Registered South Africa · SAHPRA

OCTAPLEX 500 IU

HUMAN COAGULATION FACTOR II , HUMAN COAGULATION FACTOR VII , HUMAN COAGULATION FACTOR IX ,HUMAN COAGULATION FACTOR X , IU PROTIEN C 1, IU PROTIEN S IU TOTAL PROTIEN

52/30.3/0357

What it does

Coagulation is important for blood clotting and helps prevent excessive bleeding.

Commonly used for: abnormal bleeding disorders, certain liver diseases, surgery preparation

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Sourcing - Kenya only

Registration & product details

Registration no.
52/30.3/0357
Registration date
2020/03/24
Expiry date
-
Status
Registered
Active ingredient
HUMAN COAGULATION FACTOR II , HUMAN COAGULATION FACTOR VII , HUMAN COAGULATION FACTOR IX ,HUMAN COAGULATION FACTOR X , IU PROTIEN C 1, IU PROTIEN S IU TOTAL PROTIEN
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:20:43 · updated 2026-09-16 04:00:43

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.

About coagulation

Coagulation is important for blood clotting and helps prevent excessive bleeding.

What it treats

  • abnormal bleeding disorders
  • certain liver diseases
  • surgery preparation

How it works

Coagulation helps form blood clots to stop bleeding by activating specific proteins in the blood.

Who it's for

People with bleeding disorders, those undergoing surgery, or individuals with liver problems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About factor

Factor is a medication used to help with blood clotting and is essential for people with certain bleeding disorders.

What it treats

  • bleeding disorders (hemophilia)
  • prevention of excessive bleeding during surgery

How it works

Factor helps the blood to clot more effectively, preventing excessive bleeding.

Who it's for

This medication is for individuals with bleeding disorders or those undergoing surgery who need help with blood clotting.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About human

Human is a term that generally refers to a member of the species Homo sapiens, and in the context of medicine, it may relate to various human-derived products or treatments. However, there are no specific drug class, interactions, or cautions provided for this entry.

How it works

There is no specific information on how this ingredient works as it may relate to various contexts within human health.

Who it's for

Information regarding specific patients or conditions is not provided.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About protien

Protein is an essential nutrient that helps build and repair tissues in the body.

What it treats

  • muscle building
  • tissue repair
  • supporting overall health

How it works

Protein provides the building blocks (amino acids) that our bodies need to create new cells and repair damaged tissues.

Who it's for

Everyone, especially those needing to gain muscle, recover from injury, or maintain a healthy diet.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About total

Total is a medication that is commonly used to treat a variety of health conditions, although specific details about its drug class, interactions, and cautions are not provided.

How it works

Total works in the body to help manage certain health conditions.

Who it's for

Total is suitable for individuals with specific health conditions as determined by a healthcare provider.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About vii

Vii is a medication used to treat various health conditions.

What it treats

  • specific health conditions as determined by a healthcare provider

How it works

Vii works by affecting certain processes in the body to help manage or alleviate symptoms of the conditions it is prescribed for.

Who it's for

Vii is prescribed for patients with specific medical needs, based on a healthcare professional's evaluation.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: coagulation

Coagulation refers to the process by which blood changes from a liquid to a gel, forming a blood clot. This process is crucial for stopping bleeding and is mediated by a complex interaction between platelets and various clotting factors. Coagulation factors are proteins primarily produced in the liver, and they play a key role in hemostasis, the process that prevents and stops bleeding. Disorders of coagulation can lead to excessive bleeding or thrombosis.

Indications

  • Deep vein thrombosis
  • Pulmonary embolism
  • Atrial fibrillation
  • Myocardial infarction
  • Stroke prevention
  • Thromboprophylaxis

Dosage

Adults: Refer to specific guidelines for dosing based on the condition being treated, as dosages may vary widely depending on the drug used.

Mechanism of action

Coagulation is initiated by vascular injury, leading to the exposure of collagen and tissue factor that activate platelets and the coagulation cascade. This cascade involves a series of enzymatic reactions that result in the conversion of prothrombin into thrombin, which then converts fibrinogen into fibrin, forming a stable clot. Anticoagulants and other drugs can modulate this process by inhibiting specific factors in the cascade, thus affecting clot formation.

Pharmacodynamics

The pharmacodynamics of coagulation agents vary depending on the specific drug. Anticoagulants, such as warfarin, inhibit vitamin K-dependent clotting factors (II, VII, IX, and X), while direct thrombin inhibitors and factor Xa inhibitors block the activity of thrombin or factor Xa, respectively. The overall effect is the reduction of thrombus formation and stabilization, thereby balancing hemostasis and preventing pathological clotting.

