FrancophonIA/ELRC3.0 huggingface dataset:
English: • Administer the diluted solution via intravenous infusion for 15 to 30 minutes.
Danish: • Indgiv den fortyndede opløsning via intravenøs infusion over 15-30 minutter.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE HÆTTEGLASETIKET
English: Alpivab 200 mg concentrate for solution for infusion peramivir
Danish: Alpivab 200 mg koncentrat til infusionsvæske, opløsning peramivir
English: However, in an embryo-foetal development study in rats, in which dams received continuous infusions of peramivir from day 6-17 of gestation at doses of 50, 400 or 1000 mg/kg/day, dose related increases in the incidences of reduction of the renal papillae and dilatation of the ureters were observed.
Danish: Der er imidlertid observeret dosisrelaterede stigninger i forekomsten af reducerede nyrepapiller og udvidede urinledere i en undersøgelse af embryoføtal udvikling hos rotter, hvor moderdyrene fik kontinuerlig infusion af peramivir fra drægtighedsperiodens dag 6-17 i doser på 50, 400 eller 1 000 mg/kg/dag.
English: NAME OF THE MEDICINAL PRODUCT Alpivab 200 mg concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Alpivab 200 mg koncentrat til infusionsvæske, opløsning
English: If refrigerated, allow the diluted peramivir solution to reach room temperature, then administer immediately.
Danish: Hvis den fortyndede opløsning har været på køl, skal den opnå stuetemperatur og derefter administreres med det samme.
English: NAME OF THE MEDICINAL PRODUCT Alpivab 200 mg concentrate for solution for infusion peramivir
Danish: LÆGEMIDLETS NAVN Alpivab 200 mg koncentrat til infusionsvæske, opløsning peramivir
English: Administer the diluted solution via intravenous infusion over 15 to 30 minutes.
Danish: Indgiv den fortyndede opløsning via intravenøs infusion over 15-30 minutter.
English: • If a patient receives 600 mg peramivir the required volume of peramivir concentrate is 60 mL
Danish: • Hvis en patient skal have 600 mg peramivir, er det nødvendige volumen af koncentrat af peramivir 60 ml (3 hætteglas a 20 ml).
English: How to store Alpivab
Danish: Sådan får du Alpivab
English: 13 years - <18
Danish: 13 år - < 18 år
English: In the case of a 300 mg peramivir dose, 30 mL (1½ vials) of peramivir concentrate is needed and for a 200 mg dose, only 20 mL (1 vial).
Danish: Til en dosis på 300 mg peramivir skal der klargøres 30 ml koncentrat af peramivir (1½ hætteglas), og til en dosis på 200 mg skal der kun klargøres 20 ml (1 hætteglas).
English: In the case of a 300 mg peramivir dose, 30 mL (1½ vials) of Alpivab concentrate is needed and for a 200 mg dose, only 20 mL (1 vial).
Danish: Til en dosis på 300 mg peramivir skal der klargøres 30 ml koncentrat af Alpivab (1½ hætteglas), og til en dosis på 200 mg skal der kun klargøres 20 ml (1 hætteglas).
English: Cardiac disorders electrocardiogram QT prolonged
Danish: Hjerte forlænget QT på ekg
English: gamma-glutamyltransferase, creatine phosphokinase, urea, creatinine
Danish: kreatinfosfokinase, urinstof, kreatinin i blodprøver
English: • inflammation of stomach lining
Danish: • betændelse i bughinden
English: • liver disorder
Danish: • leversygdom
English: Eye disorders vision blurred
Danish: Øjne sløret syn
English: General disorders and administration site conditions chest discomfort, fatigue *These events reported from post-authorization use occurred with different dosage and dosing schedule to that described in the SmPC.
Danish: *Disse bivirkninger, der er indberettet efter markedsføring, optrådte ved andre doseringer og doseringsregimer end dem, der er beskrevet i produktresuméet.
