FrancophonIA/ELRC3.0 huggingface dataset:
English: Total Drug Delivered [mg±SD] Fine Particle Mass < 5 µm [mg±SD] Drug Delivery Rate [mg/min] Mass Median Aerodynamic Diameter [µm ± SD]
Danish: Totalt leveret lægemiddel [mg±SD] Respirérbar dosis < 5 µm [mg±SD] Hastighed for leveret lægemiddel [mg/min]
English: • chest tightness with difficulty in breathing (rare, affecting up to 1 in 1,000 people)
Danish: • Stram forrnemmelse over brystet med åndedrætsbevær (sjælden, påvirker op til 1 ud af 1.000
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 Vantobra.
English: Contents of the pack and other information
Danish: Pakningsstørrelse og yderligere oplysninger
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator 18.
English: Inhalation use.
Danish: Brug ved inhalation.
English: Aspergillus species were more frequently recovered from the sputum of treated patients; however, clinical sequelae such as Allergic Bronchopulmonary Aspergillosis (ABPA) were reported rarely and with similar frequency as in the control group.
Danish: Kliniske følgetilstande, såsom Allergic Bronchopulmonary Aspergillosis (ABPA), blev imidlertid rapporteret sjældent og med samme hyppighed som i kontrolgruppen.
English: There are no adequate data from the use of tobramycin administered by inhalation in pregnant women.
Danish: Der er ingen sufficiente data fra anvendelsen af tobramycin administreret ved inhalation hos gravide kvinder.
English: • increased cough
Danish: • øget hosten
English: Table 2: Comparative performance data for the clinical test and reference batches: Vantobra /Tolero nebuliser handset
Danish: Tabel 2: Sammenlignende ydelsesdata for den kliniske test og reference-batches: Vantobra/Tolero nebuliser håndsæt1 og TOBI/PARI LC PLUS2.
English: Development of resistance during inhaled tobramycin therapy could limit treatment options during acute exacerbations; this should be monitored.
Danish: Udvikling af resistens under behandling med inhaleret tobramycin kunne begrænse behandlingsmulighederne under akutte forværringer.
English: If you forget to use Vantobra
Danish: Hvis du har glemt at bruge Vantobra
English: Magnesium sulphate Sulphuric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Danish: Svovlsyre (til justering af pH) Natriumhydroxid (til justering af pH) Vand til injektioner
English: What Vantobra is used for
Danish: Hvad Vantobra bruges til
English: Vomiting Mouth ulceration Nausea
Danish: Opkastning Ulceration i munden Kvalme
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read both the package leaflet of Vantobra and the Instructions for Use of the Tolero nebuliser handset before use.
Danish: ANVEMDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Læs både indlægssedlen for Vantobra og brugsanvisningen for Tolero nebuliser-håndsættet inden brug.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 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: If you stop using Vantobra
Danish: Hvis du holder op med at bruge Vantobra
English: Dyspnoea Dysphonia Pharyngitis Cough
Danish: Dyspnø Dysfoni Pharyngitis Hoste
English: If this applies to you, tell your doctor before using Vantobra.
Danish: Hvis dette gælder for dig, så fortæl det til lægen, inden du bruger Vantobra.
English: Sputum concentrations were higher and more variable with Cmax of 1,951 + 2,187 µg/g.
Danish: på 1,951 + 2,187 µg/g.
English: Occasionally, patients with a history of prolonged previous or concomitant use of intravenous aminoglycosides may experience hearing loss.
Danish: Fra tid til anden kan patienter med en anamnese med længerevarende tidligere eller samtidig brug af intravenøse aminoglycosider opleve høretab.
English: In the event of accidental ingestion of Vantobra, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract.
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: These medicines may harm the kidneys; o platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer).
Danish: o Platin-forbindelser, såsom carboplatin og cisplatin (bruges til at behandle visse former for kræft).
English: Very rare (may affect up to 1 in 10,000 people)
Danish: Meget sjælden (kan påvirke op til 1 ud af 10.000 mennesker)
English: No reproduction toxicology studies have been conducted with tobramycin administered by inhalation.
Danish: Der er ikke foretaget nogen studier over reproduktionstoksicitet med tobramycin administreret ved inhalation.
English: Bronchodilator therapy, such as salbutamol 2.
Danish: Bronchodilatator terapi, såsom salbutamol Lungefysioterapi
English: For detailed instructions on use see section 6.6.
