FrancophonIA/ELRC3.0 huggingface dataset:
English: • Patients who are taking a medicine containing sibutramine to help them to lose weight should make an appointment with their doctor at the next convenient time to discuss alternative measures to lose weight.
Danish: • Patienter, som tager et lægemiddel, der indeholder sibutramin, for at opnå vægttab, bør konsultere deres læge ved førstkommende lejlighed for at drøfte alternative foranstaltninger til at opnå vægttab.
English: The European Medicines Agency has completed a review of the safety and effectiveness of sibutramine.
Danish: Det Europæiske Lægemiddelagentur (EMA) har foretaget en vurdering af sikkerhed og virkning for sibutramin.
English: Most of the patients in the SCOUT study would not normally be given sibutramine, as the medicine is contra-indicated in patients with cardiovascular disease.
Danish: Størstedelen af patienterne i SCOUT-undersøgelsen ville normalt ikke få ordineret sibutramin, da dette lægemiddel er kontraindiceret hos patienter med kardiovaskulære lidelser.
English: Although the full data from the SCOUT study have not yet been analysed, the study's Data Safety Monitoring Board (a body of independent experts appointed to review regularly the outcome of the clinical trial) informed the Agency in October 2009 of preliminary data indicating that sibutramine is associated with more cardiovascular problems than placebo.
Danish: Selvom hele datamængden fra SCOUT-undersøgelsen endnu ikke er analyseret, underrettede undersøgelsens udvalg til overvågning af datasikkerhed (et organ sammensat af uafhængige eksperter, som løbende skal vurdere resultaterne af den kliniske undersøgelse) i oktober 2009 EMA om, at de foreløbige data indikerede, at sibutramin er forbundet med et større antal kardiovaskulære problemer end placebo.
English: Finally, looking at all of the studies of sibutramine in the management of obesity, the CHMP noted that the weight loss achieved with sibutramine treatment is modest in comparison with that obtained with placebo, with patients losing on average two to four kilograms more than with placebo.
Danish: Afslutningsvis bemærkede CHMP på baggrund af alle undersøgelserne af sibutramin til behandling af fedme, at det vægttab, der blev opnået ved behandling med sibutramin, er beskedent set i forhold til det vægttab, der blev opnået ved behandling med placebo, da patienterne i gennemsnit tabte to til fire kilo mere end ved behandling med placebo.
English: Sibutramine-containing medicines are used in the management of obesity.
Danish: Lægemidler indeholdende sibutramin anvendes til behandling af fedme.
English: However, the Committee also asked the company that makes Reductil, Abbott Laboratories, to start a study of sibutramine in patients with cardiovascular risk factors, looking particularly at the medicine's safety.
Danish: Udvalget bad dog også den virksomhed, der producerer Reductil, Abbott Laboratories, om at påbegynde en undersøgelse af sibutramin hos patienter med kardiovaskulære risikofaktorer med særligt fokus på lægemidlets sikkerhed.
English: They requested that the CHMP assess the impact of the new data on the benefit-risk balance of sibutramine to prepare an opinion on whether the marketing authorisations for products containing sibutramine should be maintained, changed, suspended or withdrawn across the EU.
Danish: Denne myndighed bad CHMP om at vurdere indvirkningen af de nye data på risk-benefit-forholdet for sibutramin med henblik på at udarbejde en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende sibutramin burde opretholdes, ændres, suspenderes eller tilbagekaldes i hele EU.
English: The CHMP noted that the SCOUT study showed an increased risk of serious cardiovascular events (such as heart attack or stroke) in patients with known cardiovascular disease taking sibutramine.
Danish: CHMP bemærkede, at SCOUT-undersøgelsen påviste en forhøjet risiko for alvorlige kardiovaskulære hændelser (såsom hjerteanfald eller slagtilfælde) hos patienter med kendte kardiovaskulære lidelser, når disse tog sibutramin.
English: The Committee also looked at other studies on the effectiveness of sibutramine for weight loss.
Danish: Udvalget så også på andre undersøgelser af virkningen af sibutramin for vægttab.
English: • Doctors should stop prescribing sibutramine-containing medicines to obese or overweight patients.
