FrancophonIA/ELRC3.0 huggingface dataset:
English: • blood clots in your lungs (pulmonary embolism) - signs include feeling short of breath or pain while breathing
Croatian: • krvni ugrušci u plućima (plućna embolija) - znakovi uključuju nedostatak daha ili bol pri disanju
English: In subjects with severe renal impairment (n=6, Cl cr < 20 mL/min/1.73 m2), the AUC of posaconazole was highly variable [> 96 % CV (coefficient of variance)] compared to other renal groups [< 40 % CV].
Croatian: U ispitanika s teškim oštećenjem funkcije bubrega (n=6, Clcr <20 ml/min/1,73 m2), AUC posakonazola jako je varirao [>96% CV (koeficijent varijabilnosti)] u usporedbi s drugim kategorijama bubrežne funkcije [<40% CV].
English: The other ingredients are: Betadex Sulfobutyl Ether Sodium (SBECD), disodium edetate, hydrochloric acid (concentrated), sodium hydroxide, water for injections.
Croatian: Drugi sastojci su: natrijev sulfobutileter β-ciklodekstrin (SBECD), dinatrijev edetat, kloridna kiselina (koncentrirana), natrijev hidroksid, voda za injekcije.
English: Noxafil is also available as 100 mg gastro-resistant tablet and 300 mg concentrate for solution for infusion.
Croatian: Noxafil je također dostupan u obliku želučanootpornih tableta od 100 mg i koncentrata za otopinu za infuziju od 300 mg.
English: Hypromellose acetate succinate Cellulose, microcrystalline Hydroxypropylcellulose (E463) Silica dental type Croscarmellose sodium Magnesium stearate
Croatian: Jezgra tablete hipromeloza acetat sukcinat celuloza, mikrokristalična hidroksipropilceluloza (E463) silicijev dioksid, dentalnog tipa karmeloza natrij, umrežena magnezijev stearat
English: 200 mg (5 mL) four times a day.
Croatian: 200 mg (5 ml) četiri puta na dan.
English: No difference in the incidence of brain ventricle enlargement between control and treated animals was observed following the subsequent 5-month treatment-free period.
Croatian: Uslijedilo je razdoblje od 5 mjeseci bez terapije, nakon kojega nisu zabilježen razlike u incidenciji povećanja moždane klijetke između kontrolnih i tretiranih životinja.
English: This should be taken into consideration for patients on a controlled sodium diet.
Croatian: O tome treba voditi računa u bolesnika koji su na dijeti s kontroliranim unosom natrija.
English: • abnormal skin sensations, such as numbness, tingling, itching, creeping, pricking or burning
Croatian: • neuobičajeni kožni osjeti, kao što su utrnulost, trnci, svrbež, žmarci, bockanje ili žarenje
English: nausea vomiting, abdominal pain, diarrhoea, dyspepsia, dry mouth, flatulence, constipation, anorectal discomfort
Croatian: mučnina povraćanje, bol u abdomenu, proljev, dispepsija, suha usta, flatulencija, konstipacija, anorektalna nelagoda
English: hypertension hypotension, thrombophlebitis, vasculitis
Croatian: hipertenzija hipotenzija, tromboflebitis, vaskulitis
English: Control Proportion (%) of patients with proven/probable Aspergillosis On-treatment period
Croatian: Posakonazol oralna suspenzija Kontrolna skupina Udio (%) bolesnika s dokazanom/vjerojatnom aspergilozom
English: Results from clinical studies in prophylaxis of Invasive Fungal Infections Study
Croatian: Tablica 6. Rezultati kliničkih ispitivanja profilakse invazivnih gljivičnih infekcija Ispitivanje
English: haemolytic uraemic syndrome, thrombotic thrombocytopenic purpura, pancytopenia, coagulopathy, haemorrhage
Croatian: hemolitičko-uremijski sindrom, trombotična trombocitopenična purpura, pancitopenija, koagulopatija, krvarenje
English: Proportion (%) of patients with proven/probable IFIs On-treatment period
Croatian: Udio (%) bolesnika s dokazanom/vjerojatnom IGI U razdoblju liječenja
English: Based on the available data in 16 of these paediatric patients, the safety profile appears to be similar to patients ≥ 18 years of age.
