FrancophonIA/ELRC3.0 huggingface dataset:
English: Method of administration Temozolomide Hexal hard capsules should be administered in the fasting state.
Danish: Administration Temozolomide HEXAL hårde kapsler bør indtages fastende.
English: If you have not been previously treated with chemotherapy, your first dose of Temozolomide Hexal will be 200 mg/m2 once daily for the first 5 days.
Danish: Hvis du ikke tidligere er blevet behandlet med kemoterapi, vil din første dosis af Temozolomide HEXAL være på 200 mg/m2 én gang dagligt i de første 5 dage.
English: Contents of the pack and other information What Temozolomide Hexal contains
Danish: Pakningsstørrelser og yderligere oplysninger Temozolomide HEXAL indeholder
English: Frimley Business Park Frimley, Camberley Surrey GU16 7SR - UK Tel: +44 1276 69 8020 uk.regaffairs@sandoz.com
Danish: Frimley Business Park Frimley, Camberley Surrey GU16 7SR - UK Tel: +44 1276 69 8020
English: Special populations Paediatric population In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Danish: Særlige populationer Pædiatrisk population Hos patienter fra 3 år bør TMZ kun bruges ved tilbagevendende eller progressivt malignt gliom.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Danish: Forebyggende behandling mod pneumocystis jirovecii pneumoni (PCP) var påkrævet under strålebehandling og konkomitant TMZ behandling.
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Danish: Grad- 3 eller Grad 4-trombocytabnormaliteter, herunder trombocytopeni-bivirkninger, blev set hos 14 % af de patienter, der fik TMZ.
English: Very rare cases of lung side effects have been observed with temozolomide.
Danish: Der er set meget sjældne tilfælde af lungebivirkninger med TMZ.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON FOR MULTIPACKS OF 20 (4 PACKS OF 5) HARD CAPSULES - WITHOUT THE BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL DELPAKNING AF MULTIPAKNING MED 20 (4 PAKNINGER MED 5) HÅRDE KAPSLER - UDEN BLUE BOX
English: Your doctor will work out your dose of Temozolomide Hexal.
Danish: Din læge vil fastsætte den præcise dosis Temozolomide HEXAL til dig.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS OF 20 (4 PACKS OF 5) HARD CAPSULES - WITH THE BLUE BOX
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON TIL MULTIPAKNING MED 20 (4 PAKNINGER MED 5) HÅRDE KAPSLER - MED BLUE BOX
English: Summary of events reported with temozolomide in the post-marketing setting Very rare:
Danish: Opsummering af bivirkninger, der er indberettet med temozolomid efter markedsføring Ikke almindelig:
English: Multipack containing 20 hard capsules (4 packs of 5 hard capsules in a type III amber glass bottle with polypropylene child-resistant closure.
Danish: Multipakning indeholdende 20 hårde kapsler (4 pakninger med 5 hårde kapsler i en type III-flaske af brunt glas med børnesikret polypropylen-låg.
English: Hepatic enzymes increased, Gamma GT increased, AST increased *A patient who was randomised to the RT arm only, received TMZ + RT.
Danish: Ikke almindelig Forhøjede leverenzymtal, forhøjet gamma GT, forhøjet AST * En patient, der kun var randomiseret til strålebehandlingsgruppen, fik TMZ + strålebehandling.
English: Other medicines and Temozolomide Hexal
Danish: Brug af anden medicin sammen med Temozolomide HEXAL
English: Multipack containing 20 hard capsules (4 packs of 5 hard capsules in an amber glass bottle [Type 3 glass] with polypropylene child-resistant closure.
Danish: Multipakning indeholdende 20 hårde kapsler (4 pakninger med 5 hårde kapsler i en brun glasflaske (type III-glas) med børnesikret polypropylen-låg.
English: - common toxicity criteria (CTC) non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea and vomiting).
Danish: − almindelige toksicitetskriterier (CTC, common toxicity criteria) for ikke-hæmatologisk toksicitet ≤ Grad 1 (undtagen alopeci, kvalme og opkastning)
English: Patients with hepatic or renal impairment The pharmacokinetics of TMZ were comparable in patients with normal hepatic function and in those with mild or moderate hepatic impairment.
Danish: Patienter med nedsat lever- eller nyrefunktion TMZ's farmakokinetik var sammenlignelig for patienter med normal leverfunktion og patienter med let til moderat leverinsufficiens.
English: Temozolomide Hexal hard capsules should be administered in the fasting state.
