FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Invanz's 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) konkluderede, at fordelene ved Invanz opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What is Invanz and what is it used for?
Danish: Hvad er Invanz, og hvad anvendes det til?
English: Treatment with Invanz lasts between 3 and 14 days, depending on the type and the severity of the infection.
Danish: Behandlingen varer mellem 3-14 dage, afhængig af infektionens type og sværhedsgrad.
English: Why is Invanz approved?
Danish: Hvorfor blev Invanz godkendt?
English: The studies examined if the infection was cured after 7 to 28 days of treatment, depending on the type of infection.
Danish: Undersøgelserne så nærmere på, om infektionen blev helbredt efter 7 til 28 dages behandling, afhængig af typen af infektion.
English: For preventing infection after colorectal surgery in adults, a single dose of Invanz is given within 1 hour before the operation.
Danish: For at forebygge infektion efter kolorektal kirurgi hos voksne gives en enkelt dosis af Invanz en time før operationen.
English: Once the infection has improved, treatment can be switched to an antibiotic that can be given by mouth.
Danish: Når infektionen er i bedring, kan der skiftes til en antibiotikabehandling, der indtages via munden.
English: Infection was absent in about 60% patients given Invanz compared with 49% of patients given cefotetan.
Danish: Der var ingen infektion hos ca. 60 % af patienterne, der fik Invanz, sammenlignet med 49% af de patienter, der fik cefotetan.
English: Prevention of infections after colorectal surgery
Danish: Forebyggelse af infektioner efter kolorektal kirurgi
English: Effectiveness was measured as absence of infection 4 weeks after treatment, which involved 952 adults.
Danish: Virkningen blev bedømt ved at se på, om der ingen infektion var 4 uger efter behandlingen, som omfattede 952 voksne.
English: It is not intended to provide practical advice on how to use Invanz.
Danish: Det er ikke en praktisk vejledning i, hvordan Invanz bør anvendes.
English: Before using Invanz, doctors should consider official guidance on the appropriate use of antibiotics.
Danish: Ved ordination af Invanz bør lægen tage hensyn til de officielle retningslinjer for forsvarlig brug af antibiotika.
English: Invanz is used when the bacteria that cause the infection are likely to be killed by the antibiotic.
Danish: Invanz anvendes, når de bakterier, der forårsager infektionen, forventes at blive dræbt af antibiotika.
English: What are the risks associated with Invanz?
Danish: Hvilke risici er der forbundet med Invanz?
English: This upsets the essential functions that keep the cells alive, and so kills the bacteria.
Danish: Dette forstyrrer livsvigtige funktioner, som holder bakterierne i live, og bakterierne dør.
English: In children, Invanz was as effective as the comparator antibiotics and had similar effectiveness to that in adults.
Danish: Hos børn var Invanz ligeså effektivt som de antibiotiske sammenligningspræparater og virkningen var tilsvarende hos voksne.
English: • community-acquired pneumonia (infection of the lungs caught away from hospital);
Danish: • samfundserhvervet lungebetændelse (lungeinfektioner, der er blevet pådraget uden for hospitalsmiljøet)
English: The active substance in Invanz, ertapenem, belongs to the group of antibiotics known as ‘carbapenems'.
Danish: Det aktive stof i Invanz, ertapenem, tilhører en gruppe af antibiotika kaldet "carbapenemer".
English: • foot infections in diabetes patients.
Danish: • fodinfektioner hos diabetespatienter
English: It must also not be used in patients who are severely allergic to other types of antibiotics, such as penicillins and cephalosporins.
Danish: Det må ikke anvendes til patienter, som har svær allergi over for andre typer af antibiotika såsom penicillin eller cefalosporin.
English: Invanz was compared with cefotetan for preventing infection after colorectal surgery.
Danish: Invanz blev sammenlignet med cefotetan til forebyggelse af infektioner efter kolorektal kirurgi.
English: Invanz can work on a range of different bacteria, which are listed in the summary of product characteristics (also part of the EPAR).
