FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare (affects less than 1 in 1,000 people)
Slovenian: Zelo pogosti (pojavijo se pri več kot 1 od 10 oseb)
English: It is important to check with your doctor or nurse before having your injection if: you have had problems with your pregnancy, if during pregnancy, your waters have broken.
Slovenian: Bodite posebno pozorni pri uporabi zdravila <izmišljeno ime>: Pomembno je, da se z zdravnikom ali medicinsko sestro posvetujete, preden dobite injekcijo tega zdravila: če ste imeli težave z nosečnostjo.
English: Owing to the hypokalaemic effect of beta-agonists, concurrent administration of serum potassium depleting agents known to exacerbate the risk of hypokalaemia, such as diuretics, digoxin, methyl xanthines and corticosteroids, should be administered cautiously after careful evaluation of the benefits and risks with special regard to the increased risk of cardiac arrhythmias arising as a result of hypokalaemia (see section 4.4).
Slovenian: Zato je v primeru sočasne uporabe zdravil, ki znižujejo kalij v serumu in za katere je znano, da povečajo tveganje za hipokaliemijo (na primer diuretikov, digoksina, metilksantinov in kortikosteroidov) potreba previdnost: uporabiti jih je treba šele po skrbni oceni koristi in tveganj in posebej upoštevaje večje tveganje za motnje srčnega ritma zaradi hipokaliemije (glejte poglavje 4.4).
English: Pulmonary oedema
Slovenian: Pljučni edem
English: Increases in maternal heart rate of the order of 20 to 50 beats per minute usually accompany infusion of beta-agonists.
Slovenian: Infundiranje agonistov adrenergičnih receptorjev beta po navadi spremlja povečanje materine srčne frekvence za okrog 20 do 50 utripov na minuto.
English: Careful control of the level of hydration is essential to avoid the risk of maternal pulmonary oedema
Slovenian: Bistveno je natančno nadzorovanje ravni hidracije, da bi se izognili tveganju za pljučni edem pri materi (glejte poglavje 4.4).
English: infusion will limit risk of fluid overload.
Slovenian: Uporaba z injekcijsko črpalko in ne z intravenskim infundiranjem zmanjša tveganje za preobremenitev s tekočino.
English: Your doctor will consider the lowering of your dose or discontinuing <invented name> if your heart rate exceeds 120 beats per minute.
Slovenian: Če vaš srčni utrip preseže 120 utripov na minuto, bo zdravnik razmislil o znižanju odmerka ali prekinitvi uporabe zdravila <izmišljeno ime>.
English: Cardiac disorders Very common:
Slovenian: Žilne bolezni Pogosti:
English: Go to top of the page 4.8 Undesirable effects [The wording below should be inserted in this section]
Slovenian: 4.8 Neželeni učinki [Spodnje besedilo je treba vnesti v to poglavje]
English: you have too much fluid in the lungs causing breathlessness (pulmonary oedema) you have high blood pressure you are diabetic.
Slovenian: če imate v pljučih preveč tekočine, ki povzroča težko dihanje (pljučni edem).
English: A maximum maternal heart rate of 120 beats per min should not be exceeded.
Slovenian: Materina največja srčna frekvenca ne sme preseči 120 utripov na minuto.
English: For the short term management of uncomplicated premature labour To arrest labour between 22 and 37 weeks of gestation in patients with no medical or obstetric contraindication to tocolytic therapy.
Slovenian: 4.1 Terapevtske indikacije [Trenutno odobrene porodničarske indikacije je treba izbrisati in nadomestiti z naslednjim:] Za kratkotrajno vodenje nezapletenega prezgodnjega poroda Za ustavitev poroda med 22. in 37. tednom nosečnosti pri bolnicah, ki nimajo internističnih ali porodničarskih kontraindikacij za tokolitično zdravljenje.
English: There have been reports of pulmonary oedema in women concomitantly administered with beta-agonists and corticosteroids.
Slovenian: Pri ženskah, ki so hkrati prejemale agoniste adrenergičnih receptorjev beta in kortikosteroide, je bil opisan pljučni edem.
