Abstral

Abstral Medication Guide

Medication Guide ABSTRAL ® (AB-stral) CII (fentanyl) Sublingual tablets 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, 800 mcg . IMPORTANT: Do not use ABSTRAL unless you are regularly using another opioid pain medicine around-the-clock

www.fda.gov

Sublingual tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER . Abstral ® 50, 100, 200, 300, 400, 600, 800 Microgram Sublingual tablets . Fentanyl Read all of this leaflet carefully before you start taking this medicine.

breakthroughcancerpain.org

The ABSTRAL REMS Program - An Overview for Inpatient Pharmacies

The ABSTRAL REMS Program - An Overview for Inpatient Pharmacies This booklet is required and approved by the FDA as part of the ABSTRAL REMS.

www.abstralrems.com

HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not ...

_____HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ABSTRAL safely and effectively. See full prescribing information for ABSTRAL.

www.accessdata.fda.gov

User ID, Password, as well as for any use, misuse or ...

1 For more information about ABSTRAL, please see Full Prescribing Information, including BOXED WARNINGS Last updated: 25 January 2011 THIS AGREEMENT GOVERNS YOUR USE OF THE SITE (AS DEFINED BELOW).

www.abstralrems.com

ProStrakan Group plc Galashiels, UK. 10th January 2011

Microsoft Word - ProStrakan Trading Update and Abstral Approval Announcement 10.01.11.doc

www.prostrakan.com

PROPOSED TRANSMUCOSAL IMMEDIATE RELEASE FENTANYL (TIRF) RISK ...

a second ABSTRAL dose (after 30 minutes) as directed by their healthcare provider. No more than two doses of ABSTRAL may be used to treat an episode of breakthrough pain.

www.fda.gov

ProStrakan Group plc ProStrakan Announces FDA Acceptance of ...

1 ProStrakan Group plc ProStrakan Announces FDA Acceptance of Abstral Filing Galashiels, UK. 6 th October 2009 - ProStrakan Group plc (LSE: PSK), the international specialty pharmaceutical company, today announces that its New Drug Application (NDA) filing for Abstral has been accepted for ...

www.prostrakan.com

Abstral (fentanyl) sublingual tablets

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 022510 * NDA APPROVAL ProStrakan, Inc. 1430 US Highway 206, Suite 110 Bedminster, NJ 07921 Attention: *Dalena DeGrezia, MBA Director, US Regulatory Affairs Dear Ms. DeGrezia: Please refer to your New ...

www.accessdata.fda.gov

Abstral® Onsolis®

A claim involving "urgent care" applies when then standard review time will seriously jeopardize the life or health of the member, or subject the member to severe pain that cannot be managed without the care or treatment requested in the subject of this request.

www.priorityhealth.com

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