natgillin/translations-raw huggingface dataset:
LÆGEMIDLETS NAVN Semglee 100 enheder/ml injektionsvæske, opløsning i fyldt pen
NAME OF THE MEDICINAL PRODUCT Semglee 100 units/ml solution for injection in pre-filled pen
Hvis der ikke er nok enheder tilbage i din pen til den næste dosis, kan du enten:
If your dose is more than the number of units left in the pen, either:
Efter subkutan injektion af insulin glargin til raske forsøgspersoner og diabetespatienter indikerer serumkoncentrationen af insulin en langsommere og en forlænget absorption uden koncentrationstoppe sammenlignet med humant NPH-insulin.
In healthy subjects and diabetic patients, insulin serum concentrations indicated a slower and much more prolonged absorption and showed a lack of a peak after subcutaneous injection of insulin glargine in comparison to human NPH insulin.
Anvend ikke Semglee, hvis du bemærker partikler i den. Anvend kun Semglee, hvis opløsningen er klar og farveløs.
Do not use Semglee if you notice particles in the solution.
Du skal altid opbevare pennen med hætten på for at undgå urenheder.
Always store the pen with the cap on, to prevent contamination.
Hvis pennen ikke holdes lodret, mens du påsætter den ydre nålehætte, kan nålen blive bøjet eller beskadiget.
Trying to attach the outer needle cap sideways may bend or damage the needle.
Før cylinderampullen indsættes i pennen, skal den opbevares i 1-2 timer ved stuetemperatur.
6.6 Special precautions for disposal and other handling Before first use, the pen must be stored at room temperature for 1 to 2 hours.
Det skal du vide, før du begynder at bruge Semglee Sådan skal du bruge Semglee Bivirkninger
What you need to know before you use Semglee
Påsæt en ny nål
Attach a new needle
B - Hold pennen lodret og sæt den ydre nålehætte lige på cylinderampulholderen som vist på billedet.
B - While holding the pen body facing upwards, attach the outer needle cap straight on to the cartridge holder as shown.
Anvend ikke Semglee pennen, hvis den er beskadiget eller ikke virker ordentligt.
Do not use Semglee pen if it is damaged or not working properly (due to mechanical defects), it has to be discarded and a new Semglee pen has to be used.
Semglee 100 enheder/ml injektionsvæske, opløsning i fyldt pen.
Semglee 100 units/ml solution for injection in pre-filled pen.
EU/1/18/1270/005
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1270/005
De farmakokinetiske og farmakodynamiske fund indikerer, at effekten af en subkutan injektion af Semglee hovedsageligt skyldes eksponering for M1.
The pharmacokinetic and pharmacodynamic findings indicate that the effect of the subcutaneous injection with Semglee is principally based on exposure to M1. Insulin glargine and the metabolite M2 were not detectable in the vast majority of subjects and, when they were detectable their concentration was independent of the administered dose of Semglee.
Brugsanvisningen i indlægssedlen skal læses omhyggeligt før Semglee fyldt pen anvendes.
Before using Semglee pre-filled pen, the instructions for use included in the package leaflet must be read carefully.
Brugsanvisningen i indlægssedlen skal læses omhyggeligt, før den fyldte pen anvendes.
Before using Semglee pen, the instructions for use included in the package leaflet must be read carefully.
Plasma-dal-koncentrationen af insulin glargin og dets vigtigste M1- og M2-metabolitter blev målt hos børn behandlet med insulin glargin.
Plasma “trough” levels of insulin glargine and its main M1 and M2 metabolites were measured in children treated with insulin glargine, revealing plasma concentration patterns similar to adults, and providing no evidence for accumulation of insulin glargine or its metabolites with chronic dosing.
Udseende og pakningsstørrelser
What Semglee looks like and contents of the pack
Hvis du for eksempel: - tager for meget insulin, - springer måltider over eller udsætter dem, - ikke spiser nok eller spiser mad, der indeholder færre kulhydrater end normalt (sukker og sukkerlignende stoffer kaldes kulhydrater; kunstige sødemidler er imidlertid IKKE kulhydrater), - mister kulhydrater på grund af opkastning eller diarré, - drikker alkohol, især hvis du ikke spiser ret meget, - dyrker mere motion end normalt eller udfører en anden form for fysisk aktivitet, - er ved at komme dig efter en skade eller operation eller andre former for stress, - er ved at komme dig efter en sygdom eller feber, - tager eller er holdt op med at tage visse andre lægemidler (se afsnit 2, "Brug af anden medicin sammen med Semglee").
carbohydrates), - you lose carbohydrates due to vomiting or diarrhoea, - you drink alcohol, particularly if you are not eating much, - you are doing more exercise than usual or a different type of physical activity, - you are recovering from an injury or operation or other stress, - you are recovering from an illness or from fever, - you are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Semglee").
Uanbrudte penne
In-use pens
Må ikke opbevares i køleskab.
Pens in use must not be stored in the refrigerator.
Subkutan injektion af Semglee er en forudsætning for den lange virkningsvarighed.
The prolonged duration of action of Semglee is dependent on its injection into subcutaneous tissue.
Medicin, der kan få dit blodsukker til at falde (hypoglykæmi), omfatter: - alle øvrige lægemidler til behandling af diabetes, - angiotensinkonverterende enzym (ACE)-hæmmere (anvendes til behandling af visse hjertesygdomme eller højt blodtryk), - disopyramid (anvendes til behandling af visse hjertesygdomme),
Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: - all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as acetylsalicylic acid, used to relieve pain and lower fever), - sulfonamide antibiotics.
Cylinderampullen er anbragt i en injektionspen til engangsbrug.
The cartridge is assembled in a disposable pen injector.
A - Klem den rensede hud sammen mellem dine fingre, hvis din læge eller sundhedspersonalet har bedt dig gøre det.
Inject your dose A - If instructed by your healthcare provider you can pinch the cleaned skin between your fingers.
A - Du skal altid kontrollere insulin-flowet før hver injektion.
A - Always prime a new pen needle before each injection.
BILAG II A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Hvis du har brugt for meget Semglee
If you use more Semglee than you should
D - Sæt hætten tilbage på cylinderampullen.
D - Replace the pen cap over the cartridge.
Der blev vist ens effekt på glycohæmoglobin og incidensen af symptomatisk hypoglykæmi i begge behandlingsgrupper.
Similar effects on glycohemoglobin and the incidence of symptomatic hypoglycemia were observed in both treatment groups, however fasting plasma glucose decreased more from baseline in the insulin glargine group than in the NPH group.
Det hjælper med at forebygge blokering af nålen og infektion.
Always use a new sterile needle for each injection as this helps stop blocked needles and prevents infections.
Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du bruger dette lægemiddel.
Inform your doctor if you are planning to become pregnant, or if you are already pregnant.
Pennens bestanddele:
Pen assembly:
Farmakoterapeutisk klassifikation: Antidiabetica.
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Virkningsvarigheden af
Frequency of administration
Du må ikke smide løse nåle i skraldespanden.
Do not throw it away.
BRUGSANVISNING
Posology
Semglees sikkerhed og virkning er ikke påvist hos børn under 2 år.
The safety and efficacy of Semglee have not been established.
LÆGEMIDLETS NAVN
Medicinal product subject to medical prescription
Dette sammendrag blev senest ajourført i 07-2014.
This summary was last updated in 07-2014.
Sorte patienter kan behøve højere dosis end hvide.
Black patients may require higher doses than white patients.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Envarsus den 18. juli 2014.
The European Commission granted a marketing authorisation valid throughout the European Union for Envarsus on 18 July 2014.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Envarsus.
This is a summary of the European public assessment report (EPAR) for Envarsus.
Envarsus indtages én gang dagligt med vand på tom mave.
Envarsus should be taken once daily with water, on an empty stomach.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Envarsus findes på agenturets websted underema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Envarsus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Der er udarbejdet en risikostyringsplan for at sikre, at Envarsus anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Envarsus is used as safely as possible.
Andre oplysninger om Envarsus
Other information about Envarsus
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Envarsus?
What measures are being taken to ensure the safe and effective use of Envarsus?
Dosis af Envarsus beregnes efter patientens vægt.
Doses of Envarsus are calculated based on the patient's weight.
Lægen bør overvåge blodets indhold af tacrolimus for at sikre, at det er inden for visse grænser.
Doctors should monitor the levels of tacrolimus in the blood to check that they stay within certain limits.
Patienterne fik enten deres behandling lagt om til Envarsus én gang dagligt eller fortsatte med Prograf to gange dagligt.
Patients were either switched to treatment with Envarsus once daily or continued Prograf treatment twice daily.
Til forebyggelse af afstødning er startdosis 0,17 mg/kg legemsvægt til patienter, der har fået en nyretransplantation, og 0,11-0,13 mg/kg dagligt til dem, der har fået en levertransplantation.
In the prevention of rejection, doses should start at 0.17 mg per kg of body weight daily in patients who have had a kidney transplant, and 0.11 to 0.13 mg per kg daily in those who have had a liver transplant.
De almindeligste bivirkninger med Envarsus (der ses hos flere end 1 af hver 10 patienter) er rysten, hovedpine, kvalme, diarré, nyreproblemer, for højt blodsukker (hyperglykæmi), sukkersyge (diabetes), for højt kaliumindhold i blodet (hyperkaliæmi), for højt blodtryk (hypertension) og søvnløshed.
The most commonly reported side effects with Envarsus (seen in more than 1 patient in 10) are tremor (shaking), headache, nausea (feeling sick), diarrhoea, kidney problems, hyperglycaemia (raised blood glucose levels), diabetes, hyperkalaemia (raised blood potassium levels), hypertension (high blood pressure) and insomnia (difficulty sleeping).
Det vil sige, at det svarer til et “referencelægemiddel”, der indeholder samme aktive stof, men har en anden sammensætning og fås i andre doser.
This means that Envarsus is similar to a ‘reference medicine' that contains the same active substance but Envarsus has been formulated in a different way and is available at different doses.
Envarsus er et “hybridt lægemiddel”.
Envarsus is a ‘hybrid medicine'.
Patienterne kan desuden få unormale resultater af leverfunktionsprøver.
Patients may also have abnormal results in liver function tests.
Hvorfor er Envarsus blevet godkendt?
Why is Envarsus approved?
Der var behandlingssvigt hos 18,3 % af dem, der fik Envarsus (49 ud af 268), og 19,6 % af dem, der fik Prograf (54 ud af 275).
Treatment failure occurred in 18.3% patients treated with Envarsus (49 out of 268), and 19.6% given Prograf (54 out of 275).
I begge grupper var der behandlingssvigt hos 2,5 % (4 af 162 patienter behandlet med Envarsus, og 4 af 162 behandlet med Prograf).
Failure rates were 2.5% in both groups (4 of 162 patients treated with Envarsus, and 4 of 162 treated with Prograf).
På grund af forskelle i sammensætning/dosering mellem Envarsus og Advagraf blev der desuden forelagt kliniske undersøgelser hos patienter.
In addition, because of the formulation/dosage differences between Envarsus and Advagraf, clinical studies in patients were also provided.
Envarsus er påvist at være mindst ligeså effektivt som Prograf i to hovedundersøgelser hos patienter med nyretransplantat.
Envarsus has been shown to be at least as effective as Prograf in two main studies in patients with kidney transplants.
Den første undersøgelse omfattede 326 patienter, der i forvejen havde et nyretransplantat og var i behandling med Prograf og andre immundæmpende lægemidler for at forebygge afstødning.
The first study involved 326 patients who had already had a kidney transplant and were being treated with Prograf and other immunosuppressants to prevent rejection.
Envarsus må ikke anvendes hos patienter, der er overfølsomme (allergiske) over for tacrolimus eller andre af indholdsstofferne, eller hos patienter, der er allergiske over for stoffer af typen makrolider (herunder antibiotika såsom erythromycin).
Envarsus must not be used in patients who are hypersensitive (allergic) to tacrolimus or any of the other ingredients, nor in those who are allergic to substances called macrolides (which include antibiotics such as erythromycin).
Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Envarsus i de godkendte doser er påvist at have en kvalitet, sikkerhed og virkning, der svarer til Advagraf og Prograf.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the approved doses of Envarsus have been shown to have a comparable quality, safety and effectiveness to Advagraf and Prograf.
Behandlingen tilpasses efter lægemidlets koncentration i blodet og dets virkning på patienten.
Treatment is adjusted according to the medicine's blood levels and the patient's response.
Da Envarsus svarer til referencelægemidlet Advagraf, forelagde ansøgeren sammenlignede oplysninger om Advagraf.
Because Envarsus is similar to the reference medicine Advagraf, the applicant provided comparative data on Advagraf.
I den anden undersøgelse blev Envarsus sammenlignet med Prograf som led i standardbehandling hos 543 patienter med en nytransplanteret nyre.
The second study compared Envarsus with Prograf as part of standard treatment in 543 patients with a newly transplanted kidney.
Envarsus gives ofte sammen med andre immundæmpende lægemidler efter transplantation.
Envarsus is often given with other immunosuppressive medicines following the transplant.
I begge undersøgelser blev virkningen hovedsagelig bedømt på det antal patienter, hos hvem behandlingen efter 12 måneder havde slået fejl (dødsfald, svigt eller afstødning af det transplanterede organ, eller patienten tabt for opfølgning).
The main measure of effectiveness in both studies was the number of patients who had treatment failure (death, failure or rejection of the transplanted organ, or loss of the patient from follow-up) after 12 months.
Tacrolimus, det aktive stof i Envarsus, er et immundæmpende lægemiddel.
Tacrolimus, the active substance in Envarsus, is an immunosuppressive medicine.
Hvad er Envarsus, og hvad anvendes det til?
What is Envarsus and what is it used for?
Envarsus fås kun på recept og må kun ordineres af en læge med erfaring inden for immundæmpende lægemidler og behandling af transplantationspatienter.
Envarsus can only be obtained with a prescription and should only be prescribed by doctors experienced in immunosuppressive medicines and in the management of transplant patients.
Envarsus er et lægemiddel, der indeholder det aktive stof tacrolimus.
Envarsus is a medicine that contains the active substance tacrolimus.
Referencelægemidlet for Envarsus er Advagraf.
The reference medicine for Envarsus is Advagraf.
Hvis du ønsker yderligere oplysninger om behandling med Envarsus, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Envarsus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Hvilke risici er der forbundet med Envarsus?
What are the risks associated with Envarsus?
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Envarsus, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Envarsus, including the appropriate precautions to be followed by healthcare professionals and patients.
Hvis der skal skiftes til et andet immundæmpende lægemiddel eller behandlingen ændres, bør dette iværksættes og overvåges af læger med erfaring i transplantation.
Switching or changes in immunosuppressive medicines should be started and monitored by experienced transplant doctors.
Ved nedsat leverfunktion kan det være nødvendigt med lavere dosis.
Lower doses may be needed in patients with reduced liver function.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Envarsus.
The Committee recommended that Envarsus be given marketing authorisation.
Det er ikke en praktisk vejledning i, hvordan Envarsus bør anvendes.
It is not intended to provide practical advice on how to use Envarsus.
Tacrolimus virker på immunsystemets T-celler, som er hovedansvarlige for, at det transplanterede organ angribes (afstødes).
Tacrolimus reduces the activity of certain cells in the immune system, called T-cells, that are primarily responsible for attacking the transplanted organ (organ rejection).
Envarsus leveres som depottabletter med 0,75, 1 eller 4 mg tacrolimus.
Envarsus is available as prolonged-released tablets containing tacrolimus (0.75, 1 and 4 mg).
Tacrolimus frigives langsomt i løbet af flere timer fra depottabletten i en form, så det let optages af kroppen.
These ‘prolonged-release' tablets allow tacrolimus to be released slowly from the tablet over several hours and in a form that the body can absorb easily, so that it need be given only once a day.
Der bruges som langtidsbehandling for at forebygge afstødning hos voksne efter en nyre- eller levertransplantation (ved afstødning angriber immunsystemet det transplanterede organ).
It is used for the long-term treatment of adult patients who have had a kidney or a liver transplant, to prevent rejection (when the immune system attacks the transplanted organ).
Til behandling af afstødning kan man prøve at give de samme startdoser.
These starting doses may also be tried for the treatment of rejection.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for de andre former af tacrolimus.
Therefore, the CHMP's view was that, as for other authorised forms of tacrolimus, the benefit outweighs the identified risk.
Envarsus kan desuden bruges til at behandle organafstødning hos voksne patienter, når andre immundæmpende lægemidler ikke virker.
Envarsus can also be used to treat organ rejection in adult patients when other immunosuppressive medicines (medicines that reduce the activity of the immune system) are not effective.
Hvordan anvendes Envarsus?
How is Envarsus used?
Hvis du ønsker praktisk vejledning om anvendelsen af Envarsus, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Envarsus, patients should read the package leaflet or contact their doctor or pharmacist.
Den fuldstændige liste over indberettede bivirkninger med Envarsus fremgår af indlægssedlen.
For the full list of all side effects reported with Envarsus see the package leaflet
Prograf er et udbredt og anerkendt lægemiddel, som indeholder tacrolimus, men frigiver det hurtigere.
These studies compared Envarsus with Prograf, a widely used and well-established tacrolimus medicine that releases tacrolimus more quickly.
Hvilke fordele viser undersøgelserne, at der er ved Envarsus?
What benefits of Envarsus have been shown in studies?
Ved skift til Envarsus skal patienter, der i forvejen er i behandling med en anden sammensætning (formulering) af tacrolimus, derfor have en 30 % lavere dosis af Envarsus end deres hidtidige dosis.
Because tacrolimus is absorbed into the body differently from Envarsus than from other tacrolimus medicines, when switching patients who are already being treated with any other formulation of tacrolimus they should be given a dose of Envarsus 30% less than their existing dose.
Materialet skal nævne de godkendte anvendelser og den godkendte dosering og påpege, at der skal udvises forsigtighed, hvis der skiftes mellem de forskellige former af tacrolimus.
In addition, the company that markets Envarsus will provide educational material for healthcare professionals who are likely to prescribe or dispense Envarsus, reminding them of its authorised uses and dosage, and the need for care if switching patients between different forms of tacrolimus.
Virksomheden forelagde desuden undersøgelser, der viste, at indtagelse af Envarsus fremkaldte koncentrationer af tacrolimus i kroppen, der tidligere var påvist at være effektive til behandling og forebyggelse af afstødning.
The company also provided studies on the levels of tacrolimus in the body after taking Envarsus, which showed that it produced levels of tacrolimus that have been previously shown to be effective in treating and preventing rejection, and reported results in 29 patients who were given Envarsus starting after a liver transplant, none of whom rejected the transplanted organ during the 360 days following transplantation.
Hvordan virker Envarsus?
How does Envarsus work?
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Adynovi.
This is a summary of the European public assessment report (EPAR) for Adynovi.
Det kan anvendes hos voksne og børn i alderen 12 år og derover.
It can be used in adults and children from 12 years of age.
Den fuldstændige EPAR for Adynovia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Adynovi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Andre oplysninger om Adynovia
Other information about Adynovi
Patienten eller dennes omsorgsgiver kan selv injicere Adynovi i hjemmet efter at have fået passende oplæring.
Patients or their carers may be able to inject Adynovi themselves at home once they have been trained appropriately.
Da dette kan tænkes at medføre problemer, især hos børn under 12 år, er Adynovi kun godkendt til voksne og børn i alderen 12 år og derover.
Since this could potentially cause problems especially in children below 12 years of age, Adynovi is only approved for use in adults and children from 12 years of age.
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Adynovi opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The European Medicines Agency decided that Adynovi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Adynovi?
What measures are being taken to ensure the safe and effective use of Adynovi?