English: The administration of beta-agonists is associated with a rise of blood glucose, which can be interpreted as an attenuation of anti-diabetic therapy; therefore individual anti-diabetic therapy may need to be adjusted (see section 4.4).
Slovenian: Uporaba agonistov adrenergičnih receptorjev beta je povezana z zvišanjem glukoze v krvi; to je mogoče tolmačiti kot zmanjšanje učinka antidiabetičnih zdravil.
English: As maternal pulmonary oedema and myocardial ischaemia have been reported during or following treatment of premature labour with beta-agonists, careful attention should be given to fluid balance and cardio-respiratory function.
Slovenian: Med zdravljenjem prezgodnjega poroda z agonisti adrenergičnih receptorjev beta sta bila opisana pljučni edem in ishemija miokarda pri materi.
English: Chest pain (due to heart problems such as angina).
Slovenian: Redki (pojavijo se pri manj kot 1 od 1.000 oseb) Bolečina v prsih (zaradi težav s srcem, na primer angine pektoris).
English: - any condition of the mother or foetus in which prolongation of the pregnancy is hazardous, e.g. severe toxaemia, intrauterine infection, vaginal bleeding resulting from placenta praevia, eclampsia or severe preeclampsia, placental abruption, or cord compression.
Slovenian: - za katero koli stanje pri gestacijski starosti < 22 tednov, - kot tokolitik pri bolnicah z obstoječo ishemično srčno boleznijo ali bolnicah s pomembnimi dejavniki tveganja za ishemično srčno bolezen, - pri grozečem splavu v 1. in 2. trimesečju nosečnosti, - pri katerem koli stanju matere ali ploda, pri katerem bi bilo podaljšanje nosečnosti nevarno, npr. huda toksemija, intrauterina okužba, nožnična krvavitev zaradi placente previe, eklampsija ali huda preeklampsija, abrupcija placente ali kompresija popkovnice, - v primeru intrauterine smrti ploda, znane smrtne prirojene ali smrtne kromosomske nepravilnosti.
English: Corticosteroids are known to increase blood glucose and can deplete serum potassium, therefore concomitant administration should be undertaken with caution with continuous patient monitoring owing to the increased risk of hyperglycaemia and hypokalaemia (see section 4.4).
Slovenian: Zato je sočasno uporabo treba začeti previdno in s stalnim nadzorom bolnice, ker obstaja večje tveganje za hiperglikemijo in hipokaliemijo (glejte poglavje 4.4).
English: Rare (affects less than 1 in 1,000 people) Unusual or irregular heartbeats High levels of sugar (glucose) and/or lactic acid in your blood Flushing (reddening) of the face
Slovenian: Redki (pojavijo se pri manj kot 1 od 1.000 oseb) Neobičajni ali neredni utripi srca
English: Respiratory, thoracic and mediastinal disorders Uncommon: *Pulmonary oedema.
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni:
English: It is important that you are given all the infusions that have been recommended.
Slovenian: Pomembno je, da prejmete vse infuzije, ki so vam jih priporočili.
English: Date of first authorisation: 4th March 2013 Date of latest renewal: 8th December 2017
Slovenian: Datum prve odobritve: 4. marec 2013 Datum zadnjega podaljšanja: 8. december 2017
English: Thereafter, revert to the original planned schedule.
Slovenian: Nato se vrnite na prvotno načrtovano razporeditev.
English: ** For the overall treatment period across the 4 studies.
Slovenian: ** Za celotno obdobje zdravljenja v štirih študijah.
English: Do not wait until the next planned dose.
Slovenian: Ne čakajte na naslednji načrtovani odmerek.
English: No specific dose recommendations can be made.
Slovenian: Specifičnih priporočil o odmerjanju ni mogoče dati.
English: Data from first interim analysis.
Slovenian: Podatki prve vmesne analize.
English: The BERENICE study included two parallel groups of patients.
Slovenian: Študija BERENICE je vključevala dve vzporedni skupini bolnikov.
