“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Von Willebrand Factor (Recombinant) (Vonvendi)

Trade Name : VONVENDI

Baxalta US Inc.

KIT, PLASMA DERIVATIVE

Strength

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Von Willebrand Factor (Recombinant) (Vonvendi) which is also known as VONVENDI and Manufactured by Baxalta US Inc.. It is available in strength of per ml. Read more

Von Willebrand Factor (Recombinant) (Vonvendi) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more

About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
  • No data
  • No data
  • VONVENDI [von Willebrand factor (recombinant)] is a recombinant von Willebrand factor (rVWF) indicated for use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for:
  • VONVENDI [von Willebrand factor (recombinant)] is a recombinant von Willebrand factor (rVWF) indicated for use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for: ()
  • On-demand treatment and control of bleeding episodes. ()
  • Perioperative management of bleeding. ()
  • For intravenous use after reconstitution only ()
  • On-demand Treatment and Control of Bleeding Episodes:
  • Perioperative Management of Bleeding:
  • For elective surgical procedure:
  • For emergency surgery:
  • VONVENDI is available as a non-pyrogenic, white to off-white, lyophilized powder for reconstitution in single-use vials containing nominally 650 or 1300 IU VWF:RCo/vial.
  • Each VONVENDI vial is labeled with the number of units of VWF:RCo expressed in IU, which are based on the current World Health Organization (WHO) standard for VWF concentrate.
  • VONVENDI is available as a lyophilized powder in single-use vials containing nominally 650 or 1300 international units VWF:RCo. ()
  • VONVENDI is contraindicated in patients who have had life-threatening hypersensitivity reactions to VONVENDI or constituents of the product (tri-sodium citrate-dihydrate, glycine, mannitol, trehalose-dihydrate, polysorbate 80, and hamster or mouse proteins). n
  • Do not use in patients who have had life-threatening hypersensitivity reactions to VONVENDI or its components (tri-sodium citrate dihydrate, glycine, mannitol, trehalose-dihydrate polysorbate 80, and hamster or mouse proteins). ()
  • No data
  • Thromboembolic reactions can occur, particularly in patients with risk factors for thrombosis. Monitor for early signs of thrombosis and have prophylaxis measures against thromboembolism instituted according to current recommendations. One out of 80 VWD subjects treated with VONVENDI in clinical trials developed proximal deep vein thrombosis in perioperative period after undergoing total hip replacement surgery. In patients requiring frequent doses of VONVENDI in combination with recombinant factor VIII, monitor plasma levels for FVIII:C because sustained excessive factor VIII plasma levels can increase the risk for thromboembolic events. ()
  • Hypersensitivity reactions, including anaphylaxis, may occur. Discontinue VONVENDI if hypersensitivity symptoms occur and administer appropriate emergency treatment. ()
  • Inhibitors to von Willebrand factor (VWF) and/or factor VIII can occur. If the expected plasma levels of VWF activity (VWF:RCo) are not attained, or if bleeding is not controlled with an appropriate dose, perform an appropriate assay to determine if an anti-VWF or anti-factor VIII inhibitors are present. ()
  • The most common adverse reactions observed in u22652% of subjects in clinical trials with VONVENDI (n=80) were generalized pruritus, vomiting, nausea, dizziness and vertigo.
  • One subject treated with VONVENDI in the surgery study for perioperative management of bleeding developed proximal deep vein thrombosis postoperatively .
  • To report SUSPECTED ADVERSE REACTIONS, contact Baxalta US Inc. at 1-800-999-1785 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • The most common adverse reactions observed (u22652% of subjects) were generalized pruritus, vomiting, nausea, dizziness, and vertigo. ()
  • One subject treated with VONVENDI in perioperative setting developed deep vein thrombosis after undergoing total hip replacement surgery. ()
  • No data
