FrancophonIA/ELRC3.0 huggingface dataset:
English: Orgalutran should not be used in people who may be hypersensitive (allergic) to ganirelix, to any of the other ingredients, to GnRH or to other GnRH analogues (medicines that have a similar structure to GnRH and modify the activity of GnRH in the body).
Danish: Orgalutran må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for ganirelix eller andre af indholdsstofferne eller over for GnRH eller GnRH-analoger (lægemidler, der har en struktur svarende til GnRH og ændrer aktiviteten af GnRH i kroppen).
English: A few days later, a hormone called human chorionic gonadotrophin (hCG) is given to trigger ovulation, and the eggs are then harvested.
Danish: Nogle få dage senere gives et hormon kaldet hCG (humant choriongonadotropin), som skal fremkalde ægløsning, hvorefter æggene kan udtages.
English: GnRH controls the secretion of another hormone called luteinising hormone (LH), which causes ovulation (the release of eggs during the menstrual cycle).
Danish: GnRH kontrollerer frigivelsen af et andet hormon, kaldet luteiniserende hormon (LH), som forårsager ovulation (ægløsning under en menstruationscyklus).
English: For the full list of all side effects reported with Orgalutran, see the package leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Orgalutran fremgår af indlægssedlen.
English: By blocking the effect of GnRH, Orgalutran stops the production of LH, and therefore prevents premature ovulation.
Danish: Orgalutran standser produktionen af LH ved at blokere virkningen af GnRH og forhindrer derfor for tidlig ægløsning.
English: Orgalutran was compared with buserelin, leuprorelin, and triptorelin (GnRH agonists: another group of medicines used to prevent premature ovulation, which work by stimulating the receptor for GnRH to such an extent that the body stops making LH).
Danish: Orgalutran blev sammenlignet med buserelin, leuprorelin og triptorelin (GnRH-agonister: en anden gruppe af lægemidler til forebyggelse af for tidlig ægløsning, som stimulerer receptoren for GnRH i tilstrækkeligt omfang til, at kroppen holder op med at producere LH).
English: Orgalutran is used to prevent premature ovulation (early release of eggs from the ovary) in women having fertility treatment and who are having ovarian stimulation (stimulation of the ovaries so that they produce more eggs).
Danish: Orgalutran anvendes til forebyggelse af præmatur ægløsning (for tidlig ægløsning fra æggestokkene) hos kvinder, som er i fertilitetsbehandling, og hvis ovarier stimuleres til at producere flere æg (ovariestimulation).
English: For further information on how to use Orgalutran, see the package leaflet.
Danish: De nærmere oplysninger om anvendelsen af Orgalutran fremgår af indlægssedlen.
English: What is Orgalutran?
Danish: Hvad er Orgalutran?
English: Orgalutran is a solution for injection in a prefilled syringe.
Danish: Orgalutran er en injektionsvæske, opløsning i fyldt injektionssprøjte.
English: What is Orgalutran used for?
Danish: Hvad anvendes Orgalutran til?
English: How has Orgalutran been studied?
Danish: Hvordan blev Orgalutran undersøgt?
English: What benefit has Orgalutran shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Orgalutran?
English: How is Orgalutran used?
Danish: Hvordan anvendes Orgalutran?
English: How does Orgalutran work?
Danish: Hvordan virker Orgalutran?
English: M1 and M2 are the only metabolites relevant in humans, both are microbiologically inactive.
Danish: M1 og M2 er de eneste relevante metabolitter hos mennesker og begge er mikrobiologiske inaktive.
English: 3641 RT Mijdrecht Netherlands
Danish: 3641 RT Mijdrecht Holland
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF AVALOX AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF AVALOX OG TILHØRENDE NAVNE (SE BILAG I)
English: Berkshire RG14 1JA United Kingdom
Danish: Berkshire RG14 1JA Storbritannien
English: B-1050 Brussel Belgium
Danish: B-1050 Brussel
English: 4.5 Interaction with other medicinal products and other forms of interaction Interactions with medicinal products
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: administration is only slightly higher than that observed after oral administration (35 mg·h/l) in accordance with the absolute bioavailability of approximately 91%.
Danish: administration er kun en smule højere end den der er observeret efter oral administration (35 mg⋅h/l), i overensstemmelse med, at den absolutte biotilgængelighed er på cirka 91 %.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Østrig:
English: - If you have a very slow heart rate (bradycardia).
Danish: - hvis De har et meget langsomt puls (bradykardi).
English: Slovenia BAYER d.o.o.
Danish: Slovenien BAYER d.o.o.
