FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 40 mg tablets
Danish: LÆGEMIDLETS NAVN Ipreziv 40 mg tabletter
English: Caution should be exercised in hypertensive patients with severe renal impairment, congestive heart failure or renal artery stenosis, as there is no experience of use of Ipreziv in these patients (see sections 4.2 and 5.2).
Danish: Der bør udvises forsigtighed hos hypertensive patienter med svært nedsat nyrefunktion, kongestivt hjertesvigt eller nyrearteriestenose, da der ikke er erfaring med brug af Ipreziv til disse patienter (se pkt.
English: White to nearly white round tablets, 9.6 mm in diameter, debossed “ASL” on one side and “80” on the other.
Danish: Hvide til næsten hvide, runde tabletter, 9,6 mm i diameter, præget med ”ASL” på den ene side og ”80” på den anden side.
English: Because no information is available regarding the use of Ipreziv during breastfeeding, Ipreziv is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.
Danish: Som alternativ anbefales behandlingsregimer med bedre etablerede sikkerhedsprofiler ved amning, specielt ved amning af nyfødte og præmature spædbørn.
English: Caution should be exercised in hypertensive patients with severe renal impairment and end stage renal disease as there is no experience of use of Ipreziv in these patients (see sections 4.4 and 5.2).
Danish: Der bør udvises forsigtighed hos hypertensive patienter med svært nedsat nyrefunktion og terminal nyresygdom, da der ikke er erfaring med brug af Ipreziv til disse patienter (se pkt.
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 20 mg tablets
Danish: LÆGEMIDLETS NAVN Ipreziv 20 mg tabletter
English: Cartons containing aluminum blisters packs integrated with desiccant.
Danish: Æsker med aluminiumblisterpakninger og tørremiddel.
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 40 mg tablets azilsartan medoxomil
Danish: LÆGEMIDLETS NAVN Ipreziv 40 mg tabletter Azilsartan medoxomil
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 80 mg tablets
Danish: LÆGEMIDLETS NAVN Ipreziv 80 mg tabletter
English: Ipreziv 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: Ipreziv kan skade dit barn alvorligt, hvis det anvendes i denne periode (se afsnittet om graviditet).
English: HOW TO STORE IPREZIV
Danish: SÅDAN SKAL DU TAGE IPREZIV
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 20 mg tablets azilsartan medoxomil
Danish: LÆGEMIDLETS NAVN Ipreziv 20 mg tabletter Azilsartan medoxomil
English: NAME OF THE MEDICINAL PRODUCT Ipreziv 80 mg tablets azilsartan medoxomil
Danish: LÆGEMIDLETS NAVN Ipreziv 80 mg tabletter Azilsartan medoxomil
English: - Heparin (a medicine for thinning the blood) - Diuretics (water tablets) - Aliskiren or other medicines to lower your blood pressure (angiotensin converting enzyme inhibitor or angiotensin II receptor blocker, such as enalapril, lisinopril, ramipril or valsartan,
Danish: Det er især vigtigt, at du fortæller det til din læge, hvis du tager et eller flere af følgende lægemidler: - Lithium (lægemiddel mod psykiske problemer) - Non-steroide anti-inflammatoriske lægemidler (NSAID), såsom ibuprofen, diclofenac eller celecoxib (smertestillende eller betændelseshæmmende lægemidler) - Aspirin (acetylsalicylsyre), hvis du tager mere end 3 g dagligt (smertestillende eller betændelseshæmmende lægemiddel) - Lægemidler, der øger mængden af kalium i dit blod; disse lægemidler omfatter kaliumtilskud, kaliumbesparende lægemidler (visse vanddrivende lægemidler) eller salterstatninger, som indeholder kalium - Heparin (blodfortyndende lægemiddel) - Diuretika (vanddrivende lægemidler) - Aliskiren eller andre blodtrykssænkende lægemidler (angiotensin-konverteringsenzymhæmmere eller angiotensin-II-receptor-blokkere, såsom enalapril, lisinopril, ramipril eller valsartan, telmisartan, irbesartan).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: When Ipreziv is taken with chlortalidone (a water tablet), higher levels of certain chemicals in the blood (such as creatinine), which are indicators of kidney function, have been seen commonly (in less than 1 in 10 users), and low blood pressure is also common.
