NOVONORM TABLET 2 mg

Nchi: Singapoo

Lugha: Kiingereza

Chanzo: HSA (Health Sciences Authority)

Nunua Sasa

Shusha Taarifa za kipeperushi (PIL)
24-10-2014
Shusha Tabia za bidhaa (SPC)
26-07-2016

Viambatanisho vya kazi:

Repaglinide

Inapatikana kutoka:

NOVO NORDISK PHARMA (SINGAPORE) PTE LTD

ATC kanuni:

A10BX02

Kipimo:

2mg/tablet

Dawa fomu:

TABLET

Tungo:

Repaglinide 2mg/tablet

Njia ya uendeshaji:

ORAL

Dawa ya aina:

Prescription Only

Viwandani na:

Boehringer Ingelheim Pharma GmbH & Co. KG

Idhini hali ya:

ACTIVE

Idhini ya tarehe:

1999-01-14

Taarifa za kipeperushi

                                1 
 
NOVONORM
®
 
0.5 MG TABLETS 
1 MG TABLETS 
2 MG TABLETS
 
Repaglinide 
 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
NovoNorm
® 
contains repaglinide as the active ingredient. The other ingredients
are listed in _List of _
_excipients_. 
 
The 0.5 mg tablet is white, round and convex, engraved with Novo
Nordisk logo (Apis bull). 
The 1 mg tablet is yellow, round and convex, engraved with Novo
Nordisk logo (Apis bull). 
The 2 mg tablet is peach-coloured, round and convex, engraved with
Novo Nordisk logo (Apis 
bull). 
 
PHARMACOTHERAPEUTIC GROUP 
Other blood glucose lowering drugs, excl. insulin. 
 
MANUFACTURER 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
THERAPEUTIC INDICATIONS 
Repaglinide is indicated in adults with type 2 diabetes mellitus
whose hyperglycaemia can no 
longer be controlled satisfactorily by diet, weight reduction
and exercise. Repaglinide is also 
indicated in combination with metformin in adults with type 2 diabetes
mellitus who are not 
satisfactorily controlled on metformin alone. Treatment should be
initiated as an adjunct to diet and 
exercise to lower the blood glucose in relation to meals. 
 
POSOLOGY AND METHOD OF ADMINISTRATION 
POSOLOGY 
Repaglinide is given preprandially and is
titrated individually to optimise glycaemic control. In 
addition to self-monitoring by the patient of blood and/or urinary
glucose, the patient’s blood 
glucose should be monitored periodically by the physician to determine
the minimum effective dose 
for the patient. Glycosylated haemoglobin levels are also of value in
monitoring the patient’s 
response to therapy. Periodic monitoring is necessary to detect
inadequate lowering of blood 
glucose at the recommended maximum level (i.e. primary failure) and to
detect loss of adequate 
blood glucose-lowering response after an initial period of
effectiveness (i.e. secondary failure). 
Short-term administration of repaglinide may be sufficient during
periods of transient loss of
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                1
NOVONORM
®
0.5 MG TABLETS
1 MG TABLETS
2 MG TABLETS
Repaglinide
QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoNorm
®
contains repaglinide as the active ingredient. The other ingredients
are listed in _List of _
_excipients_
.
NovoNorm
®
tablets are round and convex, engraved with Novo Nordisk logo (Apis
bull).
0.5 mg tablet: white
1 mg tablet: yellow
2 mg tablet: peach-coloured
THERAPEUTIC INDICATIONS
Repaglinide is indicated in adults with type 2 diabetes mellitus whose
hyperglycaemia can no
longer be controlled satisfactorily by diet, weight reduction and
exercise. Repaglinide is also
indicated in combination with metformin in adults with type 2 diabetes
mellitus who are not
satisfactorily controlled on metformin alone. Treatment should be
initiated as an adjunct to diet and
exercise to lower the blood glucose in relation to meals.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Repaglinide is given preprandially and is titrated individually to
optimise glycaemic control. In
addition to self-monitoring by the patient of blood and/or urinary
glucose, the patient’s blood
glucose should be monitored periodically by the physician to determine
the minimum effective dose
for the patient. Glycosylated haemoglobin levels are also of value in
monitoring the patient’s
response to therapy. Periodic monitoring is necessary to detect
inadequate lowering of blood
glucose at the recommended maximum dose level (i.e. primary failure)
and to detect loss of
adequate blood glucose-lowering response after an initial period of
effectiveness (i.e. secondary
failure).
Short-term administration of repaglinide may be sufficient during
periods of transient loss of
control in type 2 diabetic patients usually controlled well on diet.
_Initial dose _
The dosage should be determined by the physician, according to the
patient’s requirements. The
recommended starting dose is 0.5 mg. One to two weeks should elapse
between titration steps (as
determined by blood glucose response). If patients are transferred
from another oral hypoglycae
                                
                                Soma hati kamili
                                
                            

Tafuta arifu zinazohusiana na bidhaa hii