English: Contact your doctor if you are not sure if you belong to a patient group described below.
Danish: Kontakt Deres læge, hvis De er i tvivl om De tilhører en af patientgrupperne nedenfor.
English: - If you have a weak heart (heart failure).
Danish: - hvis De har et svagt hjerte (hjertesvigt).
English: - If you have a severe liver disease or liver enzymes (transaminases) that are higher than 5 times the upper normal limit.
Danish: - hvis De har alvorlig leversygdom eller leverenzymer (transaminaser), der er mere end 5 gange højere end den normale øvre grænse.
English: No prolongation of the QT interval was seen when a dose of 30 mg/kg was infused over 60 minutes.
Danish: Ingen forlængelse af QT-intervallet blev set, hvis 30 mg/kg blev infunderet over 60 minutter.
English: On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers.
Danish: På basis af de farmakokinetiske studier, som indtil nu er udført på patienter med leversvigt (Child-Pugh A, B), er det ikke muligt at afgøre, hvorvidt der er forskelle sammenlignet med raske forsøgspersoner.
English: If the treatment with this medicine is stopped too soon your infection may not be completely cured.
Danish: Hvis behandlingen med dette lægemiddel stoppes for tidligt, kan det være, at infektionen ikke helbredes helt.
English: Method of administration For intravenous use; constant infusion over 60 minutes (see also section 4.4).
Danish: Administration Til intravenøs brug: konstant infusion over 60 minutter (se også pkt.
English: Therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin.
Danish: Det er derfor vigtigt at overveje denne diagnose hos patienter, som udvikler alvorlig diaré under eller efter moxifloxacinbehandling.
English: Like all medicines, Avalox can cause side effects, although not everybody gets them.
Danish: Avelox kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: The Applicant accepted the restriction of cSSSI to a second-line treatment together with a warning towards MRSA in section 4.4.
Danish: Ansøgeren accepterede begrænsningen af cSSSI til andetvalgsbehandling sammen med en advarsel vedrørende MRSA i punkt 4.4.
English: Do not take Avalox if you are pregnant or breast-feeding.
Danish: Tag ikke Avelox, hvis De er gravid eller ammer.
English: Bayer Santé 13, rue Jean Jaurès 92807 Puteaux Cedex
Danish: Bayer Santé 13, rue Jean Jaurès 92807 Puteaux Cedex Frankrig
English: You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while taking Avalox.
Danish: De skal undgå langvarigt ophold i sollys eller stærkt sollys og bør ikke bruge solarium eller andre UV-lamper, mens Avelox anvendes.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under i pkt.
English: Pharmacodynamic studies of fluoroquinolones in animal infection models and in human trials indicate that the primary determinant of efficacy is the AUC24/MIC ratio.
Danish: Farmakodynamiske studier af fluoroquinoloner i infektionsmodeller hos dyr og i kliniske studier hos mennesker indikerer, at den primære determinant for virkningen er forholdet mellem AUC24/MIC.
English: After intravenous administration of moxifloxacin to dogs (30 mg/kg infused over 15, 30 or 60 minutes) the degree of QT prolongation was clearly depending on the infusion rate, i.e. the shorter the infusion time the more pronounced the prolongation of the QT interval.
Danish: Efter intravenøs administration af moxifloxacin til hunde (30 mg/kg infunderet over 15, 30 eller 60 minutter) var graden af QT-forlængelse klart afhængig af infusionshastigheden, d.v.s. jo kortere infusionstid desto mere udtalt var forlængelsen af QT-intervallet.
English: Anxiety reactions Psychomotor hyperactivity / agitation
Danish: Angstanfald Psykomotorisk hyperaktivitet/agitation
English: Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
Danish: Comercialização de Produtos Farmacêuticos Rua Quinta do Pinheiro, 5 2794-003 Carnaxide Portugal
English: Recovery of the dose (unchanged drug and metabolites) totalled to approximately 98% after intravenous administration of the drug.
Danish: Genfinding af dosen (uomdannet lægemiddelstof og metabolittter) var totalt cirka 98 % efter intravenøs indgift af lægemidlet.
English: - Avalox should be given intravenously (in the vein) only, and should not be administered into an artery.
Danish: - Avelox må kun gives intravenøst (i venen) og må ikke gives i arterier.
English: Swelling (of the hands, feet, ankles, lips, mouth, throat)
Danish: hævelser (af hænder, fødder, ankler, læber, mund og hals)
English: Resistance to fluoroquinolones can arise through mutations in DNA gyrase and topoisomerase IV. Other mechanisms may include over-expression of efflux pumps, impermeability, and protein mediated protection of DNA gyrase.
