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Rx Item-Vgo 40 30 By Valeritas

NDC 08560-9400-01 UPC/GTIN No.3-85609-40001-8 Mfg.Part No.940001BRAND: VGO NDC: 08560-9400-01,8560940001 UPC: 3-85609-40001-8,385609400018 Valeritas, IncOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Vgo 40 30 By Valeritas

$491.45$446.53

Item No.: RX157103 NDC No.8560940001 UPC No.:385609400018 NDC No.08560-9400-01 UPC/GTIN No.3-85609-40001-8 MPN 940001 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No.Rx157103 Vgo 40 30 by Valeritas, Item No.3157103 NDC No.08560940001 UPC No.385609400018 Other Name Vgo 40 Therapeutic Code 940000 Th

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V-GO DISPOSABLE INSULIN DELIVERY DEVICE-
Valeritas, Inc
Using the V-Go� Disposable Insulin Delivery Device Instructions for Patient Use
The V-Go Disposable Insulin Delivery Device should be used only by people who have been prescribed the device, and only for intended use.

Terms in bold and italic are explained in the glossary.

SECTION 1 (Part 1): INTRODUCTION AND V-Go� OVERVIEW
The V-Go provides a continuous subcutaneous insulin infusion over 24 hours. It uses a preset basal rate for between-meal and nighttime insulin. The V-Go provides on-demand bolus dosing to cover glucose intake at meals. The V-Go device is convenient and easy to operate (see Section 3 for indication).

Here is how to use the V-Go:

Fill the V-Go with insulin using the EZ Fill
Attach the V-Go to a selected site (skin area)
Push in the needle button to deliver the preset basal rate
Wear the V-Go for one (1) 24-hour period
Bolus dose at meals as prescribed by your doctor or healthcare professional
At the end of the 24-hour period, retract the needle and remove the V-Go from your body
Discard the device after use (the V-Go is 100% disposable)
Repeat these steps for the next 24-hour period using a new V-Go
Healthcare Professional Prescribing Considerations
Dosing considerations

When selecting a V-Go option, healthcare professionals should refer to their own experience when initiating continuous subcutaneous insulin infusion therapy with a patient. If unfamiliar, the healthcare professional should refer to insulin therapy guidelines from diabetes associations.
The following should be considered when initially prescribing the V-Go:
-
Understand the total daily dose of insulin your patient is actually taking with their current insulin regimen versus what is being prescribed. Selecting the correct V-Go option may lessen the risk of hypoglycemia (low blood sugar).
-
It is common practice to reduce the total daily insulin dose when starting a patient on continuous subcutaneous insulin infusion therapy and this reduction should be considered when starting a patient on the V-Go.
Other prescribing considerations

A separate prescription of a U100 fast-acting insulin is required for use with the V-Go (see Section 3 for insulins tested with the V-Go).
-
Two (2) vials of insulin are required for the V-Go 20 option.
-
Three (3) vials of insulin are required for the V-Go 30 and 40 options.
The V-Go comes in 3 options for your insulin needs. Your doctor or healthcare professional has selected the most appropriate V-Go option for you.

The 3 V-Go options are:

VGO 20

20 Units/24 hr (0.83 U/hr) basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments 1
VGO 30

30 Units/24 hr (1.25 U/hr) basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments 1
VGO 40

40 Units/24 hr (1.67 U/hr) basal rate and up to 36 Units of on-demand bolus dosing in 2-Unit increments 1
1
36 Units of insulin are available for on-demand bolus dosing in all V-Go options. Bolus doses are delivered in 2-Unit increments. You can only push the bolus delivery button 18 times in every 24-hour period. Each push of the bolus delivery button delivers 2 Units of insulin (1 push = 2 Units).
IMPORTANT: A separate prescription for insulin is required for use with the V-Go. A U100 fast-acting insulin should be used to fill the V-Go. (See Section 3 for insulins tested with the V-Go.)
V-Go 20 requires two (2) vials of insulin
V-Go 30 and 40 require three (3) vials of insulin
IMPORTANT: Let your healthcare professional know how much insulin you actually take each day. Your healthcare professional will help select the correct V-Go option for you.
The correct V-Go option may lessen the risk of hypoglycemia.
IMPORTANT: A V-Go Disposable Insulin Delivery Device that has been properly prescribed and used will deliver your insulin needs. Wear each V-Go for a full 24-hour period, including while you sleep.
IMPORTANT: Do not use other insulin products while on V-Go therapy.
Valeritas Customer Care
If you have any questions about using the V-Go� or EZ Fill, speak to a Valeritas Customer Care Representative 24/7 at 1-866-881-1209.

If you have a medical emergency while using the V-Go, call 911, your doctor, or go directly to the hospital.

Liability Disclaimer
Valeritas does not give medical advice about insulin therapy. Discuss all medical therapies with your healthcare professional.

SECTION 1 (Part 2): BEFORE YOU BEGIN
Step 1: Remove the EZ Fill from the blister packaging

EZ Fill Blister Packaging
A.
Turn the packaging over so you can read the text.
B.
Peel back on the lower right corner.
C.
Remove the EZ Fill.
Step 2: Remove the V-Go from the blister packaging

V-Go Blister Packaging
A.
Turn the packaging over so you can read the text.
B.
Peel back on the lower left corner on one of the V-Go containers.
C.
Remove the V-Go. Do not pull on the adhesive tab while removing the V-Go from the container.
NOTE: Only remove one (1) V-Go every 24 hours to fill, apply, and use. Leave the rest in their containers until you are ready to use them.
SECTION 2 (Part 1): V-Go OPERATING INSTRUCTIONS
IMPORTANT: Understanding the button names and locations is important for the successful use of the V-Go and EZ Fill.
V-Go Product Overview
Product Overview 1

Button Cover: Covers the needle button. Prevents the needle button from being pushed in. Cover must be removed for V-Go to operate.
Insulin Port: Location where insulin enters the V-Go through the EZ Fill.
Bolus Ready Button: A grey button that lies flat on one of the long edges of the V-Go. When activated, it releases the bolus delivery button. This allows for bolus dosing of insulin.
Product Overview 2
Bolus Delivery Button: A grey button next to the insulin port on one of the short edges of the V-Go. When pressed after the bolus ready button activates this button, the V-Go delivers a bolus dose of 2 Units of insulin (1 push = 2 Units).
Viewing Window: Shows a view of the insulin reservoir. A grey indicator in the window demonstrates that insulin is flowing from the device.
Product Overview 3
Needle Button: When pressed, it inserts the needle into your skin and begins the flow of insulin into your body.
Needle Release Button: A wide white button with 3 ridges on one of the long edges of the V-Go. An activated needle release button removes the needle from your body and stops the V-Go from delivering insulin.
Adhesive Pad and Liner: Once the protective adhesive liner is removed, the adhesive pad affixes the V-Go to your skin.
Product Overview 1Product Overview 2Product Overview 3
EZ Fill Product Overview
EZ Fill Bottom
(click image for full-size original)
Cap: Protects the needle inside the EZ Fill (bottom of insulin vial holder).
Finger Groove: Opening to allow for easy removal of the insulin vial.
Insulin Vial Holder: Opening in the EZ Fill where the insulin vial is placed upside down.
Insulin Supply Window: Shows a view of the insulin remaining in the insulin vial.
Plunger: When you pull this handle slowly up (about 5 seconds) and then push it down (about 25 seconds), insulin transfers from the vial into the V-Go�.
Grip: The left thumb occupies this groove throughout most of the filling process.
Drawer: The V-Go is placed in this drawer for filling. The plug sits in the drawer when the EZ Fill is not in use.
Ribbed Drawer Handle: A grooved piece at the bottom end of the EZ Fill that helps with opening and closing the drawer.
Plug: When placed in the drawer, the plug protects the EZ Fill components between each fill.
EZ Fill Bottom
Aseptic Technique
Aseptic technique helps keep the V-Go and the EZ Fill devices clean during preparation, filling, and application. Following this technique requires hand-washing and wiping the application site with an alcohol swab. It may involve wiping the V-Go device with an alcohol swab if the device comes into contact with anything else.

Use aseptic technique when you are preparing, filling, and attaching a new V-Go.

1.
Inserting a needle into your skin creates an opening where germs can enter your body. This could cause an infection at the infusion site. Always use aseptic technique. The V-Go, EZ Fill, and other supplies come to you sterilized. To keep them that way, follow these precautions:
a.
Always wash your hands thoroughly before preparing, filling, and attaching the V-Go.
b.
The infusion needle is sterile and protected within the V-Go. Do not touch the underside of the V-Go after you remove it from the sterile blister packaging. If you place the V-Go on a surface, do not let the underside touch that surface. Gently lay the V-Go on the front side of the device.
2.
If the underside of the V-Go touches something, you must wipe the underside with an alcohol swab.
3.
Do not touch the circular opening on the top of the EZ Fill plug. If you place the plug on a surface, do not let the circular opening touch that surface. If the circular opening touches something, you must wipe the circular opening with an alcohol swab.
4.
Wipe the infusion site of your skin with an alcohol swab. Let the alcohol dry before you attach the V-Go. Do not touch this site again before putting the V-Go on your skin.
SECTION 2 (Part 2): FILLING THE V-Go� WITH INSULIN USING THE EZ FILL
IMPORTANT:
The EZ Fill is intended to fill one (1) V-Go each day.
Use the EZ Fill to fill 30 V-Go devices, one (1) V-Go each day. Then discard the EZ Fill after 30 fills.
A new EZ Fill will be included in each month's supply of V-Go devices.
Do not fill and store V-Go devices ahead of time. That may result in the loss of insulin effectiveness.
Remove the EZ Fill from the refrigerator, allowing the insulin to reach room temperature (about 20 minutes) before filling the V-Go.
Step 1: Remove the plug from the EZ Fill drawer
NOTE: On day 1 when you remove the EZ Fill from the packaging, the plug will be separate from the EZ Fill; therefore, you can skip Step 1.
SECTION 3: V-Go� SAFETY INFORMATION
The V-Go is a safe and reliable device. As with many medical devices, you must be aware of safety-related issues to make sure that you are using the V-Go correctly. Always consult with your doctor or healthcare professional if you have any questions regarding the functions and operation of the V-Go.

Caution
Federal (United States) law restricts this device to sale by or on the order of a physician or properly licensed practitioner (prescription only).

Indication


V-Go 20:
The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 20 Units of insulin in one 24-hour time period (0.83 U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin.

V-Go 30:
The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 30 Units of insulin in one 24-hour time period (1.25 U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin.

V-Go 40:The V-Go Disposable Insulin Delivery Device is indicated for continuous subcutaneous infusion of 40 Units of insulin in one 24-hour time period (1.67 U/hr) and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adult patients requiring insulin.

A U100 fast-acting insulin should be used with the V-Go. Humalog� (insulin lispro, rDNA origin) and NovoLog� (insulin aspart, rDNA origin) have been tested by Valeritas, Inc. and found to be safe for use in the V-Go Disposable Insulin Delivery Device.

Before using different insulin with the V-Go, you should check the insulin label to make sure it can be used with this device.

Healthcare Professional Dosing Considerations
When selecting a V-Go option, healthcare professionals should refer to their own experience when initiating continuous subcutaneous insulin infusion therapy with a patient. If unfamiliar, the healthcare professional should refer to insulin therapy guidelines from diabetes associations.

