FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the short duration of action of TOOKAD means that the risk of enhanced phototoxicity is expected to be low provided the precautions against light exposure are stricly followed.
Danish: indgiften er kort, forventes risikoen for forstærket fototoksicitet imidlertid at være lav, forudsat at duoverholder forsigtighedsreglerne med hensyn til lyseksponering til punkt og prikke.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til injektionsvæske, opløsning
English: Photosensitisers
Danish: Lysfølsomhed
English: In healthy human male subjects, the Cmax was shown to be linear from 1.25 mg/kg to 15 mg/kg of padeliporfin di-potassium, covering the therapeutic range.
Danish: Hos raske mænd fremgik det, at Cmax var lineær fra 1,25-15,0 mg/kg padeliporfindikalium henover det terapeutiske interval.
English: Table 5: PCM301 - Effect on urinary morbidity (IPSS) - ITT population and patients meeting the indication criteria
Danish: Tabel 5: PCM301 - Effekt på urinvejsmorbiditet (IPSS) - ITT-population og patienter, der opfylder indikationskriterierne
English: You may need to stay overnight if you have not fully recovered from the general anaesthetic and depending on your condition.
Danish: Alt efter din tilstand, hvis du f.eks. ikke er kommet dig helt over bedøvelsen, kan det være, at du skal blive natten over.
English: Haematoma Hypertension
Danish: Hæmatom Hypertension
English: Tumour localisation
Danish: Tumorlokalisering
English: Each vial of TOOKAD 366 mg contains 366 mg of padeliporfin (as potassium salt).
Danish: Hvert hætteglas TOOKAD 366 mg indeholder 366 mg padeliporfin (som kaliumsalt).
English: Table 4: PCM301 - Number of subjects with radical treatment at 24 months - ITT population and patients meeting the indication criteria
Danish: Tabel 4: PCM301 - Antal forsøgspersoner, der har fået radikal behandling efter 24 månederITT-populationen og patienter, der opfylder indikationskriterierne Karakteristika
English: Table 3: PCM301 - Co-primary efficacy endpoints - Whole prostate gland and treated lobe(s)* - ITT population and patients meeting the indication criteria
Danish: Tabel 3: PCM301 - Co-primære effektmål - Hele prostata og behandlet lap/behandlede lapper* - ITT-population og patienter, der opfylder indikationskriterierne
English: No patients with photosensitive dermatitis, skin conditions such as porphyria or a history of sensitivity to sunlight have received TOOKAD in clinical studies.
Danish: I de kliniske undersøgelser var der ingen patienter med lysfølsom dermatitis, hudlidelser som f.eks. porfyri eller tidligere følsomhed over for sollys, som fik TOOKAD-behandling.
English: Libido decreased Affective disorder Encopresis
Danish: Ikke almindelig Nedsat libido Emotionelle forstyrrelser Enkoprese
English: Each carton of TOOKAD 366 mg powder for solution for injection contains an amber glass vial with a white cap.
Danish: Hver æske med TOOKAD 366 mg pulver til injektionsvæske, opløsning, indeholder et ravgult hætteglas med en hvid hætte.
English: Dysuria (bladder pain, bladder spasm, hypertonic bladder, urethral spasm, urinary tract pain).
Danish: 6 Dysuri (smerter i blæren, blærespasmer, hypertonisk blære, uretraspasmer, smerter i urinvejene).
English: Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD.
Danish: Antikoagulantia og trombocythæmmende midler (f.eks. acetylsalicylsyre) bør seponeres mindst 10 dage før TOOKAD-proceduren.
English: Although they were excluded from the clinical trials, there is a potential risk of increased stenosis post the TOOKAD-VTP procedure in patients with pre-existing stenosis (see section 4.8).
Danish: Selvom patienter med eksisterende stenose ikke indgik i de kliniske undersøgelser, vurderes det, at der er en potentiel risiko for stenose efter TOOKAD-VTP-proceduren hos sådanne patienter (se pkt.
English: Each carton of TOOKAD 183 mg powder for solution for injection contains an amber glass vial with a blue cap.
Danish: Hver æske med TOOKAD 183 mg pulver til injektionsvæske, opløsning, indeholder et ravgult hætteglas med en blå hætte.
