FrancophonIA/ELRC3.0 huggingface dataset:
English: Speak to your doctor if you need to inject your insulin by another method.
Slovenian: Pogovorite se z zdravnikom, če si morate injicirati insulin na drugačen način.
English: For storage conditions after first opening of this medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po prvem odprtju zdravila, glejte poglavje 6.3.
English: This information does not take the place of talking to your doctor, nurse, or pharmacist about your medical condition or your treatment.
Slovenian: Te informacije ne nadomestijo pogovora z zdravnikom, medicinsko sestro ali farmacevtom o vašem zdravstvenem stanju ali zdravljenju.
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing incidence (very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000).
Slovenian: Naslednji povezani neželeni učinki, ugotovljeni v kliničnih raziskavah, so navedeni spodaj po organskih sistemih in razvrščeni po padajoči pojavnosti (zelo pogosti: ≥ 1/10; pogosti: ≥ 1/100 do < 1/10; občasni: ≥ 1/1.000 do < 1/100; redki: ≥ 1/10.000 do < 1/1.000; zelo redki: < 1/10.000).
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki injekcijskega peresnika poleg oznake »EXP«.
English: E - Store the pen at room temperature (under 30°C).
Slovenian: E - Peresnik shranjujte pri sobni temperaturi (pod 30 °C).
English: • Restart the process at step 2A to attach and prime a new needle.
Slovenian: • znova začnite postopek pri koraku 2A, da namestite in pripravite novo iglo.
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavni del skupnega pakiranja, ločeno ni v prodaji.
English: Fertility Animal studies do not indicate direct harmful effects with respect to fertility.
Slovenian: Plodnost Študije na živalih ne kažejo neposrednih škodljivih učinkov na plodnost.
English: • Inject the amount left in your pen and use a new pen to give the rest of your dose, or
Slovenian: • injicirajte količino, ki je ostala v peresniku, in uporabite nov peresnik za preostanek odmerka ali
English: You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.
Slovenian: Poznati jih morate, da se boste lahko pravilno odzvali na spremembe v koncentraciji krvnega sladkorja in preprečili, da bi se preveč povečala ali zmanjšala.
English: Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.
Slovenian: Zdravnik bo morda naročil, da ga uporabljajte v kombinaciji s kratkodelujočim insulinom ali s tabletami, ki se uporabljajo za zdravljenje visokih koncentracij krvnega sladkorja.
English: A - Take the outer needle cap that you had saved in step 2D, hold it at the widest part and carefully cover the needle without touching it.
Slovenian: A - Vzemite zunanji pokrovček igle, ki ste ga shranili v koraku 2D, ga primite na najširšem delu in previdno pokrijte iglo, ne da bi se je dotaknili.
English: • made of heavy duty plastic,
Slovenian: • ki je izdelan iz trpežne plastike,
English: • Always carry an extra insulin pre-filled pen injector as recommended by your healthcare provider in case your pen gets lost or damaged.
Slovenian: • Vedno imejte pri sebi dodaten napolnjen injekcijski peresnik z insulinom, kot vam je priporočil zdravstveni delavec, če bi svoj injekcijski peresnik izgubili ali poškodovali.
English: Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Slovenian: Mešanje ali redčenje lahko spremeni profil delovanja v odvisnosti od časa; mešanje lahko povzroči precipitacijo.
English: The dose regimen (dose and timing) should be individually adjusted.
Slovenian: Odmerjanje (odmerek in čas apliciranja) je treba prilagoditi individualno.
English: If you do not keep the injection button pressed down for 10 seconds after “0” is displayed you may get the wrong dose of medicine.
Slovenian: Če gumba za injiciranje ne držite 10 sekund, po tem ko se pokaže »0«, lahko prejmete napačen odmerek zdravila.
English: If you do not follow these instructions each time you use the pen, you may either get too much or too little insulin.
Slovenian: Če pri vsakokratni uporabi injekcijskega peresnika ne upoštevate teh navodil, lahko dobite preveč ali premalo insulina.
English: • Get a new pen and inject the full dose.
Slovenian: • vzemite nov peresnik in injicirajte celoten odmerek.
English: B - Push the needle straight into the skin as shown by your healthcare provider.
Slovenian: B - Iglo potisnite naravnost v kožo, kot vam je pokazal zdravstveni delavec.
English: Since Semglee is a solution, it does not require resuspension before use.
Slovenian: Ker je zdravilo Semglee raztopina, pred uporabo ne potrebuje resuspendiranja.
