natgillin/translations-raw huggingface dataset:
The ORIGIN (Outcome Reduction with Initial Glargine INtervention) study was a multicenter, randomised, 2x2 factorial design study conducted in 12,537 participants at high cardiovascular (CV) risk with impaired fasting glucose (IFG) or impaired glucose tolerance (IGT) (12% of participants) or type 2 diabetes mellitus treated with ≤1 antidiabetic oral agent (88% of participants).
Študija ORIGIN (Outcome Reduction with Initial Glargine INtervention) je bila multicentrična, randomizirana študija s faktorskim načrtom 2 × 2, v katero je bilo vključenih 12.537 sodelujočih z velikim kardiovaskularnim (KV) tveganjem in okvarjeno glukozo na tešče (OGT) ali okvarjeno toleranco za glukozo (OTG) (12 % sodelujočih), ali s sladkorno boleznijo tipa 2, zdravljeno z ≤ 1 peroralnim antidiabetikom (88 % sodelujočih).
Do not force the dose knob to turn beyond 80 units.
Gumba za odmerek ne obračajte na silo, da bi presegli 80 enot.
As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables.
Na časovni potek delovanja insulina glargina lahko, tako kot pri vseh insulinih, vplivajo telesna dejavnost in drugi spremenljivi dejavniki.
Type I colourless glass cartridge with a plunger (bromobutyl rubber), sealed using lined seals (laminate of polyisoprene and bromobutyl rubber).
Vložek iz brezbarvnega stekla tipa I z batom (iz bromobutilne gume), zapečaten z zaporko (iz poliizoprenskega laminata in bromobutilne gume).
Concentrations were thus consistent with the time profile of the pharmacodynamic activity of insulin glargine.
Koncentracija se je torej skladala s časovnim potekom farmakodinamičnega delovanja insulina glargina.
IGF-1 receptor binding: The affinity of insulin glargine for the human IGF-1 receptor is approximately 5 to 8-fold greater than that of human insulin (but approximately 70 to 80-fold lower than the one of IGF-1), whereas M1 and M2 bind the IGF-1 receptor with slightly lower affinity compared to human insulin.
Vezava na receptorje za IGF-1: Afiniteta insulina glargina za človeški receptor IGF-1 je približno 5- do 8-krat večja kot afiniteta humanega insulina (vendar približno 70- do 80-krat manjša kot afiniteta IGF-1), presnovka M1 in M2 pa se na receptor za IGF-1 vežeta z nekoliko manjšo afiniteto kot humani insulin.
You can inject 1 to 80 units in a single injection.
Naenkrat lahko injicirate 1 do 80 enot.
Needles must not be re-used.
Igel ne smete ponovno uporabiti.
Needles to be obtained separately: Needle sizes compatible with this pen:
Igle so na voljo ločeno: Velikosti igel, združljivih s tem injekcijskim peresnikom:
Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will - determine how much Semglee per day you will need and at what time, - tell you when to check your blood sugar level, and whether you need to carry out urine tests, - tell you when you may need to inject a higher or lower dose of Semglee.
Vaš zdravnik bo, glede na vaš način življenja, izvide meritev vašega krvnega sladkorja (glukoze) in prejšnjo uporabo insulina: - določil, koliko zdravila Semglee na dan potrebujete in ob katerem času, - povedal, kdaj merite krvni sladkor in ali morate opravljati teste urina, - povedal, kdaj boste morda morali povečati ali zmanjšati odmerek zdravila Semglee.
A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.
Velika količina podatkov o nosečnicah (več kot 1000 izidov nosečnosti) ne kaže specifičnih neželenih učinkov insulina glargina na nosečnost; prav tako ne kaže, da bi insulin glargin povzročal specifične malformacije, toksične učinke za plod ali na novorojenčka.
Do not use alcohol, hydrogen peroxide, bleach, or any other liquids to clean your pen.
Za čiščenje injekcijskega peresnika ne uporabljajte alkohola, vodikovega peroksida, belila ali drugih tekočin.
C - Turn the outer needle cap in a clockwise (right) direction until it feels tightly fixed on the pen.
C - Zunanji pokrovček igle privijajte v smeri urinega kazalca (v desno), dokler ne začutite, da je dobro fiksiran na peresnik.
What Semglee is and what it is used for What you need to know before you use Semglee How to use Semglee
Kaj je zdravilo Semglee in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Semglee Kako uporabljati zdravilo Semglee Možni neželeni učinki
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)].
Primarni cilj, dokazati neinferiornost insulina glargina v primerjavi z insulinom NPH v zvezi z hipoglikemijami, ni bil dokazan - opazen je bil trend povečanja hipoglikemičnih dogodkov z insulinom glarginom [razmerje insulin glargin: NPH (95 % IZ) = 1,18 (0,97-1,44)].
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.
Farmakokinetični in farmakodinamični izsledki kažejo, da učinek subkutano injiciranega zdravila Semglee temelji predvsem na izpostavljenosti presnovku M1. Insulin glargin in presnovek M2 pri veliki večini preiskovancev nista bila zaznavna; če sta bila zaznavna, pa njuna koncentracija ni bila odvisna od uporabljenega odmerka zdravila Semglee.
You may give other people a serious infection, or get a serious infection from them.
Okužite lahko druge ali pa se lahko okužite vi.
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).
Preiskovanci so bili v razmerju 1:1 randomizirani na prejemanje insulina glargina (n=6264), titriranega tako, da je bila dosežena glukoza v plazmi na tešče ≤ 95 mg/dl (5,3 mM), ali na standardno oskrbo (n=6273).
Semglee pen has to be used as recommended in these instructions for use (see section 6.6).
Injekcijski peresnik z zdravilom Semglee je treba uporabljati v skladu s priporočili v tem navodilu za uporabo (glejte poglavje 6.6).
Semglee is a biosimilar medicinal product.
Zdravilo Semglee je podobno biološko zdravilo.
In rare cases, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyper- or hypoglycaemia (see section 5.1).
V redkih primerih je zaradi obstoja takšnih protiteles proti insulinu treba prilagoditi odmerek insulina, da bi odpravili nagnjenost k hiper-ali hipoglikemiji (glejte poglavje 5.1).
• Check that the medicine in the pen cartridge looks clear and colourless.
• Prepričajte se, da je zdravilo v injekcijskem peresniku bistro in brezbarvno.
Semglee in pre-filled pen is only suitable for injecting just under the skin (see also section 3).
Zdravilo Semglee v napolnjenem injecijskem peresniku je primerno le za injiciranje pod kožo (glejte tudi poglavje 3).
When switching from a treatment regimen with an intermediate or long-acting insulin to a regimen with Semglee, a change of the dose of the basal insulin may be required and the concomitant antidiabetic treatment may need to be adjusted (dose and timing of additional regular insulins or fast-acting insulin analogues or the dose of oral antidiabetic medicinal products).
Pri prehodu z insulina s srednjedolgim ali dolgim delovanjem na zdravljenje z zdravilom Semglee je lahko potrebna sprememba odmerka bazalnega insulina in prilagoditev sočasnega antidiabetičnega zdravljenja (odmerek in časovni razpored dodatnih rednih odmerkov insulina ali hitrodelujočih insulinskih analogov oz. odmerek peroralnih antidiabetikov).
• Sterile disposable hypodermic needle compatible with this pen
• sterilna hipodermična igla za enkratno uporabo, primerna za uporabo s tem peresnikom
Semglee should not be administered intravenously.
Zdravila Semglee se ne sme dajati intravensko.
Semglee with alcohol
Zdravilo Semglee skupaj z alkoholom
If you forget to use Semglee
Če ste pozabili uporabiti zdravilo Semglee
B - Turn the white dose knob until the yellow dose pointer lines up with your required dose.
B - Obračajte beli gumb za odmerek, dokler se rumeni kazalnik odmerka ne kaže na potreben odmerek.
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.
Če je injekcijski peresnik z zdravilom Semglee poškodovan ali ne deluje pravilno (zaradi mehanskih poškodb), ga zavrzite in uporabite novega.
D - Hold the purple injection button down for 10 seconds after the dose window shows “0” to make sure all of the insulin is injected.
D - Potem ko se v okencu odmerka prikaže »0«, držite vijoličen gumb za injiciranje 10 sekund, da se injicira ves insulin.
A - Inspect the pen: check the purple and white label on the pen to make sure:
1. korak: Pripravite svoj injekcijski peresnik A - Preglejte peresnik: preverite vijolično in belo nalepko na peresniku, da se prepričate:
Always use a new sterile needle for each injection as this helps stop blocked needles and prevents infections.
Za vsako injiciranje vedno uporabite novo sterilno iglo, saj se tako izognete zamašenim iglam in preprečite okužbe.
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat.
Primeri simptomov, ki vam povedo, da se je krvni sladkor znižal preveč ali prehitro: znojenje, vlažna in lepljiva koža, tesnoba, hiter srčni utrip, visok krvi tlak, razbijanje srca in nereden srčni utrip.
• 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).
Varnost in učinkovitost zdravila Semglee sta ugotovljeni pri mladostnikih in otrocih, starih 2 leti in več (glejte poglavje 5.1).
Rare reported side effect (may affect up to 1 in 1,000 people)
Redko poročani neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov)
If you stop using Semglee
Če ste prenehali uporabljati zdravilo Semglee
B - While holding the pen body facing upwards, attach the outer needle cap straight on to the cartridge holder as shown.
B - Medtem ko telo injekcijskega peresnika držite tako, da gleda navzgor, namestite zunanji pokrovček igle naravnost na držalo vložka tako, kot je prikazano.
• Always use a new sterile disposable needle for each injection.
• Za vsako injiciranje vedno uporabite novo sterilno iglo za enkratno uporabo.
The dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the yellow dose pointer.
Odmerek lahko popravite tako, da gumb za odmerek v nasprotno smer, dokler rumeni kazalnik ne kaže na pravilen odmerek.
Semglee must not be mixed with any other insulin or diluted.
Zdravila Semglee se ne sme mešati z nobenim drugim insulinom in se ga ne sme redčiti.
Do not use Semglee - if you are allergic to insulin glargine or any of the other ingredients of this medicine (listed in section 6).
Kaj morate vedeti, preden boste vzeli zdravilo Semglee Ne uporabljajte zdravila Semglee - če ste alergični na insulin glargin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions, loss of consciousness.
Primeri simptomov, ki nakazujejo nizek krvni sladkor v možganih, so: glavobol, huda lakota, slabost v želodcu, bruhanje, utrujenost, zaspanost, motnje spanja, nemir, agresivno vedenje, motena koncentracija, poslabšane reakcije, depresija, zmedenost, motnje govora (včasih popolna izguba govora), motnje vida, tresenje, paraliza, mravljinčenje (parestezije), omrtvelost in mravljinčenje v predelu ust, omotica, izguba nadzora nad seboj, nezmožnost poskrbeti zase, krči, izguba zavesti.
In a clinical study, symptoms of hypoglycaemia or counter-regulatory hormone responses were similar after intravenous insulin glargine and human insulin both in healthy volunteers and patients with type 1 diabetes.
V klinični študiji so bili simptomi hipoglikemije in protiregulacijski hormonski odzivi po intravenski uporabi insulina glargina in humanega insulina pri zdravih prostovoljcih in bolnikih z diabetesom tipa 1 podobni.
This pen is not recommended for use by the blind or visually impaired without the help of someone trained to use the pen.
Za osebe, ki so slepe ali imajo okvaro vida, uporaba tega injekcijskega peresnika ni priporočljiva brez pomoči osebe, ki zna uporabljati ta injekcijski peresnik.
Select and clean the injection site
5. korak: Izberite in očistite mesto injiciranja
The prolonged effect of subcutaneous insulin glargine may delay recovery from hypoglycaemia.
Podaljšani učinek subkutanega insulina glargina lahko upočasni okrevanje po hipoglikemiji.
Inject your dose A - If instructed by your healthcare provider you can pinch the cleaned skin between your fingers.
6. korak: Injicirajte odmerek A - Če vam je tako naročil zdravstveni delavec, lahko s prstoma stisnete očiščeno kožo.
• Skin and allergic reactions at the injection site The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
• Kožne in alergijske reakcije na mestu injiciranja Znaki so lahko pordelost, nenavadno močna bolečina pri injiciranju, srbenje, koprivnica, otekanje ali vnetje.
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free'.
Pomožne snovi To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni »brez natrija«.
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.
Injekcijske peresnike, ki jih uporabljate ali jih imate pri sebi za rezervo, lahko shranjujete največ 4 tedne pri temperaturi do 30°C in zaščitene pred neposredno toploto ali svetlobo.
Packs of 1, 3, 5, 10 and multipack containing 10 (2 packs of 5) pens.
Pakiranja z 1, 3, 5 in 10 injekcijskimi peresniki ter skupno pakiranje, ki vsebuje 10 (2 škatli po 5) injekcijskih peresnikov.
Read these Instructions for Use as well as the package leaflet carefully before using Semglee pre-filled pen and each time you get another pen.
Pozorno preberite ta navodila za uporabo injekcijskega peresnika ter navodilo za uporabo zdravila Semglee, preden uporabite napolnjen injekcijski peresnik z zdravilom Semglee in vsakič, ko dobite nov injekcijski peresnik.
After first use of the pen, store it at room temperature up to 30°C.
Ko injekcijski peresnik uporabite prvič, ga shranite pri sobni temperaturi do 30°C.
Do not use Semglee if you notice particles in the solution.
Zdravila Semglee ne uporabite, če v njem opazite delce.
B - Squeeze the wide part of the outer needle cap and unscrew the needle in an anti-clockwise (left) direction.
B - Stisnite široki del zunanjega pokrovčka igle in iglo odvijte v nasprotni smeri urinega kazalca (v levo).
The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
Temeljno delovanje insulina, tudi insulina glargina, je uravnavanje presnove glukoze.
With the other hand pull off the pen cap.
Z drugo roko povlecite in tako snemite pokrovček peresnika.
• Do not share your pen with other people, even if the needle has been changed.
• Injekcijskega peresnika ne delite z drugimi, tudi če zamenjate iglo.
• Do not soak or wash your pen.
• Injekcijskega peresnika ne namakajte in ne umivajte.
Trying to attach the outer needle cap sideways may bend or damage the needle.
Če bi zunanji pokrovček igle poskušali namestiti s strani, bi lahko iglo ukrivili ali poškodovali.
Multipack: 10 (2 packs of 5) pens of 3 ml.
Skupno pakiranje: 10 (2 škatli po 5) injekcijskih peresnikov s 3 ml.
Although Semglee contains the same active substance as insulin glargine 300 units/ml, these medicines are not interchangeable.
Zdravilo Semglee sicer vsebuje isto učinkovino kot insulin glargin 300 enot/ml, vendar ti zdravili nista medsebojno zamenljivi.
To reduce the risk of hypoglycemia, patients who are changing their basal insulin regimen from an insulin regimen with once daily insulin glargine 300 units/ml to a once daily regimen with Semglee should reduce their dose by approximately 20%.
Da bi zmanjšali tveganje za hipoglikemijo, je treba bolnikom, ki spreminjajo odmerjanje bazalnega insulina z insulina glargina 300 enot/ml enkrat na dan na zdravilo Semglee enkrat na dan, odmerek zmanjšati za približno 20 %.
A - Take a new sterile disposable needle and peel off the protective seal.
A - Vzemite novo sterilno iglo za enkratno uporabo in odlepite zaščitno prelepko.
Do not freeze or place next to the freezer compartment of your refrigerator or a freezer pack.
Ne zamrzujte in ne shranjujte v bližini zamrzovalnega razdelka v hladilniku ali zamrzovalnega vložka.
Do not push the purple injection button when turning the dose knob.
Ne pritiskajte vijoličnega gumba za injiciranje, medtem ko sučete gumb za odmerek.
No metabolic effects of ingested insulin glargine on the breast-fed newborn/infant are anticipated since insulin glargine as a peptide is digested into aminoacids in the human gastrointestinal tract.
Presnovnih učinkov zaužitega insulina glargina na dojenega novorojenčka/dojenčka ni pričakovati, ker se insulin glargin kot peptid v človeških prebavilih prebavi v aminokisline.
Name and address of the manufacturer(s) responsible for batch release
Ime in naslov izdelovalca odgovornega za sproščanje serij
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).
Med takšne spadajo bolniki: - ki se jim urejenost glikemije občutno izboljša, - ki se jim hipoglikemija razvije počasi, - ki so starejši, - po prehodu z živalskega na humani insulin, - ki imajo avtonomno nevropatijo, - z dolgo anamnezo diabetesa, - s psihiatrično boleznijo, - ki sočasno prejemajo določena druga zdravila (glejte poglavje 4.5).
Do not use the pen if the medicine in the cartridge looks cloudy, coloured or if you can see particles.
Injekcijskega peresnika ne uporabite, če je zdravilo v njem videti zamegljeno, obarvano ali če v njem vidite delce.
Switch from insulin glargine 300 units/ml to Semglee Semglee and insulin glargine 300 units/ml are not bioequivalent and are not directly interchangeable.
Prehod z insulina glargina 300 enot/ml na zdravilo Semglee Zdravilo Semglee in insulin glargin 300 enot/ml nista bioekvivalentna in nista medsebojno zamenljiva.
Semglee is a pre-filled disposable pen injector containing 300 units of insulin glargine in 3 mL of solution (100 units/mL).
Semglee je napolnjen injekcijski peresnik za enkratno uporabo, ki vsebuje 300 enot insulina glargina v 3 ml raztopine (100 enot/ml).
Only use needles that are compatible for use with this pre-filled pen.
Uporabljajte le igle, primerne za uporabo s tem napolnjenim injekcijskim peresnikom.
A number of substances affect glucose metabolism and may require dose adjustment of insulin glargine.
Na presnovo glukoze vplivajo številna zdravila in potrebna utegne biti prilagoditev odmerka insulina glargina.
In euglycaemic clamp studies in healthy subjects or in patients with type 1 diabetes, the onset of action of subcutaneous insulin glargine was slower than with human NPH insulin, its effect profile was smooth and peakless, and the duration of its effect was prolonged.
V študijah z evglikemično vklenjenostjo pri zdravih preiskovancih ali bolnikih z diabetesom tipa 1 je bil začetek delovanja subkutano apliciranega insulina glargina počasnejši kot humanega insulina NPH, potek njegovega delovanja je bil enakomeren in brez vrhov, trajanje delovanja pa podaljšano.
No new safety signals were seen during this extended treatment with insulin glargine.
Med tem podaljšanim zdravljenjem z insulinom glarginom niso odkrili nobenih novih varnostnih signalov.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (with blue box) multipack - 10 (2x5 pens)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (z modrim okencem) skupno pakiranje - 10 (2 x 5 injekcijskih peresnikov)
• Sharps disposal container
• vsebnik za odlaganje ostrih predmetov
E - With the pen upright, press the injection button in until it stops moving and the dose window shows
E - Medtem jo je injekcijski peresnik obrnjen navzgor, pritisnite gumb za injiciranje navznoter, da se ustavi in se na okencu odmerka pokaže »0«.
Before using the pre-filled pen, the instructions for use included in the package leaflet must be read carefully (see section 6.6).
Pred uporabo napolnjenega injekcijskega peresnika natančno preberite navodila za ravnanje v navodilu za uporabo (glejte poglavje 6.6).
Pens in use must not be stored in the refrigerator.
Injekcijskega peresnika, ki ga uporabljate, ne smete shranjevati v hladilniku.
How to use Semglee
Kako uporabljati zdravilo Semglee
D - Tap the cartridge gently with your finger to help any large air bubbles to move to the top of the cartridge.
D - S prstom nežno potrkajte po vložku, da se večji mehurčki dvignejo proti vrhu vložka.
Semglee").
(hiperglikemija).
E - Carefully pull off the inner needle cap and throw it away.
E - Previdno povlecite in snemite notranji pokrovček igle in ga zavrzite.
- 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.
- Druge sestavine zdravila so: cinkov klorid, metakrezol, glicerol, natrijev hidroksid (za uravnavanje pH) (glejte poglavje 2 »Zdravilo Semglee vsebuje natrij«), klorovodikova kislina (za uravnavanje pH) in voda za injekcije.
C - Press the purple injection button all the way in.
C - Vijolični gumb za injiciranje pritisnite do konca navznoter.
If you think you may have a problem with Semglee pen, consult your doctor, pharmacist or nurse.
Če menite, da gre za težavo z injekcijskim peresnikom z zdravilom Semglee, se posvetujte s svojim zdravnikom, farmacevtom ali medicinsko sestro.
Semglee is used to treat diabetes mellitus in adults, adolescents and children aged 2 years and above.
Zdravilo Semglee se uporablja za zdravljenje sladkorne bolezni pri odraslih, mladostnikih in otrocih, starih 2 leti in več.
• You can clean the outside of your pen by wiping it with a damp cloth.
• Zunanjost injekcijskega peresnika lahko očistite tako, da ga obrišete z vlažno krpico.