natgillin/translations-raw huggingface dataset:
I studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC oplevede 219 (13%) af 1.722 patienter, der blev behandlet med crizotinib, bradykardi (uanset kausalitet).
In studies with crizotinib in patients with either ALK-positive or ROS1-positive advanced NSCLC, all-causality bradycardia was experienced by 219 (13%) of 1722 patients treated with crizotinib.
Ødemer p (47%) Udtalt træthed
Oedemap (47%) Fatigue (30%)
Printblæk
Posology
5.2) med blindede, manuelle ekg-målinger havde 11 (21%) patienter en stigning i baseline QTcF på ≥30 til<60 ms og en patient (2%) havde en stigning i baseline QTcF på ≥60 ms. Ingen patienter havde maksimum-QTcF ≥480 ms.
In a single arm ECG substudy (see section 5.2) using blinded manual ECG measurements 11 (21%) patients had an increase from Baseline in QTcF value ≥30 to <60 msec and 1 (2%) patient had an increase from Baseline in QTcF value of ≥60 msec. No patients had a maximum QTcF ≥480 msec.
XALKORI 200 mg hårde kapsler
XALKORI 200 mg hard capsules
Opbevares utilgængeligt for børn.
The indication does not cover children and adolescents.
I alle studier hos patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC (N=1.722) sås grad 3 eller 4 neutropeni hos 212 (12%) patienter, der blev behandlet med crizotinib.
Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 3 or 4 neutropenia was observed in 212 (12%) patients treated with crizotinib.
• Træthed.
• Constipation.
Responsvarighed Måneder g (95% CI)
Duration of Response Monthsg (95% CI)
Virkningen af en moderat induktor herunder efavirenz eller rifabutin er ikke entydigt klarlagt.
The effect of a moderate inducer including but not limited to efavirenz or rifabutin is not clearly established therefore, their combination with crizotinib should be also avoided (see section 4.4).
Grapefrugt og grapefrugtjuice bør undgås, da det kan øge plasmakoncentrationen af crizotinib.
Grapefruit or grapefruit juice should be avoided since it may increase crizotinib plasma concentration; St. John's wort should be avoided since it may decrease crizotinib plasma concentration (see section 4.5).
Patienterne kunne, hvis dette var i overensstemmelse med investigators skøn, fortsætte behandlingen efter sygdomsprogression som defineret i RECIST.
Patients could continue treatment beyond the time of RECIST-defined disease progression at the discretion of the investigator.
Tidligere behandlet ALK-positiv fremskreden NSCLC - randomiseret fase 3-studie 1007 Crizotinibs virkning og sikkerhed til behandling af patienter med ALK-positiv metastaserende NSCLC, som tidligere havde fået systemisk behandling mod fremskreden sygdom, blev undersøgt i et globalt, randomiseret åbent studie 1007.
The efficacy and safety of crizotinib for the treatment of patients with ALK-positive metastatic NSCLC, who had received previous systemic treatment for advanced disease, were demonstrated in a global, randomised, open-label Study 1007.
• Forstoppelse.
• Tiredness.
XALKORI 250 mg hårde kapsler
XALKORI 250 mg hard capsules
XALKORI 200 mg hårde kapsler XALKORI 250 mg hårde kapsler crizotinib
XALKORI 200 mg hard capsules XALKORI 250 mg hard capsules crizotinib
I alle studier hos patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC (N=1.722) sås grad 3 eller grad 4 leukopeni hos 48 (3%) af de patienter, der blev behandlet med crizotinib.
Across studies in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 3 or Grade 4 leukopenia was observed in 48 (3%) patients treated with crizotinib.
I kliniske studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv fremskreden NSCLC (N=1.722) blev der rapporteret om grad 4 synsfeltdefekt med synstab hos 4 (0,2%) patienter.
In clinical studies with crizotinib in patients with either ALK-positive or ROS1-positive advanced NSCLC (N=1722), Grade 4 visual field defect with vision loss has been reported in 4 (0.2%) patients.
Ved tilbagevendende opblussen af grad ≥ 3 seponeres XALKORI permanent.
XALKORI must be permanently discontinued in case of further Grade 4 recurrence.
I alle studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv NSCLC (N = 1.722) forekom dosisnedsættelse i forbindelse med aminotransaminasestigning hos 76 (4%) patienter.
Across studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC (N=1722), dose reductions associated with transaminase elevations occurred in 76 (4%) patients.
På basis af den farmakokinetiske populationsanalyse af data fra studie 1001, 1005 og 1007 har kropsvægt eller køn ingen klinisk betydning for crizotinibs farmakokinetik.
Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, there was no clinically meaningful effect of body weight or gender on crizotinib pharmacokinetics.
• Fordøjelsesproblemer.
• Indigestion.
Ved behov bør dosis af crizotinib nedsættes som angivet herunder for patienter behandlet med crizotinib 250 mg oralt 2 gange dagligt.
If dose reduction is necessary for patients treated with crizotinib 250 mg orally twice daily, then the dose of crizotinib should be reduced as below.
På basis af den farmakokinetiske populationsanalyse af data fra studie 1001, 1005 og 1007 har alder ingen betydning for crizotinibs farmakokinetik (se pkt.
Based on the population pharmacokinetic analysis of data from Studies 1001, 1005, and 1007, age has no effect on crizotinib pharmacokinetics (see sections 4.2 and 5.1).
4.2 angående patienter, som udvikler aminotransferasestigninger.
For patients who develop transaminase elevations, see section 4.2.
XALKORI 200 mg er en hård gelatinekapsel med pink overdel og hvid underdel, der er mærket med sort blæk “Pfizer” på overdelen og “CRZ 200” på underdelen.
What XALKORI looks like and contents of the pack XALKORI 200 mg is supplied as hard gelatin capsules with pink cap and white body, printed with black ink “Pfizer” on the cap, “CRZ 200” on the body.
Bortset fra lymfopeni (med mindre dette er forbundet med kliniske hændelser, fx opportunistiske infektioner).
Withhold until recovery to Grade ≤2, then resume at the next lower dosed,e a. Except lymphopenia (unless associated with clinical events, e.g., opportunistic infections).
Lægemidler, hvis plasmakoncentration kan påvirkes af crizotinib Efter 28 dages behandling af cancer-patienter med 250 mg crizotinib 2 gange dagligt var AUC for oral midazolam 3,7 gange større end det AUCinf, som ses når midazolam administreres alene.
Following 28 days of crizotinib dosing at 250 mg taken twice daily in cancer patients, the oral midazolam AUCinf was 3.7-fold of those seen when midazolam was administered alone, suggesting that crizotinib is a moderate inhibitor of CYP3A.
I kliniske studier med crizotinib hos patienter med enten ALK-positiv eller ROS1-positiv NSCLC (N=1.722) blev der rapporteret om synsfeltdefekt med synstab af grad 4 hos 4 (0,2%) patienter.
In clinical studies with crizotinib in patients with either ALK-positive or ROS1-positive NSCLC (N=1722), Grade 4 visual field defect with vision loss has been reported in 4 (0.2%) patients.
Hvis du er i den fødedygtige alder, skal du bruge sikker prævention (ikke p-piller, fordi XALKORI kan nedsætte virkningen af p-piller), mens du tager XALKORI og mindst 90 dage efter du har afsluttet behandlingen med XALKORI.
If there is any possibility that the person taking this medicine may become pregnant or father a child, they must use adequate contraception during treatment, and for at least 90 days after completing therapy as oral contraceptives may be ineffective while taking XALKORI.
XALKORI 200 mg hårde kapsler Hver hård kapsel indeholder 200 mg crizotinib.
QUALITATIVE AND QUANTITATIVE COMPOSITION XALKORI 200 mg hard capsules Each hard capsule contains 200 mg of crizotinib.
• Nyrecyste (væskefyldt hulrum i nyrerne).
• Closed pouches of fluid within the kidneys (kidney cysts).
XALKORI 200 mg hårde kapsler crizotinib
XALKORI 200 mg hard capsules crizotinib
• Hvis du bliver behandlet med medicin nævnt under afsnittet Brug af anden medicin sammen med XALKORI.
• If you are currently treated with any of the medicines listed in section Other medicines and
XALKORI 250 mg hårde kapsler crizotinib
XALKORI 250 mg hard capsules crizotinib
Uanset kausalitet oplevede 52 (3%) af 1.722 patienter, der blev behandlet med crizotinib, nyrecyster.
All-causality complex renal cysts were experienced by 52 (3%) of 1722 patients treated with crizotinib.
Hvis patienten udvikler afvigende hæmatologiske værdier, se pkt.
For patients who develop haematologic laboratory abnormalities, see section 4.2.
Ældre Justering af startdosis er ikke nødvendig (se pkt.
No starting dose adjustment is required (see sections 5.1 and 5.2).
Dosering
Geriatric
p) Ødemer (ansigtsødemer, generaliserede ødemer, lokal hævelse, lokaliserede ødemer, perifere ødemer,
p. Oedema (Face oedema, Generalised oedema, Local swelling, Localised oedema, Oedema, Oedema peripheral, Periorbital oedema).
Ingen af de 1.722 patienter, der blev behandlet med crizotinib, seponerede behandlingen permanent på grund af synsforstyrrelser.
There were no permanent discontinuations associated with vision disorder for any of the 1722 patients treated with crizotinib.
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events d.
Discontinue during evaluation of severe vision loss a. NCI Common Terminology Criteria for Adverse Events b. XALKORI must be permanently discontinued in case of further Grade ≥3 recurrence.
ORR var 47% (95% CI: 37-58) for pemetrexed/cisplatin (p <0,0001 sammenlignet med crizotinib) og 44% (95% CI: 32-55) for pemetrexed/carboplatin (p <0,0001 sammenlignet med crizotinib).
e. ORRs were 47% (95% CI: 37, 58) for pemetrexed/cisplatin (p-value <0.0001 compared with crizotinib) and
Perikon bør undgås, da det kan nedsætte plasmakoncentrationen af crizotinib (se pkt.
Agents that may decrease crizotinib plasma concentrations
Der er set gastrointestinal perforation i kliniske studier med crizotinib.
In clinical studies with crizotinib, events of gastrointestinal perforations were reported.
Pr. 30. november 2013, hvor dataene blev opgjort.
e. Per data cutoff date 30 November 2013.
Det skal du vide, før du begynder at tage XALKORI Sådan skal du tage XALKORI Bivirkninger
What you need to know before you take XALKORI 3.
Kaplan-Meier-kurver for progressionsfri overlevelse (baseret på IRR) for hver behandlingsarm i det randomiserede fase 3-studie 1007 (samlet analysepopulation) hos patienter med tidligere behandlet ALK-positiv fremskreden NSCLC
Kaplan-Meier curves for progression-free survival (based on IRR) by treatment arm in randomised Phase 3 Study 1007 (full analysis population) in patients with previously treated ALK-positive advanced NSCLC
Kaplan-Meier-kurver for progressionsfri overlevelse (baseret på IRR) for hver behandlingsarm i det randomiserede fase 3-studie 1014 (samlet analysepopulation) hos patienter med tidligere ubehandlet ALK-positiv fremskreden NSCLC
Kaplan-Meier curves for progression-free survival (based on IRR) by treatment arm in randomised Phase 3 Study 1014 (full analysis population) in patients with previously untreated ALK-positive advanced NSCLC
XALKORI 250 mg: Hver kapsel indeholder 250 mg crizotinib.
XALKORI 200 mg: each capsule contains 200 mg crizotinib XALKORI 250 mg: each capsule contains 250 mg crizotinib
Time to tumour response [median (interval)] uger Duration of response c [median (95% CI)] uger
Objective Response Rateb [% (95% CI)] Time to Tumour Response [median (range)] weeks Duration of Responsec [median (95% CI)] weeks Progression-Free Survivalc [median (95% CI)] months
HR (95% CI) p-værdi Samlet overlevelse Antal dødsfald, n (%) Median OS i måneder (95% CI)
Number of deaths, n (%) Median OS in months (95% CI)
Kaplan-Meier-kurver for samlet overlevelse for hver behandlingsarm i det randomiserede fase 3-studie 1007 (samlet analysepopulation) hos patienter med tidligere behandlet ALK-positiv fremskreden NSCLC
Kaplan-Meier curves for overall survival by treatment arm in randomised Phase 3 Study 1007 (full analysis population) in patients with previously treated ALK-positive advanced NSCLC
Patienter, som blev behandlet med 250 mg 1 gang dagligt, eller hvis dosis blev nedsat til 250 mg 1 gang dagligt, skal have behandlingen seponeret under evaluering.
See sections 4.4 and 4.8. c. For patients treated with 250 mg once daily or whose dose was reduced to 250 mg once daily, discontinue during evaluation.
Hver hård kapsel indeholder 200 mg crizotinib.
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg crizotinib.
Hvis du har taget for mange XALKORI
If you take more XALKORI than you should
Hver hård kapsel indeholder 250 mg crizotinib.
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 250 mg crizotinib.
Vejledningen om dosisreduktion i skema 1 og 2 følges for patienter, som behandles med en lavere dosis crizotinib end 250 mg 2 gange dagligt.
For patients treated with a lower dose of crizotinib than 250 mg twice daily, then follow the dose reduction guidelines provided in Tables 1 and 2 accordingly.
PVC-folieblister indeholdende 10 hårde kapsler
PHARMACEUTICAL FORM AND CONTENTS 60 hard capsules
• Naloxon, til behandling af afhængighed og abstinenser af opioider (fx morphin).
• Naloxone, used to treat opiate drug addiction and withdrawal.
Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Pfizer Manufacturing Deutschland GmbH Betriebsstӓtte Freiburg
Kaplan-Meier-kurver for samlet overlevelse for hver behandlingsarm i det randomiserede fase 3-studie 1014 (samlet analysepopulation) hos patienter med tidligere ubehandlet ALK-positiv fremskreden NSCLC
Kaplan-Meier curves for overall survival by treatment arm in randomised Phase 3 Study 1014 (full analysis population) in patients with previously untreated ALKpositive advanced NSCLC
I den samlede analysepopulation indgik 343 patienter med ALK-positiv fremskreden NSCLC, som var diagnosticeret med Fluorescence In Situ Hybridization (FISH) inden randomiseringen.
The full analysis population included 343 patients with ALK-positive advanced NSCLC as identified by Fluorescence In Situ Hybridization (FISH) prior to randomisation: 172 patients were randomised to crizotinib and 171 patients were randomised to chemotherapy (pemetrexed + carboplatin or cisplatin; up to 6 cycles of treatment).
Der er ingen specifik antidot for overdosering med crizotinib, og behandling af overdosis er generelt understøttende.
Treatment of overdose with the medicinal product consists of general supportive measures.
Interstitiel lungesygdom i (3%)
Elevated transaminasesm (32%)
Sandsynlighed for 18 måneders overlevelse d i %
12-Month Survival Probability,d % (95% CI)
XALKORI 200 mg hårde kapsler Hvid og pink hård kapsel, der er mærket med “Pfizer” på overdelen og “CRZ 200” på underdelen.
White opaque and pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 200” on the body.
(95% CI)
HR (95% CI)b p-valuec
Anæmi b (15%) Leukopeni c (15%) Metabolisme og ernæring Nedsat appetit
Neutropeniaa (22%) Anaemiab (15%) Leukopeniac (15%)
XALKORI 250 mg hårde kapsler Pink hård kapsel, der er mærket med “Pfizer” på overdelen og “CRZ 250” på underdelen.
Pink opaque hard capsule, with “Pfizer” imprinted on the cap and “CRZ 250” on the body.
4.2, 4.8 og 5.2, hvis patienten udvikler forlænget QT-interval.
For patients who develop QTc prolongation, see sections 4.2, 4.8 and 5.2.
Dosis bør justeres hos patienter med svært nedsat nyrefunktion, som ikke kræver peritonealdialyse eller hæmodialyse (se pkt.
If patients have severe renal impairment not requiring peritoneal dialysis or haemodialysis, the dose of crizotinib should be adjusted (see sections 4.2 and 5.2).
Hjertesvigt
Cardiac failure
Hvis du får synsforstyrrelser eller føler dig svimmel eller meget træt, mens du tager XALKORI, skal du tage hensyn hertil, hvis du skal færdes i trafikken eller arbejde med maskiner.
You should take special care when driving and using machines as patients taking XALKORI may experience visual disturbances, dizziness, and tiredness.
• Hævede fødder, ankler eller hænder på grund af væskeophobning (ødemer).
• Oedema (excess fluid in body tissue, causing swelling of the hands and feet).
Mave-tarm-kanalen
Renal cyst
HR (95% CI)b p-værdi Samlet overlevelse Antal dødsfald, n (%) Median OS i måneder (95% CI) HR (95% CI) p-værdi Sandsynlighed for 6 måneders overlevelse,
6-Month Survival Probability,e % (95% CI) 1-Year Survival Probability,e % (95% CI)
XALKORI Kemoterapi
Hepatobiliary disorders
r l
Package size l t o r
Keytruda har været godkendt i EU siden juli 2015.
Keytruda has been authorised in the EU since July 2015.
Yderligere oplysninger om den aktuelle brug af Keytruda findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Further information on Keytruda's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det indeholder det aktive stof pembrolizumab.
It contains the active substance pembrolizumab.
Målet for virkning var antallet af patienter, hvis kræft skrumpede i størrelse (samlet responsrate), og den tid, som patienterne overlevede, uden at deres sygdom blev forværret (progressionsfri overlevelse).
The measures of effectiveness were the number of patients whose cancer shrank in size (overall response rate) and the time patients lived without their disease getting worse (progression free survival).
Hvad forventedes Keytruda anvendt til?
What was Keytruda expected to be used for?
Hvad er Keytruda?
What is Keytruda?
CHMP's primære betænkelighed var, at de tilgængelige data ikke gjorde det muligt at drage endelige konklusioner om Keytrudas virkning og sikkerhed hos disse patienter, og yderligere data fra igangværende undersøgelser er nødvendige for at vurdere produktets benefit/risk-forhold.
The CHMP's main concern was that the available data did not allow firm conclusions on the effectiveness and safety of Keytruda in these patients and further data from ongoing studies were needed in order to assess its benefits and risks.
Ansøgeren fremlagde data fra en undersøgelse af 123 patienter med lokalt fremskreden eller metastaserende NSCLC, hvori man sammenlignede Keytruda taget sammen med pemetrexed og carboplatin-kemoterapi med kemoterapi alene.
The applicant presented data from a study involving 123 patients with locally advanced or metastatic NSCLC, which compared Keytruda taken together with pemetrexed and carboplatin chemotherapy with chemotherapy alone.
Keytruda anvendes specifikt, når tumoren producerer et protein kaldet PD-L1 og er fremskreden eller har spredt sig til andre dele af kroppen (metastaseret).
Keytruda is used specifically when the tumour produces a protein known as PD-L1 and is advanced or has spread to other parts of the body (metastatic).
Keytruda er godkendt til behandling af melanom (hudkræft), klassisk Hogdkin-lymfom (blodkræft) og urotelial kræft (kræft i blæren og urinvejene).
Keytruda is also authorised to treat melanoma (a skin cancer), classical Hodgkin lymphoma (a blood cancer) and urothelial cancer (a cancer of the bladder and urinary tract).
Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Keytruda.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Keytruda.
I sit brev til agenturet vedrørende tilbagetrækningen oplyste virksomheden, at dens beslutning var baseret på CHMP's holdning om, at der fortsat var usikkerhed på grund af det begrænsede antal patienter, der er inkluderet i hovedundersøgelsen på trods af de data, der er fremlagt for den anvendte brug af Keytruda.
In its letter notifying the Agency of the withdrawal of application, the company stated that its decision was based on the CHMP's consideration that uncertainties remain due to the limited number of patients included in the main study, despite the data provided for Keytruda in the applied use.
Det aktive stof i Keytruda, pembrolizumab, er et monoklonalt antistof (en type protein), der er opbygget, så det genkender og blokerer en receptor kaldet PD-1.
The active substance in Keytruda, pembrolizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and block a receptor called PD-1.
Den 11. oktober 2017 meddelte Merck Sharp & Dohme officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden tilbagetrækker sin ansøgning om udvidelse af brugen af Keytruda til behandling af ikke-småcellet lungekræft (NSCLC) til også at omfatte metastatisk ikkepladecelle-NSCLC i kombination med kemoterapi.
On 11 October 2017, Merck Sharp & Dohme officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Keytruda in nonsmall cell lung cancer (NSCLC) to include metastatic non-squamous NSCLC in combination with chemotherapy.
Nogle kræftformer kan danne såkaldte PD-L1- og PD-L2-proteiner, der i kombination med PD-1 indvirker på visse celler i immunsystemet (kroppens naturlige forsvar) ved at afbryde deres aktivitet og forhindre dem i angribe kræften.
Some cancers can make proteins called PD-L1 and PD-L2 that combine with PD-1 to switch off the activity of certain cells of the immune system (the body's natural defences) preventing them from attacking the cancer.
Afgørelsen vil ikke få konsekvenser for brugen af Keytruda i de godkendte indikationer.
There are no consequences on the use of Keytruda in its authorised uses.
Keytruda forventedes anvendt i kombination med kemoterapi-lægemidlerne pemetrexed og carboplatin hos NSCLC-patienter med metastatisk 'ikke-pladecelle'-NSCLC, uanset om deres tumor danner PD-L1proteinet.
Keytruda was also expected to be used in combination with the chemotherapy medicines pemetrexed and carboplatin in NSCLC patients with metastatic ‘non-squamous' NSCLC, irrespective of whether their tumour produced the PD-L1 protein.
På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Keytruda ikke ville kunne være blevet godkendt til behandling af metastatisk ikke-pladecelle-NSCLC i tillæg til pemetrexed og carboplatin.
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Keytruda could not have been approved for the treatment of metastatic non-squamous NSCLC in combination with pemetrexed and carboplatin.
Keytruda er et kræftlægemiddel, der er godkendt til enkeltstofsbehandling af NSCLC.
Keytruda is a cancer medicine already authorised for use on its own to treat NSCLC.
Hvad sker der med Keytruda i de godkendte indikationer?
What is happening with Keytruda in its authorised uses?
Ved at blokere PD-1 forhindrer pembrolizumab kræften i at afbryde disse immuncellers aktivitet.
By blocking PD-1, pembrolizumab stops the cancer switching off these immune cells, thereby increasing the ability of the immune system to kill the cancer cells.
Emaballage Pakningsstørrelse
Package size
Dette sammendrag blev sidst ajourført i 12-2012.
This summary was last updated in 11-2012.
Til de øvrige infektioner tages de i fem dage.
For the other infections, they are taken for five days.
Det må desuden ikke anvendes sammen med en række bestemte lægemidler.
It must also not be used with a number of medicines.
Disse er nært beslægtet med makrolider.
These are closely related to the macrolides.
Den fuldstændige EPAR for Ketek findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Ketek can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Den anbefalede dosis Ketek er 800 mg (to tabletter) én gang dagligt.
The recommended dose of Ketek is 800 mg (two tablets) once a day.