RELENZA ROTADISK 5 MG/DOSE

GLAXO WELLCOME PRODUCTION - FRANCEGLAXOSMITHKLINE AUSTRALIA PTY LTD (AUSTRALIA)🇸🇬 Health Sciences Authority

Approval Date: Oct 21, 1999
Approval ID: dff316622ead50b2
Company: GLAXO WELLCOME PRODUCTION - FRANCEGLAXOSMITHKLINE AUSTRALIA PTY LTD (AUSTRALIA)
Type: Therapeutic

Approval Details

Approval Id: dff316622ead50b2
Drug Name: RELENZA ROTADISK 5 MG/DOSE
Product Name: RELENZA ROTADISK 5 MG/DOSE
Approval Number: SIN11199P
Approval Date: 1999-10-21
Registrant: GLAXOSMITHKLINE PTE LTD
Licence Holder: GLAXOSMITHKLINE PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: POWDER, METERED
Dosage: 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).
Route Of Administration: RESPIRATORY (INHALATION)
Indication Info: 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.
Contraindications: 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.
Atc Code: J05AH01
Atc Item Name: zanamivir
Pharma Manufacturer Name: GLAXOSMITHKLINE PTE LTD
Company Detail Path: /organization/glaxosmithkline-pte-ltd

Active Ingredients

ZANAMIVIR

5 mg/dose

ZANAMIVIR

5 mg/dose

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 21, 1999

Approval ID

dff316622ead50b2

Type

Therapeutic

Back to HSA Approvals