- Approval Id
- 85dff1513f2a1a73
- Drug Name
- YUPELRI® INHALATION SOLUTION 175MCG/3ML
- Product Name
- YUPELRI® INHALATION SOLUTION 175MCG/3ML
- Approval Number
- SIN16336P
- Approval Date
- 2021-09-28
- Registrant
- VIATRIS PHARMACEUTICALS PTE. LTD.
- Licence Holder
- VIATRIS PHARMACEUTICALS PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p>The recommended dose of YUPELRI inhalation solution is one 175 mcg unit-dose vial administered once daily by nebulizer using a mouthpiece.</p>
<p>YUPELRI should be administered by the orally inhaled route via a standard jet nebulizer connected to an air compressor (See Patient Information – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). The safety and efficacy of YUPELRI have been established in clinical trials when administered using the PARI LC® Sprint nebulizer with a mouthpiece and the PARI Trek® S compressor. The safety and efficacy of YUPELRI delivered from non-compressor-based nebulizer systems have not been established.</p>
<p>The YUPELRI unit-dose vial should only be removed from the foil pouch and opened IMMEDIATELY BEFORE USE. The vial and any residual content should be discarded after use.</p>
<p>No dosage adjustment is required for geriatric patients, or patients with renal impairment <em>[see sections 8.5, 8.7, Clinical Pharmacology (12.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</p>
<p>The drug compatibility (physical and chemical), efficacy, and safety of YUPELRI when mixed with other drugs in a nebulizer have not been established.</p>
- Route Of Administration
- RESPIRATORY (INHALATION)
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>YUPELRI inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product.</p>
- Atc Code
- R03BB08
- Atc Item Name
- revefenacin
- Pharma Manufacturer Name
- mylan pharmaceuticals pte. ltd.
