FrancophonIA/ELRC3.0 huggingface dataset:
English: Chronic infection of the nose, fungal infections, various infections (of the nose and throat, kidney or bladder), sterile inflammation of the layers lining the brain, serious allergic reactions, disorder of the thyroid, excessive response to stimuli, memory impairment, difficulty in speaking, unusual taste in the mouth, impaired balance, involuntary trembling, eye pain or swelling, vertigo, fluid in middle ear, peripheral coldness, vein inflammation, ear and throat swelling, abdominal distension, rapid swelling of the skin, acute inflammation of the skin, cold sweat, increased reaction of the skin to sunlight, excessive sweating also during sleep, muscle twitching, excess of serum protein in the urine, chest tightness, feeling hot, burning sensation, swelling, increased rate of breathing, changes to blood test results.
Danish: Kronisk infektion i næsen, svampeinfektioner, forskellige infektioner (i næsen eller halsen, nyrerne eller blæren), steril inflammation (betændelseslignende reaktion) i hjernehinden (aseptisk meningitis), alvorlige allergiske reaktioner, sygdomme i skjoldbruskkirtlen, overdrevet respons på stimuli, hukommelsesforstyrrelse, talebesvær, usædvanlig smag i munden, balanceforstyrrelse, ufrivillig rysten, smerter i øjet eller hævet øje, svimmelhed med fornemmelse af, at omgivelserne drejer rundt (vertigo), væske i mellemøret, kolde hænder og fødder, inflammation i en blodåre, hævelse i øre og hals, udspilet mave, hurtig opsvulmning af huden, akut inflammation i huden, koldsved, øget hudfølsomhed for sollys, voldsom sveddannelse også under søvn, muskeltrækninger, forhøjet indhold af serumprotein i urinen, trykken for brystet, varmefølelse, brændende fornemmelse i huden, hævelse, hurtig vejrtrækning, ændringer i blodprøveresultater.
English: Maintenance dose: 1 g/kg every 2 to 4 weeks or 2 g/kg every 4 to 8 weeks.
Danish: Vedligeholdelsesdosis: 1 g/kg hver 2.-4. uge eller 2 g/kg hver 4.-8. uge.
English: Dizziness, migraine, paresthesia, hypoesthesia
Danish: Svimmelhed, migræne, paræstesi, hypæstesi
English: 1.49 1.34 to 1.81 1.67 1.45 to 2.19 1.62 1.50 to 1.78
Danish: 1,49 1,34 til 1,81 1,67 1,45 til 2,19 1,62 1,50 til 1.78
English: 2.26 1.70 to 2.60 2.09 1.78 to 2.65 2.17 1.99 to 2.44
Danish: 2,26 1,70 til 2,60 2,09 1,78 til 2,65 2,17 1,99 til 2,44
English: 2.28 1.72 to 2.74 2.25 1.98 to 2.64 2.24 1.92 to 2.43
Danish: 2,28 1,72 til 2,74 2,25 1,98 til 2,64 2,24 1,92 til 2,43
English: The solution should be clear or slightly opalescent and colourless or pale yellow.
Danish: Opløsningen skal være klar eller let opaliserende samt farveløs eller bleggul.
English: Do not use KIOVIG:
Danish: Brug ikke KIOVIG:
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Appetitsløshed
English: KIOVIG 100 mg/ml solution for infusion
Danish: KIOVIG 100 mg/ml infusionsvæske, opløsning
English: 0.2-0.4 g/kg every 3-4 weeks to obtain IgG trough level of at least 5-6 g/l
Danish: 0,2-0,4 g/kg hver 3.-4. uge for at opnå IgG-dalkoncentration på mindst 5-6 g/l
English: Any infusion-related adverse events should be treated by lowering infusion rates or by stopping the infusion.
Danish: Enhver infusions relateret bivirkning bør behandles ved at nedsætte infusionshastigheden eller ved at afbryde infusionen.