  • VONVENDI is a purified rVWF expressed in Chinese Hamster Ovary (CHO) cells. VONVENDI is produced and formulated without the addition of any exogenous raw materials of human or animal origin in the cell culture, purification, or formulation of the final product. Proteins present in the final container product other than rVWF are trace quantities of mouse immunoglobulin (IgG, from the immunoaffinity purification), host cell (i.e., CHO) protein, rFurin (used to further process rVWF), and recombinant factor VIII (rFVIII).
  • Von Willebrand factor is a large multimeric glycoprotein that is normally found in plasma, and stored as ultra-large multimers in alpha-granules of platelets and intracellular organelles known as Weibel-Palade bodies, prior to secretion into the blood. Once the VWF is released to the blood stream and in contact with ADAMTS13 (a proteolytic enzyme in blood), it is cleaved to smaller sizes that can be detected with SDS agarose gels as multimer bands, representing the various species of VWF within the circulation. VONVENDI is rVWF that contains ultra-large multimers in addition to all of the multimers found in plasma as it is not exposed to proteolysis by ADAMTS13 during the manufacturing process.
  • VONVENDI is formulated as a sterile, non-pyrogenic, white to off-white powder for intravenous injection after reconstitution. VONVENDI in a single-use vial contains nominally 650 or 1300 IU VWF:RCo.
  • The product contains no preservative. When reconstituted with the provided Sterile Water for Injection the final solution contains the following stabilizers and excipients (Table 6) in targeted amounts:
  • Each vial of VONVENDI is labeled with the specific number of units of VWF: RCo expressed in IU, which are based on the current World Health Organization (WHO) standard for VWF concentrate. After reconstitution of the lyophilized powder and filtration/withdrawal into a syringe, all dosage strengths yield a clear, colorless solution, free of foreign particles. The solution in the syringe should not be used if it is cloudy or contains flakes or particles after filtration.
  • No data
  • No data
  • No data
  • No data
  • No data
  • Advise the patient:
  • BAXALTA and VONVENDI are registered trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
  • Mix2Vial is a registered trademark of Medimop Medical Projects Ltd.
  • Patented: see www.shire.com/legal-notice/product-patents
  • Baxalta US Inc
  • Issued: 02/2019
  • VONVENDI
  • [von Willebrand factor (recombinant)]
  • This leaflet summarizes important information about VONVENDI. Please read it carefully before using this medicine. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about VONVENDI. If you have any questions after reading this, ask your healthcare provider.
  • Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center.
  • You must carefully follow your healthcare provider's instructions regarding the dose and schedule for infusing VONVENDI so that your treatment will work best for you.
  • What is VONVENDI?
  • VONVENDI is a recombinant medicine used to replace low levels or not properly working von Willebrand factor in people with von Willebrand disease. Von Willebrand disease is an inherited bleeding disorder in which blood does not clot normally.
  • VONVENDI is used in adults (age 18 years and older) diagnosed with von Willebrand disease to:
  • Who should not use VONVENDI?
  • You should not use VONVENDI if you:
  • Tell your healthcare provider if you are pregnant or breastfeeding because VONVENDI may not be right for you.
  • How should I use VONVENDI?
  • VONVENDI is given directly into the bloodstream. Your first dose of VONVENDI for each bleeding episode may be administered with a recombinant factor VIII (factor VIII not produced from plasma) as instructed by your healthcare provider.
  • Your healthcare provider will instruct you whether additional doses of VONVENDI with or without recombinant factor VIII are needed.
  • You may infuse VONVENDI at a hemophilia treatment center, at your healthcare provider's office or in your home. You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center. Many people with von Willebrand disease learn to infuse VONVENDI by themselves or with the help of a family member.
  • Your healthcare provider will tell you how much VONVENDI to use based on your weight, the severity of your von Willebrand disease, and where you are bleeding.
  • Call your healthcare provider right away if your bleeding does not stop after taking VONVENDI.
