FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/530/006 30 tablets EU/1/09/530/007 90 tablets EU/1/09/530/008 120 tablets EU/1/09/530/009 270 tablets EU/1/09/530/010 360 tablets
Danish: EU/1/09/530/006 30 tabletter EU/1/09/530/007 90 tabletter EU/1/09/530/008 120 tabletter EU/1/09/530/009 270 tabletter EU/1/09/530/010 360 tabletter
English: What Repaglinide Teva looks like and contents of the pack
Danish: Repaglinid Tevas udseende og pakningstørrelse
English: Repaglinide Teva 2 mg tablets Microcrystalline cellulose (E460) Meglumine
Danish: Repaglinid Teva 2 mg tabletter Cellulose, mikrokrystallinsk (E460) Meglumin
English: EU/1/09/530/001 30 tablets EU/1/09/530/002 90 tablets EU/1/09/530/003 120 tablets EU/1/09/530/004 270 tablets EU/1/09/530/005 360 tablets
Danish: EU/1/09/530/001 30 tabletter EU/1/09/530/002 90 tabletter EU/1/09/530/003 120 tabletter EU/1/09/530/004 270 tabletter EU/1/09/530/005 360 tabletter
English: INFORMATION IN BRAILLE Repaglinide Teva 1 mg tablets
Danish: INFORMATION I BRAILLE-SKRIFT Repaglinid Teva 1 mg tabletter
English: INFORMATION IN BRAILLE Repaglinide Teva 2 mg tablets
Danish: INFORMATION I BRAILLE-SKRIFT Repaglinid Teva 2 mg tabletter
English: Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Danish: Samtidig indtagelse af gemfibrozil (600 mg 2 gange dagligt), en CYP2C8-hæmmer, og repaglinid (en enkelt dosis på 0,25 mg) øgede AUC for repaglinid med 8,1 gange og Cmax med 2,4 gange hos frivillige raske personer.
English: Repaglinide Teva 1 mg tablets Microcrystalline cellulose (E460) Meglumine
Danish: Repaglinid Teva 1 mg tabletter Cellulose, mikrokrystallinsk (E460) Meglumin
English: What Repaglinide Teva is and what it is used for What you need to know before you take Repaglinide Teva How to take Repaglinide Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Repaglinid Teva Sådan skal du tage Repaglinid Teva Bivirkninger
English: INFORMATION IN BRAILLE Repaglinide Teva 0.5 mg tablets
Danish: INFORMATION I BRAILLE-SKRIFT Repaglinid Teva 0,5 mg tabletter
English: Repaglinide Teva 1 mg tablets Each tablet contains 1 mg of repaglinide.
Danish: Hver tablet indeholder 1 mg repaglinid.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg of repaglinide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 0,5 mg repaglinid
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 1 mg tablets Repaglinide
Danish: LÆGEMIDLETS NAVN Repaglinid Teva 1 mg tabletter Repaglinid
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 0.5 mg tablets Repaglinide
Danish: LÆGEMIDLETS NAVN Repaglinid Teva 0,5 mg tabletter Repaglinid
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Repaglinid Teva Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: NAME OF THE MEDICINAL PRODUCT Repaglinide Teva 2 mg tablets Repaglinide
Danish: LÆGEMIDLETS NAVN Repaglinid Teva 2 mg tabletter Repaglinid
English: Check with your doctor if you are not sure.
Danish: Spørg lægen eller på apotekspersonalet, hvis der er noget, du er i tvivl om.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 1 mg of repaglinide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 1 mg repaglinid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 2 mg of repaglinide.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 2 mg repaglinid
English: Repaglinide Teva 2 mg tablets Each tablet contains 2 mg of repaglinide.
Danish: Hver tablet indeholder 2 mg repaglinid.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Repaglinid Teva nøjagtigt efter lægens anvisning.
English: Repaglinide Teva 0.5 mg tablet is a light blue to blue, capsule shaped tablet, debossed with "93" on one side and “210” on the other side of the tablet.
