Plasmasol

Description :
PLASMASOL is a sterile solution containing 6% Hydroxyethyl Starch (200/0.5) in isotonic Sodium Chloride solution. It is a clear, pale yellow solution.

Composition :
Each 100 ml contains: Poly (O-2-hydroxyethyl) starch INN 6.0 g, Sodium Chloride BP 0.9 g (Equals 154 mmol/L Na+ and 154 mmol/L Cl-), water for Injections BP q.s to 100 ml, Osmolarity (Theoretical) 308 mOsm/L, pH 3.5-6.0;

Indications :
PLASMASOL infusion is indicated in the treatment of hypovolaemia when plasma volume expansion is desired as an adjunct in the management of shock due to haemorrhage, surgery, sepsis, burns or other trauma. It is not a substitute for red blood cells or coagulation factors in plasma. The adjunctive use of PLASMASOL infusion in leukapheresis has also been shown to be safe and efficacious in improving the harvesting and increasing the yield of granulocytes by centrifugal means.

Dosage and administration :
PLASMASOL must be administered intravenously. Total dosage, duration and rate of infusion will depend upon the amount of blood lost and/or the haemodynamic status and general clinical condition of the patient. Dosage will need to be adjusted as necessary by monitoring the usual circulatory parameters e.g. blood pressure. The risk of circulatory overload by too rapid rate of infusion or inappropriately large doses must be borne in mind. Due to the risk for occurrence of an anaphylactic reaction, the first 10 ml - 20 ml of PLASMASOL should be infused slowly under careful observation of the patient. Maximum infusion rate: The maximum rate of infusion should be adjusted according to the clinical situation. Patients with acute haemorrhagic shock: Up to 20 ml/kg body weight/hour. In life-threatening situations: 500 ml as a rapid infusion (under pressure). The rates of infusion selected for perioperative indications and for burns and septic shock patients will usually be lowered. Maximum daily dosage : A maximum daily dosage of 2 g/kg body weight/day of Hydroxyethyl starch should not be exceeded. This corresponds to 33 ml/kg body weight/day of 6% Hydroxyethyl starch solution (approximately 2,500 ml/day in a person of 75 kg). Experience of treatment of more than 1-2 days is limited. In cases of longer treatment the daily doses have generally been lower. An increasing risk of undesirable effects with high cumulative doses should be considered. Dosage in Leukapheresis: 250 to 700 ml of PLASMASOL infusion to which citrate anticoagulant has been added is typically administered by aseptic addition to the input line of the centrifugation apparatus at a ratio of 1:8 to 1:13 to venous whole blood. The PLASMASOL infusion and citrate should be thoroughly mixed to assure effective anticoagulation of blood as it flows through the leukapheresis machine.

Use in children:
The safety and efficacy of PLASMASOL infusion in children has not been established. Administration to children should only be managed after careful benefit-risk assessment.

Use in pregnancy :
Animal reproduction studies have not been conducted with PLASMASOL infusion and it is also not known whether it can cause fetal harm or affect reproductive capacity when administered during pregnancy. PLASMASOL 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 PLASMASOL infusion is administered to a nursing woman. Contraindications: Known hypersensitivity to Hydroxyethyl starch, hypervolaemia, hyper-hydration (e.g. water intoxication), hyperchloraemia (or hypernatraemia), congestive cardiac failure, pulmonary oedema, renal failure with oliguria and anuria not related to hypervolaemia, cerebral haemorrhage, severe blood coagulation disorders & severe hepatic impairment.

Adverse effects :
The following adverse effects have been reported: vomiting, fever, chills, pruritus, submaxillary and parotid glandular enlargement, mild influenza-like symptoms, headaches, muscle pains, peripheral edema of the lower extremities, anaphylactoid reactions (periorbital edema, urticaria, wheezing), bleeding due to haemodilution, circulatory overload and pulmonary edema.

Interactions : 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.

Caution : Dextrosal is available in 500ml & 1000ml PVC (medical grade) bag.

Storage condition : Store in a dry and cool place protected against intensive light, at a temperature not exceeding 25 °C. Keep out of reach of children.

Special precautions for storage : Do not freeze.

Pack size: PLASMASOL is available in 500 ml glass bottle.