Biomina

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Biomina

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Biomina

Property Description
Active ingredient Albumin (human)
Form Sterile aqueous solution for injection
Pharmacological class Parenteral colloid, Plasma expander
Common use Restoration of circulating blood volume
Origin Human-derived (purified from plasma)

Biomina is a pharmaceutical preparation of Albumin (human), a biological drug essential for managing fluid distribution and volume within the circulatory system. This medicine, which is often commercially positioned for use in critical care settings, is classified as a parenteral colloid and a plasma expander, designed for immediate intravenous use. The active ingredient, Albumin, is a globular protein purified from the plasma of healthy human donors, making this product human-derived and a blood product.


What Type of Drug is Albumin (Human)?

Albumin (human) is primarily categorized as a plasma expander because its main function is to increase the volume of fluid circulating in the bloodstream. As a parenteral colloid, it differs fundamentally from simple crystalloid solutions, which diffuse rapidly from the blood vessels. This classification reflects its action: exerting colloid osmotic pressure (oncotic pressure) to retain and draw fluid into the vascular compartment, thereby stabilizing circulating blood volume. This crucial biological function is clinically recognized for immediate and effective plasma volume support in acute conditions. Albumin is the most important human plasma protein, vital for maintaining fluid distribution between the blood vessels and the tissues.


What is the General Purpose of This Plasma Expander?

This plasma expander's general purpose is to rapidly and effectively restore fluid balance and protein levels when a patient has a severe shortage of blood volume or Albumin itself. By drawing water back into the blood vessels, it helps reverse hypovolemia (low blood volume) and corrects low oncotic pressure caused by hypoalbuminemia (low protein levels). A typical use scenario involves stabilizing a patient experiencing significant fluid loss or plasma depletion due to conditions like severe burns or shock. Human Albumin is essential for maintaining proper blood volume in cases where blood loss is significant or when there's severe protein depletion. This highlights the drug’s verified role in supporting critical circulatory function.

Regulatory References

  1. NIH: Albumin Colloid - StatPearls

What side effects are possible with Biomina?

Possible Side Effects and Safety Information for Biomina (Albumin Human)

Official regulatory documents classify adverse reactions to Albumin (human) preparations as generally rare. The documented safety profile is intrinsically linked to the function of this medication as a plasma expander, which primarily affects the circulatory system.


Adverse Reaction Classification

System-Organ Class Common Adverse Reactions (Rarely Reported) Serious Adverse Reactions (Documented)
Immune System Urticaria, Fever, Flushing Anaphylaxis, Severe Hypersensitivity Reactions
Cardiovascular Hypotension, Headache Circulatory Failure, Pulmonary Edema, Cardiac Failure
General Chills, Nausea, Vomiting N/A

Regulatory Safety Constraints

The primary safety constraint noted in regulatory labeling concerns the risk of hypervolemia (excess fluid volume) and subsequent cardiovascular overload. This risk necessitates continuous monitoring for signs such as increased blood pressure, breathing difficulty (dyspnea), or jugular vein distension during administration.

Safety statements caution or contraindicate the use of this medicine in patients with pre-existing conditions sensitive to volume expansion, including decompensated cardiac insufficiency, severe hypertension, pre-existing pulmonary edema, and esophageal varices. Adverse reactions that are related to the infusion rate, such as flushing or fever, are documented to typically disappear rapidly upon slowing or stopping the infusion. Furthermore, as a derivative of human plasma, the official labels acknowledge an extremely remote risk for the transmission of infectious agents, despite robust safety processing.

Overdose and Emergency Response

Overdose and when to seek help

Overdose of Biomina (Albumin human) primarily results in circulatory hypervolemia, a state of excessive fluid volume in the bloodstream, consistent with the drug's action as a plasma expander. This condition occurs if the volume or rate of infusion is not adequately adjusted to the patient’s status.

Documented Overdose Manifestations

Clinical Signs and Symptoms Severe Outcomes and High-Risk Conditions
Cardiovascular overload (hypervolemia) Progression to Pulmonary edema or Circulatory failure
Symptoms include headache and dyspnea Acute severe reactions, such as Anaphylactic shock
Physical signs like jugular venous distention Patients with decompensated cardiac insufficiency or hypertension are at increased risk of severe overload

Official Regulatory Actions and When to Seek Help

Regulatory authorities mandate specific actions upon suspecting an overdose. The infusion must be stopped immediately at the first clinical signs of cardiovascular overload. Immediate medical help is required when manifestations such as dyspnea, significant increased blood pressure, or signs of raised venous pressure are observed, or if an acute reaction develops.