English: • upper abdominal pain, abdominal discomfort
Danish: • smerter i øvre del af maven, ubehag i maven
English: • nausea (feeling sick), vomiting
Danish: • kvalme, opkastning
English: • very severe skin reactions, including Steven-Johnson syndrome and dermatitis exfoliative These skin reactions are life-threatening rashes with fever and blisters and can effect the lining of the mouth and genitals.
Danish: Disse hudreaktioner er livstruende udslæt med feber og blæredannelse, som kan påvirke slimhinderne i munden og kønsorganerne.
English: Race
Danish: • kløe
English: • sleeplessness
Danish: • ledsmerter
English: 30 to 49
Danish: 4.4 og 5.1).
English: What Alpivab looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: • skin inflammation, eczema, rash, nettle-rash
Danish: • betændelse i huden, eksem, udslæt, nældefeber
English: 95% CI
Danish: 95 % KI
English: Some people will get this infection whilst very young but for others it will be much later.
Danish: Nogle personer vil få denne infektion, når de er meget unge, men for andre sker dette meget senere.
English: All patients using LOCF
Danish: Alle patienter, der anvender LOCF
English: • Information on the need to comply with the treatment in order to maximise the potential benefits.
Danish: • Information om nødvendigheden af at efterleve behandlingen for at maksimere de potentielle fordele.
English: Explain that the device should be discarded after 28 days.
Danish: Forklare, at udstyret skal kasseres efter 28 dage.
English: Breathe out slowly.
Danish: Ånd langsomt ud.
English: Protein binding is low.
Danish: Proteinbinding er lav.
English: The dose interval should be as close as possible to 12 hours.
Danish: Dosisintervallet bør være så tæt på 12 timer som muligt.
English: • There should be a 12 hour gap between doses.
Danish: • Der bør være 12 timer mellem doserne.
English: − emphasise that patients should persist with the treatment.
Danish: − Lægge vægt på, at patienter skal fortsætte med behandlingen.
English: • Unpleasant taste
Danish: • Ubehagelig smag
English: Date of first authorisation: 13/02/2012 Date of latest renewal: 26/09/2016
Danish: Dato for første markedsføringstilladelse: 13/02/2012 Dato for seneste fornyelse:26/09/2016
English: The mechanism is unknown.
Danish: Mekanismen er ukendt.
English: • have reacted badly to inhaled dry powder medicines previously unless this has already been discussed with your doctor.
Danish: • Har reageret dårligt på inhaleret tørpulvermedicin tidligere, medmindre dette allerede er blevet diskuteret med din læge.
English: Carry on from there as instructed.
Danish: Derefter fortsættes som instrueret.
English: The first dose should be given under medical supervision.
Danish: Den første dosis bør gives under lægelig overvågning.
English: • If this happens, you may be able to feel these pieces on your tongue or in your airways.
Danish: • Hvis dette sker, kan du mærke dem på tungen eller i luftvejene.
English: • Hoarse or weak, or even loss of the voice
Danish: • Hæs eller svag eller endda mistet stemme
English: There were 32 patients aged 6-12 years, 41 patients aged 13-17 years and 114 patients aged 18 years and older.
Danish: Der var 32 patienter i alderen 6-12 år, 41 patienter i alderen 13-17 år, og 114 patienter i alderen 18 år og derover.
English: If this infection is not properly controlled it will cause damage to the lungs.
Danish: Hvis denne infektion ikke kontrolleres hensigtsmæssigt, vil den forårsage skade på lungerne.
English: If it is not empty, repeat steps 7, 8 and 9 until you have inhaled all of the contents.
Danish: Hvis den ikke er tom, skal du gentage trin 7, 8 og 9, indtil du har inhaleret alt indholdet.
English: Do not drive or use any machines until the symptoms have gone away.
Danish: Du må ikke føre motorkøretøjer eller bruge maskiner, før symptomerne er forsvundet.