Danish: Temozolomide HEXAL hårde kapsler bør indtages fastende.
English: The bottles contain a desiccant pouch.)
Danish: Flaskerne indeholder et tørremiddel i pose).
English: 9/l, and the thrombocyte count is ≥ 100 x 109/l.
Danish: 9/l og trombocyttallet er ≥ 100 x 10
English: Do not swallow it.)
Danish: Fjern ikke tørremidlet fra flasken, og slug det ikke).
English: Keep this medicine out of the sight and reach of children, preferably in a locked cupboard.
Danish: Opbevar lægemidletl utilgængeligt for børn, helst i et aflåst skab.
English: Novartis (Hellas) S.A.C.I 18, Kifisias Ave. & Gyzi, 151 25 Marousi, Athens Τηλ: +30 216 6005011 regulatory.greece@sandoz.com
Danish: Novartis (Hellas) S.A.C.I 18, Kifisias Ave. & Gyzi, 151 25 Marousi, Athens
English: The bottles also contain a desiccant pouch.
Danish: Flaskerne indeholder også en pose med tørremiddel.
English: Infections and infestations Common:
Danish: Infektioner og parasitære sygdomme Almindelig
English: Table 1.TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Danish: Afbrydelse eller seponering af TMZ-dosis under konkomitant strålebehandling og TMZ
English: • if you have nausea (feeling sick in your stomach) and/or vomiting which are common side effects of Temozolomide Hexal (see section 4), your doctor may prescribe you a medicine (an anti-emetic) to help prevent vomiting.
Danish: • hvis du har kvalme og/eller kaster op, hvilket er meget almindelige bivirkninger ved Temozolomide HEXAL (se pkt.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l - thrombocyte count ≥ 100 x 109/l
Danish: − absolut neutrofiltal (ANC) ≥ 1,5 x 109/l
English: At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia,
Danish: Ved begyndelsen af serie 2 øges dosis til 200 mg/m2, hvis CTC ikke-hæmatologisk toksicitet for serie 1 er Grad ≤ 2 (undtagen alopeci, kvalme og opkastning), det absolutte neutrofiltal (ANC) er ≥ 1,5 x
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000), Not known: frequency cannot be estimated from the available data.
Danish: < 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: Febrile neutropenia, anaemia
Danish: Ikke almindelig Febril neutropeni, anæmi
English: Capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid.
Danish: − kapselindhold: vandfri lactose, kolloid vandfri silica, natriumstivelsesglycolat (type A), vinsyre, stearinsyre.
English: Temozolomide Hexal 250 mg hard capsules Each capsule contains 250 mg temozolomide.
Danish: Temozolomide HEXAL 250 mg hårde kapsler Hver kapsel indeholder 250 mg temozolomid.
English: Temozolomide Hexal 5 mg hard capsules Each capsule contains 5 mg temozolomide.
Danish: Temozolomide HEXAL 5 mg hårde kapsler Hver kapsel indeholder 5 mg temozolomid.
English: Temozolomide Hexal 20 mg hard capsules Each capsule contains 20 mg temozolomide.
Danish: Temozolomide HEXAL 20 mg hårde kapsler Hver kapsel indeholder 20 mg temozolomid.
English: How to take Temozolomide Hexal
Danish: Sådan skal du tage Temozolomide HEXAL
English: Temozolomide Hexal 180 mg hard capsules Each capsule contains 180 mg temozolomide.
Danish: Temozolomide HEXAL 180 mg hårde kapsler Hver kapsel indeholder 180 mg temozolomid.
English: Elderly patients Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Danish: Ældre patienter På baggrund af en analyse af populationsfarmakokinetikken for patienter mellem 19-78 år er TMZclearance ikke afhængig af alder. Ældre patienter (> 70 år) ser dog ud til at have øget risiko for udviklingen af neutropeni og trombocytopeni (se pkt.
English: What Temozolomide Hexal is and what it is used for What you need to know before you take Temozolomide Hexal How to take Temozolomide Hexal Possible side effects
Danish: Det skal du vide, før du begynder at tage Temozolomide HEXAL Sådan skal du tage Temozolomide HEXAL Bivirkninger
English: Temozolomide Hexal 100 mg hard capsules pink
Danish: Temozolomide HEXAL 100 mg hårde kapsler pink
English: What Temozolomide Hexal is and what it is used for
Danish: Temozolomide HEXAL er indiceret til behandling af:
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare
Danish: Hyppigheden er defineret i henhold til følgende konvention: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til
English: Temozolomide Hexal 140 mg hard capsules Each capsule contains 140 mg temozolomide.
Danish: Temozolomide HEXAL 140 mg hårde kapsler Hver kapsel indeholder 140 mg temozolomid.
English: Patients with newly-diagnosed glioblastoma multiforme
Danish: Patienter med nydiagnosticeret glioblastoma multiforme
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia,
Danish: Ikke almindelig Status epilepticus, ekstrapyramidal lidelse, hemiparese, ataksi, nedsat kognition, dysfasi, unormal gang,
English: Each hard capsule contains 131.4 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 131,4 mg vandfri lactose.
English: Temozolomide Hexal 140 mg hard capsules blue
Danish: Temozolomide HEXAL 140 mg hårde kapsler blå
English: Each hard capsule contains 102.2 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 102,2 mg vandfri lactose.
English: Each hard capsule contains 14.6 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 14,6 mg vandfri lactose.
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Danish: Hemiparese, ataksi, nedsat koordinationsevne, unormal gang, hyperæstesi, føleforstyrrelse
English: Temozolomide Hexal 5 mg hard capsules
Danish: Temozolomide HEXAL 5 mg hårde kapsler
English: Temozolomide Hexal 250 mg hard capsules white
Danish: Temozolomide HEXAL 250 mg hårde kapsler hvid
English: P.T.Hadjigeorgiou Co Ltd 31 Yildiz Street, 3042 Limassol Τηλ: 00357 - 25372425 info.pth@cytanet.com.cy
Danish: P.T.Hadjigeorgiou Co Ltd 31 Yildiz Street, 3042 Limassol
English: Temozolomide Hexal 5 mg hard capsules green
Danish: Temozolomide HEXAL 5 mg hårde kapsler grøn
English: Temozolomide Hexal 250 mg hard capsules
Danish: Temozolomide HEXAL 250 mg hårde kapsler
English: Each hard capsule contains 73 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 73 mg vandfri lactose.
English: Temozolomide Hexal 100 mg hard capsules Each capsule contains 100 mg temozolomide.
Danish: Temozolomide HEXAL 100 mg hårde kapsler Hver kapsel indeholder 100 mg temozolomid.
English: Temozolomide Hexal 140 mg hard capsules
Danish: Temozolomide HEXAL 140 mg hårde kapsler
English: Temozolomide Hexal 20 mg hard capsules yellow
Danish: Temozolomide HEXAL 20 mg hårde kapsler gul
English: The hard capsules have a white coloured body, a transparent blue coloured cap, and are imprinted with black ink.
Danish: De hårde kapsler har en hvid krop og en gennemsigtig blå hætte og er præget med sort blæk.
English: Temozolomide Hexal 20 mg hard capsules
Danish: Temozolomide HEXAL 20 mg hårde kapsler
English: Temozolomide Hexal 100 mg hard capsules
Danish: Temozolomide HEXAL 100 mg hårde kapsler
English: Temozolomide Hexal is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment, children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Danish: − børn fra 3 år, unge og voksne med malignt gliom, såsom glioblastoma multiforme eller anaplastisk astrocytom, der får recidiv eller progression efter standardbehandling.
English: Your dose of Temozolomide Hexal may need to be adjusted.
Danish: • Hvis du har problemer med leveren eller nyrerne, skal din dosis af Temozolomide HEXAL muligvis justeres.
English: Temozolomide Hexal 180 mg hard capsules
Danish: Temozolomide HEXAL 180 mg hårde kapsler
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Temozolomide HEXAL indeholder lactose (en form for sukker).Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: How to store Temozolomide Hexal
Danish: Sådan tages Temozolomide HEXAL
English: Temozolomide Hexal 20 mg capsules temozolomide
Danish: Temozolomide HEXAL 20 mg kapsler temozolomid
English: Temozolomide Hexal 140 mg capsules temozolomide
Danish: Temozolomide HEXAL 140 mg kapsler temozolomid
English: Temozolomide Hexal 5 mg capsules temozolomide
Danish: Temozolomide HEXAL 5 mg kapsler temozolomid
English: Each hard capsule contains 182.5 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 182,5 mg vandfri lactose.
English: Each hard capsule contains 168 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 168 mg vandfri lactose.
