natgillin/translations-raw huggingface dataset:
Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Diabetična ketoacidoza, redka (pojavi se lahko pri največ 1 od 1.000 bolnikov) To so znaki diabetične ketoacidoze (glejte poglavje 2 »Opozorila in previdnostni ukrepi«): - povišane ravni “ketonskih teles” v urinu ali krvi - hitra izguba telesne mase - slabost ali bruhanje - bolečine v želodcu - prekomerna žeja - hitro in globoko dihanje - zmedenost - neobičajna zaspanost ali utrujenost - sladkast zadah, sladek ali kovinski okus v ustih ali drugačen vonj urina ali znoja.
Cationic substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Kationske snovi, ki se izločajo s tubularno sekrecijo (npr. cimetidin), lahko zaradi tekmovanja za skupne ledvične tubulne prenašalne mehanizme medsebojno delujejo z metforminom.
General Synjardy should not be used in patients with type 1 diabetes.
Zdravila Synjardy ne smejo uporabljati bolniki s sladkorno boleznijo tipa 1.
• abnormalities in liver function tests, inflammation of the liver (hepatitis)
• nenormalni izvidi testov delovanja jeter, vnetje jeter (hepatitis)
The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or a higher need of insulin due to major surgery or serious illness;
Tveganje za nastanek diabetične ketoacidoze lahko povečajo dolgotrajnejše stradanje, prekomerno uživanje alkohola, dehidracija, nenadno zmanjšanje odmerka insulina ali povečana potreba po insulinu zaradi večje operacije ali resne bolezni.
• blood tests may show increases in the amount of red blood cells in your blood (haematocrit)
• krvni testi lahko pokažejo povišane vrednosti rdečih krvnih celic (hematokrit)
Complicated urinary tract infections (including serious urinary infections, pyelonephritis or urosepsis) occurred at a similar frequency in patients treated with empagliflozin compared to placebo.
Zapletene okužbe sečil (vključno z resnimi okužbami sečil, pielonefritisom ali urosepso) so se pri bolnikih, zdravljenih z empagliflozinom, pojavile s podobno pogostnostjo kot pri placebu.
Taking this medicine • Swallow the tablet whole with water.
• Tableto pogoltnite celo z vodo.
The PRAC, as a consequence, concluded that the benefit-risk balance of the SGLT2 inhibitor containing products identified in Annex A remains favourable, subject to the agreed amendments to the product information and additional pharmacovigilance activities to be reflected in the RMP.
Posledično je odbor PRAC zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo zaviralec SGLT2 in so navedena v Prilogi A, še naprej ugodno, pod pogojem, da se upoštevajo dogovorjene spremembe informacij o zdravilu ter dodatne farmakovigilančne dejavnosti, vključene v načrt za obvladovanje tveganja.
• stomach ache (abdominal pain)
• bolečina v trebuhu (abdominalna bolečina)
Blood creatinine increased/ Glomerular filtration rate decreased Haematocrit increased
2,c zvišana raven kreatinina v krvi/zmanjšana hitrost glomerulne filtracije zvišan hematokrit
Table 10 Efficacy results at 12 week in a placebo-controlled study of empagliflozin in patients with type 2 diabetes and uncontrolled blood pressure Placebo empagliflozin
Preglednica 10: Rezultati učinkovitosti v 12. tednu v s placebom nadzorovani študiji empagliflozina pri bolnikih s sladkorno boleznijo tipa 2 in nekontroliranim krvnim tlakom placebo empagliflozin
• redness of the skin (erythema) or an itchy rash (hives)
• pordelost kože (eritem) ali srbeč izpuščaj (koprivnica)
Glycaemic efficacy and cardivascular outcomes have been assessed in a total of 10,366 patients with type 2 diabetes who were treated in 9 double-blind, placebo or active-controlled clinical studies of at least 24 weeks duration, of which 2950 patients received empagliflozin 10 mg and 3701 received empagliflozin 25 mg as add-on to metformin therapy.
