FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 5 Results from open-label clinical trials in type 2 diabetes mellitus: left - prior basal insulin users, right - insulin naïve
Slovenian: Rezultati odprtih kliničnih preskušanj pri sladkorni bolezni tipa 2: levo - bolniki, ki so pred tem že uporabljali bazalni insulin, desno - bolniki, ki še niso uporabljali insulina
English: If you take a wrong type of insulin, your blood sugar level may get too high or too low.
Slovenian: Če boste uporabili napačno vrsto insulina, se vam lahko koncentracija krvnega sladkorja preveč zviša ali preveč zniža.
English: Use of Tresiba in combination with GLP-1 receptor agonists in patients with type 2 diabetes mellitus When adding Tresiba to GLP-1 receptor agonists, the recommended daily starting dose is 10 units followed by individual dosage adjustments.
Slovenian: Pri dodajanju zdravila Tresiba k zdravljenju z agonistom receptorjev GLP-1 je priporočeni začetni dnevni odmerek zdravila Tresiba 10 enot, nato pa je treba odmerek prilagoditi vsakemu bolniku posebej.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Subcutaneous use
Slovenian: POSTOPEK IN POT UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: Insulins and analogues for injection, long-acting.
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, insulini in analogi za injiciranje z dolgotrajnim delovanjem.
English: Rate of hypoglycaemia (per patient year of exposure) Severe hypoglycaemia
Slovenian: Delež hipoglikemij (na bolnik-let izpostavljenosti) Hude hipoglikemije
English: Always make sure that a drop appears at the needle tip before you inject.
Slovenian: Pred injiciranjem vedno preverite, ali se je na vrhu igle pojavila kapljica.
English: • With Tresiba 200 units/mL a dose of 2-160 units per injection, in steps of 2 units, can be administered.
Slovenian: • Pri zdravilu Tresiba 200 enot/ml se lahko izbere odmerek 2-160 enot na injekcijo, v korakih po
English: Skin changes where you use the injection (lipodystrophy): Fatty tissue under the skin may shrink (lipoatrophy) or get thicker (lipohypertrophy).
Slovenian: Spremembe kože na mestu injiciranja (lipodistrofija): Podkožno maščevje se lahko skrči (lipoatrofija)
English: Nocturnal confirmed4
Slovenian: Potrjene nočne4
English: If you forget a dose, inject the missed dose when discovering the mistake, ensuring a minimum of 8 hours between doses.
Slovenian: Če pozabite odmerek, si injicirajte pozabljeni odmerek, ko odkrijete, da ste ga pozabili.
English: Needles must not be re-used.
Slovenian: Injekcijskih igel se ne sme uporabiti večkrat.
English: Ratio: 0.86 [0.58; 1.28]
Slovenian: Razmerje: 0,86 [0,58;1,28]
English: Dispose of the needle safely after each use.
Slovenian: Iglo po vsakem injiciranju varno zavrzite.
English: If you stop using your insulin, this could lead to a very high blood sugar level and ketoacidosis (a condition with too much acid in the blood), see advice in section 4 ‘Too high blood sugar'.
Slovenian: To lahko vodi v zelo visok krvni sladkor in ketoacidozo (stanje, pri katerem je v krvi preveč kisline) (glejte nasvete v poglavju 4, podpoglavje »Previsok krvni sladkor«).
English: Linearity Dose proportionality in total exposure is observed after subcutaneous administration within the therapeutic dose range.
Slovenian: Po subkutani uporabi odmerkov v terapevtskem odmernem območju je celotna izpostavljenost sorazmerna odmerku.
English: Each mL of solution contains 200 units of insulin degludec.
Slovenian: En ml raztopine vsebuje 200 enot insulina degludek.
English: Re-use of needles may increase the risk of blocked needles leading to inaccurate dosing.
Slovenian: Večkratna uporaba injekcijskih igel lahko poveča tveganje za zamašitev injekcijske igle in posledično nenatančno odmerjanje.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) Multipack: 6 (2 packs of 3) 3 mL pre-filled pens
Slovenian: raztopina za injiciranje (FlexTouch) Skupno pakiranje: 6 (2 škatli po 3) napolnjenih injekcijskih peresnikov s 3 ml
English: Day-to-day variability in glucose-lowering effect during one dosing interval (AUCGIR,τ,SS) Day-to-day variability in glucose-lowering effect from 2-24 hours (AUCGIR2-24h,SS)
Slovenian: Dnevno nihanje učinka znižanja koncentracije glukoze v obdobju 2-24 ur (AUCGIR2-24h,SS)
English: Let them know that if you pass out, they must:
Slovenian: Povejte jim tudi, da vas morajo v primeru, da se onesvestite
English: Ratio: 0.77 [0.44; 1.35]
Slovenian: Razmerje: 0,77 [0,44;1,35]
English: Ratio: 1.03 [0.75; 1.40]
Slovenian: Razmerje: 1,03 [0,75;1,40]
English: • Ensuring you use the right type of insulin - always check the insulin label before each injection to avoid accidental mix-ups between Tresiba and other insulin products.
Slovenian: • uporabo pravega insulina; pred injiciranjem vedno preverite nalepko insulina, da po pomoti ne zamenjate zdravila Tresiba in drugih insulinskih zdravil.
English: Adjustment of dose may be necessary if patients undertake increased physical activity, change their usual diet or during concomitant illness.
Slovenian: V primeru večje telesne dejavnosti, spremenjene običajne prehrane ali spremljajoče bolezni bo morda potrebna prilagoditev odmerka.
English: If you split the dose wrong, you will inject too little or too much insulin, which can lead to too high or too low blood sugar level.
Slovenian: Če je razdeljeni odmerek napačen, boste injicirali preveč ali premalo insulina, posledično pa se lahko koncentracija krvnega sladkorja preveč zviša ali zniža.
English: Each mL of solution contains 100 units of insulin degludec.
Slovenian: En ml raztopine vsebuje 100 enot insulina degludek.
English: Ratio: 0.66 [0.49; 0.88]
Slovenian: Razmerje: 0,66 [0,49;0,88]
English: Ratio: 0.70 [0.61; 0.80]
Slovenian: Razmerje: 0,70 [0,61; 0,80]
English: Ratio: 0.75 [0.59; 0.96]
Slovenian: Razmerje: 0,75 [0,59;0,96]
English: A numerically higher rate of severe hypoglycaemia in children aged 6-11 years in the Tresiba arm was observed.
Slovenian: V skupini, ki je prejemala zdravilo Tresiba, so pri otrocih, starih 6 - 11 let, poročali o številčno večjem deležu hude hipoglikemije.
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Slovenian: raztopina za injiciranje (FlexTouch) Skupno pakiranje: 10 (2 škatli po 5) napolnjenih injekcijskih peresnikov s 3 ml
English: 1 mL solution contains 100 units insulin degludec* (equivalent to 3.66 mg insulin degludec).
Slovenian: 1 ml raztopine vsebuje 100 enot insulina degludek* (kar ustreza 3,66 mg insulina degludek).
English: Always use a new needle for each injection.
Slovenian: Za vsako injiciranje je treba vedno uporabiti novo injekcijsko iglo.
English: Tresiba is a basal insulin that forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation leading to a flat and stable glucose-lowering effect of Tresiba (see figure 1).
Slovenian: Tako nastane depo, iz katerega se insulin degludek stalno in počasi absorbira v krvni obtok, zaradi česar je zniževanje koncentracije glukoze enakomerno in stabilno (glejte sliko 1).
English: The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing.
Slovenian: Večkratna uporaba injekcijskih igel za injekcijske peresnike poveča tveganje, da se injekcijska igla zamaši, kar ima lahko za posledico premajhen ali prevelik odmerek zdravila.
English: • With Tresiba 100 units/mL a dose of 1-80 units per injection, in steps of 1 unit, can be administered.
Slovenian: • Pri zdravilu Tresiba 100 enot/ml se lahko izbere odmerek 1-80 enot na injekcijo, v korakih po
English: EU/1/12/807/001 1 pen of 3 mL EU/1/12/807/002 1 pen of 3 mL and 7 NovoFine needles EU/1/12/807/003 1 pen of 3 mL and 7 NovoTwist needles EU/1/12/807/004 5 pens of 3 mL
Slovenian: EU/1/12/807/001 1 injekcijski peresnik s 3 ml EU/1/12/807/002 1 injekcijski peresnik s 3 ml in 7 igel NovoFine EU/1/12/807/003 1 injekcijski peresnik s 3 ml in 7 igel NovoTwist EU/1/12/807/004 5 injekcijskih peresnikov s 3 ml
English: Ratio: 0.65 [0.48; 0.89]
Slovenian: Razmerje: 0,65 [0,48; 0,89]
English: MARKETING AUTHORISATION NUMBERS EU/1/12/807/007 5 cartridges of 3 mL EU/1/12/807/008 10 cartridges of 3 mL
Slovenian: 12. ŠTEVILKI DOVOLJENJA ZA PROMET Z ZDRAVILOM EU/1/12/807/007 5 injekcijskih vložkov s 3 ml EU/1/12/807/008 10 injekcijskih vložkov s 3 ml
English: Difference: -0.42 [-0.78; -0.06]
Slovenian: Razlika: -0,42 [-0,78; -0,06]
English: Difference: 0.09 [-0.04; 0.22]
Slovenian: Razlika: 0,09 [-0,04; 0,22]
English: Octreotide and lanreotide: used to treat a rare condition involving too much growth hormone (acromegaly).
Slovenian: Oktreotid in lanreotid (uporabljata se za zdravljenje akromegalije, redke hormonske motnje, ki je posledica čezmernega nastajanja rastnega hormona) lahko zvišata ali znižata vaš krvni sladkor.
English: • your blood sugar got so low that you passed out
Slovenian: • vam je krvni sladkor padel tako nizko, da ste se onesvestili, • ste uporabili injekcijo glukagona,
English: Your insulin dose may need to be changed during pregnancy and after delivery.
Slovenian: Med nosečnostjo in po porodu bo vaš odmerek insulina morda treba spremeniti.
English: Ratio: 0.82 [0.69; 0.99]
Slovenian: Razmerje: 0,82 [0,69;0,99]
English: See your delivery system manual for further instructions.
Slovenian: Za dodatna navodila glejte priročnik sistema za dajanje insulina;
English: Tresiba pre-filled pen 200 units/mL
Slovenian: Tresiba peresnik 200 enot/ml
English: Ratio: 0.64 [0.42; 0.98]
Slovenian: Razmerje: 0,64 [0,42;0,98]
English: If the insulin looks cloudy, do not use the pen.
Slovenian: Če je insulin moten, injekcijskega peresnika ne uporabite.
English: Ratio: 0.98 [0.80; 1.20]
Slovenian: Razmerje: 0,98 [0,80;1,20]
English: However, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required:
Slovenian: Vseeno pa se lahko postopoma razvije hipoglikemija, če so uporabljeni odmerki preveliki glede na bolnikovo potrebo.
English: Nocturnal confirmed3
Slovenian: Potrjene nočne3
English: Difference: 0.08 [-0.05; 0.21]
Slovenian: Razlika: 0,08 [-0,05; 0,21]
English: Ratio: 1.07 [0.89; 1.28]
Slovenian: Razmerje: 1,07 [0,89;1,28]
English: Rate ratio: 0.47 [0.31; 0.73]
Slovenian: Razmerje pojavnosti: 0,47 [0,31; 0,73]
English: Rate of hypoglycaemia (per Patient year of exposure) Severe
Slovenian: Delež hipoglikemij (na bolnik-let izpostavljenosti) Hude
English: Ratio: 0.89 [0.85; 0.94]
Slovenian: Razmerje: 0,89 [0,85; 0,94]
English: Turn until it is on tight.
Slovenian: Trdno jo privijte.
English: Headache; slurred speech; fast heartbeat; cold sweat, cool pale skin; feeling sick, feeling very hungry; tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused, difficulty in concentrating; short-lasting changes in your sight.
Slovenian: Opozorilni znaki prenizkega krvnega sladkorja - lahko se pojavijo nenadoma Glavobol, nerazločno govorjenje, hitro bitje srca, hladno znojenje, hladna in bleda koža, občutek slabosti, huda lakota, tresenje ali živčnost ali zaskrbljenost, nenavadna utrujenost, šibkost in zaspanost, občutek zmedenosti, težave s koncentracijo, kratkotrajne motnje vida.
English: Before first use Store in a refrigerator (2°C to 8°C).
Slovenian: Pred prvo uporabo Shranjujte v hladilniku (2 °C − 8 °C).
English: In addition to standard of care for diabetes and cardiovascular disease Nocturnal severe hypoglycaemia was defined as episodes between midnight and 6 a.m.
Slovenian: Huda nočna hipoglikemija je bila opredeljena kot hipoglikemija med polnočjo in 6. uro zjutraj.
English: Tresiba 200 units/mL solution for injection in pre-filled pen Tresiba 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength.
Slovenian: Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Škatla in nalepka zdravila Tresiba 200 enot/ml sta temno zelene barve s črtastim predelom, jakost je navedena v rdečem okencu.
English: The total glucose-lowering effect is comparable for Tresiba 100 units/mL and 200 units/mL after administration of the same doses of the two products.
Slovenian: Celotni učinek na znižanje koncentracije glukoze je po uporabi enakih odmerkov zdravila Tresiba 100 enot/ml in 200 enot/ml podoben.
English: Ratio: 0.75 [0.58; 0.99]
Slovenian: Razmerje: 0,75 [0,58;0,99]
English: End of trial Mean change
Slovenian: Konec preskušanja
English: The educational pack should contain: - Direct Healthcare Professional Communication letter as described below; - Summary of Product Characteristics and Package Leaflet; - Poster for display in pharmacies/diabetic units; - Patient Brochures.
Slovenian: - plakat, ki bo izobešen v lekarnah/diabetoloških enotah, - brošure za bolnike.
English: Your pen is designed to be used with NovoTwist or NovoFine single-use disposable needles up to a length of 8 mm.
Slovenian: NovoTwist ali NovoFine za enkratno uporabo, dolžine do 8 mm.
English: • Make sure the dose counter shows 0 before you start.
Slovenian: 3 Izberite odmerek • Preden začnete se prepričajte, da števec odmerka kaže 0.
English: With Tresiba, hypersensitivity (manifested with swelling of tongue and lips, diarrhoea, nausea, tiredness and itching) and urticaria were reported rarely.
Slovenian: Pri zdravilu Tresiba so o preobčutljivosti (ki se kaže v obliki otekanja jezika in ustnic, driske, navzeje,
English: Ratio: 0.64 [0.56; 0.73]
Slovenian: Razmerje: 0,64 [0,56; 0,73]
English: - The 200 units/mL pre-filled pen delivers 2-160 units in steps of 2 units.
Slovenian: - Napolnjeni injekcijski peresnik 200 enot/ml omogoča aplikacijo od 2 do 160 enot v korakih po 2 enoti.
English: Do not count the pen clicks to select the dose; - Check how many units were selected before injecting the insulin; - The dose counter shows the number of units regardless of strength and no dose conversion should be done; - Reporting of medication errors or any side effects.
Slovenian: - da števec odmerkov kaže število enot ne glede na jakost in da se odmerkov ne sme pretvarjati, - da je treba prijaviti napake z zdravilom in vse neželene učinke.
English: Tresiba 200 units/mL solution for injection in pre-filled pen Before first use:
Slovenian: Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Pred prvo uporabo:
English: Difference: 0.04 [-0.12; 0.20]
Slovenian: Razlika: 0,04 [-0,12; 0,20]
English: Example
Slovenian: (primer)
English: Detailed instructions accompanying the delivery system must be followed.
Slovenian: Upoštevati je treba podrobno navodilo,
English: The half-life after subcutaneous administration of Tresiba is determined by the rate of absorption from the subcutaneous tissue.
Slovenian: Hitrost absorpcije iz podkožnega tkiva je tista, ki določa razpolovni čas po subkutani uporabi zdravila Tresiba.
English: You may see a drop of insulin at the needle tip after injecting.
Slovenian: Po injiciranju lahko na konici igle vidite kapljico insulina.
English: In the open-label trials the effect of Tresiba was tested in patients with type 1 diabetes mellitus (Table 3), in insulin naïve patients (insulin initiation in type 2 diabetes mellitus, Table 4) and in previous insulin users (insulin intensification in type 2 diabetes mellitus, Table 5) with fixed as well as flexible dosing time (Table 6), and the reduction in HbA1c from baseline to end of trial was confirmed to be non-inferior in all trials against all comparators (insulin detemir and insulin glargine (100 units/mL)).
Slovenian: Delovanje zdravila Tresiba so preiskusili v odprtih preskušanjih pri bolnikih s sladkorno boleznijo tipa 1 (preglednica 3), bolnikih, ki še niso prejemali insulina (uvedba insulinskega zdravljenja pri sladkorni bolezni tipa 2, preglednica 4) in pri bolnikih, ki so že uporabljali insulin (intenziviranje insulinskega zdravljenja pri sladkorni bolezni tipa 2, preglednica 5), in sicer tako odmerjanje vsak dan ob istem času kot tudi prilagodljivo odmerjanje (preglednica 6).
English: Tresiba 100 units/mL solution for injection in pre-filled pen Before first use:
Slovenian: Tresiba 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku Pred prvo uporabo:
English: Ratio: 1.10 [0.79; 1.52]
Slovenian: Razmerje: 1,10 [0,79;1,52] 6
English: 1 Prepare your pen
Slovenian: 1 Pripravite injekcijski peresnik
English: • Low blood sugar (hypoglycaemia) - if your blood sugar is too low, follow the guidance for low blood sugar in section 4.
Slovenian: • nizek krvni sladkor (hipoglikemija); če se vam koncentracija krvnega sladkorja preveč zniža,
English: Tresiba 200 units/mL solution for injection in pre-filled pen One pre-filled pen contains 600 units of insulin degludec in 3 mL solution.
Slovenian: Tresiba 200 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik vsebuje 600 enot insulina degludek v 3 ml raztopine.
English: Nocturnal severe2
Slovenian: Huda nočna2
English: Inform your doctor immediately if you experience signs of heart failure such as unusual shortness of breath, rapid increase in weight or localised swelling (oedema).
Slovenian: Če občutite znake srčnega popuščanja, npr. nenavadno kratka sapa, hitro pridobivanje telesne mase ali lokalizirano otekanje (edem), nemudoma obvestite zdravnika.
English: HbA1c (%) End of trial Mean change
Slovenian: HbA1c (%) Izhodišče
English: Difference: -0.05 [-0.45; 0.35]
Slovenian: Razlika: 0,05 [-0,45; -0,35] 5
English: Odds ratio: 0.73 [0.60; 0.89]
Slovenian: Razmerje obetov: 0,73 [0,60; 0,89]
English: Rate ratio: 0.60 [0.48; 0.76]
Slovenian: Razmerje pojavnosti: 0,60 [0,48; 0,76]
English: - The 100 units/mL pre-filled pen delivers 1-80 units in steps of 1 unit.
Slovenian: - Napolnjeni injekcijski peresnik 100 enot/ml omogoča aplikacijo od 1 do 80 enot v korakih po 1 enoto.
English: Ratio: 0.58 [0.46; 0.74]
Slovenian: Razmerje: 0,58 [0,46; 0,74]
English: Difference: -0.43 [-0.61; -0.24]
Slovenian: Razlika: -0,43 [-0,61; -0,24]
English: Tresiba 100 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Slovenian: Tresiba 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku 3 ml raztopine v injekcijskem vložku (steklo tipa 1) z batom (halobutil) in plastjo laminirane gume (halobutil/poliizopren) v napolnjenem večodmernem injekcijskem peresniku (polipropilen) za enkratno uporabo.
English: Keep cartridges in the outer carton in order to protect from light.
Slovenian: Injekcijske vložke shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: How to store Tresiba
Slovenian: Shranjevanje zdravila Tresiba
English: There is no clinically relevant development of insulin antibodies after long-term treatment with Tresiba.
Slovenian: b Pojavi od 16. tedna Po dolgotrajnem zdravljenju z zdravilom Tresiba ni klinično pomembnega razvoja protiteles proti insulinu.
English: The dose steps, however, differ between the two strengths of Tresiba.
Slovenian: Za obe jakosti je odmerek naveden v enotah, vendar se odmerni koraki razlikujejo med dvema jakostma zdravila Tresiba.
English: End of treatment FPG (mmol/L)
Slovenian: Glukoza v plazmi na tešče (mmol/l)
English: Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin.
Slovenian: Vaš injekcijski peresnik je napolnjen insulinski injekcijski peresnik z gumbom za nastavitev odmerka, ki vsebuje 300 enot insulina.
English: Tresiba 100 units/mL solution for injection in pre-filled pen One pre-filled pen contains 300 units of insulin degludec in 3 mL solution.
Slovenian: Tresiba 100 enot/ml raztopina za injiciranje v napolnjenem injekcijskem peresniku En napolnjen injekcijski peresnik vsebuje 300 enot insulina degludek v 3 ml raztopine.
English: 11 multinational clinical trials of 26 or 52 weeks' duration were conducted as controlled, open-label, randomised, parallel, treat-to-target trials exposing 4,275 patients to Tresiba (1,102 in type 1 diabetes mellitus and 3,173 in type 2 diabetes mellitus).
Slovenian: V teh preskušanjih je zdravilo Tresiba prejemalo 4.275 bolnikov (1.102 s sladkorno boleznijo tipa 1 in 3.173 s sladkorno boleznijo tipa 2).
English: What Tresiba looks like and contents of the pack Tresiba is presented as a clear and colourless solution for injection in a cartridge (300 units per 3 mL).
Slovenian: Zdravilo Tresiba je na voljo kot bistra in brezbarvna raztopina za injiciranje v injekcijskem vložku (300 enot v 3 ml).
English: Discard the needle safely after each injection
Slovenian: Injekcijsko iglo po vsakem injiciranju varno zavrzite.
English: • you start being sick (vomiting)
Slovenian: • slabost (bruhanje),
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Tresiba.
Slovenian: Pred začetkom uporabe zdravila Tresiba se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: The insulin degludec glucose-lowering action at steady state shows four times lower day-to-day variability in terms of Coefficients of Variation (CV) for the glucose-lowering effect during 0-24 hours (AUCGIR,τ,SS) and 2-24 hours (AUCGIR2-24h,SS) as compared to insulin glargine, see Table 1.
Slovenian: znižanja koncentracije glukoze v 0-24 urah (AUCGIR,τ,SS) in v 2-24 urah (AUCGIR2-24h,SS), glejte preglednico 1.
English: General effects from diabetes treatment • Too low blood sugar (hypoglycaemia)
Slovenian: • Prenizek krvni sladkor (hipoglikemija)
English: The pre-filled pen 200 units/mL can provide a dose of 2-160 units in one injection in steps of 2 units.
Slovenian: Napolnjen injekcijski peresnik z 200 enotami/ml lahko injicira 2-160 enot v eni injekciji, v korakih po
English: • To see precisely how much insulin is left, use the dose counter: Turn the dose selector until the dose counter stops.
Slovenian: • Če želite videti, koliko je še insulina, uporabite števec odmerka:
English: Rate of severe or BG confirmed symptomatic hypoglycaemia3,5 Maintenance period4
Slovenian: Delež hude hipoglikemije3 Vzdrževalno obdobje4
English: *Statistically significant a Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance.
Slovenian: *Statistično značilno a Potrjena hipoglikemija je bila opredeljena kot potrjena koncentracija glukoze v plazmi < 3,1 mmol/l ali potreba po pomoči druge osebe.
English: • High blood sugar (hyperglycaemia) - if your blood sugar is too high, follow the guidance for high blood sugar in section 4.
Slovenian: • visok krvni sladkor (hiperglikemija); če se vam koncentracija krvnega sladkorja preveč zviša,
English: “Tresiba 100 units/mL” or “Tresiba 200 units/mL” is clearly marked on the pen label and packaging.
Slovenian: Na nalepki na injekcijskem peresniku in ovojnini je jasno označeno “Tresiba 100 enot/ml” ali “Tresiba 200 enot/ml”.
English: Type 1 + Type 2 diabetes mellitus (pooled) Maintenance period b
Slovenian: Sladkorna bolezen tipa 1 in tipa 2 (kumulativno)
English: Patients must visually verify the dialled units on the dose counter of the pen.
Slovenian: Bolniki morajo pogledati števec odmerka na injekcijskem peresniku, da se prepričajo, da so izbrali željeno število enot.
English: METHOD AND ROUTE OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN POT UPORABE
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi glicerol metakrezol fenol cinkov acetat klorovodikova kislina (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) voda za injekcije
English: 5 units selected
Slovenian: izbranih 5 enot primera izbranih 24 enot
English: • Do not use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose.
Slovenian: • Da bi se izognili napakam pri odmerjanju in morebitnemu prevelikemu odmerjanju, ne uporabite injekcijske brizge, da bi z njo izvlekli raztopino iz injekcijskega peresnika.