EP0330130A2 - Infusion solution container - Google Patents

Infusion solution container Download PDF

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Publication number
EP0330130A2
EP0330130A2 EP19890102943 EP89102943A EP0330130A2 EP 0330130 A2 EP0330130 A2 EP 0330130A2 EP 19890102943 EP19890102943 EP 19890102943 EP 89102943 A EP89102943 A EP 89102943A EP 0330130 A2 EP0330130 A2 EP 0330130A2
Authority
EP
European Patent Office
Prior art keywords
bag
container
container according
connector
mixing
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.)
Withdrawn
Application number
EP19890102943
Other languages
German (de)
French (fr)
Other versions
EP0330130A3 (en
Inventor
Antonius Recker
Manfred Rycyk
Matthias Wesseler
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Schiwa GmbH
Original Assignee
Schiwa GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Schiwa GmbH filed Critical Schiwa GmbH
Publication of EP0330130A2 publication Critical patent/EP0330130A2/en
Publication of EP0330130A3 publication Critical patent/EP0330130A3/en
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089Containers or vials which are to be joined to each other in order to mix their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end

Definitions

  • the invention relates to a container for infusion solutions for mixing the solution with solid and / or liquid ingredients and for applying the mixture.
  • an infusion solution with ingredients has so far been carried out by taking, for example, physiological saline solution from a glass bottle by means of a syringe with a disposable cannula and placing it in a container with dry substance. The medium then mixed therein was then transferred to the patient using an infusion device.
  • the present invention is based on the aim of creating a container for infusion solutions with which an infusion solution can be mixed with ingredients with low contamination and the mixture can be applied.
  • the container consists of a bag forming a mixing space made of flexible material, which is provided on the two narrow sides with a tubular connecting part, the connecting parts being equipped with connectors.
  • the container consists of a mixing chamber forming bag 1 made of a film material, such as PVC or other thermoplastic elastomers, which is welded or glued to the two narrow sides of the bag 2, 2 ', each with a connecting tube 3, 3' of a similar material.
  • a connector 4, 4 ' is inserted, which has a slightly larger outer diameter than that Inner hose diameter is recorded.
  • the input-side connector 4 is flush with a rubber-elastic plug 5 with the connector end section 6, so that a simple disinfection of the connector end is possible.
  • the output-side connector 4 ' is equipped with a shut-off valve 7 and 8 conical at its connection end and provided with a Luer inner cone 9.
  • this connector can also be configured in exactly the same way as the input-side connector 4.
  • the bag 1 is welded together with the connecting hoses 3, 3 'and the connectors 4, 4' in a sterilizable outer bag 10, which advantageously has a tear-open tab 11.
  • the use of the container according to the invention begins with the fact that the solid and / or liquid ingredients to be mixed are introduced into the interior of the bag 1 by means of a hollow piercing mandrel 12 which penetrates the stopper 5 and which is partially filled with the infusion solution 14.
  • the piercing mandrel is part of an adapter 15 which has a connection 16 for the storage container 13. After the contents have been introduced, the substances are mixed by shaking the bag.
  • the storage container 13 is at the same time a mixing container into which the infusion solution is transferred via the spike 12 of the adapter 15 by pressure on the bag 1. After mixing in the mixing container, the mixed solution is returned to it using the vacuum created in the bag.
  • shut-off valve 7 After connecting an application tube, for example a catheter, to the outlet-side connector 4 ', the shut-off valve 7 can be opened in order to apply the solution in the bag.
  • an application tube for example a catheter
  • the bag By means of a hanging eye 17 located on the bag 1, the bag can be attached to a corresponding hook or stand for better application of the medium when using a transfer device, for example an infusion device.
  • a transfer device for example an infusion device.

Abstract

Der Behälter ist zum Mischen von Infusionslösungen mit Inhaltsstoffen und zum Applizieren der Mischung vorgesehen. Er besteht aus einem den Mischraum bildenden Beutel (1) aus flexiblem Material, der an den beiden schmalen Seiten (2, 2') mit jeweils einem schlauchförmigen Anschlußteil (3, 3') verseheh ist, wobei die Anschlußteile mit Konnektoren (4,4') ausgestattet sind.The container is intended for mixing infusion solutions with ingredients and for applying the mixture. It consists of a bag (1) which forms the mixing space and is made of flexible material, which is provided on the two narrow sides (2, 2 ') with a tubular connecting part (3, 3') each, the connecting parts with connectors (4,4 ') are equipped.