Glikemično učinkovitost in srčno-žilne izide so proučevali v 9 dvojno slepih, s placebom ali zdravilno učinkovino nadzorovanih kliničnih študijah, v katerih je bilo zdravljenih skupaj 10.366 bolnikov s sladkorno boleznijo tipa 2 najmanj 24 tednov, od tega jih je 2.950 prejemalo empagliflozin 10 mg in 3.701 empagliflozin 25 mg kot dodatno zdravljenje k metforminu.
The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 for the products listed in Annex A;
Evropska komisija je 15. aprila 2016 sprožila postopek v skladu s členom 20 Uredbe (ES) št. 726/2004.
The PRAC also considered that additional information on amputation events should be collected through appropriate case report forms (CRFs) for clinical trials, follow-up questionnaires for postmarketing cases, use of common MedDRA preferred term (PT) lists for amputation preceding events, and appropriate meta-analyses of large studies including cardiovascular outcome studies.
Za kanagliflozin so bile amputacije spodnjih okončin (zlasti prstov) kot neželeni učinek že vključene v informacije o zdravilu; odbor PRAC je menil tudi, da je treba zbrati dodatne informacije o amputacijah, in sicer z ustreznimi obrazci za poročila o primerih v kliničnih preskušanjih, vprašalniki za spremljanje primerov v obdobju trženja, uporabo seznamov prednostnih izrazov MedDRA za znake, ki napovedujejo amputacijo, in ustreznimi metaanalizami velikih študij, vključno s študijami kardiovaskularnih izidov.
• a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034,
• pomembno zmanjšanje absolutnega tveganja za kateri koli s sladkorno boleznijo povezan zaplet v skupini z metforminom (29,8 dogodka/1.000 bolnikov-let), v primerjavi s samo dieto (43,3 dogodka/1.000 bolnikov-let), p = 0,0023, in v primerjavi z obema skupinama s sulfonilsečnino ali insulinom v monoterapiji (40,1 dogodka/1.000 bolnikov-let), p = 0,0034;
derived from postmarketing experience see section 4.4
Izhaja iz izkušenj v obdobju trženja b
respectively, were total cholesterol 5.0% and 5.2% versus 3.7%; HDL-cholesterol 4.6% and 2.7% versus -0.5%; LDL-cholesterol 9.1% and 8.7% versus 7.8%; triglycerides 5.4% and 10.8% versus
Povprečno zvišanje vrednosti od izhodiščne za zdravljenje z empagliflozinom 10 mg ali 25 mg v primerjavi s placebom je bilo 5,0 % oz. 5,2 % v primerjavi z 3,7 % za skupni holesterol; 4,6 % oz. 2,7 % v primerjavi z -0,5 % za HDL holesterol; 9,1 % oz. 8,7 % v primerjavi z 7,8 % za LDL holesterol; 5,4 % oz. 10,8 % v primerjavi z 12,1 % za trigliceride.
However, temporary interruption of treatment should be considered in patients with complicated urinary tract infections.
Vendar pa je treba pri bolnikih z zapleteno okužbo sečil razmisliti o začasni prekinitvi zdravljenja.
• genital yeast infection (thrush)
• glivična okužba spolovil (vaginalna kandidoza)
Table 7: Efficacy results at 18 and 52 weeks in a placebo-controlled study of empagliflozin as add-on to multiple daily doses of insulin with concomitant metformin therapy
Preglednica 7: Rezultati učinkovitosti v 18. in 52. tednu v s placebom nadzorovani študiji z empagliflozinom kot dodatnim zdravljenjem k večkratnim dnevnim odmerkom insulina sočasno z metforminom placebo empagliflozin
The steady state mean plasma AUC and Cmax were 1870 nmol.h and 259 nmol/l with empagliflozin 10 mg and 4740 nmol.h and 687 nmol/l with empagliflozin 25 mg once daily.
Z enkratno dnevno uporabo empagliflozina so bile v stanju dinamičnega ravnovesja vrednosti v plazmi AUC 1.870 nmol.h in Cmax 259 nmol/l za empagliflozin 10 mg ter AUC 4.740 nmol.h in Cmax 687 nmol/l za empagliflozin 25 mg. Sistemska izpostavljenost empagliflozinu se je večala sorazmerno z odmerkom.
Table 4: Efficacy results at 24 week comparing empagliflozin in combination with metformin to the individual components
Preglednica 4: Rezultati učinkovitosti pri 24-tedenski primerjavi empagliflozina v kombinaciji z metforminom z zdravljenjem le s posameznimi komponentami Empagliflozin 10 mg
• diarrhoea or stomach ache
• driska ali trebušne bolečine
Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post marketing in patients treated with SGLT2 inhibitors, including empagliflozin.
V kliničnih preskušanjih in v obdobju trženja so pri bolnikih, ki so bili zdravljeni z zaviralci SGLT2, vključno z empagliflozinom, poročali o redkih primerih diabetične ketoacidoze (DKA), vključno z življenje ogrožujočimi.
• loss of appetite
• izguba teka
Of these, a total of 794 patients received empagliflozin as add-on to metformin plus insulin, of which 266 patients were treated with empagliflozin 10 mg and 264 with empagliflozin 25 mg.
Od teh je bilo 266 ali 264 bolnikov zdravljenih z empagliflozinom 10 mg oziroma z empagliflozinom 25 mg kot dodatnim zdravljenjem k metforminu in insulinu.
Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex.
Synjardy 5 mg/850 mg filmsko obložene tablete so rumenkasto bele, ovalne, bikonveksne tablete.
Table 8 Efficacy results at 18 and 78 weeks in a placebo-controlled study of empagliflozin as add on to basal insulin with metformin
Preglednica 8: Rezultati učinkovitosti v 18. in 78. tednu v s placebom nadzorovani študiji empagliflozina kot dodatnega zdravljenja k bazalnemu insulinu z metforminom placebo empagliflozin 10 mg empagliflozin 25 mg
Table 9: Treatment effect for the primary composite endpoint, its components and mortality
Učinek zdravljenja na primarni sestavljeni opazovani dogodek, njegovi sestavni deli in umrljivost placebo empagliflozin
See subsections below for additional information Identified adverse reactions of empagliflozin monotherapy Identified adverse reactions of metformin monotherapy Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia) Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Dolgotrajno zdravljenje z metforminom so povezali z zmanjšano absorpcijo vitamina B12, kar lahko zelo redko pripelje do klinično pomembnega pomanjkanja tega vitamina (npr. megaloblastne anemije).
PRAC noted that an increased amputation risk has only become apparent with canagliflozin so far, but one large cardiovascular outcome study (DECLARE) is still on-going for dapagliflozin and amputation events were not been systematically captured within the completed large cardiovascular outcome study conducted with empagliflozin (EMPA-REG).
v zaključeni veliki študiji kardiovaskularnih dogodkov z empagliflozinom (EMPA-REG) pa amputacij niso sistematično beležili.
HbA1c (%) at week 52 Baseline (mean) Change from baseline
Vrednost HbA1c (%) v 52. tednu
• changes to the way things taste
• spremembe v okušanju
Erythema Urticaria
Ledvična okvara
HbA1c (%) at week 78 Baseline (mean) Change from baseline Difference from placebo
Vrednost HbA1c (%) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na glimepirid
Date of first authorisation: 11 January 2008 Date of latest renewal: 14 January 2013
Datum prve odobritve: 11. januar 2008 Datum zadnjega podaljšanja: 14. januar 2013
After first reconstitution the suspension should be used immediately.
Po prvi rekonstituciji morate suspenzijo uporabiti takoj.
The reconstituted suspension should be milky and homogenous without visible precipitates.
Rekonstituirana suspenzija mora biti mlečna in homogena brez vidnih oborin.
Gemcitabine (N=430)
gemcitabin (N=430)
Instructions for use, handling and disposal
Navodila za uporabo, ravnanje in odstranjevanje
• Depression, sleep problems
• depresivnost, težave s spanjem
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Pogostnost je opredeljena kot: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), občasni ( 1/1.000 do < 1/100), redki ( 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
Some settling of the reconstituted suspension may occur.
Lahko se pojavi manjše usedanje rekonstituirane suspenzije.
1 The frequency of hypersensitivity reactions is calculated based on one definitely related case in a population of 789 patients.
1 Pogostnost preobčutljivostnih reakcij je izračunana na osnovi enega primera dokazane povezave v populaciji 789 bolnikov.
AND ≥ 75,000
IN ≥ 75.000
Lactation (see section 4.6).
Dojenje (glejte poglavje 4.6).
Your doctor or pharmacist is responsible for disposing of any unused Abraxane correctly.
Vaš zdravnik ali farmacevt je odgovoren za pravilno odstranitev neuporabljenega zdravila Abraxane.
Patients with pre-existing neuropathy of Grade ≥ 2 or serious medical risk factors involving any of the major organ systems were excluded.
Bolnike s predhodno nevropatijo ≥ 2. stopnje ali resnimi medicinskimi dejavniki tveganja v zvezi s katerim koli pomembnim organskim sistemom so izključili.
Day 1 < 1500
1. dan < 1.500
The safety and efficacy of Abraxane in children and adolescents aged 0-17 years has not been established.
Varnost in učinkovitost zdravila Abraxane pri otrocih in mladostnikih, starih 0 - 17 let, nista bili dokazani.
Each drug was administered on Day 1 of each 21-day cycle.
Vsako zdravilo so dali 1. dan vsakega 21-dnevnega cikla.
Based on population pharmacokinetic analysis, the total volume of distribution is approximately 1741 L; the large volume of distribution indicates extensive extravascular distribution and/or tissue binding of paclitaxel.
Na podlagi populacijske farmakokinetične analize je celotni volumen porazdelitve približno 1741 l; velik volumen porazdelitve kaže na obsežno ekstravaskularno porazdelitev in/ali vezavo paklitaksela v tkivih.
Neutropenia was the most notable important haematological toxicity (reported in 79% of patients), and was rapidly reversible and dose dependent; leukopenia was reported in 71% of patients.
Nevtropenija je bila najbolj opazna pomembna hematološka toksičnost (o njej so poročali pri 79 % bolnikov), bila je hitro reverzibilna in odvisna od odmerka; o levkopeniji so poročali pri 71 % bolnikov.
Tell your doctor if you are taking or have recently taken any other medicines.
Obvestite svojega zdravnika, če jemljete, ste pred kratkim prejemali ali pa boste morda začeli prejemati katero koli drugo zdravilo, vključno z zeliščnimi pripravki.
• A disorder of the electrical conduction system of the heart (atrioventricular block)
• motnja električnega prevodnega sistema srca (atrioventrikularni blok)
Limiting the infusion of Abraxane to 30 minutes, as directed, reduces the likelihood of infusion-related reactions.
Omejitev infundiranja zdravila Abraxane na 30 minut, kot je navedeno v navodilih, zmanjša možnost z infuzijo povezanih reakcij.
It is not known if paclitaxel is excreted in human milk.
Ni znano, ali se paklitaksel izloča v mleko pri človeku.
What you need to know before you are given Abraxane
Kaj morate vedeti, preden boste prejeli zdravilo Abraxane
The majority of alopecia events occurred less than one month after initiation of Abraxane.
Večina primerov alopecije se je pojavila manj kot en mesec po uvedbi zdravila Abraxane.
Then, the vial should gently and slowly be swirled and/or inverted for at least 2 minutes until complete resuspension of any powder occurs.
Nato vialo pazljivo in počasi sučite in/ali obračajte vsaj 2 minuti, dokler se ves prašek popolnoma ne resuspendira.
The non-inferiority criterion was met for both PFS and OS with the upper bound of the 95% confidence interval for the associated hazard ratios being less than 1.176 (Table 13).
Kriterij neinferiornosti je bil izpolnjen tako za PFS kot za OS z zgornjo mejo 95-odstotnega intervala zaupanja za pridruženi razmerji tveganja, ki sta bili manjši od 1,176 (preglednica 13).
OR < 100,000
ALI < 100.000
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če se zdravila ne uporabi takoj, je za čas in pogoje shranjevanja med uporabo odgovoren uporabnik.
Very common: Anorexia
Zelo pogosti: anoreksija
When it happens, hair loss is pronounced (over 50%) in the majority of patients)
Kadar pride do tega, je pri večini bolnikov izpadanje las izrazito (več kot 50 %).
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Celgene Europe B.V.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Celgene Europe B.V.
The effectiveness and safety of Abraxane in patients with central nervous system (CNS) metastases has not been established.
Učinkovitost in varnost zdravila Abraxane pri bolnikih z metastazami v centralnem živčnem sistemu (CŽS) nista bili dokazani.
The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg.
Rekonstituirana suspenzija ima pH vrednost 6-7,5 in osmolalnost 300-360 mOsm/kg.
The symptoms were usually transient, typically occurred three days after Abraxane administration and resolved within a week.
Simptomi, ki so bili večinoma prehodne narave, so se navadno pojavili tri dni po prejemu zdravila Abraxane in izginili v enem tednu.
ANNEX IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
PRILOGA IV Znanstveni zaključki in podlaga za spremembo pogojev dovoljenja (dovoljenj) za promet z zdravilom
• Small bleedings in your skin due to blood clots
• majhne krvavitve v koži zaradi krvnih strdkov
The natural course of peripheral neuropathy to resolution to baseline due to cumulative toxicity of Abraxane after > 6 courses of treatment was not evaluated and remains unknown.
Naravni potek periferne nevropatije do resolucije na izhodiščno raven zaradi kumulativne toksičnosti zdravila Abraxane po > 6 zdravljenjih ni bil raziskan in ostaja neznan.
Treatment may be resumed at the next lower dose level in subsequent cycles according to the guidelines in Table 5.
V poznejših ciklih se lahko zdravljenje nadaljuje z naslednjo nižjo ravnijo odmerka v skladu s smernicami v preglednici 5.
15 of each 21-day cycle without any steroid premedication and without granulocyte colony stimulating factor prophylaxis.
8. in 15. dan vsakega 21-dnevnega cikla brez kakršne koli steroidne premedikacije in brez profilakse z granulocitne kolonije spodbujajočim faktorjem.
Pharmacokinetic data are insufficient for patients with severe renal impairment and not available for patients with end stage kidney disease.
Farmakokinetični podatki so nezadostni pri bolnikih s hudo okvaro ledvic in niso na voljo pri bolnikih s končno odpovedjo ledvic.
• medicines used to help you stabilize your mood also sometimes referred to as anti-depressants (e.g.
• zdravila, ki se uporabljajo za stabilizacijo razpoloženja, imenovani tudi antidepresivi (npr.
The median relative dose intensity of Abraxane was 81%.
Mediana relativne intenzivnosti odmerka zdravila Abraxane je bila 81 %.
The primary efficacy endpoint was overall response rate defined as the percentage of patients who achieved an objective confirmed complete response or partial response based on an independent, central, blinded radiological review using RECIST (Version 1.0).
Primarni cilj študije za dokaz učinkovitosti je bil stopnja celokupnega odziva, opredeljena kot odstotni delež bolnikov, ki so dosegli objektiven potrjen popoln odziv ali delen odziv na podlagi neodvisnega, centralnega, slepega radiološkega pregleda po smernicah RECIST (različica 1.0).
What Abraxane is used for Abraxane is used to treat the following types of cancer:
Za kaj se zdravilo Abraxane uporablja Zdravilo Abraxane se uporablja za zdravljenje naslednjih vrst raka:
Abraxane has minor or moderate influence on the ability to drive and use machines.
Zdravilo Abraxane ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Anaemia (Hb < 10 g/dl) was observed in 46% of patients on Abraxane, and was severe (Hb < 8 g/dl) in three cases.
Anemijo (Hb < 10 g/dl) so opazili pri 46 % bolnikov, ki so prejemali zdravilo Abraxane; v treh primerih pa je bila huda (Hb < 8 g/dl).
• a medicine called clopidogrel used to prevent blood clots.
• zdravilo, ki se imenuje klopidogrel in se uporablja za preprečevanje krvnih strdkov.
The response rates in all patients were 39.5% (95% CI: 24.9%-54.2%) and 47.6% (95% CI: 35.3%-60.0%), respectively.
Stopnji odzivnosti pri vseh bolnikih sta bili 39,5 % (95 % IZ: 24,9 % - 54,2 %) oziroma 47,6 % (95 % IZ: 35,3 % - 60,0 %).
• Increased liver function tests
• zvišani testi jetrne funkcije
Do not administer the reconstituted suspension if particulate matter is observed in the vial.
Ne uporabite rekonstituirane suspenzije, če v viali opazite vidne delce.
OR < 50,000
ALI < 50.000
Nausea occurred in 29% of the patients and diarrhoea in 25% of the patients.
Navzea se je pojavila pri 29 % bolnikov, diareja pa pri 25 % bolnikov.
This should be taken into consideration if you are on a controlled sodium diet.
To morate upoštevati, če ste na dieti z omejenim vnosom natrija.
a Per EMA methodological considerations for PFS endpoint, missing observations or initiation of subsequent new therapy were not used for censoring.
a Na podlagi metodoloških ugotovitev EMA za končni cilj PFS , manjkajoča opazovanja ali uvedba poznejšega novega zdravljenja pri oceni niso bili uporabljeni.
Abraxane may cause adverse reactions such as tiredness (very common) and dizziness (common) that may affect the ability to drive and use machinery.
Zdravilo Abraxane lahko povzroča neželene učinke, kot je utrujenost (zelo pogosto) in omotičnost (pogosto), ki lahko vplivajo na sposobnost upravljanja vozil in strojev.
No additional dosage reductions, other than those for all patients, are recommended for patients 65 years and older.
Za bolnike, stare 65 let in več, se ne priporoča dodatnih zmanjševanj odmerjanja, poleg tistih, ki so priporočljiva za vse bolnike.
This resulted in significantly higher exposure to unbound paclitaxel with Abraxane compared with solvent-based paclitaxel, even though the total exposure is comparable.
To je povzročilo značilno večjo izpostavljenost nevezanemu paklitakselu z zdravilom Abraxane v primerjavi s paklitakselom na bazi topila, čeprav je bila celotna izpostavljenost primerljiva.
• Infection, fever with decrease in the number of a type of white blood cell (neutrophils) in the blood,
• okužba, vročica z znižanim številom ene vrste belih krvnih celic (nevtrofilcev) v krvi,
Also, some other medicines can affect the way Abraxane works.
Tudi druga zdravila lahko vplivajo na način delovanja zdravila Abraxane.
• medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic),
• zdravila za zdravljenje okužb (tj. antibiotiki, kot so eritromicin, rifampicin itd.; posvetujte se s svojim zdravnikom, medicinsko sestro ali farmacevtom, če niste prepričani, ali je zdravilo, ki ga jemljete, antibiotik), in tudi zdravila za zdravljenje glivičnih bolezni (npr. ketokonazol)
Pronounced hair loss ≥50% is expected for the majority of patients who experience alopecia.
Izrazito izpadanje las (≥ 50 %) se pričakuje pri večini bolnikov, pri katerih se pojavi alopecija.
Alopecia was observed in >80% of the patients treated with Abraxane.
Alopecijo so opazili pri > 80 % bolnikov, ki so prejemali zdravilo Abraxane.
Inspect the suspension in the vial for particulate matter.
Preglejte suspenzijo v viali glede vidnih delcev.