Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Glaxo Wellcome UK Ltd trading as GlaxoSmithKline UK, 980 Great West Road, Brentford, Middlesex, TW8 9GS
Relenza is indicated for treatment of both influenza A and B in adults and children (≥5 years) who present with symptoms typical of influenza when influenza is circulating in the community.
Relenza is indicated for post-exposure prophylaxis of influenza A and B in adults and children (≥5 years) following contact with a clinically diagnosed case in a household (see section 5.1 for children aged 5-11 years). In exceptional circumstances, Relenza may be considered for seasonal prophylaxis of influenza A and B during a community outbreak (e.g. in case of a mismatch between circulating and vaccine strains and a pandemic situation).
Relenza is not a substitute for influenza vaccination. The appropriate use of Relenza for prevention of influenza should be determined on a case-by-case basis depending on the circumstances and the population requiring protection.
The use of antivirals for the treatment and prevention of influenza should take into consideration official recommendations, the variability of epidemiology, and the impact of the disease in different geographical areas and patient populations.
Inhaled drugs, e.g. asthma medication, should be administered prior to administration of Relenza (see section 4.4).
Treatment should begin as soon as possible, within 48 hours after onset of symptoms for adults, and within 36 hours after onset of symptoms for children.
Relenza is for administration to the respiratory tract by oral inhalation only, using the Diskhaler device provided. One blister should be utilised for each inhalation.
The recommended dose of Relenza for treatment of influenza in adults and children from the age of 5 years is two inhalations (2 × 5 mg) twice daily for five days, providing a total daily inhaled dose of 20 mg.
The recommended dose of Relenza for prevention of influenza, following close contact with an individual, is two inhalations (2 × 5 mg) once daily for 10 days. Therapy should begin as soon as possible and within 36 hours of exposure to an infected person.
The recommended dose of Relenza for prevention of influenza during a community outbreak is 2 inhalations (2 × 5 mg) once daily for up to 28 days.
No dose modification is required. (See section 5.2).
No dose modification is required. (See section 5.2).
The clinical signs and symptoms reported with overdoses of inhaled zanamivir are similar to those reported with therapeutic doses of inhaled zanamivir and/or the underlying disease.
As zanamivir has a low molecular weight, low protein binding, and small volume of distribution, it is expected to be removed by haemodialysis. Further management should be as clinically indicated or as recommended by the national poisons centre.
Shelf life: 10 years.
Do not store above 30°C.
Relenza inhalation powder is packed in a circular aluminium foil disk (a Rotadisk) with four regularly distributed blisters. An inspiration driven inhaler made of plastic (a Diskhaler) is used for administration of doses (the contents of 2 blisters constitute a dose) from these foil disks, and is provided in the pack.
The pack contains 1 or 5 foil disks and a Diskhaler.
The inhaler (Diskhaler) is loaded with a disk containing inhalation powder packed in individual blisters. These blisters are pierced when the inhaler is used, and with a deep inhalation the powder can then be inhaled through the mouthpiece down into the respiratory tract. Detailed instructions for use are enclosed in the pack.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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