Regulatory Information
BAXTER HEALTHCARE (ASIA) PTE LTD
BAXTER HEALTHCARE (ASIA) PTE LTD
Therapeutic
General Sale List
Formulation Information
SOLUTION, STERILE
2\. **Dosage and Method of Administration** Administration: - NUTRINEAL is intended for intraperitoneal administration only. Not for intravenous administration. - The intraperitoneal administration route requires the use of a specific peritoneal dialysis catheter and an appropriate administration set which connects the solution container to the patient's catheter. - NUTRINEAL should be administered at a rate that is comfortable for the patient. The volume administered is determined by the prescribing physician. - The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be initiated and supervised by the prescribing physician. - Treatment should be re-evaluated after 3 months if there is no clinical or biochemical improvement in the status of the patient. - Do not remove unit from over pouch until ready for use. - Peritoneal dialysis solutions may be warmed in the overpouch to 37°C (98.6°F) to enhance patient comfort. However, only dry heat (for example, heating pad, warming plate) should be used. Solutions should not be heated in water or in a microwave oven due to the potential for patient injury or discomfort. - Aseptic technique should be employed through the peritoneal dialysis procedure. - Do not administer unless the solution is clear and free of particulate matter. - In case of damage, the container should be discarded. - Discard any unused remaining solution - For single use only Dosage: - Dosage schedule, frequency of treatment and duration of dwell should be selected by the prescribing physician according to the patient's clinical status. - Recommended dietary allowance of protein is approximately 1.2–1.3 g/kg for dialysed adults and 2–3 g/kg for infants. Higher amounts may be necessary in several catabolic states. - For information, a 2-litre bag of Nutrineal with 1.1% amino acids provides 22g of amino acids which are equivalent to 0.30g/kg/day for a 70kg adult. - Safety and effectiveness in pediatric patients has not been established.
INTRAPERITONEAL
Medical Information
1\. **Therapeutic Indications** Nutritional supplement for malnourished renal failure patients (albumin concentration lower than 35g/litre) being maintained on peritoneal dialysis.
3\. **Contraindication** NUTRINEAL is contraindicated in patients with: - known hypersensitivity to any amino acids in the product or to any of the excipients - Serum urea level above 38mmol/L - uremic symptoms - metabolic acidosis - inborn errors of amino acid metabolism - liver insufficiency - severe hypokalemia - uncorrectable mechanical defects that prevent effective PD or increase the risk of infection - documented loss of peritoneal function or extensive adhesions that compromise peritoneal function
B05DA
等渗溶液
Manufacturer Information
BAXTER HEALTHCARE (ASIA) PTE LTD
BAXTER HEALTHCARE SA, SINGAPORE BRANCH
BAXTER HEALTHCARE SA
Active Ingredients
Documents
Package Inserts
Nutrineal PI.pdf
Approved: November 11, 2015