English: 0.2-0.4 g/kg every 3-4 weeks to obtain IgG trough level above 5g/l
Danish: 0,2-0,4 g/kg hver 3.-4. uge for at opnå IgG-dalkoncentration på over 5g/l
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Danish: screening af de enkelte bloddonationer og plasma-pools for specifikke infektionsmarkører samt anvendelse af effektive foranstaltninger under produktionen for at inaktivere/fjerne vira.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Danish: Trods disse forholdsregler kan muligheden for at overføre smitsomme stoffer ikke udelukkes helt, når lægemidler er fremstillet af humant blod eller plasma.
English: Reversible haemolytic reactions have been observed in patients, especially those with blood groups A, B, and AB.
Danish: Reversible hæmolytiske reaktioner er observeret hos patienter, særligt dem med blodtype A, B og AB. I sjældne tilfælde kan der opstå transfusionskrævende hæmolytisk anæmi efter IVIg-behandling med høje doser (se også pkt.
English: Patients who suffer from chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Danish: Patienter, der lider af kronisk inflammatorisk demyeliniserende polyneuropati (CIDP).
English: • 0.8-1g/kg given on day one; this dose may be repeated once within 3 days
Danish: • 0,8-1 g/kg givet den første dag, hvilket kan gentages en gang i løbet af 3 dage
English: Transfusion-related acute lung injury
Danish: Transfusionsrelateret akut lungeskade
English: Starting dose: 2 g/kg divided over 2 -5 consecutive days
Danish: Startdosis: 2 g/kg fordelt over 2-5 på hinanden følgende dage
English: • This medicine has been prescribed for you only.
Danish: • Lægen har ordineret KIOVIG til dig personligt.
English: Starting dose: 2 g/kg given over 2-5 consecutive days.
Danish: Startdosis: 2 g/kg givet over 2-5 på hinanden følgende dage.
English: Eye pain, eye swelling
Danish: Smerter i øjet, opsvulmet øje
English: Chills, edema, influenza-like illness, chest discomfort, chest pain, asthenia, malaise, rigors
Danish: Kuldegysninger, ødem, influenzalignende sygdom, ubehag i brystet, smerter i brystet, asteni, ubehag, rysten
English: Posology
Danish: Dosisanbefalinger
English: Anaemia, lymphadenopathy
Danish: Blod og lymfesystem Anæmi, lymfadenopati
English: The maximum IgA content is 140 micrograms/ml.
Danish: Maksimumindholdet af immunglobulin A (IgA) er 140 mikrogram/ml.
English: Chronic inflammatory demyelinating polyneuropathy (CIDP)
Danish: Kronisk inflammatorisk demyeliniserende polyneuropati (CIDP)
English: • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Danish: • Kronisk inflammatorisk demyeliniserende polyneuropati (CIDP).
English: Every 3 weeks over 1-2 days
Danish: -8. uge over 2-5 dage
English: Your doctor will make sure that the rate at which KIOVIG is infused is suitable for you.
Danish: Din læge vil sørge for, at KIOVIG gives med en hastighed, som er passende for dig.
English: Back pain, arthralgia, pain in extremity, myalgia, muscle spasms, muscular weakness
Danish: Rygsmerter, rinoréi, ekstremitetssmerter, myalgi, muskelspasmer, muskelsvaghed
English: Immunomodulation:
Danish: Immunsystemet
English: Haemolysis
Danish: Nyresvigt
English: KIOVIG 100 mg/ml solution for infusion Human normal immunoglobulin
Danish: KIOVIG 100 mg/ml infusionsvæske, opløsning Humant normalt immunglobulin
English: Immune system disorders Hypersensitivity, anaphylactic reaction
Danish: Overfølsomhed, anafylaktisk reaktion
English: Adults (18 years or above) Median 95% CI* Median 95% CI Median 95% CI Terminal half-life (days) 41.3 20.2 to 86.8 45.1 27.3 to 89.3 31.9 29.6 to 36.1 Cmin (mg/dl)/(mg/kg) (trough level)
Danish: Voksne (18 år eller derover) Median 95 % CI* Median 95 % CI Median 95 % CI
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infectious agents cannot be totally excluded.
