JP2016050205A - ノルエピネフリンの注射剤形 - Google Patents
ノルエピネフリンの注射剤形 Download PDFInfo
- Publication number
- JP2016050205A JP2016050205A JP2015167928A JP2015167928A JP2016050205A JP 2016050205 A JP2016050205 A JP 2016050205A JP 2015167928 A JP2015167928 A JP 2015167928A JP 2015167928 A JP2015167928 A JP 2015167928A JP 2016050205 A JP2016050205 A JP 2016050205A
- Authority
- JP
- Japan
- Prior art keywords
- dosage form
- norepinephrine
- aqueous solution
- injectable dosage
- container
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- SFLSHLFXELFNJZ-QMMMGPOBSA-N (-)-norepinephrine Chemical compound NC[C@H](O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-QMMMGPOBSA-N 0.000 title claims abstract description 75
- 229960002748 norepinephrine Drugs 0.000 title claims abstract description 67
- SFLSHLFXELFNJZ-UHFFFAOYSA-N norepinephrine Natural products NCC(O)C1=CC=C(O)C(O)=C1 SFLSHLFXELFNJZ-UHFFFAOYSA-N 0.000 title claims abstract description 67
- 239000002552 dosage form Substances 0.000 title claims abstract description 59
- 238000002347 injection Methods 0.000 title abstract description 36
- 239000007924 injection Substances 0.000 title abstract description 36
- 239000007864 aqueous solution Substances 0.000 claims abstract description 81
- 239000000243 solution Substances 0.000 claims abstract description 62
- 239000003963 antioxidant agent Substances 0.000 claims abstract description 43
- 235000006708 antioxidants Nutrition 0.000 claims abstract description 43
- 230000003078 antioxidant effect Effects 0.000 claims abstract description 38
- 150000003839 salts Chemical class 0.000 claims abstract description 21
- LSNNMFCWUKXFEE-UHFFFAOYSA-N Sulfurous acid Chemical compound OS(O)=O LSNNMFCWUKXFEE-UHFFFAOYSA-N 0.000 claims abstract description 18
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 claims abstract description 8
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims abstract description 8
- ZTHYODDOHIVTJV-UHFFFAOYSA-N Propyl gallate Chemical compound CCCOC(=O)C1=CC(O)=C(O)C(O)=C1 ZTHYODDOHIVTJV-UHFFFAOYSA-N 0.000 claims abstract description 8
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 claims abstract description 8
- 229930003427 Vitamin E Natural products 0.000 claims abstract description 4
- 229940087168 alpha tocopherol Drugs 0.000 claims abstract description 4
- 235000010323 ascorbic acid Nutrition 0.000 claims abstract description 4
- 229960005070 ascorbic acid Drugs 0.000 claims abstract description 4
- 239000011668 ascorbic acid Substances 0.000 claims abstract description 4
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 claims abstract description 4
- 235000010388 propyl gallate Nutrition 0.000 claims abstract description 4
- 239000000473 propyl gallate Substances 0.000 claims abstract description 4
- 229940075579 propyl gallate Drugs 0.000 claims abstract description 4
- 229960000984 tocofersolan Drugs 0.000 claims abstract description 4
- 239000011709 vitamin E Substances 0.000 claims abstract description 4
- 235000019165 vitamin E Nutrition 0.000 claims abstract description 4
- 229940046009 vitamin E Drugs 0.000 claims abstract description 4
- 239000002076 α-tocopherol Substances 0.000 claims abstract description 4
- 235000004835 α-tocopherol Nutrition 0.000 claims abstract description 4
- 235000010378 sodium ascorbate Nutrition 0.000 claims abstract 2
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 claims abstract 2
