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Attachment 1.Pdf Kyowa Hakko U.S.A., inc. KYOWA Dated: February 14, 2003 N-Acetyl-L-Hydroxyprpline New Dietary Ingredient Notification . Reference No. 1 AHP 200@ 1. Name of the drug AHP 2OO@ active agent: Oxaceprcl 2. Prescription status Ethical drug 3. Composition of the drug 4 Group of substance’s or indicatfons Antirheumatic agent W Composition Medically effective components One film-coated tablet contains 200 mg of Oxaceprol~ Other comoonents Talcum, magnesium stearate, potato starch, Makmgofe, pofymethacryfate, Povidon, propylene glycol, Simethicon, cofours E 171, E 104, E 110. 4. Fields of application Degenerative joint diseases in painful or inflammatory phases, arthroses e. g. of the knee, the.hip, the shoulder, the spinal column, the small joints; pofyarthmses; chondmpathy pateflae, arthritis, perfarthrftis, bursitis, tendinitis, tendovaginitfs. Inflemmatory connective tissue diseases. 5. Contra-indications A known hypersensifivity to Oxaceprof or one of the other components. Afthough up to now there are no indications that Oxacepml may have possfbfe teratogenic effects, it is recommended not to use Al-fP ZOO@ during a pregnancy. 6. Side effects Under the treatment with Oxaceprof occasionally there have been observed: gastrointestinal complaints, such as nausea. impaired appetite, pain in the stomach or diarrhea, which are offen of a passing nature. Seldom there may occur allergic reactions (a reddening of the skin, an itching of the skin, exarrthemae). fn exceptional cases the fallowing reactions of allergic genesis were descrfbed: loss of hair, arthrafgia,- vascufitis, urticaria. giant urticaria. aIferuic eosinorhiiia-r. -.-.- . 7. Interactions with other agents In patients under anticoagulative therapy with vitamin K-antagonists (e.g. MafCUmar@)an affectiOn of coagulation by Oxacepml cannot be excluded. A closemeshed control of the prothrombin time under simuitaneous therapy with yki 2006Dis, therefare, recommended, 8. Warning notices Doesn’t apply. 9. Most important incompatibiiities Not known up to now. IO. Dosage As far as not differently prescribed, the standard dosage is 3 x daily 1 fiirn-coated tablet- Dependingon the severity of the affection, specially at the beginning of the treatment the daily dose can be increased to 3 x 2 film-coated tablets. ll. Method and period of application AHPZOOcB film-coated tablets are preferably taken before a meal, unchewed, with sufficient liquid. The period of time for which the drug is to be administ&d depends on the character and intensity of the affection and is to be fixed individualiy. 12. Emergency procedures, symptoms and antidotes Intoxications in humans have not occurred UP to now and are actually hardly imaginable. In oral adminisfration during bio-assays, only above the 500- to IOOO-foldquantity of the sZandard dosage usual in the human field (i 0 mg/kg of body weight) toxical effects could be observed (sedation, ptosis,‘piloerection). 12. Pharmacologicai and toxicological properties, pharmacokinetics a) Pharmacolocrical DroPeties Oxaceprol shows a distinct antiphlogistic 2nd analgesic efficacy. In preciinical studies the antiphlogistic efficacy has been tested with an excellent result in various models (carrageenine paw edema, anaphyfactic joint test, carrageenine-induced pleurisy, adjwant-arthritis) and in comparison to reference antiphlogistics (indometacin, ASA, phenylbutazone, ibuprofen). These data have also been confirmed with a pyrexai erythema in the huMan model. The analgesic efficacy has been shown by the Randall-Sefitto and the Phenylchinone-Writhing-test. Ciinicafly Oxaceprol has been tested in various indication fields of degenerative joint diseases. In placebo-controlled studies as well-as double-blind and random&d studies against ibuprofen and diclof&ac the substance has been applied in the therapy of gon-, cox- and spondyf-art&o&s. While the cross-over test wfsus placebo showed the significant superiority of Oxacepml, the substance is equal to ibuprofen and dicfofenac in its symptomaticefficacy. In the therapy of rheumatoidarthritis Oxacepml shows a tendency of superiority to diclofenac. In all indication fields the typical pain parameters (e.g. pain when starting to move, rest pain and pain following exercise), but also inflammation and flexibility parameters were distinctiy improved. b) Toxicotoaical prooerties Acute toxicity When orally administered, the LDSUin rats is 7.451 mgfkg of body weight, in mice 5.688 mg/kg of body weight: when IM-applied in rats and mice, respectively, it was more than 4.000 mg/kg and 2,921 mg/kg of body weight, respectively. Chronic foxicfty The toxicity after repeated administration was determined in rats and beagles. For this purpose,the animals were given on 29 and 28 (resp.) successive days 3 dosages of the agent (4.5; 36; 288 mg/kg of body weight). 