FrancophonIA/ELRC3.0 huggingface dataset:
English: HU - Hungary AstraZeneca KFt. Park u. 3
Danish: AstraZeneca KFt. Park u. 3
English: However, the EPC study was positive for the primary progression free survival (PFS) endpoint, both overall and in the locally advanced subgroups.
Danish: Undersøgelsen var imidlertid positiv for endepunktet primær progressionsfri overlevelse, både samlet og i hver delgruppe af lokalt avanceret sygdom.
English: AT - Austria Genericon Pharma Ges.m.b.H.
Danish: Genericon Pharma Ges.m.b.H.
English: - In view of the available data, the CHMP concluded that a potential association between the use of bicalutamide 150 mg and heart failure cannot be ruled out and therefore considered that the need to further study cardiovascular morbidity and mortality remains.
Danish: - Udvalget konkluderede på grundlag af de foreliggende oplysninger, at en sammenhæng mellem brugen af bicalutamid, 150 mg, og hjertesvigt ikke kan udelukkes, og derfor fandt det fortsat nødvendigt med nærmere undersøgelse af den kardiovaskulære morbiditet og mortalitet.
English: Marketing Authorisation Holders
Danish: Indehaver af markedsføringstilladelse
English: In view of the concerns related to safety and efficacy for bicalutamide 150 mg the National Competent Authority (NCA) in Belgium considered it to be in the interest of public health to perform a new benefit/risk assessment.
Danish: På baggrund af betænkelighederne vedrørende sikkerheden og virkningen af bicalutamid, 150 mg, fandt de belgiske kompetente myndigheder, at det ville være i folkesundhedens interesse at revurdere risk/benefitforholdet.
English: Valejas - 2745-663 Barcarena
Danish: Rua Humberto Madeira, 7 Valejas - 2745-663 Barcarena
English: EAU guidelines suggest the use of prophylactic breast radiation, tamoxifen or aromatase inhibitors to manage these symptoms, although they are not licensed in this use.
Danish: I retningslinjerne fra EAU foreslås symptomerne behandlet med profylaktisk strålebehandling af brysterne, tamoxifen eller aromatasehæmmere, skønt disse midler ikke er godkendt til denne anvendelse.
English: The scope of the referral included all pending Marketing Authorisation applications as well as all Marketing Authorisations for medicinal products containing 150 mg bicalutamide.
Danish: Sagen inkluderede samtlige påbegyndte ansøgninger om markedsføringstilladelse og eksisterende markedsføringstilladelser for lægemidler indeholdende 150 mg bicalutamid.
English: How can the company rule out any role of bicalutamide 150 mg in the increased mortality due to heart failure in the Casodex arm of the EPC trial?
Danish: Hvordan udelukker firmaet, at bicalutamid, 150 mg, var medvirkende til den øgede mortalitet som følge af hjertesvigt i Casodex-armen i den kliniske undersøgelse af EPC?
English: A more specific target population is hard to define from the EPC data, and the general term “high risk” better accommodates wide differences in local practice and inevitable changes in the standard of care, and takes into account the many variables in the individual patient which may contribute to risk of progression.
Danish: Det generelle udtryk "høj risiko" rummer bedre de store forskelle i lokal praksis og de uundgåelige ændringer i standardbehandlingen, foruden at det for den enkelte patient tager hensyn til de mange variable, der kan bidrage til risikoen for progression.
English: The 4 issues raised in the referral concern the analyses of the Early Prostate Cancer Programme (EPC): - the lack of an overall survival benefit versus adverse events in ‘locally advanced prostate cancer'; - statistical concerns regarding multiplicity; - the standard of care for the placebo group in the relevant studies; - the number of deaths due to cardiac failure.
Danish: I indbringelsen blev der rejst følgende fire punkter: - den manglende fordel i total overlevelse, sammenholdt med bivirkningerne, ved "lokal avanceret prostatacancer" - statistiske betænkeligheder vedrørende multiplicitet - behandlingsstandarden for placebogruppen i de pågældende undersøgelser - antallet af dødsfald som følge af hjertesvigt.
