FrancophonIA/ELRC3.0 huggingface dataset:
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion Each vial contains 2 ml of concentrate.
Danish: Ibandronsyre Accord 2 mg koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 2 ml koncentrat.
English: Paediatric population (see section 4.2 and section 5.2).
Danish: Pædiatrisk population (se pkt.
English: Rare (may affect up to 1 in 1000 people):
Danish: Sjælden (kan forekomme hos 1 ud af 1000 behandlede):
English: Solution for injection 1 pre-filled syringe + 1 injection needle 4 pre-filled syringes + 4 injection needles
Danish: 4 fyldte injektionssprøjter + 4 kanyler
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)†
Danish: Osteonekrose i kæben†** Osteonekrose af øregangen (klassebivirkning for bisfosfonater).
English: • stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)
Danish: • mavesmerter, fordøjelsesbesvær, følelse af at være syg, opkastning eller diarré
English: Sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.
Danish: Natriumchlorid, natriumacetattrihydrat, iseddikesyre og vand til injektionsvæsker.
English: Excipients: sodium chloride, acetic acid, glacial, sodium acetate trihydrate and water for injections.
Danish: Hjælpestoffer: natriumchlorid, iseddikesyre, natriumacetattrihydrat og vand til injektionsvæsker.
English: • kidney cyst(fluid-filled sac in the kidney)
Danish: • cyste på nyren (væskefyldte blærer i nyre).
English: • stomach problems such as ‘“gastroenteritis”' or ‘“gastritis”'
Danish: • maveproblemer, såsom mave-tarmkatar eller mavekatar
English: Ibandronic acid was not studied in the paediatric population, therefore no efficacy or safety data are available for this patient population.
Danish: Ibandronsyre er ikke undersøgt i den pædiatriske population.
English: A statistically significant improvement in bone pain score was shown for intravenous ibandronic acid 6 mg compared to placebo.
Danish: Intravenøs ibandronsyre 6 mg viste i sammenligning med placebo en statistisk signifikant forbedring i knoglesmertescore.
English: • One pre-filled syringe of 3 ml solution contains 3 mg ibandronic acid (as sodium monohydrate).
Danish: • En fyldt injektionssprøjte indeholder 3 ml ibandronsyre (som natriummonohydrat).
English: • asthma attacks
Danish: • astmaanfald
English: Renal and urinary
Danish: Nyrer og urinveje
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed:
Danish: For patienter med brystkræft og knoglemetastaser med moderat nedsat nyrefunktion (kreatininclearance ≥ 30 og < 50 ml/min) eller svært nedsat nyrefunktion (kreatininclearance < 30 ml/min), som behandles for at forebygge knoglerelaterede hændelser, skal følgende dosisrekommendationer følges:
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid
Danish: Ibandronsyre Accord 2 mg koncentrat til infusionsvæske, opløsning Ibandronsyre Accord 6 mg koncentrat til infusionsvæske, opløsning ibandronsyre
English: It is recommended that the product once diluted be used immediately (see point 5 of this leaflet ‘How to store Ibandronic Acid Accord').
Danish: Det anbefales at opløsningen anvendes straks efter fortynding (se pkt.
English: Ibandronic acid should not be used during breastfeeding.
Danish: Ibandronsyre bør ikke anvendes under amning.
English: Gastritis, Dyspepsia, Diarrhoea, Abdominal pain, Nausea, Constipation
Danish: Mave-tarmkanalen Gastritis, dyspepsi, diarré, mavesmerter, kvalme, forstoppelse
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion Each vial contains 6 ml of concentrate.
Danish: Ibandronsyre Accord 6 mg koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 2 ml koncentrat.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning
English: Do not receive Ibandronic acid Accord
Danish: Du må ikke få Ibandronsyre Accord:
English: PRE-FILLED SYRINGE
Danish: Osteonekrose i kæben
English: Ibandronic acid dose
Danish: Natriumchlorid Iseddikesyre
English: For this purpose the contents of the vial are to be used as follows: - Prevention of Skeletal Events in patients with breast cancer and bone metastases - added to 100 ml isotonic sodium chloride solution or 100 ml 5 % dextrose solution and infused over at least 15 minutes.
Danish: • Forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastasertilsættes 100 ml isotonisk natriumchlorid-infusionsvæske eller 100 ml 5% glucoseinfusionsvæske og gives som infusion over mindst 15 minutter.