Description

Die Erfindung betrifft einen Behälter für Infusionslösungen zum Mischen der Lösung mit festen und/oder flüssigen Inhaltsstoffen und zum Applizieren der Mischung.The invention relates to a container for infusion solutions for mixing the solution with solid and / or liquid ingredients and for applying the mixture.

Das Mischen einer Infusionslösung mit Inhaltsstoffen erfolgte bisher dadurch, daß mittels einer Spritze mit aufgesetzter Einmalkanüle bei­spielsweise physiologische Kochsalzlösung aus einer Glasflasche entnommen und in einen Behälter mit Trockensubstanz gegeben wurde. Das dann darin vermischte Medium wurde anschließend mittels Infusionsgerät zum Patienten übergeleitet.The mixing of an infusion solution with ingredients has so far been carried out by taking, for example, physiological saline solution from a glass bottle by means of a syringe with a disposable cannula and placing it in a container with dry substance. The medium then mixed therein was then transferred to the patient using an infusion device.

Als nachteilig anzusehen ist dabei, daß einerseits dieses Verfahren sehr langwierig ist, da dabei darauf geachtet werden muß, daß bei der Zugabe des flüssigen Mediums in den Trockensubstanzbehälter kein Überdruck ent­steht, andererseits sich beim Entfernen der Kanüle aus dem Stopfen des Be­hälters u.U. Aerosole entstehen können. Beim Umgang mit hochtoxischen Substanzen, beispielsweise Cytostatika, führen Kontaminationen zu gefähr­lichen Erkrankungen.It is to be regarded as a disadvantage that on the one hand this method is very lengthy, since care must be taken to ensure that there is no excess pressure when the liquid medium is added to the dry substance container, and on the other hand that the needle may be removed from the stopper of the container. Aerosols can arise. When handling highly toxic substances, such as cytostatics, contamination leads to dangerous diseases.

Demgemäß liegt vorliegender Erfindung die Augabe zugrunde, einen Behälter für Infusionslösungen zu schaffen, mit dem eine Infusionslösung sowohl mit Inhaltsstoffen kontaminationsarm gemischt als auch die Mischung appliziert werden kann.Accordingly, the present invention is based on the aim of creating a container for infusion solutions with which an infusion solution can be mixed with ingredients with low contamination and the mixture can be applied.

Die Lösung der Aufgabe besteht nun darin, daß der Behälter aus einem einen Mischraum bildenden Beutel aus flexiblem Material besteht, der an den beiden schmalen Seiten mit jeweils einem schlauchförmigen Anschlußteil versehen ist, wobei die Anschlußteile mit Konnektoren ausgestattet sind.The solution to the problem is that the container consists of a bag forming a mixing space made of flexible material, which is provided on the two narrow sides with a tubular connecting part, the connecting parts being equipped with connectors.

Einzelheiten des erfindungsgemäßen Behälters und weitere Ausführungsformen sind anhand der ein Ausführungsbeispiel darstellenden Zeichnung nach­folgend beschrieben.Details of the container according to the invention and further embodiments are described below with reference to the drawing illustrating an exemplary embodiment.

Der Behälter besteht aus einem einen Mischraum bildenden Beutel 1 aus einem Folienmaterial, beispielsweise PVC oder anderen thermoplastischen Elastomeren, das an den beiden schmalen Beutelseiten 2, 2′ mit jeweils einem Anschlußschlauch 3, 3′ aus ähnlichem Material verschweißt oder verklebt ist. In die freien Schlauchenden ist jeweils ein Konnektor 4, 4' eingesetz, der durch geringfügig größeren Außendurchmesser als der Schlauchinnendurchmesser festgehalten ist. Der eingangsseitige Konnektor 4 ist mit einem gummielastischen Stopfen 5 bündig mit dem Konnektorendab­schnitt 6 abgeschlossen, so daß ein einfaches Desinfizieren des Konnektor­endes möglich ist.The container consists of a mixing chamber forming bag 1 made of a film material, such as PVC or other thermoplastic elastomers, which is welded or glued to the two narrow sides of the bag 2, 2 ', each with a connecting tube 3, 3' of a similar material. In each of the free hose ends, a connector 4, 4 'is inserted, which has a slightly larger outer diameter than that Inner hose diameter is recorded. The input-side connector 4 is flush with a rubber-elastic plug 5 with the connector end section 6, so that a simple disinfection of the connector end is possible.