English: The majority of patients were less than 65 years old.
Slovenian: Večina bolnic je bila starih manj kot 65 let.
English: Medicinal products to treat such reactions, as well as emergency equipment, should be available for immediate use.
Slovenian: Zdravila za zdravljenje take reakcije kot tudi oprema za nujne primere morajo biti na voljo za takojšnjo uporabo.
English: The vial must not be shaken.
Slovenian: Vial ne smemo tresti.
English: At the time of the estimate the median follow-up was 45.4 months.
Slovenian: V času ocene je spremljanje trajalo mediano 45,4 meseca.
English: Each pack contains one vial.
Slovenian: Vsako pakiranje vsebuje 1 vialo.
English: To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures.
Slovenian: Za zagotovitev točnih in ponovljivih rezultatov mora biti testiranje opravljeno v specializiranem laboratoriju, kjer se lahko zagotovi ustrezna validacija postopka testiranja.
English: < 6 weeks
Slovenian: < 6 tednov
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Slovenian: Kemijska in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi 30 °C.
English: The safety and efficacy of Perjeta in children and adolescents below 18 years of age have not been established.
Slovenian: Varnost in učinkovitost zdravila Perjeta pri otrocih in mladostnikih, mlajših od 18 let, nista raziskani.
English: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba ime in številko serije danega zdravila jasno zabeležiti.
English: The median age was 51 years, and over 99% of patients were female.
Slovenian: Mediana starost je bila 51 let in več kot 99 % obolelih je bilo žensk.
English: Results of Subgroup Analysis
Slovenian: Rezultati analize podskupin
English: Perjeta should not be given to patients under the age of 18 years because there is no information on how it works in this age group.
Slovenian: Zdravila Perjeta ne smemo dajati bolnikom, mlajšim od 18 let, ker ni podatkov o tem, kako zdravilo deluje pri tej starostni skupini.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku
English: HER2 is found in large amounts on the surface of some cancer cells where it stimulates their growth.
Slovenian: HER2 se v velikih količinah nahaja na površini nekaterih rakavih celic, kjer spodbuja njihovo rast.
English: The storage details are as follows:
Slovenian: Podrobnosti o shranjevanju:
English: Store in a refrigerator (2°C-8°C).
Slovenian: • Shranjujte v hladilniku (2 °C do 8 °C).
English: Elderly patients (> 65 years) may have a higher risk of diarrhoea compared with younger patients (< 65 years).
Slovenian: Starejši bolniki (> 65 let) imajo lahko večje tveganje za drisko v primerjavi z mlajšimi bolniki (< 65 let).
English: This leaflet was last revised in.
Slovenian: Navodilo je bilo nazadnje revidirano
English: For the first infusion:
Slovenian: Prva infuzija:
English: If you have ever had heart problems during previous treatment with trastuzumab.
Slovenian: • če ste kdaj imeli težave s srcem med predhodnim zdravljenjem s trastuzumabom;
English: They will advise you about the benefits and risks for you and your baby of taking Perjeta while you are pregnant.
Slovenian: Seznanila vas bosta s koristmi in tveganji, ki jih za vas in otroka pomeni prejemanje zdravila Perjeta med nosečnostjo.
English: Once the infusion is prepared it should be administered immediately (see section 6.3).
Slovenian: Ko je infuzija pripravljena, jo je treba uporabiti nemudoma (glejte poglavje 6.3).
English: Treat diarrhoea according to standard practice and guidelines.
Slovenian: Zdravljenje driske poteka po standardni praksi in smernicah.
English: Talk to your doctor about the best contraception for you.
Slovenian: Z zdravnikom se posvetujte o tem, katera kontracepcija je za vas najprimernejša.
English: Antibodies are cleared principally by catabolism.
Slovenian: Protitelesa se v glavnem izločajo s katabolizmom.
English: Do not stop having this medicine without talking to your doctor first.
Slovenian: Ne prenehajte zdravljenja s tem zdravilom, ne da bi se pred tem posvetovali z zdravnikom.
