natgillin/translations-raw huggingface dataset:
In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section 4.4).
V kliničnih raziskavah in v obdobju trženja so poročali o primerih neželenih učinkov na pljučih, vključno z intersticijsko boleznijo pljuč, pljučnim edemom in pljučno infiltracijo, pri čemer je v nekaj primerih prišlo do odpovedi dihanja ali sindroma akutne dihalne stiske (ARDS), ki je lahko smrten (glejte poglavje 4.4).
In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section 4.4).
V kliničnih študijah in v obdobju trženja so neželeni učinki na pljučih vključevali intersticijsko pljučno bolezen, pljučni edem in pljučne infiltrate in so imeli v nekaterih primerih za posledico dihalno odpoved ali sindrom akutne dihalne stiske (ARDS), ki sta lahko usodna (glejte poglavje 4.4).
In clinical studies and the post-marketing setting pulmonary adverse effects including interstitial lung disease, pulmonary oedema, and lung infiltration have been reported in some cases with an outcome of respiratory failure or acute respiratory distress syndrome (ARDS), which may be fatal (see section 4.4).
V kliničnih študijah in v obdobju trženja so poročali o pljučnih neželenih učinkih, ki so vključevali intersticijsko pljučno bolezen, pljučni edem in pljučne infiltrate ter so imeli v nekaterih primerih za posledico odpoved dihanja ali sindrom dihalne stiske pri odraslem (ARDS), ki je lahko usoden (glejte poglavje 4.4).
In clinical studies comparing PROCYSBI to the immediate-release cysteamine bitartrate, one third of the patients exhibited very common GI disorders (nausea, vomiting, abdominal pain).
V kliničnih študijah, v katerih so primerjali zdravilo PROCYSBI s cisteaminijevim bitartratom s takojšnjim sproščanjem, so pri tretjini bolnikov opazili zelo pogoste bolezni prebavil (navzea, bruhanje, bolečine v trebuhu).
In clinical studies concurrent administration of TNF-antagonists and abatacept has been associated with an increased risk of infections including serious infections compared to TNF-antagonists alone, without increased clinical benefit.
V kliničnih študijah je bila sočasna uporaba antagonistov TNF in abatacepta povezana s povečanim tveganjem za okužbe, vključno z resnimi okužbami, v primerjavi z uporabo samih antagonistov TNF, ni pa bilo nobene dodatne klinične koristi njegove sočasne uporabe.
In clinical studies discontinuation was achieved by reducing the dose by approximately 25% every two days.
V kliničnih študijah so dosegli ukinitev zdravila tako, da so odmerek zmanjševali za približno 25 % vsak drugi dan.
In clinical studies employing planar imaging techniques, Quadramet accumulates with a lesion-to- normal bone ratio of approximately 5 and a lesion-to-soft tissue ratio of approximately 6.
V kliničnih študijah, kjer uporabljajo planarne tehnike slikanja, se Quadramet v lezijah kopiči v razmerju približno 5:1 glede na normalno kostno tkivo in v razmerju 6:1 glede na mehko tkivo.
In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to Aloxi, were headache (9 %) and constipation (5 %).
V kliničnih študijah pri odraslih pri odmerku 250 mikrogramov (skupaj 633 bolnikov) sta bila najpogostejša neželena učinka, ki ju je mogoče pripisati zdravilu Aloxi, glavobol (9 %) in zaprtje (5 %).
In clinical studies in Cushing’s disease patients, QTcF of >500 msec was observed in two out of 201 patients.
V kliničnih študijah pri bolnikih s Cushingovo boleznijo so pri dveh bolnikih od 201 opažali dolžino intervala QTcF več kot 500 milisekund.
In clinical studies in hypertensive patients, Rasilez had no clinically important effects on total cholesterol, high density lipoprotein cholesterol (HDL-C), fasting triglycerides, fasting glucose or uric acid.
V kliničnih študijah s hipertenzivnimi bolniki zdravilo Rasilez ni klinično pomembno vplivalo na vrednosti celokupnega holesterola, holesterola lipoproteinov visoke gostote (HDL holesterola), trigliceridov na tešče, glukoze na tešče in sečne kisline.
