FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition to the ADRs described in tables 4 and 5, the following ADRs with an incidence of less than 0.1 % were associated with the use of capecitabine monotherapy based on a pooled analysis from clinical safety data from 7 clinical trials including 949 patients (2 phase III and 5 phase II clinical trials in metastatic colorectal cancer and metastatic breast cancer): cardiomyopathy, cardiac failure, sudden death, and ventricular extrasystoles.
Danish: Bivirkningerne er baseret på en samlet analyse af kliniske sikkerhedsdata fra 7 kliniske studier med 949 patienter (2 fase III- og 5 fase II-kliniske studier i metastatisk kolorektalkræft og metastatisk brystkræft) og omfatter: kardiomyopati, hjerteinsufficiens, dødsfald og ventrikulære ekstrasystoler.
English: P = 0.30
Danish: 12,1 måneder p = 0,30
English: Alopecia, Nail disorder Hyperhidrosis, Rash subcutaneous tissue disorders erythematous, Urticaria, Night sweats
Danish: Hyperhidrose, Erytematøst udslæt, Urticaria, Nattesved
English: Combination treatment consisted of first-line capecitabine (1,000 mg/m² twice daily for 14 days) combined with irinotecan (250 mg/m² on day 1) (XELIRI) and second-line capecitabine (1,000 mg/m² twice daily for 14 days) plus oxaliplatin
Danish: Kombinationsbehandlingen bestod af 1. linjebehandling med capecitabin (1.000 mg/m² to gange daglig i 14 dage) kombineret med irinotecan (250 mg/m² på dag 1) (XELIRI) og 2. linjebehandling med capecitabin (1.000 mg/m² to gange dagligt i 14 dage) plus oxaliplatin (130 mg/m² på dag 1).
English: Hiccups,
Danish: Alopeci,
English: • if you have calcium imbalances (seen in blood tests),
Danish: • hvis du har forstyrrelser i kalkstofskiftet (måles vha. blodprøver)
English: supports these results with a HR of 0.78 (95 % CI = [0.67; 0.92]; p = 0.0024) for XELOX vs. 5-FU/LV.
Danish: Analysen for det sekundære endepunkt, relapsfri overlevelse, støtter dissse resultater med en hazard ratio på 0,78 (95 % konfidensinterval = [0,67; 0,92], p = 0,0024) for XELOX versus 5-FU/LV.
English: Capecitabine and its metabolites are predominantly excreted in urine; 95.5 % of administered capecitabine dose is recovered in urine.
Danish: 95,5 % af den indgivne capecitabindosis genfandtes i urinen.
English: You must not breast-feed if you are taking Capecitabine medac and for 2 weeks after the last dose.
Danish: Du må ikke tage Capecitabine medac, hvis du er gravid eller tror, du er det. Du må ikke amme, hvis du tager Capecitabine medac og i 2 uger efter sidste dosis.
English: Premedication with antiemetics according to the oxaliplatin summary of product characteristics is recommended for patients receiving the capecitabine plus oxaliplatin combination.Adjuvant treatment in patients with stage III colon cancer is recommended for a duration of 6 months.
Danish: Præmedicinering med antiemetika i overensstemmelse med produktresumeet for oxaliplatin anbefales til patienter, som får kombinationen af capecitabin og oxaliplatin.
English: • medicines used to treat folic acid deficiency
Danish: • lægemidler til behandling af folsyremangel
English: Oedema, Chills, Influenza-like illness, Rigors, Body temperature increased
Danish: Kuldegysninger, Influenzalignende symptomer, Kulderystelser, Øget kropstemperatur
English: -2nd appearance -3rd appearance
Danish: - ved 2. forekomst - ved 3. forekomst
English: • rash, dry or itchy skin
Danish: • udslæt, tør eller kløende hud
English: Sore throat, Dysaesthesia pharynx
Danish: Ondt i halsen, Pharynxdysæstesi
English: The film-coated tablets are white to off white, oblong shaped, biconvex tablets of 14.6 mm in length and 6.7 mm in width, debossed with ‘300' on one side and plain on other side.