Danish: Invanz virker på en række forskellige bakterier, som står opført i produktresuméet (også en del af denne EPAR).
English: However, the data were not sufficient to support the use of Invanz in the treatment of urinary tract infections and skin and soft tissue infections, except foot ulcers in diabetes patients.
Danish: Dataene var imidlertid ikke tilstrækkelige til at understøtte anvendelsen af Invanz til behandling af urinvejsinfektioner og infektioner i hud og underliggende væv, med undtagelse af fodsår hos diabetespatienter.
English: For more information about treatment with Invanz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Invanz , kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Invanz must not be used in people who are hypersensitive (allergic) to ertapenem or to other antibiotics of the same group (carbapenems).
Danish: Invanz må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for ertapenem eller andre antibiotika i den samme gruppe (carbapenemer).
English: The Committee concluded that it was also effective for treatment of infection in children and for preventing infection after colorectal surgery in adults.
Danish: Udvalget konkluderede, at Invanz også var effektivt til behandling af infektion hos børn og forebyggelse af infektion efter kolorektal kirurgi hos voksne.
English: The most common side effects with Invanz (which may affect up to 1 in 10 people) are headache, diarrhoea, nausea (feeling sick), vomiting, rash (including nappy rash in children), itching, and problems around the area where the medicine is infused (including pain and inflammation of the vein).
Danish: De hyppigste bivirkninger ved Invanz (som ses hos mere end 1 person ud af 10) er hovedpine, diarré, kvalme, opkastning, udslet (herunder bleudslet hos børn), kløe og problemer i infusionsområde, hvor lægemidlet indgives (herunder smerte og betændelse i venen).
English: Invanz was compared with ceftriaxone (another antibiotic) for the treatment of adults with communityacquired pneumonia (866 patients) and urinary tract infections (592 patients), and with a combination of piperacillin and tazobactam for the treatment of abdominal infections (655 patients), gynaecological infections (412 patients), skin and soft tissue infections (infections of the skin and the tissues just beneath the skin, 540 patients); and foot infections in diabetes patients (576 patients).
Danish: Invanz blev sammenlignet med ceftriaxon (et andet antibiotikum) til behandling af voksne med samfundserhvervet lungebetændelse (866 patienters) og urinvejsinfektioner (592 patienter) og med en kombination af piperacillin og tazobactam til behandling af maveinfektioner (655 patienter), gynækologiske infektioner (412 patienter), infektioner i hud og underliggende væv (540 patienters) og fodinfektioner hos diabetespatienter (576 patienter).
English: Invanz is also used in adults to prevent infection after colorectal surgery (surgery in the lower part of the bowel, including the rectum).
Danish: Invanz anvendes også til voksne til forebyggelse af infektion efter kolorektal kirurgi (operationer i den nedre del af tarmsystemet, herunder anus).
English: The CHMP noted that Invanz was shown to be effective, albeit with a limited number of severe cases treated during the studies for abdominal infections, community-acquired pneumonia, gynaecological infections and diabetic foot infections.
Danish: CHMP fandt, at Invanz har vist sig at være effektivt, selvom der var et begrænset antal alvorlige tilfælde af patienter, der blev behandlet i løbet af undersøgelserne for maveinfektioner, samfundserhvervet lungebetændelse, gynækologiske infektioner og diabetiske fodinfektioner.
English: In studies in children, Invanz was compared with ceftriaxone (for community-acquired pneumonia, 389 children) and with ticarcillin/clavulanate (for intra-abdominal infections, 105 children).
Danish: I undersøgelser, der omfattede børn, blev Invanz sammenlignet med ceftriaxon (til samfundserhvervet lungebetændelse, 389 børn) og med ticarcillin/clavulanat (til intra-abdominale infektioner, 105 børn).
English: For practical information about using Invanz, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Invanz, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects reported with Invanz, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Invanz fremgår af indlægssedlen.
English: How is Invanz used?
Danish: Hvordan anvendes Invanz?
English: Invanz is available as a vial containing a powder which is dissolved before use to make up a solution for infusion (drip) into a vein.
Danish: Invanz fås i hætteglas som et pulver, der efter opløsning indgives ved infusion (drop) i en vene.
English: What benefits of Invanz have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Invanz?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Invanz have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Invanz.
English: How does Invanz work?
Danish: Hvordan virker Invanz?
English: • gynaecological infections;
Danish: • underlivsinfektioner hos kvinder (gynækologiske infektioner)
English: Invanz was as effective as ceftriaxone or piperacillin/tazobactam for the treatment of abdominal infections, community-acquired pneumonia, gynaecological infections and foot infections in diabetes patients: Invanz was effective for 87 to 94% of patients compared with 83 to 92% for the comparator antibiotics.
Danish: Invanz var effektivt for mellem 87 til 94% af patienterne sammenlignet med 83 til 92% ved de antibiotiske sammenligningspræparater.
English: The full EPAR and risk management plan summary for Lopinavir/Ritonavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ritonavir Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Danish: To lægemidler er bioækvivalente, når de danner den samme mængde af det aktive stof i kroppen og derfor forventes at have samme virkning.
English: This is a summary of the European public assessment report (EPAR) for Lopinavir/Ritonavir Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ritonavir Mylan.
English: When the enzyme is blocked, the virus does not replicate normally, slowing down the spread of infection.
Danish: Når enzymet blokeres, kan virussen ikke længere formere sig normalt, og derfor spredes virusset langsommere.
English: The Committee recommended that Lopinavir/Ritonavir Mylan be approved for use in the EU.
Danish: Agenturet anbefalede, at Ritonavir Mylan godkendes til anvendelse i EU.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Lopinavir/Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Kaletra.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Ritonavir Mylan er af sammenlignelig kvalitet og er bioækvivalent med Norvir.
English: Lopinavir/Ritonavir Mylan is a ‘generic medicine'.
Danish: Ritonavir Mylan er et "generisk lægemiddel".
English: For more information about treatment with Lopinavir/Ritonavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ritonavir Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Therefore, the CHMP's view was that, as for Kaletra, the benefit outweighs the identified risk.
Danish: Det var derfor agenturets opfattelse, at fordelene opvejer de identificerede risici som for Norvir.
English: It does not cure HIV infection, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Danish: Ritonavir Mylan helbreder ikke hiv-infektion eller aids, men kan holde skader på immunsystemet på afstand og forhindre de infektioner og sygdomme, der er forbundet med aids.
English: Because Lopinavir/Ritonavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Ritonavir Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What measures are being taken to ensure the safe and effective use of Lopinavir/Ritonavir Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ritonavir Mylan?
English: Lopinavir/Ritonavir Mylan is used in combination with other medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Ritonavir Mylan anvendes sammen med andre lægemidler til behandling af voksne og børn over to år, som er smittet med hiv-1 (humant immundefektvirus type 1).
English: What is Lopinavir/Ritonavir Mylan and what is it used for?
Danish: Hvad er Ritonavir Mylan, og hvad anvendes det til?
English: It is not intended to provide practical advice on how to use Lopinavir/Ritonavir Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Ritonavir Mylan bør anvendes.
English: Lopinavir/Ritonavir Mylan can only be obtained with a prescription and treatment should be started by a doctor who is experienced in managing HIV infection.
Danish: Ritonavir Mylan udleveres kun efter recept, og behandlingen bør iværksættes og overvåges af en læge med erfaring i behandling af hiv-infektion.
English: Other information about Lopinavir/Ritonavir Mylan
Danish: Andre oplysninger om Ritonavir Mylan
English: Lopinavir/Ritonavir Mylan, taken with other HIV medicines, reduces HIV in the blood and keeps the virus at a low level.
Danish: Når Ritonavir Mylan tages i kombination med andre antivirale lægemidler, nedsættes mængden af hiv i blodet, og den holdes på et lavt niveau.
English: What are the benefits and risks of Lopinavir/Ritonavir Mylan?
Danish: Hvilke fordele og risici er der forbundet med Ritonavir Mylan?
English: Lopinavir/Ritonavir Mylan contains the active substances lopinavir and ritonavir.
Danish: Ritonavir Mylan indeholder det aktive stof ritonavir.
English: For practical information about using Lopinavir/Ritonavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ritonavir Mylan, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: This means that it is similar to a ‘reference medicine' already authorised in the European Union (EU), called Kaletra.
Danish: Det betyder, at Ritonavir Mylan indeholder det samme aktive stof og virker på samme måde som et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Norvir.
English: Lopinavir/Ritonavir Mylan lopinavir / ritonavir
Danish: Ritonavir Mylan ritonavir
English: Why is Lopinavir/Ritonavir Mylan approved?
Danish: Hvorfor blev Ritonavir Mylan godkendt?
English: In adults and adolescents (aged 12 years and over), the recommended dose of Lopinavir/Ritonavir Mylan is two 200/50-mg tablets twice a day.
Danish: Den anbefalede dosis til voksne (18 år og derover) er 600 mg to gange dagligt.
English: This increases the levels of lopinavir in the blood, allowing a lower dose of lopinavir to be used for the same antiviral effect.
Danish: Derved øges koncentrationen af disse proteasehæmmere i blodet, og det forstærker deres antivirale virkning.
English: The active substances in this medicine, lopinavir and ritonavir, are protease inhibitors: they block an enzyme called protease that is involved in the replication of HIV.
Danish: Det betyder, at det blokerer et viralt enzym kaldet protease, som medvirker ved formeringen af hiv.
English: How has Lopinavir/Ritonavir Mylan been studied?
Danish: Hvordan blev Ritonavir Mylan undersøgt?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lopinavir/Ritonavir Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Ritonavir Mylan.
English: How is Lopinavir/Ritonavir Mylan used?
Danish: Hvordan anvendes Ritonavir Mylan?
English: It is available as tablets (100 mg lopinavir and 25 mg ritonavir; 200 mg lopinavir and 50 mg ritonavir).
Danish: Det fås som tabletter (100 mg) og bør tages sammen med mad.
English: The dose for smaller children depends on the child's body surface area and the other medicines that the child is taking.
Danish: Hos yngre patienter afhænger den anbefalede dosis af patientens højde og vægt.
English: How does Lopinavir/Ritonavir Mylan work?
Danish: Hvordan virker Ritonavir Mylan?
English: In Lopinavir/Ritonavir Mylan, lopinavir provides the activity and ritonavir is used as a ‘booster' that slows down the rate at which lopinavir is broken down by the liver.
Danish: Ritonavir Mylan kan anvendes som en "farmakokinetisk forstærker" (booster) til at øge koncentrationen i blodet af andre antivirale lægemidler, der tilhører samme gruppe som Ritonavir
English: Further information can be found in the summary of the risk management plan.
Danish: De nærmere oplysninger fremgår af indlægssedlen for det andet lægemiddel.
English: • > 60 years of age or
Danish: • > 60 år gammel eller
English: The following side effects have been reported but it is not known exactly how often they occur:
Danish: Følgende bivirkninger er blevet indberettet, men det vides ikke præcist, hvor ofte de forekommer:
English: 69800, France
Danish: 69800, Frankrig
English: Take your next dose at the usual time.
Danish: Tag næste dosis på det sædvanlige tidspunkt.
English: Do not take more capsules than your doctor has recommended.
Danish: Tag ikke flere kapsler, end din læge har anbefalet.
English: A risk to the newborn/infant cannot be excluded.
Danish: En risiko for den nyfødte/spædbarnet kan ikke udelukkes.
English: • If you have or think you might have a problem with your heart;
Danish: • Hvis du har eller mener, at du måske har et problem med hjertet;
English: Your doctor will prescribe the best dose for you.
Danish: Din læge vil ordinere den bedste dosis til dig.
English: Very common side effects: may affect more than 1 in 10 people Headache.
Danish: Meget almindelige bivirkninger: kan forekomme hos flere end 1 ud af 10 personer Hovedpine.
English: You can take the capsules with food or after a meal or on an empty stomach.
Danish: Du kan tage kapslerne med mad, efter et måltid eller på tom mave.
English: It is best to take the capsule(s) at the same time every day.
Danish: Det er bedst at tage kapslerne på samme tidspunkt hver dag.
English: There are limited pharmacokinetic data for this patient population.
Danish: Der er begrænsede farmakokinetiske data for denne patientpopulation.
English: Close monitoring for an effect on the QTc interval is advisable.
Danish: Omhyggelig monitorering for en virkning på QTc-intervallet er tilrådelig.
English: The starting dose should be maintained for at least one week.
Danish: Startdosis skal opretholdes i mindst en uge.
English: MedDRA System Organ Class
Danish: MedDRA systemorganklasse
English: After this time, your doctor may either increase or decrease the number of capsules that you take to find the dose best suited to you and which treats your condition most effectively.
Danish: Derefter kan din læge enten øge eller reducere antallet af kapsler, du skal tage, for at finde den dosis, der bedst passer dig, og som behandler din tilstand mest effektivt.
English: Anagrelide Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU.
Danish: Anagrelide Mylan indeholder det samme aktive stof og virker på samme måde, som et ”referencelægemiddel”, der allerede er godkendt i EU.
English: The average daily dose tended to be higher in adolescents.
Danish: Den gennemsnitlige daglige dosis havde en tendens til at være højere hos unge.
English: The amount of anagrelide that people take can be different, and this depends on your condition.
Danish: Det er forskelligt, hvilken mængde anagrelid forskellige mennesker kan indtage, og dette afhænger af din tilstand.
English: The disease may progress to myelofibrosis or AML.
Danish: Sygdommen kan progrediere til myelofibrose eller AML.
English: Speak to your doctor if you need advice with contraception.
Danish: Tal med din læge, hvis du har brug for råd vedrørende prævention.
English: Embryofoetal development studies
Danish: Embryoføtale udviklingsstudier
English: Although the rate of such progression is not known, children have a longer disease course and may, therefore, be at increased risk for malignant transformation, relative to adults.
Danish: Selvom hyppigheden for en sådan progression ikke er kendt, har børn et længere sygdomsforløb og kan derfor have en øget risiko for malign transformation i forhold til voksne.
English: An at risk patient
Danish: En patient i risikogruppe
English: Discontinuation of treatment should be considered in paediatric patients who do not have a satisfactory treatment response after approximately 3 months.
Danish: Seponering af behandlingen bør overvejes hos pædiatriske patienter, der ikke har opnået et tilfredsstillende behandlingsrespons efter ca. 3 måneder.
English: A dose-related increase in heart rate was observed during the first 12 hours, with the maximum increase occurring around the time of maximal concentrations.
Danish: Der blev observeret en dosisrelateret forøget hjerterytme i løbet af de første 12 timer med den maksimale forøgelse omkring tidspunktet for maksimale koncentrationer.
English: Take your capsules as soon as you remember.
Danish: Tag kapslerne, så snart du kommer i tanker om det.
English: There was also a trend to higher dose-normalised exposure to the active metabolite.
Danish: Der var desuden en tendens imod højere dosis-normaliseret eksponering for den aktive metabolit.
English: 6545 CM Nijmegen NETHERLANDS
Danish: 6545 CM Nijmegen Holland
English: However, as expected, patients in this age group had twice the incidence of serious adverse events (mainly cardiac).
Danish: Patienter i denne aldersgruppe havde imidlertid som forventet dobbelt så mange tilfælde af alvorlige bivirkninger (hovedsagelig vedrørende hjertet).
English: In all paediatric patients, careful titration to a patientspecific daily dose is needed.
Danish: Hos alle pædiatriske patienter er forsigtig titrering til en patientspecifik daglig dosis nødvendig.
English: The capsules must be swallowed whole.
Danish: Kapslerne skal sluges hele.