FrancophonIA/ELRC3.0 huggingface dataset:
English: Ocrevus 300 mg concentrate for solution for infusion Ocrelizumab
Croatian: Ocrevus 300 mg koncentrat za otopinu za infuziju okrelizumab
English: · You will be closely monitored while you are being given Ocrevus and for at least 1 hour after the infusion has been given.
Croatian: · Zdravstveno osoblje će Vas pomno nadzirati tijekom primjene lijeka Ocrevus i još najmanje 1 sat nakon infuzije za slučaj da se pojave bilo kakve nuspojave, primjerice reakcije na infuziju.
English: Infusion 1 300 mg in 250 mL · Initiate the infusion at a rate of 30 mL/hour for 30 minutes
Croatian: 300 mg u 250 ml · Infuziju treba započeti brzinom od 30 ml/h tijekom 30 minuta
English: Patients with mild hepatic impairment were included in clinical trials, and no change in the pharmacokinetics was observed in those patients.
Croatian: U klinička su ispitivanja bili uključeni bolesnici s blagim oštećenjem jetrene funkcije, u kojih nije primijećena nikakva promjena u farmakokinetici lijeka.
English: The table 2 summarises the ADRs that have been reported in association with the use of Ocrevus in 1311 patients (3054 patient years) during the controlled treatment periods of MS clinical trials.
Croatian: 1311 bolesnika (3054 bolesnik-godine) tijekom kontroliranih razdoblja liječenja u kliničkim ispitivanjima primjene kod MS-a.
English: In the placebo-controlled (PPMS) clinical trial, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 40.1% compared with an incidence of 25.5% in the placebo group.
Croatian: U placebom kontroliranom kliničkom ispitivanju (PPMS) reakcija na infuziju bila je najčešći štetni događaj u bolesnika liječenih lijekom Ocrevus, s ukupnom incidencijom od 40,1%, u usporedbi s
English: In the RMS clinical trials, 39.9% of Ocrevus treated patients and 33.2% interferon beta-1-a treated patients experienced an upper respiratory tract infection and 7.5% of Ocrevus treated patients and 5.2% of interferon beta-1-a treated patients experienced a lower respiratory tract infection.
Croatian: 33,2% onih koji su primali interferon beta-1a doživjelo je infekciju gornjih dišnih putova, dok se infekcija donjih dišnih putova javila u 7,5% bolesnika liječenih lijekom Ocrevus i 5,2% onih koji su primali interferon beta-1a.
English: Concentrate for solution for infusion.
Croatian: OBLIK Koncentrat za otopinu za infuziju.
English: See section 4.5 and 5.1.
Croatian: Vidjeti dijelove 4.5 i 5.1.
English: Proportion of patients with 24 week Confirmed Disability Progression Risk Reduction (Pooled Analysis Risk Reduction (Individual Studies2)
Croatian: Udio bolesnika s 24-tjednom potvrđenom progresijom onesposobljenosti Smanjenje rizika (analiza objedinjenih podataka1)
English: · Ocrevus medicinal product must be diluted before administration.
Croatian: · Ocrevus se mora razrijediti prije primjene.
English: Patients with mild renal impairment were included in clinical trials and no change in the pharmacokinetics of Ocrevus was observed in those patients.
Croatian: U klinička su ispitivanja bili uključeni bolesnici s blagim oštećenjem bubrežne funkcije, u kojih nije primijećena nikakva promjena u farmakokinetici lijeka Ocrevus.
English: It will be given as an infusion into a vein (intravenous infusion or IV infusion).
Croatian: (intravenskom infuzijom ili i.v. infuzijom).
English: Subsequent Doses
Croatian: Sljedeće doze
English: IFN 44 mcg (n=411)
Croatian: IFN 44 µg (n=411)
English: Hepatic Impairment
Croatian: Zloćudne bolesti
English: See section 4.4 and 5.1.
Croatian: Vidjeti dijelove 4.4 i 5.1.
English: With regard to disease activity, features characteristic of inflammatory activity, even in progressive MS, can be imaging-related, (i.e. T1 Gd-enhancing lesions and/or active [new or enlarging] T2 lesions).
