FrancophonIA/ELRC3.0 huggingface dataset:
English: Epidemiological studies in women who use low dose (<50 μg ethinylestradiol) combined hormonal contraceptives have found that out of 10,000 women between about 6 and 12 will develop a VTE in one year
Danish: Epidemiologiske studier hos kvinder, der anvendte lavdosis (<50 μg ethinylestradiol) hormonelle kontraceptiva af kombinationstypen fandt, at ud af 10.000 kvinder vil mellem ca. 6 og 12 kvinder udvikle en VTE i løbet af ét år.
English: If any of the above conditions change while you are using [invented name], for example a close family member experiences a thrombosis for no known reason; or you gain a lot of weight, tell your doctor.
Danish: Fortæl det til din læge, hvis nogle af ovenstående tilstande ændres, mens du bruger [særnavn], f.eks. hvis et nært familiemedlem får en blodprop uden kendt årsag, eller hvis du tager meget på i vægt.
English: • fullness, indigestion or choking feeling;
Danish: • oppustethed, fordøjelsesbesvær eller kvælningsfornemmelse
English: [This following wording should be reflected in this section]
Danish: [Følgende tekst skal reflekteres i dette punkt]
English: Package Leaflet [The wording below should be inserted at the top of the package leaflet]
Danish: Indlægsseddel [Nedenstående tekst skal indsættes øverst i indlægssedlen]
English: Desogestrel-containing CHC (9-12 events)
Danish: Kombineret hormonelt præventionsmiddel, der indeholder gestoden (9-12 hændelser)
English: [The following wording to be kept/added (as appropriate)] Extremely rarely, thrombosis has been reported to occur in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries.
Danish: [Følgende tekst skal beholdes/tilføjes (hvor relevant)] Trombose i andre blodkar er set ekstremt sjældent hos brugere af et kombineret hormonelt præventionsmiddel, f.eks. i hepatiske, mesenteriske, renale eller retinale vener og arterier.
English: In women who do not use a CHC and are not pregnant about 2 out of 10,000 will develop a VTE over the period of one year.
Danish: Hos kvinder, der ikke tager et kombineret hormonelt præventionsmiddel og som ikke er gravide, vil ca. 2 ud af 10.000 udvikle en VTE i løbet af en periode på ét år.
English: When using a combined hormonal contraceptive like [invented name] you are advised to stop smoking.
Danish: Du rådes til at holde op med at ryge, når du bruger et kombineret hormonelt præventionsmiddel som [særnavn].
English: [The following wording to be kept/added, as appropriate] Extremely rarely, thrombosis has been reported to occur in CHC users in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries.
Danish: [Følgende tekst skal beholdes/tilføjes hvor det er relevant] Trombose i andre blodkar er set ekstremt sjældent hos brugere af et kombineret hormonelt præventionsmiddel, f.eks. i hepatiske, mesenteriske, renale eller retinal vener og arterier.
English: The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with [invented name], how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.
Danish: Beslutningen om at anvende et andet præparat end et præparat med den laveste risiko for VTE, bør kun træffes efter en samtale med kvinden, så det sikres, at hun forstår risikoen for VTE med [særnavn], hvordan hendes aktuelle risikofaktorer påvirker denne risiko, og at hendes risiko for VTE er størst i det første år, hvor produktet anvendes.
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains etonogestrel or norelgestromin such as [invented name] between about 6 and 12 women will develop a blood clot in a year.
Danish: - Ud af 10.000 kvinder, der bruger et kombineret hormonelt præventionsmiddel, der indeholder etonogestrel eller norelgestromin som f.eks. [særnavn], vil mellem ca. 6-12 kvinder udvikle en blodprop i løbet af ét år.
English: • If you have an inflammation in the veins under the skin (superficial thrombophlebitis).
Danish: • hvis du har en betændelseslignende reaktion (inflammation) i venerne under huden (superficiel tromboflebitis).
English: The decision to use any product other than one known to have the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with CHCs, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use.
Danish: Beslutningen om at anvende et andet præparat end et præparat, der vides at have den laveste risiko for VTE, bør kun træffes efter en samtale med kvinden, så det sikres, at hun forstår risikoen for VTE med hormonelle kontraceptiva af kombinationstypen, hvordan hendes aktuelle risikofaktorer påvirker denne risiko, og at hendes risiko for VTE er størst i det første år, hvor produktet anvendes.
English: ANNEX III.E - etonogestrel containing combined hormonal contraceptives
Danish: Bilag III.E - Hormonelle kontraceptiva af kombinationstypen, der indeholder etonogestrel
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel or norethisterone, or norgestimate such as [Invented name], about 5-7 will develop a blood clot in a year.
Danish: - Ud af 10.000 kvinder, der bruger et kombineret hormonelt præventionsmiddel, der indeholder levonorgestrel, norethisteron eller norgestimat som f.eks. [særnavn], vil ca. 5-7 kvinder udvikle en blodprop i løbet af ét år.
English: 2 Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
Danish: 2 Middelværdi 5-7 pr. 10.000 kvindeår baseret på en relativ risiko for hormonelle kontraceptiva af kombinationstypen, der indeholder levonorgestrel, versus ingen anvendelse på ca. 2,3-3,6
English: ANNEX III.D - drospirenone containing combined hormonal contraceptives
Danish: Bilag III.D - Hormonelle kontraceptiva af kombinationstypen, der indeholder drospirenon
English: It is estimated that out of 10,000 women who use a low dose CHC that contains levonorgestrel, about 61 will develop a VTE in one year.
Danish: Det vurderes, at ud af 10.000 kvinder, der tager et kombineret lavdosis hormonelt præventionsmiddel, der indeholder levonogestrel, vil ca. 61 kvinder udvikle en VTE i løbet af ét år.
English: ANNEX III.G - norgestimate containing combined hormonal contraceptives
Danish: Bilag III.G - Hormonelle kontraceptiva af kombinationstypen, der indeholder norgestimat
English: 1 Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
Danish: 1 Middelværdi 5-7 pr. 10.000 kvindeår baseret på en relativ risiko for hormonelle kontraceptiva af kombinationstypen, der indeholder levonorgestrel, versus ingen anvendelse på ca. 2,3-3,6
English: The number of VTEs per year with low dose CHCs is fewer than the number expected in women during pregnancy or in the postpartum period.
Danish: Antallet af VTE'er pr. år med lavdosis hormonelle kontraceptiva af kombinationstypen er lavere end det forventede antal hos kvinder under graviditet eller i post partum-perioden.
English: Section 4.3 - Contraindications [This section should be amended to include the following contraindications] Combined hormonal contraceptives (CHCs) should not be used in the following conditions:
Danish: [Dette punkt skal ændres, så det inkluderer følgende kontraindikationer] Hormonelle kontraceptiva af kombinationstypen bør ikke anvendes under følgende forhold:
English: Mid-point of range of 5-7 per 10,000 WY, based on a relative risk for CHCs containing levonorgestrel versus non-use of approximately 2.3 to 3.6
Danish: Middelværdi 5-7 pr. 10.000 kvindeår baseret på en relativ risiko for hormonelle kontraceptiva af kombinationstypen, der indeholder levonorgestrel, versus ingen anvendelse på ca. 2,3-3,6
English: Section 4.6 - Fertility, pregnancy and lactation Pregnancy [The following wording should be added to this section] The increased risk of VTE during the postpartum period should be considered when re-starting [invented name] (see section 4.2 and 4.4).
Danish: 4.6 Fertilitet, graviditet og amning Graviditet [Følgende tekst skal tilføjes i dette punkt]
English: ANNEX III.B - desogestrel containing combined hormonal contraceptives
Danish: Bilag III.B - Hormonelle kontraceptiva af kombinationstypen, der indeholder desogestrel
English: [For all chlormadinone containing combined hormonal contraceptives listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Danish: [For alle hormonelle kontraceptiva af kombinationstypen, der indeholder chlormadinon, anført i Bilag I, skal de eksisterende produktoplysninger ændres (henholdsvis indsætning, erstatning eller sletning af tekst), så de svarer til nedenstående vedtagne tekst]
English: ANNEX III.C - dienogest containing combined hormonal contraceptives
Danish: Bilag III.C - Hormonelle kontraceptiva af kombinationstypen, der indeholder dienogest
English: - Out of 10,000 women who are using a combined hormonal contraceptive that contains desogestrel, such as [invented name], between about 9 and 12 women will develop a blood clot in a year.
Danish: - Ud af 10.000 kvinder, der bruger et kombineret hormonelt præventionsmiddel, der indeholder desogestrel som f.eks. [særnavn], vil mellem ca. 9-12 kvinder udvikle en blodprop i løbet af ét år.
English: ANNEX III.F - gestodene containing combined hormonal contraceptives
Danish: Bilag III.F - Hormonelle kontraceptiva af kombinationstypen, der indeholder gestoden
English: [The following should be deleted (where applicable)] There is no consensus as to whether the occurrence of these events is associated with the use of CHCs.
Danish: [Dette punkt skal ændres, så det inkluderer nedenstående tekst] Du må ikke bruge [særnavn], hvis du har nogle af nedenstående tilstande.
English: It is estimated that out of 10,000 women who use a CHC that contains levonorgestrel, about 61 will develop a VTE in a year.
Danish: Det vurderes, at ud af 10.000 kvinder, der tager et kombineret hormonelt præventionsmiddel, der indeholder levonorgestrel, vil ca. 61 kvinder udvikle en VTE løbet af ét år.
English: they occur in the first year of use of a combined hormonal contraceptive.
Danish: rådgivning, inden der træffes beslutning om anvendelse af et kombineret hormonelt præventionsmiddel.
English: [This following wording should be inserted in this section]
Danish: [Nedenstående tekst skal indsættes i dette punkt]
English: When to take special care with [Invented name]
Danish: Vær særlig forsigtig med [særnavn] i disse tilfælde
English: Out of 10,000 women who use a levonorgestrel-containing CHC about 61 will develop a VTE in one year.
Danish: Ud af 10.000 kvinder, der tager et kombineret hormonelt præventionsmiddel, der indeholder levonorgestrel, vil ca. 61 kvinder udvikle en VTE i løbet af ét år.
English: • painless blurring of vision which can progress to loss of
Danish: • uklart syn uden smerter.
English: • if you need an operation or if you are off your feet for a long time (see section ‘Blood clots');
Danish: • hvis du skal opereres, eller hvis du sidder eller ligger ned i længere tid (se punkt ‘Blodpropper');
English: • sensation of squeezing or fullness in the chest, arm or below the breastbone;
Danish: • knugende fornemmelse eller oppustethed i brystet,
English: • if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots').
Danish: • hvis du skal opereres, eller hvis du sidder eller ligger ned i længere tid (se punkt 2 ‘Blodpropper)'.
English: • if you need an operation, or you are off your feet for a long time (see in section 2 ‘Blood clots');
Danish: • hvis du skal opereres, eller hvis du sidder eller ligger ned i længere tid (se punkt 2 ‘Blodpropper';
English: [For all etonogestrel containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Danish: [For alle hormonelle kontraceptiva af kombinationstypen, der indeholder etonogestrel, anført i Bilag I, skal de eksisterende produktoplysninger ændres (henholdsvis indsætning, erstatning eller sletning af tekst efter behov), så de svarer til nedenstående vedtagne tekst]
English: Section 4.4 - Special warnings and precautions for use
Danish: 4.3) og advarslerne (se pkt.
English: [For all norgestimate containing products listed in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Danish: [For alle hormonelle kontraceptiva af kombinationstypen, der indeholdende norgestimat, anført i Bilag I, skal de eksisterende produktoplysninger ændres (indsætning, erstatning eller sletning af tekst efter behov), så de svarer til nedenstående vedtagne tekst]
English: BLOOD CLOTS
Danish: BLODPROPPER
English: It is estimated1 that out of 10,000 women who use a CHC containing drospirenone, between 9 and 12 women will develop a VTE in one year; this compares with about 62 in women who use a levonorgestrel-containing CHC.
Danish: Det vurderes,1 at ud af 10.000 kvinder, der tager et kombineret hormonelt præventionsmiddel, der indeholder desogestrel, vil mellem 9 og 12 kvinder udvikle en VTE i løbet af ét år.
English: • Are you pregnant, or do you think you might be pregnant?
Danish: • Er du gravid, eller tror du, du kan være gravid?
English: Please read it carefully.
Danish: Læs den venligst omhyggeligt.
English: However, any effects are not to be expected.
Danish: Der forventes dog ingen effekt.
English: It is of high importance that the patient is carefully checked.
Danish: Det er yderst vigtigt, at patienten undersøges grundigt.
English: Children from 5 to 12 years of age Above-mentioned indications, if relevant for this group of children
Danish: Børn fra 5 til 12 år Ovenfor nævnte indikationer hvis de er relevante for denne gruppe af børn
English: For patients in this age group it is advised to use an oral suspension.
Danish: Til patienter i denne aldersgruppe, anbefales det at anvende en oral suspension.
English: All of these reactions need urgent medical attention.
Danish: Alle disse reaktioner kræver hurtig lægebehandling.
English: So, it is only suitable for treating some types of infection.
Danish: Derfor er det kun egnet til at behandle visse typer af infektioner.
English: You should not stop the medicine just because you feel better.
Danish: Du må ikke holde op med at tage lægemidlet bare fordi, du føler dig bedre.
English: If you stop too soon, the infection may start up again.
Danish: Hvis du holder op for tidligt, kan infektionen blusse op igen.
English: Under these circumstances maximum serum concentration is achieved after 2-3 hours.
Danish: Under disse forhold opnås maximal serumkoncentration efter 2-3 timer.
English: In some cases, medicines can affect the way other medicines work.
Danish: I nogle tilfælde kan lægemidler påvirke andre lægemidlers virkning.
English: 08013 Barcelona Spain
Danish: 08013 Barcelona Spanien
English: So far, animal tests have not yielded evidence of harmfulness.
Danish: Indtil nu har dyretests ikke vist tegn på skadelighed.
English: Species for which resistance may be a problem Acinetobacter species
Danish: Arter, hvor resistens kan være et problem Acinetobacter arter
English: Although this medicine is not known to harm the unborn child, it will only be given to a pregnant woman if it is really necessary.
Danish: Selvom dette lægemiddel ikke er kendt for at skade et ufødt barn, vil det kun blive givet til gravide, hvis det virkeligt er nødvendigt.
English: Aerobes, Gram positive:
Danish: Aerober, Gram positive:
English: Early Lyme disease
Danish: Tidlig Lyme sygdom
English: It is important that you take this medicine until you finish the prescribed course.
Danish: Det er vigtigt at du tager dette lægemiddel indtil du har afsluttet den ordinerede kur.
English: The frequency of diarrhoea is related to the administered dose and may rate up to 10% with tablets.
Danish: Hyppigheden af diarré er relateret til den administrerede dosis og kan nå op på 10 % med tabletter.
English: These types of antibiotics are similar to penicillin.
Danish: Disse typer af antibiotika ligner penicillin.
English: other than S. pneumoniae:
Danish: udover S. pneumoniae:
English: The recommended doses are given below.
Danish: De anbefalede doser er angivet nedenfor.
English: Bacterial lysis is the end result.
Danish: Bakterielyse er slutresultatet.
English: Children under 5 years of age:
Danish: Børn under 5 år:
English: Take the medicine with you in the carton, so that staff will know exactly what has been taken.
Danish: Medbring lægemidlet i pakningen, så personalet kan se, nøjagtigt hvad du har taget.
English: For the conditions listed above:
Danish: For de sygdomme, der er beskrevet ovenfor:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CEFUROXIMAXETIL (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF CEFUROXIMAXETIL (se bilag I)
English: About 50% is excreted by glomerular filtration and about 50% through renal tubular secretion within 24 hours, with the majority being eliminated within 6 hours; high concentrations are achieved in the urine.
Danish: Omkring 50% udskilles ved glomerulær filtration og omkring 50% gennem renal tubulær sekretion inden for 24 timer, med hovedparten elimineret inden for 6 timer; høje koncentrationer opnås i urinen.
English: This is because it helps this medicine to be absorbed into the body.
Danish: Dette hjælper lægemidlet til at optages i kroppen.
English: The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Prævalensen af resistens kan variere geografisk og over tid for særlige arter, og lokal information er ønskelig, særlig ved behandling af svære infektioner.
English: The usual duration of therapy is 7 days (ranging from 5 to 10 days).
Danish: Den almindelige behandlingsvarighed er 7 dage (varierende fra 5 til 10 dage).
English: Patients should be informed of this common and usually self-limited reaction being a consequence of antibiotic treatment of Lyme disease.
Danish: Patienter bør gøres opmærksomme på, at denne almindelige og sædvanligvis selvbegrænsende reaktion er en konsekvens af antibiotisk behandling af Lyme sygdom.
English: Mechanism of resistance Bacterial resistance to cefuroxime may be due to one or more of the following mechanisms:
Danish: Resistensmekanismer Bakteriel resistens over for cefuroxim kan skyldes en eller flere af følgende mekanismer:
English: The plasma half-life ranges between 60 and 90 minutes and is prolonged in patients with renal impairment and in neonates.
Danish: Plasmahalveringstiden er mellem 60 og 90 minutter, og den er forlænget hos patienter med nedsat nyrefunktion og hos nyfødte.
English: FARMACÉUTICA, S.A. Gran Vía de les Corts Catalanes, 764
Danish: Gran Vía de les Corts Catalanes, 764
English: Anaerobes,
Danish: Anaerober,
English: Infections and infestations:
Danish: Infektioner og infestationer:
English: Adults and children above the age of 12
Danish: Voksne og børn over 12 år
English: This is because you might also be allergic to this medicine.
Danish: Du kan måske også være overfølsom over for dette lægemiddel.
English: The duration of treatment of early Lyme disease should be 20 days.
Danish: Behandlingsvarigheden for behandling af tidlig Lyme sygdom bør være 20 dage.
English: If you forget to take a dose of this medicine at the right time, take it as soon as you remember.
Danish: Hvis du har glemt at tage en dosis, skal du tage den, så snart du kommer i tanke om det.
English: Existing Marketing Authorisations should be varied and pending Marketing Authorisation Applications (see Annex I) should be granted to include these amendments.
Danish: De foreliggende markedsføringstilladelser bør ændres, og de ansøgninger om markedsføringstilladelse, der er under behandling (se bilag I), bør godkendes med medtagning af disse ændringer.
English: In case of pharyngotonsillitis caused by Streptococcus pyogenes a therapy duration of at least 10 days is indicated.
Danish: I tilfælde af pharyngotonsillitis forårsaget af Streptococcus pyogenes, er en behandlingsvarighed på mindst 10 dage indiceret.
English: This may result in easy bleeding or bruising.
Danish: Dette kan forårsage at man nemmere får blødninger eller blå mærker.
English: With respect to the treatment of early Lyme disease there is only clinical experience with children from the age of 12 and with adults.
Danish: Hvad angår behandling af tidlig Lyme sygdom, findes der kun klinisk erfaring med børn over 12 år og voksne.
English: This medicine should not be given to women who are breastfeeding.
Danish: Dette lægemiddel bør ikke gives til ammende kvinder.
English: The incidence is even higher (approx. 13%) at prolonged treatment of 20 days of early Lyme disease.
Danish: Forekomsten er endnu højere (ca. 13 %) ved forlænget behandlingsvarighed på 20 dage ved tidlig Lyme sygdom.
English: A 20-day treatment of Lyme disease may cause the frequency of developing diarrhoea to increase.
Danish: En 20-dages behandling af Lyme sygdom kan forårsage øget hyppighed af diarré.
English: Consequently, the Summary of Product Characteristics and package leaflet should be amended as set out in Annex III.
Danish: Produktresuméet og indlægssedlen bør derfor ændres som angivet i bilag III.
English: Children between the ages of 5 and 12
Danish: Børn mellem 5 og 12 år
English: If a superinfection occurs during treatment, appropriate measures should be taken (see section 4.8 ).
Danish: Hvis en superinfektion opstår under behandlingen, bør fornøden foranstaltning iværksættes (se afsnit 4.8.
English: Restlessness, nervousness, confusion
Danish: Rastløshed, nervøsitet, konfusion
English: Official guidance should be sought for its use and data on resistance just like for the other recommended antibiotics for this indication.
Danish: Anvendelsen bør baseres på officielle retningslinjer og resistensdata på linje med de øvrige antibiotika, der anbefales til denne indikation.
English: It diffuses across the placenta and has been detected in breast milk.
Danish: Det diffunderer over placenta og kan påvises i brystmælk.
English: Optimum absorption occurs when Cefuroximaxetil is taken shortly after a meal (50-60%).
Danish: Der opnås optimal absorption, hvis Cefuroximaxetil tages kort efter et måltid (50-60 %).
English: • hydrolysis by beta-lactamases.
Danish: • Hydrolyse af β-laktamaser.
English: It belongs to a group of antibiotics that are called cephalosporins.
Danish: Det tilhører en gruppe af antibiotika, der kaldes cefalosporiner.
English: Information on how many tablets and how often they should be taken will exactly be written on the dispensing label.
Danish: Information om hvor mange tabletter, du skal tage, og hvor ofte, vil stå nøjagtigt på recepten.
English: Dosage schedule for tablets:
Danish: Doseringsskema for tabletter:
English: Increased levels of creatinine and urea in serum, especially in patients with impaired renal function.
Danish: Almindelig Forhøjede værdier af creatinin og urinstof i serum, særligt hos patienter med nedsat nyrefunktion
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Danish: Råd fra eksperter bør indhentes, når den lokale prævalens af resistens er således, at brug af stoffet til nogle typer af infektioner er tvivlsom.
English: Al/Al strip: 36 months
Danish: Alu/alu strip: 36 måneder Alu/alu blister: 36 måneder
English: See the package leaflet for further information
Danish: Læs indlægssedlen for yderligere oplysninger
English: Certain tests for determining some substances in your blood might show different results while you take cefuroxime axetil (Coombs test).
Danish: Visse prøver, der fastslår visse stoffer i dit blod kan give anderledes resultater, mens du tager cerufoximaxetil (Coombs prøve).