ll dropletsare acceptable, but if solution flows past the frangible prior to use, do not use and discard the units.
Adding Medications
The decision to add medication should be made by the physician after careful eva luation of the patient [see DrugInteractions (7), Clinical Pharmacology (12.3)].
If the re-sealable rubber plug on the medication port is missing or partly removed, do not use the product.
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.
Preparation for Administration
1. Put on mask. Clean and/or disinfect hands.
2. Place EXTRANEAL on work surface.
3. For ULTRABAG system for manual exchange, uncoil tubing and drain bag. Ensure the patient transfer set is
closed. Break the connector (Y-set) frangible.
4. Remove pull ring from connector of solution container. If continuous fluid flow from connector is observed,discard solution container. Once the pull ring has been removed, do not reuse the solution or container.
5. Immediately attach the solution container to patient connector (transfer set) or appropriate peritoneal dialysis
set.
6. For AMBU-FLEX II, continue with therapy set-up as instructed in user manual or directions accompanyingtubing sets for automated peritoneal dialysis.
7. For ULTRABAG, follow the below steps:
Clamp solution line and then break frangible near solution bag. Hang solution container and place the drainage
container below the level of the abdomen.
Open transfer set to drain the solution from abdomen. If drainage cannot be established, contact your clinician.
When drainage complete, close transfer set.
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.
Open transfer set to fill. When fill complete, close transfer set and clamp solution line.
Put on mask. Clean and/or disinfect hands.
Disconnect ULTRABAG from transfer set and apply MINICAP.
Completion of Therapy
1. Following use, the drained fluid should be inspected for the presence of fibrin or cloudiness, which may
indicate the presence of peritonitis.
2. Discard unused portion.
3. DOSAGE FORMS AND STRENGTHS
EXTRANEAL is a clear, colorless peritoneal dialysis solution containing icodextrin as the primary osmoticingredient at a concentration of 7.5% (7.5 grams icodextrin per 100 milliliters) in an electrolyte solution with 40mEq/L lactate.
EXTRANEAL is available in the following containers and fill volumes:Container Fill Volume Peritoneal Dialysis
Modality
ULTRABAG 2 L, 2.5 L CAPD
AMBU-FLEX II 2 L, 2.5 L APD
4. CONTRAINDICATIONS
4.1 Allergy to Cornstarch or Icodextrin
EXTRANEAL is contraindicated in patients with a known allergy to cornstarch or icodextrin.
4.2 Metabolic Diseases
EXTRANEAL is contraindicated in patients with maltose or isomaltose intolerance and in patients with glycogenstorage disease.
4.3 Severe Lactic Acidosis
EXTRANEAL is contraindicated in patients with severe lactic acidosis. EXTRANEAL contains lactate which mayco |
