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EL Lantus Vials SPC V055 27102009
EL Lantus Vials SPC V055 27102009
EL Lantus Vials SPC V055 27102009
2.
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4.1
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.
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.
Lantus U
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5.1 ().
Lantus glargine,
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2, Lantus
.
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Lantus
6 .
1
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-
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2
4.4
Lantus .
(regular) .
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6 .
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7
5.
5.1
: . ,
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glargine
pH. pH
Lantus (pH 4). ,
glargine , ,
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: glargine
.
.
, glargine
.
,
, .
, .
glargine
. ,
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
, ,
, , .
6.
6.1
5 ml:
,
-,
,
,
9
,
.
10 ml:
,
-,
,
,
20,
,
.
6.2
.
.
6.3
2 .
4 25C
.
.
.
6.4
(2C 8C).
.
Lantus .
.
, 6.3.
6.5
5 ml ( 1, ) (),
( ( 1) )
( ).
1, 2, 5 10 .
10 ml ( 1, ) (), (
1, )
( ).
1 .
.
10
6.6
.
, ,
. Lantus , .
7.
()
EU/1/00/134/001-004
EU/1/00/134/012
9.
: 9 2000
: 9 2005
10.
17.09.2009
11