Croatian: Što se tiče aktivnosti bolesti, značajke karakteristične za upalnu aktivnost mogu se, čak i kod progresivnog MS-a, utvrditi oslikavanjem (tj.
English: For guidance regarding posology for patients experiencing IRR symptoms see section 4.2.
Croatian: Za smjernice o doziranju u bolesnika u kojih se pojave simptomi reakcije na infuziju vidjeti dio 4.2. Reakcije preosjetljivosti
English: Mean number of T1 Gd-enhancing lesions per MRI scan
Croatian: Srednja vrijednost broja T1 lezija naglašenih gadolinijem po MR oslikavanju
English: MRI evidence should be used to confirm inflammatory activity in all patients.
Croatian: U svih se bolesnika upalna aktivnost treba potvrditi nalazom MR oslikavanja.
English: There is no PK information available in patients with moderate or severe hepatic impairment.
Croatian: Nema dostupnih farmakokinetičkih podataka u bolesnika s umjerenim ili teškim oštećenjem jetrene funkcije.
English: Management of IRRs before the infusion
Croatian: Zbrinjavanje reakcija na infuziju prije infuzije
English: NAME OF THE MEDICINAL PRODUCT Ocrevus 300 mg concentrate for solution for infusion
Croatian: NAZIV LIJEKA Ocrevus 300 mg koncentrat za otopinu za infuziju
English: 21,7% and 10.1% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 2.4% experienced severe IRRs and 0.1% experienced lifethreatening IRRs.
Croatian: Blage i umjerene reakcije na infuziju javile su se u 21,7% odnosno 10,1% bolesnika liječenih lijekom Ocrevus, teške reakcije na infuziju javile su se u 2,4% tih bolesnika, dok su po život opasne reakcije na infuziju zabilježene u 0,1% bolesnika.
English: The two following premedications must be administered prior to each Ocrevus infusion to reduce the frequency and severity of IRRs: -100 mg intravenous methylprednisolone (or an equivalent) approximately 30 minutes prior to each Ocrevus infusion; -antihistamine approximately 30-60 minutes prior to each Ocrevus infusion; In addition, premedication with an antipyretic (e.g. paracetamol) may also be considered approximately 30-60 minutes prior to each Ocrevus infusion.
Croatian: 100 mg intravenski primijenjenog metilprednizolona (ili ekvivalenta) približno 30 minuta prije svake infuzije lijeka Ocrevus antihistaminik približno 30 - 60 minuta prije svake infuzije lijeka Ocrevus
English: Laboratory Abnormalities
Croatian: Odstupanja u laboratorijskim vrijednostima
English: The majority of IRRs were mild to moderate.
Croatian: Većina reakcija na infuziju bila je blage do umjerene težine.
English: · You might get infections more easily with Ocrevus.
Croatian: · Liječenje lijekom Ocrevus može povećati podložnost infekcijama.
English: Mean/Median disease duration since diagnosis (years) Patients naive to previous DMT
Croatian: Srednja vrijednost/medijan trajanja bolesti od dijagnoze PPMS-a (godine)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: · After dilution, Ocrevus is administered as an intravenous infusion through a dedicated line.
Croatian: Način primjene · Ocrevus se nakon razrjeđivanja primjenjuje intravenskom infuzijom kroz zasebnu liniju.
English: Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy.
Croatian: U novorođenčadi majki izloženih drugim anti-CD20 protutijelima tijekom trudnoće prijavljene su prolazna deplecija B-stanica u perifernoj krvi i limfocitopenija.
English: In the PPMS clinical trial, 48.8% of Ocrevus treated patients and 42.7% of patients who received placebo experienced an upper respiratory tract infection, and 9.9% of Ocrevus treated patients and 9.2% of patients who received placebo experienced a lower respiratory tract infection.
Croatian: 42,7% onih koji su primali placebo doživjelo je infekciju gornjih dišnih putova, dok se infekcija donjih dišnih putova javila u 9,9% bolesnika liječenih lijekom Ocrevus i 9,2% onih koji su primali placebo.
