Sta Znaci OZBILJNA NUSPOJAVA na Engleskom - Engleski Prijevod

• serious adverse reaction
• serious side effect
• serious adverse event

Primjeri korištenja Ozbiljna nuspojava na Hrvatski i njihovi prijevodi na Engleskom

Nije prijavljena nijedna ozbiljna nuspojava.
No serious adverse reaction was reported.

Ozbiljna nuspojava Effentore je sporo i/ili plitko disanje.
A serious side effect of Effentora is slow and/or shallow breathing.

Laktacidoza je rijetka, ali ozbiljna nuspojava.
Lactic acidosis is a rare but serious side effect.

Ova rijetka, ali ozbiljna nuspojava može u nekim slučajevima imati smrtni ishod.
This rare but serious side effect has occasionally been fatal.

U ispitivanju faze III mijelodisplastičnih sindroma, promijenjeno raspoloženje prijavljeno je kao česta ozbiljna nuspojava; nije prijavljeno kao nuspojava 3. ili 4. stupnja.
Altered mood was reported as a common serious adverse event in the myelodysplastic syndromes Phase III study; it was not reported as a grade 3 or 4 adverse event..

Nije prijavljena nijedna ozbiljna nuspojava povezana s primjenom lijeka Amyvid.
No serious adverse reactions related to Amyvid administration have been reported.

U kliničkim ispitivanjima, za vrijeme liječenja lijekom Vephoro u približno 43% bolesnika pojavila se najmanje jedna nuspojava, koja je u 0,36% slučajeva prijavljena kao ozbiljna nuspojava.
In these clinical trials, approximately 43% of patients experienced at least one adverse reaction during Velphoro treatment, which were reported as serious adverse reactions in 0.36.

Najčešće zabilježena ozbiljna nuspojava bila je pneumonija 9, 3.
The most commonly reported serious adverse reaction was pneumonia 9.3.

Neočekivana ozbiljna nuspojava” znači ozbiljna nuspojava čija priroda, ozbiljnost ili ishod nije u skladu s referentnim sigurnosnim informacijama;
Unexpected serious adverse reaction' means a serious adverse reaction, the nature, severity or outcome of which is not consistent with the reference safety information;

Tijekom placebom kontroliranih i otvorenih ispitivanja astme zabilježena je ozbiljna nuspojava anafilaktičke reakcije a smatrala se povezanom s reslizumabom u 3 bolesnika 0, 19.
The serious adverse reaction of anaphylactic reaction was reported and considered related to reslizumab in 3 patients(0.19%) during placebo-controlled and open-label asthma studies.

Najčešća ozbiljna nuspojava(pojavila se u otprilike 2 na 100 osoba) bila je celulitis upala gornjih slojeva kože.
The most common serious side effect(affecting around 2 in 100 people) was cellulitis infection of the upper layers of the skin.

Najčešće prijavljivana ozbiljna nuspojava bila je celulitis 1,1%; 11/976.
The most commonly reported serious adverse reaction was cellulitis 1.1%, 11/976.

Jedina ozbiljna nuspojava povezana s liječenjem BeneFIX-om prijavljena je u jednog prethodno neliječenog bolesnika kod kojeg su se pojavili preosjetljivost i razvoj inhibitora.
The only documented serious adverse event related with BeneFIX was reported from the only included PUP, who experienced hypersensitivity and inhibitor development.

Laktacidoza je rijetka ali ozbiljna nuspojava, koja ponekad može biti i smrtonosna.
Lactic acidosis is a rare but serious side effect which can occasionally be fatal.

Jedna ozbiljna nuspojava obilježena kao RPI prijavljena je kod bolesnika s Crohnovom bolešću tijekom druge infuzije( prijavljeni simptomi bili su dispneja, bronhospazam, urtikarija, crvenilo uz osjećaj vrućine, osip, te povećani krvni tlak i ubrzani srčani ritam) te je uspješno izliječena uz prekid infuzije i liječenje antihistaminikom i intravenskim hidrokortizonom.
One serious adverse event of IRR was reported in a Crohn's disease patient during the second infusion(symptoms reported were dyspnoea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate) and was successfully managed with discontinuation of infusion and treatment with antihistamine and intravenous hydrocortisone.

Najčešće prijavljivana ozbiljna nuspojava bio je sindrom imunološke rekonstitucije.
The most frequently reported serious adverse reaction was immune reconstitution syndrome.

LSCD može biti vrlo ozbiljna nuspojava s trajnim oštećenjem vida i ograničenim mogućnostima liječenja, a prestanak liječenja i/ili rana intervencija mogu spriječiti trajno oštećenje.
LSCD can be a very serious adverse reaction with permanent vision damage and limited treatment options, and discontinuation of treatment and/or early intervention may prevent permanent damage.

Najčešće prijavljivana ozbiljna nuspojava u kliničkim ispitivanjima bila je sinkopa 0, 76.
The most frequently reported serious adverse reaction in clinical studies was syncope 0.76.

Moguća ozbiljna nuspojava, odnosno angioedem(brzo oticanje dubljih kožnih tkiva i tkiva oko grla, što dovodi do otežanog disanja), rijetko se pojavljuje javlja se u manje od 1 na 100 osoba.
A potentially severe side effect, angioedema(rapid swelling of deeper skin tissues as well as the tissues around the throat, causing breathing difficulty), can occur uncommonly affecting fewer than 1 in 100 people.

Ova rijetka, ali vrlo ozbiljna nuspojava javlja se češće u žena, naročito s prekomjernom težinom.
This rare, but very serious side effect occurs more often in women, particularly if very overweight.

Zabilježena je jedna ozbiljna nuspojava u ispitanika s teškom ishemijskom kardiomiopatijom, u kojega je 6 dana nakon ispitivanja došlo do ventrikularne fibrilacije te je nastupila smrt.
There was one serious adverse reaction in a subject with severe ischaemic cardiomyopathy who experienced ventricular fibrillation and death 6 days post study.

Fibrilacija atrija pojavila se kao ozbiljna nuspojava u 1,3%(51 od 3862) bolesnica koje su primale zoledronatnu kiselinu u dozi od 5 mg i 0,6%(22 od 3852) bolesnica koje su primale placebo.
The rate of atrial fibrillation serious adverse events was 1.3%(51 out of 3,862) and 0.6%(22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.

Ruptura korpusa zabilježena je kao ozbiljna nuspojava nakon injekcije Xiapexa u 5 od 1044 bolesnika(0,5%) u kontroliranim i nekontroliranim kliničkim ispitivanjima u Peyronijevoj bolesti.
Corporal rupture was reported as a serious adverse reaction after Xiapex injection in 5 out of 1044 patients(0.5%) in the controlled and uncontrolled clinical trials in Peyronie's disease.

Hipotenzija koja je prijavljena kao ozbiljna nuspojava ili je zahtijevala prekid primjene lijeka nastupila je nakon izloženosti lijeku BRINAVESS u 2,9% bolesnika s kongestivnim zatajenjem srca, u odnosu na 0% takvih bolesnika koji su primili placebo.
Hypotension reported as a serious adverse experience or leading to medicinal product discontinuation occurred in CHF patients following exposure to BRINAVESS in 2.9% of these patients compared to 0% in placebo.

Najčešća,(može zahvatiti do 1 na 10 osoba) ozbiljna nuspojava u liječenju Angioxom je veliko krvarenje koje se može javiti na bilo kojem mjestu u tijelu primjerice u želucu, probavnom sustavu(uključujući povraćanje krvi ili izlučivanje krvi sa stolicom), trbuhu, plućima, preponama, mjehuru, srcu, oku, uhu, nosu ili mozgu.
The most common,(may affect up to 1 in 10 people) serious side effect of treatment with Angiox, is major bleeding which could occur anywhere inside the body e.g. stomach, digestive system(including vomiting blood or passing blood with the stools), abdomen, lungs, groin, bladder, heart, eye, ear, nose or brain.

Najvažnija ozbiljna nuspojava je zatajenje i oštećenje bubrega; problemi sa srcem i krvotokom poput zatajenja srca, krvnih ugrušaka u arterijama koji rezultiraju moždanim udarom i srčanim udarom; krvarenje u tumor u mozgu; sindrom poznat pod nazivom"posteriorni reverzibilni encefalopatijski sindrom" karakteriziran glavoboljom, konfuzijom, napadajima i gubitkom vida; te zatajenje jetre.
The most important serious side effects are kidney failure and impairment; problems with the heart and circulation such as heart failure, blood clots in the arteries leading to stroke or heart attack; bleeding into a tumour in the brain; a syndrome known as‘posterior reversible encephalopathy syndrome' characterised by headache, confusion, fits and loss of vision; and liver failure.

Time je povišen rizik od aritmija ili ostalih ozbiljnih nuspojava.
Thereby, increasing the risk of arrhythmias or other serious adverse reactions.

Najozbiljnija nuspojava je anafilaktička reakcija ozbiljna alergijska reakcija.
The most serious side effect is anaphylactic reaction a severe allergic reaction.

Najozbiljnije nuspojave su pokušaj samoubojstva, psihoza, respiratorna depresija i konvulzije.
The most serious adverse reactions are suicidal attempt, psychosis, respiratory depression and convulsion.

Najozbiljnija nuspojava u kliničkim ispitivanjima bio je akutni pankreatitis vidjeti dio 4.4.
The most serious adverse reaction in clinical trials was acute pancreatitis see section 4.4.