ExSept Plus Frequently Asked Questions for Dialysis
1. Why are there new indications for the use of ExSept Plus for Catheter Exit Sites? In response to requests from the dialysis field, Angelini Pharma has recently received FDA clearance for ExSept Plus for “Catheter Exit Site Care”. This new labeling will provide a very clear indication for use for dialysis care providers.
2. Is the formulation different from the ExSept Plus I am currently using? NO. ExSept Plus for Catheter Exit Sites is identical in formulation, strength, stability and shelf life to the product that has been on the market for the past 10 years. The bottle label varies slightly-identifying use for Catheter Exit Sites.
3. Is the ExSept Plus for Catheter Exit Sites compatible with different types of catheter materials? Yes, ExSept Plus for Catheter Exit Sites is compatible with all catheter materials on the market. Angelini Pharma has performed numerous catheter compatibility studies on materials such as Silicone, Carbothane© and Tecoflex© polyurethane catheters. For more information about these studies, contact email@example.com. Product compatibility is of great benefit with long term dialysis catheters.
4. What does this mean for my dialysis patient? Your dialysis patients will continue to get the same quality care and products to which they are accustom. Due to expanded claims, the ExSept Plus for Catheter Exit Sites is considered a prescription. Essentially, adoption of ExSept Plus for Catheter Exit Sites requires the Physician, Physician Assistant or Nurse Practitioner to include the use of ExSept Plus in the patient orders. (Admission, Standing or Other) Both In-center and home dialysis patients can continue to use ExSept Plus.
5. How do I use ExSept Plus for Catheter Exit Sites?ExSept Plus for Catheter Exit Sites will be used in the same fashion and manner as ExSept Plus. Manufacturer’s guidelines for use can be found at www.angelini-us.com
6. What do I do differently to use ExSept Plus for Catheter Exit Sites? In dialysis, the physician or designee will write in the patients’ orders to use ExSept Plus for Catheter Exit Sites per manufacturers’ recommendations or the facility’s policy and procedure. The order is then transcribed per clinic procedure and if tracked electronically, can be used in data collection for CQI reports.
7. How can I purchase ExSept Plus for Catheter Exit Sites? All Angelini Pharma products can be purchased through our several distributors or directly from Angelini Pharma. The product change will not affect how your facility currently obtains ExSept Plus for Catheter Exit Sites. Angelini Pharma and its distributors have ramped up inventory to ensure a smooth transition. Please contact us at firstname.lastname@example.org for a complete list of distributors.
8. Have the product codes changed? No. The product codes will not change, and are as follows:
15104 ExSept Plus for Catheter Exit Sites 100ml
15107 ExSept Plus for Catheter Exit Sites 200ml spray
15108 ExSept Plus for Catheter Exit Sites 250ml
15117 ExSept Plus for Catheter Exit Sites 500ml
9. Will there be single-dose packaging of ExSept Plus for Catheter Exit Sites? Yes. In the near future, Angelini Pharma plans to introduce a Single dose ExSept Plus Package.
10. How long are ExSept Plus and Alcavis 50 good for? Unopened, ExSept Plus and Alcavis 50 are stable for 30 months from the date of manufacture, when stored appropriately (see MSDS for storage instruction).
11. Are ExSept Plus and Alcavis 50 still good after freezing? If allowed to thaw at room temperature, frozen bottles of ExSept Plus and Alcavis 50, will maintain labeled concentration. DO NOT heat/warm the bottle to expedite thawing.