natgillin/translations-raw huggingface dataset:
Fortæl det altid til lægen eller apoteket, hvis De bruger anden medicin eller har brugt det for nylig (undtagen Deres sædvanlige opioide smertestillende medicin).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines (other than your regular opioid pain-relieving medicine), including medicines obtained without a prescription.
Ansøgningen var baseret på litteratur om fentanyl sammen med farmakokinetiske data for Rapinyl og en sammenligning af biotilgængeligheden af Rapinyl med sugetabletten Actiq, en fentanyl godkendt til transmucosal indgift efter behov.
The application was based on literature data on fentanyl, supplemented with pharmacokinetic data for Rapinyl and a comparison of Rapinyl bioavailability with Actiq lozenge, an authorised transmucosally administered fentanyl on demand.
Ansøgeren var i stand til som svar på spørgsmålene på listen med uafklarede spørgsmål at fremskaffe interimanalyser fra to igangværende kliniske fase III-sikkerheds- og effektforsøg (EN3267-005 og EN3267-007) udført i USA af Endo.
The Applicant was able to provide in the response to the LoOI the interim analyses from 2 ongoing Phase III safety and efficacy clinical studies (EN3267-005 and EN3267-007), performed in the US by Endo.
• Sjældne bivirkninger (påvirker mellem 1 og 10 ud af 10.000 brugere): Hikke
• Rare side effects (affects 1 to 10 users in 10,000): hiccups
Sikkerheden og virkningen af Rapinyl er undersøgt hos patienter, der tager lægemidlet ved starten af en periode med gennembrudssmerter.
The safety and efficacy of Rapinyl have been evaluated in patients taking the drug at the onset of the breakthrough pain episode.
Fentanyl passerer over i modermælken og kan forårsage ekstrem døsighed og overfladisk vejrtrækning hos det diende barn.
Fentanyl is passed on into breast milk and may cause extreme drowsiness and shallow breathing in the breastfed child.
Rapinyl sublinguale resoribletter fås i æsker med 10 eller 30 tabletter.
Rapinyl tablets are contained in blisters, available in cartons of 10 or 30 tablets.
[Se bilag I - udfyldes nationalt]
[See Annex I - To be completed nationally]
• Visse typer antibiotika, der bruges til at behandle betændelser (såkaldte makrolidantibiotika f.eks. erythromycin).
• Certain types of antibiotic medicines used to treat infections (called macrolides, containing e.g. erythromycin ).
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Patienter og deres plejere skal instrueres i, at Rapinyl indeholder et aktivt stof i en mænge, der kan være fatalt for et barn, og at alle tabletter derfor skal opbevares utilgængeligt for børn.
Patients and their carers must be instructed that Rapinyl contains an active substance in an amount that can be fatal to a child, and therefore to keep all tablets out of the reach and sight of children.
Dosistitrering skal foregå med særlig forsigtighed, og patienterne skal observeres omhyggeligt for tegn på fentanyltoksicitet (se pkt.
Dose titration needs to be approached with particular care and patients observed carefully for signs of fentanyl toxicity (see section 4.4).
Den smertelindrende medicin i Rapinyl er meget stærk og kan være livstruende, hvis den ved et uheld tages af et barn.
The pain-relieving medicine in Rapinyl is very strong and could be life-threatening if taken accidentally by a child. Rapinyl must be kept out of the reach and sight of children.
Anvendelse til patienter med nedsat nyre- og leverfunktion Patienter med nedsat nyre- eller leverfunktion skal observeres omhyggeligt for tegn på fentanyltoksicitet under titreringsfasen med Rapinyl (se pkt.
Use in patients with renal and hepatic impairment Patients with kidney or liver dysfunction should be carefully observed for signs of fentanyl toxicity during the Rapinyl titration phase (see section 4.4).
Andre meget almindeligt rapporterede bivirkninger omfatter: Kvalme, opkastning, obstipation, hovedpine, somnolens/træthed og svimmelhed.
Other very commonly reported adverse reactions include: nausea, vomiting, constipation, headache, somnolence/fatigue and dizziness.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - udfyldes nationalt]
NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Ansøgeren forsvarede dosis på 800 µg og redegjorde for sikkerheden ved Rapinyl, når det blev tilføjet i en kontinuerlig fentanyl- eller ikke-fentanyl opioidsmertebehandling og anså den transmucosale frigivelse af fentanyl for at frembringe ensartede resultater uafhængig af typen af baselinebehandling.
The Applicant also defended the 800ug dose and discussed the safety of Rapinyl when superimposed on a continuous fentanyl or non-fentanyl opioid pain therapy and considered that the transmucosal delivery of fentanyl produces consistent results, independent of the type of baseline therapy.
Det aktive stof i Rapinyl sublinguale resoribletter er fentanyl.
The active substance in Rapinyl sublingual tablets is fentanyl.
Rapinyl sublinguale resoribletter fås i et udvalg af styrker.
Rapinyl sublingual tablets are available in a range of strengths.
Ansøgeren beskrev de observerede signaler for alvorlige uønskede hændelser og bemærkede, at investigator kun vurderede ét tilfælde som værende relateret til forsøgslægemidlet.