Croatian: Na temelju dostupnih podataka o ovih 16 pedijatrijskih bolesnika, čini se da je sigurnosni profil lijeka sličan onomu u bolesnika u dobi od ≥ 18 godina.
English: • inflammation of the pancreas (pancreatitis) - this may cause severe stomach pain
Croatian: • upala gušterače (pankreatitis) - to može uzrokovati jake bolove u trbuhu
English: • abnormal heart rhythm - shown up on a heart trace (ECG), palpitations, slow or fast heartbeat,
Croatian: • nepravilan srčani ritam - vidi se na elektrokardiogramu (EKG-u), palpitacije, usporen ili ubrzan rad srca, povišen ili snižen krvni tlak,
English: Treatment of refractory Fungal Infections (Invasive aspergillosis, Fusariosis,
Croatian: Liječenje gljivičnih infekcija otpornih na prethodnu terapiju (invazivne aspergiloze, fuzarioze, kromoblastomikoze/micetomi, kokcidioidomikoze)
English: • cough, hiccups
Croatian: • kašalj, štucavica
English: Plasma exposure resulting from the tablet formulation was higher than observed with the oral suspension.
Croatian: Izloženost u plazmi nakon primjene formulacije u tableti bila je veća od one opažene kod oralne suspenzije.
English: cough, epistaxis, hiccups, nasal congestion, pleuritic pain, tachypnoea pulmonary hypertension, interstitial pneumonia, pneumonitis
Croatian: kašalj, epistaksa, štucavica, kongestija nosa, pleuralna bol, tahipneja plućna hipertenzija, intersticijska upala pluća, pneumonitis
English: Neuronal phospholipidosis occurred in dogs dosed for  3 months at lower systemic exposures than those obtained at therapeutic doses in humans.
Croatian: U pasa koji su primali lijek 3 mjeseca razvila se neuronska fosfolipidoza pri manjoj sustavnoj izloženosti od one koja se postiže s terapijskim dozama u ljudi.
English: Following single-dose administration of posaconazole oral suspension, there was no effect of mild and moderate renal impairment (n=18, Cl cr ≥ 20 mL/min/1.73 m2) on posaconazole pharmacokinetics; therefore, no dose adjustment is required.
Croatian: Nakon primjene jednokratne doze posakonazol oralne suspenzije, blago ili umjereno oštećenje funkcije bubrega (n=18, Clcr ≥20 ml/min/1,73 m2) nije utjecalo na farmakokinetiku posakonazola, pa nije potrebna prilagodba doze.
English: Posaconazole, after administration of 300 mg of posaconazole concentrate for solution for infusion, is slowly eliminated with a mean half-life (t½) of 27 hours and a mean clearance of 7.3 L/hr.
Croatian: Nakon primjene 300 mg posakonazol koncentrata za otopinu za infuziju, posakonazol se sporo eliminira, uz srednji poluvijek (t½) od 27 sati i srednju vrijednost prividnog klirensa od 7,3 l/h.
English: Posaconazole exhibits dose proportional pharmacokinetics after single and multiple dosing in the therapeutic dose range (200-300 mg).
Croatian: Farmakokinetika posakonazola nakon primjene jedne i višekratnih doza proporcionalna je dozi unutar raspona terapijskih doza (200 - 300 mg).
English: Noxafil 100 mg gastro-resistant tablets
Croatian: Noxafil 100 mg želučanootporne tablete
English: The primary efficacy endpoint was the incidence of proven/probable IFIs at 16 weeks post-randomisation as determined by an independent, blinded external expert panel.
Croatian: Primarna mjera ishoda za djelotvornost bila je incidencija dokazane/vjerojatne IGI 16 tjedana nakon randomizacije, prema ocjeni neovisnog vijeća vanjskih stručnjaka koji nisu znali koju je terapiju primao pojedini bolesnik.
English: • pain, back or neck pain, pain in arms or legs
Croatian: • bol, križobolja ili bol u vratu, bol u rukama ili nogama
English: Phenytoin (200 mg once a day) decreased the Cmax and AUC of posaconazole by 41 % and 50 %, respectively.
Croatian: Fenitoin (200 mg jedanput na dan) je snizio Cmax posakonazola za 41%, a AUC za 50%.
English: Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (1.7 times the 400-mg twice daily regimen based on steady-state plasma concentrations in healthy volunteers) or female rats at a dose up to 45 mg/kg (2.2 times the 400-mg twice daily regimen).
