Registered Tanzania · TMDA

Healace 0.01%

Recombinant human platelet-derived growth factor (rh-PDGF-BB) 100 mcg/5ml

TZ 20 H 0070 Gel

What it does

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

Commonly used for: bleeding disorders (hemophilia), prevention of excessive bleeding during surgery

Read more in plain English ↓

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

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Registration & product details

Registration no.
TZ 20 H 0070
Registration date
2025-03-16
Expiry date
2030-03-15
Status
Registered/Compliant
Active ingredient
Recombinant human platelet-derived growth factor (rh-PDGF-BB) 100 mcg/5ml
Dosage form
Gel
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Virchow Biotech
Country of origin
INDIA
Manufacturer location
320, 3rd floor, Swamy, Plot No 319, SBH Officers Colony, Mega Hills, Madhapur, Hyderabad, Telangana 500081, India

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:50:03 · updated 2026-09-17 03:00:44

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

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 growth

Growth refers to the process of increasing in size and development, often related to children and adolescents during their formative years.

What it treats

  • development in children and adolescents
  • growth disorders

How it works

Growth is influenced by a variety of factors including genetics, nutrition, and hormonal balances that help the body increase in size and develop properly.

Who it's for

Children and adolescents experiencing growth delays or disorders.

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 recombinant

Recombinant medications are created using genetic engineering techniques. They are used to treat various medical conditions by mimicking natural substances in the body.

What it treats

  • certain types of cancer
  • genetic disorders
  • hormonal deficiencies

How it works

Recombinant drugs work by introducing or replacing natural substances that the body may not produce enough of, helping to restore normal function.

Who it's for

These medications are typically for patients with specific health conditions requiring treatment with biological agents.

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

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: growth

Growth refers to the physiological process of increasing in size, mass, and number of cells in an organism. In humans, growth is a complex process influenced by genetic, hormonal, nutritional, and environmental factors. It occurs predominantly during childhood and adolescence, and is characterized by increases in height, weight, and organ size. Hormones such as growth hormone (GH), insulin-like growth factor 1 (IGF-1), and sex hormones play critical roles in regulating growth.

Indications

  • Growth hormone deficiency
  • Turner syndrome
  • Chronic kidney disease
  • Prader-Willi syndrome
  • Idiopathic short stature

Dosage

Children: Refer to established clinical guidelines, as specific dosing may vary based on condition and patient specifics.

Adults: Refer to established clinical guidelines, as specific dosing may vary based on condition and patient specifics.

Mechanism of action

Growth hormone stimulates growth and cell reproduction by binding to specific receptors on target tissues, primarily in the liver, muscle, and adipose tissue. This binding activates the JAK2-STAT5 signaling pathway, leading to the production of IGF-1 in the liver, which mediates many of the growth-promoting effects. Additionally, GH promotes lipolysis, increases protein synthesis, and enhances the uptake of amino acids by cells.

Pharmacodynamics

The primary pharmacodynamic effects of growth factors, especially growth hormone, include stimulation of linear growth in children, increased muscle mass, and decreased body fat. IGF-1 contributes to cellular growth and development in various tissues. The overall anabolic effects of growth hormone include enhanced protein metabolism, increased fat utilization, and an increase in the number and size of muscle fibers.

Pharmacokinetics

Growth hormone has a short half-life of approximately 20-30 minutes when administered intravenously, but its effects can last longer due to downstream signaling pathways activated by IGF-1. GH is secreted in a pulsatile manner by the anterior pituitary gland, with levels peaking during sleep. It is metabolized primarily in the liver and kidneys, and its clearance can be affected by factors such as age, body composition, and the presence of certain diseases.

Pregnancy

The effects of growth hormone therapy during pregnancy are not well established. It is generally recommended to avoid use unless absolutely necessary due to potential risks to the fetus.

Breast-feeding

Growth hormone is not expected to be excreted in breast milk, but caution is advised when considering treatment in breastfeeding individuals.

Storage

Growth hormone should be stored in a refrigerator at 2-8 degrees Celsius. Do not freeze. Protect from light.

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: recombinant

Recombinant drugs are biologically engineered medications produced using recombinant DNA technology. These drugs are designed to replace or supplement proteins or hormones that are deficient or absent in patients. They are crucial in the treatment of various conditions, including genetic disorders, certain cancers, and autoimmune diseases. Common examples include recombinant insulin for diabetes management and erythropoietin for anemia associated with chronic kidney disease.

Indications

  • Diabetes mellitus
  • Chronic kidney disease-related anemia
  • Hemophilia
  • Cancer (as targeted therapy)
  • Autoimmune diseases (e.g., rheumatoid arthritis)

Dosage

Children: Refer to specific product guidelines for dosing information.

Adults: Refer to specific product guidelines for dosing information.

Mechanism of action

Recombinant drugs function by mimicking the action of naturally occurring proteins in the body. For instance, recombinant insulin binds to insulin receptors on target tissues, facilitating glucose uptake and metabolism. Erythropoietin stimulates erythropoiesis by binding to erythropoietin receptors in the bone marrow, promoting the production of red blood cells.

Pharmacodynamics

The pharmacodynamics of recombinant drugs vary depending on the specific protein or hormone being replaced or supplemented. Generally, they exert their effects at the cellular level by interacting with specific receptors, leading to a cascade of biological responses. The therapeutic effects are usually dose-dependent and can vary based on the patient's biological response and the presence of antibodies against the recombinant product.

Pharmacokinetics

Pharmacokinetics of recombinant drugs include absorption, distribution, metabolism, and excretion (ADME) characteristics that can differ significantly based on the specific drug. Many recombinant proteins have a short half-life and require parenteral administration. They are typically distributed throughout the body via the bloodstream, metabolized by the liver and other tissues, and excreted primarily through the kidneys. The pharmacokinetics may be influenced by the patient's age, weight, and overall health.

Pregnancy

Recombinant proteins should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution is advised when administering recombinant proteins during breastfeeding, as the effects on the infant are not well established.

Storage

Store in a refrigerator at 2-8 degrees Celsius. Do not freeze, and protect from light.

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.