natgillin/translations-raw huggingface dataset:
Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of trastuzumab (see section 4.4) and have been associated with a fatal outcome.
Hude anafilaktične reakcije, ki zahtevajo takojšnje dodatno posredovanje se lahko pojavijo, ponavadi med prvo ali drugo infuzijo trastuzumaba (glejte poglavje 4.4); povezane so lahko tudi s smrtnim izidom.
AUC0-21days
AUC0-21.dan
To ensure accurate and reproducible results, the testing must be performed in a specialised laboratory, which can ensure validation of the testing procedures.
Za zagotovitev točnih in ponovljivih rezultatov mora biti testiranje opravljeno v specializiranem laboratoriju, ki lahko zagotavlja ustrezno validacijo postopka testiranja.
Very rarely, patients with severe breathing difficulties before treatment have died when they were given trastuzumab.
Zelo redko je pri bolnikih, ki so imeli hude težave z dihanjem pred začetkom zdravljenja, pri uporabi trastuzumaba prišlo do smrtnih primerov;
Anaphylactoid reactions have been observed in isolated cases.
Anafilaktoidne reakcije so opazili v posameznih primerih.
If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”).
Če boste začetni odmerek dobro prenašali, boste nadaljnje odmerke prejeli v 30 minutah (glejte poglavje 2, »Opozorila in previdnostni ukrepi«).
In addition, comparison of two years of trastuzumab treatment versus one year of trastuzumab treatment was performed.
Poleg tega so izvedli primerjavo dvoletnega zdravljenja s trastuzumabom z enoletnim zdravljenjem s trastuzumabom.
See section 5.1 for chemotherapy combination dosing.
Glejte poglavje 5.1 za odmerjanje v kombinaciji s kemoterapijo.
Chemo + trastuzumab (n = 115)
Kemoterapija + trastuzumab (n = 115)
Therefore, these patients should not be treated with KANJINTI (see section 4.3).
Zato takih bolnikov ne smemo zdraviti z zdravilom KANJINTI (glejte poglavje 4.3).
Infusion reactions, allergic-like reactions and hypersensitivity
Infuzijske reakcije, alergiji podobne reakcije in preobčutljivost
Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) foetal development period was observed.
Opazili so prehod trastuzumaba prek placente v zgodnjem obdobju (20. do 50. dan gestacije) in v poznem obdobju (120. do 150. dan gestacije) razvoja ploda.
For instructions on reconstitution of KANJINTI intravenous formulation before administration, see section 6.6.
Za navodila glede rekonstitucije zdravila KANJINTI v intravenski obliki pred dajanjem glejte poglavje 6.6.
The European Medicines Agency has waived the obligation to submit the results of studies with trastuzumab in all subsets of the paediatric population in breast and gastric cancer (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij s trastuzumabom za vse skupine pediatrične populacije pri raku dojk in raku želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Paediatric population There is no relevant use of trastuzumab in the paediatric population.
Pediatrična populacija Uporaba trastuzumaba pri pediatrični populaciji ni smiselna.
Tell a doctor or nurse straight away, if you notice any of the following side effects:
Zdravniku ali medicinski sestri morate takoj povedati, če opazite katerega od naslednjih neželenih učinkov:
These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with KANJINTI.
Ta zdravila (ali kateri koli antraciklin) lahko poškodujejo srčno mišico in zvečajo tveganje za nastanek težav s srcem ob uporabi zdravila KANJINTI;
Additionally, trastuzumab is a potent mediator of antibody-dependent cell-mediated cytotoxicity (ADCC).
Trastuzumab je tudi močan mediator od protiteles odvisne celične citotoksičnosti (antibody-dependent cell-mediated cytotoxicity - ADCC).
The difference was not statistically significant, however more than half of the patients in the anastrozole alone arm crossed over to a trastuzumab containing regimen after progression of disease.
Razlika ni bila statistično značilna, vendar pa je več kot polovica bolnikov iz skupine, ki je jemala le anastrozol po napredovanju bolezni, prešla na shemo, ki je vsebovala trastuzumab.
Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time.
Bolniki lahko nadaljujejo zdravljenje tudi med obdobji reverzibilne mielosupresije, ki je posledica kemoterapije, vendar pa jih je v tem času treba skrbno spremljati zaradi zapletov nevtropenije.
HER2 overexpression assessment
Ocena čezmernega izražanja HER2
However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Trastuzumab pa lahko zviša celokupno izpostavljenost enemu presnovku doksorubicina (7-deoksi-13-dihidro-doksorubicinonu, D7D).
In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba zaščiteno ime in številko serije uporabljenega zdravila jasno zabeležiti.
• performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
• Pripravo mora izvesti usposobljeno osebje v aseptičnih pogojih v skladu s pravili dobre prakse, zlasti glede aseptične priprave parenteralnih zdravil.
Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.
Bolnikom, pri katerih se pojavijo simptomi, povezani z infundiranjem (glejte poglavje 4.4), je treba svetovati, naj ne vozijo avtomobilov ali upravljajo strojev, dokler ti ne izzvenijo.
The presence of anti-trastuzumab antibodies had no impact on the pharmacokinetics, efficacy (determined by pathological complete response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
Prisotnost protiteles proti trastuzumabu ni vplivala na farmakokinetiko, učinkovitost (določeno s patološkim popolnim odgovorom [pCR] in preživetjem brez dogodka (Event Free Survival [EFS])) in varnost, določeno s pojavom reakcij, povezanih z aplikacijo trastuzumaba v intravenski obliki.
• abnormally low oxygen levels in the blood
• nenormalno malo kisika v krvi
KANJINTI intravenous formulation is given as an intravenous infusion (“drip”) directly into your veins.
Zdravilo KANJINTI v intravenski obliki se daje kot intravenska infuzija (»s kapljanjem«) neposredno v vaše žile.
(6.2-ne)
(6,2-no)
All the terms included are based on the highest percentage seen in pivotal clinical trials.
Pri vseh navedenih neželenih učinkih je upoštevan najvišji odstotek, opažen v ključnih kliničnih preskušanjih.
The central compartment volume was 2.62 L for patients with MBC and EBC and 3.63 L for patients with AGC.
Volumen centralnega prostora je bil 2,62 l za bolnike z MBC in EBC ter 3,63 l za bolnike z AGC.
As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during KANJINTI therapy and for 7 months after the last dose.
Ker se humani IgG1 izloča v materino mleko, potencialni škodljivi vpliv na otroka pa ni znan, naj ženske ne dojijo med zdravljenjem z zdravilom KANJINTI in še 7 mesecev po zadnjem odmerku.
In rare cases, these reactions are associated with a clinical course culminating in a fatal outcome.
V redkih primerih so imele te reakcije klinični potek, ki je privedel do smrtnega izida.
A study of trehalose, a major formulation excipient did not reveal any toxicities.
Študija trehaloze, glavne pomožne snovi, ni pokazala nobene toksičnosti.
• blood infection
• okužba krvi
The median duration of follow-up in the trastuzumab arm was 3.8 years.
Mediana spremljanja v skupini, ki je prejemala trastuzumab, je bila 3,8 leta.
It is not known whether trastuzumab is secreted in human milk.
Ni znano, ali se trastuzumab izloča v materino mleko pri ljudeh.
The dose of KANJINTI depends on your body weight.
Odmerek zdravila KANJINTI je odvisen od vaše telesne mase.
Median follow-up 8 years**
Mediani čas spremljanja 8 let**
Median follow-up 12 months*
Mediani čas spremljanja 12 mesecev*
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C - 8°C.
Če se ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik; običajno ne presegajo 24 ur pri temperaturi od 2 °C do 8 °C.
Total pathological complete response* (95% CI)
Skupni popolni patološki odgovor* (95-% IZ)
• altered taste
• sprememba okusa
The t1/2 decreases with decreasing concentrations within a dosing interval (see Table 16).
Razpolovni čas se zmanjšuje z zmanjševanjem koncentracije v odmernem intervalu (glejte preglednico 16).
• you have had heart failure, coronary artery disease, heart valve disease (heart murmurs), high blood pressure, taken any high blood pressure medicine or are currently taking any high blood pressure medicine.
• ste imeli srčno popuščanje, koronarno arterijsko bolezen, bolezen srčnih zaklopk (šum na srcu), visok krvni tlak, če jemljete ali ste jemali zdravila proti visokemu krvnemu tlaku;
+1Hypotension
+1hipotenzija pogosto
1) Using a sterile syringe, slowly inject the appropriate volume (as noted above) of sterile water for injections in the vial containing the lyophilised KANJINTI, directing the stream into the lyophilised cake.
1) Uporabite sterilno injekcijsko brizgo, počasi injicirajte primerno količino (kot navedeno zgoraj) sterilne vode za injekcije v vialo, ki vsebuje liofilizirano zdravilo KANJINTI, usmerite curek na liofiliziran prašek.
Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms (see sections 4.4 and 4.8).
Bolniki morajo biti pod nadzorom vsaj šest ur po začetku prve infuzije in dve uri po začetku nadaljnjih infuzij zaradi nevarnosti pojava simptomov, kot so zvišana telesna temperatura, mrzlica in drugi simptomi, povezani z infundiranjem (glejte poglavji 4.4 in 4.8).
The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0%).
Delež je bil najvišji pri bolnikih, ki so trastuzumab prejeli sočasno s taksanom (2,0 %).
The efficacy results from study MO16432 are summarised in Table 12.
Rezultati učinkovitosti študije MO16432 so povzeti v preglednici 12.
In this trial, 87% of patients entered had disease that was IHC3+, and 95% of patients entered had disease that was IHC3+ and/or FISH-positive.
V tem preskušanju je 87 % vključenih bolnikov imelo bolezen, ki je bila IHC 3+, 95 % vključenih bolnikov pa je imelo bolezen, ki je bila IHC 3+ in/ali FISH-pozitivna.
These events may occur as part of an infusion-related reaction or with a delayed onset.
Ti učinki se lahko pojavijo kot del infuzijske reakcije ali pa nastopijo kasneje.
It is important to check the product labels to ensure that the correct formulation is being given as prescribed.
Pomembno je preveriti ovojnino zdravila in zagotoviti, da prejmete pravilno obliko, ki vam je bila predpisana.
• You have early breast cancer, with high levels of a protein called HER2.
• imate zgodnjega raka dojk, pri katerem so izražene velike količine beljakovine, ki se imenuje HER2;
- following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
- po operaciji, kemoterapiji (neoadjuvantni ali adjuvantni) in radioterapiji (če je primerno) (glejte poglavje 5.1);
Ask your doctor or pharmacist for advice before taking any medicine.
Posvetujte se z zdravnikom ali farmacevtom, preden boste vzeli katero koli zdravilo.
A minority of patients was tested using fluorescence in-situ hybridisation (FISH).
Manjši del bolnikov so testirali z metodo fluorescenčne hibridizacije in situ (FISH).
The powder is a white to pale yellow pellet.
Prašek je bele do rahlo rumene barve.
In order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file.
Za izboljšanje sledljivosti tega zdravila morata zdravnik ali farmacevt v vašo zdravstveno kartoteko zabeležiti zaščiteno ime in številko serije zdravila, ki ste ga prejeli.
Experience of concurrent administration of trastuzumab with low-dose anthracycline regimens is currently limited to two trials (MO16432 and BO22227).
Izkušnje z dajanjem trastuzumaba sočasno s shemami, ki vsebujejo majhne odmerke antraciklinov, so trenutno vezane na dve študiji (MO16432 in BO22227).
Pre-medication may be used to reduce risk of occurrence of these events.
Za zmanjšanje tveganja pojava teh neželenih učinkov lahko uporabimo premedikacijo.
The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarised in table 6:
Rezultati učinkovitosti študije BO16348 po medianem času spremljanja 12 mesecev* in 8 let** so povzeti v preglednici 6.
The rate of infusion-related reactions of all grades varied between studies depending on the indication, the data collection methodology, and whether trastuzumab was given concurrently with chemotherapy or as monotherapy.
Pogostnost infuzijskih reakcij vseh stopenj je bila različna po študijah glede na indikacijo, metodologijo zbiranja podatkov in glede na to, ali so trastuzumab dajali sočasno s kemoterapijo ali v monoterapiji.
Study M77001: Full analysis set (intent-to-treat), 24 months results
Študija M77001: celotna skupina bolnikov (bolniki, ki so jih nameravali zdraviti, intent-to-treat), rezultati po 24 mesecih.
Monitoring may help to identify patients who develop cardiac dysfunction.
Spremljanje lahko olajša razpoznavo bolnikov, pri katerih se pojavijo motnje v delovanju srca.
Adjuvant treatment
Adjuvantno zdravljenje
Patients were treated with trastuzumab until progression of disease.
Bolniki so prejemali trastuzumab do napredovanja bolezni.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, and would not normally be longer than 24 hours at 2°C - 8°C, unless reconstitution and dilution have taken place under controlled and validated aseptic conditions.
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik; običajno ne presegajo 24 ur pri temperaturi od 2 °C do 8 °C, razen če sta rekonstitucija in redčenje potekala v kontroliranih in validiranih aseptičnih pogojih.