Croatian: U štakora, posakonazol nije imao utjecaja na plodnost mužjaka pri dozama do najviše 180 mg/kg (što je 1,7 puta više od režima doziranja 400 mg dvaput na dan, izračunato na temelju koncentracije u plazmi u stanju dinamičke ravnoteže u zdravih dobrovoljaca) niti na plodnost ženki pri dozi do najviše 45 mg/kg (što je 2,2 puta više od režima doziranja 400 mg dvaput na dan).
English: Tell your doctor if you are or think you are pregnant before you start to take Noxafil.
Croatian: Ako ste trudni ili mislite da biste mogli biti trudni, obavijestite o tome svog liječnika prije nego počnete uzimati Noxafil.
English: b: In 1899 this was the period from randomisation to last dose of study medicinal product plus 7 days; in 316 it was the period from first dose to last dose of study medicinal product plus 7 days.
Croatian: b: U Ispitivanju 1899 to je bilo razdoblje od randomizacije do primjene posljednje doze ispitivanog lijeka + 7 dana; u
English: Following administration of 800 mg per day of posaconazole as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 8 - 17 years of age (776 ng/mL) were similar to concentrations from 194 patients 18 - 64 years of age (817 ng/mL).
Croatian: Nakon primjene 800 mg posakonazola na dan, raspodijeljeno u više doza, za liječenje invazivnih gljivičnih infekcija prosječna vrijednost najnižih koncentracija posakonazola u plazmi 12 bolesnika u dobi 8-17 godina (776 ng/ml) bila je slična onoj u 194 bolesnika u dobi 18-64 godina (817 ng/ml).
English: In a study of 136 neutropenic paediatric patients 11 months - 17 years treated with posaconazole oral suspension at doses up to 18 mg/kg/day divided TID, approximately 50% met the pre-specified target (Day 7 Cav between 500 ng/mL-2,500 ng/mL).
Croatian: U ispitivanju u kojem je sudjelovalo 136 pedijatrijskih bolesnika s neutropenijom u dobi od 11 mjeseci do 17 godina koji su liječeni posakonazol oralnom suspenzijom u dozama do najviše 18 mg/kg/dan podijeljeno u 3 doze, približno 50% njih dostiglo je unaprijed specificiranu ciljnu vrijednost (Cav u 7. danu liječenja između 500ng/ml - 2500 ng/ml).
English: It should be noted that the relationship between sirolimus trough concentration and AUC is changed during coadministration with posaconazole.
Croatian: Treba naglasiti da se kod istodobne primjene sirolimusa i posakonazola mijenja odnos između najniže koncentracije i AUC-a sirolimusa.
English: diplopia, scotoma
Croatian: dvoslike, skotom
English: • abnormal skin sensations, such as numbness, tingling, itching, creeping, pricking, or burning
Croatian: • neuobičajeni kožni osjeti, kao što su utrnulost, trnci, svrbež, žmarci, bockanje ili žarenje,
English: Noxafil should be administered via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow intravenous infusion over approximately 90 minutes.
Croatian: Noxafil se mora primijeniti sporom intravenskom infuzijom tijekom približno 90 minuta kroz centralnu vensku liniju, uključujući centralni venski kateter ili periferno postavljen centralni kateter.
English: Do not breast-feed while taking Noxafil.
Croatian: Nemojte dojiti dok uzimate Noxafil.
English: Concomitant use of posaconazole and phenytoin and similar inducers (e.g. carbamazepine, phenobarbital, primidone) should be avoided unless the benefit to the patient outweighs the risk.
Croatian: Istodobnu primjenu posakonazola i fenitoina i sličnih induktora (npr. karbamazepina, fenobarbitala, primidona) treba izbjegavati, osim ako moguća korist za bolesnika nadilazi rizik liječenja.
English: • oxygen supply to the spleen is interrupted (splenic infarction) - this may cause severe stomach pain
Croatian: • prekid dotoka kisika u slezenu (infarkt slezene) - to može uzrokovati jake bolove u trbuhu
English: Effect of food on oral absorption in healthy volunteers The absorption of posaconazole was significantly increased when posaconazole 400 mg (once daily) was administered during and immediately after the consumption of a high fat meal (~ 50 grams fat) compared to administration before a meal, with Cmax and AUC increasing by approximately 330 % and 360 %, respectively.
Croatian: Apsorpcija posakonazola značajno se povećala kad je posakonazol u dozi od 400 mg (jedanput na dan) primijenjen tijekom ili neposredno nakon obroka s visokim udjelom masti (~ 50 grama masti) u usporedbi s primjenom prije jela, uz povećanje Cmax za približno 330%, a AUC-a za približno 360%.
English: Safety data at higher exposure levels achieved with posaconazole concentrate for solution for infusion are at present limited.
Croatian: Trenutno su ograničeni podaci o sigurnosti pri višim razinama izloženosti postignutima nakon primjene posakonazol koncentrata za otopinu za infuziju.
English: What Noxafil looks like and contents of the pack Noxafil concentrate for solution for infusion is a clear, colourless to yellow liquid.
Croatian: Noxafil koncentrat za otopinu za infuziju je bistra, bezbojna do žuta tekućina.
English: No effects on electrocardiograms, including QT and QTc intervals, were seen in a repeat dose safety pharmacology study in monkeys at maximal plasma concentrations 8.9-fold greater than the concentrations obtained at therapeutic doses in humans with 300 mg intravenous infusion administration.
Croatian: U farmakološkom ispitivanju sigurnosti ponovljenih doza u majmuna nisu uočeni učinci na elektrokardiograme, uključujući QT i QTc-intervale, pri maksimalnim koncentracijama u plazmi koje su bile 8,9 puta veće od koncentracija koje se postižu terapijskim dozama u ljudi uz primjenu intravenske infuzije od 300 mg.
English: Noxafil concentrate for solution for infusion should not be given by bolus administration.
Croatian: Noxafil koncentrat za otopinu za infuziju ne smije se primijeniti kao bolus.
English: hypertension hypotension, vasculitis
Croatian: hipertenzija, hipotenzija, vaskulitis
English: Study 1899 was a randomised, evaluator-blinded study of posaconazole oral suspension (200 mg three times a day) versus fluconazole suspension (400 mg once daily) or itraconazole oral solution (200 mg twice a day) in neutropenic patients who were receiving cytotoxic chemotherapy for acute myelogenous leukaemia or myelodysplastic syndromes.
Croatian: Ispitivanje 1899 bilo je randomizirano ispitivanje posakonazol oralne suspenzije (200 mg triput na dan) naspram flukonazol suspenzije (400 mg jedanput na dan) ili itrakonazol oralne otopine (200 mg dvaput na dan) u neutropeničnih bolesnika koji su primali citotoksičnu kemoterapiju za liječenje akutne mijeloične leukemije ili mijelodisplastičkog sindroma.
English: • low level of platelets (thrombocytopenia) shown in blood tests - this may lead to bleeding
Croatian: • nizak broj krvnih pločica (trombocitopenija), što se vidi na krvnim pretragama - to može dovesti do krvarenja
English: 200 mg (5 mL) three times a day.
Croatian: 200 mg (5 ml) tri puta na dan.
English: Lactated Ringer's solution 5 % dextrose with Lactated Ringer's solution 4.2 % sodium bicarbonate
Croatian: Noxafil se ne smije razrjeđivati s: Ringerovom otopinom s laktatom 5% glukozom s Ringerovom otopinom s laktatom
English: hepatic failure, hepatitis cholestatic, hepatosplenomegaly, liver tenderness, asterixis
Croatian: zatajenje jetre, kolestatski hepatitis, hepatosplenomegalija, osjetljivost jetre, asteriksis
English: Posaconazole had no effect on fertility of male rats at doses up to 180 mg/kg (2.8 times the exposure achieved from a 300 mg intravenous dose in human) or female rats at a dose up to 45 mg/kg (3.4 times the exposure from a 300 mg intravenous dose in patients).
Croatian: U štakora, posakonazol nije imao utjecaja na plodnost mužjaka pri dozama do najviše 180 mg/kg (što predstavlja 2,8 puta veću izloženost od one koja se postiže primjenom intravenske doze od 300 mg u ljudi) niti na plodnost ženki pri dozi do najviše 45 mg/kg (3,4 puta veća izloženost od one koja se postiže primjenom intravenske doze od 300 mg u bolesnika).
English: Treatment of azole-susceptible Oropharyngeal Candidiasis (OPC) A randomised, evaluator-blind, controlled study was completed in HIV-infected patients with azolesusceptible oropharyngeal candidiasis (most patients studied had C. albicans isolated at baseline).
Croatian: Provedeno je randomizirano kontrolirano ispitivanje u bolesnika zaraženih HIV-om s kandidijazom usta i ždrijela osjetljivom na azole (u većine je bolesnika na početku ispitivanja izolirana C. albicans), u kojemu ocjenitelji nisu znali koja je terapija dodijeljena kojem bolesniku.
English: A MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: The blockage will prevent the contents of your intestine from passing through to the lower bowel signs include feeling bloated, vomiting, severe constipation, loss of appetite, and cramps
Croatian: Blokada sprječava da sadržaj crijeva prijeđe u debelo crijevo, a znakovi uključuju osjećaj nadutosti,
English: • low magnesium levels - shown up in blood tests
Croatian: • niske razine magnezija - vide se na krvnim pretragama
English: • swelling of lymph glands (lymphadenopathy)
Croatian: • otečene limfne žlijezde (limfadenopatija)
English: Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 1.4-fold and 4.6-fold greater, respectively, than those achieved with the human therapeutic doses.
Croatian: Zabilježeno je povišenje sistoličkog i arterijskog krvnog tlaka (do 29 mmHg) u štakora i majmuna pri sustavnoj izloženosti 1,4 puta odnosno 4,6 puta većoj od one koja se postiže terapijskim dozama u ljudi.
English: Noxafil 100 mg gastro-resistant tablets posaconazole
Croatian: Noxafil 100 mg želučanootporne tablete posakonazol
English: • swelling of the mouth
Croatian: • oticanje usta
English: • anaemia - signs include headaches, feeling tired or dizzy, being short of breath or looking pale and a low level of haemoglobin shown up in blood tests
Croatian: • anemija - znakovi uključuju glavobolju, osjećaj umora ili omaglicu, nedostatak zraka ili blijedilo i nisku razinu hemoglobina koja se vidi na krvnim pretragama
English: • low blood pressure
Croatian: • snižen krvni tlak
English: • Administer via a central venous line, including a central venous catheter or peripherally inserted central catheter (PICC) by slow intravenous infusion over approximately 90 minutes.
Croatian: • Primijenite sporom intravenskom infuzijom tijekom približno 90 minuta kroz centralnu vensku liniju, uključujući centralni venski kateter ili periferno postavljen centralni kateter.
English: Do not use Noxafil
Croatian: Nemojte primjenjivati Noxafil
English: Plasma concentrations following administration of posaconazole intravenous concentrate for solution for infusion are generally higher than those obtained with posaconazole oral suspension.
Croatian: Koncentracije lijeka u plazmi nakon intravenske primjene posakonazol koncentrata za otopinu za infuziju u načelu su više od onih koje se postižu nakon primjene posakonazol oralne suspenzije.
English: Following administration of 800 mg per day of posaconazole oral suspension as a divided dose for treatment of invasive fungal infections, mean trough plasma concentrations from 12 patients 817 years of age (776 ng/mL) were similar to concentrations from 194 patients 18 - 64 years of age
Croatian: Nakon primjene 800 mg na dan posakonazol oralne suspenzije, raspodijeljeno u više doza, za liječenje invazivnih gljivičnih infekcija prosječna vrijednost najnižih koncentracija posakonazola u plazmi 12 bolesnika u dobi 8-17 godina (776 ng/ml) bila je slična onoj u 194 bolesnika u dobi 18-64 godina (817 ng/ml).
English: • have heart rhythm disturbance
Croatian: • tegobe sa srčanim ritmom
English: Noxafil 300 mg concentrate for solution for infusion posaconazole
Croatian: Noxafil 300 mg koncentrat za otopinu za infuziju posakonazol
English: Plasma exposure resulting from the solution for infusion was higher than observed with the oral suspension.
Croatian: Izloženost u plazmi nakon primjene otopine za infuziju bila je viša od one primijećene nakon primjene oralne suspenzije.
English: Noxafil 300 mg concentrate for solution for infusion
Croatian: Noxafil 300 mg koncentrat za otopinu za infuziju
English: Exposures after tablet administration are generally higher than, but overlapping with, exposures after administration of posaconazole oral suspension.
Croatian: Izloženost nakon primjene tablete općenito je veća od izloženosti nakon primjene posakonazol oralne suspenzije, iako se preklapaju.
English: The recommended dose is 300 mg twice a day on the first day, then 300 mg once a day, thereafter.
Croatian: Preporučena doza je 300 mg dvaput na dan prvog dana, a zatim 300 mg jedanput na dan.
English: A non-dose related incidence of thrombus/emboli in the lung was seen in the 1 month repeated dose study in the monkey.
Croatian: U jednomjesečnom ispitivanju primjene ponovljenih doza u majmuna primijećena je incidencija tromba/embolusa u plućima koja nije bila povezana s dozom.
English: Thereafter blood levels of tacrolimus should be monitored carefully during co-administration, and upon discontinuation of posaconazole, and the dose of tacrolimus should be adjusted as necessary.
Croatian: Nakon toga treba pažljivo pratiti razine takrolimusa u krvi tijekom i po prestanku istodobnog liječenja posakonazolom te po potrebi prilagoditi dozu takrolimusa.
English: • inflammation of the blood vessels
Croatian: • upala krvnih žila
English: Effects of posaconazole on other medicinal products Posaconazole is a potent inhibitor of CYP3A4.
Croatian: Posakonazol je snažan inhibitor CYP3A4.
English: What Noxafil contains The active substance is posaconazole.
Croatian: Što Noxafil sadrži Djelatna tvar je posakonazol.
English: Excipients: Betadex Sulfobutyl Ether Sodium (SBECD), disodium edetate, hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.
Croatian: Pomoćne tvari: natrijev sulfobutileter β-ciklodekstrin (SBECD), dinatrijev edetat, kloridna kiselina i natrijev hidroksid (za podešavanje pH), voda za injekcije.
English: Paediatric population There is no paediatric experience for posaconazole concentrate for solution for infusion.
Croatian: Pedijatrijska populacija Nema iskustva s primjenom posakonazol koncentrata za otopinu za infuziju u pedijatrijskoj populaciji.
English: Paediatric population There is no paediatric experience for posaconazole tablets.
Croatian: Pedijatrijska populacija Nema iskustva s posakonazol tabletama u pedijatrijskoj populaciji.
English: Cav quartile analyses of pivotal patient studies with posaconazole tablet and oral suspension Posaconazole tablet
Croatian: Tablica 3. Analize kvartila Cav-a u glavnim ispitivanjima s bolesnicima koji su uzimali posakonazol tablete i oralnu suspenziju Posakonazol tableta
English: What Noxafil contains The active substance in Noxafil is posaconazole.
Croatian: Što Noxafil sadrži Djelatna tvar u lijeku Noxafil je posakonazol.
English: • hearing problems
Croatian: • tegobe sa sluhom
English: Study 316 was a randomised, double-blind trial of posaconazole oral suspension (200 mg three times a day) versus fluconazole capsules (400 mg once daily) in allogeneic hematopoietic stem cell transplant recipients with graft-versus-host disease (GVHD).
Croatian: Ispitivanje 316 bilo je randomizirano, dvostruko slijepo ispitivanje primjene posakonazol oralne suspenzije (200 mg triput na dan) naspram flukonazol kapsula (400 mg jedanput na dan) u primatelja alogeničnih hematopoetskih matičnih stanica koji su imali reakciju presatka protiv primatelja (engl. graft-versus-host disease, GVHD).
English: Single use vial.
Croatian: Jednokratna bočica.
English: Noxafil contains sodium
Croatian: Noxafil sadrži natrij
English: Increased systolic and arterial blood pressures (up to 29 mm-Hg) were seen in rats and monkeys at systemic exposures 2.2-fold and 8.9-fold greater, respectively, than those achieved with the human therapeutic doses.
Croatian: Zabilježeno je povišenje sistoličkog i arterijskog krvnog tlaka (do 29 mmHg) u štakora i majmuna pri sustavnoj izloženosti 2,2 puta odnosno 8,9 puta većoj od one koja se postiže terapijskim dozama u ljudi.
English: • tremor
Croatian: • osjećaj treme
English: Adverse reactions by body system and frequency reported in clinical trials and/or postmarketing use*
Croatian: Tablica 2. Nuspojave prema organskim sustavima i učestalosti prijavljene u kliničkim ispitivanjima i/ili nakon stavljanja u promet * Poremećaji krvi i limfnog sustava Često: