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HUE035185T2 - Szemcseppek conjuctivochalasis kezelésére - Google Patents

Szemcseppek conjuctivochalasis kezelésére Download PDF

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Publication number
HUE035185T2
HUE035185T2 HUE12721616A HUE12721616A HUE035185T2 HU E035185 T2 HUE035185 T2 HU E035185T2 HU E12721616 A HUE12721616 A HU E12721616A HU E12721616 A HUE12721616 A HU E12721616A HU E035185 T2 HUE035185 T2 HU E035185T2
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zik
ites
conjunctivochalasis
treatment
solution
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HUE12721616A
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Shabtay Dikstein
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Resdevco Res And Development Co Ltd
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Publication of HUE035185T2 publication Critical patent/HUE035185T2/hu

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    • 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
    • A61K9/08—Solutions
    • 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
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/047—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates having two or more hydroxy groups, e.g. sorbitol
    • 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
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Description

(12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) IntCI.: of the grant of the patent: A61K 9108 <2006 01> A61K 47110 <2017 01> 13.09.2017 Bulletin 2017/37 A61K 4713212006 011 A61K 47136 <2006·01) A61K 311196(2006 01> (21) Application number: 12721616.6 (86) International application number: (22) Date of filing: 05.04.2012 PCT/IL2012/000157 (87) International publication number: WO 2012/150583 (08.11.2012 Gazette 2012/45)
(54) EYE DROPS FOR TREATMENT OF CONJUNCTIVOCHALASIS
AUGENTROPFEN ZUR BEHANDLUNG VON BINDEHAUTCHALASIS
GOUTTES OPHTALMIQUES POUR LE TRAITEMENT DE LA CONJONCTIVOCHALASIS (84) Designated Contracting States: · SOLOMON ABRAHAM; MERIN SAUL: "Theeffect AL AT BE BG CH CY CZ DE DK EE ES FI FR GB of a new tear substitute containing glycerol and GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO hyaluronate on keratoconjunctivitis sicca",
PL PT RO RS SE SI SK SM TR JOURNAL OF OCULAR PHARMACOLOGY AND THERAPEUTICS, vol. 14, no. 6, December 1998 (30) Priority: 05.05.2011 IL 21272511 (1998-12), pages 497-504, XP002682606, • MELLER DANIEL; TSENG SCHEFFER C G: (43) Date of publication of application: "Conjunctivochalasis: Literature review and
12.03.2014 Bulletin 2014/11 possible pathophysiology", SURVEY OF OPHTHALMOLOGY, vol. 43, no. 3, November (73) Proprietor: Resdevco Research and Development 1998 (1998-11), pages 225-232, XP002682607,
Co. Ltd. · DATABASE WPI Section Ch, Week 201124
91033 Jerusalem (IL) Thomson Scientific, London, GB; Class B05, AN 2011-C51484 XP002682608, ZHOU A: "Ointment (72) Inventor: DIKSTEIN, Shabtay useful for preventing and/or treating e.g. 96264 Jerusalem (IL) pterygium, comprises Aloe gel, aloin, alamycin, carbomer, sodium hyaluronate, anthraquinone (74) Representative: Lecomte &amp; Partners compound and free amino acids", -8i CN 101 940 P.O. Box 1623 701 A ((ZHOU-I) ZHOU A) 12 January 2011 1016 Luxembourg (LU) (2011-01-12) (56) References cited: Remarks: EP-A1- 2 078 527 WO-A1-00/01365 Thefilecontainstechnicalinformationsubmittedafter WO-A1-2005/067892 WO-A1-2006/119174 the application was filed and not included in this WO-A1-2006/123324 US-A- 5 106 615 specification US-A- 5 795 913 US-A1-2007 212 420 US-A1-2010 086 512 • DATABASE WPI Section Ch, Week 200442 Thomson Scientific, London, GB; Class B04, AN 2004-441694 XP002682605, GAO E; LIU J; MA F: "Composition comprising sodium hyaluronate and glycerin, useful as eye drops", -&amp; CN 1 488 404 A ((LIUJ-I) LIU J) 14 April 2004 (2004-04-14)
Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention).