Following the cessation of infusion, management involves patient reevaluation and continuous monitoring of hemodynamic performance. Supportive measures, such as the use of a diuretic, may be employed to manage the acute volume overload.

Therapeutic Uses of Biomina

Biomina (Albumin Human) is utilized in medical situations involving symptoms related to systemic imbalance.

Biomina (Albumin Human) is commonly used to help manage severe hypovolemia (low blood volume), hypoalbuminemia (low serum protein), and to support central volume depletion following large-volume paracentesis. This therapy is applied in clinical settings that involve acute or unstable symptom patterns to address severe fluid deficits and the symptoms of circulatory failure, such as dangerously low blood pressure.

This medication supports symptomatic relief by assisting in the reduction of fluid accumulation in tissues and body cavities. This action is relevant for easing symptoms of systemic edema and ascites, and may be part of symptomatic management where additional supportive care is needed.

“This therapy assists with maintaining functional stability by helping to manage the consequences of severe protein loss and sudden fluid deficits.”

It helps manage volume and fluid balance when patients are subject to acute systemic stress. This supportive care is considered relevant in high-acuity scenarios like septic shock, and contributes to easing the overall symptom load during challenging symptomatic phases.


Quick Fact: Relief for Acute Volume Deficits Biomina is considered relevant for managing acute volume deficits and low blood pressure when symptoms are driven by sudden, severe loss of plasma or blood volume.

Regulatory References

  1. DailyMed (FDA) Label for Albumin (Human)

Eligibility and Restrictions for Use

The official regulatory profile for Biomina (Albumin Human) strictly defines which populations are eligible for use and which are prohibited or restricted.

Eligibility Scope

Populations for whom use is contraindicated

  • Patients with documented hypersensitivity or severe allergic reaction to human albumin or any of the excipients.
  • Patients with severe anemia or cardiac failure that presents with normal or increased blood volume, due to the high risk of circulatory overload.

Age-related eligibility rules

  • Use is generally established for both adults and pediatric patients, including neonates, for labeled indications. Specific clinical data for the older adult population is limited, but no official age-based adjustment is required.

Condition-specific eligibility rules

  • The medicine must be used with caution in conditions where volume expansion could represent a risk, including decompensated cardiac insufficiency, uncontrolled hypertension, pulmonary edema, hemorrhagic diathesis, and severe renal or post-renal anuria.

Pregnancy and lactation eligibility status

  • Use during pregnancy is advised only if clearly needed. Official data regarding the presence of the medicine in breast milk during lactation is limited.

What should I know about interactions with other medicines?

The official regulatory profile for Biomina (Albumin human) focuses on physical compatibility and procedural constraints, as dedicated drug interaction studies involving metabolic enzymes or transporters are not documented in government labeling.

Interactions with other medicines and products

Category Interaction Restriction
Contraindicated Combinations (Mixing) Prohibited Co-administration in the Same Container: The product must not be mixed with other medicinal products in the same infusion container or line. This restriction specifically includes protein hydrolysates and amino acid solutions, as regulatory documents note the potential for physical precipitation and product instability.
Diluent Restriction Sterile Water for Injection Prohibition: Biomina must not be diluted with sterile water for injection. This combination is prohibited because the physical mixture may cause hemolysis in the recipient, an adverse outcome documented in regulatory information.
Metabolic/Pharmacologic Interactions None Documented: Official labeling confirms that formal drug-drug interaction studies—such as those evaluating effects on cytochrome P450 (CYP) enzymes or drug transporters—have not been conducted. Traditional pharmacokinetic or pharmacodynamic interactions are therefore not formally listed in the regulatory profile.

Connection to the overall interaction profile: The interaction profile established by regulatory authorities is entirely defined by mandatory procedural constraints necessary for the stable handling of this biological protein solution. These rules strictly prohibit combining Biomina with incompatible fluids in the intravenous line and mandate use only with designated diluents to prevent physical instability or adverse outcomes like hemolysis. The profile contains no information on interactions with food, alcohol, or herbal products.

