FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of {INVENTED NAME} with ultrasonic nebulisers is not recommended.
Danish: Det anbefales ikke at anvende {SÆRNAVN} med ultralydsnebulisatorer.
English: Instructions for use: Use the ampoule according to the following instructions:
Danish: Instruktioner vedrørende anvendelsen: Enkeltdosisampullen anvendes i henhold til følgende instruktioner:
English: 400-800 micrograms twice daily (total daily dose: 800 - 1600 micrograms)
Danish: 400-800 mikrogram to gange dagligt (total daglig dosis: 800 - 1600 mikrogram)
English: MARKETING AUTHORISATION NUMBER(S) [to be completed nationally]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) [udfyldes nationalt]
English: {INVENTED NAME} nebuliser suspension comes in polyethylene ampoules containing 1 ml ({INVENTED NAME} 400 micrograms) or 2 ml ({INVENTED NAME} 800 micrograms).
Danish: {SÆRNAVN} inhalationsvæske til nebulisator, suspension, leveres i enkeltdosisampuller, der indeholder 1 ml ({SÆRNAVN} 400 mikrogram) eller 2 ml ({SÆRNAVN} 800 mikrogram).
English: The starting dose of nebulised beclometasone dipropionate should take into account the frequency and severity of symptoms.
Danish: 4.2 Dosering og administration Startdosen for nebuliseret beclometasondipropionat skal afpasses efter symptomernes hyppighed og sværhedsgrad.
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription INSTRUCTIONS ON USE
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Lægemidlet er receptpligtigt
English: Check with your doctor or pharmacist if you are not sure.
Danish: SÆRNAVN}Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: The ampoule should be used according to the following instructions:
Danish: Enkeltdosisampullen skal anvendes i henhold til følgende instruktioner:
English: If only half dose of {INVENTED NAME} 800 micrograms is needed, hold the ampoule upside down, ensuring that the graduation mark is clearly visible and apply moderate pressure.
Danish: Hvis der kun er behov for en halv dosis {SÆRNAVN} af 800 mikrogram, holdes ampullen på hovedet med klart synligt målemærke, mens der trykkes let på ampullen.
English: If only half dose of {INVENTED NAME} 800 micrograms is needed, reinsert the cap upside down by pushing it onto the vial.
Danish: Hvis der kun er behov for en halv dosis {SÆRNAVN} 800 mikrogram, sættes hætten på igen ved at trykke den fast på ampullen, mens den vender på hovedet.
English: {INVENTED NAME} contains the active substance beclometasone dipropionate.
Danish: {SÆRNAVN} indeholder det aktive stof beclometasonedipropionat.
English: {INVENTED NAME}
Danish: {SÆRNAVN}
English: HOW TO TAKE {INVENTED NAME}
Danish: SÅDAN SKAL DU TAGE {SÆRNAVN}
English: The other ingredients are polysorbate 20, sorbitan laurate, sodium chloride, water for injections.
Danish: De øvrige indholdsstoffer er: polysorbat 20, sorbitanlaurat, natriumchlorid, vand til injektionsvæske.
English: It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored.
Danish: Hvis børn er i langtidsbehandling med inhalerede kortikosteroider, anbefales det at kontrollere deres højde regelmæssigt.
English: For 800 micrograms ampoule only: after the first opening of the ampoule, store it in a refrigerator (2°C8°C).
Danish: Kun for 800 mikrogram-ampuller: efter første åbning af ampullen: opbevares i køleskab (2 °C - 8 °C).
English: Once the nebuliser bowl cap is inserted, the nebuliser should be shaken gently to mix the content.
Danish: Nebuliseren bør rystes forsigtigt for at blande indholdet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [to be completed nationally]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) [udfyldes nationalt] DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN [udfyldes nationalt] 10.
English: If you use more {INVENTED NAME} than you should:
Danish: Hvis du har brugt for meget {SÆRNAVN}:
English: CLENIL and associated names (see Annex I) 400 micrograms nebuliser suspension CLENIL and associated names (see Annex I) 800 micrograms nebuliser suspension [See Annex I - To be completed nationally]
Danish: CLENIL og tilknyttede navne (se bilag I) 400 mg mikrogram nebulisator, suspension CLENIL og tilknyttede navne (se bilag I) 800 mg mikrogram nebulisator, suspension [Se bilag I - Udfyldes nationalt]
English: Beclometasone dipropionate is a glucocorticoid with potent anti-inflammatory activity with limited mineralocorticoid activity; following administration to the respiratory system by inhalation a local effect in the lower respiratory tract is obtained.
