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HSA Approval

RELENZA ROTADISK 5 mg/dose

SIN11199P

RELENZA ROTADISK 5 mg/dose

RELENZA ROTADISK 5 mg/dose

October 21, 1999

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Therapeutic

Prescription Only

Formulation Information

POWDER, METERED

**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_).

RESPIRATORY (INHALATION)

Medical Information

**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.

J05AH01

zanamivir

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

GLAXO WELLCOME PRODUCTION

GlaxoSmithKline Australia Pty Ltd

Active Ingredients

ZANAMIVIR

5 mg/dose

Zanamivir

Documents

Package Inserts

Relenza Rotadisk PI.pdf

Approved: April 26, 2018

Download

Patient Information Leaflets

Relenza Rotadisk PIL.pdf

Approved: April 26, 2018

Download
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