English: It is not to be frozen.The vials are to be kept in the outer carton to protect them from light.
Croatian: Bočice se moraju čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: How Ocrevus is given
Croatian: Kako se Ocrevus primjenjuje
English: Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Whylen Germany
Croatian: D-79639 Grenzach-Whylen
English: Percentage change in brain volume from Week 24 to week 96 Relative reduction in brain volume loss
Croatian: IFN 44 µg (n=418) Postotna promjena volumena mozga od 24. do 96. tjedna -0,572 -0,741 -0,638 -0,750 Relativno smanjenje gubitka volumena mozga
English: If there are signs of a life threatening or disabling IRR during an infusion, such as acute hypersensitivity or acute respiratory distress syndrome, the infusion must be stopped immediately and the patient should receive appropriate treatment.
Croatian: kao što su akutna preosjetljivost ili akutni sindrom respiratornog distresa, infuzija se mora odmah prekinuti, a bolesniku pružiti odgovarajuće liječenje.
English: Solutions of Ocrevus for intravenous infusion are prepared by dilution of the medicinal product into an infusion bag containing 0.9% sodium chloride, to a final concentration of approximately 1.2 mg/mL.For instructions on dilution of the medicinal product before administration see section 6.6.
Croatian: Otopine lijeka Ocrevus za intravensku infuziju pripremaju se tako da se lijek razrijedi u infuzijskoj vrećici koja sadrži otopinu natrijeva klorida od 9 mg/ml (0,9%) do konačne koncentracije od približno 1,2 mg/ml.
English: Ocrevus infusions should not be administered as an intravenous push or bolus.
Croatian: Ocrevus ne smiju se primijeniti brzom ili bolusnom intravenskom injekcijom.
English: This is because Ocrevus may pass into breast milk.
Croatian: Ne smijete dojiti tijekom liječenja lijekom Ocrevus jer Ocrevus može prijeći u majčino mlijeko.
English: Baseline characteristics
Croatian: Tablični prikaz nuspojava
English: 26.7% and 11.9% of Ocrevus treated patients experienced mild and moderate IRRs respectively, 1.4% experienced severe IRRs.
Croatian: Blage i umjerene reakcije na infuziju javile su se u 26,7% odnosno 11,9% bolesnika liječenih lijekom Ocrevus, dok su se teške reakcije na infuziju javile u njih 1,4%.
English: Clear to slightly opalescent, and colourless to pale brown solution.
Croatian: Bistra do blago opalescentna, bezbojna do blijedosmeđa otopina.
English: Proportion of patients with 24 weeks - Confirmed Disability Progression1
Croatian: Udio bolesnika s 24-tjednom potvrđenom progresijom onesposobljenosti1 Smanjenje rizika
English: Approximately 1% of the patients in the Ocrevus group had a Grade 3 lymphopenia (between 200 and 500 cells/mm3).
Croatian: 1% bolesnika u skupini liječenoj lijekom Ocrevus imalo je limfopeniju 3. stupnja (između
English: 1 Defined as an increase of ≥ 1.0 point from the baseline EDSS score for patients with baseline score of 5.5 or less, or ≥ 0.5 when the baseline score is > 5.5, Kaplan-Meier estimates at Week 120.
Croatian: Definirao se kao povećanje početnog EDSS rezultata za ≥ 1,0 bod u bolesnika čiji je početni rezultat iznosio 5,5 ili manje, odnosno za ≥ 0,5 bodova u bolesnika čiji je početni rezultat iznosio > 5,5; procjene prema
English: There is no experience in patients with moderate and severe hepatic impairment.
Croatian: Nema iskustva s primjenom u bolesnika s umjerenim i teškim oštećenjem jetrene funkcije.
English: Water for Injection
Croatian: Infuzije lijeka
English: Blood immunoglobulin M decreased
Croatian: Pretrage snižena vrijednost imunoglobulina
English: This is because it has not yet been studied in this age group.