English: Temozolomide Hexal 250 mg hard capsules temozolomide
Danish: Temozolomide HEXAL 250 mg hårde kapsler temozolomid
English: Temozolomide Hexal 250 mg capsules temozolomide
Danish: Temozolomide HEXAL 250 mg kapsler temozolomid
English: Temozolomide Hexal 180 mg capsules temozolomide
Danish: Temozolomide HEXAL 180 mg kapsler temozolomid
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance peripheral neuropathy
Danish: Hemiparese, ataksi, nedsat koordinationsevne, unormal gang, hyperæstesi, føleforstyrrelse hyperesthesia, hypoesthesia, neurologisk lidelse (NOS), perifer neuropati
English: Temozolomide Hexal 20 mg hard capsules temozolomide
Danish: Temozolomide HEXAL 20 mg hårde kapsler temozolomid
English: Temozolomide Hexal 5 mg hard capsules temozolomide
Danish: Temozolomide HEXAL 5 mg hårde kapsler temozolomid
English: Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid Stearic acid
Danish: Kolloid vandfri silica Natriumstivelsesglycolat (type A) Vinsyre
English: Temozolomide Hexal 140 mg hard capsules temozolomide
Danish: Temozolomide HEXAL 140 mg hårde kapsler temozolomid
English: Temozolomide Hexal 100 mg capsules temozolomide
Danish: Temozolomide HEXAL 100 mg kapsler temozolomid
English: Temozolomide Hexal 180 mg hard capsules temozolomide
Danish: Temozolomide HEXAL 180 mg hårde kapsler temozolomid
English: Temozolomide Hexal 100 mg hard capsules temozolomide
Danish: Temozolomide HEXAL 100 mg hårde kapsler temozolomid
English: EU/1/10/616/038 20 (4 packs of 5) hard capsules
Danish: EU/1/10/616/038 20 (4 pakninger med 5) hårde kapsler
English: Sachet Do not store above 25 °C.
Danish: Må ikke opbevares ved temperaturer over 25 °C.
English: If you take more Temozolomide Hexal than you should
Danish: Hvis du har taget for meget Temozolomide HEXAL
English: EU/1/10/616/041 20 (4 packs of 5) hard capsules
Danish: EU/1/10/616/041 20 (4 pakninger med 5) hårde kapsler
English: METHOD OF ADMINISTRATION
Danish: Efter peroral administration af
English: EU/1/10/616/037 20 (4 packs of 5) hard capsules
Danish: EU/1/10/616/037 20 (4 pakninger med 5) hårde kapsler
English: EU/1/10/616/042 20 (4 packs of 5) hard capsules
Danish: EU/1/10/616/042 20 (4 pakninger med 5) hårde kapsler
English: Keep the desiccant pouch in the bottle.
Danish: Fjern ikke tørremidlet fra flasken, og slug det ikke.
English: EU/1/10/616/039 20 (4 packs of 5) hard capsules
Danish: EU/1/10/616/039 20 (4 pakninger med 5) hårde kapsler
English: EU/1/10/616/040 20 (4 packs of 5) hard capsules
Danish: EU/1/10/616/040 20 (4 pakninger med 5) hårde kapsler
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Water
Danish: Titandioxid (E 171) Gul jernoxid (E 172)
English: The cap is imprinted with “TMZ” and the body is imprinted with “100”.
Danish: Hætten bærer et tryk med ”TMZ”.
English: ≥ 100 x 109/l.
Danish: − trombocyttal ≥ 100 x 109/l
English: Temozolomide Hexal 180 mg hard capsules maroon
Danish: Temozolomide HEXAL 180 mg hårde kapsler rødbrun
English: This summary was last updated in 03-2015.
Danish: Dette sammendrag blev senest ajourført i 03-2015.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vantobra on 18 March 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Vantobra den 18. marts 2015.
English: The medicine is not to be inhaled with any other device.
Danish: Lægemidlet må ikke inhaleres med nogen anden anordning.
English: After 28 days of treatment, the patient stops treatment for 28 days, before starting another 28-day treatment.
Danish: Efter 28 dages behandling holder patienten pause i behandlingen i 28 dage og begynder derefter på et nyt 28-dages behandlingsforløb.
English: Treatment cycles may be repeated for as long as the doctor considers the patient to be benefiting from it.
Danish: Behandlingsforløbet kan gentages, så længe lægen anser det for at være til fordel for patienten.
English: As regards safety, the Committee noted that safety profile of inhaled tobramycin was well known.
Danish: Vedrørende sikkerheden bemærkede udvalget, at sikkerhedsprofilen for inhalation af tobramycin er velkendt.
English: This is a summary of the European public assessment report (EPAR) for Vantobra.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Vantobra.
English: The recommended dose is one ampoule twice a day, ideally 12 hours apart.
Danish: Den anbefalede dosis er én ampul to gange dagligt (helst med 12 timers mellemrum).
English: The full EPAR and risk management plan summary for Vantobra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Vantobra findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vantobra is a ‘hybrid medicine'.
Danish: Vantobra er et “hybridt lægemiddel”.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Vantobra's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Vantobra opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: A risk management plan has been developed to ensure that Vantobra is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Vantobra anvendes så sikkert som muligt.
English: There were no unusual safety findings with Vantobra.
Danish: Der var ingen usædvanlige sikkerhedsmæssige resultater med Vantobra.
English: Vantobra therefore offers the advantage of better convenience and a higher likelihood of patients keeping to their treatment.
Danish: Vantobra har derfor den fordel at være mere bekvemt og øger sandsynligheden for, at patienterne overholder behandlingen.
English: If the patient is also receiving other inhaled treatments or chest physiotherapy, it is recommended that Vantobra is used last.
Danish: Hvis patienten også får andre inhalationslægemidler eller lungefysioterapi, anbefales det, at Vantobra anvendes sidst.
English: Side effects with Vantobra are not common.
Danish: Bivirkninger med Vantobra er ikke almindelige.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Vantobra, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Vantobra, herunder passende forholdsregler, som sundhedspersonale og patienter skal følge.
English: However, the following side effects are seen between 1 and 10 patients in 1,000: dyspnoea (difficulty breathing), dysphonia (hoarseness), pharyngitis (sore throat) and cough.
Danish: Følgende bivirkninger optræder dog hos mellem 1 og 10 ud af hver 1 000 patienter: Vejrtrækningsbesvær (dyspnø), hæshed (dysfoni), ondt i halsen
English: In addition, the applicant conducted a ‘bioequivalence' study in 58 patients with cystic fibrosis aged 6 years and above to determine whether Vantobra produces similar levels of the active substance in the body as the reference medicine, Tobi.
Danish: Desuden udførte ansøgeren en bioækvivalensundersøgelse hos 58 patienter over 6 år med cystisk fibrose for at fastslå, om Vantobra frembringer samme mængde af det aktive stof i kroppen som referencelægemidlet Tobi.
English: However, Vantobra differs from Tobi by having a higher concentration of the active substance and is inhaled using a different type of nebuliser.
Danish: Vantobra er dog forskelligt fra Tobi ved at indeholde en større koncentration af det aktive stof, og der anvendes en anden type nebulisator til at inhalere det.
English: P. aeruginosa is a frequent cause of infections in cystic fibrosis
Danish: P. aeruginosa er en almindelig årsag til infektioner hos patienter
English: It is not intended to provide practical advice on how to use Vantobra.
Danish: Det er ikke en praktisk vejledning i, hvordan Vantobra bør anvendes.
English: It contains the active substance tobramycin, which is the same active substance as that of the reference medicine, Tobi.
Danish: Det indeholder det aktive stof tobramycin, der er det samme som i referencelægemidlet Tobi.
English: In addition, the time it takes to inhale Vantobra is shorter than for other tobramycin nebulisers and comparable to the time taken to inhale the dry powder.
Danish: Den tid, det tager inhalere tobramycin, er kortere end med andre tobramycin-nebulisatorer og svarer til den tid, det tager at inhalere det tørre pulver.
English: It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls, resulting in damage to the bacteria, which eventually kills them.
Danish: Det virker ved at blokere produktionen af de proteiner, som P. aeruginosa behøver til opbygning af cellevæggen.
English: Vantobra is an antibiotic used for treating long-term lung infection caused by the bacteria Pseudomonas aeruginosa in patients aged six years and older who have cystic fibrosis.
Danish: Vantobra er et antibiotikum, der anvendes til behandling af langvarig lungebetændelse forårsaget af bakterien Pseudomonas aeruginosa hos patienter over seks år med cystisk fibrose.
English: For more information about treatment with Vantobra, read the package leaflet (also part of the EPAR) or contact
Danish: Hvis du ønsker yderligere oplysninger om behandling med Vantobra, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Before using Vantobra, doctors should consider official guidance on the appropriate use of antibiotics.
Danish: Ved ordination af Vantobra bør lægen tage hensyn til officielle retningslinjer for forsvarlig brug af
English: Both medicines are available as a nebuliser solution.
Danish: Begge lægemidler fås som inhalationsvæske til nebulisator.