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XYNTHA - saskatoonhealthregion.ca

2020-04-22 · Description: Xyntha ® is a sterile, lyophilized concentrate of recombinant Factor VIII (8); Xyntha ® is prepared by a modified process that eliminates any exogenous human - or animal derived protein in the cell culture process, purification, or final formulation Availability Vial sizes/dosages: Note: there are 2 different mixing devices available Xyntha ® (vial) or Xyntha …

Saskatoonhealthregion.ca

XYNTHA® | Pfizer

XYNTHA® (antihemophilic factor (recombinant)) This product information is intended only for residents of the United States. for Healthcare professionals: XYNTHA Vial Kit U.S. Physician Prescribing Information; XYNTHA Dual Chamber Syringe U.S. Physician Prescribing Information

Pfizer.com

This document applies to all Xyntha® Covenant and AHS …

Xyntha® is a sterile, lyophilized, purified, and viral-inactivated concentrate of recombinant Factor VIII. Two formats are available: o Xyntha®: a lyophilized powder for reconstitution in a single use vial. Available in 250 IU and 500 IU sizes o Xyntha® Solofuse™: a lyophilized powder for reconstitution in a prefilled dual-chamber syringe. Available in 500 IU, 1000 IU, 2000 IU and …

Albertahealthservices.ca

6878 Solofuse Recon. Steps Renewal E - Home | Hemophilia

XYNTHA® (moroctocog alfa) is used for the control and treatment of bleeding and the routine and surgical prevention of bleeding in people with hemophilia A. XYNTHA® should not be used for the treatment of other clotting factor deﬁ ciencies such as von Willebrand’s disease or hemophilia B. XYNTHA® may cause allergic reactions. Signs of allergy include hives (rash with itching), …

Pfizerhemophilia.ca

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Accounts.takeda.com

Xyntha Approved as New Hemophilia A Product - HemAware

2008-05-01 · Xyntha is produced using the same molecule as ReFacto®, Wyeth’s current hemophilia A product, but with a new, purer formulation process that is safer and eliminates almost all human and animal proteins. It is the only recombinant factor VIII product using a nonhuman/nonanimal purification process. ReFacto continues to be available to consumers. In …

Hemaware.org

HIGHLIGHTS OF PRESCRIBING INFORMATION - Pfizer

XYNTHA can last at room temperature (below 77°F) for up to 3 months. If you store XYNTHA at room temperature, carefully write down the date you put XYNTHA at room temperature, so you will know when to either put it back in the refrigerator, use it immediately, or throw it away. There is a space on the carton for you to write the date. If stored at room temperature, XYNTHA can …

Labeling.pfizer.com

Xyntha - FDA prescribing information, side effects and uses

2021-03-01 · Xyntha is also supplied in kits that include single-use vials with lyophilized powder and prefilled diluent syringes. If you use one Xyntha vial and one Xyntha SOLOFUSE for the infusion, reconstitute the Xyntha vial and the Xyntha SOLOFUSE according to the specific directions for that respective product kit. Use a separate, 10 milliliter or larger luer lock syringe …

Drugs.com

Xyntha® Single Use Vial Reconstitution

Xyntha® single use vial reconstitution Page 3 of 3 10 Slowly depress the plunger rod to inject all the diluent into the Xyntha vial 11 With the syringe still connected to the adapter, gently swirl the contents of the vial until the powder is dissolved. The final solution should be clear to slightly pearly and colourless, with no particulate matter. If it is not, the solution should be ...

Albertahealthservices.ca

final product, making it naturally free from the risk of ...

Xyntha should be administered using the pre-filled diluent syringe provided or a single sterile disposable plastic luer-lock syringe. In addition, the solution should be withdrawn from the vial using the vial adapter. 1. Attach the syringe to the luer end of the provided infusion set tubing and perform venipuncture as instructed by your hemophilia doctor or nurse. 2. Apply a tourniquet …

Pfizer.ca

HIGHLIGHTS OF PRESCRIBING INFORMATION - Pfizer

XYNTHA SOLOFUSE can last at room temperature (below 77°F) for up to 3 months. If you store XYNTHA SOLOFUSE at room temperature, carefully write down the date you put XYNTHA SOLOFUSE at room temperature, so you will know when to throw it away. There is a space on the carton for you to write the date. Throw away any unused XYNTHA SOLOFUSE after the …

Labeling.pfizer.com

Xyntha - Report Store

2018-05-04 · Xyntha (Pfizer) is a B-domain deleted recombinant factor VIII (rfVIII) product, approved in the US and EU for the prevention and treatment of bleeding episodes in patients with hemophilia A. Xyntha is produced through a similar manufacturing process as its predecessor, ReFacto (rfVIII). However, the process has been modified to allow for the elimination of animal …

Pharmastore.informa.com

Pfizer_-_Receipt_of_Xyntha_500_IU_Lot_N20360_Customer ...

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Blood.ca

Xyntha - ABOUTCANCERSERVICE

2021-01-31 · XYNTHA is a protein called coagulation factor VIII protein product that is important for helping your blood clot. XYNTHA is produced by recombinant DNA technology and is made in a laboratory, rather than isolated from human blood donors, which is where plasma derived factor VIII comes from. Mammalian cells, which have the DNA for human coagulation factor VIII put …

Aboutcancerservice.com

XYNTHA® Lyophilized Powder Instructions For Use ...

XYNTHA is also supplied in kits that have both the XYNTHA powder and the diluent within single-use prefilled dual-chamber syringes, called XYNTHA SOLOFUSE™. If you use one XYNTHA vial and one of XYNTHA SOLOFUSE™ for the infusion, reconstitute the XYNTHA vial and the XYNTHA SOLOFUSE ™ according to the specific directions for that respective product kit.

Pfizermedicalinformation.com

HIGHLIGHTS OF PRESCRIBING INFORMATION ... - HemOnc.org

XYNTHA vial and Prefilled Dual-Chamber Syringe [see Use of a XYNTHA Vial Kit and a XYNTHA Prefilled Dual-Chamber Syringe Kit (2.6)]. Note: If the patient uses more than one vial and/or prefilled dual-chamber syringeof XYNTHA per infusion, each vial and/or syringe should be reconstituted according to the instructions for that respective product kit. A separate 10 cc or …

Hemonc.org

NEW ZEALAND DATA SHEET - Medsafe

XYNTHA is administered by intravenous (IV) infusion after reconstitution of the lyophilised powder for injection with the supplied diluent (9 mg/mL (0.9%) sodium chloride solution 4mL). XYNTHA should be administered using the infusion set provided in the kit. The reconstituted solution should be used immediately or within 3 hours. XYNTHA shouldbe injected intravenously over several …

Medsafe.govt.nz

XYNTHA - Wyeth Llc Trademark Registration

Xyntha Application #77380592. Application Filed: 2008-01-25. Trademark Application Details. Status Refresh. 800. Live/Registered. REGISTERED AND RENEWED. Research: OneLook Acronym Finder; Serial Number: 77380592: Registration Number: 3607161: Mark Drawing Code: 3000: Illustration: Drawing or design which also includes word(s)/ letter(s)/number(s) Attorney …

Uspto.report

Xyntha Solofuse (antihemophilic factor (recombinant)) dose ...

XYNTHA: - Do not freeze - May be stored at room temperature not exceeding 77 degrees F for up to 3 months - Protect from light - Store product in refrigerator (36 to 46 degrees F) for up to 36 months from date of manufacture XYNTHA Solofuse: - Do not freeze - May store unreconstituted product at room temperature (up to 77 degrees F) for up to 3 ...

Pdr.net

Xyntha® is effective and safe in previously treated ...

2009-03-23 · Background: Xyntha® (albumin-free cell culture process) is a BDDrFVIII manufactured using an albumin-free cell culture process and purified using a chemically synthesized peptide affinity ligand instead of a murine monoclonal antibody. A virus-retaining filtration step has been included as an additional safety precaution during manufacture. The …

Onlinelibrary.wiley.com

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