Description
FIELD OF THE INVENTION
[0001] This invention relates to non-surgical methods for treatment of conjunctivochalasis. In particular, it relates to eyedrops comprising a solution of glycerol useful for treatment of conjunctivochalasis.
BACKGROUND OF THE INVENTION
[0002] Conjunctivochalasis, a condition characterized by excess folds of the conjunctiva, is of relatively common occurrence, especially in the elderly and in contact lens wearers. It can be a serious condition and in extreme cases requires surgical intervention. While various diseases of the eye can be treated by the application of liquid preparations administered to contact the eye, no recognized treatment of conjunctivochalasis by eye drops alone is known.
[0003] A 1998 literature review discussing treatment of conjunctivochalasis (Meller, D.; Tseng, S. C. G., "Conjunctivochalasis: Literature Review and Possible Pathophysiology"; Surv. Ophthalmol. 1998, 43, 225 - 232) concludes that while eye drops can be used to relieve dry eye syndrome, one of the symptoms of conjunctivochalasis, the only effective treatment for the disease itself is surgery.
SUMMARY OF THE INVENTION
[0004] The present invention provides eye drops useful in the treatment of or alleviation of symptoms of conjunctivochalasis which may spare surgical intervention. The eye drops are based on the use of glycerol, preferably in isotonic or nearly isotonic solution. These isotonic solutions can further comprise additional ophthalmologic medications. Glycerol is itself a humectant, i.e. is capable of holding water.
[0005] The present invention relates to an ophthalmic preparation for use in non-surgical treatment of conjunctivochalasis in accordance with appended independent claim 1 and appended dependent claims 2-15.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0006] In the following description, various aspects of the invention will be described. For the purposes of explanation, specific details are set forth in order to provide a thorough understanding of the invention. It will be apparent to one skilled in the art that there are other embodiments of the invention that differ in details without affecting the essential nature thereof. Therefore the invention is not limited by that which is described in the specification, but only as indicated in the accompanying claims, with the proper scope determined only by the broadest interpretation of said claims. [0007] The invention comprises a solution of glycerol in water. In preferred embodiments of the invention, 2.5 g of glycerol are present in each 100 ml of the prepared solution. In some embodiments of the invention, in the solution the salt concentration is less than 2 mM. In preferred embodiments of the invention, the glycerol solution is isotonic. In preferred embodiments of the invention, the viscosity of the solution is controlled by addition of a quantity of high molecular weight polymer (MW > 104 Dalton) such as hyaluronate or carbomer sufficient to bring the solution to the desired viscosity. All ingredients are of purity sufficient for use in eye drops.
[0008] The solutions are then transferred to a container appropriate for dispensing it as eye drops.
[0009] In other embodiments of the invention, the solution additionally comprises a pharmaceutically effective concentration at least one pharmacologically active agent. If necessary, any stabilizer, preservative, antioxidant, buffer or combination thereof appropriate for use with the pharmacologically active agent may be added to the solution in any concentration suitable for use in eye drops.
[0010] A typical protocol for use of the resulting eye drops to treat or to alleviate the symptoms of conjunctivochalasis is to place drops in the affected eye 3 times daily until the severity of the symptoms is reduced to an acceptable level. In particularly severe cases, more frequent applications may be necessary, and in less severe cases, a single daily dose may be sufficient. EXAMPLE 1 [0011] A solution was prepared containing:
Glycerol 2.5 g
Sodium hyaluronate 0.1 g
Water sufficient to bring to 100 ml [0012] The solution was buffered to pH of 7.2. EXAMPLE 2 [0013] A solution was prepared containing:
Glycerol 2.5 g
Sodium hyaluronate 0.015 g
Carbomer481 0.015 g
Water sufficient to bring to 100 ml [0014] The solution was adjusted to about pH of 7. EXAMPLE 3 [0015] A solution was prepared containing:
Glycerol 2.5 g
Diclofenac sodium 0.1 g Water sufficient to bring to 100 ml [0016] The solution was buffered to pH of about 7. EXAMPLE 4 [0017] A solution, containing less than 2 mM salt, was prepared as described in Example 2 above. The solution was then administered on average 3 times daily to a group of patients. The severity of the conjunctivochalasis was measured according to the LIPCOF (Lid Parallel Conjunctival Folds) scale, in which 0 represents the least severe level and 3 is very severe. Determinations of the severity of the conjunctivochalasis were made prior to treatment, one month after the start of treatment, and 6 months after the start of treatment. The results are summarized in the table below. The changes from the first LIPCOF determination to the second, and from the first to the third, are statistically significant at the p < 0.01 level.
Prior to LIPCOF Grade ... 1 month 6 months treatment N % N % N % 0 13 24.1 14 26.9 12 31.6 1 25 46.3 27 51.9 22 57.9 2 15 27.8 11 21.2 4 10.5 3 1 1.9 0 0.0 0 0.0
Claims 1. An ophthalmic preparation for use in non-surgical treatment of conjunctivochalasis; characterized in that said ophthalmic preparation comprises an aqueous solution of glycerol. 2. The ophthalmic preparation for use according to claim 1, wherein said solution is essentially isotonic. 3. The ophthalmic preparation for use according to either one of claim 1 or claim 2, wherein said solution has a pH of 7. 4. The ophthalmic preparation for use according to either one of claim 1 or claim 2, wherein said ophthalmic preparation is characterized by a salt concentration of less than 2 mM. 5. The ophthalmic preparation for use according to either one of claim 1 or claim 2, further comprising a polymer of molecular weight of at least 10,000 Dalton. 6. The ophthalmic preparation for use according to claim 5, wherein the concentration of said polymer is chosen to bring said solution to a predetermined viscosity. 7. The ophthalmic preparation for use according to claim 5, wherein said polymer is anionic. 8. The ophthalmic preparation for use according to claim 7, wherein said polymer is chosen from the group consisting of hyaluronate and carbomer. 9. The ophthalmic preparation for use according to either one of claim 1 or claim 2, further comprising a pharmaceutically effective amount of a pharmacologically active agent. 10. The ophthalmic preparation for use according to claim 9, wherein said pharmacologically active agent is diclofenac. 11. The ophthalmic preparation for use according to claim 9, further comprising at least one substance chosen from the group consisting of stabilizers, preservatives, antioxidants, and buffers. 12. The ophthalmic preparation according to any one of claims 1 - 11, for use in a non-surgical treatment for reducing severity of conjunctivochalasis as measured by a Lid Parallel Conjuctival Folds, LIPCOF, scale by application of said ophthalmic preparation from one to five times daily. 13. The ophthalmic preparation for use according to claim 12, wherein said treatment comprises application of said preparation three times daily. 14. The ophthalmic preparation according to claim 13, for use in a non-surgical treatment for reducing severity of conjunctivochalasis that produces a statistically significant reduction in a score according to said LIPCOF scale within 6 months after the initiation of the application. 15. The ophthalmic preparation according to claim 13, for use in a non-surgical treatment for reducing severity of conjunctivochalasis that produces a statistically significant reduction in a score according to said LIPCOF scale within 1 month after the initiation of the application.