English: Patients should be warned not to drive or operate machines if this occurs.
Danish: Patienter bør advares om ikke at føre motorkøretøjer eller betjene maskiner, hvis dette forekommer.
English: Additional information
Danish: Yderligere oplysninger
English: Frequencies are defined as: 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), not known (cannot be estimated from the available data).
Danish: Hyppighed defineres som: 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Like all medicines this medicine can cause side effects, although not everyone gets them.
Danish: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Capsules: no special requirements for disposal.
Danish: Kapsler: ingen særlige forholdsregler ved bortskaffelse.
English: It should be noted that treatment was not interrupted when patients received concomitant parenteral antibacterial active substances.
Danish: Det bør bemærkes, at behandlingen ikke blev afbrudt hvis patienter modtog samtidige parenterale antibakterielle aktive stoffer.
English: Safety and efficacy have been assessed in controlled studies for up to 24 weeks.
Danish: Sikkerhed og effekt er blevet vurderet i kontrollerede undersøgelser i op til 24 uger (se pkt.
English: Adjusted Treatment difference
Danish: Justeret behandlingsforskel
English: If other treatments are being taken, they should be taken in the following order: Inhaled bronchodilators
Danish: Hvis andre behandlinger anvendes, bør de anvendes i den følgende rækkefølge: Inhalations-bronkodilatorer
English: However, overdose may possibly result in higher systemic exposure.
Danish: Imidlertid kan overdosering muligvis resultere i højere systemisk udsættelse.
English: Do not give Colobreathe to children under the age of 6 years as it is not suitable for them.
Danish: Giv ikke Colobreathe til børn under 6 år, da det ikke er egnet til dem.
English: The efficacy of Colobreathe has been demonstrated in a study of 24-weeks duration.
Danish: Virkningen af Colobreathe er blevet påvist i en undersøgelse af 24 ugers varighed.
English: Once you have removed the capsule it must be used immediately.
Danish: Når du har taget kapslen ud, skal den bruges med det samme.
English: • Introduction to the product: provide information on the contents of the box ie that 28 days treatment is 56 capsules and 1 device.
Danish: • Introduktion til produktet: tilvejebringe information om indholdet af boksen, dvs. at 28 dages behandling består af 56 kapsler og et udstyr.
English: Consideration should be given to official guidance on the appropriate use of antibacterial active substances.
Danish: Der bør tages hensyn til den officielle vejledning vedrørende korrekt anvendelse af antibakterielle aktive stoffer.
English: The results of the Intent-To-Treat (ITT) population for the primary efficacy outcome are shown below:
Danish: Resultaterne for intent-to-treat-populationen for det primære effektudfald var som vist nedenfor:
English: No in-vivo interaction studies have been performed.
Danish: Der er ikke udført in vivo-interaktionsundersøgelser.
English: Explanation that using inhaled antibiotics can reduce the need for intravenous antibiotics.
Danish: En forklaring om, at anvendelse af inhaleret antibiotika kan reducere nødvendigheden for intravenøst antibiotika.
English: The order in which other treatments should be taken or carried out
Danish: Rækkefølge for andre behandlinger, som skal tages eller udføres
English: • Do not pierce the capsule more than once.
Danish: • Gennembor ikke kapslen mere end én gang.
English: • Detailed instructions about how to use the medication: starting from unpacking of the product and finishing with disposal of the used capsule and device.
Danish: • Detaljeret instruktion om hvorledes medicinen skal anvendes: Startende med udpakning af produktet og sluttende med bortskaffelse af den anvendte kapsel og udstyr.
English: The Physician and patient “DVDs/leaflet forms” should contain the following key elements and messages:
Danish: ”Læge- og patient-DVDer/brochurer” skal indeholde de følgende hovedelementer og meddelelser:
English: The adjusted treatment difference and 95% confidence interval have been back transformed from log transformed data.
