effective clotting. Human Coagulation Factor VIII 500IU provides the missing factor VIII, thereby reducing the risk of excessive bleeding and promoting normal blood clotting.
Are there any potential side effects associated with Human Coagulation Factor VIII 500IU?
Like any medication, Human Coagulation Factor VIII 500IU can have side effects. Common side effects may include infusion site reactions, headache, fever, chills, and nausea. Allergic reactions are possible but rare. It’s important to discuss any concerns about potential side effects with a healthcare provider.
How should Human Coagulation Factor VIII 500IU be stored?
This medication should be stored according to the manufacturer’s instructions. Typically, it needs to be kept in the refrigerator at a specific temperature range. It’s important to protect the medication from light and extreme temperatures. Always check the product’s packaging for specific storage guidelines.
What should I do if I miss a dose of Human Coagulation Factor VIII 500IU?
If you miss a dose, contact your healthcare provider for guidance. They will provide recommendations on how to proceed. It’s important not to double the dose to make up for a missed one, as this could lead to complications.
Can Human Coagulation Factor VIII 500IU be self-administered at home?
Yes, many individuals with hemophilia A are trained to self-administer this medication at home. Proper training is essential to ensure safe and effective administration. Healthcare professionals will provide guidance on the correct technique, dosage, and storage procedures for home use.
Is a prescription required for Human Coagulation Factor VIII 500IU?
Yes, a prescription from a healthcare provider is required to obtain Human Coagulation Factor VIII 500IU. This medication is not available over the counter and should only be used under the supervision and guidance of a medical professional.
As Human Coagulation Factor viii 500IU Exporters; We can cater to export business queries from the following geographies. We are exporting our Human Coagulation Factor viii 500IU product to 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, 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
Human Coagulation Factor viii 500IU 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)
Get in touch with Taj Pharmaceuticals Limited, the most trustworthy manufacturer of Human Coagulation Factor VIII 500IU, in order to procure large quantities at an affordable cost.
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 MEDICINAL PRODUCT:
1. Human Coagulation Factor viii 250IU
2. Human Coagulation Factor viii 500IU
2. Human Coagulation Factor viii 500IU
QUALITATIVE AND QUANTITATIVE COMPOSITION:
• Human Coagulation Factor viii 250IU
Each vial contains:
Factor viii…………………………….250IU
Sodium Citrate (as Stabilizer) ……….29.0mg
Calcium Chloride (as Stabilizer) …….1.8mg
Aminoacetic Acid (as Stabilizer) ……. 128mg
Sodium Chloride (as isotonic agent) ……… 128mg
Protein ………………. NMT 80g/L
Fibrinogen……………. NMT 80% of total protein
Na+ …………………. NMT 200mM
• Human Coagulation Factor viii 500IU
Each vial contains:
Factor viii…………………………….500IU
Sodium Citrate (as Stabilizer) ……….29.0mg
Calcium Chloride (as Stabilizer) …….1.8mg
Aminoacetic Acid (as Stabilizer) NMT 150mg
Sodium Chloride (as isotonic agent) ………NMT 128mg
Protein …………………………. NMT 40g/L
Fibrinogen……………………… NMT 80% of total Protein
Na+ ………………….…………. NMT 200mM
Each vial contains:
Factor viii…………………………….250IU
Sodium Citrate (as Stabilizer) ……….29.0mg
Calcium Chloride (as Stabilizer) …….1.8mg
Aminoacetic Acid (as Stabilizer) ……. 128mg
Sodium Chloride (as isotonic agent) ……… 128mg
Protein ………………. NMT 80g/L
Fibrinogen……………. NMT 80% of total protein
Na+ …………………. NMT 200mM
• Human Coagulation Factor viii 500IU
Each vial contains:
Factor viii…………………………….500IU
Sodium Citrate (as Stabilizer) ……….29.0mg
Calcium Chloride (as Stabilizer) …….1.8mg
Aminoacetic Acid (as Stabilizer) NMT 150mg
Sodium Chloride (as isotonic agent) ………NMT 128mg
Protein …………………………. NMT 40g/L
Fibrinogen……………………… NMT 80% of total Protein
Na+ ………………….…………. NMT 200mM
THERAPEUTIC INDICATION:
Factor VIII is a medication used to treat and prevent bleeding in people with haemophilia A and other causes of low factor VIII. It is given by slow injection into a vein. Antibody formation to factor VIII can also be a major concern for patients receiving therapy against bleeding; the incidence of these inhibitors is dependent of various factors, including the factor VIII product itself.
DOSAGE AND ADMINISTRATION:
Reconstitute with 10ml of WFI (Water for Injection)
Reconstitution may take up to 30 minutes
Use within 1 hour after reconstitution
Discard after 1 hour
Use syringe filter for administration
Do not use if the gel or precipitate is observed when reconstituted
Reconstitution may take up to 30 minutes
Use within 1 hour after reconstitution
Discard after 1 hour
Use syringe filter for administration
Do not use if the gel or precipitate is observed when reconstituted
CAUTION & WARNING:
CAUTION: Not to be sold by retail without the prescription of the registered medical practitioner
WARNING: Do not Freeze.
WARNING: Do not Freeze.
STORAGE & DOSAGE:
Storage: Store at refrigerator at 2° to 8°C in an airtight container, protected from light.
Direction for use: See package insert for further details.
Direction for use: See package insert for further details.