{"resourceType":"Bundle","id":"3eac1e26-8884-4cf7-9127-9f53d5547015","meta":{"versionId":"1","lastUpdated":"2024-04-30T08:02:23.542+00:00"},"identifier":{"system":"http://ema.europa.eu/fhir/epiDocument","value":"6206eea7-4f42-ee11-bdf5-000d3aaa033a"},"type":"document","timestamp":"2024-04-16T09:11:42.1329042+00:00","entry":[{"fullUrl":"http://ema.europa.eu/fhir","resource":{"resourceType":0,"language":25,"text":{"status":"generated","div":"<div xmlns =\"http://www.w3.org/1999/xhtml\">electronic Product Information (ePI) document</div>"},"status":0,"type":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/100000155531/terms/","code":"100000155532","display":"Summary of Product Characteristics (Swedish)"}]},"date":"2024-04-16","author":[{"identifier":{"system":"http://www.test.com","value":"systemuser"}}],"title":"Provera","section":[{"id":"d406eea7-4f42-ee11-bdf5-000d3aaa033a","title":"PRODUKTRESUMÉ","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">&#160;</div>"},"section":[{"id":"f806eea7-4f42-ee11-bdf5-000d3aaa033a","title":"1. LÄKEMEDLETS NAMN","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Provera 5 mg tabletter</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Provera 10 mg tabletter</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029792","display":"1. LÄKEMEDLETS NAMN"}]}},{"id":"4c63e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"2. KVALITATIV OCH KVANTITATIV SAMMANSÄTTNING","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">En tablett inneh&#229;ller medroxiprogesteronacetat 5 mg resp. 10 mg.</p></div>"},"section":[{"id":"7363e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Hjälpämnen med känd effekt","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Laktos och sackaros.</span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">&#160;</span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">F&#246;r fullst&#228;ndig f&#246;rteckning &#246;ver hj&#228;lp&#228;mnen, se avsnitt 6.1.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029796","display":"Hjälpämnen med känd effekt"}]}}],"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029793","display":"2. KVALITATIV OCH KVANTITATIV SAMMANSÄTTNING"}]}},{"id":"a663e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"3. LÄKEMEDELSFORM","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Tablett </span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><em><span style=\"font-size: 11.0pt;\">5 mg:</span></em><span style=\"font-size: 11.0pt;\"> runda, bl&#229;, sk&#229;rade, diameter 6,4 mm, m&#228;rkta U p&#229; den ena sidan och 286 p&#229; b&#229;da sidor om en brytsk&#229;ra p&#229; den andra sidan.</span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><em><span style=\"font-size: 11.0pt;\">&#160;</span></em></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><em><span style=\"font-size: 11.0pt;\">10 mg:</span></em><span style=\"font-size: 11.0pt;\"> runda, vita, sk&#229;rade, diameter 7,1 mm, m&#228;rkta UPJOHN 50.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029797","display":"3. LÄKEMEDELSFORM"}]}},{"id":"d563e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"4. KLINISKA UPPGIFTER","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">&#160;</div>"},"section":[{"id":"eb63e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"4.1 Terapeutiska indikationer","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: left; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif; color: black;\"><span style=\"font-size: 11.0pt;\">Till&#228;gg till cyklisk &#246;strogenbehandling peri- och postmenopausalt. Symptomlindring vid endometrios. Uppskjutande eller p&#229;skyndande av menstruation. Dysfunktionella bl&#246;dningar. Oligo- och amenorr&#233;. Dysmenorr&#233; och premenstruella besv&#228;r.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029799","display":"4.1 Terapeutiska indikationer"}]}},{"id":"ff63e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"4.2 Dosering och administreringssätt","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">&#160;</div>"},"section":[{"id":"0c64e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Dosering","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><em><span style=\"font-size: 11.0pt; color: black;\">Till&#228;gg till cyklisk &#246;strogenbehandling:</span></em><span style=\"font-size: 11.0pt; color: black;\"> 5-10 mg dagligen under de 10-12 sista dagarna av &#246;strogenintaget.