PLASMA-LYTE

Adults, the Elderly, Adolescents and Children:

The dosage and rate of administration depend on the age, weight, clinical and biological conditions of the patient and concomitant therapy. 8).

Recommended dosage:

The recommended dosage is: - for adults, the elderly and adolescents: 500 ml to 3 litres / 24h - for infants, toddlers and children: - 0-10 kg body weight : 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 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. In paediatric patients the infusion rate is 5 ml/kg/h in average but the value varies with age: 6-8 mL/kg/h for infants, 4-6 mL/kg/h for toddlers, and 2-4 mL/kg/h for children.

The infusion rate should not exceed the patient’s glucose oxidation capacities in order to avoid hyperglycaemia. Therefore the maximum acute administration rate ranges from 5mg/kg/min for adults to 10-18 mg/kg/min for babies and children, depending on the age and the total body mass.

Note: - infants and toddlers: aged from 28 days to 23 months (a toddler is an infant who can walk) - Children: aged from 2 to 11 years. Use in Paediatric Patients Safety and effectiveness of Plasma-Lyte 148 & Glucose 5% w/v solution in children have not been established by adequate and well controlled trials.

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.

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.

Glucose solutions should NOT be administered through the same infusion equipment as whole blood, as hemolysis and clumping can occur. Due to its hyper-osmolality, this solution should NOT 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 plastic 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 postmarketing experience, with unspecified Plasma-lyte products and Plasma-lyte products with Glucose, listed by MedDRA System Organ Class (SOC), then by Preferred Term in order of severity, where feasible.

Frequency is defined as very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100): rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); and not known (cannot be estimated from the available data). 4) Not known * The adverse reactions highlighted in italic are reported for other similar products 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard

Electrolyte balance Plasma-Lyte 148 & Glucose 5% w/v solution is not indicated for the treatment of hypochloraemic hypokalaemic alkalosis. Plasma-Lyte 148 & Glucose 5% w/v solution is not indicated for the primary treatment of severe metabolic acidosis neither for the treatment of hypomagnesemia.

2). g. 5) are at particular risk of acute hyponatraemia. Acute hyponatraemia can lead to acute brain oedema and life-threatening brain injury. Use in Patients with or at Risk for and from Hypermagnesemia 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 (see also Section Error! Reference source not found. - Error! ). Use in patients with Hypocalcaemia Plasma-Lyte 148 & Glucose 5% w/v solution contains no calcium, and an increase in plasma pH due to its alkalinizing effect may lower the concentration of ionized (not protein-bound) calcium.

Plasma-Lyte 148 & Glucose 5% w/v solution should be administered with particular caution to patients with hypocalcaemia. 5). The plasma potassium level of the patient should be particularly closely monitored in patients at risk of hyperkalaemia.

5): - Angiotensin converting enzyme inhibitors (ACEi) and, by extrapolation, angiotensin II receptor antagonists: hyperkalaemia potentially lethal - Tacrolimus, cyclosporine Use in patients with potassium deficiency Although Plasma-Lyte 148 & Glucose 5% w/v 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.

Depending on the volume and rate of infusion, intravenous administration of Plasma- Lyte 148 & Glucose 5% w/v solution can cause − fluid and/or solute overload resulting in overhydration/hypervolemia therefore high volume infusion must be used under specific monitoring in patients with cardiac, pulmonary or renal failure.

Use in Patients with Hypervolaemia or Overhydration, or Conditions that Cause Sodium Retention and Oedema Plasma-Lyte 148 & Glucose 5% w/v solution should be administered with particular caution to hypervolaemic or overhydrated patients.

Solutions containing sodium chloride should be carefully administered to patients with hypertension, heart failure, peripheral or pulmonary edema, impaired renal function, pre-eclampsia, aldosteronism, or other conditions associated with sodium retention (see also Section Error!

Reference source not found. - Error! ). Use in Patients with Severe Renal Impairment Plasma-Lyte 148 & Glucose 5% w/v solution should be administered with particular caution to patients with severe renal impairment. In such patients administration of Plasma-Lyte 148 & Glucose 5% w/v solution may result in sodium and/or potassium or magnesium retention.

Acid-base balance Use in Patients with or at Risk for Alkalosis Plasma-Lyte 148 & Glucose 5% w/v solution should be administered with particular caution to patients with alkalosis or at risk for alkalosis. Excess administration of Plasma-Lyte 148 & Glucose 5% w/v solution can result in metabolic alkalosis because of the presence of acetate and gluconate ions.

Other warnings Hypersensitivity Reactions Hypersensitivity/infusion reactions, including anaphylactoid reactions, have been reported with Plasma-Lyte 148 & Glucose 5% w/v solution. 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. Solutions containing glucose should be used with caution in patients with known allergy to corn or corn products. 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.

Administration of glucose containing solutions may lead to hyperglycaemia. In this case, it is recommended not to use this solution after acute ischaemic strokes as hyperglycaemia has been implicated in increasing cerebral ischaemic brain damage and impairing recovery.

During long term parenteral treatment, a convenient nutritive supply must be given to the patient, electrolyte supply should be taken into account and adjusted accordingly. Use in patients with diabetes If administered to diabetics or patients with renal insufficiency, close monitoring of glucose levels is required, and insulin and/or potassium requirements may be […]

1 The solution is also contraindicated in case of uncompensated diabetes, other known glucose intolerances (such as metabolic stress situations), hyperosmolar coma, hyperglycaemia, hyperlactataemia