FrancophonIA/ELRC3.0 huggingface dataset:
English: In treatment of type 2 diabetes mellitus, Levemir may also be used in combination with tablets for diabetes and/or with injectable anti-diabetic products, other than insulin.
Croatian: U liječenju šećerne bolesti tipa 2, Levemir se može primjenjivati i u kombinaciji s tabletama protiv šećerne bolesti i/ili lijekovima za liječenje šećerne bolesti koji se injiciraju, a nisu inzulini.
English: If a drop of insulin still does not appear, the device is defective and must not be used.
Croatian: Ako se nakon toga kapljica inzulina ne pojavi, brizgalica je neispravna i ne smijete je upotrijebiti.
English: Patients transferred to Levemir from another type of insulin may require a change in dose from that used with their usual insulin medicinal products.
Croatian: Bolesnicima koji su prešli na Levemir s druge vrste inzulina možda će biti potrebna različita doza nego kod primjene njihovih uobičajenih inzulinskih pripravaka.
English: +8 units
Croatian: + 8 jedinica
English: An open-label randomised clinical trial in patients with type 2 diabetes not reaching target with oral antidiabetic medicinal products was conducted.
Croatian: Provedeno je otvoreno, randomizirano kliničko ispitivanje u bolesnika sa šećernom bolešću tipa 2 koji nisu postigli ciljne vrijednosti s oralnim antidijabeticima.
English: *Self-Monitored Plasma Glucose
Croatian: * samomjerenje glukoze u plazmi
English: Levemir is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Croatian: Levemir je indiciran za liječenje šećerne bolesti u odraslih, adolescenata i djece u dobi od 1 ili više godina.
English: ► If you have such low blood sugar that makes you pass out, if you have had the need for an injection of glucagon, or if you have experienced many incidents of low blood sugar, talk to a doctor.
Croatian: ► Ako imate tako nisku razinu šećera u krvi da se onesvijestite, ako Vam je bila potrebna injekcija glukagona ili ako često imate nisku razinu šećera u krvi, obratite se svom liječniku.
English: Levemir was non-inferior to NPH insulin as measured by HbA1c at gestational week (GW) 36, and the reduction in mean HbA1c through pregnancy was similar, see table 4.
Croatian: Levemir nije bio inferioran NPH inzulinu s obzirom na HbA1c u 36. tjednu trudnoće (TT), a sniženje prosječne vrijednosti HbA1c bilo je slično tijekom cijele trudnoće, vidjeti Tablicu 4. Tablica 4: Glikemijska kontrola u majki
English: ► Always carry a spare Penfill cartridge in case the one in use is lost or damaged.
Croatian: Uvijek sa sobom nosite rezervni Penfill uložak, u slučaju da se onaj koji koristite izgubi ili ošteti.
English: Start by checking your pen to make sure that it contains Levemir 100 units/ml, then look at the illustrations to the right to get to know the different parts of your pen and needle.
Croatian: Levemir 100 jedinica/ml, a zatim pogledajte slike na desnoj strani da se upoznate s različitim dijelovima brizgalice i igle.
English: A MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: • The other ingredients are glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.
Croatian: • Drugi sastojci su glicerol, fenol, metakrezol, cinkov acetat, natrijev hidrogenfosfat dihidrat, natrijev klorid, kloridna kiselina, natrijev hidroksid i voda za injekcije.
English: The overall rates of maternal adverse events were similar for Levemir and NPH insulin treatment groups; however, a numerically higher frequency of serious adverse events in the mothers (61 (40%) vs. 49 (31%)) and in the newborn children (36 (24%) vs. 32 (20%)) was seen for Levemir compared to NPH insulin.
Croatian: Međutim, uočena je brojčano veća učestalost ozbiljnih štetnih događaja u majki (61 (40%) naspram 49 (31%)) i kod novorođene djece (36 (24%) naspram 32 (20%)) za Levemir u usporedbi s NPH inzulinom.
English: The following substances may reduce the patient's insulin requirements: Oral antidiabetic medicinal products, GLP-1 receptor agonists, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulphonamides.
