Ristfor
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
07-09-2023
Produktets egenskaber
(SPC)
07-09-2023
Offentlige vurderingsrapport
(PAR)
25-02-2015
Aktiv bestanddel:
sitagliptin, metformin hydrochloride
Tilgængelig fra:
Merck Sharp & Dohme B.V.
ATC-kode:
A10BD07
INN (International Name):
sitagliptin, metformin hydrochloride
Terapeutisk gruppe:
Drugs used in diabetes
Terapeutisk område:
Diabetes Mellitus, Type 2
Terapeutiske indikationer:
For patients with type-2 diabetes mellitus:Ristfor 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.Ristfor 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.Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated-receptor-gamma (PPARγ) 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 PPARγ agonist.Ristfor 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 dose of insulin and metformin alone do not provide adequate glycaemic control.
Produkt oversigt:
Revision: 27
Autorisation status:
Authorised
Autorisation dato:
2010-03-15
Indlægsseddel
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDIC
INAL PRODUCT
Ristfor 50 mg/850 mg film-
coated tablets
Ristfor 50 mg/1,000 mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ristfor 50 mg/850 mg film-coated tablets
Each tablet contains sitagliptin phosphate monohydrate
equivalent to 50
mg of sitagliptin and 850
mg
of metf
ormin hydrochloride.
Ristfor 50 mg/1,000 mg film-coated tablets
Each tablet contains sitagliptin phosphate monohydrate
equivalent to 50
mg of sitagliptin and
1,000 mg of metf
ormin hydrochloride.
For the full list of
excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Film-
coated tablet (tablet).
Ristfor 50 mg/850 mg film-coated tablets
Capsule-sh
aped, pink film
-coated tablet wi
th “515” debossed on one side.
Ristfor 50 mg/1,000 mg film-coated tablets
Capsule-shaped, red film-
coated tablet with “
577
” debossed on one side
.
4.
CLINICA
L PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult
patients with type
2 diabetes mellitus:
Ristfor
is indicated as an adjunct to diet and exercise to improve glycaemic
contro
l in patients
inadequately controlled on their maximal tolerated dose of met
fo
rmin alone or those already being
treated with
the combination of
sitagliptin and
metformin.
Ris
tfor is indicated in combination with a sulphonylurea (i.e., triple
combination t
herapy) as an
adjunct to diet and exercise in patients inadequately controll
ed
on their maximal tolerated dose of
metformin and a sulphonylurea.
Ristfor is indicated as trip
l
e combination therapy with a
peroxisome proliferator
-
activated receptor
gamma (PPAR
) ag
onist (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.
Ristfor is also indicated as add
-
on to insulin (i.e., triple combination the
rapy) a
s an adjunct to diet and
exercise to improve glycaemic control in pat
ie
nts when stable
dose
of insulin and metformin alone do
not provide adequate glycaemic contro
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDIC
INAL PRODUCT
Ristfor 50 mg/850 mg film-
coated tablets
Ristfor 50 mg/1,000 mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ristfor 50 mg/850 mg film-coated tablets
Each tablet contains sitagliptin phosphate monohydrate
equivalent to 50
mg of sitagliptin and 850
mg
of metf
ormin hydrochloride.
Ristfor 50 mg/1,000 mg film-coated tablets
Each tablet contains sitagliptin phosphate monohydrate
equivalent to 50
mg of sitagliptin and
1,000 mg of metf
ormin hydrochloride.
For the full list of
excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Film-
coated tablet (tablet).
Ristfor 50 mg/850 mg film-coated tablets
Capsule-sh
aped, pink film
-coated tablet wi
th “515” debossed on one side.
Ristfor 50 mg/1,000 mg film-coated tablets
Capsule-shaped, red film-
coated tablet with “
577
” debossed on one side
.
4.
CLINICA
L PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For adult
patients with type
2 diabetes mellitus:
Ristfor
is indicated as an adjunct to diet and exercise to improve glycaemic
contro
l in patients
inadequately controlled on their maximal tolerated dose of met
fo
rmin alone or those already being
treated with
the combination of
sitagliptin and
metformin.
Ris
tfor is indicated in combination with a sulphonylurea (i.e., triple
combination t
herapy) as an
adjunct to diet and exercise in patients inadequately controll
ed
on their maximal tolerated dose of
metformin and a sulphonylurea.
Ristfor is indicated as trip
l
e combination therapy with a
peroxisome proliferator
-
activated receptor
gamma (PPAR
) ag
onist (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.
Ristfor is also indicated as add
-
on to insulin (i.e., triple combination the
rapy) a
s an adjunct to diet and
exercise to improve glycaemic control in pat
ie
nts when stable
dose
of insulin and metformin alone do
not provide adequate glycaemic contro
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