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Tamiflu is a medicine that is to be taken when you are infected by the influenza virus. Now that I have covered what Tamiflu is briefly I will go into the details and then give you a study on

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

the effects of Tamiflu when you are pregnant and lactating because this too is an important part of pregnancy.

How Tamiflu treats the Flu

The main ingredient of the Tamiflu medicine is

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

Examples of combination products may in

the Oseltamivir phosphate. This medicine belongs among a group of medications which is called the neuraminidase inhibitors. The medicine acts in this way; it attacks the influenza virus in th

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

body and stops it from spreading inside the body. This is a great cure. You will feel the symptoms reducing within a span of two days. Most other medications for flu go for the symptoms 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

try to cure the symptoms or mask them. So you can simply say that Tamiflu treats the flu at the source of the infection.

Tamiflu Dosage

For knowing its effects on pregnancy one should

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

Combination pro

know the dosage of the capsule. Each capsule of the medication contains seventy five grams of the active drug. The capsule is a grey and light yellow capsule. For persons afflicted by the fl

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

, they re supposed to take two capsules orally; one capsule in the morning and one in the evening. For people who have been exposed to the influenza virus and they who are taking this medicine

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

as a preventive measure against the flu should take only one seventy five grams capsule in a day. In the earlier case the person is prescribed this medicine for a period of five days and in t

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

e second case for a period of seven days. So this is the approximate dosage of what a pregnant lady will have if she is faced with the consequences of taking Tamiflu.

Studies conducted on

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

he medication for pregnancy

Now I will be discussing the studies conducted on the medication for pregnancy. The FDA has categorized this drug under the medical category “C”. The data col

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

ected is insufficient to give a clear picture on the effects of Tamiflu on pregnant women and her developing fetus. As there was no human specimens in the tests initial tests were conducted on

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

Following aspects would a

rats. Then in a later stage we switched over to rabbits. The pregnant rats were given Tamiflu in different proportions. They were administered dosages of fifty, two hundred and fifty and one

dd to the challenges in developing combination products:

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

thousand five hundred milligrams for per kilogram per day. The rabbits were given fifty, one hundred and fifty and five hundred milligrams for every kilogram per day. Both these animals were

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

iven the medication by the oral route. The relative exposure rates were accounted for. In a rat the exposure for these doses was two, thirteen and a hundred times. In the case of the rabbit

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

it was four, eight and a fifty times. Pharmacokinetic study showed that fetal exposure was there in both the cases. In the case of the rats, the maternal toxicity was minimal that too in the

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

ne thousand five hundred milligram per kilogram per day group. The rabbit showed slight maternal toxicities. Skeletal abnormalities were observed in the cases where the doses were increased.

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

Professional from academic institutions, pharmaceutical industries, health care indust

However the abnormality remained in the background.

The studies came to the conclusion as such, “Tamiflu should be prescribed to a pregnant woman only if the case justifies the potential benef

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

t of the fetus.”

A similar study was conducted on rats and rabbits for the effects of Tamiflu in lactating mothers. It was observed that Oseltamivir and Oseltamivir carboxylate are given out

.

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

n the milk. A similar human study could not be conducted due to the lack of lactating mothers infected by the flu who are willing to contribute towards experimentation.

Anyway the conclusion

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

Companies that provide selfless information through particip

rawn is also the same as that drawn for the pregnancy test. It was again cited “Tamiflu should be prescribed to a pregnant woman only if the case justifies the potential benefit of the foetus.

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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