The Applicant described the observed SAE signals and noted that only one case was evaluated as related to the study drug by the investigator..
Dyreforsøg har vist reproduktionstoksicitet (e pkt.
Studies in animals have shown reproductive toxicity (see section 5.3).
Almene symptomer og reaktioner på administrationsstedet Ikke almindelig: Utilpashed
General disorders and administration site conditions Uncommon: Malaise
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).
- 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).
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
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
• Meget sjældne bivirkninger (påvirker færre end 1 ud af 10.000 brugere): Uregelmæssig hjertebanken, vejrtrækningsstop, blod i spyt, nedsat urinmængde, smertefuld sammentrækning af blæren
• 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
Sublingual anvendelse Skal opløses under tungen.
To be dissolved under the tongue.
Rapinyl 50 mikrogram Rapinyl 100 mikrogram Rapinyl 200 mikrogram Rapinyl 300 mikrogram Rapinyl 400 mikrogram Rapinyl 600 mikrogram Rapinyl 800 mikrogram
Rapinyl 50 micrograms Rapinyl 100 micrograms Rapinyl 200 micrograms Rapinyl 300 micrograms Rapinyl 400 micrograms Rapinyl 600 micrograms Rapinyl 800 micrograms
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.
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.
Meget almindelig: Svimmelhed, somnolens, hovedpine Almindelig: Vasovagal reaktion, hypoæstesi, paræstesi, hyperakusis
Very common: Dizziness, somnolence, headache Common: Vasovagal reaction, hypoaesthesia, paraesthesia, hyperacusis
• Træk fligen på folieen af en blister tilbage og tag forsigtigt resoribletten ud.
• Peel back the tab of the foil top of one blister and gently remove the tablet.
Genjustering af dosis:
Dose re-adjustment:
4.4 i produktresuméet, hvor ekstra forsigtighed under titreringen af patienter med sår i munden eller mucositis anbefales.
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.
• muskelafslappende midler
• muscle relaxants
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.
There should be no noticeable effects if you stop taking Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting.
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.
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.
Ældre, kakektiske eller debile patienter kan have en nedsat fenatylclearance, som kan medføre en længere terminal halveringstid af stoffet (se pkt.
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).
• hvis De er overfølsom (allergisk) over for fentanyl eller et af de øvrige indholdsstoffer
• if you are allergic (hypersensitive) to fentanyl or any of the other ingredients of Rapinyl • if you have severe breathing problems
• 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
• 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
Indehaver af markedsføringstilladelsen: [Se bilag I - udfyldes nationalt] (Navn og adresse) <{tlf}> <{fax}> <{e-mail}>
Marketing authorisation holder: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
• 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.
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.
Fentanyl er et særdeles lipofilt lægemiddel, der absorberes meget hurtigt via den orale mukosa og langsommere via mave-tarmkanalen.
Fentanyl is a highly lipophilic drug absorbed very rapidly through the oral mucosa and more slowly through the gastrointestinal tract.
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.
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.
• Visse typer medicin mod virus, der bruges til at behandle infektioner, der er forårsaget af vira (såkaldte proteasehæmmere, f.eks. ritonavir).
• Certain types of antiviral medicines used to treat infections caused by viruses (called protease inhibitors, containing e.g. ritonavir).
Behandling af gennembrudssmerter hos voksne patienter, der er i opioidbehandling for kroniske cancersmerter.
Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Rapinyl er en hurtigtopløsende sublingual tablet, der er beregnet til hurtigt og forudsigeligt at frigive fentanyl via slimhinden i munden.
Rapinyl is a rapidly disintegrating sublingual tablet designed to rapidly and predictably deliver fentanyl through the oral mucosa.
Rapinyl og tilhørende navne (se bilag I) 50 mikrogram sublinguale resoribletter [Se bilag I - udfyldes nationalt]
Rapinyl and associated names (see Annex I) 50 microgram sublingual tablets [See Annex I - To be completed nationally]
• snue eller tilstoppet næse, mundtørhed, ondt i halsen, hudkløe, hududslæt, irritation under tungen
• runny or blocked nose, dry mouth, sore throat, itching of the skin, skin rash, irritation under the tongue
CHMP anså den lave uønskede incidens inden for spektret hos opioidtolerante patienter for at være acceptabel og registrerede bemærkningen i produktresuméet om dosistitrering.
The CHMP considered the low adverse spectrum incidence in opioid-tolerant patients reassuring and noted the statement in the SPC on dose titration.
Rapinyl og tilhørende navne (se bilag I) 50 µg sublinguale resoribletter [Se bilag I - udfyldes nationalt]
Rapinyl and associated names (see Annex I) 50 µg sublingual tablets [See Annex I - To be completed nationally]
Som alle µ-opioidreceptoragonister fremkalder fentanyl dosisafhængig respirationsdepression.
Fentanyl, in common with all µ-opioid receptor agonists, produces dose dependent respiratory depression.