Danish: For nærmere instruktioner om brugen, se pkt.
English: • anticholinesterases such as neostigmine and pyridostigmine (used to treat muscle weakness), or botulinum toxin.
Danish: • Anticholinesteraser, såsom neostigmin og pyridostigmin (bruges til at behandle muskelsvækkelse),
English: Vantobra is available together with a Tolero nebuliser handset.
Danish: Vantobra forefindes sammen med et Tolero nebuliser-håndsæt.
English: • Assemble the Tolero nebuliser handset as illustrated in the Instructions for Use of the handset device.
Danish: • Saml Tolero nebuliser-håndsættet som illustreret i brugsanvisningen for håndsættet.
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ualmindelig (kan påvirke op til 1 ud af 100 mennesker)
English: Inhalation of nebulised tobramycin solutions may induce a cough reflex.
Danish: Inhalation af nebuliseret tobramycinopløsning kan inducere en hosterefleks.
English: How Vantobra works
Danish: Hvorledes Vantobra virker
English: What Vantobra is
Danish: Hvad Vantobra er
English: • nosebleed, runny nose
Danish: • næseblod, løbende næse
English: Other medicines and Vantobra
Danish: Brug af anden medicin sammen med Vantobra
English: PHARMACEUTICAL FORM AND CONTENTS Package contains 56 ampoules with nebuliser solution in 7 sachets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pakning indeholdende 56 ampuller med nebuliser-opløsning i 7 breve.
English: • One box with the Tolero nebuliser handset.
Danish: • Én æske med Tolero nebuliser-håndsættet.
English: • kidney problems;
Danish: • Nyreproblemer
English: • One box with a Tolero nebuliser handset.
Danish: • Én æske med et Tolero nebuliser-håndsæt.
English: Nephrotoxicity has been associated with parenteral aminoglycoside therapy.
Danish: Nefrotoksicitet er blevet forbundet med behandling med parenteralt aminoglycosid.
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjælden (kan påvirke op til 1 ud af 1.000 mennesker)
English: • The other ingredient(s) (excipient(s)) are: sodium chloride, calcium chloride, magnesium sulphate, water for injections, sulphuric acid and sodium hydroxide for pH adjustment.
Danish: - Øvrige indholdsstoffer (hjælpestoffer) er: Natriumklorid, calciumklorid, magnesiumsulfat, vand til injektioner, svovlsyre og natriumhydroxid til justering af pH.
English: • The active substance is tobramycin.
Danish: Vantobra indeholder - Aktivt stof er tobramycin.
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: See also information on clinical benefit and tolerability in sections 4.4, 4.8 and
Danish: Se også oplysninger om klinisk fordel og tolerabilitet i pkt.
English: Calcium chloride
Danish: Calciumklorid
English: What you need to know before you use Vantobra
Danish: Det skal du vide, før du begynder at bruge Vantobra
English: Inhalation use
Danish: Til brug ved inhalation
English: Frequency category Adverse Reactions
Danish: Hyppighedskategori
English: What Vantobra looks like and contents of the pack Vantobra nebuliser solution is provided in a ready-to-use ampoule.
Danish: Udseende og pakningsstørrelse Vantobra nebuliser-opløsning leveres i en ampul klar til brug.
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 box with 56 ampoules with nebuliser solution in 7 sachets.
Danish: • Én æske med: 56 ampuller med nebuliser-opløsning i 7 breve.
English: Sodium chloride
Danish: Natriumklorid
English: Asthenia Pyrexia Pain
Danish: Astheni Pyrexi Smerter Brystsmerter
English: ON Vantobra
Danish: Med Vantobra
English: - anticholinesterases, botulinum toxin (neuromuscular effects).
Danish: eller botulinum toxin.
English: Neuromuscular disorders
Danish: Neuromuskulære lidelser
English: Based on the interaction profile for tobramycin following intravenous and aerosolised administration, concurrent and/or sequential use of Vantobra is not recommended with other medicinal products with nephrotoxic or ototoxic potential, such as:
Danish: Baseret på interaktionsprofilen for tobramycin efter intravenøs og aerosoliseret administration, anbefales samtidig og/eller sekventiel anvendelse af Vantobra ikke sammen med andre lægemidler med nefrotoksisk eller ototoksisk potentiale, såsom: - amphotericin B, cefalotin, ciclosporin, tacrolimus, polymyxiner (risiko for øget nefrotoksicitet); - platin-forbindelser (risiko for øget nefrotoksicitet og ototoksicitet);
English: After administering a single dose of Vantobra 170 mg to healthy volunteers Cmax of 1.1 + 0.4 µg/ml were reached after a tmax of approximately 4 hours.