- 229960005055 sodium ascorbate Drugs 0.000 claims abstract 2
- PPASLZSBLFJQEF-RXSVEWSESA-M sodium-L-ascorbate Chemical compound [Na+].OC[C@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RXSVEWSESA-M 0.000 claims abstract 2
- 229920000642 polymer Polymers 0.000 claims description 35
- 238000001802 infusion Methods 0.000 claims description 33
- -1 polyethylene Polymers 0.000 claims description 33
- 239000012603 secondary packaging material Substances 0.000 claims description 30
- 229920000098 polyolefin Polymers 0.000 claims description 28
- 239000000463 material Substances 0.000 claims description 21
- 239000004743 Polypropylene Substances 0.000 claims description 18
- 239000012535 impurity Substances 0.000 claims description 18
- 229920001155 polypropylene Polymers 0.000 claims description 18
- WNPNNLQNNJQYFA-QRPNPIFTSA-N 4-[(1r)-2-amino-1-hydroxyethyl]benzene-1,2-diol;2,3-dihydroxybutanedioic acid Chemical compound OC(=O)C(O)C(O)C(O)=O.NC[C@H](O)C1=CC=C(O)C(O)=C1 WNPNNLQNNJQYFA-QRPNPIFTSA-N 0.000 claims description 15
- 239000004698 Polyethylene Substances 0.000 claims description 15
- 229920000573 polyethylene Polymers 0.000 claims description 15
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims description 14
- 229910052782 aluminium Inorganic materials 0.000 claims description 14
- 229920000089 Cyclic olefin copolymer Polymers 0.000 claims description 11
- 229920001400 block copolymer Polymers 0.000 claims description 10
- 229940123973 Oxygen scavenger Drugs 0.000 claims description 8
- 229920001577 copolymer Polymers 0.000 claims description 8
- 229920000515 polycarbonate Polymers 0.000 claims description 8
- 239000004417 polycarbonate Substances 0.000 claims description 8
- 229940071643 prefilled syringe Drugs 0.000 claims description 8
- LHGVFZTZFXWLCP-UHFFFAOYSA-N guaiacol Chemical group COC1=CC=CC=C1O LHGVFZTZFXWLCP-UHFFFAOYSA-N 0.000 claims description 6
- 239000004255 Butylated hydroxyanisole Substances 0.000 abstract description 11
- 235000019282 butylated hydroxyanisole Nutrition 0.000 abstract description 11
- 229940043253 butylated hydroxyanisole Drugs 0.000 abstract description 11
- CZBZUDVBLSSABA-UHFFFAOYSA-N butylated hydroxyanisole Chemical compound COC1=CC=C(O)C(C(C)(C)C)=C1.COC1=CC=C(O)C=C1C(C)(C)C CZBZUDVBLSSABA-UHFFFAOYSA-N 0.000 abstract description 11
- 230000000694 effects Effects 0.000 abstract description 3
- LNBCGLZYLJMGKP-LUDZCAPTSA-N 4-[(1r)-2-amino-1-hydroxyethyl]benzene-1,2-diol;(2r,3r)-2,3-dihydroxybutanedioic acid;hydrate Chemical compound O.OC(=O)[C@H](O)[C@@H](O)C(O)=O.NC[C@H](O)C1=CC=C(O)C(O)=C1 LNBCGLZYLJMGKP-LUDZCAPTSA-N 0.000 abstract 1
- 229960001695 norepinephrine bitartrate Drugs 0.000 abstract 1
- 150000002871 norepinephrines Chemical class 0.000 abstract 1
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 18
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 18
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 17
- 239000002738 chelating agent Substances 0.000 description 14
- 229940079593 drug Drugs 0.000 description 13
- 239000003814 drug Substances 0.000 description 13
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 12
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 12
- 239000003002 pH adjusting agent Substances 0.000 description 12
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 11
- 238000010790 dilution Methods 0.000 description 11
- 239000012895 dilution Substances 0.000 description 11
