JANUVIA 100 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

SITAGLIPTIN AS MONOHYDRATE PHOSPHATE

Commercializzato da:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

Codice ATC:

A10BH01

Forma farmaceutica:

FILM COATED TABLETS

Composizione:

SITAGLIPTIN AS MONOHYDRATE PHOSPHATE 100 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

MERCK SHARP & DOHME LLC, USA

Gruppo terapeutico:

SITAGLIPTIN

Area terapeutica:

SITAGLIPTIN

Indicazioni terapeutiche:

Januvia is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes melitus.Important limitations of use:Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis as it would not be effective in these settings.Januvia has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using Januvia.

Data dell'autorizzazione:

2023-03-31

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) – 1986
This medicine is marketed upon physician's prescription only
JANUVIA
® 25 MG JANUVIA
® 50 MG JANUVIA
® 100 MG
Film-coated tablets
Film-coated tablets Film-coated tablets
EACH FILM-COATED TABLET CONTAINS:
Sitagliptin (as monohydrate Sitagliptin (as monohydrate Sitagliptin
(as monohydrate
phosphate) 25 mg phosphate) 50 mg phosphate) 100 mg
For a list of inactive ingredients please refer to section 6
“FURTHER INFORMATION”. See also section 2.8
“Important information about some of the ingredients of the
medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
•
This leaflet contains concise information about JANUVIA. If you have
any further questions, refer to
the doctor or pharmacist
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their ailment is similar
•
This medicine is not intended for administration to children and
adolescents under 18 years of age
1. WHAT JANUVIA IS INTENDED FOR?
JANUVIA is indicated as an adjunct to diet and exercise, to improve
glycemic control in adults with type 2
diabetes mellitus.
IMPORTANT LIMITATIONS OF USE:
JANUVIA should not be used in patients with type 1 diabetes or for the
treatment of diabetic ketoacidosis, as
it would not be effective in these settings.
JANUVIA has not been studied in patients with a history of
pancreatitis. It is unknown whether patients with
a history of pancreatitis are at increased risk for the development of
pancreatitis while using JANUVIA.
THERAPEUTIC GROUP
:
DPP-4 enzyme inhibitors.
JANUVIA is a member of a class of medicines you take by mouth called
DPP-4 inhibitors (dipeptidyl
peptidase-4 inhibitors) that lowers blood sugar levels in adult
patients with type 2 diabetes mellitus.
2. BEFORE USING JANUVIA
2.1 DO NOT USE JANUVIA IF YOU:
−
are allergic (sensitive) to any of the ingredients of JANUVIA (see
section 6 "FURTHER INFORMATION"
for a complete list

Scheda tecnica

JANUVIA
® 25 MG, FILM COATED TABLETS
Each film-coated tablet contains 25 mg Sitagliptin (as monohydrate
phosphate)
JANUVIA
® 50MG, FILM COATED TABLETS
Each film-coated tablet contains 50 mg Sitagliptin (as monohydrate
phosphate)
JANUVIA
® 100MG, FILM COATED TABLETS
Each film-coated tablet contains 100 mg Sitagliptin (as monohydrate
phosphate)
1 THERAPEUTIC INDICATIONS
JANUVIA
®
is indicated as an adjunct to diet and exercise to improve glycemic
control in adults
with type 2 diabetes mellitus. _ _
IMPORTANT LIMITATIONS OF USE
JANUVIA should not be used in patients with type 1 diabetes or for the
treatment of diabetic
ketoacidosis, as it would not be effective in these settings.
JANUVIA has not been studied in patients with a history of
pancreatitis. It is unknown whether
patients with a history of pancreatitis are at increased risk for the
development of pancreatitis
while using JANUVIA. _[See_ _Warnings and Precautions (5.1)._]
_ _
2 DOSAGE AND ADMINISTRATION
2.1 RECOMMENDED DOSING
The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be
taken with or
without food.
2.2 RECOMMENDATIONS FOR USE IN RENAL IMPAIRMENT
For patients with an estimated glomerular filtration rate [eGFR]
greater than or equal to 45
mL/min/1.73 m² to less than 90 mL/min/1.73 m², no dosage adjustment
for JANUVIA is required.
For patients with moderate renal impairment (eGFR greater than or
equal to 30 mL/min/1.73 m²
to less than 45 mL/min/1.73 m²), the dose of JANUVIA is 50 mg once
daily.
For patients with severe renal impairment (eGFR less than 30
mL/min/1.73 m²) or with end-
stage renal disease (ESRD) requiring hemodialysis or peritoneal
dialysis, the dose of JANUVIA
is 25 mg once daily. JANUVIA may be administered without regard to the
timing of dialysis.
Because there is a need for dosage adjustment based upon renal
function, assessment of renal
function is recommended prior to initiation of JANUVIA and
periodically thereafter. There have
been postmarketing reports of worsening renal function in patients
with renal imp