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|Vanceril 84 mcg Double Strength Inhalation

CORTICOSTEROIDS (Inhalation)

Some commonly used brand names are:

In the U.S.—

• AeroBid ³
• AeroBid-M ³
• Azmacort ⁴
• Beclovent ¹
• Pulmicort Respules ²
• Pulmicort Turbuhaler ²
• Qvar ¹
• Vanceril ¹
• Vanceril 84 mcg Double Strength ¹

In Canada—

• Azmacort ⁴
• Beclodisk ¹
• Becloforte ¹
• Beclovent ¹
• Beclovent Rotacaps ¹
• Bronalide ³
• Qvar ¹
• Pulmicort Nebuamp ²
• Pulmicort Turbuhaler ²
• Vanceril ¹

Other commonly used names are: Beclomethasone dipropionate; Beclomethasone; Beclomethasone dipropionate

Category

• Anti-inflammatory, inhalation—Beclomethasone; Budesonide; Flunisolide; Triamcinolone
• Antiasthmatic—Beclomethasone; Budesonide; Flunisolide; Triamcinolone

Description

Inhalation corticosteroids (kor-ti-koe-STER-oids) are cortisone-like medicines. They are used to help prevent the symptoms of asthma. When used regularly every day, inhalation corticosteroids decrease the number and severity of asthma attacks. However, they will not relieve an asthma attack that has already started.

Inhaled corticosteroids work by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

This medicine may be used with other asthma medicines, such as bronchodilators (medicines that open up narrowed breathing passages) or other corticosteroids taken by mouth.

Inhalation corticosteroids are available only with your doctor"s prescription, in the following dosage forms:

• Inhalation
• Beclomethasone
  • Aerosol (U.S. and Canada)
  • Capsules for inhalation (Canada)
  • Powder for inhalation (Canada)
• Beclomethasone dipropionate HFA
  • Aerosol (U.S. and Canada)
• Budesonide
  • Powder for inhalation (U.S. and Canada)
  • Suspension for inhalation (U.S. and Canada)
• Flunisolide
  • Aerosol (U.S. and Canada)
• Triamcinolone
  • Aerosol (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For inhalation corticosteroids, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to corticosteroids. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Although studies in animals have shown that inhaled corticosteroids cause birth defects and other problems, in humans these medicines, when used in regular daily doses during pregnancy to keep the mother"s asthma under control, have not been reported to cause breathing problems or birth defects in the newborn. Also, corticosteroids may prevent the effects of poorly controlled asthma, which are known to be harmful to the baby. Before taking an inhaled corticosteroid, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether inhaled corticosteroids pass into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Inhalation corticosteroids have been tested in children and, except for the possibility of slowed growth, in low effective doses, have not been shown to cause different side effects or problems than they do in adults.

Studies have shown that slowed growth or reduced adrenal gland function may occur in some children using inhaled corticosteroids in recommended doses. However, poorly controlled asthma may cause slowed growth, especially when corticosteroids taken by mouth are needed often. Your doctor will want you to use the lowest possible dose of an inhaled corticosteroid that controls asthma. This will lessen the chance of an effect on growth or adrenal gland function. It is also important that children taking inhaled corticosteroids visit their doctors regularly so that their growth rates may be monitored.

Regular use of inhaled corticosteroids may allow some children to stop using or decrease the amount of corticosteroids taken by mouth. This also will reduce the risk of slowed growth or reduced adrenal function.

Children who are using inhaled corticosteroids in large doses should avoid exposure to chickenpox or measles. When a child is exposed or the disease develops, the doctor should be contacted and his or her directions should be followed carefully.

Before this medicine is given to a child, you and your child"s doctor should talk about the good this medicine will do as well as the risks of using it. Follow the doctor"s directions very carefully to lessen the chance that unwanted effects will occur.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of inhaled corticosteroids in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of inhaled corticosteroids. Make sure you tell your doctor if you have any other medical problems, especially:

• Cirrhosis (liver disease)—The effect of inhaled corticosteroids may be stronger in patients with this disease
• Glaucoma—Use of this medicine may cause the pressure in the eye to be increased
• Hypothyroidism (decreased production of thyroid hormone)—The effect of inhaled corticosteroids may be stronger in patients with this condition
• Infections, untreated—Using this medicine while an infection is present and is not being treated may cause the infection to get worse.
• Osteoporosis (bone disease)—Inhaled corticosteroids in high doses may make this condition worse in women who are past menopause and who are not receiving an estrogen replacement

• Tuberculosis (history of)—Use of this medicine may cause a tuberculosis infection to occur again

Proper Use of This Medicine

Inhaled corticosteroids will not relieve an asthma attack that has already started. However, your doctor may want you to continue taking this medicine at the usual time, even if you use another medicine to relieve the asthma attack.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects. Do not stop taking this medicine abruptly. This medicine should be discontinued only under the supervision of your doctor.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor . Up to 4 to 6 weeks may pass before you begin to notice improvement in your condition. It may take several months before you feel the full effects of this medicine. This may not take as long if you have already been taking certain other medicines for your asthma.

