FrancophonIA/ELRC3.0 huggingface dataset:
English: As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Danish: Som det er tilfældet med ACE-hæmmere, kan samtidig anvendelse af angiotensin-II-antagonister og NSAID medføre øget risiko for forværring af nyrefunktionen herunder muligt akut nyresvigt samt øgning af serum-kalium.
English: Respiratory, thoracic and mediastinal disorders Uncommon: cough
Danish: Luftveje, thorax og mediastinum Ikke almindelig:
English: potassium supplements salt substitutes containing potassium potassium-sparing medicines (such as certain diuretics) medicines containing lithium
Danish: • kaliumsparende medicin (som visse vanddrivende lægemidler)
English: The other side of the tablet debossed with number “7465”.
Danish: Den anden side af tabletten er præget med tallet "7465".
English: Irbesartan Teva 150 mg film-coated tablets EU/1/09/576/014 7 tablets
Danish: Irbesartan Teva 150 mg filmovertrukne tabletter EU/1/09/576/014 7 tabletter
English: In 1.7 % of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Danish: Der er set fald i hæmoglobin*, som ikke var klinisk signifikant, hos 1,7 % af de hypertensive patienter med fremskreden diabetisk nyresygdom behandlet med irbesartan.
English: The other side of the tablet debossed with number “7464”.
Danish: Den anden side af tabletten er præget med tallet "7464".
English: In patients insufficiently controlled with 150 mg once daily, the dose of irbesartan can be increased to 300 mg, or other anti-hypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Danish: Hos patienter som ikke er tilstrækkeligt kontrolleret på 150 mg, 1 gang dagligt, kan dosis af irbesartan øges til 300 mg, eller andre antihypertensiva kan tilføjes se pkt.
English: How to take Irbesartan Teva
Danish: Sådan skal du tage Irbesartan Teva
English: Irbesartan Teva 75 mg film-coated tablets EU/1/09/576/001 7 tablets
Danish: Irbesartan Teva 75 mg filmovertrukne tabletter EU/1/09/576/001 7 tabletter
English: Potassium supplements and potassium-sparing diuretics Based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Danish: Erfaringer med brug af andre lægemidler, der indvirker på renin-angiotensinsystemet, viser at samtidig brug af kalium-besparende diuretika, kaliumtilskud, kaliumholdige salterstatninger eller andre lægemidler, som kan øge serumkaliumniveauet (fx heparin), kan medføre øget serum-kalium.
English: The demonstration of renal benefit of irbesartan in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Danish: Dokumentationen for forbedring af nyresygdom ved brug af irbesartan hos hypertensive type 2-diabetikere er baseret på studier, hvor irbesartan blev brugt efter behov med tillæg af andre antihypertensive lægemidler for at nå det ønskede blodtryk (se pkt.
English: Package leaflet: information for the user Irbesartan Teva 300 mg Film-Coated Tablets
Danish: Indlægsseddel: Information til brugeren Irbesartan Teva 300 mg filmovertrukne tabletter
English: Package leaflet: information for the user Irbesartan Teva 75 mg Film-Coated Tablets
Danish: Indlægsseddel: Information til brugeren Irbesartan Teva 75 mg filmovertrukne tabletter
English: Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Danish: Patienter, der planlægger at blive gravide, bør skifte til anden antihypertensiv behandling, hvor sikkerhedsprofilen for anvendelse under graviditet er veletableret, medmindre fortsat behandling med AIIRA'er skønnes nødvendig.
English: White to off white capsule shaped, film coated tablet.
Danish: Hvide til offwhite kapselformede filmovertrukne tabletter.
English: Irbesartan 75 mg film-coated tablets are white to off white capsule shaped, film coated tablet.
Danish: Irbesartan 75 mg filmovertrukne tabletter er hvide til offwhite, kapselformede filmovertrukne tabletter.
English: Package leaflet: information for the user Irbesartan Teva 150 mg Film-Coated Tablets
Danish: Indlægsseddel: Information til brugeren Irbesartan Teva 150 mg filmovertrukne tabletter
English: Not known: impaired renal function including cases of renal failure in patients at risk (see section 4.4) Reproductive system and breast disorders
Danish: Nedsat nyrefunktion, inklusive tilfælde af nyresvigt hos risikopatienter (se pkt.
English: Irbesartan 300 mg film-coated tablets are white to off white capsule shaped, film coated tablet.
Danish: Irbesartan 300 mg filmovertrukne tabletter er hvide til offwhite, kapselformede filmovertrukne tabletter.
English: Each film-coated tablet contains 75 mg irbesartan
Danish: Hver filmovertrukket tablet indeholder 75 mg irbesartan
English: • Each Irbesartan Teva 75 mg film-coated tablet contains 75 mg irbesartan.
Danish: • Hver Irbesartan Teva 75 mg filmovertrukket tablet indeholder 75 mg irbesartan.
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendig hos patienter med let/moderat leverfunktionsnedsættelse.
English: Hypertension and type 2 diabetes with renal disease
Danish: Hypertensive patienter med type 2 diabetisk nyresygdom
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Danish: Lægemidler indeholdende aliskiren eller ACE-hæmmere Data fra kliniske studier har vist, at dobbelthæmning af renin-angiotensin-aldosteronsystemet (RAAS) gennem kombinationsbehandling med ACE-hæmmere, angiotensin II-receptorantagonister eller aliskiren er forbundet med en højere hyppighed af bivirkninger som hypotension, hyperkaliæmi og nedsat nyrefunktion (inklusive akut nyresvigt) sammenlignet med brug af et enkelt RAAS-virkende lægemiddel (se pkt.
English: Your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Irbesartan Teva” and “Warnings and precautions”).
Danish: Hvis du samtidig tager en en ACE-hæmmer eller aliskiren (se også information under overskrifterne ”Tag ikke Irbesartan Teva” og ”Advarsler og forsigtighedsregler”).
English: Each film-coated tablet contains 300 mg irbesartan
Danish: Hver filmovertrukket tablet indeholder 300 mg irbesartan
English: hepatitis, abnormal liver function Skin and subcutaneous tissue disorders Not known:
Danish: Hud og subkutane væv Ikke kendt:
English: • Each Irbesartan Teva 300 mg film-coated tablet contains 300 mg irbesartan.
Danish: • Hver Irbesartan Teva 300 mg filmovertrukket tablet indeholder 300 mg irbesartan.
English: • Each Irbesartan Teva 150 mg film-coated tablet contains 150 mg irbesartan.
Danish: • Hver Irbesartan Teva 150 mg filmovertrukket tablet indeholder 150 mg irbesartan.
English: Irbesartan 150 mg film-coated tablets are white to off white capsule shaped, film coated tablet.
Danish: Irbesartan 150 mg filmovertrukne tabletter er hvide til offwhite, kapselformede filmovertrukne tabletter.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Irbesartan Teva nøjagtigt efter lægens anvisning.
English: Renal impairment
Danish: Voldsom træthed
English: In non-clinical safety studies, high doses of irbesartan (≥ 250 mg/kg/day in rats and ≥ 100 mg/kg/day in macaques) caused a reduction of red blood cell parameters (erythrocytes, haemoglobin, haematocrit).
Danish: I ikke-kliniske sikkerhedsstudier forårsagede høje doser af irbesartan (≥ 250 mg/kg/dag hos rotter og
English: Each film-coated tablet contains 150 mg irbesartan
Danish: Hver filmovertrukket tablet indeholder 150 mg irbesartan
English: You must tell your doctor if you think that you are (or might become) pregnant.
Danish: Du skal fortælle det til din læge, hvis du tror du er gravid eller planlægger at blive gravid.
English: Irbesartan Teva 75 mg film-coated tablets Irbesartan
Danish: Irbesartan Teva 75 mg filmovertrukne tabletter Irbesartan
English: Irbesartan Teva 75 mg film-coated tablets Each film-coated tablet contains 75 mg of irbesartan
Danish: Irbesartan Teva 75 mg filmovertrukne tabletter Hver Irbesartan Teva 75 mg filmovertrukket tablet indeholder 75 mg irbesartan.
English: Gastrointestinal disorders Common:
Danish: Vaskulære sygdomme Almindelig:
English: Irbesartan Teva 75 mg film-coated tablets
Danish: Irbesartan Teva 75 mg filmovertrukne tabletter
English: At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Danish: Ved meget høje doser (≥ 500 mg/kg/dag) inducerede irbesartan degenerative ændringer i nyren hos rotter og makakaber (så som interstitiel nefritis, tubulær udvidelse,
English: Irbesartan Teva 300 mg film-coated tablets Each film-coated tablet contains 300 mg of irbesartan
Danish: Irbesartan Teva 300 mg filmovertrukne tabletter Hver Irbesartan Teva 300 mg filmovertrukket tablet indeholder 300 mg irbesartan.
