I Suggest - Home and Family

Now that your bundle of joy has arrived, it is your responsibility to keep her safe and healthy.

Immunizations/vaccinations protect your baby from serious and some l

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

ife-threatening illnesses. They boost your baby's immunity and help her make antibodies to combat infections.

Some vaccination myths busted

If all the children in h

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

Examples of combination products may in

is school are immunized, my child cannot get sick.

The chances of acquiring an infection are reduced if everyone else is immunized. But imagine what would happen if

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

everyone had the same bright idea! Protect your child with a shot and help prevent the spread of disease as well.

Vaccines often cause the diseases they are supposed

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

to prevent!

Vaccines are prepared using killed or weakened germs to prepare your child respond to the 'real' ones. Vaccine-induced disease is extremely rare.

My bab

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

Combination pro

y need not be vaccinated against the diseases, which are uncommon in my geographical region.

Germs know no geographical boundaries. They can spread via travel and im

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

migration. If your child is not protected against a particular disease, he can acquire it if exposed to the germs.

Too many shots will overburden my baby's immune sy

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

stem.

A normal baby's immune system is equipped to handle vaccines as well as the natural microbes she is exposed to everyday.

ABC of baby's first shots

The DTaP v

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

ccine defends your child against three diseases: Diphtheria, an infection that blocks the airways and can affect the heart and nerves, Tetanus or 'lock-jaw' and Pertu

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

ssis, commonly known as whooping cough.

Three common infections Measles, Mumps and Rubella (German Measles) are taken care of by the MMR vaccine.

Hib vaccine preven

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

ts meningitis, a serious infection of the membranes covering the brain caused by a bug called Haemophilus influenzae (Type b).

PCV vaccine protects your child from p

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

Following aspects would a

neumonia, meningitis and other serious infections that can be caused by another germ Pneumococcus.

You need to vaccinate your child against Hepatitis B (Hep B vaccin

dd to the challenges in developing combination products:

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

), a viral infection that can cause chronic liver diseases like cirrhosis and liver cancer.

Polio, an infection with serious complications like paralysis can be aver

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

ted by the IPV vaccine or Oral polio drops.

Your child might also be given the varicella vaccine for chickenpox and annual flu shots to thwart influenza.

Confirm th

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

e immunization schedule with your doctor, since it may vary in different countries. Maintain an immunization card for your baby to know which shot is due, when. Marki

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

ng those important dates on your calendar ensures you don't forget them.

You will also need this record when you enroll your child in a baby-care center or school.

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

Professional from academic institutions, pharmaceutical industries, health care indust

hat about immunization side effects?

Most babies will only have minor immunization side effects like fever, soreness at the injection site or mild rash. An ice pack

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

applied to the site will reduce the swelling. You doctor might prescribe acetaminophen or ibuprofen to reduce fever and pain.

Serious allergic reactions are very rar

.

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 and occur within minutes to hours of the shot. Call your doctor immediately if you observe any difficulty in breathing, wheezing, fainting, weakness, hives or exces

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

Companies that provide selfless information through particip

sive crying.

Vaccinations may be an unpleasant experience for your baby (more so for you), but a few tears now will go a long way in keeping her healthy all her life

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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