Croatian: oralni antidijabetici, agonisti GLP-1 receptora, inhibitori monoamino-oksidaze (MAO inhibitori), beta blokatori, inhibitori angiotenzin konvertirajućeg enzima (ACE inhibitori), salicilati, anabolički steroidi i sulfonamidi.
English: Analyses of nocturnal hypoglycaemia in patients with type 1 diabetes showed a significantly lower risk of minor nocturnal hypoglycaemia (able to self-treat and confirmed by capillary blood glucose less than 2.8 mmol/l or 3.1 mmol/l if expressed as plasma glucose) than with NPH insulin, whereas no difference was seen in type 2 diabetes.
Croatian: Analize noćnih hipoglikemija u bolesnika sa šećernom bolešću tipa 1 pokazale su značajno manji rizik za lakše noćne hipoglikemije (bolesnik si je mogao sam pomoći, a vrijednost glukoze bila je potvrđeno manja od 2,8 mmol/l u kapilarnoj krvi, odnosno manja od 3,1 mmol/l u plazmi) nego uz NPH inzulin, dok u šećernoj bolesti tipa 2 nije utvrđena razlika.
English: Each ml contains 100 units of insulin detemir.
Croatian: Jedan ml sadrži 100 jedinica detemir inzulina.
English: Injection site reactions are seen more frequently during treatment with Levemir than with human insulin products.
Croatian: Reakcije na mjestu injiciranja češće su tijekom liječenja lijekom Levemir nego pripravcima humanog inzulina.
English: • Dial the number of units required by turning the dose selector clockwise (picture C).
Croatian: • Okrenite izbornik doze u smjeru kazaljke na satu kako biste odabrali potreban broj jedinica (slika C).
English: C. Take a new disposable needle and tear off the paper tab.
Croatian: Uzmite novu jednokratnu iglu i otrgnite papirnati pokrov.
English: • Replace the big outer needle cap and unscrew the needle (picture E).
Croatian: • Vratite veliki vanjski zatvarač igle i odvijte iglu (slika E).
English: Continuous rotation of the injection site within the particular injection area reduces the risk of developing these reactions.
Croatian: Neprestano mijenjanje mjesta injiciranja unutar određenog područja umanjuje rizik od razvoja ovih reakcija.
English: Results support the use of Levemir in adolescent patients with type 2 diabetes mellitus.
Croatian: Rezultati podupiru uporabu lijeka Levemir u adolescentnih bolesnika sa šećernom bolešću tipa 2.
English: The efficacy and safety of Levemir has been studied for up to 12 months, in three randomised controlled clinical trials in adolescents and children (n=1045 in total); the trials included in total 167 children aged 1-5 years.
Croatian: Djelotvornost i sigurnost lijeka Levemir ispitivane su do 12 mjeseci u tri randomizirana, kontrolirana klinička ispitivanja u adolescenata i djece (n=1045 ukupno).
English: If one SMPG measurement 3.1-4.0 mmol/l (56-72 mg/dl)
Croatian: Ako je jedno SMGP 3,1-4,0 mmol/l (56-72 mg/dl)
English: NPH insulin Insulin glargine
Croatian: NPH inzulin Glargin inzulin
English: Within-patient variation in absorption is lower for Levemir than for other basal insulin preparations.
Croatian: Intraindividualna varijabilnost apsorpcije je kod lijeka Levemir manja nego kod drugih pripravaka bazalnog inzulina.
English: If you forget to take your insulin your blood sugar may get too high (hyperglycaemia).
Croatian: Ako ste zaboravili primijeniti inzulin razina šećera u krvi može biti previsoka (hiperglikemija).
English: The prolonged action of Levemir is mediated by the strong self-association of insulin detemir molecules at the injection site and albumin binding via the fatty acid side-chain.
Croatian: Produljeno djelovanje lijeka Levemir posljedica je jakog međusobnog vezanja molekula detemir inzulina na mjestu injiciranja te vezanja za albumin putem postraničnog lanca masnih kiselina.
English: Levemir can be used in adolescents and children aged 1 year and above.
Croatian: Levemir se može koristiti u adolescenata i djece u dobi od 1 ili više godina.
English: Mean HbA1c (%) at GW 36
Croatian: Prosječni HbA1c (%) u
English: Injecting your dose Make sure that you receive your full dose by using the right injection technique.