English: • The insulin looks clear and colourless.
Slovenian: • da je insulin videti bister in brezbarven,
English: The needle sizes compatible with this pen are: - 31G, 5 mm, - 32G, 4-6 mm, - 34G, 4 mm.
Slovenian: Velikosti igel, združljivih s tem injekcijskim peresnikom: - 31 G, 5 mm, - 32 G, 4-6 mm, - 34 G, 4 mm.
English: If you do not have a sharps container, you may use a household container that is:
Slovenian: Če nimate vsebnika za odlaganje ostrih predmetov, lahko uporabite gospodinjski vsebnik:
English: It should be considered whether it is advisable to drive or use machines in these circumstances.
Slovenian: V takšnih okoliščinah je treba razmisliti, ali je priporočljivo, da bolnik vozi ali upravlja stroje.
English: • Check the pen label to make sure that you are taking the correct type of insulin.
Slovenian: • Preverite nalepko injekcijskega peresnika in se prepričajte, da boste uporabili pravilno vrsto insulina.
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.
Slovenian: A - Izberite mesto injiciranja, kot vam je razložil zdravstveni delavec, očistite ga z novim alkoholnim robčkom in počakajte, da se koža posuši, preden injicirate svoj odmerek.
English: If this occurs:
Slovenian: V tem primeru:
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v šestih mesecih po izdaji dovoljenja predložiti prvo redno posodobljeno poročilo o varnosti zdravila.
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.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Pred prvo uporabo mora biti injekcijski peresnik 1 do 2 uri na sobni temperaturi.
English: If your dose is more than the number of units left in the pen, either:
Slovenian: Če je vaš odmerek večji od števila enot, ki so ostale v injekcijskem peresniku:
English: Do NOT inject Semglee in a vein, since this will change its action and may cause hypoglycaemia.
Slovenian: Zdravila Semglee NE injicirajte v veno, ker to spremeni njegovo delovanje in lahko povzroči hipoglikemijo.
English: • Go to Step 7 for instructions on safely removing the needle.
Slovenian: • glejte 7. korak navodil glede varnega odstranjevanja igel;
English: Do not use the needle if the protective seal is damaged or missing as the needle may not be sterile.
Slovenian: Igle ne uporabite, če je zaščitna zaporka poškodovana ali manjka, saj v tem primeru igla morda ni sterilna.
English: If you accidentally turn past 2 units, turn back the dose knob in the opposite direction to the correct number of units.
Slovenian: Če pomotoma obrnete na več kot 2 odmerka, gumb za odmerek obrnite v nasprotni smeri na pravilno število enot.
English: This should be kept in mind if treatment with the combination of pioglitazone and Semglee is considered.
Slovenian: To je potrebno upoštevati pri zdravljenju s kombinacijo pioglitazona in zdravila Semglee.
English: • Keep your pen away from moisture, dust, direct sunlight and places where the temperature may get too high or low (see storage section at the beginning of these instructions)
Slovenian: • Injekcijski peresnik hranite tako, da bo zaščiten pred vlago, prahom in neposredno sončno svetlobo, in ga ne shranite na mestih, kjer bi bila temperatura lahko previsoka ali prenizka (glejte poglavje glede shranjevanja na začetku teh navodil).
English: It should be administered once daily at any time but at the same time each day.
Slovenian: Zdravilo Semglee je treba aplicirati enkrat na dan, in sicer kadar koli, vendar vsak dan ob istem času.
English: C - Put the needle in a sharps disposal container (see Step 8 for instructions on disposal)
Slovenian: C - Iglo zavrzite v vsebnik za odlaganje ostrih predmetov (za navodila glede odstranjevanja glejte 8. korak).
English: The white dose knob will turn and you will hear “clicks” as you press down.
Slovenian: Beli gumb za odmerek se bo sukal, vi pa boste ob pritisku slišali »klikanje«.
English: • upright and stable during use,
Slovenian: • ki je med uporabo lahko postavljen pokončno in stabilno,
English: You will hear a “click” for each unit turned.
Slovenian: Pri vsaki enoti boste zaslišali »klik«.
English: The prolonged duration of action of Semglee is dependent on its injection into subcutaneous tissue.
Slovenian: Podaljšano delovanje zdravila Semglee je odvisen od tega, ali je injiciran v podkožno tkivo.
English: If you are unable to read or follow all of the instructions on your own, ask for help from someone trained to use this pen.
Slovenian: Če informacij ne morete prebrati in razumeti sami, prosite za pomoč nekoga, ki zna uporabljati ta injekcijski peresnik.
English: • Check the expiration date on the pen label.
Slovenian: • Preverite rok uporabnosti na nalepki na peresniku.
English: Do not push the injection button sideways or block the white dose knob with your fingers as this will stop you from injecting the medicine.
Slovenian: Gumba za injiciranje ne pritiskajte s strani in s prsti ne blokirajte belega gumba za odmerek, saj lahko s tem zaustavite injiciranje zdravila.
English: Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.
Slovenian: Natančno upoštevate navodila za odmerjanje, nadziranje bolezni (testi krvi in urina), prehrano in telesno dejavnost (telesno delo in telovadbo) ter za postopek injiciranja, ki vam jih je dal zdravnik.
English: Medication errors have been reported in which other insulins, particularly short-acting insulins, have been accidentally administered instead of insulin glargine.
Slovenian: O napakah zdravljenja so poročali, ko so bili drugi insulini, posebno insulini, ki delujejo na kratek rok, pomotoma aplicirani namesto insulina glargina.
English: What Semglee is and what it is used for
Slovenian: Kaj je zdravilo Semglee in za kaj ga uporabljamo
English: Do not put the pen back in the refrigerator after using it.
Slovenian: Po uporabi ga ne dajte nazaj v hladilnik.
English: Remove the needle as described in Step 7, and discard the pen or return it to the pharmacist.
Slovenian: Igle odstranite po navodilih iz 7. koraka in injekcijski peresnik zavrzite ali ga vrnite farmacevtu.
English: Read carefully the "Instructions for Use" included in this package leaflet.
Slovenian: Natančno preberite »Navodila za uporabo«, ki jih vključuje to navodilo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - Packs of 1, 3, 5 and 10
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA - pakiranja po 1, 3, 5 in 10
English: • can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
Slovenian: • ki ga je mogoče zapreti s tesno prilegajočim se pokrovom, ki je odporen na prebadanje, tako da ostri predmeti ne morejo pasti ven,
English: Priming is complete when you can see drops of insulin.
Slovenian: Postopek polnjenja je končan, ko zagledate kapljice insulina.
English: The used pen may be discarded in your household waste after you have removed the needle.
Slovenian: Uporabljen injekcijski peresnik lahko odložite med gospodinjske odpadke, potem ko ste odstranili iglo.
English: Semglee is injected under the skin.
Slovenian: Zdravilo Semglee se injicira pod kožo.
English: D - Wipe the rubber seal (at the front of the cartridge) with a new alcohol wipe.
Slovenian: D - Obrišite gumijasto zaporko (na sprednjem delu vložka) z novim alkoholnim robčkom.
English: Combination of Semglee with pioglitazone
Slovenian: Kombinacija zdravila Semglee s pioglitazonom
English: The pen has a purple and white label and a purple injection button.
Slovenian: Injekcijski peresnik ima vijolično in belo nalepko ter vijoličen gumb za injiciranje.
English: Changes in strength, brand (manufacturer), type (regular, NPH, lente, long-acting, etc.), origin (animal, human, human insulin analogue) and/or method of manufacture may result in the need for a change in dose.
Slovenian: Spremembe jakosti, zaščitne znamke (izdelovalec), tipa (običajni humani insulin, NPH, lente, dolgodelujoči), izvora (živalski, humani, analog humanega insulina) in/ali načina izdelave, lahko posledično vplivajo na spremembo odmerjanja.
English: You may need to talk about - the availability of your insulin in the country you are visiting, - supplies of insulin, needles etc., - correct storage of your insulin while travelling, - timing of meals and insulin administration while travelling, - the possible effects of changing to different time zones, - possible new health risks in the countries to be visited, - what you should do in emergency situations when you feel unwell or become ill.
Slovenian: Med vprašanji, o katerih se boste morali pogovoriti, so - dosegljivost vašega insulina v državi, v katero se odpravljate, - zaloge insulina, igel itd., - pravilno shranjevanje insulina med potovanjem, - časovni razpored obrokov in dajanje insulina med potovanjem, - možni vplivi spremembe časovnih con, - možna nova zdravstvena tveganja v državah, ki jih boste obiskali, - kaj storiti v nujnih primerih, ko se ne počutite dobro ali zbolite.
English: Keep twisting the needle until it comes off the pen.
Slovenian: Iglo še naprej obračajte, dokler je ne snamete s peresnika.
English: As you turn the white dose knob to set your dose, it will extend out and you will hear a “click” at each unit dialled.
Slovenian: Medtem ko obračate beli gumb za odmerek, da bi nastavili odmerek, se bo gumb pomikal navzven in pri vsaki doseženi enoti boste zaslišali »klik«.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1270/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1270/005
English: After subcutaneous injection of Semglee in diabetic patients, insulin glargine is rapidly metabolized at the carboxyl terminus of the Beta chain with formation of two active metabolites M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Slovenian: Po subkutanem injiciranju zdravila Semglee bolnikom s sladkorno boleznijo, se insulin glargin hitro presnovi na karboksilnem koncu verige beta; nastaneta aktivna presnovka M1 (21AGly-insulin) in M2 (21A-Gly-des-30B-Thr-insulin).
English: B - Turn the white dose knob to 2 dose units.
Slovenian: B - Beli gumb obrnite na 2 enoti odmerka.
English: Very rare reported side effects (may affect up to 1 in 10,000 people) In very rare cases, dysgeusia (taste disorders) and myalgia (muscular pain) can occur.
Slovenian: Zelo redko poročani neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) V zelo redkih primerih se lahko pojavita disgevzija (motnje okušanja) in mialgija (bolečine v mišicah).
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.
Slovenian: Ko injekcijski peresnik vzamete iz hladilnika, ga odložite na ravno površino, preden ga uporabite, pa počakajte, da se ogreje na sobno temperaturo (med 15°C in 30°C).
English: This may affect your blood sugar level.
Slovenian: To lahko vpliva na koncentracijo vašega krvnega sladkorja.
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.
Slovenian: Vaša sposobnost koncentracije ali reagiranja se vam lahko zmanjša, če: - imate hipoglikemijo (nizko koncentracijo krvnega sladkorja), - imate hiperglikemijo (visoko koncentracijo krvnega sladkorja), - imate težave z vidom.
English: Insulin glargine did not alter the relative risk for CV disease and CV mortality when compared to standard of care.
Slovenian: Insulin glargin v primerjavi s standardno oskrbo ni spremenil relativnega tveganja za KV bolezen ali KV umrljivost.
English: Put the pen cap aside to be used later.
Slovenian: Pokrovček peresnika odložite, da ga boste ponovno uporabili pozneje.
English: In patients with type 2 diabetes mellitus, Semglee can also be given together with orally active antidiabetic medicinal products.
Slovenian: Pri bolnikih z diabetesom mellitusom tipa 2 je mogoče zdravilo Semglee uporabljati tudi skupaj s peroralnimi antidiabetičnimi zdravili.
English: These units are exclusive to Semglee and are not the same as IU or the units used to express the potency of other insulin analogues (see section 5.1).
Slovenian: Te enote veljajo izključno za zdravilo Semglee in niso enake mednarodnim enotam (i.e.) ali enotam, ki se uporabljajo za izražanje jakosti drugih insulinskih analogov (glejte poglavje 5.1).
English: Make sure you have the following items before injecting your dose:
Slovenian: Poskrbite, da boste pred injiciranjem odmerka imeli pri roki naslednje:
English: Solution for injection 1 pen of 3 ml 3 pens of 3 ml 5 pens of 3 ml 10 pens of 3 ml
Slovenian: raztopina za injiciranje 1 injekcijski peresnik s 3 ml 3 injekcijski peresniki s 3 ml 5 injekcijskih peresnikov s 3 ml 10 injekcijskih peresnikov s 3 ml
English: *Insulin glargine is produced by recombinant DNA technology in Pichia pastoris.
Slovenian: *Insulin glargin je pridobljen s tehnologijo rekombinantne DNA iz bakterij Pichia pastoris.
English: C - Check the insulin through the cartridge holder to make sure:
Slovenian: C - Skozi držalo vložka poglejte insulin in se prepričajte:
English: At baseline, participants had a median HbA1c value of 6.4% and median on-treatment HbA1c values ranged from 5.9 to 6.4% in the insulin glargine group, and 6.2% to 6.6% in the standard care group throughout the duration of follow-up.
Slovenian: Izhodiščno so imeli preiskovanci mediano vrednost HbA1c 6,4 %; mediana vrednost HbA1c med zdravljenjem je segala od 5,9 do 6,4% v skupini z insulinom glarginom in od 6,2% do 6,6% v skupini s standardno oskrbo med celotnim trajanjem spremljanja.
English: Semglee is not the insulin of choice for the treatment of diabetic ketoacidosis.
Slovenian: Zdravilo Semglee ni insulin prve izbire za zdravljenje diabetične ketoacidoze.
English: B - Hold the pen body with one hand.
Slovenian: B - Telo injekcijskega peresnika držite z eno roko.
English: In clinical studies, subgroup analyses based on age and gender did not indicate any difference in safety and efficacy in insulin glargine-treated patients compared to the entire study population.
Slovenian: Analize podskupin po starosti in spolu v kliničnih študijah niso pokazale razlik v varnosti in učinkovitosti pri bolnikih, zdravljenih z insulinom glarginom, v primerjavi s celotno raziskovano populacijo.
English: In general, the side effects in children and adolescents of 18 years of age or less are similar to those seen in adults.
Slovenian: Navadno so neželeni učinki pri otrocih in mladostnikih, starih 18 let ali manj, podobni neželenim učinkom pri odraslih.
English: In the following situations, the management of your diabetes may require a lot of care (for example, adjustment to insulin dose, blood and urine tests): - If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
Slovenian: V sledečih okoliščinah lahko vodenje vaše sladkorne bolezni zahteva posebno skrb (npr. prilagoditev odmerka insulina, preiskave krvi in urina): - Če ste bolni ali se huje poškodujete, se lahko koncentracija krvnega sladkorja zviša
English: The rates of severe hypoglycaemia (affected participants per 100 participant years of exposure) were 1.05 for insulin glargine and 0.30 for standard care group and the rates of confirmed non-severe hypoglycaemia were 7.71 for insulin glargine and 2.44 for standard care group.
Slovenian: Deleža hudih hipoglikemij (prizadeti sodelujoči na 100 sodelujoči-let izpostavljenosti) sta bila 1,05 za insulin glargin in 0,30 za skupino s standardno oskrbo, deleža potrjenih ne-hudih hipoglikemij pa sta bila 7,71 za insulin glargin in 2,44 za skupino s standardno oskrbo.
English: Switch from other insulins to Semglee
Slovenian: Prehod z drugih insulinov na zdravilo Semglee
English: OTHER SPECIAL WARNING(S), IF NECESSARY Use only clear and colourless solutions.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Uporabite samo bistro in brezbarvno raztopino.
English: Before first using the pen, store the cartons containing the pen in the refrigerator (2°C to 8°C).
Slovenian: Preden injekcijski peresnik uporabite prvič, dajte škatlo, ki vsebuje injekcijski peresnik, v hladilnik (2°C-8°C).
English: Other medicines and Semglee
Slovenian: Druga zdravila in zdravilo Semglee
English: Only use needles that are compatible with Semglee pen (see “Instructions for Use”).
Slovenian: Uporabljajte le igle, primerne za uporabo z injekcijskim peresnikom z zdravilom Semglee (glejte »Navodila za uporabo«).
English: Due to more sustained basal insulin supply with Semglee, less nocturnal but more early morning hypoglycaemia can be expected.
Slovenian: Zaradi enakomernejšega sproščanja bazalnega insulina je pri zdravilu Semglee mogoče pričakovati manj nočnih, a več zgodnjih jutranjih hipoglikemij.
English: INFORMATION IN BRAILLE Semglee
Slovenian: PODATKI V BRAILLOVI PISAVI Semglee
English: If you do not see any insulin at the needle tip after 4 priming attempts the needle may be clogged.
Slovenian: Če na konici igle tudi po 4 poskusih priprave ne vidite kapljic insulina, je igla morda zamašena.
English: 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).
Slovenian: 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).
English: Do not force the dose knob to turn beyond 80 units.
Slovenian: Gumba za odmerek ne obračajte na silo, da bi presegli 80 enot.
English: As with all insulins, the time course of action of insulin glargine may be affected by physical activity and other variables.
Slovenian: Na časovni potek delovanja insulina glargina lahko, tako kot pri vseh insulinih, vplivajo telesna dejavnost in drugi spremenljivi dejavniki.
English: Type I colourless glass cartridge with a plunger (bromobutyl rubber), sealed using lined seals (laminate of polyisoprene and bromobutyl rubber).
Slovenian: Vložek iz brezbarvnega stekla tipa I z batom (iz bromobutilne gume), zapečaten z zaporko (iz poliizoprenskega laminata in bromobutilne gume).