FrancophonIA/ELRC3.0 huggingface dataset:
English: These medicines may harm the o platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer).
Danish: Disse lægemidler kan o Platin-forbindelser, såsom carboplatin og cisplatin (bruges til at behandle visse former for kræft).
English: Talk to your doctor if you are concerned about this.
Danish: Tal med din læge, hvis dette
English: • Use Vantobra only with the Tolero nebuliser handset shown in the picture below to make sure you inhale the correct dose.
Danish: • Brug kun Vantobra sammen med Tolero nebuliser-håndsætte vist på billedet nedenfor for at sikre, at du inhalerer den korrekte dosis.
English: In the event of inadvertent administration of Vantobra by the intravenous route, signs and symptoms of parenteral tobramycin overdose may occur, including dizziness, tinnitus, vertigo, loss of hearing acuity, respiratory distress and/or neuromuscular blockage and renal impairment.
Danish: I tilfælde af utilsigtet administration af Vantobra intravenøst, kan tegn og symptomer på parenteral tobramycin overdosering forekomme, inklusive svimmelhed, tinnitus, vertigo, tab af hørselsskarphed, åndedrætsbesvær og/eller neuromuskulær blokering og nedsat nyrefunktion.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: No effect on male or female fertility was observed in animal studies after subcutaneous administration (see
Danish: Der blev ikke observeret nogen effekt på mandlig eller kvindelig fertilitet i dyreforsøg efter subkutan
English: Do not use this medicine after the expiry date which is stated on the ampoule or the pouch or carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på ampullen, posen eller kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: o amphotericin B, cefalotin, polymyxins (used to treat microbial infections), ciclosporin,
Danish: o Amphotericin B, cefalotin, polymyxiner (bruges til at behandle mikrobielle infektioner),
English: If your underlying lung disease seems to become worse while you are using Vantobra, tell your doctor straight away.
Danish: Hvis din underliggende lungesygdom synes at blive værre, mens du bruger Vantobra, så kontakt straks din
English: Clinical experience with tobramycin nebuliser solutions reports dysphonia and tinnitus in patients treated with tobramycin.
Danish: Klinisk erfaring med tobramycin nebuliser-opløsninger rapporterer dysphoni og tinnitus hos patienter behandlet med tobramycin.
English: Biotransformation Tobramycin is not metabolised and is primarily excreted unchanged in the urine.
Danish: Tobramycin metaboliseres ikke og udskilles primært uændret i urinen.
English: It is bactericidal at concentrations equal to or slightly greater than inhibitory concentrations.
Danish: Det er baktericidt ved koncentrationer lig med eller en anelse større end
English: 4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: To re-start the treatment, press and hold the On/Off button again for one full second to
Danish: For at genstarte behandlingen trykkes On/Off knappen igen ned og holdes nede ét fuldt sekund for at genoptage behandlingen.
English: It is supplied in a carton that contains two inner cartons, one with the medicine (56 ampoules with nebuliser solution in 7 pouches), and one with the nebuliser handset.
Danish: Det leveres i en karton, der indeholder to indre kartonner, den ene med medicinen (56 ampuller med nebuliser-opløsning i 7 poser), og en med nebuliser håndsættet.
English: There are also links to other websites about rare diseases and treatments.
Danish: og på Sundhedsstyrelsens hjemmeside: http://www.sst.dk Der er også links til andre websteder om sjældne sygdomme og om, hvordan de behandles.
English: • worsening of lung function test results Very rare (may affect up to 1 in 10,000 people)
Danish: • forværring af testresultater for lungefunktion Meget sjælden (kan påvirke op til 1 ud af 10.000 mennesker)
English: Hypoxia Hyperventilation
Danish: Hyperventilation Sinusitis
English: • Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with
Danish: • Brug et nyt Tolero nebuliser-håndsæt til hver behandlingscyklus (28 dage on-treatment) som
English: In controlled clinical trials with Vantobra the most frequent adverse reactions in cystic fibrosis patients with P. aeruginosa infection were cough and dysphonia.
Danish: I kontrollerede kliniske afprøvninger med Vantobra var de hyppigste bivirkningsreaktioner hos patienter med cystisk fibrose med P. aeruginosa infektion hoste og dysphoni.
English: Do not use the Tolero nebuliser handset for any other medicine.
Danish: Lad være at bruge Tolero nebuliser-håndsættet til nogen anden
English: These medicines may cause muscle weakness to appear or become worse.
Danish: Disse lægemidler kan medføre fremkaldelse af muskelsvækkelse eller gøre den
English: In general, toxicity is seen at higher systemic tobramycin levels than are achievable by inhalation of the recommended clinical dose.