Danish: Beclometasondipropionat er et glukokortikoid med potent antiinflammatorisk aktivitet og begrænset mineralokortikoid aktivitet.
English: WHAT YOU NEED TO KNOW BEFORE YOU USE {INVENTED NAME}
Danish: DET SKAL DU VIDE, FØR DU BEGYNDER AT BRUGE {SÆRNAVN} Brug ikke {SÆRNAVN}:
English: You should see your doctor as soon as possible if you experience these symptoms.
Danish: Hvis du oplever disse symptomer, skal du hurtigst muligt kontakte din læge.
English: Adults and adolescents (from 12 years of age) :
Danish: De anbefalede startdoser er: Voksne og unge (som er fyldt 12 år):
English: Gargling with water immediately after inhalation may help to prevent this effect.
Danish: Denne bivirkning kan forebygges ved at gurgle med vand umiddelbart efter inhalationen.
English: Use the ampoules within 3 months from the first opening the pouch.
Danish: Anvend ampullerne inden for 3 måneder, efter posen åbnes første gang.
English: After the first opening of the ampoule, store it in a refrigerator (2-8°C).
Danish: Efter første åbning af ampullen: opbevares i køleskab (2-8°C).
English: After the first opening of the ampoule, store in a refrigerator (2°C - 8°C).
Danish: Efter første åbning af ampullen: opbevares i køleskab (2 °C - 8 °C).
English: No significant effect on morning serum cortisol levels was reported in asthmatic patients after a 3-week treatment period of 1600 and 3200 µg per day b.i.d.
Danish: Efter en 3-ugers behandlingsperiode med 1600 og 3200 µg dagligt (b.i.d.)
English: Exp: Use the ampoules within 3 months from the first opening the pouch.
Danish: Udløbsdato: Anvend ampullerne inden for 3 måneder, efter posen åbnes første gang.
English: Wheezing
Danish: Amning
English: Rinsing your mouth or gargling with water immediately after inhalation may help to prevent these effects.
Danish: Disse bivirkninger kan forebygges ved at skylle munden eller gurgle med vand umiddelbart efter inhalationen.
English: LIST OF EXCIPIENTS Excipients: polysorbate 20, sorbitan laurate, sodium chloride, water for injections
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestoffer: polysorbat 20, sorbitanlaurat, natriumchlorid, vand til injektionsvæske
English: However, at therapeutic doses of beclometasone dipropionate no effect on the breastfed newborns/infants are anticipated.
Danish: Men der forventes ingen påvirkning af det ammede barn ved terapeutiske doser af beclometasondipropionat.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Danish: Ændringerne til de relevante afsnit i produktresumeet og indlægssedlen er resultatet af referral-proceduren.
English: • If you have an infection of nasal and paranasal cavities you have to be treated with suitable therapies,
Danish: • Hvis du har infektion i næse- eller bihuler, skal du behandles hensigtsmæssigt, selvom det ikke udgør en specifik kontraindikation for brug af {SÆRNAVN}.
English: Rare side effects (may affect up to 1 in 1000people):
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1000 personer):
English: Excipients: polysorbate 20, sorbitan laurate, sodium chloride, water for injections
Danish: Hjælpestoffer: polysorbat 20, sorbitanlaurat, natriumchlorid, vand til injektionsvæske
English: Systemic effect of inhaled corticosteroids (including beclometasone dipropionate) may occur particularly when administered at high doses for prolonged periods of time: these may include adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma (see section 4.4).
Danish: Disse kan omfatte suppression af binyrerne, nedsat mineraltæthed i knogler, væksthæmning hos børn og unge, katarakt og glaukom (se pkt.
English: CLENIL and associated names (see Annex I) 400 micrograms nebuliser suspension
Danish: CLENIL og tilknyttede navne (se bilag I) 400 mg mikrogram nebulisator, suspension
English: 4.1 Therapeutic indications
Danish: KLINISKE OPLYSNINGER 4.1 Terapeutiske indikationer {SÆRNAVN} er indiceret til:
English: Nevertheless, as precautionary measure when high doses of beclometasone dipropionate are inhaled you should avoid breast-feeding for 4 h after administration.
Danish: Du bør alligevel som forsigtighedsregel undlade amning i 4 timer efter inhalation af høje doser af beclometasondipropionat.
English: CLENIL and associated names (see Annex I) 800 micrograms nebuliser suspension
Danish: CLENIL og tilknyttede navne (se bilag I) 800 mg mikrogram nebulisator, suspension
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAPÆSKE
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 2 ml ampoule contains 800 micrograms beclometasone dipropionate.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver 2 ml enkeltdosisampul indeholder 800 mikrogram beclometasondipropionat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each 1 ml ampoule contains 400 micrograms beclometasone dipropionate.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver 1 ml enkeltdosisampul indeholder 400 mikrogram beclometasondipropionat.
English: 5 ampoules containing 1 ml suspension each
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Inhalationsvæske til nebulisator, suspension 5 enkeltdosisampuller, der hver indeholder 1 ml inhalationsvæske, suspension
English: Each 2 ml ampoule contains 800 micrograms beclometasone dipropionate.
Danish: Hver 2 ml enkeltdosisampul indeholder 800 mikrogram beclometasondipropionat.
English: Each 1 ml ampoule contains 400 micrograms beclometasone dipropionate.
Danish: Hver 1 ml enkeltdosisampul indeholder 400 mikrogram beclometasondipropionat.
English: • sore throat (pharyngitis, laryngitis).
Danish: • ondt i halsen (svælgkatar, betændelse i strubehovedet).
English: Starting from the top, then in the middle (Figure B).
Danish: Adskil forsigtigt en ny ampul fra strippen, først fra toppen og derefter i midten (fig. B),
English: Annex III Product information
Danish: BILAG III ÆNDRINGER TIL RELEVANTE AFSNIT I PRODUKTRESUMÉET OG INDLÆGSSEDLEN
English: POSSIBLE SIDE EFFECTS
Danish: Skema over bivirkninger
English: Each polyethylene ampoule contains 400 micrograms beclometasone dipropionate suspension in 1 ml.
Danish: Hver 1 ml polyethylen enkeltdosisampul indeholder 400 mikrogram vandfrit beclometasondipropionat som suspension.
English: Follow the manufacturer's instructions for cleaning your nebuliser.
Danish: Ved rengøring af nebulisatoren skal fremstillerens anvisning følges.
English: Each polyethylene ampoule contains 800 micrograms beclometasone dipropionate suspension in 2 ml.
Danish: Hver 2 ml polyethylen enkeltdosisampul indeholder 800 mikrogram vandfrit beclometasondipropionat som suspension.
English: For 800 micrograms ampoule: after the first opening of the ampoule, store it in a refrigerator (2-8°C).
Danish: For 800 mikrogram-ampuller: opbevares i køleskab (2 C - -8 °C) efter første åbning af ampullen.
English: Nebuliser suspension.
Danish: Inhalationsvæske til nebulisator, suspension.
English: Each ampoule contains 400 micrograms beclometasone dipropionate suspension in 1 ml.
Danish: Hver 1 ml enkeltdosisampul indeholder 400 mikrogram vandfrit beclometasondipropionat som suspension.
English: Each ampoule contains 800 micrograms beclometasone dipropionate suspension in 2 ml.
Danish: Hver 2 ml enkeltdosisampul indeholder 800 mikrogram vandfrit beclometasondipropionat som suspension.
English: Patients with GPA or MPA must also not receive Blitzima if they have severe heart problems.
Danish: Patienter med GPA eller MPA må heller ikke få Blitzima, hvis de har svære hjerteproblemer.
English: The full EPAR for Blitzima can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Blitzima findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Blitzima.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Blitzima.
English: This means that Blitzima is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Blitzima svarer til et biologisk lægemiddel (også kaldet "referencelægemidlet"), der allerede er godkendt i Den Europæiske Union (EU).
English: Patients are also to receive an alert card to carry at all times, instructing them to contact their doctor immediately if they have any of the listed symptoms of infection.
Danish: Patienterne vil desuden få udleveret et patientkort, som de altid skal have på sig, med instruktioner om straks at kontakte lægen, hvis de får nogen af de nævnte symptomer på infektion.
