natgillin/translations-raw huggingface dataset:
Contraception Women of childbearing potential must use one effective method of contraception for 4 weeks before therapy, during therapy, and until 4 weeks after lenalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Kontracepcija Ženske v rodni dobi morajo 4 tedne pred začetkom zdravljenja, med zdravljenjem in 4 tedne po zdravljenju z lenalidomidom in celo med morebitnimi prekinitvami odmerjanja uporabljati eno učinkovito kontracepcijsko metodo, razen če se zavežejo popolni in neprekinjeni abstinenci, ki se potrjuje vsak mesec.
If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
Če bolnica ne uporablja učinkovite kontracepcije, jo je treba napotiti k ustrezno usposobljenemu zdravniku, ki ji bo svetoval, za katero kontracepcijsko metodo naj se odloči, da jo lahko začne uporabljati.
The following can be considered to be examples of suitable methods of contraception: • Implant • Levonorgestrel-releasing intrauterine system (IUS) • Medroxyprogesterone acetate depot • Tubal sterilisation • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses • Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
Primeri ustreznih kontracepcijskih metod so: • vsadek, • intrauterini sistem (IUS), ki sprošča levonorgestrel, • depo medroksi- progesteron acetata, • sterilizacija jajcevodov; • spolni odnosi samo z moškim partnerjem, ki so mu opravili vazektomijo; vazektomijo je treba potrditi z dvema negativnima preiskavama sperme; • tablete za zaviranje ovulacije le s progesteronom (t. j. dezogestrel).
Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide and dexamethasone, combined oral contraceptive pills are not recommended (see also section 4.5).
Zaradi povečanega tveganja za vensko trombembolijo pri bolnicah z multiplim mielomom, ki jemljejo lenalidomid in deksametazon, uporaba kombiniranih peroralnih kontracepcijskih tablet ni priporočena (glejte tudi poglavje 4. 5).
If a patient is currently using combined oral contraception the patient should switch to one of the effective method listed above.
Če bolnica trenutno uporablja kombinirano peroralno kontracepcijo, mora preiti na eno od zgoraj navedenih učinkovitih metod.
The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone (see section 4.5).
Pri sočasnem zdravljenju z deksametazonom se lahko učinkovitost kontracepcijskih steroidov zmanjša (glejte poglavje 4. 5).
Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia.
5 Intrauterini vložki, ki sproščajo baker, na splošno niso priporočljivi zaradi možnega tveganja za nastanek okužb ob času vstavitve in menstrualno krvavitvijo, ki lahko ogrozijo bolnice z nevtropenijo ali trombocitopenijo.
This
Test nosečnosti V skladu z lokalno prakso je treba pri ženskah v rodni dobi opraviti test nosečnosti pod zdravniškim nadzorom, z občutljivostjo vsaj 25 m i. e. / ml, kot je opisano spodaj.
5 requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Ta zahteva vključuje ženske v rodni dobi, ki upoštevajo popolno in neprekinjeno abstinenco.
Prior to starting treatment A medically supervised pregnancy test should be performed during the consultation, when lenalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Pred začetkom zdravljenja Test nosečnosti pod zdravniškim nadzorom je treba opraviti med posvetom, ko se predpiše lenalidomid, ali v 3 dneh pred obiskom pri zdravniku, ki predpiše zdravilo, po tem, ko je bolnica vsaj 4 tedne že uporabljala učinkovito kontracepcijo.
Follow-up and end of treatment A medically supervised pregnancy test should be repeated every 4 weeks, including 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.
Sledenje in konec zdravljenja Test nosečnosti pod zdravniškim nadzorom je treba ponoviti vsake 4 tedne, vključno s 4 tedni po koncu zdravljenja, razen v primeru potrjene sterilizacije jajcevodov.
Men It is not known whether lenalidomide is present in semen.
Moški Ni znano, ali je lenalidomid prisoten v spermi.
Therefore all male patients should use condoms throughout treatment duration, during dose interruption and for 1 week after cessation of treatment if their partner is of childbearing potential and has no contraception.
Zato morajo vsi moški bolniki uporabljati kondom ves čas trajanja zdravljenja, med prekinitvijo odmerjanja in en teden po koncu zdravljenja, če njihova partnerica lahko zanosi in ne uporablja kontracepcije.
Additional precautions Patients should be instructed never to give this medicinal product to a nother person and to return any unused capsules to their pharmacist at the end of treatment.
Dodatni previdnostni ukrepi Bolnikom je treba naročiti, da nikoli ne dajo svojega zdravila drugim in da po koncu zdravljenja vrnejo neporabljene kapsule farmacevtu.
Patients should not donate blood or semen during therapy or for 1 week following discontinuation of lenalidomide.
Bolniki med zdravljenjem z lenalidomidom ali en teden po prekinitvi zdravljenja ne smejo darovati krvi ali sperme.
Educational materials In order to assist patients in avoiding foetal exposure to lenalidomide, the Marketing Authorisation Holder will provide educational material to health care professionals to reinforce the warnings about the expected teratogenicity of lenalidomide, to provide advice on contraception before therapy is started, and to provide guidance on the need for pregnancy testing.
Zdravniki bodo dajali nasvete o kontracepciji pred začetkom zdravljenja in o potrebi testa nosečnosti.
Full patient information about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme should be given by the physician to women of childbearing potential and, as appropriate, to male patients.
