- Approval Id
- 343ff3470a685fdb
- Drug Name
- DIANEAL LOW CALCIUM (2.5 MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 2.5% DEXTROSE
- Product Name
- DIANEAL LOW CALCIUM (2.5 MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 2.5% DEXTROSE
- Approval Number
- SIN06626P
- Approval Date
- 1991-10-14
- Registrant
- VANTIVE PTE. LTD.
- Licence Holder
- VANTIVE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- GENERAL SALE LIST
- Dosage Form
- SOLUTION, STERILE
- Dosage
- <p><u><strong>AMBU-FLEX Container For Peritoneal Dialysis</strong></u><br>
<strong>Dosage and Administration</strong></p>
<p>DIANEAL Low Calcium peritoneal dialysis solutions are intended for intraperitoneal administration only. Not for intravenous administration.</p>
<p>Do not administer if the solution is discolored, cloudy, contains particulate matter or shows evidence of leakage, if seals are not intact.</p>
<p>The mode of therapy (Intermittent Peritoneal Dialysis [IPD], Continuous Ambulatory Peritoneal Dialysis [CAPD], or Automated Peritoneal Dialysis [APD]), frequency of treatment, formulation, exchange volume, duration of dwell, and length of dialysis should be selected by the physician responsible for and supervising the treatment of the individual patient.</p>
<p>To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for that exchange.</p>
<p>As the patient’s body weight becomes closer to the ideal dry weight, lowering the dextrose (glucose) concentration of DIANEAL is recommended. DIANEAL 4.25% dextrose (glucose)-containing solution has the highest osmolarity of the Dianeal solutions and using it for all exchanges may cause dehydration.</p>
<p>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.</p>
<p>The addition of heparin to the dialysis solution may be indicated to aid in prevention of catheter blockage in patients with peritonitis, or when the solution drainage contains fibrinous or proteinaceous material. 500 to 1000 USP units of heparin per liter of solution has been recommended for adults. For children, 50 USP units of heparin per 100 mL of dialysis fluid has been recommended.</p>
<p>Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If, in the informed judgement of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.</p>
<p>Aseptic technique must be employed throughout the peritoneal dialysis procedure.</p>
<p>The drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis.</p>
<p>Discard any unused remaining solutions.</p>
<p>For single use only.</p>
<p><strong>Intermittent Peritoneal Dialysis (IPD)</strong></p>
<p>For maintenance dialysis of chronic renal failure patients.</p>
<p>The cycle of instillation, dwell and removal of dialysis fluid is repeated sequentially over a period of hours (8 to 36 hours) as many times per week as indicated by the condition of the patient. For chronic renal failure patients, maintenance dialysis is often accomplished by periodic dialysis (3 to 5 times weekly) for shorter time periods (8 to 14 hours per session).</p>
<p><strong>Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD)</strong></p>
<p>For maintenance dialysis of chronic renal failure patients. Patients on continuous ambulatory peritoneal dialysis (CAPD) typically perform 4 cycles per day (24 hours). Patients on automated peritoneal dialysis (APD) typically perform 4–5 cycles at night and up to 2 cycles during the day. The fill volume depends on body size, usually from 2.0 to 2.5 liters per 1.73m<sup>2</sup>.</p>
<p>It is recommended that adult patients being placed on peritoneal dialysis or, in the case of pediatric patients, the selected caretaker, (as well as the patient, when suitable), should be appropriately trained in a program which is under the supervision of a physician.</p>
<p><strong>Directions for Use</strong></p>
<p>Use aseptic technique.</p>
<p>For complete system preparation, see directions accompanying ancillary equipment.</p>
<p>Warming the DIANEAL Low Calcium peritoneal dialysis solution, if desired, should be done in the overpouch using dry heat only. For patient comfort, the solution should be at body temperature (37°C/98.6°F). The solution container should be comfortably warm to the touch. Exceeding 45°C (113°F) solution temperature may be detrimental to the solution; do not overheat. If the warming method itself exceeds 45°C (113°F), frequently check the solution container and remove it from the heat source when the container becomes warm to the touch.</p>
<p><strong>To Open</strong></p>
<p>Tear overpouch down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. If supplemental medication is desired, follow directions below before preparing for administration. Check for minute leaks by squeezing container firmly.</p>
<p><strong>To Add Medication</strong></p>
<p>Additives may be incompatible.</p>
<p>If the resealable rubber plug on the medication port is missing or partially removed, do not use product if medication is to be added.</p>
<ol>