The following should be considered when initially prescribing the V-Go:

Understand the total daily dose of insulin your patient is actually taking with their current insulin regimen versus what is being prescribed. Selecting the correct V-Go option may lessen the risk of hypoglycemia.
It is common practice to reduce the total daily insulin dose when starting a patient on continuous subcutaneous insulin infusion therapy and this reduction should be considered when starting a patient on the V-Go.
Warnings
Insulin requirements

If you have to make regular adjustments or modifications to your basal rate during a 24-hour period, or if the amount of insulin used at meals requires adjustments of less than 2-Unit increments, use of the V-Go may result in hypoglycemia.

The following conditions may occur during insulin therapy with the V-Go.

Hypoglycemia:

Intensive management of diabetes with too much insulin has been associated with an increase in the incidence of hypoglycemia (low blood sugar).
Hyperglycemia and diabetic ketoacidosis (DKA):

Any insulin delivery interruption may result in hyperglycemia (high blood sugar) or the onset of diabetic ketoacidosis.
If you have a medical emergency while using the V-Go, call 911, your doctor, or go directly to the hospital.

Precautions
General
The following are a number of general precautions you should consider when using the V-Go� Disposable Insulin Delivery Device.

The V-Go is magnetic resonance (MR) unsafe.

You should remove the V-Go before having an X-ray, MRI, or CT scan (or any similar test or procedure). Replace with a new V-Go after the test or procedure is completed.

You should monitor your blood glucose levels based on your doctor's or healthcare professional's recommendation. American Diabetes Association guidelines suggest that patients test blood glucose 3 or more times daily.

You should act quickly to respond to abnormal blood sugar levels.

Notify your doctor or healthcare professional of any serious hypoglycemia or hyperglycemia. Tell your doctor or healthcare professional of any increased frequency in abnormally high or low blood glucose test results.
You should create a plan with your doctor or healthcare professional in case a problem occurs when you are unable to reach him or her for advice.

You should create a plan with your doctor or healthcare professional on how to manage your bolus (mealtime) dosing using the V-Go, including what to do if you lose count while bolus dosing or if you forget to take a bolus dose.

You should carry an emergency kit of insulin supplies, if instructed by your doctor or healthcare professional, in case you develop a problem with the V-Go that stops your insulin delivery. Tell a family member or friend where you keep your emergency kit items.

You should speak with your doctor or healthcare professional regarding what to have in the emergency kit, which often includes the following items:

Fast-acting glucose tablets

Blood glucose and urine ketone monitoring supplies

Back-up insulin, insulin syringe, and needles with directions from your doctor or healthcare professional regarding how much insulin to take

Dressing and adhesive
You should avoid exposing the V-Go to direct sunlight.

You should avoid exposure to extremely hot temperatures. Remove the V-Go prior to hot tub, whirlpool, or sauna use and replace with a new filled V-Go afterward.

You should check that the V-Go is securely in place during and after periods of increased physical activity. Check that the V-Go is securely in place if it has been exposed to water or gone under water to the depth of 3 feet, 3 inches (1 meter). The V-Go can go under water and will continue to work safely.

You should follow these precautions to help prevent problems with the V-Go placement:

1.
Never use insulin that appears cloudy. Cloudy insulin may be inactive. Do not use cloudy insulin with the V-Go.
2.
Do not expose the insulin to extreme changes in temperature. Check the insulin package insert for temperature variation.
3.
Practice aseptic technique when preparing, filling, and attaching the V-Go.
4.
Check the adhesive site for redness, irritation, and inflammation when you remove a used V-Go and before you attach a new V-Go.
5.
Change the application site each time you change the V-Go. See Section 2 (Part 3) Step 3. Changing the site will ensure proper absorption of insulin. The new site should be at least 1 inch away from the previous site.
6.
Do not apply the V-Go to a site that has excess hair or is irritated, infected, or unhealthy for any reason. Consult with your doctor or healthcare professional about how to prepare and maintain these sites.
7.
Avoid attaching the V-Go to sites that may interfere with your clothing, accessories, or car seatbelts.
8.
Do not attach the V-Go to sites with rigorous movement and stretching due to exercise or job-related activities.
Hypoglycemia
Low blood sugar is the most common side effect associated with any insulin, including the insulin delivered using the V-Go�. Symptoms of low blood sugar may vary and can happen suddenly.