Danish: Alligevel kan muligheden for at overføre smitsomme stoffer ikke helt udelukkes, når lægemidler er fremstillet af humant blod eller plasma.
English: UNIQUE IDENTIFIER - 2D BARCODE
Danish: ENTYDIG D-STREGKODE
English: starting dose 2g/kg maintenance dose: 1g/kg
Danish: startdosis: 2 g/kg
English: starting dose: 2 g/kg maintenance dose: 1 g/kg or 2 g/kg given over 2-5 days every 2-4 weeks or every 4-8 weeks over 2-5 days
Danish: startdosis: 2 g/kg vedligeholdelsesdosis: 1 g/kg eller 2 g/kg givet over 2-5 dage hver 2.-4. uge eller hver 4.
English: Endocrine disorders
Danish: Det endokrine system Sygdomme i skjoldbruskkirtel
English: In divided doses over 2-5 days every 3 weeks over 1-2 days
Danish: Vedligeholdelsesdosis: 1 g/kg i opdelte doser over 2-5 dage hver 3. uge over 1-2 dage
English: Thyroid disorder
Danish: Anafylaktisk shock
English: Infections and infestations Bronchitis, nasopharyngitis
Danish: Bronkitis, rinoré
English: If you use more KIOVIG than you should
Danish: Hvis du har brugt for meget KIOVIG
English: Immediate packaging
Danish: Emballage Pakningstørrelse
English: 48 hours.
Danish: 48 timer.
English: Do not refrigerate or freeze.
Danish: Må ikke nedkøles eller nedfryses.
English: Grounds for one additional renewal
Danish: Grunde til én yderligere fornyelse
English: Do not expose to radioactive irradiation (X-rays).
Danish: Må ikke udsættes for radioaktiv bestråling (røntgen).
English: You should be very cautious when bending and putting weight on your treated knee.
Danish: Du skal være meget forsigtig, når du bøjer og lægger vægt på dit behandlede knæ.
English: Patients had to agree to actively participate in a strict rehabilitation protocol and follow-up program.
Danish: Patienterne skulle acceptere at deltage aktivt i en streng genoptræningsprotokol og et opfølgningsprogram.
English: Tell your doctor immediately if you notice any of these symptoms.
Danish: Fortæl det straks til lægen, hvis du mærker nogle af disse symptomer.
English: Patient number (Pt N°) {patient number} Patient initials (Pt initials) {patient initials}
Danish: Patientnummer (Pt. nr.) {patientnummer} Patientinitialer (Pt. initialer) {patientinitialer}
English: See section 4.
Danish: Jf. afsnit 4.
English: The purpose is to repair the defect with healthy and functional cartilage over time.
Danish: Målet er at reparere defekten med sundt og funktionsdygtigt brusk over tid.
English: To protect your knee, you will have to wear a brace.
Danish: For at beskytte dit knæ skal du bære en støtteskinne.
English: Please inform your doctor if you are pregnant or think you may be pregnant.
Danish: Fortæl det til din læge, hvis er gravid eller overvejer at blive gravid.
English: Your surgeon will give you more information.
Danish: Kirurgen vil give dig yderligere oplysninger.
English: A defect can be caused by acute trauma, such as a fall.
Danish: En defekt kan forårsages af akut traume som f.eks. et fald.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/563/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/563/001
English: It is very important to carefully observe the recommendations of your doctor and/or physical therapist.
Danish: Det er meget vigtigt, at du nøje følger lægens og/eller fysioterapeutens anbefalinger.
English: Trendelenburg's symptom
Danish: Trendelenburgs symptom
English: Store between 15°C - 25°C.
Danish: Opbevares ved temperaturer mellem 15 °C og 25 °C.
English: No specific safety signal was detected in these patients.
Danish: Der blev ikke påvist specifikke sikkerhedssignaler hos disse patienter.
English: Further clinical data in patients with larger lesions are foreseen to be collected in the future.
Danish: Yderligere kliniske data fra patienter med større læsioner forventes indsamlet i fremtiden.
