SYNAZE NASAL SPRAY

CIPLA LIMITED (INDIA)🇸🇬 Health Sciences Authority

Approval Date: Jun 5, 2017
Approval ID: 2dcd5d1933b1f7cc
Company: CIPLA LIMITED (INDIA)
Type: Therapeutic

Approval Details

Approval Id: 2dcd5d1933b1f7cc
Drug Name: SYNAZE NASAL SPRAY
Product Name: SYNAZE NASAL SPRAY
Approval Number: SIN15256P
Approval Date: 2017-06-05
Registrant: VIATRIS PRIVATE LIMITED
Licence Holder: VIATRIS PRIVATE LIMITED
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: SPRAY, METERED
Dosage: DOSAGE AND ADMINISTRATION Dosage Adults, adolescents and children (6 years and older) One spray in each nostril twice daily (morning and evening). Children below 6 years SYNAZE nasal spray is not recommended for use in children below 6 years of age as safety and efficacy has not been established in this age group. Elderly No dose adjustment is required in this population (see Pharmacokinetics under Special Populations – Age and PRECAUTIONS – Use in the Elderly – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal and hepatic impairment No dose adjustment is required in patients with renal impairment or mild to moderate hepatic impairment (see Pharmacokinetics under Special Populations – Renal Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Caution is required when treating patients with severe hepatic impairment (see Pharmacokinetics under Special Populations – Hepatic Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Duration of treatment SYNAZE nasal spray is suitable for long-term use. There is no restriction regarding duration of use. Method of Administration SYNAZE Nasal Spray is for administration by the nasal route only. Preparing the spray: Shake the bottle gently before each use for about 5 seconds. Then, remove the protective cap. Prior to first use, SYNAZE nasal spray must be primed by pressing down and releasing the pump 6 times until a fine mist appears. If SYNAZE nasal spray has not been used for more than 7 days, reprime by pressing down and releasing the pump a number of times until a fine mist is produced. Do not prick the nozzle in case spray is not obtained. Clean the actuator with water. Using the spray: After blowing the nose, spray the suspension once into each nostril keeping the head tilted downward. After each use, wipe the spray tip and replace the protective cap.
Route Of Administration: NASAL
Indication Info: INDICATIONS Symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 6 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate.
Contraindications: CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients.
Atc Code: R01AD58
Atc Item Name: fluticasone, combinations
Pharma Manufacturer Name: PHARMLINE MARKETING PTE. LTD.
Company Detail Path: /organization/pharmline-marketing-pte-ltd

Active Ingredients

Fluticasone propionate

0.0365 %w/w

Azelastine hydrochloride

0.1 %w/w

AZELASTINE HYDROCHLORIDE

0.1% W/W

FLUTICASONE PROPIONATE

0.0365% W/W

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Jun 5, 2017

Approval ID

2dcd5d1933b1f7cc

Type

Therapeutic

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