English: Additional supportive clinical trial information
Slovenian: Dodatne podporne informacije kliničnih preskušanj
English: Perjeta and trastuzumab can be given in any order.
Slovenian: Zdravilo Perjeta in trastuzumab je mogoče dati v katerem koli vrstem redu.
English: 3-year event-free rate derived from Kaplan-Meier estimates.
Slovenian: 3-letni delež brez dogodkov je dobljen iz Kaplan-Meierjevih ocen.
English: ≥ 6 weeks
Slovenian: ≥ 6 tednov
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the following measures: Description
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: Diarrhoea is a condition where your body produces more watery stools than normal.
Slovenian: Driska je stanje, ko telo proizvede več tekočega blata kot ponavadi.
English: °° Infusion reaction includes a range of different terms within a time window, see “Description of selected adverse reactions” below.
Slovenian: °° Infuzijska reakcija zajema skupino različnih izrazov v časovnem razponu, glejte “Opis izbranih neželenih učinkovˮ spodaj.
English: What Perjeta is and what it is used for
Slovenian: Kaj je zdravilo Perjeta in za kaj ga uporabljamo
English: In clinical trials, single doses higher than 25 mg/kg (1727 mg) have not been tested.
Slovenian: V kliničnih preskušanjih niso testirali enkratnih odmerkov, večjih od 25 mg/kg (1727 mg).
English: Read all of this leaflet carefully before you start being given this medicine because it contains important information for you.
Slovenian: Preden začnete dobivati to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
English: Based on modifications made to the study treatment, most reactions were assessed as secondary to docetaxel infusions.
Slovenian: Na podlagi prilagoditev raziskovanega zdravljenja so večino reakcij ocenili kot posledico infuzij docetaksela.
English: Feeling sick or being tired
Slovenian: • slabost ali utrujenost
English: Those studies included the pivotal trials CLEOPATRA (n=808), NEOSPHERE (n=417), TRYPHAENA (n=225), and APHINITY (n=4804) [pooled in Table 2].
Slovenian: Te študije vključujejo ključna preskušanja CLEOPATRA (n = 808), NEOSPHERE (n = 417), TRYPHAENA (n = 225) in APHINITY (n = 4804)
English: For the initial dose, the recommended infusion period is 60 minutes.
Slovenian: Priporočeni čas infundiranja začetnega odmerka je 60 minut.
English: Before starting treatment, you must tell your doctor or nurse if you are pregnant or breast-feeding, or if you think you may be pregnant or are planning to have a baby.
Slovenian: Pred začetkom zdravljenja morate zdravniku ali medicinski sestri povedati, če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev.
English: Interruption of treatment with pertuzumab should be considered if no improvement in the patient's condition is achieved.
Slovenian: Razmisliti je treba o prekinitvi zdravljenja s pertuzumabom, če ne dosežemo izboljšanja bolnikovega stanja.
English: In both treatment groups, the proportion of patients experiencing febrile neutropenia was highest in the first cycle of therapy and declined steadily thereafter.
Slovenian: V obeh zdravljenih skupinah je bil delež bolnikov, pri katerih se je pojavila febrilna nevtropenija, največji med prvim ciklom zdravljenja, nato pa se je postopoma znižal.
English: Most of these patients had received prior anthracycline therapy and 11% of all patients had received prior trastuzumab.
Slovenian: Večina teh bolnikov je predhodno prejela zdravljenje z antraciklini, 11 % vseh bolnikov pa je predhodno prejemalo trastuzumab.
English: The median clearance (CL) of pertuzumab was 0.235 litres/day and the median half-life was 18 days.
Slovenian: Mediani očistek (Cl) pertuzumaba je bil 0,235 litra/dan, mediani razpolovni čas je bil 18 dni.
English: Number of IDFS events/Total N (%)
Slovenian: Število dogodkov IDFS / Skupaj n (%)
English: In a subset of monkeys, chronic dosing (7 to 26 weekly doses) resulted in episodes of severe secretory diarrhoea.
