natgillin/translations-raw huggingface dataset:
Substanser, der inducerer CYP3A4-aktiviteten, kan forårsage en øget metabolisering af gefitinib og dermed reducere gefitinibs plasmakoncentration.
CYP3A4 inducers may increase metabolism of gefitinib and decrease gefitinib plasma concentrations.
• Kvalme
Nausea
EGFR-mutation negativ
EGFR mutation-negative
Der sås en reduktion i overlevelsen hos unger af drægtige og fødende rotter ved administration af en dosis på 20 mg/kg/dag.
When administered to the rat throughout gestation and parturition, there was a reduction in pup survival at a dose of 20 mg/kg/day.
BLISTER/ALUMINIUMFOLIE-LAMINATINDPAKNING
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER/ALUMINIUM FOIL LAMINATE FLOW WRAP
• Røde og ømme øjenlåg
Red and sore eyelids
Hos nogle patienter, som tager warfarin sammen med gefitinib, er der rapporteret forøget International Normaliseret Ratio (INR) og/eller blødningstilfælde (se pkt.
International normalised ratio (INR) elevations and/or bleeding events have been reported in some patients taking warfarin together with gefitinib (see section 4.5).
Neglelidelser
Vomiting
Sandsynlighed for EGFR-mutation
Odds of EGFR mutation
Blødning, så som epistaxis og hæmaturi
Hepatotoxicity and liver impairment
6.1 Hjælpestoffer
6.1List of excipients
Kvalme, hovedsageligt let (CTC grad 1) Stomatit, overvejende let (CTC grad 1)
Asthenia, predominantly mild (CTC grade 1)
Meget almindelig Diarré, hovedsageligt let eller moderat (CTC grad 1 eller 2)
Diarrhoea, mainly mild or moderate (CTC grade 1 or 2) Vomiting, mainly mild or moderate (CTC grade 1 or 2) Nausea, mainly mild (CTC grade 1)
I et forsøg blev et begrænset antal patienter behandlet ugentligt med doser fra 1.500 mg til 3.500 mg. I dette forsøg øgedes IRESSAeksponeringen ikke med større doser, og bivirkningerne var for det meste lette til moderate i sværhedsgrad og i overensstemmelse med IRESSAs sikkerhedsprofil.
In this study IRESSA exposure did not increase with increasing dose, adverse events were mostly mild to moderate in severity, and were consistent with the known safety profile of IRESSA.
Meget almindelig Asteni, hovedsageligt let (CTC grad 1) Almindelig
Stomatitis, predominantly mild in nature (CTC grade 1)
261 71,2 % vs. 47,3 % [12,0 % vs. 34,9 %]
261 71.2% vs 47.3%
Bivirkninger efter systemorganklasse og frekvens Metabolisme og ernæring Meget almindelig Anoreksi, let eller moderat (CTC-grad 1 eller 2) Øjne
Adverse reactions by system organ class and frequency Metabolism and nutrition disorders
Andelen af ILSbivirkninger med fatalt udfald var 38,6 %.
The proportion of ILD-type events with a fatal outcome was
• Hæmoragisk blærebetændelse (blærebetændelse med blod i urinen).
Haemorrhagic cystitis (burning sensations during urination and frequent, urgent need to urinate with blood in the urine).
Sjælden: kan forekomme hos op til 1 ud af 1.000 personer
Rare: side effects (may affect up to 1 in 1000 people) Inflammation of the blood vessels in the skin.
Kutan vaskulitis
Vascular disorders
18,8 m vs. 17,4 m p=0,1087
4m p=0.1087
Dehydrering, som følge af diarré, kvalme, opkastning eller anoreksi Tør mund*, hovedsageligt let (CTC grad 1)
Dehydration, secondary to diarrhoea, nausea, vomiting or anorexia
Gefitinibs eksponering reduceredes med 47 % i et studie med raske frivillige forsøgspersoner, hvor gastrisk pH var fastholdt over 5.
In a trial in healthy volunteers where gastric pH was maintained above pH 5, gefitinib exposure was reduced by 47%, likely due to impaired solubility of gefitinib in the stomach (see sections 4.4 and 4.5).
Oral suspension Oral anvendelse
Oral suspension
1 flaske + 1 flaskeadapter + 3 orale sprøjter
1 bottle +1 adaptor + 3 oral syringes
Flaske (glas)
Bottle (glass)
Orfadin 4 mg/ml
EU/1/04/303/005 Orfadin 4 mg/ml
MF (EU)-nummer
MA (EU) number Invented name
London, den 23. juli 2009 Dok.
London, 23 July 2009 Doc.
ref. EMA/123942/2010 EMEA/H/C/1041
Ref. EMEA/448660/2009 EMEA/H/C/1041
Det primære mål for virkningen var, hvor længe patienterne overlevede.
The main measure of effectiveness was how long the patients lived.
I 2008 havde CHMP udarbejdet en liste over spørgsmål, som virksomheden skulle besvare.
In 2008, the CHMP had formulated a list of questions to be answered by the company.
Virksomheden havde heller ikke fremlagt tilstrækkelig dokumentation for, at lægemidlet var sikkert, at det kunne fremstilles på en pålidelig måde, eller at det ikke ville være skadeligt for miljøet eller for personer i tæt kontakt med patienten.
Also, the company had not supplied enough evidence to demonstrate that the product was safe, that it could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.
Det skulle anvendes, når kræften var refraktær (ikke responderer på behandling) eller recidiverende (bliver ved med at komme tilbage).
It was to be used when the cancer was refractory (does not respond to treatment) or recurrent (keeps coming back).
Virksomheden skulle indsende sit svar til Udvalget for Avancerede Terapier (CAT) i overensstemmelse med de nye EUbestemmelser om avancerede terapier.
The company had to submit their responses to the Committee for Advanced Therapies (CAT) in line with new European Union regulations on advanced therapies.
Det er en lægemiddeltype, der virker ved at afgive gener til kroppen.
This is a type of medicine that works by delivering genes into the body.
De nye gener får så kroppen til at producere eller holde op med at producere et protein, der kan være med til at behandle en sygdom.
The new genes then make the body produce or stop the production of a protein which may help treat a disease.
Endelig bemærkede CHMP, at der var utilstrækkelige information om lægemidlets toksicitet, dets fordeling i kroppen og den rolle, som visse gener og urenheder, der er fundet i lægemidlet, spiller.
Finally, the CHMP noted that there was insufficient information on the product's toxicity, its distribution in the body and the role of some genes and impurities found in the product.
Ansøgningsproceduren var ved dag 120, da virksomheden trak sin ansøgning tilbage.
The application was at day 120 of the procedure when the company withdrew.
Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Contusugene Ladenovec Gendux contusugen ladenovec
Questions and answers on the withdrawal of the marketing authorisation application for Contusugene Ladenovec Gendux contusugene ladenovec
Virkningerne af Contusugene Ladenovec Gendux blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Contusugene Ladenovec Gendux were first tested in experimental models before being studied in humans.
Contusugene Ladenovec Gendux forventedes anvendt til behandling af pladecellekræft i hoved og hals (en kræfttype, der opstår i cellerne i mund, næse, hals eller øre).
Contusugene Ladenovec Gendux was expected to be used to treat squamous cell carcinoma of the head and neck (a type of cancer that starts in the cells lining the mouth, nose, throat or ear).
Eftersom kræftceller indeholder beskadiget DNA, bidrager p53-proteinet enten til at reparere DNA eller får cellerne til at dø.
Because cancer cells contain damaged DNA, the p53 protein either helps to repair the DNA or causes the cells to die.
P53-proteinet mindsker også dannelsen af blodkar, som forsyner kræftcellerne med blod.
The p53 protein also reduces the formation of blood vessels supplying the cancer cells.
I en hovedundersøgelse, der omfattede 123 patienter med recidiverende eller refraktært pladecellekræft i hoved og hals, blev Contusugene Ladenovec Gendux sammenlignet med methotrexat (et andet lægemiddel mod kræft).
In one main study involving 123 patients with refractory or recurrent squamous cell carcinoma of the head and neck, Contusugene Ladenovec Gendux was compared with methotrexate (another anti-cancer medicine).
Virksomheden trak dog sin ansøgning tilbage inden.
But, the company withdrew its application before responding to the questions.
CHMP var af den opfattelse, at virksomheden ikke havde påvist, at Contusugene Ladenovec Gendux var gavnligt for patienterne.
The Committee was of the opinion that the company had not shown that Contusugene Ladenovec Gendux was beneficial to patients.
Den 12. juni 2009 meddelte Gendux Molecular Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Contusugene Ladenovec Gendux til behandling af recidiverende eller refraktær pladecellekræft i hoved og hals.
On 12 June 2009, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Contusugene Ladenovec Gendux for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Contusugene Ladenovec Gendux ikke kunne have været godkendt til behandling af recidiverende eller refraktær pladecellekræft i hoved og hals.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Contusugene Ladenovec Gendux could not have been approved for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
Virus i Contusugene Ladenovec Gendux er en "adenovirus", som er blevet modificeret, så den ikke forårsager sygdom hos mennesker.
The virus in Contusugene Ladenovec Gendux is an ‘adenovirus' that has been modified so that it does not cause disease in humans.
Contusugene Ladenovec Gendux blev udviklet som et lægemiddel til avanceret terapi, kaldet et "genterapiprodukt".
Contusugene Ladenovec Gendux was developed as a type of advanced therapy medicine called a ‘gene therapy product'.
Ved at øge produktionen af p53-proteinet forventedes Contusugene Ladenovec Gendux at helbrede kræften eller hæmme dens udvikling.
By increasing the production of the p53 protein, Contusugene Ladenovec Gendux was expected to cure or slow down the growth of the cancer.
Contusugene Ladenovec Gendux er en injektionsvæske, suspension, der indeholder det aktive stof contusugen ladenovec.
Contusugene Ladenovec Gendux is a suspension for injection that contains the active substance contusugene ladenovec.
Hvad er Contusugene Ladenovec Gendux?
What is Contusugene Ladenovec Gendux?
Det aktive stof i Contusugene Ladenovec Gendux, contusugen ladenovec, er en virustype, som er blevet modificeret, så den kan transportere p53-genet ind i kroppens celler.
The active substance in Contusugene Ladenovec Gendux, contusugene ladenovec, is a type of virus that has been modified so that it can carry the p53 gene into the cells of the body.
Efter at være blevet sprøjtet ind i tumoren, forventedes det, at Contusugene Ladenovec Gendux ville transportere p53-genet ind i kræftcellerne, og at genet fik cellen til at øge produktionen af p53proteinet.
Once injected into the tumour, Contusugene Ladenovec Gendux was expected to carry the p53 gene into the cancer cells, where the gene was expected to make the cell increase the production of the p53 protein.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Contusugene Ladenovec Gendux eller i programmer for anvendelse af Contusugene Ladenovec Gendux med særlig udleveringstilladelse?
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Contusugene Ladenovec Gendux?
Hvad forventedes Contusugene Ladenovec Gendux anvendt til?
What was Contusugene Ladenovec Gendux expected to be used for?
Virksomheden har ikke informeret CHMP om patienter, som deltager i kliniske undersøgelser med Contusugene Ladenovec Gendux eller i programmer for anvendelse af Contusugene Ladenovec Gendux med særlig udleveringstilladelse.
The Company did not inform the Agency of any patients in clinical trials or compassionate use programmes using Contusugene Ladenovec Gendux.
Dett medfører celledød, når DNA ikke kan repareres, og det er med til at kontrollere blodkardannelsen.
The p53 protein normally contributes to the repair of damaged DNA, causes cell death when the DNA cannot be repaired and helps control the formation of blood vessels.
Hvordan forventedes Contusugene Ladenovec Gendux at virke?
How is Contusugene Ladenovec Gendux expected to work?
Følgende nye bivirkninger blev tilføjet under denne procedure:
The following new adverse reactions were added during this procedure:
Anvendelse under graviditet blev bibeholdt i dette afsnit.
Use during pregnancy was agreed to be kept in this section.
Der er forskelle mellem medlemsstaterne vedrørende de enkelte underafsnit i dette afsnit.
There are differences between Member States concerning the individual paragraphs in this section.
Samlet resumé af den videnskabelige vurdering af Tavanic og relaterede navne (se bilag I)
Overall summary of the scientific evaluation of Tavanic and associated names (see Annex I)
Der blev ligeledes vedtaget et harmoniseret Modul 3.
A harmonised Module 3 was also adopted.
På verdensbasis blev levofloxacin først godkendt i 1993 i Japan, herefter i USA i 1996.
Worldwide, levofloxacin was first approved in 1993 in Japan followed by the United States in 1996.
Som konklusion vedtog CHMP en harmoniseret ordlyd til afsnit 5.1.
In conclusion, the CHMP adopted a harmonised wording for section 5.1
EUCAST-oplysningerne blev rettet ind efter de gældende EUCAST-anbefalinger.
The EUCAST information was aligned with the current EUCAST recommendations.
Desuden er ordlyden vildledende, idet den forudsætter, at standardbehandlingen er monoterapi.
Furthermore, the wording is misleading as it implies that standard treatment is monotherapy.
Disse koncentrationer giver tilstrækkelig baktericid virkning på bakteriestammer med følsomhed op til 0,5-1 mg/l.
These concentrations provide sufficient bactericidal activity on bacterial strains with sensitivity level up to 0.5-1 mg/l.
Makrolidernes rolle er imidlertid i mange lande aftaget dramatisk på grund af det stigende resistensniveau hos S. pneumoniae.
However, the role of macrolides has dramatically decreased in many countries due to the increased level of S pneumoniae resistance.
På grundlag af gennemgangen af data vedtog CHMP et harmoniseret Modul 3.
Based on the review of data the CHMP adopted a harmonised Module 3.
Den foreslåede harmoniserede ordlyd af indikationen fandtes bedre at afspejle de nuværende overordnede europæiske behandlingsanbefalinger.
The proposed harmonised indication wording was considered to better reflect the current overall European treatment recommendations.
Ved harmoniseringen af produktresuméerne blev alle relevante terapeutiske og regulatoriske retningslinjer i EU taget i betragtning.
The SPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Ovennævnte undersøgelser løser ikke dette problem, da der ikke er udført placebokontrollerede undersøgelser.
The studies above mentioned do not permit to overcome this issue as no placebocontrolled studies were performed.
Metoden og den statistiske tilgang blev gennemgået sammen med de forelagte data, og CHMP fandt, at den estimerede hyppighed var passende.
The method and the statistical approach together with the data provided were reviewed and the CHMP considered the estimated frequency to be appropriate.
Der blev ikke fundet andre afvigelser i dette afsnit vedrørende særlige populationer: Nedsat nyrefunktion og/eller ældre patienter.
No other discrepancies in this section were detected in regard to special populations: impaired renal function and/or elderly.
De fleste isolater af MRSA er imidlertid resistente over for levofloxacin.
However, most MRSA isolates are resistant to levofloxacin.
Denne indikation støttedes af tre hovedundersøgelser og har været godkendt i EU siden 1997.
Three pivotal studies supported this indication, granted in the EU since 1997.
Afsnit 4.6 - Fertilitet, graviditet og amning
Section 4.6 - Fertility, Pregnancy and Lactation
På ovenstående grundlag finder CHMP, at benefit/risk-forholdet for Tavanic og relaterede navne er positivt, og at de harmoniserede produktinformationer kan godkendes.
Based on the above, the CHMP considers the benefit/risk ratio of Tavanic and associated names to be favourable and the harmonised Product Information documents to be approvable.
• Hypoglykæmisk koma, på linje med CCSI version 4 for levofloxacin, der blev indleveret som en del af PSUR 27
• Hypoglycaemic coma, in line with the CCSI version 4 for levofloxacin submitted as part of the PSUR 27;
Antibiotikabehandlingen kan herefter tilpasses dyrkningsresultater og klinisk respons.
Antibiotic therapy may subsequently be changed in the light of culture results and clinical response.
Officielle retningslinjer for hensigtsmæssig brug af antibiotika bør følges.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Advarslen om forebyggelse af fotosensibilisering blevet yderligere revideret med en anbefaling om forsigtighed under behandlingen og 48 timer efter ophør af behandlingen.
The warning on prevention of photosensitisation was revised to further recommend precaution during treatment and 48 hours following treatment discontinuation.
Denne henvisningsprocedure omfatter derfor ikke en vurdering af levofloxacin, 750 mg.
Thus, the outcome of this referral procedure does not include any evaluation of levofloxacin 750 mg.
Desuden bestemtes det at tilføje forholdsregler for anvendelse til behandling af miltbrand i afsnit 4.4 med henvisning til nationale og/eller internationale konsensus-dokumenter.
In addition, it was agreed to include precautions for use in case of treatment of anthrax in section 4.4 to include reference for consultation of national and/or international consensus documents.
Den gyldne standard for disse patogener er fortsat penicillin (bortset fra MRSA (meticillinresistente Staphylococcus aureus)).
The gold standard for these pathogens remains penicillin (with the exception of MRSA - Methicillin-resistant staphylococcus aureus).
Resultaterne af de udførte test viser tilfredsstillende overensstemmelse og ensartethed af produkternes vigtigste kvalitetsegenskaber, og det blev konkluderet, at produkterne må forventes at have tilfredsstillende og ensartede egenskaber i klinikken.
The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics, and these in turn lead to the conclusion that the products should have a satisfactory and uniform performance in the clinic.
Siden godkendelsen af denne indikation i EU er yderligere 22 undersøgelser blevet tilgængelige, herunder fire nyere undersøgelser, hvor levofloxacin blev anvendt som sammenligningsstof over for tigecyclin (to undersøgelser), doxycyclin (én undersøgelse) og nemonoxacin (én undersøgelse).
Since the granting of this indication in the EU, twenty two additional studies have become available including 4 recent trials of levofloxacin used as a comparator versus tigecycline (2 studies), docycycline (one study) and nemonoxacin (one study).
Desuden slettedes oplysningen om den kombinationsbehandling, der kan være nødvendig ved nosokomielle infektioner forårsaget af P. aeruginosa, da det ikke blevet anset for hensigtsmæssigt at lade den indgå i dette afsnit.
In addition, the information on the combination treatment that may be required in case of nosocomial infections due to P. aeruginosa was deleted since it is considered not appropriate to be included in this section.
Antibiotikabehandling indiceres og påbegyndes sædvanligvis empirisk, således at behandlingen dækker typiske organismer med eller uden atypiske organismer.
Antibiotic therapy is indicated and usually starts empirically, covering typical organisms with or without atypical organisms.
• Ligamentruptur, i henhold til en oversigt, der blev fremlagt af indehaveren af markedsføringstilladelsen, hvori der konstateredes en mulig kausal sammenhæng, i nogle tilfælde uden alternative forklaringer, kombineret med biologisk plausibilitet.
• Ligament rupture, in line with a review provide by the MAH in which possible causal relationship in some cases without alternative explanations in combination with biological plausibility were identified.
I betragtning af omfanget af harmoniseringen af indlægssedlen aftaltes det, at der skulle forelægges en læsbarhedstest efter vedtagelsen af denne henvisningsprocedure.
Considering the extent of the harmonisation of the PL a Readability Testing was agreed to be submitted after the adoption of this referral procedure.
Dette afsnit blev yderligere ændret med klar angivelse af, at behandling med levofloxacin er kontraindiceret under amning og med tilføjelse af oplysninger om fertilitet, ligeledes i overensstemmelse med CHMP's ”Guideline on risk assessment of medicinal products on human reproduction and lactation: From data to labelling”, januar 2009.
This section was further amended to clearly mention that treatment with levofloxacin is contraindicated during breastfeeding and to include information on fertility also in line with the CHMP Guideline on risk assessment of medicinal products on human reproduction and lactation: From data to labelling, January 2009.
Det blev besluttet at indsætte en krydsreference til advarselsafsnittene om resistensmønsteret.
A cross reference to the warning sections with regards resistance patterns was agreed.
Hvad dette angår, viste en nypubliceret epidemiologisk undersøgelse øget risiko (OR 4,5) for retinaløsning i forbindelse med fluorquinoloner.
In this regard a recent published epidemiologic study revealed an increased risk (OR 4.5) of fluoroquinolones for retinal detachment.
Ukompliceret cystitis (se afsnit 4.4)
Uncomplicated cystitis (see section 4.4)
Desuden blev det vedtaget at tage hensyn til de europæiske retningslinjer, der kun anbefaler quinoloner som førstevalgsbehandling, hvis resistensraten af E. coli (som er årsag til 70-80 % af alle urinvejsinfektioner forårsaget af gramnegative bakterier) er under 10 %.
It was further agreed that consideration should be given to the European guidelines whereby quinolones are only recommended as first line therapy if the resistance rate for E. coli (responsible for 70-80% of all UTIs caused by Gram-negative) is below 10%.
Et almindeligt forhold, der må tages i betragtning, er, at akut bakteriel sinuitis sædvanligvis er en ikke svær infektion med høj spontan helbredelsesrate (90 %).
A general consideration to be taken into account is that ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Indehaveren af markedsføringstilladelsen fremlagde alle foreliggende data for denne indikation, dvs. in vitro-data, ikkekliniske data, farmakokinetiske data og data fra amerikanske Centers of Disease Control and Prevention (CDC), og foreslog en harmoniseret indikation.
The MAH provided all data available for this indication namely, in vitro data, non-clinical data, pharmacokinetic data and data published by the US Centers of Disease Control and Prevention (CDC) and proposed an harmonised indication.
Herunder revideredes tabellen over tærskelværdier fra European Committee on Antimicrobial Susceptibility Testing (EUCAST) og tabellen over følsomme arter.
In particular, the table of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints and the table of susceptible species were revised.
Således blev Bacteroides sp. bortset fra B. fragilis slettet på grund af den naturlige intermediære følsomhed for det aktive stof.
Namely, the inclusion of bacteroides sp. other than B. fragilis was removed due to the natural intermediate susceptibility to levofloxacin.
Advarslen om pneumokokpneumoni blev slettet, da den blev anset for at være dækket af oplysningerne i afsnit 4.1 om, at levofloxacin i sådanne tilfælde kun bør overvejes som behandlingsalternativ.
The warning on pneumococcal pneumonia was deleted since it was considered covered by the information included in section 4.1 that levofloxacin should only be considered as alternative treatment in such cases.