Namenda = Ebixa ®

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Ebixa® memantine

Ebixa 10 mg tablet is on the approved list in the Netherlands.

It is possible to order Ebixa ® 10mg on prescription through a reliable source, Meerburg Pharmacy.

Axura®/Namenda®/Ebixa® are different brand names of the same medicine.

Ebixa® fax order form (Acrobat)

Ebixa® fax order form (Word 2002)

Voice Mail call back service: US toll free (1) 877 839 2664.

Ebixa's European approved indication is in the treatment of moderate severe to severe Alzheimer's disease.

Patient Information

Patient information leaflet in English (wait to download)

Prospecto (Español)

Notice (Français)

Prescribing Information

In English (wait to download)

En Español

En Français

Namenda ® USA prescribing information (wait to download)

Ebixa is available for international importation on patient label.

Important Notice

Meerburg Pharmacy neither promotes nor encourages the use and importation of medications in any way.

Each country has its own laws and regulations for the importation of medication to protect their citizens.

e.g. USA: http://www.customs.gov/xp/cgov/travel/alerts/medication_drugs.xml

e.g. Australia: http://www.health.gov.au/tga/docs/html/bringmed/persimp.htm

e.g. Canada (EN): http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorat/imp_hum_drug_per_use_enf_dir_tc_e.html

e.g. Canada (FR): http://www.hc-sc.gc.ca/hpfb-dgpsa/inspectorat/imp_hum_drug_per_use_enf_dir_tc_f.html

Ordering requirements:

Ebixa® is available for international shipment.

Before ordering Ebixa ® it is important that you read the package leaflet and discuss any questions you might have with your doctor. Your caregiver may be able to assist you with any details you wish to discuss.

As Ebixa® is probably not approved in your country yet, it can be dispensed in situations where a patient cannot be treated suitably with approved medication:

  1. The specialist has thorough experience in the treatment of Alzheimer's disease and is well aware of the therapeutical indications, contra-indications, precautions, drug interactions and side effects of Ebixa® and has informed the patient that this medication is unapproved (informed consent); for example see below*)
  2. The doctor declares that he is aware that Ebixa® is not on the approved list and that no effective alternative treatment is available domestically (no approved alternatives); for example see below *)
  3. The patient declares that Ebixa® is for own use and provide the name and address of the qualified doctor (in your country) responsible for evaluation of the treatment with Ebixa® (declaration); (on order form)
  4. If you meet the above mentioned conditions and you have a valid prescription, you can order Ebixa®

Meerburg Pharmacy will guarantee that the recipient will receive the Ebixa medication or else no charges will be made.

We cannot be responsible for knowing all aspects of the taxes and duties which may be applied in the country to which we are shipping. In some cases, duties and taxes may be as much as as 75% of the total value of the shipment (India). Some countries levy VAT on personal importation . Those costs are the responsibility of the recipient.

*) Example of doctors declaration:

This doctor’s declaration must show your name and date of birth. Your doctor may choose his own words and must use his letterhead. An example:

To whom it may concern:

This is to certify that I have prescribed the drug Ebixa for my patient ________________, DOB _________.

I realize that this medication is not available in __________ and that is classified as an investigational drug. I have informed my patient of this fact and have discussed with him the possible drug interactions and side effects which could occur. My patient will be under my constant care while she is taking this medication.

Should you have any further questions for me do not hesitate to contact me.

Sincerely, ______________ , M.D.

Ordering procedures and prices:

Prices, product information, procedures and conditions of shipment are specified on our order forms.

You can order Ebixa 10mg tablets either online, by fax or by mail. Initial prescriptions and doctor's letters can be faxed to our (US-toll free) fax number (1) 877 839 2664.

Meerburg Pharmacy recommends you to use our electronic order form to prevent errors. However we have a fax order form with all information; We suggest you to print the fax order form for a (3 page) overview with all relevant information. All prices on our order forms include FedEx International Priority shipment.

Fax/Mail order form with procedures and prices (print this out for reference):

Ebixa® fax order form (Acrobat)

Ebixa® fax order form (Word 2002)

Order forms for liquid (drop) presentation are available on request

Electronic order forms:

Ebixa® secure online order form SSL 128 bit secure

If you get an error, your browser might not support 128 bit secure data transmission. Please adjust your browser or select the standard form instead.

Ebixa® standard online order form standard security

Email service: I have specific questions about Ebixa = Memantine (click here)

Voice Mail call back service: US toll free (1) 877 839 2664.

Scientific Publications :

Other information:


Information about memantine from the Alzheimer's Association Fact Sheet:

Memantine is a drug developed by the German company Merz + Co. for treatment of symptoms of dementia. The drug has been approved in Germany for more than 10 years, where it is marketed by Merz under the trade name Axura®.

In May 2002, the European Union's Committee for Proprietary Medicinal Products approved memantine for treatment of moderately severe to severe Alzheimer's throughout the European Union, where it is marketed by Lundbeck as Ebixa®.

Memantine appears to protect the brain's nerve cells against excess amounts of glutamate, a messenger chemical released in large amounts by cells damaged by Alzheimer's disease or certain other neurological disorders. The attachment of glutamate to cell surface "docking sites" called N-methyl-D-aspartate (NMDA) receptors permits calcium to flow freely into the cell, which in turn may lead to cell degeneration. Memantine may prevent this destructive sequence by adjusting the activity of glutamate.

