natgillin/translations-raw huggingface dataset:
Additional adverse reactions associated with the use of medicinal products containing pravastatin or fenofibrate observed in clinical trials and post- marketing experience that may potentially occur with Pravafenix are listed below.
Dodatne nuspojave povezane s primjenom lijekova koji sadrže pravastatin i fenofibrat opažene u kliničkim ispitivanjima i iskustvu nakon stavljanja lijeka u promet, a koje se mogu javiti s Pravafenixom, navedene su u nastavku.
Additional adverse reactions characteristic of an allergic response were also reported – including anaphylactic reaction (18 %) and bronchospasm (4 %).
Također su prijavljene i dodatne nuspojave karakteristične za alergijski odgovor - uključujući anafilaktičku reakciju (18%) i bronhospazam (4%).
Additional adverse reactions not listed in Table 2 have been reported in patients who received other doses (either < or > 3 mg/kg) of ipilimumab in clinical trials of melanoma.
Dodatne nuspojave koje nisu navedene u tablici 2 zabilježene su u bolesnika koji su primili drugačije doze (< ili > 3 mg/kg) ipilimumaba u kliničkim ispitivanjima liječenja melanoma.
Additional adverse reactions observed when used outside of the recommended dose and indication (i.e. used in CTCL at an initial dose >300mg/m2/day or in non-CTCL cancer indications):
Dodatne nuspojave opažene kod primjene doza izvan preporučenih razina i indikacije (tj. primijenjenih kod CTCL-a u početnoj dozi od >300mg/m2 na dan ili onkoloških indikacija bez CTCL-a):
Additional adverse reactions related to post-marketing experience with thalidomide and not seen in the pivotal study include: toxic epidermal necrolysis (see section 4.4), intestinal obstruction, hypothyroidism, sexual dysfunction, tumour lysis syndrome (see section 4.4), gastro-intestinal perforations, allergic reactions (hypersensitivity, angioedema/urticaria) (see section 4.4), hearing impaired or deafness, renal failure, myocardial infarction (see section 4.4), worsening of Parkinson’s disease symptoms, severe infections (e.g. fatal sepsis including septic shock) (see section 4.4), convulsions, atrial fibrillation, atrioventricular block (see section 4.4), menstrual disorders including amenorrhea (see section 4.4), pancreatitis, gastrointestinal haemorrhage (see section 4.4), hepatic disorders (see section 4.4), posterior reversible encephalopathy syndrome (PRES), pulmonary hypertension (see section 4.4) and viral infections, including herpes zoster and hepatitis B virus reactivation (see section 4.4).
Dodatne nuspojave u vezi s talidomidom nakon stavljanja lijeka na tržište, a koje nisu primijećene u pivotalnom ispitivanju, uključuju: toksičnu epidermalnu nekrolizu (vidjeti dio 4.4), opstrukciju crijeva, hipotireoidizam, spolnu disfunkciju, sindrom lize tumora (vidjeti dio 4.4), perforacije u probavnom sustavu, alergijske reakcije (preosjetljivost, angioedem/urtikarija) (vidjeti dio 4.4), oštećenje sluha ili gluhoću, zatajenje bubrega, infarkt miokarda (vidjeti dio 4.4), pogoršanje simptoma Parkinsonove bolesti, teške infekcije (npr. smrtonosna sepsa uključujući septički šok) (vidjeti dio 4.4), konvulzije, fibrilaciju atrija, atrioventrikularni blok (vidjeti dio 4.4), poremećaje menstrualnog ciklusa uključujući amenoreju (vidjeti dio 4.4), pankreatitis, gastrointestinalno krvarenje (vidjeti dio 4.4), poremećaje funkcije jetre (vidjeti dio 4.4), sindrom reverzibilne posteriorne encefalopatije (PRES), plućnu hipertenziju (vidjeti dio 4.4) i virusne infekcije, uključujući reaktivaciju virusa herpes zostera i hepatitisa B (vidjeti dio 4.4).
Additional adverse reactions reported during post- marketing experience with CellCept are described below with the frequencies reported within brackets if known.
Dodatne nuspojave prijavljene tijekom post-marketinškog praćenja sigurnosti primjene lijeka CellCept navedene su u nastavku s učestalošću navedenom u zagradama ako je ona poznata.