Treatment with KANJINTI alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Samostojno zdravljenje z zdravilom KANJINTI ali v kombinaciji s taksanom lahko vpliva na srce, še posebno, če ste se kdaj zdravili z antraciklinom (taksani in antraciklini sta dve drugi vrsti zdravil, ki se uporabljata za zdravljenje raka).
At the time of the analysis a total of 349 randomised patients had died: 182 patients (62.8%) in the control arm and 167 patients (56.8%) in the treatment arm.
Do časa analize je umrlo skupaj 349 randomiziranih bolnikov: 182 bolnikov (62,8 %) v kontrolni skupini in 167 bolnikov (56,8 %) v skupini, ki je prejemala tudi trastuzumab.
The clinical relevance of these antibodies is not known.
Klinični pomen pojava protiteles ni znan.
Administration as an intravenous push or bolus is prohibited.
Uporaba zdravila kot hitra intravenska infuzija ali bolus je prepovedana.
Three-weekly and weekly schedule
3-tedenski in tedenski režim
At the time of a safety update after a median of 3.5-3.8 years follow-up, an analysis of DFS reconfirms the magnitude of the benefit shown in the definitive analysis of DFS.
Ob pregledu varnosti po mediani spremljanja 3,5 do 3,8 leta je analiza preživetja brez bolezni ponovno potrdila velikost koristi, prikazane v končni analizi preživetja brez bolezni.
In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50% of tumour cells.
V splošnem velja, da je rezultat metode CISH pozitiven, če obstaja več kot 5 kopij gena HER2 na jedro v več kot 50 % tumorskih celic.
Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments.
Predhodna kemoterapija mora vsebovati vsaj en antraciklinski in taksanski derivat, razen če bolniki za takšno zdravljenje niso bili primerni.
Your doctor may prescribe KANJINTI for the treatment of breast and gastric cancer when:
Vaš zdravnik vam lahko zdravilo KANJINTI predpiše za zdravljenje raka dojk in raka želodca, če:
The reconstituted solution should not be frozen.
Pripravljene raztopine ne smemo zamrzniti.
(12.3-ne)
(12,3-no)
In order to prevent medication errors it is important to check the vial labels to ensure that the medicine being prepared and given is KANJINTI (trastuzumab) and not trastuzumab emtansine.
Za preprečitev napak pri dajanju zdravila je pomembno preveriti nalepke na vialah in tako zagotoviti, da je pripravljeno in uporabljeno zdravilo KANJINTI (trastuzumab) in ne trastuzumab emtanzin.
AC→PH (vs.AC→P) (NSABP B-31 and NCCTG N9831)*
AC → PH (v primerjavi z AC → P) (NSABP B-31 in NCCTG N9831)*
• swelling of the face, lips and throat
• otekanje obraza, ustnic in grla
*Cmin,ss - Cmin at steady-state **Cmax,ss = Cmax at steady-state *** time to 90% of steady-state
*Cmin, ss - Cmin v stanju dinamičnega ravnovesja **Cmax, ss = Cmax v stanju dinamičnega ravnovesja *** čas do 90 % stanja dinamičnega ravnovesja
In the pivotal trial of docetaxel (100 mg/m2 infused over 1 hour) with or without trastuzumab, 60% of the patients had received prior anthracycline-based adjuvant chemotherapy.
V ključnem preskušanju docetaksela (100 mg/m2, infudirano v 1 uri) s trastuzumabom ali brez njega je 60 % bolnikov predhodno prejelo adjuvantno kemoterapijo na osnovi antraciklinov.
Appropriate aseptic technique should be used for reconstitution and dilution procedures.
Za postopek rekonstitucije in redčenja je treba uporabiti ustrezno aseptično tehniko.
In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, CHF, LVEF of < 55%, older age.
Previdnost je potrebna tudi pri zdravljenju bolnikov s povečanim srčnim tveganjem, npr. hipertenzijo, dokumentirano koronarno arterijsko boleznijo, kongestivnim srčnim popuščanjem, LVEF < 55 %, starejših bolnikih.
• Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients listed in section 6.1
• Preobčutljivost za trastuzumab, murine beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
To ensure validation of testing procedures and the generation of accurate and reproducible results, HER2 testing must be performed in a laboratory staffed by trained personnel.
Za zagotovitev validacije postopkov testiranja in pridobitev točnih in ponovljivih rezultatov mora biti testiranje HER2 opravljeno v laboratoriju z ustrezno usposobljenim osebjem.