Gargling and rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing. Your doctor may also want you to use a spacer device to lessen these problems.

Inhaled corticosteroids are used with a special inhaler and usually come with patient directions. Read the directions carefully before using this medicine . If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly .

For patients using beclomethasone, flunisolide, or triamcinolone inhalation aerosol:

• When you use the inhaler for the first time, or if you have not used it in a while, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, test or prime it.
• To test or prime most inhalers:
  • Insert the metal canister firmly into the clean mouthpiece according to the manufacturer"s instructions. Check to make sure the canister is placed properly into the mouthpiece.
  • Take the cover off the mouthpiece and shake the inhaler three or four times.
  • Hold the inhaler well away from you at arm"s length and press the top of the canister, spraying the medicine into the air two times. The inhaler will now be ready to provide the right amount of medicine when you use it.
• To use most inhalers:
  • Using your thumb and one or two fingers, hold the inhaler upright with the mouthpiece end down and pointing toward you.
  • Take the cover off the mouthpiece. Check the mouthpiece and remove any foreign objects. Then gently shake the inhaler three or four times.
  • Hold the mouthpiece away from your mouth and breathe out slowly to the end of a normal breath.
  • Use the inhalation method recommended by your doctor:
    • Open-mouth method—Place the mouthpiece about 1 or 2 inches (2 finger widths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so that the spray does not hit the roof of your mouth or your tongue.
    • Closed-mouth method—Place the mouthpiece in your mouth between your teeth and over your tongue with your lips closed tightly around it. Do not block the mouthpiece with your teeth or tongue.
  • Start to breathe in slowly through your mouth and, at the same time, press the top of the canister one time to get 1 puff of medicine. Continue to breathe in slowly for 3 to 5 seconds. Count the seconds while inhaling. It is important to press the top of the canister and breathe in slowly at the same time so the medicine gets into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly.
  • Hold your breath as long as you can up to 10 seconds. This gives the medicine time to settle in your airways and lungs.
  • Take the mouthpiece away from your mouth and breathe out slowly.
  • If your doctor has told you to inhale more than 1 puff of medicine at each dose, gently shake the inhaler again, and take the next puff, following exactly the same steps you used for the first puff. Press the canister one time for each puff of medicine.
  • When you are finished, wipe off the mouthpiece and replace the cap.
• Your doctor, nurse, or pharmacist may want you to use a spacer device with the inhaler. A spacer helps get the medicine into the lungs and reduces the amount of medicine that stays in your mouth and throat.
  • To use a spacer device with the inhaler:
    • Attach the spacer to the inhaler according to the manufacturer"s directions. There are different types of spacers available, but the method of breathing remains the same with most spacers.
    • Gently shake the inhaler and spacer three or four times.
    • Hold the mouthpiece of the spacer away from your mouth and breathe out slowly to the end of a normal breath.
    • Place the mouthpiece into your mouth between your teeth and over your tongue with your lips closed around it.
    • Press down on the canister top once to release 1 puff of medicine into the spacer. Within one or two seconds, start to breathe in slowly through your mouth for 3 to 5 seconds. Count the seconds while inhaling. Do not breathe in through your nose.
    • Hold your breath as long as you can up to 10 seconds.
    • Breathe out slowly. Do not remove the mouthpiece from your mouth. Breathe in and out slowly two or three times to make sure the spacer device is emptied.
    • If your doctor has told you to take more than 1 puff of medicine at each dose, gently shake the inhaler and spacer again and take the next puff, following exactly the same steps you used for the first puff. Do not spray more than 1 puff at a time into the spacer.
    • When you are finished, remove the spacer device from the inhaler and replace the cover of the mouthpiece.
• Clean the inhaler mouthpiece, and spacer at least once a week.
  • To clean the inhaler:
    • Remove the canister from the inhaler and set the canister aside.
    • Wash the mouthpiece, cap, and spacer with warm, soapy water. Then, rinse well with warm, running water.
    • Shake off the excess water and let the inhaler parts air-dry completely before putting the inhaler back together.
• Check with your pharmacist to see if you should save the inhaler piece that comes with this medicine after the medicine is used up. Refill units may be available at a lower cost. However, remember that the inhaler is meant to be used only for the medicine that comes with it. Do not use the inhaler for any other inhalation aerosol medicine, even if the cartridge fits.

