RU2017118396A - Шприц и способ подготовки шприца - Google Patents
Шприц и способ подготовки шприца Download PDFInfo
- Publication number
- RU2017118396A RU2017118396A RU2017118396A RU2017118396A RU2017118396A RU 2017118396 A RU2017118396 A RU 2017118396A RU 2017118396 A RU2017118396 A RU 2017118396A RU 2017118396 A RU2017118396 A RU 2017118396A RU 2017118396 A RU2017118396 A RU 2017118396A
- Authority
- RU
- Russia
- Prior art keywords
- needle
- syringe
- water vapor
- shell
- preceding paragraphs
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 6
- 239000003814 drug Substances 0.000 claims 3
- 238000002386 leaching Methods 0.000 claims 3
- 239000000463 material Substances 0.000 claims 3
- 239000000126 substance Substances 0.000 claims 3
- YXIWHUQXZSMYRE-UHFFFAOYSA-N 1,3-benzothiazole-2-thiol Chemical compound C1=CC=C2SC(S)=NC2=C1 YXIWHUQXZSMYRE-UHFFFAOYSA-N 0.000 claims 2
- 229960000074 biopharmaceutical Drugs 0.000 claims 2
- 102000004169 proteins and genes Human genes 0.000 claims 2
- 108090000623 proteins and genes Proteins 0.000 claims 2
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 claims 1
- 239000011248 coating agent Substances 0.000 claims 1
- 238000000576 coating method Methods 0.000 claims 1
- 150000001875 compounds Chemical class 0.000 claims 1
- 239000012530 fluid Substances 0.000 claims 1
- 229920003048 styrene butadiene rubber Polymers 0.000 claims 1
- 229920002725 thermoplastic elastomer Polymers 0.000 claims 1
- 239000011701 zinc Substances 0.000 claims 1
- 229910052725 zinc Inorganic materials 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B3/00—Packaging plastic material, semiliquids, liquids or mixed solids and liquids, in individual containers or receptacles, e.g. bags, sacks, boxes, cartons, cans, or jars
- B65B3/003—Filling medical containers such as ampoules, vials, syringes or the like
- B65B3/006—Related operations, e.g. scoring ampoules
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
- B65B7/00—Closing containers or receptacles after filling
- B65B7/16—Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Diabetes (AREA)
- Epidemiology (AREA)
- Surgery (AREA)
- Mechanical Engineering (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Dermatology (AREA)
- Pharmacology & Pharmacy (AREA)
Claims (19)
1. Шприц (1; 18; 19), имеющий продольный корпус (2; 28; 29) с внутренним пространством (22; 228; 229), в котором расположено фармацевтическое вещество, иглу, соединенную с одним продольным концом корпуса (2; 28; 29), а также жесткий кожух (3; 38; 39) для иглы, заключающий в себя иглу, отличающийся тем, что жесткий кожух (3; 38; 39) для иглы непроницаем для водяного пара.
2. Шприц (1; 18; 19) по п.1, в котором смежная с иглой часть (31; 318; 319) жесткого кожуха (3; 38; 39) для иглы, прилегающая к игле, имеет низкую степень выщелачивания.
3. Шприц (1; 18; 19) по п.2, в котором низкая степень выщелачивания представляет собой низкую степень выщелачивания цинка.
4. Шприц (1; 18; 19) по любому из предшествующих пунктов, в котором жесткий кожух (3; 38; 39) для иглы содержит непроницаемую для водяного пара оболочку (338; 339, 349).
5. Шприц (1; 18; 19) по п.4, в котором оболочка (338; 339, 349) содержит воск.
6. Шприц (1; 18; 19) по п.4 или 5, в котором оболочка (338; 339, 349) содержит непроницаемый для водяного пара контейнер (339), заполненный текучей средой на водной основе.
7. Шприц (1; 18; 19) по любому из пп.1-3, в котором жесткий кожух (3; 38; 39) для иглы содержит смежную с иглой часть (31; 318; 319), прилегающую к игле, выполненную из непроницаемого для водяного пара материала.
8. Шприц (1; 18; 19) по п.7, в котором непроницаемый для водяного пара материал представляет собой термопластичный эластомер на основе этилен-пропилен-диен-метилена.
9. Шприц (1; 18; 19) по п.7, в котором непроницаемый для водяного пара материал представляет собой стирол-бутадиеновое каучуковое соединение, свободное от 2-меркаптобензотиазола.
10. Шприц (1; 18; 19) по любому из предшествующих пунктов, в котором внутреннее пространство (22; 228; 229) корпуса (2; 28; 29) уплотнено плунжером (4; 48; 49) на стороне, противоположной игле.
11. Шприц (1; 18; 19) по любому из предшествующих пунктов, в котором игла выполнена за одно целое с корпусом (2; 28; 29).
12. Шприц (1; 18; 19) по любому из предшествующих пунктов, в котором фармацевтическое вещество представляет собой биофармацевтическое вещество.
13. Шприц (1; 18; 19) по п.12, в котором биофармацевтическое вещество содержит белок.
14. Шприц (1; 18; 19) по п.13, в котором вещество содержит белок, концентрация которого находится в диапазоне от около 50 до около 250 мг/мл.
15. Способ подготовки шприца (1; 18; 19), имеющего продольный корпус (2; 28; 29) с внутренним пространством (22; 228; 229) и иглу, соединенную с одним продольным концом корпуса (2; 28; 29), в котором осуществляют:
заправку фармацевтического вещества во внутреннее пространство (22; 228; 229) корпуса (2; 28; 29) шприца (1; 18; 19),
уплотняют внутреннее пространство (22; 228; 229) корпуса (2; 28; 29) шприца (1; 18; 19) путем проталкивания плунжера (4; 48; 49) через отверстие на продольном конце корпуса (2; 28; 29), противоположном игле, а также
заключают иглу в непроницаемый для водяного пара жесткий кожух (3; 38; 39) для иглы.
16. Способ по п.15, в котором заключение иглы в жесткий кожух (3; 38; 39) для иглы содержит надевание колпачка (32; 328; 329) для иглы на иглу и покрытие колпачка (32; 328; 329) для иглы непроницаемой для водяного пара оболочкой (338; 339, 349).
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201462072625P | 2014-10-30 | 2014-10-30 | |
US62/072,625 | 2014-10-30 | ||
PCT/EP2015/075302 WO2016066821A1 (en) | 2014-10-30 | 2015-10-30 | Syringe and method of preparing a syringe |
Publications (3)
Publication Number | Publication Date |
---|---|
RU2017118396A true RU2017118396A (ru) | 2018-12-04 |
RU2017118396A3 RU2017118396A3 (ru) | 2019-05-29 |
RU2708974C2 RU2708974C2 (ru) | 2019-12-12 |
Family
ID=51982433
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
RU2017118396A RU2708974C2 (ru) | 2014-10-30 | 2015-10-30 | Шприц и способ подготовки шприца |
Country Status (10)
Country | Link |
---|---|
US (2) | US20170333641A1 (ru) |
EP (1) | EP3212252A1 (ru) |
JP (1) | JP6752787B2 (ru) |
KR (1) | KR20170076726A (ru) |
CN (2) | CN107148287A (ru) |
BR (1) | BR112017008658A2 (ru) |
CA (1) | CA2963325A1 (ru) |
MX (1) | MX2017005512A (ru) |
RU (1) | RU2708974C2 (ru) |
WO (1) | WO2016066821A1 (ru) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10780228B2 (en) | 2012-05-07 | 2020-09-22 | Medline Industries, Inc. | Prefilled container systems |
JP6752150B2 (ja) * | 2014-10-30 | 2020-09-09 | 中外製薬株式会社 | シリンジキャップを具備した、針付プレフィルドシリンジ製剤 |
JP6798993B2 (ja) | 2014-12-23 | 2020-12-09 | メルツ ファーマ ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コンパニー コマンディト ゲゼルシャフト アウフ アクティーン | ボツリヌス毒素プレフィルド容器 |
US20170349313A1 (en) * | 2016-06-01 | 2017-12-07 | Centurion Medical Products Corporation | Methods for manufacturing non-glass prefilled syringes |
EP3753601B1 (en) | 2019-06-21 | 2024-09-18 | Samia Trigo Arbache | Needle improvements for drug delivery using tattoo machines |
EP4190354A4 (en) * | 2020-07-28 | 2024-12-04 | Chugai Seiyaku Kabushiki Kaisha | Prefilled syringe preparation with needle, provided with needle shield and including novel modified antibody |
Family Cites Families (23)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4964866A (en) * | 1989-11-22 | 1990-10-23 | Becton, Dickinson And Company | Needle sheath assembly |
DE4438360C2 (de) | 1994-10-27 | 1999-05-20 | Schott Glas | Vorfüllbare partikelarme, sterile Einmalspritze für die Injektion von Präparaten und Verfahren zu ihrer Herstellung |
JP3538255B2 (ja) * | 1995-03-10 | 2004-06-14 | ブラッコ インターナショナル ビーヴィ | プレフィルドシリンジとピストンロッドの包装体 |
EP0803261A4 (en) * | 1995-08-09 | 2000-03-01 | Tetsuro Higashikawa | SYRINGE, SEAL COVER AND METHOD FOR IT AND SLIDE VALVE WITH SPRAYERS |
US20020095134A1 (en) | 1999-10-14 | 2002-07-18 | Pettis Ronald J. | Method for altering drug pharmacokinetics based on medical delivery platform |
DE19954373B4 (de) | 1999-11-11 | 2011-01-27 | Helvoet Pharma Belgium N.V. | Schutzkappe für eine Kanüle |
FR2816848B1 (fr) | 2000-11-17 | 2003-06-20 | Rumpler Technologies | Dispositif de protection pour aiguille de seringue |
EP1418957A4 (en) | 2001-07-25 | 2010-02-24 | Injectimed Inc | METHOD AND DEVICE FOR DISPLAYING OR COVERING A PERCUT PUNCTURE SITE |
JP2004229750A (ja) | 2003-01-28 | 2004-08-19 | Nipro Corp | プレフィルドシリンジ及びそのバレルの製造方法 |
EP1502616A1 (de) | 2003-08-01 | 2005-02-02 | Bünder Glas GmbH | Nadelschutz für eine Glasspritze |
US20050075611A1 (en) * | 2003-10-01 | 2005-04-07 | Hetzler Kevin G. | Low extractable, thermoplastic syringe and tip cap |
CN100488580C (zh) * | 2003-10-01 | 2009-05-20 | 贝克顿·迪金森公司 | 可萃取物低的热塑性注射器和针尖盖帽 |
JP4652082B2 (ja) * | 2005-02-28 | 2011-03-16 | ユニチカ株式会社 | 生分解性防湿材料およびその製造方法 |
BRPI0908361A2 (pt) * | 2008-02-07 | 2015-04-07 | Amgen Inc | Seringas previamente cheias contendo composição e métodos de preparação das mesmas e de estabilização de agente de ligação específico em composição. |
CA2803613C (en) * | 2010-06-29 | 2018-12-11 | Cv Holdings, Llc | Syringe with integrated needle |
JOP20190250A1 (ar) * | 2010-07-14 | 2017-06-16 | Regeneron Pharma | صيغ مستقرة تحتوي على الأجسام المضادة لمضاد عامل نمو الأعصاب |
JP2013043957A (ja) * | 2011-08-25 | 2013-03-04 | Sumitomo Rubber Ind Ltd | 針キャップ用ゴム組成物 |
BR112015007018B1 (pt) * | 2012-10-04 | 2021-12-28 | Fresenius Kabi Austria Gmbh | Disposição de aplicação com um fluido de ingrediente farmacêutico |
WO2014059012A1 (en) | 2012-10-12 | 2014-04-17 | Sio2 Medical Products, Inc. | Process for the internal coating of hollow bodies |
DK2968729T3 (en) * | 2013-03-14 | 2018-12-03 | Fresenius Kabi Deutschland Gmbh | OXYGEN SENSITIVE PACKAGING SYSTEM |
EP2826508A1 (en) | 2013-07-18 | 2015-01-21 | Becton Dickinson France | A tip cap and an injection device having a distal tip sealed by a tip cap |
CN106794322A (zh) | 2014-10-02 | 2017-05-31 | 住友橡胶工业株式会社 | 喷嘴帽 |
JP6752150B2 (ja) | 2014-10-30 | 2020-09-09 | 中外製薬株式会社 | シリンジキャップを具備した、針付プレフィルドシリンジ製剤 |
-
2015
- 2015-10-30 CN CN201580058611.4A patent/CN107148287A/zh active Pending
- 2015-10-30 JP JP2017523258A patent/JP6752787B2/ja not_active Expired - Fee Related
- 2015-10-30 CN CN202211314610.XA patent/CN115607771A/zh active Pending
- 2015-10-30 WO PCT/EP2015/075302 patent/WO2016066821A1/en not_active Application Discontinuation
- 2015-10-30 BR BR112017008658A patent/BR112017008658A2/pt active Search and Examination
- 2015-10-30 KR KR1020177013554A patent/KR20170076726A/ko not_active Withdrawn
- 2015-10-30 MX MX2017005512A patent/MX2017005512A/es unknown
- 2015-10-30 US US15/523,048 patent/US20170333641A1/en not_active Abandoned
- 2015-10-30 CA CA2963325A patent/CA2963325A1/en not_active Abandoned
- 2015-10-30 RU RU2017118396A patent/RU2708974C2/ru active
- 2015-10-30 EP EP15790506.8A patent/EP3212252A1/en not_active Withdrawn
-
2022
- 2022-02-18 US US17/675,509 patent/US11771843B2/en active Active
Also Published As
Publication number | Publication date |
---|---|
CN107148287A (zh) | 2017-09-08 |
WO2016066821A1 (en) | 2016-05-06 |
CN115607771A (zh) | 2023-01-17 |
KR20170076726A (ko) | 2017-07-04 |
JP6752787B2 (ja) | 2020-09-09 |
RU2708974C2 (ru) | 2019-12-12 |
MX2017005512A (es) | 2018-08-16 |
RU2017118396A3 (ru) | 2019-05-29 |
JP2017538463A (ja) | 2017-12-28 |
US11771843B2 (en) | 2023-10-03 |
EP3212252A1 (en) | 2017-09-06 |
BR112017008658A2 (pt) | 2017-12-19 |
US20170333641A1 (en) | 2017-11-23 |
US20220203041A1 (en) | 2022-06-30 |
CA2963325A1 (en) | 2016-05-06 |
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