FrancophonIA/ELRC3.0 huggingface dataset:
English: Clenil was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopekzdravila za uporabo v humani medicini (CMDh) je ugotovila, da je za zdravilo Clenil potrebno usklajevanje.
English: What is Clenil?
Slovenian: Kaj je zdravilo Clenil?
English: Recommendations are as stated above for adults.
Slovenian: Priporočila so enaka zgoraj navedenim priporočilom za odrasle.
English: Date of latest renewal: 10/07/2011
Slovenian: Datum zadnjega podaljšanja: 10/07/2011
English: Your doctor will monitor you carefully if you
Slovenian: Zdravnik vas bo skrbno nadzoroval, če
English: The ability to generate a primary or anamnestic humoral response to any vaccine has not been studied.
Slovenian: Zmožnosti za sprožitev primarnega ali anamnestičnega humoralnega odziva na katerokoli cepivo niso preučevali.
English: 33.1% Not Applicable
Slovenian: 33,1 % ni veljavno
English: 36 (19-NR)
Slovenian: 36 (19-ND)
English: 44 (28-NR)
Slovenian: 44 (28-ND)
English: This may predispose patients to opportunistic infections.
Slovenian: Bolniki so zaradi tega lahko dovzetni za oportunistične okužbe.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: The frequencies are based on clinical trial data.
Slovenian: Pogostnosti temeljijo na podatkih iz kliničnih preskušanj.
English: Procedures for proper handling and disposal should be observed.
Slovenian: Upoštevati je treba postopke za pravilno ravnanje in odstranjevanje.
English: Therefore, haematological monitoring of patients is indicated.
Slovenian: Zato je potrebno hematološko nadzorovanje bolnikov.
English: The majority of these reactions are mild to moderate in severity.
Slovenian: Večina teh reakcij je bilo blagih do zmernih.
English: The frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000).
Slovenian: Pogostnosti so določene kot zelo pogosto (≥ 1/10), pogosto (≥ 1/100 do < 1/10), občasno (≥ 1/1000 do < 1/100), redko (≥ 1/10.000 do < 1/1000), zelo redko (<1/10.000).
English: • The risk of opportunistic infections, in particular CMV viraemia
Slovenian: • tveganje oportunističnih okužb, še posebej za viremijo CMV
English: In general, older patients (over 65 years of age) tolerate cytotoxic therapy less well than younger individuals.
Slovenian: Na splošno starejši bolniki (starejši od 65 let) citotoksično zdravljenje prenašajo slabše kot mlajši posamezniki.
English: All doses should be administered by intravenous infusion over approximately 2 hours.
Slovenian: Vse odmerke je treba intravensko infundirati v približno 2 urah.
English: Chromosomal aberrations were categorized according to Döhner's hierarchical model.
Slovenian: Kromosomske spremembe so bile razvrščene glede na Döhnerjev hierarhični model.
English: Undesirable effects observed during post-marketing surveillance
Slovenian: Neželeni učinki, o katerih so poročali med postmarketinškim spremljanjem
English: This can only be accepted if preparation of the solution takes place under strictly aseptic conditions and the solution is protected from light.
Slovenian: To je sprejemljivo le, če priprava raztopine poteka pod strogimi aseptičnimi pogoji in je raztopina zaščitena pred svetlobo.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report
Slovenian: V skladu s smernico CHMP o sistemih za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
English: Patients with these conditions may be at higher risk of a heart attack.
Slovenian: Pri bolnikih s temi težavami je lahko tveganje za srčno kap večje.
English: The following information is intended for medical or healthcare professionals only:
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju
English: The antigen has been found on a small percentage (< 5%) of granulocytes, but not on erythrocytes or platelets.
Slovenian: Antigen so odkrili tudi na majhnem odstotku (< 5 %) granulocitov, ne pa na eritrocitih ali trombocitih.
English: Undesirable effects in previously treated patients
Slovenian: Neželeni učinki pri predhodno že zdravljenih bolnikih
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6.3.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 06/07/2001
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 06/07/2001
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found in certain cells in the body.
Slovenian: Monoklonsko protitelo je protitelo (vrsta beljakovine), ki je namenjeno za prepoznavanje in vezavo na določeno strukturo (ki se imenuje antigen) in se nahaja v nekaterih celicah v telesu.
English: Your doctor will be monitoring the effects of treatment and your progress carefully by examining you and by taking blood samples for analysis on a regular basis.
Slovenian: Zdravnik bo učinke zdravljenja in vaš napredek natančno nadzoroval z rednimi pregledi in odvzemi krvi za preiskave.
English: They are usually only mild or moderate problems and they gradually diminish during the course of
Slovenian: Učinki so ponavadi le blagi ali zmerni in se med zdravljenjem postopoma zmanjšajo.
English: The MabCampath solution must be prepared according to the instructions provided in section 6.6.
Slovenian: Raztopino zdravila MabCampath je treba pripraviti po navodilih, navedenih v poglavju 6.6.
English: Therapy should be discontinued if there is evidence of disease progression.
Slovenian: Zdravljenje je treba prekiniti, če se pojavijo znaki napredovanja bolezni.
English: It is not known if MabCampath can affect human reproductive capacity (see section 5.3).
Slovenian: Ni znano, ali zdravilo MabCampath vpliva na sposobnost razmnoževanja pri človeku (glejte poglavje 5.3).
English: • are over 65 years of age as you may be more intolerant to the medicine than other patients.
Slovenian: • ste starejši od 65 let, kajti mogoče je da boste zdravilo prenašali težje kot drugi bolniki.
English: With repeated administration and consequent plasma concentration accumulation, the rate of elimination approached zero-order kinetics.
Slovenian: Po ponavljajoči uporabi in posledičnem kopičenju v plazmi se je hitrost izločanja približala kinetiki ničelnega reda.
English: Key elements to be included in the educational brochure
Slovenian: Ključne komponente izobraževalne brošure
English: Determination of the efficacy of MabCampath is based on overall response and survival rates.
Slovenian: Določitev učinkovitosti zdravila MabCampath temelji na celotnem odzivu in deležih preživetja.
English: • Recommendation to avoid vaccination with live vaccines for at least 12 months following MabCampath therapy
Slovenian: • priporočilo o izogibanju cepljenja z živim cepivom vsaj 12 mesecev po zdravljenju z zdravilom MabCampath
English: Since CLL occurs commonly in this older age group, these patients should be monitored carefully (see section 4.2).
Slovenian: Ker se KLL ponavadi pojavlja pri starejših, je treba te bolnike natančno nadzorovati (glejte poglavje 4.2).
English: Patients have received repeated unit doses of up to 240 mg of MabCampath.
Slovenian: Bolniki so dobili ponavljajoče posamezne odmerke do 240 mg zdravila MabCampath.
English: The frequency of grade 3 or 4 adverse events, such as fever, hypotension and anaemia, may be higher in these patients.
Slovenian: Pogostnost neželenih učinkov 3. in 4. stopnje, npr. zvišane telesne temperature, hipotenzije in anemije, je pri teh bolnikih lahko večja.
English: If you experience early side effects the initial smaller doses may be repeated until the effects go away or reduce.
Slovenian: Če se pojavijo zgodnji neželeni učinki, boste večkrat zapored dobili začetne manjše odmerke, dokler ti učinki ne minejo ali se ne zmanjšajo.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC04.
Slovenian: Farmakoterapevtska skupina: Antineoplastična sredstva, monoklonska protitelesa, oznaka ATC: L01XC04.
English: EBV-associated lymphoproliferative disorders, in some cases fatal, have been reported.
Slovenian: Poročali so o z EBV povezanimi limfoproliferativnimi boleznimi, ki so bile v nekaterih primerih smrtne.
English: • antibiotics and antivirals may be given to provide you with extra protection.
Slovenian: • za dodatno zaščito morda dobili antibiotike in protivirusna zdravila.
English: MabCampath is contraindicated during pregnancy.
Slovenian: Zdravilo MabCampath je kontraindicirano med nosečnostjo.
English: Once a patient meets all laboratory and clinical criteria for a complete response, MabCampath should be discontinued and the patient monitored.
Slovenian: Ko bolnik izpolni vsa laboratorijska in klinična merila popolnega odziva, je treba uporabo zdravila MabCampath prekiniti in bolnika nadzorovati.
English: • are allergic to alemtuzumab or to proteins of a similar origin or to any of the other ingredients of MabCampath (see section 6 “Further Information”).
Slovenian: • ste alergični (preobčutljivi) na alemtuzumab, beljakovine podobnega izvora ali katerokoli sestavino zdravila MabCampath (glejte poglavje 6 »Dodatne informacije«).
