JANUVIA

Valsts: Indonēzija

Valoda: indonēziešu

Klimata pārmaiņas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktīvā sastāvdaļa:

SITAGLIPTIN PHOSPHATE

Pieejams no:

ORGANON PHARMA INDONESIA TBK - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

SITAGLIPTIN PHOSPHATE

Deva:

64.25 MG

Zāļu forma:

TABLET SALUT SELAPUT

Vienības iepakojumā:

DRUM, MAKSIMUM @ 35 KG

Ražojis:

MERCK SHARP & DOHME LTD. - United Kingdom

Autorizācija datums:

2021-07-17

Produkta apraksts

JANUVIA™
25/50/100 MG TABLETS
(Sitagliptin 25/50/100 mg)
INDICATIONS AND USAGE
•
MONOTHERAPY
JANUVIA
TM
is indicated as an adjunct to diet and exercise to improve glycemic
control in patients with type 2 diabetes mellitus.
•
COMBINATION WITH METFORMIN OR PPAR
 AGONIST
Januvia is indicated in patients with type 2 diabetes mellitus to
improve glycemic
control in combination with Metformin or a PPAR

agonist (i.e. thiazolidinediones)
when the single agent alone, with diet and exercise, does not provide
adequate
glycemic control.
•
COMBINATION WITH METFORMIN AND SULFONYLUREA
Januvia is indicated in patients with type 2 diabetes mellitus to
improve glycemic
control in combination with metformin and a sulfonylurea when dual
therapy with
these agents, with diet and exercise, does not provide adequate
glycemic control.
•
COMBINATION WITH INSULIN
Januvia is also indicated as add-on to insulin (with or without
metformin) when diet
and exercise plus stable dose of insulin do not provide adequate
glycemic control.
When Januvia is used in combination with a sulfonylurea or with
insulin, a lower dose of
the sulfonylurea or insulin may be considered to reduce the risk of
hypoglycemia.
DOSAGE AND ADMINISTRATION
RECOMMENDED DOSING
The recommended dose of JANUVIA is 100 mg once daily as monotherapy or
as
combination therapy with metformin or a PPARγ agonist (e.g.,
thiazolidinediones),
metformin and sulfonylurea, stable dose of insulin (with or without
metformin). JANUVIA
can be taken with or without food.
When used in combination with metformin or a PPAR

agonist, the dose of
metformin
or
PPAR

agonist
should
be
maintained,
and
Januvia
administered
concomitantly.
When Januvia is used in combination with a sulfonylurea or with
insulin, a lower
dose
of
the
sulfonylurea
or
insulin
may
be
considered
to
reduce
the
risk
of
DISETUJUI OLEH BPOM : 29/10/2021
ID : EREG100373VR12100471
EREG100373VR12100477
EREG100373VR12100478
hypoglycaemia
PATIENTS WITH RENAL IMPAIRMENT
Because there is a dosage adjustment based upon