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TRAJENTA FILM-COATED TABLETS 5MG [SIN14101P]
Active ingredients: TRAJENTA FILM-COATED TABLETS 5MG
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Product Info
TRAJENTA FILM-COATED TABLETS 5MG
[SIN14101P]
Product information
Active Ingredient and Strength | LINAGLIPTIN - 5 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | WEST-WARD COLUMBUS INC. - UNITED STATES |
Registration Number | SIN14101P |
Licence Holder | BOEHRINGER INGELHEIM SINGAPORE PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | A10BH05 |
4.1 Therapeutic indications
TRAJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (see Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
4.2 Posology and method of administration
Posology
Adults
The recommended dose is 5 mg once daily. TRAJENTA can be taken with or without a meal at any time of the day.
Special populations
Renal impairment
No dose adjustment is required for patients with renal impairment.
Hepatic Impairment
No dose adjustment is required for patients with hepatic impairment.
Elderly
No dose adjustment is necessary. Experience in patients older than > 75 years of age is limited.
Paediatric population
A clinical trial did not establish efficacy in paediatric patients 10 to 17 years of age (see section 4.8, 5.1 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Therefore, treatment of children and adolescents with TRAJENTA is not recommended.
TRAJENTA has not been studied in paediatric patients under 10 years of age.
Method of administration
Missed dose
If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken at the same day.
4.3 Contraindications
Hypersensitivity to the active ingredient or any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