Danish: Generelt ses toksicitet ved højere systemiske tobramycinniveauer, end der forefindes ved inhalation af den
English: Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).
Danish: Vantobra er indiceret til behandlingen af kronisk lungeinfektion, der skyldes Pseudomonas aeruginosa hos patienter i alderen 6 år og opefter med cystisk fibrose (CF),.
English: Bronchodilator therapy, such as salbutamol
Danish: Bronchodilatator terapi, såsom salbutamol Lungefysioterapi
English: Asthenia Pyrexia Pain
Danish: Astheni Pyrexi
English: Where patients are receiving several inhaled medicinal products and chest physiotherapy, it is recommended
Danish: Hvor patienter får adskillige inhalerede lægemidler og lungefysioterapi, anbefales det at Vantobra anvendes
English: Use a new Tolero nebuliser handset for each treatment cycle (28 days on-treatment) as provided with the
Danish: Anvend et nyt Tolero nebuliser-håndsæt til hver behandlingscyklus (28 dage med behandling) som leveres
English: Diarrhoea Abdominal pain
Danish: Abdominalsmerter Udslæt
English: Tell your doctor or a pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig,
English: • The Tolero nebuliser handset must be cleaned and disinfected as described in the instructions for use
Danish: • Tolero nebuliser-håndsættet skal rengøres og desinficeres som beskrevet i anordningens
English: Haemoptysis Epistaxis
Danish: Hæmoptyse Epistaxis
English: Unabsorbed tobramycin following administration by inhalation is probably eliminated primarily in expectorated sputum.
Danish: Uabsorberet tobramycin efter administration ved inhalation er sandsynligvis elimineret primært i det
English: Other medicinal products that have been reported to increase the potential toxicity of parenterally administered aminoglycosides include:
Danish: Andre lægemidler, der er rapporteret at øge den potentielle toksicitet ved parenteralt administrerede
English: • hyperventilating, low oxygen levels in your blood, sinusitis • diarrhoea, pain in and around the stomach
Danish: • hyperventilering, lave iltniveauer i dit blod, sinusitis
English: 6.6 Special precautions for disposal and other handling The contents of one ampoule should be emptied into the medication reservoir of the Tolero nebuliser handset and administered by inhalation until no medicine is left in the reservoir.
Danish: Indholdet af én ampul skal tømmes ned i medicinreservoiret på Tolero nebuliser-håndsættet og administreres ved inhalation, indtil der ikke er medicin tilbage i reservoiret.
English: • One carton with the Tolero nebuliser handset.
Danish: • Én karton med Tolero nebuliser-håndsættet.
English: Excipients: sodium chloride, calcium chloride, magnesium sulphate, water for injections, sulphuric acid and sodium hydroxide for pH adjustment.
Danish: Hjælpestoffer: Natriumklorid, calciumklorid, magnesiumsulfat, vand til injektioner, svovlsyre og natriumhydroxid til justering af pH.
English: 1 connected with an eBase controller or eFlow rapid controller 2 connected with a PARI Boy SX compressor
Danish: 2 tilsluttet en PARI Boy SX kompressor
English: Package leaflet: Information for the patient Vantobra 170 mg nebuliser solution Tobramycin
Danish: Indlægsseddel: Information til patienten Vantobra 170 mg nebuliser-opløsning Tobramycin
English: • One carton with a Tolero nebuliser handset.
Danish: • Én karton med et Tolero nebuliser-håndsæt.
English: You should not mix or dilute Vantobra with any other medicine in your Tolero nebuliser handset which is If you are taking several different treatments for cystic fibrosis, you should take them in the following order: 1.
Danish: Du bør ikke blande eller fortynde Vantobra med noget andet lægemiddel i dit Tolero nebuliser-håndsæt, som
English: Vantobra
Danish: Opbevaring af Vantobra
English: In the event of accidental ingestion of Vantobra, toxicity is unlikely as tobramycin is poorly absorbed from
Danish: I tilfælde af indtagelse af Vantobra ved et uheld er toksicitet usandsynlig, da tobramycin bliver ringe absorberet fra en intakt mave-tarm-kanal.
English: A.
Danish: mennesker).
English: • One carton with: 56 ampoules with nebuliser solution in 7 pouches.
Danish: • Én karton med: 56 ampuller med nebuliser-opløsning i 7 poser.
English: If you are taking one or more of the above medicines, talk to your doctor before you use Vantobra.
Danish: Hvis du tager et eller flere af de ovenfor nævnte lægemidler, så fortæl det til din læge, inden du bruger
English: • laryngitis (inflammation of the voice box that can cause voice alteration, sore throat and difficulty swallowing)
Danish: Sjælden (kan påvirke op til 1 ud af 1.000 mennesker) • laryngitis (inflammation af stemmebåndene, der kan medføre ændring af stemmen, ondt i halsen og
English: NAME OF THE MEDICINAL PRODUCT Vantobra 170 mg nebuliser solution Tobramycin
Danish: LÆGEMIDLETS NAVN Vantobra 170 mg nebuliser-opløsning Tobramycin
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON CONTAINING THE MEDICINE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE KARTON INDEHOLDELDE LÆGEMIDLET
English: Tobramycin did not impair fertility in male or female rats at subcutaneous doses up to 100 mg/kg/day.
Danish: Tobramycin nedsatte ikke fertilitet hos han- eller hunrotter ved subkutaner doser på op til
English: Vantobra is used in patients with cystic fibrosis aged 6 years and older to treat lung infections caused by
Danish: Vantobra bruges til patienter med cystisk fibrose i alderen fra 6 år og opefter til at behandle lungeinfektioner, der skyldes bakterier, der hedder Pseudomonas aeruginosa.
English: What Vantobra contains - The active substance is tobramycin.
Danish: - Aktivt stof er tobramycin.
English: Each ampoule of 1.7 ml contains 170 mg tobramycin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver ampul på 1,7 ml indeholder 170 mg tobramycin.
English: • One carton with the medicinal product: 56 ampoules with nebuliser solution in 7 pouches.
Danish: • Én karton med lægemidlet: 56 ampuller med nebuliser-opløsning i 7 forseglede poser af aluminiumsfolie.
English: Other side effects may include:
Danish: Nogle bivirkninger kan være alvorlige
English: It belongs to a class of antibiotic medicines
Danish: Det hører til en klasse af antibiotiske lægemidler, der kaldes aminoglycosider.
English: Read both the package leaflet of Vantobra and the Instructions for Use of the Tolero nebuliser handset before
Danish: ANVEMDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs både indlægssedlen for Vantobra og brugsanvisningen for Tolero nebuliser-håndsættet inden brug.
English: Once opened an ampoule should be used immediately, and any remaining product should be discarded.
Danish: Når den først er åbnet, skal ampullen anvendes med det samme, og
English: How to use Vantobra
Danish: Hvis du holder op med at bruge Vantobra
English: 4.2 Posology and method of administration
Danish: 6.6 Regler for bortskaffelse og anden håndtering
English: - The other ingredient(s) (excipient(s)) are: sodium chloride, calcium chloride, magnesium sulphate,
Danish: - Øvrige indholdsstoffer (hjælpestoffer) er: Natriumklorid, calciumklorid, magnesiumsulfat, vand til injektioner, svovlsyre og natriumhydroxid til justering af pH.
English: What Vantobra looks like and contents of the pack Vantobra nebuliser solution is provided in a ready-to-use ampoule.
Danish: Vantobra nebuliser-opløsning leveres i en ampul klar til brug.
English: 5.3 Preclinical safety data
Danish: Resumé af sikkerhedsprofilen
English: Dizziness
Danish: Pruritus
English: Somnolence
Danish: Urticaria
English: Anorexia
Danish: Diarré
English: Sinusitis
Danish: Hypoxi
English: Other inhaled medicines
Danish: Andre lægemidler til inhalation Vantobra
English: See section 4.
Danish: på cirka 4 timer.
English: *Results from breath simulation and cascade impactor measurements.
Danish: Resultater fra respirationssimulation og kaskadeimpaktormålinger tilsluttet en eBase eller eFlow rapid controller
English: Package contains 56 ampoules with nebuliser solution in 7 pouches.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pakning indeholdende 56 ampuller med nebuliser-opløsning i 7 poser.
English: Ear disorder
Danish: Nedsat nyrefunktion
English: Fungal infection
Danish: Bivirkninger
English: Page 2/2©EMEA 2006
Danish: 1/1 ©EMEA 2006
English: If you need more information about your animal's medical condition or treatment, contact your veterinarian.
Danish: EU-nummer Særnavn Styrke Lægemiddelform Dyrearter, som læge
English: European Medicines Agency
Danish: Tilbageholdelsestid
English: Why has Medicinal Oxygen Air Liquide Santé been approved?