Patentansprüche 1. Ophthalmologische Zubereitung zur Anwendung in nichtchirurgischer Behandlung von Bindehautchalasis; dadurch gekennzeichnet, dass die ophthalmologische Zubereitung eine wässrige Lösung von Glycerol umfasst. 2. Ophthalmologische Zubereitung zur Anwendung nach Anspruch 1, wobei die Lösung im Wesentlichen isotonisch ist. 3. Ophthalmologische Zubereitung zur Anwendung nach einem von Anspruch 1 oder Anspruch 2, wobei die Lösung einen pH-Wert von 7 hat. 4. Ophthalmologische Zubereitung zur Anwendung nach einem von Anspruch 1 oder Anspruch 2, wobei die ophthalmologische Zubereitung durch eine Salzkonzentration von weniger als 2 mM gekennzeichnet ist. 5. Ophthalmologische Zubereitung zur Anwendung nach einem von Anspruch 1 oder Anspruch 2, weiter ein Polymer mit einer Molmasse von mindestens 10.000 Dalton umfassend. 6. Ophthalmologische Zubereitung zur Anwendung nach Anspruch 5, wobei die Konzentration des Polymers dazu ausgewählt ist, die Lösung auf eine vorgegebene Viskosität zu bringen. 7. Ophthalmologische Zubereitung zur Anwendung nach Anspruch 5, wobei das Polymer anionisch ist. 8. Ophthalmologische Zubereitung zur Anwendung nach Anspruch 7, wobei das Polymer aus der aus Hyaluronat und Carbomer bestehenden Gruppe ausgewählt ist. 9. Ophthalmologische Zubereitung zur Anwendung nach einem von Anspruch 1 oder Anspruch 2, weiter eine pharmazeutisch wirksame Menge eines pharmakologisch wirksamen Stoffs umfassend. 10. Ophthalmologische Zubereitung zur Anwendung nach Anspruch 9, wobei der pharmakologisch wirksame Stoff Diclofenac ist. 11. Ophthalmologische Zubereitung zur Anwendung nach Anspruch 9, weiter mindestens eine Substanz umfassend, die aus der Gruppe ausgewählt ist, bestehend aus Stabilisatoren, Konservierungsstoffen, Antioxidantien und Puffern. 12. Ophthalmologische Zubereitung nach einem der Ansprüche 1-11, zur Anwendung in einer nicht-chirurgischen Behandlung zur Verringerung der Schwere von Bindehautchalasis, gemessen durch eine lidkantenparallele konjunk-tivale Falten-Skala (LIPCOF-Skala), durch Anwendung derophthalmologischen Zubereitung zwischen ein und fünf Mal täglich. 13. Ophthalmologische Zubereitung zur Anwendung nach Anspruch 12, wobei die Behandlung die Anwendung der Zubereitung dreimal täglich umfasst. 14. Ophthalmologische Zubereitung nach Anspruch 13, zur Anwendung in einer nicht-chirurgischen Behandlung zur Verringerung der Schwere von Bindehautchalasis, die zu einerstatistisch signifikanten Verringerung in einer Wertung gemäß besagter LIPCOF-Skala innerhalb von 6 Monaten nach Beginn der Anwendung führt. 15. Ophthalmologische Zubereitung nach Anspruch 13, zur Anwendung in einer nicht-chirurgischen Behandlung zur Verringerung der Schwere von Bindehautchalasis, die zu einerstatistisch signifikanten Verringerung in einer Wertung gemäß besagter LIPCOF-Skala innerhalb von 1 Monat nach Beginn der Anwendung führt.
Revendications 1. Préparation ophtalmique pour son utilisation dans le traitement non chirurgical d’une conjunctivochalasis, caractérisée en ce que ladite préparation ophtalmique comprend une solution aqueuse de glycérol. 2. Préparation ophtalmique pourson utilisation selon la revendication 1, dans laquelle ladite solution est essentiellement isotonique. 3. Préparation ophtalmique pour son utilisation selon l’une quelconque des revendications 1 ou 2, dans laquelle ladite solution possède un pH égal à 7. 4. Préparation ophtalmique pour son utilisation selon l’une quelconque des revendications 1 ou 2, dans laquelle ladite préparation ophtalmique se caractérise par une concentration de sel inférieure à 2 mM. 5. Préparation ophtalmique pour son utilisation selon l’une quelconque des revendications 1 ou 2, comprenant en outre un polymère dont le poids moléculaire s’élève à au moins 10.000 Daltons. 6. Préparation ophtalmique pourson utilisation selon la revendication 5, dans laquelle la concentration dudit polymère est sélectionnée pour amener ladite solution à une viscosité prédéterminée. 7. Préparation ophtalmique pour son utilisation selon la revendication 5, dans laquelle ledit polymère est anionique. 8. Préparation ophtalmique pour son utilisation selon la revendication 7, dans laquelle ledit polymère est choisi parmi le groupe constitué par un hyaluronate et un carbomère. 9. Préparation ophtalmique pour son utilisation selon l’une quelconque des revendications 1 ou 2, comprenant en outre une quantité pharmaceutiquement efficace d’un agent actif du point de vue pharmacologique. 10. Préparation ophtalmique pourson utilisation selon la revendication 9, dans laquelle ledit agent actif du point de vue pharmacologique est le diclofenac. 11. Préparation ophtalmique pourson utilisation selon la revendication 9, comprenant en outre au moins une substance choisie parmi le groupe constitué par des stabilisateurs, des conservateurs, des antioxydants et des tampons. 12. Préparation ophtalmique selon l’une quelconque des revendications 1 à 11, pour son utilisation dans un traitement non chirurgical destiné à réduire la gravité d’une conjunctivochalasis comme mesurée par une échelle LIPCOF, pli conjonctival parallèle au bord palpébral, via l’application de ladite préparation ophtalmique à raison de un à cinq fois par jour. 13. Préparation ophtalmique pourson utilisation selon la revendication 12, dans laquelle ledit traitement comprend une application de ladite préparation à raison de trois fois par jour. 14. Préparation ophtalmique selon la revendication 13, pourson utilisation dans un traitement non chirurgical destiné à réduire la gravité d’une conjunctivochalasis, qui procure une réduction statistiquement significative dans un score conforme à ladite échelle LIPCOF dans un laps de temps de 6 mois après le déclenchement de l’application. 15. Préparation ophtalmique selon la revendication 13, pourson utilisation dans un traitement non chirurgical destiné à réduire la gravité d’une conjunctivochalasis, qui procure une réduction statistiquement significative dans un score conforme à ladite échelle LIPCOF dans un laps de temps de 1 mois après le déclenchement de l’application.
REFERENCES CITED IN THE DESCRIPTION
This list of references cited by the applicant is for the reader’s convenience only. It does not form part of the European patent document. Even though great care has been taken in compiling the references, errors or omissions cannot be excluded and the EPO disclaims all liability in this regard.
Non-patent literature cited in the description • MELLER, D. ; TSENG, S. C. G. Conjunctivochalasis:
Literature Review and Possible Pathophysiology.
Surv. Ophthalmol., 1998, vol. 43, 225-232 [0003]

Claims (5)

  1. βΟΒΡΡΕΚ CQfWHCTIVOCHAlASIS KEZgtlMRg SZA.8A0AIMIIQENYPONTOK 1. 5ζαο:Α§ζαΡ (aphiakaiA; k%sz&amp;neny sikaiwazasra coaiyneiiwxftateais {koldhadya-bstegsag} si&amp;rn~$;eb0azs;l kozeiasbre. msl leiteme^i bogy az araiM szAmAszak kaszlkaAay isitakbazzs giie«fin vi'zas oldatSt 2. to 1, igenypAai szabnb aiteswasra ahoi az ami'iten aidai iAnyagSbsn izofenits; 3. to 1. vagy &amp; Ipdaypoat swibis swntoiS kaszikw;y oikaSmazasrs. ahoi az. amiitett sk&amp;t pH 7 addkksl biii.
