グリセオール注インタビューフォーム

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1 IF FAX 1 200mL 300mL 500mL 20g 30g 50g 10g 15g 25g 1.8g 2.7g 4.5g 0.9W/V 200mL500mL mL

2 IF 1 MR 63 IF 10 IF 2IF IF IF 3IF 4 9 IF IF IF 11 1 IF IF 4IF IF MR IF IF MR Drug Safety Update IF

3

4

5 1961 Virno 1970 Baylor Meyer %625, % % % % () %952, % % % %() 1

6 GLYCEOL Injection glycerin INN glycerol (JAN)(JAN) Concentrated Glycerin(JAN)Fructose(JAN) NaCl C3H8O3 MW92.09 C6H12O6 MW NaCl MW58.44 Propane1,2,3triolIUPAC DFructopyranoseIUPAC Sodium ChlorideIUPAC 2

7 CGA3O CAS

8 1) 2) 1) 1) (99.5) 2) (95) 1g 1.05mL(96w/v) 40mL(2.4w/v) 1) (99.5) 1g 2.8mL 2.7mL (99.5)(95)100mL 0.17g75% 0.7g 1,2) 100 2) 15 70% ) 4

9 mp.18 2) mp.102~104() 2) 1) 2) 20 D ) ph 4.0g 20mL ph 4.0~6.5 1,2) ph 1.0g 10mL ph 4.5~ ) 14 2) 14 (1)(120)23 5mL (2) 5

10 1) 14 (1)(120) (2)(120) 1) g 50mL 50mL 30 (11)10mL mL 0.1molL : 2 0.1mol / L 1mL9.209mg C3H8O3 2) 14 4g 0.2mL 80mL mL mm D (C6H12O6)(mg)D ) 14 50mg 50mL 0.1molL 0.1mol /L 1mL5.844mg NaCl 6

11 1 200mL300mL500mL ph ph ph mL 300mL 500mL 20g 30g 50g 10g 15g 25g 1.8g 2.7g 4.5g 0.9W/V 7

12 25 60%RH 40 75%RH mL PE 300mL PE 500mL PE 200mL PE 300mL PE 500mL PE ph 5 ph 5 NaCl ()ph(5-) 90110% 95105%NaCl w/v% %RH mL PE 300mL PE 500mL PE ph 5 NaCl ph(5-) 90110% 95105%NaCl w/v%

13 3) 1)2) 90 () 24 1)2)pH 0.5 3) 90 9 (AC17) S 25- K.C.L. S 0.9w/v%Na,Cl154Eq/L 5 (1) (2) (3) (4) 9

14 10mL 100mL 1.000g 0.500g 100mL 5L AT(G)AT(F)AS(G) AS(F) A T(G) () 100 A S(G) AT(G) AS(G) A T(F) () 100 A S(F) AT(F) AS(F) 8mm 300mm mol/L 6 5L (Rs) mL 30mL 0.1mol/L () 0.1mol /L 1mL5.844mg NaCl 10

15 () mL mL mL mL 4590 (61) 500mL 2 4) ( ) 1 500mL 1000mL ) ( ) 500mL ) mL 120 vital signs( ) 500mL

16 (61 ) 15w/v (5w/v)500mL 2 4) (215 ) 20w/v 500mL ) 1) ) ) 12

17 4) 7) 8) 9) 10) baloon cold-injury 11) 12,13) 4,14) 1517) 16,18,19) 20) 6,21) 13

18 3 10%500mL ml/min mg/dL 3 22) No S.E. (0 ) (2 ) (3 ) (5 ) ±

19 15

20 14 C 23) (hr) a) a) S.E. ATP 3 DHAP 3 16) 16

21 5 17

22 14 C 65% 14 CO2 48 TCA cycle ATP 13% 9% 1% 23) (hr) a) b) S.E. a) b) 14 (hr) trace trace S.E. a) 4 (7,14,56,89w/v) 14 C 14 CO2 56w/v 14 CO2 56w/v 89w/v 14 CO2 23) 18

23 14 19

24

25 -1,6-FBPase 24) FBPase 25) 8,

26 () ( ) 623 5,206 5, () (%) ( ) 7(1.12) 26(0.50) 33(0.57) 0(0.00) 10(0.19) 10(0.17) 0(0.00) 6(0.12) 6(0.10) 1(0.16) 5(0.10) 6(0.10) 0(0.00) 4(0.08) 4(0.07) 0(0.00) 1(0.02) 1(0.02) 0(0.00) 1(0.02) 1(0.02) 1(0.16) 0(0.00) 1(0.02) () ( ) 326 2,495 2, () (%) 14(4.29) 43(1.72) 57(2.02) 0(0.00) 16(0.64) 16(0.57) 0(0.00) 15(0.60) 15(0.53) 1(0.31) 10(0.40) 11(0.39) 0(0.00) 7(0.28) 7(0.25) 0(0.00) 4(0.16) 4(0.14) 0(0.00) 3(0.12) 3(0.11) 0(0.00) 2(0.08) 2(0.07) 0(0.00) 2(0.08) 2(0.07) 0(0.00) 2(0.08) 2(0.07) 0(0.00) 1(0.04) 1(0.04) 0(0.00) 1(0.04) 1(0.04) 0(0.00) 1(0.04) 1(0.04) 22

27 () () 615 1, , ()

28 24

29 26) LD50 8g/kg 3.0g/kg 6.0g/kg 3.0g/kg 10%30% 6.0g/kg g/kg 6.0g/kg 6.0g/kg ()rotarod 6.0g/kg 26) 6.0g/kg 3.0g/kg 26) g/kg 10100mg 1g/kg g/kg 1 1.5g/kg 3.0g/kg Na,Cl K Na K 1.5g/kg K 25

30 26) 10 2g/mL BaCl g/mL 310 4g/mL mg g/kg 1.5g/kg 26) 10% 2 4g/kg 4 27) in vitro in vivo in vitro 20.8mg/mL Ca 2.5 g/kg Ca 8 1.0g/kg14 28) 65mg/ kg S.D g/kg 4 500mL 26)

31 26,27) 10mL/kg1 10mL/kg3 26) 24g/kg 1g/kg 26,27,29) 1020L/kg ,26,27,3033) 31 20% 21 10% 27

32 2 6 (1) (2)U 2 Y (3) (4) 200mL mL mL10 20 D mL AMZ

33 () 200mL mL mL mL A mL A mL A

34 (10)1791(1977) 555(7)2327(1978) 675(4)476(1981) 757(6)2017(1980) 817(7)635(1989) 972(4)408(1968) 1026(4)765(1977) 11 26(10)1817(1977) 12Neurol. Med. Chir.22(12)963(1982) 13Neurol. Med. Chir.22(12)972(1982) 1446(6)731(1977) 15 54(9)3068(1977) 16Meyer, J. S. et al.circulation, 51701(1975) 17Ott, E. O. et al.neurology, (1974) 18Sloviter, H. A. et al.nature, (1966) 19Meyer, J. S. et al.stroke, 3168(1972) 20 82(12)932(1978) 21 76(8)1068(1982) 22 (1977) 23 15(2)307(1978) 24Hasegawa,Y. et alpediatrics International,45(1)5(2003) 25Yazaki, M. et alintern. Med., 44(3)188(2005) 26 (1972,1973,1977) 27 (1973,1976) 2826(9)1745(1977) 29 (1976) 30 54(4)1373(1977) 3155(3)929(1978) (1977) 3374(5)521(1980) 30

35 Glyceol Inj Glyceol Inj Fandasy Company Limited Glyceol Inj Siam Pharmaceutical Co.LTD

36 32

37

1 MR 63 2 IF 10 3 IF 2 IF IF IF 3 IF A4 9 IF IF IF 11 1 IF IF 4 IF IF MR IF IF MR Drug Safety Update IF

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