FrancophonIA/ELRC3.0 huggingface dataset:
English: Regarding the use of sertraline in Hepatic Insufficiency and in Renal Insufficiency, the CHMP agreed with the wording proposed by the MAH for harmonisation.
Danish: Med hensyn til anvendelse af sertralin ved nedsat leverfunktion og nedsat nyrefunktion erklærede CHMP sig enigt i den formulering, indehaveren af markedsføringstilladelsen havde foreslået til harmonisering.
English: The CHMP concluded that the safety in children and adolescents has not sufficiently been established and that a commitment to further investigate safety in paediatric patients is required in order to adopt the following indication: “Sertraline is indicated for the treatment of obsessive compulsive disorder (OCD) in adults and paediatric patients aged 6-17 years.” with the condition that the following text is inserted in the section 5.1 “Pharmacodynamic Properties” of the SPC: "Long term safety and efficacy data are lacking for this paediatric population.
Danish: CHMP konkluderede, at sikkerheden hos børn og unge ikke er tilstrækkeligt påvist, og at der er behov for en yderligere forpligtelse til at undersøge sikkerheden for pædiatriske patienter, hvis følgende indikation skal godkendes: "Sertralin er indiceret til behandling af obsessiv-kompulsiv tilstand (OCD) hos voksne samt hos børn på 6-17 år."
English: Zoloft has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Danish: Det er blevet bestemt af den humanmedicinske koordineringsgruppe for gensidig anerkendelse og decentrale procedurer (CMD(h)), at oplysningerne om Zoloft bør harmoniseres.
English: ATCvet code: QI09AA07.
Danish: ATCvet-kode: QI09AA07
English: These reactions resolve spontaneously over a period of approximately 14-21 days without any major consequence on the general health status of the animals.
Danish: Disse reaktioner aftager spontant over en periode på ca. 14-21 dage, uden væsentlige konsekvenser for dyrenes almene helbredstilstand.
English: In laboratory studies and field trials:
Danish: Fra laboratoriestudier og feltforsøg:
English: In such cases it is advised to perform PCV2 serology, using suitable diagnostics, to select the most appropriate vaccination schedule.
Danish: I sådanne tilfælde kan det tilrådes at udføre PCV2-serologi, ved anvendelse af egnet diagnostik, for at vælge det bedst egnede vaccinationsprogram.
English: In the event of such reactions, treatment may be needed.
Danish: I disse tilfælde kan behandling være nødvendig.
English: Burgwedel Biotech GmbH Im Langen Felde 5
Danish: Burgwedel Biotech GmbH Im Langen Felden 5
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12/01/2009.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 12/01/2009
English: 22 weeks.
Danish: 22 uger.
English: Simethicon
Danish: Simeticon
English: Vaccination may result in a transient impairment of growth rate in the immediate period after administration of the vaccine.
Danish: Vaccination kan resultere i forbigående nedsat tilvækst i perioden umiddelbart efter vaccinering.
English: EU/2/08/091/003 100 ml EU/2/08/091/004 200 ml EU/2/08/091/005 500 ml EU/2/08/091/006 10 x 20 ml EU/2/08/091/007 10 x 50 ml EU/2/08/091/008 10 x 100 ml EU/2/08/091/009 10 x 200 ml EU/2/08/091/010 10 x 500 ml
Danish: EU/2/08/091/001 20 ml EU/2/08/091/002 50 ml EU/2/08/091/003 100 ml EU/2/08/091/004 200 ml EU/2/08/091/005 500 ml EU/2/08/091/006 10 x 20 ml EU/2/08/091/007 10 x 50 ml EU/2/08/091/008 10 x 100 ml EU/2/08/091/009 10 x 200 ml EU/2/08/091/010 10 x 500 ml
English: In post marketing experience:
Danish: Erfaringer fra post markedsføring:
English: Avoid use of vaccination equipment with rubber parts.
Danish: Undgå at anvende vaccinationsudstyr med gummidele.
English: Vaccine to stimulate active immunity against porcine circovirus type 2.
Danish: Vaccine til stimulering af aktiv immunitet mod porcint circovirus type 2.
