- Approval Id
- 1f9b62d6ea2b5093
- Drug Name
- RYALTRIS NASAL SPRAY 600/25MCG
- Product Name
- RYALTRIS NASAL SPRAY 600/25MCG
- Approval Number
- SIN16523P
- Approval Date
- 2022-06-28
- Registrant
- LOTUS INTERNATIONAL PTE. LTD.
- Licence Holder
- LOTUS INTERNATIONAL PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SPRAY, SUSPENSION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>Dosage</strong><br>
<strong>Adults and Adolescents (12 Years of Age and Older)</strong><br>
The recommended dosage of RYALTRIS® is 2 sprays in each nostril twice daily.<br>
<strong>Children (6 to 11 Years of Age)</strong><br>
The recommended dosage of RYALTRIS® is 1 spray in each nostril twice daily.</p>
<p><strong>Paediatric</strong><br>
In children 6 to 11 years of age, safety of RYALTRIS® beyond 2 weeks of use has not been assessed.<br>
The safety and effectiveness of RYALTRIS® in paediatric patients below the age of 6 years has not been established.</p>
<p><strong>Administration</strong><br>
Administer RYALTRIS® by the intranasal route only. Avoid spraying RYALTRIS® into the eyes or mouth.</p>
<p>Shake the bottle well before each use.</p>
<p>Priming: Prime RYALTRIS® before initial use by releasing 6 sprays. When RYALTRIS® has not been used for 14 days or more, re-prime by releasing 2 sprays or until a fine mist appears.</p>
<p><strong>Missed Dose</strong><br>
If a single dose is missed, the next dose should be taken when it is due. A double dose should not be taken at the same time.</p>
- Route Of Administration
- NASAL
- Indication Info
- <p><strong>INDICATIONS</strong><br>
RYALTRIS® is indicated for the treatment of moderate to severe symptoms associated with allergic rhinitis and rhinoconjunctivitis in patients 6 years of age and older.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
RYALTRIS® is contraindicated for patients who:</p>
<ul>
<li>Are hypersensitive to this medicine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Qualitative and Quantitative Composition – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li>Have untreated fungal, bacterial, or tuberculosis infections of the respiratory tract.</li>
</ul>
- Atc Code
- R01AD59
- Atc Item Name
- mometasone, combinations
- Pharma Manufacturer Name
- LOTUS INTERNATIONAL PTE. LTD.