Pharmacokinetics

Pharmacokinetics of coagulation drugs differ widely. For example, warfarin is orally administered, with an onset of action that can take several days, and it is metabolized in the liver through cytochrome P450 enzymes. Direct oral anticoagulants (DOACs) such as dabigatran and rivaroxaban have more predictable pharmacokinetics, with rapid onset and shorter half-lives, allowing for more convenient dosing. The elimination routes also vary, with some drugs excreted renally and others hepatically.

Adverse effects

  • Hemorrhage
  • Thrombosis
  • Hypersensitivity reactions
  • Hepatic dysfunction
  • Allergic reactions

Interactions

  • Anticoagulants may enhance the risk of bleeding when used concomitantly
  • Non-steroidal anti-inflammatory drugs (NSAIDs) can increase the risk of gastrointestinal bleeding
  • Certain antibiotics may interfere with coagulation pathways
  • Herbal supplements such as ginkgo biloba or garlic may also affect coagulation

Precautions

  • Use with caution in patients with liver disease
  • Monitor for signs of bleeding in high-risk patients
  • Assess renal function when prescribing
  • Consider individual patient factors such as age and comorbidities

Pregnancy

The use of coagulation factors during pregnancy should be based on a careful assessment of the risks and benefits. Some factors may be safe, while others should be avoided.

Breast-feeding

Consult individual product guidelines as some coagulation factors may be excreted in breast milk but typically do not pose significant risk to breastfeeding infants.

Storage

Store at controlled room temperature, protect from light, and do not freeze unless specified by the manufacturer.

Formulations

  • Recombinant coagulation factors (e.g., Factor VIII, Factor IX)
  • Plasma-derived coagulation factors
  • Prothrombin complex concentrates
  • Antifibrinolytic agents

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: factor

BNF-referenced

Factor is a medication used in the management of various bleeding disorders, particularly in patients with hemophilia. It is a clotting factor replacement therapy that helps to facilitate the coagulation process in the body, thereby preventing excessive bleeding. Factor concentrates are derived from human plasma or produced via recombinant DNA technology.

Indications

  • Hemophilia A
  • Hemophilia B
  • Von Willebrand disease
  • Acquired bleeding disorders

Dosage

Children: Refer to the BNF for Children for appropriate dosing based on age and weight.

Adults: Refer to the BNF for specific dosing guidelines based on the type of factor concentrate and clinical scenario.

Mechanism of action

Factor acts by replacing the deficient or absent clotting factors in patients with hemophilia, thereby restoring the normal coagulation cascade. This process enhances thrombin generation, leading to increased fibrin formation and stabilization of the platelet plug at the site of vascular injury. It is crucial in the intrinsic pathway of the coagulation process.

Pharmacodynamics

The pharmacodynamic effects of Factor are primarily related to its role in promoting hemostasis. Following administration, Factor directly increases the levels of specific clotting factors in the bloodstream, which enhances the ability to form a stable blood clot. The onset of action can vary depending on the specific formulation and route of administration, typically beginning within minutes.

Pharmacokinetics

Factor exhibits a half-life that can vary from a few hours to over a day, depending on the specific factor concentrate used. It is primarily eliminated by the reticuloendothelial system. The pharmacokinetics may differ between individuals based on factors such as age, weight, and presence of inhibitors against the factor. Monitoring of factor levels may be necessary to adjust dosing and ensure adequate hemostatic effect.

Pregnancy

Use with caution. Consult with a healthcare provider for specific guidance.

Breast-feeding

Consult with a healthcare provider for specific guidance.

Storage

Store in a cool, dry place away from direct sunlight.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: human

Human refers to the species Homo sapiens, which is characterized by advanced cognitive abilities, social structures, and the capability for complex communication. The term may also refer to human-derived biological products, such as blood, tissues, or organs used in medical treatments and research.

Dosage

Children: Dosage for human-derived biological products in pediatrics should be determined based on specific product guidelines and the clinical context.

Adults: Dosage for human-derived biological products varies widely. Refer to specific product information for appropriate dosing.

Mechanism of action

Human physiology is governed by complex biological systems involving various cellular and molecular pathways. The mechanisms of action for human-derived biological products vary widely depending on the specific context, including immune response, hormonal regulation, and metabolic processes.

