This medication is an anti-viral drug used to treat infants and young children who have a severe lung infection caused by a certain virus (respiratory syncytial virus-RSV). Nearly all children become infected with this virus before they are 3 years old. Most cases are mild and do not require anti-viral drugs. This medication is used to treat severe RSV infections that need treatment in a hospital.

Ribavirin for inhalation is not recommended for use in adults.

This medication is given by a health care professional. It is given by continuous inhalation as directed by the doctor, usually for 12 to18 hours a day for 3 to 7 days. A special machine (small-particle aerosol generator) is used to make a mist, which is then inhaled through the mouth or nose.

Health care workers providing care to patients receiving this medication should learn all precautions for handling/giving this medication (such as wearing a mask, room ventilation). The manufacturer recommends that health care workers who are pregnant should consider avoiding direct care of patients using this medication. This medication must not be used during pregnancy since it may harm an unborn baby. Consult the manufacturer's package or the hospital/occupational safety guidelines for details.

Chest soreness may occur. Redness/irritation of the eye or eyelid may also occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

Remember that this medication has been prescribed because the doctor has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor right away if your child has any serious side effects, including:

• pale/bluish skin around the mouth/lips/fingernails
• worsening of breathing trouble
• slow/fast/irregular heartbeat

Get medical help right away if your child has any very serious side effects, including:

• fainting
• seizure

This medication may rarely cause anemia, usually within 1 to 2 weeks after treatment is started. Tell the doctor right away if you notice any symptoms of anemia such as unusual tiredness or fast/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before your child receives ribavirin for inhalation, tell the doctor or pharmacist if your child is allergic to it; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of:

• breathing disorders (such as asthma)

Before having surgery, tell the doctor or dentist about all the products your child uses (including prescription drugs, nonprescription drugs, and herbal products).

This product is not usually used by adults. It is unlikely to be used during pregnancy or breastfeeding. Consult your doctor if you have any questions about this product. (See also health care worker information in How to Use section.)

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• certain HIV drugs (didanosine, stavudine, zidovudine)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as lung function, blood counts) should be done while your child is using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If a dose is interrupted or stopped, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital and will not be stored at home.