Danish: • Læger bør ophøre med at ordinere lægemidler indeholdende sibutramin til adipøse eller overvægtige patienter.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of sibutramine do not outweigh its risks, and that all marketing authorisations for medicines containing sibutramine should be suspended throughout Europe.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) har konkluderet, at fordelene ved sibutramin ikke opvejer risiciene, og at alle markedsføringstilladelser for lægemidler indeholdende sibutramin suspenderes i hele Europa.
English: As a result, in 2002, the company started the SCOUT study (Sibutramine Cardiovascular Outcome Trial) to determine the impact of weight loss with sibutramine on cardiovascular problems in a large group of overweight and obese patients at high risk for cardiovascular disease.
Danish: Som følge heraf påbegyndte virksomheden i 2002 undersøgelsen SCOUT (Sibutramine Cardiovascular Outcome Trial) for at fastlægge virkningen af vægttab med sibutramin på kardiovaskulære problemer i en stor gruppe af overvægtige og adipøse patienter med høj risiko for kardiovaskulære lidelser.
English: • Pharmacist should no longer dispense sibutramine-containing medicines.
Danish: • Apoteker bør ophøre med at udlevere lægemidler indeholdende sibutramin.
English: Nevertheless the Committed considered that an increased risk can also apply to patients for whom sibutramine can be prescribed because obese and overweight patients are likely to be at risk of cardiovascular disease.
Danish: Udvalget fandt imidlertid, at der også kan gælde en øget risiko for patienter, til hvem sibutramin kan ordineres, da adipøse og overvægtige patienter har større risiko for at blive ramt af kardiovaskulære lidelser.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of sibutramine-containing medicines do not outweigh their risks, and therefore recommended that the marketing authorisations for sibutramine-containing medicines be suspended across the EU.
Danish: På grundlag af en vurdering af de aktuelt tilgængelige data og de videnskabelige drøftelser i udvalget konkluderede CHMP, at fordelene ved lægemidler indeholdende sibutramin ikke opvejer risiciene.
English: The study compared sibutramine with placebo (a dummy treatment), and looked not only at how much weight the patients were losing, but also at the occurrence of cardiovascular events, such as heart attack, stroke and cardiac arrest.
Danish: Det blev ikke alene undersøgt, hvor meget patienterne tabte sig, men også hvor mange af patienterne der oplevede kardiovaskulære hændelser, såsom hjerteanfald, slagtilfælde og hjertestop.
English: At that time, the CHMP concluded that the benefits of sibutramine for the management of obese and
Danish: CHMP konkluderede på daværende tidspunkt, at fordelene ved sibutramin til behandling af fedme og overvægt opvejede risiciene herved.
English: It is used in adults for the following:
Danish: Det anvendes hos voksne til at:
English: This is a summary of the European public assessment report (EPAR) for Inhixa.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Inhixa.
English: The dose and how long the medicine is given for, as well as whether it is given with other medicines, depend on the condition to be prevented or treated.
Danish: Dosen og behandlingsvarigheden, samt om det skal gives samtidigt med andre lægemidler, afhænger af den lidelse, der skal forebygges eller behandles.
English: This means that Inhixa is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Inhixa svarer til et biologisk lægemiddel (også kaldet "referencelægemidlet"), der allerede er godkendt i Den Europæiske Union (EU).
English: Other information about Inhixa
Danish: Andre oplysninger om Inhixa
English: Doses must be adjusted in patients with severely reduced kidney function.
Danish: Dosen skal tilpasses hos patienter med svært nedsat nyrefunktion.
English: This helps to stop the formation of new blood clots and control existing ones.
Danish: Dette medvirker til at stoppe dannelsen af nye blodpropper og kontrollere eksisterende blodpropper.
English: The Committee recommended that Inhixa be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Inhixa.
English: What measures are being taken to ensure the safe and effective use of Inhixa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Inhixa?
English: • to treat certain types of myocardial infarction (heart attack);
Danish: • behandle visse typer af hjerteanfald (myokardieinfarkt)
English: The company also provided information from published studies showing the benefits of enoxaparin in preventing and treating blood clots.
Danish: Virksomheden har også fremlagt oplysninger fra offentliggjorte undersøgelser, der påviser fordelene ved enoxaparin til forebyggelse og behandling af blodpropper.
English: What is Inhixa and what is it used for?
Danish: Hvad er Inhixa, og hvad anvendes det til?
English: In addition, increased levels of liver enzymes in the blood (a sign of possible liver problems) are very common (may affect more than 1 in 10 people).
Danish: Desuden er forhøjede niveauer af leverenzymer i blodet (et tegn på mulige leverproblemer) en meget almindelig bivirkning (kan forekomme hos mere end 1 ud af 10 personer).
English: When blood clots develop inside blood vessels they may restrict the blood flow to the organs, including the heart.
Danish: Når der opstår blodpropper inde i blodårerne, kan de blokere for blodtilstrømningen til organerne, herunder hjertet.
English: • to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.
Danish: • forebygge, at der dannes blodpropper, når blodet løber gennem en dialysemaskine for at få fjernet giftige stoffer.
English: Why is Inhixa approved?
Danish: Hvorfor blev Inhixa godkendt?
English: It is not intended to provide practical advice on how to use Inhixa.
Danish: Det er ikke en praktisk vejledning i, hvordan Inhixa bør anvendes.
English: Enoxaparin increases the effect of antithrombin III, a natural substance that controls the blood's clotting factors and helps prevent blood from clotting inside the body.
Danish: Enoxaparin øger virkningen af antitrombin III, der er et naturligt stof, som kontrollerer blodstørkningsfaktorerne og medvirker til at forhindre blodet inde i kroppen i at størkne.
English: In addition, a study in 20 healthy subjects has shown the same doses of the two products given by injection under the skin produced similar effects on blood clotting factors, using various measures that reflect the way the medicine works in the body.
Danish: Derudover har en undersøgelse af 20 raske forsøgspersoner vist, at de samme doser af de to lægemidler givet som indsprøjtning under huden har samme effekt på blodstørkningsfaktorerne, ud fra forskellige værdier, der afspejler, hvordan lægemidlet virker i kroppen.
English: In the treatment of unstable angina and heart attack Inhixa is given with aspirin (acetylsalicylic acid).
Danish: Ved behandling af ustabil angina pectoris og hjerteanfald gives Inhixa sammen med aspirin (acetylsalicylsyre).
English: The most common side effect with Inhixa (which may affect more than 1 in 10 people) is haemorrhage (bleeding); serious bleeding occurred in around 4 people in 100 given Inhixa to prevent blood clots during surgery.
Danish: Den hyppigste bivirkning ved Inhixa (som kan forekomme hos mere end 1 ud af 10 personer) er blødning; alvorlig blødning er set hos ca. 4 ud af 100 personer, der har fået Inhixa til forebyggelse af blodpropper under operation.
English: Inhixa is a ‘biosimilar medicine'.
Danish: Inhixa er et "biosimilært" lægemiddel.
English: Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) considered that there are no clinically meaningful differences between Inhixa and Clexane in terms of effectiveness and safety and took the view that, as for Clexane, the benefit outweighs the identified risk.
Danish: Agenturets Udvalg for Lægemidler til mennesker (CHMP) konkluderede, at der ikke er nogen klinisk betydningsfuld forskel mellem Inhixa og Clexane, hvad angår virkning og sikkerhed, og at fordelene opvejer de identificerede risici som for Clexane.
English: What are the risks associated with Inhixa?
Danish: Hvilke risici er der forbundet med Inhixa?
English: Extensive laboratory studies comparing Inhixa with Clexane have shown that Inhixa is highly similar to Clexane in terms of structure, purity and biological activity.
Danish: Omfattende laboratorieundersøgelser, der sammenlignede Inhixa med Clexane, har vist, at Inhixa minder meget om Clexane, hvad angår struktur, renhed og biologisk aktivitet.
English: The reference medicine for Inhixa is Clexane.
Danish: Referencelægemidlet for Inhixa er Clexane.
English: Inhixa must not be used in patients with existing major bleeding, severe disorders of blood clotting, or with conditions that increase the risk of, or from, bleeding, such as stomach ulcers or stroke.
Danish: Inhixa må ikke gives til patienter med eksisterende større blødning, alvorlige problemer med blodpropdannelse eller lidelser, der øger risikoen for blødning eller problemer i forbindelse hermed, f.eks. mavesår eller slagtilfælde.