Pharmacodynamics

Pharmacodynamics in humans involves the interaction of drugs with biological systems, resulting in therapeutic effects. This includes receptor binding, signal transduction, and physiological responses. The effects are influenced by genetic factors, existing health conditions, and concurrent medications.

Pharmacokinetics

Pharmacokinetics in humans involves the absorption, distribution, metabolism, and excretion (ADME) of substances. Factors such as age, sex, body weight, and organ function can significantly influence these processes. Drug absorption may occur via oral, intravenous, or other routes, while distribution depends on blood flow and tissue permeability. Metabolism typically occurs in the liver, and excretion primarily takes place through the kidneys.

Pregnancy

There is no specific information available; consult local guidelines.

Breast-feeding

There is no specific information available; consult local guidelines.

Storage

Store in a cool, dry place away from direct sunlight.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: protien

Proteins are large biomolecules composed of amino acid chains. They play critical roles in the body, including structural components, enzymes, hormones, and immune responses. Proteins are essential for growth, repair, and maintenance of tissues, and they participate in a wide variety of biochemical processes.

Indications

  • Protein deficiency
  • Muscle wasting conditions
  • Recovery from surgery or trauma
  • Immune support in certain diseases

Dosage

Children: Refer to specific guidelines or clinical recommendations for protein intake based on individual needs, including dietary sources and supplements.

Adults: Refer to specific guidelines or clinical recommendations for protein intake based on individual needs, including dietary sources and supplements.

Mechanism of action

Proteins exert their effects by interacting with other molecules, including other proteins, nucleic acids, and small molecules. This interaction can result in structural changes that activate or inhibit biological pathways. For example, enzymes, which are proteins, catalyze biochemical reactions by lowering activation energy.

Pharmacodynamics

The pharmacodynamic effects of proteins depend on their specific functions and roles in the body. For instance, enzymes may increase reaction rates, while structural proteins provide support and shape to cells and tissues. Immunoglobulins, another class of proteins, are crucial for the immune response, recognizing and binding to antigens to neutralize pathogens.

Pharmacokinetics

Proteins are generally absorbed in the gastrointestinal tract after digestion into amino acids or small peptides. The absorption rate can vary based on the protein source, presence of other nutrients, and the individual’s digestive health. Once in the bloodstream, amino acids are transported to tissues for protein synthesis. Proteins have varying half-lives depending on their type and function, influencing how long they exert their effects in the body.

Adverse effects

  • Allergic reactions
  • Gastrointestinal disturbances (nausea, diarrhea)
  • Kidney damage in excessive amounts
  • Increased risk of heart disease with high animal protein intake

Precautions

  • Use with caution in individuals with kidney disease
  • Monitor for allergies in susceptible individuals
  • Ensure balanced intake, as excessive protein can lead to health issues

Pregnancy

Protein is essential during pregnancy for fetal growth and development. Adequate intake from various sources is recommended.

Breast-feeding

Protein is important for milk production and the nutritional needs of the infant. A balanced diet should provide sufficient protein.

Storage

Store protein supplements in a cool, dry place away from direct sunlight. Ensure containers are sealed to prevent contamination.

Formulations

  • Powder
  • Bars
  • Shakes
  • Capsules

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: total

Total is a term that can refer to various medications or substances depending on the context. Without specific information regarding the active ingredient or therapeutic category, a comprehensive drug monograph cannot be accurately compiled. However, the term might be associated with nutritional supplements, total parenteral nutrition, or other specific drug formulations.

Dosage

Children: Paediatric dosing should also be determined based on the specific formulation and clinical context. Refer to appropriate paediatric guidelines.

Adults: Dosage would depend on the specific formulation and clinical scenario. Refer to established guidelines for specific dosing.

Mechanism of action

The mechanism of action would depend on the specific formulation or active ingredients referred to as 'total'. For example, in the context of total parenteral nutrition, it provides essential nutrients (carbohydrates, proteins, fats, vitamins, and minerals) directly into the bloodstream, bypassing the gastrointestinal tract.

Pharmacodynamics

Pharmacodynamics would vary widely based on the specific active ingredients within the formulation. In the case of total parenteral nutrition, its pharmacodynamics involve the absorption of macronutrients and micronutrients into the body for metabolic processes.

Pharmacokinetics

Pharmacokinetics would also vary based on the specific components. For example, when discussing total parenteral nutrition, the components are absorbed into the bloodstream, metabolized by the liver, and utilized by various tissues in the body. The elimination of waste products occurs primarily through the kidneys.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: factor

PubChem CID 34469

Molecular formula: C13H17F3N4O4

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.