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Dianeal PD2

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Dianeal PD-2

Indications
Dosage
How Supplied

INDICATIONS

DIANEAL peritoneal dialysis solutions are indicated for patients in acute or chronic renal failure.

DOSAGE AND ADMINISTRATION

Basic Dosing Information

DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only. Not for intravenous administration.

Select mode of therapy, frequency of treatment, formulation, fill volume, duration of dwell, and length of dialysis based on the patient's clinical condition, fluid, electrolyte and specific needs.The fill volume depends on body size, usually from 2.0 to 2.5 liters per 1.73m² for adults.

DIANEAL is intended for use in Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD). Refer to directions accompanying ancillary equipment for CAPD and APD system preparation.

Product Selection

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. As the patient’s body weight becomes closer to the ideal dry weight, lowering the dextrose concentration of DIANEAL is recommended. DIANEAL 4.25% dextrose-containing solution has the highest osmolarity of the DIANEAL solutions and using it for all exchanges may cause dehydration [see Dosage Forms and Strengths].

Adding Medications

If the resealable rubber plug on the medication port is missing or partly removed, do not use the product if medication is to be added.

To add a medication:

  1. Put on mask. Clean and/or disinfect hands.
  2. Prepare medication port site using aseptic technique.
  3. Using a syringe with a 1-inch long, 25-to 19-gauge needle, puncture the medication port and inject additive.
  4. Reposition container with container ports up and evacuate medication port by squeezing and tapping it.
  5. Mix solution and additive thoroughly.

Directions For Use

Warming

DIANEAL can be warmed to 37°C (98.6°F). Only dry heat should be used. For CAPD, it is best to warm solutions within the overwrap using a heating pad. Do not immerse DIANEAL in water for warming. Do not use a microwave oven to warm DIANEAL.

To Open

To open, tear the overwrap down at the slit and remove the solution container. Do not use sharp objects to remove the overwrap.

Product Inspection

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use solutions that are cloudy, discolored, contain visible particulate matter, or show evidence of leakage.

Some opacity of the plastic, due to moisture absorption during the sterilization process, may be observed. This does not affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap. The opacity should diminish gradually.

Inspect the bag connector to ensure the tip protector (pull ring, blue pull tip, or blue twist-off tip) is attached. Do not use if the tip protector is not attached to the connector. Inspect the DIANEAL container for signs of leakage and check for minute leaks by squeezing the container firmly. If the container has frangible(s), inspect that they are positioned correctly and are not broken. Do not use DIANEAL if the frangible(s) are broken or leaks are suspected as sterility may be impaired.

For DIANEAL in ULTRABAG, inspect the tubing and drain container for presence of solution. Small droplets are acceptable, but if solution flows past the frangible prior to use, do not use and discard the units.

CAPD Therapy Using ULTRABAG Containers

Select appropriate formulation from Table 1. Put on mask. Clean and/or disinfect hands. Using aseptic technique;

  1. Uncoil tubing and drain bag, ensuring that the transfer set is closed.
  2. Break the connector (Y-set) frangible.
  3. Remove the tip protector from connector of solution container. Do not reuse the solution or container once the tip protector is removed.
  4. Immediately attach the solution container to patient connector (transfer set).
  5. Clamp solution line and then break frangible near solution bag. Hang solution container and place the drainage container below the level of the abdomen.
  6. Open transfer set to drain the solution from abdomen. If drainage cannot be established, contact your clinician. When drainage complete, close transfer set.
  7. Remove clamp from solution line and flush new solution to flow into the drainage container for 5 seconds to prime the line. Clamp drain line after flush complete.
  8. Open transfer set to fill. When fill complete, close transfer set.
  9. Disconnect ULTRABAG from transfer set and apply MINICAP.
  10. Upon completion of therapy, discard any unused portion.
APD Therapy Using AMBU-FLEX Containers With Pull Rings Or Plastic Containers With Blue Pull Tips

Select appropriate formulation from Table 1 or 2. Put on mask. Clean and/or disinfect hands. Using aseptic technique;

  1. Remove the tip protector from connector of solution container. Do not reuse the solution or container once the tip protector is removed.
  2. Immediately attach the solution container to an appropriate automated peritoneal dialysis set.
  3. Continue therapy as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis.
  4. Upon completion of therapy, discard any unused portion.
APD Therapy Using Plastic Containers With Blue Twist-Off Tips

Select appropriate formulation from Table 3.

  1. Put on mask. Clean and/or disinfect hands. Using aseptic technique;
  2. Place and fasten blue outlet port clamp on solution bag administration port, between the blue connector and the solution container.
  3. Remove the blue twist-off tip from connector of solution container. Do not reuse the solution or container once the blue twist-off tip is removed.
  4. Immediately insert the spike of the automated peritoneal dialysis set into the solution bag port.
  5. Continue therapy as instructed in user manual or directions accompanying tubing sets for automated peritoneal dialysis.
  6. Upon completion of therapy, discard any unused portion.

HOW SUPPLIED

Dosage Forms And Strengths

DIANEAL is formulated with the following ionic concentrations:

Table 1 : DIANEAL PD-2 and Low Calcium Peritoneal Dialysis Solution ULTRABAG CONTAINER for CAPD therapy AMBU-FLEX CONTAINER with pull ring for APD therapy

  OSMOLARITY (mOsmol/L) (calc) pH Ionic Concentration (mEq/L)
Sodium Calcium Magnesium Chloride Lactate
DIANEAL PD-2 1.5% Dextrose 346 5.2 (4.0 to 6.5) 132 3.5 0.5 96 40
DIANEAL PD-2 2.5% Dextrose 396 5.2 (4.0 to 6.5) 132 3.5 0.5 96 40
DIANEAL PD-2 4.25% Dextrose 485 5.2 (4.0 to 6.5) 132 3.5 0.5 96 40
DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 344 5.2 (4.0 to 6.5) 132 2.5 0.5 95 40
DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 395 5.2 (4.0 to 6.5) 132 2.5 0.5 95 40
DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 483 5.2 (4.0 to 6.5) 132 2.5 0.5 95 40

Table 2 : DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue pull tip for APD therapy

  OSMOLARITY (mOsmol/L) (calc) pH Ionic Concentration (mEq/L)
Sodium Calcium Magnesium Chloride Lactate
DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 344 5.0 to 6.5 132 2.5 0.5 95 40
DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 395 5.0 to 6.5 132 2.5 0.5 95 40
DIANEAL Low Calcium (2.5 mEq/L) 4.25% Dextrose 483 5.0 to 6.5 132 2.5 0.5 95 40

Table 3 : DIANEAL Low Calcium Peritoneal Dialysis Solution Plastic container with blue twist-off tip for APD therapy

  OSMOLARITY (mOsmol/L) (calc) pH Ionic Concentration (mEq/L)
Sodium Calcium Magnesium Chloride Lactate
DIANEAL Low Calcium (2.5 mEq/L) 1.5% Dextrose 344 5.0 to 5.6 132 2.5 0.5 95 40
DIANEAL Low Calcium (2.5 mEq/L) 2.5% Dextrose 395 5.0 to 5.6 132 2.5 0.5 95 40

Storage And Handling

DIANEAL peritoneal dialysis solutions are available in the following single-dose containers and fill volumes as shown in Tables 7-8:

Table 7 : DIANEAL Peritoneal Dialysis Solutions for CAPD therapy

Container Fill Volume (mL) Container Size (mL) Product Code NDC
ULTRABAG DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
2000 2000 5B9866 0941-0426-52
2500 3000 5B9868 0941-0426-53
3000 5000 5B9857 0941-0426-55
DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose
2000 2000 5B9876 0941-0427-52
2500 3000 5B9878 0941-0427-53
3000 5000 5B9858 0941-0427-55
DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose
2000 2000 5B9896 0941-0429-52
2500 3000 5B9898 0941-0429-53
3000 5000 5B9859 0941-0429-55
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose
1500 2000 5B9765 0941-0424-51
2000 2000 5B9766 0941-0424-52
2500 3000 5B9768 0941-0424-53
3000 5000 5B9757 0941-0424-55
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
1500 2000 5B9775 0941-0430-51
2000 2000 5B9776 0941-0430-52
2500 3000 5B9778 0941-0430-53
3000 5000 5B9758 0941-0430-55
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose
1500 2000 5B9795 0941-0433-51
2000 2000 5B9796 0941-0433-52
2500 3000 5B9798 0941-0433-53
3000 5000 5B9759 0941-0433-55

Table 8 : DIANEAL Peritoneal Dialysis Solutions for APD therapy

Container Fill Volume (mL) Container Size (mL) Product Code NDC
AMBU-FLEX CONTAINER with pull ring DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose
1000 1000 L5B5163 0941-0411-05
2000 3000 L5B5166 0941-0411-06
3000 3000 L5B5169 0941-0411-04
5000 6000 L5B5193 0941-0411-07
6000 6000 L5B9710 0941-0411-11
DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose
1000 1000 L5B5173 0941-0413-05
2000 3000 L5B5177 0941-0413-06
3000 3000 L5B5179 0941-0413-04
5000 6000 L5B5194 0941-0413-07
6000 6000 L5B9711 0941-0413-01
DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose
1000 1000 L5B5183 0941-0415-05
2000 3000 L5B5187 0941-0415-06
3000 3000 L5B5189 0941-0415-04
5000 6000 L5B5195 0941-0415-07
6000 6000 L5B9712 0941-0415-01
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose
2000 3000 L5B4825 0941-0409-06
3000 3000 L5B9901 0941-0409-05
5000 6000 L5B4826 0941-0409-07
6000 6000 L5B9770 0941-0409-01
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
2000 3000 L5B9727 0941-0457-08
3000 3000 L5B9902 0941-0457-02
5000 6000 L5B5202 0941-0457-05
6000 6000 L5B9771 0941-0457-01
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose
2000 3000 L5B9747 0941-0459-08
3000 3000 L5B9903 0941-0459-02
5000 6000 L5B5203 0941-0459-05
6000 6000 L5B9772 0941-0459-01
Plastic container with blue pull tip DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose
5000 5000 EZPB5245R 0941-0484-01
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
5000 5000 EZPB5255R 0941-0487-01
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose
5000 5000 EZPB5265R 0941-0490-01
Plastic container with blue twist-off tip DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose
6000 6000 VBB4928US 0941-0472-01
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose
6000 6000 VBB4931US 0941-0475-01

All DIANEAL peritoneal dialysis solutions have overfills which are declared on container labeling.

Freezing of solution may occur at temperatures below 0°C (32°F). Allow to thaw naturally in ambient conditions and thoroughly mix contents by shaking.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F): brief exposure up to 40°C (104°F) does not adversely affect the product.

Store in moisture barrier overwrap and in carton until ready to use.

Baxter Healthcare Corporation Deerfield, IL 60015 US. Revised: Aug 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/2/2016

Indications
Dosage
How Supplied

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