PATIENT INFORMATION

D’OXYVA (deoxyhemoglobin vasodilator) medical carbon dioxide

Circularity Healthcare, LLC

 

PATIENT INFORMATION

D’OXYVA®

(deoxyhemoglobin vasodilator)
medical carbon dioxide pressurized mini gas cartridges 

(pronounced: DOX-y-va) 

Updated: October 15, 2017 

 

Read the Patient Information and User Manual that comes with D’OXYVA before you start taking it and each time you get a refill. There may be new information. This leaflet does not replace talking with your doctor about your condition or treatment. 

D’OXYVA is intended for significant enhancements in the regulation of the autonomic nervous system (ANS) including tissue microcirculation with cellular oxygenation, which is being recognized in a rapidly growing number of published randomized clinical trials leading to a variety of significant clinical outcomes. In short, D’OXYVA has demonstrated outsized improvements in blood circulation, cellular oxygenation, tissue perfusion in the microvessels, micro-, and macro-vascular functions, and neural signal activation in the autonomic nervous system according to randomized human clinical trials.

Microcirculation and autonomic nervous system dysfunction is increasingly regarded by the mainstream scientific medical community as the underlying cause of the most widespread health complications for both the young and elderly. Among other things, restrictions in these processes impede normal organ functions, the flow of antibodies, white blood cells and platelets, and rob the skin and body of oxygen and essential nutrients.

D’OXYVA is a relatively affordable, low-risk, non-invasive, non-toxic, non-opioid, both adjunct and stand-alone solution for the forward-looking health facility and patient wanting to significantly reduce cost of treatment and readmission rates, while improving patient compliance. 

For example, in controlled human clinical studies with D’OXYVA, severe (Wagner stage II – III) diabetic ulcer wounds typically healed and closed within 4 – 8 weeks with an average 2 applications per day and 125 total, costing about $1,500 at out-of-pocket retail price. In comparison, according to various market research studies such as conducted by the Mayo Clinic, the direct cost to treat such wounds with existing modalities yielding only 15 – 20% success is roughly $6,000 – $20,000 annually in the U.S. (not counting indirect cost estimates that are multiples of direct cost) that affects well over 7 million people in the U.S. alone.

The recommended average starting dose of D’OXYVA is 16g CO2 twice daily for 5 days per week for the first 2 weeks and once daily for 5 days per week for another 2 weeks. The average maintenance dose of D’OXYVA can be once a day for 3 days per week. The starting and maintenance dose of D’OXYVA should be individualized according to patient characteristics such as goals of therapy and response.

Blood flow (perfusion index), oxygen (SpO2 and TcPO2), blood pressure, blood glucose, heart rate variability, sympathetic/parasympathetic nerve activity, blood pH, and other vitals should be analyzed within 2 to 4 weeks after starting D’OXYVA and dosage adjusted according to results.

Stopping D’OXYVA after only 4 weeks is not recommended and it may not provide the expected long-term benefits even if major benefits and clinical outcomes were realized!

D’OXYVA is becoming exceptionally advantageous for the patient, health care practitioner, and the entire healthcare system, and is starting to provide substantial cost savings and improvements in quality of life for a wide variety of health complications for people of all ages and backgrounds.

Do not take D’OXYVA if you: 

•are pregnant or think you may be pregnant, or are planning to become pregnant. D’OXYVA has never been reported or tested to cause harm to a pregnant woman or an unborn baby. U.S. FDA regulatory compliance requires that you are notified of any potential risks and if you get pregnant, stop taking D’OXYVA and call your doctor right away. 

•are allergic to D’OXYVA or any of its ingredients. The active ingredient is purified carbon dioxide. 

D’OXYVA has not been studied in children under 10 years of age.

D’OXYVA has never been reported to cause any serious side effects. Mild side effects have happened only to a small number of people such as lightheadedness. Your doctor can monitor you for them. These side effects usually go away after a few applications or if D’OXYVA is stopped. 

Call your doctor right away if you have: 

•muscle problems like weakness, tenderness, or pain that happen without a good reason, especially if you also have a fever or feel more tired than usual. This may be an early sign of a rare muscle problem. 

•muscle problems that do not go away even after your doctor has advised you to stop taking D’OXYVA. Your doctor may do further tests to diagnose the cause of your muscle problems. 

•allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing which may require treatment right away. 

•nausea and vomiting. 

•passing brown or dark-colored urine. 

•you feel more tired than usual 

•your skin and whites of your eyes get yellow. 

•stomach pain. 

•allergic skin reactions. 

In clinical studies, patients reported no adverse side effects while taking D’OXYVA. 

Talk to your doctor or pharmacist if you have side effects that bother you or that will not go away. 

These are not all the side effects of D’OXYVA. Ask your doctor or pharmacist for a complete list.

•Store D’OXYVA at room temperature, 68 to 77°F (20 to 25°C). 

•Do not keep medicine that is out of date or that you no longer need. 

•Keep D’OXYVA and all medicines out of the reach of children. Be sure that if you throw medicine away, it is out of the reach of children.

Circularity Healthcare’s complaint handling is governed by ISO13485 Quality Management System and we usually replace items that malfunction due to manufacturing issues within 24-48 hours from approval of claim. Typically, approval takes about 24-72 hours from receipt of claim. Circularity’s D’OXYVA® devices and EasyTwist Cartridges carry a 5-year limited warranty.

***We will refund your full D’OXYVA purchase price if you do not achieve any improvements (proof of purchase required, improvements measured from absolute baseline without taking D’OXYVA).

Please contact our customer service for more information about how to return your item. Thank you.

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