FrancophonIA/ELRC3.0 huggingface dataset:
English: Recent scientific data have concluded that the main causes of lactic acidosis are cardiogenic or hypovolemic shock, severe heart failure, severe trauma, and sepsis; therefore lactic acidosis is not primarily caused by metformin treatment.
Danish: Af nyere videnskabelige data er det konkluderet, at hovedårsagerne til laktatacidose er kardiogent eller hypovolæmisk chok, svær hjerteinsufficiens, svære traumer og sepsis; laktatacidose forårsages således ikke primært af metforminbehandling,
English: Moreover, metformin treatment slows the further deterioration of renal function and provides additional significant micro-and macrovascular benefits in this patient population.
Danish: Behandling med metformin bremser desuden den videre forværring af nyrefunktionen og har betydelige mikro- og makrovaskulære fordele hos denne patientpopulation.
English: Moreover, recent clinical guidelines in the treatment of T2DM recommend the use of metformin in moderate renal impairment.
Danish: I de seneste kliniske retningslinjer for behandling af T2DM anbefales desuden anvendelse af metformin ved moderat nedsat nyrefunktion.
English: The most common side-effects observed in association with metformin use in diabetic individuals are mild to moderate gastrointestinal events including diarrhea, nausea, vomiting, abdominal pain, and decreased appetite.
Danish: De hyppigste bivirkninger, der er iagttaget ved anvendelse af metformin hos personer med diabetes, er lette til moderate gastrointestinale hændelser, herunder diarré, kvalme, opkastning, abdominalsmerter og nedsat appetit.
English: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for metformin containing products
Danish: CHMP anbefaler derfor ændring af betingelserne for markedsføringstilladelsen for lægemidler, der indeholder metformin.
English: Currently the use of metformin in patients with renal failure is not harmonised across the EU, being contraindicated in patients with different stages of moderate renal failure depending on the member state and product.
Danish: På nuværende tidspunkt er anvendelse af metformin hos patienter med nyresvigt ikke harmoniseret i EU, idet det er kontraindiceret ved forskellige stadier af moderat nedsat nyrefunktion, alt efter medlemsstat og produkt.
English: The risk of lactic acidosis is very rare in clinical practice and in the majority of cases only observed in emergency care.
Danish: Risikoen for laktatacidose er i klinisk praksis meget sjælden, og størstedelen af tilfældene er kun iagttaget hos akutte patienter.
English: It is considered in the interest of the Union that the adequacy of the current recommendations for metformin containing products is re-evaluated with respect to the use in patients with moderate renal failure, taking into account the available information on the risk of lactic acidosis.
Danish: Det anses for at være i Unionens interesse at revurdere tilstrækkeligheden af de gældende anbefalinger for lægemidler, der indeholder metformin hvad angår anvendelse hos patienter med moderat nedsat nyrefunktion, når de foreliggende oplysninger om risikoen for laktatacidose tages i betragtning.
English: As there is a clear relationship between renal function and metformin exposure, a recommendation for a daily dose of 2000 mg/day and 1000 mg/day dose in patients with moderate renal impairment stages 3a and 3b, respectively, can be concluded from the data provided.
Danish: Da der er klar sammenhæng mellem nyrefunktion og eksponering for metformin, kan det af de forelagte data konkluderes, at der bør anbefales en dosering på 2 000 mg dagligt og 1 000 mg dagligt ved moderat nedsat nyrefunktion på henholdsvis stadium 3a og 3b.
English: In addition, routine pharmacovigilance activities will be extended to include a cumulative review and a targeted follow up questionnaire on lactic acidosis cases to be submitted in subsequent PSURs.
Danish: Den rutinemæssige lægemiddelovervågning vil desuden blive udvidet med en kumulativ gennemgang og et målrettet opfølgende spørgeskema vedrørende tilfælde af laktatacidose, som skal forelægges i efterfølgende PSUR'er.
English: Based on the review of all available data on safety and efficacy, the benefit-risk balance of medicinal products containing metformin remains favourable and it is recommended that the marketing authorisations are varied regarding the use in renal impairment.
Danish: Baseret på gennemgangen af alle foreliggende data om sikkerhed og virkning er benefit/risk-forholdet for lægemidler, der indeholder metformin fortsat positivt, og det anbefales at ændre markedsføringstilladelserne hvad angår anvendelsen ved nedsat nyrefunktion.
English: • The CHMP considered that publications in the medical literature have shown that metformin at reduced dose may be safely used in patients with moderate renal impairment.
Danish: • CHMP fandt, at det i medicinske publikationer er påvist, at metformin i reduceret dosis kan anvendes sikkert hos patienter med moderat nedsat nyrefunktion.
English: • The CHMP considered the evidence from epidemiological studies, which have shown that lactic acidosis is a very rare condition that occurs most often in patients with acute renal or cardiorespiratory illness or sepsis.
Danish: • CHMP gennemgik evidensen fra epidemiologiske undersøgelser, der har vist, at laktatacidose er en meget sjælden tilstand, som oftest forekommer hos patienter med akut renal eller kardiorespiratorisk sygdom eller sepsis.
English: In addition, routine risk minimisation will be extended to include cumulative review of lactic acidosis in the PSURs and a targeted questionnaire.
Danish: Den rutinemæssige risikominimering vil desuden blive udvidet med kumulativ gennemgang af laktatacidose i PSUR'erne og et målrettet spørgeskema.
English: • The CHMP reviewed the totality of the data submitted by the MAHs on the safety and efficacy of metformin containing medicinal products for the treatment of Type 2 diabetes mellitus in subjects with moderate renal impairment (GFR 30-59 ml/min) with a focus on the risk of lactic acidosis.
Danish: • CHMP gennemgik samtlige data, der var forelagt af markedsføringstilladelsesindehaverne vedrørende sikkerheden og virkningen af lægemidler, der indeholder metformin til behandling af diabetes mellitus type 2 hos personer med moderat nedsat nyrefunktion (GFR 30-59 ml/min) med fokus på risikoen for laktatacidose,
English: In conclusion, the possible elevated risk of lactic acidosis could be sufficiently minimised in patients with moderate renal impairment (GFR greater than 30 ml/min) with a clear dosing recommendation, additional monitoring of GFR levels before and during treatment, and updated warnings and precautions in the SmPC and package leaflet.
Danish: Som konklusion kunne den mulige forhøjede risiko for laktatacidose minimeres tilstrækkeligt hos patienter med moderat nedsat nyrefunktion (GFR over 30 ml/min) gennem en klar dosisanbefaling, ekstra overvågning af GFR før og under behandlingen, og ajourførte advarsler og forsigtighedsregler i produktresuméet og indlægssedlen.
English: In view of the above, the CHMP concluded that the benefit-risk balance of metformin containing medicinal products is favourable subject to changes to the product information as described above.
Danish: På ovenstående baggrund konkluderede CHMP, at benefit/risk-forholdet for lægemidler, der indeholder metformin er positivt, forudsat at produktinformationen ændres som beskrevet ovenfor.
English: Overall, metformin has been used safely in patients with moderate renal impairment at reduced doses without causing significant metformin or lactate plasma elevations.
Danish: Overordnet er metformin ved reduceret dosis blevet anvendt risikofrit hos patienter med moderat nedsat nyrefunktion uden at medføre væsentligt forhøjet indhold af metformin eller laktat i plasma.
English: Apart from lactic acidosis, the overall safety profile of metformin in patients with moderate renal impairment is similar to the safety profile in patients with normal renal function.
Danish: Bortset fra laktatacidose svarer den overordnede sikkerhedsprofil af metformin hos patienter med moderat nedsat nyrefunktion til sikkerhedsprofilen hos patienter med normal nyrefunktion.
English: The benefits of metformin in the treatment of T2DM in patients with moderate renal impairment have been demonstrated in terms of the reduction of cardiovascular risk and all-cause mortality.
Danish: Samlet resumé af den videnskabelige vurdering Metformins fordele til behandling af T2DM hos patienter med moderat nedsat nyrefunktion er påvist i form af nedsat kardiovaskulær risiko og dødelighed af alle årsager.
English: • The CHMP considered that there is evidence from clinical and epidemiological studies indicating the benefits of the use of metformin containing medicinal products in patients with moderate renal impairment (GFR 30-59 ml/min).
Danish: • CHMP fandt, at kliniske og epidemiologiske undersøgelser giver evidens for fordelene ved at anvende lægemidler, der indeholder metformin hos patienter med moderat nedsat nyrefunktion (GFR 30-59 ml/min),
English: • The CHMP was of the view that the risk of lactic acidosis can be minimised in patients with moderate renal impairment with clear dosing recommendations, additional monitoring of GFR levels before and during treatment and updated warnings and precautions in the Summary of Product Characteristics (SmPC) and Package Leaflet (PL).
Danish: • CHMP var af den opfattelse, at risikoen for laktatacidose kan minimeres hos patienter med moderat nedsat nyrefunktion gennem klare dosisanbefalinger, supplerende overvågning af GFR før og under behandlingen og ajourføring af advarsler og forsigtighedsregler i produktresuméet og indlægssedlen.
English: In addition, published epidemiological studies indicate that metformin is often used in clinical practice in patients with moderate renal impairment as reflected in current clinical guidelines without a marked increase in risk of lactic acidosis or other serious side effects.
Danish: Publicerede epidemiologiske undersøgelser tyder desuden på, at metformin i klinisk praksis ofte anvendes hos patienter med moderat nedsat nyrefunktion uden markant forhøjet risiko for laktatacidose eller andre alvorlige bivirkninger, således som dette afspejles i gældende kliniske retningslinjer,
English: The CHMP, as a consequence, considers that the benefit-risk balance of metformin containing products remains favourable subject to the amendments to the product information.
Danish: CHMP finder følgelig, at benefit/risk-forholdet for lægemidler, der indeholder metformin fortsat er positivt under forudsætning af, at der foretages ændringer af produktinformationen.
English: REVERSE {number} {YYYY MM}
Danish: MODSATTE SIDE {nummer} {ÅÅÅÅ MM}
English: • adequate fracture reduction and stabilization to ensure mechanical stability
Danish: • tilstrækkelig frakturreduktion og stabilisering til at sikre mekanisk stabilitet
English: The educational programme is aimed:
Danish: Uddannelsesprogrammets mål er:
English: See section 5.1.
Danish: Se afsnit 5.1.
English: • The product should not be placed in direct contact with certain types of bones.
Danish: • Præparatet må ikke placeres i direkte kontakt med visse typer knogler.
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 afsnit 6.6.
English: Date of latest renewal: 20 July 2012
Danish: Dato for første tilladelse: 9. september 2002 Dato for seneste fornyelse: 20. juli 2012
English: The selected pieces can be further cut as required.
Danish: De valgte stykker kan klippes yderligere efter behov.
English: While no harmful effects have been noted, the long-term effects are unknown.
Danish: Selvom ingen skadelige virkninger er registreret, er langtidsvirkningerne ukendte.
English: • if you have been diagnosed with or are being treated for cancer.
Danish: • hvis De har fået stillet en diagnose om eller behandles for kræft.
English: Your surgeon will know which bones to avoid.
Danish: Kirurgen ved, hvilke knogler der skal undgås.
English: Dispense onto matrix and wait 15 min.
Danish: Påføres matrixen og vent 15 minutter.
English: Unknown
Danish: Ukendt
English: Patients were followed for 12 months after soft-tissue closure.
Danish: Patienterne blev fulgt i 12 måneder efter lukning af bløddele.
English: The product must be used within 2 hours after preparation.
Danish: Præparatet skal anvendes inden for 2 timer efter klargøringen.
English: These data are supplemented with information from use of InductOs in the general population.
Danish: Disse data leveres med informationer fra brug af InductOs i den almene population.
English: • if the doctor treating you decides that you have inadequate blood supply at the fracture site.
Danish: • hvis lægen, der behandler dem, mener, at De har utilstrækkelig blodforsyning ved frakturstedet.
English: In the non-sterile field
Danish: I det ikke-sterile område
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De får dette lægemiddel.
English: The clinical relevance of these effects is unknown.
Danish: Den kliniske relevans af denne virkning er ukendt.
English: This radiographic finding may be asymptomatic or symptomatic.
Danish: Dette radiografiske fund kan være asymtomatisk eller symptomatisk.
English: In this process, both bone resorption and formation occur.
Danish: I denne proces sker der både knogleresorption og -dannelse.
English: Localised infection5*
Danish: Lokal infektion5*
English: InductOs should be used by an appropriately qualified surgeon.
Danish: InductOs bør bruges af en kirurg med passende kvalifikationer.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates 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: • if you are still growing (skeletally immature).
Danish: • hvis De stadig vokser (har et umodent skelet).
English: 5 Observed during use in acute tibia fractures * Additional information provided below
Danish: 5 Observeret under anvendelse ved akutte tibiafrakturer * Supplerende oplysninger angivet nedenfor
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: In case of overdose (i.e. a patient receives a concentration or amount of dibotermin alfa greater than recommended), treatment should be supportive.
Danish: I tilfælde af overdosering (hvis en patient får en koncentration eller mængde af dibotermin alfa, der er større end anbefalet) skal behandlingen være støttende.
English: For these special populations, the physician is advised to give a careful consideration to the benefits and risks for the specific patient before using InductOs.
Danish: For disse særlige populationer tilrådes lægen at foretage nøje afvejning af fordele og risici for den pågældende patient, før InductOs anvendes.
English: The powder is white.
Danish: Pulveret er hvidt.
English: The frequency of this side effect is unknown and cannot be estimated from the available data.
Danish: Hyppigheden af denne bivirkning er ukendt og kan ikke vurderes ud fra de tilgængelige data.
English: 6422 PJ Heerlen The Netherlands tel +31 (0) 45 566 8000 fax +31 (0) 45 566 8012
Danish: 6422 PJ Heerlen Holland tlf +31 (0) 45 566 8000 fax +31 (0) 45 566 8012
English: InductOs must not be used in concentrations higher than 1.5 mg/ml (see section 4.9).
Danish: InductOs må ikke anvendes i koncentrationer højere end 1,5 mg/ml (se afsnit 4.9).
English: The matrix is white.
Danish: Matrixen er hvid.
English: Failure to follow the method of administration of InductOs may compromise its safety and efficacy.
Danish: Manglende overholdelse af metoden til administration af InductOs kan kompromittere sikkerheden og virkningen.
English: The medicinal product is administered by implantation.
Danish: Lægemidlet administreres ved implantation.
English: To the extent possible, the accessible surface area of the fracture (fracture lines and defects) should be covered with InductOs.
Danish: I det omfang, det er muligt, skal frakturens tilgængelige overflade (frakturlinjer og defekter) dækkes med InductOs.
English: The remaining patients participated in studies using InductOs for indications not currently approved in the EU.
Danish: De resterende patienter, der deltog i studierne med InductOs, behandledes for indikationer, der ikke for øjeblikket er godkendt i EU.
English: Clinical pharmacology studies demonstrate that the matrix alone is not osteoinductive and is no longer present in biopsies taken as early as 16 weeks post-implantation.
Danish: Kliniske farmakologistudier påviser, at matrix alene ikke er osteoinduktiv og ikke længere er til stede i biopsier, der tages allerede 16 uger efter implantationen.
English: The solvent is a clear colourless liquid.
Danish: Solvenset er en klar, farveløs væske.
English: The healthcare professional educational material should contain:
Danish: Uddannelsesmaterialet til læger og sundhedspersonale skal indeholde:
English: • Healthcare professionals educational material
Danish: • Uddannelsesmateriale til læger og sundhedspersonale
English: • Any active malignancy or patient undergoing treatment for a malignancy
Danish: • aktiv malignitet eller patienter i behandling for malignitet
English: InductOs is contraindicated for patients with:
Danish: InductOs er kontraindiceret til patienter med:
English: • adequate neurovascular status (e.g. absence of compartment syndrome, low risk of amputation)
Danish: • tilstrækkelig neurovaskulær status (d.v.s. fravær af kompartment syndrom, lav risiko for amputation)
English: • Persistent compartment syndrome or neurovascular residua of compartment syndrome
Danish: • vedvarende kompartment syndrom eller neurovaskulært residuum af kompartment syndromet
English: The doctor will determine how much InductOs you will receive, depending on the size and number of fractures.
Danish: Deres læge vil afgøre, hvor meget InductOs De skal have, afhængigt af bruddets størrelse og antal brud.
English: In the sterile field
Danish: I det sterile område
English: The frequencies of adverse reactions identified during post-marketing use of InductOs are not known as these reactions were reported from a population of uncertain size.
Danish: De hyppigheder af bivirkninger, der identificeredes under brug efter markedsføring af InductOs, er ikke kendt, da disse reaktioner er indberettet fra en population af ukendt størrelse.
English: Wait a MINIMUM of 15 minutes before using the prepared InductOs product.
Danish: Vent MINDST 15 minutter, før det klargjorte InductOs præparat anvendes.
English: Additional educational materials for healthcare professionals are available on the following URL: [URL to be included] <and the <Member State> website>.
Danish: Yderligere uddannelsesmateriale til sundhedspersonale er tilgængeligt på følgende internetadresse: [indsæt internetadresse] <og <medlemsstats> webside>.
English: METHOD OF ADMINISTRATION Implantation.
Danish: ADMINISTRATIONSMETODE Implantation.
English: • for treating a fracture that is disease-related (e.g., fractures due to Paget's disease or cancer).
Danish: • til behandling af sygdomsrelaterede frakturer (f.eks. brud som skyldes Paget's sygdom eller kræft).
English: These results were independently corroborated by a radiology panel blinded to treatment.
Danish: Disse resultater blev bekræftet af et uafhængigt udvalg af af radiologer, som var blindet for behandlingen.
English: • used with interbody fusion devices made from material other than titanium, PEEK or bone
Danish: • anvendt med interkorporale fusionsdevices lavet af andet materiale end titan, PEEK eller knogle
English: InductOs contains sodium
Danish: InductOs indeholder natrium
English: The safety and efficacy of InductOs have not been established in the following conditions:
Danish: Sikkerhed og virkning af InductOs er ikke fastslået under følgende forhold:
English: Over time, the sponge will gradually disappear as new bone is formed.
Danish: Svampen vil forsvinde gradvist over tid, efterhånden som der dannes ny knogle.
English: Dibotermin alfa dose
Danish: Dibotermin alfa-dosis
English: Over 1700 patients have received InductOs in clinical studies.
Danish: Mere end 1.700 patienter er behandlet med InductOs i kliniske studier.
English: Bone formation outside the intervertebral disc space is not desirable as it may have a deleterious impact on local neurovascular structures.
Danish: Knogledannelse uden for det intervertebrale diskusrum er ikke ønskelig, da det kan have en skadelig virkning på lokale neurovaskulære strukturer.
English: InductOs is intended for use in patients with the following:
Danish: InductOs er beregnet til anvendelse hos patienter med følgende:
English: The MAH shall ensure that in each Member State where InductOs is marketed, all healthcare professionals who are expected to use InductOs are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal i hvert medlemsstat, hvor InductOs markedsføres, sikre, at alle læger og alt sundhedspersonale, der forventes at anvende InductOs, forsynes med følgende uddannelsespakke:
English: • if you are allergic to dibotermin alfa or bovine collagen or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for dibotermin alfa eller bovint kollagen eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: • Whenever the risk management system is modified, especially as the result of new information being received that lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: Peak levels of circulating dibotermin alfa (0.1% of the implanted dose) were observed within 6 hours following implantation.
Danish: Den største mængde cirkulerende dibotermin alfa (0,1 % af den implanterede dosis) blev observeret inden for 6 timer efter implantationen.
English: • adequate haemostasis (i.e., providing a relatively dry implantation site)
Danish: • tilstrækkelig hæmostase (det vil sige tilvejebringelse af et relativt tørt implantationssted)
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: InductOs kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: There are no or limited amount of data from the use of dibotermin alfa in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af dibotermin alfa til gravide kvinder.
English: • implanted at locations other than lumbar spine
Danish: • implanteret andre steder end lumbal rygsøjle
English: There is no information on the excretion of dibotermin alfa/metabolites in human milk.
Danish: Der foreligger ingen data for udskillelse af dibotermin alfa/metabolitter i human mælk.