FrancophonIA/ELRC3.0 huggingface dataset:
English: 4 Observed for fasting normal levels at baseline (< 5.56 mmol/l) which increased to high (≥ 7 mmol/l).
Croatian: 4 Uočena kod normalnih vrijednosti natašte na početku (< 5,56 mmol/l) koje su porasle na visoke (≥ 7 mmol/l).
English: • rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Croatian: • ubrzano lupanje srca, uznemirenost/agresivnost, teškoće pri govoru, neuobičajene pokrete
English: After reconstitution: 150 mg/ml olanzapine.
Croatian: Nakon pripreme za primjenu: 150 mg/ml olanzapina.
English: In the event of an injection site related adverse reaction occuring, appropriate measures to manage these events should be taken (see section
Croatian: U slučaju nastanka nuspojave na mjestu primjene injekcije moraju se poduzeti odgovarajuće mjere za njezino zbrinjavanje (vidjeti dio 4.8).
English: Olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Croatian: Olanzapin pamoat hidrat odgovara 405 mg olanzapina.
English: 210 mg/2 weeks or 405 mg/4 weeks 150 mg/2 weeks or 300 mg/4 weeks
Croatian: 150 mg/2 tjedna ili 300 mg/4 tjedna
English: Bromobutyl stopper with rust colour seal.
Croatian: Bromobutilni čep s poklopcem boje hrđe.
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPADHERA.
Croatian: • U bolesnika koji koriste lijek ZYPADHERA zabilježene su povećane razine šećera i masnoća (triglicerida i kolesterola) u krvi.
English: • acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness, and drowsiness or sleepiness; slower breathing, aspiration, high or low blood pressure, abnormal rhythms of the heart.
Croatian: ukočenosti mišića te omamljenosti ili pospanosti; usporeno disanje, aspiracija, visoki ili niski krvni tlak, abnormalan srčani ritam.
English: Attach a syringe (if not already attached) to the Luer connection of the device with an easy twisting motion.
Croatian: Pričvrstite štrcaljku (ako već nije pričvršćena) na Luer nastavak zaštitnog pokrova za iglu tako da je lagano zakrenete.
English: Olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Croatian: Olanzapin pamoat hidrat odgovara 300 mg olanzapina.
English: ZYPADHERA 405 mg powder: Type I glass vial.
Croatian: ZYPADHERA 405 mg prašak: bočica od stakla tipa I.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for ZYPADHERA
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za lijek ZYPADHERA i.m.
English: Thus no particular interaction is expected as verified through in vivo studies where no inhibition of metabolism of the following active substances was found: tricyclic antidepressant (representing mostly CYP2D6 pathway), warfarin (CYP2C9), theophylline (CYP1A2) or diazepam (CYP3A4 and 2C19).
Croatian: Stoga se ne očekuju posebne interakcije, što je i potvrđeno in vivo ispitivanjima u kojima nije nađena inhibicija metabolizma sljedećih djelatnih tvari: tricikličkog antidepresiva (koji se metabolizira uglavnom putem
English: ZYPADHERA 210 mg powder: Type I glass vial.
Croatian: ZYPADHERA 210 mg prašak: bočica od stakla tipa I.
English: Patients should be advised not to breast feed an infant if they are taking olanzapine.
Croatian: Bolesnice se mora savjetovati da ne doje ako se liječe olanzapinom.
English: A mass balance study showed that approximately 57% of radiolabelled olanzapine appeared in urine, principally as metabolites.
Croatian: radioizotopom obilježenog olanzapina pojavljuje u mokraći, pretežno u obliku metabolita.
English: Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska.
English: Bradycardia QTc prolongation (see section 4.4)
Croatian: Srčani poremećaji bradikardija, produljenje QTcintervala (vidjeti dio 4.4)
English: ZYPADHERA 300 mg powder: Type I glass vial.
Croatian: ZYPADHERA 300 mg prašak: bočica od stakla tipa I.
English: ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Croatian: ZYPADHERA 210 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem Jedna bočica sadrži olanzapin pamoat hidrat, što odgovara 210 mg olanzapina.
English: • Blood disorders
Croatian: • imate krvne poremećaje
English: Some excess product will remain in the vial.
Croatian: U bočici će ostati određena količina lijeka.
English: Transient, asymptomatic elevations of hepatic aminotransferases, ALT, AST have been seen commonly, especially in early treatment.
Croatian: Funkcija jetre Prolazna, asimptomatska povišenja jetrenih aminotransferaza, ALT-a, AST-a često su bila uočena,
English: Olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Croatian: Olanzapin pamoat hidrat koji odgovara 210 mg olanzapina.
English: How to store ZYPADHERA
Croatian: Kako čuvati lijek ZYPADHERA
English: Bromobutyl stopper with steel blue colour seal.
Croatian: Bromobutilni čep s poklopcem plave boje.
English: ZYPADHERA 405 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 405 mg olanzapine.
Croatian: ZYPADHERA 405 mg: Jedna bočica sadrži olanzapin pamoat hidrat koji odgovara 405 mg olanzapina.
English: EXP {MM/YYYY}
Croatian: Rok valjanosti {MM/GGGG}
English: Olanzapine
Croatian: olanzapina.
English: Other common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and in early treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Croatian: Druge česte nuspojave (mogu se javiti u manje od 1 na 10 osoba) uključuju promjene u razinama nekih krvnih stanica i cirkulirajućih masnoća te, u ranim fazama liječenja, privremena povećanja razine jetrenih enzima; povećanja razine šećera u krvi i mokraći; povećanje razine mokraćne kiseline i kreatin fosfokinaze u krvi; osjećaj veće gladi; omaglicu; nemir; nevoljno drhtanje; neuobičajene pokrete
English: Bromobutyl stopper with olive colour seal.
Croatian: Bromobutilni čep s poklopcem maslinaste boje.
English: ZYPADHERA 210 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 210 mg olanzapine.
Croatian: ZYPADHERA 210 mg: Jedna bočica sadrži olanzapin pamoat hidrat koji odgovara 210 mg olanzapina.
English: ZYPADHERA 300 mg: Each vial contains olanzapine pamoate monohydrate equivalent to 300 mg olanzapine.
Croatian: ZYPADHERA 300 mg: Jedna bočica sadrži olanzapin pamoat hidrat koji odgovara 300 mg olanzapina.
English: STEP 3: Reconstituting ZYPADHERA 1.
Croatian: KORAK 3: Rekonstitucija lijeka ZYPADHERA
English: DO NOT INJECT INTRAVENOUSLY OR SUBCUTANEOUSLY.
Croatian: NE DAVATI LIJEK INTRAVENSKI NITI SUPKUTANO.
English: • Weight gain has been seen in patients taking ZYPADHERA.
Croatian: • U bolesnika koji koriste lijek ZYPADHERA zabilježen je porast tjelesne težine.
English: An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath.
Croatian: Alergijska reakcija može se prepoznati po pojavi simptoma poput osipa, svrbeža,
English: If the product is not used immediately, it should be shaken vigorously to re-suspend.
Croatian: Ako se lijek ne upotrijebi odmah, potrebno ga je kasnije snažno protresti da se resuspendira.
English: ZYPADHERA contains the active substance olanzapine.
Croatian: Što je ZYPADHERA i za što se koristi ZYPADHERA sadrži djelatnu tvar olanzapin.
English: Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea, or vomiting have been reported rarely (≥0.01% and <0.1%) when oral olanzapine is stopped abruptly.
Croatian: Kod naglog prestanka peroralne primjene olanzapina rijetko su prijavljeni (≥ 0,01% i < 0,1%) akutni simptomi poput znojenja, nesanice, tremora, anksioznosti, mučnine ili povraćanja.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release Lilly S.A., Avda.
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Additional tapping may be required if clumps remain.
Croatian: Može biti potrebno dodatno lupkanje ako se vide zaostale grudice. (vidjeti Sliku B)
English: STEP 1: Preparing materials Pack includes:
Croatian: Rekonstitucija KORAK 1: Pripremanje pribora
English: FOR DEEP INTRAMUSCULAR GLUTEAL INJECTION ONLY.
Croatian: SAMO ZA PRIMJENU INTRAMUSKULARNOM INJEKCIJOM DUBOKO U PODRUČJE
English: Very common symptoms in overdose (>10% incidence) include tachycardia, agitation/aggressiveness, dysarthria, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.
Croatian: agitaciju/agresivnost, dizartriju, različite ekstrapiramidne simptome i smanjenje razine svijesti u rasponu od sedacije do kome.
English: The magnitude of changes in fasting total cholesterol, LDL cholesterol, triglycerides, and prolactin (see sections 4.4 and 4.8) were greater in adolescents than in adults.
Croatian: (vidjeti dijelove 4.4 i 4.8) bio je veći u adolescenata nego u odraslih.
English: Maintenance treatment of adult patients with schizophrenia sufficiently stabilised during acute treatment with oral olanzapine.
Croatian: 4.1 Terapijske indikacije Terapija održavanja u odraslih bolesnika sa shizofrenijom koji su odgovarajuće stabilizirani oralnim oblikom olanzapina tijekom liječenja akutne faze.
English: (See Figure B)
Croatian: (vidjeti dio 4.6)
English: Temporal association of olanzapine treatment and venous thromboembolism has been reported uncommonly (≥ 0.1% and < 1%).
Croatian: Manje često (≥ 0,1% i < 1%) prijavljena je vremenska povezanost liječenja olanzapinom i venske tromboembolije (VTE).
English: ZYPADHERA olanzapine powder and solvent for prolonged release suspension for injection
Croatian: ZYPADHERA olanzapin prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem SAMO ZA PRIMJENU INTRAMUSKULARNOM INJEKCIJOM DUBOKO U PODRUČJE
English: Injection site related adverse events
Croatian: Nuspojave na mjestu primjene
English: Engage the needle safety device.
Croatian: Namjestite pokrov za zaštitu igle.
English: (≥ 6.2 mmol/l) were very common.
Croatian: (≥ 5,17 - < 6,2 mmol/l) do visokih (≥ 6,2 mmol/l) bile su vrlo česte.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija ZYPADHERA 405 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
English: • One 19-gauge, 38 mm Hypodermic safety needle
Croatian: • Jednu hipodermalnu zaštićenu iglu od 19G i duljine 38 mm
English: Pregnancy, puerperium and perinatal conditions
Croatian: Stanja vezana uz trudnoću, babinje i perinatalno razdoblje sindrom ustezanja u novorođenčadi
English: • Vial of ZYPADHERA powder for prolonged release suspension for injection
Croatian: • Bočicu ZYPADHERA praška za suspenziju za injekciju s produljenim oslobađanjem • Bočicu otapala za lijek ZYPADHERA
English: The mean increase in olanzapine AUC was 52 % and 108 % respectively.
Croatian: 52% odnosno 108%.
English: RECONSTITUTION AND ADMINISTRATION INSTRUCTIONS
Croatian: OZNAČIVANJE I UPUTA O LIJEKU
English: Renal and/or hepatic impairment
Croatian: Psihoza povezana s demencijom i/ili poremećaji ponašanja
English: Once withdrawn from vial into the syringe, the suspension should be used immediately.
Croatian: Jednom kada se iz bočice povuče u štrcaljku, suspenzija se mora odmah upotrijebiti.
English: NAME OF THE MEDICINAL PRODUCT ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection Olanzapine
Croatian: ZYPADHERA 210 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem olanzapin
English: High uric acid 10
Croatian: visoka razina mokraćne kisline10
English: Supplementation
Croatian: Dodavanje
English: 7 Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been reported when olanzapine is stopped abruptly.
Croatian: 7 Kod naglog prekida primjene olanzapina prijavljivani su sljedeći akutni simptomi: znojenje, nesanica, tremor, anksioznost, mučnina i povraćanje.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton ZYPADHERA 210 mg powder and solvent for prolonged release suspension for injection
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija ZYPADHERA 210 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
English: Tardive dyskinesia
Croatian: Način primjene ISKLJUČIVO
English: NAME OF THE MEDICINAL PRODUCT ZYPADHERA 405 mg powder and solvent for prolonged release suspension for injection Olanzapine
Croatian: ZYPADHERA 405 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem olanzapin
English: What is in this leaflet:
Croatian: Pakiranje sadrži:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label ZYPADHERA 210 mg powder for prolonged release suspension for injection
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica bočice ZYPADHERA 210 mg prašak za suspenziju za injekciju s produljenim oslobađanjem
English: Fluoxetine (a CYP2D6 inhibitor), single doses of antacid (aluminium, magnesium) or cimetidine have not been found to significantly affect the pharmacokinetics of olanzapine.
Croatian: (aluminij, magnezij) ili cimetidina na farmakokinetiku olanzapina.
English: NAME OF THE MEDICINAL PRODUCT ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection Olanzapine
Croatian: ZYPADHERA 300 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem olanzapin
English: 1) Description of post injection syndrome - Education about the 2 intramuscular formulations of olanzapine, including packaging differences - Description of reconstitution and proper administration technique - Recommendation for a 3-hour on-site observation period post injection - Recommendation that, immediately prior to a patient leaving the health care facility, it should be confirmed that the patient is alert, oriented, and absent of any signs or symptoms of overdose - Recommendation that the 3-hour observation period should be extended as clinically appropriate for patients who exhibit any signs or symptoms consistent with olanzapine overdose - Recommendation for informing patients that for the remainder of the day of the injection, they should not drive or operate machinery, should be vigilant for signs and symptoms of a post injection syndrome event, and should be able to obtain assistance if needed - Description of the most common symptoms reported with olanzapine overdose that represent the clinical manifestation in post injection syndrome events - Recommendation for appropriate monitoring until the event resolves if an event should occur
Croatian: Opis pripreme i ispravne tehnike primjene - Preporuku za 3-satno razdoblje opservacije na mjestu davanja lijeka nakon injekcije - Preporuku da se neposredno prije otpusta bolesnika iz zdravstvene ustanove mora potvrditi da je bolesnik priseban, orijentiran i da nema znakova ni simptoma predoziranja
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label ZYPADHER 405 mg powder for prolonged release suspension for injection
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica bočice ZYPADHERA 405 mg prašak za suspenziju za injekciju s produljenim oslobađanjem
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton ZYPADHERA 300 mg powder and solvent for prolonged release suspension for injection
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija ZYPADHERA 300 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
English: (Table 1)
Croatian: Tablici 1.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label ZYPADHERA 300 mg powder for prolonged release suspension for injection
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica bočice ZYPADHERA 300 mg prašak za suspenziju za injekciju s produljenim oslobađanjem
English: Powder None
Croatian: NITI SUPKUTANO.
English: Eli Lilly Italia S.p.A. Tel: + 39 055 42571
Croatian: ТП "Ели Лили Недерланд" Б.В. - България Тел: + 359 2 491 41 40
English: 2) Recommendations for monitoring of patients for glucose, lipids, and weight
Croatian: - Preporuku za odgovarajući nadzor dok događaj ne prestane, ako se pojavi 2) Preporuku za praćenje glukoze, lipida i tjelesne težine u bolesnika
English: What ZYPADHERA contains
Croatian: Kako ZYPADHERA izgleda i sadržaj pakiranja
English: DO NOT ADMINISTER INTRAVENOUSLY OR SUBCUTANEOUSLY
Croatian: NE DAVATI LIJEK INTRAVENSKI NITI SUPKUTANO
English: Eli Lilly Nederland B.V. Tel: + 31(0) 30 6025800
Croatian: Eli Lilly farmacevtska družba, d.o.o. Tel: + 386 (0) 1 580 00 10
English: 5 Observed for fasting normal levels at baseline (< 1.69 mmol/l) which increased to high
Croatian: 5 Opažena kod normalnih vrijednosti natašte na početku (< 1,69 mmol/l) koje su porasle na visoke (≥ 2,26 mmol/l).
English: Dogs tolerated single oral doses up to 100 mg/kg without mortality.
Croatian: Psi su podnosili jednokratne oralne doze do
English: Butyl stopper with purple seal.
Croatian: Butilni čep s ljubičastim poklopcem.
English: Oedema
Croatian: Mutagenost
English: Neuroleptic malignant syndrome (see section 4.4)12
Croatian: (uključujući okulogiraciju)11 tardivna diskinezija11 amnezija9 dizartrija mucanje11 sindrom nemirnih nogu maligni neuroleptički sindrom (vidjeti dio 4.4)12 simptomi ustezanja7, 12
English: You should not be given ZYPADHERA if you have:
Croatian: Ako ste primili više lijeka ZYPADHERA nego što ste trebali
English: Adverse reactions seen with olanzapine The undesirable effects listed below have been observed following administration of olanzapine.
Croatian: Nuspojave primijećene kod primjene olanzapina Nuspojave navedene u nastavku teksta uočene su kod primjene olanzapina.
English: Powder and solvent for prolonged release suspension for injection Powder: yellow solid
Croatian: Prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
English: MARKETING AUTHORISATION NUMBER(S) EU/1/08/479/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/479/001
English: How ZYPADHERA is given
Croatian: Kako primjenjivati lijek ZYPADHERA
English: AS THE SHEATH IS PRESSED (Fig. 1), THE NEEDLE IS FIRMLY ENGAGED INTO THE SHEATH (Fig. 2).
Croatian: KADA JE POKROV PRITISNUT (Slika 1),
English: MARKETING AUTHORISATION NUMBER (S) EU/1/08/479/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/479/002
English: Reproductive system and breast disorders Erectile dysfunction in males
Croatian: Poremećaji reproduktivnog sustava i dojki erektilna disfunkcija u muškaraca smanjeni libido u muškaraca i žena amenoreja povećanje dojki galaktoreja u žena ginekomastija/
English: MARKETING AUTHORISATION NUMBER (S) EU/1/08/479/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/479/001
English: MARKETING AUTHORISATION NUMBER (S) EU/1/08/479/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/08/479/003
English: Wash your hands with soap and water.
Croatian: Operite ruke sapunom i vodom.
English: You do not need to do anything about it.
Croatian: U tom pogledu ne treba učiniti ništa.
English: 2 years.
Croatian: 2 godina.
English: 9/L prior to treatment.
Croatian: 9/l prije liječenja.
English: Other warming methods should not be used.
Croatian: Ne smiju se koristiti druge metode zagrijavanja.
English: 1230 Vienna
Croatian: 1230 Beč
English: ≥ 75 to < 100*
Croatian: ≥75 do <100*
English: Do not inject into the same site each time.
Croatian: Nemojte injicirati svaki put u isto mjesto.
English: There may be new information.
Croatian: Možda sadrži nove informacije.
English: This reaction typically resolves spontaneously after a few days of treatment.
Croatian: Ta reakcija obično prolazi spontano nakon nekoliko dana liječenja.
English: Wait seconds
Croatian: Pričekajte sekundi
English: LSM Difference (SE)
Croatian: LSM razlika (SE)
English: Safety Spring (inside body)
Croatian: Sigurnosna opruga (unutar tijela)
English: Harcourt Centre, Harcourt Road Dublin 2, Ireland
Croatian: Harcourt Centre, Harcourt Road Dublin 2, Irska
English: For example, do not warm in a microwave or hot water, or near other heat sources.
Croatian: Na primjer, nemojte je zagrijavati u mikrovalnoj pećnici ili vrućoj vodi, ili u blizini drugih izvora topline.
English: Definitive assessments were limited in some cases as covariates were limited by the overall low numbers.
Croatian: Definitivne procjene bile su ograničene u određenim slučajevima jer su kovarijante bile ograničene općim niskim brojevima.
English: Treatment should be discontinued.
Croatian: Liječenje treba prekinuti.
English: This suggests an immunologically related mechanism.
Croatian: To ukazuje na imunološki povezan mehanizam.
English: Week 66
Croatian: 66. tjedan
English: Your doctor may refer you to an eye specialist for a check-up if it is necessary.
Croatian: Liječnik će Vas možda uputiti specijalistu za oči na pregled, ako je to potrebno.
English: Do not inject through clothing.
Croatian: Nemojte injicirati kroz odjeću.
English: These events are usually either self-limiting or can be managed using symptomatic treatment.
Croatian: Ti su događaji obično samoograničavajući ili se mogu kontrolirati simptomatskim liječenjem.
English: It is important that you tell your doctor if you are already being treated with any of the following:
Croatian: Važno je da liječnika obavijestite ako se već liječite s nečim od sljedećeg:
English: Do not let the needle touch any surface.
Croatian: Nemojte dozvoliti da igla dodiruje bilo koju površinu.
English: Corticosteroids recommended.
Croatian: Preporučuju se kortikosteroidi.
English: This does not mean that the injection is finished.
Croatian: To ne znači da je injekcija dovršena.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli primijeniti bilo koje druge lijekove.
English: Tattoos and scars should also be avoided.
Croatian: Potrebno je također izbjegavati tetovaže i ožiljke.
English: mean (SD) 1 Based on clinical database
Croatian: (mjeseci) srednja vrijednost (SD) 1 Na temelju kliničke baze podataka
English: Hold the plunger fully down and wait 5 seconds
Croatian: Držite klip potpuno dolje i pričekajte 5 sekundi
English: Every week
Croatian: Svaki tjedan
English: This can lead to bruising as well as other more serious problems such as excessive bleeding and internal bleeding.
Croatian: To može dovesti do nastanka modrica kao i do drugih, ozbiljnijih problema kao što su prekomjerno krvarenje i unutarnje krvarenje.
English: Subjects that terminate the treatment early irrespective of the reason or have missing week 66 data are considered as non-responders.
Croatian: Ispitanici koji prekinu liječenje prijevremeno bez obzira na razlog ili čiji podaci u 66. tjednu nedostaju smatraju se osobama koje nisu postigle odgovor.
English: Dosing should be paused until 3 successive values > 100.
Croatian: Doziranje treba pauzirati do postizanja 3 puta zaredom vrijednosti >100.
English: Every 2 weeks
Croatian: Svaka 2 tjedna
English: Let the skin air dry.
Croatian: Pričekajte da se koža osuši na zraku.
English: A risk to the breastfed newborn/infant cannot be excluded.
Croatian: Ne može se isključiti rizik za dojeno novorođenče/dojenče.