Danish: Capecitabine medac 300 mg filmovertrukne tabletter De filmovertrukne tabletter er hvide til off-white, aflange, bikonvekse tabletter, 14,6 mm lange og 6,7 mm brede, præget med ”300” på den ene side og jævne på den anden side.
English: Combination therapy with capecitabine and docetaxel in locally advanced or metastatic breast cancer Data from one multicentre, randomised, controlled phase III clinical trial support the use of capecitabine in combination with docetaxel for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Danish: Data fra et randomiseret, kontrolleret, klinisk fase III-multicenterstudie støtter anvendelsen af capecitabin i kombination med docetaxel til behandling af patienter med lokalt fremskreden eller metastatisk brystkræft, hos hvem cytotoksisk kemoterapi, inklusive et antracyklin, har svigtet.
English: 604 patients were randomised to treatment with 5-FU and leucovorin (Mayo regimen: 20 mg/m² leucovorin intravenous followed by 425 mg/m² intravenous bolus 5-FU, on days 1 to 5, every 28 days).
Danish: 20 mg/m² leucovirin intravenøst efterfulgt af en 5-FU bolus på 425 mg/m² intravenøst på dag 1 til 5, hver 28. dag).
English: LIST OF EXCIPIENTS Also contains anhydrous lactose and sodium, read the package leaflet before use.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også vandfri lactose og natrium.
English: Lacrimation increased Visual disorders, Dry eye, Eye pain, Visual impairment, Vision blurred
Danish: Øget tåresekretion Synsforstyrrelser, Tørre øjne, Øjensmerter,
English: Capecitabine medac 150 mg film-coated tablets Hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc
Danish: Capecitabine medac 150 mg filmovertrukne tabletter Hypromellose (E464), titandioxid (E 171), gul jernoxid (E172), rød jernoxid (E 172), talkum.
English: Hyperbilirubinaemia, Liver function test abnormalities
Danish: Hyperbilirubinæmi, Unormal leverfunktionstest
English: INFORMATION IN BRAILLE Capecitabine medac 300 mg
Danish: INFORMATION I BRAILLESKRIFT Capecitabine medac 300 mg
English: • swelling (oedema), chills and rigors
Danish: • hævelse (ødem), kulderystelser og stivhed
English: Table 1 Standard and reduced dose calculations according to body surface area for a starting dose of capecitabine of 1,250 mg/m².
Danish: Tabel 1 Standard og reducerede dosisberegninger ud fra legemsoverfladeareal for en initialdosis af capecitabin på 1.250 mg/m² Dosisniveau på 1.250 mg/m² (to gange dagligt)
English: The film-coated tablets are peach coloured, oblong shaped, biconvex tablets of 15.9 mm in length and 8.4 mm in width, debossed with ‘500' on one side and plain on other side.
Danish: Capecitabine medac 500 mg filmovertrukne tabletter De filmovertrukne tabletter er ferskenfarvede, aflange, bikonvekse tabletter, 15,9 mm lange og 8,4 mm brede, præget med ”500” på den ene side og jævne på den anden side.
English: Dose modifications for toxicity when capecitabine is used as a 3-weekly cycle in combination with other medicinal products should be made according to table 3 above for capecitabine and according to the appropriate summary of product characteristics for the other medicinal product(s).
Danish: Når capecitabin anvendes i en tre ugers-serie i kombination med andre lægemidler, skal dosisændring foretages i henhold til tabel 3 ovenfor for capecitabin og efter det pågældende produktresumé for det andet lægemiddel/de andre lægemidler.
English: Excipients
Danish: Encephalopati
English: Musculoskeletal
Danish: • muskelspasmer
English: INFORMATION IN BRAILLE Capecitabine medac 150 mg
Danish: INFORMATION I BRAILLESKRIFT Capecitabine medac 150 mg
English: INFORMATION IN BRAILLE Capecitabine medac 500 mg
Danish: INFORMATION I BRAILLESKRIFT Capecitabine medac 500 mg
English: The film-coated tablets are light peach coloured, oblong shaped, biconvex tablets of 11.4 mm in length and 5.3 mm in width, debossed with ‘150' on one side and plain on other side.