</span></p>\n<p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">&#160;<br /><em>Symptomlindring vid endometrios:</em> 5-10 mg dagligen. Behandlingen skall p&#229;g&#229; tills kliniska tecken p&#229; endometrios f&#246;rsvunnit - i allm&#228;nhet 6 m&#229;nader eller mer. Vid sm&#229;bl&#246;dningar, som kan upptr&#228;da speciellt i b&#246;rjan av behandlingen, &#246;kas dosen med 5 mg dagligen. N&#228;r bl&#246;dningen upph&#246;rt, kan f&#246;rs&#246;k g&#246;ras att s&#228;nka dosen igen.</span></p>\n<p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">&#160;<br /><em>Uppskjutande av menstruation:</em> 10 mg dagligen med b&#246;rjan cirka 1 vecka f&#246;re v&#228;ntad menstruation. Bl&#246;dningen kommer som regel n&#229;gra dagar efter behandlingens uts&#228;ttande.</span></p>\n<p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">&#160;<br /><em>P&#229;skyndande av menstruation:</em> 10 mg dagligen fr&#229;n cykelns 6-8:e dag under 1 vecka. Bl&#246;dningen kommer som regel n&#229;gra dagar efter behandlingens uts&#228;ttande.</span></p>\n<p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">&#160;<br /><em>Dysfunktionella bl&#246;dningar:</em> 5-10 mg under minst 10 dagar.</span></p>\n<p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">&#160;<br /><em>Oligo- och amenorr&#233;: </em>Vid <em>oligomenorr&#233;</em> ges 5-10 mg dagligen under 1 vecka. I allm&#228;nhet fordras ej n&#229;got &#246;strogentillskott. Vid <em>amenorr&#233;, </em>om bortfallsbl&#246;dning &#228;r &#246;nskv&#228;rd, ges Provera som vid oligomenorr&#233;, och i regel i kombination med &#246;strogener. Det &#246;strogena hormonet ges h&#228;rvid under 3&#160;veckor, och under sista veckan i kombination med Provera. En bl&#246;dning kommer i allm&#228;nhet 2-5 dagar efter sista behandlingsdagen. Behandlingen upprepas cykliskt.</span></p>\n<p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">&#160;</span></p>\n<p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><em><span style=\"font-size: 11.0pt; color: black;\">Dysmenorr&#233; och premenstruella besv&#228;r: </span></em><span style=\"font-size: 11.0pt; color: black;\">5-10 mg dagligen under 7 dagar f&#246;re v&#228;ntad menstruation.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029801","display":"Dosering"}]}},{"id":"2664e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Administreringssätt","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>-</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029803","display":"Administreringssätt"}]}}],"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029800","display":"4.2 Dosering och administreringssätt"}]}},{"id":"4564e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"4.3 Kontraindikationer","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-indent: -1.1pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">&#214;verk&#228;nslighet mot den aktiva substansen eller mot n&#229;got hj&#228;lp&#228;mne som anges i avsnitt 6.1.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029805","display":"4.3 Kontraindikationer"}]}},{"id":"5364e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"4.4 Varningar och försiktighet","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: left; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif; color: black;\"><span style=\"font-size: 11.0pt;\">Behandlingen b&#246;r inledas med gynekologisk unders&#246;kning och kontroll av blodtryck och br&#246;st. Unders&#246;kningen b&#246;r upprepas ca en g&#229;ng per &#229;r vid fortsatt behandling. Vaginal bl&#246;dning av ok&#228;nd etiologi skall utredas f&#246;re behandlingen p&#229;b&#246;rjas.</span></p>\n<p style=\"text-align: left; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif; color: black;\"><span style=\"font-size: 11.0pt;\">Vaginalbl&#246;dning som upptr&#228;der vid icke f&#246;rv&#228;ntad tidpunkt skall utredas i samr&#229;d med specialist.</span></p>\n<p style=\"text-align: left; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif; color: black;\"><span style=\"font-size: 11.0pt;\">Patienten b&#246;r upplysas om att l&#228;karen skall kontaktas om stark huvudv&#228;rk, synst&#246;rning och/eller olaga vaginalbl&#246;dning upptr&#228;der.