FrancophonIA/ELRC3.0 huggingface dataset:
English: In a randomised comparative phase III trial, 398 subjects over 65 years of age received 0.1 ml of IDflu by intradermal route and 397 subjects over 65 years of age received 0.5 ml of a trivalent inactivated adjuvanted (MF-59 containing) influenza vaccine at the same dosage administered by intramuscular route.
Danish: I en randomiseret komparativ fase III undersøgelse fik 398 personer over 65 år 0,1 ml IDflu administreret intrakutant, og 397 personer over 65 år fik 0,5 ml trivalent inaktiveret influenzavaccine (med samme dosis) med adjuvans (MF-59) administreret intramuskulært.
English: • Temporary reduction in the number of blood particles called platelets which can result in bruising or bleeding, temporary swelling of the glands in the neck, armpit or groin.
Danish: • Forbigående fald i antallet af blodplader, der kan resultere i blå mærker eller blødning,
English: Data were as follows (values in brackets show the 95% confidence intervals):
Danish: Data var som følger (værdierne i parentes viser 95 % konfidensintervallerne): Intrakutan 15µg A/H3N2
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Influenza virus (inactivated, split) of the following strains*: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) .............................................................................................................................. 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .............................................................................................................................. 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 micrograms HA**
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Influenzavirus (inaktiveret, split) fra følgende stammer*: A/California/7/2009 (H1N1)pdm09 - lignende stamme (A/California/7/2009, NYMC X-179A) .................................................................................................................................. 15 mikrogram HA** A/Hong Kong/4801/2014 (H3N2) - lignende stamme (A/Hong Kong/4801/2014, NYMC X-263B) .................................................................................................................................. 15 mikrogram HA** B/Brisbane/60/2008 - lignende stamme (B/Brisbane/60/2008, vild type) ............... 15 mikrogram HA**
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Sanofi Pasteur SA, 2, avenue Pont Pasteur, F-69007 Lyon, France.
Danish: Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen: Sanofi Pasteur SA, 2 avenue Pont Pasteur, F-69007 Lyon,
English: Very common reactions (may affect more than 1 in 10 people) - At the injection site: redness, hardness, swelling, itching and pain.
Danish: Meget almindelige reaktioner (kan forekomme hos flere end 1 ud af 10 patienter) - På injektionsstedet: rødme, hævelse, hårdhed, kløe og smerter.
English: The active substances are Influenza virus (inactivated split) of the following strains*: A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A) .............................................................................................................................. 15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B) .............................................................................................................................. 15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type) ..................... 15 micrograms HA**
Danish: De aktive indholdsstoffer er influenzavirus (inaktiveret, split) fra følgende stammer*: A/California/7/2009 (H1N1)pdm09 - lignende stamme (A/California/7/2009, NYMC X-179A) .................................................................................................................................. 15 mikrogram HA** A/Hong Kong/4801/2014 (H3N2) - lignende stamme (A/Hong Kong/4801/2014, NYMC X-263B) .................................................................................................................................. 15 mikrogram HA** B/Brisbane/60/2008 - lignende stamme (B/Brisbane/60/2008, vild type) ............... 15 mikrogram HA**
English: The vaccine should be allowed to reach room temperature before use.
Danish: Vaccinen skal have lov til at opnå stuetemperatur, før den anvendes.
English: • The vaccine should be allowed to reach room temperature before use.
Danish: • Vaccinen skal have lov til at opnå stuetemperatur, før den anvendes.
English: Influenza virus (inactivated, split) of the following strains: A/California/7/2009 (H1N1)pdm09 - like strain A/Hong Kong/4801/2014 (H3N2) - like strain
Danish: A/California/7/2009 (H1N1)pdm09 - lignende stamme A/Hong Kong/4801/2014 (H3N2) - lignende stamme
English: Immunisation should be carried out by intradermal route.
Danish: Vaccinen skal administreres intrakutant.
English: (immunosuppression) due to disease or medicines, because the vaccine may not work very well in this case.
Danish: - De skal fortælle det til Deres læge, hvis Deres immunforsvar er svækket (immunsuppression) uanset om det skyldes sygdom eller medicin, da dette kan betyde, at vaccinen i så fald ikke fungerer så godt.
English: After repetitive yearly injections the safety profile of IDflu is similar to the previous injections.
Danish: Efter gentagne årlige injektioner svarer IDflus sikkerhedsprofil til den, der sås ved de tidligere b. Oversigt over bivirkninger i tabelform
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine (see
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Som ved alle injicerbare vacciner, bør passende medicinsk behandling og overvågning altid være til rådighed i tilfælde af, at der skulle opstå en anafylaktisk reaktion efter administration af vaccinen (se
English: INSTRUCTION FOR USE
Danish: BRUGSANVISNING
English: IDflu is administered to you by your doctor or nurse.
Danish: De vil få IDflu af Deres læge eller sygeplejerske.
English: Talk to your doctor, pharmacist or nurse before using IDflu.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De tager IDflu.
English: Rare reactions (may affect up to 1 in 1000 people) - Tingling or numbness, inflammation of nerves, itching and rash.
Danish: Sjældne reaktioner (kan forekomme hos op til 1 ud af 1000 patienter) - Prikkende fornemmelse eller følelsesløshed, nervebetændelse, kløe og udslæt
English: • The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Danish: • Mikro-injektionssystemet til intrakutan injektion består af en fyldt injektionssprøjte med en mikro-nål (1,5 mm) og et nåleafskærmningssystem.
English: 4.5 Interaction with other medicinal products and other forms of interaction IDflu may be given at the same time as other vaccines.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 February 2009
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: IDflu is a vaccine.This vaccine is recommended to help to protect you against flu.
Danish: Denne vaccine er beregnet til at give beskyttelse imod influenza.
English: Hypersensitivity to the active substances, to any of the excipients listed in section 6.1, or to any residues such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Danish: 6.1, eller over for nogle af reststofferne som f.eks. fra æg (ovalbumin, kyllingeproteiner), neomycin,
English: The Micro-Injection System for intradermal injection consists of a pre-filled syringe with a micro-needle (1.5 mm) and a needle shielding system.
Danish: Mikroinjektionssystemet til intrakutan injektion består af en fyldt injektionssprøjte med en mikro-nål (1,5 mm) og et nåleafskærmningssystem.
English: Sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen
Danish: Natriumchlorid, kaliumchlorid, dinatriumphosphatdihydrat, kaliumdihydrogenphosphat og vand til
English: IDflu 15 microgram/strain suspension for injection Influenza vaccine (split virion, inactivated)
Danish: IDflu 15 mikrogram/stamme injektionsvæske, suspension Influenzavaccine (split virion, inaktiveret)
English: HOW TO USE IDflu
Danish: SÅDAN FÅR DE IDflu
English: Injection is considered successful whether or not the presence of a wheal is In case of presence of liquid at the injection site after vaccine administration, re
Danish: Injektionen betragtes som vellykket uanset om der observeres tilstedeværelse af et prik i huden eller ej.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret i MM/ÅÅÅÅ Andre informationskilder
English: Uncommon reactions (may affect up to 1 in 100 people) - Tiredness, joint pain and increased sweating.
Danish: Ikke almindelige reaktioner (kan forekomme hos op til 1 ud af 100 patienter) - Træthed, ledsmerter og øget svedtendens
English: With the same hand, push very firmly with the thumb on the plunger to activate the You hear a click and a shield comes out to cover the needle.
Danish: Brug den samme hånd som ved injektionen, og tryk meget kraftigt med tommelfingeren på stemplet for at aktivere nåleafskærmningen.
English: Immunisation should be carried out on separate limbs.
Danish: Injektionerne skal gives på forskellige ekstremiteter.
English: - This vaccine has been prescribed for you only.
Danish: - Lægen har ordineret IDflu til Dem personligt.
English: IDflu is a suspension for injection in a pre-filled syringe of 0.1 ml with a Micro-Injection System in
Danish: IDflu er en injektionsvæske, suspension i en fyldt injektionssprøjte på 0,1 ml med mikroinjektionssystem i pakninger med 1, 10 eller 20.
English: See also section 3.
Danish: Se punkt.
English: 1/ REMOVE NEEDLE CAP
Danish: 1/ TAG NÅLEHÆTTEN AF
English: Warnings and precautions
Danish: sikkerhed og virkning.
English: • Any component that may be present in very small amounts such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde and octoxinol 9.
Danish: kyllingeproteiner), neomycin, formaldehyd og octoxinol 9.
English: Micro-needle Window
Danish: Mikro-nål
English: - Feeling generally unwell, fever (38.0°C or higher) and shivering.