1.nrats, apart from local e&cts mused by the application - (inflammatory processes at th8 injection site) no unwanted effects occurred. tn dogs, with the two lower dosages, no effects occurred. Wtth the highest dosage, slight changes on cornea and renal tubules were dbserved, the pathologicalimportance of which is not known. No cases of death occuned. Mutagenicity Oxaceprol was extensivelytested with regard to mutagenic properties. No indications of any mutagenic potential were found. Carcinogenicity There don’t exist any tests on carcinogenicity; from bio-assays and clinical tests there didn’t result any indications of a tumorigenic potential. Reproduction In rabbits, with the highest dosage of 288 mglkg of body weight, teratorgenic effects were observed -which, however, were not reproducible in a second, identically conducted $udy. There don? exist any data on the piacentat transportation of Oxaceprol in humans nor data on the transition into mother’s milk. c> Pharmacokinetic oroperties absorption 3.5 hours after oral applicationof Oxaceprol there are maximal plasma levels. The bio-availabilityafter oral administration amounts to about 30%. Due to is aqueous solubiiity, Oxaceprol is distributed in the w’t;ole organism. it permeates into the sinovial liquid. No plasma-pmfein bond has been proved. ‘Thereare no indications of a cumulation. Eiimina tion After JM or IV application the elimination half-time amounts to an average of 2 hours. The elimination occws excfusiveiy by renai way. The excretion is unchangedand complete. Oxatiprol is neither incorpoiated nor metabolised. 14. Other indications Doesn’t apply. 15. indications on stability AHP 20U@1film-coated tablets have a shelf life o f 3 years. After the expiration date the drug may not be used any more. 16. Indications on storage none a) Indication on waste disposal Unused rests o f the drug need not be taken to a seoarate1 waste disposal. 17. Presentation and package .&es 100 film-coated tablets (N3) 300 film-coated tablets - -., -18. Stare of information March 1999 ._ 19. Name or company and address of the pharmaceutical business Producer/pharm. business: Chephasaar Chem.-pharrn. FabrikGmbH MUhlstrasse 50 D-66386 St. lngbert tel.: (0 68 94) 97-l -0 fax: (0 68 94) 971 - 199 Co-distributor; Rosen Pharma GmbH D-66377 St. Jngbert Distributor: MIP Pharma GmbH D-66386St lnabert Fachinformation AHP200@ Wir kstoff: Oxacepr oi 1. Bezeichnung des Arrneimittels (Hauuijtung, Hautjucken, Exan- AHP 200” theme). In Eintelf%en wurden 13. Pharmakologische und toxikolo- Wirkstoff: Oxaceprol folgende Reaktionen allergischer gische Eigenschaften, phanna- Genese besci-wieben: Haaraus- kokinetik 2. Verschreibungsstatus/Apothe- fail, Gelenkschmerzen, Vaskuli- a) Pharmakologische Eigenschaften kenpflicht tiS, Ut-tikaria. Quinckeddem, Oxaceprol zeigt eine ausgeprlgt Verschreibungspfiichtig allergische Eosinophilie. antiphlogistische und analg&- sche Wirksamkeit. 3. Zusammensetzung des Arznei- 7. Wechselwirkungen mit anderen mittels Mitteln In praklinischen Studien ist die a) Stoff- oder Indikationsgruppe Bei Patienten urrter &ttikoaguIa- antiphlogistische Effektivitit in Antirheumatikum tiver Therapie mit Viimin-K-An- verschiedenen Modellen (Carra- tagonisten (2. B. MarcumaP) geenin-Pfotenddem, anaphylak- b) Zusammensetzunq kann eine Beeinflussung der tischer Gelenktest, Canageenin- Blutgerinnung durch Oxaceprol induzierte Pleuritis, Adjuvarts-Ar- anneilich wirksame Bestandteile nicht ausgeschlossen werden. thitk) und im Vergleich N Re- Gne Filmtablette enthsilt Gne engmaschige Kontroile der ferenzamiphlogisdk (Indome- 200 mg Oxaceprol. Prothrombinzeit unter der tadn, ASS, Phenyibutazon, ibu- gfeiohzetigen Therapie mit profen) mit ausgezeichnetem G- Sons-tine BesGinctteile AHP 200° wird daher empfoh- gebnis gepnX worden. Diese Taikum. Magnesiumstearat, Kar- len. Daten sind anhand eines toffeftirke, Makrogole, Poly- Pyrexal-Erythems such im Hu- methacrylat, Povidon, Ropylen- 8. Wamhinweise manmodell best&&t. glykol, Simethicon, Farbstoffe E entfNt 171, E 104, E 110. Die analgetische Wirksamkeit ist 9. Mchtigste InkompatibilXiten durch den Randall-Seliio- und 4. Anwendungsgebiete bisher nicht bekannt den Phenylchinon-Writhing-Test Degenerative Gelenketiankun- gezeigt worden. gen in schmerzhaften oder ent- 10. Dosietung ziindlichen Stadien (Arthrosen Soweit nicht anders verordnet, KIinisch ist Oxaceprol in ver- LB. des Knies, der Hiifte, der betragt die Normdosierung 3 x schiedenen lndikaticnsgebieten Schuiter, der WirbelsSule, der tPglich 1 Fiimtablette. Je nach degenerativer Gelenkeriuankun- kleinen Gelenke; Polyarthrosen; Schwefe det Erkrankung kann gen geprijft worden. In Flacebc- Chondropathia patellae), Arthri- die Tagesdosis, besanders zu
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