FrancophonIA/ELRC3.0 huggingface dataset:
English: The Applicant described the observed SAE signals and noted that only one case was evaluated as related to the study drug by the investigator..
Danish: Ansøgeren beskrev de observerede signaler for alvorlige uønskede hændelser og bemærkede, at investigator kun vurderede ét tilfælde som værende relateret til forsøgslægemidlet.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Danish: Dyreforsøg har vist reproduktionstoksicitet (e pkt.
English: General disorders and administration site conditions Uncommon: Malaise
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Utilpashed
English: - the CHMP considered the benefit/risk of Rapinyl to be positive the CHMP has recommended the amendment of the Summaries of Product Characteristics and the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Rapinyl and associated names (see Annex I).
Danish: anbefaler CHMP ændring af produktresuméerne og godkendelse af de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Rapinyl og tilknyttede navne (se bilag I).
English: What Rapinyl is and what it is used for Before you take Rapinyl How to take Rapinyl Possible side effects How to store Rapinyl Further information
Danish: Rapinyls virkning, og hvad De skal bruge det til Det skal De vide, før De begynder at tage Rapinyl Sådan skal De tage Rapinyl Bivirkninger
English: • Very rare side effects (affects less than 1 user in 10,000): irregular heartbeat, stopping breathing, blood in the saliva, decrease in amount of urine, painful contraction of the bladder
Danish: • Meget sjældne bivirkninger (påvirker færre end 1 ud af 10.000 brugere): Uregelmæssig hjertebanken, vejrtrækningsstop, blod i spyt, nedsat urinmængde, smertefuld sammentrækning af blæren
English: To be dissolved under the tongue.
Danish: Sublingual anvendelse Skal opløses under tungen.
English: Rapinyl 50 micrograms Rapinyl 100 micrograms Rapinyl 200 micrograms Rapinyl 300 micrograms Rapinyl 400 micrograms Rapinyl 600 micrograms Rapinyl 800 micrograms
Danish: Rapinyl 50 mikrogram Rapinyl 100 mikrogram Rapinyl 200 mikrogram Rapinyl 300 mikrogram Rapinyl 400 mikrogram Rapinyl 600 mikrogram Rapinyl 800 mikrogram
English: Furthermore, the CHMP was not convinced by the Applicant claim of bioavailability of fentanyl comparison between Rapinyl and Actiq, requesting a robust demonstration of similarity in systemic exposure.
Danish: CHMP blev ikke overbevist af ansøgerens påstand om sammenligningen af biotilgængeligheden af fentanyl mellem Rapinyl og Actiq, og de krævede en overbevisende påvisning af ligheden i den systemiske eksponering.
English: Very common: Dizziness, somnolence, headache Common: Vasovagal reaction, hypoaesthesia, paraesthesia, hyperacusis
Danish: Meget almindelig: Svimmelhed, somnolens, hovedpine Almindelig: Vasovagal reaktion, hypoæstesi, paræstesi, hyperakusis
English: • Peel back the tab of the foil top of one blister and gently remove the tablet.
Danish: • Træk fligen på folieen af en blister tilbage og tag forsigtigt resoribletten ud.
English: Dose re-adjustment:
Danish: Genjustering af dosis:
English: The Applicant implemented a revised a cautionary statement in section 4.4 of the SPC, recommending extra caution during the titration of patients with mouth wounds or mucositis.
Danish: 4.4 i produktresuméet, hvor ekstra forsigtighed under titreringen af patienter med sår i munden eller mucositis anbefales.
English: • muscle relaxants
Danish: • muskelafslappende midler
English: There should be no noticeable effects if you stop taking Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting.
Danish: Der skulle ikke forekomme nogen bemærkelsesværdige virkninger, hvis De holder op med at tage Rapinyl, men mulige abstinenssymptomer er angst, rysten, svedudbrud, bleghed, kvalme og opkastning.
English: Due to the low number of patients exposed for a long time, the final results of the studies EN3267-005 and EN3267-007 should be provided as conditions to the Marketing Authorisations.
