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HSA Approval

Avamys Nasal Spray 27.5 mcg/spray

SIN13666P

Avamys Nasal Spray 27.5 mcg/spray

Avamys Nasal Spray 27.5 mcg/spray

June 23, 2009

GLAXOSMITHKLINE PTE LTD

GLAXOSMITHKLINE PTE LTD

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantGLAXOSMITHKLINE PTE LTD
Licence HolderGLAXOSMITHKLINE PTE LTD

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SPRAY, SUSPENSION

**Dosage and Administration** _AVAMYS_ Nasal Spray is for administration by the intranasal route only. For full therapeutic benefit regular scheduled usage is recommended. Onset of action has been observed as early as 8 hours after initial administration. It may take several days of treatment to achieve maximum benefit. An absence of an immediate effect should be explained to the patient _(see Clinical Studies_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **Populations** For the treatment of seasonal allergic rhinitis and perennial allergic rhinitis: **Adults and Adolescents (12 years and older)** The recommended starting dosage is 2 sprays (27.5 micrograms per spray) in each nostril once daily (total daily dose, 110 micrograms). Once adequate control of symptoms is achieved, dose reduction to 1 spray in each nostril once daily (total daily dose, 55 micrograms) may be effective for maintenance. **Children (2 to 11 years)** The recommended starting dosage is 1 spray (27.5 micrograms per spray) in each nostril once daily (total daily dose, 55 micrograms). Patients not adequately responding to 1 spray in each nostril once daily (total daily dose, 55 micrograms) may use 2 sprays in each nostril once daily (total daily dose, 110 micrograms). Once adequate control of symptoms is achieved, dose reduction to 1 spray in each nostril once daily (total daily dose, 55 micrograms) is recommended. **Children (under 2 years of age)** There are no data to recommend use of intranasal fluticasone furoate for the treatment of seasonal or perennial allergic rhinitis in children under 2 years of age. **Elderly** No dosage adjustment required _(see Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **Renal impairment** No dosage adjustment required _(see Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_. **Hepatic impairment** No dosage adjustment is required in patients with hepatic impairment _(see Warnings and Precautions, and Pharmacokinetics_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _)_.

NASAL

Medical Information

**Indications** _AVAMYS_ Nasal Spray is indicated for the treatment of the symptoms of allergic rhinitis in patients 2 years of age and older.

**Contraindications** _AVAMYS_ Nasal Spray is contraindicated in patients with hypersensitivity to any of the ingredients.

R01AD12

fluticasone furoate

Manufacturer Information

GLAXOSMITHKLINE PTE LTD

Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)

Glaxo Wellcome S.A.

Active Ingredients

Fluticasone Furoate (micronised)

0.0275mg/spray

Fluticasone furoate

Documents

Package Inserts

Avamys Nasal Spray PI.pdf

Approved: December 23, 2020

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Avamys Nasal Spray 27.5 mcg/spray - HSA Approval | MedPath