FrancophonIA/ELRC3.0 huggingface dataset:
English: These included: nonsteroidal anti-inflammatory agents (including acetylsalicylic acid), anilides (such as paracetamol), H2 blockers and proton pump inhibitors, diuretics, digoxin and cardiac glycosides, organic nitrates and other vasodilators for cardiac diseases, calcium channel blockers, beta blockers, ACE inhibitors, angiotensin II antagonists, selective beta-2 adrenoceptor agonists, oral anticoagulants, platelet aggregation inhibitors, statins, fibrates and benzodiazepine derivatives.
Danish: De omfattede følgende: Nonsteroide antiinflammatoriske midler (inklusive acetylsalicylsyre), anilider (såsom paracetamol), HR2R-receptorantagonister og syrepumpehæmmere, diuretika, digoxin og hjerteglycosider, organiske nitrater og andre vasodilatatorer til hjertesygdom, calciumantagonister, betablokkere, ACE-hæmmere, angiotensin II-antagonister, selektive beta-2-adrenoceptoragonister, peroral antikoagulantia, trombocytfunktionshæmmende midler, statiner, fibrater og benzodiazepinderivater.
English: As divalent cations can form complexes with oral tetracycline (e.g. doxycycline) and quinolone antibiotics (e.g. ciprofloxacin) at the gastro-intestinal level and thereby reduce their absorption,
Danish: Divalente kationer kan danne komplekser med peroralt tetracyclin (f.eks. doxycyclin) og quinolon (f.eks. ciprofloxacin) i det gastrointestinale system, hvorved absorptionen af disse antibiotika reduceres.
English: Therefore, administration of PROTELOS and such products should be separated by at least two hours (see sections 4.2 and 5.2).
Danish: Der bør derfor gå mindst to timer mellem administration af PROTELOS og denne type produkter (se pkt.
English: PROTELOS contains aspartame (E951):
Danish: PROTELOS indeholder aspartam (E951)
English: The efficacy of PROTELOS was demonstrated in men with osteoporosis in a 2-year, doubleblind,placebo-controlled study with a main analysis after one year in 243 patients (Intention to treatpopulation, 161 patients received strontium ranelate) at high risk of fracture (mean age 72,7 years; mean lumbar BMD T-score value of -2.6; 28% of prevalent vertebral fracture).
Danish: PROTELOS' effekt hos mænd med osteoporose blev demonstreret i et 2-årigt, dobbeltblindet, placebokontrolleret studie med en hovedanalyse efter ét år hos 243 patienter (intention to treatpopulation, 161 patienter fik strontiumranelat) med høj frakturrisiko (gennemsnitsalder 72,7 år; gennemsnitlig lumbal BMD T-score på -2,6; 28 % med prævalent vertebral fraktur).
English: Package leaflet: Information for the patient PROTELOS 2 g granules for oral suspension Strontium ranelate
Danish: Indlægsseddel: Information til patienten PROTELOS 2 g granulat til oral suspension Strontiumranelat
English: In an a-posteriori analysis of patients from the pooled SOTI and TROPOS studies with baseline lumbar spine and / or femoral neck BMD in the osteopenic range and without prevalent fracture but with at least one additional risk factor for fracture (N=176), PROTELOS reduced the risk of a first vertebral fracture by 72% over 3 years (incidence of vertebral fracture 3.6% with strontium ranelate vs. 12.0% with placebo).
Danish: I en à posteriori-analyse af patienter ud fra de samlede resultater af SOTI og TROPOS med BMDværdier for columna lumbalis og/eller collum femoris ved baseline, der svarede til osteopeni, og uden udbredte frakturer, men med mindst én yderligere risikofaktor (N = 176) reducerede PROTELOS risikoen for første vertebralfraktur med 72 % i løbet af 3 år (incidens af vertebralfraktur 3,6 % med strontiumranelat versus 12,0 % med placebo).
English: In patients over 80 years of age at inclusion, a pooled analysis of SOTI and TROPOS studies showed that PROTELOS reduced the relative risk of experiencing new vertebral fractures by 32% over 3 years (incidence of 19.1% with strontium ranelate vs. 26.5% with placebo).
Danish: Hos patienter, der var over 80 år ved inklusion, viste en analyse af de samlede resultater fra SOTI og TROPOS, at PROTELOS nedsatte den relative risiko for at få nye vertebralfrakturer med 32 % i løbet af 3 år (incidensen var 19,1 % med strontiumranelat versus 26,5 % med placebo).
English: simultaneous administration of strontium ranelate with these medicinal products is not recommended.
Danish: Strontiumranelat bør derfor ikke anvendes samtidig med disse lægemidler.
English: If you develop a rash or serious skin symptoms (see section 4), stop taking PROTELOS, seek urgent advice from a doctor and tell him that you are taking this medicine.
Danish: Hvis De udvikler hududslæt eller alvorlige hudsymptomer (se punkt 4) skal De stoppe med at tage PROTELOS og straks søge læge.
English: - if you are immobilised permanently or for some time such as being wheel-chair bound, or confined to bed or if you are to undergo an operation or recovering from an operation.
Danish: - hvis De er immobil, dvs. Deres bevægelighed er nedsat permanent eller i nogen tid, og De fx er bundet til en kørestol eller sengeliggende, eller hvis De skal opereres eller er ved at komme
English: If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after PROTELOS.
Danish: Hvis De får syreneutraliserende medicin (mod halsbrand), skal De helst tage dem mindst 2 timer efter, at De tager PROTELOS.
English: EU/1/04/288/005 84 sachets (3 packs of 28) EU/1/04/288/006 100 sachets
Danish: EU/1/04/288/005 84 breve (3 pakker med 28 i hver) EU/1/04/288/006 100 breve
English: ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ Τηλ: +30 210 939 1000
Danish: Τηλ: +30 210 939 1000
English: In the absence of bone safety data in patients with severe renal impairment treated with strontium ranelate, PROTELOS is not recommended in patients with a creatinine clearance below 30 ml/min (see section 5.2).
Danish: Da der ikke foreligger data for knoglerelateret sikkerhed hos strontiumranelatbehandlede patienter med alvorligt nedsat nyrefunktion, anbefales PROTELOS ikke til patienter med kreatininclearance < 30 ml/min (se pkt.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION PROTELOS 2 g granules for oral suspension.
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) PROTELOS 2 g granulat til oral suspension.
English: No evidence of clinical interactions or relevant increase of blood strontium levels with medicinal products expected to be commonly prescribed concomitantly with PROTELOS in the target population were found during clinical trials.
Danish: Der er i kliniske studier ikke påvist klinisk interaktion eller relevant stigning i plasmakoncentrationen af strontium med lægemidler, som normalt kan forventes at blive ordineret samtidig med PROTELOS til målgruppen.
English: Severe cutaneous adverse reactions (SCARs): Stevens-Johnson syndrome and toxic epidermal necrolysis* (see section
Danish: Alvorlige kutane bivirkninger: StevensJohnsons syndrom og toksisk epidermal nekrolyse* (se pkt.
English: Annopol 6B - 03-236 Warszawa, Poland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Danish: På lægemidlets trykte indlægsseddel skal der anføres navn og adresse på den fremstiller, som er ansvarlig for frigivelsen af den pågældende batch.
English: Given the slow absorption, PROTELOS should be taken at bedtime, preferably at least two hours after eating (see sections 4.5 and 5.2).
Danish: På grund af den langsomme absorption bør PROTELOS tages ved sengetid og fortrinsvis mindst 2 timer efter et måltid (se pkt.
English: How to take PROTELOS
Danish: Sådan skal De tage PROTELOS
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
Danish: Les Laboratoires Servier Industrie, 905, route de Saran -F-45520 Gidy, Frankrig Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
English: If symptoms or signs of SJS or TEN (e.g. progressive skin rash often with blisters or mucosal lesions) or DRESS (e.g. rash, fever, eosinophilia and systemic involvement (e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, PROTELOS treatment should be discontinued immediately.
Danish: Hvis der er symptomer eller tegn på SJS eller TEN (fx progressivt udslæt, ofte med blister, eller slimhindelæsioner) eller på DRESS (fx udslæt, feber, eosinofili og systemisk påvirkning (fx adenopati, hepatitis, interstitiel nefropati, interstitiel lungesygdom)), bør PROTELOS øjeblikkeligt seponeres.
English: Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of PROTELOS.
Danish: Der er rapporteret potentielt livstruende hududslæt (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse og svære overfølsomhedsreaktioner (DRESS)) ved anvendelse af PROTELOS.
English: In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase in myocardial infarction has been observed in PROTELOS treated patients compared to placebo (see section 4.8).