English: Ibandronic acid Accord 2 mg concentrate for solution for infusion ibandronic acid
Danish: Ibandronsyre Accord 2 mg koncentrat til infusionsvæske, opløsning ibandronsyre
English: Paediatric population (see section 4.2 and section 5.1)
Danish: 4.2 og 5.1)
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion ibandronic acid
Danish: Ibandronsyre Accord 6 mg koncentrat til infusionsvæske, opløsning ibandronsyre
English: Osteonecrosis of jaw†**
Danish: Inflammation i øjet †**
English: Your doctor may do regular blood tests while you are receiving Ibandronic acid Accord.
Danish: • Det bliver givet som infusion i en blodåre Lægen kan vælge at tage regelmæssige blodprøver, mens du er i behandling med Ibandronsyre Accord, for at undersøge, om du får den rigtige mængde medicin.
English: For patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events in patients with breast cancer and metastatic bone disease the following dosing recommendations should be followed (see section 5.2):
Danish: For patienter med brystkræft og knoglemetastaser med moderat nedsat nyrefunktion (kreatininclearance ≥ 30 og < 50 ml/min) eller svært nedsat nyrefunktion (kreatininclearance < 30 ml/min), som behandles for at forebygge knoglerelaterede hændelser, skal følgende dosisrekommendationer følges (se pkt.
English: = serum calcium (mmol/l) - [0.02 x albumin (g/l)] + 0.8 Or
Danish: = Serum-calcium (mmol/l) - [0,02 x albumin (g/l)] + 0,8 Eller Albuminkorrigeret serum-calcium (mg/dl)
English: Placebo ibandronic acid 2.5 mg daily
Danish: Ibandronsyre 2,5 mg daglig
English: NAME OF THE MEDICINAL PRODUCT Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe
Danish: LÆGEMIDLETS NAVN Ibandronsyre Accord 3 mg injektionsvæske, opløsning, i fyldt injektionssprøjte
English: Dosage: Prevention of Skeletal Events in Patients with Breast Cancer and Bone Metastases The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenously given every 3-4 weeks.
Danish: Den anbefalede dosis ved forebyggelse af knoglerelaterede hændelser hos patienter med brystkræft og knoglemetastaser er 6 mg administreret intravenøst hver 3.-4. uge.
English: 1 vial (2 mg/2 ml)
Danish: 2 mg 4 mg 6 mg
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: • Spørg lægen, apoteksspersonalet eller sundhedspersonalet, hvis der er mere, du vil vide.
English: How to use Ibandronic acid Accord
Danish: Sådan skal du bruge Ibandronsyre Accord
English: Deafness
Danish: Amning
English: Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.Care must be taken not to administer Ibandronic acid Accord concentrate for solution for infusion via intra-arterial or paravenous administration, as this could lead to tissue damage.
Danish: Det skal omhyggeligt sikres, at Ibandronsyre Accord koncentrat til infusionsvæske, opløsning, ikke administreres som intra-arterialt eller paravenøst, da det kan forsage vævsskade.
English: What Ibandronic acid Accord looks like and contents of the pack Ibandronic acid Accord 3 mg solution for injection in pre-filled syringes is a clear colourless solution.
Danish: Ibandronsyre Accord 3 mg injektionsvæske, opløsning, i fyldte injektionssprøjter er en klar, farveløs opløsning.
English: Sodium chloride Sodium acetate trihydrate Glacial acetic acid Water for injections
Danish: Natriumchlorid Natriumacetattrihydrat Iseddikesyre
English: Ibandronic acid Accord 6 mg concentrate for solution for infusion One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as 6.75 mg ibandronate sodium monohydrate).
Danish: Ibandronsyre Accord 6 mg koncentrat til infusionsvæske, opløsning Et hætteglas med 6 ml koncentrat til infusionsvæske, opløsning indeholder 6 mg ibandronsyre (som
English: Ibandronic acid injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients (see section 4.4 and section 5.2)
Danish: behandling med ibandronsyre ikke anbefales til patienter med serumkreatinin højere end 200μmol/l (2,3mg/dl) eller med en kreatininclearance mindre end 30 ml/min (se pkt.
English: Protein binding in human plasma is approximately 87% at therapeutic concentrations, and thus interaction with other medicinal products, due to displacement is unlikely.
Danish: Interaktioner med andre lægemidler på grund af displacering er derfor usandsynlig.
