FrancophonIA/ELRC3.0 huggingface dataset:
English: Concerns were raised on the proposed indications by an objecting member state, Germany.
Danish: Medlemsstaten Tyskland gjorde indsigelser på grund af betænkeligheder vedrørende de foreslåede indikationer.
English: Furthermore the difficulty to assess the sole efficacy of bleomycin when results are obtained with combination regimens is recognized, however the overall favourable efficacy of bleomycin containing regimen supports the indication for bleomycin.
Danish: Det anerkendes desuden, at virkningen af bleomycin alene dårligt kan vurderes ved kombinationsbehandling, men den overordnede positive virkning af behandling, hvori bleomycin indgår, understøtter indikationen for bleomycin.
English: Most of the presented data describe bleomycin as component of multidrug chemotherapy including cisplatin and therefore the individual contribution of bleomycin cannot be unequivocally determined, however a number of studies and publications clearly indicate that bleomycin demonstrates efficacy.
Danish: Størstedelen af de fremlagte oplysninger beskriver bleomycin som en del af en multistof-kemoterapi indeholdende cisplatin, og derfor kan bleomycins virkning ikke fastsættes entydigt.
English: Bleomycin belongs to the cytostatic antibiotics: it is a mixture of structurally related, alkaline, water soluble, glycopeptide antibiotics with a cytostatic effect.
Danish: Det er en blanding af strukturelt relaterede, alkaliske, vandopløselige, glycopeptidantibiotika med en cytostatisk virkning.
English: Intraperitoneal administration Local/Intratumoral injections
Danish: Intraperitoneal anvendelse Lokal/Intratumoral anvendelse
English: the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination Group procedure as mentioned in Annex III for Bleomycin Pharmachemie and associated names (see Annex I).
Danish: Ud fra følgende betragtninger: - de observerede toksicitetsrisici opvejes af den fastslåede virkning af bleomycin, - virkningen af bleomycin fastslås af den offentliggjorte litteratur samt aktuelle behandlingsvejledninger i Europa og Nordamerika, - og på baggrund af den aktuelle terapeutiske anvendelse af bleomycin, har CHMP anbefalet at udstede markedsføringstilladelser, hvortil produktresuméet, etiketteringen og indlægssedlen bibeholdes i de endelige udgaver, der er fremkommet under koordinationsgruppens procedure som nævnt i bilag III for Bleomycin Pharmachemie og tilknyttede navne (se bilag I).
English: - Squamous cell carcinoma of Head and neck (SCCHN) - Squamous cell carcinoma of external genitalia: penile carcinoma, cervix carcinoma.
Danish: - Pladecellekarcinomer i hoved og hals - Pladecellekarcinomer i ydre kønsdele: peniscancer, cancer i livmoderhalsen - (Non-)Hodgkins lymfomer og andre maligne lymfomer - Testikelcancer - Interpleural behandling af malign pleural effusion
English: In addition to the documentation already provided during the decentralised procedure, supporting a modest but certain role for bleomycin in the treatment of SCCHN, a number of recent reports support the role of bleomycin in conjunction with other chemotherapeutic moieties, identifying both a recovery ratio (RR) of 34% in second line treatment and the improvement of loco-regional control and survival in patients with advanced HNC through concomitant postoperative radio- and chemotherapeutical treatment with mitomycin C and bleomycin.
Danish: Der ses en helbredelsesrate på 34 % ved andetvalgsbehandling samt forbedret lokoregional kontrol og overlevelse hos patienter med fremskreden hoved-hals-cancer ved hjælp af samtidig postoperativ strålebehandling og kemoterapeutisk behandling med mitomycin C og bleomycin.
English: Bleomycin is intended for the treatment of: - Squamous cell carcinoma (SCC) of the head and neck, external genitalia and cervix.
Danish: Bleomycin er beregnet til behandling af: - Pladecellekarcinomer i hoved og hals, ydre kønsdele og livmoder - Hodgkins lymfomer - (Non-)Hodgkins lymfomer af intermediær og høj malignitet hos voksne - Testikelcancer (seminom og nonseminom) - Interpleural behandling af malign pleural effusion
English: Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Local/Intratumoral injections
Danish: Intramuskulær anvendelse Subkutan anvendelse Intravenøs anvendelse Intraarteriel anvendelse Intrapleural anvendelse Lokal/Intratumoral anvendelse
English: Member State EU/EEA
Danish: European Medicines Agency
English: Intramuscular injection Intravenous administration Intra-pleural injection
Danish: Intramuskulær anvendelse Intravenøs anvendelse Intrapleural anvendelse
English: Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration
Danish: Intramuskulær anvendelse Subkutan anvendelse Intravenøs anvendelse Intraarteriel anvendelse Intrapleural anvendelse Intraperitoneal anvendelse Lokal anvendelse
English: Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection
Danish: Intramuskulær anvendelse Subkutan anvendelse Intravenøs anvendelse Intraarteriel anvendelse
English: • if you are more than 3 months pregnant.
Danish: • hvis du er længere end 3 måneder henne i din graviditet.
English: Such conditions should be corrected before the administration of Sabervel.
Danish: Sådanne tilstande skal korrigeres før administration af Sabervel.
English: Sabervel should not be given to children under 18 years of age.
Danish: Sabervel må ikke gives til børn under 18 år.
English: Risk Management Plan (RMP) Not applicable
Danish: Risikostyringsprogram (RMP) Ikke relevant.
English: This medicine should not be used in children and adolescents (under 18 years) because the safety and efficacy have not yet been fully established.
Danish: Dette lægemiddel bør ikke anvendes til børn og unge (under 18 år), da sikkerhed og virkning ikke er blevet fuldstændig klarlagt.
English: You can take Sabervel with or without food.
Danish: Du kan tage Sabervel med eller uden mad.
English: Use in Children
Danish: Brug til børn
English: The volume of distribution is 53 - 93 litres.
Danish: Fordelingsvolumenet er 53-93 liter.
English: • if you suffer from heart problems
Danish: • hvis du lider af hjerteproblemer
English: Children should not take Sabervel
Danish: Børn må ikke tage Sabervel
English: The terminal elimination half-life of irbesartan is 11 - 15 hours.
Danish: Den terminale halveringstid for irbesartan er 11-15 timer.
English: Following oral or intravenous administration of
Danish: Efter oral eller intravenøs administration af
English: Do not pass it on to others.
Danish: Lad derfor være med at give Sabervel til andre.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first Authorization: 13 April 2012
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første Markedsføringstilladelse : 13 April 2012
English: Sabervel is indicated in adults for the treatment of essential hypertension.
Danish: Sabervel er indiceret til voksne til behandling af essentiel hypertension.
English: The PSUR submission schedule should follow the PSUR submission schedule for the reference medicinal product.
Danish: Tidsplanen for indsendelse af PSUR skal følge tidsplanen for referencelægemidlets indsendelse af PSUR.
English: • if you are taking any of the following medicines used to treat high blood pressure:
Danish: • hvis du samtidig tager et af følgende lægemidler til behandling af for højt blodtryk:
English: orthostatic hypotension*
Danish: Ortostatisk hypotension*
English: Like all medicines, Sabervel can cause side effects, although not everybody gets them.
Danish: Sabervel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Sabervel is used in adult patients
Danish: Sabervel anvendes til voksne patienter
English: No specific information is available on the treatment of overdose with Sabervel.
Danish: Der foreligger ikke specifikke oplysninger om behandling af overdosering med Sabervel.
English: • The active substance is irbesartan.
Danish: • Aktivt stof: irbesartan.
English: Paediatric population: the safety and efficacy of Sabervel in children aged 0 to 18 has not been established.
Danish: Pædiatrisk population: Sabervel s sikkerhed og virkning hos børn i alderen 0 til 18 år er ikke fastlagt.
English: Peak plasma concentrations are attained at 1.5 - 2 hours after oral administration.
Danish: Spidskoncentrationen i plasma opnås 1,5-2 timer efter oral administration.
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Sabervel” and “Warnings and precautions”).
Danish: Hvis du samtidig tager en ACE-hæmmer eller aliskiren (se også information under overskrifterne ” Tag ikke Sabervel” og ”Advarsler og forsigtighedsregler”).
English: • to treat high blood pressure (essential hypertension)
Danish: • til at behandle forhøjet blodtryk (hypertension)
English: Name and address of the manufacturers responsible for batch release J. Uriach y Compañía, S.A.
Danish: Navn og adresse på fremstillerne ansvarlige for batchfrigivelse J. Uriach y Compañía, S.A.
English: Lactose: this medicinal product contains lactose.
Danish: Lactose: Dette lægemiddel indeholder lactose.
English: Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity.
Danish: Erfaringerne med behandling af voksne, med doser op til 900 mg/dag i 8 uger, viste ingen toksicitet.
English: • medicines containing lithium
Danish: • medicin, der indeholder lithium
English: Mechanism of action: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Danish: Virkningsmekanisme: Irbesartan er en potent, oral aktiv, selektiv angiotensin-II receptor (type AT1) antagonist.
English: (It is also better to avoid Sabervel in early pregnancy
Danish: (Det er også bedre at lade være med at tage Sabervel i begyndelsen af graviditeten - se afsnittet om graviditet)
English: Taking Sabervel with food and drink Sabervel can be taken with or without food.
Danish: Brug af Sabervel sammen med mad og drikke Sabervel kan tages med og uden mad.
English: hepatitis, abnormal liver function
Danish: Hepatitis, abnorm leverfunktion
English: • potassium-sparing medicines (such as certain diuretics)
Danish: • kaliumsparende medicin (som visse vanddrivende lægemidler)
English: No significant effects on the number of corpora lutea, implants, or live fetuses were observed.
Danish: Der blev ikke observeret signifikante forandringer i antallet af corpora lutea, implantater eller levende fostre.
English: Always take Sabervel exactly as your doctor has told you.
Danish: Tag altid Sabervel nøjagtigt efter lægens anvisning.
English: • if you receive Sabervel for diabetic kidney disease.
Danish: • hvis du får Sabervel for diabetisk nyresygdom.
English: An accompanying improvement in the glomerular filtration rate (GFR) was not observed during the first three months of treatment.
Danish: Der sås ikke efterfølgende forbedringer i den glomulærefiltrationshastighed (GFR) under behandlingen de første 3 måneder.
English: C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Danish: C irbesartan, kan 80-85% af den cirkulerende radioaktivitet i plasma tilskrives uomdannet irbesartan.
English: Sabervel is unlikely to affect your ability to drive or use machines.
Danish: Sabervel påvirker sandsynligvis ikke din evne til at køre bil eller betjene maskiner.
English: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Danish: - en ACE-hæmmer (f.eks. enalapril, lisinopril, ramipril), især hvis du har nyrerproblemer i forbindelse med sukkersyge
English: Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
Danish: Irbesartan reducerede signifikant den relative risiko i det kombinerede primære endepunkt med fordobling af serum-kreatinin, slutstadium af nyresygdom (ESRD) eller totalmortalitet.
English: The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/min, respectively.
Danish: Total body- og nyre-clearance er henholdsvis 157-176 og 3-3,5 ml/min.
English: See also information under the heading “Do not take Sabervel”.
Danish: Se også information under overskriften ”Tag ikke Sabervel:”
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne, arvelige problemer med galactoseintolerans, Lappisk lactasemangel eller glucose-galactosemalabsorption bør ikke anvende dette lægemiddel.
English: After either oral or IV administration of
Danish: Efter enten oral eller intravenøs administration af
English: Subgroups consisting of gender, race, age, duration of diabetes, baseline blood pressure, serum creatinine, and albumin excretion rate were assessed for treatment effect.
Danish: Subgrupperopdelt efter køn, race, alder, varighed af diabetes, baseline-blodtryk, serum-kreatinin, og udskillelseshastighed af albumin blev undersøgt for behandlingseffekt.
English: arthralgia, myalgia (in some cases associated with increased plasma creatine kinase
Danish: Artralgi, myalgi (i nogle tilfælde forbundet med øgede niveauer af plasmakreatinkinase), muskelkramper
English: In particular, the addition of a diuretic such as hydrochlorothiazide has been shown to have an additive effect with Sabervel (see section 4.5).
Danish: Specielt har tillæg af diuretika som hydrochlorthiazid vist sig at have en additiv virkning med Sabervel (se pkt.
