HOME >> MEDICINE >> NEWS
FDA approves room temperature storage of ZLB Behring's Helixate FS

King of Prussia, PA--(BUSINESS WIRE)--Oct. 7, 2005 -- ZLB Behring announced today that Helixate FS has received approval to be stored at room temperature (up to 25 degrees C, 77 degrees F) for three months. The new storage guidelines for the treatment will provide users with greater flexibility and simplify storage options.

The United States Food and Drug Administration (FDA) approved the storage labeling change based on data from testing to assure the labeled potency (number of recombinant FVIII units contained in a vial) remains within specified limits through the expiration date of the product. The room temperature storage option is expected to be a significant convenience for Helixate FS users.

"This is great news to moms like me," said Rhonda Boni-Burden, mother of a child with hemophilia A. "This will allow greater flexibility when traveling and while attending sporting events. This really is a welcome convenience."

Starting in November 2005, each package of Helixate FS will include a special notification with details on the new labeling. While the new room temperature storage option may be used, ZLB Behring recommends refrigerating (2 degrees- 8 degrees C, 36 degrees- 46 degrees F) Helixate FS whenever possible. Please refer to the full prescribing information for Helixate FS for complete product information. If you have additional questions, please contact ZLB Behring Medical Information at 1-800-504-5434 or visit www.zlbbehring.com.


'"/>

Contact: Sheila Burke
Sheila.Burke@zlbbehring.com
610-878-4209
Edelman Public Relations
7-Oct-2005


Page: 1

Related medicine news :

1. DFG approves 11 new Collaborative Research Centers
2. FDA approves ZYFLO CR extended-release tablets for chronic treatment of asthma
3. FDA approves Dey, L.P.s Perforomist inhalation solution for maintenance treatment of COPD
4. VCR -- FDA approves home discharge for US patients
5. FDA approves prescription Zaditor for over-the-counter relief from itchy eyes
6. FDA approves Vectibix to treat patients with metastatic colorectal cancer
7. 5,000 rare diseases need drugs, but Europe only approves a handful each year
8. FDA approves new indication for Topamax as initial monotherapy for adults and children with epilepsy
9. FDA approves first blood test to predict risk for stroke
10. FDA approves Boostrix a new US vaccine for adolescents against pertussis
11. Lowering body temperature could aid standard stroke treatment

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... Vegas, Nevada (PRWEB) , ... October 13, 2017 , ... ... 7® Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD ... dose required and providing a CBD form that can be easily incorporated into liquid ...
(Date:10/13/2017)... ... 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills is proud ... and unique items from across the nation, this holiday-themed event will raise funds and ... the VNA. The boutique will be open Saturday, November 4 (10:00 a.m. – ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... and Agile Software Development, has been awarded a contract by the Center for ... Agreement (BPA) aims to accelerate the enterprise use of Agile methodologies in a ...
(Date:10/12/2017)... ... , ... Planet Fitness, one of the largest and fastest growing franchisors and ... flagship location in Covington, LA at 401 N. U.S. Highway 190, in January of ... Depot in the Holiday Square shopping center. Its location allows it to serve both ...
(Date:10/12/2017)... ... 12, 2017 , ... Information about the technology: , Otomagnetics ... enable prevention of a major side effect of chemotherapy in children. Cisplatin and ... For cisplatin, hearing loss is FDA listed on-label as a dose limiting toxicity. ...
Breaking Medicine News(10 mins):
(Date:10/5/2017)... Ill. , Oct. 5, 2017  In ... Association of Oral and Maxillofacial Surgeons (AAOMS) released ... opioids – to be used as a first-line ... pain. Recognizing ... the AAOMS White Paper "Opioid Prescribing: Acute and ...
(Date:10/2/2017)... Oct. 2, 2017 Diplomat Pharmacy, Inc. (NYSE: ... Software and Consulting, LLC , and named its founder ... based in Tennessee , will operate ... expands EnvoyHealth,s service offerings for health care partners to ... "In an interoperable world, technology ...
(Date:10/2/2017)... Oct. 2, 2017 The Rebound mobile app is ... to reverse the tide of prescription drug addiction. The app ... medicine intake and stepping down their dosage in a safe, ... in December 2017; the first 100,000 people to sign up ... http://www.rebound-solution.com/ ...
Breaking Medicine Technology:
Cached News: