Source: Health Products Regulatory Authority (ZA) Publisher: Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Customer Care: 0860/ADCOCK (232625)
TRINTOGEN 5 5 mg Film-coated tablets.
TRINTOGEN 10 10 mg Film-coated tablets.
TRINTOGEN 20 20 mg Film-coated tablets.
| Pharmaceutical Form |
|---|
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Film-coated tablets. TRINTOGEN 5: Pink, almond-shaped, biconvex film-coated tablet debossed with "L" on one side and "07" on the other side (approximately 6,0 mm in length and 3,3 mm in width). TRINTOGEN 10: Yellow, almond-shaped, biconvex film-coated tablet debossed with "L" on one side and "08" on the other side (approximately 7,2 mm in length and 4,2 mm in width). TRINTOGEN 20: Red, almond-shaped, biconvex film-coated tablet debossed with '612' on one side and plain on other side (approximately 8,8 mm in length and 5,2 mm in width). |
TRINTOGEN 5: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 5 mg vortioxetine.
TRINTOGEN 10: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 10 mg vortioxetine.
TRINTOGEN 20: Each film-coated tablet contains vortioxetine hydrobromide equivalent to 20 mg vortioxetine.
For full list of excipients, see section 6.1.
| Active Ingredient |
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Vortioxetine is a 5-HT3, 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the 5-HT transporter, leading to modulation of neurotransmission in several systems, including predominantly the serotonin but probably also the norepinephrine, dopamine, histamine, acetylcholine, GABA and glutamate systems. This multimodal activity is considered responsible for the antidepressant and anxiolytic-like effects and the improvement of cognitive function, learning and memory observed with vortioxetine in animal studies. |
| List of Excipients |
|---|
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Colloidal anhydrous silica Coating: TRINTOGEN 5: Opadry Pink 03F84770, consisting of: HPMC 2910/Hypromellose TRINTOGEN 10: Opadry Yellow 03F520217, consisting of: Ferrosoferric oxide/black iron oxide TRINTOGEN 20: Opadry Brown 03F565072, consisting of: Ferrosoferric oxide/black iron oxide |
TRINTOGEN is packed in Alu/Alu blister pack of cold form blister (made of OPA film, soft tempered aluminium foil and PVC film) and aluminium foil. Such blisters are further packed in a carton along with the professional information and patient information leaflet.
Available in pack sizes of 28's and 30's.
Not all pack sizes may be marketed.
Adcock Ingram Limited, 1 New Road, Erand Gardens, Midrand, 1685, Customer Care: 0860/ADCOCK (232625)
TRINTOGEN 5: 55/1.2/0129
TRINTOGEN 10: 55/1.2/0130
TRINTOGEN 20: 55/1.2/0131
19 July 2022
| Drug | Countries | |
|---|---|---|
| TRINTOGEN | South Africa |
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