Podevta solution for Injection in cartridge 100 Unitsml

国家: 新加坡

语言: 英文

来源: HSA (Health Sciences Authority)

有效成分:

Insulin glargine

可用日期:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC代码:

A10AE04

剂量:

100Units/ml(10.9134mg/3ml)

药物剂型:

INJECTION, SOLUTION

组成:

Insulin glargine 100Units/ml(10.9134mg/3ml)

给药途径:

SUBCUTANEOUS

处方类型:

Prescription Only

厂商:

Sanofi-Aventis Deutschland GmbH

授权状态:

ACTIVE

授权日期:

2011-09-01

资料单张

 
1
PODEVTA
® 
100 UNITS/ML 

solution for Injection in cartridge

_Insulin glargine_ 
[sanofi-aventis logo] 

1) Solution for injection in cartridge to be used with OptiClik
®

2) Solution for injection in cartridge to be used with OptiPen
®

THIS PACKAGE INSERT IS CONTINUALLY UPDATED: PLEASE READ CAREFULLY
BEFORE USING A 
NEW PACK. IN CASE OF ANY QUESTION, PLEASE CONTACT YOUR
PHYSICIAN OR PHARMACIST. 

COMPOSITION 
Each ml of the solution for injection contains 3.64mg of the
active substance insulin glargine, 
corresponding to 100 IU human insulin. Each cartridge contains 3ml, equivalent to 300 IU. 
Insulin glargine is an insulin analogue produced by recombinant
DNA technology using 
_Escherichia coli _(K 12 strains). 
For excipients, see section “List of excipients” 

PHARMACEUTICAL FORM 
Solution for injection. Podevta is a clear colourless solution. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
For the treatment of adults, adolescents and children of  6 years
or above with diabetes mellitus, 
where treatment with insulin is required. 

POSOLOGY AND METHOD OF ADMINISTRATION 
Podevta contains insulin
glargine an insulin analogue with a prolonged duration of action.
It 
should be administered once daily at any time but at the
same time each day. 
The dosage
and timing of dose of Podevta should be individually adjusted.
In patients with type 2 
diabetes mellitus, Podevta can also be given
together with orally active anti-diabetic medicinal 
products. 

CHILDREN 
In children, efficacy and safety of Podevta
have only been demonstrated when given in the 
evening. Due to limited experience, the efficacy and safety of
Podevta have not been 
demonstrated in children below the age of 6 years. 

TRANSITION FROM OTHER INSULINS TO PODEVTA 
When changing from a treatment regimen with an intermediate
or long-actin

产品特点

1
PODEVTA
®
100 UNITS/ML
solution for Injection in cartridge
_Insulin glargine_
[sanofi-aventis logo]
1) Solution for injection in cartridge to be used with OptiClik
®
2) Solution for injection in cartridge to be used with OptiPen
®
THIS PACKAGE INSERT IS CONTINUALLY UPDATED: PLEASE READ CAREFULLY
BEFORE USING A
NEW PACK. IN CASE OF ANY QUESTION, PLEASE CONTACT YOUR PHYSICIAN OR
PHARMACIST.
COMPOSITION
Each ml of the solution for injection contains 3.64mg of the active
substance insulin glargine,
corresponding to 100 IU human insulin. Each cartridge contains 3ml,
equivalent to 300 IU.
Insulin
glargine
is
an
insulin
analogue
produced
by
recombinant
DNA
technology
using
_Escherichia coli _(K 12 strains).
For excipients, see section “List of excipients”
PHARMACEUTICAL FORM
Solution for injection. Podevta is a clear colourless solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
For the treatment of adults, adolescents and children of 6 years or
above with diabetes mellitus,
where treatment with insulin is required.
POSOLOGY AND METHOD OF ADMINISTRATION
Podevta contains insulin glargine an insulin analogue with a prolonged
duration of action. It
should be administered once daily at any time but at the same time
each day.
The dosage and timing of dose of Podevta should be individually
adjusted. In patients with type 2
diabetes mellitus, Podevta can also be given together with orally
active anti-diabetic medicinal
products.
CHILDREN
In children, efficacy and safety of Podevta have only been
demonstrated when given in the
evening.
Due
to
limited
experience,
the
efficacy
and
safety
of
Podevta
have
not
been
demonstrated in children below the age of 6 years.
TRANSITION FROM OTHER INSULINS TO PODEVTA
When changing from a treatment regimen with an intermediate or
long-acting insulin to a regimen
with Podevta, a change of the dose of the basal insulin may be
required and the concomitant anti-
diabetic treatment may need to be adjusted (dose and timing of
additional regular insulins or fast-
acting insulin analogues o