FrancophonIA/ELRC3.0 huggingface dataset:
English: The incidence of stroke mortality was 2.2 per 1,000 women per year for raloxifene versus 1.5 per 1,000 women per year for placebo (see section 4.4).
Danish: Hyppigheden af død som følge af apopleksi var 2,2 pr. 1.000 kvinder pr. år for raloxifen mod 1.5 pr. 1.000 kvinder pr. år for placebo (se pkt.
English: Common: Leg cramps
Danish: Almindelig: Kramper i benene
English: Phadisco Ltd Τηλ: +357 22 715000
Danish: Τηλ: +357 22 715000
English: Uncommon side effects (affects 1 to 10 users in 1000) are:
Danish: Ikke almindelig (kan ramme 1 til 10 ud af 1.000 patienter):
English: • Mild breast symptoms such as pain, enlargement and tenderness
Danish: • Lette symptomer i brystet, såsom smerter, hævelse, ømhed
English: Optruma does not treat postmenopausal symptoms, such as hot flushes.
Danish: Optruma kan ikke lindre symptomer, såsom hedestigninger, som opstår i forbindelse med overgangsalderen.
English: In patients with moderate and mild renal impairment, Optruma should be used with caution.
Danish: Optruma bør anvendes med forsigtighed til patienter med let til moderat nedsat nyrefunktion.
English: Severe renal impairment.
Danish: Svært nedsat nyrefunktion.
English: Optruma are white, oval, film coated tablets which are marked with the number 4165.
Danish: Optruma er hvide, ovale tabletter med et filmovertræk.
English: • If you are being treated or have been treated for blood clots in the legs (deep vein thrombosis),
Danish: • hvis De bliver eller har været behandlet for blodpropper (blodprop i benene, blodprop i lungerne eller blodprop i øjets nethinde).
English: You can also report side effects directly via the national reporting system listed in Appendix V*.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: No clinically relevant effects of the co-administration of the agents on raloxifene plasma concentrations were identified.
Danish: En klinisk relevant påvirkning af raloxifen-plasmakoncentrationer ved samtidig administration af disse lægemidler blev ikke observeret.
English: In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
Danish: Hos voksne patienter, der tog mere end 120 mg på én gang, omfattede de rapporterede symptomer kramper i benene og svimmelhed.
English: Optruma 60 mg film coated tablets
Danish: LÆGEMIDLETS NAVN Optruma 60 mg filmovertrukne tabletter
English: There is no relevant use of Optruma in the paediatric population.
Danish: Optruma bør ikke anvendes til børn uanset alder. Der er ingen relevante indikationer for Optruma i den pædiatriske population.
English: In a 21-month carcinogenicity study in mice, there was an increased incidence of testicular interstitial cell tumours and prostatic adenomas and adenocarcinomas in males given 41 or 210 mg/kg, and prostatic leiomyoblastoma in males given 210 mg/kg.
Danish: Systemisk eksponering (AUC) for raloxifen var i denne gruppe ca. 400 gange større end hos postmenopausale kvinder, som fik en dosis på 60 mg. I en 21 måneders carcinogenicitetsundersøgelse af mus sås en øget forekomst af testikulære interstitialcelletumorer og prostataadenomer og -adenocarcinomer blandt hanner, som fik 41 eller 210 mg/kg, og prostataleiomyoblastomer blandt hanner, som fik 210 mg/kg.
English: No cases of raloxifene overdose were reported during clinical trials.
Danish: I de kliniske studier var der ikke rapporter om tilfælde med overdosering af raloxifen.
English: The clinically most important adverse reactions reported in postmenopausal women treated with Optruma were venous thromboembolic events (see section 4.4), which occurred in less than 1% of treated patients.
Danish: De vigtigste, kliniske bivirkning, som er rapporteret hos postmenopausale kvinder behandlet med Optruma, var venøse tromboemboliske hændelser (se pkt.
English: EU/1/98/074/001 14 film coated tablets EU/1/98/074/002 28 film coated tablets EU/1/98/074/003 84 film coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/98/074/001 14 filmovertrukne tabletter
English: • Skin around the vein is red and painful (superficial vein thrombophlebitis)
Danish: • Rød og smertende hud omkring en vene (årebetændelse med blodprop i huden)
English: Carnauba wax
Danish: Carnaubavoks
English: • Leg cramps
Danish: • Kramper i benene
English: EXP {MM/YYYY}
Danish: EXP
English: Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukken tablet indeholder 60 mg raloxifenhydrochlorid svarende til 56 mg raloxifen fri base.
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller apoteketspersonalet.
