FrancophonIA/ELRC3.0 huggingface dataset:
English: Combisyn Lactating Cow Intramammary Suspension (Combisyn) is an intramammary suspension containing amoxicillin, clavulanic acid and prednisolone.
Danish: Combisyn Lactating Cow Intramammary Suspension (Combisyn) er en intramammær suspension, der indeholder amoxicillin, clavulansyre og prednisolon.
English: - if you have diarrhoea for more than one day.
Danish: - hvis De har diarré i mere end én dag.
English: Approximately 2% of the radioactivity was eliminated in the urine.
Danish: Omkring 2 % af radioaktiviteten blev elimineret i urinen.
English: Results continuously improved with increasing experience over the course of 11 years.
Danish: Resultaterne blev kontinuerligt forbedret med øget erfaring over en periode på 11 år.
English: The liquid has a sweet taste.
Danish: Væsken har en sød smag.
English: It is not known exactly how often these side effects occur.
Danish: Det vides ikke nøjagtigt, hvor ofte disse bivirkninger forekommer.
English: However, cases of spontaneous abortion have been reported.
Danish: Imidlertid er spontane aborter blevet rapporteret.
English: These effects are more frequent if you also drink alcohol.
Danish: Disse virkninger ses oftere, hvis De også drikker alkohol.
English: The 3 studies demonstrated similar survival rates.
Danish: De 3 undersøgelser viser de samme overlevelsesrater.
English: This medicine should be taken twice a day.
Danish: Denne medicin bør tages to gange daglig.
English: Date of first authorisation: 15 May 2009 Date of latest renewal: 17 Feb 2014
Danish: Dato for første markedsføringstilladelse: 15. maj 2009 Dato for seneste fornyelse: 17. februar 2014
English: You should keep in regular contact with your doctor.
Danish: De bør jævnligt være i kontakt med Deres læge.
English: Efficacy results of the largest studies in each indication are summarised below.
Danish: Virkningsresultaterne for de største undersøgelser af hver indikation er opsummeret nedenfor.
English: To date, no other relevant epidemiological data are available.
Danish: Der foreligger ikke på nuværende tidspunkt andre relevante epidemiologiske data.
English: The course of pre-existing infections may be aggravated.
Danish: Forløbet af eksisterende infektionssygdomme kan forværres.
English: Place the cup with water on a stable surface.
Danish: Placer koppen med vand på en stabil overflade.
English: Wait at least 1 hour until the next meal.
Danish: Der skal gå mindst 1 time til det næste måltid.
English: If you follow these instructions, you will get the right amount of granules from the sachet.
Danish: Hvis De følger disse anvisninger, vil De få den rette mængde granulat fra brevet.
English: It could potentially influence the health of the baby or adversely influence the course of the pregnancy.
Danish: Det kan potentielt påvirke barnets sundhed eller påvirke forløbet af graviditeten negativt.
English: Rinse the glass or cup once with the same amount of water and drink this, too.
Danish: Skyl glasset eller koppen en gang med den samme mængde vand som før og drik også dette.
English: Infections including opportunistic infections
Danish: Infektioner, herunder opportunistiske infektioner
English: If you have forgotten to take your Modigraf, wait until it is time for the next dose, and then continue as before.
Danish: Hvis De har glemt at tage Deres Modigraf, skal De vente til det er tid for næste dosis, og derefter fortsætte som hidtil.
English: Do not take a double dose to make up for forgotten individual doses.
Danish: Tag ikke dobbelt dosis for at erstatte en glemt dosis.
English: Modigraf is used in adults and children.
Danish: Modigraf anvendes til voksne og børn.
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis tidspunktet for en PSUR indsendelse og for opdatering af en RMP er sammenfaldende, kan de fremsendes samtidig.
English: It is normal that some granules stay behind; the sachet was designed that way.
Danish: Det er normalt, at noget granulat bliver tilbage; sådan er brevet designet.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Dette lægemiddel kan, som al anden medicin, give bivirkninger, men ikke alle får bivirkninger.
English: If overdose occurs, general supportive measures and symptomatic treatment should be conducted.
Danish: I tilfælde af overdosering skal der udføres generelle understøttende foranstaltninger og symptomatisk behandling.
English: Data on oral bioavailability of Modigraf in other indications is not available.
