Irish Medicines Board update on Pandemic A(H1N1)v vaccines - Drug Safety Newsletter - Special Edition (19/10/2009)
Irish Medicines Board update on Oseltamivir (Tamiflu) and Zanamivir (Relenza) - Drug Safety Newsletter - Special Edition (30/9/2009)
Anti-viral medicines are used for the early treatment and prevention of influenza infection. Pending the availability of virus-specific vaccines two medicines Tamiflu® (oseltamivir) and Relenza® (zanamivir) are expected to be widely used in the event of an influenza pandemic with Pandemic (H1N1) 2009. These medicines when taken early in the illness (within 48 hours) can both shorten the duration of infection and reduce the serious complications of influenza.
Information on how these medicines should be used and a list of the known possible side effects can be found in the Summary of Product Characteristics (SmPC) for these products (listed hereunder).
Tamiflu (oseltamivir) - Summary of Product Characteristics
Tamiflu is taken by mouth. The European Medicines Agency (EMEA) has reviewed the use of Tamiflu (ostelamivir) and Relenza (zanamivir).
Anti-viral medicines are used for the early treatment and prevention of influenza infection. Pending the availability of virus-specific vaccines two medicines (oseltamivir) and (zanamivir) are expected to be widely used in the event of an influenza pandemic with Pandemic (H1N1) 2009. These medicines when taken early in the illness (within 48 hours) can both shorten the duration of infection and reduce the serious complications of influenza.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that during the pandemic:-
- Tamiflu can be used in children younger than one year of age -
- Tamiflu can be used in women who are pregnant or breastfeeding -
- Tamiflu 75mg Capsule Summary of Product Characteristics
- Tamiflu 75mg Capsule Patient Information Leaflet
- Tamiflu Oral Suspension Summary of Product Characteristics
- Tamiflu Oral Suspension Patient Information Leaflet
- Tamiflu 30mg Hard Capsule Summary of Product Characteristics
- Tamiflu 45mg Hard Capsule Summary of Product Characteristics
- Tamiflu 30mg/45mg Hard Capsule Patient Information Leaflet
On October 1st 2009 the EMEA recommended updating Tamiflu product information to give more information on the use of Tamiflu in the treatment of influenza in children under the age of 6 months and in post-exposure prevention of influenza in children under the age of one year during a pandemic influenza outbreak.
Information on the extension of shelf life for Tamiflu from 5 to 7 years click here to view
Information on recommendations for Tamiflu use in children under 1 year (21/10/2009)
Relenza - Summary of Product Characteristics (SmPCs)
Relenza is taken by inhalation. The European Medicines Agency (EMEA) has reviewed the use of Tamiflu (ostelamivir) and Relenza (zanamivir). The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that during the pandemic:-
- Relenza can be used in women who are pregnant or breastfeeding -
Relenza inhalation powder Summary of Product Characteristics
Relenza inhalation powder Patient Information Leaflet
As with all medicines, Tamiflu and Relenza may cause side effects. The wider prescribing of these medicines in a pandemic situation may reveal rare effects that have not previously been observed.
Updated information for oseltamivir (Tamiflu®) and zanamivir (Relenza®) will be published as necessary on the IMB website at www.imb.ie and on the European Medicines Agency website