English: At that time, the RMS concluded that Casodex (bicalutamide) 150 mg should not be used in the treatment of ‘localised' prostate cancer, however, it was concluded that the benefit/risk balance remained positive for selected patients in ‘locally advanced' prostate cancer, as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Danish: RMS konkluderede dengang, at Casodex (bicalutamid) 150 mg ikke burde anvendes til behandling af "lokaliseret" prostatacancer, men at risk/benefit-forholdet stadig var positivt for udvalgte patienter med "lokalt avanceret" prostatacancer, som umiddelbar behandling enten alene eller som adjuverende behandling til radikal prostatektomi eller strålebehandling.
English: CASODEX (Bicalutamide) 150 mg was studied as a treatment for patients with localised (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer in a combined analysis of 3 placebo controlled double-blind studies in 8113 patients, where CASODEX was given as immediate hormonal therapy or as adjuvant to radical prostatectomy or radiotherapy, (primarily external beam radiation).
Danish: Casodex (bicalutamid) 150 mg blev undersøgt til behandling af patienter med lokaliseret (T1-T2, N0 eller NX, M0) eller lokalt avanceret (T3-T4, N0, NX, N+, M0; T1-T2, N+, M0) ikke-metasteret prostatacancer i en kombineret analyse af 3 placebokontrollerede studier med i alt 8113 patienter.
English: Note: This Annex III (Amendments to the Summary of Product Characteristics) is the one that was Annexed to the Commission Decision on this Article 31 referral for bicalutamide 150 mg containing medicinal products.
Danish: Bemærk: Dette bilag III (ændringer til produktresuméet) er identisk med det, der blev vedlagt Kommissionens afgørelse om den i henhold til artikel 31 indbragte sag vedrørende lægemidler indeholdende bicalutamid 150 mg. Teksten havde gyldighed på daværende tidspunkt.
English: AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Danish: ÆNDRINGER TIL PRODUKTRESUMEET
English: ET - Estonia Astrazeneca UK Ltd. Stanhope Gate 15
Danish: Astrazeneca UK Ltd. Stanhope Gate 15
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR BICALUTAMIDE 150MG CONTAINING MEDICINAL PRODUCTS
Danish: ÆNDRINGER SOM SKAL INKLUDERES I DE RELEVANTE AFSNIT AF PRODUKTRESUMEET FOR PRODUKTER SOM INDEHOLDER 150 MG BICALUTAMID
English: The requested additional analyses of the EPC trial data confirm an increased risk for deaths coded as heart failures (however, with no overall excess risk in the cardiovascular system), an increased risk of urogenital symptoms (including gynaecomastia and breast pain) mainly during the first year of intake, and further indicate the absence of an adverse effect on thromboembolic events during the follow-up (supported by a pattern of events inconsistent with hormonal effects).
Danish: De anmodede supplerende analyser af data fra EPC-undersøgelserne bekræfter, at der er øget risiko for dødsfald registreret som hjertesvigt (dog uden forhøjet total kardiovaskulær risiko) og øget risiko for urogenitale symptomer (herunder gynækomasti og smerter i brysterne), hovedsagelig i det første behandlingsår.
English: 1037 Wien
Danish: Schwarzenbergplatz 7 1037 Wien
English: - The Committee considered that bicalutamide 150 mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to treatment of patients at high risk of disease progression.
Danish: - Udvalget fandt, at bicalutamid, 150 mg, er effektivt til behandling af lokal avanceret prostatacancer, men at indikationen bør indskrænkes til patienter med høj risiko for progression af sygdommen.
English: FI - Finland Orion Corporation Orionintie 1, PO Box 65
Danish: Orion Corporation Orionintie 1, PO Box 65 02101 Espoo
English: Quinta da Beloura 2710-444 Sintra
Danish: Generis Farmacêutica, S.A. Office Park da BelouraEdifício 4 Quinta da Beloura 2710-444 Sintra
English: It seems intuitive that for good prognosis patients who have also received treatment of curative intent, the addition of bicalutamide might confer less benefit than in other patients.
Danish: Umiddelbart forekommer det indlysende, at patienter, der desuden har fået behandling med kurativt sigte, ved tillægsbehandling med bicalutamid ikke opnår så stor en forbedring af prognosen som andre patienter.
English: - The outcome of the 4th analysis of the EPC data should be provided to the RMS and the NCAs where bicalutamide 150 mg is authorised.
Danish: - Resultaterne af den fjerde analyse af EPC-data indberettes til referencemedlemsstaten og til de nationale kompetente myndigheder i de stater, hvor bicalutamid, 150 mg, er godkendt.
English: A new pharmacoepidemiological study will be undertaken as part of an agreed Risk Management Plan (RMP), a post-opinion commitment to get a better understanding of cardiovascular risk.
Danish: Der skal udføres en ny farmakopidemiologisk undersøgelse som led i en godkendt risikostyringsplan med forpligtelse til at skaffe bedre indsigt i den kardiovaskulære risiko, efter at udtalelsen er afgivet.
English: Further, the referral concerned only the locally advanced prostate cancer indication based on the Early Prostate Cancer study programme, and the directly related wording in sections 4.1 and 5.1 of the SPC.
Danish: Yderligere omfattede sagen kun indikationen lokalt avanceret prostata cancer baseret på EPC's kliniske udviklingsprogram og den direkte relaterede tekst i pkt.
English: The aim of the study is to estimate the incidence of heart failure, cardiovascular morbidity and mortality in patients with prostate cancer, compared to the general population.
Danish: Undersøgelsens formål bliver at vurdere incidensen af hjertesvigt samt den kardiovaskulære morbiditet og mortalitet hos patienter med prostatacancer i forhold til den almindelige befolkning.
English: Its authorised indications include the treatment of patients with locally advanced prostate cancer, as an immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Danish: De godkendte indikationer er lokalt avanceret prostatacancer som umiddelbar behandling enten alene eller i kombination med anden behandling eller som adjuverende behandling til radikal prostatektomi eller strålebehandling.
English: 1.09 (0.85 to 1.39)
Danish: 1.09 (0.85 til 1.39)
English: RO-Romania AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire,
Danish: AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire,
English: AT - Austria Astra Zeneca Österreich GmbH Schwarzenbergplatz 7
Danish: Astra Zeneca Österreich GmbH
English: A reduction in risk of objective disease progression was seen across most patient groups but was most evident in those at highest risk of disease progression.
Danish: Reduktionen var tydeligst hos patientgrupper med højst risiko for sygdomsprogression.
English: 0.81 (0.66 to 1.01)
Danish: 0.81 (0.66 til 1.01)
English: 0.65 (0.44 to 0.95)
Danish: 0.65 (0.44 til 0.95)
English: 20 Queen Frederiks Street, Office 301 1066 Nicosia, Cyprus
Danish: 20 Queen Frederiks Street, Office 301
English: Ingers Industrial Solutions S.R.O.
Danish: Ingers Industrial Solutions Bicaluplex
English: Further, the study should include prostate cancer subgroups to include those on bicalutamide, and those treated with LHRH analogues, orchidectomy, and other hormonal therapies.
Danish: Undersøgelsen skal desuden omfatte prostatacancer-undergrupper bestående af patienter, der behandles med bicalutamid, med GnRH-analoger, med orkiektomi eller med anden hormonbehandling.
English: 8054 Graz
Danish: Hafnerstraße 211 8054 Graz
English: Progression-free survival in locally advanced disease by therapy sub-group
Danish: Progressionsfri overlevelse ved lokal avanceret sygdom, fordelt på behandlingsundergrupper
English: Section 5.1 of the SPC was amended to note that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, might be to defer hormonal therapy until signs that the disease is progressing.
Danish: 5.1 i produktresuméet blev ændret med en bemærkning om, den optimale behandlingsstrategi for patienter med lav risiko for progression af sygdommen, navnlig i forbindelse med adjuverende behandling efter radikal prostatektomi, kan være at udskyde hormonbehandlingen, indtil der opstår tegn på progression af sygdommen.
English: 4.1 Therapeutic indications [Invented name] 150mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
Danish: 4.1 Terapeutiske indikationer [Lægemiddelnavn] 150 mg er indiceret til behandling af lokalt avanceret prostatacancer med høj risiko for sygdomsprogression, enten som umiddelbar behandling alene eller som adjuverende behandling ved radikal prostatektomi eller ved strålebehandling (se afsnit 5.1).
English: The results should be reported to the RMS and the NCAs where bicalutamide 150 mg is authorised.
Danish: Resultaterne skal indberettes til referencemedlemsstaten og til de nationale kompetente myndigheder i de stater, hvor bicalutamid, 150 mg, er godkendt.
English: Events (%) in placebo patients
Danish: Hændelser (%) hos placebo-patienter
English: 02200 Espoo
Danish: Luomanportti 3 02200 Espoo
English: The PFS results are given again below:
Danish: Resultaterne for progressionsfri overlevelse er gengivet nedenfor:
English: 600 Capability Green Luton, Bedfordshire LU1 3LU
Danish: Capability Green Luton, Bedfordshire, LU1 3LU, UK
English: 0.60 (0.49 to 0.73)
Danish: 0.60 (0.49 til 0.73)
English: 0.75 (0.61 to 0.91)
Danish: 0.75 (0.61 til 0.91)
English: Events (%) in Casodex patients
Danish: Hændelser (%) hos Casodexpatienter
English: BE - Belgium NV AstraZeneca SA Egide Van Ophemstraat 110
Danish: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussel
English: Further, the study will include prostate cancer subgroups to include those on Casodex (bicalutamide), and those treated with luteinizing hormone-releasing hormone (LHRH) analogues, orchidectomy, and other hormonal therapies.
Danish: Cancer-undergrupperne i undersøgelsen skal bestå af de patienter, der er i behandling med Casodex (bicalutamid) og dem, hvis behandling består i GnRHanaloger, orkiektomi eller anden hormonbehandling.
English: 0.56 (0.40 to 0.78)
Danish: 0.56 (0.40 til 0.78)
English: At the initial authorisation of the early prostate cancer indication, the data for overall survival were too immature to allow an analysis, however it makes sense to subsequently analyse this endpoint in the same subgroups, and there are favourable trends in overall survival for patients with locally advanced disease receiving Casodex (bicalutamide) alone, and for patients also receiving radiotherapy.
Danish: Ved den oprindelige godkendelse af indikationen prostatacancer i tidligt stadium var data vedrørende total overlevelse for præliminære til at kunne analyseres, men det giver mening efterfølgende at analysere dette endepunkt i de samme undergrupper.
English: Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.
Danish: Klinikerne kan derfor skønne, at den optimale behandlingsstrategi for patienter med lav risiko for progression af sygdommen, navnlig i forbindelse med adjuverende behandling efter radikal prostatektomi, kan være at udskyde hormonbehandlingen, indtil der opstår tegn på progression af sygdommen."
English: GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS Whereas
Danish: BEGRUNDELSE FOR ÆNDRINGEN AF PRODUKTRESUMÉET
English: EL - Greece Astrazeneca SA 4 Theotocopoulou & Astronauton 151 25 Marousi-Athens
Danish: EL - Grækenland Astrazeneca SA 4 Theotocopoulou & Astronauton
English: Deaths (%) in placebo patients
Danish: Døde (%) placebopatienter
English: SE-151 85 Södertälje
Danish: AstraZeneca AB Västra Mälarehamnen 9 SE-151 85 Södertälje
English: EL - Greece Alvia SA 18th klm Athens-Marathon Ave 153 44 Pallini Attiki
Danish: EL - Grækenland Alvia SA 18th klm Athens-Marathon Ave
English: 15 Stanhope Gate London, W1K 1LN United Kingdom
Danish: AstraZeneca UK Limited 15 Stanhope Gate London, W1K 1LN United Kingdom
English: Albert-Schweitzer Gasse 3
Danish: Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3 1140 Wien
English: It is difficult to obtain overall survival data in patients with early prostate cancer due to its insidious course.