Danish: Den justerede behandlingsdifference og 95 % konfidensinterval er tilbagetransformeret fra log-transformerede data.
English: Explanation of the Turbospin and how it works.
Danish: En forklaring vedrørende Turbospin og hvorledes den virker.
English: The ITT population excluded patients who had been treated but demonstrated no evidence of chronic infection.
Danish: ITT-populationen omfattede patienter, der var blevet behandlet, men ikke udviste nogen tegn på kronisk infektion.
English: Store in the original package until immediately before use in order to protect from moisture.
Danish: Opbevares i den originale yderpakning indtil umiddelbart før anvendelse for at beskytte mod fugt.
English: • Raised temperature
Danish: • Forhøjet temperatur
English: Treatment may be continued for as long as the physician considers that the patient is obtaining clinical benefit.
Danish: Behandling bør fortsættes, så længe lægen mener, at patienten har klinisk fordel af behandlingen.
English: The subjects were aged 6 years and above and had an FEV1% predicted of 25-75%.
Danish: Forsøgspersonerne var 6 år eller derover og havde en FEV1 % forventet på 25-75%.
English: Remove the Turbospin inhaler from your mouth and hold your breath for about 10 seconds or for as long as is comfortable, then breathe out slowly.
Danish: Fjern Turbospin-inhalatoren fra munden og hold vejret i ca. 10 sekunder, eller så længe det er behageligt; ånd derefter langsomt ud.
English: The data from the primary outcome parameter, change in FEV1 % predicted, are not normally distributed.
Danish: Data fra de primære resultatparametre, ændring i FEV1, % forudset er normalt fordelt.
English: • Protein in the urine (found by testing)
Danish: • Protein i urinen (konstateres ved en test)
English: • Discussion about common side effects and in particular cough and taste abnormality: Explanation that:
Danish: • Diskussion om almindelige bivirkninger og særligt hoste og smagsforandringer: En forklaring om:
English: Oral fungal super-infection
Danish: Oral super-svampeinfektion
English: No force is required.
Danish: Det er ikke nødvendigt at bruge kræfter.
English: Your doctor will decide how long you/your child's treatment should last.
Danish: Lægen vil beslutte, hvor længe din/dit barns behandling skal fortsætte.
English: One study in cystic fibrosis patients gives the steady-state volume of distribution as 0.09 l/kg.
Danish: En undersøgelse af patienter med cystisk fibrose viser et steady-state distributionsvolumen på 0,09 L/kg.
English: The above side effects have been seen in people of all ages with similar frequency.
Danish: De ovennævnte bivirkninger er blevet set med samme hyppighed hos personer i alle aldre.
English: • The capsule is now pierced and the contents can be inhaled.
Danish: • Kapslen er herefter gennemboret, og indholdet kan inhaleres.
English: − that cough decreases with repeated use of the product and should stabilize after the first month or so.
Danish: − at hoste aftager med gentagen anvendelse af produktet og bør være stabiliseret efter ca. en måned.
English: Take care not to cover the air slits with your fingers or mouth during inhalation.
Danish: Pas på, at du ikke dækker luftsprækkerne med dine fingre eller mund under inhalationen.
English: Hold that position before continuing to follow through with the piercing.
Danish: Hold denne position, inden du fortsætter med at udføre gennemboringen.
English: Do not try to loosen the capsule by repeatedly pressing the piston.
Danish: Du må ikke prøve at løsne kapslen ved at trykke på stemplet gentagne gange.
English: Since the mechanism of action of the polymyxins is different from that of other antibacterial agents, resistance to colistin and polymyxin by the above mechanism alone would not be expected to result in resistance to other drug classes.
Danish: Eftersom virkningsmekanismen for polymyxinerne er forskellig fra den af andre antibakterielle midler, ville resistens over for colistin og polimycin på grund af ovennævnte mekanisme alene ikke forventes at resultere i resistens over for andre lægemiddelklasser.