For patients using beclomethasone capsules for inhalation:

• Do not swallow the capsules. The medicine will not work if you swallow it .
• To load the inhaler:
  • Make sure your hands are clean and dry.
  • Do not insert the capsule into the inhaler until just before you are ready to use this medicine.
  • Take the inhaler from its container. Hold the inhaler by the mouthpiece and twist the barrel in either direction until it stops.
  • Take a capsule from its container. Hold the inhaler upright with the mouthpiece pointing downward. Press the capsule, with the clear end first, firmly into the raised small hole.
  • Make sure the top of the capsule is even with the top of the hole. This will push the old used capsule shell, if there is one, into the inhaler.
  • Hold the inhaler on its side with the white dot facing up. Twist the barrel quickly until it stops. This will break the capsule into two halves so the powder can be inhaled.
• To use the inhaler:
  • Hold the inhaler away from your mouth and breathe out slowly to the end of a normal breath.
  • Keep the inhaler on its side and place the mouthpiece in your mouth. Close your lips around it, and tilt your head slightly back. Do not block the mouthpiece with your teeth or tongue.
  • Breathe in slowly through your mouth until you have taken a full deep breath.
  • Take the inhaler from your mouth and hold your breath as long as you can up to 10 seconds. This gives the medicine time to settle in your airways and lungs.
  • Hold the inhaler well away from your mouth and breathe out to the end of a normal breath.
  • If your doctor has told you to use a second capsule, follow the same steps you used for the first capsule.
  • When you have finished using the inhaler, pull the two halves of the inhaler apart and throw away the empty capsule shells. There is no need to remove the shell left in the small hole, except before cleaning.
  • Put the two halves of the inhaler back together again and place it into its container to keep it clean.
• To clean the inhaler:
  • Every two weeks, take the inhaler apart and wash the two halves of the inhaler in clean, warm water. Make sure the empty capsule shell is removed from the small raised hole.
  • Shake out the excess water.
  • Allow all parts of the inhaler to dry before you put it back together.
• The inhaler should be replaced every 6 months.

For patients using beclomethasone powder for inhalation:

• To load the inhaler:
  • Make sure your hands are clean and dry.
  • Do not insert the cartridge until just before you are ready to use this medicine.
  • Take off the dark brown mouthpiece cover and make sure the mouthpiece is clean.
  • Hold the white cartridge by the exposed corners and gently pull it out until you see the ribbed sides of the cartridge.
  • Squeeze the ribbed sides and take out the cartridge unit from the body of the inhaler.
  • Place the disk containing the medicine onto the white wheel with the numbers facing up. Allow the underside of the disk to fit into the holes of the wheel.
  • Slide the cartridge unit with wheel and disk back into the body of the inhaler. Gently push the cartridge in and pull it out again. The disk will turn.
  • Continue to turn the disk in this way until the number 8 appears in the side indicator window. Each disk has eight blisters containing the medicine. The window will display how many doses you have left after you use it each time, by counting down from 8. For example, when you see the number 1, you have one dose left.
  • To replace the empty disk with a full disk, follow the same steps you used to load the inhaler. Do not throw away the wheel when you discard the empty disk.
• To use the inhaler:
  • Hold the inhaler flat in your hand. Lift the rear edge of the lid until it is fully upright.
  • The plastic needle on the front of the lid will break the blister containing one inhalation of medicine. When the lid is raised as far as it will go, both the upper and the lower surfaces of the blister will be pierced. Do not lift the lid if the cartridge is not in the inhaler. Doing this will break the needle and you will need a new inhaler.
  • After the blister is broken open, close the lid. Keeping the inhaler flat and well away from your mouth, breathe out to the end of a normal breath.
  • Raise the inhaler to your mouth, and place the mouthpiece in your mouth.
  • Close your lips around the mouthpiece and tilt your head slightly back. Do not block the mouthpiece with your teeth or tongue. Do not cover the air holes on the side of the mouthpiece.
  • Breathe in through your mouth as fast as you can until you have taken a full deep breath.
  • Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out. This gives the medicine time to settle in your airways and lungs.
  • Hold the inhaler well away from your mouth and breathe out to the end of a normal breath.
  • Prepare the cartridge for your next inhalation. Pull the cartridge out once and push it in once. The disk will turn to the next numbered dose as seen in the indicator window. Do not pierce the blister until just before the inhalation.
• To clean the inhaler: Brush away the loose powder each day with the brush provided.
• The inhaler should be replaced every 6 months.