English: What measures are being taken to ensure the safe and effective use of Blitzima?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Blitzima?
English: In this study improvement was seen in 96% of cases (67 of 70 patients) with Blitzima and 90% (63 of 70 patients) with Rituxan.
Danish: I denne undersøgelse sås der en forbedring i 96 % af tilfældene (67 ud af 70 patienter) med Blitzima og 90 % af tilfældene (63 ud af 70 patienter) med Rituxan.
English: Other information about Blitzima
Danish: Andre oplysninger om Blitzima
English: The most common side effects with rituximab are reactions related to the infusion (such as fever, chills and shivering) which occur in most cancer patients and in more than 1 in 10 GPA or MPA patients at the time of the first infusion.
Danish: De hyppigste bivirkninger ved rituximab er reaktioner i forbindelse med infusionen (såsom feber, kuldegysninger og rysten), som optræder hos de fleste kræftpatienter og hos mere end 1 ud af 10 GPA- eller MPA-patienter på tidspunktet for den første infusion.
English: Blitzima should be given under the close supervision of an experienced healthcare professional and in a place where facilities for resuscitating patients are immediately available.
Danish: Desuden bør Blitzima gives under tæt overvågning af en erfaren sundhedsperson på et sted, hvor genoplivningsudstyr er umiddelbart tilgængeligt.
English: Because Blitzima is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Blitzima.
Danish: Da Blitzima er et biosimilært lægemiddel, behøver alle de undersøgelser af rituximabs virkning og sikkerhed, der er udført for MabThera, ikke at blive gentaget for Blitzima.
English: What is Blitzima and what is it used for?
Danish: Hvad er Blitzima, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Blitzima.
Danish: Det er ikke en praktisk vejledning i, hvordan Blitzima bør anvendes.
English: Other serious side effects include hepatitis B reactivation (return of previous active liver infection with hepatitis B virus) and a rare and severe brain infection known as progressive multifocal leukoencephalopathy (PML).
Danish: Andre alvorlige bivirkninger er genopblussen af hepatitis B-leverbetændelse (reaktivering af tidligere aktiv infektion med hepatitis B-virus) og den sjældne, svære hjerneinfektion progressiv multifokal leukoencefalopati (PML).
English: Blitzima must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients.
Danish: Blitzima må ikke anvendes hos personer, der er overfølsomme (allergiske) over for rituximab, museproteiner eller et af de øvrige indholdsstoffer.
English: Why is Blitzima approved?
Danish: Hvorfor blev Blitzima godkendt?
English: The study showed that Blitzima and MabThera had comparable effects on arthritis symptoms: after 24 weeks, the proportion of patients with a 20% improvement in symptom score (called ACR20) was 74% (114 of 155 patients) with Blitzima and 73% (43 of 59 patients) with MabThera.
Danish: Undersøgelsen viste, at Blitzima og MabThera havde en sammenlignelig virkning på gigtsymptomer: Andelen af patienter, som opnåede en forbedring på 20 % i symptomscoren (kaldet ACR20) efter 24 uger, var 74 % (114 ud af 155 patienter) med Blitzima og 73 % (43 ud af 59 patienter) med MabThera.
English: Therefore, the Agency's view was that, as for MabThera, the benefit outweighs the identified risk and it recommended that Blitzima be given marketing authorisation.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for MabThera, og det anbefalede udstedelse af en markedsføringstilladelse for Blitzima.
English: The reference medicine for Blitzima is MabThera.
Danish: Referencelægemidlet for Blitzima er MabThera.
English: Blitzima contains the active substance rituximab.
Danish: Blitzima indeholder det aktive stof rituximab.
English: Further evidence came from supportive studies, including one involving 121 patients with advanced follicular lymphoma, where adding Blitzima to chemotherapy medicines was at least as effective as adding Rituxan, the US version of MabThera.
Danish: Der var yderligere evidens fra underbyggende undersøgelser, herunder en undersøgelse, som omfattede 121 patienter med fremskredent follikulært lymfom, hvor det var mindst lige så effektivt at tilføje Blitzima til kemoterapi som at tilføje Rituxan, den amerikanske version af MabThera.
English: Doctors prescribing Blitzima for cancer will be provided with educational material reminding them of the need to use the medicine only by infusion into a vein.
