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VIRAZOLE (RIBAVIRIN) AEROSOL 6G
Active substance(s): RIBAVIRIN
Virazole® 6 g Aerosol
Read all of this leaflet carefully before you start
using this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor, pharmacist or nurse.
• If you get any side effects, talk your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
In this leaflet:
an Aiolos Nebuliser) through which
Virazole is given, 5 to 10 minutes before
visitors see the patient.
Pregnancy, breast-feeding and
It is especially important for women who are
pregnant, trying to become pregnant, or who are
breast-feeding and sexually active men, to avoid
exposure to Virazole Aerosol. This is because the
risk of Virazole Aerosol c ausing harm to the unborn
baby is unknown.
1. What Virazole is and what it is used for
2. What you need to know before you use
Virazole Aerosol contains latex rubber
3. How Virazole Aerosol is given
4. Possible side effects
5. How Virazole Aerosol is stored
6. Further information
Other medicines and Virazole aerosol
1. WHAT VIRAZOLE IS AND WHAT IT IS
Virazole belongs to a group of medicines called
antivirals. Antiviral agents are used to treat viruses
which cause infections. Virazole is used to treat a
virus called Respiratory Syncytial Virus (RSV).
This virus infects the lungs. Virazole Aerosol is
only to be used in babies and children.
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE VIRAZOLE AEROSOL
Do not use Virazole Aerosol
If you are allergic to ribavirin
Warnings and precautions
Virazole Aerosol is given to patients using a mask
or a hood. It is possible that some of the Virazole
may escape the mask or hood and lead to other
people (e.g. visitors to the patient, doctors and
nurses) being accidentally exposed to Virazole and
breathing in the medicine.
To minimise unnecessary exposure to Virazole the
doctor or nurse should turn off the machine (called
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The container of this medicine contains latex
rubber, which may cause severe allergic reactions
Tell the doctor or nurse if you know that the patient
is taking or has recently taken any other medicines,
including medicines obtained without a prescription.
3. HOW VIRAZOLE AEROSOL IS GIVEN
Virazole Aerosol is used only in a hospital and is
administered by a doctor or nurse.
Virazole Aerosol is usually given to patients using a
mask or a hood. To administer Virazole, the doctor
or nurse dissolves the Virazole powder in sterile
water. This solution is then aerosolised (converted
into a fine mist of droplets) using a device
(equipment) called an Aiolos Nebuliser. The Aiolos
Nebuliser is connected to a face mask or hood so
that the patient can breathe in the aerosol (fine
droplets) into the infected lungs.
Patients who are on a ventilator to help them
breathe will be monitored closely by the nurse or
doctor during treatment with Virazole to prevent
build up of Virazole fluid in the tubing associated
with the ventilator equipment.
The usual dose is one vial of Virazole (equivalent
to 6 g of ribavirin), inhaled each day over a period
of 12 to 18 hours. Usually the treatment is given
over 3 days. Sometimes the doctor may decide to
treat the patient for up to 7 days.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Virazole can cause side effects,
although not everybody gets them.
It is very important that you immediately seek
medical advice if hypersensitivity occurs.
Tell your doctor, pharmacist or nurse if you
develop any of the following side effects:
Uncommon (may affect up to 1 in 100 people):
Abnormal liver functioning
Rare (may affect up to 1 in 1,000 people):
Decrease in the number of red blood cells (that may
cause fatigue, shortness of breath, dizziness),
headache, red and itchy eyes, heart attack,
pneumonia, collapsed lung, sore throat.
Very rare (may affect up to 1 in 10,000 people):
Shortness of breath, cough, slow or shallow
breathing, rapid or deep breathing, you stop
Not known (frequency cannot be estimated from
Changes in the way your heart beats, low or high
blood pressure, a tight chest, nausea, vomiting,
stomach pain, rash, skin irritation, itchy skin, red skin.
Visitors and hospital staff may be accidentally
exposed to Virazole Aerosol (see Section 2,
“WHAT YOU NEED TO KNOW BEFORE YOU
USE VIRAZOLE AEROSOL”). This can cause
headache, wheezing, fever, and nasal congestion.
These effects are most likely to happen in the
doctors or nurses giving Virazole Aerosol to the
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide
more information on the safety of this medicine.
This product should not be used after
the expiry date shown on the box and
Virazole vials. The expiry date refers
to the last day of that month.
Once Virazole has been mixed with
sterile water it should be used within
Medicines should not be disposed of
via wastewater or household waste.
The pharmacist should provide instructions as to
how to dispose of medicines no longer r equired.
These measures will help to protect the
6. FURTHER INFORMATION
What Virazole contains
• The active substance is ribavirin. Each vial of
Virazole contains 6 g of ribavirin.
• There are no other ingredients.
What Virazole looks like and contents
of the pack
Virazole is supplied in packs of three vials.
Each vial contains 6 g of ribavirin
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd.
Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford,
CM22 6PU, UK
Labiana Pharmaceuticals S.L.U.,
08757-Corbera de Llobregat
For any information about this medicine,
please contact the Marketing Authorisation Holder.
This leaflet was last revised in August 2014.
5. HOW VIRAZOLE AEROSOL IS STORED
All medicines should be kept out of the reach and
sight of children.
Hospital staff should store Virazole in a dry place
below 25 ºC.
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Studio Oberländer • Rubensstrasse 33 • 60596 Frankfurt am Main • Germany
Tel. +49 69 631520-85 • Fax +49 69 631520-87 • E-Mail: email@example.com
MEDA Pharma GmbH & Co. KG
Virazole 6g Aerosol
Pharma Code: 73E0EUC
190 x 252 mm
11,0 / 13,5 p
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09. 10. 2014