Danish: Resistens over for fluoroquinoloner kan opstå via mutationer i DNA-gyrase og -topoisomerase IV. Andre mekanismer kan omfatte overekspression af efflukspumper, impermeabilitet og proteinmedieret beskyttelse af DNA-gyrase.
English: Using Avalox with food and drink The effect of Avalox is not influenced by food including dairy products.
Danish: Brug af Avelox sammen med mad og drikke Virkningen af Avelox påvirkes ikke af mad inklusive mejeriprodukter.
English: This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes.
Danish: Dette kan medføre en øget risiko for ventrikulære arytmier, herunder torsades de pointes.
English: In in vivo tests, no evidence of genotoxicity was found despite the fact that very high moxifloxacin doses were used.
Danish: I in vivo-tests blev der ikke fundet tegn på genotoksicitet trods af anvendelse af meget høje doser af moxifloxacin.
English: - If you are a child or an adolescent still growing.
Danish: - hvis De er barn eller ung i voksealderen.
English: Do not use Avalox after the expiry date which is stated on the label on the bottle bag and carton.
Danish: Brug ikke Avelox efter den udløbsdato, der står på pakningen.
English: Moxifloxacin was non-carcinogenic in an initiation-promotion study in rats.
Danish: Moxifloxacin var ikke karcinogent i et initiation-promotion studie med rotter.
English: Distinct alteration of the electrical activity of the heart (ECG) in patients with decreased blood potassium
Danish: tydelig ændring i den elektriske hjerteaktivitet (EKG) hos patienter med nedsat kaliumindhold i blodet
English: Pharmacokinetics are linear in the range of 50 - 1200 mg single oral dose, up to 600 mg single intravenous dose and up to 600 mg once daily dosing over 10 days.
Danish: Farmakokinetikken er lineær i intervallet 50-1.200 mg givet som enkelt dosis, op til 600 mg som enkelt intravenøs dosis og op til 600 mg ved én daglig dosering i 10 dage.
English: Avalox works by killing bacteria that cause infections if they are caused by bacteria that are susceptible to moxifloxacin.
Danish: Avelox virker ved at dræbe bakterier, der forårsager infektioner, hvis de er forårsaget af bakterier, der er følsomme over for moxifloxacin.
English: ageusia in very rare cases) Confusion and disorientation Sleep disorders (predominantly insomnia) Tremor
Danish: ageusi i meget sjældne tilfælde) Forvirring og desorientering Søvnforstyrrelser (hovedsageligt insomni)
English: The following side effects have been observed during treatment with Avalox.
Danish: Følgende bivirkninger er set under behandling med Avelox.
English: Increase of skin sensitivity
Danish: øget hudfølsomheden
English: Increase in transaminases
Danish: Øgning af transaminaser
English: Moxifloxacin undergoes Phase II biotransformation and is excreted via renal (approximately 40%) and biliary/faecal (approximately 60%) pathways as unchanged drug as well as in the form of a sulpho-compound (M1) and a glucuronide (M2).
Danish: Moxifloxacin gennemgår fase II biotransformation og udskilles via renale (ca. 40 %) og galde/fækale (ca. 60 %) udskillelsesveje som uomdannet lægemiddel såvel som i form af en sulfoforbindelse (M1) og et glukuronid (M2).
English: Intravenous moxifloxacin was not associated with an increased incidence of events that would be considered surrogates for a QTcrelated arrhythmia.
Danish: Intravenøs moxifloxacin var ikke forbundet med en øget incidens af hændelser, der kunne betragtes som surrogater for en QTcrelateret arytmi.
English: - If you are taking other medicines that result in certain abnormal ECG changes (see section Taking other medicines).
Danish: - hvis De tager andre lægemidler, der resulterer i unormale EKG-ændringer (se afsnittet 2.
English: A feeling of self-detachment (not being yourself), insanity (potentially leading to self harm)
Danish: forandret personlighed (ikke være sig selv), sindssyge (kan måske føre til, at man gør skade på sig selv)
English: Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN.
Danish: Grundet begrænsede kliniske data er Avelox også kontraindiceret til patienter med nedsat leverfunktion (Child-Pugh C) og til patienter med stigning i transaminaser > 5 gange øvre normalværdi (ULN).
English: Maximum concentrations of 5.4 mg/kg and 20.7 mg/l (geometric mean) were reached in bronchial mucosa and epithelial lining fluid, respectively, 2.2 h after an oral dose.