Danish: Efter administration af en enkelt dosis Vantobra 170 mg til raske frivillige blev Cmaks.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: EVENTUELT ANDRE SÆRLIGE ADVARSLER
English: If any of these apply to you, tell your doctor before using Vantobra.
Danish: Vis noget af dette gælder for dig, så fortæl det til lægen, inden du bruger Vantobra.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE BREV
English: NAME OF THE MEDICINAL PRODUCT Vantobra 170 mg nebuliser solution tobramycin
Danish: LÆGEMIDLETS NAVN Vantobra 170 mg nebuliser-opløsning Tobramycin
English: Please also refer to nephrotoxicity information in section 4.4 and excretion information in section
Danish: 4.4 og oplysning om udskillelse i pkt.
English: NAME OF THE MEDICINAL PRODUCT Vantobra 170 mg nebuliser solution
Danish: LÆGEMIDLETS NAVN Vantobra 170 mg nebuliser-opløsning
English: • One box with the medicinal product: 56 ampoules with nebuliser solution in 7 sachets.
Danish: • Én æske med lægemidlet: 56 ampuller med nebuliser-opløsning i 7 forseglede breve af aluminiumsfolie.
English: Pulmonary function test decreased
Danish: Nedsat lungefunktionstest
English: - If you have any further questions, ask your doctor, or pharmacist.
Danish: Er du i tvivl, så spørg lægen.
English: • shortness of breath
Danish: • Stram fornemmelse over brystet
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 aminoglycosider omfatter: - anticholinesteraser, botulinum toksin (neuromuskulære virkninger).
English: How to use Vantobra
Danish: Sådan skal du bruge Vantobra
English: Malaise
Danish: Udslæt
English: Nephrotoxicity
Danish: Tobramycin
English: Other inhaled medicines 4.
Danish: Andre lægemidler til inhalation
English: What you need to know before you use Vantobra 3.
Danish: Det skal du vide, før du begynder at bruge Vantobra Sådan skal du bruge Vantobra Bivirkninger
English: Renal impairment
Danish: Svimmelhed Afoni
English: 1, and TOBI/PARI LC PLUS Performance parameter/ Drug/Device combination*
Danish: Ydelsesparameter/lægemiddel/anordn ing kombination
English: Do not throw away any medicines via household waste.
Danish: Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: INNER BOX CONTAINING THE MEDICINE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE INDRE ÆSKE INDEHOLDENDE LÆGEMIDLET
English: Dizziness Aphonia Headache
Danish: Hæmoptyse Epistaxis
English: If you use more Vantobra than you should
Danish: Hvis du har brugt for meget Vantobra
English: Chest physiotherapy 3.
Danish: Moosstrasse 3
English: Artiss and associated names
Danish: Artiss og relaterede navne
English: Tisseel / Tissucol and associated names
Danish: Tisseel/Tissucol og relaterede navne
English: • which regulator should be used, in line with manufacturer recommendations and the SmPC
Danish: • hvilken regulator, der skal anvendes henhold til producentens anvisninger og brugsanvisningen i produktresuméet
English: • restriction to open wound subcutaneous surgery only
Danish: • kravet om, at anvendelsen skal begrænses til åbne subkutane kirurgiske indgreb.
English: • which regulator(s) should be used, in line with manufacturer recommendations and the SmPC
Danish: • hvilke(n) regulator(er), der skal anvendes, alt efter producentens anvisninger og brugsanvisningen i produktresuméet.
English: • for laparoscopic surgery restriction to only use if the minimum spray distance of 2cm
Danish: • ved laparoskopiske indgreb: begrænsning af anvendelsen til tilfælde, hvor det med sikkerhed kan bedømmes, om den minimale sprayafstand på 2 cm er overholdt (anbefalet område 2-5 cm); obligatorisk brug af CO2
English: The Marketing Authorisation Holder (MAH) shall submit to the national competent authority, within one month of the European Commission decision on this procedure (EMEA/H/A-31/1337), an EU risk management plan for the product according to the EU Good Vigilance Practices which includes the safety concern of gas embolism.
Danish: Senest en måned efter Europa-Kommissionens afgørelse om denne procedure (EMEA/H/A-31/1337) indsender indehaveren af markedsføringstilladelsen en EU-risikostyringsplan for produktet til de nationale kompetente myndigheder.
English: The Marketing Authorisation Holder (MAH) shall submit to the national competent authority, within one month of the European Commission decision on this procedure (EMEA/H/A-31/1337), an EU risk management plan for the products according to the EU Good Vigilance Practices which includes the safety concern of gas embolism.
Danish: Senest en måned efter Europa-Kommissionens afgørelse om denne procedure (EMEA/H/A-31/1337) indsender indehaveren af markedsføringstilladelsen en EU-risikostyringsplan for de pågældende produkter til de nationale kompetente myndigheder.
English: The MAH should ensure within two years, that the product is used in accordance with the SmPC, with a pressure regulator device that delivers a maximum pressure of no more than 2.0 bar (28.5 psi).
Danish: Senest efter to år sørger indehaveren af markedsføringstilladelsen for, at produktet anvendes i overensstemmelse med produktresuméet med en trykregulator, der afgiver et maksimalt tryk på højst 2,0 bar (28,5 psi).
English: The MAH should ensure within two years, that the product is used in accordance with the SmPC, with a pressure regulator device that delivers a maximum pressure of no more than 1.5 bar (22 psi) in minimally invasive/laparoscopic procedures.
Danish: Indehaveren af markedsføringstilladelsen sørger senest efter to år for, at produktet ved minimalt invasive/laparoskopiske indgreb anvendes i overensstemmelse med produktresuméet med en trykregulator, hvis maksimumtryk er 1,5 bar (22 psi).
English: The MAH should ensure within two years, that the product is used in accordance with the SmPC, with a pressure regulator device that delivers a maximum pressure of no more than 2.0 bar (28.5 psi) in open wound surgery.
Danish: Indehaveren af markedsføringstilladelsen sørger senest efter to år for, at produktet ved åbne kirurgiske indgreb anvendes i overensstemmelse med produktresuméet med en trykregulator, hvis maksimumtryk er 2,0 bar (28,5 psi).
English: How much to take
Danish: Hvor meget skal jeg tage
English: No specific antidote exists.
Danish: Der findes ingen specifik antidot.
English: • Always wear a hat and clothes which cover your arms and legs
Danish: • Brug altid en hat og tøj, der dækker arme og ben
English: Children and adolescents This medicine must not be given to children or teenagers.
Danish: Brug til børn og teenagere Denne medicin må ikke gives til børn eller teenagere.
English: These effects are normally mild or moderate and often disappear after a short time.
Danish: Disse bivirkninger er normalt lette eller moderate og forsvinder ofte efter kort tid.
English: It may be necessary to confirm positive opiate screens by more specific method.
Danish: Det kan være nødvendigt at bekræfte positive opiatscreeninger med en mere specifik metode.
English: Protect your skin from sunlight
Danish: Beskyt din hud mod sollys
English: After the Commission decision the Member State competent authorities, in liaison with the reference Member State, will update the product information as required.
Danish: Efter Kommissionens beslutning vil medlemsstaternes relevante myndigheder, i samarbejde med referencemedlemslandet, opdatere produktoplysningerne som krævet.
English: Do not stop taking Tavanic just because you feel better.
Danish: Du må ikke holde op med at tage Tavanic, bare fordi du får det bedre.
English: Species for which acquired resistance may be a problem
Danish: Arter, hvor erhvervet resistens kan være et problem
English: This leaflet does not contain all the information about your medicine.
Danish: Denne indlægsseddel indeholder ikke alle oplysninger om din medicin.
English: • You have an allergic reaction.
Danish: • Du får en allergisk reaktion.
English: Your doctor may need to take regular blood tests to check how well your blood can clot.
Danish: Din læge vil muligvis tage regelmæssige blodprøver for at kontrollere, hvor godt dit blod størkner.
English: Other forms of interactions
Danish: Andre former for interaktioner
English: This belongs to a group of medicines called antibiotics.
Danish: Den tilhører en medicingruppe kaldet antibiotika.
English: These metabolites account for <5% of the dose and are excreted in urine.
Danish: Disse metabolitter udgør <5 % af dosis og udskilles i urinen.
English: Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Danish: Frekvenserne er defineret i henhold til følgende konvention: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Prevention of photosensitisation
Danish: Forebyggelse af fotosensibilisering
English: Gender differences
Danish: Kønsforskelle
English: These may be signs of something called ‘neuropathy'
Danish: Det kan være tegn på en tilstand, der kaldes ”neuropati”
English: Other relevant information
Danish: Anden relevant information
English: • Swallow the tablets whole with a drink of water
Danish: • Synk tabletterne hele og drik et glas vand til
English: Some of these side effects can affect you being able to concentrate and your reaction speed.
Danish: Nogle af disse bivirkninger kan påvirke din evne til at koncentrere sig og din reaktionshastighed.
English: There is no clinically relevant interaction with food.
Danish: Der er ingen klinisk relevant interaktion med mad.
English: It works by killing the bacteria that cause infections in your body.
Danish: Det virker ved at dræbe de bakterier, der forårsager infektioner i din krop.
English: Treating physicians should refer to national and/or international consensus documents regarding the treatment of anthrax.
Danish: Læger henvises til national og/eller international konsensus vedrørende behandling af anthrax.
English: The information given below is based on data from clinical studies in more than 8300 patients and on extensive post marketing experience.
Danish: Nedenstående oplysninger er baseret på data fra kliniske studier med mere end 8.300 patienter og på omfattende erfaring efter markedsføring.
English: Anti-peristaltic medicinal products are contraindicated in this clinical situation.
Danish: Peristaltikhæmmende lægemidler er kontraindicerede i denne kliniske situation.
English: If you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose.
Danish: Hvis du har glemt at tage en dosis, skal du tage den. så snart du kommer i tanker om det, medmindre det næsten er tid til din næste dosis.
English: • Take this medicine by mouth
Danish: • Tag medicinen gennem munden
English: This medicine is authorised in the Member States of the EEA under the following names: Tavanic
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navn: Tavanic
English: Approximately 30 - 40% of levofloxacin is bound to serum protein.
Danish: Ca. 30-40 % af levofloxacin er bundet til serumprotein.
English: Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:
Danish: Fortæl det til din læge, hvis nogen af følgende bivirkninger bliver alvorlige eller varer længere end et par dage:
English: • The tablets may be taken during meals or at any time between meals
Danish: • Tabletterne kan tages under et måltid eller når som helst mellem måltider
English: The renal clearance of levofloxacin was reduced by cimetidine (24%) and probenecid (34%).
Danish: Den renale clearance af levofloxacin blev reduceret af cimetidin (24 %) og probenecid (34 %).
English: • Medicines known to affect the way your heart beats.
Danish: • Medicin, der vides at påvirke den måde, dit hjerte slår.
English: • Your doctor will decide on how many Tavanic tablets you should take
Danish: • Din læge vil afgøre, hvor mange Tavanic tabletter du skal tage
English: In the event of overdose, symptomatic treatment should be implemented.
Danish: Ved overdosering bør symptomatisk behandling iværksættes.
English: These effects can be attributed to inhibition of topoisomerase II.
Danish: Disse effekter kan tilskrives inhibering af topoisomerase II.
English: • Sleeping problems
Danish: • Søvnproblemer
English: • The length of your treatment will depend on how serious your infection is.
Danish: • Behandlingslængden afhænger af, hvor alvorlig din infektion er.
English: If you stop taking the tablets too soon, the infection may return, your condition may get worse or the bacteria may become resistant to the medicine.
Danish: Hvis du holder op med at tage tabletterne for tidligt, kan infektionen vende tilbage, din tilstand forværres, eller bakterierne kan blive modstandsdygtige over for medicinen.
English: If this happens, do not drive or carry out any work that requires a high level of attention.
Danish: Hvis dette sker, må du ikke køre bil eller motorcykel eller cykle eller udføre nogen form for arbejde, der kræver meget opmærksomhed.
English: Keep out of direct sunlight while taking this medicine and for 2 days after you stop taking it.
Danish: Undgå direkte sollys, mens du tager denne medicin og i 2 dage efter, du er holdt op med medicinen.
English: The identification and antimicrobial susceptibility tests on any such isolate must be repeated and if the result is confirmed the isolate must be sent to a reference laboratory.
Danish: Identifikation og test for antimikrobiel følsomhed af et sådant isolat skal gentages, og hvis resultatet bekræftes, skal isolatet sendes til et referencelaboratorium.
English: Urine tests for opiates
Danish: Urinprøver for opiater
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officielle retningslinjer vedrørende hensigtsmæssig brug af antibakterielle lægemidler bør tages i betragtning.