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Meda Pharmaceuticals




PRIVACY POLICY


LAST UPDATED: July, 2015

Thank you for your interest in Meda Pharmaceuticals Inc. Meda invites you to explore our websites and learn more about us and our products. As you do so, please know that Meda respects your privacy and is committed to protecting the personal information that you share with us. This Privacy Policy summarizes our standards for collecting, using, storing and sharing the personal information that we, or companies that work with us, obtain from our websites.

Meda Pharmaceuticals Inc. is the United States subsidiary of Meda AB, a global specialty pharmaceutical company based in Sweden. This Privacy Policy applies only to Meda Pharmaceuticals Inc., and to Meda owned websites, and the data collected within those websites, specifically identified as intended for use only by residents of the United States and its territories that link to this policy.

Meda's Privacy Policy does not apply to third-party online resources, even if our website offers courtesy links to them. Meda does not control the content or the privacy practices of third-party resources. Read the Privacy Policy of any website or other online resource that you visit to ensure that you understand and agree with it. (That applies to our Privacy Policy too - we want you to read it carefully). If you have questions about our policy, or how Meda protects the privacy of your personal information, you may contact us at privacy@Meda.us.

Meda Pharmaceuticals, Inc. reserves the right to update or change this Privacy Policy.

The term "personal information" is used to describe information that can be readily used to identify a specific living person. Examples of personal information that could potentially be collected within a Meda website include an individual's name, an individual's street address or an individual's email address. Information that relates to an individual, but could not be used to identify a specific individual, is not considered "personal information". For example, the state of residence alone would not be considered personal information, but if this were to be combined with an individual's street address, this would be considered "personal information" as it could be used to identify a specific individual.

De-identified information is information that has been stripped of features that would permit the identification of the underlying individual. When de-identified information about multiple people is put together, it is referred to as "aggregated" and de-identified information. Meda reserves the right to choose to aggregate personal information obtained from individuals through a variety of different channels. Any data aggregation of personal information will be done in a manner consistent with this Privacy Policy and any additional privacy notifications provided.

Meda collects personal information to improve your experience as a user of Meda's websites. Collected personal information enables Meda to provide topics of interest that are more relevant to your as a user. In addition, information collected via Meda websites can provide mechanisms to assist with the improvement of Meda products and services as well as help better design features and better identify resources that users would like to see Meda offer.

Meda collects personal information online through websites and other sponsored resources. At times, we will work with other companies that collect personal information at our request. When Meda works with a third party company, the work is regulated by an agreement that, among other things, requires the third party company to properly protect the personal information it collects for us.

There are an assortment of tools that Meda may employ to collect personal information, including, but not limited to:

Direct Collection. This is collecting personal information from you by requesting that you complete an online form or participate in an interactive survey or display. Contact details, such as your name, street address, email address, telephone number, birth date, etc. are often collected directly. So is health status, so that Meda can provide you with information that is more likely to be relevant.

"Cookies". At times Meda, and at times advertisers on our websites, will employ the use cookies. A "cookie" is a data file that a website may place on your computer's hard drive. In general, cookies are used to simplify and improve your communication and interaction with a website. A website sponsor's ability to use a cookie to retrieve information from your computer can help customize the presentation of products and services, or help the website sponsor enhance their services to you. Some cookies are temporary and erased when you leave the Internet or shut down; others stay on your computer unless or until they are removed. If you do not wish to receive cookies from Meda websites, you can adjust your Web browser's preferences on your computer. Please be aware that you can still visit our websites if you refuse cookies; but you may find that some of the features do not work, or do not work as well. Meda does not use cookies to retrieve information from your computer unless the information is related to our website or your interaction with our website.

Meda may use Google Analytics, a third party provider of analytics tools or a similar third party service to analyze information about visits to our website. For information about opting out of Google Analytics, please visit:
https://tools.google.com/dlpage/gaoptout.

Some Internet browsers offer what often is referred to as "do not track" mechanisms for browser users to automatically signal privacy preferences to websites that they visit. Internet browsers have only begun to include these features relatively recently. Our website(s) do not currently respond to do-not-track-signals. We may revisit the issue in the future. In the meantime, however, you can exercise other choices available, including limiting the placement of browser cookies on your device using your browser's cookie control features and other choices described in this Policy.

Web pixels. These are tiny graphics similar to cookies. Web pixels collect information that cannot be used to identify you personally such as the addresses of websites you view, the website that you viewed immediately prior to visiting our website, or the address of the website where the link used to reach the our website was accessed. In addition, web pixels can be used to monitor whether email communications have been opened.

In general, Meda websites are not directed at children and most of the online services offered by Meda are designed for adults, age 18 or older.

Where available, you may update personal information by modifying information that was previously entered into either a Web form or data fields located within a Meda website. If you wish to access personal information collected by Meda, you may contact privacy@Meda.us for purposes of ensuring accuracy or completeness of personal information. Please be aware that you may not always be able to access the information that has been collected. For instance, your ability to access and correct personal information will be limited where we believe it would interfere with our ability to fulfill legal or ethical obligations or to address legal claims. Access and correction of personal information will not be allowed if it would result in disclosure of a third party's personal information, or lead to a breach of contract or disclosure of trade secrets or other protected business information.

Meda strives to protect personal information as it is transmitted from your computer to our websites. Due to the open nature of the Internet, Meda cannot guarantee that our interactions with you, or your interactions with Meda, will be free from unauthorized access by third parties. Meda protects our servers and data with a firewall and endeavors to protect personal information within our possession, custody, or control from unauthorized access, disclosure, alteration or destruction. Employees and business partners with access to your personal information must have a business-related "need to know" in order to perform their job functions for Meda. However, Meda also depends upon you to help secure information by protecting your own copies of passwords and related access codes for our websites.

Personal information is accessible to Meda, including its subsidiaries, divisions and groups worldwide, and to individuals and organizations that use personal information solely for, and at the direction of, Meda. Uses and disclosures of personal information by external individuals and organizations acting on Meda's behalf are governed by agreements that require personal information to be protected appropriately. Personal information about you only will be used and disclosed by Meda and individuals and organizations working on its behalf, in a manner consistent with this Privacy Policy, other applicable privacy notices, and as explicitly permitted or required by applicable laws, rules and regulations.

In general, Meda does not sell or barter your personal information to third parties. However, if Meda decides to reorganize or divest its business through sale, merger or acquisition, it is possible that personal information will be shared with actual or prospective buyers. If that happens, Meda will obtain a written agreement that personal information will be properly protected. Except where explicitly permitted, required by law, or provided in this Privacy Policy, personal information will not otherwise be shared without your consent.

You will have some choices about whether and/or when to share personal information with Meda. In cases where you are affirmatively requested to provide information, such as to complete a form, a survey, or application on a Meda website, you may decline to do so. Please understand, however, that in some cases certain information is required to complete an application, form, or survey, and if you decline to provide the information requested, you may not be able use certain functionalities of our websites.

In addition, you may be given additional choices in the context of particular preferences tools or functions that are made available through Meda's websites or opportunities to opt-out of future email or other communications using the opt-out choices offered within those communications.


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Indication
  • FELBATOL (felbamate) should not be used as initial therapy in epilepsy (see Warnings in full Prescribing Information).
  • FELBATOL is recommended for use only in those patients who do not respond well to other treatments and whose epilepsy is so severe that the potential risk of developing aplastic anemia (a severe blood disorder) or liver failure is outweighed by the potential benefit of felbamate treatment.
  • After the patient or their caregiver has discussed the potential risks of Felbatol treatment with their doctor and have provided written consent, FELBATOL treatment can be considered. FELBATOL, by itself or in combination with other drugs is approved for the treatment of partial seizures, with or without generalization, in adults with epilepsy, and as combination therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
Important Risk Information
  • FELBATOL should not be used in patients with a history of any blood or liver problems.
  • Routine blood tests should be performed that can help identify potential blood or liver problems.
  • FELBATOL should be discontinued if there is evidence that blood or liver problems have occurred.
  • Monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
  • The most common adverse experiences observed in clinical studies are loss of appetite, vomiting, insomnia, nausea, headache, and sleepiness.
Please see the full Prescribing Information for additional safety information.