Danish: Maximumkoncentrationer på 5,4 mg/kg og 20,7 mg/l (geometrisk middelværdi) blev opnået i henholdsvis bronkialslimhinden og epitelial væskefilm (epithelial lining fluid) 2,2 timer efter en oral dosis.
English: Fluoroquinolones exhibit a concentration dependent killing of bacteria.
Danish: Fluoroquinoloner udviser en koncentrationsafhængig ødelæggelse af bakterier.
English: Abnormal fast heart rate, fainting, high blood pressure, low blood pressure
Danish: unormal, hurtig hjerteslag, besvimmelse, forhøjet blodtryk, for lavt blodtryk
English: Changes in INR
Danish: INR-forandringer
English: Vomiting Gastrointestinal and abdominal pains
Danish: Opkastning Gastrointestinale og abdominale smerter Diaré
English: Finally, the Applicant claimed that the superior potency and pharmacokinetics of moxifloxacin avoids the selection of quinolone resistant isolates of S. pneumoniae.
Danish: Endelig hævdede ansøgeren, at moxifloxacins bedre styrke og farmakokinetiske egenskaber hindrer selektionen af quinolon-resistente isolater af S. pneumoniae.
English: Avalox may make you feel dizzy or light-headed or you might faint for a short period.
Danish: Avelox kan medføre svimmelhed eller uklarhed, eller De kan besvime i en kortere periode.
English: 151 25 Marousi - Athens Greece
Danish: 151 25 Marousi
English: - There is limited experience on use of sequential intravenous/oral Avalox for the treatment of infection of the lungs (pneumonia) acquired outside the hospital.
Danish: - Der er begrænset erfaring med anvendelsen af skiftende intravenøs/oral Avelox-behandling til lungeinfektion (lungebetændelse) erhvervet uden for hospitalet.
English: very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), swelling (incl.
Danish: meget sjælden livstruende shock (f.eks. åndedrætsbesvær, blodtryksfald, hurtig puls), hævelser (inkl.
English: After repeated dosing in healthy volunteers moxifloxacin increased Cmax of digoxin approximately 30% without affecting AUC or trough levels.
Danish: Efter gentagen dosering til raske forsøgspersoner forøgede moxifloxacin Cmax for digoxin med ca. 30 % uden påvirkning af AUC eller dalkoncetrationer.
English: Please contact your doctor before you continue the treatment if you suddenly start to feel unwell or notice yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or disturbances of thought or wakefulness.
Danish: Kontakt Deres læge, før De fortsætter behandlingen, hvis De pludselige bliver utilpas eller bemærker en gulfarvning af det hvide i øjnene, mørk urin, hudkløe, tendens til at bløde eller tankeforstyrrelser eller søvnløshed.
English: “Complicated skin and skin structure infections only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection (see section 4.4)”
Danish: “Anvendes udelukkende til komplicerede infektioner i hud og blødt væv, når det anses for uhensigtsmæssigt at anvende de antibakterielle midler, der almindeligvis anbefales til den indledende behandling af denne infektion (se punkt 4.4)”
English: Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
Danish: Patienter skal rådes til at kontakte deres læge inden behandlingen fortsættes, hvis tegn og symptomer af fulminant hepatitis udvikler sig såsom hurtigt udviklende asteni forbundet med gulsot, mørk urin, blødningstendens eller hepatisk encefalopati.
English: - You may develop diarrhoea whilst taking, or after taking, antibiotics including Avalox.
Danish: - De kan få diaré under behandling, eller efter behandling, med antibiotika inklusive Avelox.
English: Avalox is used in adults for treating the following bacterial infections: - Infection of the lungs (pneumonia) acquired outside the hospital - Infections of the skin and soft tissue
Danish: Avelox anvendes til behandling af voksne med følgende bakterielle infektioner: - lungeinfektion (lungebetændelse) erhvervet uden for hospitalet - infektioner i hud og bløddele
English: Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis
Danish: sprængning af sene, betændelse i led, muskelstivhed, forværring af symptomer for myasthenia gravis
English: increase of a special liver enzyme in the blood (LDH)), increase of bilirubin in the blood, increase of a special liver enzyme in the blood (gamma-glutamyl-transferase and/or alkaline phosphatase)
Danish: forhøjet indhold af af specielle leverenzymer i blodet (LDH)), forhøjet bilirubin i blodet, forhøjet indhold af specielle leverenzymer i blodet (gamma-glytamyltransferase og/eller alkalisk fosfatase)
English: Alterations of the skin and mucous membranes (painful blisters in the mouth/nose or at the penis/vagina), potentially life-threatening (Stevens-Johnson-Syndrome, toxic epidermal necrolysis)
Danish: ændringer i hud og slimhinder (smertefulde blærer i munden/næsen eller ved penis/skeden), kan være livstruende (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse)
English: Increased blood clotting Allergic Reactions Uncommon: Allergic reaction Rare:
Danish: øget størkningsevne Allergiske reaktioner Ikke almindelige:
English: - If you suffer from myasthenia gravis using Avalox may worsen the symptoms of your disease.
Danish: - Hvis De lider af myasthenia gravis, kan behandling med Avelox forværre symptomerne på sygdommen.
English: In dogs, high oral doses (≥ 60 mg/kg) leading to plasma concentrations ≥ 20 mg/l caused changes in the electroretinogram and in isolated cases an atrophy of the retina.
Danish: Hos hunde medførte høje orale doser (>60 mg/kg) med deraf følgende plasmakoncentrationer på >20 mg/l ændringer i elektroretinogrammet og i isolerede tilfælde atrofi af retina.
English: loss of smell), abnormal dreams, balance disorder and poor co-ordination (due to dizziness), convulsions, disturbed concentration, impaired speech, partial or total loss of memory
Danish: tab af lugtesansen), unormale drømme, balance- og koordineringsforstyrrelser (som følge af svimmelhed), krampetrækninger, koncentrationsforstyrrelser, taleforstyrrelser, delvist eller helt tab af hukommelsestab
English: Important information about some of the ingredients of Avalox This medicinal product contains 787mg (approximately 34mmol) sodium per dose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Avelox Dette lægemiddel indeholder 787 mg (ca. 34 mmol) natrium pr. dosis.
English: Nervous System Common:
Danish: Nervesystemet Almindelig:
English: The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic exposure to moxifloxacin in cases of oral overdose.
Danish: Ved oral overdosering kan anvendelse af aktivt kul tidligt i absorptionsforløbet være nyttig for at undgå en voldsom stigning i systemisk eksponering for moxifloxacin.
English: Avalox will always be given to you by a doctor or healthcare professional.
Danish: Avelox-infusionsvæske vil altid blive givet af en læge eller sygeplejerske.
English: Jaundice (yellowing of the whites of the eyes or skin), inflammation of the liver
Danish: gulsot (gulfarvning af det hvide i øjnene eller af huden), leverbetændelse
English: In some cases your doctor may start your treatment with Avalox solution for infusion and then continue your treatment with Avalox tablets.
Danish: I nogle tilfælde vil lægen starte behandlingen med Avelox-infusionsvæske og derpå fortsætte behandlingen med Aveloxtabletter.
English: Excipient: 250 ml of solution for infusion contains 34 mmol sodium.
Danish: Hjælpestoffer: 250 ml opløsning til infusionsvæske indeholder 34 mmol natrium.
English: The duration of treatment depends upon the type of infection, and how well you respond to treatment but the recommended durations of use are:
Danish: Behandlingsvarigheden vil afhænge af infektionstypen og af, hvor godt De reagerer på behandlingen.
English: If you stop using Avalox
Danish: Hvis De holder op med at få Avelox
English: Before using Avalox for the first time - Avalox can temporarily change your heart's ECG, which can very rarely lead to life-threatening disturbances of the heart rhythm.
Danish: Før De tager Avelox-infusionsvæske - Avelox kan midlertidigt ændre hjertediagrammet, hvilket meget sjældent kan medføre livstruende forstyrrelser i hjerterytmen.
English: In conclusion, the CHMP considered that the use of IV moxifloxacin for treatment of communityacquired pneumonia (CAP) or complicated skin and soft tissue infections (cSSTI) should be qualified as follows:
Danish: CHMP var således af den opfattelse, at der for brugen af intravenøs moxifloxacin til behandling af samfundserhvervet pneumoni (CAP) eller komplicerede infektioner i hud og blødt væv (cSSSI) burde gælde følgende ordlyd:
English: double and blurred vision
Danish: dobbelsyn og sløret syn
English: When using Avalox - The risk of cardiac abnormalities may increase with the dose and the speed of the infusion into your vein.
Danish: Når De tager Avelox-infusionsvæske - Risikoen for hjerteforstyrrelser kan øges ved højere dosis og højere hastighed for indsprøjtningen i Deres blodåre.
English: In conventional repeated dose studies moxifloxacin revealed haematological and hepatic toxicity in rodents and non-rodents.
Danish: Konventionelle studier med gentagne doser viste, at moxifloxacin er hæmatologisk og hepatisk toksisk hos gnavere og ikke-gnavere.