For patients using budesonide powder for inhalation:

• To prime the inhaler:
  • Unscrew the cover of the inhaler and lift it off.
  • Hold the inhaler upright with the brown piece pointing downward. Turn the brown piece of the inhaler in one direction as far as it will go. Then twist it back until it clicks. Repeat this step one more time and the inhaler will be primed.
  • Prime each new inhaler before using it the first time. After it has been primed, it is not necessary to prime it again, even if you put it aside for a long period of time.
• To load the inhaler:
  • Unscrew the cover of the inhaler and lift it off.
  • Hold the inhaler upright with the brown piece pointing downward. Turn the brown piece of the inhaler in one direction as far as it will go. Then twist it back until it clicks.
• To use the inhaler:
  • Hold the inhaler away from your mouth and breathe out slowly to the end of a normal breath.
  • Place the mouthpiece in your mouth and close your lips around it. Tilt your head slightly back. Do not block the mouthpiece with your teeth or tongue.
  • Breathe in quickly and evenly through your mouth until you have taken a full deep breath.
  • Hold your breath and remove the inhaler from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out. This gives the medicine time to settle in your airways and lungs.
  • Hold the inhaler well away from your mouth and breathe out to the end of a normal breath.
  • Replace the cover on the mouthpiece to keep it clean.
• This inhaler delivers the medicine as a very fine powder. You may not taste, smell, or feel this medicine.
• This inhaler should not be used with a spacer.
• When the indicator window begins to show a red mark, there are about 20 doses left. When the red mark covers the window, the inhaler is empty.

For patients using budesonide suspension for inhalation:

• This medicine is to be used in a power-operated nebulizer equipped with a face mask or mouthpiece. Your doctor will advise you on which nebulizer to use. Make sure you understand how to use the nebulizer. If you have any questions about this, check with your doctor.
• Any opened ampul should be protected from light. The medicine in an open ampul must be used promptly after the ampul is opened. Ampuls should be used within 2 weeks after the envelope containing them is opened.
• To prepare the medicine for use in the nebulizer:
  • Remove one ampul from the sheet of five units and shake it gently.
  • Hold the ampul upright. Open it by twisting off the wing.
  • Squeeze the contents of the ampul into the cup of the nebulizer. If you use only half of the contents of an ampul, add enough of the sodium chloride solution provided to dilute the solution.
  • Gently shake the nebulizer. Then attach the face mask to the nebulizer and connect the nebulizer to the air pump.
• To use the medicine in the nebulizer:
  • This medicine should be inhaled over a period of 10 to 15 minutes.
  • Breathe slowly and evenly, in and out, until no more mist is left in the nebulizer cup.
  • Rinse your mouth when you are finished with the treatment. Wash your face if you used a face mask.
• To clean the nebulizer:
  • After each treatment, wash the cup of the nebulizer and the mask or mouthpiece in warm water with a mild detergent.
  • Allow the nebulizer parts to dry before putting them back together again.

Dosing—The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

• For beclomethasone
• For inhalation aerosol:
  • For bronchial asthma:
    • Adults and children 12 years of age and older—
    • Children 6 to 12 years of age—
    • Children up to 6 years of age—Use and dose must be determined by your doctor.
• For capsules for inhalation or powder for inhalation:
  • For bronchial asthma:
    • Adults and teenagers 14 years of age and older—At first, 200 mcg three or four times a day. Then your doctor may reduce the dose, based on your condition.
    • Children 6 to 14 years of age—At first, 100 mcg two to four times a day. Then your doctor may reduce the dose, based on your condition.
    • Children up to 6 years of age—Use and dose must be determined by the doctor.

• For beclomethasone dipropionate HFA
• For inhalation aerosol:
  • For bronchial asthma:
    • Adults and children 12 years of age and older—
    • Children up to 5 years of age—Use and dose must be determined by your doctor.
    • Children 5 to 11 years of age—1 puff (40 mcg) two times a day.

