Virazole (Ribavirin) Aerosol 6g
Patient Information Leaflet neso
Patient Information Leaflet neso
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:
1. What Virazole is and what it is used for
2. What you need to know before you use Virazole Aerosol
3. How Virazole Aerosol is given
4. Possible side effects
5. How Virazole Aerosol is stored
6. Further information
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
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 causing harm to the unborn baby is unknown.
Virazole Aerosol contains latex rubber
The container of this medicine contains latex rubber, which may cause severe allergic reactions Other medicines and Virazole aerosol
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 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.
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 °C.
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 required. 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.
neDO
34973E0EU-C00
56UK2028103-00-R
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GroBe: |
190 x 252 mm |
Korrektur: 4. | |
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Text: |
11,0 / 13,5 p |
Datum: 09. 10. 2014 |
0113_GI_Virazole 6g_56UK2028103-00-R.indd 3 09.10.14 09:16