Efficib

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

sitagliptin, metformin hydrochloride

Saadav alates:

Merck Sharp and Dohme B.V

ATC kood:

A10BD07

INN (Rahvusvaheline Nimetus):

sitagliptin, metformin

Terapeutiline rühm:

Drugs used in diabetes

Terapeutiline ala:

Diabetes Mellitus, Type 2

Näidustused:

For patients with type-2 diabetes mellitus:Efficib 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.Efficib 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.Efficib 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.Efficib 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.

Toote kokkuvõte:

Revision: 33

Volitamisolek:

Authorised

Loa andmise kuupäev:

2008-07-15

Infovoldik

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDI
CINAL PRODUCT
Efficib 50 mg/850 mg film-
coated tablets
Efficib 50 mg/1,000 mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Efficib 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.
Efficib 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).
Efficib 50 mg/850 mg film-coated tablets
Capsule-sh
aped, pink film
-coated tablet with
“515” debossed on one side.
Efficib 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:
Efficib
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.
Efficib
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 s
u
lphonylurea.
Efficib
is indicated as tr
iple
combination therapy with a
peroxisome proliferator
-
activated receptor
gamma (PPAR

) agonist
(i.e., a thiazolidinedione) as an adjunct to diet and exercise
in patients
inadequately controlled on their maximal to
l
erated dose of metformin and a PPAR

agonist.
Efficib is also indicated as add
-
on to insulin (i.e., triple combination ther
apy) a
s an adjunct to diet and
exercise to improve glycaemic control in pati
en
ts when stable
dose
of insulin and metformin alone do
not provide adequate glycaemic contro

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDI
CINAL PRODUCT
Efficib 50 mg/850 mg film-
coated tablets
Efficib 50 mg/1,000 mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Efficib 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.
Efficib 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).
Efficib 50 mg/850 mg film-coated tablets
Capsule-sh
aped, pink film
-coated tablet with
“515” debossed on one side.
Efficib 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:
Efficib
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.
Efficib
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 s
u
lphonylurea.
Efficib
is indicated as tr
iple
combination therapy with a
peroxisome proliferator
-
activated receptor
gamma (PPAR

) agonist
(i.e., a thiazolidinedione) as an adjunct to diet and exercise
in patients
inadequately controlled on their maximal to
l
erated dose of metformin and a PPAR

agonist.
Efficib is also indicated as add
-
on to insulin (i.e., triple combination ther
apy) a
s an adjunct to diet and
exercise to improve glycaemic control in pati
en
ts when stable
dose
of insulin and metformin alone do
not provide adequate glycaemic contro