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RELENZA ROTADISK 5 mg/dose

Prescription Only
Drug type: Therapeutic
ATC code: J05AH01
Dosage form: POWDER, METERED
Route of administration: RESPIRATORY (INHALATION)
Active ingredient: ZANAMIVIR; ZANAMIVIR

Indications

Treatment of Influenza:

Relenza is indicated for treatment of infections due to influenza A and B viruses in adults and children 5 years and older.

Prophylaxis:

Relenza is indicated for prophylaxis of both influenza A and B in adults and juveniles 12 years and older.

Contra-indications

Hypersensitivity to any ingredient of the preparation (see Pharmaceutical Particulars – List of Excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindicated in patients with severe milk protein allergy.

Dosage and Method of Administration

Relenza is for administration to the respiratory tract by oral inhalation only, using the Diskhaler device provided.

Patients scheduled to take inhaled drugs, e.g. fast acting bronchodilators, at the same time as Relenza should be advised to administer that drug prior to administration of Relenza.

Treatment of Influenza:

Adults and children 5 years and older:

The recommended dose of Relenza is two inhalations (2 x 5 mg) twice daily for five days, providing a total daily inhaled dose of 20 mg.

For maximum benefit, treatment should begin as soon as possible but no later than 48 hours after onset of symptoms.

Prophylaxis:

Adults and juveniles 12 years and older:

The recommended dose of Relenza is two inhalations (2 x 5 mg) once daily for 10 days, providing a total daily inhaled dose of 10 mg. The treatment can be prolonged for up to one month at the most if the exposure risk lasts more than 10 days.

The full course of prophylaxis therapy should be completed as prescribed.

Impaired Renal or Hepatic Function: No dose modification is required (see Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Elderly patients: No dose modification is required (see Pharmacokinetic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric patients: No dose modification is required (see Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Registrant
GLAXOSMITHKLINE PTE LTD
Approval Date
1999-10-21
Approval Number
SIN11199P
Manufacturer
GLAXO WELLCOME PRODUCTION GlaxoSmithKline Australia Pty Ltd
Licence Holder
GLAXOSMITHKLINE PTE LTD