natgillin/translations-raw huggingface dataset:
System Organ Class (SOC)
Organski sistemi
least one clinical trial)
najmanj enem kliničnem preskušanju)
between the study arms in at least one clinical trial)
preiskovanimi skupinami v najmanj enem kliničnem preskušanju)
Sepsis Abscess Infection
sepsa absces okužba
lymphatic systems disorders
limfatičnega sistema
Thrombocytopenia Neutropenia
trombocitopenija nevtropenija
Peripheral sensory neuropathy
periferna senzorična
Dysgeusia Headache
cerebrovaskularni
Eye disorders
paragevzija
Cardiac disorders
nevropatija
Cardiac failure congestive
zaplet sinkopa somnolenca glavobol
Supraventricular tachycardia
glavobol bolezni oči
7
Srčne bolezni
NCI-CTC Grade 3-5 Reactions
kongestivno srčno popuščanje supraventrikularna tahikardija
All Grade Reactions
Žilne bolezni
(≥ 10% difference
hipertenzija
System Organ Class (SOC)
trombembolija (arterijska) *
least one clinical trial)
hipertenzija
between the study arms in at least one clinical trial)
globoka venska tromboza krvavitev Bolezni dihal, prsnega
Very common
pljučna embolija
Common
dispneja
Very Common
koša in
Vascular disorders
dispneja
Hypertension
epistaksa
Thromboembolism (arterial)*
mediastinalnega prostora
Hypertension
hipoksija epistaksa
Deep vein thrombosis Haemorrhage Respiratory, thoracic and mediastinal disorders
rinitis
Pulmonary embolism Dyspnoea Hypoxia Epistaxis
Bolezni prebavil
Dyspnoea Epistaxis Rhinitis
diareja
Gastrointestinal disorders
perforacija prebavil
Diarrhoea Nausea
konstipacija
Intestinal Perforation Ileus
navzea
Constipation Stomatitis
stomatitis
Intestinal obstruction Abdominal pain Gastrointestinal disorder
intestinalna obstrukcija bolečina v trebuhu bolezen prebavil
Rectal haemorrhage
rektalna krvavitev
Skin and subcutaneous
Bolezni kože in
Palmar-plantar
palmarno- plantarna
erythrodysaesthesia syndrome
eritrodistezija
Dry skin discolouration
suha koža obarvanje kože
connective tissue and bone disorders
Bolezni mišično - skeletnega sistema in vezivnega tkiva
Renal and urinary
mišična oslabelost
Proteinuria
Bolezni sečil
Proteinuria
proteinurija okužba sečil
disorders
Proteinurija
General disorders and
Splošne težave in
administration site conditions
spremembe na mestu aplikacije
Asthenia Pain
astenija bolečina
* Pooled arterial thromboembolic events including cerebrovascular accident, myocardial infarction, transient ischaemic attack and other arterial thromboembolic events.
8 * Predstavlja vse trombembolične arterijske dogodke, vključno s cerebrovaskularnimi zapleti, miokardnim infarktom, tranzitorno ishemično atako in druge arterijske trombembolične dogodke.
Further information on selected serious adverse drug reactions:
Dodatne informacije o določenih resnih neželenih učinkih
Avastin has been associated with serious cases of gastrointestinal perforation or fistulae (see also under heading Fistulae).
Perforacije prebavil (glejte poglavje 4. 4) Zdravilo Avastin so povezovali z resnimi primeri perforacije prebavil ali fistulo (glejte tudi poglavje Fistula).
Gastrointestinal perforation have been reported in clinical trials with an incidence of less than 1% in patients with metastatic breast cancer or non-squamous non-small cell lung cancer, and in up to 2.0% in metastatic colorectal cancer patients.
O perforacijah prebavil so v kliničnih preskušanjih pri bolnikih z metastatskim rakom dojk ali neskvamoznim nedrobnoceličnim rakom pljuč poročali z incidenco manjšo od 1%, pri bolnikih z metastatskim rakom debelega črevesa in danke pa z incidenco do 2, 0%.
Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all Avastin treated patients.
O smrtnem izidu so poročali pri približno eni tretjini resnih primerov perforacije prebavil, ki predstavljajo med 0, 2% in 1% vseh bolnikov, zdravljenih z zdravilom Avastin.
The presentation of these events varied in type and severity, ranging from free air seen on the plain abdominal X-ray, which resolved without treatment, to intestinal perforation with abdominal abscess and fatal outcome.
Klinična slika teh dogodkov se je razlikovala po vrsti in resnosti teh dogodkov: od vidnega prostega zraka na nativnem rentgenogramu, kar se je pozdravilo brez zdravljenja, do perforacije črevesja z abdominalnimi abscesi in smrtnim izidom.
In some cases underlying intra-abdominal inflammation was present, either from gastric ulcer disease, tumour necrosis, diverticulitis, or chemotherapy-associated colitis.
V nekaterih primerih je bilo prisotno spremljajoče vnetje znotraj trebušne votline zaradi ulkusne bolezni želodca, nekroze tumorja, divertikulitisa ali kolitisa povezanega s kemoterapijo.
Avastin use has been associated with serious cases of fistulae including events resulting in death.
Fistula (glejte poglavje 4. 4) Uporaba zdravila Avastin je bila povezana z resnimi primeri fistule, vključno s smrtnimi dogodki.
In clinical trials, gastrointestinal fistulae have been reported with an incidence of up to 2% in patients with metastatic colorectal cancer, but were also reported less commonly in patients with other types of cancers.
V kliničnih preskušanjih so o gastrointestinalni fistuli poročali pri do 2% bolnikov z metastatskim rakom debelega črevesa in danke, pri drugih vrstah raka pa so o njih poročali manj pogosto.
Uncommon (≥ 0.1% to < 1%) reports of other types of fistulae that involve areas of the body other than the gastrointestinal tract (e. g. bronchopleural, urogenital and biliary fistulae) were observed across various indications.
Občasno (≥ 0, 1% do < 1%) so pri različnih indikacijah poročali o drugih tipih fistul, ki se v telesu pojavljajo izven prebavil (plevrobronhialna, urogenitalna in žolčna fistula).
Events were reported at various time points during treatment ranging from one week to greater than 1 year from initiation of Avastin, with most events occurring within the first 6 months of therapy.
Največ dogodkov se je pojavilo v prvih 6 mesecih zdravljenja.
As Avastin may adversely impact wound healing, patients who had major surgery within the last 28 days were excluded from participation in phase III clinical trials.
Celjenje ran (glejte poglavje 4. 4) Bolniki, ki so imeli večjo operacijo v zadnjih 28 dneh pred pričetkom zdravljenja, niso bili vključeni v klinična preskušanja faze III, saj lahko zdravilo Avastin negativno vpliva na celjenje ran.
The incidence varied between 10% (4/ 40) and 20% (3/ 15).
Incidenca se je gibala med 10% (4/ 40) in 20% (3/ 15).
In locally recurrent and metastatic breast cancer, Grade 3-5 wound healing complications were observed in 1.1% of patients receiving Avastin + paclitaxel and in none of the patients receiving paclitaxel alone.
Pri bolnikih, ki so prejemali le paklitaksel, pa jih niso opazili.
An increased incidence of hypertension (all grades) of up to 34% has been observed in Avastin-treated patients in clinical trials compared with up to 14% in those treated with comparator.
Hipertenzija (glejte poglavje 4. 4) V kliničnih preskušanjih so pri bolnikih, ki so se zdravili z zdravilom Avastin, opazili zvečano incidenco hipertenzije (vseh stopenj) do 34% v primerjavi z do 14% pri bolnikih, zdravljenih v primerjalni skupini.
Grade 3 and 4 hypertension (requiring oral anti-hypertensive medication) in patients receiving Avastin ranged from 3.0% to 17.9%.
Bolnikov s hipertenzijo stopnje 3 in 4 (potrebno zdravljenje s peroralnimi antihipertenzivi), ki so se zdravili z zdravilom Avastin, je bilo od 3 do 17, 9%.
Grade 4 hypertension (hypertensive crisis) occurred in up to 1.0% of patients treated with Avastin and chemotherapy compared to up to 0.2% of patients treated with the same chemotherapy alone.
Hipertenzija stopnje 4 (hipertenzivna kriza) se je pojavila pri do 1, 0% bolnikov, ki so se zdravili z zdravilom Avastin in kemoterapijo v primerjavi z do 0, 2% bolnikov, ki so se zdravili z enako kemoterapijo brez zdravila Avastin.
Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensin-converting enzyme inhibitors, diuretics and calcium-channel blockers.
9 Hipertenzija je bila v večini primerov ustrezno uravnana s peroralnimi antihipertenzivi, kot so zaviralci angiotenzinske konvertaze, diuretiki in blokatorji kalcijevih kanalčkov.
In clinical trials, proteinuria has been reported within the range of 0.7% to 38% of patients receiving Avastin.
Proteinurija (glejte poglavje 4. 4) V kliničnih preskušanjih so o proteinuriji poročali v obsegu od 0, 7 do 38% bolnikov, zdravljenih z zdravilom Avastin.
Proteinuria ranged in severity from clinically asymptomatic, transient, trace proteinuria to nephrotic syndrome, with the great majority as Grade 1 proteinuria.
Proteinurija je po resnosti obsegala od klinično asimptomatske, prehodne, proteinurije v sledovih vse do nefrotskega sindroma, večinoma pa je bila proteinurija stopnje 1.
Grade 3 proteinuria was reported in < 3% of treated patients: however, in patients treated for advanced and/ or metastatic renal cell carcinoma this was up to 7%.
O proteinuriji stopnje 3 so poročali pri < 3% zdravljenih bolnikov; pri bolnikih zdravljenih zaradi napredovalega in/ ali metastatskega raka ledvičnih celic pa pri do 7% bolnikov.
Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of treated patients.
Proteinurijo stopnje 4 (nefrotski sindrom) so opazili pri do 1, 4% zdravljenih bolnikov.
The proteinuria seen in clinical trials was not associated with renal dysfunction and rarely required permanent discontinuation of therapy.
Proteinurija, ki so jo opazili pri zdravljenju v kliničnih preskušanjih, ni bila povezana z ledvično disfunkcijo in je redko zahtevala prenehanje zdravljenja.
In most clinical studies urine protein levels of ≥ 2g / 24 hrs led to the holding of Avastin until recovery to < 2g/ 24 hrs.
V večini kliničnih študij so koncentracije beljakovin v seču ≥ 2 g/ 24 ur povzročile prekinitev zdravljenja z zdravilom Avastin, dokler ni prišlo do zmanjšanja < 2 g/ 24 ur.
In clinical trials across all indications the overall incidence of NCI-CTC Grade 3-5 bleeding events ranged from 0.4% to 5% in Avastin treated patients, compared with up to 2.9% of patients in chemotherapy control group.
V kontrolni skupini, ki je prejemala kemoterapijo, je ta odstotek znašal do 2, 9%.
The haemorrhagic events that have been observed in clinical studies were predominantly tumour- associated haemorrhage (see below) and minor mucocutaneous haemorrhage (e. g. epistaxis).
Krvavitve, ki so jih opazili v kliničnih študijah, so bile večinoma krvavitve povezane s tumorjem (glejte spodaj) in manjše kožne in sluznične krvavitve (na primer epistaksa).
Major or massive pulmonary haemorrhage/ haemoptysis has been observed primarily in studies in patients with non-small cell lung cancer (NSCLC).
Krvavitev povezana s tumorjem (glejte poglavje 4. 4) Večjo ali masivno krvavitev v pljučih/ hemoptizo so opazili predvsem v kliničnih študijah pri bolnikih z nedrobnoceličnim rakom pljuč.
Possible risk factors include squamous cell histology, treatment with antirheumatic/ anti-inflammatory drugs, treatment with anticoagulants, prior radiotherapy, Avastin therapy, previous medical history of atherosclerosis, central tumour location and cavitation of tumours prior to or during therapy.
Med možnimi dejavniki tveganja so ploščatocelična histologija, zdravljenje z antirevmatičnimi/ protivnetnimi zdravili, zdravljenje z antikoagulanti, predhodna radioterapija, zdravljenjem z Avastinom, anamneza ateroskleroze, centralna lokalizacija tumorja in razpad tumorjev med zdravljenjem.
Patients with NSCLC of known squamous cell histology or mixed cell type with predominant squamous cell histology were excluded from subsequent phase III studies, while patients with unknown tumour histology were included.
Bolniki s ploščatoceličnim nedrobnoceličnim rakom pljuč ali mešanim celičnim tipom s prevladujočo ploščatocelično histologijo v nadaljnje študije faze III niso bili vključeni, bolniki z neznano histologijo tumorja pa so bili.
In patients with NSCLC excluding predominant squamous histology, all grade events were seen with a frequency of up to 9% when treated with Avastin plus chemotherapy compared with 5% in the patients treated with chemotherapy alone.
Pri bolnikih, ki so prejemali le kemoterapijo, so dogodke opazili pri do 5% bolnikov.
Grade 3-5 events have been observed in up to 2.3% of patients treated with Avastin plus chemotherapy as compared with < 1% with chemotherapy alone.
Pri bolnikih zdravljenih le s kemoterapijo je ta odstotek znašal < 1%.
Major or massive pulmonary haemorrhage/ haemoptysis can occur suddenly and up to two thirds of the serious pulmonary haemorrhages resulted in a fatal outcome.
Večja ali masivna krvavitev v pljučih/ hemoptiza se lahko pojavi nenadoma, pri do dveh tretjinah resnih krvavitev v pljučih je prišlo do smrtnega izida.
Gastrointestinal haemorrhages, including rectal bleeding and melaena have been reported in colorectal cancer patients, and have been assessed as tumour-associated haemorrhages.
Ocenili so jih kot krvavitve, povezane s tumorjem.
Tumour-associated haemorrhage was also seen rarely in other tumour types and locations, including a case of central nervous system (CNS) bleeding in a patient with hepatoma with occult CNS metastases (see section 4.3) and another patient who developed continuous oozing of blood from a thigh sarcoma with necrosis.
Pri bolniku s stegenskim sarkomom z nekrozo pa je prišlo do stalnega iztekanja krvi iz tumorja.
Across all clinical trials, mucocutaneous haemorrhage has been seen in 20% - 40% of Avastin- treated patients.
10 Pri 20% do 40% bolnikov, ki so bili zdravljeni z zdravilom Avastin v vseh kliničnih preskušanjih, je prišlo do krvavitev iz kože in sluznic.
These were most commonly NCI-CTC Grade 1 epistaxis that lasted less than 5 minutes, resolved without medical intervention and did not require any changes in the Avastin treatment regimen.
Večinoma je šlo za epistakse stopnje 1 po lestvici NCI- CTC, ki so trajale manj kot 5 minut, so prenehale brez zdravniške pomoči in niso zahtevale sprememb sheme zdravljenja z zdravilom Avastin.
Clinical safety data suggest that the incidence of minor mucocutaneous haemorrhage (e. g. epistaxis) may be dose-dependent.
Klinični podatki o varnosti nakazujejo, da je incidenca manjših krvavitev iz kože in sluznic (na primer epistaksa) lahko odvisna od odmerka.
There have also been less common events of minor mucocutaneous haemorrhage in other locations, such as gingival bleeding or vaginal bleeding.
Manj pogosto je prihajalo tudi do manjših krvavitev iz kože in sluznic na drugih mestih, kot na primer krvavitev iz dlesni ali vaginalnih krvavitev.
Thromboembolism (see section 4.4):
Trombembolija (glejte poglavje 4. 4)
An increased incidence of arterial thromboembolic events was observed in patients treated with Avastin across indications, including cerebrovascular accidents, myocardial infarction, transient ischemic attacks, and other arterial thromboembolic events.
Arterijska trombembolija Pri bolnikih zdravljenih z zdravilom Avastin so pri vseh indikacijah poročali o povečani incidenci arterijskih trombemboličnih dogodkov, vključno s cerebrovaskularnimi dogodki, miokardnim infarktom, tranzitornimi ishemičnimi atakami in drugimi arterijskimi trombembolični dogodki.
In clinical trials, the overall incidence of arterial thromboembolic events ranged up to 3.8% in the Avastin containing arms compared with up to 1.7% in the chemotherapy control arms.
V kliničnih preskušanjih je bila celokupna incidenca arterijskih trombemboličnih dogodkov pri bolnikih zdravljenih z Avastinom do 3, 8%, v kontrolnih skupinah, v katerih so prejemali kemoterapijo, pa do 1, 7%.
Fatal outcome was reported in 0.8% of patients receiving Avastin compared to 0.5% in patients receiving chemotherapy alone.
O smrtnem izidu so poročali pri 0, 8% bolnikov, zdravljenih z zdravilom Avastin, v primerjavi z 0, 5% bolnikov, ki so prejemali le kemoterapijo.
Myocardial infarction was reported in 1.4% of patients
O cerebrovaskularnih dogodkih (vključno s tranzitornimi ishemičnimi atakami) so poročali pri do 2, 3% bolnikov, ki so jih zdravili z zdravilom Avastin v kombinaciji s kemoterapijo v primerjavi z 0, 5% bolnikov, ki so bili zdravljeni le s kemoterapijo.
10 treated with Avastin in combination with chemotherapy compared to 0.7% of patients treated with chemotherapy alone.
O miokardnem infarktu so poročali pri 1, 4% bolnikov, ki so jih zdravili s kombinacijo zdravila Avastin in kemoterapije v primerjavi z 0, 7% bolnikov, ki so bili zdravljeni le s kemoterapijo.
In one clinical trial, AVF2192g, patients with metastatic colorectal cancer who were not candidates for treatment with irinotecan were included.
Bolniki z metastatskim rakom debelega črevesa in danke, ki niso bili primerni za zdravljenje z irinotekanom, so bili vključeni v klinično preskušanje AVF2192g.
In this trial arterial thromboembolic events were observed in 11% (11/ 100) of patients compared to 5.8% (6/ 104) in the chemotherapy control group.
V tem preskušanju so opazili arterijske trombembolične dogodke pri 11% bolnikov (11/ 100) v primerjavi s kontrolno skupino, ki je prejemala le kemoterapijo, kjer so te dogodke opazili pri 5, 8% (6/ 104).
The incidence of venous thromboembolic events in clinical trials was similar in patients receiving Avastin in combination with chemotherapy compared to those receiving the control chemotherapy alone.
Venska trombembolija Incidenca venskih trombemboličnih dogodkov v kliničnih preskušanjih je bila pri bolnikih, ki so prejemali zdravilo Avastin v kombinaciji s kemoterapijo in bolnikih v kontrolni skupini, ki so prejemali le kemoterapijo, podobna.
Venous thromboembolic events include deep venous thrombosis, pulmonary embolism and thrombophlebitis.
Venski trombembolični dogodki so vključevali globoko vensko trombozo, pljučni embolizem in tromboflebitis.
In clinical trials across indications, the overall incidence of venous thromboembolic events ranged from 2.8% to 17.3% of Avastin-treated patients compared with 3.2% to 15.6% in the control arms.
V kliničnih preskušanjih vseh indikacij je celokupna incidenca venskih trombemboličnih dogodkov znašala od 2, 8 do 17, 3% pri bolnikih zdravljenih z Avastinom v primerjavi s kontrolnimi skupinami, kjer je znašala od 3, 2 do 15, 6%.
Grade 3-5 venous thromboembolic events have been reported in up to 7.8% of patients treated with chemotherapy plus bevacizumab compared with up to 4.9% in patients treated with chemotherapy alone.
O venskih trombemboličnih dogodkih stopnje 3 do 5 so poročali pri do 7, 8% bolnikov, ki so jih zdravili s kemoterapijo in bevacizumabom, v primerjavi z do 4, 9% pri bolnikih, ki so jih zdravili samo s kemoterapijo.
Patients who have experienced a venous thromboembolic event may be at higher risk for a recurrence if they receive Avastin in combination with chemotherapy versus chemotherapy alone.
Pri bolnikih, pri katerih se je pojavil venski trombembolični dogodek, obstaja povečano tveganje za ponovitev, če prejemajo zdravilo Avastin v kombinaciji s kemoterapijo kot pa če prejemajo le kemoterapijo.
Congestive Heart Failure (CHF) In clinical trials with Avastin, congestive heart failure (CHF) was observed in all cancer indications studied to date, but occurred predominantly in patients with metastatic breast cancer.
Kongestivno srčno popuščanje V kliničnih preskušanjih z zdravilom Avastin so kongestivno srčno popuščanje opazili pri vseh indikacijah raka, ki so jih preiskovali do sedaj, pojavilo pa se je predvsem pri bolnikih z metastatskim rakom dojk.
In two phase III studies (AVF2119g and E2100) in patients with metastatic breast cancer an increase of CHF Grade 3 or more with Avastin was seen.
V študijah faze III (AVF2119g in E2100) so pri bolnikih z metastatskim rakom dojk, ki so jemali zdravilo Avastin, opazili porast kongestivnega srčnega popuščanja stopnje 3 ali več.
CHF was reported in up to 3.5% of patients treated with Avastin compared with up to 0.9% in the control arms.
Kongestivno srčno popuščanje se je pojavilo pri največ 3, 5% bolnikov zdravljenih z zdravilom Avastin, v kontrolni skupini pa pri največ 0, 9% bolnikov.
Most of these patients showed improved symptoms and/ or left ventricular function following appropriate medical therapy.
Pri večini bolnikov so se simptomi in/ ali iztisni delež levega prekata izboljšali po ustreznem zdravljenju.
In most clinical trials of Avastin, patients with pre-existing CHF of NYHA (New York Heart Association (NYHA) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
11 V večino kliničnih preskušanj z zdravilom Avastin bolniki, ki so imeli kongestivno srčno popuščanje pred pričetkom zdravljenja (NYHA - New York Heart Association II−IV) niso bili vključeni, zato informacije o tveganju za kongestivno srčno popuščanje pri tej populaciji niso na voljo.
Prior anthracyclines exposure and/ or prior radiation to the chest wall may be possible risk factors for the development of CHF.
Predhodno zdravljenje z antraciklini ali predhodno obsevanje prsnega koša ali oboje sta lahko dejavnika tveganja za razvoj kongestivnega srčnega popuščanja.
Elderly Patients In randomised clinical trials, age > 65 years was associated with an increased risk of developing arterial thromboembolic events, including cerebrovascular accidents (CVAs), transient ischaemic attacks (TIAs) and myocardial infarctions (MIs).
Starejši bolniki V randomiziranih kliničnih preskušanjih je bila starost nad 65 let pri zdravljenju z zdravilom Avastin povezana s povečanjem tveganja za razvoj arterijskih trombemboličnih dogodkov, vključno s cerebrovaskularnimi dogodki, tranzitornimi ishemičnimi atakami in miokardnimi infarkti.
Other reactions with a higher frequency seen in patients over 65 were grade 3-4 leucopenia and thrombocytopenia; and all grade neutropenia, diarrhoea, nausea, headache and fatigue as compared to those aged ≤ 65 years when treated with Avastin (see sections 4.4 and 4.8 under Thromboembolism).
Druge reakcije, ki so jih pri bolnikih starejših od 65 let opazili z višjo pogostnostjo v primerjavi z bolniki, starimi 65 let ali manj, so bile levkopenija in trombocitopenija stopnje 3 do 4, vse stopnje nevtropenije, diareja, navzea, glavobol in utrujenost (glejte poglavji 4. 4 in 4. 8 pod Trombembolija).
No increase in the incidence of other reactions, including gastrointestinal perforation, wound healing complications, hypertension, proteinuria, congestive heart failure, and haemorrhage was observed in elderly patients (> 65 years) receiving Avastin as compared to those aged ≤ 65 years treated with Avastin.
Pri starejših bolnikih (> 65 let) zdravljenih z zdravilom Avastin v primerjavi z bolniki starimi 65 let ali manj, zdravljenimi z zdravilom Avastin, ni bilo opaziti povečanja incidence drugih neželenih učinkov, vključno s perforacijami prebavil, zapleti pri celjenju ran, hipertenzijo, proteinurijo, kongestivnim srčnim popuščanjem in krvavitvami.
Decreased neutrophil count, decreased white blood cell count and presence of urine protein may be associated with Avastin treatment.
Laboratorijske nepravilnosti Zmanjšanje števila nevtrofilcev, zmanjšanje števila levkocitov in prisotnost beljakovin v seču so lahko povezani z zdravljenjem z zdravilom Avastin.
Across clinical trials, the following Grade 3 and 4 laboratory abnormalities occurred in patients treated with Avastin with at least a 2% difference compared to the corresponding control groups:
V kliničnih preskušanjih so se pri bolnikih, ki so se zdravili z zdravilom Avastin v primerjavi z ustreznimi kontrolnimi skupinami naslednje laboratorijske nepravilnosti stopnje 3 in 4 pojavile z najmanj 2 -% razliko: hiperglikemija, zmanjšana koncentracija hemoglobina, hipokaliemija, hiponatriemija, zmanjšano število belih krvnih celic, zvečano internacionalno normalizirano razmerje.
Post-marketing experience:
Izkušnje po prihodu zdravila na trg
Reactions (frequency*)
Neželeni učinki (pogostnost *)