Janumet
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
07-09-2023
Charakterystyka produktu
(SPC)
07-09-2023
Sprawozdanie z oceny publicznego
(PAR)
05-07-2013
Składnik aktywny:
sitagliptin, metformin hydrochloride
Dostępny od:
Merck Sharp & Dohme B.V.
Kod ATC:
A10BD07
INN (International Nazwa):
sitagliptin, metformin
Grupa terapeutyczna:
Drugs used in diabetes
Dziedzina terapeutyczna:
Diabetes Mellitus, Type 2
Wskazania:
For patients with type 2 diabetes mellitus:Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.Janumet is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.Janumet is indicated as triple combination therapy with a PPAR agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.Janumet is also indicated as add on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dosage of insulin and metformin alone do not provide adequate glycaemic control.
Podsumowanie produktu:
Revision: 30
Status autoryzacji:
Authorised
Data autoryzacji:
2008-07-16
Ulotka dla pacjenta
1
ANNEX I
SUM
MARY OF
PRODUCT CHARACTE
RISTICS
2
1.
NAME OF T
HE MEDICINAL PRODUCT
Janumet 50 mg/850 mg film-coated tablets
Janumet 50 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITAT
I
VE COMPOSITION
Janumet 50 mg/850 mg film-coated tablets
Each tab
let contains sitagliptin
phospha
te monohydrate
equivalent to 50
mg of sitagliptin and 850
mg
of metf
ormin hydrochloride.
Janumet 50 mg/1,000 mg film-coated tablets
Each tablet contains sitagliptin phosphate monohydrate
equivalent to 50
mg of sitagliptin a
nd
1,000 mg of metformin hydrochloride.
For the full
list of excipients, see
section 6.1.
3.
PHAR
MACEUTIC
AL FORM
Film-
coated tablet (tablet).
Janumet 50 mg/850 mg film-coated tablets
Capsule-sh
aped, pink film
-coated tab
let with “515” debossed on one s
ide.
Janumet 50 mg/1,000 mg film-coated tablets
Capsule-shaped, red film-
coated tablet with “
577
” d
ebossed on one side
.
4.
CLINICA
L PARTICULARS
4.1
THERAPEUTIC INDI
CATIONS
For adult
patients with type
2 diabetes mel
litus:
Janumet
is indicated as an a
djunct to diet and exercise to i
mprove glycaemic co
ntrol in patients
inadequately controlled on thei
r maximal tolerated d
ose of metfo
rmin alone or those already being
treated with
the combination of
sitagliptin and
metformin.
Janumet i
s indicated in combi
nation with a sulphonylurea (i.e
., triple combinati
on therapy) as an
adjunct to diet and exercise in
patients inadequatel
y controlled
on their maximal tolerated dose of
metform
in and a sulphonylurea.
Janumet is indicate
d as triple comb
ination therapy with
a peroxisome proliferator-activ
ated receptor
gamma (PPAR
)
agonist (i.e., a thiazolidinedione) as a
n adjunct to diet and
exercise in patients
inadequately controlled o
n their
maximal tolerated dose of metformin and a PP
AR
agonist.
J
anumet is also indic
ated as add-on to insulin (i.e.,
triple combination
therap
y) as an adjunct to diet
and exercise to i
mprove glycaemic cont
rol in patie
nts when stable
dose
of insulin and
metformin alone
do not provide adequate
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Charakterystyka produktu
1
ANNEX I
SUM
MARY OF
PRODUCT CHARACTE
RISTICS
2
1.
NAME OF T
HE MEDICINAL PRODUCT
Janumet 50 mg/850 mg film-coated tablets
Janumet 50 mg/1,000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITAT
I
VE COMPOSITION
Janumet 50 mg/850 mg film-coated tablets
Each tab
let contains sitagliptin
phospha
te monohydrate
equivalent to 50
mg of sitagliptin and 850
mg
of metf
ormin hydrochloride.
Janumet 50 mg/1,000 mg film-coated tablets
Each tablet contains sitagliptin phosphate monohydrate
equivalent to 50
mg of sitagliptin a
nd
1,000 mg of metformin hydrochloride.
For the full
list of excipients, see
section 6.1.
3.
PHAR
MACEUTIC
AL FORM
Film-
coated tablet (tablet).
Janumet 50 mg/850 mg film-coated tablets
Capsule-sh
aped, pink film
-coated tab
let with “515” debossed on one s
ide.
Janumet 50 mg/1,000 mg film-coated tablets
Capsule-shaped, red film-
coated tablet with “
577
” d
ebossed on one side
.
4.
CLINICA
L PARTICULARS
4.1
THERAPEUTIC INDI
CATIONS
For adult
patients with type
2 diabetes mel
litus:
Janumet
is indicated as an a
djunct to diet and exercise to i
mprove glycaemic co
ntrol in patients
inadequately controlled on thei
r maximal tolerated d
ose of metfo
rmin alone or those already being
treated with
the combination of
sitagliptin and
metformin.
Janumet i
s indicated in combi
nation with a sulphonylurea (i.e
., triple combinati
on therapy) as an
adjunct to diet and exercise in
patients inadequatel
y controlled
on their maximal tolerated dose of
metform
in and a sulphonylurea.
Janumet is indicate
d as triple comb
ination therapy with
a peroxisome proliferator-activ
ated receptor
gamma (PPAR
)
agonist (i.e., a thiazolidinedione) as a
n adjunct to diet and
exercise in patients
inadequately controlled o
n their
maximal tolerated dose of metformin and a PP
AR
agonist.
J
anumet is also indic
ated as add-on to insulin (i.e.,
triple combination
therap
y) as an adjunct to diet
and exercise to i
mprove glycaemic cont
rol in patie
nts when stable
dose
of insulin and
metformin alone
do not provide adequate
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