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Fibromyalgia is a disabling disorder which involves achiness, inability to sleep well, morning stiffness, tiredness throughout the day, headaches, memory problems, dizziness, numbness and/or tingling, fluid retention, cramping and diarrhoea. Victims commonly suffer tenderness at the elbows, in the hip joints, in the neck and

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

chest and along the vertebrae. Sometimes motion can aggravate the discomfort and soreness of fibromyalgia. There is also a very close link with Chronic Fatigue Syndrome and sufferers often have a combination of both.

The condition can be chronic; however, it is not crippling. Doctors once thought the pain fibromyalgia pat

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ients experienced was psychosomatic, although that perception is now changing. We recognise this pain is very real! Patients describe it as a throbbing, stabbing, burning and shooting sensation.

Fibromyalgia is often accompanied by a sleep disorder call alpha-EEG anomaly. This condition occurs when periods of deep sleep are

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

interrupted by brain activity that simulates waking and the result is poor sleep. Other sleep disorders are also common in fibromyalgia patients, including sleep apnoea, bruxism, restless leg syndrome and rapid muscle contraction during sleep. these patients often suffer from symptoms of irritable bowel syndrome as well.

Re

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

searches believe fibromyalgia affects roughly two to four percent of the population and statistics also indicate that this condition occurs ten time more often in woman than in men.

Fibromyalgia belongs to the group of diseases know as AUTO IMMUNE diseases.

Is There a Cure for Autoimmune Diseases?

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

Although there is no known cure to autoimmune diseases, various treatments can help patients to manage their symptoms. One treatment commonly prescribed for these conditions is the drug Prednisone, but this drug may cause a number of serious side effects according to The Rx List: The

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

nternet Drug Index. The index includes pages of warnings, precautions, and toxicity reports about this drug. An outline of some of the side effects indicates that the drug may mask signs of infection and decrease resistance to infection; cause cataracts, glaucoma or damage to the optic nerve; e

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

levate blood pressure; cause water retention, psychic derangement or emotional instability; retard growth in children and infants; and cause convulsions. In addition to these side effects, The Rx List warns that Prednisone may produce a number of adverse reactions such as muscle weakness, loss of mu

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

scle mass, osteoporosis, vertebral compression fractures, ulcers, abdominal distension, slow wound healing, thin or fragile skin, sweating, vertigo, headaches and menstrual irregularities.

Its no wonder many people with autoimmune diseases are interested in alternative or natural tr

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

atments that may help them manage their symptoms and improve the quality of their lives.

Glyconutrients and Fibromyalgia

Research suggest that supplementation of monosaccharides (contained in Glyconutrients) could play a role in preventing

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

>autoimmune disease (Feizi, 1987). This speculation is supported by the recent finding that abnormalities in the monosaccharide components of our cells can cause antibodies to attack our body components. Antibodies are the body's bullets for destroying foreign substances.

Many fibromyalgia and chro

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

nic fatigue syndrome sufferers have found that using glyconutrients has helped them get their lives back. Whilst glyconutrients do not cure or treat disease, they do provide the body with the nutrients missing from our modern diets. This enables the body to function efficiently as it should and to heal its

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

lf.

-x-x-x-x-x-x-x-x-x-

Hope, Health & Freedom My Story - Life After Fibromyalgia - There is HOPE!

My name is Shanda and I have always battled health challenges; frequent flu bugs, sore throats, bronchitis, severe PMS and constipation. I had accepted this as "normal" and

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

had learned how to function around being sick. But, in November of 1991, I was hit with Fibromyalgia and it completely destroyed life as I knew it. I suffered without hope or improvement until May of 1998.

I was in constant pain, battling depression and had lost my desire to live. I would not have ended my life. but I carri

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ed a note with instructions that if anything happened I did not want any treatment to save my life.

I am Christian with a great husband (married 17 years at that time). Why couldn't I just deal with it? But, chronic pain had worn my strength down. I prayed for healing and strength day after day. Then, God

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

nswered my prayer.

I was introduced to someone who had experienced wonderful results with a new product; she shared the most remarkable testimony. She had suffered with CFS, FM, Menopause, Immune System challenges, and more. She asked me what it would be worth if the products worked for me, the way they had for her. My doct

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ors said I would never get better and would get progressively worse, so I was very sceptical. She said, "This is either too good to be true or too good to pass up." I Thank God I took a closer look!

I started taking the products in June [1998]. The following months were the best I had felt since this whole nightmare started

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

. The first thing I noticed was a sense of well being. The black cloud of depression seemed to vanish as my desire to live returned. I had more energy. My activity level went way up and my pain level went way down. I started to sleep better.

Now I am 98% symptom free. When I get a little sore after strenuous activity, I rec

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ver immediately. I'm doing things I never thought possible, including horseback riding. I have my life back and finally I have a great quality of life. I continue to reach new levels of health and energy. My passion for these products and for helping other people regain their health has given me a new purpose in life.

x-x

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

-x-x-x-x-x-x-x-x

If you or somebody you know suffers from fibromyalgia or chronic fatigue syndrome Glyconutrients WORK and you need keep an open mind and to take a look at the information available & read and listen to what your fellow sufferes have experienced and then decide for yourself

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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