Mechanism of Action

Biomina's mechanism involves binding as an allosteric modulator to the A2 B receptor subtype, which is predominantly expressed on the surface of osteoclast progenitor cells. This interaction inhibits NF-kappa B signaling and simultaneously activates JAK/STAT pathway signaling. The net effect is the suppression of RANKL-mediated osteoclast differentiation and an upregulation of OPG gene expression by adjacent osteoblasts. This action modulates the balance between osteoblast-mediated bone formation and osteoclast-mediated bone resorption, resulting in a net positive shift in bone mineral density markers. Furthermore, Biomina downregulates the transcription of specific pro-inflammatory cytokines, including TNF-alpha and IL-6, by inhibiting the phosphorylation cascade downstream of the TLR-4 receptor.

Dosage and Administration Information

The administration of Biomina (Albumin human) is performed according to established clinical protocols, reflecting its use as an intravenous parenteral colloid in supervised medical settings. The medicine is supplied as a sterile aqueous solution in specific concentrations, such as 5%, 20%, and 25%.


Official Usage Patterns

Administration is intravenous (IV) infusion only. Dosing is highly variable and individualized, determined by the patient's circulating volume status and observed hemodynamic response, not by a fixed schedule. The maximum permitted daily dose should generally not exceed 2 grams per kilogram (g/kg) of body weight.

For adults experiencing hypovolemia, a typical initial dose is 25 grams, which may be repeated after a period of 15 to 30 minutes if stabilization is not reached. For conditions like acute nephrosis, the product may be administered once daily as part of a course lasting 7 to 10 days.

Preparation and Procedural Rules

The solution is administered directly but may be diluted, if necessary, using 0.9% sodium chloride or 5% dextrose in water. A specific constraint requires that the solution must not be diluted with Sterile Water for Injection due to the potential for hemolysis. The infusion rate is adjusted to the patient's condition, with the 25% solution generally infused at a controlled rate of 1 to 2 mL per minute when shock is absent. Administration must commence promptly and be completed within 4 hours of puncturing the vial stopper.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Biomina (Albumin Human)


Evidence for Use in Acute Volume Management and Shock

The evidence base for Biomina (Albumin human) includes Randomized Controlled Trials (RCTs) and comprehensive meta-analyses that compared its administration with other fluids in research settings where the circulatory system requires support due to acute, severe conditions.

Study Focus: Severe Blood Volume Loss (Hypovolemia)

Research has primarily focused on the use of Albumin in patients experiencing a severe, sudden drop in circulating blood volume due to trauma, surgery, or severe fluid loss. Studies monitored immediate outcomes related to physiological strain, such as the measurement of blood volume changes and the monitoring of low blood pressure measurements. However, the available data highlights that follow-up durations were limited, typically focused on the acute phase, and comparative evidence is lacking for some specific patient situations.

Study Focus: Support in Septic Shock

Biomina was evaluated in large-scale, multicenter RCTs involving critically ill adults with septic shock. These research protocols examined outcomes related to overall survival rates (usually tracked for 28 or 90 days), the resolution of circulatory failure, and whether patients required continued support from medications like vasopressors. Findings were mixed regarding survival patterns when compared to alternative fluids. Research is ongoing to determine the specific timing and dose administration protocols that were associated with the best outcomes in studies for various acute conditions.


Evidence for Managing Protein and Fluid Imbalance

Research also explores the use of Biomina in managing serious imbalances related to the body's proteins and fluids, including correcting very low protein levels and managing fluid accumulation associated with some medical procedures.

Study Focus: Correcting Low Serum Protein

Studies have explored the role of Albumin in correcting hypoalbuminemia (very low serum protein levels), often in the context of conditions like liver disease. Research primarily examined changes in laboratory values, such as the rise in serum albumin concentration. While the laboratory change data show patterns related to protein level change, findings describing patterns observed in associated clinical symptoms were mixed across different types of underlying conditions, suggesting that evidence quality varies across studies for these outcomes.

Study Focus: Volume Support During Procedures (Paracentesis)

The evidence base includes focused Randomized Trials where the post-procedural administration of Albumin was studied in patients undergoing large-volume fluid removal (paracentesis) due to cirrhosis. These trials primarily monitored outcomes describing episodic or acute changes, focusing on monitoring the incidence of post-procedure complications, specifically Post-Paracentesis Circulatory Dysfunction (PPCD). Findings indicate patterns indicating differences in the incidence of complications in patients who received Albumin compared to those who received no volume support.


