FrancophonIA/ELRC3.0 huggingface dataset:
English: In the short-term studies, the CHMP considered that the effect of Cymbalta/Xeristar was too small to be relevant for patients: there was no clear demonstration of improvement in symptoms, and the modest effects of Cymbalta/Xeristar could be due to the medicine's effect of improving the patients' mood.
Danish: I de kortvarige undersøgelser var virkningen af Cymbalta/Xeristar efter CHMP's mening for beskeden til at være relevant for patienterne: Der var ingen klar påvisning af bedring af symptomer, og den beskedne virkning af Cymbalta/Xeristar kunne skyldes lægemidlets virkning på bedring af patientens stemningsleje.
English: What is Cymbalta/Xeristar?
Danish: Hvad er Cymbalta/Xeristar?
English: The active substance in Cymbalta/Xeristar, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Danish: Det aktive stof i Cymbalta/Xeristar, duloxetin, er en selektiv serotonin-noradrenalin genoptagelseshæmmer.
English: At that point in time, the CHMP was of the opinion that the benefits of Cymbalta/Xeristar in the treatment of fibromyalgia did not outweigh its risks.
Danish: CHMP var på daværende tidspunkt af den opfattelse, at fordelene ved Cymbalta/Xeristar til behandling af fibromyalgi ikke opvejede risiciene herved.
English: The companies that applied for authorisation are Eli Lilly Nederland B.V. (for Cymbalta) and Boehringer Ingelheim International GmbH (for Xeristar).
Danish: (for Cymbalta) og Boehringer Ingelheim International GmbH (for Xeristar).
English: The CHMP was concerned that the effectiveness of Cymbalta/Xeristar in treating fibromyalgia had not been shown sufficiently.
Danish: CHMP var betænkelig ved, at Cymbalta/Xeristars effekt med hensyn til behandling af fibromyalgi ikke var tilstrækkeligt påvist.
English: How is Cymbalta/Xeristar expected to work?
Danish: Hvordan forventes Cymbalta/Xeristar at virke?
English: What was Cymbalta/Xeristar expected to be used for?
Danish: Hvad havde man forventet, at Cymbalta/Xeristar skulle anvendes til?
English: Four of the studies were short-term, lasting between three and six months, and comparing Cymbalta/Xeristar with placebo (a dummy treatment) in a total of 1,411
Danish: I undersøgelserne sammenlignedes Cymbalta/Xeristar med placebo (en uvirksom behandling) hos i alt 1 411 patienter.
English: 3.3 mg Powder for suspension for implantation
Danish: 3,3 mg Pulvere til implantation, suspension
English: Invented name Strength Pharmaceutical Form Route of Administration
Danish: Særnavn Styrke LægemiddelformIndgivelsesvej Emballage
English: 1 vial l t o r
Danish: 1 g t r
English: Pregabalin Mylan Pharma is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Danish: Pregabalin Mylan Pharma fås som kapsler (25, 50, 75, 100, 150, 200, 225 og 300 mg) og udleveres kun efter recept.
English: The full EPAR for Pregabalin Mylan Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Pregabalin Mylan Pharma findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: To stop treatment with Pregabalin Mylan Pharma the dose should be reduced gradually, over at least a week.
Danish: For at indstille behandlingen med Pregabalin Mylan Pharma bør dosis reduceres gradvist i løbet af mindst en uge.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Mylan Pharma on 25 June 2015.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Pregabalin Mylan Pharma den 25. juni 2015.
English: This means that Pregabalin Mylan Pharma contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Lyrica.
Danish: Det betyder, at Pregabalin Mylan Pharma 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 Lyrica.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Mylan Pharma.
Danish: Der er allerede gennemført undersøgelser af fordelene og risiciene ved det aktive stof i de godkendte anvendelser med referencelægemidlet, Lyrica, og det er ikke nødvendigt at gentage disse med Pregabalin Mylan Pharma.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Mylan Pharma has been shown to have comparable quality and to be bioequivalent to Lyrica.
Danish: Udvalget for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Pregabalin Mylan Pharma er af sammenlignelig kvalitet og er bioækvivalent med Lyrica.
English: This is a summary of the European public assessment report (EPAR) for Pregabalin Mylan Pharma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Pregabalin Mylan Pharma.