Danish: Sygdommens snigende forløb gør det vanskeligt at skaffe data for total overlevelse af patienter med prostatacancer i tidligt stadium.
English: FI - Finland Ratiopharm GmbH Graf-Arco-Strasse 3
Danish: Ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: With reference to the adequacy of treatment in the placebo group in the EPC studies, given that at the time of initiation of these studies there was no widely agreed standard of care in locally advanced prostate cancer (something which remains the case), the empirical design of the studies, which compared Casodex (bicalutamide) 150mg or placebo when given as an adjunct to “standard care” is considered reasonable.
Danish: Hvad angår tilstrækkeligheden af behandlingen i placebogruppen i EPC-undersøgelserne fandtes der ved påbegyndelse af undersøgelserne ingen bredt anerkendt standardbehandling ved lokal avanceret prostatacancer (hvilket stadig ikke er tilfældet).
English: Venda Nova 2700-487 Amadora
Danish: Farma-APS, Produtos Farmacêuticos, S.A. Rua João de Deus, 19 Venda Nova 2700-487 Amadora
English: FI - Finland Tad Pharma GmbH Heinz-Lohmann-Strasse 5
Danish: Tad Pharma GmbH Heinz-Lohmann-Strasse 5 27472 Cuxhaven, Germany
English: Benefit is generally a function of risk progression and in patients with locally advanced disease; benefit is reduced after surgery or in cases where radiotherapy is likely to be curative.
Danish: Hos patienter med lokalt avanceret sygdom er fordelen mindre efter operation og når strålebehandlingen kan forventes at være kurativ.
English: - The CHMP concluded that the benefit/risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.
Danish: - Udvalget konkluderede, at benefit/risk-forholdet for lægemidler indeholdende bicalutamid, 150 mg, til den godkendte indskrænkede indikation er gunstigt anbefalede CHMP opretholdelse af markedsføringstilladelserne for alle de produkter og udstedelse af markedsføringstilladelse for alle de ansøgninger, der er refereret til i bilag I til udtalelsen.
English: 20 Queen Frederiks Street, Office 301 1066 Nicosia, Cyprus FI - Finland Peseri Trading Limited El Greco House
Danish: Peseri Trading Limited El Greco House 20 Queen Frederiks Street, Office 301
English: In view of this, the benefit-risk profile for the use of CASODEX is not considered favourable in this group of patients.
Danish: Af den årsag er det ikke favorabelt at anvende Casodex til patienter med lokaliseret prostatacancer.
English: BG - Bulgaria AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire, LU1 3LU, UK
Danish: AstraZeneca UK Limited Horizon Place 600 Capability Green Luton, Bedfordshire LU1 3LU
English: As a consequence, the CHMP has recommended to maintain the Marketing Authorisations for all medicinal products and to grant Marketing Authorisations for all applications referred to in Annex I of the Opinion in accordance with the amendments to the relevant sections of the Summary of Product Characteristics, set out in Annex III of the Opinion.
Danish: De skal være i overensstemmelse med ændringerne af de pågældende afsnit af produktresuméet, som fremgår af bilag III til udtalelsen.
English: SK - Slovakia AstraZeneca UK Limited Silk Road Business Park Macclesfield
Danish: AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA
English: Other aspects of the SPC and the other indication for bicalutamide 150 mg, which is approved in some EU member states, were not within the scope of the referral.
Danish: Sagen omfattede hverken øvrige dele af produktresuméet eller øvrige godkendte indikationer for bicalutamid 150 mg.