Danish: På grund af det lille antal patienter, der er blevet eksponeret i længere i tid, skal de endelige resultater af forsøg EN3267-005 og EN3267-007 fremsendes som betingelse for markedsføringstilladelserne.
English: Elderly, cachectic or generally impaired patients may have a lower fentanyl clearance, which could cause a longer terminal half-life for the compound (see sections 4.2 and 4.4).
Danish: Ældre, kakektiske eller debile patienter kan have en nedsat fenatylclearance, som kan medføre en længere terminal halveringstid af stoffet (se pkt.
English: • if you are allergic (hypersensitive) to fentanyl or any of the other ingredients of Rapinyl • if you have severe breathing problems
Danish: • hvis De er overfølsom (allergisk) over for fentanyl eller et af de øvrige indholdsstoffer
English: • Common side effects (affects 1 to 10 users in 100): feeling confused, feeling anxious or nervous, hallucinations, abnormal thinking, muscle twitching, difficulty sleeping, strange dreams, tongue or taste problems, flushing, mouth ulcers/blisters, blockage of the gut, difficulty swallowing, being accident-prone
Danish: • Almindelige bivirkninger (påvirker mellem 1 og 10 ud af 100 brugere): forvirring, angst eller nervøsitet, hallucinationer, unormal tankegang, muskeltrækninger, søvnbesvær, underlige drømme, tunge- eller smagsproblemer, blussen, sår/blærer i munden, tarmblokering, synkebesvær, tilbøjelighed til at komme galt afsted
English: Marketing authorisation holder: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: Indehaver af markedsføringstilladelsen: [Se bilag I - udfyldes nationalt] (Navn og adresse) <{tlf}> <{fax}> <{e-mail}>
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
English: Before you start treatment with Rapinyl, you must have been regularly taking or using a prescribed strong pain-relieving medicine, called an opioid, to control your persistent pain.
Danish: • hvis De har alvorlige vejrtrækningsproblemer Inden De påbegynder behandlingen med Rapinyl, skal De regelmæssigt have taget eller brugt et ordineret, stærkt smertestillende lægemiddel, som kaldes et opioid, til at kontrollere Deres vedvarende smerter.
English: Fentanyl is a highly lipophilic drug absorbed very rapidly through the oral mucosa and more slowly through the gastrointestinal tract.
Danish: Fentanyl er et særdeles lipofilt lægemiddel, der absorberes meget hurtigt via den orale mukosa og langsommere via mave-tarmkanalen.
English: In this study, the primary criteria chosen (SPID) and the time chosen for assessment of efficacy (30 min) do not seem appropriate to evaluate the efficacy of a treatment on BTP episodes, which are known to present a median duration of 30 min.
Danish: I dette forsøg ser de valgte primære kriterier (SPID) og tiden, der er valgt til vurdering af effekt (30 min.), ikke ud til at være passende til at vurdere effekten af en behandling på BTP-episoder, som er kendt for at have en middelvarighed på 30 min. CHMP var af den mening, at ansøgeren skulle fremlægge en analyse af 30% og 50% af de responderende efter 10 og 15 minutter for bedre at kunne vurdere den klinisk relevante profil for tid-effekt.
English: • Certain types of antiviral medicines used to treat infections caused by viruses (called protease inhibitors, containing e.g. ritonavir).
Danish: • Visse typer medicin mod virus, der bruges til at behandle infektioner, der er forårsaget af vira (såkaldte proteasehæmmere, f.eks. ritonavir).
English: Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Danish: Behandling af gennembrudssmerter hos voksne patienter, der er i opioidbehandling for kroniske cancersmerter.
English: Rapinyl is a rapidly disintegrating sublingual tablet designed to rapidly and predictably deliver fentanyl through the oral mucosa.
Danish: Rapinyl er en hurtigtopløsende sublingual tablet, der er beregnet til hurtigt og forudsigeligt at frigive fentanyl via slimhinden i munden.
