|
URGENT: Field Correction of Transfer Sets
Packed with Humate-P
Initiated by : CSL Behring
Event Id : 129
Event Date : 07-26-2007
Therapy Humate-P®
NDC Number: 00053-7615 and 00053-7620
Lot Number: All
Size: All sizes
Packaging: N/A
Expiration Date: N/A
Reason:
CSL Behring has identified that blisters of the blue transfer set, which is
provided with Humate-P (STN #103960) may have small holes and the trasfer
set should not be used anymore. The lyophilized product Humate-P and the
diluent supplied with the Humate-P are not impacted by the defect in the
transfer set.
Action :
If you are in possession of Humate-P, please contact your product provider
(homecare companies, hemophilia treatment centers, specialty pharmacies,
distributors, hospitals, et.al) to obtain a replacement transfer device
(Mix2VialT). CSL Behring is making available the alternate transfer device
(Mix2Vial) for all providers to replace the current transfer set.
This notice pertains only to the transfer set that was packaged with Humate-P.
It is important to note that there is no problem with the Humate-P product
or diluent.
THERE IS NO NEED TO RETURN ANY HUMATE-P VIALS TO YOUR
PROVIDER.
If you should have questions regarding this letter, please contact:
Natalie Thoma, R.Ph. or her associates at CSL Behring
Consumer Affairs:
1-(888)-508-6978.
In the event of an emergency (when additional shipment of Humate-P is
required - such as surgery): the treating physician should contact Medical
Affairs (800-504-5434) for authorization to
release product for it to be shipped.
Other Information If you need assistance, please call Stericycle, Inc. at
1-888-UPDATE-U.
PAIN STUDY - Looking for Participants
Pain is a known complication in persons with bleeding
disorders, often related to joint disease. The hemophilia treatment center
in Detroit is conducting a national pain study to evaluate how your pain
medicine works, if your pain management makes your quality of life better,
and who you turn to when you need pain management. The goal of the project
is to improve pain management for persons with bleeding disorders. Specific
questions about many areas will include your daily level of pain, treatment
measures your currently use or have tried and the effect pain has on your
daily life.
The study is only open to persons with hemophilia or
von Willebrand Disease ages 18 and older. If you are interested call
Angela Lambing at 313-916-9094 or Michelle Witkop at 231-935-7227.
To learn more about the study log onto
www.henryford.com/painstudy or call 800-580-4347. This study is
completely voluntary.
April
1, 2004
Study Looks at Risk Factors for Range-of-Motion Limitations In Young Males
with Hemophilia
March
28, 2004
Experts Team Up During National DVT Awareness Month
March
24, 2004
A Paradox Explains How von Willebrand Factor Works
March
22, 2004
DNA Chip Can Detect HIV, HBV and HCV in Blood
March
20, 2004
Peptide with Potential to Inhibit SARS Identified
March
18, 2004
Noninvasive HCV Test Developed to Assess Liver Status
March
8, 2004
New At-Home Device Would Check Blood Clotting Readings
March
3, 2004
Some Anti-Depressants Can Cause Internal Bleeding
March
1, 2004
West Nile Virus Transmissions Thwarted by Blood Screening Procedure
March
1, 2004
Drug Combo Shows Highest Success Rates for HCV
March
2, 2004
Bayer Receives Approval for HIV Test To Be Used In Plasma Donations
February 21, 2004
Bleeding Disorders Symposium Takes Place in Saudi Arabia
February 23, 2004
Study Shows Anti-HCV Therapy Sould Be a Priority in HIV/HCV Patients
February 17, 2004
Early Development of Biotherapeutics Event
February 16, 2004
Study Says Liver Transplant Should Be Considered for Coinfected Patients
February 16, 2004
AIDS Vaccine Trial Begins in Germany
February 16, 2004
Research Turns Up New Form of Mad Cow Disease
February 13, 2004
Mad Cow Disease Finding Reviewed by FDA Advisory Committee
January
26, 2004
New Technology May Improve Protein Replacement Therapies
January 26, 2004
Intracranial Hemorrhage Study Encourages Prompt Treatment
January 26, 2004
Wyeth Withdraws ReFacto FDA Application for Investigational Drug as it
Prepares to Consolidate Factor Production in Sweden
January
23, 2004
UK Announces Plan to Compensate Hepatitis C Victims
January
22, 2004
Japanese Transfusion Recipient Infected by HIV-tainted Blood