English: For practical information about using Inhixa, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Inhixa, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: The active substance in Inhixa, enoxaparin, is one of a group of anticoagulant medicines called ‘low-molecular weight heparins'.
Danish: Det aktive stof i Inhixa, enoxaparin, tilhører gruppen af antikoagulerende (blodfortyndende) midler, der kaldes "lavmolekylære hepariner".
English: It is usually given as an injection under the skin although in the treatment of a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI) it is first given as an injection into a vein, and to prevent clots in haemodialysis machines it is injected directly into the tube carrying the blood.
Danish: Det gives typisk som en indsprøjtning under huden, men ved behandling af en type hjertetilfælde, der kaldes akut ST-elevationsmyokardieinfarkt (STEMI), gives det som en indsprøjtning i en blodåre, og ved forebyggelse af blodpropper i forbindelse med hæmodialyse (blodrensning) indsprøjtes det direkte i den slange, der fører blodet gennem dialysemaskinen.
English: The active substance in Inhixa is enoxaparin sodium.
Danish: Det aktive stof i Inhixa er enoxaparinnatrium.
English: Inhixa is an anticoagulant medicine (a medicine to prevent blood clots).
Danish: Inhixa er et antikoagulerende (blodfortyndende) lægemiddel til forebyggelse af blodpropper.
English: The safety profiles of the two medicines were also considered similar, based on laboratory testing.
Danish: Ud fra laboratorieundersøgelser anses de to lægemidler også for at have samme sikkerhedsprofil.
English: Enoxaparin sodium
Danish: Enoxaparinnatrium
English: • to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg);
Danish: • behandle lidelser, der er forbundet med blodpropper, f.eks. dyb venetrombose (hvor blodproppen opstår i en dyb blodåre, typisk i benet)
English: • to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they are bedridden due to illness;
Danish: • forebygge blodpropper, der opstår inde i blodårerne, og som forhindrer blodet i at flyde frit (venøs tromboembolisme), navnlig hos patienter, der skal opereres, eller som har en større risiko for blodpropper, fordi de er sengeliggende på grund af sygdom
English: Studies have shown that Inhixa has a highly similar structure and biological activity to Clexane and has the same effect on blood clotting factors.
Danish: Undersøgelser har vist, at Inhixas struktur og biologiske aktivitet minder meget om Clexanes, og at de to lægemidler har samme effekt på blodstørkningsfaktorerne.
English: How is Inhixa used?
Danish: Hvordan anvendes Inhixa?
English: For the full list of all side effects reported with Inhixa, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Inhixa fremgår af indlægssedlen.
English: The full EPAR for Inhixa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Inhixa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Hvis du ønsker yderligere oplysninger om behandling med Inhixa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Inhixa have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Inhixa.
English: What benefits of Inhixa have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Inhixa?
English: Inhixa is available as a solution for injection in pre-filled syringes.
Danish: Inhixa fås som injektionsvæske i fyldte sprøjter.
English: • to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
Danish: • behandle en alvorlig type brystsmerte, der skyldes problemer med blodtilstrømningen til hjertet
English: How does Inhixa work?
Danish: Hvordan virker Inhixa?
English: Do not pass it on to others.
Danish: Giv den ikke til andre.
English: • you are pregnant or wish to become pregnant
Danish: • du er gravid eller ønsker at blive gravid
English: From a microbiological point of view, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal produktet anvendes umiddelbart.
English: • This medicine has been prescribed for you.
Danish: • Denne medicin er udskrevet til dig.
English: References (not all submitted are listed)
Danish: Referencer (listen indeholder ikke alle de forelagte)
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen henviser til sidste dag i den angivne måned.
English: It may harm them, even if their symptoms are the same as yours.
Danish: Det kan skade dem, selv om de har de samme symptomer, som du.
English: Twelve hours after i.v.
Danish: 12 timer efter i.v.
English: It is advisable never to use several medicines at the same time without consulting your doctor first.
Danish: Det er fornuftigt aldrig at anvende flere lægemidler samtidig uden først at spørge lægen til råds.
English: • children aged below 5 years
Danish: • til børn under 5 år
English: Anaerobes are generally less sensitive.
Danish: Anaerober er normalt mindre følsomme.
English: The following information is intended for medical or healthcare professionals only:
Danish: Følgende oplysninger er kun tiltænkt læger og sundhedspersonale:
English: 18 months
Danish: 18 måneder.
English: The enzyme DNA-gyrase plays a crucial role in this process.
Danish: Enzymet DNA-gyrase spiller en afgørende rolle i denne proces.
English: If a prolonged treatment is necessary, a reassessment of treatment should be done at 2 months at the latest.
Danish: Er der behov for forlænget behandling skal der foretages en revurdering af behandling senest efter 2 måneder.
English: Use during pregnancy is contraindicated.
Danish: Anvendelsen under graviditet er kontraindiceret.
English: Not all pack sizes may be marketed.
Danish: Ikke alle pakningsstørrelser behøver at være markedsførte
English: The treatment should be continued for at least three days after the signs of the infection have disappeared.
Danish: Behandlingen bør vare i mindst tre dage efter at symptomerne på infektionen er forsvundet.
English: This condition is life-threatening and may have a fatal outcome.
Danish: Denne situation er livstruende og kan få en dødelig udgang.
English: • If you have any further questions, ask your doctor or pharmacist.
Danish: • Har du yderligere spørgsmål, så spørg din læge eller apoteket.
English: During the referral procedure the Applicant/Marketing Authorisation Holder was requested to submit:
Danish: Under indbringelsesproceduren blev ansøgeren/indehaveren af markedsføringstilladelsen anmodet om at fremlægge:
English: I-37063 Isola della Scala (VR), Italy
Danish: I-37063 Isola della Scala (VR), Italien
English: This medicinal product is authorised in the Member States of the EEA under following names:
Danish: Dette lægemiddel er godkendt i EU medlemdslandende under følgende navne:
English: The above-mentioned substances are converted by a specific enzyme (CYP1A2).
Danish: Ovennævnte lægemiddelstoffer omdannes ved hjælp af et specifikt enzym (CYP1A2).
English: During or after treatment - if one of the following conditions occurs:
Danish: Under eller efter behandling- hvis nogen af følgende tilstande opstår:
English: This may cause epileptic seizures.
Danish: Dette kan forårsage epileptiske anfald.
English: These recommendations are also in line with current treatment guidelines, with clinical practice in most European countries and with the recommendations of previously approved European original and generic ciprofloxacin products.
Danish: Disse anbefalinger er ligeledes i overensstemmelse med de gældende retningslinjer for behandling, med den kliniske praksis i de fleste europæiske lande og med anbefalingerne for tidligere godkendte europæiske oprindelige og generiske ciprofloxacin-produkter.
English: If these reactions recur or exacerbate during a following infusion no further infusions should be administered.
Danish: Hvis reaktionerne vender tilbage eller forværres under en efterfølgende infusion bør der ikke indgives yderligere infusion.
English: Dosage as follows:
Danish: Dosering som følger:
English: Depression or psychoses lead to self-endangering behaviour in some cases.
Danish: Depression eller psykose kan i nogle tilfælde føre til selvdestruktiv adfærd.
English: Sequential therapy can also be used.
Danish: Sekvensterapi kan ligeledes anvendes.
English: This may increase the risk of methotrexate associated toxic reactions.
Danish: Dette kan føre til øget risiko for methotrexatrelaterede toksiske reaktioner.
English: Very rare: psychotic reactions.
Danish: Meget sjælden: Psykotiske reaktioner.
English: In this case you should immediately consult your doctor.
Danish: I dette tilfælde bør du kontakte din læge med det samme.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs denne indlægsseddel omhyggeligt før du begynder at bruge medicinen.
English: POSSIBLE SIDE EFFECTS
Danish: HVILKE MULIGE BIVIRKNINGER
English: Physicians are recommended to follow current national and/or international consensus documents regarding the treatment of anthrax.
Danish: Lægerne anbefales at følge nationale og/eller internationale konsensusdokumenter for så vidt angår behandling af antrax.
English: The recommended duration of treatment is 10 - 14 days.
Danish: Anbefalet behandlingsvarighed er 10-14 dage.
English: Furthermore, you should drink a sufficient amount of liquid (about 1.5 - 2 litres daily).
Danish: Du bør endvidere drikke rigeligt (ca. 1,52 l pr. dag).
English: Mechanism of resistance:
Danish: Mekanisme for resistens: