FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients administering Apidra by CSII must have an alternative insulin delivery system available in case of pump system failure (see section 4.4 and 4.8).
Croatian: Bolesnici koji primaju lijek Apidra kontinuiranom supkutanom infuzijom inzulina moraju imati dostupan alternativni sustav za primjenu inzulina, u slučaju kvara pumpe (vidjeti dijelove 4.4 i 4.8).
English: Injection site reactions Local hypersensitivity reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene sistemske reakcije preosjetljivosti
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 100 Units insulin glulisine (equivalent to 3.49 mg).
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml sadrži 100 jedinica inzulina glulizina (što odgovara 3,49 mg).
English: Substances that may enhance the blood-glucose-lowering activity and increase susceptibility to hypoglycaemia include oral antidiabetic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors (MAOIs), pentoxifylline, propoxyphene, salicylates and sulphonamide antibiotics.
Croatian: Tvari koje mogu pojačati učinak na snižavanje razine glukoze u krvi i povećati sklonost hipoglikemiji obuhvaćaju oralne antidijabetike, inhibitore angiotenzin konvertirajućeg enzima (ACE), dizopiramid, fibrate, fluoksetin, inhibitore monoaminooksidaze (MAO inhibitore), pentoksifilin, propoksifen, salicilate i sulfonamidske antibiotike.
English: Apidra 100 Units/ml solution for injection in a vial: Most of the cases were related to handling errors or pump system failure when Apidra was used with CSII.
Croatian: Apidra 100 jedinica/ml otopina za injekciju u bočici: Većina slučajeva bila je povezana s pogrešnim rukovanjem ili kvarom pumpnog sustava prilikom primjene lijeka Apidra putem kontinuirane supkutane infuzije inzulina.
English: Do not use it after this time period.
Croatian: Uložak se ne smije upotrijebiti nakon isteka tog vremenskog razdoblja.
English: Apidra must not be mixed with any preparation other than NPH human insulin.
Croatian: Apidra se ne smije miješati ni s jednim lijekom osim s ljudskim NPH inzulinom.
English: Data indicated that insulin glulisine administered 2 minutes before the meal gives similar postprandial glycaemic control compared to regular human insulin given 30 minutes before the meal.
Croatian: Podaci pokazuju da inzulin glulizin primijenjen 2 minute prije obroka ima sličan učinak na postprandijalnu regulaciju glikemije kao i obični ljudski inzulin primijenjen 30 minuta prije obroka.
English: Insulin glulisine given 15 minutes (GLULISINE post) after start of a meal compared to regular human insulin given 2 minutes (REGULAR pre) before start of the meal (figure 1C).
Croatian: Inzulin glulizin primijenjen 15 minuta (GLULIZIN poslije) nakon početka obroka u usporedbi s običnim ljudskim inzulinom primijenjenim 2 minute (OBIČNI prije) prije početka obroka (slika 1C).
English: One unit of insulin glulisine has the same glucose-lowering activity as one unit of regular human insulin.
Croatian: Jedna jedinica inzulina glulizina ima jednak učinak na sniženje razine glukoze kao i jedna jedinica običnog ljudskog inzulina.
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, D-65926 Frankfurt Germany
Croatian: Sanofi-Aventis Deutschland GmbH Industriepark Höchst, D-65926 Frankfurt Njemačka
English: Pens in use must not be stored in the refrigerator.
Croatian: Brizgalice u uporabi ne smije se odlagati u hladnjak.
English: Apidra in a pre-filled pen is only suitable for injecting just under the skin (see also section 3).
Croatian: Apidra u napunjenoj brizgalici prikladna je isključivo za injiciranje pod kožu (također vidjeti dio 3).
English: Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins (see section 4.4).
Croatian: Prije svake injekcije uvijek se mora provjeriti naljepnica na inzulinu kako ne bi došlo do pogrešaka u primjeni zbog zamjene inzulina glulizina i drugih inzulina (vidjeti dio 4.4).