English: Rapinyl and associated names (see Annex I) 50 microgram sublingual tablets [See Annex I - To be completed nationally]
Danish: Rapinyl og tilhørende navne (se bilag I) 50 mikrogram sublinguale resoribletter [Se bilag I - udfyldes nationalt]
English: • runny or blocked nose, dry mouth, sore throat, itching of the skin, skin rash, irritation under the tongue
Danish: • snue eller tilstoppet næse, mundtørhed, ondt i halsen, hudkløe, hududslæt, irritation under tungen
English: The CHMP considered the low adverse spectrum incidence in opioid-tolerant patients reassuring and noted the statement in the SPC on dose titration.
Danish: CHMP anså den lave uønskede incidens inden for spektret hos opioidtolerante patienter for at være acceptabel og registrerede bemærkningen i produktresuméet om dosistitrering.
English: Rapinyl and associated names (see Annex I) 50 µg sublingual tablets [See Annex I - To be completed nationally]
Danish: Rapinyl og tilhørende navne (se bilag I) 50 µg sublinguale resoribletter [Se bilag I - udfyldes nationalt]
English: Fentanyl, in common with all µ-opioid receptor agonists, produces dose dependent respiratory depression.
Danish: Som alle µ-opioidreceptoragonister fremkalder fentanyl dosisafhængig respirationsdepression.
English: • Uncommon side effects (affects 1 to 10 users in 1,000): feeling restless, feeling detached, moodswings, trembling, difficulty speaking, being forgetful, loss of coordination, vertigo, slow or fast heartbeat, high blood pressure, difficulty breathing, slow or shallow breathing, asthma, bloating, wind, thirst, difficulty going to the toilet, change in frequency of going to the toilet, feeling unwell
Danish: • Ualmindelige bivirkninger (påvirker mellem 1 og 10 ud af 1.000 brugere): rastløshed, isolationsfornemmelse, humørsvingninger, rysten, talebesvær, glemsomhed, tab af koordinationsevne, svimmelhed, langsomme eller hurtige hjerteslag, højt blodtryk, vejrtrækningsbesvær, langsom eller overfladisk vejrtrækning, astma, oppustethed, luft i tarmen, tørst, afføringsbesvær, ændringer i hyppigheden af toiletbesøg, utilpashed
English: PHARMACEUTICAL FORM AND CONTENTS Sublingual tablet
Danish: LÆGEMIDDELFORM OG INHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Sublingual resoriblet
English: Rapinyl is a treatment for people who must already regularly be taking strong pain-relieving medicine (opioids) for their persistent cancer pain, but require treatment for their breakthrough pain.
Danish: Rapinyl e beregnet til behandling af personer, som allerede regelsmæssigt tager stærke, smertelindrede lægemidler (oipoider) mod vedvarende cancersmerter, men som kræver behandling af gennembrudssmerter.
English: There should be no noticeable effects on cessation of treatment with Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting.
Danish: Der forventes ingen mærkbare virkninger ved seponering af behandling med Rapinyl, men mulige abstinenssymptomer er angst, tremor, svedudbrud, bleghed, kvalme og opkastning.
English: Common: Myoclonus, insomnia, taste disorders Uncommon: Abnormal gait/coordination, vertigo, amnesia, speech disorders, tremor
Danish: Almindelig: Myoclonus, insomni, smagsforstyrrelser Ikke almindelig: Unormal gang/koordination, vertigo, amnesi, taleforstyrrelser, tremor Luftveje, thorax og mediastinum
English: Rapinyl is intended for the treatment of breakthrough pain in patients using opioid therapy for chronic cancer pain.
Danish: Rapinyl er beregnet til behandlingen af gennembrudssmerter hos patienter, der er i opioidbehandling for kroniske cancersmerter.
English: Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed child. Fentanyl should only be used by breast-feeding women if the benefits clearly outweigh the potential risks for both mother and child.
Danish: Fentanyl bør kun administreres til ammende kvinder, hvis fordelene helt klart opvejer de potentielle risici for både moder og barn.
English: • low blood pressure, flushing/feeling hot, slow shallow breathing, feeling weak, feeling faint,
Danish: • lavt blodtryk, blussen/varmefølelse, langsom overfladisk vejrtrækning, svaghed, fornemmelse af at være ved at besvime, nedsat følsomhed over for berøring, følelsesløshed eller snurren
English: Carton Label
Danish: Blisterkort
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: Er De i tvivl, så spørg lægen eller apoteket.