What is Still Uncertain About Biomina Research

The evidence quality varies across studies when comparing Albumin to less-expensive fluid alternatives, making broad conclusions difficult. Additionally, many results apply only to the populations studied (often critically ill), and research focusing on long-term outcomes related to functional recovery is not fully established.

Key Studies & References

  1. Human Albumin (Regulatory/Label Information)
  2. Albumin in the management of cirrhosis and its complications: beyond the evidence. A review.
  3. The role of albumin in the management of decompensated cirrhosis: A critical review
  4. NICE Guideline: Sepsis: recognition, assessment and early management (Evidence Base for Fluid Management)

Frequently Asked Questions (FAQ)

Common questions about Biomina (FAQ)


Q: What is Biomina used for besides its main purpose?

According to official documents, in addition to its main use, Biomina is indicated for managing conditions like hypovolemia (low blood volume) and hypoalbuminemia (low protein levels in the blood). The label describes its use as an adjunct in specific conditions such as acute nephrosis and severe ovarian hyperstimulation syndrome (OHSS).

Q: Can Biomina cause long-term side effects?

Regulatory documents primarily detail the safety profile and adverse reactions that may occur during or shortly after administration, such as hypervolemia (fluid overload) or allergic reactions. Specific information regarding effects that manifest only many years later is not consistently detailed in initial labeling.

Q: How quickly do the side effects of Biomina start?

Official product information indicates that adverse reactions, when they occur, are usually related to the infusion itself. These reactions are described as normally disappearing rapidly when the infusion rate is slowed down or the administration is temporarily stopped.

Q: Do the side effects of Biomina go away?

Regulatory guidance notes that adverse reactions that occur during infusion are typically expected to disappear rapidly when the infusion rate is slowed or stopped.

Q: Is it common to feel [Vague Symptom] when starting Biomina?

The list of adverse reactions described in the official product information includes commonly reported effects such as flushing, headache, chills, fever, and nausea. Patients who experience any symptoms are typically advised to report them to the administering healthcare professional.

Q: Is the list of side effects in the leaflet complete?

Official regulatory documents generally note that the published list of side effects may not be exhaustive, and that other side effects not listed may occur in some patients.

Q: Does Biomina interact with common over-the-counter pain relievers?

Official information states that no specific interactions of human albumin with other medicinal products are known. However, albumin is a natural protein that binds to various substances, including some drugs, within the body.

Q: Can I take Biomina if I'm also taking vitamins or supplements?

While there are no specific interactions listed for vitamins or supplements, official documents recommend that all co-administered substances, including herbal remedies or nutritional supplements, be discussed with the patient's healthcare provider.

Q: Are there any foods or drinks I need to avoid while on Biomina?

Official documentation does not typically list specific foods or drinks to avoid. However, regulatory information suggests that a patient's diet be discussed with their healthcare professional.

Q: Does alcohol interact with Biomina?

Official documentation suggests that the use of alcohol be discussed with a patient's healthcare professional before or during treatment.

Q: How long does it take for Biomina to start working?

When administered to adequately hydrated patients, the primary volume-expanding effect of the 25% solution is described as increasing circulating plasma volume by approximately 3.5 times the infused volume within 15 minutes.

Q: How long do the effects of Biomina last after taking it?

The biological half-life of human albumin is approximately 13 to 19 days. The duration of the immediate volume expansion effects can persist for many hours, which is dependent on the patient’s initial blood volume status.

Q: Is Biomina safe for people over 65?

Regulatory information states that no specific information is available on the relationship of age to the effects of albumin in geriatric patients. The determination of use in this population is a clinical judgment.

Q: Can children or teenagers take Biomina?

Official labeling indicates that the product is intended for administration to pediatric patients only when clinically needed. Specific dosing guidelines for certain pediatric uses are included in the labeling for healthcare professionals.

Q: What are the official warnings about using Biomina during pregnancy?

Albumin is categorized as Pregnancy Category C by the FDA. The label indicates that administration during pregnancy is considered when the potential benefit is determined to outweigh the potential risk.

Q: Is Biomina safe to use while breastfeeding?

Official documents state that there are no adequate studies for determining infant risk when using this medication during breastfeeding. Albumin is a normal protein found in breast milk.

Q: What does 'contraindication' mean for Biomina?

A contraindication is a condition or factor that serves as a reason to withhold a certain medical treatment. For this product, these include a history of hypersensitivity to albumin preparations.

Q: Who should definitely avoid taking Biomina?

The medicine is contraindicated in patients who have known hypersensitivity (severe allergic reaction) to albumin preparations. It is also generally avoided in patients with certain conditions like severe anemia or cardiac failure with normal or increased intravascular volume.

Q: Are there any specific medical conditions that prevent me from taking Biomina?

Official labeling lists specific conditions where caution or avoidance is required. These include conditions where volume expansion could be harmful, such as decompensated heart failure, hypertension, pulmonary edema, severe anemia, and renal anuria.

Q: Does Biomina affect mood or sleep?

The adverse reaction list includes central nervous system (CNS) effects such as headache, dizziness, and confusion. These effects are typically transient and may be related to changes in fluid balance or the rate of infusion.

Q: Can Biomina cause weight changes?

The official label warns against hypervolemia (too much fluid in the blood) and circulatory overload. This fluid imbalance may lead to temporary swelling (edema) in the face, fingers, or lower legs.

Q: Does taking Biomina affect my ability to drive?

Adverse reactions such as dizziness, fainting, or blurred vision are listed in the official documents. These types of effects can impact a person's ability to perform activities requiring mental alertness, such as driving.

Q: Is Biomina a controlled substance?

Official documentation from regulatory bodies, such as the FDA or DEA, does not list warnings or scheduling information related to controlled substance status.

Q: If I have a mild reaction to Biomina, what does the official guidance say?

Official guidance states that if a mild reaction occurs, the symptoms are described as normally disappearing rapidly when the infusion rate is slowed down or the infusion is stopped. Patients are generally advised to report all reactions to the supervising healthcare professional.

Q: What are the signs of a serious allergic reaction to Biomina?

Signs of a serious allergic reaction (anaphylaxis) listed in official documents include rash, itching, hoarseness, trouble breathing or swallowing, or swelling of the hands, face, or mouth. These symptoms are often noted in official documents as requiring immediate clinical evaluation.

Q: How does Biomina affect blood pressure or heart rate?

The official label lists hypertension, hypotension, and tachycardia (increased heart rate) as possible adverse reactions. Official documents indicate that regular monitoring of arterial blood pressure and pulse rate is necessary during administration.

Q: Do I need any special monitoring or lab tests while taking Biomina?

Regulatory documents indicate that the patient's status, including electrolyte levels, coagulation factors, and hemodynamic status, is subject to close monitoring during and after administration.

Q: What are the risks if I have kidney or liver problems and take Biomina?

The official label notes that the medicine requires caution in patients with severe hepatic (liver) or renal (kidney) disease. Official documents indicate that close monitoring is necessary in these situations.

Q: Does Biomina need to be kept in the refrigerator?

Official storage instructions typically indicate storage at +2 C to +25 C (36 F to 77 F). The labeling explicitly states that the product must not be frozen.

Q: What is the typical time frame a person is prescribed Biomina for?

The duration of treatment is highly variable and depends on the patient's condition and individualized clinical need. Administration may range from a single dose repeated after 15 to 30 minutes for acute volume replacement, to a course lasting 7 to 10 days for certain conditions like acute nephrosis.

How should Biomina be stored and disposed of?

How to Store and Dispose of Biomina

The storage and handling of Biomina (Albumin Human) must strictly follow the requirements defined in official regulatory labeling.

Official Storage Requirements

  • Temperature and Light: The medicine must be stored at a temperature below 30 C (86 F) and must be protected from light. It is mandatory not to freeze the solution.
  • Packaging: Biomina should be kept in its original container until use. The solution must be visually inspected before use and must be discarded if it is cloudy or contains visible particles.
  • Child Safety: The product must be kept out of the reach and sight of children.

Disposal Instructions

As a sterile, single-use solution, any unused portion of the product must be discarded immediately after the vial is opened. Final disposal of unused or expired Biomina must be carried out according to local regulations for pharmaceutical waste.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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