Danish: Data for oral biotilgængelighed for Modigraf til andre indikationer er ikke tilgængelig.
English: In general children need higher doses per kg of body weight to achieve the same effective levels in the blood as adults.
Danish: Generelt behøver børn højere doser pr. kg kropsvægt for at opnå de samme effektive niveauer i blodet som voksne.
English: The required dose is calculated from the weight of the patient, using the minimum number of sachets possible.
Danish: Den nødvendige dosis beregnes ud fra patientens vægt ved at bruge det mindste mulige antal breve.
English: You should limit your exposure to the sun and UV (ultraviolet) light whilst taking Modigraf.
Danish: De bør begrænse Deres udsættelse for sollys og UV (ultraviolet) lys, mens De tager Modigraf.
English: The dose may vary depending upon the immunosuppressive regimen chosen.
Danish: Dosis kan variere afhængig af det valgte immunsuppressive regime.
English: Suspend the granules in water.
Danish: Opslæm granulatet i vand.
English: Your dose depends on your general condition and on which other immunosuppressive medicines you are taking.
Danish: Dosis afhænger af Deres generelle tilstand og af, hvilken anden immundæmpende medicin De tager.
English: Clinical efficacy and safety of tacrolimus administered twice daily in other primary organ transplantation
Danish: Klinisk virkning og sikkerhed for tacrolimus administreret to gange dagligt ved anden primær organtransplantation
English: Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Modigraf.
Danish: Kør ikke bil og lad være med at bruge værktøj eller maskiner, hvis De føler Dem svimmel eller søvnig eller har problemer med at se klart, efter De har taget Modigraf.
English: The recommended initial doses presented below are intended to act solely as a guideline.
Danish: De anbefalede begyndelsesdoser angivet nedenfor er kun vejledende.
English: Stir, or swirl gently until the granules have been suspended completely.
Danish: Rør eller hvirvl forsigtigt, indtil granulatet er fuldstændigt opslæmmet.
English: The use of live attenuated vaccines should be avoided.
Danish: Brug af levende, svækkede vacciner skal undgås.
English: Modigraf is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period.
Danish: Modigraf administreres rutinemæssigt sammen med andre immunsuppressive stoffer i den initiale, post-operative periode.
English: < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: febrile neutropenia
Danish: febril neutropeni
English: Modigraf with food and drink
Danish: Brug af Modigraf sammen med mad og drikke
English: During treatment, careful monitoring with EBV-PCR is recommended.
Danish: Under behandlingen bør man overvåge EBV-PCR nøje.
English: An alternative strategy was published where oral tacrolimus was administered within 12 hours post transplantation.
Danish: En alternativ strategi er publiceret hvor oral tacrolimus blev givet inden for 12 timer efter transplantationen.
English: Positive EBV-PCR may persist for months and is per se not indicative of lymphoproliferative disease or lymphoma.
Danish: Positiv EBV-PCR kan strække sig over måneder og indikerer per se ikke lymfoproliferativ sygdom eller lymfom.
English: Your doctor will advise you on the number of sachets that you need to open and the volume of water that is required to make a suspension.
Danish: Deres læge vil oplyse Dem om det antal breve og den mængde vand, der skal anvendes til at lave en suspension.
English: Tacrolimus may cause visual and neurological disturbances.
Danish: Tacrolimus kan give visuelle og neurologiske forstyrrelser.
English: In some cases, it was necessary to switch to alternative immunosuppression.
Danish: I nogle tilfælde var det nødvendigt at skifte til alternativ immunosuppression.
English: Modigraf therapy requires careful monitoring by adequately qualified and equipped personnel.
Danish: Behandling med Modigraf kræver omhyggelig monitorering af velkvalificeret og specielt uddannet personale.
English: The half-life in paediatric transplant patients averages approximately 12 hours.
Danish: Halveringstiden hos pædiatriske transplanterede patienter er gennemsnitligt ca. 12 timer.
English: toxic epidermal necrolysis (Lyell's syndrome)
Danish: toksisk epidermal nekrolyse (Lyells syndrom)
English: Materials used to prepare and administer the suspension, e.g. drinking vessels, cups, or tubing, must not contain PVC.
Danish: Udstyr, som anvendes til at fremstille og administrere suspensionen, f.eks. drikkekar, kopper eller slanger, må ikke indeholde PVC.
English: These may worsen kidney or nervous system problems when taken together with Modigraf.
Danish: Disse kan forværre problemer med nyrerne eller centralnervesystemet, hvis de tages sammen med Modigraf.
English: Available tacrolimus is generally rapidly absorbed.
Danish: Tilgængeligt tacrolimus absorberes almindeligvis hurtigt.
English: Children and adolescents may experience the same side effects as adults.
Danish: Børn og unge kan opleve de samme bivirkinger som voksne.
English: Tacrolimus is not compatible with PVC (polyvinylchloride) plastics.
Danish: Tacrolimus er ikke forligelig med PVC (polyvinylchlorid)-plastik.
English: Investigations very common:
Danish: Undersøgelser Meget almindelig:
English: Your doctor will usually reduce your Modigraf dose once your condition has stabilised.
Danish: Lægen vil sædvanligvis reducere Modigrafdosis, når Deres tilstand er stabiliseret.
English: Elderly patients There is no evidence currently available to indicate that dosing should be adjusted in older people.
Danish: Ældre personer Det er på nuværende tidspunkt ikke påvist, at doseringen skal justeres hos ældre personer.
English: As gastrointestinal perforation is a medically important event that may lead to a life-threatening or serious condition, adequate treatments should be considered immediately after suspected symptoms or signs occur.
Danish: Da gastrointestinal perforation er en væsentlig klinisk hændelse, der kan føre til en alvorlig eller livstruende tilstand, bør passende behandling overvejes umiddelbart efter, mistænkte symptomer eller tegn opstår.
English: Following your organ transplant (e.g. liver, kidney, heart), your body's immune system will try to reject the new organ.
Danish: Efter en organtransplantation (f.eks. lever, nyre, hjerte) vil kroppens immunsystem forsøge at afstøde det nye organ.
English: Hold the opened sachet between thumb and index finger above the cup with the open side of the sachet facing downwards.
Danish: Hold det åbne brev mellem tommel- og pegefinger med den åbne side nedad henover koppen.
English: Not known (frequency cannot be estimated from the available data): Abnormality of the optic nerve (optic neuropathy)
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data): - Forandring i synsnerven (optisk neuropati)
English: Make sure that you receive the same tacrolimus medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different tacrolimus medicine.
Danish: Sørg for at De får den samme tacrolimusmedicin hver gang, De henter Deres medicin, medmindre Deres transplantationslæge har godkendt, at De skifter til en anden tacrolimusmedicin.
English: Pain in extremity has been described in a number of published case reports as part of CalcineurinInhibitor Induced Pain Syndrome (CIPS).
Danish: Smerte i ekstremiteterne er blevet beskrevet i en række offentliggjorte casestudier som del af CalcineurinInhibitor Induced Pain Syndrome (CIPS).
English: Your doctor may need to adjust your dose of Modigraf.
Danish: Deres læge er måske nødt til at justere Deres Modigrafdosis.
English: As with other potent immunosuppressive compounds, the risk of secondary cancer is unknown (see section 4.8).
Danish: Som ved andre potente immunsuppressive midler er risikoen for sekundær cancer ukendt (se pkt.
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to
Danish: Liste over bivirkninger Bivirkningernes frekvens er defineret som følger: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10),
English: If you need to have any vaccinations, please tell your doctor before.
Danish: Hvis De skal vaccineres, så fortæl det til Deres læge på forhånd.
English: How to prepare the Modigraf sachets for use?
Danish: Hvordan skal Modigrafbrevene forberedes til brug?
English: This effect may be enhanced if tacrolimus is administered in association with alcohol.
Danish: Denne effekt kan forøges, hvis tacrolimus administreres sammen med alkohol.
English: The incidences of acute rejection were numerically lower with tacrolimus in all 3 studies and one of the studies reported a significantly lower incidence of bronchiolitis obliterans syndrome with tacrolimus.
Danish: Incidensen af akut afstødning var numerisk lavere med tacrolimus i alle 3 undersøgelser, og en af undersøgelserne rapporterede signifikant lavere incidens af oblitererende bronchiolitis-syndrom med tacrolimus.