English: Irbesartan Teva 300 mg film-coated tablets Irbesartan
Danish: Irbesartan Teva 300 mg filmovertrukne tabletter Irbesartan
English: Irbesartan Teva 150 mg film-coated tablets Each film-coated tablet contains 150 mg of irbesartan
Danish: Irbesartan Teva 150 mg filmovertrukne tabletter Hver Irbesartan Teva 150 mg filmovertrukket tablet indeholder 150 mg irbesartan.
English: Irbesartan Teva 300 mg film-coated tablets EU/1/09/576/027 7 tablets EU/1/09/576/028 14 tablets
Danish: Irbesartan Teva 75 mg filmovertrukne tabletter EU/1/09/576/027 7 tabletter EU/1/09/576/028 14 tabletter EU/1/09/576/029 28 tabletter
English: What Irbesartan Teva is and what it is used for What you need to know before you take Irbesartan Teva How to take Irbesartan Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Irbesartan Teva Sådan skal du tage Irbesartan Teva Bivirkninger
English: No dose adjustment is necessary in patients with impaired renal function.
Danish: Det er ikke nødvendigt at dosisjustere patienter med nedsat nyrefunktion.
English: Irbesartan Teva 150 mg film-coated tablets Irbesartan
Danish: Irbesartan Teva 150 mg filmovertrukne tabletter Irbesartan
English: In patients with mild to moderate cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.
Danish: Irbesartans farmakokinetiske parametre ændres ikke væsentligt hos patienter med mild/moderat cirrose.
English: if you are more than 3 months pregnant (it is also better to avoid Irbesartan Teva in early pregnancy - see pregnancy section).
Danish: (Det er også bedre at lade være med at tage Irbesartan Teva i begyndelsen af graviditeten - se afsnittet om graviditet).
English: Uncommon: diarrhoea, dyspepsia/heartburn Not known:
Danish: Diarré, dyspepsi/halsbrand
English: hyperkalaemia Nervous system disorders Common:
Danish: Nervesystemet Almindelig:
English: Irbesartan Teva 150 mg film-coated tablets
Danish: Irbesartan Teva 150 mg filmovertrukne tabletter
English: Irbesartan Teva 300 mg film-coated tablets
Danish: Irbesartan Teva 300 mg filmovertrukne tabletter
English: PHARMACEUTICAL FORM AND CONTENTS
Danish: LISTE OVER HJÆLPESTOFFER LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE)
English: How to store Irbesartan Teva Contents of the pack and other information
Danish: YDERLIGERE OPLYSNINGER Irbesartan Teva indeholder:
English: orthostatic hypotension* Uncommon: flushing
Danish: Ortostatisk hypotension*
English: When irbesartan is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Danish: Nyrefunktionsnedsættelse og nyretransplantation Der anbefales periodisk kontrol af serum-kalium- og serum-kreatinin, hvis irbesartan anvendes til patienter med nedsat nyrefunktion.
English: EU/1/09/576/038 50 x 1 tablet (unit dose) EU/1/09/576/039 56 x 1 tablet (unit dose) EU/1/09/576/042 28 tablets (calendar pack)
Danish: EU/1/09/576/038 50 x 1 tablet (enhedsblister) EU/1/09/576/039 56 x 1 tablet (enhedsblister) EU/1/09/576/042 28 tabletter (kalenderblister)
English: EU/1/09/576/012 50 x 1 tablet (unit dose) EU/1/09/576/013 56 x 1 tablet (unit dose) EU/1/09/576/040 28 tablets (calendar pack)
Danish: EU/1/09/576/012 50 x 1 tablet (enhedsblister) EU/1/09/576/013 56 x 1 tablet (enhedsblister) EU/1/09/576/040 28 tabletter (kalenderblister)
English: EU/1/09/576/025 50 x 1 tablet (unit dose) EU/1/09/576/026 56 x 1 tablet (unit dose) EU/1/09/576/041 28 tablets (calendar pack)
Danish: EU/1/09/576/025 50 x 1 tablet (enhedsblister) EU/1/09/576/026 56 x 1 tablet (enhedsblister) EU/1/09/576/041 28 tablets (kalenderblister)
English: What Irbesartan Teva is and what it is used for
Danish: Irbesartan Teva anvendes til voksne patienter
English: Irbesartan Teva prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower.
Danish: Irbesartan Teva forebygger at angiotensin-II binder sig til disse receptorer.