- 239000001301 oxygen Substances 0.000 description 11
- 229910052760 oxygen Inorganic materials 0.000 description 11
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 11
- 239000003795 chemical substances by application Substances 0.000 description 10
- 239000010410 layer Substances 0.000 description 10
- 239000011780 sodium chloride Substances 0.000 description 9
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 8
- 229960001484 edetic acid Drugs 0.000 description 8
- 239000000203 mixture Substances 0.000 description 8
- 229910052757 nitrogen Inorganic materials 0.000 description 7
- 239000000047 product Substances 0.000 description 7
- 230000005540 biological transmission Effects 0.000 description 6
- 239000013065 commercial product Substances 0.000 description 6
- 239000011261 inert gas Substances 0.000 description 6
- 229940028395 levophed Drugs 0.000 description 6
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 6
- 235000010262 sodium metabisulphite Nutrition 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- 239000008215 water for injection Substances 0.000 description 6
- 238000004458 analytical method Methods 0.000 description 5
- 238000010926 purge Methods 0.000 description 5
- 229940001584 sodium metabisulfite Drugs 0.000 description 5
- XKRFYHLGVUSROY-UHFFFAOYSA-N Argon Chemical compound [Ar] XKRFYHLGVUSROY-UHFFFAOYSA-N 0.000 description 4
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 description 4
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 4
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 4
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 4
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 4
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 4
- 206010020751 Hypersensitivity Diseases 0.000 description 4
- 229930195725 Mannitol Natural products 0.000 description 4
- QPCDCPDFJACHGM-UHFFFAOYSA-N N,N-bis{2-[bis(carboxymethyl)amino]ethyl}glycine Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(=O)O)CCN(CC(O)=O)CC(O)=O QPCDCPDFJACHGM-UHFFFAOYSA-N 0.000 description 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 4
- 229930006000 Sucrose Natural products 0.000 description 4
- 239000002253 acid Substances 0.000 description 4
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 4
- 239000000872 buffer Substances 0.000 description 4
- 239000001110 calcium chloride Substances 0.000 description 4
- 229910001628 calcium chloride Inorganic materials 0.000 description 4
- 238000002425 crystallisation Methods 0.000 description 4
- 230000008025 crystallization Effects 0.000 description 4
- 239000008121 dextrose Substances 0.000 description 4
- 229910001873 dinitrogen Inorganic materials 0.000 description 4
- 238000002845 discoloration Methods 0.000 description 4
- 229940124274 edetate disodium Drugs 0.000 description 4
- 238000009472 formulation Methods 0.000 description 4
- 239000000594 mannitol Substances 0.000 description 4
- 235000010355 mannitol Nutrition 0.000 description 4
- 239000005022 packaging material Substances 0.000 description 4
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- 230000035699 permeability Effects 0.000 description 4
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- 239000001103 potassium chloride Substances 0.000 description 4
- 235000011164 potassium chloride Nutrition 0.000 description 4
- 238000001556 precipitation Methods 0.000 description 4
- GEHJYWRUCIMESM-UHFFFAOYSA-L sodium sulfite Chemical compound [Na+].[Na+].[O-]S([O-])=O GEHJYWRUCIMESM-UHFFFAOYSA-L 0.000 description 4
- 239000000600 sorbitol Substances 0.000 description 4
- 239000005720 sucrose Substances 0.000 description 4
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 description 3
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- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
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- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 2
- OVBJJZOQPCKUOR-UHFFFAOYSA-L EDTA disodium salt dihydrate Chemical compound O.O.[Na+].[Na+].[O-]C(=O)C[NH+](CC([O-])=O)CC[NH+](CC([O-])=O)CC([O-])=O OVBJJZOQPCKUOR-UHFFFAOYSA-L 0.000 description 2
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- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
- 229920004552 POLYLITE® Polymers 0.000 description 2
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- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
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- 238000012371 Aseptic Filling Methods 0.000 description 1
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical class OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 description 1
- LSNNMFCWUKXFEE-UHFFFAOYSA-M Bisulfite Chemical compound OS([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-M 0.000 description 1
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- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 1
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- 229940001482 sodium sulfite Drugs 0.000 description 1
- WZWGGYFEOBVNLA-UHFFFAOYSA-N sodium;dihydrate Chemical compound O.O.[Na] WZWGGYFEOBVNLA-UHFFFAOYSA-N 0.000 description 1
- 238000002693 spinal anesthesia Methods 0.000 description 1
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- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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Abstract
Description
a.治療有効量の、ノルエピネフリンまたはその薬理学的に許容される塩
b.亜硫酸塩抗酸化剤ではない抗酸化剤
を含有する、室温で安定である水溶液を含んでなる、すぐに投与することのできる注射剤形を提供する。
Claims (15)
- a.以下を含有する、室温で安定である水溶液
I.治療有効量の、ノルエピネフリンまたはその薬理学的に許容される塩、および
II.亜硫酸塩抗酸化剤ではない抗酸化剤
を含んでなる、すぐに投与することのできる(ready-to-administer)注射剤形。 - 前記抗酸化剤が、ブチル化ヒドロキシルアニソール、アスコルビン酸、アスコルビン酸ナトリウム、没食子酸プロピル、ビタミンE、またはアルファ‐トコフェロールから選択される、請求項1に記載の注射剤形。
- 前記抗酸化剤が、ブチル化ヒドロキシルアニソールである、請求項2に記載の注射剤形。
- ブチル化ヒドロキシルアニソールが、約0.001mg/mLから約0.01mg/mLの範囲の量で前記水溶液中に存在する、請求項3に記載の注射剤形。
- ノルエピネフリンが、約0.001mg/mLから約0.2mg/mLの範囲の量で存在する、請求項1に記載の注射剤形。
- ノルエピネフリンまたはその薬理学的に許容される塩が、ノルエピネフリン酒石酸水素塩である、請求項1に記載の注射剤形。
- ノルエピネフリン酒石酸水素塩が、約0.002mg/mLから約0.4mg/mLの範囲の量で存在する、請求項6に記載の注射剤形。
- 前記水溶液のpHが、約3.0から約4.5の範囲である、請求項1に記載の注射剤形。
- 前記水溶液が、所望に応じて二次パッケージ材でさらにパッケージされてよい容器中に充填され、前記容器または前記二次パッケージ材のいずれかは、前記溶液を光から保護するように設計される、請求項1に記載の注射剤形。
- 前記容器が、ポリオレフィンポリマー、ポリエチレン、ポリプロピレン、シクロオレフィンポリマー、シクロオレフィンコポリマー、ポリプロピレン系ポリオレフィンポリマー、ポリカーボネート、修飾ポリオレフィン‐ポリエチレンポリマー、スチレン‐ポリオレフィン系ポリマー、およびそれらのブロックコポリマーを含む群より選択される材料から作られる、請求項9に記載の注射剤形。
- 前記二次パッケージ材が、アルミニウムパウチおよび酸素捕捉剤を含む、請求項9に記載の注射剤形。
- 前記容器が、プレフィルドシリンジであり、およびノルエピネフリンが、約0.05mg/mLから約0.2mg/mLの範囲の量で前記水溶液中に存在する、請求項9に記載の注射剤形。
- 前記容器が、注入バッグであり、およびノルエピネフリンが、約0.004mg/mLから約0.15mg/mLの範囲の量で前記水溶液中に存在する、請求項9に記載の注射剤形。
- 前記注射剤形が、室温で安定であり、および室温またはそれより低い温度で少なくとも12ヶ月間保存後の前記水溶液中の不純物の合計値が、2.0重量%以下である、請求項1に記載の注射剤形。
- 以下を含有する水溶液
ノルエピネフリンまたはその薬理学的に許容される塩の治療有効量、
亜硫酸塩抗酸化剤ではない抗酸化剤
を含み、前記溶液は、室温で12ヶ月間保存された場合に、4%未満のS異性体含有量を有するすぐに投与することのできる注射剤形。
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IN2759MU2014 | 2014-08-28 |
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