English: The active substance in Pregabalin Mylan Pharma, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Danish: Det aktive stof i Pregabalin Mylan Pharma, pregabalin, minder i struktur om kroppens egen "neurotransmitter", gamma-aminosmørsyre (GABA), men dets biologiske virkninger er meget anderledes.
English: The Committee recommended that Pregabalin Mylan Pharma be approved for use in the EU.
Danish: Udvalget anbefalede, at Pregabalin Mylan Pharma godkendes til anvendelse i EU.
English: Pregabalin Mylan Pharma is a medicine used to treat adults with the following conditions:
Danish: Pregabalin Mylan Pharma er et lægemiddel til behandling af voksne med følgende tilstande:
English: Because Pregabalin Mylan Pharma 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 Pregabalin Mylan Pharma er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: As for every medicine, the company provided studies on the quality of Pregabalin Mylan Pharma.
Danish: Som for alle lægemidler fremlagde virksomheden undersøgelser af kvaliteten af Pregabalin Mylan Pharma.
English: For more information about treatment with Pregabalin Mylan Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Pregabalin Mylan Pharma, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Pregabalin Mylan Pharma is a ‘generic medicine'.
Danish: Pregabalin Mylan Pharma er et "generisk lægemiddel".
English: What measures are being taken to ensure the safe and effective use of Pregabalin Mylan Pharma?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Pregabalin Mylan Pharma?
English: For practical information about using Pregabalin Mylan Pharma, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Pregabalin Mylan Pharma, bør du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Pregabalin Mylan Pharma contains the active substance pregabalin.
Danish: Pregabalin Mylan Pharma indeholder det aktive stof pregabalin.
English: It is not intended to provide practical advice on how to use Pregabalin Mylan Pharma.
Danish: Det er ikke en praktisk vejledning i, hvordan Pregabalin Mylan Pharma bør anvendes.
English: What are the benefits and risks of Pregabalin Mylan Pharma?
Danish: Hvilke fordele og risici er der forbundet med Pregabalin Mylan Pharma?
English: What is Pregabalin Mylan Pharma and what is it used for?
Danish: Hvad er Pregabalin Mylan Pharma, og hvad anvendes det til?
English: Other information about Pregabalin Mylan Pharma
Danish: Andre oplysninger om Pregabalin Mylan Pharma
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pregabalin Mylan Pharma 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 Pregabalin Mylan Pharma.
English: Why is Pregabalin Mylan Pharma approved?
Danish: Hvorfor blev Pregabalin Mylan Pharma godkendt?
English: How has Pregabalin Mylan Pharma been studied?
Danish: Hvordan blev Pregabalin Mylan Pharma undersøgt?
English: How is Pregabalin Mylan Pharma used?
Danish: Hvordan anvendes Pregabalin Mylan Pharma?
English: How does Pregabalin Mylan Pharma work?
Danish: Hvordan virker Pregabalin Mylan Pharma?
English: This will reduce the risk of any problems.
Danish: Dette vil nedsætte risikoen for eventuelle problemer.
English: This will help to make the treatment more effective.
Danish: Det vil gøre behandlingen mere effektiv.
English: The possibility of sensitisation should be taken into account.
Danish: Muligheden for sensibilisering skal tages i betragtning.
English: Let it dry completely before you use it again.
Danish: Lad den tørre helt, før du bruger den igen.
English: Symptoms usually last a few hours or up to one day.
Danish: Symptomerne varer normalt et par timer eller op til en dag.
English: Protein binding has been stated as 33 to 50% depending on the methodology used.
Danish: Proteinbinding er blevet fastlagt til at være fra 33 % til 50 % afhængigt af den anvendte metodologi.
English: Just take your next dose at the usual time.
Danish: Tag blot den næste dosis til sædvanlig tid.
English: Repeat steps 3 to 7 in the same way until you have taken your whole dose.
Danish: Gentag trin 3 til 7 på samme måde, indtil hele dosis er taget.
English: Add a small amount of water.
Danish: Tilsæt en lille smule vand.
English: S=susceptible, R=resistant
Danish: S = følsom, R = resistent
English: The serum half-life is between 1 and 1.5 hours.
Danish: Halveringstiden i serum ligger mellem 1 og 1,5 time.
English: • Treatment of early Lyme disease.
Danish: • Behandling af tidlig Lyme-sygdom.
English: 5 insufficient evidence that the species in question is a good target for therapy with the drug.
Danish: 5 Utilstrækkelig evidens for, at de pågældende arter er et godt mål for behandling med lægemidlet.
English: If you don't complete the full course of treatment, the infection may come back.
Danish: Hvis du ikke gennemfører hele behandlingen, kan infektionen komme igen.
English: An MIC with a comment but without an accompanying S or R-categorization may be reported.
Danish: En MIC med en kommentar, men uden en tilhørende S- eller R-kategorisering, kan være rapporteret.
English: Don't drive or use machines if you do not feel well.
Danish: Kør ikke bil og betjen ikke maskiner, hvis du ikke føler dig godt tilpas.
English: Don't delay.
Danish: Vent ikke.
English: Zinnat is used to treat infections of:
Danish: Zinnat anvendes til at behandle infektioner i:
English: Zinnat is an antibiotic used in adults and children.
Danish: Zinnat er et antibiotikum, der anvendes til voksne og børn.
English: See ‘Conditions you need to look out for' in Section 4.
Danish: Se ('Tilstande, du skal holde øje med') under punkt 4.
English: These may affect up to 1 in 100 people:
Danish: Disse kan forekomme hos op til 1 ud af 100 personer:
English: If the latter is damaged or not present, the product should be returned to the pharmacist.
Danish: Hvis forseglingen er beskadiget eller mangler, skal produktet returneres til apoteket.
English: Volume per dose (mL)
Danish: Volumen pr. dosis (ml)
English: Streptococcus A, B, C and G
Danish: Streptococcus A, B, C og G
English: Zinnat is not recommended for children aged under 3 months, as the safety and effectiveness are not known in this age group.
Danish: Zinnat anbefales ikke til børn under 3 måneder, da sikkerhed og virkning ikke kendes for denne aldersgruppe.
English: • yellowing of the whites of the eyes or skin
Danish: • gulfarvning af det hvide i øjnene eller huden
English: Don't chew, crush or split the tablets - this may make the treatment less effective.
Danish: Du må ikke tygge, knuse eller dele tabletterne det kan gøre behandlingen mindre effektiv.
English: Optimum absorption occurs when it is administered shortly after a meal.
Danish: Optimal absorption opnås ved administration kort efter et måltid.
English: In many areas, ESBL detection and characterization is recommended or mandatory for infection control purposes.
Danish: I mange områder er ESBL-detektion og -bestemmelse anbefalet eller obligatorisk af hensyn til infektionskontrol.
English: Breastfeeding might have to be discontinued due to these effects.
Danish: Det kan være nødvendigt at stoppe amningen på grund af disse bivirkninger.
English: • the weight and age of the child, up to a maximum of 500 mg per day.
Danish: • barnets vægt og alder, op til højst 500 mg om dagen.
English: Data from large clinical studies were used to determine the frequency of very common to rare undesirable effects.
Danish: Data fra store kliniske studier blev anvendt til at fastlægge hyppigheden af meget almindelige til sjældne bivirkninger.
English: The usual course of therapy is seven days (may range from five to ten days).
Danish: Den sædvanlige behandlingstid er 7 dage (kan variere fra 5 til 10 dage).
English: This side effect is more likely if you take Zinnat for a long time.
Danish: Der er større risiko for denne bivirkning, hvis du tager Zinnat i en længere periode
English: Studies in animals have shown no harmful effects on pregnancy, embryonal or foetal development, parturition or postnatal development.
Danish: Dyrestudier har ikke vist skadelige virkninger på graviditet, den embryonale eller føtale udvikling, fødsel eller postnatal udvikling.
English: Other side effects Other side effects have occurred in a very small number of people, but their exact frequency is unknown:
Danish: Andre bivirkninger Andre bivirkninger er set hos meget få personer, men den nøjagtige hyppighed kendes ikke:
English: Contact your doctor or your nearest hospital emergency department immediately.
Danish: Kontakt straks lægen eller den nærmeste skadestue.
English: Zinnat can make you dizzy and have other side effects that make you less alert.
Danish: Zinnat kan gøre dig svimmel og give andre bivirkninger, som kan gøre dig mindre opmærksom.