English: • you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
Danish: Sig det inden behandlingen til din læge eller sygeplejerske (sundhedspersonalet), hvis du: har problemer med din mund eller dine tænder, for eksempel dårlige tænder eller tandkødssygdom, eller hvis det er planlagt, at du skal have trukket en tand ud.
English: In the pivotal two-year study in postmenopausal women with osteoporosis (BM16550), the overall safety of intravenous injection of ibandronic acid 3 mg every 3 months and oral ibandronic acid 2.5 mg daily were shown to be similar.
Danish: I det pivotale to-års studie hos postmenopausale kvinder med osteoporose (BM 16550) var sikkerheden af i.v.
English: How to receive Ibandronic Acid Accord
Danish: Sådan får du Ibandronsyre Accord
English: Ibandronic acid Accord concentrate for solution for infusion should be administered as an intravenous infusion.
Danish: Ibandronsyre Accord koncentrat til infusionsvæske, opløsning, skal efter fortynding gives som en intravenøs infusion.
English: Analgesic use *
Danish: Analgetika forbrug* 0,90
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 2 mg of ibandronic acid (as sodium monohydrate).
Danish: Hvert hætteglas indeholder 2 mg ibandronsyre (som natriummonohydrat ).
English: Ibandronic acid Accord 3 mg solution for injection in pre-filled syringe Ibandronic acid
Danish: Ibandronsyre Accord 3 mg injektionsvæske, opløsning, i fyldt injektionssprøjte ibandronsyre
English: • deafness
Danish: • vægttab
English: Existing hypocalcaemia must be corrected before starting ibandronic acid injection therapy.
Danish: Eksisterende hypokalcæmi skal behandles, før i.v.
English: Up to now there is no experience of acute poisoning with ibandronic acid concentrate for solution for infusion.
Danish: 4.9 OverdoseringErfaring savnes vedrørende akut forgiftning ved brug af ibandronsyre koncentrat til infusionsvæske, opløsning.
English: No evidence of direct foetal toxicity or teratogenic effects were observed for ibandronic acid in intravenously treated rats and rabbits.
Danish: Der fandtes ikke tegn på direkte føtal toksisk eller teratogen effekt af ibandronsyre hos intravenøst behandlede rotter og kaniner I reproduktionsstudier hos rotter var effekten på fertiliteten øget præimplantationstab ved orale doser på 1 mg/kg/døgn og derover.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelig (kan forekomme hos 1 ud af 100 behandlede):
English: The median time to relapse (re-increase of serum albumin-corrected serum calcium above 3 mmol/l) was 18-19 days for the 2 mg and 4 mg doses.
Danish: Mediantiden for tilbagefald (stigning af serum albuminkorrigeret serum-calcium til over 3 mmol/l) var 18-19 dage for doserne 2 mg og 4 mg. Mediantiden for tilbagefald var 26 dage med en dosis på 6 mg. Et begrænset antal patienter (50 patienter) har fået to infusioner mod hyperkalcæmi.
English: Posology
Danish: Knoglesmerter
English: • Prevention of Skeletal Events - added to 100 ml isotonic sodium chloride solution or 100 ml
Danish: • Forebyggelse af knoglerelaterede hændelser - tilsættes til 100 ml isotonisk natriumchloridinfusionsvæske eller 100 ml 5 % glucoseinfusionsvæske og infunderes over mindst 15 minutter.
English: EXP: Read the package leaflet for the shelf life after dilution.
Danish: Anvendes inden Læs indlægssedlen for opbevaringstid efter fortynding.
English: PHARMACEUTICAL FORM Solution for injection (injection) Clear, colourless solution.
Danish: LÆGEMIDDELFORM Injektionsvæske, opløsning (injektion).
English: Ibandronic acid Accord 3 mg injection Ibandronic acid
Danish: behandling med ibandronsyre 3 mg.
English: Hypocalcaemia
Danish: Hypokalcæmi.
English: Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Ibandronsyre Accord Fortæl altid lægen, sundhedspersonalet eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig.
English: Date of first authorisation: 20 September 2006 Date of latest renewal: 27 July 2011
Danish: Dato for første markedsføringstilladelse: 20. september 2006 Dato for seneste fornyelse: 27. juli 2011
English: Gardasil should be administered as soon as possible after being removed from the refrigerator.
Danish: Gardasil skal administreres så hurtigt som muligt, efter det er taget ud af køleskabet.
