Description:

Haemaccel 3.5% Colloidal Infusion 500ml is a plasma volume expander (colloid solution) used to restore and maintain circulating blood volume in cases of hypovolemia (low blood volume). It is indicated for short-term management of acute hypovolemia due to surgery, trauma, burns, hemorrhage, shock (e.g., septic, hemorrhagic, or burn shock), and conditions requiring rapid volume replacement when blood or blood products are not immediately available or suitable. It is not a blood substitute or oxygen carrier but expands plasma volume by attracting and retaining fluid in the vascular space. In Ghana (Accra), it is a prescription IV fluid used in hospitals, emergency departments, and surgical wards for fluid resuscitation and volume support.

Prescription:

Prescription-only (requires a doctor’s prescription in Ghana; administered intravenously only by healthcare professionals in hospitals/clinics—never self-administer; not OTC due to IV route, need for monitoring, and risk of fluid overload or allergic reactions).

Therapeutic Category:

Plasma Volume Expander / Colloid Intravenous Solution (Modified gelatine-based colloid for hypovolemia.

Active Ingredients/Composition:

• Active ingredient: Succinylated gelatine (modified fluid gelatine) – 3.5% w/v (35 g per 1000 ml; 17.5 g per 500 ml bag).
  • Average molecular weight ~30,000 Da; provides oncotic pressure similar to plasma. Other ingredients: Electrolytes for isotonicity:
  • Sodium chloride – approx. 0.9% (isotonic with plasma).
  • Sodium hydroxide and/or hydrochloric acid (pH adjustment to 7.0–7.5).
  • Water for injection. The solution is clear, colourless to pale yellow, sterile, and pyrogen-free.

Vitamins: None.

Minerals: Yes – Sodium (from sodium chloride) – approx. 154 mmol/L (isotonic electrolyte profile); trace calcium in some formulations, but primarily sodium-based.

Variant:

• Haemaccel 3.5% Colloidal Infusion 500ml (standard bag size). Related variants: Haemaccel 500ml or 1000ml bags, or other gelatine-based colloids (e.g., Gelofusine, which is similar succinylated gelatine). The 500ml bag is the most common size for infusion.

Consume Type:

Intravenous – Infusion (sterile solution given via IV drip or slow push; administered only by healthcare professionals).

Directions/Usage: Administered only in clinical settings by trained personnel.

• Adults: Dosage individualized based on blood loss, hemodynamic status, and response (typically 500–1500 ml or more as initial resuscitation, infused rapidly or as needed to maintain blood pressure/volume).
• Children: Weight-based (10–20 ml/kg or as per protocol).
• Infusion rate: Rapid for hypovolemic shock (e.g., 500 ml over 5–10 minutes initially), then titrated.
• Maximum daily dose: Usually up to 20–30 ml/kg (or higher in severe cases, guided by monitoring).
• Monitor vital signs, central venous pressure, haematocrit, and urine output during infusion.
• Use immediately after opening; do not use if cloudy or particles present.

Common Side Effects: Common (mild):

• Transient increase in blood volume (may cause fluid overload if over-infused).
• Mild allergic reactions (flushing, urticaria, fever).
• Hypotension or tachycardia (if infused too rapidly). Rare/serious (seek immediate help): Anaphylactoid/anaphylactic reactions (rash, bronchospasm, hypotension, shock – rare but can be severe), fluid overload (pulmonary edema, heart failure), or coagulopathy (dilutional effect).

Package Type:

Plastic infusion bag of 500ml (flexible, transparent or semi-transparent bag with ports for administration set; labelled with product name, concentration, volume, batch, expiry, and instructions).

Storage Advice: Store at room temperature (below 25–30°C) in original packaging, protected from light. Do not freeze. Do not use after expiry or if bag is damaged/leaking. Once opened, use immediately.

Safety Advice:

• Administered only under medical supervision (risk of anaphylactoid reactions – monitor closely during first 500 ml and have resuscitation equipment ready).
• Contraindicated in hypersensitivity to gelatine, severe hypervolemia, severe heart failure, or conditions where volume expansion is contraindicated (e.g., pulmonary edema).
• Caution in renal impairment (may accumulate), liver disease, bleeding disorders, or elderly patients.
• Monitor for fluid overload (e.g., jugular venous pressure, lung sounds), electrolytes, and haematocrit.
• Not a blood substitute – does not carry oxygen or clotting factors; use blood products if significant haemorrhage.
• If rash, breathing difficulty, severe hypotension, or swelling occurs during infusion, stop immediately and treat (antihistamines, steroids, epinephrine if anaphylaxis).
• Keep out of reach of children.

Product Substitutes: Similar gelatine-based colloid plasma expanders in Ghana include:

• Gelofusine 4% (succinylated gelatine 4% – similar to Haemaccel).
• Generic succinylated gelatine 3.5% or 4% infusion (various importers). Alternatives: Hydroxyethyl starch (HES) solutions (e.g., Voluven – though restricted in some countries), albumin 5%/20%, or crystalloids (e.g., normal saline, Ringer’s lactate) for volume expansion. Consult doctor/pharmacist in Accra (e.g., hospital pharmacy) for alternatives.

Manufacturer/Marketer:

Varies by exact batch (Hemaccel originally by Hoechst/Aventis, now generics often by Indian manufacturers like Samarth Life Sciences, Fresenius Kabi, or local Ghanaian producers). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked in hospital pharmacies).

Country of Origin:

India or Germany (original Haemaccel from Germany; most generic succinylated gelatine 3.5% infusions imported from India to Ghana; BP-compliant generics common in African markets).