English: (other than P. vulgaris) Providencia spp.
Danish: (andre end P. vulgaris) Providencia spp.
English: Children (<40 kg) Indication
Danish: Tabel 2: Børn (< 40 kg) Indikation
English: Clostridium difficile overgrowth
Danish: Overvækst af Clostridium difficille
English: Depending on the illness or how you or your child responds to treatment, the initial dose may be changed or more than one course of treatment may be needed.
Danish: Afhængigt af sygdommen eller af, hvordan dit barn reagerer på behandlingen, kan lægen ændre dosis, eller det kan være nødvendigt med mere end et behandlingsforløb.
English: Zinnat should be prescribed to pregnant women only if the benefit outweighs the risk.
Danish: Zinnat må kun ordineres til gravide kvinder, hvis fordelene opvejer risici.
English: Constitution/Administration instructions The bottle should be shaken vigorously before the medication is taken.
Danish: Vejledning til klargøring/administration Flasken skal omrystes grundigt, inden medicinen tages.
English: Cefuroxime is usually active against the following microorganisms in vitro.
Danish: Cefuroxim er normalt aktivt over for de følgende mikroorganismer in vitro:
English: Placebo-controlled trial data were not available.
Danish: Placebokontrollerede studiedata var ikke tilgængelige.
English: Zinnat suspension contains sugar (sucrose).
Danish: Zinnat suspension indeholder sukker (saccharose).
English: Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment (see section 4.8).
Danish: Langvarig anvendelse kan desuden resultere i overvækst af andre ikke-følsomme mikroorganismer (f.eks. enterokokker og Clostridium difficile), som kan nødvendiggøre afbrydelse af behandlingen (se kt. 4.8).
English: If you need a blood test
Danish: Hvis du skal have taget en blodprøve
English: • red blood cells destroyed too quickly (haemolytic anaemia).
Danish: • røde blodlegemer, der ødelægges for hurtigt (hæmolytisk anæmi).
English: No studies on the effects on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget studier af indflydelsen på evnen til at føre motorkøretøj eller betjene maskiner.
English: The frequencies assigned to all other undesirable effects (i.e. those occurring at <1/10,000) were mainly determined using post-marketing data and refer to a reporting rate rather than true frequency.
Danish: De hyppigheder, der er blevet fastsat for alle andre bivirkninger (dvs. bivirkninger observeret hos < 1/10.000), er overvejende fastlagt ved anvendelse af data efter markedsføring og refererer til en indberetningshyppighed snarere end til en reel hyppighed.
English: If using a dosing syringe, allow the reconstituted suspension to stand for at least one hour before taking the first dose.
Danish: Hvis der anvendes en doseringssprøjte, skal den rekonstituerede suspension stå i mindst 1 time, før den første dosis tages.
English: * All methicillin-resistant S. aureus are resistant to cefuroxime.
Danish: *Alle methicilin-resistente S.aureus er resistente over for cefuroxim.
English: Children aged two years or older with otitis media or, where appropriate, with more severe infections
Danish: Børn i alderen 2 år eller ældre med alvorlig otitis media eller ved alvorligere infektioner, når det er hensigtsmæssigt
English: Directions for reconstituting suspension in multidose bottles
Danish: Vejledning til rekonstitution af suspension i flerdosisbeholdere
English: If you take too much Zinnat you may have neurological disorders, in particular you may be more likely to have fits (seizures).
Danish: Hvis du har taget for meget Zinnat, kan du få neurologiske forstyrrelser, du kan især have større sandsynlighed for at få kramper (krampeanfald).
English: Where incidences have been calculated from clinical trial data, these were based on drug-related (investigator assessed) data.
Danish: Hvor hyppigheden er beregnet ud fra kliniske studiedata, blev disse baseret på lægemiddelrelaterede data (vurderet af investigator).
English: expert advice should be sought when the local prevalence of resistance is such that the utility of cefuroxime axetil in at least some types of infections is questionable.
Danish: Ekspertrådgivning bør indhentes, når den lokale forekomst af resistens er sådan, at nytteværdien af cefuroxim til i det mindste nogle typer af infektioner er tvivlsom.
English: Spain - Nivador
Danish: Spanien - Nivador
English: Lyme disease
Danish: Lyme-sygdom
English: 4 The beta-lactam susceptability of beta-haemolytic streptococci groups A, B, C and G is inferred from the penicillin susceptibility.
Danish: 4 Beta-laktamfølsomhed af beta-hæmolytiske streptokokgrupper A, B, C og G er baseret på følsomhed for penicillin.
English: Don't take an extra dose to make up for a missed dose.
Danish: Du må ikke tage en dobbeltdosis som erstatning for en glemt dosis.
English: Recommended dosage
Danish: Anbefalet dosering
English: Your doctor will consider the benefit of treating you with Zinnat against the risk to your baby.
Danish: Lægen vil afveje fordelene ved at behandle dig med Zinnat over for risikoen for barnet.
English: • Acute otitis media.
Danish: • Akut otitis media.
English: As with other antibiotics, use of cefuroxime axetil may result in the overgrowth of Candida.
Danish: Som for andre antibiotika kan anvendelse af cefuroximaxetil resultere i overvækst af Candida.
English: Staphylococcus aureus (methicillin susceptible)*
Danish: Staphylococcus aureus ( methicillin-følsomme)*
English: 4.4 Special warnings and precautions for use
Danish: .4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Take Zinnat after food.
Danish: Tag Zinnat efter et måltid.
English: There is no experience of using Zinnat in children under the age of 3 months.
Danish: Der er ingen erfaringer med anvendelse af Zinnat hos børn under 3 måneder.
English: Hold the bottle firmly.
Danish: Hold godt fast på flasken.
English: Check with your doctor that Zinnat is suitable for you.
Danish: Spørg lægen, om Zinnat er egnet til dig.
English: However, as this medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.
Danish: Zinnat kan imidlertid medføre svimmelhed, og patienter skal rådes til at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner.
English: Use the oral dosing syringe supplied with the pack to measure your dose accurately:
Danish: Brug den orale doseringssprøjte, som følger med i pakningen, til at afmåle dosis nøjagtigt:
English: • the severity and type of infection
Danish: • infektionens sværhedsgrad og type.
English: Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet samt reproduktions- og udviklingstoksicitet.
English: standard individual dose given every 24 hours
Danish: Individuel standarddosis administreret hver 24. time
English: Zinnat can affect the results of a test for blood sugar levels, or a blood screen called the Coombs test.
Danish: Zinnat kan påvirke analyseresultaterne for blodsukker eller en blodprøve, der kaldes Coombs' test.
English: Pharmacotherapeutic group: antibacterials for systemic use, second-generation cephalosporins, ATC code: J01DC02
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, 2. generationscefalosporiner, ATC-kode: J01DC02
English: The following convention has been utilised for the classification of frequency: very common ≥ 1/10; common ≥ 1/100 to < 1/10, uncommon ≥ 1/1,000 to < 1/100; rare ≥ 1/10,000 to < 1/1,000; very rare < 1/10,000 and not known (cannot be estimated from the available data).
Danish: Behandlingsrelaterede bivirkninger af alle grader er listet nedenfor efter systemorganklasse (i henhold til MedDRA-konventionen), hyppighed og hvor alvorlig, den er. Der er benyttet følgende konvention til klassificering af hyppigheden: meget almindelig ( 1/10); almindelig ( 1/100 til < 1/10), ikke almindelig ( 1/1.000 til < 1/100), sjælden ( 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Zinnat can also be used: • to treat Lyme disease (an infection spread by parasites called ticks).
Danish: Zinnat kan også anvendes til: • behandling af Lyme-sygdom (en infektion, der bliver spredt af flåter (en parasit)).
English: Tell the person taking the sample that you are taking Zinnat.
Danish: Fortæl den person, der tager prøven, at du tager Zinnat.
English: If you take too much Zinnat
Danish: Hvis du har taget for meget Zinnat
English: The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data (for example from placebo-controlled studies) for calculating incidence were not available.
Danish: Hyppigheder anført for bivirkninger nedenfor er estimater, idet de tilgængelige data for de fleste reaktioner ikke er tilstrækkelige (f.eks. fra placebokontrollerede studier) til at kunne beregne hyppigheden.
English: Germany - Elobact
Danish: Tyskland - Elobact
English: • a decrease in the number of white blood cells
Danish: • nedsat antal hvide blodlegemer