FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.7 Effects on ability to drive and use machines Agomelatine has minor influence on the ability to drive and use machines.Considering that dizziness and somnolence are common adverse reactions, patients should be cautioned about their ability to drive or operate machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Agomelatin malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Efficacy was also observed in more severely depressed patients (baseline HAM-D ≥ 25) in all positive placebo-controlled trials.
Croatian: Djelotvornost je također zamijećena kod bolesnika s teškom depresijom (početna vrijednost HAM-D≥
English: - alcohol use disorder and /or substantial alcohol intake and in patients receiving concomitant medicinal products associated with risk of hepatic injury.
Croatian: pretilost/prekomjerna tjelesna težina/nealkoholna bolest masne jetre, diabetes, poremećaj vezan uz uporabu alkohola i/ili znatan unos alkohola ili drugi istodobno primijenjeni lijekovi povezani s rizikom od oštećenja jetre;
English: NAME OF THE MEDICINAL PRODUCT Valdoxan 25 mg tablets agomelatine
Croatian: NAZIV LIJEKA Valdoxan 25 mg tablete agomelatin
English: United Kingdom Servier Laboratories Ltd
Croatian: Servier Laboratories (Ireland) Ltd.
English: You may be more likely to think like this: - if you have previously had thoughts about killing or harming yourself.
Croatian: − ako ste prethodno razmišljali o samoozljeđivanju ili samoubojstvu.
English: Caution should be exercised when prescribing Valdoxan with moderate CYP1A2 inhibitors (e.g. propranolol, enoxacin) which may result in increased exposure of agomelatine.
Croatian: Kombinacija s inhibitorima CYP1A2 (vidjeti dijelove 4.3 i 4.5) Valdoxan s umjerenim CYP1A2 inhibitorima (npr. propranolol, enoksacin) treba propisivati uz oprez, jer oni mogu dovesti do povećane izloženosti agomelatinu.
English: Tel: +371 67502039
Croatian: SIA Servier Latvia Tel: +371 67502039
English: Jaundice*
Croatian: Povraćanje*
English: Valdoxan contains sodium
Croatian: Valdoxan sadrži natrij
English: Diarrhoea Constipation Abdominal pain Vomiting*
Croatian: Konstipacija Bol u abdomenu
English: Discontinuation symptoms include: dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking.
Croatian: uznemirenost ili tjeskobu, glavobolju, mučninu, povraćanje i drhtanje.
English: Treatment duration
Croatian: Prekid liječenja
English: Following oral administration, agomelatine is rapidly metabolised mainly via hepatic CYP1A2; CYP2C9 and CYP2C19 isoenzymes are also involved but with a low contribution.
Croatian: Nakon peroralne primjene, agomelatin se brzo metabolizira uglavnom putem CYP1A2 u jetri;
English: 1 NAME OF THE MEDICINAL PRODUCT Valdoxan 25 mg film-coated tablets
Croatian: NAZIV LIJEKA Valdoxan 25 mg filmom obložene tablete
English: België/Belgique/Belgien
Croatian: België/Belgique/Belgien S.A. Servier Benelux N.V.
English: Servier Laboratories (Ireland) Ltd. Tel: +353 (0)1 663 8110
Croatian: United Kingdom Servier Laboratories Ltd Tel: +44 (0)1753 666409
English: Lactose monohydrate Maize starch
Croatian: Laktoza hidrat
English: These side effects include: - Very common side effects (may affect more than 1 in 10 people) :headache - Common side effects (may affect up to 1 in 10 people): dizziness, sleepiness (somnolence), difficulty in sleeping (insomnia), feeling sick (nausea), diarrhoea, constipation, abdominal pain, back pain, tiredness, anxiety, abnormal dreams, increased levels of liver enzymes in your blood, vomiting, weight increased.
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba): glavobolja − Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba): omaglica, pospanost
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: Povidon (K 30)
English: 3 PHARMACEUTICAL FORM
Croatian: 14. NAČIN IZDAVANJA LIJEKA
English: Valdoxan is for oral use.
Croatian: Valdoxan se uzima kroz usta.
English: 6 PHARMACEUTICAL PARTICULARS
Croatian: FARMAKOLOŠKA SVOJSTVA
English: Povidone (K30) Sodium starch glycolate type A Stearic acid
Croatian: Natrijev škroboglikolat, vrsta A Stearatna kiselina
English: It is not advisable to drink alcohol while you are being treated with Valdoxan.
Croatian: Za vrijeme uzimanja lijeka Valdoxan treba izbjegavati konzumaciju alkohola.
English: Elderly
Croatian: Parestezija
English: Weight decreased* * Frequency estimated from clinical trials for adverse reactions detected from spontaneous report (1) Few cases were exceptionally reported with fatal outcome or liver transplantation in patients with hepatic risk factors.
Croatian: (1) Izuzetno su zabilježeni malobrojni slučajevi sa smrtnim ishodom ili transplantacijom jetre u bolesnika s rizičnim čimbenicima za nastanak oštećenja jetre
English: - Uncommon side effects (may affect up to 1 in 100 people): migraine, pins and needles in the fingers and toes (paraesthesia), blurred vision, restless legs syndrome (a disorder that is characterized by an uncontrollable urge to move the legs), ringing in the ears, excessive sweating (hyperhidrosis), eczema, pruritus, urticaria (hives), agitation, irritability, restlessness, aggressive behaviour, nightmares, mania/hypomania (see also under “Warnings and precautions” in section 2), suicidal thoughts or behaviour,confusion, weight decreased.
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba): migrena, trnci i bockanje u prstima ruku i nožnim prstima (parestezija), zamagljen vid, sindrom nemirnih nogu
English: Gastrointestinal Disorders
Croatian: Prijavljivanje nuspojava
English: Further information on Edistride can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Edistride.
Croatian: Više informacija o lijeku Edistride dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Edistride.
English: This authorisation was based on the authorisation granted for Forxiga in 2012.
Croatian: Odobrenje se temeljilo na odobrenju koje je izdano za lijek Forxiga 2012.
English: Edistride received a marketing authorisation valid throughout the EU on 9 November 2015.
Croatian: Lijek Edistride dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 9. studenoga 2015.
English: What is Edistride and what is it used for?
Croatian: Što je Edistride i za što se koristi?
English: For type 2 diabetes, the dose of Edistride is 10 mg once a day.
Croatian: Za dijabetes tipa 2, doza lijeka Edistride je 10 mg jedanput na dan.
English: What measures are being taken to ensure the safe and effective use of Edistride?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Edistride?
English: Other information about Edistride
Croatian: Ostale informacije o lijeku Edistride
English: The dose is 5 mg once a day and the medicine should be used with precautions to prevent diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).
Croatian: Doza je 5 mg jedanput na dan, a lijek treba uzimati oprezno kako bi se spriječila dijabetička ketoacidoza (ozbiljna komplikacija dijabetesa koja uzrokuje visoke razine ketona u krvi).
English: Both combinations reduced HbA1c levels by 0.52 percentage points after 52 weeks.
Croatian: U objema kombinacijama razine HbA1c smanjile su se za 0,52 postotna boda nakon 52 tjedna.
English: The Agency concluded that the benefits of Edistride outweigh its risks and recommended that it be granted marketing authorisation.
Croatian: Agencija je zaključila da koristi od lijeka Edistride nadmašuju s njim povezane rizike te je preporučila izdavanje odobrenja za stavljanje lijeka u promet.
English: An overview of Edistride and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Edistride i zašto je odobren u EU-u
English: Side effects reported with Edistride are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Edistride pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Edistride is available as tablets (5 and 10 mg) and can only be obtained with a prescription.
Croatian: Lijek Edistride dostupan je u obliku tableta (od 5 i 10 mg) te se izdaje samo na recept.
English: If it is used with insulin or medicines that help the body produce insulin, the doses of these other medicines may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
Croatian: Ako se primjenjuje s inzulinom ili lijekovima koji pospješuju proizvodnju inzulina u tijelu, doze tih drugih lijekova možda će trebati smanjiti kako bi se smanjio rizik od hipoglikemije (niske razine šećera u krvi).
English: Diabetes can occur when the body does not make enough insulin to control the amount of glucose (sugar) in the blood or when the body is cannot use insulin effectively.
Croatian: Dijabetes može nastati kada tijelo ne proizvodi dovoljno inzulina za kontrolu razine glukoze (šećera) u krvi ili kada tijelo ne može učinkovito iskoristiti inzulin.
English: In addition, beneficial reductions in weight and blood pressure occurred in patients treated with Edistride.
Croatian: Osim toga, došlo je i do korisnog smanjenja težine i krvnog tlaka u bolesnika liječenih lijekom Edistride.
English: As for all medicines, data on the use of Edistride are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Edistride kontinuirano se prate.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Edistride have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Edistride također se nalaze u sažetku opisa svojstava i u uputi o lijeku.
English: The main measure of effectiveness was the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Croatian: Glavna mjera djelotvornosti bila je koncentracija glikoziliranog hemoglobina (HbA1c) u krvi, koja daje naznaku o tome koliko se dobro kontrolira glukoza u krvi.
English: Edistride's common side effects were related to the way the medicine works, such as increased genital and, to a smaller degree, urinary infection, and are considered manageable.
Croatian: Učestale nuspojave pri primjeni lijeka Edistride bile su povezane s načinom na koji lijek djeluje, odnosno radilo se o povećanom broju genitalnih infekcija i, u manjoj mjeri, o urinarnim infekcijama, a te je nuspojave bilo moguće kontrolirati.
English: Edistride is a diabetes medicine used for adults whose condition is not controlled well enough.
Croatian: Edistride je lijek protiv dijabetesa koji se koristi u odraslih osoba kod kojih se ne postiže dovoljno dobra kontrola bolesti.
English: What are the risks associated with Edistride?
Croatian: Koji su rizici povezani s lijekom Edistride?
English: Why is Edistride authorised in the EU?
Croatian: Zašto je lijek Edistride odobren u EU-u?
English: The company that markets Edistride will provide information on precautions to prevent diabetic ketoacidosis in patients with type 1 diabetes, including a patient alert card, and a guide for patients and their carers, as well as a guide for healthcare professionals, including a prescriber's checklist.
Croatian: Tvrtka koja stavlja lijek Edistride u promet dostavit će informacije o mjerama opreza za sprječavanje dijabetičke ketoacidoze u bolesnika s dijabetesom tipa 1, uključujući karticu s upozorenjima za bolesnika, kao i vodič za bolesnike i njihove njegovatelje te vodič za zdravstvene radnike, uključujući kontrolni popis za liječnika koji propisuje lijek.
English: The study indicated that dapagliflozin's effects were in line with those of other diabetes medicines that also work by blocking SGLT2.
Croatian: Ispitivanje je pokazalo da su učinci dapagliflozina bili u skladu s učincima drugih lijekova za liječenje dijabetesa koji također djeluju tako da blokiraju SGLT2.
English: A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease.
Croatian: U dugoročnom ispitivanju na više od 17 000 bolesnika s dijabetesom tipa 2 praćeni su učinci dapagliflozina na kardiovaskularne bolesti (povezane sa srcem i cirkulacijom).
English: The European Medicines Agency considered that Edistride was effective for treating type 2 diabetes when given alone or in combination with other diabetes medicines which work in different ways.
Croatian: Europska agencija za lijekove zaključila je da je lijek Edistride učinkovit u liječenju dijabetesa tipa 2 kada se uzima kao monoterapija ili u kombinaciji s drugim lijekovima za liječenje dijabetesa koji djeluju na različite načine.
English: For more information about using Edistride, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Edistride pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.
English: In type 2 diabetes, it is used with appropriate diet and exercise in patients who cannot take metformin (another diabetes medicine).
Croatian: U liječenju dijabetesa tipa 2 lijek se koristi uz odgovarajuću dijetu i tjelovježbu u onih bolesnika koji ne mogu uzimati metformin (drugi lijek protiv dijabetesa).
English: Precautions have been recommended to reduce the risk of diabetic ketoacidosis and the Agency has asked for further studies to determine its frequency in patients with type 1 diabetes treated with Edistride.
Croatian: Preporučuju se mjere opreza radi smanjenja rizika od dijabetičke ketoacidoze i Agencija je zatražila dodatna ispitivanja kako bi se utvrdila njezina učestalost u bolesnika s dijabetesom tipa 1 koji se liječe lijekom Edistride.
English: In a study involving 814 patients with type 2 diabetes, Edistride used in combination with metformin was at least as effective as a sulphonylurea (another type of diabetes medicines) used with metformin.
Croatian: U ispitivanju koje je obuhvatilo 814 bolesnika s dijabetesom tipa 2, lijek Edistride kad se primjenjivao u kombinaciji s metforminom bio je barem jednako učinkovit kao sulfonilureja (drugi lijek protiv dijabetesa) u kombinaciji s metforminom.
English: The most common side effect in patients with type 1 diabetes (which may affect up to 1 in 10 people) is genital infection, especially in women and a common side effect (which may affect up to 1 in 100 people) is diabetic ketoacidosis.
Croatian: Najčešća nuspojava u bolesnika s dijabetesom tipa 1 (koja se može javiti u najviše 1 na 10 osoba) jest genitalna infekcija, posebno u žena, a česta nuspojava (koja se može javiti u najviše 1 na 100 osoba) jest dijabetička ketoacidoza.
English: What benefits of Edistride have been shown in studies?
Croatian: Koje su koristi od lijeka Edistride utvrđene u ispitivanjima?
English: Edistride increased the risk of diabetic ketoacidosis considerably in patients with type 1 diabetes and it is recommended for this condition only in overweight and obese patients.
Croatian: Primjenom lijeka Edistride znatno se povećao rizik od dijabetičke ketoacidoze u bolesnika s dijabetesom tipa 1 te se za to stanje preporučuje samo u pretilih bolesnika i onih s prekomjernom tjelesnom težinom.
English: In two studies involving 1,648 patients with type 1 diabetes whose blood sugar was not controlled well enough on insulin alone, adding Edistride 5 mg decreased HbA1c levels after 24 hours by 0.37% and by 0.42% more than adding placebo.
Croatian: U dvama ispitivanjima kojima je bilo obuhvaćeno 1 648 bolesnika s dijabetesom tipa 1 čija se razina šećera u krvi nije dovoljno dobro kontrolirala primjenom inzulina kao monoterapije, dodavanjem lijeka Edistride od 5 mg nakon 24 sata smanjile su se razine HbA1c za 0,37 % i 0,42 % više nego dodavanjem placeba.
English: How does Edistride work?
Croatian: Kako djeluje Edistride?
English: The most common side effect with Edistride in patients with type 2 diabetes (which may affect more than 1 in 10 people) is hypoglycaemia, especially when used in combination with a sulphonylurea or insulin.
Croatian: Najčešća nuspojava lijeka Edistride u bolesnika s dijabetesom tipa 2 (koja se može javiti u više od 1 na 10 osoba) jest hipoglikemija, posebno ako se lijek primjenjuje u kombinaciji sa sulfonilurejom ili inzulinom.
English: Edistride contains the active substance dapagliflozin.
Croatian: Edistride sadržava djelatnu tvar dapagliflozin.
English: By blocking the action of SGLT2, dapagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Croatian: Blokiranjem djelovanja bjelančevine SGLT2, dapagliflozin omogućuje izlučivanje veće količine glukoze mokraćom, čime se smanjuje razina glukoze u krvi.
English: For type 1 diabetes, treatment with Edistride should be started and supervised by a specialist in type 1 diabetes.
Croatian: Za oboljele od dijabetesa tipa 1, liječenje lijekom Edistride treba započeti i nadzirati liječnik specijalist za dijabetes tipa
English: In four other studies involving 2,370 patients, adding Edistride to other diabetes medicines decreased HbA1c levels by 0.54-0.68 percentage points more than adding placebo after 24 weeks.
Croatian: U četirima drugim ispitivanjima u kojima je sudjelovalo 2 370 bolesnika, dodavanjem lijeka Edistride drugim lijekovima protiv dijabetesa smanjila se razina HbA1c za 0,54 - 0,68 postotnih bodova više nego dodavanjem placeba nakon 24 tjedna.
English: In type 1 diabetes, Edistride is used with insulin in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control the diabetes well enough.
Croatian: U osoba oboljelih od dijabetesa tipa 1 s prekomjernom tjelesnom težinom (indeks tjelesne mase od najmanje 27 kg/m2) Edistride se primjenjuje u kombinaciji s inzulinom kada se inzulinom kao monoterapijom ne postiže dovoljno dobra kontrola dijabetesa.
English: The active substance in Edistride, dapagliflozin, blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Croatian: Djelatna tvar u lijeku Edistride, dapagliflozin, blokira djelovanje bjelančevine u bubrezima naziva suprijenosnik natrija i glukoze 2 (SGLT2).
English: The company will also conduct a study to estimate the frequency of diabetic ketoacidosis in patients with type 1 diabetes treated with Edistride.
Croatian: Tvrtka će provesti i ispitivanje kako bi se procijenila učestalost dijabetičke ketoacidoze u bolesnika s dijabetesom tipa 1 koji se liječe lijekom Edistride.
English: For the full list of side effects and restrictions with Edistride, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Edistride potražite u uputi o lijeku.
English: In two studies involving 840 patients with type 2 diabetes, Edistride when used alone decreased HbA1c levels by 0.66 percentage points more than placebo (a dummy treatment) after 24 weeks.
Croatian: U dvama ispitivanjima kojima je obuhvaćeno 840 bolesnika s dijabetesom tipa 2, nakon 24 tjedna primjenom lijeka Edistride kao monoterapije smanjena je razina HbA1c za 0,66 postotnih bodova više od placeba (prividnog liječenja).
English: Adding Edistride to insulin treatment in patients with type 1 diabetes whose diabetes could not be controlled well enough with insulin was also effective.
Croatian: U bolesnika s dijabetesom tipa 1 čiji se dijabetes nije mogao dovoljno dobro kontrolirati učinkovitim se pokazalo i dodavanje lijeka Edistride terapiji inzulinom.
English: Edistride was found effective in several studies in patients with type 2 and type 1 diabetes.
Croatian: U nekoliko ispitivanja koja su obuhvatila bolesnike s dijabetesom tipa 2 i tipa 1 utvrđena je učinkovitost lijeka Edistride.
English: or for whom a statin is contraindicated.
Croatian: (koji ne podnose statine)
English: c Nominal significance.
Croatian: c Nominalna značajnost.
English: Then, leave the door open.
Croatian: Zatim ostavite vratašca otvorena.
English: Cumulative Incidence (%)
Croatian: Kumulativna incidencija (%)
English: Injection is complete when:
Croatian: Injiciranje je dovršeno kada:
English: Warning: Do not modify the device.
Croatian: Upozorenje: Nemojte izvoditi promjene na uređaju.
English: The green light should now be off.
Croatian: Zelena svjetlost trebala bi biti ugašena.
English: Then LIFT thumb.
Croatian: Zatim PODIGNITE palac.
English: The recommended dose depends on the underlying condition:
Croatian: Preporučena doza ovisi o podležećem stanju:
English: Inject the entire contents.
Croatian: Injicirajte cijeli sadržaj.
English: This will make the injection more comfortable.
Croatian: Tako će primjena injekcije biti ugodnija.
English: N Injection takes about 9 minutes.
Croatian: N Injiciranje traje približno 9 minuta.
English: Swing the door to the left.
Croatian: Zakrenite vratašca ulijevo.
English: Relative humidity range is 15% to 85%.
Croatian: Raspon relativne vlažnosti je od 15% do 85%.
English: Your injection could take about 15 seconds.
Croatian: Injiciranje može potrajati oko 15 sekundi.
English: Tell your healthcare provider if you are allergic to latex.
Croatian: Obavijestite zdravstvenog djelatnika ako ste alergični na lateks.
English: After removal, check the medicine window.
Croatian: Nakon uklanjanja, provjerite prozorčić lijeka.
English: Wash your hands thoroughly with soap and water.
Croatian: Temeljito operite ruke sa sapunom i vodom.
English: Component of a multi-pack, can't be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati zasebno.
English: MedDRA system organ class (SOC)
Croatian: System Organ Class, SOC)
English: 45 minutes.
Croatian: 45 minuta.
English: e Assessment of time to hospitalisation for unstable angina was ad-hoc.
Croatian: e Procjena vremena do hospitalizacije zbog nestabilne angine bila je ad hoc.
English: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, U.S.A.
Croatian: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, SAD.
English: • It is important that you do not try to give yourself the injection unless you have received training from your healthcare provider.
Croatian: • Važno je da ne pokušavate davati sebi injekciju ako niste prošli obuku od strane zdravstvenog djelatnika.
English: Do not use if packaging is damaged
Croatian: Ne koristiti ako je pakiranje oštećeno
English: It contains electronics that should not get wet.
Croatian: Uređaj sadrži elektroničke dijelove koji se ne smiju smočiti.
English: Therefore, no dose adjustments are necessary based on body weight.
Croatian: Stoga, prilagodbe doze nisu potrebne na temelju tjelesne težine.
English: • Allergic reactions including rash
Croatian: • Alergijske reakcije, uključujući osip
English: If the plunger did not fill the window, contact your doctor.
Croatian: Ako klip nije ispunio prozorčić, obratite se svom liječniku.
English: Then, contact your doctor who will tell you when you should schedule your next dose, and follow the new schedule exactly as your doctor has told you.
Croatian: Zatim, obavijestite svog liječnika koji će odrediti vrijeme primjene Vaše sljedeće doze, te slijedite novi raspored točno onako kako Vam je rekao liječnik.
English: ATC code: C10AX13
Croatian: ATK oznaka: C10AX13
English: C Gather all materials needed for your injection and then wash your hands thoroughly with soap and water.
Croatian: C Prikupite svu opremu potrebnu za injiciranje i zatim temeljito operite ruke sapunom i vodom.
English: Be very careful not to push out any medicine.
Croatian: Budite jako pažljivi kako ne biste uklonili dio lijeka.
English: Contact your doctor or pharmacist immediately.
Croatian: Odmah obavijestite svog liječnika ili ljekarnika.
English: It is not known if Repatha will harm your unborn baby.
Croatian: Nije poznato može li Repatha naštetiti Vašem nerođenom djetetu.
English: If an error occurs, the automated mini-doser cannot be used.
Croatian: Ako dođe do pogreške, automatizirani mini-dozator se ne može upotrijebiti.
English: Repatha has not been tested in pregnant women.
Croatian: Repatha nije ispitana u trudnica.