DIANEAL Low Calcium with Dextrose

Basic Dosing Information DIANEAL peritoneal dialysis solutions are intended for intraperitoneal administration only. Not for intravenous or intra-arterial 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 1.73m 2 for adults. DIANEAL peritoneal dialysis solutions are 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 solution 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 ] .

Directions for Use Warming DIANEAL peritoneal dialysis solution 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 solutions in water for warming. Do not use a microwave oven to warm DIANEAL solutions. 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 or blue pull tip) is attached. Do not use if the tip protector is not attached to the connector.

Inspect the DIANEAL solution 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 solution if the frangible(s) are broken or leaks are suspected as sterility may be impaired.

For DIANEAL solutions in ULTRABAG containers, 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 container from transfer set and apply MINICAP disconnect cap. 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 or pull rings Select appropriate formulation from Table 1, 2 or 3.

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.

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 ] . 2.2 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 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 or blue pull tip) is attached.

Do not use if the tip protector is not attached to the connector. Inspect the DIANEAL solution 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 solution if the frangible(s) are broken or leaks are suspected as sterility may be impaired.

For DIANEAL solutions in ULTRABAG containers, 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.