DK1832279T3 - Fremgangsmåde til fremstilling af suspensioner indeholdende partikler med aktivt stof til brug for en indgivelse ved inhalation - Google Patents
Fremgangsmåde til fremstilling af suspensioner indeholdende partikler med aktivt stof til brug for en indgivelse ved inhalation Download PDFInfo
- Publication number
- DK1832279T3 DK1832279T3 DK06017746.6T DK06017746T DK1832279T3 DK 1832279 T3 DK1832279 T3 DK 1832279T3 DK 06017746 T DK06017746 T DK 06017746T DK 1832279 T3 DK1832279 T3 DK 1832279T3
- Authority
- DK
- Denmark
- Prior art keywords
- particles
- treatment
- pressure
- active ingredient
- sterile
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/902—Specified use of nanostructure
- Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/902—Specified use of nanostructure
- Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
- Y10S977/906—Drug delivery
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S977/00—Nanotechnology
- Y10S977/902—Specified use of nanostructure
- Y10S977/904—Specified use of nanostructure for medical, immunological, body treatment, or diagnosis
- Y10S977/926—Topical chemical, e.g. cosmetic or sunscreen
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Dispersion Chemistry (AREA)
- Pulmonology (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Otolaryngology (AREA)
- Immunology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Steroid Compounds (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
- Manufacturing Of Micro-Capsules (AREA)
Claims (10)
1. Fremgangsmåde til fremstilling af en vandig suspension til behandling af luftvejssygdomme ved pulmonær eller nasal inhalation omfattende beclome-tasondiproprionat som aktiv bestanddel i form af partikler med en størrelse, der er egnet til inhalation, hvilken fremgangsmåde omfatter de følgende trin: a) at dispergere en vandig opløsning i en turboemulgator; b) at tilsætte den mikroniserede aktive bestanddel til den vandige fase; c) at dispergere de mikroniserede partikler af den aktive bestanddel i den vandige fase ved at anvende en hastighed på mellem 2000 og 3000 rpm i et tidsrum på 15-20 minutter; og d) yderligere at underkaste den opnåede vandige suspension en homogeniseringsbehandling under højtryk med en homogeniseringsindretning, som omfatter en højtrykspumpe, der leverer et tryk på op til 1500 bar.
2. Fremgangsmåde ifølge krav 1, hvor den vandige suspension fra trin d) underkastes en cyklus af homogeniseringsbehandling ved et tryk, der ligger mellem 500 og 1000 bar, hvor mindst 90 % af partiklerne ved afslutningen af behandlingen har en gennemsnitlig diameter på mindre end eller lig med 5 micron.
3. Fremgangsmåde ifølge krav 1 eller 2, kendetegnet ved, at hastigheden ligger mellem 2500 og 2600 rpm.
4. Fremgangsmåde ifølge et af kravene 1 til 3, kendetegnet ved, at turbo-emulgatoren monteres med en spindelvarmekappe og et vakuumsystem.
5. Fremgangsmåde ifølge et af de foregående krav, kendetegnet ved, at den vandige opløsning omfatter et hjælpestof udvalgt fra gruppen bestående af befugtningsmidler, viskositetsforøgende midler, konserveringsmidler, stabiliseringsmidler, isotoniske midler og puffere.
6. Fremgangsmåde ifølge krav 2, kendetegnet ved, at homogeniseringsbehandlingen finder sted ved et tryk, der ligger mellem 600 og 800 bar.
7. Fremgangsmåde ifølge krav 1, kendetegnet ved, at den vandige suspension inddeles i enkeltdosisbeholdere.
8. Fremgangsmåde ifølge krav 7, kendetegnet ved, at beholderne udformes på forhånd eller fremstilles ved at anvende teknologien "oppustning, opfyldning og forsegling".
9. Fremgangsmåde ifølge krav 1, hvor luftvejssygdommene er udvalgt fra gruppen bestående af allergiske tilstande og/eller inflammatoriske tilstande i næsen eller lungerne.
10. Fremgangsmåde ifølge krav 9, hvor luftvejssygdommene er astma eller bronchopulmonær dysplasi.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IT1998MI002364A IT1303692B1 (it) | 1998-11-03 | 1998-11-03 | Procedimento per la preparazione di sospensioni di particelle difarmaci da somministrare per inalazione. |
EP99955895A EP1126823B1 (en) | 1998-11-03 | 1999-10-28 | A process for the preparation of sterile therapeutically acceptable beclomethasone dipropionate |
Publications (1)
Publication Number | Publication Date |
---|---|
DK1832279T3 true DK1832279T3 (da) | 2015-10-05 |
Family
ID=11380994
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK06017746.6T DK1832279T3 (da) | 1998-11-03 | 1999-10-28 | Fremgangsmåde til fremstilling af suspensioner indeholdende partikler med aktivt stof til brug for en indgivelse ved inhalation |
DK99955895T DK1126823T3 (da) | 1998-11-03 | 1999-10-28 | Fremgangsmåde til fremstilling af sterilt terapeutisk acceptabelt beclometason-dipropionat |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK99955895T DK1126823T3 (da) | 1998-11-03 | 1999-10-28 | Fremgangsmåde til fremstilling af sterilt terapeutisk acceptabelt beclometason-dipropionat |
Country Status (26)
Country | Link |
---|---|
US (1) | US6464958B1 (da) |
EP (2) | EP1832279B1 (da) |
JP (1) | JP2002528484A (da) |
KR (1) | KR100783096B1 (da) |
CN (1) | CN1158997C (da) |
AT (1) | ATE352288T1 (da) |
AU (1) | AU762367B2 (da) |
BR (2) | BRPI9917701B1 (da) |
CA (2) | CA2349268C (da) |
CY (2) | CY1107659T1 (da) |
CZ (2) | CZ300650B6 (da) |
DE (1) | DE69935002T2 (da) |
DK (2) | DK1832279T3 (da) |
EA (1) | EA003228B1 (da) |
ES (1) | ES2281197T3 (da) |
HU (2) | HU226734B1 (da) |
IT (1) | IT1303692B1 (da) |
NO (1) | NO20012175L (da) |
NZ (1) | NZ511305A (da) |
PL (1) | PL195908B1 (da) |
PT (1) | PT1126823E (da) |
SI (1) | SI1126823T1 (da) |
SK (2) | SK285487B6 (da) |
TR (1) | TR200101209T2 (da) |
WO (1) | WO2000025746A2 (da) |
ZA (1) | ZA200103526B (da) |
Families Citing this family (42)
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WO1996025918A1 (en) * | 1995-02-24 | 1996-08-29 | Nanosystems L.L.C. | Aerosols containing nanoparticle dispersions |
KR20070051953A (ko) | 1998-11-02 | 2007-05-18 | 엘란 코포레이션, 피엘씨 | 다입자 변형 방출 조성물 |
AUPQ573300A0 (en) * | 2000-02-21 | 2000-03-16 | Australian Nuclear Science & Technology Organisation | Controlled release ceramic particles, compositions thereof, processes of preparation and methods of use |
NZ523693A (en) * | 2000-07-10 | 2004-08-27 | Chiron Corp | Macrolide formulations for inhalation and methods of treatment of endobronchial infections |
SG98420A1 (en) * | 2000-07-13 | 2003-09-19 | Purzer Pharmaceutical Co Ltd | Method for transferring one or more active ingredients between different phase carriers |
US6667344B2 (en) | 2001-04-17 | 2003-12-23 | Dey, L.P. | Bronchodilating compositions and methods |
US20030091513A1 (en) * | 2001-10-03 | 2003-05-15 | Mohsen Nahed M. | Method to generate water soluble or nonwater soluble in nanoparticulates directly in suspension or dispersion media |
US20030129242A1 (en) * | 2002-01-04 | 2003-07-10 | Bosch H. William | Sterile filtered nanoparticulate formulations of budesonide and beclomethasone having tyloxapol as a surface stabilizer |
WO2003070285A1 (en) | 2002-02-19 | 2003-08-28 | Resolution Chemicals Limited | Solvent-based sterilisation of pharmaceuticals |
ITMI20020808A1 (it) * | 2002-04-17 | 2003-10-17 | Chiesi Farma Spa | Procedimento per la preparazione di una sospensione sterile di particelle di beclometasone dipropionato da somministrare per inalazione |
US20040105778A1 (en) * | 2002-10-04 | 2004-06-03 | Elan Pharma International Limited | Gamma irradiation of solid nanoparticulate active agents |
ITMI20022674A1 (it) * | 2002-12-18 | 2004-06-19 | Chiesi Farma Spa | Procedimento per la preparazione di formulazioni sterili a base di principi attivi farmaceutici cristallini micronizzati da somministrare come sospensioni acquose per inalazione. |
US20040208833A1 (en) * | 2003-02-04 | 2004-10-21 | Elan Pharma International Ltd. | Novel fluticasone formulations |
ATE426398T1 (de) * | 2003-02-20 | 2009-04-15 | Constant Res & Dev Ltd | Prozess zur herstellung einer dexamethason enthaltenden formulierung zur oralen anwendung |
EP1454636A1 (en) * | 2003-03-04 | 2004-09-08 | Dompé S.P.A. | Sterilization of glucocorticoid drug particles for pulmonary delivery |
US8912174B2 (en) | 2003-04-16 | 2014-12-16 | Mylan Pharmaceuticals Inc. | Formulations and methods for treating rhinosinusitis |
US7811606B2 (en) * | 2003-04-16 | 2010-10-12 | Dey, L.P. | Nasal pharmaceutical formulations and methods of using the same |
US9808471B2 (en) | 2003-04-16 | 2017-11-07 | Mylan Specialty Lp | Nasal pharmaceutical formulations and methods of using the same |
EP1626742A1 (en) * | 2003-05-22 | 2006-02-22 | Elan Pharma International Limited | Sterilization of dispersions of nanoparticulate active agents with gamma radiation |
TWI359675B (en) | 2003-07-10 | 2012-03-11 | Dey L P | Bronchodilating β-agonist compositions |
GB0319500D0 (en) * | 2003-08-19 | 2003-09-17 | Resolution Chemicals Ltd | Particle-size reduction apparatus,and use thereof |
ITMI20032054A1 (it) | 2003-10-22 | 2005-04-23 | Monteres S R L | Processo per la preparazione di sospensioni farmaceutiche da inalare. |
RU2006121347A (ru) * | 2003-11-18 | 2008-01-10 | Янсонг ШЭН (US) | Устройство для вдыхания, оказывающее благотворное влияние |
PE20050941A1 (es) * | 2003-12-16 | 2005-11-08 | Nycomed Gmbh | Suspensiones acuosas de ciclesonida para nebulizacion |
US7892483B2 (en) * | 2004-03-12 | 2011-02-22 | Cipla Limited | Sterilization process |
EP1729729B1 (en) | 2004-03-23 | 2014-04-23 | Novartis AG | Pharmaceutical compositions |
GB0406515D0 (en) * | 2004-03-23 | 2004-04-28 | Novartis Ag | Organic compounds |
ITMI20040795A1 (it) * | 2004-04-23 | 2004-07-23 | Eratech S R L | Composizione farmaceutica solida secca suo processo di preparazione e sospensione acquosa stabile ottenuta dalla stessa |
GB0410995D0 (en) * | 2004-05-17 | 2004-06-23 | Norton Healthcare Ltd | Heat sterilization of glucocorticosteroids |
GB0425266D0 (en) | 2004-11-16 | 2004-12-15 | Norton Healthcare Ltd | Pharmaceutical manufacturing process |
EP2623095A1 (en) * | 2004-11-16 | 2013-08-07 | Elan Pharma International Limited | Injectable nanoparticulate olanzapine formulations |
GB0427568D0 (en) * | 2004-12-16 | 2005-01-19 | Resolution Chemicals Ltd | Particle-size reduction apparatus, and the use thereof |
ES2388287T3 (es) | 2005-01-20 | 2012-10-11 | Eratech S.R.L. | Procedimiento para la preparación de suspensiones concentradas de fármacos y kit correspondiente |
EP1968547A1 (en) * | 2005-11-29 | 2008-09-17 | Farmabios S.p.A. | Process for the preparation of micronised sterile steroids |
JP2009543803A (ja) * | 2006-07-12 | 2009-12-10 | エラン・ファルマ・インターナショナル・リミテッド | モダフィニルのナノ粒子製剤 |
PT2229148E (pt) * | 2007-12-13 | 2014-05-26 | Novartis Ag | Processo para preparação de uma substância farmacológica particulada e substancialmente cristalina |
AU2010252354B2 (en) * | 2009-05-25 | 2016-05-19 | Chiesi Farmaceutici S.P.A. | A therapeutic combination comprising a pulmonary surfactant and a steroid |
RU2611665C2 (ru) | 2011-05-03 | 2017-02-28 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Улучшенный состав суспензии кортикостероида для ингаляционного введения |
RU2600796C2 (ru) | 2011-05-04 | 2016-10-27 | КЬЕЗИ ФАРМАЧЕУТИЧИ С.п.А. | Местный состав, содержащий кортикостероид в качестве активного ингредиента |
CN104739811A (zh) * | 2015-02-27 | 2015-07-01 | 上海臣邦医药科技有限公司 | 一种糖皮质激素雾化吸入混悬液及其制备方法 |
TWI773641B (zh) * | 2015-05-08 | 2022-08-11 | 日商活效製藥股份有限公司 | 含有糖皮質類固醇(glucocorticoids)之奈米微粒子之水性懸浮液劑 |
WO2023136787A1 (en) * | 2022-01-17 | 2023-07-20 | Arven Ilac Sanayi Ve Ticaret Anonim Sirketi | Process for the preparation of a sterile, homogeneous suspension for inhalation by nebulization |
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DE69002718T2 (de) * | 1989-09-08 | 1993-12-23 | Glaxo Group Ltd | Medikamente. |
US5126123A (en) * | 1990-06-28 | 1992-06-30 | Glaxo, Inc. | Aerosol drug formulations |
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US5046326A (en) | 1990-10-24 | 1991-09-10 | Thermo King Corporation | Transport refrigeration system |
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GB9202519D0 (en) * | 1992-02-06 | 1992-03-25 | Glaxo Group Ltd | Medicaments |
IL101387A (en) * | 1992-03-26 | 1999-11-30 | Pharmos Ltd | Emulsion with enhanced topical and/or transdermal systemic effect utilizing submicron oil droplets |
UY24147A1 (es) * | 1995-01-20 | 1996-02-02 | Gruenenthal Chemie | Procedimiento y dispositivo para preparar composiciones dispersables por aspersion de aerosoles |
US6135628A (en) * | 1995-10-13 | 2000-10-24 | Boehringer Ingelheim Pharmceuticals, Inc. | Method and apparatus for homogenizing aerosol formulations |
IT1286496B1 (it) * | 1996-11-20 | 1998-07-15 | Leetrim Ltd Dublin | Composizione farmaceutica orale ad attivita' antipiretica,analgesica ed antiinfiammatoria |
SE9704186D0 (sv) * | 1997-11-14 | 1997-11-14 | Astra Ab | New composition of matter |
-
1998
- 1998-11-03 IT IT1998MI002364A patent/IT1303692B1/it active
-
1999
- 1999-10-28 EA EA200100397A patent/EA003228B1/ru not_active IP Right Cessation
- 1999-10-28 BR BRPI9917701A patent/BRPI9917701B1/pt not_active IP Right Cessation
- 1999-10-28 AU AU12666/00A patent/AU762367B2/en not_active Ceased
- 1999-10-28 JP JP2000579190A patent/JP2002528484A/ja active Pending
- 1999-10-28 ES ES99955895T patent/ES2281197T3/es not_active Expired - Lifetime
- 1999-10-28 HU HU0104230A patent/HU226734B1/hu unknown
- 1999-10-28 CN CNB998129348A patent/CN1158997C/zh not_active Expired - Lifetime
- 1999-10-28 US US09/830,884 patent/US6464958B1/en not_active Expired - Lifetime
- 1999-10-28 HU HU0700446A patent/HU230121B1/hu unknown
- 1999-10-28 DE DE69935002T patent/DE69935002T2/de not_active Expired - Lifetime
- 1999-10-28 BR BRPI9915251A patent/BRPI9915251B8/pt not_active IP Right Cessation
- 1999-10-28 NZ NZ511305A patent/NZ511305A/en unknown
- 1999-10-28 CZ CZ20011541A patent/CZ300650B6/cs not_active IP Right Cessation
- 1999-10-28 PT PT99955895T patent/PT1126823E/pt unknown
- 1999-10-28 DK DK06017746.6T patent/DK1832279T3/da active
- 1999-10-28 CA CA002349268A patent/CA2349268C/en not_active Expired - Lifetime
- 1999-10-28 CA CA2614633A patent/CA2614633C/en not_active Expired - Lifetime
- 1999-10-28 WO PCT/EP1999/008176 patent/WO2000025746A2/en active Application Filing
- 1999-10-28 EP EP06017746.6A patent/EP1832279B1/en not_active Expired - Lifetime
- 1999-10-28 KR KR1020017005023A patent/KR100783096B1/ko active IP Right Grant
- 1999-10-28 PL PL99347908A patent/PL195908B1/pl unknown
- 1999-10-28 SK SK593-2001A patent/SK285487B6/sk not_active IP Right Cessation
- 1999-10-28 TR TR2001/01209T patent/TR200101209T2/xx unknown
- 1999-10-28 EP EP99955895A patent/EP1126823B1/en not_active Expired - Lifetime
- 1999-10-28 SI SI9930948T patent/SI1126823T1/sl unknown
- 1999-10-28 AT AT99955895T patent/ATE352288T1/de active
- 1999-10-28 CZ CZ2007-211A patent/CZ306939B6/cs not_active IP Right Cessation
- 1999-10-28 SK SK94-2006A patent/SK288316B6/sk not_active IP Right Cessation
- 1999-10-28 DK DK99955895T patent/DK1126823T3/da active
-
2001
- 2001-05-02 NO NO20012175A patent/NO20012175L/no not_active Application Discontinuation
- 2001-05-02 ZA ZA200103526A patent/ZA200103526B/en unknown
-
2007
- 2007-03-29 CY CY20071100437T patent/CY1107659T1/el unknown
-
2015
- 2015-07-23 CY CY20151100651T patent/CY1116943T1/el unknown
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