WARNING
1. APLASTIC ANEMIA THE USE OF FELBATOL® (felbamate) IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBATOL® SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE (SEE INDICATIONS). ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR CONTINUED ON FELBATOL® WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION.
AMONG FELBATOL® TREATED PATIENTS, APLASTIC ANEMIA (PANCYTOPENIA IN THE PRESENCE OF A BONE MARROW LARGELY DEPLETED OF HEMATOPOIETIC PRECURSORS) OCCURS AT AN INCIDENCE THAT MAY BE MORE THAN A 100 FOLD GREATER THAN THAT SEEN IN THE UNTREATED POPULATION (I.E., 2 TO 5 PER MILLION PERSONS PER YEAR). THE RISK OF DEATH IN PATIENTS WITH APLASTIC ANEMIA GENERALLY VARIES AS A FUNCTION OF ITS SEVERITY AND ETIOLOGY; CURRENT ESTIMATES OF THE OVERALL CASE FATALITY RATE ARE IN THE RANGE OF 20 TO 30%, BUT RATES AS HIGH AS 70% HAVE BEEN REPORTED IN THE PAST.
THERE ARE TOO FEW FELBATOL® ASSOCIATED CASES, AND TOO LITTLE KNOWN ABOUT THEM TO PROVIDE A RELIABLE ESTIMATE OF THE SYNDROME’S INCIDENCE OR ITS CASE FATALITY RATE OR TO IDENTIFY THE FACTORS, IF ANY, THAT MIGHT CONCEIVABLY BE USED TO PREDICT WHO IS AT GREATER OR LESSER RISK.
IN MANAGING PATIENTS ON FELBATOL®, IT SHOULD BE BORNE IN MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT BE SEEN UNTIL AFTER A PATIENT HAS BEEN ON FELBATOL® FOR SEVERAL MONTHS (E.G., ONSET OF APLASTIC ANEMIA AMONG FELBATOL® EXPOSED PATIENTS FOR WHOM DATA ARE AVAILABLE HAS RANGED FROM 5 TO 30 WEEKS). HOWEVER, THE INJURY TO BONE MARROW STEM CELLS THAT IS HELD TO BE ULTIMATELY RESPONSIBLE FOR THE ANEMIA MAY OCCUR WEEKS TO MONTHS EARLIER. ACCORDINGLY, PATIENTS WHO ARE DISCONTINUED FROM FELBATOL® REMAIN AT RISK FOR DEVELOPING ANEMIA FOR A VARIABLE, AND UNKNOWN, PERIOD AFTERWARDS.
IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING APLASTIC ANEMIA CHANGES WITH DURATION OF EXPOSURE. CONSEQUENTLY, IT IS NOT SAFE TO ASSUME THAT A PATIENT WHO HAS BEEN ON FELBATOL® WITHOUT SIGNS OF HEMATOLOGIC ABNORMALITY FOR LONG PERIODS OF TIME IS WITHOUT RISK.
IT IS NOT KNOWN WHETHER OR NOT THE DOSE OF FELBATOL® AFFECTS THE INCIDENCE OF APLASTIC ANEMIA. IT IS NOT KNOWN WHETHER OR NOT CONCOMITANT USE OF ANTIEPILEPTIC DRUGS AND/OR OTHER DRUGS AFFECTS THE INCIDENCE OF APLASTIC ANEMIA.
APLASTIC ANEMIA TYPICALLY DEVELOPS WITHOUT PREMONITORY CLINICAL OR LABORATORY SIGNS, THE FULL BLOWN SYNDROME PRESENTING WITH SIGNS OF INFECTION, BLEEDING, OR ANEMIA. ACCORDINGLY, ROUTINE BLOOD TESTING CANNOT BE RELIABLY USED TO REDUCE THE INCIDENCE OF APLASTIC ANEMIA, BUT, IT WILL, IN SOME CASES, ALLOW THE DETECTION OF THE HEMATOLOGIC CHANGES BEFORE THE SYNDROME DECLARES ITSELF CLINICALLY. FELBATOL® SHOULD BE DISCONTINUED IF ANY EVIDENCE OF BONE MARROW DEPRESSION OCCURS.
2. HEPATIC FAILURE