Additional adverse reactions reported during post-marketing are described below with the frequencies reported within brackets if known.
Dodatne nuspojave prijavljene tijekom post-marketinškog praćenja sigurnosti primjene lijeka CellCept navedene su u nastavku s učestalošću navedenom u zagradama ako je ona poznata.
Additional adverse reactions reported during post-marketing are described below with the frequencies reported within brackets if known.
Dodatne nuspojave prijavljene tijekom postmarketinškog praćenja sigurnosti primjene lijeka CellCept navedene su u nastavku s učestalošću navedenom u zagradama ako je ona poznata.
Additional adverse reactions that have been seen with either of the active substances (bimatoprost or timolol), and may potentially occur also with GANFORT are listed below in Table 2 (bimatoprost) and Table 3 (timolol):
Dodatne nuspojave opažene s jednom od djelatnih tvari (bimatoprost ili timolol), i koje bi se također mogle pojaviti s otopinom GANFORT navedene su u Tablici 2 (bimatoprost) i Tablici 3 (timolol):
Additional adverse reactions that have been seen with either of the active substances (bimatoprost or timolol), and may potentially occur also with GANFORT single-dose, are listed below in Table 3 (bimatoprost) and Table 4 (timolol):
Dodatne nuspojave opažene s jednom od djelatnih tvari (bimatoprost ili timolol), i koje bi se također mogle pojaviti s otopinom jednodoznog GANFORT-a navedene su u nastavku u Tablici 3 (bimatoprost) i Tablici 4 (timolol):
Additional adverse reactions that have been seen with ophthalmic beta-blockers and may potentially occur also with GANFORT are listed below in Table 3:
Dodatne nuspojave opažene s oftalmološkim beta-blokatorima i koje bi se također mogle pojaviti s GANFORT-om navedene su u Tablici 3:
Additional adverse reactions that have been seen with ophthalmic beta-blockers and may potentially occur also with GANFORT single-dose are listed below in Table 4:
Dodatne nuspojave opažene s oftalmološkim beta-blokatorima i koje bi se također mogle pojaviti s jednodoznim GANFORT-om navedene su u nastavku u Tablici 4:
Additional adverse reactions that were seen commonly ≤ 1 day following a leukapheresis procedure in controlled clinical trials included fatigue (5.5%), muscle spasm (4.0%), chills (3.0%), dizziness (2.8%), and anaemia (2.8%).
Dodatne nuspojave koje su zabilježene često ≤ 1 dan nakon postupka leukafereze u kontroliranim kliničkim ispitivanjima uključivale su umor (5,5%), grčeve u mišićima (4,0%), zimicu (3,0%), omaglicu (2,8%) i anemiju (2,8%).
Additional adverse reactions were observed in adult patients treated with aprepitant for postoperative nausea and vomiting (PONV) and a greater incidence than with ondansetron: abdominal pain upper, bowel sounds abnormal, constipation*, dysarthria, dyspnoea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, sub-ileus*, visual acuity reduced, wheezing.
Sljedeće nuspojave zabilježene su češće u odraslih bolesnika koji su primali aprepitant zbog postoperativne mučnine i povraćanja (engl. postoperative nausea and vomiting, PONV) nego u bolesnika koji su primali ondanzetron: bol u gornjem dijelu abdomena, neobični zvukovi u crijevima, konstipacija*, dizartrija, dispneja, hipoestezija, nesanica, mioza, mučnina, poremećaji osjeta, nelagoda u trbuhu, sub-ileus*, smanjena oštrina vida, piskanje pri disanju.
Additional adverse reactions were observed in patients treated with aprepitant for postoperative nausea and vomiting (PONV) and a greater incidence than with ondansetron: abdominal pain upper, bowel sounds abnormal, constipation*, dysarthria, dyspnoea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, sub-ileus*, visual acuity reduced, wheezing.
Sljedeće nuspojave zabilježene su češće u bolesnika koji su primali aprepitant zbog postoperativne mučnine i povraćanja (engl. postoperative nausea and vomiting, PONV) nego u bolesnika koji su primali ondanzetron: bol u gornjem dijelu abdomena, neobični zvukovi u crijevima, konstipacija*, dizartrija, dispneja, hipoestezija, nesanica, mioza, mučnina, poremećaji osjeta, nelagoda u trbuhu, sub-ileus*, smanjena oštrina vida, piskanje u plućima.
Additional analyses suggest that the surgical procedure type did not influence the trends in efficacy endpoints and the efficacy of IONSYS was similar across the range of body mass indices studied (< 25 to > 40 kg/m2 Body Mass Index).
Dodatne analize upućuju na to da vrsta kirurškog zahvata nije utjecala na trendove u mjerama ishoda djelotvornosti, a djelotvornost sustava IONSYS bila je slična u ispitanom rasponu indeksa tjelesne mase (indeks tjelesne mase od <25 do ≥40 kg/m2).
Additional antihypertensive agents (excluding ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium blockers) were added as needed to help achieve the blood pressure goal.
Dodatni antihipertenzivi (isključ ujuć i ACE inhibitore, antagoniste receptora angiotenzina II i dihidropiridinske blokatore kalcijevih kanala) dodavani su prema potrebi kako bi se postigao ciljni krvni tlak.
Additional blood glucose controls should be considered in diabetic patients. β2 adrenoreceptor agonists
Dodatne kontrole glukoze u krvi mora se razmotriti u bolesnika s dijabetesom.
Additional cases of pancreatitis not associated with sphincter of Oddi spasm were reported in clinical studies.
U kliničkim ispitivanjima prijavljeni su dodatni slučajevi pankreatitisa nepovezanog sa spazmom Oddijevog sfinktera.
Additional cases per
Dodatni slučajevi na 1000 korisnica HNL
Additional cases per 1,000 ET users
Dodatni slučajevi na 1000 korisnica ET
Additional cases per 1,000 ET users over 5 years (95% CI)
Dodatni slučajevi na 1000 korisnica ET tijekom 5 godina (95%-tni IP)
Additional cases per 1,000 ET users over 5 years (95%CI)
Dodatni slučajevi na 1000 korisnica ET tijekom 5 godina (95%-tni IP)
Additional cases per 1,000 never-users of HRT over a 5 year period*
Dodatni slučajevi na 1000 novih korisnica HNL tijekom 5 godina
Additional caution should be exercised in patients who are prone to a disturbance of water or electrolyte balance (e.g. elderly, patients with CV diseases, diabetes, hypertension), and electrolyte control should be considered.
Dodatne mjere opreza su potrebne ako su bolesnici skloni poremećajima ravnoteže vode ili elektrolita (npr. bolesnici starije dobi, bolesnici s kardiovaskularnim bolestima, dijabetesom, hipertenzijom), te se mora razmotriti kontrola elektrolita.
Additional CBC tests may be performed in accordance with local requirements.
Dodatne krvne slike mogu biti učinjene u skladu s lokalnim propisima.
Additional CE marked oral syringes compatible with the reclosable bottle cap adapter can be obtained from a pharmacy.
Dodatne oralne štrcaljke s oznakom CE koje su kompatibline s nastavkom za bocu s čepom za ponovno zatvaranje, mogu se nabaviti u ljekarni.
Additional clinical experience has been generated with Kyprolis monotherapy in patients with relapsed and refractory multiple myeloma.
U bolesnika s recidivirajućim i refraktornim multiplim mijelomom ostvareno je dodatno kliničko iskustvo u monoterapiji lijekom Kyprolis.
Additional data also supports effectiveness of Kalydeco in children aged 2 to 5 years of age with a G551D or S549N mutation.
Dodatnim je podatcima također potvrđena djelotvornost lijeka Kalydeco u djece u dobi od 2 do 5 godina s mutacijom G551D ili S549N.
Additional data from supportive studies showed a similar effect of Ravicti in children from 2 months of age.
Dodatni podaci iz potpornih ispitivanja pokazali su sličan učinak lijeka Ravicti u djece u dobi od 2 mjeseca.
Additional data is required to conclude on the influence of K103N when associated with other NNRTIs mutations.
Za zaključak o utjecaju K103N kada je povezan s drugim mutacijama NNRTI, potrebni su dodatni podaci.
Additional doses may need to be considered for persons who do not respond or have a sub- optimal response to a course of vaccinations.