</span></p>\n<p style=\"text-align: left; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif; color: black;\"><span style=\"font-size: 11.0pt;\">Porfyri.</span></p></div>"},"section":[{"id":"3a93c7c1-4d46-ee11-be6e-000d3aaa0403","title":"Provera innehåller laktos och sackaros","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: left; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif; color: black;\"><span style=\"font-size: 11.0pt;\">Patienter med n&#229;got av f&#246;ljande s&#228;llsynta &#228;rftliga tillst&#229;nd b&#246;r inte anv&#228;nda detta l&#228;kemedel: galaktosintolerans, total laktasbrist, fruktosintolerans, glukos-galaktosmalabsorption eller sukras-isomaltasbrist.</span></p></div>"}}],"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029806","display":"4.4 Varningar och försiktighet"}]}},{"id":"7264e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"4.5 Interaktioner med andra läkemedel och övriga interaktioner","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Medroxiprogesteronacetat (MPA) metaboliseras <em>in vitro</em> i huvudsak genom hydroxylering via CYP3A4. Inga specifika interaktionsstudier har utf&#246;rts f&#246;r att utv&#228;rdera de kliniska effekterna av CYP3A4-inducerare eller -h&#228;mmare p&#229; MPA. P&#229;verkan p&#229; MPA:s plasmakoncentrationer kan f&#246;rv&#228;ntas vid kombination med den typen av substanser.&#160; </span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029809","display":"4.5 Interaktioner med andra läkemedel och övriga interaktioner"}]}},{"id":"7764e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"4.6 Fertilitet, graviditet och amning","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">&#160;</div>"},"section":[{"id":"8264e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Graviditet","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"margin: 0cm; text-align: justify; font-size: 12pt; font-family: 'Times New Roman', serif; color: black;\"><span style=\"font-size: 11.0pt;\">Provera tabletter skall inte ges under graviditet.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029812","display":"Graviditet"}]}},{"id":"8564e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Amning","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"margin: 0cm; text-align: justify; font-size: 12pt; font-family: 'Times New Roman', serif; color: black;\"><span style=\"font-size: 11.0pt; font-family: 'Times New Roman', serif;\">Medroxiprogesteronacetat uts&#246;ndras i br&#246;stmj&#246;lk men vid terapeutiska doser av Provera f&#246;rv&#228;ntas inga effekter p&#229; ammade nyf&#246;dda/sp&#228;dbarn.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029813","display":"Amning"}]}},{"id":"8b64e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Fertilitet","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Vid orala doser kan Provera tabletter h&#228;mma &#228;gglossning.</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029814","display":"Fertilitet"}]}}],"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029811","display":"4.6 Fertilitet, graviditet och amning"}]}},{"id":"9664e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"4.7 Effekter på förmågan att framföra fordon och använda maskiner","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Provera har ingen eller f&#246;rsumbar effekt p&#229; f&#246;rm&#229;gan att framf&#246;ra fordon och anv&#228;nda maskiner.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029815","display":"4.7 Effekter på förmågan att framföra fordon och använda maskiner"}]}},{"id":"dd64e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"4.8 Biverkningar","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">Vid l&#229;ngtidsbehandling med gestagen till kvinnor i fertil &#229;lder &#228;r rubbningar i menstruationscykeln vanliga. Rubbningen kan inneb&#228;ra att menstruationscykeln blir f&#246;rkortad, men &#228;ven andra m&#246;nster s&#229;som oregelbundna, l&#229;ngdragna eller glesa bl&#246;dningar, liksom amenorr&#233;, kan f&#246;rekomma. <br /><br /></span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">I nedanst&#229;ende tabell &#228;r alla biverkningar presenterade efter klassificering av organsystem och frekvens enligt f&#246;ljande: vanliga </span><span style=\"font-size: 11.0pt;\">(</span><span style=\"font-size: 11.0pt; font-family: Symbol;\">&#179;</span><span style=\"font-size: 11.0pt;\">1/100, &lt;1/10) och mindre vanliga (</span><span style=\"font-size: 11.0pt; font-family: Symbol;\">&#179;</span><span style=\"font-size: 11.0pt;\">1/1&#160;000, &lt;1/100).