English: Common: Gastro-intestinal occlusion, dysphagia, mouth ulcers/stomatitis, tongue disorder Uncommon: Enlarged abdomen, flatulence, thirst Rare: Hiccups
Danish: Almindelig: Gastrointestinal okklusion, dysfagi, mundsår/stomatitis, tungelidelse Ikke almindelig: Forstørret abdomen, flatulens, tørst Sjælden: Hikke
English: • vomiting, diarrhoea, constipation, stomach ache, bloated feeling, indigestion, loss of appetite
Danish: • opkastning, diaré, forstoppelse, mavepine, oppustet fornemmelse, fordøjelsesbesvær,
English: 50 microgram sublingual tablet is a white pentagon-shaped tablet 100 microgram sublingual tablet is a white round tablet 200 microgram sublingual tablet is a white oval-shaped tablet 300 microgram sublingual tablet is a white triangle-shaped tablet 400 microgram sublingual tablet is a white diamond-shaped tablet 600 microgram sublingual tablet is a white “D”-shaped tablet 800 microgram sublingual tablet is a white capsule-shaped tablet
Danish: 50 mikrogram subingual resoriblet er en hvid femkantet tablet 100 mikrogram sublingual resoriblet er en hvid, rund tablet 200 mikrogram sublingual resoriblet er en hvid, oval tablet 300 mikrogram sublingual resoriblet er en hvid, trekantet tablet 400 mikrogram sublingual resoriblet er en hvid, diamantformet tablet 600 mikrogram sublingual resoriblet er en hvid ”D”-formet tablet 800 mikrogram sublingual resoriblet er en hvid, kapselformet tablet
English: Do not swallow
Danish: Må ikke synkes.
English: However, due to the quite low number of patients exposed for a long time, the Applicant was asked to provide the final results of the studies EN3267-005 and EN3267-007 and the full safety analysis data on SAEs as conditions to the Marketing Authorisations.
Danish: På grund af det temmelig lille antal patienter, der er blevet eksponeret i længere i tid, skal de endelige resultater fra forsøg EN3267-005 og EN3267-007 samt data fra den komplette sikkerhedsanalyse om alvorlige uønskede hændelser imidlertid fremsendes som betingelse for markedsføringstilladelserne.
English: Opioid-naïve patients because of the risk of life-threatening respiratory depression.
Danish: Anvendelsen af Rapinyl er kontraindiceret til opioidnaive patienter på grund af risikoen for livstruende respirationsdepression.
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BILAG III PRODUKTRESUME ETIKETTERING OG INDLÆGSSEDDEL
English: Undesirable effects typical of opioids are to be expected with Rapinyl; they tend to decrease in intensity with continued use.
Danish: De har tendens til at aftage i intensitet ved fortsat brug.
English: What Rapinyl looks like and contents of the pack
Danish: Rapinyls udseende og pakningsstørrelse
English: In addition, a clinically relevant time-effect profile appropriate for an episode of breakthrough painl and meaningful clinical benefits for the patients were shown; patients could identify an effective dose of Rapinyl and use it successfully to control multiple episodes of breakthrough pain.
Danish: Desuden blev der påvist en klinisk relevant profil for tideffekt, der var passende for en episode med gennembrudssmerter og betydningsfulde kliniske fordele for patienterne.
English: Vascular disorders Common: Vasodilation
Danish: Almindelig: Vasodilatation
English: Marketing Authorisation Holder and Manufacturer:
Danish: Indehaveren af markedsføringstilladelsen og fremstiller
English: The Applicant provided data from a study investigating the pharmacokinetics of Rapinyl in 8 opioid tolerant cancer patients, which demonstrated that the pharmacokinetic parameters in patients were not different from those in healthy volunteers, with a similar pharmacokinetic variability.
Danish: Dataene viste, at de farmakokinetiske parametre hos patienter ikke var forskellige fra parametrene hos raske frivillige med en lignende farmakokinetisk variabilitet.