  2. 4. Az. 1 , va§y 2, 'igbnypont ssersntl szoroto® kaszitAiAay sikaimazasra, Ahoi s nemah szenieszeli kAszifolsnyt oiyah s&amp;onoenirAoiAjgtieffizi,. amoiy -kisebb, «*ηί·2 sail.
  3. 5. Az 1 vagy 2 igeaypooi szadnti szeiTibszeii kaszstfmny aikaknazAsra. ansely ΙαΡαΗϊαζ toyAbbs aov oiyao poikr^H. amasyogb hioisteMtbmegA sggaldbP iSOSS DakA·;, δ Az 5 igAaypoat sza'in-i sze^aszetl kasziansoy alkaiinazasfa, ahoi az erokioii poiiiaor ΗοΑΡοηΡΑΗφ bgy van HasiaszkvA. bogy az ραΗΙΙαΡ oioaiai egy ρΙοϊα ipsgbatbfPzo't yiszko^sca vlgya,
  4. 7, Az 5. igeaypeni szobok szaiziAszaa kbozibnAny skkaknazdsra, ahoi az SkhiiW pokroa? goipnos
    3. A A igboypoot szorioh szeroaszoti kaszipnany aikoteazasrg. ahoi az aaaiiau poiimer a kavetkazak kozdi va&amp;szlhalo kk biakifopat as kafbsmr, S. Az 1. yapy 2. igapypAai szaabii szAmAszak kaszHasoy aiksknAzasra, asaaiy iariahpaz iavA&amp;PA agy gyiiQybszgikag sktH szsb gyApygazaplag halAkahy A'sebayisAppsa,
  5. 10, A S, sgAaypont azAdhil szegiAszak kaszbmAsy aikai^azasrs, ahoi az sssabieb pygayaszatkag skbv szar dskbfeoak idioiofeasap 11 AS. igsaypobt yzariali szsjaeazgk ksszibaAny slkaimazasrs, amaiy tabakagz tov^bbS isgalabb agy sayagattaabaiaocA; § kovatedk kbzal kivaigsztva: siabikzAibszsrok (staOiksary iaridsilAszarak (p-awvsiive), aaliaHdAhsak As pofesk, / Λ; '} gt-«y!<oua\ W'>yKi v-n\i azeraaszaii keaziPaaay slkaimazSara. gsiA-sAPaszak kAZaiAspArs sonipgctivoehalgsH saiyossagaaak csgkkAntsse?«; sbopyaa az LiPCOF skdiabaa iUd ParakAi CohjpocSyai Folds (szanbAjsz&amp;ka; patbozafoos koiAhadysradgzii van twvo, amikof az arnlifeb szersaszak kAaziiaisay oaooiaa agyOiszof yso aikaimazaa. 13. A12. Igapypen· azabots szsa;gszsi kAszikabay aikaffnazAsra, amikAf az amlifeh. kazalAs tefMbszz&amp;az asHItAK kAsziboany alkala-iazasai aapaaia haiwszor 14. A 13, fganyponi. szarlat; szaa-sazAli k^szitmAny aikaksAzasra aoavsAPAAzak kszsissbAP a CArskiaoilyoebalasis sbiyosaApaoak csdkkantas&amp;s,. ameiy siabsztikakag szigrkiikbns esokksnest IdAz aiS a psa'szPirsPso (scorak az ea;l itait UPCOP zkaiabaa § hsaappal az. aikaimazga bgiadbasa uiin. la, A 13. igenypoAt szadAls szsinsszAk kAszibaAgy aikaimazte aaa'i-SAPAsza·; kozAkssbAn a AAiphbCkygoPgissls aolyossapagak caokkAniasefA, ssiAiy statiszlikaiisg szigaiilkaas csokkenasi idaz ala a pAPlszambgp {scorai az Arnktab UPCOP skaiafean 1 baaappal az. aikalsTiazas baladiiasa ;baa,
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