To help prevent hypoglycemic episodes, follow these precautionary steps:

1.
Know the symptoms of hypoglycemia. Do not ignore these symptoms, no matter how mild they may be.
2.
Always carry a fast-acting sugar replacement (such as candy, juice, or glucose tablets) in the event of a hypoglycemic episode.
3.
The V-Go delivery rate can vary by up to +/- 10% from device to device. Even though the chance of this happening is remote, you should monitor your glucose level at least 3 times per day or as recommended by your doctor. Your doctor or healthcare professional may recommend specific times for you to check your blood glucose.
4.
Check your blood glucose before driving or operating heavy machinery. Appropriate blood glucose levels are required to maintain alertness.
IMPORTANT: If your glucose level falls below 70 mg/dL, you may be hypoglycemic (low blood sugar) and you should take immediate action to raise your blood glucose level. This may be done by taking glucose tablets, eating candy, drinking juice, or doing as your doctor or healthcare professional instructs. You should retest your blood glucose after 15 minutes and if it is still below 70 mg/dL continue to take steps to increase your blood glucose level until it reaches your normal level.
Consult with your doctor or healthcare professional to understand how to best recognize and manage low blood glucose.
Hyperglycemia and Diabetic Ketoacidosis (DKA)
To help prevent serious hyperglycemia (high blood sugar) and the possibility of diabetic ketoacidosis (DKA), follow these precautions:

1.
Check your blood glucose frequently based on your doctor's or healthcare professional's recommendation. Your doctor or healthcare professional may recommend specific times for you to check your blood glucose.
IMPORTANT: Nausea and vomiting are often the first signs of DKA. To avoid DKA, be prepared and act quickly. Don't assume your blood glucose is high because you are under stress, have the flu, or miscalculated your last meal bolus.
2.
Be sure you know when to test for ketones and when your doctor or healthcare professional expects you to call with results.
3.
Know your blood glucose target ranges and when your doctor or healthcare professional expects you to report trouble. When your blood glucose is high, be prepared to administer insulin. If you suspect that the V-Go is not delivering insulin, refer to the Troubleshooting section of this manual on page 41.
4.
Keep yourself well hydrated, especially during illness or exercise.
5.
Do not treat DKA yourself. If you suspect DKA, contact your doctor or healthcare professional.
Adverse Reactions
Site Infection/Abscesses
Infections at the infusion site may occur. Proper site preparation and frequent site rotation (refer to Section 2 (Part 3) Step 3A to 3D) can minimize infections. Remove the V-Go immediately if the area around the V-Go becomes sore, red, or swollen. Apply a new V-Go to a new, clean site away from the suspected infected area. Do not discontinue therapy without the advice of your doctor or healthcare professional.

Skin Irritation
A more common problem than infection is skin irritation. Skin may become irritated by the adhesive pad on the V-Go or by the way the V-Go is positioned on your skin. Skin irritation can occur but does not lead to any further clinical complication.

NDC 08560-9400-01 UPC/GTIN No.3-85609-40001-8 Mfg.Part No.940001
RX ITEM-Vgo 40 30 By Valeritas
NDC 08560-9400-01 UPC/GTIN No.3-85609-40001-8 Mfg.Part No.940001

BRAND: VGO NDC: 08560-9400-01,8560940001 UPC: 3-85609-40001-8,385609400018 Valeritas, Inc
Vgo 40 30 By Valeritas
BRAND: VGO NDC: 08560-9400-01,8560940001 UPC: 3-85609-40001-8,385609400018 Valeritas, Inc

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
SUB-Q INSULIN DEVICE, 40
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
AmericanPharmaWholesale.com
Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.