SYNTHAMIN 17 WITHOUT ELECTROLYTES 10% AMINO ACID INTRAVENOUS INFUSION

BAXTER HEALTHCARE (ASIA) PTE LTD

BAXTER HEALTHCARE (ASIA) PTE LTD

Therapeutic

General Sale List

INJECTION

**Posology and method of administration** The solution is for administration by intravenous infusion through a central venous catheter with the tip located in the central vena cava. The total daily dose of the solution depends on the patient’s metabolic requirement and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual nitrogen requirements. In addition to meeting nitrogen needs, the rate of administration is governed, especially during the first few days of therapy, by the patient’s ability to tolerate glucose. Daily intake of amino acids, electrolytes and glucose should be increased gradually to the maximum required dose as indicated by frequent determination of urine and blood sugar levels. Recommended daily dietary allowances for protein range from 2.2g/kg of body weight for infants to 56g of protein per day for adults weighing 70kg. An associated source of non-protein energy should be administered in a quantity not less than 0.75 megajoules (180kcal) per gram of nitrogen. In the initial treatment of severe trauma or in the presence of marked malnutrition, higher doses of amino acids with correspondingly larger quantities of carbohydrate will be necessary to promote adequate patient response to therapy. The degree of negative nitrogen balance being treated is the primary consideration in determining replacement therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient (see section Incompatibilities – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Fat emulsion co-administration should be considered when prolonged parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). As indicated on an individual basis, vitamins and trace elements and other components (including glucose and lipids) can be added to the parenteral nutrition regimen to meet nutrient needs and prevent deficiencies and complications from developing (see section Incompatibilites – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). The osmolarity of a specific infusion solution must be taken into account when peripheral administration is considered. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The flow rate should be increased gradually during the first hour. The flow rate must be adjusted taking into account the dose being administered, the daily volume intake, and the duration of the infusion. Use of a final filter is recommended during administration of all parenteral nutrition solutions. When used in neonates and children below 2 years, the solution (in containers and administration sets) should be protected from light exposure after admixture through administration. **Paediatric Population** In children, the dosage of parenteral nutrition should be individually tailored to the amino acid, electrolyte and energy requirements to the patient.