Danish: Der er ofte (forekommer hos færre end 1 ud af 10 brugere) set forhøjet indhold af visse stoffer i blodet (såsom kreatinin), hvilket viser hvordan nyrerne fungerer, når Ipreziv tages sammen med chlortalidon (vanddrivende lægemiddel).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 20 mg of azilsartan medoxomil (as potassium).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 20 mg azilsartan medoxomil (som kalium).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg of azilsartan medoxomil (as potassium).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 80 mg azilsartan medoxomil (som kalium).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg azilsartan medoxomil (as potassium)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 40 mg azilsartan medoxomil (som kalium)
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg of azilsartan medoxomil (as potassium).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver tablet indeholder 40 mg azilsartan medoxomil (som kalium).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg azilsartan medoxomil (as potassium)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 80 mg azilsartan medoxomil (som kalium)
English: Hemoglobin and hematocrit
Danish: Forhøjet blodkreatininfosfokinase
English: Ipreziv is for oral use.
Danish: Ipreziv skal tages gennem munden.
English: No special requirements.
Danish: Ikke almindelig Sjælden
English: However, these antibodies do not seem to have an effect on the way the medicine works.
Danish: Disse antistoffer synes imidlertid ikke at påvirke den måde, lægemidlet virker på.
English: The main measure of effectiveness was the increase in height of patients after one year of treatment.
Danish: Behandlingens virkning blev hovedsagelig målt på patienternes højdevækst efter et års behandling.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Somatropin Biopartners on 05.08.2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Somatropin Biopartners den 05.08.2013.
English: The full EPAR for Somatropin Biopartners can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Somatropin Biopartners findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used to treat children aged 2 to 18 years who are failing to grow normally because they do not have enough growth hormone.
Danish: Det anvendes til behandling af børn mellem 2 og 18 år, der ikke vokser normalt, fordi de ikke har nok væksthormon.
English: The dose may need to be adjusted, depending on the patient's response to treatment and the side effects the patient experiences.
Danish: Det kan være nødvendigt at tilpasse dosis efter patientens reaktion på behandlingen og de bivirkninger, patienten kommer ud for.
English: This is a summary of the European public assessment report (EPAR) for Somatropin Biopartners.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Somatropin Biopartners.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Somatropin Biopartners' 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) besluttede, at fordelene ved Somatropin Biopartners opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Somatropin Biopartners is injected under the skin once a week.
Danish: Somatropin Biopartners injiceres under huden én gang om ugen.
English: In addition, the company that markets Somatropin Biopartners will provide further long-term data on the effectiveness and safety of the medicine.
Danish: Desuden skal den virksomhed, der markedsfører Somatropin Biopartners, forelægge yderligere oplysninger om effektiviteten og sikkerheden af lægemidlet på lang sigt.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce it. Somatropin Biopartners replaces the natural hormone.
Danish: Det fremstilles ved "rekombinant DNA-teknologi": Hormonet produceres ved dyrkning af gærceller, der har fået indsat et gen (DNA), som gør dem i stand til at producere det. Somatropin Biopartners erstatter det naturlige hormon.
English: A risk management plan has been developed to ensure that Somatropin Biopartners is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Somatropin Biopartners anvendes så sikkert som muligt.
English: In children, the recommended dose is 0.5 mg per kilogram body weight, injected once a week.
Danish: Til børn er den anbefalede dosis 0,5 mg pr. kg legemsvægt én gang ugentligt.
English: In adults, the most common side effects (which may affect more than 1 in 10 people) are swelling, mild hyperglycaemia (high blood sugar levels) and headache.
Danish: Hos voksne er de hyppigste bivirkninger (som kan forekomme hos flere end 1 ud af 10 behandlede) hævelse, let hyperglykæmi (forhøjet blodsukker) og hovedpine.
English: In adults, the recommended dose is 2 mg injected once a week, except for female patients also taking oral oestrogen who should receive 3 mg once a week.
Danish: Til voksne er den anbefalede dosis 2 mg, der injiceres én gang om ugen, dog skal kvindelige patienter, som også får oralt østrogen, have 3 mg én gang ugentligt.
English: The active substance in Somatropin Biopartners, somatropin, is identical to the human growth hormone.
Danish: Det aktive stof i Somatropin Biopartners, somatropin, er identisk med det menneskelige væksthormon.
English: Somatropin Biopartners must not be used in patients with an active tumour or an acute lifethreatening illness.
Danish: Somatropin Biopartners må ikke anvendes hos patienter med en aktiv svulst eller en akut livstruende sygdom.
English: The study showed that Somatropin Biopartners was as effective as Genotropin at promoting growth: children receiving Somatropin Biopartners grew around 11.7 cm in one year, compared with 12.0 cm in children receiving Genotropin.
Danish: Undersøgelsen viste, at Somatropin Biopartners var lige så effektivt som Genotropin til at fremme væksten: Børn, der fik Somatropin Biopartners, voksede ca. 11,7 cm på et år, sammenholdt med 12,0 cm hos dem, der fik Genotropin.
English: The patient or caregiver can inject Somatropin Biopartners themselves, after training by a doctor or a nurse.
Danish: Patienten eller dennes omsorgsgiver kan selv injicere Somatropin Biopartners efter at have fået instruktion af en læge eller en sygeplejerske.
English: Somatropin Biopartners is a medicine that contains human growth hormone (also known as somatropin).
Danish: Somatropin Biopartners er et lægemiddel, der indeholder humant væksthormon (også kaldet somatropin).
English: It is also used in adults with a lack of growth hormone who may have either had growth hormone deficiency as children or developed it later during adulthood.
Danish: Det anvendes desuden hos voksne, der mangler væksthormon, enten fordi de har lidt under væksthormonmangel som børn eller har udviklet mangel på hormonet i voksenalderen.
English: Treatment with Somatropin Biopartners should be started and monitored by a doctor experienced in diagnosing and treating patients with growth hormone deficiency.
Danish: Behandling med Somatropin Biopartners bør indledes og overvåges af en læge med erfaring i diagnosticering og behandling af patienter med væksthormonmangel.
English: It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Danish: Væksthormon fremmer væksten hos børn og unge og har desuden betydning for stofskiftet af proteiner, fedtstoffer og kulhydrater.
English: Adults treated with Somatropin Biopartners had an average reduction of body fat of 1 kg while body fat in those treated with placebo increased by 0.5 kg.
Danish: Voksne, der blev behandlet med Somatropin Biopartners, fik i gennemsnit mindsket kroppens fedtindhold med 1 kg, mens fedtindholdet i kroppen steg med 0,5 kg hos dem, der blev behandlet med placebo.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Somatropin Biopartners, 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 Somatropin Biopartners, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: This study compared Somatropin Biopartners with placebo (a dummy treatment) and measured the decrease in body fat (which is normally high in adults with growth hormone deficiency) after 6 months of treatment.
Danish: I undersøgelsen blev Somatropin Biopartners sammenlignet med placebo (en virkningsløs behandling), og der blev foretaget måling af mindskelsen i kroppens fedtindhold (som normalt er højt hos voksne med væksthormonmangel) efter seks måneders behandling.
English: In children, the most common side effects with Somatropin Biopartners (which may affect more than 1 in 10 people) are injection site swelling and development of antibodies (proteins that are produced in response to Somatropin Biopartners).
Danish: Hos børn er de mest almindelige bivirkninger ved Somatropin Biopartners (som kan forekomme hos flere end 1 ud af 10 behandlede) hævelse på injektionsstedet og dannelse af antistoffer (proteiner, der produceres som reaktion på Somatropin Biopartners).
English: In adults who lack growth hormone, Somatropin Biopartners has a modest effect in decreasing body fat.
Danish: Hos voksne med væksthormonmangel har Somatropin Biopartners en moderat nedsættende virkning på kroppens fedtindhold.
English: For more information about treatment with Somatropin Biopartners, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Somatropin Biopartners, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Somatropin Biopartners?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Somatropin Biopartners?
English: Other information about Somatropin Biopartners
Danish: Andre oplysninger om Somatropin Biopartners
English: Somatropin Biopartners is available as a powder and solvent which are made into a suspension for injection.
Danish: Somatropin Biopartners fås som et pulver og et solvens (en opløsningsvæske), der bruges til at fremstille en suspension (opslæmning), som gives som indsprøjtning.
English: What is Somatropin Biopartners and what is it used for?
Danish: Hvad er Somatropin Biopartners, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Somatropin Biopartners.
Danish: Det er ikke en praktisk vejledning i, hvordan Somatropin Biopartners bør anvendes.
English: The Committee concluded that Somatropin Biopartners is as effective in children who fail to grow normally as other somatropin-containing treatments given daily.
Danish: Udvalget konkluderede, at hos børn, der ikke vokser normalt, er Somatropin Biopartners lige så effektivt som andre lægemidler indeholdende somatropin, der gives dagligt.
English: The study compared Somatropin Biopartners given once a week with another somatropin-containing medicine called Genotropin given once a day.
Danish: I undersøgelsen blev Somatropin Biopartners, der blev indgivet én gang om ugen, sammenlignet med et andet somatropinholdigt lægemiddel, Genotropin, som blev indgivet én gang om dagen.
English: Somatropin Biopartners has been studied in one main study involving 180 children with a lack of growth hormone.
Danish: Somatropin Biopartners er blevet undersøgt i én hovedundersøgelse, der omfattede 180 børn med væksthormonmangel.
English: Somatropin Biopartners has also been studied in one main study involving 151 adults with growth hormone deficiency.
Danish: Somatropin Biopartners blev desuden undersøgt i én hovedundersøgelse hos 151 voksne med væksthormonmangel.
English: For the full list of all side effects reported with Somatropin Biopartners, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Somatropin Biopartners fremgår af indlægssedlen.
English: Growth hormone is a substance secreted by the pituitary gland (a gland located at the base of the brain).
Danish: Væksthormon er et stof, der udskilles af hypofysen (en kirtel, der ligger nederst i hjernen).
English: Regarding its safety, the side effects reported with Somatropin Biopartners were similar to those of other daily somatropin medicines, with the exception of increased injection site reactions in children, which should be balanced against the convenience of weekly injections.
Danish: Vedrørende sikkerheden svarede de indberettede bivirkninger med Somatropin Biopartners til bivirkningerne af lægemidler, der indeholder somatropin og gives dagligt, bortset fra mere udtalte reaktioner på injektionsstedet hos børn, hvilket modsvares af fordelen ved kun at skulle have injektionerne én gang om ugen.
English: For practical information about using Somatropin Biopartners, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Somatropin Biopartners, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What are the risks associated with Somatropin Biopartners?
Danish: Hvilke risici er der forbundet med Somatropin Biopartners?
English: Why is Somatropin Biopartners approved?
Danish: Hvorfor er Somatropin Biopartners blevet godkendt?
English: How is Somatropin Biopartners used?
Danish: Hvordan anvendes Somatropin Biopartners?
English: What benefits of Somatropin Biopartners have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Somatropin Biopartners?
English: How does Somatropin Biopartners work?
Danish: Hvordan virker Somatropin Biopartners?
English: Wash your hands before and after applying the ointment.
Danish: Vask dine hænder før og efter påføring af salven.
English: * Activity has been satisfactorily demonstrated in clinical studies
Danish: * Aktivitet er tilstrækkelig demonstreret i kliniske studier.
English: This might lead to side effects.
Danish: Dette kan give bivirkninger.
English: Patients aged from 2 months to 24 months
Danish: Patienter i alderen 2 måneder til 24 måneder
English: 95% Exact CI
Danish: 95 % CI
English: Confidence interval was not adjusted for multiplicity.
Danish: Konfidensintervallet blev ikke justeret for multiplicitet.
English: Safety and efficacy have not been established in the following:
Danish: Sikkerhed og effekt er ikke klarlagt ved:
English: Neither of these findings is of clinical relevance.
Danish: Ingen af disse fund er kliniske relevante.
English: Consideration should be given to official guidance on the appropriate use of antibacterial medicinal
Danish: Der bør tages hensyn til officielle guidelines om hensigtsmæssig anvendelse af antibakterielle
English: If you stop using Altargo too soon, the bacteria may start to grow again and your infection may come back.
Danish: Hvis du holder op med at bruge Altargo for tidligt, kan bakterierne begynde at vokse igen og infektionen kan komme tilbage.
English: Application site irritation (including burning sensation)
Danish: Irritation på applikationsstedet (herunder brændende fornemmelse)
English: In patients aged less than 18 years the total surface area treated should be no more than 2% of the body surface area.
Danish: Hos patienter under 18 år må det behandlede områdes totale overfladeareal ikke overskride 2 % af legemsoverfladen.
English: It must not be put in the eyes, on the mouth or lips, inside the nose or inside the female genital area.
Danish: Det må ikke komme i kontakt med øjne, munden eller læberne, indersiden af næsen eller indersiden af det kvindelige kønsorgan.
English: Retapamulin is approximately 94% bound to human plasma proteins.
Danish: Retapamulin er ca. 94 % bundet til humane plasmaproteiner.
English: No dosage adjustment is necessary.
Danish: Dosisjustering ikke nødvendigt.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem
English: Hypersensitivity, including angioedema
Danish: Overfølsomhed, herunder angioødem
English: Not all pack sizes may be marketed in your country.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Date of first authorisation: 24 May 2007 Date of latest renewal: 20 April 2012
Danish: Dato for seneste fornyelse: 20. april 2012
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the
Danish: Hvis tidsfristen for en PSUR og for opdatering af en RMP er sammenfaldende, kan de
English: CI: confidence interval.
Danish: CI: konfidensinterval.
English: However, due to the low systemic plasma levels that have been observed, no safety problems are foreseen.
Danish: På grund af de lave systemiske plasmaniveauer forventes der ikke sikkerhedsproblemer.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: • Infected small lacerations, abrasions, or sutured wounds.
Danish: • Inficerede mindre rifter, hudafskrabninger eller suturerede sår.
English: Patients not showing a clinical response within two to three days should be re-evaluated and alternative therapy should be considered (see section 4.4).
Danish: Patienter, som ikke udviser et klinisk respons, indenfor 2 til 3 dage, bør reevalueres, og alternativ behandling bør overvejes (se pkt.
English: See also section 4 of this leaflet.
Danish: Se også punkt 4 i denne indlægsseddel.
English: Discard open tubes 7 days after opening, even if they are not empty.
Danish: oC. Smid tuben væk efter 7 dages åbning også selvom tuben ikke er tom.
English: It is possible that using Altargo in children who are taking certain medicines (such as some medicines used to treat fungal infections) could result in blood concentrations of Altargo that are higher than usual.
Danish: Det er muligt, at brug af Altargo til børn, der får visse typer af medicin (såsom visse lægemidler, som anvendes til behandling af svampeinfektioner), kan medføre koncentrationer af Altargo i blodet, der er højere end normalt.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apoteket til råds, før du bruger dette lægemiddel.