English: In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function if you are going to have an operation (surgery) or be given anaesthetics if you are taking any of the following medicines used to treat high blood pressure: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems - aliskiren
Danish: • hvis du samtidig tager et af følgende lægemidler til behandling af for højt blodtryk: en ACE-hæmmer (f.eks. enalapril, lisinopril, ramipril), især hvis du har nyrerproblemer i forbindelse med sukkersyge aliskiren
English: Hepatic impairment
Danish: Vertigo, hovedpine
English: Renal impairment and kidney transplantation
Danish: Hepatitis, abnorm leverfunktion
English: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Irbesartan Teva for diabetic kidney disease.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager Irbesartan Teva.
English: Adolescents and adults
Danish: Unge og voksne
English: In controlled clinical studies, signs and symptoms were actively monitored during a 42-day follow-up period.
Danish: I kontrollerede kliniske studier blev tegn og symptomer aktivt monitoreret i en opfølgningsperiode på 42 dage.
English: Because these adverse reactions were reported spontaneously, it is not possible to reliably estimate their frequency.
Danish: Da disse bivirkninger blev rapporteret spontant, er det ikke muligt at foretage et pålideligt estimat af deres hyppighed.
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 myndighederne i medlemslandene i samråd med referencelandet (RMS) opdatere produktinformationen som påkrævet.
English: Priorix contains sorbitol.
Danish: Priorix indeholder sorbitol
English: PRIORIX has not been evaluated in fertility studies.
Danish: PRIORIX er ikke blevet evalueret i fertilitetsstudier.
English: The vaccinees were also requested to report any clinical events during the study period.
Danish: De vaccinerede blev også bedt om at rapportere alle kliniske hændelser i forsøgsperioden.
English: Immediate measures depend on the severity of the reaction (see section 4.4).
Danish: De umiddelbare tiltag afhænger af reaktionens sværhedsgrad (se pkt.
English: • fever higher than 39.5°C
Danish: • feber over 39,5 °C
English: As this anergy may last up to a maximum of 6 weeks, tuberculin testing should not be performed within that period after vaccination to avoid false negative results.
Danish: Da denne anergi kan vare op til maksimalt 6 uger, bør der ikke laves tuberkulintest inden for denne periode efter vaccination for at undgå falsk negative resultater.
English: Although there are no data available concerning the protective efficacy of PRIORIX, immunogenicity is accepted as an indication of protective efficacy.
Danish: Selvom der ikke er tilgængelige data vedrørende PRIORIX' beskyttende effekt, anerkendes immunogenicitet som en indikation på beskyttelseseffekt.
English: Accidental intravascular administration may give rise to severe reactions or even shock.
Danish: Utilsigtet intravaskulær administration kan medføre alvorlige reaktioner eller shock.
English: * Encephalitis has been reported with a frequency below 1 per 10 million doses.
Danish: *Encefalitis er blevet indberettet med en hyppighed på under 1 pr. 10 millioner vaccinedoser.
English: Of these 147 subjects received PRIORIX and VARILRIX concomitantly.
Danish: Ud af disse fik 147 børn PRIORIX og Varilrix samtidigt.
English: Pregnancy must be avoided for one month after vaccination.
Danish: Graviditet skal undgås i 1 måned efter vaccination.
English: • abnormal crying
Danish: • unaturlig gråd
English: The exception to this was pain at the injection site which was “Common” after the first vaccine dose and “Very common” after the second vaccine dose.
Danish: En undtagelse var smerter på injektionsstedet, som var "almindelig" efter første vaccinedosis og "meget almindelig" efter anden vaccinedosis.
English: Dispose of in accordance with local regulations
Danish: Bortskaffes i henhold til lokale retningslinjer
English: Cases of overdose (up to 2 times the recommended dose) have been reported during post-marketing surveillance.
Danish: Der er indberettet tilfælde af overdosering (op til 2 gange den anbefalede dosis) efter markedsføring.
English: Your doctor will advise if additional doses of vaccine are needed.
Danish: Lægen vil vurdere, om det er nødvendigt med flere vaccinationer.
English: • fever of 38°C or higher
Danish: • feber på 38 °C eller højere.
English: PRIORIX is contraindicated during pregnancy (see section 4.3).
Danish: PRIORIX er kontraindiceret under graviditet (se pkt.