Croatian: jer njihova uporaba nije ispitana.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Ocrevus 300 mg concentrate for solution for infusion ocrelizumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Ocrevus 300 mg koncentrat za otopinu za infuziju okrelizumab i.v. primjena nakon razrjeđivanja
English: Primary efficacy endpoint Proportion of patients with 12 weeks - Confirmed Disability Progression1 (primary endpoint)
Croatian: Udio bolesnika s 12-tjednom potvrđenom progresijom onesposobljenosti1 (primarna mjera ishoda) Smanjenje rizika
English: Clinical Endpoints
Croatian: Kliničke mjere ishoda
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Croatian: 79639 Grenzach-Wyhlen
English: Clinical efficacy and safety
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV
English: Percentage change in Timed 25-Foot Walk from baseline to Week 120 Relative reduction in progression rate of walking time
Croatian: Timed 25-Foot Walk, T25-FW) od početka ispitivanja do 120. tjedna
English: If you are able to become pregnant (conceive), you must use contraception: · during treatment with Ocrevus and · for 12 months after your last infusion of Ocrevus.
Croatian: Ako možete zatrudnjeti, morate koristiti kontracepciju:
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: Odlaganje neupotrijebljenih lijekova/lijekova kojima je istekao rok valjanosti
English: 1 vial
Croatian: 1. ispitivanje
English: Read the SmPC for additional information.
Croatian: Za dodatne informacije pročitajte sažetak opisa svojstava lijeka.
English: The following infections have been seen in patients treated with Ocrevus in MS: - Very common: may affect more than 1 in 10 people upper respiratory tract infection flu.
Croatian: Vrlo česte: mogu se javiti u više od 1 na 10 osoba - infekcija gornjih dišnih putova - gripa
English: Ocrevus (see section 4.3).
Croatian: (vidjeti dio 4.8).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the healthcare professional and would normally not be longer than 24 hours at 2°C - 8°C and subsequently 8 hours at room temperature.
Croatian: Pripremljeni lijek ne bi se smio čuvati dulje od 24 sata na temperaturi od 2°C do 8°C, a nakon toga dulje od
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
Croatian: Razlozi za izmjenu uvjeta odobrenja za stavljanje lijeka u promet
English: Infusion instruction
Croatian: 1. infuzija
English: They will watch you closely while you are being given this medicine.
Croatian: Pažljivo će Vas nadzirati tijekom njegove primjene, za slučaj da se pojavi bilo koja nuspojava.
English: Investigations
Croatian: 3. ispitivanje
English: The studies enrolled patients with active disease.
Croatian: U klinička su ispitivanja bili uključeni bolesnici s blagim oštećenjem jetrene funkcije.
English: In active-controlled (RMS) clinical trials, IRR was the most common adverse event in patients treated with Ocrevus with an overall incidence of 34.3% compared with an incidence of 9.9% in the interferon beta-1a treatment group (placebo infusion).
Croatian: U kliničkim ispitivanjima kontroliranima aktivnim lijekom (RMS) reakcija na infuziju bila je najčešća nuspojava u bolesnika liječenih lijekom Ocrevus, s ukupnom incidencijom od 34,3% u usporedbi s
English: Patients with mild hepatic impairment were included in clinical trials.
Croatian: U klinička su ispitivanja bili uključeni bolesnici s blagim oštećenjem bubrežne funkcije.
English: · Tell your doctor or nurse straight away if you have any of these signs of infection during or after Ocrevus treatment: fever or chills cough that does not go away herpes (such as cold sore, shingles or genital sores).
Croatian: · Odmah obavijestite svog liječnika ili medicinsku sestru ako tijekom ili nakon liječenja lijekom Ocrevus primijetite bilo koji od ovih znakova infekcije:
English: NAME OF THE MEDICINAL PRODUCT Ocrevus 300 mg concentrate for solution for infusion ocrelizumab
Croatian: Uputa o lijeku: Informacije za bolesnika Ocrevus 300 mg koncentrat za otopinu za infuziju okrelizumab
English: Lymphocytes
Croatian: PPMS-a).
English: Immunisations
Croatian: Imunogenost
English: Respiratory, thoracic and mediastinal disorders
Croatian: Geometrijska srednja vrijednost titra protutijela
English: Package leaflet: Information for the patient
Croatian: Relativno povećanje (analiza objedinjenih podataka
English: EU (MA) number Invented name
Croatian: Dodatak A EU (MA) broj
English: Inactivated bluetongue virus, serotype 8, strain BTV-8/BEL2006/02 RP* ≥ 1
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 8, soj BTV-8/BEL2006/02 RP* ≥ 1
English: *Relative Potency by a mice potency test compared to a reference vaccine efficacious in sheep and cattle **Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep.
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 4, soj SPA-1/2004 RP** ≥ 0,8 *Relativna potentnost utvrđena u ispitivanju potentnosti na miševima u usporedbi s referentnim cjepivom koje se pokazalo djelotvornim kod ovaca i goveda ** Relativna potentnost sa potentnosti u miševa u usporedbi s referentnim cjepivom učinkovitim kod ovaca.
English: Inactivated bluetongue virus, serotype 4, strain SPA-1/2004 RP** ≥ 0.8
Croatian: Inaktivirani virus bolesti plavog jezika, serotip 1, soj BTV-1/ALG2006/01 E1RP* ≥ 1
English: --1 Each dose of 2 ml of vaccine contains one of the following inactivated bluetongue virus strains: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1
Croatian: --1 Jedna doza od 2 ml cjepiva sadrži jedan od sljedećih inaktiviranih sojeva virusa bolesti plavog jezika:
English: 1 dose (1 ml) contains: Hepatitis A virus (inactivated)1,2
Croatian: 1 doza (1 ml) cjepiva sadrži: inaktivirani virus hepatitisa A1,2
English: 1Produced on human diploid (MRC-5) cells 2Adsorbed on aluminium hydroxide, hydrated
Croatian: 1umnožen na ljudskim diploidnim (MRC-5) stanicama adsorbiran na aluminijev hidroksid, hidratiziran
English: 3Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology 4Adsorbed on aluminium phosphate
Croatian: Al proizveden tehnologijom rekombinantne DNA na stanicama kvasca (Saccharomyces cerevisiae) 4adsorbiran na aluminijev fosfat
English: Hepatitis B surface antigen3,4
Croatian: 720 ELISA jedinica površinski antigen hepatitisa B3,4
English: (glass)
Croatian: (Zaštićeno) ime
English: More information
Croatian: Više informacija
English: • If you have any questions speak to your healthcare professional.
Croatian: • Ako imate pitanja, obratite se svojem zdravstvenom djelatniku.
English: Always follow the instructions of your healthcare professional.
Croatian: Uvijek slijedite upute zdravstvenog djelatnika.
English: Recommendations for healthcare professionals
Croatian: Preporuke za zdravstvene djelatnike
English: • Always carefully check the product selected in electronic prescribing or dispensing systems.
Croatian: • uvijek pozorno provjeriti odabrani proizvod u elektroničkim sustavima propisivanja ili doziranja;
English: More detailed information on such dose adjustment is provided in the product information.
Croatian: Detaljnije informacije povezane s takvom prilagodbom doze navedene su u informacijama o proizvodu.
English: Recommendations for patients and carers
Croatian: Preporuke za bolesnike i njegovatelje
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27. studenoga 2015. EMA/134145/2015
English: Focus on colour differentiation, warning statements on carton/label and other safety design features (such as tactile elements on the pre-filled pen).
Croatian: Usredotočite se na razlikovanje boja, upozorenja na kartonu/naljepnici te na sigurnosne značajke dizajna (kao što su taktilni elementi na unaprijed napunjenoj olovci).
English: Further information on the safe use of these medicines and other ways to minimise the possible risk of medication errors with these medicines can be found in the guidance on risk minimisation strategies for high-strength and fixed-combination insulin products.
Croatian: Dodatne informacije o sigurnoj uporabi tih lijekova i drugim načinima smanjenja mogućih rizika od pogrešaka pri propisivanju tih lijekova mogu se pronaći u smjernicama za strategije smanjenja rizika za inzulinske proizvode velike jačine i određene kombinacije.
English: • Pharmacists should be aware that insulins are now available in different strengths.
Croatian: • Ljekarnici bi trebali biti svjesni da su sada dostupni inzulini različitih jačina.
English: • During the switch to high-strength insulin and in the weeks after the switch you should measure your blood sugar levels more frequently.
Croatian: • Tijekom prijelaza na inzulin velike jačine i u tjednima nakon prijelaza trebali biste češće mjeriti razinu šećera u krvi.
English: Read the instructions in your package leaflet carefully before using this medicine.
Croatian: Pozorno pročitajte upute o lijeku prije uporabe lijeka.
English: • If different short-and long-acting insulins are being prescribed together, the differences in appearance and use between the two pen devices must be highlighted.
Croatian: • Ako su različiti inzulini kratkog i dugog djelovanja propisani zajedno, moraju se istaknuti razlike u izgledu i uporabi između dvaju uređaja s olovkom.
English: 1 In exceptional cases your dose may need to be changed because of differences in the way the high-strength and standard strength solutions are taken up into the body - your doctor will advise you if this is needed.
Croatian: 1 U iznimnim slučajevima dozu je potrebno promijeniti zbog razlika u načinima unosa u tijelo otopina velike jačine i otopina standardne jačine - vaš će vas liječnik savjetovati ako to bude potrebno.
English: • Ensure that your patients are adequately informed on how to use their high-strength insulin.
Croatian: • Pobrinite se da bolesnici budu odgovarajuće obaviješteni o tome kako se koristiti inzulinom velike jačine.
English: • Tell patients to closely monitor their blood sugar levels when starting high-strength insulin and in the weeks after.
Croatian: • Uputite bolesnike da pozorno prate razine šećera u krvi u početku primjene inzulina velike jačine i u tjednima nakon toga.
English: Medicines containing high-strength insulin may allow patients to receive a high dose in a single injection, and help meet an increasing need for higher doses of insulin.
Croatian: Lijekovi koji sadržavaju inzulin velike jačine mogu bolesnicima omogućiti primanje velike doze jednom injekcijom te pomoći zadovoljiti sve veću potrebu za većim dozama inzulina.
English: • Patients who are blind or with poor vision must be instructed to always get assistance from another person who has good vision and is trained in using the insulin pen device.
Croatian: • Slijepim ili slabovidnim bolesnicima mora se objasniti da uvijek zatraže pomoć druge osobe koja ima dobar vid i koja se zna koristiti uređajem s inzulinskom olovkom.
English: Pharmacists should also check that patients have been trained on how to use the new pen.
Croatian: Ljekarnici bi također trebali provjeriti jesu li bolesnici osposobljeni za korištenje olovkom.
English: A high-strength insulin is a medicine that contains insulin at a concentration of more than the standard 100 units/ml, which for many years has been the only strength available across the EU.
Croatian: Inzulin velike jačine lijek je koji sadržava inzulin u koncentraciji većoj od 100 standardnih jedinica/ml, koja je godinama bila jedina jačina dostupna diljem EU-a.
English: However, there are differences in the way high-strength insulin products are used compared with existing insulin formulations of standardstrength and there is therefore a risk of medication errors and accidental mix-ups.
Croatian: Međutim, postoje razlike u načinu na koji se inzulinski proizvodi velike jačine upotrebljavaju u usporedbi s postojećim inzulinskim pripravcima standardne jačine te stoga postoji rizik od pogrešaka pri propisivanju lijekova i slučajnih zabuna.
English: The dose counter of the pen device displays the number of units of insulin irrespective of strength.
Croatian: Brojač doza uređaja s olovkom prikazuje broj jedinica inzulina neovisno o jačini.
English: • Always prescribe the insulin dose in units (“units” to be spelled out and stated in lower case) and include the dose frequency.
Croatian: • Uvijek propišite dozu inzulina u jedinicama („jedinice” treba pisati cijelom riječi i malim slovima) i navedite učestalost primjene doze.