Danish: Repaglinid Teva 0,5 mg tablet er en lyseblå til blå, kapselformet tablet, mærket med ”93” på den ene side og med ”210” på den anden side af tabletten.
English: Repaglinide Teva 1 mg tablet is a yellow to light yellow, capsule shaped tablet, debossed with "93" on one side and “211” on the other side of the tablet.
Danish: Repaglinid Teva 1 mg tablet er en gul til lysegul, kapselformet tablet, mærket med ”93” på den ene side og med ”211” på den anden side af tabletten.
English: Pregnancy
Danish: Kvalme
English: Repaglinide Teva 2 mg tablet is a mottled peach, capsule shaped tablet, debossed with "93" on one side and “212” on the other side of the tablet.
Danish: Repaglinid Teva 2 mg tablet er en spættet ferskenfarvet, kapselformet tablet, mærket med ”93” på den ene side og med ”212” på den anden side af tabletten.
English: How to take Repaglinide Teva
Danish: Sådan skal du tage Replaginid Teva
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Repaglinid Teva, skal du henvende dig til den lokale repræsentant:
English: Mechanism of action Repaglinide is a short-acting oral secretagogue.
Danish: Repaglinid er et oralt β-celle stimulerende korttidsvirkende antidiabetikum.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
English: Reporting of side effects If you get any side effects, talk to your doctor or pharmacist.
Danish: Tal med lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Repaglinide Teva 0.5 mg tablets Light blue to blue, capsule shaped tablet, debossed with "93" on one side and “210” on the other side.
Danish: Lyseblå til blå, kapselformet tablet, mærket med ”93” på den ene side og med ”210” på den anden side.
English: MA (EU) number (Invented) name
Danish: MT (EU)-nummer (Særnavn) Navn
English: *See next section below
Danish: *Se næste afsnit nedenfor
English: Tell your doctor what happened.
Danish: Fortæl din læge hvad der skete.
English: This is called ‘priming'.
Danish: Dette kaldes ‘priming'.
English: Repeat step 5 three times.
Danish: Gentag trin 5 tre gange.
English: Elderly (older than 65 years)
Danish: Ældre (over 65 år)
English: Date of first authorisation: 31 August 2010 Date of latest renewal: 17 July 2015
Danish: Dato for første markedsføringstilladelse: 31. august 2010 Dato for seneste fornyelse: 17. juli 2015
English: • not knowing where you are (disorientated)
Danish: • du ved ikke, hvor du er (desorienteret)
English: This should clear any blockage.
Danish: Dette vil fjerne alle blokeringer.
English: Date of priming: ……….
Danish: Dato for priming: ……….
English: It is very important to follow your doctor's instructions.
Danish: Det er meget vigtigt, at du følger din læges anvisninger.
English: Therefore it is not possible to definitively separate the effects of PecFent alone.
Danish: Derfor er det ikke muligt definitivt at adskille virkningerne af PecFent alene.
English: • Information on the correct indication
Danish: • Information om den korrekte indikation
English: The patient should be instructed how to do this correctly.
Danish: Patienten skal instrueres i, hvordan dette udføres korrekt.
English: The main pharmacokinetic parameters are shown in the following table.
Danish: De vigtigste farmakokinetiske parametre vises i følgende tabel.
English: This is because it may then give you the wrong dose.
Danish: Dette skyldes, at den i så fald kan give dig den forkerte dosis.
English: It can increase the risk of getting serious side effects.
Danish: Det kan øge risikoen for alvorlige bivirkninger.
English: Clinical signs and symptoms may be manifest from these hormonal changes.
Danish: Kliniske tegn og symptomer kan være manifestationer fra disse hormonelle forandringer.
English: One hundred of these patients continued treatment for up to 26 months in an extension phase.
Danish: Af disse patienter fortsatte 100 med behandling i op til 26 måneder i en forlængelsesfase.
English: Patients should be carefully monitored until an effective dose is reached.
Danish: Patienterne bør overvåges omhyggeligt, indtil en effektiv dosis opnås.
English: • seeing or hearing things that are not really there (hallucinations/delirium), feeling confused
Danish: • ser eller hører ting, som ikke er der i virkeligheden (hallucinationer/delirium), føle sig forvirret
English: Once you have found the right dose
Danish: Når du har fundet den korrekte dosis
English: • you think you are becoming dependent on PecFent
Danish: • mener, at du er ved at blive afhængig af PecFent
English: Abuse potential and tolerance
Danish: Potentiale for misbrug og tolerans
English: PecFent is not approved for use in children under 18 years of age.
Danish: PecFent er ikke godkendt til brug til børn under 18 år.
English: Make sure that you use the strength that your doctor has prescribed for you.
Danish: Sørg for at du anvender den styrke, som din læge har ordineret til dig.
English: • You will NOT hear a click when you press down .
Danish: • Du hører IKKE et klik, når du trykker.
English: Patients should not use more than 4 doses per day.
Danish: Patienterne må ikke bruge over 4 doser om dagen.
English: The relevance of these findings to humans is unknown.
Danish: Relevansen af disse fund for mennesker er ukendt.
English: The efficacy of a given dose should be assessed over the ensuing 30 minute period.
Danish: Virkningen af en given dosis bør vurderes i løbet af den efterfølgende 30-minutters periode.
English: This will tilt the bottle slightly (Figure 5).
Danish: Dette vil placere flasken lidt på skrå (Figur 5).
English: After first use: 60 days
Danish: Efter første anvendelse: 60 dage
English: PecFent with food, drink and alcohol
Danish: Brug af PecFent sammen med mad, drikke og alkohol
English: Dose increase should be undertaken with caution.
Danish: Dosisforøgelser bør foretages med forsigtighed.
English: Call an ambulance or ask someone else to call one straight away if you:
Danish: Ring efter en ambulance eller spørg andre om at straks at ringe efter en, hvis du:
English: • It is more than 5 days since you primed your bottle for the first time.
Danish: • Der er gået mere end 5 dage, siden du primede flasken første gang.
English: • increased blood sugar
Danish: • forhøjet blodsukker
English: The plasma protein binding of fentanyl is 80 - 85 %.
Danish: Fentanyls plasmaproteinbinding er 80 - 85 %.
English: • feeling “high”
Danish: • følelse af at være “høj”
English: Dispose of the PecFent bottle and start a new one if:
Danish: Bortskaf flasken med PecFent og start på en ny, hvis:
English: • After the first spray, number 1 will appear in the counting window.
Danish: • Efter den første dosis vil tallet 1 fremkomme i tællervinduet.
English: • changes in blood cells (detected by laboratory tests)
Danish: • ændret niveau af blodlegemer (fundet ved laboratorieprøver)
English: Note: You may not feel anything happen in your nose at all - do not trust this to mean the spray did not operate - rely on the click and number counter.
Danish: Bemærk: Det kan være, at du slet ikke kan mærke noget i din næse - lad være med tro, at sprayen derfor ikke fungerede - stol på klikket og tælleren.
English: • Do not use PecFent if you are pregnant or might get pregnant, unless your doctor has told you to.
Danish: • Brug ikke PecFent, hvis du er gravid eller måske kan blive gravid, medmindre din læge har fortalt dig, at du skal.
English: This will go up to the number 2 when the spray is used again.
Danish: Tallet går op på nummer 2, når sprayen bruges igen.
English: Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl.
Danish: Tolerans og fysisk og/eller psykologisk afhængighed kan udvikles ved gentagen administration af opioider, såsom fentanyl.
English: Breathe in gently through your nose and out through your mouth.
Danish: Træk vejret roligt ind gennem næsen og ud gennem munden.
English: • you suffer a severe blow to the head
Danish: • du får et alvorligt slag i hovedet
English: Its primary therapeutic actions are analgesia and sedation.
Danish: Den primære terapeutiske virkning er analgesi og sedation.
English: • you experience pain or increased sensitivity to pain (hyperalgesia) which does not respond to a higher dosage of your medicine as prescribed by your doctor
Danish: • oplever smerter eller øget følsomhed for smerte (hyperalgesi), der ikke reagerer på en højere dosis af din medicin, som lægen har ordineret
English: • you have problems with your heart especially slow heart rate
Danish: • du har problemer med dit hjerte, især en meget langsom hjertefrekvens
English: Patients and their carers must be instructed that PecFent contains an active substance in an amount that can be fatal to a child.
Danish: Patienter og deres plejere skal informeres om, at PecFent indeholder et aktivt stof i en mængde, der kan være dødelig for et barn.
English: Coma is also known to occur.
Danish: Koma kan også forekomme.
English: • It comes on even though you have taken your usual opioid pain killer (such as morphine,
Danish: • De opstår, selvom du har taget din normale smertestillende opioidmedicin (såsom morfin,
English: Of the patients entering the titration phase, only 7 (6.1 %) were unable to be titrated to an effective dose due to lack of efficacy and 6 (5.3 %) withdrew due to adverse events.
Danish: Af de patienter, som indgik i titreringsfasen, var kun 7 (6,1 %) ude af stand til at blive titreret til en effektiv dosis pga. manglende virkning, og 6 (5,3 %) trak sig tilbage pga. uønskede hændelser.
English: • blue skin colour
Danish: • blå hudfarve
English: • Do not change the dose yourself.
Danish: • Du må ikke selv ændre doseringen.
English: Frequently, these will cease or decrease in intensity with continued use of the medicinal product, as the patient is titrated to the most appropriate dose.
Danish: Ofte vil disse ophøre eller aftage i intensitet ved fortsat brug af lægemidlet, da patienten titreres til den mest hensigtsmæssige dosis.
English: Of the 355 patients treated in the open-label treatment phase, 90 % required no increase in dose.
Danish: Ud af de 355 patienter, som blev behandlet i denne åbne behandlingsfase, behøvede 90 % ingen dosisforhøjelse.
English: If you are not sure about the right dose or how much PecFent to use, ask your doctor.
Danish: Hvis du ikke er sikker på den korrekte dosis eller hvor meget PecFent, der skal anvendes, skal du spørge din læge til råds.
English: If this happens, do not drive or use any tools or machines.
Danish: Hvis dette forekommer, må du ikke føre motorkøretøj eller arbejde med værktøj eller maskiner.
English: It is recommended that you prime the bottle immediately before use rather than in advance (Note: This 2 spray bottle cannot be re-primed.
Danish: Det anbefales, at du primer flasken umiddelbart inden brug i stedet for i forvejen (bemærk, at denne flaske med 2 spraydoser ikke kan primes igen.
English: Bottles contain:
Danish: Flaskerne indeholder:
English: There are no adequate data from the use of fentanyl in pregnant women.
Danish: Der er ingen tilstrækkelige data fra anvendelse af fentanyl til gravide kvinder.
English: It is more than 90 % eliminated by biotransformation to N-dealkylated and hydroxylated inactive metabolites.
Danish: Over 90 % elimineres ved biotransformation til N-dealkylerede og hydroxylerede inaktive metabolitter.
English: • You will feel some increased resistance when you press down and the finger grips will only move a small amount.
Danish: • Der vil være en noget øget modstand, når du trykker, og fingergrebene vil kun bevæge sig en smule.
English: Never try to fix the nasal spray yourself or take it apart.
Danish: Forsøg aldrig selv at reparere næsesprayen eller skille den ad.
English: Partially used PecFent bottles may contain enough medicine to be harmful or life-threatening to a child.
Danish: Delvist brugte flasker med PecFent kan indeholde tilstrækkelig medicin til at være skadelig eller livstruende for et barn.
English: Other side effects (frequency not known (frequency cannot be estimated from the available data))
Danish: Andre bivirkninger (hyppighed ikke kendt) (hyppighed kan ikke estimeres ud fra forhåndenværende data))
English: Prior to launch in each member State the MAH shall agree the final educational material with the National Competent Authority.
Danish: Før markedsføring i hvert medlemsland, skal indehaveren af markedsføringstilladelsen nå til enighed om det endelige uddannelsesmateriale med den nationale kompetente myndighed.
English: This medicine should only be used by patients taking other opioids.
Danish: Dette lægemiddel bør kun anvendes af patienter, som tager andre opioider.
English: • difficulty in or inability to pass water
Danish: • besvær med eller ude af stand til at lade vandet
English: If the PecFent nasal spray is blocked or does not spray properly
Danish: Hvis PecFent næsesprayen er blokeret eller ikke kan spraye ordentligt
English: The main binding protein is alpha-1-acid glycoprotein, but both albumin and lipoproteins contribute to some extent.
Danish: Det hovedsagelige bindingsprotein er alfa-1-syreglykoprotein, men både albumin og lipoproteiner bidrager i nogen grad.
English: Norfentanyl is not pharmacologically active in animal studies.
Danish: Norfentanyl er ikke farmakologisk aktiv i dyreforsøg.
English: Patients should be advised not to blow their nose immediately after PecFent administration.
Danish: Patienterne skal rådes til ikke at pudse næse straks efter administration af PecFent.
English: This is because it may cause breathing problems in your baby.
Danish: Dette skyldes, at det kan forårsage vejrtrækningsproblemer hos dit spædbarn.
English: • You may feel sleepy, dizzy or have problems with your eyesight after using PecFent.
Danish: • Du kan føle dig søvnig, svimmel eller have problemer med dit syn efter at have brugt PecFent.
English: • a lack of concentration or increased activity
Danish: • koncentrationsbesvær eller forøget aktivitet
English: Once an effective dose has been established during titration, patients should continue to take this dose up to a maximum of 4 doses per day.
Danish: Når en effektiv dosis er blevet fastlagt i løbet af titreringen, bør patienterne fortsætte med at tage denne dosis, maksimalt op til 4 doser pr. dag.
English: It is important that the long acting opioid treatment used to treat the patient's persistent pain has been stabilised before PecFent therapy begins.
Danish: Det er vigtigt, at den langvarige opioidbehandling, der anvendes til at behandle patientens vedvarende smerter, er stabiliseret, før behandling med PecFent påbegyndes.
English: The 2 spray bottle cannot be re-primed and once both doses are used, or if longer than 5 days since priming, the bottle and contents should be discarded as described in section 6.6.
Danish: Flasken med 2 spraydoser kan ikke primes igen, og når begge doser er brugt, eller hvis der er gået mere end 5 dage siden priming, skal både flaske og indhold kasseres som beskrevet i punkt 6.6.
English: Close the other nostril with a finger from your other hand (Figure 5).
Danish: Luk det andet næsebor med en finger fra din anden hånd (Figur 5).
English: If you have not been using these medicines you must not use PecFent, because it may increase the risk that breathing could become dangerously slow and/or shallow, or even stop.
Danish: Hvis du ikke har brugt denne slags medicin, må du ikke anvende PecFent, fordi det kan øge risikoen for, at dit åndedræt kunne blive faretruende langsomt og/eller overfladisk eller endda helt ophøre.
English: AUC (pg.hour/ml) 2460.5 (17.9 4359.9 (29.8) 7513.4 (26.7) 17272 (48.9) 3735.0 (32.8) t1/2 (hour) *Data for Tmax presented as median (range).
Danish: AUC (pg·time/ml) 2460,5 (17,9) 4359,9 (29,8) 7513,4 (26,7) 17272 (48,9) 3735,0 (32,8) t1/2 (time) *Data for Tmax foreligger som median (interval).
English: Coadministration with medicinal products that induce 3A4 activity may reduce the efficacy of PecFent.
Danish: Samtidig administration af lægemidler, der inducerer 3A4-aktivitet, kan reducere PecFents virkning.
English: • PecFent that has passed the expiry date or is no longer required may still contain enough medicine to be harmful to other people, especially children.
Danish: • Hvis PecFents udløbsdato er overskredet, og den ikke længere behøves, kan den stadig indeholde nok medicin til at forårsage skade på andre mennesker, især børn.
English: Do not change the dose of PecFent or your other pain medicines yourself.
Danish: Du må ikke selv ændre dosis af PecFent eller din anden smertestillende medicin.
English: Your doctor will tell you how many sprays (1 or 2) you should use to treat your breakthrough pain episode.
Danish: Din læge vil fortælle dig, hvor mange doser (1 eller 2) du skal tage for at behandle din episode med gennembrudssmerter.
English: • feeling depressed, worried, slow or nervous
Danish: • følelse af at være deprimeret, bekymret, langsom eller nervøs
English: If your doctor has prescribed a second spray, repeat steps 5 to 9, using the other nostril.
Danish: Hvis din læge har ordineret endnu en spray, skal trin 5 til 9 gentages i det andet næsebor.
English: Less than 7 % of an administered dose of fentanyl is excreted unchanged in the urine and only about 1 % is excreted unchanged in the faeces.
Danish: Under 7 % af den administrerede fentanyl-dosis udskilles i urinen i uændret form og kun ca. 1 % udskilles i fæces i uændret form.
English: • See ‘Using the PecFent bottle' for instructions on how to use a dose.
Danish: • Se ‘Sådan anvendes flasken med PecFent' for vejledning om, hvordan en dosis bruges.
English: • Talk to your doctor about whether it will be safe for you to drive or use tools or machines after using PecFent.
Danish: • Tal med din læge om, hvorvidt det er sikkert for dig at føre motorkøretøj eller arbejde med værktøj eller maskiner efter at have brugt PecFent.
English: • you have not been taking the same dose of your daily opioid medicine for your constant pain for some time
Danish: • du ikke har taget den samme dosis af din daglige opioidmedicin for dine konstante smerter i et stykke tid
English: When you hear a click let go of the grips.
Danish: Når du hører et klik, slipper du grebene.
English: Check that there is a green bar or a number showing in the counting window (Figure 4): this confirms that the PecFent bottle has been primed (see ‘Preparing the PecFent bottle for use' above).
Danish: Kontrollér at der er en grøn søjle eller et tal i tællervinduet (Figur 4): dette bekræfter, at flasken med PecFent er blevet primet (se ‘Sådan klargøres flasken med PecFent til brug' ovenfor).
English: • Do not drive or use tools or machines until you know how this medicine makes you feel.
Danish: • Lad være med at føre motorkøretøj eller arbejde med værktøj eller maskiner, indtil du ved, hvordan denne medicin påvirker dig.
English: Stay sitting for at least 1 minute after using the nasal spray.
Danish: Bliv siddende i mindst 1 minut efter at have brugt næsesprayen.
English: Phenylethyl alcohol
Danish: Phenylethylalkohol
English: • Tell your doctor about your pain and how PecFent is working.
Danish: • Fortæl din læge om dine smerter, og hvordan PecFent virker for dig.
English: Fentanyl may produce bradycardia.
Danish: Fentanyl kan forårsage bradykardi.
English: Once your constant pain is controlled, your doctor may then change your dose of PecFent.
Danish: Når dine konstante smerter er under kontrol, kan din læge så ændre din dosis af PecFent.
English: There was no indication that older patients tended to titrate to lower doses or experience more adverse reactions.
Danish: Der var ingen indikation for, at ældre patienter var tilbøjelige til at titrere til lavere doser eller til at få flere bivirkninger.