Danish: Lægemidlet er ikke længere autoriseret til salg
English: MA (EU) Number
Danish: MF (EU)-nummer (Særnavn) Navn
English: • amendments in the product information in sections 4.1, 4.2, 4.3, 4.4, 4.6, 4.8 and 5.3 of the
Danish: • ændringer i produktresuméets punkt 4.1, 4.2, 4.3, 4.4, 4.6, 4.8 og 5.3:
English: Preclinical and clinical safety
Danish: Præklinisk og klinisk sikkerhed
English: • the efficacy was also high in case where it was not possible to place the product directly in contact with the pulp,
Danish: • effektiviteten også var høj i tilfælde, hvor det ikke var muligt at anbringe produktet i direkte kontakt med pulpa,
English: • is carcinogenic in humans as stated by the IARC (Group 1),
Danish: • er karcinogent hos mennesker som anført af IARC (gruppe 1),
English: Annex II Scientific conclusions and grounds for revocation of the marketing authorisations
Danish: Bilag II Videnskabelige konklusioner og begrundelse for tilbagetrækning af markedsføringstilladelserne
English: The CHMP considers that this risk is unacceptable taking into account the estimated benefit of the product and the existing safer alternatives.
Danish: CHMP finder denne risiko uacceptabel i betragtning af den skønnede fordel ved produktet og de eksisterende sikrere alternativer.
English: • a number of ADRs have reported a lack of effect.
Danish: • en række af bivirkningsindberetningerne omtaler manglende virkning.
English: Finally, with regards to the reduction of exposure from 7 to 3 days, the CHMP does not find this measures acceptable since half of the periodontal necrosis cases reported in post-marketing period occurred within 3 days.
Danish: Hvad endelig angår nedsættelsen af eksponeringen fra 7 til 3 dage finder CHMP ikke denne foranstaltning acceptabel, da halvdelen af de indberettede tilfælde af parodontal nekrose optrådte inden for tre dage.
English: Alternative techniques (such as several types of local/regional anesthesics, general anesthesia, gas for inhalation) may be available.
Danish: Alternative teknikker kan være tilgængelige (såsom forskellige lokale/regionale anæstetika, generel anæstesi, inhalationsgas).
English: Therefore, in accordance with Article 32 of Directive 2001/83/EC, the CHMP recommends the revocation of the marketing authorisations for all medicinal products referred to in Annex I pursuant to Article 116 of Directive 2001/83/EC.
Danish: I overensstemmelse med artikel 32 i direktiv 2001/83/EF anbefaler CHMP derfor tilbagetrækning af markedsføringstilladelserne for alle lægemidler omhandlet i bilag I i medfør af artikel 116 i direktiv 2001/83/EF.
English: The efficacy of the product is based on the above-mentioned single small prospective non-comparative study dated 1969, which estimated the efficacy in painless devitalisation of pulp to be 88% under optimal circumstances of use.
Danish: Produktets virkning bygger på ovennævnte enkelte lille prospektive, ikke-sammenlignende undersøgelse fra 1969, hvor effektiviteten til smertefri devitalisering af pulpa blev bestemt til 88 % under optimale anvendelsesbetingelser.
English: The provided study demonstrated low but measurable systemic level of arsenic after dental use.
Danish: Den forelagte undersøgelse viste et lavt, men måleligt niveau af arsen efter dental anvendelse.
English: The expert panel concluded that the benefit/risk of the product was negative.
Danish: Ekspertpanelet konkluderede, at benefit/risk-forholdet for produktet var negativt.
English: • introduce a contraindication in children, pregnant and lactating women;
Danish: • at indføre en kontraindikation hos børn, gravide og ammende kvinder
English: The design of the study and the small number of subjects included did not allow a reliable assessment of the efficacy in a way to have a comparison with the current standard treatment.
Danish: Undersøgelsens design og det lave antal deltagende personer tillod ikke pålidelig vurdering af virkningen på en måde, der gør det muligt at sammenligne med en nutidig standardbehandling.
English: The CHMP is of the view that the reported systemic exposure aggravates the earlier concern about the potential genotoxicity of the products.
Danish: CHMP finder, at den beskrevne systemiske eksponering bestyrker de tidligere betænkeligheder ved den potentielle genotoksicitet af produkterne.
English: The risk of carcinogenicity is established by the local or systemic passage of arsenic.
Danish: Risikoen for karcinogenicitet fremkommer ved lokal eller systemisk optagelse af arsen.
English: o to restrict the indication to the last line use i.e. in the situations when anaesthesia techniques are not available or not possible to use in the EU patients;
Danish: o begrænsning af indikationen til sidstevalgsbehandling, dvs. situationer, hvor anæstesi ikke er til rådighed eller ikke kan anvendes hos EU-patienter,
English: Therefore, the CHMP recommended the revocation of the marketing authorisations for the medicinal products referred to in Annex I.