Slovenian: V podskupini opic je kronična uporaba (od 7 do 26 tedenskih odmerkov) povzročila pojavljanje hude sekretorne driske.
English: Compared with published data for similar regimens without pertuzumab, high pCR rates were observed in all 3 treatment arms (see Table 4).
Slovenian: V primerjavi z objavljenimi podatki za podobne sheme brez pertuzumaba so bili visoki deleži pCR opaženi v vseh treh zdravljenih skupinah (glejte Preglednico 4).
English: This clinical assessment should be based on the severity of the preceding reaction and response to administered treatment for the adverse reaction (see section 4.2).
Slovenian: Ta klinična ocena mora temeljiti na tem, kako huda je bila prejšnja reakcija in odzivu na zdravljenje neželenega učinka (glejte poglavje 4.2).
English: Clinical response represents patients with a best overall response of CR or PR during the neoadjuvant period (in the primary breast lesion).
Slovenian: Klinični odgovor predstavlja bolnike z najboljšim celokupnim odgovorom CR ali PR med neoadjuvantnim obdobjem (v primarni prsni leziji).
English: No statistically significant differences were found between the two treatment groups in Health Related Quality of Life as assessed by FACT-B TOI-PFB scores.
Slovenian: Med terapevtskima skupinama niso ugotovili statistično značilnih razlik v z zdravjem povezani kakovosti življenja, ocenjeni s FACT-B TOI-PFB.
English: Patients should have a pre-treatment LVEF of ≥ 55% (≥ 50% after completion of the anthracycline component of chemotherapy, if given).
Slovenian: Bolniki morajo imeti LVEF pred zdravljenjem ≥ 55 % (≥ 50 % po koncu antraciklinske komponente kemoterapije, če je uporabljena).
English: Some of the side effects which you get may be due to your breast cancer.
Slovenian: Nekateri neželeni učinki, ki se vam lahko pojavijo, so lahko posledica raka dojk.
English: Simes corr. for CMH test)
Slovenian: (Simesova korekcija za test CMH)
English: Approximate 95% CI for difference of two response rates using Hauck-Anderson method.
Slovenian: Približno 95-% interval zaupanja za razliko med deležema odgovora z uporabo Hauck-Andersonove metode.
English: There is limited amount of data from the use of pertuzumab in pregnant women.
Slovenian: Podatkov o uporabi pertuzumaba pri nosečnicah je malo.
English: ° Hypersensitivity/anaphylactic reaction is based on a group of terms.
Slovenian: ° Preobčutljivost/anafilaktična reakcija je osnovana na skupini izrazov.
English: The breast cancer has been identified to be of the “HER2-positive” form - your doctor will test you for this.
Slovenian: • če so rak dojke označili kot “HER2-pozitivna oblika” - zdravnik vas bo napotil na te preiskave;
English: For all following infusions, if the first infusion was well tolerated:
Slovenian: Nadaljnje infuzije, če ste prvo infuzijo dobro prenesli:
English: Treatment should include standard anthracycline- and/or taxane-based chemotherapy.
Slovenian: Zdravljenje mora vključevati standardno kemoterapijo na osnovi antraciklina in/ali taksana.
English: Infusion reactions, allergic or anaphylactic (more severe allergic) reactions can happen.
Slovenian: Pojavijo se lahko infuzijske reakcije, alergijske ali anafilaktične (hujše alergijske) reakcije.
English: After completion of chemotherapy, patients received radiotherapy and/or hormone therapy as per local clinical standard.
Slovenian: Po dokončanju kemoterapije so bolniki prejemali obsevanje in/ali hormonsko zdravljenje v skladu z lokalnim kliničnim standardom.
English: The number of infusions you will be given depends on how you respond to treatment and whether you are receiving treatment before or after surgery (neoadjuvant or adjuvant therapy) or for disease which has spread.
Slovenian: • Število infuzij, ki jih boste dobili, je odvisno od tega, kako se boste odzvali na zdravljenje in tega, ali se boste zdravili pred ali po operaciji (neoadjuvantno ali adjuvantno) ali za razsejano bolezen.