Danish: Læger, der ordinerer Blitzima mod kræft, vil få udleveret undervisningsmateriale, der minder dem om nødvendigheden af kun at anvende lægemidlet ved infusion i en vene.
English: Blitzima can only be obtained with a prescription.
Danish: Blitzima udleveres kun efter recept.
English: What are the risks associated with Blitzima?
Danish: Hvilke risici er der forbundet med Blitzima?
English: Thus, all these data were considered sufficient to conclude that Blitzima will behave in the same way in terms of effectiveness as MabThera in its approved indications.
Danish: Alle disse oplysninger blev således anset for tilstrækkelige til at konkludere, at Blitzima vil have de samme egenskaber som MabThera, hvad angår effektivitet ved de godkendte indikationer.
English: In addition, Blitzima has been compared with MabThera given into a vein in a main study involving 372 patients with active rheumatoid arthritis (an inflammatory disease).
Danish: Desuden er Blitzima blevet sammenlignet med MabThera ved indgivelse i en vene i en hovedundersøgelse, der omfattede 372 patienter med aktiv rheumatoid artritis (en inflammatorisk sygdom).
English: Blitzima is a ‘biosimilar medicine'.
Danish: Blitzima er et "biosimilært" lægemiddel.
English: For more information about treatment with Blitzima, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Blitzima, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Blitzima is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Danish: Blitzima er et lægemiddel, der anvendes til behandling af voksne med følgende former for blodkræft og betændelsesbetingede (inflammatoriske) sygdomme:
English: The company that markets Blitzima will provide doctors and patients using the medicine for non-cancer conditions with educational material including information on the need to give the medicine where facilities for resuscitation are available and on the risk of infection, including PML.
Danish: Virksomheden, der markedsfører Blitzima, vil udlevere undervisningsmateriale til læger og patienter, som anvender lægemidlet til andre sygdomme end kræft, herunder information om, at lægemidlet skal gives på et sted, hvor der er genoplivningsudstyr tilgængeligt, og om risikoen for infektion, herunder PML.
English: In addition, a study comparing Blitzima to MabThera in patients with rheumatoid arthritis (which can support its use in other inflammatory disorders such as GPA and MPA) showed that both medicines are similarly effective, and a supportive study in follicular lymphoma showed effectiveness in cancer.
Danish: Endvidere viste en undersøgelse, der sammenlignede Blitzima med MabThera hos patienter med reumatoid artritis (og som kan underbygge dets anvendelse ved andre inflammatoriske sygdomme som GPA og MPA), at begge lægemidler er lige effektive, og en underbyggende undersøgelse af patienter med follikulært lymfom viste effektivitet ved kræft.
English: Studies have also shown that giving Blitzima produces similar levels of the active substance in the body to giving MabThera.
Danish: Undersøgelser har også vist, at indgivelse af Blitzima frembringer samme mængde af det aktive stof i kroppen som indgivelse af MabThera.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Blitzima has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Blitzimas og MabTheras struktur, renhed og biologiske aktivitet svarer til hinanden, og at de fordeles i kroppen på samme måde.
English: Laboratory studies comparing Blitzima with MabThera have shown that the active substance in Blitzima is highly similar to that in MabThera in terms of structure, purity and biological activity.
Danish: Laboratorieundersøgelser, der sammenligner Blitzima med MabThera, har vist, at det aktive stof i Blitzima svarer til MabThera, hvad angår struktur, renhed og biologisk aktivitet.
English: For practical information about using Blitzima, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Blitzima, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: How is Blitzima used?
Danish: Hvordan anvendes Blitzima?
English: For the full list of side effects reported with Blitzima, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Blitzima fremgår af indlægssedlen.
English: What benefits of Blitzima have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Blitzima?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Blitzima have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Blitzima.
English: When rituximab attaches to CD20, it causes the death of B cells, which helps in lymphoma and CLL, where B cells have become cancerous.
Danish: Når rituximab binder sig til CD20, dør B-cellerne.
English: How does Blitzima work?
Danish: Hvordan virker Blitzima?
English: The active substance in Blitzima, rituximab, is a monoclonal antibody (a type of protein) designed to recognise and attach to a protein called CD20 present on the surface of B cells (types of white blood cells).
Danish: Det er fremstillet, så det genkender og binder sig til proteinet CD20, der findes på overfladen af hvide blodlegemer af typen B-celler.