English: C irbesartan, about 20% of the radioactivity is recovered in the urine, and the remainder in the faeces.
Danish: C irbesartan, genfindes ca. 20% radioaktivitet i urinen og resten i afføringen.
English: Titanium dioxide (E171)
Danish: Hypromellose Titandioxid (E171) Macrogol 400
English: It is important that you continue to take Sabervel until your doctor tells you otherwise.
Danish: Det er vigtigt, at du fortsætter med at tage Sabervel, indtil lægen siger du kan stoppe.
English: • if you are allergic (hypersensitive) to irbesartan or any other ingredients of Sabervel
Danish: • hvis du er overfølsom (allergisk) over for irbesartan eller et af de øvrige indholdsstoffer i
English: Sabervel is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Danish: Sabervel anbefales ikke til ammende mødre, og lægen vil sædvanligvis vælge en anden behandling til dig, hvis du ønsker at amme dit barn, især hvis dit barn er nyfødt eller født for tidligt.
English: In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function
Danish: I dette tilfælde kan lægen tage regelmæssige blodprøver med særlig henblik på at måle kaliumniveauet i blodet, hvis nyrefunktionen er nedsat.
English: Paediatric population:
Danish: Pædatrisk population:
English: • if you get excessive vomiting or diarrhoea
Danish: • hvis du får hyppig opkastning eller diarré
English: Pregnancy: Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Danish: Graviditet: Behandling med Angiotensin II-Receptor-Antagonister (AIIRAer) bør ikke påbegyndes under graviditet.
English: Sabervel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Danish: Ved en dosis på 150 mg 1 gang dagligt giver Sabervel generelt en bedre 24-timers blodtrykskontrol end 75 mg.
English: Based on its pharmacodynamic properties, irbesartan is unlikely to affect this ability.
Danish: På baggrund af de farmakodynamiske egenskaber er det dog usandsynligt, at irbesartan vil påvirke denne evne.
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%).
Danish: Regression til normo albuminuri (< 30 mg/dag) forekom hyppigere i gruppen, der fik irbesartan 300 mg (34%) end i placebogruppen (21%).
English: Elderly patients: although consideration should be given to initiating therapy with 75 mg in patients over 75 years of age, dosage adjustment is not usually necessary for the elderly.
Danish: Ældre patienter: Selvom initialdosis på 75 mg bør overvejes til patienter >75 år, er det sædvanligvis ikke nødvendigt at dosisjustere ældre patienter.
English: There is no experience regarding the administration of Sabervel in patients with a recent kidney transplantation.
Danish: Der foreligger ingen erfaring vedrørende administration af Sabervel til nyligt nyretransplanterede patienter.
English: Therefore, the use of Sabervel is not recommended.
Danish: Derfor frarådes brug af Sabervel.
English: Studies in animals indicate that the radiolabeled irbesartan is detected in rat and rabbit fetuses.
Danish: Dyrestudier indikerer, at radioaktivt mærket irbesartan kan påvises i rotte- og kaninfostre.
English: C.V. MEDILINE LTD
Danish: MEDILINE LTD
English: Sabervel belongs to a group of medicines known as angiotensin-II receptor antagonists.
Danish: Sabervel tilhører en medicingruppe, der kaldes angiotensin II- receptorantagonister.
English: Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Danish: Lithium: Der er rapporteret reversibel øgning af serum-lithiumkoncentrationer og toksicitet ved samtidig administration af lithium og angiotensin-konverterende enzymhæmmere.
English: Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18 - 40
Danish: Irbesartan AUC- og Cmax -værdier var også noget større hos ældre patienter (≥ 65 år) end hos yngre patienter (18-40 år).
English: diarrhoea, dyspepsia/heartburn
Danish: Diarré, dyspepsi/halsbrand
English: Cartons of 28, 56, 90 or 98 film-coated tablets in PVC/PVDC-aluminium/PVDC blisters.
Danish: Æsker med 28, 56, 90 eller 98 filmovertrukne tabletter i PVC/PVDC-aluminium/PVDC blistere.
English: Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Danish: Rodopi Prefecture, Block No 5,Rodopi 69300,Grækenland
English: Lithium: the combination of lithium and Sabervel is not recommended (see section 4.5).
Danish: Lithium: Kombination af lithium og Sabervel frarådes (se pkt.
English: Sabervel slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Danish: Sabervel mindsker faldende nyrefunktionen hos patienter med forhøjet blodtryk og type 2- diabetes.
English: • potassium supplements
Danish: • kaliumtilskud
English: If you take more Sabervel than you should: If you accidentally take too many tablets, contact your doctor immediately.
Danish: Hvis du har taget for meget Sabervel Hvis du ved et uheld har taget for mange tabletter, skal du omgående kontakte lægen.
English: Hyperkalaemia* occurred more often in diabetic patients treated with irbesartan than with placebo.
Danish: Undersøgelser: Meget almindelig Hyperkaliæmi* forekommer hyppigere blandt diabetiske patienter behandlet med irbesartan end med placebo.
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Silica colloidal anhydrous Hypromellose Magnesium stearate.
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Croscarmellosenatrium silica kolloid vandfri Hypromellose Magnesiumstearat.
English: Sabervel is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Danish: Sabervel bør ikke bruges tidligt i graviditeten, og du må ikke tage Sabervel, hvis du er længere end 3 måneder henne i din graviditet, da det kan skade dit barn alvorligt, hvis det bruges i den periode (se afsnittet om graviditet).
English: Rodopi Prefecture, Block No 5, Rodopi 69300, Greece For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Danish: Rodopi Prefecture, Block No 5,Rodopi 69300,Grækenland Hvis du vil have yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant
English: Other medicines and Sabervel
Danish: Brug af anden medicin sammen med Sabervel
English: Your doctor will normally advise you to stop taking Sabervel before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Sabervel.
Danish: Du skal fortælle det til din læge, hvis du tror du er gravid eller planlægger at blive gravid; din læge vil normalt anbefale, at du stopper med at tage Sabervel, inden du bliver gravid, eller så snart du ved, at du er gravid og vil anbefale, at du tager anden medicin i stedet for Sabervel.
English: Do not use Sabervel after the expiry date which is stated on the carton and on the blister after EXP.
Danish: Tag ikke Sabervel efter den udløbsdato, der står på pakningen.
English: The frequency of the side effects listed below is defined using the following convention: Very common: at least 1 in 10 patients or more Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients
Danish: Nedenstående bivirkningers hyppighed angives på følgende måde: Meget almindelig: 1 ud af 10 patienter eller flere Almindelig: mindst 1 ud af 100 og færre end 1 ud af 10 patienter Ikke almindelig: mindst 1 ud af 1000 og færre end 1 ud af 100 patienter
English: What Sabervel contains
Danish: Sabervel indeholder:
English: • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Danish: • hvis du har sukkersyge eller nedsat nyrefunktion, og du også tager et blodtrykssænkende lægemiddel, der indeholder aliskiren
English: Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with Sabervel (see section 4.4).
Danish: En forudgående behandling med høje doser diuretika kan medføre hypovolæmi og risiko for hypotension, når behandlingen med Sabervel påbegyndes (se pkt.
English: No dosage adjustment is necessary in elderly patients.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter.
English: While this is not documented with Sabervel, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Danish: Selvom dette ikke er dokumenteret for Sabervel, kan der forventes en lignende effekt med angiotensin-IIreceptorantagonister.
English: The blood pressure lowering effect of irbesartan is evident within 1-2 weeks, with the maximal effect occurring by 4-6 weeks after start of therapy.
Danish: Irbesartan blodtrykssænkende effekt er tydelig i løbet af 1-2 uger, og den maksimale effekt viser sig 4-6 uger efter behandlingsstart.
English: Metabolism and nutrition disorders: Not known:
Danish: Metabolisme og ernæring: Ikke kendt:
English: As is the case with other medicinal products that affect the renin-angiotensin system, black hypertensive patients have notably less response to irbesartan monotherapy.
Danish: Ligesom for andre lægemidler, der påvirker reninangiotensinsystemet, gælder det, at sorte hypertensionpatienter responderer betydeligt dårligere på irbesartanmonoterapi.
English: If you forget to take Sabervel:
Danish: Hvis du har glemt at tage Sabervel
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/