English: For the group with a longer time since onset of symptoms there were no apparent differences between the 2 groups.
Danish: I gruppen, hvor der var gået længere tid, siden symptomernes opståen, var der ikke nogen synlige forskelle mellem de to grupper.
English: Pain relief medicinal products should be used according to the recommendations of the responsible surgeon.
Danish: Smertestillende lægemidler bør anvendes i henhold til den ansvarlige kirurgs anbefalinger.
English: The estimated benefit was larger in the ChondroCelect group but the results did not reach statistical significance.
Danish: Den forventede fordel var større i ChondroCelect-gruppen, men resultaterne var ikke statistisk signifikante.
English: A decision should be made whether to discontinue breast-feeding taking into account the potential benefits of the treatment for the woman and the potential risk to the infant.
Danish: Der skal tages stilling til, om amningen skal afbrydes under hensyntagen til behandlingens potentielle fordele for kvinden og den potentielle risiko for barnet.
English: It will take at least four weeks to select and culture the cells to make ChondroCelect.
Danish: Det vil tage mindst fire uger at udvælge og dyrke cellerne til fremstilling af ChondroCelect.
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of ChondroCelect remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Danish: Baseret på data, der er blevet tilgængelige siden udstedelsen af den oprindelige markedsføringstilladelser, anser CHMP, at benefit-risk balancen for ChondroCelect stadig er positiv, men anser, at dets sikkerhedsprofil skal overvåges tæt af følgende grunde:
English: Post-marketing experience with respect to patient number, i.e. 444 patients and duration of follow-up is still quite limited, and doesn't warrant granting a renewal with unlimited validity.
Danish: Erfaring efter markedsføring med hensyn til patientantal, dvs. 444 patienter og varighed af opfølgning, er stadig ret begrænset og berettiger ikke til udstedelse af en fornyelse med ubegrænset validitet.
English: In these patients, a periosteal flap was used to secure the implant.
Danish: Hos disse patienter anvendtes en periosteal flap til at sikre implantatet.
English: - have a growth plate of the knee that is not fully closed
Danish: Har en vækstplade i knæet, der ikke er fuldt lukket.
English: The surgeon will be informed as early in the process as possible, and should hence select an alternative treatment for the patient concerned.
Danish: Kirurgen vil så tidligt som muligt i forløbet blive informeret herom og bør herefter vælge en alternativ behandling af den pågældende patient.
English: Therefore the treated knee should be protected according to the recommendations as outlined in the appropriate rehabilitation schedule, to avoid early damage which might lead to graft failure.
Danish: Derfor bør det behandlede knæ beskyttes i overensstemmelse med anbefalingerne som skitseret i den relevante genoptræningsplan for at undgå tidlig beskadigelse, der kan føre til, at transplantationen mislykkes.
English: Since this product will be used during your knee surgery, the hospital staff is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal
Danish: Da lægemidlet vil blive anvendt under din knækirurgi, har hospitalspersonalet ansvaret for den korrekte opbevaring af lægemidlet både før og under dets anvendelse og for en korrekt
English: Although it is thought that these reactions are mostly surgery-related, a potential influence of the expanded chondrocytes cannot be completely excluded.
Danish: Selv om det menes, at disse reaktioner hovedsageligt er kirurgirelaterede, kan en potentiel påvirkning fra de opformerede chondrocytter ikke fuldstændigt udelukkes.
English: During the rehabilitation period, the level of weight-bearing will increase gradually, depending on your weight and the size of the cartilage defect.
Danish: Under genoptræningen vil vægtbelastningen blive øget gradvist afhængigt af din vægt og størrelsen af bruskdefekten.
English: Ask your doctor for more information as to which pain medication you can safely use.
Danish: Bed lægen om yderligere oplysninger om, hvilke smertestillende lægemidler du kan anvende
English: Date of latest renewal: 22 August 2014
Danish: Dato for første markedsføringstilladelse: 5. oktober 2009 Dato for seneste fornyelse: 22. august 2014
English: After surgery, you will have to follow a rehabilitation program for approximately one year, to allow your knee to heal well.
Danish: Efter operationen skal du følge et genoptræningsprogram i omkring et år, så dit knæ kan hele ordentligt.
English: Your doctor or physical therapist will give you more details on your rehabilitation.
Danish: Lægen eller fysioterapeuten giver dig flere oplysninger om din genoptræning.
English: If you do not follow your rehabilitation schedule, the risk of treatment failure may increase.
Danish: Hvis du ikke følger genoptræningsprogrammet, kan risikoen for, at behandlingen slår
English: Patients with femoral epiphyseal growth plate that is not fully closed
Danish: Patienter med epifyseal vækstplade, der ikke er fuldt lukket.
English: In the pivotal study there was no influence of Body Mass Index (BMI) on outcome but bibliographic data shows that a BMI over 30 may adversely affect the success of the procedure.
Danish: I det pivotale studie havde Body Mass Index (BMI) ikke nogen indflydelse på resultatet, men bibliografiske data viser, at et BMI over 30 kan påvirke procedurens succes i negativ retning.
English: Related to surgical intervention of the knee
Danish: Relateret til kirurgisk indgreb i knæet
English: The product is packaged in several layers of packaging material which guarantee sterility and stable temperature conditions for 48 hours if stored at room temperature.
Danish: Lægemidlet pakkes i flere lag emballeringsmateriale, hvilket garanterer sterilitet og stabile temperaturforhold i 48 timer, hvis det opbevares ved stuetemperatur.
English: In some cases it can be possible that the source chondrocytes of the patient are not expandable or that the release criteria are not met, due to poor biopsy quality, patient characteristics, or manufacturing failure.
Danish: I nogle tilfælde er det muligt, at kilden til patientens chondrocytter ikke kan opdyrkes, eller at frigivelseskriterierne ikke er opfyldt på grund af dårlig kvalitet af biopsien, patientens karakteristika eller en fremstillingsfejl.
English: Adverse reactions occurred in 78.4% of the patients over a 36-months postoperative follow-up period..
Danish: Der opstod bivirkninger hos 78,4 % af patienterne over en 36 måneder lang
English: These were generally mild and disappeared in the weeks following surgery.
Danish: Disse var generelt milde og forsvandt i ugerne efter operationen.
English: • Cartilage is a tissue that is present in every joint.
Danish: • Brusk er et væv, der findes i alle led.
English: These studies have demonstrated that this type of fibrin sealant can be safely used with ChondroCelect.
Danish: Disse undersøgelser har vist, at denne type fibrinforsegler kan anvendes sikkert sammen med ChondroCelect.
English: • The surgical checklist to be completed at the operating theatre immediately prior to the first incision confirming the right patient, the right product, the right side of the implantation, and the type of biological membrane and fibrin sealant to be used in the procedure.
Danish: • Den kirurgiske tjekliste, som skal udfyldes på operationsstuen umiddelbart forud for første incision, hvorpå det bekræftes, at det er den rigtige patient, det rigtige lægemiddel, den rigtige side af implantationen, og hvilken type biologisk membran og fibrinforsegling der vil blive anvendt i proceduren
English: Synovitis and subchondral bone injuries have been reported in animal models and are possible risks with the use of ChondroCelect.
Danish: Synovitis og subchondrale knogleskader er blevet rapporteret i dyremodeller og er mulige risici forbundet med brug af ChondroCelect.
English: Frequencies are defined according to the following convention: 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).
Danish: meget almindelig ((≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10,000).
English: Conventional reproductive and developmental toxicity studies are not considered relevant, given the nature and the intended clinical use of the autologous cell therapy product.
Danish: Konventionelle reproduktions- og udviklingsmæssige toksicitetsundersøgelser anses ikke for at være relevante på grund af arten og den tilsigtede kliniske anvendelse af det autologe lægemiddel til celleterapi.
English: The efficacy of ChondroCelect was studied in a phase III, multicenter, randomized, controlled trial (TIG/ACT/01/2000) and the first two years of its 4-year extension phase (TIG/ACT/01/2000EXT).
Danish: Effekten af ChondroCelect blev undersøgt i en randomiseret, kontrolleret, fase 3multicenterundersøgelse (TIG/ACT/01/2000) og i de første to år af en fireårig udvidelsesfase af denne (TIG/ACT/01/2000EXT).
English: ChondroCelect should not be sterilised.
Danish: ChondroCelect bør ikke steriliseres.
English: The safety and efficacy in children and adolescents (aged less than 18) have not been established.
Danish: Sikkerhed og virkning hos børn og unge (under 18 år) er endnu ikke klarlagt.
English: PharmaCell Cell Manufacturing Facility B.V., Urmonderbaan 20B, 6167 RD Geleen, Netherlands
Danish: PharmaCell Cell Manufacturing Facility B.V., Urmonderbaan 20B, 6167 RD Geleen,
English: Patients could be treatment-naïve or might have undergone previous arthroscopic or other surgical repair procedure(s).
Danish: Patienterne kunne være behandlingsnaive eller kunne have undergået tidligere artroskopi eller en anden kirurgisk procedure.
English: Patients aged between 18 and 50 years, who had a single symptomatic cartilage lesion between 1 and 5 cm2 of the femoral condyles met the inclusion criteria.
Danish: Patienter mellem 18 og 50 år, som havde en enkelt symptomatisk brusklæsion på mellem 1 og 5 cm2 af femurkondylerne, opfyldte kriterierne.
English: Inflammation resolved with time and parameters returned to baseline levels with only some very mild and local signs of synovitis remaining in a few animals.
Danish: Inflammationen forsvandt med tiden, og parametrene vendte tilbage til udgangsniveauerne med blot meget milde og lokale tegn på synovitis hos nogle få dyr.
English: The safety data obtained in these patients do not indicate a particular safety concern.
Danish: Sikkerhedsdataene fra disse patienter tyder ikke på særlige sikkerhedsproblemer.
English: Visit 1: evaluation of the cartilage defect and biopsy On the first visit, the surgeon will evaluate your cartilage defect during an exploratory operation (arthroscopy).
Danish: Besøg 1: evaluering af bruskdefekten og biopsien Ved det første besøg vurderer kirurgen din bruskdefekt under en undersøgende operation (artroskopi).
English: According to current literature the incidence of cartilage hypertrophy can be reduced by using a collagen membrane to cover the lesion site instead of using a periosteal flap (Gooding et al., 2006; Niemeyer et al., 2008).
Danish: Det fremgår af faglitteraturen, at forekomsten af bruskhypertrofi kan nedbringes ved at anvende en collagenmembran til dækning af læsionsområdet i stedet for en periosteal flap (Gooding et al., 2006; Niemeyer et al., 2008).
English: Non-clinical data based on implantation of expanded cartilage cells in goats and mice did not reveal special hazard for humans.
Danish: Ikke-kliniske data baseret på implantation af opformerede bruskceller i geder og mus indikerer ingen særlig risiko for mennesker.
English: If, based on the benefit/risk assessment of the responsible surgeon treatment of patients below 18 years is considered, special attention should be given to ensure that the growth plate is completely closed.
Danish: Hvis behandling af patienter under 18 år overvejes på baggrund af den ansvarlige kirurgs risikovurdering, bør man være særlig opmærksom på at sikre, at vækstpladen er helt
English: The safety data obtained in these patients do not indicate a particular safety concern, and confirm a lower incidence of hypertrophy as suggested by scientific literature on the use of collagen membranes versus periost.
Danish: Sikkerhedsdata fra disse patienter tyder ikke på særlige sikkerhedsproblemer, og de bekræfter en lavere forekomst af hypertrofi som antydet i faglitteraturen om anvendelse af collagenmembraner versus periost.
English: Romeinse straat 12/2, 3001 LEUVEN Belgium info@tigenix.com
Danish: Romeinse straat 12/2, 3001 LEUVEN Belgien info@tigenix.com