KANJINTI is a biosimilar medicinal product.
Zdravilo KANJINTI je podobno biološko zdravilo.
Trastuzumab 1 Year N = 1,693
trastuzumab 1 leto n = 1.693
Table 6 Efficacy results from study BO16348
Rezultati učinkovitosti študije BO16348
Study H0648g: IHC3+ patient subset
Študija H0648g: IHC 3+ podskupina bolnikov
Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in “Warnings and precautions” (see section 4.4).
Podrobnosti o dejavnostih za zmanjšanje tveganja v skladu z evropskim načrtom za obvladovanje tveganja (RMP) so navedene v poglavju »Posebna opozorila in previdnostni ukrepi« (glejte poglavje
The non-linear elimination parameter values were 8.81 mg/day for the maximum elimination rate (Vmax) and 8.92 μg/mL for the Michaelis-Menten constant (Km) for the MBC, EBC, and AGC patients.
Vrednosti parametrov nelinearnega izločanja so bile 8,81 mg/dan za največjo hitrost izločanja (Vmax) in 8,92 µg/ml za Michaelis-Mentenovo konstanto (Km) za bolnike z MBC, EBC in AGC.
Study H0649g: IHC3+ patient subset
Študija H0649g: IHC 3+ podskupina bolnikov
Instructions for aseptic reconstitution
Navodila za aseptično rekonstitucijo
During a KANJINTI infusion, chills, fever and other flu like symptoms may occur.
Med infuzijo zdravila KANJINTI se lahko pojavijo mrzlica, zvišana telesna temperatura in drugi simptomi, podobni gripi.
These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
Lahko jih zdravimo z analgetikom/antipiretikom, kot je meperidin ali paracetamol, ali antihistaminikom, kot je difenhidramin.
If a pregnant woman is treated with KANJINTI, or if a patient becomes pregnant while receiving KANJINTI or within 7 months following the last dose of KANJINTI, close monitoring by a multidisciplinary team is desirable.
Če se noseča ženska zdravi z zdravilom KANJINTI ali če bolnica zanosi med zdravljenjem z zdravilom KANJINTI ali v obdobju 7 mesecev po prejemu zadnjega odmerka zdravila KANJINTI, je zaželeno, da jo skrbno spremlja multidisciplinarna ekipa.
420 mg vial
420 mg viala
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa; ATC oznaka: L01XC03
On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the trastuzumab infusion.
V zelo redkih primerih so se infuzijski in pljučni simptomi pojavili več kot šest ur po začetku infuzije trastuzumaba.
Women of childbearing potential should be advised to use effective contraception during treatment with KANJINTI and for 7 months after treatment has concluded (see section 5.2).
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem z zdravilom KANJINTI ter še 7 mesecev po zaključku zdravljenja uporabljajo učinkovito kontracepcijo (glejte poglavje 5.2).
Time to steadystate*** (week)
Čas do stanja dinamičnega ravnovesja*** (tedni)
Patients treated with KANJINTI are at increased risk for developing CHF (New York Heart Association [NYHA] class II-IV) or asymptomatic cardiac dysfunction.
Pri bolnikih, ki so se zdravili z zdravilom KANJINTI, obstaja večje tveganje za pojav kongestivnega srčnega popuščanja (New York Heart Association - NYHA, razred II-IV) ali asimptomatične motnje v delovanju srca.
If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion.
Če je bolnik polnitveni odmerek dobro prenašal, lahko nadaljnje odmerke dajemo kot 30-minutne infuzije.
Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms (see section 4.2).
Če se pojavi infuzijska reakcija, je potrebno infundiranje zdravila KANJINTI prekiniti ali upočasniti njegovo hitrost in bolnika nadzorovati, dokler vsi simptomi ne izzvenijo (glejte poglavje 4.2).
KANJINTI should not be diluted with glucose solutions since these cause aggregation of the protein.
Zdravila KANJINTI ne redčite z raztopinami glukoze, ker le-te povzročajo agregacijo beljakovin.
Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out.
Podrobnejših farmakokinetičnih študij pri starejših bolnikih in tistih z ledvično ali jetrno okvaro niso opravili.
Some of these side effects may be serious and may lead to hospitalisation.
Nekateri od teh neželenih učinkov so lahko resni in vas lahko zaradi njih zdravijo v bolnišnici.
Dose reduction
Zmanjšanje odmerka