Virazole
6 g Aerosol
Ribavirin
- Keep this leaflet. You may need to read it again.
- This leaflet tells you about Virazole Aerosol.
- It does not contain all the information about Virazole.
- If you have any questions or are unsure of anything ask the doctor or nurse.
- If any side effect occurs and this becomes serious, tell the doctor or hospital pharmacist.
In this leaflet:
- 1. What Virazole is and what it is used for
- 2. Before Virazole Aerosol is given
- 3. How Virazole Aerosol is given
- 4. Possible side effects
- 5. How Virazole Aerosol is stored
- 6. Further information
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.
Before Virazole Aerosol Is Given
Take special care with Virazole
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 SPAG or Aiolos
Nebuliser) through which Virazole is given, 5 to 10 minutes before visitors see the patient. It is especially important for women who are pregnant, trying to become pregnant, or who are breast-feeding, to avoid exposure to Virazole Aerosol. This is because the risk of Virazole Aerosol causing harm to the unborn baby is unknown.
Using other medicines
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.
If adults are given Virazole
The following information is included in case an adult is given this medicine: Virazole should not be used in women who are pregnant, may become pregnant, or who are breast-feeding.
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 a Small Particle Aerosol Generator (SPAG) or a device called an Aiolos
Nebuliser. The SPAG or 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.
Possible Side Effects
Like all medicines, Virazole can cause side effects, although not everybody gets them.
The following have occasionally been reported during treatment with Virazole:
- Pneumonia
- Breathing becomes more difficult
- Collapse of the lung
- Anaemia (a reduction in red blood cells that can make the skin pale and cause weakness or breathlessness) has been reported when ribavirin has been given by injection and orally. Anaemia may also arise rarely with Virazole Aerosol.
It is not known whether Virazole caused all these problems.
If you are concerned about these side effects or if you notice any side effects not listed in this leaflet,
please tell the doctor or hospital pharmacist.
Visitors and hospital staff may be accidentally exposed to Virazole Aerosol (see Section 2, “Before Virazole Aerosol is Given”). 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.
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 25ºC.
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 waste-water 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.
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
Manufacturer
For any information about this medicine, please contact the Marketing Authorisation Holder.
This leaflet was last revised in June 2009.
34973E0EU-B00
562104V2103UK00
No comments:
Post a Comment