FrancophonIA/ELRC3.0 huggingface dataset:
English: To reduce the risk of nocturnal and early morning hypoglycaemia, patients who are changing their basal insulin regimen from a twice daily NPH insulin to a once daily regimen with Semglee should reduce their daily dose of basal insulin by 20-30% during the first weeks of treatment.
Danish: For at mindske risikoen for natlig hypoglykæmi og hypoglykæmi tidligt om morgenen skal patienter, der omstilles fra basalinsulin givet 2 gange dagligt som NPH-insulin til Semglee givet 1 gang dagligt, nedsætte den daglige dosis af basalinsulin med 20-30% i de første behandlingsuger.
English: Semglee is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above.
Danish: Semglee anvendes til behandling af sukkersyge (diabetes mellitus) hos voksne, unge og børn fra 2 år og opefter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING IMMEDIATE CARTON (without blue box) component of multipack - 5 pens
Danish: INDERKARTON (uden blå boks) komponent af mulitipakning - 5 penne
English: - The other ingredients are: zinc chloride, metacresol, glycerol, sodium hydroxide (for pH adjustment) (see section 2 “Semglee contains sodium”), hydrochloric acid (for pH adjustment) and water for injections.
Danish: - Øvrige indholdsstoffer: zinkchlorid, metacresol, glycerol, natriumhydroxid (til pH-justering) (se afsnit 2 “Semglee indeholder natrium”), saltsyre (til pH-justering) og vand til injektionsvæsker.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with blue box) multipack - 10 (2x5 pens)
Danish: YDERKARTON - (uden blå boks) multipakning - 10 (2x5) penne
English: Semglee pen delivers insulin in increments of 1 unit up to a maximum single dose of 80 units.
Danish: Semglee pennen afgiver 1 enhed insulin ad gangen op til en maksimal enkeltdosis på 80 enheder.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure.
Danish: Kombinationsbehandling med Semglee og pioglitazon Der er indrapporteret tilfælde af hjertesvigt ved anvendelse af pioglitazon i kombination med insulin, særligt hos patienter med risikofaktorer for udvikling af hjertesvigt.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Danish: Navn og adresse på fremstilleren af det biologisk aktive stof Biocon Sdn.
English: After first use of the pen, store it at room temperature up to 30°C.
Danish: Efter du har brugt pennen første gang, skal den opbevares ved stuetemperatur (op til 30°C).
English: The primary aim of demonstrating non-inferiority of insulin glargine to NPH in all hypoglycaemia was not met and there was a trend to an increase of hypoglycemic events with insulin glargine [insulin glargine: NPH rate ratio (95% CI) = 1.18 (0.97-1.44)].
Danish: Dette mål blev ikke nået, og der var en tendens til stigning i hypoglykæmiske episoder med insulin glargin [insulin glargin:NPH rate ratio (95% CI) = 1,18 (0,97; 1,44)].
English: There are no clinically relevant differences in serum insulin or glucose levels after abdominal, deltoid or thigh administration of Semglee.
Danish: Der er ikke set klinisk relevante forskelle i serum-insulin og glucoseniveau efter indgift af Semglee på abdomen, lår eller overarm.
English: If you have injected too much Semglee, your blood sugar level may become too low (hypoglycaemia).
Danish: Hvis du har injiceret for meget Semglee, kan dit blodsukker blive for lavt (hypoglykæmi).
English: If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straight away (see the box at the end of this leaflet).
Danish: Hvis du får symptomer på for lavt blodsukker (hypoglykæmi) skal du straks gøre noget for at øge dit blodsukker (se det indrammede afsnit sidst i indlægssedlen).
English: Semglee is a pre-filled disposable pen injector containing 300 units of insulin glargine in 3 mL of solution (100 units/mL).
Danish: Semglee er en fyldt injektionspen til engangsbrug med 300 enheder insulin glargin i 3 ml opløsning (100 enheder/ml).
English: D - Wipe the rubber seal (at the front of the cartridge) with a new alcohol wipe.
Danish: D - Tør gummipakningen (i toppen af cylinderampulholderen) af med en ny afspritningsserviet.
English: Your ability to concentrate or react may be reduced if: - you have hypoglycaemia (low blood sugar levels), - you have hyperglycaemia (high blood sugar levels), - you have problems with your sight.
Danish: Din koncentrations- og reaktionsevne kan være nedsat, hvis du: - har hypoglykæmi (for lavt blodsukker), - har hyperglykæmi (for højt blodsukker),
English: Excipients: zinc chloride, metacresol, glycerol, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections
Danish: Hjælpestoffer: zinkchlorid, metacresol, glycerol, saltsyre og natriumhydroxid (til pH-justering), vand til injektionsvæsker
English: Put the pen cap aside to be used later.
Danish: Læg hætten til side til senere brug.
English: Each pen contains 3 ml of solution for injection, equivalent to 300 units.
Danish: Hver pen indeholder 3 ml injektionsvæske, opløsning svarende til 300 enheder.
English: If you have missed a dose of Semglee or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia).
Danish: Hvis du har sprunget en dosis Semglee over, eller hvis du ikke har injiceret nok insulin, kan blodsukkeret blive for højt (hyperglykæmi).
English: Pre-filled pens in use or carried as a spare may be stored for a maximum of 4 weeks not above 30°C and away from direct heat or direct light.
Danish: Når den fyldte pen er taget ud af køleskabet enten for at blive taget i brug eller for at blive medtaget som reserve, kan den opbevares ved temperaturer på op til 30°C i indtil 4 uger væk fra direkte varme og direkte lys.
English: These include patients: - in whom glycaemic control is markedly improved, - in whom hypoglycaemia develops gradually, - who are elderly, - after transfer from animal insulin to human insulin, - in whom an autonomic neuropathy is present, - with a long history of diabetes, - suffering from a psychiatric illness, - receiving concurrent treatment with certain other medicinal products (see section 4.5).
Danish: Disse omfatter: - patienter, hvor den glykæmiske kontrol er forbedret betydeligt, - patienter, hvor hypoglykæmi udvikles gradvist, - ældre patienter, - efter skift fra animalsk insulin til humant insulin, - patienter, som lider af autonom neuropati, - patienter med en lang diabetes-anamnese, - patienter, som har en psykisk lidelse, - patienter, som er i samtidig behandling med visse andre lægemidler (se pkt.
English: The pre-filled pen delivers insulin in increments of 1 unit up to a maximum single dose of 80 units.
Danish: Den fyldte pen afgiver 1 enhed insulin ad gangen op til en maksimal enkeltdosis på 80 enheder.
English: Solution for injection 1 pen of 3 ml 3 pens of 3 ml 5 pens of 3 ml 10 pens of 3 ml
Danish: 3 penne á 3 ml 5 penne á 3 ml 10 penne á 3 ml
English: C - Press the purple injection button all the way in.
Danish: C - Tryk den lilla injektionsknap helt i bund.
English: Make sure you have the following items before injecting your dose:
Danish: Du skal sørge for at have følgende til rådighed, før du bruger din pen:
English: Do not freeze or place next to the freezer compartment or a freezer pack.
Danish: Må ikke nedfryses eller placeres i direkte berøring med frostboks eller fryseelementer.
English: Do not apply lubricants such as oil.
Danish: Du må ikke smøre pennen med f.eks. olie.
English: The dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the yellow dose pointer.
Danish: Hvis du vil ændre din dosis, kan du gøre det ved at dreje dosisvælgerne enten frem eller tilbage, indtil den gule markør peger på den korrekte dosis.
English: After you take a pen out of the refrigerator, rest it on a flat surface and wait for it to reach room temperature between 15°C to 30°C before you use it.
Danish: Når du har taget pennen ud af køleskabet, skal den placeres på en plan bordplade, indtil den har nået stuetemperatur (15°C-30°C).
English: With the other hand pull off the pen cap.
Danish: Tag hætten af med den anden hånd.
English: Each ml of the solution contains 100 units of insulin glargine (equivalent to 3.64 mg).
Danish: Hver ml opløsning indeholder 100 enheder insulin glargin (svarende til 3,64 mg).
English: General disorders and administration site conditions Injection site reactions include redness, pain, itching, hives, swelling, or inflammation.
Danish: Almene symptomer og reaktioner på indgivelsesstedet Reaktioner på injektionsstedet omfatter rødme, smerter, kløe, udslæt, hævelse eller inflammation.
English: What Semglee contains
Danish: Semglee indeholder:
English: Injection sites include your arms, thighs, buttocks and abdomen.
Danish: Mulige injektionssteder er arme, lår, balder og mave.
English: The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if - you are elderly, if you have had diabetes for a long time or if you suffer from a certain type of nervous disease (diabetic autonomic neuropathy), - you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly, - you have almost normal or, at least, greatly improved blood sugar levels, - you have recently changed from an animal insulin to a human insulin such as Semglee, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Danish: - du er ældre, hvis du har haft diabetes i lang tid, eller hvis du lider af en bestemt form for sygdom i nervesystemet (diabetisk autonom neuropati), - du for nylig har haft hypoglykæmi (f.eks. dagen før), eller hvis tilstanden udvikles langsomt, - du har et næsten normalt eller i det mindste betydeligt forbedet blodsukker, - du for nyligt er skiftet fra animalsk insulin til humant insulin såsom Semglee, - du tager eller har taget visse andre lægemidler (se afsnit 2, "Brug af anden medicin sammen med Semglee").
English: Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Danish: Stoffer, som kan forstærke den blodsukkersænkende effekt, og som kan øge risikoen for hypoglykæmi, omfatter orale antidiabetika, ACE (angiotensinkonverterende converting enzymeenzym)-hæmmere, disopyramid, fibrater, fluoxetin, monoaminoxidase (MAO)-hæmmere, pentoxifyllin, propoxyphen, salicylater og sulfonamidantibiotika.
English: Handling of the pen
Danish: Vedligeholdelse af pennen
English: If administration by syringe is necessary, a vial should be used (see section 4.2).
Danish: Hvis administration med sprøjte er nødvendig, skal et hætteglas anvendes (se pkt.
English: Before using the pre-filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6).
Danish: Brugsanvisningen i indlægssedlen skal læses omhyggeligt, før Semglee fyldt pen anvendes (se pkt.6.6)
English: NN: {number}
Danish: Ελλάδα
English: ATC Code: A10AE04.
Danish: Insuliner og analoger til injektion, langtidsvirkende, ATC-kode: A10AE04.
English: You must always check the insulin label before each injection to avoid mix-ups between Semglee and other insulins.
Danish: Du skal altid kontrollere etiketten før hver injektion for at undgå forveksling mellem Semglee og andre insuliner.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Semglee 100 units/ml solution for injection insulin glargine
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Semglee 100 enheder/ml injektionsvæske, opløsning insulin glargin
English: Do not use the pen if the medicine in the cartridge looks cloudy, coloured or if you can see particles.
Danish: Du må ikke bruge pennen, hvis væsken er uklar, farvet eller indeholder partikler.
English: Adherence of the patient to the dose and dietary regimen, correct insulin administration and awareness of hypoglycaemia symptoms are essential to reduce the risk of hypoglycaemia.
Danish: For at mindske risikoen for hypoglykæmi er det vigtigt, at patienten overholder dosering og diæt, administrerer insulinet korrekt, og er opmærksom på symptomer på hypoglykæmi.
English: B - Squeeze the wide part of the outer needle cap and unscrew the needle in an anti-clockwise (left) direction.
Danish: B - Tryk på den ydre nålehætte som vist på billedet og skru nålen af mod uret (mod venstre).
English: Examples include: - you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage, - your insulin pen does not work properly, - you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever, - you are taking or have taken certain other medicines (see section 2, "Other medicines and
Danish: Hvis for eksempel: - du ikke har injiceret dit insulin eller ikke har injiceret nok, eller hvis det har mistet noget af sin virkning, f.eks. på grund af forkert opbevaring, - din insulinpen ikke fungerer rigtigt, - du dyrker mindre motion end sædvanlig eller er stresset (følelsesmæssigt ude af balance eller er ophidset, eller hvis du har en skade, er blevet opereret, har en infektion eller feber, - du tager eller har taget visse lægemidler (se afsnit 2, "Brug af anden medicin sammen med
English: Read carefully the "Instructions for Use" included in this package leaflet.
Danish: Læs omhyggeligt brugsanvisningen, som er vedlagt denne indlægsseddel.
English: Physiological concentrations of endogenous IGF-1 may activate the mitogenic-proliferative pathway; however, the therapeutic concentrations found in insulin therapy, including in Semglee therapy, are considerably lower than the pharmacological concentrations required to activate the IGF-1 pathway.
Danish: De terapeutiske koncentrationer ved insulinbehandling, inklusive behandling med Semglee, er dog betydeligt lavere end den farmakologiske koncentration, som kræves for at aktivere IGF-1-mekanismen.
English: C - Hold the pen body facing upwards with one hand.
Danish: C - Hold pennen lodret med den ene hånd.
English: The pen that you are using should be thrown away after 4 weeks of first use, even if it still has insulin left in it. See Step 8 for instructions on disposal.
Danish: Når du har brugt pennen i 4 uger, skal den kasseres, også selvom pennen stadig indeholder insulin.
English: D - Carefully pull off the outer needle cap and put it aside.
Danish: D - Tag forsigtigt den ydre nålehætte af og opbevar den til senere.
English: Semglee 100 units/ml solution for injection in a pre-filled pen is a clear colourless solution.
Danish: Semglee 100 enheder/ml, injektionsvæske, opløsning i en fyldt pen er en klar farveløs opløsning.
English: Substances that may reduce the blood-glucose-lowering effect include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and progestogens, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, atypical antipsychotic medicinal products (e.g. clozapine and olanzapine) and protease inhibitors.
Danish: Stoffer, som nedsætter den blodsukkersænkende effekt, omfatter kortikosteroider, danazol, diazoxid, diuretika, glukagon, isoniazid, østrogener og gestagener, phenothiazinderivater, somatropin, sympatomimetiske lægemidler (f.eks. adrenalin, salbutamol, terbutalin), thyreoideahormoner, atypiske antipsykotiske lægemidler (f.eks. clozapin og olanzapin) og proteasehæmmere.
English: Medicines that may cause your blood sugar level to rise (hyperglycaemia) include: - corticosteroids (such as "cortisone" used to treat inflammation), - danazol (medicine acting on ovulation), - diazoxide (used to treat high blood pressure), - diuretics (used to treat high blood pressure or excessive fluid retention), - glucagon (pancreas hormone used to treat severe hypoglycaemia), - isoniazid (used to treat tuberculosis), - oestrogens and progestogens (such as in the contraceptive pill used for birth control), - phenothiazine derivatives (used to treat psychiatric disorders), - somatropin (growth hormone), - sympathomimetic medicines (such as epinephrine [adrenaline], salbutamol, terbutaline used to treat asthma), - thyroid hormones (used to treat thyroid gland disorders), - atypical antipsychotic medicines (such as clozapine, olanzapine), - protease inhibitors (used to treat HIV).
Danish: Medicin, der kan få dit blodsukker til at stige (hyperglykæmi), omfatter: - kortikosteroider (såsom kortison, anvendes til behandling af betændelsestilstande), - danazol (medicin der virker på ægløsning), - diazoxid (anvendes til behandling af højt blodtryk), - vanddrivende lægemidler (anvendes til behandling af højt blodtryk eller overdreven væskeophobning), - glucagon (bugspytkirtelhormon, der anvendes til behandling af meget lavt blodsukker), - isoniazid (anvendes til behandling af tuberkulose), - østrogener og gestagener (findes i f.eks. p-piller, der anvendes som præventionsmiddel), - phenothiazinderivater (anvendes til behandling af psykiske sygdomme), - somatropin (væksthormon), - sympatomimetika (såsom adrenalin, salbutamol og terbutalin, anvendes til behandling af astma), - thyreoideahormoner (anvendes til behandling af sygdomme i skjoldbruskkirtlen), - atypiske antipsykotiske lægemidler (såsom clozapin, olanzapin), - proteasehæmmere (anvendes til behandling af HIV).
English: Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: Andre informationskilder Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • Adolescents and children aged 2 years and older patients Safety and efficacy of Semglee have been established in adolescents and children aged 2 years and older (see section 5.1).
Danish: Semglees sikkerhed og virkning er påvist hos unge og børn i alderen 2 år og derover (se pkt.
English: Semglee contains insulin glargine.
Danish: Semglee indeholder insulin glargin.
English: How to use Semglee
Danish: Sådan skal du bruge Semglee
English: E - Carefully pull off the inner needle cap and throw it away.
Danish: E - Tag forsigtigt den indre nålehætte af, og kassér den.
English: Do not use Semglee - if you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at bruge Semglee Brug ikke Semglee: - hvis du er allergisk over for insulin glargin eller et af de øvrige indholdsstoffer i Semglee
English: Do not push the purple injection button when turning the dose knob.
Danish: Du må ikke trykke på den lilla injektionsknap, samtidig med du drejer på dosisvælgeren.
English: Semglee 100 units/ml solution for injection in pre-filled pen insulin glargine
Danish: Semglee 100 enheder/ml injektionsvæske, opløsning i fyldt pen insulin glargin
English: Semglee contains insulin glargine, an insulin analogue, and has a prolonged duration of action.
Danish: Semglee indeholder insulin glargin, en insulin-analog.
English: A - Select the injection site as explained to you by your healthcare provider, clean with a new alcohol wipe and let your skin dry before you inject your dose.
Danish: Rengør huden med en ny afspritningsserviet og lad huden tørre, før du injicerer din dosis.
English: Participants were randomised (1:1) to receive insulin glargine (n=6264), titrated to reach FPG ≤95 mg/dl (5.3 mM), or standard care (n=6273).
Danish: FPG ≤ 5,3 mM (95 mg/dl), eller standardbehandling (n=6.273).
English: B - Turn the white dose knob to 2 dose units.
Danish: B - Drej den hvide dosisvælger, indtil den står ved mærket 2.
English: Keep your pen and needles out of sight and reach of children.
Danish: Penne og nåle skal opbevares utilgængeligt for børn.
English: NAME OF THE MEDICINAL PRODUCT Semglee 100 units/ml solution for injection in pre-filled pen
Danish: LÆGEMIDLETS NAVN Semglee 100 enheder/ml injektionsvæske, opløsning i fyldt pen
English: If your dose is more than the number of units left in the pen, either:
Danish: Hvis der ikke er nok enheder tilbage i din pen til den næste dosis, kan du enten:
English: 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.
Danish: 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.
English: Do not use Semglee if you notice particles in the solution.
Danish: Anvend ikke Semglee, hvis du bemærker partikler i den. Anvend kun Semglee, hvis opløsningen er klar og farveløs.
English: Always store the pen with the cap on, to prevent contamination.
Danish: Du skal altid opbevare pennen med hætten på for at undgå urenheder.
English: Trying to attach the outer needle cap sideways may bend or damage the needle.
Danish: Hvis pennen ikke holdes lodret, mens du påsætter den ydre nålehætte, kan nålen blive bøjet eller beskadiget.
English: 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.
Danish: Før cylinderampullen indsættes i pennen, skal den opbevares i 1-2 timer ved stuetemperatur.
English: What you need to know before you use Semglee
Danish: Det skal du vide, før du begynder at bruge Semglee Sådan skal du bruge Semglee Bivirkninger
English: Attach a new needle
Danish: Påsæt en ny nål
English: B - While holding the pen body facing upwards, attach the outer needle cap straight on to the cartridge holder as shown.
Danish: B - Hold pennen lodret og sæt den ydre nålehætte lige på cylinderampulholderen som vist på billedet.
English: 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.
Danish: Anvend ikke Semglee pennen, hvis den er beskadiget eller ikke virker ordentligt.
English: Semglee 100 units/ml solution for injection in pre-filled pen.
Danish: Semglee 100 enheder/ml injektionsvæske, opløsning i fyldt pen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1270/005
Danish: EU/1/18/1270/005
English: 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.
Danish: De farmakokinetiske og farmakodynamiske fund indikerer, at effekten af en subkutan injektion af Semglee hovedsageligt skyldes eksponering for M1.
English: Before using Semglee pre-filled pen, the instructions for use included in the package leaflet must be read carefully.
Danish: Brugsanvisningen i indlægssedlen skal læses omhyggeligt før Semglee fyldt pen anvendes.
English: Before using Semglee pen, the instructions for use included in the package leaflet must be read carefully.
Danish: Brugsanvisningen i indlægssedlen skal læses omhyggeligt, før den fyldte pen anvendes.