PLASMA-LYTE

8). Monitoring of serum sodium is particularly important for hypotonic fluids. ). g. 4. 8). The recommended dosage is: 500 ml to 3 litres / 24 h.

Administration rate:

The infusion rate is usually 40 mL/kg/24h in adults, the elderly and adolescents. When used for intraoperative fluid replacement, normal rate can be higher and is about 15 mL/kg/h. Use in Geriatric Patients When selecting the type of infusion solution and the volume/rate of infusion for a geriatric patient, consider that geriatric patients are generally more likely to have cardiac, renal, hepatic, and other diseases or concomitant drug therapy.

4) in children have not been established by adequate and well controlled trials. Treatment of paediatric patients is described in literature. The dosage varies with weight: • 0-10 kg body weight: up to 100 ml/kg/24h • 10-20 kg body weight: 1000 ml + (50 ml/kg over 10 kg)/24h • > 20 kg body weight: 1500 ml + (20 ml/kg over 20 kg)/24h.

The administration rate varies with weight: • 0-10 kg body weight: 6-8 ml/kg/h • 10-20 kg body weight: 4-6 ml/kg/h • > 20 kg body weight: 2-4 ml/kg/h Method of administration: The administration is performed by intravenous route. The solution should be administered with sterile equipment using an aseptic technique.

The equipment should be primed with the solution in order to prevent air entering the system. This solution can be administered before, during or after a blood transfusion. Due to its iso-osmolality, this solution can be administered through a peripheral vein.

The solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless the solution is clear and the seal is intact. Do not remove unit from overwrap until ready for use.

The inner bag maintains the sterility of the solution. Administer immediately following the insertion of infusion set. Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is completed.

Pressurizing intravenous solutions contained in flexible plastics containers to increase flow rates can result in air embolism if the residual air in the container is not fully evacuated prior to administration. Use of a vented intravenous administration set with the vent in the open position could result in air embolism.

Vented intravenous administration sets with the vent in the open position should not be used with flexible plastic containers. Additives may be introduced before infusion or during infusion through the injection site

The following adverse reactions have been reported in the post-marketing experience, with various electrolyte solutions similar to Plasma-lyte, listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible.

2. 5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

WARNINGS

4) is not indicated for the treatment of hypochloraemic hypokalaemic alkalosis. 4) is not indicated for the primary treatment of severe metabolic acidosis neither for the treatment of hypomagnesaemia. Use in Patients with or at Risk for and from Hypermagnaesemia Parenteral magnesium salts should be used with caution in less severe degrees of renal impairment and in patients with myasthenia gravis.

Patients should be monitored for clinical signs of excess magnesium, particularly when being treated for eclampsia. 4) contains no calcium, and an increase in plasma pH due to its alkalinizing effect may lower the concentration of ionized (not protein-bound) calcium.

4) should be administered with particular caution to patients with hypocalcaemia. Use in Patients with or at Risk for Hyperkalaemia Solutions containing potassium salts should be administered with caution to patients with cardiac disease or conditions predisposing to hyperkalaemia such as renal or adrenocortical insufficiency, acute dehydration, or extensive tissue destruction as occurs with severe burns.

The plasma potassium level of the patient should be particularly closely monitored in patients at risk of hyperkalaemia. 5). 4) solution has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency and therefore it should not be used for this purpose.

Fluid balance/renal function. Risk of Fluid and/or Solute Overload and Electrolyte Disturbances The patient’s clinical status and laboratory parameters (fluid balance, blood and urine electrolytes as well as acid-base balance) must be monitored during use of this solution.

4) can cause − fluid and/or solute overload resulting in overhydration/hypervolaemia therefore high volume infusion must be used under specific monitoring in patients with cardiac, pulmonary or renal failure. High volume infusion must be used under specific monitoring in patients with cardiac or pulmonary failure and in patients with non-osmotic vasopressin release (including SIADH), due to the risk of hospital-acquired hyponatraemia (see below).

g. 5) are at particular risk of acute hyponatraemia upon infusion of hypotonic fluids. Acute hyponatraemia can lead to acute hyponatraemic encephalopathy (cerebral oedema) characterized by headache, nausea, seizures, lethargy and vomiting.

Patients with cerebral oedema are at particular risk of severe, irreversible and life-threatening brain injury. g. meningitis, intracranial bleeding, cerebral contusion and brain oedema) are at particular risk of the severe and life-threatening brain swelling caused by acute hyponatraemia.

4) should be administered with particular caution to hypervolaemic or overhydrated patients. 5 – Interactions with other Medicinal Products and forms of interaction). 4) should be administered with particular caution to patients with severe renal impairment.

4) may result in sodium and/or potassium or magnesium retention. 4) should be administered with particular caution to patients with alkalosis or at risk for alkalosis. 4) can result in metabolic alkalosis because of the presence of acetate and gluconate ions.

4). The infusion must be stopped immediately if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Administration Administration in the postoperative period shortly after recovery from neuromuscular block should be used with caution since magnesium salts can lead to recurarisation effect.

When used concomitantly with parenteral nutrition, electrolyte supply should be taken into account and adjusted accordingly. PRECAUTIONS Interference with laboratory tests for gluconate containing solutions There have been reports of false-positive test results using the Bio-Rad Laboratories Platelia […]

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