English: Prostatitis Genital pain Prostatic pain
Danish: Prostatitis Smerter i kønsdelene11
English: In a patient treated at 2 mg/kg of TOOKAD, one case of Grade 3 ischaemic optic neuropathy was reported 33 days after the VTP procedure.
Danish: Der er rapporteret om ét tilfælde af iskæmisk optisk grad 3-neuropati 33 dage efter VTP-proceduren hos en patient behandlet med TOOKAD i en dosis på 2 mg/kg.
English: TOOKAD-VTP arm
Danish: TOOKAD-VTPgruppe
English: Table 2: PCM301 - Baseline characteristics by arm for the Intention-To-Treat (ITT) population and patients meeting the indication criteria
Danish: Tabel 2: PCM301 - Baseline-karakteristika pr. gruppe for ITT-populationen (Intention-ToTreat) og patienter, der opfylder indikationskriterierne
English: Each vial of TOOKAD 183 mg contains 183 mg of padeliporfin (as potassium salt).
Danish: Hvert hætteglas TOOKAD 183 mg indeholder 183 mg padeliporfin (som kaliumsalt).
English: - General and musculoskeletal pain (muscle/bony pain, pain in the end of the limbs, back pain or bleeding into the joints), - Haematospermia (presence of blood in the ejaculate), - High blood pressure, - Increases in blood lipids, lactate dehydrogenase increased, white blood cell increased, creatine phosphokinase increased, potassium decreased, prostatic specific antigen (PSA) increased, - Skin reaction, erythema (reddening), rash, dryness, pruritus, depigmentation, - Abnormal blood tests related to coagulation, - Discomfort in the abdominal region, - Fatigue (tiredness).
Danish: forhøjet kreatininfosfokinase, nedsat kaliumniveau, forhøjet PSA (prostataspecifikt antigen) - hudreaktion, erytem (rødme), udslæt, tørhed, kløe (pruritus), depigmentering - unormale blodværdier relateret til størkningsevnen - ubehag i maveregionen - træthed.
English: Genito-urinary infections
Danish: Urogenitale infektioner
English: Table 6: PCM301 - Effect on erectile function (IIEF) - ITT population and patients meeting the indication criteria
Danish: Tabel 6: PCM301 - Effekt på erektil funktion (IIEF) - ITT-population og patienter, der opfylder indikationskriterierne
English: TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection padeliporfin
Danish: TOOKAD 183 mg pulver til injektionsvæske, opløsning TOOKAD 366 mg pulver til injektionsvæske, opløsning padeliporfin
English: The vial should rest in an upright position for 3 minutes without further shaking or moving.
Danish: Hætteglasset skal stå og hvile sig i 3 minutter uden yderligere drejebevægelser.
English: Blood lactate dehydrogenase increased Blood triglyceride increased Gamma-glutamyltransferase increased Blood cholesterol increased Blood creatine phosphokinase increased Blood potassium decreased Low density lipoprotein increased Neutrophil count increased PSA increased
Danish: Ikke almindelig Forhøjet laktatdehydrogenase i blodet Forhøjede triglycerider i blodet Forhøjet gammaglutamyltransferase Forhøjet kolesterol i blodet
English: TOOKAD 366 mg powder for solution for injection Each vial contains 366 mg of padeliporfin (as di-potassium salt).
Danish: TOOKAD 366 mg pulver til injektionsvæske, opløsning Hvert hætteglas indeholder 366 mg padeliporfin (som dikaliumsalt).
English: TOOKAD 183 mg powder for solution for injection TOOKAD 366 mg powder for solution for injection
Danish: TOOKAD 183 mg pulver til injektionsvæske, opløsning TOOKAD 366 mg pulver til injektionsvæske, opløsning
English: Prostatic pain (prostatism, prostatic disorders, prostatic fibrosis).
Danish: 12 Smerter i prostata (prostatisme, prostataforstyrrelser, prostatafibrose).
English: Age (years) Mean (SD) Range: min, max Patients aged > 75 year old, n (%) Unilateral disease, n (%) Bilateral disease, n (%)
Danish: Unilateral sygdom, n (%) Bilateral sygdom, n (%)
English: Rectal haemorrhage (anal haemorrhage).
Danish: 3 Rektal blødning (anal blødning).