January
20, 2004
A Powder to Halt Nose Bleeds Quickly
January
13, 2004
Mad Cow Disease Update
December 30, 2003
Mad Cow Disease Update
December 24, 2003
First Detection of Mad Cow Disease in the US
December 21, 2003
ABO Blood Type and Race Affects Measurement of von Willebrand Factor
Activity
December 20, 2003
Despite St. Louis Plant Shutdown, No Interruption in ReFacto Production,
Says Wyeth
December 19, 2003
Possible
Transmission of Variant Creutzfeldt-Jakob Disease in Transfusion Recipient
December 18, 2003
Gene Therapy Evaluated for Market Introduction
December 16, 2003
Two Organizations Collaborate to Improve Treatment for Patients with
Inhibitors
December 2, 2003
Business Is Booming for Genetic Counselors
November 24, 2003
British Journal Recommends Immunization for Patients with Bleeding Disorders
November 18, 2003
Latin American Parasite Threatens US Blood Supply
November 17, 2003
Hepatitis C Vaccine to be Tested on Humans
November 17, 2003
Transjugular Liver Biopsy Is Safe for Patients with Certain Bleeding
Disorders
November 10, 2003
Addition of a Disulfide Bond to Factor VIIIa Prolongs Its Life in Blood
November 5, 2003
Grifols Acquires Assets of Alpha Therapeutic Corporation
October
28, 2003
Pegasys Found Superior to Current Hepatitis B Treatments
October
23, 2003
Warning About Use of Kaltera
October
18, 2003
New Drug Shows Promise in Curing Genetic Diseases, Including Hemophilia
October
17, 2003
Death Rates Fall After AIDS Contamination Treatment
October
4, 2003
Bayer Announces Intention to Divest Plasma Business
September 22, 2003
New Study of Hemophilia Drug Begins
September 5, 2003
Previous HCV treatment reduces risk of liver toxicity during HIV treatment
September 5, 2003
New Technology Uses Yeast to Produce Proteins; Process Could Create Drugs
for Hemophilia and Other Therapies
September 1, 2003
SPECT imaging may replace liver biopsies in HIV/HCV coinfected patients
August
27, 2003
Early response to individualized weight-based PegIntron and Rebetol
hepatitis C therapy allows accurate prediction of treatment success
August 20, 2003
Hypotoxicity Linked to Antiretroviral HIV-1 Protease Inhibitor Therapy
August 11, 2003
Hypotoxicity Linked to Antiretroviral HIV-1 Protease Inhibitor Therapy
August 02, 2003
Mothers of People with Hemophilia Protected From Heart Diseases
July 7,
2003
Bayer Biological Products Announces First Recipients of Bayer Hemophilia
Awards
May
5, 2003
Collaborative Effort between Industry and Academia Yields Results that May
Lead to New HIV Treatment
May 1,
2003
Antiretroviral Therapy Prevents Liver Damage in Patients Coinfected with
HIV and HCV
April
11, 2003
Aventis Behring Files Patent Infringement Lawsuits Against Baxter and Bayer
April
4, 2003
Benefits of Central Venous Access Devices in Children Outweigh Risks,
According to Study
April
1, 2003
New Patient Privacy Rules to Take Effect
March 11, 2003
FDA Approves New AIDS Drug
February 11, 2003
FDA Launches Concerning Innovative Medical Products
January 21, 2003
FDA Suspends 27 Gene Therapy Trials After Second Child in France Falls
Ill
January
13, 2003
Preliminary Clinical Trial Data Presented at ASH Meeting Demonstrates that
Gene Therapy Product Can Achieve Therapeutic Level of Factor IX in Humans
January
5, 2003
FDA Approves New Drug Combination for Hepatitis C
January
2 , 2003
Limited Availability of EMLA Cream
December 5, 2002
Study Shows Gene Therapy Effective in Treatment of Heart Disease
November 22, 2002
Update on Health Risk Posed by Smallpox Vaccinations for People With HIV
October
13, 2002
FDA Approval of Bayer Manufacturing Process Will Make Additional Factor VIII
Available
October
20, 2002
Advisory Panel Recommends Continuation of Gene Therapy Experiments, Despite
Side Effects Shown by "Bubble Boy" in France
October
22, 2002
Gene Therapy Study: Sustained Levels of Factor IX Achieved in Rhesus
Macaques
October
25, 2002
New Therapy for Hepatitis C Shows Promise
September 24, 2002
Boy Leaves Bubble After Gene Therapy Fixes Immune System
September 6, 2002
Transplants in HIV Patients Should Proceed, But Drug Interactions Can Be
Concern, Conclude Researchers
August 2002
·Ethicists Support Transplants for HIV+ Patients
·Two Patients Contract HIV from Florida Blood Transfusions
·Nosebleeds Reported by Viagra Patients in UK
|