English: Conditions which may make the early warning symptoms of hypoglycaemia different or less pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease, medicinal products such as beta blockers or after transfer from animal-source insulin to human insulin.
Croatian: Među stanja koja mogu promijeniti neke rane upozoravajuće simptome hipoglikemije ili ih učiniti manje izraženima ubrajaju se dugotrajna šećerna bolest, intenzivirana inzulinska terapija, dijabetička neuropatija, primjena lijekova poput beta-blokatora te prijelaz sa inzulina životinjskog podrijetla na ljudski inzulin.
English: Before using SoloStar, the Instructions for use included in the Package leaflet must be read carefully.
Croatian: Prije uporabe brizgalice SoloStar moraju se pažljivo pročitati upute za uporabu koje su sastavni dio upute o lijeku.
English: Do not put SoloStar next to the freezer compartment or a freezer pack.
Croatian: SoloStar se ne smije staviti neposredno uz zamrzivač ili rashladni uložak.
English: It must only be used if the solution is clear, colourless, with no solid particles visible, and if it is of water-like consistency.
Croatian: Smije se upotrijebiti samo ako je otopina bistra, bezbojna, bez vidljivih krutih čestica i ako je vodenaste konzistencije.
English: When mixed with NPH human insulin, Apidra should be drawn into the syringe first.
Croatian: Kad se miješa s ljudskim NPH inzulinom, u štrcaljku se prvo mora povući lijek Apidra.
English: Elderly Very limited pharmacokinetic data are available for elderly patients with diabetes mellitus.
Croatian: Starije osobe Farmakokinetički podaci za starije bolesnike sa šećernom bolešću vrlo su oskudni.
English: Another phase I study with insulin glulisine and insulin lispro in a non-diabetic population in 80 subjects with a wide range of body mass indices (18-46 kg/m²) has demonstrated that rapid action is generally maintained across a wide range of body mass indices (BMI), while total glucose lowering effect decreases with increasing obesity.
Croatian: Drugo ispitivanje faze I s inzulinom glulizinom i inzulinom lispro u 80 ispitanika sa širokim rasponom indeksa tjelesne mase (18-46 kg/m2) u populaciji koja ne boluje od šećerne bolesti pokazala je da je brzo djelovanje inzulina uglavnom očuvano u širokom rasponu indeksa tjelesne mase (ITM), dok se ukupan učinak sniženja razine glukoze u krvi smanjuje s povećanjem pretilosti.
English: Apidra 100 Units/ml solution for injection in a cartridge EU/1/04/285/005-012
Croatian: Apidra 100 jedinica/ml otopina za injekciju u ulošku EU/1/04/285/005-012
English: How to store Apidra
Croatian: Kako primjenjivati lijek Apidra
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (10 ml vial)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (bočica od 10 ml)
English: A phase I study in patients with type 1 diabetes mellitus assessed the glucose lowering profiles of insulin glulisine and regular human insulin administered subcutaneously at a dose of 0.15 Units/kg, at different times in relation to a 15-minute standard meal.
Croatian: U ispitivanju faze I s bolesnicima koji boluju od šećerne bolesti tipa 1 procjenjivao se profil sniženja razine glukoze u krvi djelovanjem inzulina glulizina i običnog ljudskog inzulina, primijenjenih supkutano u dozi od 0,15 jedinica/kg u različito vrijeme u odnosu na 15-minutni standardni obrok.
English: Each vial contains 10 ml of solution for injection, equivalent to 1000 Units.
Croatian: Jedna bočica sadrži 10 ml otopine za injekciju, što odgovara 1000 jedinica.
English: Do not use the vial after this time period.
Croatian: Brizgalica se ne smije upotrijebiti nakon isteka tog vremenskog razdoblja.
English: Each vial contains 10 ml solution (1000 Units).
Croatian: Jedna bočica sadrži 10 ml otopine (1000 jedinica).
English: When given 2 minutes prior to meal, insulin glulisine provided better postprandial control than regular human insulin given 2 minutes before the meal.
Croatian: Kad se inzulin glulizin daje 2 minute prije obroka, postiže se bolja postprandijalna regulacija razine glikemije nego kad se obični ljudski inzulin primijeni 2 minute prije obroka.
English: Read carefully the "SoloStar Instructions for use" included in this package leaflet.
Croatian: Pažljivo pročitajte „Upute za uporabu brizgalice SoloStar“ koje su sastavni dio ove Upute o lijeku.
English: Apidra vials are for use with insulin syringes with the corresponding unit scale and for use with an insulin pump system.
Croatian: Apidra bočice namijenjene su uporabi samo sa inzulinskim štrcaljkama s odgovarajućom odmjernom skalom i uporabi putem inzulinske pumpe.
English: Insulin glulisine shows low plasma protein binding, similar to human insulin.
Croatian: Inzulin glulizin u malom se postotku veže za proteine u plazmi, slično kao ljudski inzulin.
English: Apidra in cartridges is only suitable for injecting just under the skin using a reusable pen (see also section 3).
Croatian: Apidra u ulošcima prikladna je isključivo za injiciranje pod kožu upotrebom brizgalice za višekratnu primjenu (također vidjeti dio 3).
English: Substances that may reduce the blood-glucose-lowering activity include corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetic medicinal products (e.g. epinephrine [adrenaline], salbutamol, terbutaline), thyroid hormones, oestrogens, progestins (e.g. in oral contraceptives), protease inhibitors and atypical antipsychotic medicinal products (e.g. olanzapine and clozapine).
Croatian: Tvari koje mogu smanjiti učinak na snižavanje razine glukoze u krvi obuhvaćaju kortikosteroide, danazol, diazoksid, diuretike, glukagon, izoniazid, derivate fenotiazina, somatropin, simpatomimetičke lijekove (npr. epinefrin [adrenalin], salbutamol, terbutalin), hormone štitnjače, estrogene, progestine (npr. u oralnim kontraceptivima), inhibitore proteaze i atipične antipsihotike (npr. olanzapin i klozapin).
English: Limited pharmacokinetic data are available in elderly patients with diabetes mellitus.
Croatian: Farmakokinetički podaci o starijim osobama sa šećernom bolešću su ograničeni.
English: When used with a subcutaneous insulin infusion pump, Apidra must not be mixed with diluents or any other insulin.
Croatian: Kada se primjenjuje uz pomoć pumpe za supkutanu infuziju inzulina, Apidra se ne smije miješati s otapalima ni drugim inzulinima.
English: Apidra 100 Units/ml solution for injection in a vial EU/1/04/285/001-004
Croatian: Apidra 100 jedinica/ml otopina za injekciju u bočici EU/1/04/285/001-004
English: Rare reported side effect (may affect up to 1 in 1,000 people)
Croatian: Rijetko prijavljene nuspojave: (mogu se javiti u 1 na 1000 osoba)
English: Unopened vials
Croatian: Neotvorene brizgalice
English: To ensure you get the accurate dose, the Apidra cartridges are to be used only with the following pens: - JuniorSTAR which delivers doses in steps of 0.5 units - ClikSTAR, Tactipen, Autopen 24, AllStar or AllStar PRO which deliver doses in steps of 1 unit.
Croatian: Apidra ulošci smiju se upotrebljavati samo sa sljedećim brizgalicama: - JuniorSTAR, kojim se može dozirati lijek Apidra u koracima od 0,5 jedinica - OptiPen, ClikSTAR, Tactipen, Autopen 24, AllStar i AllStar PRO kojima se može dozirati lijek
English: D-65926 Frankfurt am Main, Germany
Croatian: D-65926 Frankfurt na Majni, Njemačka
English: • General disorders and administration site conditions Systemic hypersensitivity reactions may include urticaria, chest tightness, dyspnoea, allergic dermatitis and pruritus.
Croatian: Sistemske reakcije preosjetljivosti mogu uključivati urtikariju, pritisak u prsima, dispneju, alergijski dermatitis i svrbež.
English: INSTRUCTIONS ON USE Open here
Croatian: Ovdje otvoriti
English: Тел.
Croatian: KONC.
English: After first use: The product may be stored for a maximum of 4 weeks below 25°C.
Croatian: Nakon prve uporabe: Lijek se može čuvati najdulje 4 tjedna na temperaturi ispod 25°C.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svome liječniku, ljekarniku ili medicinskoj sestri.
English: Before insertion of the cartridge into the reusable pen, the cartridge must be stored at room temperature for 1 to 2 hours.
Croatian: Prije umetanja uloška u brizgalicu za višekratnu uporabu, uložak se mora držati na sobnoj temperaturi jedan do dva sata.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of insulin glulisine in pregnant women.
Croatian: Podaci o primjeni inzulina glulizina u trudnica ne postoje ili su malobrojni (manje od 300 ishoda trudnoća).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL (pre-filled pen SoloStar)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BRIZGALICE (napunjena brizgalica SoloStar)
English: You must always check the insulin label before each injection to avoid mix-ups between Apidra and other insulins.
Croatian: Prije svake injekcije uvijek morate provjeriti naljepnicu na inzulinu kako ne biste zamijenili lijek Apidra s drugim inzulinima.
English: Pre-filled pens in use (or carried as a spare) may be stored for a maximum of 4 weeks below 25°C and away from direct heat or direct light.
Croatian: Napunjene brizgalice u uporabi (ili rezervne brizgalice) mogu se čuvati najdulje 4 tjedna na temperaturi ispod 25°C, zaštićene od izvora topline i izravne svjetlosti.
English: Insulin glulisine has a more rapid onset of action and a shorter duration of action than regular human insulin.
Croatian: Inzulin glulizin počinje djelovati brže i djeluje kraće u odnosu na obični ljudski inzulin.
English: Before use always attach a new needle, and perform a safety test. Only use needles that are compatible for use with SoloStar (see “SoloStar Instructions for use”).
Croatian: Koristite samo igle koje su prikladne za uporabu s brizgalicom SoloStar (vidjeti „Upute za uporabu brizgalice SoloStar“).
English: Inspect the vial before use.
Croatian: Prije uporabe pregledajte uložak.
English: Apidra SoloStar solution for injection in a pre-filled pen.
Croatian: Apidra SoloStar otopina za injekciju u napunjenoj brizgalici.
English: Insulin reservoir
Croatian: Spremnik inzulina
English: Apidra in cartridges is only suitable for injecting just under the skin using a reusable pen.
Croatian: Apidra u ulošcima je prikladna samo za ubrizgavanje neposredno je isključivo za injiciranje pod kožu upotrebom pomoću brizgalice za višekratnu primjenuuporabu.
English: - The other ingredients are: metacresol (see section 2 under “Apidra contains metacresol”), sodium chloride (see section 2 under “Important information about some of the ingredients of Apidra”), trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.
Croatian: - Ostali sastojci su: metakrezol (vidjeti dio 2, pod “Apidra sadrži metakrezol”), natrijev klorid (vidjeti dio 2, pod “Važna informacija o nekim sastojcima lijeka Apidra”), trometamol, polisorbat 20, koncentrirana kloridna kiselina, natrijev hidroksid, voda za injekcije.
English: A 12-week phase III clinical study performed in patients with type 1 diabetes mellitus receiving insulin glargine as basal therapy indicate that the immediate post-meal administration of insulin glulisine provides efficacy that was comparable to immediate pre-meal insulin glulisine (0-15 minutes) or regular insulin (30-45 minutes).
Croatian: U 12-tjednom kliničkom ispitivanju faze III provedenom u bolesnika sa šećernom bolešću tipa 1 koji su primali inzulin glargin kao bazalnu terapiju pokazalo se da je primjena inzulina glulizina neposredno nakon obroka jednako učinkovita kao i kad se inzulin glulizin ili obični inzulin primijene neposredno prije obroka (inzulin glulizin 0-15 min prije, a obični inzulin 30-45 minuta prije obroka).
English: Insulin glulisine administered 15 minutes after starting the meal gives similar glycaemic control as regular human insulin given 2 minutes before the meal (see figure 1).
Croatian: Inzulin glulizin primijenjen 15 minuta nakon početka obroka ostvaruje slične rezultate kao i obični ljudski inzulin primijenjen 2 minute prije obroka (vidjeti sliku 1).
English: • Always attach a new needle before each use.
Croatian: • Prije svake uporabe uvijek morate pričvrstiti novu iglu.
English: In-use pens For storage conditions after first opening of the medicinal product, see section 6.3.
Croatian: Brizgalice u uporabi Uvjete čuvanja nakon prvog otvaranja lijeka vidjeti u dijelu 6.3.
English: Injection sites and infusion sites within an injection area (abdomen, thigh or deltoid) should be rotated from one injection to the next.
Croatian: Pri svakoj primjeni treba unutar odgovarajućeg područja tijela (abdomen, bedro ili područje deltoideusa) promijeniti mjesto u koje se daje injekcija ili infuzija.
English: Each cartridge contains 3 ml of solution for injection, equivalent to 300 Units.
Croatian: Jedan uložak sadrži 3 ml otopine za injekciju, što odgovara 300 jedinica.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Sanofi-Aventis Deutschland GmbH
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sanofi-Aventis Deutschland GmbH
English: Each cartridge contains 3 ml solution (300 Units).
Croatian: Jedan uložak sadrži 3 ml otopine (300 jedinica).
English: - The active substance is insulin glulisine.
Croatian: - Djelatna tvar je inzulin glulizin.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Apidra SoloStar 100 Units/ml solution for injection Insulin glulisine
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Apidra SoloStar 100 jedinica/ml otopina za injekciju inzulin glulizin
English: After its first use, the product may be stored for a maximum of 4 weeks below 25°C.
Croatian: Nakon prve uporabe, lijek se može čuvati najdulje 4 tjedna na temperaturi ispod 25°C.
English: Each ml of the solution contains 100 Units of insulin glulisine (equivalent to 3.49 mg).
Croatian: Jedan ml otopine sadrži 100 jedinica inzulina glulizina (što odgovara 3,49 mg).
English: The patient should be advised to read the instructions for use included in the package leaflet carefully before using SoloStar.
Croatian: Bolesnika treba uputiti da prije uporabe brizgalice SoloStar pažljivo pročita upute za uporabu koje su sastavni dio upute o lijeku.
English: The product may be stored for a maximum of 4 weeks below 25°C.
Croatian: Lijek se može čuvati najdulje 4 tjedna na temperaturi ispod 25°C.
English: As for all insulins, injection sites and infusion sites within an-injection area (abdomen, thigh or upper arm) must be rotated from one injection to the next.
Croatian: Kao kod svih inzulina, pri svakoj primjeni mora se unutar odgovarajućeg područja tijela (trbuh, bedro ili nadlaktica) promijeniti mjesto u koje se daje injekcija ili infuzija.
English: Once in use, the vial may be stored for a maximum of 4 weeks in the outer carton below 25°C away from direct heat or direct light.
Croatian: Kad je u uporabi, bočica se može čuvati najdulje 4 tjedna u vanjskom pakiranju na temperaturi ispod 25°C, zaštićena od izvora topline i izravne svjetlosti.
English: Common reported side effects (may affect up to 1 in 10 people)
Croatian: Često prijavljene nuspojave (mogu se javiti u 1 na 10 osoba)
English: EU/1/04/285/001 1 vial of 10ml EU/1/04/285/002 2 vials of 10ml.
Croatian: EU/1/04/285/001 1 bočica od 10 ml EU/1/04/285/002 2 bočice od 10 ml EU/1/04/285/003 4 bočice od 10 ml EU/1/04/285/004 5 bočica od 10 ml
English: However, insulin requirements may be reduced in the presence of renal impairment.
Croatian: Ipak, potrebe za inzulinom mogu biti smanjene u slučaju oštećenja bubrežne funkcije.
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”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici na brizgalici iza "EXP".
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 cartridges are available.
Croatian: Dostupna su pakiranja od 1, 3, 4, 5, 6, 8, 9 i 10 uložaka.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Sanofi-Aventis Deutschland GmbH
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Sanofi-Aventis Deutschland GmbH
English: Do not use this medicine after the expiry date, which is stated on the carton and on the label of the vial after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici na ulošku iza "EXP".
English: Medicines that may cause your blood sugar level to fall (hypoglycaemia) include: - all other medicines to treat diabetes, - angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), - disopyramide (used to treat certain heart conditions), - fluoxetine (used to treat depression), - fibrates (used to lower high levels of blood lipids), - monoamine oxidase (MAO) inhibitors (used to treat depression), - pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever), - sulphonamide antibiotics.
Croatian: Lijekovi koji mogu uzrokovati pad razine šećera u krvi (hipoglikemiju) obuhvaćaju: - sve druge lijekove za liječenje šećerne bolesti, - inhibitore angiotenzin konvertirajućeg enzima (ACE-inhibitore) (koriste se za liječenje nekih srčanih poremećaja ili visokog krvnog tlaka), - dizopiramid (koristi se za liječenje nekih srčanih bolesti), - fluoksetin (koristi se za liječenje depresije), - fibrate (koriste se za snižavanje visokih razina masnoća u krvi), - inhibitore monoamino-oksidaze (MAO inhibitore) (koriste se za liječenje depresije), - pentoksifilin, propoksifen, salicilate (poput aspirina, koriste se za ublažavanje bolova i snižavanje tjelesne temperature), - sulfonamidne antibiotike.
English: To prevent any kind of contamination, the re-usable pen should be used by a single patient only.
Croatian: Da bi se spriječila bilo kakva kontaminacija, napunjenu brizgalicu smije koristiti samo jedan bolesnik.
English: Apidra is an antidiabetic agent, used to reduce high blood sugar in patients with diabetes mellitus; it may be given to adults, adolescents and children, 6 years of age and older.
Croatian: Apidra je antidijabetički lijek koji se koristi za snižavanje razine šećera u krvi u bolesnika sa šećernom bolešću.
English: When used with an insulin infusion pump, Apidra must not be mixed with other medicinal products.
Croatian: Kad se Apidra primjenjuje uz pomoć inzulinske infuzijske pumpe, ne smije se miješati ni s jednim drugim lijekom.
English: Read the package leaflet before use.
Croatian: Pregledajte uložak ugrađen u jednokratnu brizgalicu prije nego što je upotrijebite.
English: Insulin label must always be checked before each injection to avoid medication errors between insulin glulisine and other insulins.
Croatian: Prije svake injekcije uvijek se mora provjeriti naljepnica na inzulinu kako ne bi došlo do pogrešaka u primjeni zbog zamjene inzulina glulizina i drugih inzulina.
English: The dose window must show “0” following the safety test.
Croatian: Nakon testa sigurnosti u prozorčiću za doziranje mora biti “0”.
English: Apidra 100 Units/ml solution for injection in a vial is a clear, colourless, aqueous solution with no particles visible.
Croatian: Apidra 100 jedinica/ml otopina za injekciju u ulošku je bistra, bezbojna, vodena otopina bez vidljivih čestica.
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pens are available.
Croatian: Dostupna su pakiranja od 1, 3, 4, 5, 6, 8, 9 i 10 brizgalica.
English: The product may be stored for a maximum of 4 weeks below 25°C away from direct heat or direct light.
Croatian: Lijek se može čuvati najdulje 4 tjedna na temperaturi ispod 25°C, zaštićen od izvora topline i izravne svjetlosti.
English: Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens are available.
Croatian: Dostupna su pakiranja od 1, 3, 4, 5, 6, 8, 9 i 10 napunjenih brizgalica.
English: Organ system classes
Croatian: MedDRA organski sustav