Danish: I poolede, randomiserede, placebokontrollerede studier med postmenopausale, osteoporotiske patienter er der observeret en betydeligt højere frekvens af myokardieinfarkt hos PROTELOSbehandlede patienter sammenlignet med placebo (se pkt.
English: o If symptoms or signs of Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) (e.g. rash, fever, eosinophilia and systemic involvement, e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, PROTELOS treatment should be discontinued immediately.
Danish: o Hvis der opstår symptomer eller tegn på Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) eller medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS) (fx udslæt, feber, eosinofili og systemisk påvirkning, fx adenopati, hepatitis, interstitiel neuropati, interstitiel lungesygdom), bør PROTELOSbehandlingen øjeblikkelig afbrydes.
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 PROTELOS Fortæl altid lægen eller apotekspersonalet, hvis De bruger anden medicin eller har gjort det for nylig.
English: You can take PROTELOS again when you have finished taking these antibiotics.
Danish: Når behandlingen med antibiotika er afsluttet, kan De atter begynde at tage PROTELOS.
English: You should stop taking PROTELOS if you have to take oral tetracyclines such as doxycycline or quinolones such as ciprofloxacin (two types of antibiotics).
Danish: Hvis De skal have antibiotika såsom tetracykliner såsom doxycyclin eller quinoloner såsom ciprofloxacin til indtagelse gennem munden, bør De holde op med at tage PROTELOS.
English: PROTELOS can interact with milk and milk products, so it is important that you mix PROTELOS only with water to be sure it works properly.
Danish: Derfor er det vigtigt kun at blande PROTELOS med vand for at sikre, at det virker korrekt.
English: NAME OF THE MEDICINAL PRODUCT PROTELOS 2 g granules for oral suspension
Danish: LÆGEMIDLETS NAVN PROTELOS 2 g granulat til oral suspension.
English: Life-threatening cutaneous reactions (Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of PROTELOS.
Danish: Livstruende hudreaktioner som Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) og DRESS-syndromet (medikamentelt udslæt med eosinofili og systemiske symptomer) er rapporteret i forbindelse med PROTELOS.
English: st year
Danish: 3 år.
English: The recommended dose is one 2 g sachet a day.
Danish: Den sædvanlige dosis er et brev med 2 g en gang daglig.
English: If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of PROTELOS, you must not be re-started on PROTELOS at any time If you are of Asian origin, you may be at higher risk of skin reactions.
Danish: Hvis De har udviklet Stevens-Johnsons syndrom, toksisk epidermal nekrolyse eller DRESS ved behandling med PROTELOS, må De aldrig tage PROTELOS igen.
English: Talk to your doctor or pharmacist before taking PROTELOS: - if you are at risk of heart disease, this includes high blood pressure, high cholesterol, diabetes,
Danish: Kontakt lægen eller apotekspersonalet, før De tager PROTELOS: - hvis De har risiko for hjertesygdom.
English: What PROTELOS looks like and contents of the pack PROTELOS is available in sachets containing yellow granules for oral suspension.
Danish: PROTELOS fås som breve, der indeholder et gult granulat til oral suspension.
English: When a VTE occurs, PROTELOS should be stopped.
Danish: I tilfælde af en venøs tromboembolisk komplikation bør PROTELOS seponeres.
English: PROTELOS should be discontinued as soon as possible in the event of an illness or a condition leading to immobilisation (see section 4.3) and adequate preventive measures taken.
Danish: 4.3), bør PROTELOS seponeres snarest muligt, og der bør træffes passende forebyggende foranstaltninger.
English: Food, milk and milk products reduce the absorption of strontium ranelate.
Danish: Brug af PROTELOS sammen med mad og drikke Mad, mælk og mælkeprodukter nedsætter optagelsen af strontiumranelat.
English: Mannitol (E421)
Danish: Aspartam (E951) Maltodextrin Mannitol (E421)
English: No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Dosisjustering ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: Pyrexia (in association with hypersensitivity skin reactions)
Danish: Ikke almindelig Pyreksi (i forbindelse med dermale overfølsomhedsreaktioner)
English: Continuation of treatment with PROTELOS in patients developing severe renal impairment should be considered on an individual basis.
Danish: Hos patienter, der udvikler alvorligt nedsat nyrefunktion, bør det vurderes individuelt, om behandlingen med PROTELOS kan fortsættes.
English: Other medicines and PROTELOS:
Danish: Oversigt over indlægssedlen:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/288/004 56 sachets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/288/004 56 breve
English: How PROTELOS works
Danish: Sådan virker PROTELOS
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/288/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/288/002
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret PROTELOS til Dem personligt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/288/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/288/001
English: PROTELOS is contra-indicated in patients with a past history of venous thromboembolic events (see section 4.3) and should be used with caution in patients at risk of VTE.
Danish: PROTELOS er kontraindiceret hos patienter med VTE i anamnesen (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/288/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/288/003
English: What PROTELOS is and what it is used for What you need to know before you take PROTELOS How to take PROTELOS
Danish: Det skal De vide, før De begynder at tage PROTELOS Sådan skal De tage PROTELOS Bivirkninger
English: Strontium ranelate is not recommended for patients with severe renal impairment (creatinine clearance below 30 ml/min) (see sections 4.4 and 5.2).No dose adjustment is required in patients with mild-to-moderate renal impairment (30-70 ml/min creatinine clearance) (see sections 4.4 and 5.2).
Danish: Dosisjustering er ikke nødvendig hos patienter med let til moderat nyrefunktionsnedsættelse (kreatininclearance 30-70 ml/min) (se pkt.
English: DATE OF REVISION OF THE TEXT
Danish: Eλλάδα ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ
English: Excipient
Danish: Paræstesi
English: The application can be repeated, if necessary.
Danish: Appliceringen kan om nødvendigt gentages.
English: If these symptoms occur, the administration should be discontinued immediately.
Danish: Hvis disse symptomer forekommer, skal administrationen afbrydes omgående.
English: Such substances should be removed as much as possible before applying the product.
Danish: Sådanne stoffer skal så vidt muligt fjernes, inden produktet appliceres.
English: 1 or 2
Danish: 1 eller 2
English: This leaflet was last approved in 12/2016.
Danish: Denne indlægsseddel blev senest ændret 12/2016.
English: The frequency of the type of event is not known (cannot be estimated from available data).
Danish: Hyppigheden af denne bivirkning er ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Bleeding at target sites was mild or moderate.
Danish: Blødningen på målområderne var mild eller moderat.
English: Higher dosages up to 4g (including re-application and treatment of more than a single bleeding site) may be needed.
Danish: Der kan være behov for højere doser på op til 4 g (inklusive reapplicering og behandling af mere end et enkelt blødningssted).
English: Maximum amount of Raplixa recommended is 3 gram.
Danish: Den maksimalt anbefalede mængde Raplixa er 3 gram.
English: Elderly Dose adjustment not required.
Danish: Ældre Dosisjustering ikke nødvendig.
English: • Use preferred pressurised CO2 instead of pressurised air
Danish: • Anvendelse af foretrukken CO2 under tryk i stedet for luft under tryk
English: Raplixa is indicated in adults over 18 years of age.
Danish: Raplixa er indiceret til voksne over 18 år.
English: As with any protein product, allergic type hypersensitivity reactions are possible.
Danish: Som ved ethvert proteinholdigt produkt kan der forekomme allergiske overfølsomhedsreaktioner.
English: In case of shock, standard medical treatment for shock should be implemented.
Danish: I tilfælde af shock iværksættes standardbehandling for shock.
English: Human plasma
Danish: Humant plasma
English: 35041 Marburg (Stadtteil Michelbach) Germany
Danish: 35041 Marburg (Stadtteil Michelbach) Tyskland
English: Recommended distance from target tissue
Danish: Anbefalet afstand til målvæv
English: What you need to know before you are treated with Raplixa
Danish: Det skal du vide, før, du bliver behandlet med Raplixa
English: The fibrin adhesion system initiates the last phase of physiological blood coagulation.
Danish: Fibrinadhæsionssystemet initierer den sidste fase af den fysiologiske blodkoagulation.
English: Prior to launch of Raplixa in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Før Raplixa lanceres i de enkelte medlemsstater, skal indehaveren af markedsføringstilladelsen aftale indholdet af og formatet for uddannelsesprogrammet, herunder kommunikationsmedier, distributionsformer og andre aspekter af programmet, med det enkelte lands kompetente myndighed.
English: Fibrin sealants may, in rare cases (up to 1 in 1,000 people), cause an allergic reaction.
