Podevta solution for Injection in vial 100 Unitsml

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

Insulin glargine

Предлага се от:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

АТС код:

A10AE04

дозиране:

100Units/ml(36.378mg/10ml)

Лекарствена форма:

INJECTION, SOLUTION

Композиция:

Insulin glargine 100Units/ml(36.378mg/10ml)

Начин на приложение:

SUBCUTANEOUS

Вид предписание :

Prescription Only

Произведено от:

Sanofi-Aventis Deutschland GmbH

Статус Оторизация:

ACTIVE

Дата Оторизация:

2011-09-01

Данни за продукта

Podevta 100IU/ml Vial
Proposed clean PI
1
PODEVTA
®
100 UNITS/ML
solution for Injection in vial
_Insulin glargine_
[sanofi-aventis logo]
This p ackage in sert is cont inually up d at ed : p lease read caref
ully b ef ore
usin g a new p ack. In case of any q uest ion, p lease cont act your p
hysician
or p h arm acist
COMPOSITION
Each m l of t he solut ion f or in ject ion cont ains 3.64m g of t he
act ive sub st ance
insulin glargine, corresp ond ing t o 100 IU h um an in sulin . Each
vial cont ain s 10m l,
eq uivalent t o 1000 IU.
Insulin glargine is an insulin analo gue p ro d uced b y recom b inant
DNA t echnology
usin g _Escherichia coli _(K 12 st rain s).
For excip ient s, see sect ion “List of excip ien t s”
PHARMACEUTICAL FORM
Solut ion f or in ject ion. Pod evt a is a clear colourless solut ion
.
CLINICAL PARTICULARS
1. THERAPEUTIC INDICATIONS
For t he t reat m ent of ad ult s, ad olescent s an d ch ild ren of 6
years or ab ove w it h
d iab et es m ellit us, w here t reat m en t w it h in sulin is req
uired .
POSOLOGY AND METHOD OF ADMINISTRATION
Pod evt a cont ains insulin glargine an insulin an alogue w it h a p
rolonged d urat ion of
act ion. It should b e ad m inist ered once d aily at any t im e b ut
at t he sam e t im e each
d ay.
The d o sage and t im ing of d ose of Po d evt a should b e in d ivid
ually ad just ed . In
p at ien t s w it h t yp e 2 d iab et es m ellit us, Pod evt a can
also b e given t oget her w it h
orally act ive ant i-d iab et ic m ed icin al
p rod uct s.
CHILDREN
In child ren , ef f icacy and saf et y of Pod evt a have only b een d
em o nst rat ed w hen
given in t he even ing. Due t o lim it ed exp erience, t h e ef f
icacy and saf et y of Pod evt a
have not b een d em onst rat ed in ch ild ren b elo w t he age of 6
years.
TRANSITION FROM OTHER INSULINS TO PODEVTA
When changing f rom a t reat m en t regim en w it h an int erm ed iat
e or long-act ing
insulin t o a regim en w it h Po d evt a, a ch ange o f t he d ose of
t he b asal insulin m ay b e
req uired and t he concom