Plasmasol IV Infusion 6%+0.9%

Uses

Therapy and prophylaxis of volume deficiency (hypovolaemia) and shock (volume replacement therapy) in connection with surgery (haemorrhagic shock). Injuries (traumatic shock), infections (septic shock), bums (bum shock). Savings of donor blood during surgery e,g acute normovolaemic haemodilution. Therapeutic dilution of blood (haemodilution)

Plasmasol IV Infusion 6%+0.9% is also used to associated treatment for these conditions: Hypovolaemia, Granulocyte yield increaseAllergic Rhinitis (AR), Corneal Edema, Dehydration, Dehydration Hypertonic, Fluid Loss, Hemodilution, Hypertension Intracranial, Hypokalemia, Hyponatremia, Hypotonic Dehydration, Hypovolaemia, Increased Intra Ocular Pressure (IOP), Inflammation of the Nasal Mucosa, Isotonic Dehydration, Metabolic Acidosis, Nasal Congestion, Nasal irritation, Oliguria caused by Acute Renal Failure (ARF), Potassium deficiency, Sinusitis, Skin Irritation, Sodium Depletion, Dryness of the nose, Hypochloremic state, Mild Metabolic acidosis, Mild, moderate Metabolic Acidosis, Electrolyte replacement, Fluid replacement therapy, Heart-Lung-Machine, Oral rehydration therapy, Parenteral Nutrition, Parenteral rehydration therapy, Peritoneal dialysis therapy, Plasma Volume Replacement, Regional Citrate Anticoagulation (RCA), Renal Replacement Therapies, Urine alkalinization therapy, Wound irrigation therapy, Ear wax removal, Fluid and electrolyte maintenance therapy, Increased renal excretion of toxic substances, Maintenance source of fluid and electrolytes, Parenteral drug administration, Reducing brain mass

How Plasmasol IV Infusion 6%+0.9% works

Hydroxyethyl starch (HES) is one of the most frequently used plasma substitutes. Recent studies have indicated that HES may reduce capillary leakage.

Sodium and chloride — major electrolytes of the fluid compartment outside of cells (i.e., extracellular) — work together to control extracellular volume and blood pressure. Disturbances in sodium concentrations in the extracellular fluid are associated with disorders of water balance.

Dosage

Plasmasol IV Infusion 6%+0.9% dosage

Adult: Dose Up to 50 mL of (hydroxyethyl starch in sodium chloride injection) per kg of body weight per day (equivalent to 3 g hydroxyethyl starch and 7.7 mEq sodium per kg of body weight). This dose is equivalent to 3500 mL of (hydroxyethyl starch in sodium chloride injection) for a 70 kg patient.

Pediatric Dose: Dosage in children should be adapted to the individual patient colloid needs, taking into account the disease state, as well as the hemodynamic and hydration status

Newborns and infants: 2-12 years: Mean dose of 36 mL/kg IV

Give initial 10-20 mL by slow IV infusion and monitor for anaphylactoid reaction

Side Effects

From the accumulated clinical development experience, expected adverse reactions after administration of (hydroxyethyl starch in sodium chloride injection) occurring in less than 10% of patients are as follows: Immune system disorders (Rare, > 0.01% to < 0.1 %): anaphylactoid reactions (hypersensitivity, mild influenzalike symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema). In the event of an intolerance reaction, the infusion should be discontinued immediately and the appropriate emergency medical treatment initiated. Skin and subcutaneous tissue disorders (Common, > 1 to < 10%, dose dependent): Prolonged administration of high dosages of hydroxyethyl starch may cause pruritus (itching) which is an undesirable effect observed with all hydroxyethyl starches.

Toxicity

LDF50 (IV, rabbit): 8460 mg/Kg.

The rare inadvertent intravascular administration or rapid intravascular absorption of hypertonic sodium chloride can cause a shift of tissue fluids into the vascular bed, resulting in hypervolemia, electrolyte disturbances, circulatory failure, pulmonary embolism, or augmented hypertension.

Precaution

Anaphylactoid reactions (mild influenza-like symptoms, bradycardia, tachycardia, bronchospasm, non-cardiac pulmonary edema) have been reported with solutions containing hydroxyethyl starch. If a hypersensitivity reaction occurs, administration of the drug should be discontinued immediately and the appropriate treatment and supportive measures should be undertaken until symptoms have resolved. Fluid status and rate of infusion should be assessed regularly during treatment, especially in patients with cardiac insufficiency or severe kidney dysfunction. In cases of severe dehydration, a crystalloid solution should be given first. Generally, sufficient fluid should be administered in order to avoid dehydration. Caution should be observed before administering (hydroxyethyl starch in sodium chloride injection) to patients with severe liver disease or severe bleeding disorders (e.g., severe cases of von Willebrand's disease).

Interaction

The safety and compatibility of other additives, other than citrate anticoagulant, have not been established. Incompatibilities: In the absence of incompatibility studies this medicinal product must not be mixed with other medicinal products.

Volume of Distribution

5.9 L.

The volume of distribution is 0.64 L/kg.

Elimination Route

Peak concentration (C(max), 4.34 mg/mL)

Absorption of sodium in the small intestine plays an important role in the absorption of chloride, amino acids, glucose, and water. Chloride, in the form of hydrochloric acid (HCl), is also an important component of gastric juice, which aids the digestion and absorption of many nutrients.

Half Life

Terminal half-life is 16.1 h. Elimination half-life is 12 h.

17 minutes

Clearance

31.4 mL/min

Elimination Route

Approximately 62 % of HES was excreted as hydroxyethyl starch molecules in urine within 72 hours.

Substantially excreted by the kidneys.

Pregnancy & Breastfeeding use

Use in pregnancy: Animal reproduction studies have not been conducted with Hydroxyethyl Starch in Sodium Chloride infusion and it is also not known whether it can cause fetal harm or affect reproductive capacity when administered during pregnancy. This infusion should be given during pregnancy only if clearly needed

Use during lactation: It is not known whether Hydroxyethyl starch is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hydroxyethyl Starch in Sodium Chloride infusion is administered to a nursing woman.

Contraindication

Known hypersensitivity to hydroxyethyl starch fluid overload (hyperhydration) and especially in cases of pulmonary edema and congestive heart failure renal failure with oliguria or anuria not related to hypovolemia patients receiving dialysis treatment severe hypernatremia or severe hyperchloremia intracranial bleeding.

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