English: Bicalutamid CTArzneimittel
Danish: Bicalutamid "Genericon"
English: Germany
Danish: Medlemsstat
English: The SPC has been amended accordingly and notes in section 5.1 that, for patients with locally advanced disease “A reduction in risk of objective disease progression… was most evident in those at highest risk of disease progression.
Danish: 5.1, at for patienter med lokalt avanceret sygdom "var der en signifikant fordel for de patienter, som havde lokalt avanceret cancer prostatae.
English: Overall survival in locally advanced disease by therapy sub-group Analysis population Deaths (%) in CASODEX patients
Danish: Analysepopulation Døde (%) Casodexpatienter
English: Bicalutamida Prostec 150 mg
Danish: Bicalutamid CT-Arzneimittel 150 mg
English: 112 (4 x 28) tablets (multipack)
Danish: 112 (4 x 28) tabletter (multipakning)
English: Invented name Strength Pharmaceutical Form
Danish: Særnavn Styrke Lægemiddelform Administration
English: Solution for injection Subcutaneous use Pre-filled syringe (glass) with on body-injector (Onpro kit)
Danish: Subkutan anvendelse Fyldt injektionssprøjte (glas) med on-body-injektor (Onpro-kit)
English: Solution for injection Subcutaneous use pre-filled syringe (glass) without blister
Danish: Subkutan anvendelse Fyldt injektionssprøjte (glas) uden blisterpakning
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe + on body injector (Onpro kit)
Danish: 1 fyldt injektionssprøjte + on-body-injektor (Onprokit)
English: Solution for injection Subcutaneous use pre-filled syringe (glass) with needle guard
Danish: Subkutan anvendelse Fyldt injektionssprøjte (glas) med kanylebeskyttelse
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe with needle guard
Danish: Subkutan anvendelse Fyldt injektionssprøjte (glas) 0,6 ml (10 mg/ml)
English: 1 bottle + 1 dosing syringe + 1 adapter
Danish: 1 flaske + 1 doseringssprøjte + 1 adaptor
English: Blister (PVC/alu foil)
Danish: Oral anvendelse Blisterpakning (PVC/alu)
English: Film-coated tablet
Danish: 300 mg Filmovertrukne tabletter
English: 20mg/mL Oral solution Oral use
Danish: 20 mg/ml
English: Bottle (HDPE)
Danish: Oral opløsning Oral anvendelse Flaske (HDPE)
English: Immediate Packaging
Danish: Styrke Lægemiddelform Administration Emballage Indhold Pakningsstørrelse
English: This will make it easier for you to do more activities.
Danish: Dette gør det nemmere for Dem at foretage flere aktiviteter.
English: • At the request of the European Medicines Agency.
Danish: • Efter anmodning fra det Europæiske Lægemiddelagentur.
English: Steady state in volunteers is reached within about 6 days.
Danish: Steady state hos frivillige nås inden for cirka 6 dage.
English: In all cases, INR should be monitored on a regular schedule.
Danish: INR skal i alle tilfælde monitoreres regelmæssigt.
English: (16%)) was improved after 12 weeks of treatment.
Danish: (16%)) blev forbedret efter 12 ugers behandling.
English: The advice of a hepatologist is recommended.
Danish: Rådgivning fra en hepatolog anbefales.
English: below);
Danish: nedenfor);
English: It may be taken with or without food and without regard to the time of day.
Danish: Den kan tages med eller uden mad uden hensyntagen til tidspunktet på dagen.
English: A NOAEL has not been established.
Danish: En NOAEL er ikke blevet fastlagt.
English: Do not take more than one tablet each day.
Danish: Tag ikke mere end én tablet om dagen.
English: • If you are a child or adolescent under 18 years old.
Danish: • Hvis De er barn eller ung under 18 år.
English: • If you have or have had a serious liver problem;
Danish: • Hvis De har eller har haft et alvorligt leverproblem.
English: It is important to have these tests every month during treatment, even if you do not have any symptoms at all.
Danish: Det er vigtigt, at disse prøver tages hver måned under behandlingen, selvom De ikke har symptomer.