English: (end of study results)
Danish: (resultater ved studieafslutning)
English: Not all pack sizes are marketed.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: What other important information should you or your child know about Gardasil
Danish: Hvilke andre vigtige ting, skal du eller dit barn vide om Gardasil
English: However, these data are insufficient to recommend use of Gardasil during pregnancy.
Danish: Disse data er dog ikke tilstrækkelige til at anbefale brug af Gardasil under graviditet.
English: In this study, a durable protection was statistically demonstrated to approximately 12 years.
Danish: I dette studie blev varig beskyttelse i op til cirka 12 år påvist statistisk.
English: * Post Marketing adverse events (frequency cannot be estimated from the available data).
Danish: * Bivirkninger efter markedsføring (hyppigheden kan ikke estimeres ud fra forhåndenværende data).
English: Vaccination should be postponed until completion of pregnancy.
Danish: Vaccination bør udsættes til graviditeten er afsluttet.
English: The following side effects can be seen after the use of Gardasil:
Danish: Følgende bivirkninger kan ses efter brug af Gardasil:
English: If you are from 14 years of age
Danish: Hvis du er 14 år eller ældre
English: N Number of cases
Danish: N Antal tilfælde
English: You should continue to follow your doctor's advice on cervical smear/Pap tests and preventative and protective measures.
Danish: Du skal blive ved med at følge din læges anvisninger vedrørende livmoderhalsundersøgelser/Pap-tests og forebyggende og beskyttende forholdsregler.
English: Consequently, the frequency of these adverse events is qualified as "not known".
Danish: Derfor er hyppigheden af disse bivirkninger betegnet som "ikke kendt".
English: The requirement for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The vaccine should be used as supplied; no dilution or reconstitution is necessary.
Danish: Vaccinen skal anvendes, som den leveres; der er hverken behov for fortynding eller rekonstitution.
English: The duration of immunity following a 3-dose series has been observed for up to 14 years post-vaccination.
Danish: Der blev set på immunitetsvarigheden efter en serie på 3 doser i op til 14 år efter vaccination.
English: Gardasil has not been shown to have a therapeutic effect.
Danish: Det er ikke blevet påvist, at Gardasil har en terapeutisk effekt.
English: If you miss a scheduled injection, your doctor will decide when to give the missed dose.
Danish: Hvis du glemmer en planlagt injektion, vil din læge beslutte, hvornår den manglende dosis skal gives.
English: The data on Gardasil administered during pregnancy did not indicate any safety signal.
Danish: Data på Gardasil indgivet under graviditet indikerede ingen sikkerhedsrisiko.
English: • you or your child developed an allergic reaction after receiving a dose of Gardasil.
Danish: • Hvis du eller dit barn har udviklet en allergisk reaktion efter at have modtaget en dosis Gardasil
English: CIN 3 and AIS have been accepted as immediate precursors of invasive cervical cancer.
Danish: CIN 3 og AIS er blevet accepteret som umiddelbare forstadier til invasiv cervixcancer.
English: Gardasil is intended to prevent these diseases.
Danish: Gardasil er beregnet til at forebygge disse sygdomme.
English: Patients were followed for up to 4 years (median 3.6 years).
Danish: Patienterne blev fulgt i op til 4 år (median 3,6 år).
English: *, Guillain-Barré syndrome*, syncope sometimes accompanied by tonic-clonic movements*
Danish: *, Guillain-Barré-syndrom*, synkope undertiden efterfulgt af toniske/kloniske kramper*
English: 9- to 15-Year-Old Boys
Danish: 9-15-årige drenge
English: Long-term follow-up studies were conducted to determine the duration of protection.
Danish: Længerevarende opfølgningsstudier blev udført for at fastslå varigheden af beskyttelse.
English: Post-Marketing Experience
Danish: Erfaringer efter markedsføring
English: Efficacy against PIN grades 1/2/3 was not demonstrated.
Danish: Der blev ikke påvist effekt imod PIN grad 1/2/3.
English: 16- to 26-Year-Old Women (Protocols 013 and 015)
Danish: 16- til 26-årige kvinder (Protokol 013 og 015)
English: Since no vaccine is 100% effective and Gardasil will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
Danish: Eftersom ingen vaccine er 100 % effektiv, og Gardasil ikke vil yde beskyttelse mod alle HPV typer eller mod eksisterende HPVinfektioner, er rutinemæssig cervikal screening fortsat af yderste vigtighed og skal udføres i overensstemmelse med lokale retningslinjer.
English: Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Danish: Selv om besvimelsesepisoder er ualmindelige, skal patienterne holdes under opsyn i 15 minutter efter de er blevet vaccineret med HPV-vaccine.
English: Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Gardasil should not receive further doses of Gardasil.
Danish: Personer, som udvikler symptomer, der indikerer overfølsomhed, efter at have modtaget en dosis Gardasil, bør ikke modtage yderligere doser Gardasil.
English: At the end of this period Gardasil should be used or discarded.
Danish: Derefter skal Gardasil bruges eller bortskaffes.
English: Therefore, tell the doctor or nurse if you fainted with a previous injection.
Danish: Derfor skal du fortælle det til lægen eller sygeplejersken, hvis du tidligere er besvimet i forbindelse med en injektion.
English: MSM are at higher risk of anal HPV infection compared to the general population; the absolute benefit of vaccination in terms of prevention of anal cancer in the general population is expected to be very low.
Danish: MSM har en større risiko for anal HPV-infektion i forhold til den almene befolkning, og den absolutte gevinst ved vaccination med henblik på forebyggelse af analcancer i den almene befolkning forventes at være meget lav.
English: Use of hormonal contraceptives did not appear to affect the immune response to Gardasil.
Danish: Brug af hormonale antikonceptionsmidler lod ikke til at påvirke immunresponset over for Gardasil.
English: Gardasil may not have an optimal effect if: • used with medicines that suppress the immune system.
Danish: Gardasil vil muligvis ikke have en optimal virkning hvis: • det anvendes sammen med medicin, der hæmmer immunsystemet.
English: Naïve to ≥ 1 HPV Type
Danish: Naive over for ≥ 1 HPV-type
English: What you need to know before you receive Gardasil
Danish: Det skal du vide, før du får Gardasil
English: Table 1 also includes additional adverse events which have been spontaneously reported during the post-marketing use of Gardasil worldwide.
Danish: Tabel 1 indeholder desuden bivirkninger, der er indberettet spontant under anvendelse af Gardasil efter markedsføring over hele verden.
English: Safety was evaluated in either the entire study population (6 studies) or in a predefined subset (one study) of the study population using vaccination report card (VRC)-aided surveillance for 14 days after each injection of Gardasil or placebo.
Danish: Sikkerheden blev vurderet i enten hele studiepopulationen (6 studier) eller i en prædefineret undergruppe af studiepopulationen (ét studie) via overvågning ved hjælp af vaccinationsrapporteringskort i 14 dage efter hver injektion af enten Gardasil eller placebo.
English: HPV types 6 and 11 are responsible for approximately 90% of genital wart cases.
Danish: HPV-typerne 6 og 11 er ansvarlige for cirka 90 % af tilfældene af kønsvorter.
English: Table 1 presents vaccine-related adverse reactions which were observed among recipients of Gardasil at a frequency of at least 1.0% and also at a greater frequency than observed among placebo recipients.
Danish: Tabel 1 viser vaccinerelaterede bivirkninger, der blev observeret hos Gardasil-recipienter med en hyppighed på mindst 1,0 % og også med større hyppighed, end der blev observeret blandt placeborecipienter.
English: [Very Common (≥1/10); Common (≥1/100 to 1/10); Uncommon (≥1/1,000 to 1/100); Rare (≥1/10,000 to 1/1,000); Very Rare (1/10,000)]
Danish: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Gardasil may be given to women who are breast-feeding or intend to breast-feed.
Danish: Gardasil kan gives til kvinder, som ammer eller planlægger at amme.
English: Among 15,706 individuals who received Gardasil and 13,617 individuals who received placebo, there were 39 cases of non-specific arthritis/arthropathy reported, 24 in the Gardasil group and 15 in the placebo group.
Danish: Blandt 15.706 personer, der fik Gardasil, og 13.617 personer, der fik placebo, blev der rapporteret 39 tilfælde af uspecifik artritis/artropati, 24 af tilfældene optrådte i Gardasilgruppen og 15 af tilfældene i placebogruppen.
English: Gardasil is intended for adolescents and adults from 9 years of age onwards.
Danish: Gardasil er beregnet til unge og voksne fra 9-års alderen og ældre.
English: The safety and efficacy of Gardasil in children below 9 years of age have not been established.
Danish: Gardasils sikkerhed og virkning hos børn under 9 år er ikke klarlagt.