EL Lantus Vials SPC V055 27102009

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1.

Lantus 100 M/ml

2.

ml 100 glargine ( 3,64 mg).


5 ml 500 M 10 ml
1000 M.
glargine DNA Escherichia
coli.
, . 6.1.

3.

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.

4.

4.1

, 6
.
4.2

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Lantus U
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Lantus glargine,
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Lantus
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Lantus

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Lantus

20-30%. , ,
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5.

5.1

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glargine
pH. pH
Lantus (pH 4). ,

glargine , ,
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: glargine
.

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glargine
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glargine
.
clamp 1
glargine NPH,
.
:


* (mg/kg/)

6
5
4

glargine

NPH

2
1
0
0

10

15

20

25

()

30

*
( ).

glargine
.
glargine
.
,
glargine
1.
Lantus ( )
, NPH ( ), 5
, 1.024 2,
3
(ETDRS) .
Lantus
NPH.
5.2

,

glargine NPH.

glargine.
glargine NPH.
H glargine
2-4 .
glargine
.
glargine
21A-Gly-insulin 21A-Gly-des30B-Thr-insulin. glargine
.


glargine .
5.3


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6.

6.1

5 ml:
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,
9

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.
10 ml:
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20,
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.
6.2

.
.
6.3

2 .

4 25C
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.
6.4


(2C 8C).
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Lantus .
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, 6.3.
6.5

5 ml ( 1, ) (),
( ( 1) )
( ).
1, 2, 5 10 .
10 ml ( 1, ) (), (
1, )
( ).
1 .
.

10

6.6

.
, ,
. Lantus , .
7.

Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main,


8.

()

EU/1/00/134/001-004
EU/1/00/134/012
9.

: 9 2000
: 9 2005
10.

17.09.2009

11

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