FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed.
Danish: Tilgængelige data fra epidemiologiske studier viser en kumulativ dosisafhængig forbindelse mellem hydrochlorthiazid og non-melanom hudkræft.
English: White to yellowish white on one side and yellow marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm.
Danish: Tolaget, bikonveks, oval tablet, hvid til gullig på den ene side og gult marmoreret på den anden side, tabletdimensioner 18 mm x 9 mm.
English: What Tolucombi is and what it is used for What you need to know before you take Tolucombi How to take Tolucombi
Danish: Det skal du vide, før du begynder at tage Tolucombi Sådan skal du tage Tolucombi Bivirkninger
English: Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Danish: Hver tablet indeholder 80 mg telmisartan og 12,5 mg hydrochlorthiazid.
English: ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporine or other medicinal products such as heparin sodium).
Danish: Lægemidler, som kan øge kaliumniveauet eller udløse hyperkaliæmi (f.eks. ACE-hæmmere, kaliumbesparende diuretika, kaliumtilskud, saltsubstitutter der indeholder kalium, ciclosporin eller andre lægemidler, f.eks. heparin-natrium)
English: Tolucombi 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Danish: Tolucombi 40 mg/12,5 mg tabletter telmisartan/hydrochlorthiazid
English: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed (see also sections 4.4 and 5.1).
Danish: Tilgængelige data fra epidemiologiske studier viser en kumulativ dosisafhængig forbindelse mellem hydrochlorthiazid og non-melanom hudkræft (se også pkt.
English: Acute Myopia and Angle-Closure Glaucoma
Danish: Akut myopi og snævervinklet glaukom
English: SUN
Danish: SØN
English: Tolucombi 80 mg/12.5 mg tablets
Danish: Tolucombi 80 mg/12,5 mg tabletter
English: - Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase, leading to a lowering of your blood pressure.
Danish: Thiazider får urinmængden til at stige og det fører til, at blodtrykket falder.
English: Tolucombi 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Danish: Tolucombi 80 mg/12,5 mg tabletter telmisartan/hydrochlorthiazid
English: White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 15 mm x 7 mm.
Danish: Tolaget, bikonveks, oval tablet, hvid til næsten hvid eller svagt lyserød på den ene side og lyserød marmoreret på den anden side, tabletdimensioner 15 mm x 7 mm.
English: Renal and urinary disorders Not known: Nephritis interstitial, renal dysfunction, glycosuria
Danish: Interstitiel nefrit, nedsat nyrefunktion, glukosuri
English: Reproductive system and breast disorders Uncommon: Erectile dysfunction
Danish: Det reproduktive system og mammae Ikke almindelig:
English: White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm.
Danish: Tolaget, bikonveks, oval tablet, hvid til næsten hvid eller svagt lyserød på den ene side og lyserød marmoreret på den anden side, tabletdimensioner 18 mm x 9 mm.
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Tabuleret sammendrag af bivirkninger
English: General disorders and administration site conditions Uncommon: Chest pain
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke almindelig:
English: United Kingdom Consilient Health (UK) Ltd. Tel: + 44 (0)203 751 1888
Danish: Tel: + 44 (0)203 751 1888
English: General disorders and administration site conditions Not known: Pyrexia
Danish: Almene symptomer og reaktioner på administrationsstedet Ikke kendt:
English: Warnings and precautions Talk to your doctor before taking Tolucombi if you are suffering or have ever suffered from any of the following conditions or illnesses: - Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før du tager Tolucombi, hvis du har eller har haft en medicinsk lidelse eller sygdom, især hvis det er en af dem, der er nævnt nedenfor: - Lavt blodtryk (hypotension), som kan forekomme, når du er dehydreret (har for lidt kropsvæske) eller har saltmangel på grund af enten vanddrivende medicin, saltfattig diæt, diaré, opkastning eller hæmodialyse - Nyresygdom eller nyretransplantation - Forsnævring af blodkarrene til den ene eller begge nyrer (nyre-arteriestenose) - Leversygdom - Hjerteproblemer - Sukkersyge - Urinsyregigt (podagra) - Forhøjet aldosteronniveau (vand og salt ophobning i kroppen og ubalance i blodets indhold af mineraler) - Bindevævssygdommen systemisk lupus erythematosus (også kaldet lupus eller SLE), en sygdom, hvor kroppens immunsystem angriber kroppen - Det aktive indholdsstof i hydrochloridthiazide kan forårsage en usædvanlig reaktion, hvilket medfører nedsat syn og øjensmerter.
English: OUTER CARTON
Danish: Ydre pakning
English: FRI
Danish: FRE
English: Infections and infestations Not known: Sialadenitis
Danish: Infektioner og parasitære sygdomme Ikke kendt:
English: Arthralgia, muscle cramps, pain in limb
Danish: Artralgi, muskelkramper, smerter i ekstremiteter
English: TUE
Danish: LØR
English: Hepatobiliary disorders Not known: Jaundice hepatocellular, jaundice cholestatic
Danish: Hepatocellulær gulsot, kolestatisk gulsot
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Danish: Samtidig behandling med angiotensin II-receptorantagonister og stoffer der hæmmer cyclooxygenasen, kan medføre en yderligere svækkelse hos nogle patienter, der allerede har nedsat nyrefunktion (dehydrering, alder).
English: Tolucombi 40 mg/12.5 mg tablets:
Danish: Tolucombi 40 mg/12,5 mg tabletter
English: If you take more Tolucombi than you should
Danish: Hvis du har taget for mange Tolucombi
English: - Severe hepatic impairment.
Danish: - Svært nedsat leverfunktion.
English: 80 mg/12.5 mg tablets: White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm.
Danish: 40 mg/12,5 mg tabletter: dobbeltlaget, hvælvet, oval tablet, hvid til næsten hvid eller svagt lyserød på den ene side og lyserød marmoreret på den anden side, tabletdimensioner 15 mm x 7 mm. 80 mg/12,5 mg tabletter: dobbeltlaget, hvælvet, oval tablet, hvid til næsten hvid eller svagt lyserød på den ene side og lyserød marmoreret på den anden side, tabletdimensioner 18 mm x 9 mm. 80 mg/25 mg tabletter: dobbeltlaget, hvælvet, oval tablet, hvid til gullig på den ene side og gult marmoreret på den anden side, tabletdimensioner 18 mm x 9 mm.
English: - Cholestasis and biliary obstructive disorders.
Danish: - Galdeophobning i galdegange og galdeobstruktion.
English: Immune system disorders Not known: Anaphylactic reactions, hypersensitivity
Danish: Anafylaktiske reaktioner, overfølsomhed
English: THU
Danish: TIR
English: The overall incidence and pattern of adverse reactions reported with telmisartan/hydrochlorothiazide 80 mg/25 mg was comparable with telmisartan/hydrochlorothiazide 80 mg/12.5 mg. A doserelationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Danish: Den totale incidens og mønster af bivirkninger rapporteret ved brug af Tolucombi 80 mg/25 mg var sammenlignelig med Tolucombi 80 mg/12,5 mg.
English: Thrombocytopenia (sometimes with purpura) Not known: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis
Danish: Aplastisk anæmi, hæmolytisk anæmi, knoglemarvssvigt, leukopeni, neutropeni, agranulocytose
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Tolucombi Fortæl altid lægen eller på apoteket, hvis du tager anden medicin eller har gjort det for nylig.
English: Avastin has been authorised since January 2005.
Danish: Avastin har været godkendt siden januar 2005.
English: The study also looked at how long the patients survived.
Danish: I undersøgelsen så man endvidere på, hvor længe patienterne overlevede.
English: The company that applied for the change to the authorisation is Roche Registration Limited.
Danish: Virksomheden, som ansøgte om ændring af tilladelsen er Roche Registration Limited.
English: There were two main measures of effectiveness: the number of patients whose tumours had responded to treatment ; and ‘progressionfree survival' (the number of patients who were still alive and whose disease had not got worse) after six months of treatment.
Danish: Der var to primære effektmål: antallet af patienter, hvis tumorer havde reageret på behandlingen, og ‘progressionsfri overlevelse' (antallet af patienter, som stadig var i live, og hvis sygdom ikke var blevet værre) efter seks måneders behandling.
English: International non-proprietary name (INN): bevacizumab
Danish: Internationalt fællesnavn (INN): bevacizumab
English: The company presented the results of one main study involving 167 patients with glioblastoma that had come back after one or two previous courses of treatment.
Danish: Virksomheden fremlagde resultaterne af en hovedundersøgelse med deltagelse af 167 patienter med glioblastoma, som var kommet tilbage efter et eller to tidligere behandlingsforløb.
English: In glioblastoma, Avastin is expected to work in the same way as it does in its existing indications.
