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VIRAZOLE (RIBAVIRIN) AEROSOL 6G

Active substance(s): RIBAVIRIN

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Patient Information Leaflet

Virazole® 6 g Aerosol
Ribavirin

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
fertility

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

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
USED FOR
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.

09.10.14 09:16

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
breathing.
Not known (frequency cannot be estimated from
available data):

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
patient.
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:
www.mhra.gov.uk/yellowcard
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
24 hours.
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
environment.
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
white powder.
Marketing Authorisation Holder

Meda Pharmaceuticals Ltd.
Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford,
CM22 6PU, UK
Manufacturer

Labiana Pharmaceuticals S.L.U.,
Casanova 27-31
08757-Corbera de Llobregat
(Barcelona), Spain
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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34973E0EU-C00
56UK2028103-00-R

09.10.14 09:16

Studio Oberländer • Rubensstrasse 33 • 60596 Frankfurt am Main • Germany
Tel. +49 69 631520-85 • Fax +49 69 631520-87 • E-Mail: info@studio-oberlaender.de
Gebrauchsinformation

MOCK-UP

Hersteller:

MEDA Pharma GmbH & Co. KG

Benutzte Farben:

Produkt:

Virazole 6g Aerosol

Schwarz

Meda-Nr.

56UK2028103-00-R

Pharma Code: 73E0EUC
Item Code:

34973E0EU-C00

Land:

Größe:

190 x 252 mm

Korrektur: 4.

Text:

11,0 / 13,5 p

Datum:

0113_GI_Virazole 6g_56UK2028103-00-R.indd 3

United Kingdom

09. 10. 2014

09.10.14 09:16

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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