English: Date of last renewal: 13/12/2013
Danish: Dato for seneste fornyelse af markedsføringstilladelse: 13/12/2013
English: Transient local reactions at the injection site were very commonly observed after vaccination mainly in the form of a hard, warm and sometimes painful swelling (diameter up to 10 cm).
Danish: Meget almindeligt blev observeret forbigående lokale reaktioner på injektionsstedet i form af en hård, varm og nogle gange smertefuld hævelse (med en diameter på op til 10 cm).
English: In very rare cases anaphylactic-type reactions can occur, which may be life-threatening.
Danish: I meget sjældne tilfælde kan opstå anafylaktiske reaktioner som kan være livstruende.
English: In case of doubt, apply the two shot vaccination schedule.
Danish: I tvivlstilfælde, vælg programmet med 2 vaccinationer.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary)
Danish: 4.10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/091/001-010
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/08/091/001 - 010
English: Following the administration of a double dose of vaccine no side effects other than those described under “adverse reactions” have been observed.
Danish: Efter brug af dobbelt dosis er der ikke set andre reaktioner end de, der er beskrevet under ”Bivirkninger”.
English: Before using the vaccine allow it to reach room temperature (15-25 °C) and shake well before use.
Danish: Lad vaccinen opnå stuetemperatur (15-25°C) og omryst grundigt inden brug.
English: Pregnancy and lactation: Do not use during pregnancy and lactation.
Danish: Drægtighed og laktation: Bør ikke anvendes under drægtighed og laktation.
English: Vials are closed with a nitryl rubber stopper and a coded aluminium cap.
Danish: Hætteglas er lukket med en nitryl-gummiprop og forseglet med en kodet aluminiumshætte.
English: 2 weeks
Danish: 2 uger.
English: Opalescent white, with brown resuspendable sediment.
Danish: Opaliserende hvid, med brunt oprysteligt bundfald.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Do not use this veterinary medicinal product after the expiry date (EXP) which is stated on the carton and the vial.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato (UDL.D.
English: Store in a refrigerator (2 °C - 8 °C).
Danish: Opbevares i køleskab (2°C - 8°C)
English: For the active immunisation of pigs to reduce the virus load in blood and lymphoid tissues and to reduce mortality and weight loss associated with PCV2 infection occurring during the fattening period.
Danish: Til aktiv immunisering af svin med henblik på at reducere virusmængden i blod og lymfoidt væv samt til reduktion af dødelighed og vægttab i opvækstperioden i forbindelse med en PCV2-infektion.
English: High levels of MDA may be expected when sows/gilts are vaccinated against PCV2 virus or when sows/gilts have recently been exposed to high levels of PCV2 virus.
Danish: Høje niveauer af maternelle antistoffer kan forventes, når søer/gylte er vaccineret mod PCV2-virus, eller når søer/gylte kort tid forinden har været udsat for et højt niveau af PCV2 virus.
English: When it is expected that higher levels of maternally derived antibodies against PCV2 are present, the following schedule of two vaccinations is advised: the first injection (2 ml) can be given from an age of 3-5 days, the second injection (2 ml) 2-3 weeks later.
Danish: Hvis det forventes, at grisen har et højt niveau af maternelle antistoffer mod PCV2, anbefales følgende program med 2 vaccinationer: Den første injektion (2 ml) kan gives fra 3-5-dages-alderen efterfulgt af anden injektion (2 ml) 2-3 uger senere.
English: IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated porcine circovirus vaccine.
Danish: IMMUNOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: Inaktiveret vaccine mod porcint circovirus.
English: Immediate systemic hypersensitivity-like reactions were commonly observed after vaccination, resulting in minor neurological symptoms such as tremors and/or excitation, which normally resolve within minutes without requiring treatment.
Danish: Almindeligt kan der kort tid efter vaccination opstå en akut overfølsomheds-lignende reaktion resulterende i lettere neurologiske symptomer, som kramper og/eller ekscitation, som normalt aftager efter nogle minutter uden at kræve behandling.
English: In individual animals, an increase of rectal temperature of 2.5 °C lasting less than 24 hours was uncommonly observed.
Danish: I enkelte dyr sås en ualmindelig stigning af rektaltemperaturen med op til 2,5 °C varende mindre end 24 timer.
English: A transient increase in body temperature, normally not exceeding 1 °C, was very commonly observed until 2 days after vaccination.