Danish: Almindelige reaktioner (kan forekomme hos op til 1 ud af 10 patienter) - Blå mærker på injektionsstedet - En generel følelse af utilpashed, feber (38,0 °C eller højere) og kulderystelser
English: In this case, the
Danish: Er De i tvivl, så
English: NAME OF THE MEDICINAL PRODUCT IDflu 15 microgram/strain, suspension for injection Influenza vaccine (split virion, inactivated) Strains 2016/2017
Danish: IDflu 15 mikrogram/stamme, injektionsvæske, suspension Influenzavaccine (split virion, inaktiveret)
English: These side
Danish: Vindue
English: Cattle and Sheep
Danish: Kvæg og får
English: * Relative potency (mice potency test) compared to a reference vaccine that was shown efficacious in the target animal species.
Danish: * Relativ styrke (styrketest i mus) som blev sammenlignet med en referencevaccine, der blev påvist at være effektiv hos dyrearterne.
English: EU/2/14/178/001 Zulvac SBV --1 Suspension for injection
Danish: EU/2/14/178/001 Zulvac SBV --1 Injektionsvæske, suspension
English: Inactivated Schmallenberg virus, strain BH80/11-4: ≥ 1 RP*/2 ml (for cows) or ≥ 1 RP*/ml (for sheep).
Danish: Inaktiveret Schmallenberg-virus, stamme BH80/11-4: ≥ 1 RP*/2 ml (kvæg) eller ≥ 1 RP*/ml (får).
English: Intramuscular use or subcutaneous use.
Danish: Intramuskulæranvendels e eller subkutan anvendelse
English: Vial (HDPE) 50 ml
Danish: 50 ml
English: Zero days
Danish: 1 hætteglas 0 dage
English: Target species
Danish: Dyrearter , som lægemidl et er beregnet til
English: The Agency issued its opinion on 17 October 2019.
Danish: Agenturet fremsatte sin udtalelse den 17. oktober 2019.
English: What is Vanflyta and what was it intended to be used for?
Danish: Hvad er Vanflyta, og hvad forventedes det anvendt til?
English: How does Vanflyta work?
Danish: Hvordan virker Vanflyta?
English: The company that applied for authorisation, Daiichi Sankyo Europe GmbH, may ask for re-examination of the opinion within 15 days of receiving the opinion.
Danish: Den virksomhed, der har ansøgt om tilladelse, Daiichi Sankyo Europe GmbH, kan anmode om, at udtalelsen bliver revurderet, inden for 15 dage efter at have modtaget udtalelsen.
English: 18 October 2019 EMA/559309/2019 EMEA/H/C/004468
Danish: 18. oktober 2019 EMA/559309/2019 EMEA/H/C/004468
English: Further information on the orphan designation can be found on the Agency's website: ema.europa.eu/medicines/human/orphan-designations/eu309622.
Danish: Yderligere oplysninger om lægemidler til sjældne sygdomme findes på agenturets websted under: ema.europa.eu/medicines/human/orphan-designations/eu309622.
English: What were the main reasons for refusing the marketing authorisation?
Danish: Hvad var hovedårsagerne til at give afslag på ansøgningen om markedsføringstilladelse?
English: Therefore, the Agency's opinion was that the benefits of Vanflyta did not outweigh its risks and it recommended refusing marketing authorisation.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Vanflyta ikke opvejede risiciene, og anbefalede afslag på ansøgningen om markedsføringstilladelse.
English: Although the results from the main study indicated a marginal improvement in overall survival for patients given Vanflyta, the study had important limitations which meant that the effectiveness of Vanflyta could not be sufficiently demonstrated.
Danish: Selvom resultaterne fra hovedforsøget viste en marginal forbedring i samlet overlevelse for patienter, der fik Vanflyta, havde studiet væsentlige begrænsninger, som betød, at Vanflytas virkning ikke kunne påvises tilstrækkeligt.
English: Refusal of the marketing authorisation for Vanflyta (quizartinib) EMA/559309/2019
Danish: Afslag på ansøgningen om markedsføringstilladelse for Vanflyta (quizartinib) EMA/559309/2019
English: If you are in a clinical trial or compassionate use programme and need more information about your treatment, speak with your clinical trial doctor.
Danish: Hvis du deltager i et klinisk studie eller i et program for anvendelse med særlig udleveringstilladelse og har behov for yderligere oplysninger om din behandling, kan du kontakte den læge, der behandler dig.
English: Refusal of the marketing authorisation for Vanflyta (quizartinib)
Danish: Afslag på ansøgningen om markedsføringstilladelse for Vanflyta (quizartinib)
English: The company presented the results of a study in 367 patients with FLT3-ITD positive AML whose disease did not respond to treatment or came back after treatment.
Danish: Virksomheden fremlagde resultaterne af et studie hos 367 patienter med FLT3-ITD-positiv AML, hvis sygdom kom tilbage eller ikke reagerede på behandling.
English: The European Medicines Agency has recommended the refusal of the marketing authorisation for Vanflyta, a medicine intended for the treatment of adults with acute myeloid leukaemia (AML) (a cancer of the white blood cells).
Danish: Det Europæiske Lægemiddelagentur har anbefalet afslag på ansøgningen om markedsføringstilladelse for Vanflyta, et lægemiddel til behandling af voksne med akut myeloid leukæmi (AML, kræft i de hvide blodlegemer).
English: Vanflyta was designated an ‘orphan medicine' (a medicine used in rare diseases) on 23 March 2009 for the treatment of AML.
Danish: Vanflyta blev udpeget som "lægemiddel til sjældne sygdomme" den 23. marts 2009 til behandling af AML.
English: Vanflyta contains the active substance quizartinib and was to be available as tablets.
Danish: Vanflyta indeholder det aktive stof quizartinib og skulle markedsføres som tabletter.
English: Vanflyta was to be used in adult patients whose disease had come back or did not respond to previous treatments and for continuation of treatment after the patient had undergone a haematopoietic stem cell transplant (HSCT, a transplant of cells that can develop into different types of blood cells).
Danish: Vanflyta skulle anvendes hos voksne patienter, hvis sygdom var kommet tilbage eller ikke reagerede på tidligere behandlinger, og som fortsat behandling efter en såkaldt hæmopoietisk stamcelletransplantation (HSCT, transplantation af celler, der kan udvikle sig til forskellige typer blodlegemer).
English: By blocking FLT3, quizartinib is expected to stop cancer cells from multiplying and thus slow down the progression of the disease.
Danish: Ved at blokere for FLT3 forventes quizartinib at forhindre kræftcellerne i at dele sig, så sygdommens udvikling bremses.
English: It works by blocking FLT3, a protein involved in cell growth and proliferation.
Danish: Det virker ved at blokere for FLT3-proteinet, der er involveret i cellernes vækst og formering.
English: The active substance in Vanflyta, quizartinib, is a ‘receptor tyrosine kinase inhibitor'.
Danish: Det aktive stof i Vanflyta, quizartinib, er en såkaldt "receptortyrosinkinasehæmmer".
English: The company informed the Agency that there are no consequences for patients in clinical trials or in compassionate use programmes with Vanflyta.
Danish: Virksomheden har informeret agenturet om, at beslutningen ikke vil få konsekvenser for patienter, der deltager i kliniske studier med Vanflyta eller i programmer for anvendelse med særlig udleveringstilladelse.
English: Vanflyta was developed as a cancer medicine for the treatment of a type of AML called ‘FLT3-ITD positive' (when the cancer cells have a certain change in the gene for a protein called FLT3).
Danish: Vanflyta blev udviklet som et kræftlægemiddel til behandling af såkaldt "FLT3-ITD-positiv" AML (dvs. kræftceller, der har en bestemt forandring i genet for FLT3-proteinet).
English: cancer medicines and the main measure of effectiveness was overall survival (how long patients lived) after being given Vanflyta or the comparator medicines.
Danish: Vanflyta blev sammenlignet med andre kræftlægemidler, idet det primære mål for virkning var samlet overlevelse (hvor længe patienterne lever) efter at have fået Vanflyta eller sammenligningspræparater.
English: Does this refusal affect patients in clinical trials or compassionate use programmes?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske studier eller i programmer for anvendelse med særlig udleveringstilladelse?
English: Frequency (%)
Danish: Frekvens (%)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/547/001-007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/09/547/001-007
English: The most common side effect (affects 1 to 10 patients in 100) reported with clopidogrel is bleeding.
Danish: Den mest almindelige bivirkning (hos 1 til 10 patienter ud af 100) der er set med clopidogrel er blødning.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som
English: • Adults and elderly Clopidogrel should be given as a single daily dose of 75 mg with or without food.
Danish: • Voksne og ældre Clopidogrel bør gives som en enkelt daglig dosis på 75 mg med eller uden fødeindtagelse.
English: Some other medicines may influence the use of Clopidogrel Sandoz or vice versa.
Danish: Visse andre typer medicin kan påvirke brugen af Clopidogrel Sandoz eller omvendt.
English: Taking Clopidogrel Sandoz with food and drink Clopidogrel Sandoz may be taken with or without food.
Danish: Brug af Clopidogrel Sandoz sammen med mad og drikke Clopidogrel Sandoz kan tages med eller uden mad.
English: If you forget to take a dose of Clopidogrel Sandoz, but remember within 12 hours of your usual time, take your tablet straight away and then take your next tablet at the usual time.
Danish: Hvis De glemmer at tage en dosis Clopidogrel Sandoz til sædvanlig tid, men kommer i tanke om det i løbet af 12 timer, skal De omgående tage tabletten og dernæst tage den næste tablet til sædvanlig tid.
English: In another study it was shown that administering clopidogrel and omeprazole 12 hours apart did not prevent their interaction that is likely to be driven by the inhibitory effect of omeprazole on CYP2C19.
Danish: I et andet studie blev det vist, at administration af clopidogrel og omeprazol med 12 timers mellemrum ikke hindrede deres interaktion, som sandsynligvis skyldes omeprazols hæmmende effekt på CYP2C19.
English: Do not use Clopidogrel Sandoz if you notice any visible sign of damage of blister or film-coated tablets.
Danish: Brug ikke Clopidogrel Sandoz hvis De bemærker synlige tegn på skade på blisterpakningen eller de filmovertrukne tabletter.
English: Children and adolescents Clopidogrel Sandoz is not intended for use in children or adolescents.
Danish: Børn og unge Clopidogrel Sandoz må ikke gives til børn og unge.
English: Other side effects reported with clopidogrel are: -Common side effects:
Danish: Øvrige bivirkninger ved clopidogrel: - Almindelige bivirkninger:
English: If you stop taking Clopidogrel Sandoz Do not stop the treatment.
Danish: Hvis De holder op med at tage Clopidogrel Sandoz De må ikke ophøre med behandlingen.
English: • Paediatric patients The safety and efficacy of clopidogrel in children and adolescents have not yet been
Danish: • Børn og unge Sikkerhed og virkning af clopidogrel hos børn og unge er endnu ikke fastslået.
English: Do not use Clopidogrel Sandoz after the expiry date which is stated on the carton and on the blister after EXP.
Danish: Brug ikke Clopidogrel Sandoz efter den udløbsdato, som er angivet på æsken og blisterpakningen.
English: Like all medicines, Clopidogrel Sandoz can cause side effects, although not everybody gets them.
Danish: Clopidogrel Sandoz kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The association between CYP2C19 genotype and clopidogrel treatment outcome was evaluated in 2 post hoc clinical trial analyses (substudies of CLARITY [n = 465] and TRITON-TIMI 38 [n = 1,477]) and 5 cohort studies (total n = 6,489).
Danish: Sammenhængen mellem CYP2C19-genotype og udfald af clopidogrelbehandlingen blev evalueret i 2 kliniske post-hoc analyser (substudier af CLARITY [n=465] og TRITON-TIMI 38 [n=1.477]) og 5 kohortestudier (total n=6.489).
English: If you are pregnant or suspect that you are pregnant, you should tell your doctor or your pharmacist before taking Clopidogrel Sandoz.
Danish: Hvis De er gravid eller har mistanke om, at De kan være gravid, skal De fortælle det til Deres læge eller apoteket, før De tager Clopidogrel Sandoz.
English: If you take more Clopidogrel Sandoz than you should Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Danish: Hvis De har taget for meget Clopidogrel Sandoz Kontakt Deres læge eller tag på den nærmeste skadestue på grund af den øgede blødningsrisiko.
English: In patients who were enrolled in the trial on the sole basis of a recent myocardial infarction, clopidogrel was numerically inferior, but not statistically different from ASA (RRR = -4.0%; CI: -22.5 to 11.7 [p = 0.639]).
Danish: Hos de patienter, som alene indgik i undersøgelsen på grund af et nyligt myokardieinfarkt, lå clopidogrel numerisk lavere, men ikke statistisk forskelligt fra ASA (RRR = 4,0 %, CI: -22,5 til 11,7 [p=0,639]).
English: Clopidogrel Sandoz is unlikely to affect your ability to drive or to use machines.
Danish: Det er usandsynligt, at Clopidogrel Sandoz vil påvirke Deres evne til at køre eller betjene maskiner.
English: No conclusive data on the pharmacodynamic interaction of clopidogrel and other PPIs are available.
Danish: Der foreligger ingen konklusive data vedrørende farmakodynamisk interaktion mellem clopidogrel og andre PPI'er.
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Clopidogrel Sandoz.
Danish: Hvis De mener, at ovenstående gælder for Dem, eller hvis De overhovedet er i tvivl, så rådfør Dem med Deres læge, inden De tager Clopidogrel Sandoz.