- Approval Id
- 49adb2b72feb461d
- Drug Name
- NUTRINEAL PD4 WITH 1.1% AMINO ACID SOLUTION
- Product Name
- NUTRINEAL PD4 WITH 1.1% AMINO ACID SOLUTION
- Approval Number
- SIN09353P
- Approval Date
- 1997-05-27
- Registrant
- VANTIVE PTE. LTD.
- Licence Holder
- BAXTER HEALTHCARE (ASIA) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- General Sale List
- Dosage Form
- SOLUTION, STERILE
- Dosage
- <p>2. <u><strong>Dosage and Method of Administration</strong></u><br>
Administration:</p>
<ul class="dash">
<li>NUTRINEAL is intended for intraperitoneal administration only. Not for intravenous administration.</li>
<li>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.</li>
<li>NUTRINEAL should be administered at a rate that is comfortable for the patient. The volume administered is determined by the prescribing physician.</li>
<li>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.</li>
<li>Treatment should be re-evaluated after 3 months if there is no clinical or biochemical improvement in the status of the patient.</li>
<li>Do not remove unit from over pouch until ready for use.</li>
<li>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.</li>
<li>Aseptic technique should be employed through the peritoneal dialysis procedure.</li>
<li>Do not administer unless the solution is clear and free of particulate matter.</li>
<li>In case of damage, the container should be discarded.</li>
<li>Discard any unused remaining solution</li>
<li>For single use only</li>
</ul>
<p>Dosage:</p>
<ul class="dash">
<li>Dosage schedule, frequency of treatment and duration of dwell should be selected by the prescribing physician according to the patient's clinical status.</li>
<li>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.</li>
<li>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.</li>
<li>Safety and effectiveness in pediatric patients has not been established.</li>
</ul>
- Route Of Administration
- INTRAPERITONEAL
- Indication Info
- <p>1. <u><strong>Therapeutic Indications</strong></u><br>
Nutritional supplement for malnourished renal failure patients (albumin concentration lower than 35g/litre) being maintained on peritoneal dialysis.</p>
- Contraindications
- <p>3. <u><strong> Contraindication</strong></u><br>
NUTRINEAL is contraindicated in patients with:</p>
<ul class="dash">
<li>known hypersensitivity to any amino acids in the product or to any of the excipients</li>
<li>Serum urea level above 38mmol/L</li>
<li>uremic symptoms</li>
<li>metabolic acidosis</li>
<li>inborn errors of amino acid metabolism</li>
<li>liver insufficiency</li>
<li>severe hypokalemia</li>
<li>uncorrectable mechanical defects that prevent effective PD or increase the risk of infection</li>
<li>documented loss of peritoneal function or extensive adhesions that compromise peritoneal function</li>
</ul>
- Atc Code
- B05DA
- Atc Item Name
- 等渗溶液
- Pharma Manufacturer Name
- BAXTER HEALTHCARE (ASIA) PTE LTD
