Description:

Human Albumin Solution IP 20% (Flexbumin 100ml by Takeda) is a sterile, non-pyrogenic, 20% human albumin solution prepared from pooled human plasma. It is used as a plasma volume expander and colloid to restore and maintain circulating blood volume in cases of hypovolemia (low blood volume) due to burns, trauma, shock, surgery, or acute blood loss. It is also indicated for hypoalbuminemia (low serum albumin) in conditions such as liver cirrhosis, nephrotic syndrome, and critical care settings, as well as for therapeutic plasmapheresis and cardiopulmonary bypass priming. The 20% concentration provides higher oncotic pressure than 5% albumin, allowing effective volume expansion with smaller volumes. In Ghana (Accra), it is a prescription IV product used in hospitals, ICUs, and emergency departments for fluid resuscitation and albumin replacement.

Prescription: Prescription-only (requires a doctor’s prescription in Ghana; administered only by healthcare professionals via intravenous infusion in hospitals/clinics; not OTC due to IV route, risk of fluid overload, and need for monitoring).

Therapeutic Category:

Plasma Volume Expander / Human Albumin Solution (Colloid for hypovolemia and hypoalbuminemia).

Active Ingredients/Composition:

• Active ingredient: Human albumin – 20% w/v (20 g per 100 ml).
  • Derived from human plasma (screened and processed to remove viruses).
  • Contains approximately 130–160 mEq/L sodium and is stabilized with sodium caprylate and N-acetyltryptophan. Other ingredients: Sodium chloride (for isotonicity), sodium caprylate and N-acetyltryptophan (stabilizers), water for injection. The solution is clear, slightly viscous, yellow to amber, sterile, and ready-to-use.

Vitamins: None.

Minerals: None (contains sodium from sodium chloride and stabilizers, but not a therapeutic mineral supplement).

Variant:

• Flexbumin 20% 100ml (standard 20% concentration in 100ml flexible container). Related variants: Flexbumin 20% 50ml or 250ml bags, Flexbumin 5% (lower concentration for larger volume expansion), or human albumin 20% in glass bottles (older format). The 100ml 20% bag is the most common size for adult use.

Consume Type:

Injectable – Intravenous (IV) infusion (ready-to-use solution; administered only by healthcare professionals; slow infusion via infusion set).

Directions/Usage: Administered only in hospital/clinic with monitoring (vital signs, fluid balance, central venous pressure if needed).

• Hypovolemia/shock: Dose individualized (typically 250–500 ml 20% albumin over 30–60 minutes, repeated as needed based on hemodynamic response).
• Hypoalbuminemia: 0.5–1 g/kg IV (e.g., 100–200 ml 20% albumin), infused slowly over 1–4 hours.
• Rate: Usually 1–2 ml/kg/hour (do not exceed 2–4 ml/minute in adults to avoid fluid overload).
• Always use dedicated IV line; do not mix with other medications unless compatible.
• Monitor for signs of fluid overload (pulmonary edema, hypertension) and allergic reactions.
• Duration: Single or repeated doses based on clinical need.

Common Side Effects: Common:

• Flushing, warmth, or chills during infusion.
• Mild hypotension or tachycardia (if infused too rapidly).
• Nausea, vomiting.
• Urticaria (hives) or mild allergic reactions. Rare/serious (seek immediate help): Anaphylactic shock, severe hypotension, pulmonary edema (fluid overload), febrile non-hemolytic transfusion reactions, or transmission of infection (very rare with modern plasma processing).

Package Type:

Flexible plastic container (bag) of 100 ml (single-dose, non-reclosable; labelled with product name, concentration, volume, batch, expiry, and administration instructions).

Storage Advice: Store at room temperature (below 25–30°C) in original packaging, protected from light. Do not freeze. Do not use if bag is damaged, leaking, or solution is cloudy/turbid. Use immediately after opening; discard unused portion.

Safety Advice:

• Administered only under medical supervision (risk of fluid overload – monitor vital signs, lung sounds, and central venous pressure).
• Contraindicated in severe anaemia, heart failure with pulmonary edema, or hypersensitivity to albumin.
• Caution in cardiac failure, severe anaemia, or patients with normal or high albumin levels (risk of hypervolemia).
• Infuse slowly (especially in cardiac/renal patients) to prevent circulatory overload.
• Monitor for allergic reactions (stop infusion if rash, dyspnoea, or hypotension occurs; have epinephrine/antihistamines ready).
• Not a blood substitute or oxygen carrier – does not replace red cells or clotting factors.
• Keep out of reach of children.

Product Substitutes: Similar human albumin 20% solutions in Ghana include:

• Generic human albumin 20% 100ml (various importers).
• Albuminar or Albuked (other brands if stocked).
• Human Albumin 20% BP (local or other generics).
• Lower concentration: Human Albumin 5% (for larger volume needs). Consult hospital pharmacy or doctor in Accra for availability.

Manufacturer/Marketer:

Takeda Pharmaceutical Company Limited (original brand holder for Flexbumin human albumin solution). Marketed/distributed in Ghana by Takeda regional affiliates or local importers/pharmacies (widely stocked in hospital pharmacies).

Country of Origin:

United States or Austria (Flexbumin is often manufactured in the USA or Europe by Takeda/Baxter facilities; imported to Ghana and available in local hospitals/pharmacies).