EVALUATION OF POSTMARKETING EXPERIENCE SUGGESTS THAT ACUTE LIVER FAILURE IS ASSOCIATED WITH THE USE OF FELBATOL®. THE REPORTED RATE IN THE U.S. HAS BEEN ABOUT 6 CASES OF LIVER FAILURE LEADING TO DEATH OR TRANSPLANT PER 75,000 PATIENT YEARS OF USE. THIS RATE IS AN UNDERESTIMATE BECAUSE OF UNDER REPORTING, AND THE TRUE RATE COULD BE CONSIDERABLY GREATER THAN THIS. FOR EXAMPLE, IF THE REPORTING RATE IS 10%, THE TRUE RATE WOULD BE ONE CASE PER 1,250 PATIENT YEARS OF USE. OF THE CASES REPORTED, ABOUT 67% RESULTED IN DEATH OR LIVER TRANSPLANTATION, USUALLY WITHIN 5 WEEKS OF THE ONSET OF SIGNS AND SYMPTOMS OF LIVER FAILURE. THE EARLIEST ONSET OF SEVERE HEPATIC DYSFUNCTION FOLLOWED SUBSEQUENTLY BY LIVER FAILURE WAS 3 WEEKS AFTER INITIATION OF FELBATOL®. ALTHOUGH SOME REPORTS DESCRIBED DARK URINE AND NONSPECIFIC PRODROMAL SYMPTOMS (E.G., ANOREXIA, MALAISE, AND GASTROINTESTINAL SYMPTOMS), IN OTHER REPORTS IT WAS NOT CLEAR IF ANY PRODROMAL SYMPTOMS PRECEDED THE ONSET OF JAUNDICE. IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING HEPATIC FAILURE CHANGES WITH DURATION OF EXPOSURE.
IT IS NOT KNOWN WHETHER OR NOT THE DOSAGE OF FELBATOL® AFFECTS THE INCIDENCE OF HEPATIC FAILURE. IT IS NOT KNOWN WHETHER CONCOMITANT USE OF OTHER ANTIEPILEPTIC DRUGS AND/OR OTHER DRUGS AFFECT THE INCIDENCE OF HEPATIC FAILURE.
FELBATOL® SHOULD NOT BE PRESCRIBED FOR ANYONE WITH A HISTORY OF HEPATIC DYSFUNCTION. TREATMENT WITH FELBATOL® SHOULD BE INITIATED ONLY IN INDIVIDUALS WITHOUT ACTIVE LIVER DISEASE AND WITH NORMAL BASELINE SERUM TRANSAMINASES. IT HAS NOT BEEN PROVED THAT PERIODIC SERUM TRANSAMINASE TESTING WILL PREVENT SERIOUS INJURY BUT IT IS GENERALLY BELIEVED THAT EARLY DETECTION OF DRUG-INDUCED HEPATIC INJURY ALONG WITH IMMEDIATE WITHDRAWAL OF THE SUSPECT DRUG ENHANCES THE LIKELIHOOD FOR RECOVERY. THERE IS NO INFORMATION AVAILABLE THAT DOCUMENTS HOW RAPIDLY PATIENTS CAN PROGRESS FROM NORMAL LIVER FUNCTION TO LIVER FAILURE, BUT OTHER DRUGS KNOWN TO BE HEPATOTOXINS CAN CAUSE LIVER FAILURE RAPIDLY (E.G., FROM NORMAL ENZYMES TO LIVER FAILURE IN 2-4 WEEKS). ACCORDINGLY, MONITORING OF SERUM TRANSAMINASE LEVELS (AST AND ALT) IS RECOMMENDED AT BASELINE AND PERIODICALLY THEREAFTER. WHILE THE MORE FREQUENT THE MONITORING THE GREATER THE CHANCES OF EARLY DETECTION, THE PRECISE SCHEDULE FOR MONITORING IS A MATTER OF CLINICAL JUDGEMENT. FELBATOL® SHOULD BE DISCONTINUED IF EITHER SERUM AST OR SERUM ALT LEVELS BECOME INCREASED = 2 TIMES THE UPPER LIMIT OF NORMAL, OR IF CLINICAL SIGNS AND SYMPTOMS SUGGEST LIVER FAILURE (SEE PRECAUTIONS). PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON FELBATOL® AND ARE WITHDRAWN FROM THE DRUG FOR ANY REASON SHOULD BE PRESUMED TO BE AT INCREASED RISK FOR LIVER INJURY IF FELBATOL® IS REINTRODUCED. ACCORDINGLY, SUCH PATIENTS SHOULD NOT BE CONSIDERED FOR RETREATMENT.