FrancophonIA/ELRC3.0 huggingface dataset:
English: In post-marketing period, there was one case of elevated blood pressure in a patient using the ophthalmic vasoconstrictor tetrahydrozoline hydrochloride while taking rasagiline.
Croatian: U razdoblju nakon stavljanja lijeka u promet bio je jedan slučaj povišenog krvnog tlaka u bolesnika koji je primijenjivao oftalmički vazokonstriktor tetrahidrozolinklorid tijekom uzimanja razagilina.
English: Adverse reactions are listed below in Tables 1 and 2 by system organ class and frequency using the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Nuspojave su navedene u tablicama 1 i 2 prema klasifikaciji organskih sustava i učestalosti prema sljedećem pravilu: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1 000 i < 1/100),
English: *See section description of selected adverse reactions Adjunct Therapy
Croatian: *Vidjeti dio s opisom odabranih nuspojava Dodatna terapija
English: The difference between the mean change from baseline to week 26/termination (LOCF, Last Observation Carried Forward) was statistically significant (UPDRS, parts I-III: for rasagiline 1 mg compared to placebo -4.2, 95% CI [-5.7, -2.7]; p<0.0001; for rasagiline 2 mg compared to placebo -3.6, 95% CI [-5.0, -2.1]; p<0.0001, UPDRS Motor, part II: for rasagiline 1 mg compared to placebo -2.7, 95% CI [-3.87, -1.55], p<0.0001; for rasagiline 2 mg compared to placebo -1.68, 95% CI [-2.85, -0.51], p=0.0050).
Croatian: Last Observation Carried Forward; posljednje provedeno zapažanje preneseno dalje) je bila statistički značajna (UPDRS, dijelovi I-III: za razagilin 1 mg u usporedbi s placebom -4,2, 95 % CI [-5,7, -2,7]; p< 0,0001; za razagilin 2 mg u usporedbi s placebom -3,6, 95 % CI [-5,0, -2,1]; p< 0,0001, UPDRS motorička, dio II: za razagilin 1 mg u usporedbi s placebom 2,7, 95 % CI [-3,87, -1,55], p< 0,0001; za razagilin 2 mg u usporedbi s placebom -1,68, 95 % CI
English: Each tablet contains 1 mg of rasagiline (as mesilate).
Croatian: Svaka tableta sadrži 1 mg razagilina (u obliku mesilata).
English: Talk to your doctor before taking AZILECT - If you have any liver problems - You should speak with your doctor about any suspicious skin changes.
Croatian: - morali biste razgovarati sa svojim liječnikom o bilo kakvim sumnjivim promjenama na koži.
English: In vitro studies showed that rasagiline at a concentration of 1 µg/ml (equivalent to a level that is 160 times the average Cmax ~ 5.9-8.5 ng/ml in Parkinson's disease patients after 1 mg rasagiline multiple dosing), did not inhibit cytochrome P450 isoenzymes, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A.
Croatian: 160 puta veća od prosječne Cmax ~ 5,9-8,5 ng/ml u bolesnika s Parkinsonovom bolešću nakon višekratnog doziranja 1 mg razagilina) nije inhibirao izoenzime citokroma P450, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2El, CYP3A4 i CYP4A.
English: With MAO inhibitors there have been reports of medicinal product interactions with the concomitant use of sympathomimetic medicinal products.
Croatian: Simpatomimetici Kod MAO inhibitora su prijavljene interakcije lijekova pri istodobnoj primjeni simpatomimetskih lijekova.
English: It can be used together with or without Levodopa (another medicine that is used to treat Parkinson's disease).
Croatian: Može se primjeniti zajedno s levodopom ili bez levodope (drugi lijek koji se primjenjuje za liječenje
English: Neoplasms benign, malignant and unspecified
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine
English: Your doctor may need to adjust or stop your dose (see section 4).