English: Common: Hallucinations, confusion, anxiety, nervousness, abnormal thinking, abnormal dreams Uncommon: Agitation, depersonalisation, emotional lability
Danish: Almindelig: Hallucinationer, konfusion, angst, nervøsitet, unormal tankegang, unormale drømme
English: The 100 microgram tablet is a white round tablet The 200 microgram tablet is a white oval-shaped tablet The 300 microgram tablet is a white triangle-shaped tablet The 400 microgram tablet is a white diamond-shaped tablet The 600 microgram tablet is a white “D”-shaped tablet The 800 microgram tablet is a white capsule-shaped tablet
Danish: 50 mikrogram resoribletten er en hvid, femkantet tablet 100 mikrogram resoribletten er en hvid, rund tablet 200 mikrogram resoribletten er en hvid, oval tablet 300 mikrogram resoribletten er en hvid, trekantet tablet 400 mikrogram resoribletten er en hvid, diamantformet tablet 600 mikrogram resoribletten er en hvid, ”D”-formet tablet 800 mikrogram resoribletten er en hvid, kapselformet tablet
English: Renal and urinary disorders Uncommon: Urinary retention, change in urinary frequency Very rare: bladder spasm, oliguria
Danish: Ikke almindelig: Urinretention, miktionsforstyrrelser Meget sjælden: Blærespasmer, oliguri
English: Pharmacotherapeutic group: Phenylpiperidine derivatives, ATC code: N02ABO3
Danish: ATC-kode: N02AB03
English: The following medicines may reduce the effects of Rapinyl: • Certain types of strong pain killers containing e.g. buprenorphine or pentazocine
Danish: • Visse typer stærke smertestillende lægemidler, der f.eks. indeholder buprenorphin eller pentazocin
English: DATE OF REVISION OF THE TEXT
Danish: Godkendelse af navn under behandling
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apoteket, hvis der er noget De er i tvivl om eller føler Dem usikker på.
English: Applicant for analyzing only SAEs at this stage are endorsed, and the absence of new important safety issues was considered re-assuring by the CHMP, a full safety analysis should be provided by the Applicant.
Danish: Desuden skal ansøgeren fremsende en komplet sikkerhedsanalyse, selv om de af ansøgeren angivne årsager til kun at analysere alvorlige uønskede hændelser på dette stadie accepteres, og selv om de manglende nye væsentlige sikkerhedsproblemer af CHMP anses for at være acceptable.
English: Each sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate)
Danish: Hver sublingual resoriblet indeholder 50 mikrogram fentanyl (som citrat) 100 mikrogram fentanyl (som citrat)
English: Discontinuation of therapy:
Danish: Seponering af behandling:
English: One sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate)
Danish: En sublingual resoriblet indeholder: 50 mikrogram fentanyl (som citrat) 100 mikrogram fentanyl (som citrat)
English: Rapinyl 100 microgram sublingual tablets Rapinyl 200 microgram sublingual tablets Rapinyl 300 microgram sublingual tablets Rapinyl 400 microgram sublingual tablets Rapinyl 600 microgram sublingual tablets Rapinyl 800 microgram sublingual tablets
Danish: Rapinyl 100 mikrogram sublinguale resoribletter, Rapinyl 200 mikrogram sublinguale resoribletter Rapinyl 300 mikrogram sublinguale resoribletter Rapinyl 400 mikrogram sublinguale resoribletter Rapinyl 600 mikrogram sublinguale resoribletter Rapinyl 800 mikrogram sublinguale resoribletter
English: In conclusion, the CHMP noted that no new data was provided by the Applicant during the procedure but disagreed with the Applicant point of view that further clinical efficacy and safety data are not needed, indeed the justification relies entirely on a bridging strategy that assumes that the bioavailability obtained with Rapinyl is twice higher than that obtained with Actiq at the same molar dose.
Danish: Afslutningsvis bemærkede CHMP, at der ikke blev fremlagt nye data af ansøgeren under proceduren, men var uenig med ansøgeren i, at yderligere data om klinisk effekt og sikkerhed ikke er nødvendige.
English: Common: Vomiting, abdominal pain, diarrhoea, constipation, stomach discomfort, dyspepsia, dry mouth
Danish: Almindelig: Opkastning, mavesmerter, diaré, obstipation, mavegener, dyspepsi, xerostomi
English: Rapinyl 800 µg sublingual tablets
Danish: Rapinyl 800 µg sublinguale resoribletter
English: Maintenance therapy:
Danish: Vedligeholdelsesbehandling:
English: Taking the medicine
Danish: Indtagelse af medicinen
English: HOW TO TAKE RAPINYL
Danish: SÅDAN SKAL DE TAGE RAPINYL
English: Take special care with Rapinyl
Danish: Vær ekstra forsigtig med at tage Rapinyl
English: Rapinyl 400 µg sublingual tablets
Danish: Rapinyl 400 µg sublinguale resoribletter
English: HOW TO STORE RAPINYL
Danish: SÅDAN OPBEVARER DE RAPINYL
English: Rapinyl 600 µg sublingual tablets
Danish: Rapinyl 600 µg sublinguale resoribletter
English: Rapinyl 600 microgram sublingual tablets
Danish: Rapinyl 600 mikrogram sublinguale resoribletter
English: Respiratory thoracic and mediastinal disorders Uncommon: Hypoventilation, asthma, dyspnoea, Very rare: Apnoea, haemoptysis
Danish: Ikke almindelig: Hypoventilation, astma, dyspnø
English: Rapinyl 100 µg sublingual tablets
Danish: Rapinyl 100 µg sublinguale resoribletter
English: Rapinyl 800 microgram sublingual tablets
Danish: Rapinyl 800 mikrogram sublinguale resoribletter
English: Rapinyl 300 µg sublingual tablets
Danish: Rapinyl 300 µg sublinguale resoribletter
English: Rapinyl 400 microgram sublingual tablets
Danish: Rapinyl 400 mikrogram sublinguale resoribletter
English: Whereas
Danish: Hjerte
English: Rapinyl 200 µg sublingual tablets
Danish: Rapinyl 200 µg sublinguale resoribletter
English: Skin and subcutaneous tissue disorders Very common: Sweating
Danish: Hud og subkutane væv
English: 800 micrograms fentanyl (as citrate)
Danish: 800 mikrogram fentanyl (som citrat)
English: Skin and subcutaneous tissue disorders Common: Rash, pruritus
Danish: Almindelig: Udslæt, pruritus
English: 200 micrograms fentanyl (as citrate)
Danish: 200 mikrogram fentanyl (som citrat)
English: The active substance is fentanyl.
Danish: Aktivt stof: Fentanyl.
English: 300 micrograms fentanyl (as citrate)
Danish: 300 mikrogram fentanyl (som citrat)
English: 400 micrograms fentanyl (as citrate)
Danish: 400 mikrogram fentanyl (som citrat)
English: 600 micrograms fentanyl (as citrate)
Danish: 600 mikrogram fentanyl (som citrat)
English: Sublingual use.
Danish: Resoriblet, sublingual
English: Marketing Authorisation Holder
Danish: Medlemsstat Indehaver af marketingsgodkendelse
English: Rapinyl 200 microgram sublingual tablets
Danish: Rapinyl 200 mikrogram sublinguale resoribletter
English: Psychiatric disorders Common: Depression, anorexia, concentration impaired, euphoria
Danish: Ikke almindelig: Uro, depersonalisation, emotionel labilitet
English: Rapinyl 300 microgram sublingual tablets
Danish: Rapinyl 300 mikrogram sublinguale resoribletter
English: Rapinyl 100 microgram sublingual tablets
Danish: Rapinyl 100 mikrogram sublinguale resoribletter
English: Do not pass it on to others.
Danish: Lad derfor være med at give Rapinyl til andre.
English: EU (MA) Number
Danish: EU-nummer (markedsføringstilla delsesnummer)
English: Annex I List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States
Danish: Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform, styrker, administyrationsvej, indehavere af markedsføringstilladelser i medlemsstaterne
English: Netherlands Sanofi-Aventis Netherlands B.V.
Danish: Sanofi-Aventis Netherlands B.V.