• For budesonide
• For powder for inhalation:
  • For bronchial asthma:
    • Adults—200 to 800 micrograms (mcg) two times a day. A lower dose of 200 mcg or 400 mcg once daily, either in the morning or in the evening, may sometimes be used for mild to moderate asthma when the symptoms are well controlled. The higher doses generally are used for patients previously treated with other corticosteroids. Then your doctor may increase or decrease the dose, depending on your condition.
    • Children 6 years of age and older—At first, 200 mcg two times a day. Then your doctor may increase the dose to 400 mcg two times a day, depending on your condition. A lower dose of 200 mcg or 400 mcg once daily, either in the morning or in the evening, may sometimes be used for mild to moderate asthma when the symptoms are well controlled.
    • Children up to 6 years of age—Use and dose must be determined by the doctor.
• For suspension for inhalation:
  • For bronchial asthma:
    • Adults and children 8 years of age and older—1000 to 2000 micrograms (mcg) mixed with enough sterile sodium chloride solution for inhalation, if necessary, to make 2 to 4 milliliters (mL). This solution is used in a nebulizer for a period of ten to fifteen minutes. The medicine should be used two times a day.
    • Children 12 months to 8 years of age—250 to 500 mcg mixed with enough sterile sodium chloride solution for inhalation, if necessary, to make 2 to 4 mL. This solution is used in a nebulizer for a period of ten to fifteen minutes. The medicine should be used two times a day.
    • Children up to 12 months of age—Use and dose must be determined by the doctor.

• For flunisolide
• For inhalation aerosol:
  • For bronchial asthma:
    • Adults and children 4 years of age and older—500 micrograms (mcg) (2 puffs) two times a day, morning and evening.
    • Children up to 4 years of age—Use and dose must be determined by the doctor.

• For triamcinolone
• For inhalation aerosol:
  • For bronchial asthma:
    • Adults and children 12 years of age and older—At first, 200 micrograms (mcg) (2 puffs) two to four times a day. Then your doctor may reduce the dose, based on your condition. In severe asthma, your doctor may want you to take a higher dose.
    • Children 6 to 12 years of age—At first, 100 to 200 mcg (1 or 2 puffs) three or four times a day. Then your doctor may adjust your dose, based on your condition.
    • Children up to 6 years of age—Use and dose must be determined by the doctor.

Missed dose—If you miss a dose of this medicine, use it as soon as possible. Then use any remaining doses for that day at regularly spaced times.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the aerosol or suspension form of this medicine from getting too cold or freezing. This medicine may be less effective if the container is cold when you use it.
• The 84-mcg-per-metered-spray product of beclomethasone should not be stored for longer than 6 months after it has been removed from its moisture-protective pouch. After 6 months, any remaining medicine should be discarded.
• Do not puncture, break, or burn the aerosol container, even after it is empty.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your doctor if:

• You go through a period of unusual stress to your body, such as surgery, injury, or infection .
• You have an asthma attack that does not improve after you take a bronchodilator medicine.
• You are exposed to viral infections, such as chickenpox or measles.
• Signs of infection occur, especially in your mouth, throat, or lung .
• Your symptoms do not improve or if your condition gets worse .

Your doctor may want you to carry a medical identification card stating that you are using this medicine and that you may need additional medicine during times of emergency, a severe asthma attack or other illness, or unusual stress.

Before you have any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine .

For patients who are also regularly taking a corticosteroid by mouth in tablet or liquid form:

• Do not stop taking the corticosteroid taken by mouth without your doctor"s advice, even if your asthma seems better . Your doctor may want you to reduce gradually the amount you are taking before stopping completely to lessen the chance of unwanted effects.
• When your doctor tells you to reduce the dose, or to stop taking the corticosteroid taken by mouth, follow the directions carefully. Your body may need time to adjust to the change. The length of time this takes may depend on the amount of medicine you were taking and how long you took it. It is especially important that your doctor check your progress at regular visits during this time . Ask your doctor if there are special directions you should follow if you have a severe asthma attack, if you need any other medical or surgical treatment, or if certain side effects occur. Be certain that you understand these directions, and follow them carefully.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Additional side effects may occur if you take this medicine for a long time. Check with your doctor if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, some of the inhaled corticosteroids are used in certain patients with the following medical condition:

• Croup in children (budesonide)

Revised: 06/03/2003

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