Human Coagulation Factor viii 250 IU

Human Coagulation Factor viii 250 IU Technical Specification:

Human Coagulation Factor viii 250IU Manufacturers, Suppliers in India:

Taj Pharmaceuticals is of the prominent Human Coagulation Factor viii 250IU 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 250IU.

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 250IU 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 250IU 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 250IU suppliers in India prefer Taj Pharmaceuticals due to the reliability and purity of its products. Taj Pharmaceuticals, the well-known Human Coagulation Factor viii 250IU 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 250IU 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 40g/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.

As Human Coagulation Factor viii 250IU Exporters; We can cater to export business queries from the following geographies. We are exporting our Human Coagulation Factor viii 250IU product to 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 250IU 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)