<li>Prepare medication site.</li>
<li>Using a syringe with a 1 inch long 19 to 25 gauge needle, puncture resealable medication port and inject.</li>
<li>Position container with ports up and evacuate the medication port by squeezing and tapping it.</li>
<li>Mix solution and medication thoroughly.</li>
</ol>
<p><strong>Preparation for Administration</strong></p>
<ol>
<li>Place container on table or suspend from support (depending on technique).</li>
<li>Remove protector from outlet port of container. If a continuous fluid flow is noted, discard container.</li>
<li>Attach appropriate solution set to container. Refer to complete directions in hardware manual and/or directions accompanying set.</li>
<li>Proceed as instructed by your healthcare professional.</li>
</ol>
<p>Discard unused portion.</p>
<p><u><strong>ULTRABAG System For Continuous Ambulatory Peritoneal Dialysis (CAPD)</strong></u><br>
<strong>Dosage and Administration</strong><br>
The solution is used for dialysis therapy by instilling into the peritoneal cavity. DIANEAL solutions are intended for intraperitoneal administration only. Not for intravenous administration.</p>
<p>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.</p>
<p>Patients on continuous ambulatory peritoneal dialysis (CAPD) typically perform 4 cycles per day (24 hours). Patients on automated peritoneal dialysis (APD) typically perform 4–5 cycles at night and up to 2 cycles during the day. The fill volume depends on body size, usually from 2.0 to 2.5 liters per 1.73m<sup>2</sup>.</p>
<p>To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to select the peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements for each exchange.</p>
<p>As the patient’s body weight becomes closer to the ideal dry weight, lowering the dextrose (glucose) concentration of DIANEAL is recommended. DIANEAL 4.25% dextrose (glucose)-containing solution has the highest osmolarity of the Dianeal solutions and using it for all exchanges may cause dehydration.</p>
<p>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.</p>
<p>The addition of heparin to the dialysis solution may be indicated to aid in prevention of catheter blockage in patients with peritonitis, or when the solution drainage contains fibrinous or proteinaceous material. 500 to 1000 USP units of heparin per liter of solution has been recommended for adults. For children, 50 USP units of heparin per 100 mL of dialysis fluid has been recommended.</p>
<p>Discard any unused remaining solution.</p>
<p>For single use only.</p>
<p><strong>Directions for Use</strong><br>
Use aseptic technique.</p>
<p><strong>Preparation for Administration</strong></p>
<ol>
<li>Tear overpouch down side at a slit and remove the solution. Check for minute leaks by squeezing container firmly.</li>
<li>Remove the protector from outlet port at the bottom of the container.</li>
<li>Attach administration set, according to the direction accompanying the set.</li>
<li>Suspend the container from eyelet support in the upper part of the bag.</li>
<li>Instill/drain the dialysis fluid in the ULTRABAG in the procedure described below.</li>
</ol>
<p><strong>Administration:</strong></p>
<ol>
<li>Remove the cap of the connection tube on the patient side.</li>
<li>Connect the connection tube connector of the ULTRABAG to the tip of connection tube on the patient side.</li>
<li>Drain intraperitoneal waste fluid via the waste fluid bag.</li>
<li>After drainage, clamp the connection tube on the patient side, and open the seal of the outlet on the fluid bag of the dialysis solution.</li>
<li>Wash the circuit with about 100 ml of a fresh dialysis fluid (for 10 seconds) and pour into the waste fluid tube.</li>
<li>Subsequently, clamp the waste fluid tube and release the clamp of the connection tube on the patient side to instill the fresh dialysis fluid intraperitoneally.</li>
<li>After infusion, detach the connection tube on the patient side from the connection tube connector of the ULTRABAG.</li>
<li>Attach the cap to the tip of the connection tube on the patient side to complete the replacement procedure.</li>
</ol>
- Route Of Administration
- INTRAPERITONEAL
- Indication Info
- <p><u><strong>AMBU-FLEX Container For Peritoneal Dialysis</strong></u><br>
<strong>Indications and Usage</strong></p>
<p>DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis.</p>
<p><u><strong>ULTRABAG System For Continuous Ambulatory Peritoneal Dialysis (CAPD)</strong></u><br>
<strong>Indications and Usage</strong><br>
DIANEAL Low Calcium peritoneal dialysis solutions in ULTRABAG containers are indicated for use in chronic renal failure patients being maintained on continuous ambulatory peritoneal dialysis when nondialytic medical therapy is judged to be inadequate.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
DIANEAL is contraindicated in patients with:</p>
<ul>
<li>pre-existing severe lactic acidosis.</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