Danish: CHMP anbefalede derfor tilbagetrækning af markedsføringstilladelserne for de i bilag I angivne lægemidler.
English: The CHMP concludes that arsenic trioxide:
Danish: CHMP konkluderede, at arsentrioxid:
English: Finally the CHMP noted that no national, European and international guideline endorse the use of arsenic dental paste in clinical practice.
Danish: Endelig bemærkede CHMP, at ingen nationale, europæiske eller internationale retningslinjer støtter klinisk anvendelse af arsenholdig dental pasta.
English: In addition, for safety assessment, the CHMP noted that this short study does not confirm the absence of arsenic leakage, granulomas or decrease in bone density.
Danish: Vedrørende sikkerhedsvurderingen bemærkede CHMP derudover, at denne korte undersøgelse ikke bekræfter fravær af udsivning af arsen, granulomer eller nedsat knogletæthed.
English: • Communication to Health Care Professionals concerning the instructions of use (via a dear Health Care Professional Communication and educational materials).
Danish: • information til sundhedspersoner om produktets anvendelse (via en direkte meddelelse til sundhedspersoner og informationsmateriale),
English: Even in case of the best practice the necrotic adverse reactions cannot be ruled out due to the specifics of dental anatomy or accidental spillage.
Danish: Selv når bedste praksis gennemføres, kan nekrotiske bivirkninger ikke udelukkes på grund af de dentale anatomiske forhold og accidentelt spild.
English: • The monitoring and analysis of reported cases including a specific questionnaire to collect evidence of the indication of the product (use in second intention), sealing of the cavity and the duration of the application.
Danish: • overvågning og analyse af indberettede tilfælde, herunder et særligt spørgeskema til dokumentation af indikationerne for produktet (anvendelse til sekundær heling), tætning af kaviteten og varigheden af påføringen.
English: In addition, the CHMP is of the view that the proposed measures to mitigate the risk of necrosis are not so different from the current recommendations and common knowledge on the conditions of use of the product and though the effectiveness of those current measures would not mitigate the risk associated with those products.
Danish: Desuden finder CHMP, at de foreslåede foranstaltninger til afbødning af risikoen for nekrose ikke adskiller sig så meget fra de nuværende anbefalinger og almindeligt kendskab til produktets anvendelsesbetingelser, skønt de gældende foranstaltninger ikke effektivt afbøder den forbundne risiko ved disse produkter.
English: The French National Competent Authority (NCA) considered that the modifications of the SmPC proposed by the MAHs were neither acceptable nor appropriate given the genotoxicity data provided and the recommendation of the expert panel.
Danish: Den nationale franske kompetente myndighed fandt, at de af markedsføringstilladelsesindehaverne foreslåede ændringer af produktresuméet hverken var acceptable eller passende på baggrund af de forelagte genotoksicitetsdata og anbefalingen fra ekspertpanelet.
English: Based on this positive genotoxicity results (clastogenicity) the MAHs informed the Competent Authorities of a potential serious impact on the benefit risk balance of the products.
Danish: På grundlag af disse positive resultater for genotoksicitet (klastogenicitet) underrettede indehaveren af markedsføringstilladelse de kompetente myndigheder om potentielt alvorlige implikationer for benefit/risk-forholdet af produkterne.
English: A literature review was performed by the Marketing Authorisations Holders (MAHs) (Septodont and A.T.O.
Danish: Indehaverne af markedsføringstilladelserne (Septodont og A.T.O.
English: The MAH created in June 2013 an expert panel to characterise the risks and further assess the need for potential changes to the Marketing Authorisations (MAs) of the concerned product.
Danish: Indehaveren af markedsføringstilladelse nedsatte i juni 2013 et ekspertpanel til karakterisering af risiciene og nærmere vurdering af behovet for eventuelle ændringer i markedsføringstilladelserne for det berørte produkt.
English: The CHMP notes that:
Danish: CHMP bemærker, at:
English: • no clinical practice guideline endorses the use of arsenic dental paste,
Danish: • ingen kliniske retningslinjer støtter anvendelsen af dental pasta med arsen,
English: The risk of genotoxicity including human fertility, foetal development and carcinogenicity induced by arsenic trioxide was reviewed.
Danish: Risikoen for genotoksicitet, herunder påvirkning af menneskers fertilitet og fosterudvikling, samt karcinogenicitet fremkaldt af arsentrioxid, blev gennemgået.