Source: Health Products Regulatory Authority (ZA) Revision Year: 2025 Publisher: Sandoz SA (Pty) Ltd<sup>1</sup>, Magwa Crescent West, Waterfall City, Jukskei View, 2090, Tel: 20 February 2025 1 Company Reg. No.: 1990/001979/07
SINTRINE ORAL GRANULES.
| Pharmaceutical Form |
|---|
|
Oral granules. White to off white granules. |
Each sachet of SINTRINE ORAL GRANULES contains 4.15 mg of montelukast sodium equivalent to 4.00 mg of montelukast.
SINTRINE ORAL GRANULES contains mannitol (484.70mg per sachet).
For full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Τhe CysLT type-1 (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. |
| List of Excipients |
|---|
|
Hydroxypropyl cellulose |
Pouch laminate sachet (PET/Aluminium foil/PE).
The sachets are packed in an outer cardboard carton.
Packs sizes of 7, 10, 14, 20, 28, 30 and 100 sachets.
Not all pack sizes may be marketed.
Sandoz SA (Pty) Ltd1, Magwa Crescent West, Waterfall City, Jukskei View, 2090, Tel: 20 February 2025
1 Company Reg. No.: 1990/001979/07
47/10.3/0743
08 March 2022
| Drug | Countries | |
|---|---|---|
| SINTRINE | South Africa |
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