eparation.
Product Selection
To avoid the risk of severe dehydration and hypovolemia and to minimize the loss of protein, it is advisable to selectthe peritoneal dialysis solution with the lowest level of osmolarity consistent with the fluid removal requirements forthat exchange. As the patient’s body weight becomes closer to the ideal dry weight, lowering the dextroseconcentration of DIANEAL solution is recommended. DIANEAL 4.25% dextrose-containing solution has thehighest osmolarity of the DIANEAL solutions and using it for all exchanges may cause dehydration [see DosageForms and Strengths (3)].
2.2 Adding Medications
If the resealable rubber plug on the medication port is missing or partly removed, do not use the product ifmedication 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.
2.3 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, itis best to warm solutions within the overwrap using a heating pad. Do not immerse DIANEAL solutions in water forwarming. 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 removethe 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 doesnot affect the solution quality or safety and may often leave a slight amount of moisture within the overwrap. Theopacity 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 tipprotector is not attached to the connector. Inspect the DIANEAL solution container for signs of leakage and checkfor minute leaks by squeezing the container firmly. If the container has frangible(s), inspect that they are positionedcorrectly and are not broken. Do not use DIANEAL solution if the frangible(s) are broken or leaks are suspected assterility 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 p |