Der ausgangsseitige Konnektor 4′ ist mit einem Abbrechventil 7 ausge­stattet und an seinem Anschlußende 8 kegelförmig ausgebildet sowie mit einem Luer-Innenkonnus 9 versehen. Dieser Konnektor kann jedoch auch genauso ausgebildet sein wie der eingangsseitige Konnektor 4.The output-side connector 4 'is equipped with a shut-off valve 7 and 8 conical at its connection end and provided with a Luer inner cone 9. However, this connector can also be configured in exactly the same way as the input-side connector 4.

Zur sterilen Aufbewahrung des Behälters ist der Beutel 1 zusammen mit den Anschlußschläuchen 3, 3′und den Konnektoren 4, 4′ in einem sterilisier­baren Umbeutel 10 eingeschweißt, der vorteilhafterweise eine Aufreiß­lasche 11 aufweist.For sterile storage of the container, the bag 1 is welded together with the connecting hoses 3, 3 'and the connectors 4, 4' in a sterilizable outer bag 10, which advantageously has a tear-open tab 11.

Der Gebrauch des erfindungsgemäßen Behälters beginnt zunächst damit, daß die festen und/oder flüssigen beizumischenden Inhaltsstoffe mittels eines hohlen, den Stopfen 5 durchdringenden Einstechdorns 12 aus einem Vorrats­behälter 13 in das Innere des Beutels 1 eingeleitet werden, der teilweise mit der Infusionslösung 14 gefüllt ist. Der Einstechdorn ist Teil eines Adapters 15, der einen Anschluß 16 für den Vorratsbehälter 13 besitzt. Nach dem Einleiten der Inhaltsstoffe wird durch Schütteln des Beutels die Vermischung der Substanzen durchgeführt.The use of the container according to the invention begins with the fact that the solid and / or liquid ingredients to be mixed are introduced into the interior of the bag 1 by means of a hollow piercing mandrel 12 which penetrates the stopper 5 and which is partially filled with the infusion solution 14. The piercing mandrel is part of an adapter 15 which has a connection 16 for the storage container 13. After the contents have been introduced, the substances are mixed by shaking the bag.

In einer weiteren Ausführungsform des Behälters nach der Erfindung ist der Vorratsbehälter 13 gleichzeitig Mischbehälter, in den die Infusionslösung über den Einstechdorn 12 des Adapters 15 durch Druck auf den Beutel 1 übertragen wird. Nach erfolgter Vermischung im Mischbehälter wird die Mischlösung mit Hilfe des im Beutel entstandenen Unterdrucks in diesen zurückgeführt.In a further embodiment of the container according to the invention, the storage container 13 is at the same time a mixing container into which the infusion solution is transferred via the spike 12 of the adapter 15 by pressure on the bag 1. After mixing in the mixing container, the mixed solution is returned to it using the vacuum created in the bag.

Nach Anschluß eines Applizierschlauches, beispielsweise eines Katheters, am ausgangsseitigen Konnektor 4′ kann das Abbrechventil 7 geöffnet werden, um die im Beutel befindliche Lösung zu applizieren.After connecting an application tube, for example a catheter, to the outlet-side connector 4 ', the shut-off valve 7 can be opened in order to apply the solution in the bag.

Durch eine am Beutel 1 befindliche Aufhängeöse 17 kann der Beutel bei Verwendung eines Überleitungsgerätes, beispielsweise eines Infusions­gerätes, an einem entsprechenden Haken bzw. Ständer zur besseren Applikation des Mediums befestigt werden.By means of a hanging eye 17 located on the bag 1, the bag can be attached to a corresponding hook or stand for better application of the medium when using a transfer device, for example an infusion device.

Claims (8)

1. Behälter für Infusionslösungen zum Mischen der Lösung mit festen und/oder flüssigen Inhaltsstoffen und zum Applizieren der Mischung, gekennzeichnet durch einen den Mischraum bildenden Beutel (1) aus flexiblem Material, der an den beiden schmalen Seiten (2, 2′) mit jeweils einem schlauchförmigen Anschlußteil (3, 3′) versehen ist, wobei die Anschlußteile mit Konnektoren (4,4′) ausgestattet sind.1. container for infusion solutions for mixing the solution with solid and / or liquid ingredients and for applying the mixture, characterized by a mixing chamber forming bag (1) made of flexible material, which on the two narrow sides (2, 2 ') with each a tubular connector (3, 3 ') is provided, the connectors being equipped with connectors (4,4'). 2. Behälter nach Anspruch 1, dadurch gekennzeichnet, daß das eingangs­seitige Anschlußteil (3) mit einem einen gummielastischen Stopfen (5) aufnehmenden Konnektor (4) abgeschlossen ist.2. Container according to claim 1, characterized in that the input-side connection part (3) with a rubber-elastic plug (5) receiving connector (4) is completed. 3. Behälter nach Anspruch 1 und 2, dadurch gekennzeichnet, daß das ausgangsseitige Anschlußteil (3′) mit einem ein Abbrechventil (7) aufweisenden Konnektor (4′) abgeschlossen ist.3. Container according to claim 1 and 2, characterized in that the outlet-side connection part (3 ') with a a break-off valve (7) having connector (4') is completed. 4. Behälter nach Anspruch 1 bis 3, dadurch gekennzeichnet, daß der ausgangsseitige Konnektor (4′) an seinem Anschlußende (8) kegelförmig ausgebildet ist.4. Container according to claim 1 to 3, characterized in that the output-side connector (4 ') is conical at its connecting end (8). 5. Behälter nach Anspruch 1 bis 4, dadurch gekennzeichnet, daß der ausgangsseitige Konnektor (4′) an seinem Anschlußende (8) einen Luer-Innenkonus (9) aufweist.5. Container according to claim 1 to 4, characterized in that the output-side connector (4 ') at its connection end (8) has a Luer inner cone (9). 6. Behälter nach Anspruch 1 bis 5, dadurch gekennzeichnet, daß für den Behälter ein sterilisierbarer Umbeutel (10) vorgesehen ist, der eine Aufreißlasche (11) aufweist.6. Container according to claim 1 to 5, characterized in that a sterilizable outer bag (10) is provided for the container, which has a tear tab (11). 7. Behälter nach Anspruch 1 bis 6, dadurch gekennzeichnet, daß dem Beutel (1) ein weiterer Mischbehälter (13) zugeordnet ist, der mittels eines Adapters (15) mit dem eingangsseitigen Konnektor (4) des Beutels verbindbar ist.7. Container according to claim 1 to 6, characterized in that the bag (1) is associated with a further mixing container (13) which can be connected by means of an adapter (15) to the input-side connector (4) of the bag. 8. Behälter nach Anspruch 1 bis 7, dadurch gekennzeichnet, daß am Beutel (1) eine Aufhängeöse (17) angeordnet ist, um das Gemisch mittels eines Überleitungsgerätes zu infundieren.8. A container according to claim 1 to 7, characterized in that a hanging eye (17) is arranged on the bag (1) in order to infuse the mixture by means of a transfer device.
EP19890102943 1988-02-25 1989-02-21 Infusion solution container Withdrawn EP0330130A3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE19888802443 DE8802443U1 (en) 1988-02-25 1988-02-25
DE8802443U 1988-02-25

Publications (2)

Publication Number Publication Date
EP0330130A2 true EP0330130A2 (en) 1989-08-30
EP0330130A3 EP0330130A3 (en) 1991-06-05

Family

ID=6821079

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19890102943 Withdrawn EP0330130A3 (en) 1988-02-25 1989-02-21 Infusion solution container

Country Status (7)

Country Link
US (1) US5002530A (en)
EP (1) EP0330130A3 (en)
JP (1) JPH027966A (en)
DE (1) DE8802443U1 (en)
DK (1) DK87189A (en)
FI (1) FI890822A (en)
NO (1) NO890794L (en)

Cited By (6)

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US5330464A (en) * 1992-03-11 1994-07-19 Baxter International Inc. Reliable breakable closure mechanism
DE4322165A1 (en) * 1993-07-03 1995-01-19 Onkopharm Arzneimittel Gmbh Systemic solution for the connection of vessels containing pharmaceutical products in a contamination-free manner
DE4422960A1 (en) * 1994-04-28 1995-11-02 Primed Medizintechnik Gmbh One-piece application device for contamination-free administration of drugs, especially cytostatics
DE4433669A1 (en) * 1994-04-28 1996-01-18 Primed Medizintechnik Gmbh Connector for the contamination-free administration of medicinal products in solid starting form (cytostatics)
US5899877A (en) * 1994-04-28 1999-05-04 Primed Halberstadt Medizintechnik Gmbh One-piece dispensing device for the contamination-free administration of medicaments (cytostatica)
US6132413A (en) * 1998-03-06 2000-10-17 Baxter International Inc. Breakable cannula assemblies and methods for manipulating them

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US5304163A (en) * 1990-01-29 1994-04-19 Baxter International Inc. Integral reconstitution device
US5782733A (en) * 1992-10-26 1998-07-21 Innoflex Incorporated Zippered film and bag
US6159192A (en) 1997-12-04 2000-12-12 Fowles; Thomas A. Sliding reconstitution device with seal
US7425209B2 (en) * 1998-09-15 2008-09-16 Baxter International Inc. Sliding reconstitution device for a diluent container
US7074216B2 (en) * 1998-09-15 2006-07-11 Baxter International Inc. Sliding reconstitution device for a diluent container
US7358505B2 (en) * 1998-09-15 2008-04-15 Baxter International Inc. Apparatus for fabricating a reconstitution assembly
AR021220A1 (en) 1998-09-15 2002-07-03 Baxter Int CONNECTION DEVICE FOR ESTABLISHING A FLUID COMMUNICATION BETWEEN A FIRST CONTAINER AND A SECOND CONTAINER.
US6113583A (en) 1998-09-15 2000-09-05 Baxter International Inc. Vial connecting device for a sliding reconstitution device for a diluent container
JP2003135563A (en) * 2001-11-02 2003-05-13 Nipro Corp Small bag-shaped medicine container
US7641851B2 (en) * 2003-12-23 2010-01-05 Baxter International Inc. Method and apparatus for validation of sterilization process
US20050133729A1 (en) * 2003-12-23 2005-06-23 Archie Woodworth Apparatus and method for fabricating a reconstitution assembly
JP6150523B2 (en) * 2010-02-05 2017-06-21 デカ・プロダクツ・リミテッド・パートナーシップ Infusion pump apparatus, method and system
RU2616261C2 (en) * 2011-12-29 2017-04-13 Оцука Фармасьютикал Фэктори, Инк Protective shall, portective module, equipped with such shell, medical solution supply system and method for medical solution delivery

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US3788369A (en) * 1971-06-02 1974-01-29 Upjohn Co Apparatus for transferring liquid between a container and a flexible bag
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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5330464A (en) * 1992-03-11 1994-07-19 Baxter International Inc. Reliable breakable closure mechanism
DE4322165A1 (en) * 1993-07-03 1995-01-19 Onkopharm Arzneimittel Gmbh Systemic solution for the connection of vessels containing pharmaceutical products in a contamination-free manner
DE4422960A1 (en) * 1994-04-28 1995-11-02 Primed Medizintechnik Gmbh One-piece application device for contamination-free administration of drugs, especially cytostatics
DE4433669A1 (en) * 1994-04-28 1996-01-18 Primed Medizintechnik Gmbh Connector for the contamination-free administration of medicinal products in solid starting form (cytostatics)
DE4433669C2 (en) * 1994-04-28 1999-02-25 Primed Medizintechnik Gmbh One-piece application device for the contamination-free administration of pharmaceuticals in solid starting form, in particular cytostatics
US5899877A (en) * 1994-04-28 1999-05-04 Primed Halberstadt Medizintechnik Gmbh One-piece dispensing device for the contamination-free administration of medicaments (cytostatica)
US6132413A (en) * 1998-03-06 2000-10-17 Baxter International Inc. Breakable cannula assemblies and methods for manipulating them

Also Published As

Publication number Publication date
FI890822A0 (en) 1989-02-21
DE8802443U1 (en) 1988-09-01
JPH027966A (en) 1990-01-11
NO890794D0 (en) 1989-02-24
US5002530A (en) 1991-03-26
EP0330130A3 (en) 1991-06-05
FI890822A (en) 1989-08-26
NO890794L (en) 1989-08-28
DK87189D0 (en) 1989-02-24
DK87189A (en) 1989-08-26

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