English: Must not be used in women with child bearing potential (see section 4.6).
Danish: Må ikke anvendes af fertile kvinder (se pkt.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystemet Ikke almindelig: Trombocytopenia
English: Film coated tablet.
Danish: LÆGEMIDDELFORM Filmovertrukne tabletter.
English: Laboratórios Vitória S.A. Tel: + 351- 21 4758300
Danish: Tel: + 351- 21 4758300
English: If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product.
Danish: Kontakt lægen, før De tager denne medicin, hvis lægen har fortalt Dem, at De ikke tåler visse sukkerarter,
English: This was peripheral oedema, which occurred in the prevention population at an incidence of 3.1 % for Optruma and 1.9 % for placebo; and in the treatment population occurred at an incidence of 7.1 % for Optruma and 6.1 % for placebo.
Danish: Perifert ødem, som ikke var statistisk signifikant (p > 0,05), men som viste en signifikant dosistendens, forekom med en hyppighed på 3,1 % for Optruma og 1,9 % for placebo blandt deltagere i studier til forebyggelse af osteoporose og med en hyppighed på 7,1 % for Optruma og 6,1 % for placebo blandt deltagere i studie til behandling af osteoporose.
English: Eli Lilly Slovakia s.r.o.
Danish: Slovenská republika Eli Lilly Slovakia, s.r.o.
English: This leaflet was last revised in month YYYY.
Danish: Denne indlægsseddel blev senest ændret
English: • Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
Danish: • Gener fra mave-tarmkanalen såsom kvalme, opkastning, mavesmerter, fordøjelsesbesvær
English: DD month YYYY
Danish: Phadisco Ltd
English: Optruma is used to treat and prevent osteoporosis in postmenopausal women.
Danish: Optruma bruges til at behandle og forebygge knogleskørhed hos kvinder, der har passeret overgangsalderen (postmenopausal osteoporose).
English: Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause.
Danish: Knogleskørhed er en sygdom, som gør Deres knogler tynde og skrøbelige.
English: Industrie Farmaceutiche Riunite s.r.l.
Danish: Esteve Pharmaceuticals, S.A.
English: Package leaflet: Information for the user Optruma 60 mg film coated tablets raloxifene hydrochloride
Danish: LÆGEMIDLETS NAVN OPTRUMA 60 mg filmovertrukne tabletter raloxifenhydrochlorid
English: Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800
Danish: Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800 United Kingdom Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000
English: Tel: +39-055 56801
Danish: Industrie Farmaceutiche Riunite s.r.l Tel: +39-055 56801
English: 14 film coated tablets 28 film coated tablets 84 film coated tablets
Danish: 84 filmovertrukne tabletter
English: Charles de Giorgio Ltd. Tel: + 356 25600 500
Danish: Tel: + 356 25600 500
English: Optruma must not be taken by women of child bearing potential.
Danish: Optruma må ikke anvendes af fertile kvinder.
English: Eli Lilly Ges.m.b.H.
Danish: m.b.H.
English: 100 film coated tablets
Danish: 28 filmovertrukne tabletter
English: What Optruma looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: Optruma
Danish: Amning
English: Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 60 mg raloxifenhydrochlorid svarende til 56 mg raloxifen
English: If you take more Optruma than you should you could have leg cramps and dizziness.
Danish: De kan få kramper i benene eller blive svimmel, hvis De har taget flere Optruma tabletter, end De skal.
English: Esteve Pharmaceuticals, S.A. Tel: + 34-93 446 60 00
Danish: Tel: + 34-93 446 60 00
English: Lilly Hungária Kft. Tel: + 36 1 328 5100
Danish: Tel: + 36 1 328 5100
English: Optruma should not be used in children of any age.
Danish: Opbevares utilgængeligt for børn.
English: Tablet core:
Danish: Nedsat leverfunktion:
English: a) Skeletal Effects
Danish: a) Effekt på knoglevæv
English: Manufacturer
Danish: Opbevaring
English: These can be taken from you or from a donor.
Danish: De kan tages fra dig selv eller fra en donor.
English: The significance of these changes is unknown.
Danish: Betydningen af disse ændringer kendes ikke.
English: It is therefore difficult to recommend an optimum method.
Danish: Det er derfor vanskeligt at anbefale den bedste metode.
English: 10291 Prigorje Brdovečko Croatia
Danish: 10291 Prigorje Brdovečko Kroatien
English: Wash your hands thoroughly with soap and water.
Danish: Vask hænderne grundigt med vand og sæbe
English: Date of first authorisation: 08 June 2010 Date of latest renewal: 27 May 2015
Danish: Dato for første markedsføringstilladelse: 08. juni 2010 Dato for seneste fornyelse: 27. maj 2015
English: cells mean that direct comparison between different studies is difficult.
Danish: + celler betyder, at direkte sammenligning mellem forskellige studier er vanskelig.
English: The most suitable places for injection are:
Danish: De mest velegnede indsprøjtningssteder er:
English: These symptoms generally develop in a rapid fashion.
Danish: Disse symptomer udvikler sig typisk hurtigt.
English: The subcutaneous route is preferred in most cases.
Danish: Subkutan administration foretrækkes i de fleste tilfælde.
English: Although this interaction has not been formally investigated, there is no evidence that such an interaction is harmful.
Danish: Selvom denne interaktion ikke er formelt undersøgt, er der ikke evidens for, at den er skadelig.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt bør produktet anvendes omgående.
English: You should talk to your doctor about your risks of developing cancers of the blood and what testing should be done.
Danish: Du bør tale med din læge om risikoen for at udvikle blodkræft, og hvilke undersøgelser der skal udføres.
English: If you are a stem cell donor, you must be aged between 16 and 60 years.
Danish: Hvis du er stamcelledonor, skal du være mellem 16 og 60 år.
English: European Retrospective Study (2004)
Danish: Europæisk retrospektivt studie (2004)
English: THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:
Danish: FØLGENDE OPLYSNINGER ER TILTÆNKT LÆGER OG SUNDHEDSPERSONALE:
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Danish: Som det er tilfældet med alle terapeutiske proteiner, er der mulighed for immunogenicitet.
English: You may notice a small air bubble in the syringe.
Danish: Måske bemærker du en lille luftboble i sprøjten.
English: At the end of this period, the product should not be put back in the refrigerator and should be disposed of.
Danish: Ved afslutningen af denne periode må lægemidlet ikke sættes tilbage i køleskabet, men skal bortskaffes,
English: How is Nivestim given and how much should I take?
Danish: Hvordan gives Nivestim, og hvor meget skal jeg have?
English: These changes all reversed after discontinuation of treatment.
Danish: Alle disse ændringer forsvandt efter seponering af behandlingen.
English: The usual dose varies depending on your illness and weight.
Danish: Den normale dosis afhænger af din sygdom og vægt.
English: Growth factors are proteins that are produced naturally in the body but they can also be made using biotechnology for use as a medicine.
Danish: Vækstfaktorer er proteiner, der produceres naturligt i kroppen, men de kan også fremstilles ved hjælp af bioteknologi og anvendes som et lægemiddel.
English: Perform the injection using the technique described above.
Danish: Foretag indsprøjtningen med den teknik, som er beskrevet herover.
English: Do not increase the dose your doctor has given you.
Danish: Du må ikke øge dosen, som din læge har fastsat til dig.
English: Binding antibodies do occur as expected with all biologics; however, they have not been associated with neutralising activity at present.
Danish: Der opstår bindende antistoffer, som det forventes med alle biologiske midler; de har imidlertid ikke været forbundet med neutraliserende aktivitet på nuværende tidspunkt.
English: This medicine may cause dizziness.
Danish: Dette lægemiddel kan forårsage svimmelhed.
English: How long will I have to take Nivestim?
Danish: Hvor længe skal jeg tage Nivestim?
English: Regular monitoring of blood counts is recommended (see above).
Danish: Det anbefales at kontrollere blodtallene regelmæssigt (se ovenfor).
English: The choice of route should depend on the individual clinical circumstance.
Danish: Administrationsvejen bør afhænge af de individuelle, kliniske omstændigheder.
English: Meta-Analysis (2003)
Danish: Metaanalyse (2003)
English: Sixty-five percent of the patients studied in the SCN trial program were under 18 years of age.
Danish: Femogtres procent af de patienter, som blev behandlet i programmet for SCN, var under 18 år.
English: This section contains information on how to give yourself an injection of Nivestim.
Danish: Dette afsnit indeholder oplysninger om, hvordan du kan give dig selv en indsprøjtning med Nivestim.
English: The volume of distribution in blood is approximately 150 ml/kg.
Danish: Distributionsvolumenet i blod er ca. 150 ml/kg.
English: When the response has been obtained the minimal effective dose to maintain this level should be established.
Danish: Når dette respons er nået, skal den mindste effektive dosis til opretholdelse af dette niveau fastlægges.
English: You do not have to remove the air bubble before injecting.
Danish: Du behøver ikke at fjerne luftboblen før injektionen.
English: For intravenous or subcutaneous use.
Danish: Til intravenøs eller subkutan brug.
English: A risk to the newborns/infants cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko for nyfødte/spædbørn.
English: Timing of leukapheresis: one or two leukapheresis on days 5 and 6 are often sufficient.
Danish: Tidsskema for leukaferese: Det er ofte tilstrækkeligt med en eller to leukafereser på dag 5 og 6.
English: To give yourself a subcutaneous injection you will need the following items:
Danish: For at kunne give dig selv en subkutan indsprøjtning har du brug for følgende udstyr:
English: Regular blood tests will be taken to monitor the number of white blood cells in your body.
Danish: Du vil regelmæssigt få taget blodprøver for at måle antallet af hvide blodlegemer i din krop.
English: • increase of certain enzymes in the blood
Danish: • Stigning i visse enzymer i blodet
English: The frozen pre-filled syringes can be thawed and then refrigerated for future use.
Danish: De frosne fyldte sprøjter kan tøs op og derefter anbringes i køleskab til fremtidig brug.
English: Patients with HFI cannot break down fructose, which may cause serious side effects.
Danish: Patienter med HFI kan ikke nedbryde fructose, hvilket kan forårsage alvorlige bivirkninger.
English: Thereafter, it is recommended that the ANC is measured at least twice per week for the first two weeks and subsequently once per week or once every other week during maintenance therapy.
Danish: Derefter, anbefales det at bestemme ANC mindst to gange ugentligt i de første 2 uger og derefter en gang ugentligt eller en gang hver anden uge under resten af behandlingen.
English: Overall, reports were more common after IV administration.
Danish: Rapporterne var generelt hyppigere efter i.v.
English: ANC = absolute neutrophil count
Danish: ANC = absolut neutrofiltal
English: You will need to have your injections at about the same time every day.
Danish: Du skal tage indsprøjtningen hver dag, omtrent på samme tid af dagen.
English: • Antiseptic wipes (if recommended by your doctor or nurse).
Danish: • Antiseptiske spritservietter (hvis lægen eller sygeplejersken anbefaler det)
English: • unusual change in the urine
Danish: • Usædvanlige ændringer i urin
English: If you think you have injected more than you should, contact your doctor as soon as possible.
Danish: Hvis du tror, du har injiceret mere, end du skal have, skal du kontakte din læge så hurtigt som muligt.
English: Your doctor may want to monitor you closely, see section 4 of the package leaflet.
Danish: Din læge vil måske overvåge din tilstand nøje, se punkt 4 i indlægssedlen.
English: Leukapheresis should be started at day 5 and continued until day 6 if needed in order to collect 4 x 10
Danish: Der bør påbegyndes leukaferese på dag 5, og den bør om nødvendigt fortsætte indtil dag 6 for at indsamle 4 x 10
English: If you become pregnant during Nivestim treatment, please inform your doctor.
Danish: Hvis du bliver gravid under behandling med Nivestim, skal du fortælle det til lægen.
English: The choice of mobilisation method should be considered in relation to the overall objectives of treatment for an individual patient.
Danish: Valget af mobiliseringsmetode bør overvejes under hensyntagen til det overordnede formål for behandlingen af den individuelle patient.
English: Your doctor may regularly test your urine if you experience this side effect or if protein is found in your urine (proteinuria).
Danish: Din læge vil muligvis kontrollere din urin regelmæssigt, hvis du får denne bivirkning, eller hvis der konstateres protein i din urin (proteinuri).
English: Nevertheless, a risk of promotion of a malignant myeloid clone cannot be excluded.
Danish: Risikoen for dannelsen af en malign myeloid klon kan dog ikke udelukkes.
English: If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine.
Danish: Hvis du (eller dit barn) har arvelig fructoseintolerans (HFI), som er en sjælden arvelig sygdom, må du (eller dit barn) ikke få dette lægemiddel.
English: Choose a different injection site each time.
Danish: Vælg et nyt indsprøjtningssted fra gang til gang.
English: Effects of filgrastim on prenatal development have been studied in rats and rabbits.
Danish: Virkningerne af filgrastim på den prænatale udvikling er undersøgt på rotter og kaniner.
English: Nivestim is a biosimilar medicinal product.
Danish: Nivestim er et biosimilært lægemiddel.
English: Your doctor will tell you how much Nivestim you should take.
Danish: Din læge vil fortælle dig, hvor meget Nivestim du skal have.
English: Pinch a large area of skin, taking care not to touch the area you have cleaned.
Danish: Klem et stort hudområde sammen og pas på ikke at berøre det område, som du har renset.
English: In other circumstances, additional leukapheresis is recommended.
Danish: Under andre forhold anbefales yderligere leukafereser.
English: Causes of transient neutropenia, such as viral infections should be excluded.
Danish: Årsager til forbigående neutropeni som f.eks. virusinfektioner bør udelukkes.
English: Do not use Nivestim
Danish: Brug ikke Nivestim
English: If more than one leukapheresis is required, particular attention should be paid to donors with platelets < 100 x 10
Danish: Hvis det er nødvendigt med mere end én leukaferese, bør man være særlig opmærksom hos donorer, som har et trombocyttal < 100 x 10
English: This should be considered when interpreting bone-imaging results.
Danish: Det bør der tages hensyn til ved tolkning af resultaterne af knoglescanning.
English: Dose adjustment is not required in these circumstances.
Danish: Det er ikke nødvendigt at justere dosis i disse tilfælde.
English: However, you should not attempt this unless you have been properly trained first by your healthcare provider.
Danish: Du må imidlertid ikke forsøge at gøre dette, medmindre du er blevet grundigt instrueret og oplært i det af sundhedspersonalet.
English: Filgrastim should be discontinued and appropriate treatment given.
Danish: Behandlingen med filgrastim bør afbrydes, og der skal gives passende behandling.
English: You, or people caring for you, can be taught how to give subcutaneous injections so that you can continue your treatment at home.
Danish: Du eller dine plejere kan lære, hvordan injektioner under huden gives, så du kan fortsætte din behandling derhjemme.
English: Some cases of splenic rupture were fatal.
Danish: Nogle tilfælde af miltruptur var fatale.
English: Your healthcare professional should always record the exact product you are using.
Danish: Din læge skal altid notere præcist, hvilket lægemiddel du bruger.
English: It is recommended to perform morphologic and cytogenetic bone marrow examinations in patients at regular intervals (approximately every 12 months).
Danish: Det anbefales at udføre morfologiske og cytogenetiske knoglemarvsundersøgelser hos patienterne med regelmæssige intervaller (ca. hver 12. måned).
English: It is advisable to wait and see how you feel after taking Nivestim and before driving or operating machinery.
Danish: Det tilrådes, at du venter og ser, hvordan du har det, når du har taget Nivestim, før du fører motorkøretøj eller betjener maskiner.
English: Learning to give your own injections will mean that you will not have to wait at home for a nurse to call, nor will you have to go to the hospital or clinic every day to receive your injections.
Danish: Hvis du har lært at give indsprøjtningen selv, behøver du ikke at sidde hjemme og vente på en sygeplejerske eller at tage på sygehuset hver dag for at få din indsprøjtning.
English: Only clear solutions without particles should be used.
Danish: Der må kun bruges klar opløsning uden partikler.
English: Take special care with other products that stimulate white blood cells
Danish: Vær særlig forsigtig med andre produkter, der stimulerer de hvide blodlgemer
English: Decide where to inject Nivestim - find a place on the front of your abdomen or the front of your thigh.
Danish: Beslut dig for, hvor du skal indsprøjte Nivestim - find et sted på maven eller på forsiden af låret.
English: The recommendation of a minimum yields of ≥ 2.0 x 10
Danish: Anbefalingen af en minimumshøst på ≥ 2,0 x 10
English: Infections and malignancies causing myelosuppression
Danish: Infektioner og maligne sygdomme, som forårsager myelosuppression
English: Following established chemotherapy for solid tumours, lymphomas, and lymphoid leukaemia, it is expected that the duration of treatment required to fulfil these criteria will be up to 14 days.
Danish: Efter etableret kemoterapi for solide tumorer, lymfomer og lymfoid leukæmi forventes det, at behandlingsvarigheden for opfyldelse af disse kriterier kan være op til 14 dage.
English: There are 1, 5, 8 or 10 syringes in each pack.
Danish: Der er 1, 5, 8 eller 10 sprøjter i en pakning.
English: A reduction in the number of white blood cells (neutropenia) can occur for several reasons and makes your body less able to fight infection.
Danish: Antallet af hvide blodlegemer kan falde (neutropeni) af flere årsager og gør kroppen mindre i stand til at bekæmpe infektioner.
English: You will need to take Nivestim until your white blood cell count is normal.
Danish: Du skal tage Nivestim, indtil dit antal af hvide blodlegemer er normalt.
English: Do not choose an area which is tender, red, bruised or scarred.
Danish: Vælg ikke et område, som er ømt, rødt, har blå mærker eller er arret.
English: Rate of generation of antibodies against filgrastim is generally low.
Danish: Raterne af produktion af antistoffer mod filgrastim er generelt lave.