I Advice - Health and Fitness

With my very first pregnancy I was diagnosed with Hyperemesis Gravidarum.

The medical definition: Excessive vomiting in pregnancy. Hyper means "ov

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

er"; emesis means "vomiting"; gravidarum means "pregnant state."

I have a different definition: Excessive, Severe, Extreme, Exhausting, Constant,

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

Examples of combination products may in

ontinuous, Life Changing nausea and vomiting in pregnancy. That is probably an understatement.

I’ve had severe morning sickness with all seven of

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

my healthy children. And with one that died at three months prenatal. Throwing up throughout the morning into the afternoon and continuing into the

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

evening was exhausting. I was admitted to the hospital several times for dehydration and so miserable from nausea for so long that I could not rem

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

Combination pro

mber what feeling good felt like.

After experiencing severe morning sickness 8 times, here are a few things I have learned;

12 WAYS YOU CAN HELP

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

A MOM COPE WITH MORNING SICKNESS (at any level of nausea):

1. Help with the duties and responsibilities that she is unable to do. Offer to do spec

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

fic jobs that would help her, or her family. Meals for her family, laundry, dishes, childcare....the bathroom (ugh!).

2. Give her a card of encour

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

agement. A small token of kindness can go a long way to encourage her.

3. If talking with someone is a good distraction for her, call or visit her

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

often. The days and nights can go by very slowly.

4. Give her something pretty to look at. Beautiful things can be uplifting to see. Especially if

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

she grounded to one part of the house for most of the day.

5. Read to her. Write her a poem. Sing to her, if she wants you to. It’s nice for her

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

Following aspects would a

to know that she is remembered, as she feels the world going on without her.

6. Be aware...her nose is most likely extremely sensitive. Don not co

dd to the challenges in developing combination products:

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

e near her if you have the slightest scent of cologne, aftershave, perfume, fabric softener, smoke, etc...on you.

7. Use encouraging words and te

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

nder comments. This can be an emotionally trying experience and all conversations need to be optimistic and focus on the positive.

8. Humor can

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

e a welcome addition to her day. A funny book, movie, or even yourself ( can you tell a joke?)…may bring a smile. Making her laugh can bring much

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

eeded relief.

9. Be supportive. Even though you cannot truly relate…It's real and miserable...try to understand how she feels!

10. In extreme cas

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

Professional from academic institutions, pharmaceutical industries, health care indust

es: Change her bedding, towels, throw-up bowl.....I know it may be gross! But..........you wanted to know how to help=)

11. Read "Never Say This..

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

" and "What Not To Assume"" at www.MyMorningSickness.com

12. If anything sounds good to her....get it now!

These 12 ideas can greatly benefit th

.

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

e sick mom who has anywhere from a slight to severe case of nausea. If the mom has been diagnosed with HG, monitor her closely and make sure she ge

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

Companies that provide selfless information through particip

s the medical attention she needs from a caring health practitioner. It is a serious condition.

OK, now you know what to do......let's get started

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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