Croatian: Vaš liječnik će možda morati prilagoditi dozu ili prekinuti liječenje
English: If increased somnolence or new episodes of falling asleep during activities of daily living (e.g. watching television, passenger in a car, etc.) are experienced at any time during treatment, the patients should not drive or participate in potentially dangerous activities.
Croatian: gledanja televizije, vožnje u automobilu kao putnik itd.) bilo kada tijekom liječenja, bolesnik ne smije voziti niti sudjelovati u potencijalno opasnim aktivnostima.
English: If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking AZILECT do not drive or operate machinery (see section 2).
Croatian: Ako ste osjetili izrazitu pospanost i/ili epizode iznenadnog nastupa sna prije ili za vrijeme uzimanja lijeka AZILECT, nemojte upravljati vozilima ili strojevima (pogledajte dio 2).
English: Serotonin syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Croatian: Serotoninski sindrom*, Prekomjerna dnevna pospanost i epizode iznenadnog nastupa sna*
English: White, high-density polyethylene bottle with or without a child-resistant cap containing 30 tablets.
Croatian: Bočice Bijele bočice od polietilena visoke gustoće sa ili bez sigurnosnog zatvarača za djecu koje sadržavaju
English: Ask your doctor for advice before you drive and operate machines, since Parkinson's disease itself as well as the treatment with AZILECT may influence your ability to do so. AZILECT can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
Croatian: Upitajte svog liječnika za savjet prije upravljanja vozilima i rada sa strojevima jer Parkinsonova bolest sama po sebi, kao i liječenje lijekom AZILECT, može utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: There was also a statistically significant improvement over placebo with the rasagiline 0.5 mg group, yet the magnitude of improvement was lower.
Croatian: 0,5 mg skupini u usporedbi s placebom, iako je razmjer poboljšanja bio manji.
English: In Parkinson's disease patients receiving rasagiline as adjunct therapy to chronic levodopa treatment, there was no clinically significant effect of levodopa treatment on rasagiline clearance.
Croatian: Kod bolesnika s Parkinsonovom bolešću koji primaju kroničnu terapiju levodopom i razagilin kao dodatnu terapiju nije bilo klinički značajnog učinka terapije levodopom na klirens razagilina.
English: In patients taking AZILECT and/or other medicines used to treat Parkinson's disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed.
Croatian: Kod bolesnika koji uzimaju AZILECT i/ili druge lijekove koji se koriste za liječenje Parkinsonove bolesti bila su opažena ponašanja kao što su kompulzije, opsesivne misli, ovisnost o kockanju, prekomjerno trošenje, impulzivno ponašanje i nenormalno visok seksualni nagon ili povećanje misli i osjećanja povezanih sa seksualnošću.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTER PACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA ZA BLISTER PAK
English: Renal impairment No special precautions are required in patients with renal impairment.
Croatian: Nisu potrebne posebne mjere opreza u bolesnika s oštećenjem bubrega.
English: AZILECT 1 mg tablets rasagiline
Croatian: AZILECT 1 mg tablete razagilin
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Rasagiline may cause daytime drowsiness, somnolence, and, occasionally, especially if used with other dopaminergic medicinal products - falling asleep during activities of daily living.
Croatian: Prekomjerna dnevna pospanost i epizode iznenadnog nastupa sna Razagilin može uzrokovati dnevnu omamljenost, somnolenciju te povremeno, posebice ako se primjenjuje s drugim dopaminergičkim lijekovima, padanje u san tijekom dnevnih aktivnosti.
English: AZILECT tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.
Croatian: AZILECT tablete su bijele do bjelkaste, okrugle, plosnate tablete kosih rubova, s utisnutom oznakom „GIL” i „1” ispod toga na jednoj strani, i bez oznake na drugoj strani.
English: - The active substance is rasagiline.
Croatian: - Djelatna tvar je razagilin.
English: Co-administration of rasagiline and ciprofloxacin (an inhibitor of CYP1A2) increased the AUC of rasagiline by 83%.
Croatian: Istodobna primjena razagilina i ciprofloksacina (inhibitora CYP1A2) je povećala AUC razagilina za
English: In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/day (134 patients) or rasagiline 2 mg/day (132 patients) and were treated for 26 weeks, there was no active comparator.
Croatian: (138 bolesnika), razagilin 1 mg/dan (134 bolesnika) ili razagilin 2 mg/dan (132 bolesnika) i bili su liječeni 26 tjedana, nije bilo aktivnog komparatora.
English: In clinical studies in Parkinson's disease patients the most commonly reported adverse reactions were: headache, depression, vertigo, and flu (influenza and rhinitis) in monotherapy; dyskinesia, orthostatic hypotension, fall, abdominal pain, nausea and vomiting, and dry mouth in adjunct to levodopa therapy; musculoskeletal pain, as back and neck pain, and arthralgia in both regimens.
Croatian: U kliničkim ispitivanjima Parkinsonove bolesti nuspojave koje su bolesnici najčešće prijavljivali bile su: glavobolja, depresija, vrtoglavica i gripa (influenca i rinitis) kod monoterapije; diskinezija, ortostatska hipotenzija, pad, bol u abdomenu, mučnina i povraćanje te suha usta kod dodatne terapije uz levodopu;
English: In both studies, the primary measure of efficacy was the change from baseline to treatment period in the mean number of hours that were spent in the “OFF” state during the day (determined from “24-hour” home diaries completed for 3 days prior to each of the assessment visits).
Croatian: „OFF“ stanju tijekom dana (određivano iz „24-satnih“ kućnih dnevnika popunjavanih tijekom 3 dana prije svakog posjeta procjene) od početne vrijednosti do razdoblja liječenja.
English: There was a significant and beneficial effect in quality of life (as assessed by PD-QUALIF scale).
Croatian: Učinak na kvalitetu života bio je značajan i koristan
English: Depression, Hallucinations*
Croatian: Depresija Halucinacije
English: Patients and carers should be made aware of the behavioural symptoms of impulse control disorders that were observed in patients treated with rasagiline, including cases of compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying.
Croatian: Bolesnici i skrbnici moraju biti upoznati sa bihevioralnim simptomima poremećaja kontrole impulsa koji su bili primjećeni kod bolesnika liječenih razagilinom, uključujući slučajeve kompulzija, opsesivnih misli, patološkog kockanja, povećanog libida, hiperseksualnosti,
English: Rasagiline's pharmacokinetics characteristics in subjects with mild (CLcr 50-80 ml/min) and moderate (CLcr 30-49 ml/min) renal impairment were similar to healthy subjects.
Croatian: Karakteristike farmakokinetike razagilina u osoba s blagim (CLcr 50-80 ml/min) i umjerenim
English: Carpal tunnel syndrome, Balance disorder accident syndrome*, Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes*
Croatian: Poremećaj ravnoteže rni inzult sindrom*, Prekomjerna dnevna pospanost i epizode iznenadnog nastupa sna*
English: Results of five tyramine challenge studies (in volunteers and Parkinson's disease patients), together with results of home monitoring of blood pressure after meals (of 464 patients treated with 0.5 or 1 mg/day of rasagiline or placebo as adjunct therapy to levodopa for six months without tyramine restrictions), and the fact that there were no reports of tyramine/rasagiline interaction in clinical studies conducted without tyramine restriction, indicate that rasagiline can be used safely without dietary tyramine restrictions.
Croatian: 1 mg/dan razagilina ili placebom kao dodatnom terapijom levodopi kroz šest mjeseci bez restrikcija tiramina) i činjenicom da nije bilo prijava tiramin/razagilin interakcija u kliničkim ispitivanjima provedenim bez restrikcije tiramina, upućuju na to da se razagilin može primijenjivati sigurno bez dijetalnih restrikcija tiramina.
English: The tabulated list below includes adverse reactions which were reported with a higher incidence in placebo-controlled studies in patients receiving 1 mg/day rasagiline.
Croatian: Niže navedeni tablični popis uključuje nuspojave koje su bile prijavljene s većom incidencijom u placebo kontroliranim ispitivanjima u bolesnika koji su primali 1 mg/dan razagilina.
English: ICDs can occur in patients treated with dopamine agonists and/or dopaminergic treatments.
Croatian: iznenadni nastup sna) mogu se javiti kod bolesnika liječenih agonistima dopamina i/ili drugim dopaminergičkim lijekovima.
English: Incidence of skin melanoma in placebo-controlled clinical studies was 2/380 (0.5%) in rasagiline 1 mg as adjacent to levodopa therapy group vs. 1/388 (0.3%) incidence in placebo group.
Croatian: (0,5 %) u skupini koja je primala razagilin u dozi od 1 mg kao dodatnu terapiju levodopi naspram incidencije od 1/388 (0,3 %) u skupini koja je primala placebo.
English: The following were reported during post-marketing exposure with unknown frequency: compulsions, compulsive shopping, dermatillomania, dopamine dysregulation syndrome, impulse-control disorder, impulsive behaviour, kleptomania, theft, obsessive thoughts, obsessive-compulsive disorder, stereotypy, gambling, pathological gambling, libido increased, hypersexuality, psychosexual disorder, sexually inappropriate behaviour.
Croatian: poremećaj kontrole impulsa, impulzivno ponašanje, kleptomanija, krađa, opsesivne misli, opsesivno kompulzivni poremećaj, stereotipija, kockanje, patološko kockanje, povećani libido, hiperseksualnost, psihoseksualni poremećaj, neprimjereno seksualno ponašanje.
English: After oral administration of 14C-labelled rasagiline, elimination occurred primarily via urine (62.6%) and secondarily via faeces (21.8%), with a total recovery of 84.4% of the dose over a period of 38 days.
Croatian: a sekundarno putem fecesa (21,8 %), s potpunim izlučivanjem 84,4 % doze lijeka tijekom razdoblja od
English: - Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome) - If you notice any suspicious skin changes because there is a higher risk of skin cancer (not exclusively melanoma) in patients with Parkinson's disease (see section 2).
Croatian: - Ako primijetite sumnjive promjene na koži zbog toga jer postoji povećani rizik od raka kože (koji ne mora nužno biti melanom) u bolesnika s Parkinsonovom bolešću (pogledajte dio 2).
English: Not known: frequency cannot be estimated from the available data - Elevated blood pressure - Excessive drowsiness - Sudden onset of sleep
Croatian: - povišeni krvni tlak - prekomjerna omamljenost - iznenadni nastup sna
English: Not known disorders
Croatian: Nepoznato sustava
English: Do not take the following medicines while taking AZILECT: - Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson's disease,
Croatian: Nemojte uzimati sljedeće lijekove dok uzimate AZILECT: - inhibitore monoaminooksidaze (MAO) (npr. za liječenje depresije ili Parkinsonove bolesti ili za bilo koju drugu indikaciju), uključujući lijekove i prirodne preparate bez recepta npr. gospinu travu - petidin (snažan lijek protiv boli).
English: Musculoskeletal pain,
Croatian: Sindrom karpalnog tunela,
English: You must wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO inhibitors or pethidine.
Croatian: Morate čekati najmanje 14 dana nakon prestanka liječenja AZILECT-om i početka liječenja MAO
English: The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.5).
Croatian: Istodobna primjena razagilina s drugim lijekovima Istodobnu primjenu razagilina i fluoksetina ili fluvoksamina potrebno je izbjegavati (vidjeti dio 4.5).
English: Excessive daytime sleepiness (EDS) and sudden sleep onset (SOS) episodes Excessive daily sleepiness (hypersomnia, lethargy, sedation, sleep attacks, somnolence, sudden onset of sleep) can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Croatian: Prekomjerna dnevna pospanost i epizode iznenadnog nastupa sna Prekomjerna dnevna pospanost (hipersomnija, letargija, sedacija, napadaji sna, somnolencija,
English: ≤ 50 mg/daily, trazodone ≤ 100 mg/daily, citalopram ≤ 20 mg/daily, sertraline ≤ 100 mg/daily, and paroxetine ≤ 30 mg/daily (see section 4.5).
Croatian: U kliničkim ispitivanjima razagilina nije bila dozvoljena istodobna upotreba fluoksetina ili fluvoksamina s razagilinom, ali sljedeći antidepresivi i doze bili su dozvoljeni u ispitivanjima razagilina: amitriptilin ≤ 50 mg/dnevno, trazodon ≤ 100 mg/dnevno, citalopram ≤ 20 mg/dnevno, sertralin ≤ 100 mg/dnevno i paroksetin ≤ 30 mg/dnevno (vidjeti dio 4.5).
English: Abdominal pain, Constipation, Nausea and vomiting, Dry mouth
Croatian: - Bilo koja kombinacija halucinacija, vrućice, nemira, nevoljnog drhtanja i znojenja
English: - Flatulence - Abnormal results of blood tests (leucopenia) - Joint pain (arthralgia) - Musculoskeletal pain - Joint inflammation (arthritis) - Numbness and muscle weakness of the hand (carpal tunnel syndrome) - Decreased weight - Abnormal dreams - Difficulty in muscular coordination (balance disorder) - Depression - Dizziness (vertigo) - Prolonged muscle contractions (dystonia) - Runny nose (rhinitis) - Irritation of the skin (dermatitis) - Rash - Bloodshot eyes (conjunctivitis) - Urinary urgency
Croatian: - vjetrovi - abnormalni rezultati krvnih testova (leukopenija) - bol u zglobovima (artralgija) - mišićno-koštana bol - upala zglobova (artritis)
English: In study III, patients were randomly assigned to receive placebo (159 patients), rasagiline 0.5 mg/day (164 patients), or rasagiline 1 mg/day (149 patients), and were treated for 26 weeks.
Croatian: U ispitivanju III, bolesnici su metodom slučajnog odabira bili raspodijeljeni da prime placebo (159 bolesnika), razagilin 0,5 mg/dan
English: In study III, the mean difference compared to placebo was -0.94h, 95% CI [-1.36, -0.51], p<0.0001.
Croatian: 95 % CI [-1,36, -0,51], p< 0,0001.
English: Uncommon (may affect up to 1 in 100 people) - Stroke (cerebrovascular accident) - Heart attack (myocardial infarction) - Blistering rash (vesiculobullous rash)
Croatian: - moždani udar (cerebrovaskularni događaj) - srčani udar (infarkt miokarda) - osip s mjehurićima (vezikulobulozni osip)
English: Pregelatinised maize starch Colloidal anhydrous silica Stearic acid
Croatian: 6.1 Popis pomoćnih tvari manitol kukuruzni škrob kukuruzni škrob, prethodno geliran silicijev dioksid, koloidni, bezvodni stearatna kiselina talk
English: In mice, increased incidences of combined bronchiolar/alveolar adenoma and/or carcinoma were observed at systemic exposures, 144 - 213 times the expected plasma exposure in humans at 1 mg/day.
Croatian: U miševa je opažena povećana incidencija kombiniranih bronhiolarnih/alveolarnih adenoma i/ili karcinoma pri sistemskim ekspozicijama
English: Especially tell your doctor if you are taking any of the following medicines: - Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants) - The antibiotic ciprofloxacin used against infections - The cough suppressant dextromethorphan - Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine
Croatian: - antibiotik ciprofloksacin koji se primjenjuje protiv infekcija - dekstrometorfan koji se primjenjuje protiv kašlja - simpatomimetike poput onih sadržanih u kapima za oči, nazalnim i oralnim dekongestivima i lijekovima za prehladu koji sadrže efedrin ili pseudoefedrin.
English: Nervous system Dyskinesia
Croatian: Poremećaji probavnog sustava
English: Neck pain, Arthritis
Croatian: Bol u vratu Artritis
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU
English: Cerebrovascular accident
Croatian: Cerebrovask ularni inzult
English: Tel.: + 385 1 37 20 000
Croatian: Pliva Hrvatska d.o.o. Tel.: + 385 1 37 20 000
English: Tel: +421 2 572 679 11
Croatian: TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 2 572 679 11
English: How to store AZILECT
Croatian: Moguće nuspojave Kako čuvati AZILECT
English: Renal impairment
Croatian: Vezikulobulo zni osip
English: EU Number
Croatian: EU-broj
English: EU/1/05/322/002 Yttriga vial (glass) 1 vial (flat bottom)
Croatian: 1 bočicu (dno u obliku slova V)
English: 4 (4 x 1) prefilled syringes (multipack)
Croatian: 4 (4 x 1) napunjene štrcaljke (višestruko pakiranje)
English: Repeat every 24 hours.
Croatian: Ponavljati svaka 24 sata.
English: (pre- and postoperative)
Croatian: (pre- i postoperacijski)
English: It may harm them,
Croatian: Dobne skupine (godine)
English: The contents of the pack are:
Croatian: Sadržaj pakiranja je:
English: - See your doctor immediately if your bleeding does not stop as expected.
Croatian: - Odmah posjetite liječnika ako Vam se krvarenje ne zaustavi prema očekivanju.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at temperatures up to 25C.
Croatian: Dokazana je kemijska i fizikalna stabilnost tijekom 3 sata na temperaturama do 25
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Croatian: To je naročito važno kod promjene laboratorija i/ili reagensa korištenih u testu.
English: Always wash your hands prior to performing the following procedures.
Croatian: Prije sljedećih postupaka uvijek operite ruke.
English: Ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Pitajte svog liječnika ili ljekarnika za savjet prije nego uzmete ovaj lijek.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
English: Administration (Intravenous Injection):
Croatian: Primjena (intravenska injekcija):
English: Do not stop taking BeneFIX without consulting your doctor.
Croatian: Nemojte prestati primjenjivati BeneFIX bez savjetovanja s liječnikom.
English: These reactions are potentially life-threatening.
Croatian: Te reakcije su potencijalno opasne po život.
English: White/almost white powder and clear and colourless solvent.
Croatian: Bijeli/gotovo bijeli prašak i bistro i bezbojno otapalo.
English: • Fast heart rate, low blood pressure
Croatian: • ubrzani puls, niski krvni tlak
English: Blood should not enter the syringe.
Croatian: Krv ne bi smjela ući u štrcaljku.
English: The specific activity of BeneFIX is not less than 200 IU/mg protein.
Croatian: Specifična aktivnost BeneFIX-a nije manja od 200 IU/mg proteina.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Croatian: Trombin potom pretvara fibrinogen u fibrin pa se može formirati ugrušak.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of genotoxicity.
Croatian: Neklinički podaci ne ukazuju na posebnu opasnost za ljude na temelju konvencionalnih ispitivanja genotoksičnosti.
English: - If you are allergic to nonacog alfa or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na nonakog alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: The parameters estimated using the final 2-compartment model are shown in Table 2.
Croatian: Parametri procijenjeni koristeći finalni model s 2 odjeljka prikazani su u Tablici 2.
English: Safety analysis of 25 evaluable patients reflected a safety profile as expected.
Croatian: Analiza sigurnosnih podataka 25 ocjenjivih bolesnika odražavala je očekivani sigurnosni profil lijeka.