English: Perjeta will be stored by the health professionals at the hospital or clinic.
Slovenian: Zdravilo Perjeta bodo shranjevali zdravstveni delavci v bolnišnici ali ambulanti.
English: Table 3 Summary of efficacy from CLEOPATRA study Parameter
Slovenian: Povzetek učinkovitosti iz študije CLEOPATRA
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreeed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Patients may continue therapy during periods of reversible chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
Slovenian: Bolniki lahko med obdobji reverzibilne mielosupresije, povzročene s kemoterapijo, nadaljujejo z zdravljenjem, vendar jih je v tem času treba skrbno spremljati zaradi zapletov, ki jih lahko povzroči nevtropenija.
English: Treatment with Perjeta may affect the heart.
Slovenian: Zdravljenje z zdravilom Perjeta lahko vpliva na srce.
English: In the analyses of patient-reported outcomes, a 10-point difference was considered clinically meaningful.
Slovenian: V analizah rezultatov samoocene bolnikov je kot klinično pomembna veljala razlika 10 točk.
English: If it has been 6 weeks or more since your last visit a higher Perjeta dose of 840 mg will be given to you.
Slovenian: Če je od vašega zadnjega obiska minilo 6 tednov ali več, boste prejeli večji odmerek
English: Duration of Response †^ n=
Slovenian: Trajanje odgovora †^
English: Patients should be observed closely for hypersensitivity reactions.
Slovenian: Bolnike je treba skrbno opazovati glede preobčutljivostnih reakcij.
English: Perjeta may harm the unborn baby.
Slovenian: Zdravilo Perjeta lahko škoduje nerojenemu otroku.
English: It is supplied in a glass vial containing 14 ml concentrate.
Slovenian: Na voljo je v stekleni viali, ki vsebuje 14 ml koncentrata.
English: Medical review of these 15 reports showed that in 8/15 cases, the reported events were not indicative of IRR/hypersensitivity/anaphylaxis.
Slovenian: Medicinski pregled teh 15 poročil je pokazal, da v 8/15 primerov poročani dogodki niso nakazovali na infuzijsko reakcijo/preobčutljivost/anafilaksijo.
English: 4. p-value from Cochran-Mantel-Haenszel test, with Simes multiplicity adjustment.
Slovenian: Vrednost p iz Cochran-Mantel-Haenszelovega testa s Simesovo korekcijo za večkratne primerjave.
English: Perjeta will be given to you by a doctor or nurse in a hospital or clinic.
Slovenian: Zdravilo Perjeta vam bo dal zdravnik ali medicinska sestra v bolnišnici ali ambulanti.
English: A decrease in the number or low amount of white blood cells (shown in a blood test), with or without fever, which may increase the risk of an infection.
Slovenian: • zmanjšanje števila ali majhno količino belih krvnih celic (to pokaže preiskava krvi) z zvišano telesno temperaturo ali brez nje, kar lahko poveča tveganje za okužbo;
English: Roche Polska Sp.z o.o.
Slovenian: Polska Roche Polska Sp.z o.o.
English: Demographics were well balanced between the two treatment arms.
Slovenian: Demografske značilnosti so bile med terapevtskima skupinama dobro uravnotežene.
English: The incidence of left ventricular dysfunction and cardiac failure congestive reflect the MedDRA Preferred Terms reported in the individual studies.
Slovenian: Incidenca disfunkcije levega ventrikla in kongestivnega srčnega popuščanja odraža preferenčne izraze po MedDRA, o katerih so poročali pri posameznih študijah.
English: The final analysis of OS was performed when 389 patients had died (221 in the placebo-treated group and 168 in the Perjeta-treated group).
Slovenian: Končna analiza celokupnega preživetja je bila izvedena, ko je umrlo 389 bolnikov (221 v skupini, ki je prejemala placebo, in 168 v skupini, ki je prejemala zdravilo Perjeta).