Danish: Ved glioblastoma forventes Avastin at virke på samme måde som til dets eksisterende indikationer.
English: It was to be used when the disease had relapsed (come back after previous treatment).
Danish: Det skulle anvendes, når sygdommen var kommet tilbage efter tidligere behandling.
English: Questions and answers on the recommendation for the refusal of a change to the marketing authorisation for Avastin
Danish: Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om ændring af markedsføringstilladelsen for Avastin
English: There are no consequences on the use of Avastin in its authorised indications, for which the balance of benefits and risks remains unchanged.
Danish: Det får ingen konsekvenser at anvende Avastin til de godkendte indikationer, for hvilken benefit/riskforholdet forbliver uændret.
English: Avastin was also expected to be used to treat another type of cancer called glioblastoma.
Danish: Avastin forventedes også anvendt til behandling af en anden kræfttype kaldet glioblastoma.
English: Glioblastoma is a type of brain tumour that affects the ‘glial' cells (the cells that surround and support the nerve cells).
Danish: Glioblastoma er en art hjernesvulst, der påvirker gliacellerne (de celler, der omgiver og støtter nervecellerne).
English: Half of the patients received Avastin alone and the other half received Avastin together with irinotecan.
Danish: Den ene halvdel af patienterne fik Avastin som eneste behandling, mens den anden halvdel fik Avastin sammen med irinotecan.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Danish: Et monoklonalt antistof er et antistof (en form for protein), der er opbygget, så det genkender og binder sig til en bestemt struktur (kaldet et antigen), der findes i kroppen.
English: It contains the active substance bevacizumab.
Danish: Det indeholder det aktive stof bevacizumab.
English: What are the consequences of the refusal for patients in clinical trials using Avastin?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Avastin?
English: Avastin was to be used in on its own or in combination with irinotecan (another anticancer medicine).
Danish: Avastin skulle anvendes alene eller i kombination med irinotecan (et andet lægemiddel mod kræft).
English: It is already used in combination with other medicines to treat cancer of the colon or rectum (large intestine), breast cancer, non-small cell lung cancer and kidney cancer.
Danish: Det anvendes allerede i kombination med andre lægemidler til behandling af kræft i tyktarmen eller endetarmen, brystkræft, ikke-småcellet lungekræft og nyrekræft.
English: The change concerned an extension of indication to add the treatment of glioblastoma after relapse.
Danish: Ændringen vedrørte en udvidelse af indikationen til også at omfatte behandling af glioblastoma efter tilbagefald.
English: Bevacizumab has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Danish: Bevacizumab er udviklet til at binde sig til vaskulær endotelvækstfaktor (VEGF), et protein, som cirkulerer i blodet og får blodkar til at vokse.
English: On 19 November 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Avastin.
Danish: Den 19. november 2009 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgning om ændring af markedsføringstilladelsen for lægemidlet Avastin.
English: What is happening with Avastin for the treatment of colorectal, breast, lung and kidney cancer?
Danish: Hvad sker der med Avastin til behandling af kolorektal-, bryst-, lunge- og nyrekræft?
English: In addition, the CHMP could not interpret the findings on survival because the study did not compare Avastin directly with any other treatments.
Danish: Derudover kunne CHMP ikke fortolke resultaterne vedrørende overlevelse, fordi Avastin ikke blev sammenlignet direkte med andre behandlinger i undersøgelsen.
English: The active substance in Avastin, bevacizumab, is a monoclonal antibody.
Danish: Det aktive stof i Avastin, bevacizumab, er et monoklonalt antistof.
English: The CHMP was concerned that the company had not provided sufficient evidence of the medicine's benefits, because the number of patients who responded to treatment was not dramatic and because response rates may not be a suitable measure of the medicine's effectiveness.
Danish: CHMP fandt grund til betænkelighed ved, at virksomheden ikke havde forelagt tilstrækkelig dokumentation for fordelene ved lægemidlet, da antallet af patienter, der reagerede på behandlingen, ikke var særligt højt, og responsrater ikke nødvendigvis var en hensigtsmæssig målestok for lægemidlets virkning.
English: Therefore, at that point in time, the CHMP was of the opinion that the balance of benefits and risks of Avastin in the treatment of glioblastoma after relapse could not be established.
Danish: Derfor var det på daværende tidspunkt CHMP's opfattelse, at benefit/risk-forholdet for Avastin til behandling af glioblastoma efter tilbagefald ikke kunne fastslås.
English: The full European Public Assessment Report for Avastin is available here.
Danish: Den fuldstændige EPAR for Avastin findes her.
English: Avastin is a concentrate that is made up into a solution for infusion (drip into a vein).
Danish: Avastin er et koncentrat, der blandes til en opløsning til infusion (dråbetilførsel i en vene).
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials with Avastin for glioblastoma.
Danish: Virksomheden har til CHMP oplyst, at afslaget ikke vil få konsekvenser for patienter, der på nuværende tidspunkt deltager i kliniske undersøgelser med Avastin til behandling af glioblastoma.
English: Marketing Authorisation Holder (Name and address): Reference Member State:
Danish: Indehaver af markedsføringstilladelsen (navn og adresse): Referencemedlemsstat:
English: Blister (PVC/Alu)
Danish: Blisterpakning (PVC/alu)
English: If no improvement is seen within 5 days of starting therapy, the diagnosis should be re-evaluated and a different course of therapy considered.
Danish: Hvis der ikke observeres en forbedring af patientens tilstand efter 5 dage, bør diagnosen re-evalueres og en anden terapi overvejes.
English: The Applicant was requested to provide justification for the three-fold increase in the dose for the additional indication.
Danish: Ansøgeren blev anmodet om at fremlægge en begrundelse for den tredobbelte øgning af dosis til den yderligere indikation.
English: ATCvet code: QJ01MA95.
Danish: ATC kode: QJ 01 MA95
English: 5.9 Overdosage
Danish: 5.9 Overdosering
English: Symptomatic therapy is recommended.
Danish: Symptomatisk behandling anbefales.
English: FURTHER INFORMATION 7.1 Marketing authorisation Number 7.2 Legal category
Danish: YDERLIGERE OPLYSNINGER 7.1 Markedsføringstilladelsens nummer (numre)
English: 5.8 Dosage and Method of administration
Danish: 5.8 Dosering og administration
English: Orbax Tablets are contraindicated in juvenile dogs during the rapid growth phase (up to 8 months of age in small and medium sized breeds, up to 12 months in large and up to 18 months of age in giant breeds).
Danish: Orbax er kontraindiceret i unge hunde i fasen med meget hurtig vækst (op til 8 måneders alderen i små og mellemstore racer, op til 12 måneders alderen i store racer og op til 18 måneders alderen i meget store racer).
English: Escherichia coli Proteus mirabilis Staphylococcus intermedius Staphylococcus aureus Pasteurella multocida Enterobacter agglomerans Klebsiella pneumoniae
Danish: Proteus mirabilis Staphylococcus intermedius Staphylococcus aureus Pasteurella multocida Enterobacter agglomerans Klebsiella pneumoniae
English: The plasma elimination half life is approximately 6 hours.
Danish: Plasmahalveringstiden er ca. 6 timer.
English: Some mutations that can confer resistance to the fluoroquinolones can also confer resistance to other classes of antibiotics such as the cephalosporins and tetracyclines.
Danish: Visse mutationer som kan lede til resistens overfor fluorquinoloner kan også føre til resistens overfor andre klasser af antibiotika såsom cephalosporiner og tetracykliner.
English: The potential effects of orbifloxacin on the retina of the dog have not been studied.
Danish: Den potentielle effekt af orbifloxacin på retina hos hund er ikke undersøgt.
English: Mild side effects such as vomiting, soft faeces or diarrhoea may occasionally occur in some animals.
Danish: Lette bivirkninger såsom opkastning, blød afføring eller diarrè kan lejlighedsvis observeres i enkelte dyr.
English: Welwyn Garden City Herts AL7 1TW United Kingdom
Danish: Welwyn Garden City Herts AL7 1TW Det Forenede Kongerige
English: Heavy reliance on a single class of antibiotic may result in the induction of resistance in a bacterial population.
Danish: Omfattende anvendelse af en enkelt klasse af antibiotika kan inducere resistens i en given population af bakterier.
English: They also agreed that to use a lower dose than 7.5 mg/kg is not recommended due to the risk of resistance emerging and also a possible lack of efficacy.
Danish: CVMP var også enig i, at det ikke kunne anbefales at anvende en lavere dosis end 7,5 mg/kg som følge af risikoen for fremkomst af resistens og muligvis også manglende effekt.
English: Film coating containing titanium dioxide (E171)
Danish: Overtræksfilmen indeholder titandioxid (E171)
English: 5.11 Withdrawal periods
Danish: 5.11 Tilbageholdelsestider
English: Orbax is licensed for the treatment of urinary tract infections for dogs in a number of Member States and the Applicant submitted an application for the extension of the indication to cover the treatment of skin and soft tissue infections at a different dose to that recommended for the original claim.
Danish: Orbax er godkendt til behandling af urinvejsinfektioner hos hunde i en række medlemsstater, og ansøgeren indgav en ansøgning om udvidelse af indikationen til også at omfatte behandling af hud- og bløddelsinfektioner i en dosis, som adskiller sig fra den dosis, der blev anbefalet i den oprindelige påstand.
English: Bacterial resistance to the fluoroquinolones may occur through alterations in bacterial cell wall permeability, activation of an efflux pump or alteration in the 4-quinolone molecule's binding site via mutation of DNA gyrase or topoisomerase IV. Resistance to one fluoroquinolone frequently results in resistance to all (cross-resistance).
Danish: Bakteriel resistens mod fluorquinoloner kan opstå ved ændring af permeabiliteten i bakteriens cellevæg, ved aktivering af efflux pumpen eller ved ændring i 4-quinolon molekylets binding til receptor via mutation af DNA gyrasen eller topoisomerase IV. Resistens overfor et fluorquinolon medfører ofte resistens overfor alle fluorquinoloner (krydsresistens).
English: Fluoroquinolones have been shown to induce erosion of the articular cartilage in juvenile animals, the dog being particularly sensitive.
Danish: Fluorquinoloner har vist sig at kunne inducere erosion af ledbrusken i unge dyr, den periode hvor hunden er speciel følsom.
English: Taking into account that it is preferable to recommend a single dose (rather than a dose range) for treatment; the risk of antimicrobial resistance of a lower dose, in pathogens causing skin infections, as concentrations in skin are lower than in the urinary tract; that the recommended dose was confirmed to be effective in a clinical trial;
Danish: det er at foretrække, at der kun anbefales en enkelt dosis (frem for et dosisinterval) til behandling, risikoen for antimikrobiel resistens ved en lavere dosis i patogener, som forårsager hudinfektioner, da koncentrationerne i huden er lavere end i urinvejene, i en klinisk undersøgelse blev det bekræftet, at den anbefalede dosis var effektiv,
English: Schering-Plough A/S Hvedemarken 12 DK-3520 Farum Denmark
Danish: Schering-Plough A/S Hvedemarken 12 DK-3520 Farum Danmark
English: Maximum plasma concentrations of 2.3 and 6.8 g/ml are achieved within two hours following administration at 2.5 and 7.5 mg/kg, respectively.
Danish: Maximale plasmakoncentrationer på 2,3 og 6,8 mg/ml opnås indenfor 2 timer efter dosering af henholdsvis 2,5 og 7,5 mg/kg.
English: the CVMP agreed that the recommended dose of 7.5 mg/kg is sufficient to ensure appropriate treatment of skin infections in the dog.
Danish: var CVMP enig i, at den anbefalede dosis på 7,5 mg/kg er tilstrækkelig til at sikre en egnet behandling af hudinfektioner hos hunde.
English: 5.3 Contraindications
Danish: 5.3 Kontraindikationer
English: 6.3 Special storage precautions
Danish: 6.3 Særlige opbevaringsforhold
English: Approximately 50% of an orally administered dose is excreted in the urine as unchanged drug.
Danish: Hos hunde udskilles ca. 50% af den oralt administrerede dosis uændret i urinen.
English: The basis for the arbitration procedure was the concerns raised by Denmark and Spain, that the three fold increase in the dose of orbifloxacin recommended for the treatment of skin and soft tissue infections compared to the recommended dose for the treatment of urinary tract infections was not justified.
Danish: Grundlaget for voldgiftsproceduren var de spørgsmål, som Danmark og Spanien havde rejst, nemlig at den tredobling af orbifloxacin-dosis, som blev anbefalet til behandling af hud- og bløddelsinfektioner, ikke var berettiget i sammenligning med den anbefalede dosis til behandling af urinvejsinfektioner.
English: Therefore, the CVMP has recommended the granting of the Marketing Authorisations for which the Summaries of Product Characteristics are set out in Annex III for Orbax.
Danish: Derfor har CVMP anbefalet, at der udstedes markedsføringstilladelser for Orbax.
English: Orbifloxacin has been shown to be active against most strains of the following organisms.
Danish: Orbifloxacin har vist sig at have effekt på de fleste stammer af de følgende organismer.