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There are two types of mercury that pollute our environment. Methyl Mercury is more hazardous to humans and other animals than elemental mercury. The sources of

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

methyl mercury are unknown. It is believed that methyl mercury is the result of bacteria that modifies elemental mercury and escapes from landfills into the a

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

Examples of combination products may in

ir.

Elemental mercury, found in urban storm water sediment is the result of fluorescent light, electrical switches, thermometers and other mercury containing d

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

evices that are not disposed of properly.

Mercury is very dangerous to humans. The vapors from Mercury affects the nervous system. The lungs, kidneys, skin and

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

eyes are all affected by Mercury. Mercury can have disastrous effects on fetuses and affect child development.

Mercury is used is a wide variety of application

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

Combination pro

s. Some of the most common places where Mercury is found includes:

Light switches (Mercury conducts electricity)
Paints. (Mercury gives paint its

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

color)

Thermometers

Remote batteries. (Mercury is used to store energy in batteries)

Mercury is a dangerous element for human to breathe. The p

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

roblem is that Mercury scatters very easily and the vapors are colorless and odorless. Exposure can occur without anyone being aware of the danger. Exposure can

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

occur when thermometers or fluorescent bulbs are broken.

When Mercury vapors are inhaled, Only 7 percent of the absorbed mercury is exhaled from the body. The ba

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

lance of the Mercury is absorbed into the body causing irreparable damage.

Mercury Spill Kits are the best defense against mercury vapors. These kits are designed

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

to contain all of the necessary equipment to contain, clean and dispose of a mercury spill. Designed for smaller spills, this kit includes vapor suppressors, a me

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

Following aspects would a

rcury aspirator, personal protective equipment, and mercury disposal containers and an instruction booklet. The mercury spill kit is portable, durable, and require

dd to the challenges in developing combination products:

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

no mixing.

To quickly and effectively contain a Mercury Spill do the following:

* Use personal protective equipment gear before starting a cleanup. Protective g

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

ear includes gloves made of polyethylene or nitrile rubber, splash goggles and chemically resistant aprons should be worn when working with or around mercury.

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

* Use a Mercury monitor to determine mercury levels in the air.

* Check Mercury levels before, during and after cleanup.

* Mercury should be scooped together. Pic

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

k Mercury up with a syringe, pump tube or scoop.

* Put Mercury into a closed container to eliminate further emissions.

* Use sponges or powders to pick up any mer

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

Professional from academic institutions, pharmaceutical industries, health care indust

ury that is left. and help suppress vapors.

* Sweep the entire area with a special vacuum - Do Not use a regular vacuum

* After cleanup test for emissions to ensu

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

re all of the mercury has been removed.

* Waste containers with sealable lids must be used. Containers must be labeled appropriately for proper handling

It is al

.

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

most impossible to have no exposure to Mercury because it is almost a staple in our air. However in close quarters when a Mercury spill occurs, the amount of Mercu

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

Companies that provide selfless information through particip

ry vapors is extremely dangerous. Taking quick effective action using a self contained Mercury Spill Kit will curtail the amount of vapors and environmental damage

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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