Croatian: Kako biste bili sigurni da ste primili cijelu dozu inzulina, primijenite pravilnu tehniku injiciranja.
English: The blood glucose lowering effect of Levemir is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Croatian: Učinak lijeka Levemir na snižavanje razine glukoze u krvi posljedica je olakšanog ulaska glukoze nakon vezanja inzulina na receptore na mišićnim i masnim stanicama te istovremene inhibicije otpuštanja glukoze iz jetre.
English: K. Remove the needle from the skin.
Croatian: Izvadite iglu iz kože.
English: These reactions include pain, redness, hives, inflammation, bruising, swelling and itching at the injection site.
Croatian: Te reakcije uključuju bol, crvenilo, koprivnjaču, upalu, modrice, oticanje i svrbež na mjestu injiciranja.
English: Common - Injection site reactions
Croatian: Često - reakcije na mjestu injiciranja
English: Levemir should not be added to infusion fluids.
Croatian: Levemir se ne smije dodavati u infuzijske tekućine.
English: • Always make sure that a drop appears at the needle tip before injection (picture B).
Croatian: • Prije injiciranja uvijek provjerite je li se na vrhu igle pojavila kapljica (slika B).
English: Levemir was studied in an open-label randomised controlled clinical trial, pregnant women with type 1 diabetes (n=310) were treated in a basal-bolus treatment regimen with Levemir (n=152) or NPH insulin (n=158) as basal insulin, both in combination with NovoRapid (see section 4.6).
Croatian: Levemir je ispitan u otvorenom, randomiziranom, kontroliranom kliničkom ispitivanju, u kojemu su trudnice koje imaju šećernu bolest tipa 1 (n=310) liječene bazal-bolus terapijom u kojoj su Levemir (n=152) ili NPH inzulin (n=158) primjenjivani kao bazalni inzulin i u oba slučaja kombinirani s lijekom NovoRapid (vidjeti dio 4.6).
English: Studies in patients with type 2 diabetes treated with basal insulin in combination with oral antidiabetic medicinal products demonstrated that glycaemic control (HbA1c) with Levemir is comparable to NPH insulin and insulin glargine and associated with less weight gain, see Table 2 below.
Croatian: Ispitivanja u bolesnika sa šećernom bolešću tipa 2 liječenih bazalnim inzulinom u kombinaciji s oralnim antidijabeticima pokazala su da je regulacija glikemije (HbA1c) s lijekom Levemir usporediva s NPH inzulinom i glargin inzulinom te povezana s manjim porastom tjelesne težine, vidjeti Tablicu 2
English: LIST OF EXCIPIENTS glycerol, phenol, metacresol, zinc acetate, disodium phosphate dihydrate, sodium chloride, hydrochloric acid/sodium hydroxide for pH adjustment and water for injections
Croatian: glicerol, fenol, metakrezol, cinkov acetat, natrijev hidrogenfosfat dihidrat, natrijev klorid, kloridnu kiselinu/natrijev hidroksid za podešavanje pH i vodu za injekcije.
English: 1 ml solution contains 100 units insulin detemir (equivalent to 14.2 mg).
Croatian: 1 ml otopine sadrži 100 jedinica detemir inzulina (što odgovara 14,2 mg).
English: The most frequently reported adverse reaction is hypoglycaemia.
Croatian: Hipoglikemija Hipoglikemija je najčešće prijavljivana nuspojava.
English: Levemir is for injection under the skin (subcutaneously).
Croatian: Levemir je namijenjen injiciranju pod kožu (supkutano).
English: ► If the insulin does not appear water clear, colourless and aqueous.
Croatian: ► ako inzulin nije bistar, bezbojan i voden.
English: During use or when carried as a spare: Levemir InnoLet that is being used or carried as a spare should not be kept in the refrigerator.
Croatian: Tijekom uporabe ili kada lijek nosite kao rezervni: Levemir InnoLet koji koristite ili nosite kao rezervni ne smijete odlagati u hladnjak.
English: Insulins and analogues for injection, long-acting: ATC code: A10AE05.
Croatian: ATK oznaka: A10AE05.
English: • Remove the paper tab from a new disposable needle.