English: Tell your doctor immediately if during treatment you suffer from: problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Danish: Fortæl straks Deres læge, hvis De under behandlingen lider af: problemer med Deres syn, såsom sløret syn, ændringer i farvesynet, problemer med at se detaljer eller hvis Deres synsfelt bliver begrænset.
English: There is no evidence that male and female patients require different doses to achieve similar trough levels.
Danish: Der er ikke evidens for at mandlige og kvindelige patienter kræver forskellig dosis for at opretholde samme niveau.
English: These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating hepatic or renal function or neurological symptoms.
Danish: Disse infektioner er ofte forbundet med en høj total immunosuppressiv belastning og kan føre til alvorlige eller fatale tilstande, som lægerne bør overveje i differentialdiagnosticeringen af immunsupprimerede patienter med forringet lever- eller nyrefunktion eller neurologiske symptomer.
English: Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
Danish: Efter oral og intravenøs administration af 14C-mærket tacrolimus blev størstedelen af radioaktiviteten elimineret i fæces.
English: In some patients, tacrolimus appears to be continuously absorbed over a prolonged period yielding a relatively flat absorption profile.
Danish: Hos nogle patienter bliver tacrolimus absorberet kontinuert over en lang periode, hvilket giver en relativt flad absorptionsprofil.
English: No studies on the effects of tacrolimus (Modigraf) on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af tacrolimus' (Modigraf) virkning på evnen til at føre motorkøretøj eller betjene maskiner.
English: Packs containing 50 sachets are available.
Danish: Pakninger med 50 breve er tilgængelige.
English: Modigraf is taken orally twice daily, usually in the morning and evening.
Danish: Modigraf tages gennem munden to gange dagligt, sædvanligvis om morgenen og om aftenen.
English: Severe effects may occur, including allergic and anaphylactic reactions (a very serious type of allergic reaction with fainting and difficulty breathing, which needs immediate medical attention).
Danish: Alvorlige bivirkninger kan forekomme, herunder allergiske og anafylaktiske reaktioner (en meget alvorlig type allergisk reaktion med besvimelse og åndedrætsbesvær, som omgående kræver medicinsk behandling).
English: Children and adolescents will receive doses of Modigraf calculated in the same way as adults.
Danish: Børn og unge vil få Modigraf-doser beregnet på samme måde som voksne.
English: Most cases have been reversible, occurring with tacrolimus blood trough concentrations much higher than the recommended maximum levels.
Danish: De fleste tilfælde har været reversible og er forekommet ved tacrolimusblodkoncentrationer, der er langt højere end den anbefalede maksimale koncentration.
English: Monitoring of whole blood trough levels therefore provides a good estimate of systemic exposure.
Danish: Måling af koncentrationer i fuldblod giver derfor et godt skøn over den systemiske eksponering.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler
English: Absorption of tacrolimus is variable.
Danish: Absorptionen af tacrolimus er variabel.
English: If the physical appearance has changed from the normal white granules, or if dose instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.
Danish: Hvis medicinen ikke længere ser ud som det normale hvide granulat, eller hvis dosis er ændret, så kontakt Deres læge eller apoteket hurtigst muligt for at sikre, at De har fået den rigtige medicin.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Hvis Deres læge har fortalt Dem, at De ikke tåler visse sukkerarter, skal De kontakte lægen, før De tager denne medicin.
English: This typically presents as a bilateral and symmetrical, severe, ascending pain in the lower extremities and may be associated with supra-therapeutic levels of tacrolimus.
Danish: Dette fremstår typisk som en bilateral og symmetrisk, svær stigende smerte i underekstremiteterne og kan være associeret med supra-terapeutiske niveauer af tacrolimus.
English: Tacrolimus treatment can be considered in pregnant women, when there is no safer alternative and when the perceived benefit justifies the potential risk to the foetus.
Danish: Behandling med tacrolimus kan overvejes til gravide kvinder, når der ikke findes andre sikre alternativer, og de opnåede fordele opvejer den potentielle risiko for fosteret.
English: blindness not known:
Danish: Ikke kendt:
English: Highly variable age dependent total body clearance and half life were observed in limited paediatric clinical investigations, especially in early childhood.
Danish: Kraftigt varierende aldersafhængig total clearance og halveringstid blev observeret i begrænsede kliniske undersøgelser, særligt i den tidlige barndom.
English: Carefully open the prescribed number of sachets, e.g. with a pair of scissors at the point indicated with an arrow.
Danish: Åbn forsigtigt det ordinerede antal breve, f.eks. med en saks, ved det sted, der er markeret med en pil.
English: 50 sachets containing granules for oral suspension.
Danish: 50 breve indeholdende granulat til oral suspension.
English: Tacrolimus is a highly potent immunosuppressive agent and has proven activity in both in vitro and in vivo experiments.
Danish: Tacrolimus er et meget potent immunsuppressivt middel, der har vist aktivitet i både in vitro- og in vivoundersøgelser.
English: The half-life of tacrolimus is long and variable.
Danish: Halveringstiden for tacrolimus er lang og varierer.
English: In general, paediatric patients require doses 1½ - 2 times higher than the adult doses to achieve similar blood levels.
Danish: Pædiatriske patienter kræver generelt doser som er 1½ - 2 gange højere end voksendoser for at opretholde samme niveau.
English: After oral administration (0.30 mg/kg/day) to paediatric liver transplant patients, steady-state concentrations of tacrolimus were achieved within 3 days in the majority of patients.
Danish: Efter oral administration (0,30 mg/kg/dag) til pædiatriske leverpatienter blev steady state koncentrationerne for tacrolimus opnået inden for 3 dage hos størstedelen af patienterne.
English: All patients reported risk factors for PRCA such as parvovirus B19 infection, underlying disease or concomitant medications associated with PRCA.
Danish: Alle patienter havde risikofaktorer for PRCA såsom parvovirus B19 infektion, underliggende sygdom eller samtidig behandling med lægemidler associeret med PRCA.
English: Therapeutic drug monitoring
Danish: Terapeutisk lægemiddelovervågning
English: The frequency of blood level monitoring should be based on clinical needs.
Danish: Målingernes hyppighed bør afhænge af det kliniske behov.
English: You will need to take Modigraf every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Danish: De skal tage Modigraf hver dag så længe, De har behov for immundæmpende medicin, for at forebygge afstødning af Deres transplanterede organ.
English: Embryofoetal toxicity was observed in rats and rabbits and was limited to doses that caused significant toxicity in maternal animals.
Danish: Embryoføtal toksicitet blev observeret hos rotter og kaniner og var begrænset til doser, som forårsagede signifikant toksicitet hos moderdyrene.
English: Your doctor will tell you exactly how many sachets to take.
Danish: Lægen vil oplyse Dem om præcis, hvor mange breve, De skal bruge.
English: Concomitant use of these substances may require decreased tacrolimus doses in nearly all patients.
Danish: Samtidig brug af disse lægemidler kan nødvendiggøre nedsættelse af doseringen af tacrolimus hos næsten alle patienter.
English: Mycophenolic acid.
Danish: Mycophenolsyre.
English: The total daily dose of Modigraf granules should be administered in 2 equal doses.
Danish: Den totale daglige dosis Modigrafgranulat bør administreres som 2 lige store doser.
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult and paediatric patients.
Danish: Behandling af transplantatafstødning, der er resistent over for behandling med andre immunsuppressive lægemidler hos voksne og pædiatriske patienter.
English: In total 34 patients switched treatment from ciclosporin to tacrolimus, whereas only 6 tacrolimus patients required alternative therapy.
Danish: I alt skiftede 34 patienter behandling fra ciclosporin til tacrolimus, mens kun 6 tacrolimuspatienter havde behov for alternativ behandling.
English: There is limited experience in non-Caucasian patients and patients at elevated immunological risk (e.g. retransplantation, evidence of panel reactive antibodies, PRA).
Danish: Der er begrænset erfaring med ikke-kaukasiske patienter og patienter med forhøjet immunologisk risiko (f.eks. retransplantation, påvisning af PRA (panelreaktive antistoffer)).
English: Pour the prescribed volume of water (at room temperature) into a glass or cup, up to a maximum of 50 ml.
Danish: Hæld den ordinerede mængde vand (stuetemperatur) op i et glas eller en kop, højst op til 50 ml.
English: Tacrolimus may prolong the QT interval and may cause Torsades de Pointes.
Danish: Tacrolimus kan forlænge QT-intervallet og forårsage torsades de pointes.