natgillin/translations-raw huggingface dataset:
The observed 99% drop in Doppler signal intensity within 10 minutes (t1/2 approximately 2 minutes) was in agreement with the decline in measurable blood levels of perflutren.
Uočeni pad od 99% u intenzitetu Doppler signala u roku od 10 minuta (t1/2 otprilike 2 minute) bio je u skladu sa smanjenjem mjerljivih razina perflutrena u krvi.
The observed adverse drug reactions were overall similar to those seen in adults (see section 4.8).
Zabilježene nuspojave na lijek sveukupno su bile slične onima zabilježenima u odraslih (vidjeti dio 4.8).
The observed adverse effect level for embryo-foetal toxicity in this study was 10 µg/kg/day, which corresponded to a systemic exposure of approximately 3 – 5 times the exposures observed in patients treated with the clinical dose.
Razina uočenih štetnih učinaka za embriofetalnu toksičnost u ovom ispitivanju iznosila je 10 µg/kg na dan što je odgovaralo sistemskom izlaganju od približno 3-5 puta većem od izlaganja uočenog kod bolesnika liječenih kliničkom dozom.
The observed adverse reactions for roflumilast in Study RO-2455- 404-RD were in line with those already included in section 4.8.
Nuspojave zabilježene u ispitivanju RO-2455-404-RD bile su u skladu s onima već zabilježenim u dijelu 4.8.
The observed adverse reactions from a pediatric clinical trial with the H5N1 vaccine are listed below.
Nuspojave zabilježene u pedijatrijskom kliničkom ispitivanju cjepiva H5N1 navedene su niže.
The observed adverse reactions which occurred more frequently with lenalidomide and dexamethasone than placebo and dexamethasone in pooled multiple myeloma clinical trials (MM-009 and MM-010) were fatigue (43.9%), neutropenia (42.2%), constipation (40.5%), diarrhoea (38.5%), muscle cramp (33.4%), anaemia (31.4%), thrombocytopenia (21.5%), and rash (21.2%).
Primijećene nuspojave koje su se u udruženim višestrukim kliničkim ispitivanjima multiplog mijeloma (MM-009 i MM-010) češće javile s lenalidomidom i deksametazonom nego s placebom i deksametazonom, bile su umor (43,9%), neutropenija (42,2%), konstipacija (40,5%), proljev (38,5%), grčevi u mišićima (33,4%), anemija (31,4%), trombocitopenija (21,5%) i osip (21,2%).
The observed adverse reactions which occurred more frequently with lenalidomide and dexamethasone than placebo and dexamethasone in pooled multiple myeloma clinical trials (MM-009 and MM-010) were fatigue (43.9%), neutropenia (42.2%), constipation (40.5%), diarrhoea (38.5%), muscle cramp (33.4%), anaemia (31.4%), thrombocytopenia (21.5%), and rash (21.2%).
Primijećene nuspojave, koje su se u udruženim višestrukim kliničkim ispitivanjima multiplog mijeloma (MM-009 i MM-010) češće javile s lenalidomidom i deksametazonom nego s placebom i deksametazonom, bile su: umor (43,9%), neutropenija (42,2%), konstipacija (40,5%), proljev (38,5%), grčevi u mišićima (33,4%), anemija (31,4%), trombocitopenija (21,5%) i osip (21,2%).
The observed difference in HbA1c over placebo was -0.72% after 52 weeks.
Primijećena razlika u HbA1c u odnosu na placebo bila je -0,72% nakon 52 tjedna.
The observed drug accumulation index is  2 times with once daily dosing, suggesting an effective accumulation half-life of about 24 hours.
Primijećeni indeks akumulacije lijeka je  2 puta veći s doziranjem jednom dnevno, što ukazuje na efektivni poluvijek akumulacije od oko 24 sata.
The observed excess risk of fractures for women in this dataset on pioglitazone is therefore 0.8 fractures per
Opaženo povećanje rizika od prijeloma u žena u ovom sklopu podataka o pioglitazonu stoga iznosi
The observed excess risk of fractures for women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use.
Opaženo povećanje rizika od prijeloma kosti u žena koje su u ovom ispitivanju uzimale pioglitazon je iznosilo 0,5 prijeloma na 100 bolesničkih godina primjene.
The observed excess risk of fractures for women on pioglitazone in this study is therefore 0.5 fractures per 100 patient years of use.
Opaženo povećanje rizika od prijeloma kosti u žena koje su u ovom ispitivanju uzimale pioglitazon stoga je iznosilo 0,5 prijeloma na 100 bolesnik- godina primjene.
The observed frequency is in line with control groups and prevalence reported in literature for symptomatic pre- menopausal women of this age group (mean of 40 years).
Opažena učestalost odgovara podacima za kontrolne skupine i prevalenciji objavljenoj u literaturi za žene ove dobne skupine (prosjek od 40 godina) sa simptomima predmenopauze.
The observed geometric mean ratios of Viramune prolonged-release to Viramune immediate-release were ~90 % for Cmin,ss and AUCss with 90 % confidence intervals within 80 %-125 %; the ratio for Cmax,ss was lower and consistent with a once-daily prolonged-release dosage form.
Opaženi omjeri geometrijske srednje vrijednosti Viramunea s produljenim oslobađanjem i Viramunea s trenutnim oslobađanjem bili su ~90 % za Cmin,ss i AUCss s intervalom pouzdanosti 90 % unutar 80 %-125 %; omjer za Cmax,ss bio je niži i odgovarao je jednokratnom dnevnom obliku doziranja s produljenim oslobađanjem.
The observed group C booster response with Nimenrix was similar to that observed in subjects primed and boosted with a monovalent MenC-CRM conjugate vaccine.
Uočeni odgovor grupe C na docjepljivanje cjepivom Nimenrix bio je sličan onome koji je uočen kod ispitanika koji su primarno cijepljeni i docijepljeni monovalentnim konjugiranim cjepivom MenC- CRM.
The observed incidence of antibody positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease, therefore, comparison of the incidence of antibodies to other products may be misleading.
Na uočenu incidenciju pozitivnog testa na protutijela može utjecati nekoliko čimbenika uključujući metodologiju testa, postupanje s uzorcima, vrijeme uzimanja uzoraka, istodobno primijenjeni lijekovi i osnovna bolest pa stoga usporedba pojavnosti protutijela u odnosu na druge lijekove može biti pogrešna.
The observed incidence of major and of minor non-ICH bleeds were similar in both groups:
Primijećena incidencija velikih i malih neintrakranijalnih krvarenja bila je slična u obje skupine:
The observed incidence of the less severe form of neutropenia (neutrophils <1.5x109/l) is 4.9% (2.5 cases per 100 patient-years).
Opažena incidencija manje teškog oblika neutropenije (neutrofili <1,5x109/l) je 4,9% (2,5 slučaja na 100 bolesnika-godina).
The observed lamivudine half-life of elimination is 5 to 7 hours.
Poluvrijeme izlučivanja lamivudina iznosi 5 - 7 sati.
The observed mean (SD) activity time profile following a single dose of ALPROLIX in patients with severe haemophilia B is shown below (see Table 6).
Opažena srednja vrijednost (SD) profila aktivnosti u vremenu nakon jedne doze lijeka ALPROLIX u bolesnika s teškom hemofilijom B prikazana je niže (vidjeti tablicu 4).
The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (22.2/17.2 mmHg with 40 mg/5 mg; 22.5/19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (21.0/17.6 mmHg) and associated with significant lower oedema rates (1.4 % with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg).
Primijećene prosječne promjene sistoličkog/dijastoličkog krvnog tlaka uz kombiniranu terapiju s amlodipinom 5 mg (-22,2/- 17,2 mmHg s 40 mg/5 mg; -22,5/19,1 mmHg uz 80 mg/5 mg) bile su usporedive ili veće od onih primijećenih uz amolodipin 10 mg (-21,0/-17,6 mmHg) te povezane sa značajno nižim stopama edema (1,4 % uz 40 mg/5 mg; 0,5 % uz 80mg/5 mg; 17,6 % uz amlodipin 10 mg).
The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (22.2/17.2 mmHg with 40 mg/5 mg; 22.5/19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (21.0/17.6 mmHg) and associated with significant lower oedema rates (1.4 % with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg).
Primijećene prosječne promjene sistoličkog/dijastoličkog krvnog tlaka uz kombiniranu terapiju s amlodipinom 5 mg (-22,2/- 17,2 mmHg s 40 mg/5 mg; -22,5/19,1 mmHg uz 80 mg/5 mg) bile su usporedive ili veće od onih primijećenih uz amolodipin 10 mg (-21,0/-17,6 mmHg) te povezane sa značajno nižom učestalošću edema (1,4 % uz 40 mg/5 mg; 0,5 % uz 80 mg/5 mg; 17,6 % uz amlodipin 10 mg).
The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (22.2/17.2 mmHg with 40 mg/5 mg; 22.5/19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (21.0/17.6 mmHg) and associated with significant lower oedema rates (1.4 % with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg).
Primijećene prosječne promjene sistoličkog/dijastoličkog krvnog tlaka uz kombiniranu terapiju s amlodipinom 5 mg (-22,2/- 17,2 mmHg s 40 mg/5 mg; -22,5/19,1 mmHg uz 80 mg/5 mg) bile su usporedive ili veće od onih primijećenih uz amolodipin 10 mg (-21,0/-17,6 mmHg) te povezane sa značajno nižom učestalošću edema (1,4 % uz 40 mg/5 mg; 0,5 % uz 80mg/5 mg; 17,6 % uz amlodipin 10 mg).
The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (22.2/17.2 mmHg with 40 mg/5 mg; 22.5/19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (21.0/17.6 mmHg) and associated with significant lower oedema rates (1.4 % with 40 mg/5 mg; 0.5% with 80 mg/5 mg; 17.6 % with amlodipine 10 mg).
Primijećene prosječne promjene sistoličkog/dijastoličkog krvnog tlaka uz kombiniranu terapiju s amlodipinom 5 mg (-22,2/- 17,2 mmHg s 40 mg/5 mg; -22,5/-19,1 mmHg uz 80 mg/5 mg) bile su usporedive ili veće od onih primijećenih uz amolodipin 10 mg (-21,0/-17,6 mmHg) te povezane sa značajno nižom učestalošću edema (1,4% uz 40 mg/5 mg; 0,5% uz 80mg/5 mg; 17,6% uz amlodipin 10 mg).
The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg (22.2/17.2 mmHg with 40 mg/5 mg; 22.5/19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg (21.0/17.6 mmHg) and associated with significant lower oedema rates (1.4% with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg).
Primijećene prosječne promjene sistoličkog/dijastoličkog krvnog tlaka uz kombiniranu terapiju s amlodipinom 5 mg (-22,2/- 17,2 mmHg s 40 mg/5 mg; -22,5/-19,1 mmHg uz 80 mg/5 mg) bile su usporedive ili veće od onih primijećenih uz amolodipin 10 mg (-21,0/-17,6 mmHg) te povezane sa značajno nižim stopama edema (1,4% uz 40 mg/5 mg; 0,5% uz 80mg/5 mg; 17,6% uz amlodipin 10 mg).
The observed OS benefit was consistently demonstrated across subgroups of patients including baseline ECOG performance status, M stage, history of brain metastases, and baseline LDH level.
Opaženi korisni učinci na OS dosljedno su bili primjetni u svim podskupinama bolesnika, uključujući početni funkcionalni ECOG status, metastatski stadij, metastaze u mozgu u anamnezi i početnu vrijednost LDH.
The observed signs and symptoms for overdose were consistent with the known undesirable events associated with topotecan (see section 4.8).
Nije poznat antidot za predoziranje topotekanom.
The observed signs and symptoms for overdose were consistent with the known undesirable events associated with topotecan (see section 4.8).
Primijećeni znakovi i simptomi predoziranja bili su u skladu s poznatim nuspojavama povezanima s primjenom topotekana (vidjeti dio 4.8).
The observed treatment difference (95% CI) between ivacaftor and placebo was 10.7% (7.3, 14.1) (P<0.0001).
Opažena terapijska razlika (95% CI) između ivakaftora i placeba iznosila je 10,7% (7,3; 14,1) (P < 0,0001).
The observed values of the peak concentrations are 9 fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
Opažene vrijednosti vršnih koncentracija su 9 puta veće nego IC50 abakavira od 0,08 µg/ml ili 0,26 µM kad se abakavir daje u dozi od 600 mg dvaput na dan.
The observed values of the peak concentrations are 9 fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
Opažene vrijednosti vršnih koncentracija su 9 puta veće nego IC50 abakavira od 0,08 g/ml ili 0,26 M kad se abakavir daje u dozi od 600 mg dvaput na dan.
The observed values of the peak concentrations are 9 fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
Opažene vrijednosti vršnih koncentracija su 9 puta veće nego IC50 abakavira od 0,08 g/ml ili 0,26 M, kad se abakavir daje u dozi od 600 mg dvaput na dan.
The observed values of the peak concentrations are 9 fold greater than the IC50 of abacavir of 0.08 µg/ml or 0.26 µM when abacavir is given at 600 mg twice daily.
Primijećene vrijednosti vršnih koncentracija deveterostruko su veće od IC50 abakavira od 0,08 µg/ml ili 0,26 µM nakon primjene doze abakavira od 600 mg dvaput na dan.
The OBT was selected on the basis of the subject’s prior treatment history and baseline genotypic and phenotypic viral resistance measurements.
OBT je određen temeljem iskustava iz ranijeg liječenja bolesnika kao i određivanjem početne genotipske i fenotipske rezistencije virusa.
The occurrence of activity-neutralising antibodies (inhibitors) is a very rare event in previously treated patients receiving factor IX-containing products.
Pojava protutijela (inhibitora) koji poništavaju njegovu aktivnost je vrlo rijetka pojava u dosad liječenih pacijenata koji su primali lijekove koji sadrže faktor IX.
The occurrence of anaphylaxis remained rare between the double blind and long-term open-label experience.
Pojava anafilaksije je bila rijetko zabilježena i u dvostruko slijepom i dugoročnom otvorenom ispitivanju.
The occurrence of diarrhea seems to be dose-dependent between 1 and 3 mg/kg/day.
Pojava proljeva čini se ovisna o dozi od 1 i 3 mg/kg/dnevno.
The occurrence of IgE antibodies was not fully explored.
Pojava IgE protutijela nije u potpunosti istražena.
The occurrence of neutralising antibodies (inhibitors) to factor VIII is well known in the treatment of patients with haemophilia A. As with all coagulation factor VIII products, patients are to be monitored for the development of inhibitors that are to be titrated in Bethesda Units (BUs) using the Nijmegen modification of the Bethesda assay.
Nastanak neutralizirajućih protutijela (inhibitora) na faktor VIII dobro je poznat u liječenju bolesnika s hemofilijom A. Kao i sa svim lijekovima s koagulacijskim faktorom VIII, bolesnike je potrebno nadzirati zbog razvoja inhibitora, koje treba titrirati u Bethesda jedinicama (BU) primjenjujući Nijmegenovu modifikaciju Bethesda-testa.
The occurrence of secondary cancers, including AML and MDS, may occur during or after treatment with Pixuvri.
Pojava sekundarnih maligniteta, uključujući AML i MDS, može se javiti za vrijeme ili poslije liječenja Pixuvriom.
The occurrence of such a reaction is more likely in the first year of treatment.
Pojavnost takve rekacije vjerojatnija je u prvoj godini liječenja.
The occurrence of such reactions depends on individual factors, such as dietary habits, dosage, exercise and stress.
Pojava takvih reakcija ovisi, kao što je slučaj kod svih terapija za liječenje dijabatesa, individualnim faktorima kao što su prehrambene navike, doza, tjelovježba i stres.
The occurrence of such reactions depends on individual factors, such as dietary habits, dosage, exercise and stress.
Pojava takvih reakcija ovisi, kao što je slučaj kod svih terapija za liječenje dijabatesa, o individualnim faktorima kao što su prehrambene navike, doza, tjelovježba i stres.
The occurrence of the first episode of acute otitis media caused by S. pneumoniae was approximately halved among children who were given the vaccine compared with those given the comparator.
Nastupanje prve epizode akutne otitis media uzrokovane bakterijom S. pneumoniae bilo je umanjeno za otprilike pola u djece koja su primila cjepivo u usporedbi s onom djecom koja su primila komparator.
The occurrence of these events may be linked to the patients’ disease evolution.
Pojava ovih dogañaja može se povezati s napredovanjem osnovne bolesti.
The odd numbers, after the number 1, are shown as full lines.
Neparne brojeve, nakon broja jedan,
The odd numbers, after the number 1, are shown as full lines.
Neparne brojeve, nakon broja jedan, označava puna crta.
The odd numbers, after the number one, are shown as full lines.
Neparne brojeve, nakon broja jedan, označava puna crta.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2 – 5%.
Stope edema u skupinama koje su primale usporedni lijek (sulfonilureju, metformin) iznosile su 2–5%.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Stope edema u skupinama koje su primale usporedni lijek (sulfonilureju, metformin) bile su 2–5%.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2-5%.
Stope edema u skupinama koje su primale usporedni lijek (sulfonilureju, metformin) iznosile su 2–5%.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2–5%.
Stope edema u skupinama koje su primale usporedni lijek (sulfonilureju, metformin) iznosile su 2-5%.
The oedema rates for comparator groups (sulphonylurea, metformin) were 2–5%.
Stope edema u skupinama koje su primale usporedni lijek (sulfonilureju, metformin) iznosile su 2–5%.
The oedema related events (peripheral oedema, generalised oedema, and oedema) were consistently lower in patients who received Twynsta as compared to patients who received amlodipine 10 mg.
Bilo je konstatno manje edema (periferni edem, generalizirani edem i edem) kod bolesnika koji su primali Twynstu u usporedbi s bolesnicima koji su primali amlodipin 10 mg.
The off-white, oval tablets are imprinted with “Renagel 400” on one side.
Bjelkaste, ovalne tablete na jednoj strani imaju otisnutu oznaku “Renagel 400”.
The off-white, oval tablets are imprinted with “Renagel 800” on one side.
Bjelkaste, ovalne tablete na jednoj strani imaju otisnutu oznaku “Renagel 800”.
The off-white, oval tablets are imprinted with “SH800” on one side.
Bjelkaste, ovalne tablete na jednoj strani imaju otisnutu oznaku “SH800”.
The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty breathing or fluid in your stomach or chest.
OHSS može postati težak s jasno uvećanim jajnicima, smanjenim stvaranjem mokraće, dobivanjem na težini, poteškoćama pri disanju te nakupljanjem tekućine u trbuhu ili prsnom košu.
The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and possible fluid accumulation in your stomach or chest.
OHSS može postati ozbiljan s jasno uvećanim jajnicima, smanjenim stvaranjem mokraće, dobivanjem na težini, poteškoćama u disanju te mogućim nakupljanjem tekućine u trbuhu ili prsnom košu.
The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and possible fluid accumulation in your stomach or chest.
OHSS može postati ozbiljan s jasno uvećanim jajnicima, smanjenim stvaranjem mokraće, dobivanjem na tjelesnoj težini, poteškoćama u disanju te mogućim nakupljanjem tekućine u trbuhu ili prsima.
The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
OHSS može postati težak uz jasno uvećane jajnike, smanjeno stvaranje mokraće, povećanje tjelesne težine, poteškoće pri disanju i/ili s mogućim nakupljanjem tekućine u trbuhu ili prsnom košu.
The OHSS may become severe with clearly enlarged ovaries, decreased urine production, weight gain, difficulty in breathing and/or possible fluid accumulation in your stomach or chest.
OHSS može postati težak uz jasno uvećane jajnike, smanjeno stvaranje urina, dobivanje na težini, poteškoće pri disanju i/ili s mogućim nakupljanjem tekućine u trbuhu ili prsnom košu.
The on-animal ovicidal activity of (S)-methoprene results from either direct penetration of the eggshell of newly laid eggs or from absorption through the cuticle of the adult fleas. (S)-Methoprene is also effective in preventing flea larvae and pupae from developing, which prevents contamination of the environment of the treated animals with the immature stages of fleas.
Na životinjama ovicidna aktivnost (S)-metoprena očituje se izravnim prodiranjem kroz ljusku novo izleglih jaja ili apsorpcijom kroz kutikulu odraslih buha. (S)-metopren učinkovito prekida razvoj kukuljice i ličinke, te sprječava nagomilavanje nezrelih stadija buha u okolišu.
The on-animal ovicidal activity of (S)-methoprene results from either direct penetration of the eggshell of newly laid eggs or from absorption through the cuticle of the adult fleas. (S)-methoprene is also effective in preventing flea larvae and pupae from developing, which prevents contamination of the environment of the treated animals with the immature stages of fleas.
Ovicidalno djelovanje (S)-metoprena na životinjama posljedica je bilo izravnog ulaska u ljusku novo izleglog jajašca ili apsorpcije kroz kutikulu odraslih buha. (S)-metopren je također učinkovit u sprječavanju razvoja buhe u fazi larve i kukuljice, čime se sprječava kontaminaciju okoliša tretiranih životinja buhama u stadiju razvoja.
The on-demand treatment of acute bleeds or breakthrough bleeds with NovoThirteen has not been studied in clinical trials.
Liječenje akutnih krvarenja prema potrebi ili probojnih krvarenja lijekom NovoThirteen nije ispitivano u kliničkim ispitivanjima.
The once daily regimen of abacavir is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.
Režim doziranja abakavira jedanput na dan podupire multicentrična, dvostruko slijepa, kontrolirana studija (CNA30021), provedena na 770 prethodno neliječenih odraslih bolesnika zaraženih virusom HIV tijekom 48 tjedana.
The once weekly dose of romiplostim should be increased by increments of 1 μg/kg until the patient achieves a platelet count ≥ 50 x 109/l.
Daljnja tjedna doza romiplostima mora se povećavati za po 1 µg/kg, sve dok se kod bolesnika ne postigne broj trombocita ≥ 50 x 109/l.
The one-month standard pack contains 56 x 30 mg tablets.
Standardno pakiranje za mjesec dana liječenja sadrži 56 tableta x 30 mg.
The ones marked may be related to busulfan.
Nuspojave označene zvjezdicom (*) mogu biti povezane s primjenom busulfana.
The only adverse event reported to date was hypotension.
Jedina do sada prijavljena nuspojava je hipotenzija.
The only adverse reactions commonly leading to discontinuation of Tasmar in clinical trials was diarrhoea (see section 4.4).
Jedina nuspojava koja je obično vodila do prekida liječenja Tasmarom u kliničkim ispitivanjima bio je proljev (vidjeti dio 4.4).
The only common adverse reaction observed following Cinryze infusion in clinical studies was rash; descriptions of rash characteristics were non-specific, but were typically described as involving the upper extremities, chest, abdomen, or injection site.
Jedina česta nuspojava opažena nakon infuzije lijeka Cinryze u kliničkim ispitivanjima bio je osip; opisi značajki osipa bili su nespecifični, ali tipično se navodilo da zahvaćaju ekstremitete, prsište, abdomen ili mjesto injekcije.
The only common side effect seen in studies with Cinryze (seen in between 1 and 10 patients in 100) is rash, which is not serious and typically involves the arms, chest, abdomen or the injection site.
Jedina česta nuspojava lijeka Cinryze zabilježena u ispitivanjima (zabilježena u 1 do 10 na 100 bolesnika) jest osip blažeg stupnja koji uglavnom zahvaća ruke, prsa, abdomen ili mjesto injekcije.
The only consistently reported adverse event was musculoskeletal pain which is no different from the experience in the adult population.
Jedina dosljedno prijavljivana nuspojava bila je mišićno-koštanu bol, što se ne razlikuje od iskustva u odrasle populacije.