Memantine's action in the glutamate system differs from the activity of the cholinesterase inhibitors that are currently approved in the United States for treatment of Alzheimer's. Cholinesterase inhibitors temporarily boost levels of acetylcholine, another messenger chemical that becomes deficient in the Alzheimer brain. These differing modes of action raise the possibility that individuals may be able to take memantine either as stand-alone therapy or in combination with cholinesterase inhibitors.

Drug for Late Stages of Alzheimer's Is Approved

By THE ASSOCIATED PRESS

Published: October 18, 2003

WASHINGTON, Oct. 17 — The Food and Drug Administration on Friday approved a new option for people with Alzheimer's disease, the first treatment specifically for late stages of the illness.

The drug, memantine, has long been sold in Germany, and many people in the United States have bought it over the Internet.

Now that memantine has been approved, Forest Laboratories will sell it in the United States under the brand name Namenda for patients with moderate to severe symptoms of Alzheimer's. The company said the drug should be on pharmacy shelves in January.

Memantine does not offer miraculous benefits. The drug agency's scientific advisers, in evaluating it last month, worried that memantine's availability could give false hope to families of the most severely ill.

In studies, some patients who took memantine have experienced improvements in memory and thinking skills. But for the vast majority, the drug merely slows the pace of deterioration, letting patients maintain certain functions a little longer.

The nation's four other Alzheimer's medications — Aricept, Exelon, Reminyl and Cognex — work in the early stages of the disease. Those drugs work very differently than memantine does. They delay the breakdown of a brain chemical called acetylcholine, which is needed for nerve cells to communicate.

Memantine, in contrast, blocks excess amounts of another brain chemical, glutamate, which can damage or kill nerve cells.

About four million Americans have Alzheimer's disease, and one million are believed to suffer severe symptoms.



FDA Advisory Committee Recommends Approval for Namenda (Memantine HCl) For Moderate to Severe Alzheimer's Disease

NEW YORK, NY -- September 25, 2003 -- Forest Laboratories (NYSE: FRX) announced that an advisory committee to the U.S. Food and Drug Administration (FDA) unanimously recommended the approval of Namenda(TM), previously known by its generic name memantine HCl, for the treatment of moderate to severe Alzheimer's disease. The FDA will consider the recommendation of the Peripheral and Central Nervous System Drugs Advisory Committee as it completes review of the New Drug Application for Namenda.

"Forest is pleased with today's unanimous vote to recommend the approval of memantine," said Lawrence Olanoff, M.D., Ph.D., Executive Vice President of Scientific Affairs at Forest Laboratories. "Memantine has shown a significant and consistent benefit for moderate to severe Alzheimer's patients in multiple, well-controlled trials when used alone or in combination with a currently approved treatment. It is the first in a new class of Alzheimer's medications with a mechanism of action that differs from currently available therapies. We will work with the FDA to attempt to achieve the approval of memantine as soon as possible. We expect memantine to be available within a few months of FDA approval."

Meeting in Bethesda, Maryland, the Advisory Committee comprised of experts in dementia and other neurological disorders, reviewed data from two U.S. placebo-controlled Phase III clinical trials and an earlier trial conducted among nursing home patients in Europe. Phase III data included a 28-week monotherapy study of 252 patients published earlier this year in the New England Journal of Medicine and a six-month, 401-patient study of Namenda used in combination with an ongoing regimen of the commonly used Alzheimer's agent donepezil. In clinical trials, Namenda has been safe and well tolerated. The most common adverse advents observed in clinical trials are dizziness, headache, fatigue and somnolence.

"The number of people suffering from moderate to severe disease is significant today, and the prevalence of the disease will continue to grow exponentially," said Steven DeKosky, MD, Chairman of Neurology at the University of Pittsburgh and presenter at today's hearing. "Currently, this is a population that is at risk of being left behind. Memantine, if approved, should be an important addition to the treatments a physician can offer patients."

About Namenda and Alzheimer's Disease

Namenda (memantine HCl) is the first of a new class of medications for Alzheimer's disease with a mechanism of action distinct from currently available drugs. Namenda is a low to moderate affinity NMDA (N-methyl-D-aspartate) receptor antagonist. It is thought that overexcitation of NMDA receptors by the neurotransmitter glutamate may play a role in Alzheimer's disease since glutamate plays an integral role in the neural pathways associated with learning and memory. The excitotoxicity produced by abnormal levels of glutamate is thought to be responsible for neuronal cell dysfunction and the eventual cell death observed in Alzheimer's disease. Namenda is thought to selectively block the excitotoxic effects associated with abnormal transmission of glutamate, while allowing for the physiological transmission associated with normal cell functioning.

Alzheimer's is a progressive disease of the brain that is the most common type of dementia. The term dementia is used to describe the progressive loss of cognitive, intellectual or functional abilities. The Alzheimer's Association projects that by 2010 more than 5.5 million people in the United States will have Alzheimer's disease. Currently, all Alzheimer's medications approved in the United States belong to a class of agents called acetylcholinesterase inhibitors, which are indicated for patients with mild to moderate symptoms of the disease. Currently, there are no approved therapies in the United States for people who have progressed beyond the mild to moderate stages of the disease.

SOURCE: Forest Laboratories, Inc.

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Last update: 05.25.08 (this page)
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