In clinical studies in kidney transplant patients receiving Envarsus, the most frequent adverse reactions (at least in 2% of patients) were tremor, diabetes mellitus, blood creatinine increased, urinary tract infection, hypertension, BK virus infection, renal impairment, diarrhoea, toxicity to various agents, and toxic nephropathy all of which are known to occur in the respective patient population under immunosuppressive treatment.
V kliničnih študijah pri bolnikih s presaditvijo ledvic, ki so jemali zdravilo Envarsus, so bili najpogosteje poročani neželeni učinki (pojavili so se pri vsaj 2 % bolnikov) tremor, sladkorna bolezen, zvišanje kreatinina v krvi, okužbe sečil, hipertenzija, okužba z virusom BK, okvara ledvic, driska, toksičnost na različne učinkovine in toksična nefropatija, za katere je znano, da se pri imunosupresivnem zdravljenju pojavljajo pri zadevni populaciji bolnikov.
In clinical studies in Parkinson’s patients, the 6 month-specific rates of peripheral oedema remained at about 4% through the entire observation period up to 36 months.
V kliničnih študijah pri bolnikih s Parkinsonovo boleznijo je bila po šestih mesecih specifična pogostnost perifernih edemov približno 4-odstotna in je taka ostala ves čas opazovanja do 36 mesecev.
In clinical studies in patients treated with pembrolizumab 2 mg/kg every 3 weeks or 10 mg/kg every two or three weeks, 19 (1.7%) of 1,087 evaluable patients tested positive for treatment-emergent antibodies to pembrolizumab.
V kliničnih študijah pri bolnikih, zdravljenih s pembrolizumabom v odmerku 2 mg/kg na 3 tedne ali 10 mg/kg na dva ali tri tedne, je imelo 19 (1,7 %) od 1.087 ocenjenih bolnikov pozitiven izvid testiranja med zdravljenjem nastalih protiteles proti pembrolizumabu.
In clinical studies in patients with advanced phase CML receiving SPRYCEL at the recommended dose (n=304), grade 3 or 4 fluid retention was reported in 8% of patients, including grade 3 or 4 pleural and pericardial effusion reported in 7% and 1% of patients, respectively.
V kliničnih študijah pri bolnikih s KML v napredovalem obdobju, ki so zdravilo SPRYCEL prejemali v priporočenem odmerku (n=304), so o zastajanju tekočin stopnje 3 ali 4 poročali pri 8% bolnikov, vključno s plevralnim izlivom stopnje 3 ali 4, o katerem so poročali pri 7% bolnikov, in perikardialnim izlivom stopnje 3 ali 4, o katerem so poročali pri 1% bolnikov.
In clinical studies in patients with HIV, the only undesirable effects that were consistently considered to be related to filgrastim administration were musculoskeletal pain, bone pain and myalgia.
V kliničnih študijah pri bolnikih s HIV so bili edini neželeni učinki, dosledno ocenjeni kot povezani z uporabo filgrastima, mišično-skeletna bolečina, bolečina v kosteh in mialgija.
In clinical studies in patients with HIV, the only undesirable effects that were consistently considered to be related to filgrastim administration were musculoskeletal pain, bone pain and myalgia.
V kliničnih študijah pri bolnikih s HIV so bili edini neželeni učinki, za katere je vedno prevladalo mnenje, da so povezani z dajanjem filgrastima, mišično-skeletna bolečina, pretežno blage do zmerne bolečine v kosteh in mialgija.
In clinical studies in patients with HIV, the only undesirable effects that were consistently considered to be related to filgrastim administration were musculoskeletal pain, bone pain and myalgia.
V kliničnih študijah pri bolnikih s HIV so bili edini neželeni učinki, za katere so utemeljeno menili, da so povezani z uporabo filgrastima, mišično-skeletna bolečina, bolečina v kosteh in mialgija.
In clinical studies in RA and CAPS patients, transient elevations of liver enzymes have been seen uncommonly.
V kliničnih študijah bolnikov z RA in CAPS so občasno opazili prehodna zvišanja vrednosti jetrnih encimov.
In clinical studies in RA patients, thrombocytopenia has been reported in 1.9% of treated patients compared to 0.3% in the placebo group.
V kliničnih študijah bolnik z RA so poročali o trombocitopeniji pri 1,9 % zdravljenih bolnikov v primerjavi z 0,3 % v skupini, ki je prejemala placebo.
In clinical studies in RA patients, transient elevations of liver enzymes have been seen uncommonly.
V kliničnih študijah bolnikov z RA in CAPS so občasno opazili prehodna zvišanja vrednosti jetrnih encimov.
In clinical studies in volunteers rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated.
V kliničnih študijah pri prostovoljcih so ti dobro prenesli rosiglitazon, uporabljen v enkratnih peroralnih odmerkih do 20 mg.
In clinical studies in which some of the vaccinees received Infanrix hexa concomitantly with Prevenar (PCV7) as a booster (4th) dose of both vaccines, fever  38.0°C was reported in 43.4% of infants receiving Prevenar and Infanrix hexa at the same time as compared to 30.5% of infants receiving the hexavalent vaccine alone.
V kliničnih študijah, v katerih so nekateri cepljeni otroci dobili cepivo Infanrix hexa sočasno s cepivom Prevenar (PCV7) kot obnovitveni (4.) odmerek obeh cepiv, so poročali o zvišani telesni temperaturi  38,0 °C pri 43,4 % otrok, ki so obenem dobili cepivo Prevenar in cepivo Infanrix hexa, v primerjavi s 30,5 % otrok, ki so dobili samo heksavalentno cepivo.
In clinical studies involving 1680 patients, OPATANOL was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg.
V kliničnih študijah pri 1680 bolnikih so zdravilo OPATANOL vkapali v obe očesi enkrat do štirikrat na dan v času do štirih mesecev, kot monoterapijo ali kot adjuvantno terapijo ob loratadinu v odmerku 10 mg.
In clinical studies involving 2170 patients treated with DuoTrav the most frequently reported treatment-related adverse reaction was ocular hyperaemia (12.0%)..
Najpogosteje poročan z zdravljenjem povezan neželen učinek v kliničnih študijah pri 2170 bolnikih, zdravljenih z zdravilom DuoTrav, je bila očesna hiperemija (12,0%).
In clinical studies involving 2732 patients treated with AZOPT as monotherapy or adjunctive therapy to timolol maleate 5 mg/ml, the most frequently reported treatment-related adverse reactions were: dysgeusia (6.0%) (bitter or unusual taste, see description below) and temporary blurred vision (5.4%) upon instillation, lasting from a few seconds to a few minutes (see also section 4.7).
V kliničnih študijah pri 2732 bolnikih, zdravljenih z zdravilom AZOPT v obliki monoterapije ali dodatnega zdravljenja s timololijevim maleatom 5 mg/ml, so bili, z zdravljenjem povezani, najpogostejši neželeni učinki naslednji: disgevzija (6,0%) (grenak ali nenavaden okus, glejte opis spodaj) in začasno zamegljen vid (5,4%) po vkapanju zdravila, ki je trajal od nekaj sekund do nekaj minut (glejte tudi poglavje 4.7).
In clinical studies involving 63 paediatric patients between 0 and 12 years of age and 24 adolescents between 12 and 18 years of age with severe haemophilia A no difference in the safety profile of NovoEight was observed between paediatric patients and adults.
V kliničnih študijah, ki so zajele 63 pediatričnih bolnikov, starih od 0 do 12 let, in 24 mladostnikov, starih od 12 do 18 let, ki so imeli hudo hemofilijo A, pri pediatričnih bolnikih niso ugotovili razlik v varnostnih značilnostih zdravila NovoEight v primerjavi z odraslimi.
In clinical studies Lonsurf was administered within 1 hour after completion of the morning and evening meals (see section 4.2).
V kliničnih študijah so zdravilo Lonsurf jemali najpozneje 1 uro po zaključku jutranjega in večernega obroka (glejte poglavje 4.2).
In clinical studies low white blood cell counts were seen in 2.1% of Fampyra patients versus 1.9% of patients on placebo.
V kliničnih študijah so opazili znižanje belih krvnih celic pri 2,1 % bolnikov, ki so jemali zdravilo Fampyra, v primerjavi z 1,9 % bolnikov, ki so prejemali placebo.
In clinical studies MenACWY-TT-039 and MenACWY-TT-040 a single dose of Nimenrix elicited rSBA responses against the four meningococcal groups, with a response against group C that was comparable to the one elicited by the licensed MenC-CRM vaccine in term of percentages with rSBA titres ≥8 (Table 1).
V kliničnih študijah MenACWY-TT-039 in MenACWY-TT-040 je en odmerek cepiva Nimenrix povzročil odzive rSBA proti štirim meningokoknim skupinam; odziv proti skupini C je bil (kar zadeva odstotke s titri rSBA ≥ 8) primerljiv odzivu na odobreno cepivo MenC-CRM (preglednica 1).
In clinical studies of Genvoya, increases in serum creatinine occurred by Week 2 of treatment and remained stable through 96 weeks.
V kliničnih študijah z zdravilom Genvoya se je pojavilo zvišanje serumskega kreatinina do 2. tedna zdravljenja in je ostalo stabilno do konca 96. tedna.
In clinical studies of HIV-1 uninfected individuals, small decreases in BMD were observed.
V klinični študiji, ki je vključevala posameznike, ki niso bili okuženi z virusom HIV–1, so opazili majhno zmanjšanje MKG.
In clinical studies of non-liposomal irinotecan administered on a weekly dosage schedule, patients with modestly elevated baseline serum total bilirubin levels (1.0 to 2.0 mg/dl) had a significantly greater likelihood of experiencing first cycle Grade 3 or Grade 4 neutropenia than those with bilirubin levels that were less than 1.0 mg/dl.
V kliničnih študijah z neliposomskim irinotekanom, danim v obliki tedenskega odmerjanja, so imeli bolniki z zmerno zvišanimi ravnmi izhodiščnega skupnega bilirubina v serumu (1,0 do 2,0 mg/dl) pomembno večjo verjetnost, da v prvem ciklu doživijo nevtropenijo 3. ali 4. stopnje, kot bolniki z ravnmi bilirubina pod 1,0 mg/dl.
In clinical studies of patients with non-Hodgkin’s lymphoma and multiple myeloma, mobilisation of tumour cells has not been observed with plerixafor.
V kliničnih študijah pri bolnikih z ne-Hodgkinovim limfomom in multiplim mielomom niso opazili mobilizacije tumorskih celic s pleriksaforjem.
In clinical studies of patients with Non-Hodgkin’s lymphoma, the addition of rituximab to a mobilisation regimen of plerixafor and G-CSF did not impact patient safety or CD34+ cell yield.
V kliničnih študijah pri bolnikih z ne-Hodgkinovim limfomom dodatek rituksimaba k predpisanemu odmerjanju pleriksaforja in G-CSF za mobilizacijo ni vplival na varnost bolnikov ali na število CD34+ celic.
In clinical studies of prolonged-release exenatide, approximately 45 % of patients had low titre antibodies to exenatide at study endpoint.
Na koncu kliničnih študij z eksenatidom v obliki s podaljšanim sproščanjem je imelo približno 45 % bolnikov nizke titre protiteles proti eksenatidu.
In clinical studies of RA, 775 patients treated with daily Kineret doses of 30mg, 75mg, 150mg, 1mg/kg or 2mg/kg, there was an increase of 2.4% to 5.3% in total cholesterol levels 2 weeks after start of Kineret treatment, without a dose-response relationship.
V kliničnih študijah RA je bilo 775 bolnikov zdravljenih z dnevnimi odmerki 30 mg, 75 mg, 150 mg, 1 mg/kg ali 2 mg/kg zdravila Kineret in 2 tedna po začetku zdravljenja z zdravilom Kineret se je raven skupnega holesterola povišala z 2,4 % na 5,3 %, neodvisno od odmerka.
In clinical studies of RA, 775 patients treated with daily Kineret doses of 30mg, 75mg, 150mg, 1mg/kg or 2mg/kg, there was an increase of 2.4% to 5.3% in total cholesterol levels 2 weeks after start of Kineret treatment, without a dose-response relationship.
V kliničnih študijah RA je bilo 775 bolnikov zdravljenih z dnevnimi odmerki30 mg, 75 mg, 150 mg, 1 mg/kg ali 2 mg/kg zdravila Kineret in 2 tedna po začetku zdravljenja z zdravilom Kineret se je raven skupnega holesterola povišala z 2,4 % na 5,3 %, neodvisno od odmerka.
In clinical studies of secondarily infected open wounds, the efficacy of retapamulin was inadequate in patients with infections caused by MRSA.
V kliničnih študijah sekundarno okuženih odprtih ran pri bolnikih z okužbami, povzročenimi z MRSA, učinkovitost retapamulina ni bila zadostna.
In clinical studies of sunitinib and from post-marketing experience, seizures have been observed in subjects with or without radiological evidence of brain metastases.
V kliničnih študijah s sunitinibom in v obdobju trženja so konvulzije opažali pri preskušancih z radiološkimi znaki metastaz v možganih ali brez njih.
In clinical studies of treatment-experienced patients, rash, irrespective of causality, was more commonly observed with regimens containing ISENTRESS and darunavir compared to those containing ISENTRESS without darunavir or darunavir without ISENTRESS.
V kliničnih študijah pri že zdravljenih bolnikih so ne glede na vzrok izpuščaj pogosteje opazili pri bolnikih, ki so prejemali zdravilo ISENTRESS in darunavir, kot pri bolnikih, ki so prejemali zdravilo ISENTRESS brez darunavirja ali darunavir brez zdravila ISENTRESS.
In clinical studies of up to two years duration, there was no accelerated decline beyond 3-6 months.
V kliničnih študijah, ki so trajale do 2 leti dolgo, po prvih 3-6 mesecih ni bilo pospešenega zmanjševanja.
In clinical studies Orgalutran was used with recombinant human follicle stimulating hormone (FSH) or corifollitropin alfa, the sustained follicle stimulant.
V kliničnih študijah so zdravilo Orgalutran uporabljali skupaj z rekombinantnim folikle stimulirajočim hormonom (FSH) ali korifolitropinom alfa, dolgo delujočim stimulatorjem foliklov.
In clinical studies patients converted from twice daily Prograf were converted to Envarsus at 1: 0.85(mg:mg).
V kliničnih študijah so pri prehodu bolnikov z zdravila Prograf dvakrat na dan na zdravilo Envarsus uporabili razmerje 1:0,85 (mg:mg).
In clinical studies patients older than 65 years tended to titrate to a lower effective dose than younger patients.
V kliničnih študijah je bil učinkovit odmerek pri bolnikih, starih več kot 65 let, običajno nižji kot pri mlajših bolnikih.
In clinical studies patients using inhaled tobramycin continued to take dornase alfa, bronchodilators, inhaled corticosteroids and macrolides.
V kliničnih študijah so bolniki, ki so inhalirali tobramicin, še naprej uporabljali dornazo alfa, bronhodilatatorje, inhalacijske kortikosteroide in makrolide.
In clinical studies performed in this population ribavirin and interferon alfa-2b were used in doses of 15 mg/kg/day and 3 million international units (MIU)/m2 three times a week respectively (Table 1).
V kliničnih študijah, opravljenih na tej populaciji, so uporabljali odmerek ribarivina 15 mg/kg/dan in odmerek interferona alfa-2b 3 milijone mednarodnih enot (MIU)/m2 tri krat na dan (Preglednica 1).
In clinical studies performed in this population ribavirin and interferon alfa-2b were used in doses of 15 mg/kg/day and 3 million international units (MIU)/m2 three times a week respectively (Table 2).
V kliničnih študijah izvajanih s to populacijo sta se ribavirin in interferon alfa-2b uporabljal v odmerku 15 mg/kg/dan in 3 milijone internacionalnih enot (MIU)/m2 trikrat na dan (preglednica 2).
In clinical studies Rasilez has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated GFR < 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
V kliničnih študijah zdravila Rasilez niso raziskovali pri hipertenzivnih bolnikih s hudo okvaro ledvic (kreatinin v serumu ≥ 150 μmol/l oziroma 1,70 mg/dl pri ženskah in ≥ 177 μmol/l oziroma 2,00 mg/dl pri moških in/ali ocenjeno GFR < 30 ml/min/1,73 m2), pri bolnikih, ki so se že zdravili z dializo, pri bolnikih z nefrotskim sindromom ali z renovaskularno hipertenzijo.
In clinical studies seizures were observed in 1.4% of cinacalcet treated patients and 0.7% of placebo- treated patients.
V kliničnih študijah so konvulzije opažali pri 1,4% bolnikov, zdravljenih s cinakalcetom in 0,7% bolnikov, ki so dobivali placebo.
In clinical studies seizures were observed in 1.4% of Mimpara treated patients and 0.7% of placebo-treated patients.
V kliničnih študijah so konvulzije opažali pri 1,4 % bolnikov, zdravljenih z zdravilom Mimpara, in 0,7 % bolnikov, ki so dobivali placebo.
In clinical studies Sprimeo has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated GFR < 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
V kliničnih študijah zdravila Sprimeo niso raziskovali pri hipertenzivnih bolnikih s hudo okvaro ledvic (kreatinin v serumu ≥ 150 μmol/l oziroma 1,70 mg/dl pri ženskah in ≥ 177 μmol/l oziroma 2,00 mg/dl pri moških in/ali ocenjeno hitrostjo GFR < 30 ml/min/1,73 m2), pri bolnikih, ki so se že zdravili z dializo, pri bolnikih z nefrotskim sindromom ali z renovaskularno hipertenzijo.
In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10-25 years at the time of enrolment), Cervarix was administered to 16,142 females whilst
V klinične študije so bile vključene deklice in ženske, stare od 10 do 72 let (ob vključitvi je bilo 79,2 % žensk starih od 10 do 25 let).
In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 in subjects aged 18-60 years the anti-haemagglutinin (anti- HA) antibody responses were as follows:
V kliničnih študijah, ki so pri preiskovancih v starosti od 18 do 60 let ocenile imunogenost cepiva z adjuvansom AS03 in vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 (H5N1), so bili odzivi protiteles na anti-hemaglutinin (anti-HA) naslednji:
In clinical studies that evaluated the immunogenicity of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 in subjects aged 18-60 years the anti-haemagglutinin (anti- HA) antibody responses were as follows:
V kliničnih študijah, v katerih so ocenjevali imunogenost cepiva z adjuvansom AS03 z vsebnostjo 3,75 µg HA pridobljeno iz A/Vietnam/1194/2004 pri preiskovancih starih 18-60 let, so bili odzivi antihemaglutininskih (anti-HA) protiteles naslednji:
In clinical studies the mean apparent clearance of exenatide is 9 l/h and the mean terminal half-life is 2.4 h.
V kliničnih študijah je povprečni opaženi očistek eksenatida 9 l/h in povprečni končni razpolovni čas 2,4 h.
In clinical studies these side effects were stopped immediately upon intravenous administration of a standard dose of diazepam.
V kliničnih študijah so stranski učinki takoj izginili po endovenoznem dajanju standardnega odmerka diazepama.
In clinical studies with 73 previously treated patients (PTP, defined as having ≥100 exposure days), followed over 4 years, no de-novo inhibitors were observed.
V kliničnih študijah pri 73 predhodno zdravljenih bolnikih (PTP, kar pomeni, da so bili izpostavljeni več kot 100 dni), ki so jih spremljali štiri leta, niso ugotovili de novo nastanka inhibitorjev.
In clinical studies with adults who received Pandemic influenza vaccine H5N1 MedImmune, the most common side effects were headache and upper respiratory tract infection (inflammation of the nose, throat, and sinuses).
V kliničnih študijah pri odraslih, ki so dobili Cepivo proti pandemski gripi H5N1 MedImmune, so bili najpogostejši neželeni učinki glavobol in okužbe zgornjih dihal (vnetje nosu, žrela in obnosnih votlin).
In clinical studies with Aerius, the following side effects were reported as: Children
V kliničnih študijah z zdravilom Aerius so poročali o naslednjih neželenih učinkih: Otroci
In clinical studies with Aerius, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
V kliničnih študijah z zdravilom Aerius so poročali o naslednjih neželenih učinkih: Pogosti: naslednji se lahko pojavijo pri največ 1 od 10 bolnikov