natgillin/translations-raw huggingface dataset:
In this study, 87% of patients had disease that was IHC 3+, and 95% of patients entered had disease that was IHC 3+ and/or FISH positive.
V tej študiji je imelo 87 % bolnic bolezen, ki je bila IHK 3+, 95 % vključenih bolnic pa je imelo bolezen, ki je bila IHK 3+ in/ali FISH-pozitivna.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22nd May 2012
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 22. 5. 2012
Overall, the study results demonstrate a positive benefit risk ratio for TAC compared to FAC.
V celoti rezultati študije dokazujejo ugodno razmerje koristi in tveganja TAC v primerjavi s FAC.
Pharmacokinetic parameters estimated by the model were very close to those estimated from phase I studies.
Z modelom dobljeni farmakokinetični parametri so bili zelo blizu parametrom, ocenjenim v študijah I. faze.
In about 20% of these cases there were no risk factors for acute renal failure such as concomitant nephrotoxic medicinal products and gastrointestinal disorders.
V približno 20 % teh primerov ni bilo nobenih dejavnikov tveganja za akutno ledvično odpoved, npr. sočasnih nefrotoksičnih zdravil ali bolezni prebavil.
If new or worsening pulmonary symptoms develop, patients should be closely monitored, promptly investigated, and appropriately treated.
Če se pojavijo novi simptomi ali pride do poslabšanja pljučne funkcije, je treba bolnike skrbno spremljati, nemudoma preiskati in ustrezno zdraviti.
For storage conditions of the diluted medicinal product, see section 6.3.
Za pogoje shranjevanje raztopljenega zdravila glejte poglavje 6.3.
• infections, decrease in the number of red (anaemia), or white blood cells (which are important in fighting infection) and platelets
• okužbe, zmanjšanje števila rdečih krvnih celic (anemija), belih krvnih celic (ki so pomembne za premagovanje okužbe) in trombocitov,
This leaflet was last revised in {MM/YYYY}
Navodilo je bilo nazadnje revidirano dne
About 80% of the radioactivity recovered in faeces is excreted during the first 48 hours as one major inactive metabolite and 3 minor inactive metabolites and very low amounts of unchanged medicinal product.
Približno 80 % radioaktivnosti v blatu se izloči v prvih 48 urah v obliki enega pomembnega in treh manj pomembnih neaktivnih presnovkov; zelo malo zdravila se izloči nespremenjenega.
You must not become pregnant during treatment with this medicine and must use an effective method of contraception during therapy, because DOCETAXEL KABI may be harmful for the unborn baby.
Med zdravljenjem s tem zdravilom ne smete zanositi in morate uporabljati učinkovito kontracepcijsko zaščito, ker zdravilo DOCETAKSEL KABI lahko škoduje vašemu nerojenemu otroku.
Method of administration For instructions on preparation and administration of the product, see section 6.6.
Način uporabe Za navodila glede priprave in dajanja zdravila glejte poglavje 6.6.
Docetaxel1 n = 94
docetaksel1 n = 94
A survival update analysis conducted with a median follow-up time of 41.6 months no longer showed a statistically significant difference although always in favour of the TCF regimen and showed that the benefit of TCF over CF is clearly observed between 18 and 30 months of follow up.
Ponovna analiza preživetja, narejena pri medianem času spremljanja 41,6 mesecev, ni več pokazala statistično značilne razlike, čeprav je bila shema s TCF še vedno ugodnejša; pokazala pa je, da so koristi TCF v primerjavi s CF jasno opazne med 18. in 30. mesecem spremljanja.
Treatment is repeated every three weeks.
Terapija se ponavlja na tri tedne.
• redness and swelling of the palms of your hands or soles of your feet which may cause your skin to peel (this may also occur on the arms, face, or body)
• pordelost in otekanje dlani ali podplatov, ki lahko povzroči olupljenje kože (to se lahko pojavi tudi na rokah, obrazu ali telesu),
The incidence of serious adverse events was higher in older people compared to younger patients.
Incidenca resnih neželenih učinkov je bila pri starejših bolnikih večja kot pri mlajših.
If this happens, you must tell your doctor immediately
Če se to zgodi, morate nemudoma obvestiti zdravnika.
Hormonal receptor status
Stanje hormonskih receptorjev
This was also statistically significant with an HR of 0.71; 95% CI 0.56-0.90; log-rank test p = 0.004.
Tudi to je bilo statistično značilno: RO 0,71, 95 % IZ 0,56-0,90, log-rang test p = 0,004.
*a hazard ratio of less than 1 indicates that TAC is associated with a longer disease-free survival and overall survival compared to FAC
*Razmerje tveganj manj kot 1 pomeni, da je TAC povezan z daljšim preživetjem brez bolezni in daljšim celotnim preživetjem kot FAC.
Meeting relative indication for chemotherapya
Izpolnjena relativna indikacija za kemoterapijoa
All patients on the docetaxel-containing arm of the TAX 323 and TAX 324 studies, received prophylactic antibiotics.
Vsi bolniki v kraku z docetakselom TAX 323 in TAX 324 raziskav so prejemali antibiotično profilakso.
Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Zavedati se je treba, da je to verjetno podcenjen delež, kajti znano je, da docetaksel sam v odmerku 100 mg/m2 povzroči nevtropenijo pri 97 % bolnikov, 76 % stopnje 4, na podlagi najnižjega števila celic v krvi.
Severe reactions were characterised by hypotension and/or bronchospasm or generalized rash/erythema (see section 4.4).
Za hude reakcije so bili značilni hipotenzija in/ali bronhospazem ali generaliziran izpuščaj/eritem (glejte poglavje 4.4).
The primary analysis was done when all patients had a follow-up of greater than 5 years (median follow-up time of 77 months).
Primarna analiza je bila opravljena, ko je obdobje spremljanja pri vseh bolnicah preseglo 5 let (mediano spremljanje: 77 mesecev).
Docetaxel belongs to the group of anti-cancer medicines called taxoids.
Docetaksel spada v skupino zdravil za zdravljenje raka, imenovanih taksani.
This is because DOCETAXEL KABI or the other medicine may not work as well as expected and you may be more likely to get a side effect.
Bodisi zdravilo DOCETAKSEL KABI bodisi drugo zdravilo namreč mogoče ne bo delovalo tako dobro, kot bi bilo pričakovati, in verjetneje je, da se bo pri vas pojavil kakšen neželen učinek.
Patients must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration).
Bolniki morajo dobiti premedikacijo z antiemetiki in primerno hidracijo (pred in po dajanju cisplatina).
See also section “DOCETAXEL KABI contains ethanol (alcohol)” below.
Glejte tudi poglavje "Zdravilo DOCETAKSEL KABI vsebuje etanol (alkohol)" spodaj.
Treatment difference: 7.1% [95% CI: 0.7; 13.5] *: Corrected for multiple comparisons and adjusted for stratification factors (stage of disease and region of treatment), based on evaluable patient population.
razlika zdravljenj: 7,1 % [95 % IZ: 0,7, 13,5] *: Korigirano za multiple primerjave in prilagojeno za stratifikacijske faktorje (stadij bolezni in predel zdravljenja) na podlagi ocenljive populacije bolnikov.
TAC = docetaxel, doxorubicin and cyclophosphamide FAC = 5-fluorouracil, doxorubicin and cyclophosphamide CI = confidence interval
TAC = docetaksel, doksorubicin in ciklofosfamid FAC = 5-fluorouracil, doksorubicin in ciklofosfamid IZ = interval zaupanja
Patients previously treated with chemotherapy with or without radiotherapy
Bolniki, predhodno zdravljeni s kemoterapijo z radioterapijo ali brez nje
Caution is recommended for patients with neutropenia, particularly at risk for developing gastrointestinal complications.
Previdnost je priporočljiva pri bolnikih z nevtropenijo, zlasti če imajo tveganje za pojav zapletov na prebavilih.
Docetaxel is metabolised by CYP3A4 and prednisone is known to induce CYP3A4.
Docetaksel se presnavlja s CYP3A4, za prednizon pa je znano, da inducira CYP3A4.
Overall survival (Primary end-point):
statistična analiza celotno preživetje (primarna končna točka)
The amount of alcohol in this medicinal product may impair your ability to drive or use machines.
Količina alkohola v tem zdravilu lahko zmanjša vašo sposobnost vožnje in upravljanja strojev.
In the pivotal study the initial docetaxel infusion was started the day following the first dose of trastuzumab.
V študiji osrednjega pomena so s prvo infuzijo docetaksela začeli dan po prvem odmerku trastuzumaba.
Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Vnetje pljuč se lahko razvije tudi, če se zdravljenje z docetakselom uporablja sočasno z radioterapijo),
For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer (see section 5.1).
Pri bolnikih z operabilnim rakom dojke z negativnimi bezgavkami mora biti adjuvantno zdravljenje omejeno na bolnike, primerne za prejemanje kemoterapije v skladu z mednarodno sprejetimi merili za primarno zdravljenje zgodnjega raka dojke (glejte poglavje 5.1).
The positive benefit risk ratio for TAC compared to FAC remained unchanged.
Ugodno razmerje koristi in tveganja za TAC v primerjavi s FAC je ostalo nespremenjeno.
Interruption of docetaxel therapy is recommended until diagnosis is available.
Priporočljiva je prekinitev zdravljenja z docetakselom, dokler ni postavljena diagnoza.
Patients with impaired vision should undergo a prompt and complete ophthalmologic examination.
Bolniki z okvaro vida morajo takoj opraviti popoln oftalmološki pregled.
The subsequent docetaxel doses were administered immediately after completion of the trastuzumab infusion, if the preceding dose of trastuzumab was well tolerated.
Nadaljnji odmerki docetaksela so bili aplicirani nemudoma po zaključku infuzije trastuzumaba, če so bolniki predhodni odmerek trastuzumaba dobro prenašali.
Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of docetaxel, thus facilities for the treatment of hypotension and bronchospasm should be available.
Preobčutljivostne reakcije se lahko pojavijo v nekaj minutah po začetku infundiranja docetaksela, zato mora biti na voljo vse, kar je potrebno za zdravljenje hipotenzije in bronhospazma.
Age category 1 <50 years ≥50 years
Starostna kategorija 1 < 50 let ≥ 50 let
Docetaxel is an antineoplastic agent which acts by promoting the assembly of tubulin into stable microtubules and inhibits their disassembly which leads to a marked decrease of free tubulin.
Docetaksel je antineoplastična učinkovina, ki deluje tako, da spodbuja povezovanje tubulina v stabilne mikrotubule in zavira njihovo razgrajevanje, kar izrazito zmanjša količino prostega tubulina.
Symptoms such as early abdominal pain and tenderness, fever, diarrhoea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly.
Simptomi kot so: abdominalne bolečine in občutljivost, povišana telesna temperatura, driska z ali brez nevtropenije, so lahko zgodnja manifestacija resne gastrointestinalne toksičnosti ter jih je potrebno nemudoma ovrednotiti in zdraviti.
Patients with operable node-positive breast cancer (TAX 316)
Bolniki z operabilnim rakom dojke s pozitivnimi bezgavkami (TAX 316)
Neutrophil nadirs occurred at a median of 7 days but this interval may be shorter in heavily pre-treated patients.
Najmanjše število nevtrofilcev so ugotavljali po mediani 7 dni, vendar je ta čas lahko krajši pri bolnikih, ki so že bili intenzivno zdravljeni.
Menopausal status
Menopavzalno stanje
Before each treatment with DOCETAXEL KABI, you will have blood tests to check that you have enough blood cells and sufficient liver function to receive DOCETAXEL KABI.
Pred vsako uporabo zdravila DOCETAKSEL KABI boste opravili preiskave krvi za ugotovitev, ali imate dovolj krvnih celic in zadostno delovanje jeter, da lahko dobite zdravilo DOCETAKSEL KABI.
Reactions were characterised by a rash including localised eruptions mainly on the feet and hands (including severe hand and foot syndrome), but also on the arms, face or thorax, and frequently associated with pruritus.
Za te reakcije je bil značilen izpuščaj, vključno z lokaliziranimi erupcijami, predvsem na dlaneh in stopalih (vključno z resnim roka/noga sindromom), pa tudi na rokah, obrazu in prsnem košu; pogosto jih je spremljalo srbenje.
Hypersensitivity reactions have generally occurred within a few minutes following the start of the infusion of docetaxel and were usually mild to moderate.
Preobčutljivostne reakcije so se praviloma pojavile v nekaj minutah po začetku infundiranja docetaksela in so bile ponavadi blage do zmerne.
The second interim analysis was done after 400 DFS events had been recorded overall, which led to a median follow-up of 55 months.
Druga vmesna analiza je bila opravljena po 400 zabeleženih dogodkih preživetja brez bolezni (DFS) v celoti; tako je bilo mediano obdobje spremljanja 55 mesecev.
Patients who received docetaxel every three weeks demonstrated significantly longer overall survival compared to those treated with mitoxantrone.
Pri bolnikih, ki so prejemali docetaksel vsake tri tedne so prikazali značilno daljše skupno preživetje v primerjavi s tistimi, ki so bili zdravljeni z mitoksantronom.
Therefore, docetaxel must not be used during pregnancy unless clearly indicated.
Zato se docetaksela med nosečnostjo ne sme uporabljati, razen če ni drugače predpisano.
A population pharmacokinetic analysis has been performed with docetaxel in 577 patients.
Farmakokinetične analize docetaksela na populaciji so opravili pri 577 bolnikih.
The safety and efficacy of DOCETAXEL KABI in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Varnost in učinkovitost zdravila DOCETAKSEL KABI za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
Exploratory subgroup analyses for disease-free survival for patients who meet the 2009 St. Gallen chemotherapy criteria - (ITT population) were performed and presented here below
Opravljene so bile eksplorativne analize podskupin glede preživetja brez bolezni pri bolnicah, ki izpolnjujejo St.-Gallenska merila 2009 za kemoterapijo (populacija ZNZ); predstavljene so spodaj
In case of white blood cells disturbances, you may experience associated fever or infections.
Če imate spremenjeno število belih krvnih celic, se lahko pojavijo povišana telesna temperatura ali okužbe.
Overall, quality of life (QoL) and clinical benefit results consistently indicated improvement in favour of the TCF arm.
V celoti pa rezultati kakovosti življenja in klinične koristi dosledno kažejo izboljšanje v kraku s TCF.
Dose adjustments during treatment
Prilagajanje odmerka med zdravljenjem
Once added to the infusion bag
Potem, ko je zdravilo dodano v infuzijsko vrečo
DOCETAXEL KABI will be given by infusion into one of your veins (intravenous use).
Zdravilo DOCETAKSEL KABI boste dobili v infuziji v eno od ven (intravenska uporaba).
During radiotherapy, carboplatin (AUC 1.5) was given weekly as a one-hour intravenous infusion for a maximum of 7 doses.
Med radioterapijo so vsak teden dobili karboplatin (AUC 1,5) v enourni intravenski infuziji do največ 7 odmerkov.
Between infusions of DOCETAXEL KABI the following may occur, and the frequency may vary with the combinations of medicines that are received
Med infuzijami zdravila DOCETAKSEL KABI se lahko pojavijo naslednji neželeni učinki in pogostnost se lahko razlikuje glede na kombinacijo zdravil, ki so uporabljena:
Of the 333 patients treated with docetaxel every three weeks in a prostate cancer study, 209 patients were 65 years of age or greater and 68 patients were older than 75 years.
Od 333 bolnikov z rakom prostate v študiji, ki so bili zdravljeni z docetakselom vsake tri tedne, je bilo 209 bolnikov starih 65 let ali več, 68 bolnikov pa je bilo starih nad 75 let.
The secondary endpoint, PFS, demonstrated a 29% risk reduction of progression or death and a 22 month improvement in median PFS (35.5 months for TPF and 13.1 for PF).
Sekundarna končna točka, preživetje brez napredovanja (PBN), je pokazala 29 % zmanjšanje tveganja za napredovanje ali smrt ter 22-mesečno izboljšanje medianega PBN (35,5 mesecev pri TPF in 13,1 pri PF).
In combination with cisplatin
V kombinaciji s cisplatinom
After opening of the vial
Viala po odprtju
TAC-treated patient subsets according to prospectively defined major prognostic factors were analysed:
Podskupine bolnic, zdravljenih s TAC, so analizirali po prospektivno opredeljenih prognostičnih dejavnikih:
In addition, docetaxel was found to be active on some but not all cell lines over expressing the p-glycoprotein which is encoded by the multidrug resistance gene.
Poleg tega je ugotovljeno, da je docetaksel aktiven na nekaterih, ne pa na vseh celičnih linijah s hipereksprimiranim p-glikoproteinom, ki ga kodira gen za rezistenco proti več zdravilom.
The most commonly reported adverse reactions of docetaxel alone are: neutropenia (which was reversible and not cumulative; the median day to nadir was 7 days and the median duration of severe neutropenia (< 500 cells/mm3) was 7 days), anaemia, alopecia, nausea, vomiting, stomatitis, diarrhoea and asthenia.
Najpogosteje opisani neželeni učinki na sam docetaksel so: nevtropenija (ki je bila reverzibilna in ni bila kumulativna; srednji čas do najmanjšega števila je bil 7 dni, srednje trajanje hude nevtropenije (< 500 celic/mm3) pa 7 dni), anemija, alopecija, navzea, bruhanje, stomatitis, driska in astenija.
The final analysis was performed when all patients had reached their 10-year follow-up visit (unless they had a DFS event or were lost to follow up before).
Končna analiza je bila opravljena, ko so vse bolnice prišle na pregled po 10-letnem spremljanju (razen če se jim je prej pojavil dogodek DFS ali so se prej izgubile spremljanju).
Docetaxel has been shown in vitro to disrupt the microtubular network in cells which is essential for vital mitotic and interphase cellular functions.
In vitro docetaksel dokazano zmoti celično mikrotubulno mrežje, nujno za mitotično in interfazno celično delovanje.
• swelling caused by faulty lymphatic drainage
• otekanje zaradi nepravilne limfatične drenaže,
Docetaxel achieves high intracellular concentrations with a long cell residence time.
Docetaksel doseže visoko znotrajcelično koncentracijo in ima dolg čas zadrževanja v celicah.
If a dose greater than 190 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/ml docetaxel is not exceeded.
Če je potrebni odmerek večji od 190 mg docetaksela, uporabite več infuzijskega vehikla, tako da končna koncentracija v raztopini za infundiranje ne preseže 0,74 mg docetaksela/ml.
Do not use this medicine after the expiry date which is stated on the outer carton and on the label of the vial after Exp.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini in na nalepki na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Patients with 4+ nodes
Bolnice s 4+ bezgavkami
If you have any further questions on the use of this medicine, ask your doctor, or hospital pharmacist.
Če imate glede uporabe tega zdravila še kakšna vprašanja, vprašajte zdravnika ali bolnišničnega farmacevta.
Very rare cases of hepatitis, sometimes fatal primarily in patients with pre-existing liver disorders, have been reported.
Opisani so zelo redki primeri hepatitisa, včasih s smrtnim izidom, pri bolnikih z že prej obstoječo boleznijo jeter.
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.
Poleg tega sta fizikalna in kemijska stabilnost med uporabo dokazani za 48 ur pri temperaturi od 2 °C do 8 °C, če je bila raztopina pripravljena v vrečki, ki ne vsebuje PVC in tako kot je priporočeno.
Disseminated intravascular coagulation (DIC), often in association with sepsis or multi-organ failure, has been reported.
Poročali so o diseminirani intravaskularni koagulaciji (DIK), pogosto v povezavi s sepso ali multiorgansko odpovedjo.
1-year Survival (%)
1-letno preživetje (%)
The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.
Raztopino za infundiranje v infuzijski vreči je treba uporabiti v 6 urah na temperaturi do 25 °C, to vključuje tudi 1 uro infundiranja bolniku.
Surgical resection was allowed following chemotherapy, before or after radiotherapy.
Kirurška resekcija je bila dovoljena po kemoterapiji, pred radioterapijo ali po njej.
Patients who experience febrile neutropenia and/or neutropenic infection should have their docetaxel dose reduced to 60 mg/m² in all subsequent cycles (see sections 4.4 and 4.8).
Bolnicam, ki se jim pojavi febrilna nevtropenija in/ali nevtropenična okužba, je treba odmerek docetaksela v vseh nadaljnjih ciklih zmanjšati na 60 mg/m2 (glejte poglavji 4.4 in 4.8).
Febrile neutropenia and neutropenic infection occurred in 17.2% and 13.5% of patients respectively, regardless of G-CSF use.
Febrilna nevtropenija se je pojavila pri 17,2 % bolnikov, nevtropenična okužba pa pri 13,5 % bolnikov, ne glede na uporabo G-CSF.
Primary prophylactic G-CSF was made mandatory in TAC arm after 230 patients were randomised .
Primarna profilaktična uporaba G-CSF je postala v kraku TAC obvezna po randomizaciji 230 bolnic.
When combined to docetaxel, the clearance of carboplatin was about 50% higher than values previously reported for carboplatin monotherapy.
V kombinaciji z docetakselom je bil očistek karboplatina približno 50 % večji od vrednosti, opisanih med monoterapijo s karboplatinom.
Patients in both treatment arms were to receive 7 weeks of CRT following induction chemotherapy with a minimum interval of 3 weeks and no later than 8 weeks after start of the last cycle (day 22 to day 56 of last cycle).
Bolniki v obeh terapevtskih krakih so po indukcijski kemoterapiji dobili 7 tednov kemoradioterapije; najkrajši presledek je bil 3 tedne in ne več kot 8 tednov po začetku zadnjega cikla (22. do 56. dan zadnjega cikla).
It should be used within 6 hours (including the one hour infusion intravenous administration).
Porabiti jo je potrebno v 6 urah (to vključuje tudi 1 uro intravenskega infundiranja bolniku).
In case of combination with CYP3A4 inhibitors, the occurrence of docetaxel adverse reactions may increase, as a result of reduced metabolism.
V primeru kombinirane uporabe z zaviralci CYP3A4 se zaradi zmanjšane presnove lahko poveča pojavljanje neželenih učinkov docetaksela.
These results are consistent with the pharmacological activity of docetaxel.
Ti izsledki se skladajo s farmakološkim delovanjem docetaksela.
The combined administration of docetaxel, cisplatin and 5-fluorouracil in 12 patients with solid tumours had no influence on the pharmacokinetics of each individual medicinal product.
Kombinacija docetaksela, cisplatina in 5-fluorouracila pri 12 bolnikih s čvrstimi tumorji ni vplivala na farmakokinetiko vsakega posameznega zdravila.
If you develop acute or worsening problems with your lungs (fever, shortness of breath or cough), please tell your doctor, hospital pharmacist or nurse immediately.
Če se pojavijo akutne težave s pljuči ali pride do poslabšanja simptomov (povišana telesna temperatura, težko dihanje/kratka sapa ali kašelj), takoj obvestite svojega zdravnika, bolnišničnega farmacevta ali medicinsko sestro.
The adverse reactions considered to be possibly or probably related to the administration of docetaxel have been obtained in:
Podatki o neželenih učinkih, ki so morda ali verjetno povezani z uporabo docetaksela, so bili zbrani pri:
Without primary G-CSF prophylaxis (n = 111) n (%)
Brez primarne profilakse z G-CSF (n = 111) n (%)
• decrease in blood pressure; irregular or rapid heart beat
• znižanje krvnega tlaka, nereden ali hiter srčni utrip,