English: Median duration of treatment was 11.7 weeks for first-line patients and 9.0 weeks for previously
Slovenian: Povprečno zdravljenje bolnikov traja 11,7 tednov, za predhodno zdravljene bolnike pa 9 tednov.
English: You should inform your doctor if you are taking or have recently taken any other medicines, even
Slovenian: Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: • steroids, antihistamines or analgesics (treatment for fever) to help reduce some of the side effects.
Slovenian: • steroide, antihistaminike ali analgetike (proti zvišani telesni temperaturi), ki bodo pomagali zmanjšati nekatere neželene učinke.
English: • have heart disease or chest pains and/or you are receiving treatment to reduce high blood pressure, as MabCampath may make these conditions worse.
Slovenian: • imate bolno srce ali bolečine v prsnem košu in/ali dobivate zdravila proti visokemu krvnemu tlaku, kajti zdravilo MabCampath lahko te težave poslabša.
English: In CLL, too many lymphocytes are produced.
Slovenian: Pri KLL nastaja preveč limfocitov.
English: • are a woman of childbearing potential or a fertile man, then you should use effective contraceptive methods before you start treatment, during treatment and for 6 months after treatment.
Slovenian: • če ste ženska v rodni dobi ali ploden moški, morate pred začetkom zdravljenja, med zdravljenjem in še 6 mesecev po njem uporabljati učinkovito kontracepcijo.
English: United Kingdom/Ireland Genzyme Therapeutics Ltd. (United
Slovenian: United Kingdom/Ireland Genzyme Therapeutics Ltd. (United Kingdom),
English: • abdominal bleeding (e.g. in the stomach and intestine)
Slovenian: • krvavitve v trebuhu (npr. v želodcu in črevesju)
English: MabCampath treatment may continue for up to 12 weeks depending on your progress.
Slovenian: Zdravljenje z zdravilom MabCampath lahko traja do 12 tednov, odvisno od vašega odziva na zdravljenje.
English: It is used in patients for whom treatment combinations including fludarabine (another medicine used in leukaemia) are not appropriate.
Slovenian: Uporablja se pri bolnikih, za katere kombinacija zdravljenja, ki vključuje fludarabin (drugo zdravilo, ki se uporablja za zdravljenje levkemije), ni primerno.
English: Steady-state concentrations were reached after about 6 weeks of dosing.
Slovenian: Ravnovesna koncentracija je bila dosežena po približno 6 tednih uporabe.
English: The safety and efficacy of MabCampath in children aged less than 17 years of age have not been
Slovenian: Varnost in učinkovitost zdravila MabCampath pri otrocih, mlajših od 17 let, še nista bili dokazani.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in
Slovenian: Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
English: • unusual increased or altered sensitivity to touch
Slovenian: • nenavadno povečana ali spremenjena občutljivost za dotik
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3.3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, sprejetem v različici 3.3 načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnih posodobitvah RMP v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
English: Blood and lymphatic system disorders: Severe bleeding reactions have been reported.
Slovenian: Bolezni krvi in limfatičnega sistema: Poročali so o hudih krvavitvah.
English: Histopathology results from bone marrow samples revealed no remarkable changes attributable to treatment.
Slovenian: Histopatološki izvidi vzorcev kostnega mozga niso pokazali posebnih sprememb, ki bi jih bilo mogoče pripisati zdravljenju.
English: Caution should be used in treating patients with ischaemic heart disease, angina and/or in patients receiving an antihypertensive medicinal product.
Slovenian: Previdnost je potrebna pri zdravljenju bolnikov z ishemično boleznijo srca, angino pektoris in/ali bolnikih, ki dobivajo antihipertenzivna zdravila.
English: MabCampath treatment may reduce your natural resistance to infections
Slovenian: Zdravljenje z zdravilom MabCampath lahko zmanjša vašo naravno odpornost proti okužbam zato boste
English: Single intravenous doses of 10 and 30 mg/kg produced moderate to severe dose related hypotension accompanied by a slight tachycardia.
Slovenian: Posamezni intravenski odmerki 10 in 30 mg/kg so povzročili zmerno do hudo z odmerkom povezano hipotenzijo, ki jo je spremljala blaga tahikardija.
English: In most patients, dose escalation to 30 mg can be accomplished in 3-7 days.
Slovenian: Pri večini bolnikov se lahko odmerek postopoma povečuje 3 do 7 dni do 30 mg.
English: The MAH shall ensure that all doctors who prescribe MabCampath are provided with a healthcare professional information pack containing the following:
Slovenian: Imetnik dovoljenja za promet bo poskrbel, da bodo imeli vsi zdravniki, ki predpisujejo zdravilo MabCampath, na voljo strokovno zdravstveno opisno dokumentacijo, ki bo vsebovala naslednje:
English: The dosage of MabCampath will not be increased until the effects are reduced.
Slovenian: Zdravnik odmerka zdravila MabCampath ne bo povečal, dokler se učinki ne zmanjšajo.
English: Rai Stage III/IV Disease
Slovenian: Stadij po Raiju RAI III/IV
English: Any spillage or waste material should be disposed of by incineration.
Slovenian: Morebitni razliti ali odpadni material je treba odstraniti s sežigom.
English: The MAH shall agree the details of an educational brochure with the National Competent
Slovenian: Imetnik dovoljenja za promet se bo o podrobnostih izobraževalne brošure dogovoril s pristojnimi nacionalnimi programi.
English: Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Germany.
Slovenian: Bayer Schering Pharma AG, Müllerstrasse 178, D-13342 Berlin, Nemčija
English: The tables below report adverse reactions by MedDRA system organ classes (MedDRA SOCs).
Slovenian: V preglednicah so navedeni neželeni učinki glede na organske sisteme po klasifikaciji MedDRA (MedDRA SOC).
English: • generally feeling unwell, weakness, pain in various parts of the body (muscle, back, chest,
Slovenian: • splošno slabo počutje, šibkost, bolečine v različnih delih telesa (mišicah, hrbtu, prsnem košu,
English: Alemtuzumab does not appear to damage haematopoietic stem cells or progenitor cells.
Slovenian: Kaže, da alemtuzumab ne okvari hematopoetskih matičnih celic ali izvornih celic.
English: No information is available for events that occur at lower frequency, due to the size of the population studied; n=147 for first line treated patients and n=149 for previously treated patients.
Slovenian: Za učinke, ki se pojavljajo manj pogosto, podatki zaradi velikosti študijske populacije niso na voljo; n=147 za predhodno nezdravljene bolnike (zdravljenje prvega izbora), in n=149 za predhodno že zdravljene bolnike.
English: Asymptomatic laboratory positive Cytomegalovirus (CMV) viraemia should not necessarily be considered a serious infection requiring interruption of therapy.
Slovenian: Pozitivnost na asimptomatsko laboratorijsko citomegalovirusno viremijo (CMV) še ni nujno resna okužba, ki predvideva prekinitev zdravljenja.
English: Speak to your doctor before receiving any vaccinations.
Slovenian: Pred vsakim cepljenjem se pogovorite s svojim zdravnikom.
English: The secondary objectives included complete response (CR) and overall response (CR or partial response) rates using the 1996 NCIWG criteria, the duration of response, time to alternative treatment and safety of the two treatment arms.
Slovenian: Sekundarni cilji vključujejo popolni odziv (CR) in celokupni odziv (CR ali delni odziv) po kriterijih 1996 NCIWG za trajanje odziva, časa do alternativnega zdravljenja in varnosti obeh načinov zdravljenja.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C-8°C).
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 °C - 8 °C).
English: Reversible neutropenia was seen following daily intravenous or subcutaneous dosing for 30 days, but not following single doses or daily dosing for 14 days.
Slovenian: Reverzibilno nevtropenijo so opažali po 30-dnevnem vsakodnevnem intravenskem ali subkutanem odmerjanju, ne pa po posameznih odmerkih ali 14-dnevnem vsakodnevnem odmerjanju.
English: In addition, an oral antihistamine, e.g. diphenhydramine 50 mg, and an analgesic, e.g. paracetamol 500 mg, may be given.
Slovenian: Poleg tega je mogoče uporabiti peroralen antihistaminik, npr. 50 mg difenhidramina, in analgetik, npr. 500 mg paracetamola.
English: However, if retreatment is considered, it may be prudent to confirm the presence of CD52 expression.
Slovenian: Pred odločitvijo o ponovnem zdravljenju pa je smiselno potrditi ekspresijo CD52.
English: Diseases related to an overactive immune system where your immune system attacks your own body can lead to low red blood cells, low blood platelets and/or low white blood cells, and nerve disorders, and these can also be fatal.