Danish: Fibrinvævsklæbere kan i sjældne tilfælde (op til 1 ud af 1000 patienter) give en allergisk reaktion.
English: Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis.
Danish: Understøttende behandling, hvor kirurgiske standardteknikker ikke er tilstrækkelige til at forbedre hæmostasen.
English: In the event of overdose, patients must be closely monitored for signs or symptoms of adverse reactions and appropriate symptomatic treatment and supportive measures instituted.
Danish: I tilfælde af overdosering skal patienterne monitoreres tæt for tegn eller symptomer på bivirkninger, og passende symptomatisk og understøttende behandling skal iværksættes.
English: No formal interaction studies have been performed.
Danish: Der er ikke udført nogen formelle interaktionsforsøg.
English: The product should only be administered according to the instructions and with the devices recommended for this product.
Danish: Produktet må kun administreres i henhold til anvisningerne og med de enheder, der anbefales til produktet.
English: Such reactions may especially be seen, if the preparation is applied repeatedly, or administered to patients known to be hypersensitive to constituents of the product.
Danish: Sådanne reaktioner kan især ses, hvis præparatet appliceres gentagne gange eller administreres til patienter med kendt overfølsomhed over for produktets bestanddele.
English: Conventional surgical techniques such as suture, ligature and cautery were ineffective or impractical.
Danish: Konventionelle kirurgiske teknikker som sutur, ligatur og kauterisation var uvirksomme eller ikke praktisk mulige.
English: 1 vial 0.5 g 1 vial 1 g 1 vial 2 g
Danish: 1 hætteglas 0,5 g 1 hætteglas 1 g 1 hætteglas 2 g
English: The Guide for healthcare professionals shall inform on the following key elements:
Danish: Vejledningen til læger og sundhedspersonale skal informere om følgende nøgleelementer:
English: • Nearby areas should be protected to make sure that Raplixa is only applied onto the surface which is to be treated.
Danish: Nærliggende områder skal beskyttes for at sikre, at Raplixa kun påføres den overflade, der skal behandles.
English: The pressure should be within the range recommended by ProFibrix.
Danish: Trykket skal ligge inden for det område, der anbefales af ProFibrix.
English: Use and Application
Danish: Anvendelse og applicering
English: • Risk of life-threatening air or gas embolism if the product is sprayed incorrectly
Danish: • Risiko for livstruende luft- eller gasemboli, hvis produktet ikke sprayes korrekt
English: It is called an air or gas embolism.
Danish: Det kaldes en luft- eller gasemboli.
English: Application of the product must be individualised by the treating surgeon.
Danish: Applikation af produktet skal tilpasses individuelt af den behandlende kirurg.
English: Clinical studies in the EU were done with the CE marked Spongostan gelatin sponge.
Danish: Der er udført kliniske forsøg i EU med den CE-mærkede Spongostan-gelatinesvamp.
English: Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: The outer aluminium foil sachet may be opened in a non-sterile operating area.
Danish: Den ydre aluminiumspose kan åbnes i et ikke-sterilt operationsområde.
English: Do not use this medicine after the expiry date which is stated on the label.
Danish: Brug ikke lægemidlet efter den dato, der står på pakningen.
English: Human Fibrinogen
Danish: Humant fibrinogen
English: Before administration of Raplixa care is to be taken that parts of the body outside the desired application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites.
Danish: Før administration af Raplixa skal de dele af kroppen, som ligger uden for det ønskede applikationsområde, beskyttes tilstrækkeligt (tildækkes) for at forhindre vævsadhæsion på uønskede steder.
English: Table 1: Composition of Raplixa (per gram powder) Component
Danish: Tabel 1: Sammensætning af Raplixa (pr. gram pulver) Komponent
English: Name and address of the manufacturers of the biological active substances CSL Behring GmbH
Danish: Navn og adresse på fremstilleren (fremstillerne) af det (de) biologisk aktive stof(fer) CSL Behring GmbH
English: Air or gas emboli
Danish: Luft- eller gasemboli
English: In absence of compatibility studies, Raplixa must not be mixed with other medicinal products.
Danish: Da der ikke foreligger studier af eventuelle uforligeligheder, må Raplixa ikke blandes med andre lægemidler.
English: Raplixa may also be used with medical air.
Danish: Raplixa kan også anvendes med medicinsk luft.
English: For instructions on use of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om anvendelse af lægemidlet før administration, se pkt.