FrancophonIA/ELRC3.0 huggingface dataset:
English: Common side effects (may affect up to 1 in 10 people) are:
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) er:
English: Aspartate aminotransferase increased (7.7%) (G3/4: 1.4%)
Danish: Forhøjet ASAT (7,7 %) (G3/4: 1,4 %)d
English: Mucosal
Danish: Liposarkom
English: (See section 5.2) Elderly patients
Danish: (angivet i punkt 6) - hvis du ammer
English: Tel: + 44 (0)208 600 1400
Danish: Eisai Ltd. Tel: + 44 (0)208 600 1400
English: Diarrhoea (18.7%) (G3/4: 0.8%) Vomiting (18.1%) (G3/4: 1.0%)
Danish: Opkastning (18,1 %) (G3/4: 1,0 %)
English: OS in ITT Population HALAVEN (n=554)
Danish: HALAVEN (n=554)
English: Nail disorder Night sweats Dry skin
Danish: Neglesygdom Nattesved
English: Dysgeusia Dizziness (9.0%) (G3/4: 0.4%)d
Danish: Svimmelhed (9,0 %) (G3/4: 0,4 %)
English: Weight decreased (11.4%) (G3/4: 0.4%)d a
Danish: Vægttab (11,4 %) (G3/4: 0,4 %)
English: Rash (4.9%) (G3/4:
Danish: Udslæt (4,9 %) (G3/4: Pruritus (3,9 %) (G3/4:
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: NAME OF THE MEDICINAL PRODUCT HALAVEN 0.44 mg/ml solution for injection
Danish: HALAVEN 0,44 mg/ml injektionsvæske, opløsning
English: Overall survival Number of Events Median months Hazard Ratio (95% CI) Nominal pvalue Progression-free survival Number of Events Median months Hazard Ratio (95% CI) Nominal pvalue
Danish: Antal hændelser Antal måneder (median) Hazard ratio (95 % CI) Nominel p-værdi
English: (22.5%) (G3/4: 0.7%)d Hypokalaemia (6.8%) Decreased appetite (G3/4: 2.0%)
Danish: Hypokaliæmi (6,8 %) (G3/4: 2,0 %) Hypomagnesiæmi (2,8 %) (G3/4: 0,3 %) Dehydrering (2,8 %) (G3/4: 0,5 %)
English: Musculoskeletal and connective tissue disorders
Danish: Knogler led, muskler og bindevæv
English: (TPC)
Danish: (Svíþjóð)
English: Sími: + 46 (0)8 501 01 600 (Svíþjóð)
Danish: Eisai AB Sími: + 46 (0)8 501 01 600
English: Hazard Ratio (95% CI)
Danish: Antal hændelser Median (måneder) Hazard ratio (95% CI)
English: Water for injections
Danish: Oversigt over indlægssedlen
English: • If you forget the dose before a meal:
Danish: - Hvis du glemmer dosen før et måltid:
English: The PPC prompts you with messages on the screen.
Danish: PPC prompter dig med beskeder på skærmen.
English: The pump system will also be programmed and tested prior to your leaving the hospital.
Danish: Pumpesystemet vil også blive programmeret og testet før du forlader hospitalet.
English: You may feel symptoms of high blood sugar after you eat.
Danish: Du kan føle symptomer på højt blodsukker efter du spiser.
English: All procedures must be performed under sterile conditions.
Danish: Alle procedurer skal foregå under sterile forhold.
English: • Contamination and/or infection
Danish: • Kontaminering og/eller infektion.
English: Alternatively, it may emerge gradually over a period of several weeks.
Danish: Alternativt kan behovet udvikle sig gradvist over en periode på adskillige uger.
English: You must also make sure you get enough carbohydrates.
Danish: Du skal også sørge for fortsat at få tilstrækkeligt med kulhydrater.
English: This can be verified by checking the insulin daily history on the PPC at each visit.
Danish: Dette kan blive bekræftet ved at tjekke den daglige insulinhistorik på PPC'en ved hvert besøg.
English: • The potential for surgical and clinical complications and how to respond in the event any such complications arise.
Danish: • Muligheden for kirurgiske og kliniske komplikationer samt hvordan man skal reagere i tilfælde af, at sådanne komplikationer opstår.
English: These materials shall contain content closely similar to the mock-ups provided in the currently approved risk management plan annexes.
Danish: Disse materialer skal indeholde inhold nøje svarende til mock-ups fastsat i de nuværende godkendte bilag for risikostyringsplan.
English: If you need to deliver one additional bolus, press “SEL” and then “ACT”.
Danish: Hvis du har brug for at indgive en ekstra bolus, tryk da ”SEL” og derefter ”ACT”.
English: • Patient selection criteria
Danish: • Patientudvælgelseskriterier
English: Date of first authorisation: 21 February 1997 Date of latest renewal: 21 February 2007
Danish: Dato for første markedsføringstilladelse: 21. februar 1997 Dato for seneste fornyelse: 21. februar 2007
English: There is no experience with Insuman Implantable in children and adolescents below 18 years.
Danish: Der er ikke erfaring med Insuman Implantable til børn og unge under 18 år.
English: • ensuring that pen and needle work properly
Danish: • Sikre at pen og nål virker korrekt.
English: Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
Danish: Fortæl din læge hvis du planlægger at blive gravid eller hvis allerede er gravid.
English: You may exceed this limit by programming only one bolus within 10 minutes.
Danish: Du kan overskride denne grænse ved at programmere en enkelt dosis indenfor 10 minutter.
English: Your SoloStar is designed to work accurately and safely.
Danish: SoloStar er designet til at virke præcist og sikkert.
English: If this happens, immediately contact your doctor who is trained to perform pump investigations.
Danish: Hvis dette sker, kontakt da øjeblikkeligt din læge som er trænet i at udføre pumpeundersøgelser.
English: • Information on the risk management plan, the safety concerns and the risk minimisation measures
Danish: • Information om risikostyringsplan, sikkerhedsmæssige forholdsregler og risikominimeringsforanstaltninger
English: The mean pharmacokinetic profile is shown in figure 1.
Danish: Den gennemsnitlige farmakokinetiske profil er vist i figur 1.
English: The refill procedure should be performed every 40 to 45 days.
Danish: Genopfyldningsproceduren skal udføres efter 40 til 45 dage.
English: HIGH STRENGTH
Danish: HØJ STYRKE
English: • Severe allergic reaction with low blood pressure (shock)
Danish: - Alvorlig allergisk reaktion med lavt blodtryk (shock)
English: This should be kept in mind if treatment with the combination of pioglitazone and Insuman is considered.
Danish: Dette skal tages i betragtning, hvis kombinationsbehandling med pioglitazon og Insuman overvejes.
English: Alarms in your PPC will let you know if your reservoir level is getting low.
Danish: Alarmer på din PPC vil advare dig ved lave reservoirniveauer.
English: Close metabolic monitoring is recommended during the transition and in the initial weeks thereafter.
Danish: Omhyggelig metabolisk monitorering anbefales i overgangsperioden og i de initiale uger der følger.
English: This medicine contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. det er i det væsentlige ”natriumfrit”.
English: However, the average insulin requirement is often 0.5 to 1.0 IU per kg body weight per day.
Danish: Det gennemsnitlige insulinbehov udgør dog ofte 0,5-1,0 IE pr. kg legemsvægt pr. døgn.
English: This procedure should always be scheduled in advance of PPC “low reservoir” or “empty reservoir” messages with the patient.
Danish: Denne procedure skal altid planlægges på forhånd med patienten før PPC-beskederne ”low reservoir” eller ”empty reservoir” vises.
English: The puncture site within a given injection area must be changed regularly (generally, every 1 to 3 days).
Danish: Injektionsstedet inden for det enkelte injektionsfelt skal skiftes regelmæssigt (normalt med 1-3 dages mellemrum).
English: Do not extend this period of time.
Danish: Lad være med at overskride tidsperioden.
English: The pump is not connected to a glucose meter.
Danish: Pumpen er ikke forbundet til et glucometer.
English: It is recommended to perform the rinse procedure every 6 months or as necessary based on the refill accuracy criterion.
Danish: Det anbefales at udføre skylleproceduren hver 6. måned eller efter behov baseret på kriteriet for genopfyldningsnøjagtighed.
English: It is recommended to perform the rinse procedure every 6 months.
Danish: Det anbefales at foretage skylleprocedure hver 6. måned.
English: Surgical and medicinal procedures
Danish: Kirurgiske og medicinske procedurer
English: • Warnings and precautions when using an implantable pump
Danish: • Advarsler og forsigtighedsregler ved brug af en implanterbar pumpe
English: A stroke volume of between 0.42 μl to 0.58 μl without backflow is indicative of a catheter occlusion.
Danish: Et slagvolumen mellem 0,42 µl til 0,58 µl uden tilbageløb er indikation af en kateterokklusion.
English: Daily doses and timing of administration
Danish: Daglig dosis og tidspunkt for administration
English: The time between two refill procedures cannot exceed 45 days for insulin in-use stability reasons.
Danish: Tiden imellem to genopfyldningsprocedurer må ikke overskride 45 dage grundet stabiliteten af insulin i anvendelse.
English: She/he is trained to perform pump investigations.
Danish: Hun/han er trænet i at udføre pumpeundersøgelser.
English: In addition, antibiotic prophylactic measures are required before and after pump implantation to reduce the risk of pump pocket infection.
Danish: Desuden er det påkrævet, at der tages antibiotiske profylaktiske forholdsregler, både før og efter implantation af pumpen, for at mindske risikoen for infektion af pumpens lomme.
English: Diagnostic procedures must be performed to check if the problem is due to the pump or catheter.
Danish: Diagnostiske procedurer skal foretages for at klarlægge om problemet skyldes pumpen eller kateteret.
English: Based on your needs, you may need to replace your insulin earlier.
Danish: Baseret på dine behov kan det være nødvendigt at udskifte din insulin tidligere.
English: No food effect is expected on Cmax, Tmax and AUC values following CIPII administration.
Danish: Ingen madeffekt er forventet på Cmax, Tmax og AUC-værdier som følge af CIPII-administration.
English: The MAH shall ensure that the training programme for centres includes the following key elements:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at træningsprogrammet for centrene indeholder følgende nøgleelementer:
English: Frequent adjustments of insulin doses under strict medical supervision are often required for several weeks following pump implantation.
Danish: Hyppige justeringer af insulindosis under nøje overvågning af en læge er ofte nødvendige i flere uger efter implantation af en pumpe.
English: Hyperglycaemia can become serious and lead to a serious condition (ketoacidosis).
Danish: Hyperglykæmi kan være alvorligt og medføre en alvorlig tilstand (ketoacidose).
English: The need to adjust (e.g. reduce) the dose may become evident immediately after transfer.
Danish: Behovet for at justere (for eksempel reducere) dosen kan blive tydeligt omgående efter skiftet.
English: Any unused insulin should be disposed of in accordance with local requirements and should not be reused.
Danish: Al ubrugt insulin skal bortskaffes i overensstemmelse med lokale krav og må ikke genanvendes.
English: Mean HbA1c value at baseline was 8.1%.
Danish: Middelværdien af HbA1c var ved udgangspunktet 8,1 %.
English: Intraperitoneal use
Danish: Intraperitoneal anvendelse
English: The insulin solution must be then degassed according to the degassing procedure described in the Physician's manual.
Danish: Insulinopløsningen skal derefter afgasses i henhold til afgasningsproceduren beskrevet i lægens manual.
English: If the rinse procedure fails to restore the stroke volume and accurate delivery, an extended rinse procedure needs to be performed.
Danish: Hvis det ikke lykkes skylleproceduren at genoprette slagvolumen og nøjagtig levering er det nødvendigt at udføre en udvidet skylleprocedure.
English: Refilling the pump is a sterile procedure which must be carried out in the hospital or clinic.
Danish: Genopfyldning af pumpen er en steril procedure, som skal foregå på et hospital eller på en klinik.
English: Failure to do this may cause permanent damage to the pump.
Danish: Undladelse kan medføre permanent skade på pumpen.
English: Before initial pump implantation, 72.4% of these patients had been treated by continuous subcutaneous insulin infusion (CSII) and 17.8% by subcutaneous multi-injection.
Danish: Før den initiale implantation af pumpen, var 72,4 % af disse patienter blevet behandlet med kontinuert, subkutan infusion af insulin (CSII) og 17,8 % med subkutan multiinjektion.
English: Alternatively you can contact the Marketing Authorisation Holder listed at the end of this leaflet.
Danish: Alternativt kan du kontakte indehaveren af markedsføringstilladelsen, som står anført til sidst i denne indlægsseddel.
English: Depending on blood glucose values, an appropriate bolus amount must be programmed to remove the sterile rinse buffer solution from the catheter.
Danish: Afhængigt af blodglucoseværdier skal en passende bolusmængde programmeres for at fjerne den sterile skyllebufferopløsning fra katetret.
English: Reservoir refilling must be performed by trained and qualified personnel in accordance with the instructions provided by the pump manufacturer.
Danish: Pumpens reservoir skal genopfyldes af trænet og kvalificeret personale i henhold til instruktioner fremsat af pumpens fremstiller.
English: A calculated refill accuracy of less than 85% is indicative of insulin under-delivery.
Danish: En beregnet genopfyldningsnøjagtighed på mindre end 85 % er en indikation af insulinunderlevering.
English: This seems to be reversible when your catheter is repositioned or your insulin infusion stopped and without consequences on your health (see section 4).
Danish: Dette lader til at være opretteligt, når dit kateter bliver omplaceret eller når din insulinfusion bliver stoppet og uden konsekvenser for dit helbred (se punkt 4).
English: This can be reduced by continuously wearing an abdominal binder until the capsule has formed (about 1 month) and limiting patient activities immediately following device implant.
Danish: Dette kan reduceres ved konstant at gå med et abdominalbælte indtil bindevævskapslen er dannet (cirka en måned) og ved at begrænse patientens aktiviteter umiddelbart efter implantation af enheden.
English: • Patient emergency information cards
Danish: • Nødsituationsinformationskort til patienter
English: Use only clear and colourless solutions.
Danish: Kun klare og farveløse opløsninger må anvendes.
English: The patient blood glucose levels must be monitored at least every 15 minutes following the flush.
Danish: Patientens blodglucoseniveau skal monitoreres mindst hvert 15. minut efter gennemskylning.
English: If the flush procedure is unsuccessful, catheter replacement surgery is usually performed.
Danish: Hvis gennemskylningen mislykkes bliver der normalt udført kateterudskiftningskirurgi.
English: In addition, if patients are attempting to deliver more than 2.5 times the programmed maximum bolus amount within a one hour period, the PPC will display the “HOURLY MAX EXCEEDED” message to warn the patients.
Danish: Derudover, hvis patienterne forsøger at dosere mere end 2,5 gange den programmerede maksimale bolusdosis inden for en time, vil PPC vise beskeden ”HOURLY MAX EXCEEDED” for at advare patienterne.
English: The study included 168 patients with type 1 diabetes mellitus, previously treated with the semi-synthetic human insulin.
Danish: Studietomfattede 168 patienter med type 1-diabetes mellitus som tidligere blev behandlet med det semisyntetiske human insulin.
English: Due to the size of the pump, adolescents who have not reached the adult size must not be implanted.
Danish: Grundet pumpens størrelse må unge, der ikke er fuldt udviklede, ikke implanteres.
English: This may require a change to your insulin dose (see section 4).
Danish: Dette kan kræve en ændring i din insulindosis (se punkt 4).
English: Intravenous insulin therapy must generally take place in an intensive care unit or under comparable monitoring and treatment conditions (see "Daily doses and timing of administration").
Danish: Intravenøs insulinbehandling bør som hovedregel foregå på en intensivafdeling eller under lignende monitorerings- og behandlingsforhold (se ”Døgndosis og tidspunkt for administration”).
English: No clinical symptoms, macroscopically visible changes or irritations in the abdominal cavity were observed.
Danish: Ingen kliniske symptomer, makroskopisk visuelle ændringer eller irritationer i bughulen blev observeret.
English: Insuman Implantable should not be used during pregnancy unless the clinical condition of the woman requires treatment with Insuman Implantable.
Danish: Insuman Implantable skal ikke bruges under graviditet medmindre kvindens kliniske tilstand kræver behandling med Insuman Implantable.
English: She/he is trained to perform pump procedures which are needed tomake sure your pump works properly.
Danish: Hun/han er trænet i at udføre pumpeprocedurer, der er nødvendige for at sikre, at pumpen fungerer korrekt.
English: The amount of insulin is constantly monitored through the PPC which communicates with the pump via radio waves.
Danish: Mængden af insulin monitoreres konstant ved hjælp af PPC'en, som kommunikerer med pumpen vha. radiobølger.
English: In another study, rats also received the same semi-synthetic insulin via an intraperitoneally implanted osmotic mini-pump infusion for up to 6 weeks.
Danish: I et andet studium modtog rotter den samme semi-syntetiske insulin gennem en intraperitonealt implanteret osmotisk mini-pumpe infusion i op til 6 uger.
English: Please check the reverse (insulin) side of this leaflet for instructions on how to store SoloStar.
Danish: Læs venligst den modsatte (insulin) side af denne indlægsseddel vedrørende hvordan SoloStar opbevares.
English: During the catheter flush procedure 13 units of insulin are manually pushed through the catheter and delivered to the patient.
Danish: Ved kateter skylleproceduren bliver 13 insulinenheder manuelt skubbet gennem katetret og leveret til patienten.
English: The frequency of this reaction varies with patient population and dose regimens.
Danish: Hyppigheden varierer med patientpopulation og dosisregimer.
English: Under-delivery due to a problem with the pump
Danish: Underlevering grundet et problem med pumpen
English: If you experience severe low blood sugar levels, this may indicate a problem with your pump.
Danish: Hvis du oplever alvorligt lave blodsukkerniveauer kan dette tyde på et problem med din pumpe.
English: These patients are not adequately controlled despite intensive injection of insulin under their skin (multiple daily injections or insulin pump therapy).
Danish: Disse patienter er ikke er tilstrækkeligt kontrollerede på trods af intensive injektioner af insulin under huden (flere daglige injektioner eller insulinpumpebehandling).
English: Clinically relevant over-delivery of insulin was not observed during a 4 year period of evaluation of the Medtronic MiniMed Implantable Pump; however, this does not exclude the potential for such an occurrence.
Danish: Der blev ikke observeret klinisk relevant overlevering af insulin under en 4-årig evalueringsperiode af Medtronic MiniMed Implantable Pump; dette udelukker dog ikke den potentielle risiko for sådan en sådan hændelse.
English: Infection of the pump pocket
Danish: Infektion af pumpens lomme
English: Insulin does not cross the placental barrier.
Danish: Insulin passerer ikke placentabarrieren.
English: • Patients' responsibilities regarding insulin treatment as well as refill frequency and maintenance of the pump as outlined in the key messages in the patient information leaflet;
Danish: • Patienternes ansvar i forhold til insulinbehandling samt frekens for genopfyldning og vedligeholdelse af pumpen som beskrevet i nøglebeskederne i indlægssedlen;
English: In healthy subjects, the serum half-life of insulin is approximately 4 to 6 minutes.
Danish: Hos raske personer er insulins serum-halveringstid omkring 4-6 minutter.
English: Otherwise stroke volume values outside this range or the detection of backflow is indicative of a pump problem.
Danish: Værdier for slagvolumen udenfor dette interval eller detektion af tilbageløb er en indikation af et problem med pumpen.
English: The co-primary endpoint was change in HbA1c from baseline and the pump refill accuracy after 4 refill cycles (162 ± 21 days).
Danish: Det co-primære endepunkt var ændringer i HbA1c fra udgangspunktet samt genopfyldningens nøjagtighed efter 4 genopfyldninger (162 ± 21 dage).
English: The stroke volume measurement procedure tests pump function, while a catheter flush procedure tests catheter patency.
Danish: Slagvolumenmålemetoden tester pumpefunktionen, mens en kateter skylleprocedure tester katetres åbenhed.
English: During the refill procedure it is important to fill out the refill worksheet and to calculate refill accuracy to evaluate system function.
Danish: Under genopfyldningsproceduren er det vigtigt at udfylde regnearket og udregne genopfyldningsnøjagtigheden for at evaluere systemets funktion.
English: The patient should correct resistant hyperglycaemia with a standard dose of subcutaneous insulin.
Danish: Patienten skal korrigere resistent hyperglykæmi med en standarddosis af subkutan insulin.
English: The insulin usage and clinical symptoms may be identical to those of pump under-delivery.
Danish: Insulinforbruget og de kliniske symptomer kan være identiske med dem ved pumpeunderlevering.
English: It is known that insulin can form aggregates, fibrils and gel-like structures when it is subjected to chemical and/or physical stress, e.g. increased temperatures and shaking.
Danish: Det er et kendt fænomen, at insulin kan danne aggregater, fibriller og gelelignende strukturer, når det udsættes for kemisk og/eller fysisk belastning f.eks. temperaturøgning og rystninger.
English: The patient should only be released once blood glucose levels are stable and within the safe range.
Danish: Patienten må først frigives, når blodglucoseniveauerne er stabile og indenfor sikkert interval.
English: Dose regimen adjustment may be necessary when changing patients from one insulin preparation to another.
Danish: Justering af insulindosisregime kan være nødvendig ved skift af patienter fra en insulinformulering til en anden.
English: The reservoir is completely filled (approximately 15 ml or 6,000 units of Insuman Implantable), independently of the patients needs.
Danish: Reservoiret skal fyldes helt (omkring 15 ml eller 6.000 IE af Insuman Implantable), uanset patientens individuelle behov.
English: • Recognition of signs and symptoms of severe hypoglycaemia and the appropriate actions to take
Danish: • Opdagelse af tegn og symptomer på svær hypoglykæmi samt hvilke passende foranstaltninger,
English: All pump procedures (such as pump refill, rinsing of the pump, pump investigations to check whether your pump works properly) are performed using sterile technique to avoid risk of infection.
Danish: Alle pumpeprocedurer (pumpegenopfyldning, rensning af pumpen, pumpeundersøgelser der kan tjekke om pumpen fungerer korrekt) udføres vha. steril teknik for at undgå risiko for infektion.
English: If you need to increase your insulin to maintain your blood sugar level, if you experience refractory hyperglycaemia, this may indicate a problem with the pump.
Danish: Hvis det er nødvendigt at øge din insulin for at vedligeholde dit blodsukkerniveau, hvis du oplever refraktær hyperglykæmi kan dette tyde på et problem med pumpen.
English: The MAH shall ensure that all centres are adequately supplied with the following in the appropriate national language(s):
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle centre er tilstrækkeligt forsynet med følgende på relevante nationale sprog:
English: It may also indicate that the refill needle is not properly seated in the pump inlet valve.
Danish: Det kan også indikere, at genopfyldningsnålen ikke sidder korrekt i pumpens indløbsventil.
English: A rinse procedure of the pump is performed to reverse this condition.
Danish: En skylleprocedure for pumpen udføres for at korrigere denne tilstand.
English: The patient plays a significant role in diagnosing and correcting hyperglycemia linked to pump performance problems.
Danish: Patienten spiller en vigtig rolle i diagnosticeringen og i at korrigere hyperglykæmi forbundet med problemer med pumpens ydeevne.