Business Dump - Travel and Leisure

For some countries no immunizations are necessary, but the further off the beaten track you go the more necessary it is to take precautions. Be aware that there is often a greater risk of disease with children and in pregnancy.

Leave plenty of time to get y

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

our vaccinations before you set off: some of them require an initial shot followed by a booster, and some vaccinations should not be given together. It is recommended you seek medical advice at least six weeks prior to travel.

Record all vaccinations on a I

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

Examples of combination products may in

ternational Health Certificate, which is available from your physician or government health department.

Discuss your requirements with your doctor, vaccinations which may be required include:

Cholera:

Despite its poor protection, in some situations it may

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

be wise to have the cholera vaccine eg for the trans-Africa traveler. Very occasionally travelers are asked by immigration officials to present a certificate, even though all countries and the WHO have dropped a cholera immunisation as a health requirement.

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

You might be able to get a certificate without having the injection from a doctor or health centre sympathetic to the vagaries of travel in Africa.

Hepatitis A:

The most common travel-acquired illness after diarrhea which can put you out of action for week

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

Combination pro

. Havrix is a vaccination which provides long term immunity (possibly more than 10 years) after an initial injection and a booster at six to 12 months. Gamma globulin is not a vaccination but is ready-made antibody collected from blood donations. It should b

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

e given close to departure because, depending on the dose, it only protects for two to six months.

Hepatitis B:

This disease is spread by blood or by sexual activity. Travelers who should consider a hepatitis B vaccination include those visiting countries

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

here there are known to be many carriers, where blood transfusions may not be adequately screened or where sexual contact is a possibility. It involves three injections, the quickest course being over three weeks with a booster at 12 months.

Japanese B Ence

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

phalitis:

This mosquito-borne disease is not of great risk to travelers. It occurs in Asia. Consider the vaccination if spending a month or longer in a high risk area, making repeated trips to a risk area or visiting during an epidemic. It involves three in

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

ections over 30 days. The vaccine is expensive and has been associated with serious allergic reactions so the decision to have it should be balanced against the risk of contracting the illness.

Meningococcal Meningitis - Healthy people carry this disease; i

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

is transmitted like a cold and you can die from it within a few hours. There are many carriers and vaccination is recommended for travelers to certain parts of Asia, India, Africa and South America. It is also required of all Haj pilgrims entering Saudi Ara

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

Following aspects would a

bia. A single injection will give good protection for three years. The vaccine is not recommended for children under two years because they do not develop satisfactory immunity from it.

Polio:

Polio is a serious, easily transmitted disease, still prevalent

dd to the challenges in developing combination products:

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

in many developing countries. Everyone should keep up to date with this vaccination. A booster every 10 years maintains immunity.

Rabies:

Vaccination should be considered by those who will spend a month or longer in a country where rabies is common, especi

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

ally if they are cycling, handling animals, caving, traveling to remote areas, or for children (who may not report a bite). Pre-travel rabies vaccination involves having three injections over 21 to 28 days. If someone who has been vaccinated is bitten or scr

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

tched by an animal they will require two booster injections of vaccine, those not vaccinated require more.

Tetanus & Diphtheria:

Tetanus can be a fatal wound infection and diphtheria can be a fatal throat infection Everyone should have these vaccinations.

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

fter an initial course of three injections, boosters are necessary every 10 years.

Tuberculosis:

TB risk to travelers is usually very low. For those who will be living with or closely associated with local people in high risk areas such as Asia, Africa and

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

Professional from academic institutions, pharmaceutical industries, health care indust

some parts of the Americas and Pacific, there may be some risk. As most healthy adults do not develop symptoms, a skin test before and after travel to determine whether exposure has occurred may be considered. A vaccination is recommended for children livin

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

in these areas for three months or more.

Typhoid:

This is an important vaccination to have where hygiene is a problem. Available either as an injection or oral capsules.

Yellow Fever:

Yellow fever is now the only vaccine which is a legal requirement for

.

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

entry into many countries, usually only enforced when coming from an infected area. Protection lasts 10 years and is recommended where the disease is endemic, eg Africa and South America. You usually have to go to a special yellow fever vaccination centre.

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

Companies that provide selfless information through particip

accination poses some risk during pregnancy but if you must travel to a high-risk area it is advisable; note that people allergic to eggs may not be able to have this vaccine.

Before you travel discuss immunizatio with your doctor.

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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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