English: This should be taken into consideration in patients with reduced kidney function or patients on a controlled potassium diet where a rise in serum potassium would be considered detrimental (see section 4.2).
Danish: Der vil dog være tale om en større dosis hos patienter, der vejer over 115 kg. Der skal tages hensyn til dette hos patienter med nedsat nyrefunktion og patienter på kaliumkontrolleret diæt, hvis det vurderes, at en stigning i serumkalium kan være skadeligt (se pkt.
English: Range: min, max Estimated prostate volume (cc) Mean (SD)
Danish: Estimeret prostatavolumen (cc) Gennemsnit (SD) Interval: min., maks.
English: These medicines (e.g. acetylsalicylic acid) should be stopped at least 10 days before the VTP procedure with TOOKAD and re-started at least 3 days after the procedure.
Danish: Antitrombotiske midler (lægemidler, der nedsætter blodpladernes evne til at klumpe sammen) Disse lægemidler (f.eks. acetylsalicylsyre) bør stoppes mindst 10 dage før VTP-proceduren med TOOKAD og ikke genstartes før tidligst 3 dage efter proceduren.
English: Abdominal discomfort Abnormal faeces Diarrhoea
Danish: Urogenital infektion1 Ikke almindelig Prostata-absces
English: Back pain (intervertebral disc protrusion).
Danish: 5 Rygsmerter (intervertebral diskusprotrusion).
English: Urinary retention/urethral stricture
Danish: Urinretention/uretrastriktur
English: Micturition disorders (micturition urgency, pollakiuria, nocturia, urine flow decreased, urinary straining).
Danish: 7 Vandladningsforstyrrelser (vandladningstrang, pollakisuri, nykturi, nedsat urinflow,
English: T1, n (%)
Danish: Kliniske stadier T1, n (%)
English: The main inclusion criteria were low-risk prostate cancer with Gleason 3 + 3 prostate adenocarcinoma as a maximum, two to three cores positive for cancer and a maximum cancer core length of 5 mm in any core (at least 3 mm for patients with only one positive core), clinical stage up to T2a, PSA ≤ 10 ng/mL, prostate volume equal or greater than 25 cc and less than 70 cc.
Danish: 5 mm (mindst 3 mm for patienter med kun én positiv knude), klinisk stadie op til T2a, PSA ≤ 10 ng/ml, prostatavolumen ≥ 25 cc og < 70 cc.
English: Skin depigmentation Skin reaction
Danish: Depigmentering Hudreaktioner
English: See also under “Other medicines and TOOKAD” for the effects of anticoagulants and antiplatelet medicines.
Danish: Se også afsnittet "Brug af anden medicin sammen med TOOKAD" med hensyn til indvirkningen af blodfortyndende lægemidler og lægemidler, der nedsætter blodpladernes evne til at klumpe sammen.
English: 60 watts or equivalent (i.e. 6 watts for LED lights, 12 watts for fluorescent low-energy lights).
Danish: Patienten må kun anvende glødepærer med en maksimal effekt på 60 watt eller tilsvarende (dvs. 6 watt for LED-lys, 12 watt for lavenergipærer).
English: Post-authorisation efficacy study (PAES): In order to further investigate long-term efficacy of TOOKAD and its impact on disease progression including potential impact on the efficacy of subsequent radical therapy in patients with low risk prostate cancer (excluding very low risk) as well as further characterise the long term safety of TOOKAD, the MAH should conduct and submit the results of a long-term observational cohort study of patients with unilateral low risk localised prostate cancer treated with TOOKAD VTP (CLIN1501 PCM401).
Danish: Tidsfrist langsigtede sikkerhed ved TOOKAD nærmere skal indehaveren af markedsføringstilladelsen gennemføre og indsende resultaterne af et langvarigt observationelt kohorte-studie af patienter med unilateral, lokaliseret lavrisiko-prostatacancer behandlet med TOOKAD-VTP (CLIN1501 PCM401).
English: See section 4.5 for interactions with photosensitizing medicinal products.
Danish: For interaktioner med fotosensibiliserende lægemidler, se pkt.
English: Adjusted Hazard Ratio (95% CI) = 0.34 (0.24 ; 0.46) ; p value ≤ 0.001
Danish: 39 (50,0)j gJusteret hazard ratio (95 %-KI) = 0,34 (0,24-0,46); p-værdi ≤ 0,001 hJusteret hazard ratio (95 %-KI) = 0,31 (0,20-0,50); p-værdi ≤ 0,001
English: Standard handling of syringes should follow.
Danish: Sprøjten skal derefter håndteres i henhold til de gængse procedurer.
English: Catheter site pain Laser device failure Infusion site bruising Nodule
Danish: Ikke almindelig Asteni Smerter omkring kateteret Laserapparatsvigt Blå mærker ved infusionsstedet Knudedannelse
English: Total number of positive cores Mean (SD)
Danish: Samlet antal positive knuder Gennemsnit (SD) Interval: min., maks.
English: How TOOKAD is stored
Danish: Sådan får du TOOKAD
English: Adjusted Hazard Ratio (95% CI) = 0.11 (0.05 ; 0.25) ; p value ≤ 0.001
Danish: Justeret hazard ratio (95 %-KI) = 0,17 (0,12-0,27); p-værdi ≤ 0,001 jJusteret hazard ratio (95 % CI) = 0,11 (0,05-0,25); p-værdi ≤ 0,001 * De behandlede lapper i AS-gruppen var defineret som lapper med sygdom ved baseline.
English: TOOKAD is indicated as monotherapy for adult patients with previously untreated, unilateral, low-risk, adenocarcinoma of the prostate with a life expectancy ≥ 10 years and: - Clinical stage T1c or T2a, - Gleason Score ≤ 6, based on high-resolution biopsy strategies, - PSA ≤ 10 ng/mL, - 3 positive cancer cores with a maximum cancer core length of 5 mm in any one core or 1-2 positive cancer cores with ≥ 50 % cancer involvement in any one core or a PSA density ≥ 0.15 ng/mL/cm
Danish: - Klinisk stadie T1c eller T2a - Gleason-score ≤ 6 baseret på biopsier taget ved brug af højopløsningsteknik - PSA ≤ 10 ng/ml - 3 cancerpositive knuder, der hver har en længde på maks.
English: Hepatic impairment
Danish: Ikke almindelig Hovedpine Svimmelhed
English: Medicines with a potentially photosensitising effect: - Certain antibiotics used to treat infection (tetracyclines, sulphonamides, quinolones).
Danish: Lægemidler, der kan fremkalde lysfølsomhed: - visse typer af antibiotika til behandling af infektioner (tetracykliner, sulfonamider, quinoloner) - visse lægemidler til behandling af psykiske lidelser (phenothiaziner) - visse lægemidler til behandling af type 2-diabetes (hypoglykæmiske sulfonamider) - visse lægemidler til behandling af for højt blodtryk, ødemer, hjertesvigt eller nyresvigt (thiazid diuretika) - et lægemiddel til behandling af svampeinfektioner (griseofulvin) - et lægemiddel til behandling af hjertearytmier (amiodaron)
English: NAME OF THE MEDICINAL PRODUCT TOOKAD 366 mg powder for solution for injection padeliporfin
Danish: TOOKAD 366 mg pulver til injektionsvæske, opløsning padeliporfin
English: Dysuria
Danish: Diarré
English: Haemorrhoids Anorectal discomfort Abdominal pain Rectal haemorrhage
Danish: Urinlækage efter indgrebet Indgrebsrelaterede smerter Udflåd efter indgrebet
English: Urinary incontinence
Danish: Urininkontinens8
English: No biopsy result, n (%) Subjects who had radical therapy leading to missing biopsy, n (%)
Danish: Intet biopsiresultat, n (%) 38 (18,4) 86 (41,5) 11 (13,8) Forsøgspersoner, der fik radikal behandling med deraf følgende manglende biopsi, n (%)
English: Adverse reaction
Danish: Anorektalt ubehag2
English: Muscular and connective tissue disorders
Danish: Muskuloskeletale smerter Ekstremitetssmerter
English: - You have abnormal blood clotting.
Danish: Unormal blodstørkning
English: Use in patients with abnormal clotting
Danish: Patienter med unormal blodkoagulation
English: g g h
Danish: AS-gruppe
English: NAME OF THE MEDICINAL PRODUCT TOOKAD 183 mg powder for solution for injection padeliporfin
Danish: TOOKAD 183 mg pulver til injektionsvæske, opløsning padeliporfin
English: In addition, inserting needles into the prostate gland and inserting a urinary catheter for the procedure may be associated with further side effects.
Danish: Det kan være forbundet med yderligere bivirkninger, når der indsættes nåle i prostatakirtlen, og når der anlægges et urinkateter.
English: Hepatotoxicity
Danish: Levertoksicitet4
English: Urethral stenosis
Danish: Rygsmerter5
English: Genito-urinary tract infection
Danish: Unormal blodkoagulation14
English: If you have any questions on the use of this medicine, ask your doctor, your pharmacist or your nurse.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet, hvis der er noget, du er i tvivl om.
English: This appearance is normal
Danish: Dette udseende er normalt.
English: • he/she has not been gaining weight and growing as expected.
Danish: • han/hun ikke vokser (vægt og højde) som forventet.
English: Bond et al. (2018) suggested some noncompliance to such recommendation in a recent conference abstract.
Danish: Bond et al. (2018) foreslog manglende efterlevelse af en sådan anbefaling i et nyligt konferenceabstrakt.
English: * Because these events were reported spontaneously, it is not possible to reliably estimate their frequency.
Danish: * Fordi disse hændelser er rapporteret spontant, er det ikke muligt at estimere hyppigheden pålideligt.
English: Some cases of overdose have been reported.
Danish: Der er rapporteret nogle tilfælde af overdosering.
English: (7) NA: Not available.
Danish: (7) NA: Ikke tilgængelig.
English: (cases/controls)
Danish: (tilfælde/ kontrolgruppe)
English: America; 11 countries
Danish: Latinamerika; 11 lande
English: Vaccine effectiveness estimate is based on 41 fully vaccinated cases and 175 fully vaccinated controls.
Danish: Estimat for vaccine-effektiviteten er baseret på 41 fuldt vaccinerede tilfælde og 175 fuldt vaccinerede kontroller.
English: The following side effects may happen with this vaccine:
Danish: Følgende bivirkninger kan forekomme med denne vaccine:
English: Natural fluctuations of the incidence of the disease may also influence the observed temporal effect.
Danish: Naturlige udsving i forekomsten af sygdommen kan også påvirke den observerede tidsmæssige effekt.
English: It is important that you follow the instructions of your doctor or nurse regarding return visits.
Danish: Det er vigtigt at følge din læges eller sygeplejerskens instruktioner med hensyn til efterfølgende besøg.
English: Schedule Studies conducted in
Danish: Program Studier udført i
English: The presence of a minor infection is not a contra-indication for immunisation.
Danish: Tilstedeværelse af en mindre infektion er ikke en kontraindikation mod immunisering.
English: 2°C to 8°C
Danish: 2°C til 8°C
English: No point estimate was available for the remaining study.
Danish: Intet punktestimat foreligger for resten af studierne.
English: The use of Rotarix should be based on official recommendations.
Danish: Anvendelse af Rotarix skal baseres på officielle anbefalinger.
English: (1) The number of fully vaccinated (2 doses) and unvaccinated cases and controls is given.
Danish: (1) Antallet af fuldt vaccinerede (2 doser) samt uvaccinerede tilfælde og kontrolgrupper er anført.
English: • If the membrane has not been pierced return to section B and repeat steps 2, 3 and 4.
Danish: • Hvis membranen ikke er blevet perforeret, gå tilbage til afsnit B og gentag punkt 2, 3 og 4.
English: South Africa, Malawi
Danish: Sydafrika, Malawi
English: Sterile water
Danish: Sterilt vand
English: Frequencies are reported as:
Danish: Hyppighederne er rapporteret som:
English: • There should be a hole at the top of the tube.
Danish: • Der skal være et hul på toppen af tuben.
English: The vaccination course consists of two doses.
Danish: Vaccinationsprogrammet består af to doser.
English: This is so that the unused oral tubes can be used for the next vaccination.
Danish: Dette er for at de ubrugte tuber kan bruges ved den næste vaccination.
English: 50 tubes
Danish: 50 tuber
English: There should be an interval of at least 4 weeks between doses.
Danish: Der skal være et interval på mindst 4 uger mellem doserne.
English: 10, 14 weeks and 6, 10, 14 weeks (Pooled)
Danish: 10, 14 uger og uger (pooled)
English: Both components must be mixed together before your child receives the vaccine.
Danish: De to komponeter skal blandes sammen inden dit barn får vaccinen.
English: As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Danish: Da fordelene ved vaccination er stor for denne gruppe børn, bør vaccination ikke udelades eller udskydes.
English: - Infants who have known or suspected immunodeficiency
Danish: - Spædbørn, som har kendt eller mistænkt immundefekt
English: Impact on mortality§
Danish: Indvirkning på dødelighed§
English: • Give the vaccine straight away.
Danish: • Giv vaccinen med det samme.
English: When these stools were tested for the presence of live vaccine strain, only 17% were positive.
Danish: Ved undersøgelse af disse afføringsmaterialer for levende vaccinestammer var kun 17 % positive.
English: If you notice anything abnormal, do not use the vaccine.
Danish: Hvis du bemærker noget unormalt, skal du ikke bruge vaccinen.
English: Safety in infants with human immunodeficiency (HIV) infection
Danish: Sikkerhed hos børn med human immundefekt (hiv)-infektion
English: These data should be interpreted with caution.
Danish: Disse data skal fortolkes med forsigtighed.
English: If the reconstituted vaccine is not used within 24 hours, it should be discarded.
Danish: Såfremt den rekonstituerede vaccine ikke anvendes inden for 24 timer, skal den smides ud.
English: Rotavirus infection is the most common cause of severe diarrhoea in infants and young children.
Danish: Infektion med rotavirus er den mest udbredte årsag til alvorlig diarré hos spædbørn og småbørn.
English: Rotarix should not be used in children over 24 weeks of age.
Danish: Rotarix bør ikke anvendes til børn over 24 uger.
English: • Submit an application at the latest in 2020 to amend the particulars of the marketing authorisation in order to render the medicinal product PCV-free.
Danish: • Indsende en ansøgning senest i år 2020 omkring ændring i detaljer i markedsføringstilladelsen, for derved at gøre lægemidlet PCV-fri.
English: This was supported by a very short time-to-onset (from immediate onset to a few hours), the absence of coadministered vaccines or drugs, and the rapid resolution of the event, with or without treatment.
Danish: Dette blev understøttet af en meget kort tid-til-indtræden (fra øjeblikkelig indtræden til et par timer), fravær af samtidigt administrerede vacciner eller lægemidler, og hurtig bedring af hændelsen, med eller uden behandling.
English: Clinical studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
Danish: Kliniske studier viste, at immunresponset på og sikkerhedsprofilen af de administrerede vacciner ikke blev påvirket.
English: Impact on hospitalisation§
Danish: Indvirknig på hospitalisering§
English: The vaccine is to be administered orally without mixing with any other vaccines or solutions.
Danish: Vaccinen skal administreres oralt uden opblanding med andre vacciner eller opløsninger.
English: not less than 106.0 CCID50
Danish: ikke mindre end 106,0 CCID50
English: If not used immediately, in-use storage should not be longer than 24 hours and at a temperature between 2-25°C.
Danish: Anvendes vaccinen ikke straks, bør opbevaringstiden ikke være længere end 24 timer ved temperaturer 2 ºC - 25 ºC.
English: - Do not use the affected oral tube if you notice anything unusual.
Danish: - Brug ikke den påvirkede tube, hvis du bemærker noget unormalt.
English: All of these strains are circulating worldwide.
Danish: Alle disse stammer cirkulerer i hele verden.
English: A minor infection such as a cold should not be a problem, but talk to your doctor first.
Danish: En mindre infektion såsom forkølelse bør ikke være noget problem, men tal med lægen inden vaccinationen.
English: These data should be interpreted with caution
Danish: Disse data skal tolkes med forsigtighed
English: • Provide, on a 6-month basis, updates on the progress being made on the activities set out in the implementation plan for the development of a PCV-free vaccine, as agreed by CHMP on 15 September 2016: every June and December until the PCV-free Rotarix application.
Danish: • Fremsende opdatering hver 6. måned omkring de fremskridt der er foretaget på de aktiviteter der er fastsat i implementeringsplanen for udvikling af en PCV-fri vaccine, som vedtaget af CHMP d. 15. september 2016: hver juni og december indtil PCV-fri Rotarix ansøgning.