Danish: Meget almindeligt blev observeret en forbigående stigning i kropstemperaturen, normalt ikke overstigende 1°C, i op til 2 dage efter vaccination.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til intramuskulær anvendelse.
English: SPECIAL WARNING(S), IF NECESSARY Accidental self-injection is dangerous.
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER, OM NØDVENDIGT Utilsigtet injektion er farlig.
English: Administer one dose (2 ml), by intramuscular injection in the neck in the area behind the ear, according to the following schedule:
Danish: Indgiv en dosis (2 ml) ved intramuskulær injektion i nakkemuskulaturen i området bag øret i henhold til følgende program:
English: Adjuvants:
Danish: Adjuvans:
English: Administer one dose of 2 ml by intramuscular injection in the neck, in the area behind the ear, according to the following schedule:
Danish: Indgiv en dosis (2 ml) ved intramuskulær injektion i nakkemuskulaturen, i området bag øret, i henhold til følgende program:
English: No data are available on the use of the vaccine in breeding boars.
Danish: Der foreligger ingen dokumentation om brug af vaccinen til avlsorner.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 2 ml contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosis af 2 ml indeholder:
English: Pack sizes: cardboard boxes with either 1 or 10 vials of 20, 50, 100, 200 or 500 ml (10, 25, 50, 100 or 250 doses).
Danish: Pakningsstørrelser: Kartonæsker med enten 1 eller 10 hætteglas af 20, 50, 100, 200 eller 500 ml (10, 25, 50, 100 eller 250 doser).
English: In the case of low to medium levels of maternally derived antibodies against PCV2 a single vaccination (2 ml) to pigs from an age of 3 weeks onwards is advised.
Danish: I tilfælde af lave til middelhøje niveauer af maternelle antistoffer mod PCV2, anbefales det at give en enkelt dosis (2 ml) til grise fra 3 ugers-alderen.
English: Before using the vaccine, allow it to reach room temperature and shake well before use.
Danish: Lad vaccinen opnå stuetemperatur og omryst grundigt inden brug.
English: Following the administration of a double dose of vaccine no side effects other than those described in section 4.6 have been observed.
Danish: Der ikke observeret andre reaktioner efter brug af dobbelt dosis end de, der allerede er nævnt under punkt 4.6.
English: Dl-α-tocopheryl acetate
Danish: Dl-α-tocopherylacetat
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vials {20 and 50 ml}
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas {20 ml og 50 ml}
English: Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and, in rare cases, could result in the loss of the affected finger if prompt medical attention is not given.
Danish: Uforsætlig injektion/selvinjektion kan medføre alvorlige smerter og hævelser, navnlig ved injektion i led eller fingre, og kan i sjældne tilfælde medføre tab af den pågældende finger, hvis den ikke behandles omgående.
English: Shelf-life after first opening the container: 8 hours.
Danish: Opbevaringstid efter første åbning af hætteglasset: 8 timer.
English: EXPIRY DATE EXP {month/year} Once broached, use within 8 hours.
Danish: 10. UDLØBSDATO UDL.D., {måneder/år} Efter anbrud/åbning anvendes inden 8 timer.
English: From the data provided, it can be concluded that a single dose regimen of vaccination breaks through up to medium levels and double dose regimen through medium to high levels of maternally derived antibodies in piglets.
Danish: Af den fremlagte dokumentation kan konkluderes, at et enkeltdosis-vaccinationsprogram gennembryder op til middelhøje niveauer af maternelle antistoffer.
English: PCV2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units.
Danish: PCV2 ORF2 subunit antigen: ≥4,5 log2 ELISA enheder
English: Cardboard boxes with either 1 or 10 PET vials of 20, 50, 100, 200 or 500 ml.
Danish: Kartonæsker med enten 1 eller 10 PET-hætteglas a 20, 50, 100, 200 eller 500 ml.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Per 2 ml dose:
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Pr. dosis a 2 ml:
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES One dose of 2 ml contains:
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER 1 dosis af 2 ml indeholder:
English: In some piglets depression and a reduced feed intake for up to 5 days were uncommonly observed.
Danish: Nedstemthed og nedsat ædelyst i op til 5 dage var en ualmindelig observation i nogle smågrise.
English: 5831 AN Boxmeer
Danish: Wim de Körverstraat 35 5831 AN Boxmeer Holland
English: Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units* * Antibody titre obtained according to the in vivo potency test in chickens.
Danish: Porcint circovirus type 2 ORF2 subunit-antigen; mindst 4,5 log2 ELISA-enheder* * Antistoftiter opnået ved in vivo potency-test i kyllinger.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes {20, 50, 100, 200 and 500 ml}
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton æske (20, 50, 100, 200 og 500 ml)
English: Porcine circovirus type 2 ORF2 subunit antigen: ≥ 4.5 log2 ELISA units.
Danish: Porcint circovirus type 2 ORF2 subunit-antigen: ≥ 4,5 log2 ELISA-enheder
English: Light liquid paraffin
Danish: Paraffinolie, tynd
English: 25 mg dl-α-tocopheryl acetate
Danish: 25 mg dl-α-tocopherylacetat 346 mg paraffinolie, tynd
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV emulsion for injection
Danish: VETERINÆRLÆGEMIDLETS NAVN Porcilis PCV injektionsvæske, emulsion
English: Avoid multiple vial broaching.
Danish: Undgå at anbryde hætteglas gentagne gange.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Porcilis PCV emulsion for injection for pigs
Danish: VETERINÆRLÆGEMIDLETS NAVN Porcilis PCV injektionsvæske, emulsion til svin
English: PACKAGE LEAFLET FOR: Porcilis PCV emulsion for injection for pigs
Danish: INDLÆGSSEDDEL for: Porcilis PCV injektionsvæske, emulsion til svin
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vials {100, 200 and 500 ml}
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas {100, 200 og 500 ml)
English: Porcine circovirus type 2 ORF2 subunit antigen: at least 4.5 log2 ELISA units (as determined in the in vivo potency test in chickens)
Danish: Porcint circovirus type 2 ORF2 subunit antigen: ≥ 4,5 log2 ELISA enheder (som målt i in vivo styrketest i kyllinger) Adjuvanser:
English: Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Danish: Uforsætlig injektion/selvinjektion kan medføre alvorlige smerter og hævelser, navnlig ved injektion i led eller fingre.
English: Lot
Danish: Batch
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International BV
Danish: Intervet International B.V.
English: Excipients.
Danish: i.m.
English: Do not use during pregnancy and lactation.
Danish: Lægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt.
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International BV
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse:
English: EMEA-number Invented Name Strength Pharmaceutical Form
Danish: EMEA nummer Opfundet navn Styrke Lægemiddelform
English: 0.5 mg/ml Oral suspension Dogs amber glass bottle (type III), 2 polypropylene dosing syringes.
Danish: 0.5 mg/ml Oral suspension Hunde
English: Target species Route of administration
Danish: Administrationsmåde
English: It is given once a week as an injection under the skin.
Danish: Det gives en gang om ugen som en injektion under huden.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nplate on 4 February 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nplate den 4. februar 2009.
English: Other information about Nplate
Danish: Andre oplysninger om Nplate
English: This is a summary of the European public assessment report (EPAR) for Nplate.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Nplate.
English: What measures are being taken to ensure the safe and effective use of Nplate?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Nplate?
English: What is Nplate and what is it used for?
Danish: Hvad er Nplate, og hvad anvendes det til?
English: Because the number of patients with ITP is low, the disease is considered ‘rare', and Nplate was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 May 2005.
Danish: Da antallet af patienter med ITP er lavt, betragtes sygdommen som "sjælden", og Nplate blev udpeget som "lægemiddel til sjældne sygdomme" den 27. maj 2005.
English: It is not intended to provide practical advice on how to use Nplate.
Danish: Det er ikke en praktisk vejledning i, hvordan Nplate bør anvendes.
English: Romiplostim has been designed to attach to and stimulate the same targets (receptors) as thrombopoietin.
Danish: Romiplostim er designet til at binde sig til og stimulere de samme mål (receptorer) som trombopoietin.
English: The improvement in platelet count was long-lasting and clinically relevant in both groups, although the treatment only manages symptoms and is not a cure.
Danish: Forbedringen i blodpladeantallet var langvarig og klinisk relevant hos begge grupper, selv om behandlingen kun modvirker symptomerne og ikke helbreder.
English: Nplate is used when treatment with medicines such as corticosteroids or immunoglobulins has not worked.
Danish: Nplate anvendes, når behandling med lægemidler såsom kortikosteroider eller immunglobuliner ikke har haft nogen virkning.
English: Why is Nplate approved?
Danish: Hvorfor blev Nplate godkendt?
English: The company that markets Nplate will provide doctors a ‘dosing calculator' to help them calculate the sometimes very small volumes of Nplate that need to be injected.
Danish: Virksomheden, der markedsfører Nplate, vil udlevere en "dosisberegner" til lægerne for at hjælpe dem med at beregne de undertiden meget små mængder Nplate, der skal injiceres.
English: Nplate contains the active substance romiplostim.
Danish: Nplate indeholder det aktive stof romiplostim.
English: All studies compared Nplate with placebo (a dummy treatment).
Danish: I alle studierne blev Nplate sammenlignet med placebo (en uvirksom behandling).
English: What are the risks associated with Nplate?
Danish: Hvilke risici er der forbundet med Nplate?
English: The full EPAR for Nplate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Nplate findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Treatment should be stopped if the platelet count does not rise enough to reduce the risk of bleeding after 4 weeks of treatment with the maximum dose of Nplate.
Danish: Behandlingen skal stoppes, hvis antallet af blodplader ikke når højt nok op til at mindske risikoen for blødning efter 4 ugers behandling med maksimumdosen af Nplate.
English: Two main studies in adults and a third one in children found Nplate effective for the treatment of longstanding ITP.
Danish: I to hovedstudier hos voksne og en tredje hos børn blev Nplate fundet effektiv til behandling af kronisk ITP.
English: The European Medicines Agency decided that Nplate's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Nplate opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Nplate.
English: Nplate must not be used in people who are hypersensitive (allergic) to romiplostim, any of the other ingredients, or proteins produced by Escherichia coli (a bacterium).
Danish: Nplate må ikke anvendes til personer, der er overfølsomme (allergiske) over for romiplostim, et eller flere af de øvrige indholdsstoffer eller proteiner, der produceres af Escherichia coli (en bakterie).
English: Nplate can only be obtained with a prescription and treatment with it should be supervised by a doctor who has experience in treating blood disorders.
Danish: Nplate udleveres kun efter recept, og behandlingen skal overvåges af en læge med erfaring i behandling af blodsygdomme.
English: Patients with ITP have low platelet counts and are at risk of bleeding.
Danish: Patienter med ITP har et lavt antal blodplader og har risiko for blødning.
English: The starting dose depends on the patient's weight, and is then adjusted to maintain platelet counts at the target levels.
Danish: Startdosen afhænger af patientens vægt og justeres efterfølgende for at holde antallet af blodplader på målniveauerne.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Nplate can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Nplate findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Long-term studies involving over 1,000 patients, some treated for longer than 5 years, confirmed that Nplate remained effective both in patients whose spleen had been removed and those who had their spleen.
Danish: Langtidsstudier hos over 1.000 patienter, hvoraf nogle blev behandlet i over 5 år, bekræftede, at Nplate forblev effektiv både hos patienter, der havde fået milten fjernet, og patienter, der havde milten i behold.
English: Doctors can also receive a home administration training pack, which includes materials on training patients who will inject themselves with Nplate, and materials for patients on how to prepare the medicine for injection.
Danish: Lægerne kan også få udleveret en undervisningspakke med materiale om, hvordan de instruerer patienter, der skal give sig selv injektionerne med Nplate i hjemmet, og materiale til patienterne om, hvordan de klargør lægemidlet til injektion.
English: Patients were treated for 24 weeks and the main measure of effectiveness was the increase in platelet count above a threshold of 50 million platelets per millilitre of blood during at least 6 of the last 8 weeks of treatment.
Danish: Patienterne blev behandlet i 24 uger, og virkningen blev hovedsageligt målt på stigningen i blodpladeantallet til over en tærskel på 50 mio. blodplader pr. ml blod i mindst 6 af de sidste 8 behandlingsuger.
English: Adults whose platelet levels are stable may inject the medicine themselves after they have been properly trained.
Danish: Voksne, hvis blodplader ligger på et stabilt niveau, kan selv indgive lægemidlet, når de er blevet behørigt instrueret heri.