</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">&#160;</span></p>\n<table class=\"MsoNormalTable\" style=\"width: 576px; border-collapse: collapse; border: none;\" border=\"1\" cellspacing=\"0\" cellpadding=\"0\">\n<thead>\n<tr style=\"page-break-inside: avoid; height: 8.45pt;\">\n<td style=\"width: 127.35pt; border: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm; text-align: center; font-size: 10pt; font-family: 'Times New Roman Bold', serif; font-weight: bold;\"><span style=\"font-family: 'Times New Roman', serif;\">Organsystem-klass</span></p>\n</td>\n<td style=\"width: 5.0cm; border: solid windowtext 1.0pt; border-left: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm; text-align: center; font-size: 10pt; font-family: 'Times New Roman Bold', serif; font-weight: bold;\"><span style=\"font-family: 'Times New Roman', serif;\">Vanliga</span></p>\n<p style=\"margin: 0cm; text-align: center; font-size: 10pt; font-family: 'Times New Roman Bold', serif; font-weight: bold;\"><span style=\"font-family: 'Times New Roman', serif;\">&#160;</span></p>\n</td>\n<td style=\"width: 163.0pt; border: solid windowtext 1.0pt; border-left: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm 0cm 0cm -4pt; text-align: center; font-size: 10pt; font-family: 'Times New Roman Bold', serif; font-weight: bold;\"><span style=\"font-family: 'Times New Roman', serif;\">Mindre vanliga</span></p>\n<p style=\"margin: 0cm 0cm 0cm -4pt; text-align: center; font-size: 10pt; font-family: 'Times New Roman Bold', serif; font-weight: bold;\"><span style=\"font-family: 'Times New Roman', serif;\">&#160;</span></p>\n</td>\n</tr>\n</thead>\n<tbody>\n<tr style=\"page-break-inside: avoid; height: 8.45pt;\">\n<td style=\"width: 127.35pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\"><strong>Metabolism och nutrition</strong></p>\n</td>\n<td style=\"width: 5.0cm; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">V&#228;tskeretention</p>\n</td>\n<td style=\"width: 163.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">&#160;</td>\n</tr>\n<tr style=\"page-break-inside: avoid; height: 8.45pt;\">\n<td style=\"width: 127.35pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\"><strong>Psykiatriska tillst&#229;nd</strong></p>\n</td>\n<td style=\"width: 5.0cm; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">Nedst&#228;mdhet</p>\n</td>\n<td style=\"width: 163.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">Minskad libido</p>\n</td>\n</tr>\n<tr style=\"page-break-inside: avoid; height: 8.45pt;\">\n<td style=\"width: 127.35pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\"><strong>Centrala och perifera nervsystemet</strong></p>\n</td>\n<td style=\"width: 5.0cm; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">Huvudv&#228;rk</p>\n</td>\n<td style=\"width: 163.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">&#160;</p>\n</td>\n</tr>\n<tr style=\"page-break-inside: avoid; height: 72.85pt;\">\n<td style=\"width: 127.35pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\"><strong>Magtarmkanalen</strong></p>\n</td>\n<td style=\"width: 5.0cm; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">Illam&#229;ende</p>\n</td>\n<td style=\"width: 163.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">&#160;</p>\n</td>\n</tr>\n<tr style=\"page-break-inside: avoid; height: 40.4pt;\">\n<td style=\"width: 127.35pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\"><strong>Lever och gallv&#228;gar</strong></p>\n</td>\n<td style=\"width: 5.0cm; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">&#160;</p>\n</td>\n<td style=\"width: 163.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">P&#229;verkan p&#229; leverfunktionen</p>\n</td>\n</tr>\n<tr style=\"page-break-inside: avoid; height: 26.35pt;\">\n<td style=\"width: 127.35pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\"><strong>Hud och subkutan v&#228;vnad</strong></p>\n</td>\n<td style=\"width: 5.0cm; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">&#160;</p>\n</td>\n<td style=\"width: 163.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"text-align: center; margin: 0cm; 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border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\">&#160;</p>\n</td>\n</tr>\n<tr style=\"page-break-inside: avoid; height: 66.75pt;\">\n<td style=\"width: 127.35pt; border: solid windowtext 1.0pt; border-top: none; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm; font-size: 10pt; font-family: 'Times New Roman', serif;\"><strong>Unders&#246;kningar och provtagningar</strong></p>\n</td>\n<td style=\"width: 5.0cm; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm 0cm 0cm 10.45pt; text-align: center; font-size: 10pt; font-family: 'Times New Roman', serif;\">Vikt&#246;kning</p>\n</td>\n<td style=\"width: 163.0pt; border-top: none; border-left: none; border-bottom: solid windowtext 1.0pt; border-right: solid windowtext 1.0pt; padding: 0cm 5.4pt 0cm 5.4pt;\" valign=\"top\">\n<p style=\"margin: 0cm 0cm 0cm 10.45pt; font-size: 10pt; font-family: 'Times New Roman', serif;\">&#160;</p>\n</td>\n</tr>\n</tbody>\n</table>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">&#160;</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><br /><br /></p></div>"},"section":[{"id":"3e65e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Rapportering av misstänkta biverkningar","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Det &#228;r viktigt att rapportera misst&#228;nkta biverkningar efter att l&#228;kemedlet godk&#228;nts. Det g&#246;r det m&#246;jligt att kontinuerligt &#246;vervaka l&#228;kemedlets nytta-riskf&#246;rh&#229;llande. H&#228;lso- och sjukv&#229;rdspersonal uppmanas att rapportera varje misst&#228;nkt biverkning till (se detaljer nedan).</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">&#160;</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">L&#228;kemedelsverket</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Box 26</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">751 03 Uppsala</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Webbplats: <a href=\"https://www.lakemedelsverket.se\">www.lakemedelsverket.se</a></span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">&#160;</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029818","display":"Rapportering av misstänkta biverkningar"}]}}],"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029816","display":"4.8 Biverkningar"}]}},{"id":"5665e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"4.9 Överdosering","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Det finns inga rapporter om allvarliga, skadliga effekter vid &#246;verdos. Symtomen som kan upptr&#228;da &#228;r de som anges under biverkningar. Behandlingen &#228;r symtomatisk.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029819","display":"4.9 Överdosering"}]}}],"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029798","display":"4. KLINISKA UPPGIFTER"}]}},{"id":"a565e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"5. FARMAKOLOGISKA EGENSKAPER","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">&#160;</div>"},"section":[{"id":"c065e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"5.1 Farmakodynamiska egenskaper","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">Farmakoterapeutisk grupp: gestagener, ATC-kod: G03DA02</span></p>\n<p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">&#160;</span></p>\n<p style=\"text-indent: -0.55pt; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">Provera inneh&#229;ller acetatestern av medroxiprogesteron. <br />MPA har progesteronliknande effekt och &#246;verf&#246;r &#246;strogenstimulerat endometrium till sekretionsfas. Denna egenskap utnyttjas i kliniken f&#246;r att h&#228;mma en endogent eller exogent &#229;stadkommen &#246;strogeninducerad hyperproliferation av endometriet, som vid tillf&#246;rsel av MPA i adekvat dos omvandlas till sekretionsslemhinna.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029822","display":"5.1 Farmakodynamiska egenskaper"}]}},{"id":"2e66e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"5.2 Farmakokinetiska egenskaper","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">&#160;</div>"},"section":[{"id":"3466e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Absorption","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">P&#229; grund av sv&#229;rl&#246;sligheten &#228;r absorptionen av oralt MPA l&#229;g och uppvisar en stor individuell variation. Maximal plasmakoncentration uppn&#229;s efter 1-4 timmar. Plasmaniv&#229;erna &#228;r proportionella mot den givna dosen. </span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">&#160;</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Administrering tillsammans med mat &#246;kar biotillg&#228;ngligheten av MPA. En 10&#160;mg-dos oralt MPA som togs direkt f&#246;re eller efter en m&#229;ltid &#246;kade genomsnittligt C<sub>max</sub> (51 respektive 77&#160;%) och genomsnittligt AUC (18 respektive 33&#160;%) f&#246;r MPA. Halveringstiden f&#246;r MPA p&#229;verkades inte n&#228;r det togs tillsammans med mat.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029828","display":"Absorption"}]}},{"id":"3966e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Distribution","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: left; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif; color: black;\"><span style=\"font-size: 11.0pt;\">MPA &#228;r ungef&#228;r 90 % proteinbundet, prim&#228;rt till albumin. Ingen MPA-bindning sker med k&#246;nshormonbindande globulin.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029829","display":"Distribution"}]}},{"id":"4166e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Metabolism","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><span style=\"font-size: 11.0pt; font-family: 'Times New Roman', serif;\">Efter oral dosering metaboliseras MPA i stor utstr&#228;ckning i levern med minst 16 identifierade metaboliter av MPA, &#228;ven om metabolismen &#228;r ofullst&#228;ndigt utredd. Vid oxidativ metabolism i levern bildas hydroxi-MPA som konjugeras till att bilda glukoronider och i mindre utstr&#228;ckning till sulfater.&#160;<em>In vitro</em>-studier i humana levermikrosomer tyder p&#229; att CYP3A4 prim&#228;rt &#228;r involverat i den &#246;vergripande metabolismen av MPA. Metaboliternas farmakologiska aktivitet &#228;r ok&#228;nd. </span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029830","display":"Metabolism"}]}},{"id":"4b66e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"Eliminering","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: left; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif; color: black;\"><span style=\"font-size: 11.0pt;\">De konjugerade metaboliterna elimineras i galla och urin.</span><span style=\"font-size: 11.0pt;\"> Modersubstansens halveringstid i eliminationsfasen &#228;r cirka 50 timmar.</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029831","display":"Eliminering"}]}}],"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029827","display":"5.2 Farmakokinetiska egenskaper"}]}},{"id":"6a66e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"5.3 Prekliniska säkerhetsuppgifter","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>-</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029834","display":"5.3 Prekliniska säkerhetsuppgifter"}]}}],"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029821","display":"5. FARMAKOLOGISKA EGENSKAPER"}]}},{"id":"7266e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"6. FARMACEUTISKA UPPGIFTER","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\">&#160;</div>"},"section":[{"id":"7866e6ad-4f42-ee11-bdf5-000d3aaa033a","title":"6.1 Förteckning över hjälpämnen","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">Laktosmonohydrat 84,2 mg resp. 110 mg </span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">Majsst&#228;rkelse </span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">Talk </span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">Socker 1,47 resp. 2 mg </span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">Flytande paraffin </span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">Kalciumstearat </span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt; color: black;\">F&#228;rg&#228;mne (indigokarmin E 132 enbart i tabletter 5mg)</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029837","display":"6.1 Förteckning över hjälpämnen"}]}},{"id":"6bc1deb3-4f42-ee11-bdf5-000d3aaa033a","title":"6.2 Inkompatibiliteter","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">Ej relevant.</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029838","display":"6.2 Inkompatibiliteter"}]}},{"id":"aac1deb3-4f42-ee11-bdf5-000d3aaa033a","title":"6.3 Hållbarhet","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>5 &#229;r.</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029839","display":"6.3 Hållbarhet"}]}},{"id":"d5c1deb3-4f42-ee11-bdf5-000d3aaa033a","title":"6.4 Särskilda förvaringsanvisningar","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">Inga s&#228;rskilda f&#246;rvaringsanvisningar.</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029840","display":"6.4 Särskilda förvaringsanvisningar"}]}},{"id":"e7c1deb3-4f42-ee11-bdf5-000d3aaa033a","title":"6.5 Förpackningstyp och innehåll","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">Tryckf&#246;rpackning.</p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">&#160;</p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><em><span style=\"font-size: 11.0pt;\">F&#246;rpackningsstorlekar:</span></em></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Provera tabletter 5 mg&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; 40 st, 100 st</span></p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Provera tabletter 10 mg&#160;&#160;&#160;&#160;&#160;&#160;&#160; 10 st, 40 st, 100 st</span></p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029841","display":"6.5 Förpackningstyp och innehåll"}]}},{"id":"01c2deb3-4f42-ee11-bdf5-000d3aaa033a","title":"6.6 Särskilda anvisningar för destruktion och övrig hantering","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">Inga s&#228;rskilda anvisningar.</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029842","display":"6.6 Särskilda anvisningar för destruktion och övrig hantering"}]}}],"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029836","display":"6. FARMACEUTISKA UPPGIFTER"}]}},{"id":"2bc2deb3-4f42-ee11-bdf5-000d3aaa033a","title":"7. INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">Pfizer AB</p>\n<p style=\"text-align: justify; margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">113 63 Stockholm</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029844","display":"7. INNEHAVARE AV GODKÄNNANDE FÖR FÖRSÄLJNING"}]}},{"id":"34c2deb3-4f42-ee11-bdf5-000d3aaa033a","title":"8. NUMMER PÅ GODKÄNNANDE FÖR FÖRSÄLJNING","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">Provera tabletter 5 mg: 10337</p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\">Provera tabletter 10 mg: 10995</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029845","display":"8. NUMMER PÅ GODKÄNNANDE FÖR FÖRSÄLJNING"}]}},{"id":"42c2deb3-4f42-ee11-bdf5-000d3aaa033a","title":"9. DATUM FÖR FÖRSTA GODKÄNNANDE/FÖRNYAT GODKÄNNANDE","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p style=\"margin: 0cm 0cm 0cm 1cm; text-indent: -1cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><em><span style=\"font-size: 11.0pt;\">Provera tabletter 5 mg</span></em></p>\n<p style=\"margin: 0cm 0cm 0cm 1cm; text-indent: -1cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Datum f&#246;r det f&#246;rsta godk&#228;nnandet: 31 januari 1986</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Datum f&#246;r den senaste f&#246;rnyelsen: 30 juni 2009</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">&#160;</span></p>\n<p style=\"margin: 0cm 0cm 0cm 1cm; text-indent: -1cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><em><span style=\"font-size: 11.0pt;\">Provera tabletter 10 mg</span></em></p>\n<p style=\"margin: 0cm 0cm 0cm 1cm; text-indent: -1cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Datum f&#246;r det f&#246;rsta godk&#228;nnandet: 30 juni 1989</span></p>\n<p style=\"margin: 0cm; font-size: 12pt; font-family: 'Times New Roman', serif;\"><span style=\"font-size: 11.0pt;\">Datum f&#246;r den senaste f&#246;rnyelsen: 30 juni 2009</span></p>\n<p>&#160;</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029846","display":"9. DATUM FÖR FÖRSTA GODKÄNNANDE/FÖRNYAT GODKÄNNANDE"}]}},{"id":"52c2deb3-4f42-ee11-bdf5-000d3aaa033a","title":"10. DATUM FÖR ÖVERSYN AV PRODUKTRESUMÉN","text":{"status":"generated","div":"<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>2024-04-16</p></div>"},"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029847","display":"10. DATUM FÖR ÖVERSYN AV PRODUKTRESUMÉN"}]}}],"code":{"coding":[{"system":"https://spor.ema.europa.eu/v1/lists/200000029659/terms/","code":"200000029791","display":"PRODUKTRESUMÉ"}]}}]}}]}