Croatian: • Otrgnite papirnati pokrov s nove igle za jednokratnu uporabu.
English: Your InnoLet is a simple, compact pre-filled pen able to deliver 1 to 50 units in increments of 1 unit.
Croatian: InnoLet je jednostavna, kompaktna napunjena brizgalica, kojom se odmjeravanjem po 1 jedinice, mogu birati doze u rasponu od 1 do 50 jedinica.
English: Levemir provides up to 24 hours of basal insulin coverage.
Croatian: Levemir pokriva bazalne potrebe za inzulinom do 24 sata.
English: Clinical trial data - Levemir add-on to liraglutide+metformin Study week Randomised
Croatian: Tablica 3: Podaci iz kliničkog ispitivanja - Levemir kao dodatak uz liraglutid+metformin
English: There was no clinically relevant difference in pharmacokinetics of Levemir between patients with renal or hepatic impairment and healthy subjects.
Croatian: Nisu utvrđene klinički značajne razlike u farmakokinetici lijeka Levemir između bolesnika s oštećenjem bubrega ili jetre i zdravih ispitanika.
English: Dose proportionality in serum concentrations (maximum concentration, extent of absorption) is observed after subcutaneous administration in the therapeutic dose range.
Croatian: Nakon supkutane primjene doza u terapijskom rasponu, koncentracije u serumu (maksimalna koncentracija, stupanj apsorpcije) proporcionalne su dozi.
English: Dispose of it carefully and put the pen cap back on your FlexPen.
Croatian: Pažljivo bacite iglu u otpad i vratite zatvarač na brizgalicu FlexPen.
English: Levemir is presented as a solution for injection.
Croatian: Levemir je otopina za injekciju.
English: In clinical trials using basal bolus insulin therapy, the overall rates of hypoglycaemia with Levemir and NPH insulin were similar.
Croatian: U kliničkim ispitivanjima u kojima su ispitanici liječeni bazal-bolus inzulinskom terapijom, ukupne stope hipoglikemije bile su slične uz Levemir i NPH inzulin.
English: Zinc acetate
Croatian: Metakrezol Cinkov acetat
English: +3 units
Croatian: +3 jedinice
English: • Caregivers must be very careful when handling used needles -to reduce the risk of needle injury and cross-infection.
Croatian: • Osobe koje skrbe za bolesnika moraju biti vrlo oprezne pri rukovanju rabljenim iglama kako bi smanjile rizik od uboda iglom i prijenosa infekcije.
English: • Always carry an extra pen and new needles with you, in case of loss or damaged.
Croatian: • Uvijek sa sobom nosite rezervnu brizgalicu i nove igle za slučaj da izgubite ili oštetite onu koju trenutno koristite.
English: The safety and efficacy of Levemir in children below the age of 1 year have not been established.
Croatian: Sigurnost i djelotvornost lijeka Levemir u djece mlađe od 1 godine nisu ustanovljene.
English: Always watch the dose counter to know how many units you inject.
Croatian: Uvijek gledajte brojčanik doze kako biste znali koliko ste jedinica injicirali.
English: MARKETING AUTHORISATION NUMBER EU/1/04/278/014
Croatian: 12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/04/278/014
English: Allergic reactions, potentially allergic reactions, urticaria, rash, eruptions Allergic reactions, potentially allergic reactions, urticaria, rash and eruptions are uncommon when Levemir is used in basal-bolus regimen.
Croatian: Alergijske reakcije, potencijalno alergijske reakcije, urtikarija, osip i erupcije javljaju se manje često kad se Levemir primjenjuje u sklopu bazal-bolus terapije.
English: Can be stored in a refrigerator (2°C-8°C).
Croatian: Može se čuvati u hladnjaku (2°C-8°C).
English: Preparing your Levemir FlexTouch pen Check the name and coloured label on your Levemir FlexTouch pen to make sure that it contains the type of insulin you need.
Croatian: Provjerite naziv i boju naljepnice na Vašoj Levemir FlexTouch brizgalici kako biste bili sigurni da sadrži vrstu inzulina koju trebate.
English: In long-term trials in patients with type 1 diabetes receiving a basal-bolus insulin therapy, fasting plasma glucose was improved with Levemir compared with NPH insulin.
Croatian: U dugotrajnim ispitivanjima u bolesnika sa šećernom bolešću tipa 1 koji su bili na bazal-bolus inzulinskoj terapiji, razina glukoze u plazmi natašte poboljšana je uz Levemir u odnosu na NPH inzulin.
English: ► Levemir Penfill cartridges are designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Croatian: ► Levemir Penfill ulošci namijenjeni su uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
English: • Always check that the push-button is fully depressed and the dose selector is set to 0.
Croatian: Odmjeravanje doze • Uvijek provjerite je li potisni gumb pritisnut do kraja, a izbornik doze postavljen na 0.
English: They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentrating, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Croatian: Simptomi hipoglikemije obično se javljaju naglo, a mogu uključivati: hladan znoj, hladnu blijedu kožu, umor, nervozu ili tremor, anksioznost, neuobičajen umor ili slabost, konfuznost, poteškoće s koncentracijom, omamljenost, izrazitu glad, promjene vida, glavobolju, mučninu i palpitacije.
English: Less weight gain (SD score, weight corrected for gender and age) was observed with Levemir than with NPH insulin.
Croatian: Uz Levemir je zabilježen manji porast tjelesne težine (SD vrijednost, težina prilagođena s obzirom na spol i dob) u odnosu na NPH inzulin.
English: There was no clinically relevant difference in pharmacokinetics of Levemir between elderly and young patients.
Croatian: Nisu utvrđene klinički značajne razlike u farmakokinetici lijeka Levemir između starijih i mladih bolesnika.
English: There are no clinically relevant differences between genders in pharmacokinetic properties of Levemir.
Croatian: Spol Nisu utvrđene klinički značajne razlike u farmakokinetičkim svojstvima lijeka Levemir između spolova.
English: Activity profiles of Levemir in patients with type 1 diabetes
Croatian: Slika 1: Profili djelovanja lijeka Levemir u bolesnika sa šećernom bolešću tipa 1
English: HbA1c ≤6% targets at both GW 24 and GW
Croatian: Udio bolesnica koje su postigle ciljne vrijednosti HbA1c ≤ 6% i u 24. i u 36.
English: 0-26 weeks 0.286 0-52 weeks 0.228
Croatian: 0-26 tjedana 0,286 0-52 tjedna 0,228
English: Levemir is a long-acting insulin analogue used as a basal insulin.
Croatian: Levemir je dugodjelujući inzulinski analog koji se koristi kao bazalni inzulin.
English: During use or when carried as a spare: You can carry your Levemir FlexPen with you and keep it at a temperature below 30°C or in a refrigerator (2°C to 8°C) for up to 6 weeks.
Croatian: Tijekom uporabe ili kada lijek nosite kao rezervni: Levemir FlexPen možete nositi sa sobom i čuvati na temperaturi ispod 30°C ili u hladnjaku (2°C do 8°C) do 6 tjedana.
English: • Sympathomimetics (such as epinephrine [adrenaline], or salbutamol, terbutaline used to treat asthma)
Croatian: • simpatomimetike (poput epinefrina [adrenalina] ili salbutamola, terbutalina koji se koriste za liječenje astme) • hormon rasta (lijek za stimulaciju rasta kostiju i tkiva s izraženim utjecajem na metaboličke procese u tijelu)
English: Fast improvement in blood glucose control may be associated with acute painful neuropathy, which is usually reversible.
Croatian: Naglo poboljšanje regulacije glikemije može biti povezano s akutnom bolnom neuropatijom,
English: Levemir Penfill 3 ml solution in cartridge (type 1 glass) with a plunger (bromobutyl) and a rubber closure
Croatian: 3 ml otopine u ulošku (staklo tipa 1) s klipom (brombutil) i gumenim zatvaračem (brombutil/poliizopren).
English: During use or when carried as a spare: You can carry your Levemir FlexTouch with you and keep it at a temperature below 30°C or in a refrigerator (2°C to 8°C) for up to 6 weeks.
Croatian: Tijekom uporabe ili kada lijek nosite kao rezervni: Levemir FlexTouch možete nositi sa sobom i čuvati na temperaturi ispod 30°C ili u hladnjaku (2°C do 8°C) do 6 tjedana.
English: Levemir Penfill is designed to be used with Novo Nordisk insulin delivery systems and NovoFine or NovoTwist needles.
Croatian: Levemir Penfill namijenjen je uporabi s pomagalima za primjenu inzulina proizvođača Novo Nordisk i iglama NovoFine ili NovoTwist.
English: A major hypoglycaemic episode is defined as an episode where the subject was not able to treat him/herself and if glucagon or i.v.
Croatian: Teškom epizodom hipoglikemije smatrala se ona u kojoj si ispitanik nije mogao sam pomoći i ako je bilo potrebno primijeniti glukagon ili glukozu i.v.; vidjeti Tablicu 3.
English: Each cartridge contains 300 units of insulin detemir in 3 ml solution for injection.
Croatian: Jedan uložak sadrži 300 jedinica detemir inzulina u 3 ml otopine za injekciju.
English: • At the request of the European Medicines Agency
Croatian: Ažurirani RMP treba dostaviti: • na zahtjev Europske agencije za lijekove;
English: For patients who require twice daily dosing to optimise blood glucose control, the evening dose can be administered in the evening or at bedtime.
Croatian: U bolesnika kojima je za optimalnu regulaciju glikemije potrebno doziranje dva puta dnevno, večernja se doza može primijeniti navečer ili prije odlaska na spavanje.
English: Levemir contains less than 1 mmol sodium (23 mg) per dose, i.e. Levemir is essentially ‘sodium-free'.
Croatian: Važne informacije o nekim sastojcima lijeka Levemir Levemir sadrži manje od 1 mmol (23 mg) natrija po dozi, tj.
English: Based on post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment do not indicate any differences to the broader experience in the general population.
Croatian: vrsta i ozbiljnost nuspojava opaženih u starijih bolesnika i bolesnika s oštećenjem bubrega ili jetre ne upućuju na razlike u odnosu na šire iskustvo u općoj populaciji.
English: 0-26 weeks 43.1 0-52 weeks 51.9
Croatian: 0-26 tjedna 43,1 0-52 tjedna 51,9
English: Use the dose selector on your Levemir FlexTouch pen to select your dose.
Croatian: Odaberite svoju dozu uz pomoć izbornika doze na Vašoj Levemir FlexTouch brizgalici.
English: Subsequently, dosage should be adjusted individually.
Croatian: Nakon toga doziranje treba prilagoditi individualnim potrebama.
English: The absolute bioavailability of insulin detemir when administered subcutaneous is approximately
Croatian: Apsolutna bioraspoloživost detemir inzulina kod supkutane primjene iznosi otprilike 60%.
English: Each pre-filled pen contains 300 units of insulin detemir in 3 ml solution for injection.
Croatian: Jedna napunjena brizgalica sadrži 300 jedinica detemir inzulina u 3 ml otopine za injekciju.
English: When turning the dose selector be careful not to push the pushbutton as insulin will come out.
Croatian: Pazite da ne pritisnete potisni gumb kad okrećete izbornik doze jer će inzulin tada iscuriti.
English: On rare occasions, injection site reactions may require discontinuation of Levemir.
Croatian: Zbog reakcija na mjestu injiciranja rijetko će biti potrebno prekinuti liječenje lijekom Levemir.
English: Pack sizes of 1 (with or without needles), 5 (without needles) or a multipack with 2 x 5 (without needles) pre-filled pens of 3 ml.
Croatian: Veličine pakiranja: 1 (sa ili bez igala), 5 (bez igala) ili višestruko pakiranje od 2 x 5 (bez igala)
English: 6.6 Special precautions for disposal and other handling Do not use this medicinal product if you notice that the solution is not clear, colourless and aqueous.
Croatian: Nemojte primjenjivati ovaj lijek ako primijetite da otopina nije bistra, bezbojna i vodena.
English: Concomitant diseases in the kidney, liver or affecting the adrenal, pituitary or thyroid gland can require changes in insulin dose.
Croatian: Popratne bolesti bubrega, jetre ili one koje zahvaćaju nadbubrežnu žlijezdu, hipofizu ili štitnjaču mogu uvjetovati promjenu doze inzulina.