Treba razmotriti primjenu dodatnih doza u osoba koje nakon završenog cijepljenja nisu odgovorile ili je njihov odgovor suboptimalan.
Additional effects, observed in other studies included: QTc interval prolongation, LVEF reduction and testicular tubular atrophy, increased mesangial cells in kidney, haemorrhage in gastro-intestinal tract and oral mucosa, and hypertrophy of anterior pituitary cells.
Dodatni učinci opaženi u drugim ispitivanjima obuhvaćaju produljenje QTc-intervala, smanjenje istisne frakcije lijeve klijetke i atrofiju tubula testisa, povećanje mezangijskih stanica u bubregu, krvarenje u gastrointestinalnom traktu i sluznici usne šupljine te hipertrofiju stanica prednjeg režnja hipofize.
Additional endpoints of the study included cytogenetic response (in the 10 mg arm major and minor cytogenetic responses were observed in 30.0% and 24.0% of subjects, respectively), assessment of Health Related Quality of Life (HRQoL) and progression to acute myeloid leukaemia.
Dodatni ishodi ispitivanja uključivali su citogenetički odgovor (u skupini ispitanika koja je primala dozu od 10 mg, u 30,0% opaženi su mali citogenetički odgovori a u 24,0% veliki citogenetički odgovori), procjenu kvalitete života povezanu sa zdravljem (Health Related Quality of Life, HRQoL) i napredovanje bolesti u akutnu mijeloičnu leukemiju.
Additional evaluations included duration of response (DOR) and progression-free survival (PFS) by investigator and blinded independent review committee (BIRC) assessment, and overall survival (OS).
Dodatne evaluacije uključivale su trajanje odgovora (engl. duration of response, DOR) i preživljenje bez progresije (engl. progression-free survival, PFS) prema ispitivačevoj procjeni, te procjenu odbora za maskirano neovisno ocjenjivanje (engl. blinded independent review committee, BIRC) i ukupno preživljenje (engl. overall survival, OS).
Additional excipients for 375 mg tablet: Macrogol
Dodatne pomoćne tvari u tabletama od 375 mg: makrogol
Additional excipients for 750 mg tablet: Glycerol triacetate
Dodatne pomoćne tvari u tabletama od 750 mg: gliceroltriacetat
Additional exploratory pCR rates included nodal status (ypT0/isN0 and ypT0N0).
Dodatne eksploracijske stope pCR-a uključivale su status zahvaćenosti limfnih čvorova (ypT0/isN0 i ypT0N0).
Additional infant formula, beverage or food may be given after consumption of the entire mixture.
Dodatnu dojenačku formulu, piće ili hranu može se dati nakon što je uzeta cjelokupna mješavina.
Additional information about QT prolonging medicinal agents, is provided in Section 4.4. The influence of TRISENOX on the efficacy of other antileukaemic medicinal products is unknown.
Dodatne informacije o lijekovima koji produljuju QT interval nalaze se u dijelu 4.4. Utjecaj TRISENOXA na djelotvornost drugih lijekova protiv leukemije nije poznat.
Additional information about these potentially inflammatory adverse reactions is provided in “Description of selected adverse reactions” and section 4.4. Data presented in those sections primarily reflect experience from a Phase 3 study, MDX010-20.
Dodatne informacije o ovim potencijalno upalnim nuspojavama nalaze se u dijelu “Opis odabranih nuspojava” i dijelu 4.4. Podaci prikazani u tim dijelovima primarno pokazuju iskustvo iz ispitivanja faze III, MDX010-20.
Additional information for Temomedac 20 mg hard capsules
Dodatne informacije za Temomedac 20 mg tvrde kapsule
Additional information in special populations:
Dodatne informacije za posebne populacije:
Additional information is available from the studies conducted with a vaccine similar in composition to Focetria but containing antigen derived from H5N1 viruses.
Dodatne informacije dostupne su iz ispitivanja provedenih s cjepivom sastava sličnog Focetriji no koje sadrži antigen dobiven iz H5N1virusa.
Additional information is shown in the following Table 3
Dodatni podaci prikazani su u tablici 3.
Additional information on handling of Zoledronic acid medac 4 mg/100 ml solution for infusion, including guidance on the preparation of reduced doses using the Zoledronic acid medac ready-to-use bottle, is provided in section 4.2.
Dodatne informacije o rukovanju Zoledronatnom kiselinom medac 4 mg/100 ml otopinom za infuziju, uključujući upute za pripremu sniženih doza pomoću boce s gotovom Zoledronatnom kiselinom medac, nalaze se u dijelu 4.2.
Additional information on handling of Zometa, including guidance on preparation of reduced doses, is provided in section 4.2.
Dodatne informacije o rukovanju Zometom uključujući upute za pripremu sniženih doza, nalaze se u dijelu 4.2.
Additional information on handling on Zoledronic Acid Teva, including guidance on preparation of reduced doses, is provided in section 4.2.
Dodatne informacije o rukovanju Zoledronatnom kiselinom Teva, uključujući upute za pripremu sniženih doza, nalaze se u dijelu 4.2.
Additional information on handling on Zoledronic acid Teva, including guidance on the preparation of reduced doses using the Zoledronic acid ready-to-use bottle, is provided in section 4.2.
Dodatne informacije o rukovanju Zoledronatnom kiselinom Teva, uključujući upute za pripremu sniženih doza korištenjem boce Zoledronatne kiseline Teva spremne za uporabu, nalaze se u dijelu 4.2.
Additional information on how Methylthioninium chloride Proveblue can be given is provided in section 3 of the Package Leaflet.
Dodatne informacije o tome kako se Methylthioninium chloride Proveblue primjenjuje su dane u dijelu 3 ove Upute o lijeku.
Additional information on hydrochlorothiazide interactions
Dodatne informacije o interakcijama hidroklorotiazida
Additional information on hydrochlorothiazide interactions
Dodatne informacije o interakcijama s hidroklorotiazidom
Additional information on hydrochlorothiazide interactions:
Dodatne informacije o interakcijama hidroklorotiazida:
Additional information on special population
Dodatne informacije za posebne populacije bolesnika
Additional information on special populations
Parkinsonova bolest
Additional information on special populations
POSEBNE MJERE ČUVANJA
Additional information on special populations
Posebne populacije
Additional information on the individual active substances of the fixed dose combination
Dodatne informacije o pojedinim djelatnim tvarima fiksne kombinirane doze
Additional information on the individual components
Dodatne informacije o pojedinačnim komponentama
Additional injections may be given if the disease persists, but the interval between injections should be at least one month.
Dodatne se injekcije mogu davati ako bolest ustraje, međutim interval između injekcija mora biti barem mjesec dana.
Additional injections of Elonva should not be given within the same treatment cycle. (See also section 4.2.)
Ne smiju se davati dodatne injekcije lijeka Elonva unutar istog ciklusa liječenja (također vidjeti dio 4.2).
Additional injections, when indicated, should be conservative in such patients.
Primjena dodatnih injekcija, kada je to indicirano, treba biti konzervativna u takvih bolesnika.
Additional label after reconstitution and radiolabelling with sodium pertechnetate (99mTc) solution
Dodatna oznaka nakon rekonstitucije i radioaktivnog obilježavanja otopinom natrijevog pertehnetata (99mTc).
Additional laboratory and field studies were conducted with Circovac in piglets.
Nadalje, laboratorijska i terenska ispitivanja provedena su s VMP-om Circovac u prasadi.
Additional listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers.
Dodatno navedene nuspojave uključuju reakcije zabilježene unutar skupine lokalno primijenjenih beta blokatora.
Additional LVEF monitoring is recommended for patients with LVEF ≤ 45% (See Table 5 in section 4.2 for specific dose modifications).
U bolesnika u kojih je LVEF ≤ 45% preporučuje se dodatno praćenje LVEF-a (vidjeti Tablicu 5 u dijelu 4.2 za specifične prilagodbe doze).
Additional maintenance treatments included long-acting beta2 -adrenergic agonists (LABA), leukotriene modifiers, long-acting muscarinic antagonists (LAMA), theophylline, and oral corticosteroids (OCS).
Dodatna terapija održavanja obuhvaćala je dugodjelujuće agoniste beta2 adrenergičkih receptora (engl. long-acting beta2 agonists, LABA), modifikatore leukotrijena, dugodjelujuće antagoniste muskarinskih receptora (engl. long-acting muscarinic antagonists, LAMA), teofilin i oralne kortikosteroide (OKS).
Additional methods of non-hormonal
Kad se hormonska kontracepcija primjenjuje
Additional monitoring
Dodatno praćenje
Additional non- hormonal forms of contraception are recommended when using Zebinix (see sections 4.5 and 4.6).
Za vrijeme korištenja Zebinixa, preporučuju se dodatni nehormonski oblici kontracepcije (vidjeti dijelove 4.5 i 4.6).
Additional periodic distributions after launch should be performed, notably after safety substantial product information modifications justifying educational material updates.
Potrebno je provoditi dodatnu periodičku distribuciju nakon stavljanja lijeka u promet, posebno nakon značajnih sigurnosnih izmjena informacija o lijeku koje opravdavaju nadopunu edukacijskog materijala.
Additional Phase III studies
Dodatne studije faze III
Additional prespecified subgroup analyses were conducted to evaluate the efficacy of tumour PD-L1 expression at predefined levels of 1%, 5% and 10%.
Provedene su i dodatne unaprijed specificirane analize podskupina radi ocjenjivanja djelotvornosti kod unaprijed utvrđenih razina tumorske ekspresije PD-L1 od 1%, 5% i 10%.
Additional Prevenar (7-valent) immunogenicity data: children with sickle cell disease
Dodatni podaci o imunogenosti Prevenara (7-valentnog): djeca s bolesti srpastih stanica
Additional reactions reported from post-marketing experience are included in italics in the list below.
Dodatne nuspojave prijavljene nakon stavljanja lijeka u promet u donjoj su Tablici navedene kurzivom.
Additional reactions reported from post-marketing experience are included in italics in the list below.
Dodatne nuspojave prijavljene nakon stavljanja lijeka u promet u Tablici su navedene kurzivom.
Additional reactions reported from postmarketing experience are included in italics in the list below.
Dodatne nuspojave prijavljene nakon stavljanja lijeka u promet u Tablici ispod navedene su kurzivom.
Additional reactions reported from postmarketing experience are included in italics in the list below.
Dodatne nuspojave prijavljene nakon stavljanja lijeka u promet u Tablici navedene su kurzivom.
Additional reactions reported in some cases were myocardial infarction, atrial fibrillation, pulmonary oedema and acute reversible thrombocytopenia.
Dodatne reakcije prijavljene u nekim slučajevima obuhvaćale su infarkt miokarda, fibrilaciju atrija, plućni edem i akutnu reverzibilnu trombocitopeniju.
Additional required materials
Dodatan potrebni materijal
Additional requirements in patients with mild to moderate renal impairment and in patients aged over 75 years:
Dodatni zahtjevi u skupini bolesnika s blagim do umjerenim oštećenjem bubrega i bolesnika iznad 75 godina starosti:
Additional resuscitation fluids (crystalloid and colloid solutions) should be available for volume expansion in case of a significant fall in blood pressure.
Dodatne tekućine za nadoknadu (kristaloidne i koloidne otopine) moraju biti dostupne za ekspanziju volumena u slučaju značajnog pada krvnog tlaka.
Additional risk minimisation measure
Dodatne mjere minimizacije rizika
Additional risk minimisation measures
Dodatne mjere minimizacije rizika:
Additional risk minimisation measures (Humalog 200 units/ml)
Dodatne mjere minimizacije rizika (Humalog 200 jedinica/ml)
Additional risk minimisation measures (Liprolog 200 units/ml)
Dodatne mjere minimizacije rizika (Liprolog 200 jedinica/ml)
Additional risk minimisation measures>
Dodatne mjere minimizacije rizika
Additional safety data from this study will also be provided.
Bit će dostavljeni i dodatni podaci proizašli iz ispitivanja u vezi sa sigurnom primjenom lijeka.
Additional safety information from clinical studies experience
Dodatne informacije o sigurnosti iz kliničkih ispitivanja
Additional side effects
Dodatne nuspojave
Additional side effects (frequency not known – frequency cannot be estimated from available data) which may occur with Ketek are:
Dodatne nuspojave (nepoznate učestalosti - učestalost se ne može procijeniti iz dostupnih podataka) koje se mogu pojaviti kod liječenja Ketekom su: