FrancophonIA/ELRC3.0 huggingface dataset:
English: (add-on to metformin: placebo +5.9 mg/dl, empagliflozin 10 mg: -46.0 mg/dl, empagliflozin 25 mg: -44.6 mg/dl, add-on to metformin and a sulphonylurea: placebo -2.3 mg/dl, empagliflozin 10 mg: -35.7 mg/dl, empagliflozin 25 mg: -36.6 mg/dl).
Danish: Behandling med empagliflozin som supplement til metformin eller metformin og et sulfonylurinstof medførte et klinisk relevant fald i 2 timers postprandial glucose (måltidstolerancetest) ved 24 uger (supplement til metformin: placebo +5,9 mg/dl, empagliflozin 10 mg: -46,0 mg/dl, empagliflozin 25 mg: -44,6 mg/dl, supplement til metformin og et sulfonylurinstof: placebo -2,3 mg/dl, empagliflozin 10 mg: -35,7 mg/dl, empagliflozin 25 mg: -36,6 mg/dl).
English: Major hypoglycaemia (hypoglycaemia requiring assistance) No increase in major hypoglycaemia was observed with empagliflozin compared to placebo as monotherapy, add-on to metformin, add-on to metformin and a sulfonylurea, and add-on to pioglitazone with or without metformin.
Danish: Svær hypoglykæmi (med behov for blodsukkerregulering) Sammenlignet med placebo som monoterapi, supplement til metformin, supplement til metformin og et sulfonyurinstof og supplement til pioglitazon med eller uden metformin, sås ingen stigning i hyppighed af svær hypoglykæmi med empagliflozin.
English: FPG of -20.5 mg/dl [-1.14 mmol/l] for empagliflozin 10 mg and -23.2 mg/dl [-1.29 mmol/l] for empagliflozin 25 mg compared to placebo (7.4 mg/dl [0.41 mmol/l]).
Danish: I fire placebokontrollerede studier sås middelændringer fra baseline i forhold til placebo i FPG på -20,5 mg/dl [-1,14 mmol/l] for empagliflozin 10 mg og -23,2 mg/dl [-1,29 mmol/l] for empagliflozin 25 mg sammenlignet med placebo (7,4 mg/dl [0,41 mmol/l]), når empagliflozin blev givet som monoterapi eller i kombinationsbehandling til metformin, pioglitazon eller metformin plus et sulfonylurinstof.
English: Jardiance 25 mg film-coated tablets
Danish: Jardiance 25 mg filmovertrukne tabletter
English: Jardiance should not be initiated in patients with an eGFR below 60 ml/min/1.73 m2 or
Danish: Jardiance bør ikke initieres hos patienter med en eGFR under 60 ml/min/1,73 m2 eller CrCl <60 ml/min.
English: Dysuria a see subsections below for additional information b derived from postmarketing experience * see section 4.4
Danish: Dysuri a Se nedenstående delpunkter vedrørende yderligere oplysninger b
English: Empagliflozin should not be initiated in patients with an eGFR <60 ml/min/1.73 m or
Danish: Empagliflozin bør ikke initieres hos patienter med en eGFR <60 ml/min/1,73 m2 eller CrCl <60 ml/min.
English: Baseline (mean) Change from baseline5
Danish: Baseline (middelværdi) Ændring fra baseline5
English: Increased urinationa
Danish: Urinvejsinfektion
English: Due to the mechanism of action, the efficacy of empagliflozin is dependent on renal function.
Danish: Virkningen af empagliflozin afhænger, på grund af virkningsmekanismen, af patientens nyrefunktion, hvorfor nyrefunktionen bør vurderes:
English: Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Danish: Baseret på den farmakokinetiske populationsanalyse havde køn ingen klinisk relevant indvirkning på empagliflozins farmakokinetik.
English: Empagliflozin
Danish: Uringlucose
English: What Jardiance looks like and contents of the pack Jardiance 10 mg film-coated tablets are round, pale yellow, biconvex and bevel-edged.
Danish: Jardiance 10 mg filmovertrukne tabletter er runde, lysegule, bikonvekse med affaset kant.
English: Baseline (mean) Change from baseline4
Danish: Baseline (middelværdi) Ændring fra baseline4
English: Due to its mechanism of action, patients taking Jardiance will test positive for glucose in their urine.
Danish: Test for glucose i urinen vil være positiv på grund af Jardiances virkningsmekanisme.
English: Baseline (mean) Change from baseline2
Danish: Baseline (middelværdi) Ændring fra baseline2
English: The efficacy and safety of empagliflozin as add-on to multiple daily insulin with or without concomitant metformin therapy was evaluated in a double-blind, placebo-controlled trial of 52 weeks duration.
Danish: Empagliflozin som supplement til kontinuerlig insulinbehandling I et 52 ugers dobbeltblindet, placebokontrolleret studie, undersøgtes empagliflozins virkning og sikkerhed som supplement til kontinuerlig insulinbehandling med eller uden samtidig metforminbehandling .
English: Interaction studies conducted in healthy volunteers suggest that the pharmacokinetics of empagliflozin were not influenced by co-administration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Danish: Administration af metformin, glimepirid, pioglitazon, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemid og hydrochlorthiazid til raske frivillige i et interaktionsstudie viste, at der er ingen påvirkning af empagliflozins farmakokinetik.
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets Jardiance 25 mg film-coated tablets
Danish: Jardiance 10 mg filmovertrukne tabletter Jardiance 25 mg filmovertrukne tabletter
English: It is unknown if Jardiance is harmful to the unborn child. Do not use Jardiance if you are breast-feeding.
Danish: Det vides ikke, om Jardiance er skadeligt for det ufødte barn.
English: Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Danish: Baseret på den farmakokinetiske populationsanalyse havde BMI ingen klinisk relevant indvirkning på empagliflozins farmakokinetik.
English: What Jardiance is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with empagliflozin (see sections 4.2 and 4.8).
Danish: Risikoen for hypoglykæmi kan øges ved anvendelse af insulin og beta-cellestimulerende midler, som for eksempel sulfonylurinstoffer, hvorfor det kan være nødvendigt at reducere insulindosis og dosis af beta-cellestimulerende midler for at reducere risikoen for hypoglykæmi, når disse anvendes i kombination med empagliflozin (se pkt.
English: Tabulated list of adverse reactions
Danish: Liste over bivirkninger opstillet i tabel
English: Insulin and insulin secretagogues
Danish: Viena - Sucursala Bucureşti
English: The efficacy and safety of empagliflozin as add on to basal insulin with or without metformin and/or a sulphonylurea was evaluated in a double-blind, placebo-controlled trial of 78 weeks duration.
Danish: I et 78 ugers dobbeltblindet, placebokontrolleret studie undersøgtes empagliflozins virkning og sikkerhed som supplement til basal insulin med eller uden samtidig metformin og/eller et sulfonylurinstof.
English: Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin based on the population pharmacokinetic analysis.
Danish: Baseret på den farmakokinetiske populationsanalyse havde alder ingen klinisk relevant indvirkning på empagliflozins farmakokinetik.
English: No data in humans are available on excretion of empagliflozin into milk.
Danish: Det er ukendt, om empagliflozin udskilles i human mælk.
English: - Prior to initiation of any concomitant medicinal product that may have a negative impact on renal function.
Danish: 4.2, 5.1 og 5.2) - Før initiering af behandling med et andet lægemiddel, som kan have en negativ virkning på nyrefunktionen.
English: Бьорингер Ингелхайм РЦВ ГмбХ и Ко.
Danish: Бьорингер Ингелхайм РЦВ ГмбХ и Ко КГклон България
English: NAME OF THE MEDICINAL PRODUCT Jardiance 10 mg film-coated tablets Empagliflozin
Danish: Jardiance 10 mg filmovertrukne tabletter empagliflozin
English: NAME OF THE MEDICINAL PRODUCT Jardiance 25 mg film-coated tablets Empagliflozin
Danish: Jardiance 25 mg filmovertrukne tabletter empagliflozin
English: In patients where DKA is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately.
Danish: Empagliflozin skal straks seponeres hos patienter med formodet eller verificeret diabetisk ketoacidose.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: The study was conducted in North America, Latin America, Asia Pacific and Europe.
Danish: Studiet blev udført i Nordamerika, Latinamerika, Asien og Stillehavsområdet og Europa.
English: If you are between 9 and 14 years old
Danish: Hvis du er mellem 9 og 14 år
English: Frequencies are reported as:
Danish: Hyppigheden er rapporteret som:
English: Duration of protection has not fully been established.
Danish: Varigheden af beskyttelse er ikke endeligt fastsat.
English: Paediatric population (children < 9 years of age)
Danish: Pædiatrisk population (børn < 9 år)
English: See sections 4.4 and 5.1 for important information on the data that support this indication.
Danish: 4.4 og 5.1 for vigtige oplysninger om de data, der underbygger indikationen.
English: Administer the vaccine.
Danish: Administrer vaccinen.
English: Please speak to your doctor for more information.
Danish: Tal med lægen for yderligere oplysninger.
English: However, do not drive or use any machines if you are feeling unwell.
Danish: Du må dog ikke føre motorkøretøj eller betjene maskiner, hvis du føler dig utilpas.
English: Use with other vaccines
Danish: Anvendelse sammen med andre vacciner
English: The total number of injections you will receive depends on your age at the time of the first injection.
Danish: Antallet af injektioner, som du skal have, afhænger af din alder på tidspunktet for den første injektion.
English: In accordance with Article 114 of Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I henhold til artikel 114 i direktiv 2001/83/EF foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium udpeget hertil.
English: • if you have a severe infection with a high temperature.
Danish: • hvis du har en alvorlig infektion med høj feber.
English: These subjects were followed for serious adverse events over the entire study period.
Danish: Disse personer blev overvåget for alvorlige bivirkninger i hele studieperioden.
English: Therefore, appropriate precautions against sexually transmitted diseases should continue to be used.
Danish: Nødvendige forholdsregler mod seksuelt overførte sygdomme skal derfor fortsat tages.
English: The vaccination schedule depends on the age of the subject.
Danish: Vaccinationsprogrammet afhænger af personens alder.
English: • if you are allergic to any of the active substances or any of the other ingredients of this vaccine (listed in section 6).
Danish: • hvis du er allergisk over for de aktive stoffer eller et af de øvrige indholdsstoffer i denne vaccine (angivet i punkt 6).
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i køleskab.
English: Specific studies of the vaccine in pregnant women were not conducted.
Danish: Der er ikke udført specifikke studier med vaccination af gravide kvinder.
English: No fertility data are available.
Danish: Der foreligger ingen fertilitetsdata.
English: Very common Myalgia Common
Danish: Meget almindelig Myalgi Almindelig
English: The GMTs were, however, lower in women above 25 years.
Danish: GMT var imidlertid lavere hos kvinder over 25 år.
English: The majority of these reactions were of mild to moderate severity and were not long lasting.
Danish: Hovedparten af disse reaktioner var lette til moderate i sværhedsgrad og forsvandt efter kort tid.
English: The data showed comparable immunogenicity in males and females.
Danish: Dataene viste en sammenlignelig immunogenicitet hos mandlige og kvindelige personer.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier over eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Read all of this leaflet carefully before you start receiving this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du bliver vaccineret, da den indeholder vigtige oplysninger.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodiumfree”.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natriumfri.
English: Final analysis was performed at study conclusion, 7 years after 1st vaccination.
Danish: Den endelige analyse blev udført ved afslutningen af studiet, som var 7 år efter 1. vaccination.
English: Use with hormonal contraceptive
Danish: Anvendelse sammen med hormonelle kontraceptionsmidler
English: It is important that procedures are in place to avoid injury from faints.
Danish: Det er vigtigt, at nødvendige foranstaltninger er til stede for at undgå skader efter besvimelse.
English: 20 micrograms
Danish: 20 mikrogram
English: When the value zero is included, i.e. when the lower limit of the CI is <0, the efficacy is not considered statistically significant.
Danish: Når værdien nul indgår, dvs. når den nedre grænse af CI er mindre end nul, anses effekten for ikke at være statistisk signifikant.
English: Twelve-month persistent infection was evaluated as additional efficacy endpoint.
Danish: 12måneders persisterende infektion blev evalueret som et yderligere endepunkt for effekt.
English: Immunogenicity in HIV infected women
Danish: Immunogenicitet hos hiv-inficerede kvinder
English: The GMTs appeared to be lower in the HIV infected group (non overlapping 95% confidence interval).
Danish: GMT syntes at være lavere i gruppen med hiv-inficerede (ikke overlappende 95 % konfidensinterval).
English: 0.5 milligrams Al3+ in total
Danish: 0,5 milligram Al3+ totalt
English: If you do not finish the complete vaccination course (two or three injections depending on your age at vaccination), you may not get the best response and protection from the vaccination.
Danish: Hvis du ikke afslutter det fulde vaccinationsprogram (to eller tre vaccinationer afhængigt af din alder ved første vaccination), er det ikke sikkert, at du får den fulde virkning og beskyttelse af vaccinen.
English: This does not constitute a sign of deterioration.
Danish: Det er ikke et tegn på nedbrydelse.
English: Therefore tell the doctor or nurse if you or your child fainted with a previous injection.
Danish: Du skal derfor fortælle lægen eller sygeplejersken, hvis du eller dit barn tidligere er besvimet i forbindelse med en injektion.
English: In clinical studies, approximately 60% of women who received Cervarix used hormonal contraceptives.
Danish: I kliniske studier brugte ca. 60 % af kvinderne, som fik Cervarix, hormonel prævention.
English: • aching muscles, muscle tenderness or weakness (not caused by exercise)
Danish: • muskelsmerter, muskelømhed eller svaghed (som ikke skyldes motion)
English: However, it is unknown whether vaccine-induced antibodies are excreted in human breast milk.
Danish: Det er dog uvist, om vaccineinducerede antistoffer udskilles i humant modermælk.
English: It is important that you follow the instructions of your doctor or nurse regarding return visits.
Danish: Det er vigtigt, at du følger lægens eller sygeplejerskens instruktion mht. opfølgende vaccinationsbesøg.
English: A similar kinetic profile was observed with the neutralising antibodies.
Danish: En tilsvarende kinetikprofil blev set med de neutraliserende antistoffer.
English: Initially seropositive and seronegative subjects reached similar titres after vaccination.
Danish: Initialt seropositive og seronegative personer opnåede stort set samme titer efter vaccination.
English: Clinical efficacy in women aged 15 to 25 years
Danish: Klinisk effekt hos kvinder i alderen 15 til 25 år
English: • allergic reactions.
Danish: • overfølsomhedsreaktioner.
English: The vaccine has not been shown to have a therapeutic effect.
Danish: Det er ikke påvist, at vaccinen har en terapeutisk effekt.
English: Animal studies have shown that the efficacy of L1 VLP vaccines is largely mediated by the development of a humoral immune response.
Danish: Dyreforsøg har vist, at effekten af L1-VLP-vacciner i høj grad beror på udviklingen af et humoralt immunrespons.
English: It might be necessary to postpone the vaccination until recovery.
Danish: Det kan være nødvendigt at udskyde vaccinationen, til du er rask igen.
English: Inclusion of this subset allowed assessment of prophylactic efficacy in a population that is thought to reflect a real-world setting, as adult women are the age group generally targeted for cervical screening.
Danish: Ved at inkludere denne delgruppe af kvinder, var det muligt at vurdere profylatisk effekt i en population, som menes at afspejle sammensætningen i den virkelige verden, da voksne kvinder er den aldersgruppe, der generelt er målrettet cervikal screening.
English: However, during the clinical development program, a total of 10,476 pregnancies were reported including 5,387 in women who had received Cervarix.
Danish: Under det kliniske udviklingsprogram er der imidlertid rapporteret 10.476 graviditeter, heriblandt 5.387 hos kvinder, der havde fået Cervarix.
English: Functional antibodies were not determined.
Danish: Funktionelle antistoffer blev ikke målt.
English: 50 micrograms
Danish: 50 mikrogram
English: Cervarix is a turbid white suspension.
Danish: Cervarix er en uklar, hvid suspension.
English: This cohort included women with normal or low-grade cytology at baseline and excluded only women with high-grade cytology (0.5% of the total population).
Danish: Denne kohorte inkluderede kvinder med normal eller low-grade cytologi ved baseline, og kun kvinder med high-grade cytologi (0,5 % af den totale population) blev ekskluderet.
English: Fever (≥38°C) Uncommon Other injection site reactions such as induration, local paraesthesia
Danish: Feber (≥ 38 °C) Ikke almindelig Andre reaktioner på injektionsstedet såsom induration, lokal paræstesi
English: Cervarix should only be used during breast-feeding when the possible advantages outweigh the possible risks.
Danish: Cervarix bør kun gives i ammeperioden, når mulige fordele opvejer mulige risici.
English: Date of latest renewal: 17 September 2012.
Danish: Dato for første markedsføringstilladelse: 20. september 2007 Dato for seneste fornyelse: 17. september 2012
English: In study 008, immunogenicity up to month 48 was similar to the response observed in study 001.
Danish: I studie 008 var immunogeniciteten i op til 48 måneder sammenlignelig med responset observeret i studie 001.
English: Sodium chloride (NaCl)
Danish: Natriumchlorid (NaCl)
English: % Efficacy (95% CI)
Danish: % Effekt (95 % CI)
English: Cervarix should be used in accordance with official guidelines.
Danish: Cervarix skal anvendes i overensstemmelse med officielle retningslinjer.
English: Name and address of the manufacturers of the biological active substance
Danish: Navn og adresse på fremstillerne af de biologisk aktive stoffer
English: Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Danish: Denne vaccine kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The clinical relevance of this observation is not known.
Danish: Den kliniske relevans af denne observation kendes ikke.
English: Cervarix is not recommended for use in children below 9 years of age due to lack of data on safety and immunogenicity in this age-group.
Danish: Cervarix bør ikke bruges til børn under 9 år på grund af manglende data om sikkerhed og immunogenicitet i denne aldersgruppe.
English: Since the VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.
Danish: Da VLP ikke indeholder viralt DNA, kan det ikke inficere celler, reproducere sig eller forårsage sygdom.
English: **If flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose and the third dose between 5 and 12 months after the first dose.
Danish: **Hvis der er behov for et fleksibelt vaccinationsprogram, kan den anden dosis administreres mellem 1 og 2½ måned efter første dosis og den tredje dosis mellem 5 og 12 måneder efter første dosis.
English: A minor infection such as a cold should not be a problem, but talk to the doctor first.
Danish: En lettere infektion som f.eks. forkølelse bør ikke være noget problem, men tal med lægen, inden du bliver vaccineret.
English: Timing and need of booster dose(s) has not been established.
Danish: Tidspunkt og behov for boosterdosis er ikke fastlagt.
English: The study was not powered to assess efficacy against disease caused by individual HPV types.
Danish: Studiet var ikke designet til at vurdere effekt mod sygdom forårsaget af individuelle HPV-typer.
English: This cohort included women with or without current and/or prior HPV infection.
Danish: Denne kohorte inkluderede kvinder med eller uden eksisterende og/eller forudgående HPV-infektion.
English: In all clinical trials individuals who had received immunoglobulin or blood-derived products within 3 months prior to the first vaccine dose were excluded.
Danish: I samtlige kliniske undersøgelser blev personer, som havde modtaget immunoglubulin eller blodderivater i 3 måneder forud for den første vaccinedosis, udelukket.
English: You will receive 2 injections:
Danish: Skal du have 2 injektioner:
English: The vaccine should be well shaken before use.
Danish: Vaccinen skal omrystes omhyggeligt før brug.
English: The most common adverse reaction observed after vaccine administration was injection site pain which occurred after 78% of all doses.
Danish: Den hyppigste bivirkning efter administration af vaccine var smerter på injektionsstedet, som blev set efter 78 % af alle doser.
English: The vaccine is therefore not indicated for treatment of cervical cancer or cervical intraepithelial neoplasia (CIN).
Danish: Vaccinen er derfor ikke indiceret til behandling af cervixcancer eller cervikal intraepitelialneoplasi (CIN).
English: Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100)
Danish: Almindelig (≥ 1/100 til < 1/10) Ikke almindelig (≥ 1/1.000 til < 1/100)
English: Duration of the immune response in women aged 26 years and older
Danish: Varighed af immunresponset hos kvinder i alderen 26 år og derover
English: B-1330 Rixensart, Belgium
Danish: B-1330 Rixensart, Belgien
English: 4.4 Special warnings and precautions for use As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Som for alle andre injicerbare vacciner, skal relevant medicinsk behandling og overvågning være umiddelbart tilgængelig for det tilfælde, at der opstår en sjælden anafylaktisk reaktion efter administration af vaccinen.
English: Cervarix should be administered as soon as possible after being removed from the refrigerator.
Danish: Cervarix skal administreres umiddelbart efter, at den er taget ud af køleskab.
English: However, stability has been demonstrated when stored outside the refrigerator for up to 3 days at temperatures between 8°C and 25°C or for up to 1 day at temperatures between 25°C and 37°C.
Danish: Der er dog påvist stabilitet ved opbevaring uden for køleskab i op til 3 dage ved temperaturer mellem 8 ºC og 25 ºC eller i op til 1 dag ved temperaturer mellem 25 ºC og 37 ºC.
English: Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
Danish: Bivirkninger, som ansås for at have en mulig sammenhæng med vaccinationen, er kategoriseret ud fra hyppighed.