Slovenian: Bolezni, povezane s prekomerno aktivnim imunskim sistemom, pri katerih vaš imunski sistem napade vaše telo, lahko povzročijo zmanjšanje števila rdečih krvnih celic, zmanjšanje števila trombocitov in/ali zmanjšanje števila belih krvnih celic in živčne bolezni ter so prav tako lahko usodne.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: • abnormal sensation/feeling or movement
Slovenian: • neobičajni občutki ali gibanje
English: Care should be taken to ensure the sterility of the prepared solution particularly as it contains no antimicrobial preservatives.
Slovenian: Pomembno je zagotoviti sterilnost pripravljene raztopine, še zlasti ker ne vsebuje antimikrobnih konzervansov.
English: Because MabCampath is a recombinant humanized protein, a P450 mediated drug-drug interaction would not be expected.
Slovenian: Ker je zdravilo MabCampath rekombinantni humaniziran protein, ni pričakovati medsebojne interakcije med zdraviloma in posredovanim P450.
English: There are no definitive studies of MabCampath which assess its impact on fertility.
Slovenian: Ni dokončnih študij o zdravilu MabCampath, ki bi ocenjevale njegov vpliv na plodnost.
English: Usually one or more of these effects happen during the first week after the start of treatment:
Slovenian: Ponavadi se prvi teden po začetku zdravljenja pojavi eden ali več teh učinkov:
English: Alemtuzumab has been designed to bind to a glycoprotein (a protein that is coated with sugar molecules) that is found on the surface of lymphocytes.
Slovenian: Alemtuzumab se veže na glikoproteine (beljakovina, ki je prekrita z molekulami sladkorja), ki se nahajajo na površini limfocitov.
English: The following table outlines the recommended procedure for dose modification following the occurrence of haematological toxicity while on therapy:
Slovenian: Naslednja preglednica prikazuje postopke, ki se priporočajo za prilagoditev odmerka po pojavu hematoloških toksičnih učinkov med zdravljenjem.
English: Because of the potential for a fatal reaction to transfusion of any blood products following treatment with MabCampath, it is recommended that you speak to your doctor regarding the irradiation of blood products prior to receiving the transfusion.
Slovenian: Zaradi možnosti smrtno nevarne reakcije na transfuzijo katerih koli krvnih izdelkov po zdravljenju z zdravilom MabCampath vam priporočamo, da se pred transfuzijo s svojim zdravnikom posvetujete o obsevanju krvnih izdelkov.
English: Although no formal drug interaction studies have been performed with MabCampath, there are no known clinically significant interactions of MabCampath with other medicinal products.
Slovenian: Kljub temu, da študij medsebojnega delovanja zdravil z zdravilom MabCampath niso izvedli, znanih klinično pomembnih interakcij zdravila MabCampath z drugimi zdravili ni.
English: Safety data in previously treated B-CLL patients are based on 149 patients enrolled in single-arm studies of MabCampath (Studies 1, 2, and 3).
Slovenian: Podatki o varnosti za predhodno že zdravljene bolnike z B-KLL temeljijo na 149 bolnikih, vključenih v neprimerjalne študije zdravila MabCampath (študija 1, 2 in 3).
English: These symptoms can be ameliorated or avoided if premedication and dose escalation are utilised (see section 4.4).
Slovenian: Te simptome je mogoče preprečiti ali ublažiti s premedikacijo in stopnjevanjem odmerka (glejte poglavje 4.4).
English: The recommended anti-infective prophylaxis treatment appears to be effective in reducing the risk of PCP and herpes infections (see section 4.4).
Slovenian: Kaže, da priporočena protimikrobna zaščita učinkovito zmanjša tveganje za PCP in okužbo s herpes zostrom (glejte poglavje
English: A trend towards improved PFS was observed in patients with 17p deletion, trisomy 12 and normal karyotype, which did not reach significance due to small sample size.
Slovenian: Nagnjenje proti izboljšani vrednosti PFS je mogoče opaziti pri bolnikih z izbrisom 17p, trisomijo 12 in normalnim kariotipom, ki zaradi majhne vzorčne skupine ni tako pomemben.
English: Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Netherlands
Slovenian: Genzyme Europe BV, Gooimeer 10, 1411 DD Naarden, Nizozemska
English: Store in a refrigerator (2C-8C).
Slovenian: Shranjujte v hladilniku (2 C - 8 C).
English: Reconstituted solution: MabCampath contains no antimicrobial preservative.
Slovenian: Rekonstituirana raztopina: Zdravilo MabCampath ne vsebuje protimikrobnih konzervansov.
English: Like all medicines, MabCampath can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo MabCampath neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.