• 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
• 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
LÆGEMIDDELFORM OG INHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Sublingual resoriblet
PHARMACEUTICAL FORM AND CONTENTS Sublingual tablet
Rapinyl e beregnet til behandling af personer, som allerede regelsmæssigt tager stærke, smertelindrede lægemidler (oipoider) mod vedvarende cancersmerter, men som kræver behandling af gennembrudssmerter.
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.
Der forventes ingen mærkbare virkninger ved seponering af behandling med Rapinyl, men mulige abstinenssymptomer er angst, tremor, svedudbrud, bleghed, kvalme og opkastning.
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.
Almindelig: Myoclonus, insomni, smagsforstyrrelser Ikke almindelig: Unormal gang/koordination, vertigo, amnesi, taleforstyrrelser, tremor Luftveje, thorax og mediastinum
Common: Myoclonus, insomnia, taste disorders Uncommon: Abnormal gait/coordination, vertigo, amnesia, speech disorders, tremor
Rapinyl er beregnet til behandlingen af gennembrudssmerter hos patienter, der er i opioidbehandling for kroniske cancersmerter.
Rapinyl is intended for the treatment of breakthrough pain in patients using opioid therapy for chronic cancer pain.
Fentanyl bør kun administreres til ammende kvinder, hvis fordelene helt klart opvejer de potentielle risici for både moder og barn.
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.
• lavt blodtryk, blussen/varmefølelse, langsom overfladisk vejrtrækning, svaghed, fornemmelse af at være ved at besvime, nedsat følsomhed over for berøring, følelsesløshed eller snurren
• low blood pressure, flushing/feeling hot, slow shallow breathing, feeling weak, feeling faint,
Blisterkort
Carton Label
Er De i tvivl, så spørg lægen eller apoteket.
• If you have any further questions, ask your doctor or pharmacist.
Almindelig: Gastrointestinal okklusion, dysfagi, mundsår/stomatitis, tungelidelse Ikke almindelig: Forstørret abdomen, flatulens, tørst Sjælden: Hikke
Common: Gastro-intestinal occlusion, dysphagia, mouth ulcers/stomatitis, tongue disorder Uncommon: Enlarged abdomen, flatulence, thirst Rare: Hiccups
• opkastning, diaré, forstoppelse, mavepine, oppustet fornemmelse, fordøjelsesbesvær,
• vomiting, diarrhoea, constipation, stomach ache, bloated feeling, indigestion, loss of appetite
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
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
Må ikke synkes.
Do not swallow
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.
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.
Anvendelsen af Rapinyl er kontraindiceret til opioidnaive patienter på grund af risikoen for livstruende respirationsdepression.
Opioid-naïve patients because of the risk of life-threatening respiratory depression.
BILAG III PRODUKTRESUME ETIKETTERING OG INDLÆGSSEDDEL
ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
De har tendens til at aftage i intensitet ved fortsat brug.
Undesirable effects typical of opioids are to be expected with Rapinyl; they tend to decrease in intensity with continued use.
Rapinyls udseende og pakningsstørrelse
What Rapinyl looks like and contents of the pack
Desuden blev der påvist en klinisk relevant profil for tideffekt, der var passende for en episode med gennembrudssmerter og betydningsfulde kliniske fordele for patienterne.
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.
Almindelig: Vasodilatation
Vascular disorders Common: Vasodilation
Indehaveren af markedsføringstilladelsen og fremstiller
Marketing Authorisation Holder and Manufacturer:
Dataene viste, at de farmakokinetiske parametre hos patienter ikke var forskellige fra parametrene hos raske frivillige med en lignende farmakokinetisk variabilitet.
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.
Almindelig: Hallucinationer, konfusion, angst, nervøsitet, unormal tankegang, unormale drømme
Common: Hallucinations, confusion, anxiety, nervousness, abnormal thinking, abnormal dreams Uncommon: Agitation, depersonalisation, emotional lability
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
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
Ikke almindelig: Urinretention, miktionsforstyrrelser Meget sjælden: Blærespasmer, oliguri
Renal and urinary disorders Uncommon: Urinary retention, change in urinary frequency Very rare: bladder spasm, oliguria
ATC-kode: N02AB03
Pharmacotherapeutic group: Phenylpiperidine derivatives, ATC code: N02ABO3
• Visse typer stærke smertestillende lægemidler, der f.eks. indeholder buprenorphin eller pentazocin
The following medicines may reduce the effects of Rapinyl: • Certain types of strong pain killers containing e.g. buprenorphine or pentazocine
Godkendelse af navn under behandling
DATE OF REVISION OF THE TEXT
Spørg lægen eller apoteket, hvis der er noget De er i tvivl om eller føler Dem usikker på.
You should check with your doctor or pharmacist if you are not sure.
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.
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.
Hver sublingual resoriblet indeholder 50 mikrogram fentanyl (som citrat) 100 mikrogram fentanyl (som citrat)
Each sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate)
Seponering af behandling:
Discontinuation of therapy:
En sublingual resoriblet indeholder: 50 mikrogram fentanyl (som citrat) 100 mikrogram fentanyl (som citrat)
One sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate)
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
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