  • Use the reconstituted product (after mixing dry product with the supplied sterile water) immediately. If not, store at room temperature not to exceed 25u00b0C (77u00b0F) for up to three hours. Discard after three hours.
  • What should I tell my healthcare provider before I use VONVENDI?
  • You should tell your healthcare provider if you:
  • What are the possible side effects of VONVENDI?
  • You can have an allergic reaction to VONVENDI.
  • Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
  • Side effects that have been reported with VONVENDI include: nausea, vomiting, tingling or burning at infusion site, chest discomfort, dizziness, hot flashes, itching, high blood pressure, muscle twitching, unusual taste, blood clots and increased heart rate.
  • These are not all the possible side effects with VONVENDI. You can ask your healthcare provider for information that is written for healthcare professionals.
  • Tell your healthcare provider about any side effects that bother you or do not go away.
  • What are the VONVENDI dosage strengths?
  • VONVENDI with Sterile Water for Injection and Mix2Vial reconstitution device comes in two different dosage strengths.
  • How do I store VONVENDI?
  • What else should I know about VONVENDI and von Willebrand Disease?
  • Your body can form inhibitors to von Willebrand factor or factor VIII. An inhibitor is part of the body's normal defense system. If you form inhibitors, they may stop VONVENDI or FVIII from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to von Willebrand factor or factor VIII.
  • Medicines are sometimes prescribed for purposes other than those listed here. Do not use VONVENDI for a condition for which it is not prescribed. Do not share VONVENDI with other people, even if they have the same symptoms that you have.
  • Resources at Baxalta available to the patients:
  • For more product information on VONVENDI, please visit or call 1-888-423-8283.
  • For information on additional Baxalta patient resources, please visit www.VONVENDI.com.
  • Baxalta US Inc
  • Issued: 02/2019
  • VONVENDI
  • [von Willebrand factor (recombinant)]
  • (For intravenous use only)
  • For first dose for each bleeding episode, use with recombinant factor VIII as instructed by your physician.
  • See below for step-by-step instructions for reconstituting and administrating VONVENDI:
  • Reconstitution:
  • Administration:
  • Important: Contact your healthcare provider or local hemophilia treatment center if you experience any problems
  • BAXALTA and VONVENDI are registered trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
  • Mix2Vial is a registered trademark of Medimop Medical Projects Ltd.
  • Patented: see www.shire.com/legal-notice/product-patents
  • Baxalta US Inc
  • Issued: 02/2019
  • NDC 0944-7551-02
  • VONVENDIvon Willebrand factor(Recombinant)
  • NO COAT
  • ACTUAL POTENCY
  • Single-use vials, lyophilized powder for solution
  • For Intravenous Administration After Reconstitution Only.
  • Rx Only
  • Shire
  • NDC 0944-7550-01
  • VONVENDIvon Willebrand factor(Recombinant)
  • Single-use vial, lyophilized powder, sterile
  • Rx Only
  • For Intravenous Administration AfterReconstitution Only.
  • Baxalta US Inc.
  • 5 mLNDC 52919-003-08
  • Shire
  • Sterile Water for Injection, USPfor reconstitution of accompanying product
  • Do not use unless clear. No antimicrobial agent or other substancehas been added. Do not use for intravascular injection without makingapproximately isotonic by additon of suitable solute.
  • Rx Only
  • 0742003
  • Single dose containerNonpyrogenic
  • NDC 0944-7553-02
  • VONVENDIvon Willebrand factor(Recombinant)
  • NO COAT
  • ACTUAL POTENCY
  • Single-use vials, lyophilized powder for solution
  • For Intravenous Administration After Reconstitution Only.
  • Rx Only
  • Shire
  • NDC 0944-7552-01
  • VONVENDIvon Willebrand factor(Recombinant)
  • Single-use vial, lyophilized powder, sterile
  • Rx Only
  • For Intravenous Administration AfterReconstitution Only.
  • Baxalta US Inc.
  • 10 mL NDC 52919-005-05
  • Shire
  • Sterile Water for Injection, USPfor reconstitution of accompanying product
  • Do not use unless clear. No antimicrobial agent or other substancehas been added. Do not use for intravascular injection without makingapproximately isotonic by addition of suitable solute.Discard unused portion. n
  • 0742208
  • Single dose containerNonpyrogenic

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.