English: Overdose is unlikely by the inhaled route but has been recognised after systemic use.
Danish: Overdosering er usandsynlig ved anvendelse af administrationsvejen inhalation, men er anerkendt efter systemisk anvendelse.
English: There is no specific antidote, therefore management should be done by supportive treatment.
Danish: Der findes ingen specifik modgift, og overdosering håndteres derfor med støttende behandling.
English: The safety of Colobreathe has been assessed in a total of 237 subjects (225 cystic fibrosis patients and 12 healthy volunteers).
Danish: Sikkerheden af Colobreathe er blevet vurderet hos i alt 237 forsøgspersoner (225 patienter med cystisk fibrose og 12 raske frivillige forsøgspersoner).
English: • Ringing or buzzing noises in the ear, problems with balance
Danish: • Ringen eller brummen for øret, balanceproblemer
English: Warnings and precautions Tell your doctor if you/your child has ever had any of the following conditions:
Danish: Advarsler og forsigtighedsregler Fortæl lægen, hvis du/dit barn nogensinde har haft nogen af følgende sygdomme:
English: If any of these effects become a problem, please contact your doctor who may change your treatment.
Danish: Hvis nogle af disse virkninger bliver et problem, skal du spørge din læge til råds, så han/hun kan ændre din behandling.
English: Components of the PEG-gelatin hard capsules:
Danish: Indholdsstoffer i de hårde PEG-gelatinekapsler:
English: 2031 GA Haarlem The Netherlands.
Danish: 2031 GA Haarlem Holland.
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftning og behandlingskomplikationer
English: Colobreathe is available in packs containing either 8 or 56 hard capsules.
Danish: Colobreathe fås i pakninger, der indeholder enten 8 eller 56 hårde kapsler.
English: This may be related to Candida albicans infection or hypersensitivity.
Danish: Disse kan være relateret til infektion med Candida albicans eller overfølsomhed.
English: The Marketing Authorisation Holder shall ensure that all physicians who are expected to prescribe or use Colobreathe are provided with a healthcare professional and patient educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle læger, som forventes at ordinere eller anvende Colobreathe, tilvejebringes en sundhedspersonale- og patientuddannelsespakke, der indeholder følgende:
English: Nonclinical data reveal no special hazard for humans based on conventional studies of genotoxicity.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af genotoksicitet.
English: • Lack of energy, tiredness
Danish: • Mangel på energi, træthed
English: Do not stop your treatment early unless your doctor says you can.
Danish: Stop ikke behandlingen, medmindre lægen siger, at du/dit barn skal.
English: Of these, 187 patients aged 6 years and above were exposed to Colobreathe one capsule twice daily in a 24-week, phase 3 comparative study.
Danish: Af disse blev 187 patienter i alderen 6 år og derover udsat for Colobreathe en kapsel to gange daglig i en 24-ugers, fase 3-sammenlignende undersøgelse.
English: Treatment with colistimethate sodium or colistin did not induce the activity of any enzyme tested (CYP1A2, 2B6, 2C8, 2C9, 2C19 and 3A4/5).
Danish: Behandling med colistimethatnatrium eller colistin inducerede ikke aktiviteten af nogen af de undersøgte enzymer (CYP1A2, 2B6, 2C8, 2C9, 2C19 og 3A4/5).
English: • Unusual noises in the chest (your doctor would hear this when listening to your lungs with a stethoscope)
Danish: • Usædvanlige lyde i brystet (din læge kan høre dette ved at lytte til dine lunger med et stetoskop)
English: Animal studies of safety pharmacology, repeated dose toxicity or toxicity to reproduction, employing routes assuring systemic exposure, showed no particular hazard.
Danish: Dyreundersøgelser af sikkerhedsfarmakologi, toksicitet ved gentagen dosis eller reproduktionstoksicitet, ved anvendelse af administrationsveje, der sikrer systemisk udsættelse, viste ingen særlig risiko.
English: Change in FEV1 (% predicted) from baseline at Week 24 (ITT Population) Patient group Colobreathe
Danish: Ændring i FEV1 (% forventet) fra baseline e ved uge 24 (ITT-population) Patientgruppe Colobreathe
English: − these are only of nuisance value for most patients
Danish: − At disse sædvanligvis kun er en mindre gene for de fleste patienter.
English: Your doctor, pharmacist or nurse should show you/your child how to inhale the medicine when you/your child first start treatment:
Danish: Din læge, apotekspersonalet eller sundhedspersonalet bør vise dig/dit barn, hvordan medicinen skal inhaleres, når du eller dit barn starter på behandlingen:
English: The capsules are packed in blister packs supplied in cartons containing:
Danish: Kapslerne er pakket i blisterpakninger, som ligger i æsker med:
English: As 80% of a parenteral dose can be recovered unchanged in the urine, and there is no biliary excretion, it can be assumed that the remaining drug is inactivated in the tissues.
Danish: Eftersom 80 % af en parenteral dosis kan genfindes uforandret i urinen, og der finder ikke udskillelse sted via galden, kan det antages, at det tilbageværende lægemiddel inaktiveres i vævene.
English: Efficacy was measured by the change in FEV1 % predicted compared to baseline after a 24-week treatment period.
Danish: Effekten blev målt som ændringen i FEV11 % forventet sammenlignet med baseline efter en 24-ugers behandlingsperiode.
English: Then, breathe in slowly and deeply through your mouth at a rate sufficient for you to hear or feel the capsule spinning.
Danish: Træk derefter vejret langsomt og dybt gennem munden i et tempo, så du kan høre eller mærke kapslen snurre rundt.
English: Place the mouthpiece between your lips and teeth.
Danish: Placér derefter mundstykket mellem læberne og tænderne.
English: You/your child may get an unpleasant taste in your mouth after inhaling Colobreathe.
Danish: Du/dit barn kan få en ubehagelig smag i munden efter inhalation af Colobreathe.
English: Overdose can also cause acute renal failure characterised by decreased urine output and increased serum concentrations of BUN and creatinine.
Danish: Overdosering kan også forårsage akut nyresvigt, karakteriseret ved nedsat urinproduktion og forøgede serumkoncentrationer af BUN og kreatinin.
English: Colistimethate sodium should be used with extreme caution in patients with porphyria.
Danish: Colistimethatnatrium bør anvendes med ekstrem forsigtighed hos patienter med porfyri.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver hyppighedsgruppering præsenteres bivirkninger i faldende rækkefølge efter alvorlighed.
English: • Excessive production of saliva
Danish: • Overdreven produktion af spyt
English: Do not use this medicine after the expiry date, which is stated on the outer carton and blister after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter Anv.
English: Occasionally, very small pieces of the capsule shell can get into your mouth or airways.
Danish: Indimellem kan meget små stykker af kapslens skal komme ind i munden eller luftvejene.
English: • The chances of the capsule breaking into pieces are increased if the capsule is pierced more than once during Step 6.
Danish: • Risikoen for, at kapslen går i stykker, er større, hvis kapslen gennembores mere end én gang i trin
English: Polymyxins persist in the liver, kidney, brain, heart and muscle.
Danish: Polymyxiner vedbliver i leveren, nyren, hjernen, hjertet og muskulaturen.
English: Gently insert the capsule into the chamber with the widest end first.
Danish: Sæt forsigtigt kapslen ind i kamret med den bredeste ende først.
English: Currently there is no experience of overdose with the use of Colobreathe.
Danish: Der findes på nuværende tidspunkt ingen erfaring med overdosering ved anvendelsen af Colobreathe.
English: Pharmacotherapeutic group: antibacterials for systemic use, other antibacterials.
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, andre antibakterielle midler.