Danish: Capecitabine medac 150 mg filmovertrukne tabletter De filmovertrukne tabletter er lys ferskenfarvede, aflange, bikonvekse tabletter, 11,4 mm lange og 5,3 mm brede, præget med ”150” på den ene side og jævne på den anden side.
English: How to take Capecitabine medac
Danish: Sådan skal du tage Capecitabine medac
English: • Recent or concomitant treatment with brivudine (see section 4.4 and 4.5 for drug drug interaction),
Danish: • Nylig eller samtidig behandling med brivudin (se pkt.
English: Capecitabine medac 300 mg film-coated tablets Hypromellose (E464)
Danish: Capecitabine medac 300 mg filmovertrukne tabletter Hypromellose (E464)
English: Capecitabine medac 150 mg film-coated tablets Hypromellose (E464)
Danish: Capecitabine medac 150 mg filmovertrukne tabletter Hypromellose (E464)
English: Capecitabine medac 500 mg film-coated tablets Hypromellose (E464)
Danish: Capecitabine medac 500 mg filmovertrukne tabletter Hypromellose (E464)
English: Median PFS and overall survival (OS) times were shorter for XELIRI versus FOLFIRI (PFS 5.9 versus 9.6 months and OS 14.8 versus 19.9 months), in addition to which excessive rates of diarrhoea were reported in patients receiving the XELIRI regimen (41 % XELIRI, 5.1 % FOLFIRI).
Danish: Den mediane progressionsfri overlevelse og samlede overlevelse var kortere for XELIRI versus FOLFIRI (progressionsfri overlevelse 5,9 måneder versus 9,6 måneder og samlet overlevelse 14,8 versus 19,9 måneder).
English: Capecitabine medac 300 mg film-coated tablets Each film-coated tablet contains 300 mg capecitabine.
Danish: Capecitabine medac 300 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder 300 mg capecitabin.
English: A significant reduction in the risk of progression was associated with FOLFIRI (HR, 0.76; 95 % CI, 0.62-0.95; P < 0.01), a result partly due to poor tolerance to the XELIRI regimens used.
Danish: FOLFIRI blev associeret med en signifikant reduktion i risikoen for progression (hazard ratio = 0,76; 95 % konfidensinterval 0,62 - 0,95; p < 0,01).
English: Body system Very common
Danish: Meget almindelig
English: cisplatin, irinotecan)
Danish: irinotecan)
English: Capecitabine medac 300 mg film-coated tablets Hypromellose (E464), titanium dioxide (E171), talc Capecitabine medac 500 mg film-coated tablets Hypromellose (E464), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), talc
Danish: Capecitabine medac 500 mg filmovertrukne tabletter Hypromellose (E464), titandioxid (E 171), gul jernoxid (E172), rød jernoxid (E 172), talkum.
English: Capecitabine medac 500 mg film-coated tablets Each film-coated tablet contains 500 mg capecitabine.
Danish: Capecitabine medac 500 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder 500 mg capecitabin.
English: Skin and
Danish: Tør hud,
English: The hazard ratio for overall survival was 0.94 (95 % CI: 0.89; 1.00, p = 0.0489) indicating that capecitabine-containing regimens are non-inferior to 5-FU-containing regimens.
Danish: Hazard ratio for samlet overlevelse var 0,94 (95 % konfidensinterval: 0,89, 1,00; p = 0,0489).
English: Deficiency of DPD may lead to increased toxicity of capecitabine (see section 4.3 and 4.4).
Danish: DPD-aktiviteten er det hastighedsbestemmende trin. DPD-deficit kan medføre øget toksicitet af capecitabin (se pkt.
English: The median follow up at the time of the primary analyses in the intentto-treat population was 2.1 years; data from analyses following an additional 6 months of follow up are also included in table 9.
Danish: Data fra analyser efter yderligere 6 måneders followup fremgår også af tabel 9.
English: In this trial, 944 patients were randomised to 3-week cycles for 24 weeks with capecitabine (1,000 mg/m² twice daily for 2 weeks followed by a 1-week rest period) in combination with oxaliplatin (130 mg/m² intravenous infusion over 2 hours on day 1 every 3 weeks); 942 patients were randomised to bolus 5-FU and leucovorin.
Danish: I dette studie blev 944 patienter randomiseret til 3-ugers-cykler i 24 uger med capecitabin (1.000 mg/m² to gange dagligt i 2 uger, efterfulgt af én uges pause) i kombination med oxaliplatin (130 mg/m² intravenøs infusion over 2 timer på dag 1 hver 3. uge).
English: - EOF: epirubicin (50 mg/m² as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m² given as a 2 hour infusion on day 1 every three weeks), and 5-FU (200 mg/m² daily given by continuous infusion via a central line).
Danish: - EOF: epirubicin (50 mg/m² som bolus på dag 1 hver 3. uge), oxaliplatin (130 mg/m² som en totimers infusion på dag 1 hver 3. uge) og 5-FU (200 mg/m² dagligt givet som kontinuerlig infusion via en central linje).
English: - ECX: epirubicin (50 mg/m² as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m² as a two hour infusion on day 1 every 3 weeks), and capecitabine (625 mg/m² twice daily continuously).
Danish: - ECX: epirubicin (50 mg/m² som bolus på dag 1 hver 3. uge), cisplatin (60 mg/m² som en totimers infusion på dag 1 hver 3. uge) og capecitabin (625 mg/m² to gange dagligt givet kontinuerligt).
English: Data from two multicentre phase II clinical trials support the use of capecitabine monotherapy for treatment of patients after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
Danish: Monoterapi med capecitabin efter svigt af taxoider og kemoterapi, som indeholder antracykliner, og af patienter, til hvem behandling med antracykliner ikke er indiceret Data fra to kliniske multicenterstudier i fase II støtter anvendelsen af capecitabin-monoterapi hos patienter, hos hvem taxoider og et antracyklinindeholdende kemoterapiregime har svigtet, eller hos hvem yderligere antracyklinbehandling ikke er indiceret.
English: • if you have liver or kidney diseases,
Danish: • hvis du har lever- eller nyrelidelser
English: - EOX: epirubicin (50 mg/m² as a bolus on day 1 every 3 weeks), oxaliplatin (130 mg/m² given as a 2 hour infusion on day 1 every three weeks), and capecitabine (625 mg/m² twice daily continuously).
Danish: - EOX: epirubicin (50 mg/m² som bolus på dag 1 hver 3. uge), oxaliplatin (130 mg/m² som en totimers infusion på dag 1 hver 3. uge) og capecitabin (625 mg/m² to gange dagligt givet kontinuerligt).
English: Capecitabine medac 300 mg film-coated tablets Each film-coated tablet contains 15 mg anhydrous lactose.
Danish: Capecitabine medac 300 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder 15 mg vandfri lactose.
English: - ECF: epirubicin (50 mg/ m² as a bolus on day 1 every 3 weeks), cisplatin (60 mg/m² as a two hour infusion on day 1 every 3 weeks) and 5-FU (200 mg/m² daily given by continuous infusion via a central line).
Danish: - ECF: epirubicin (50 mg/m² som bolus på dag 1 hver 3. uge), cisplatin (60 mg/m² som en totimers infusion på dag 1 hver 3. uge) og 5-FU (200 mg/m² dagligt givet som kontinuerlig infusion via et centralt venekateter).
English: Capecitabine medac 500 mg film-coated tablets Each film-coated tablet contains 25 mg anhydrous lactose.
Danish: Capecitabine medac 500 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder 25 mg vandfri lactose.
English: Table 9 Key efficacy results for the non-inferiority analysis of study NO16967 PRIMARY ANALYSIS
Danish: Tabel 9 Nøgleresultater fra non-inferioritetsanalyserne af studie NO16967 PRIMÆRE ANALYSE XELOX (PPP*: N = 251; ITT**: N = 313)
English: White to off-white, oblong shaped, biconvex tablet, debossed with ‘300' on the one side and plain on the other side.
Danish: Capecitabine medac 300 mg filmovertrukne tabletter Hvid til off-white, aflang, bikonveks tablet, præget med ”300” på den ene side og jævn på den anden side.
English: painless swelling or erythema of the hands and/or feet and/or discomfort which does not disrupt the patient's normal activities.
Danish: Grad 1 HFS defineres som følelsesløshed, dysæstesi/paræstesi, prikken, hævelse eller erytem uden smerter af hænderne og/eller fødderne og/eller ubehag, der ikke påvirker patienternes daglige aktiviteter.
English: Peach coloured, oblong shaped, biconvex tablet, debossed with ‘500' on the one side and plain on the other side.
Danish: Capecitabine medac 500 mg filmovertrukne tabletter Ferskenfarvet, aflang, bikonveks tablet, præget med ”500” på den ene side og jævn på den anden side.
English: Light peach coloured, oblong shaped, biconvex tablet, debossed with ‘150' on the one side and plain on the other side.
Danish: Capecitabine medac 150 mg filmovertrukne tabletter Lys ferskenfarvet, aflang, bikonveks tablet, præget med ”150” på den ene side og jævn på den anden side.
English: Capecitabine medac 150 mg film-coated tablets Each film-coated tablet contains 150 mg capecitabine.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Capecitabine medac 150 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder 150 mg capecitabin.
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 150 mg film-coated tablets capecitabine
Danish: LÆGEMIDLETS NAVN Capecitabine medac 150 mg filmovertrukne tabletter capecitabin
English: +Infection, Oral herpes
Danish: Herpes viral infektion,
English: heartburn (reflux of food from the stomach), blood in the stool
Danish: smerter i den nedre del af maven, utilpashed i maven, halsbrand (maveindhold, der vender tilbage til spiserøret), blod i afføringen
English: A reduction of the starting dose in these patients may be considered to avoid serious toxicity.There is insufficient data to recommend a specific dose in patients with partial DPD activity as measured by specific test.
Danish: Det kan overvejes at reducere startdosis hos disse patienter, for at undgå alvorlig toksicitet.
English: HFS (see section 4.4)
Danish: HFS (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 300 mg film-coated tablets capecitabine
Danish: LÆGEMIDLETS NAVN Capecitabine medac 300 mg filmovertrukne tabletter capecitabin
English: NAME OF THE MEDICINAL PRODUCT Capecitabine medac 500 mg film-coated tablets capecitabine
Danish: LÆGEMIDLETS NAVN Capecitabine medac 500 mg filmovertrukne tabletter capecitabin
English: Capecitabine medac 150 mg film-coated tablets
Danish: Capecitabine medac 150 mg tabletter capecitabin
English: There are no side effects caused by stopping treatment with capecitabine.
Danish: Hvis du holder op med at tage Capecitabine medac Der er ingen bivirkninger forbundet med at stoppe behandlingen med capecitabin.
English: Capecitabine medac 300 mg film-coated tablets
Danish: Capecitabine medac 300 mg tabletter capecitabin
English: Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Capecitabine medac Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin, eller har gjort det for nylig.
English: Capecitabine medac 500 mg film-coated tablets
Danish: Capecitabine medac 500 mg tabletter capecitabin
English: Aphasia, Memory impairment, Ataxia, Syncope, Balance disorder, Sensory disorder, Neuropathy peripheral
Danish: Balanceforstyrrelser, Føleforstyrrelser, Perifer neuropati
English: • muscle spasm
Danish: Vandfri lactose
English: Back pain, Arthralgia pain, Facial pain, Musculoskeletal stiffness, Muscular weakness
Danish: Hævelse af led, Knoglesmerter, Ansigtssmerter, Muskuloskeletal stivhed,
English: • bowel obstruction, collection of fluid in the abdomen, inflammation of the small or large intestine, the stomach or the oesophagus, pain in the lower abdomen, abdominal discomfort,
Danish: • tarmobstruktion, ophobning af væske i maven, betændelse i tarmene, maven eller spiserøret,
English: • narrowing or blockage of tear duct (lacrimal duct stenosis)
Danish: • forsnævring eller tilstopning af tårekanalerne
English: • vertigo, ear pain
Danish: • følelse af at snurre rundt (vertigo), øresmerter
English: Capecitabine medac 150 mg film-coated tablets Each film-coated tablet contains 7 mg anhydrous lactose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på Capecitabine medac 150 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder 7 mg vandfri lactose.
English: Gastroesophageal reflux disease, Oral pain,
Danish: Esophagitis, Abdominalt ubehag, Gastroøsofageal reflux,
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Capecitabine medac indeholder lactose, vandfri Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Hypocalcaemia,
Danish: Dysfagi,
English: Appetite decreased Hypokalaemia, Hyponatraemia,
Danish: Hypokaliæmi, Hyponatriæmi, Hypomagnesiæmi, Hypokalcæmi, Hyperglycæmi
English: 600 mg/ m² intravenous 22 hr
Danish: 600 mg/m² i.v.
English: Half-life is approximately 30 minutes.
Danish: Halveringstiden er ca. 30 minutter.
English: This is recommended to be performed every 6 months.
Danish: Det anbefales, at dette gøres hver sjette måned.
English: Final report: 6 years after approval.
Danish: Endelig rapport: 6 år efter godkendelse.
English: Draft protocol to be submitted 2 months after notification of the European Commission decision
Danish: Protokoludkast forelægges 2 måneder efter underretning om Europa-Kommissionens beslutning
English: • The importance of maintaining aseptic conditions.
Danish: • vigtigheden af opretholdelse af aseptiske betingelser,
English: Tel: +353 768 888 035 mail@clinuvel.com
Danish: Tlf: +353 768 888 035 mail@clinuvel.com
English: The following side effects are considered to be:
Danish: Følgende bivirkninger anses for at være:
English: Talk to your doctor before receiving SCENESSE if you are over 70 years of age.
Danish: Kontakt lægen, før du får SCENESSE, hvis du er over 70 år.
English: • The importance of recruiting and entering patients in the EU Registry,
Danish: • vigtigheden af at rekruttere og indføre patienterne i EU-registeret,
English: • How to access and use the EU Registry.
Danish: • hvordan man får adgang til EU-registeret og anvender det.
English: The registry should collect data from both patients and physicians.
Danish: Registeret skal omfatte data fra både patienter og læger.
English: This effect was observed only at exposure levels approximately 8 times higher than human exposure.
Danish: Denne virkning iagttoges kun ved et eksponeringsniveau på ca. 8 gange den humane eksponering.
English: A referral to a dermatology specialist might be necessary.
Danish: Henvisning til en hudspecialist kan være nødvendig.
English: Do not use SCENESSE
Danish: Brug ikke SCENESSE
English: The safety and efficacy of afamelanotide in children and adolescents aged 0 to 17 years have not yet been established.
Danish: Afamelanotids sikkerhed og virkning hos børn og unge fra 0 til 17 år er endnu ikke klarlagt.
English: • Educational video,
Danish: • uddannelsesvideo,
English: The safety profile is based on pooled data from clinical studies in 425 patients.
Danish: Sikkerhedsprofilen er baseret på poolede data fra kliniske undersøgelser hos 425 patienter.
English: SCENESSE is administered subcutaneously under aseptic conditions as described below.
Danish: SCENESSE administreres subkutant under aseptiske betingelser som beskrevet nedenfor.
English: This medicine should not be given to children and adolescents under 18 years of age because it has not been tested in this age group.
Danish: Dette lægemiddel må ikke anvendes hos børn og unge under 18 år, da det ikke er afprøvet hos denne aldersgruppe
English: One implant is injected every 2 months during the spring and summer months.
Danish: Der gives et implantat hver anden måned i forårs- og sommermånederne.
English: Date of latest renewal: 19 November 2019
Danish: Dato for første markedsføringstilladelse: 22 december 2014 Dato for seneste fornyelse: 19 november 2019
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data)
Danish: Hyppighed inddeles på følgende måde: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1 000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Intermediate reports: annual submission.
Danish: Interimsrapporter: forelægges årligt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/969/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/14/969/001