English: In case an epidemiological situation requires vaccinating infants in their first year of life (e.g. outbreak or travel to endemic regions), a second dose of PRIORIX should be given in the second year of life, preferably within three months after the first dose.
Danish: Hvis en epidemiologisk situation kræver vaccination af et barn i det første leveår (f.eks. udbrud eller rejse til epidemiske områder), skal der gives yderligere en dosis PRIORIX i det andet leveår, fortrinsvis inden for 3 måneder efter den første dosis.
English: EXP: After reconstitution, use promptly or within 8 hours if stored in a refrigerator
Danish: EXP: Anvendes straks efter rekonstitution eller inden for 8 timer ved opbevaring i køleskab
English: No adverse reactions have been associated to the overdose.
Danish: Ingen bivirkninger er associeret til overdoseringen.
English: Non-clinical data reveal no special hazard for humans based on general safety studies.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra generelle sikkerhedsstudier.
English: Kawasaki syndrome
Danish: Kawasakis syndrom
English: If you or your child is vaccinated within 72 hours after contact with someone with measles, Priorix will to some extent protect you against the disease.
Danish: Hvis du eller dit barn vaccineres inden for 72 timer efter kontakt med en person med mæslinger, vil Priorix i nogen grad beskytte dig eller dit barn mod sygdommen.
English: PRIORIX has no or negligible influence on the ability to drive and use machines.
Danish: PRIORIX påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj eller betjene maskiner.
English: Therefore a second dose of PRIORIX should be given within three months to provide optimal immune responses.
Danish: Der skal derfor gives yderligere en dosis PRIORIX inden for 3 måneder efter den første dosis for at opnå optimale immunrespons.
English: MMR-associated thrombocytopenia is rare and generally selflimited.
Danish: MFR-associeret trombocytopeni er sjælden og sædvanligvis selvbegrænsende.
English: The safety and immunogenicity of PRIORIX in adolescents and adults has not been specifically studied in clinical trials.
Danish: Sikkerheden ved og immunogeniciteten af PRIORIX hos unge og voksne er ikke specifikt undersøgt i kliniske studier.
English: The measles and mumps components of the vaccine are produced in chick embryo cell culture and may therefore contain traces of egg protein.
Danish: Mæslinge- og fåresyge-komponenterne i vaccinen er fremstillet i kyllingeembryo-vævskulturer og kan derfor indeholde spor af æggeprotein.
English: • transient, painful swelling of the testicles
Danish: • forbigående, smertefuld hævelse af testiklerne.
English: A second dose should be given according to official recommendations.
Danish: Der skal gives to doser i henhold til de officielle retningslinjer.
English: Children vaccinated in their first year of life may not be fully protected.
Danish: Børn, der vaccineres i deres første leveår, er ikke nødvendigvis fuldt beskyttede.
English: A clinical trial enrolled 300 healthy children 9 to 10 months of age at the time of first vaccine dose.
Danish: I et klinisk studie blev der inkluderet 300 raske børn i alderen 9-10 måneder på tidspunktet for den første vaccination.
English: You or your child should be closely monitored as the responses to the vaccines may not be sufficient to ensure a protection against the illness (see section 2).
Danish: Du eller dit barn skal følges nøje, da vaccinen muligvis ikke vil give tilstrækkelig beskyttelse mod sygdommene (se punkt 2).
English: Your doctor will advise you.
Danish: Lægen vil tage stilling til dette.
English: Read all of this leaflet carefully before you or your child receives this vaccine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn får denne vaccine, da den indeholder vigtige oplysninger.
English: If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, or 6 weeks after vaccination with Priorix.
Danish: Hvis der skal udføres en tuberkulintest, skal dette gøres enten før, samtidigt med eller 6 uger efter vaccination med Priorix.
English: Infants in their first year of life may not respond sufficiently to the components of the vaccines.
Danish: Spædbørn i deres første leveår responderer muligvis ikke tilstrækkeligt på vaccinernes komponenter.
English: A history of contact dermatitis to neomycin is not a contraindication.
Danish: Kontaktdermatitis over for neomycin i anamnesen er ikke kontraindikation.
English: The seroconversion rates to the three components were comparable to those seen after subcutaneous administration.
Danish: Serokonverteringsraterne for de tre komponenter var sammenlignelige med de serokonverteringsrater, der sås efter subkutan administration.
English: Pharmaco-therapeutic group: Viral vaccine, ATC code J07BD52
Danish: Farmakoterapeutisk klassifikation: Virale vacciner, ATC-kode: J07BD52.