Ristfor

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
07-09-2023
Tabia za bidhaa Tabia za bidhaa (SPC)
07-09-2023
Ripoti ya Tathmini ya umma Ripoti ya Tathmini ya umma (PAR)
25-02-2015

Viambatanisho vya kazi:

sitagliptin, metformin hydrochloride

Inapatikana kutoka:

Merck Sharp & Dohme B.V.

ATC kanuni:

A10BD07

INN (Jina la Kimataifa):

sitagliptin, metformin hydrochloride

Kundi la matibabu:

Drugs used in diabetes

Eneo la matibabu:

Diabetes Mellitus, Type 2

Matibabu dalili:

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.

Bidhaa muhtasari:

Revision: 27

Idhini hali ya:

Authorised

Idhini ya tarehe:

2010-03-15

Taarifa za kipeperushi

                                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
                                
                                Soma hati kamili

Tabia za bidhaa

                                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
                                
                                Soma hati kamili

Bidhaa zinazofanana

Viambatanisho vya kazi sitagliptin, metformin hydrochloride

sitagliptin, metformin hydrochloride

ATC kanuni A10BD07

A10BD07

Mzalishaji au wazalishaji wadogowadogo Merck Sharp & Dohme B.V.

Merck Sharp & Dohme B.V.

INN (Jina la Kimataifa) sitagliptin, metformin hydrochloride

sitagliptin, metformin hydrochloride

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Tafuta arifu zinazohusiana na bidhaa hii

Taadhari Ristfor sitagliptin, metformin hydrochloride

Ristfor sitagliptin, metformin hydrochloride

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Historia ya nyaraka Historia ya nyaraka

Ristfor