Zdravniki morajo ženskam v rodni dobi in, kjer je ustrezno, moškim bolnikom, dati vse informacije o pričakovanem teratogenem tveganju in strogih ukrepih za preprečevanje nosečnosti, ki so določeni v programu za preprečevanje nosečnosti.
Venous thromboembolism The combination of lenalidomide with dexamethasone is associated with an increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with multiple myeloma (see sections 4.5 and 4.8).
Venska trombembolija Kombinacija lenalidomida in deksametazona je pri bolnikih z multiplim mielomom povezana s povečanim tveganjem globoke venske tromboze (GVT) in pljučne embolije (PE) (glejte poglavji 4. 5 in 4. 8).
Concomitant administration of erythropoietic agents or previous history of DVT may also increase thrombotic risk in these patients.
Sočasna uporaba eritropoetskih zdravil ali GVT v anamnezi lahko pri teh bolnikih tudi povečata tveganje za trombozo.
Therefore, erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone.
Zato je treba eritropoetska zdravila ali druga zdravila, ki lahko povečajo tveganje za trombozo, kot je hormonsko nadomestno zdravljenje, pri bolnikih z multiplim mielomom, ki prejemajo lenalidomid v kombinaciji z deksametazonom, uporabljati previdno.
A haemoglobin concentration above 13 g/dl should lead to discontinuation of erythropoietic agents.
Če je koncentracija hemoglobina nad 13 g/ dl je treba prekiniti uporabo eritropoetskih zdravil.
Prophylactic antithrombotic medicines, such as low molecular weight heparins or warfarin, should be recommended, especially in patients with additional thrombotic risk factors.
Bolnikom je treba svetovati, naj poiščejo zdravniško pomoč, če se pojavijo simptomi, kot so zasoplost, bolečine v prsnem košu in otekanje rok ali nog.
The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient’s underlying risk factors.
Priporočiti je treba uporabo profilaktičnih antitrombotikov, kot so heparini z majhno molekulsko maso ali varfarin, zlasti pri bolnikih z dodatnimi dejavniki tveganja za trombozo.
Neutropenia and thrombocytopenia The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients
6 Odločitev o uporabi antitrombotičnih profilaktičnih ukrepov je treba prejeti po temeljiti oceni obstoječih dejavnikov tveganja pri posameznem bolniku.
6 compared with 0.6% in placebo/dexamethasone-treated patients; see section 4.8).
Nevtropenija in trombocitopenija Pri bolnikih z multiplim mielomom je kombinacija lenalidomida in deksametazona povezana s povečano incidenco nevtropenije 4. stopnje (5, 1% pri bolnikih, ki so prejemali lenalidomid/ deksametazon, v primerjavi z 0, 6% pri bolnikih, ki so prejemali placebo/ deksametazon; glejte poglavje 4. 8).
Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients; see section 4.8).
Epizode febrilne nevtropenije 4. stopnje so opazili nepogosto (0, 6% pri bolnikih, ki so prejemali lenalidomid/ deksametazon, v primerjavi z 0, 0% pri bolnikih, ki so prejemali placebo/ deksametazon; glejte poglavje 4. 8).
A dose reduction may be required (see section 4.2).
Morda bo treba zmanjšati odmerek (glejte poglavje 4. 2).
The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasone-treated patients; see section 4.8).
Pri bolnikih z multiplim mielomom je kombinacija lenalidomida in deksametazona povezana s povečano incidenco trombocitopenije 3. in 4. stopnje (9, 9% 3. stopnje in 1, 4% 4. stopnje pri bolnikih, ki so prejemali lenalidomid/ deksametazon, v primerjavi z 2, 3% 3. stopnje in 0, 0% 4. stopnje pri bolnikih, ki so prejemali placebo/ deksametazon; glejte poglavje 4. 8).
Patients and physicians are advised to be observant for signs and symptoms of bleeding, including petechiae and epistaxes especially in case of concomitant medication susceptible to induce bleeding (see Section 4.8 Haemorrhagic disorders).
Bolnikom in zdravnikom se svetuje, naj bodo pozorni na znake in simptome krvavitev, vključno s petehijami in epistaksami, posebno v primeru sočasnega jemanja zdravila, ki lahko povzroči krvavitev (glejte poglavje 4. 8 Krvavitve).
A dose reduction of lenalidomide may be required (see section 4.2).
Morda bo treba zmanjšati odmerek lenalidomida (glejte poglavje 4. 2).
Therefore, co-administration of lenalidomide with other myelosuppressive agents should be undertaken with caution.
Zato je treba biti pri sočasni uporabi lenalidomida in drugih mielosupresivnih zdravil previden.
Renal impairment Lenalidomide is substantially excreted by the kidney.
Okvarjeno delovanje ledvic Lenalidomid se v glavnem izloča skozi ledvice.
Therefore care should be taken in dose selection and monitoring of renal function is advised in patients with renal impairment (see section 4.2).
Zato je pri izbiri odmerka potrebna previdnost, priporočeno pa je tudi nadzorovati delovanje ledvic pri bolnikih z okvarjenim delovanjem ledvic (glejte poglavje 4. 2).
Thyroid function Cases of hypothyroidism have been reported and monitoring of thyroid function should be considered.
Delovanje ščitnice Poročali so o primerih hipotiroidizma, zato je treba pretehtati možnost nadzorovanja delovanja ščitnice.
Peripheral neuropathy Lenalidomide is structurally related to thalidomide, which is known to induce severe peripheral neuropathy.
Periferna nevropatija Lenalidomid je strukturno soroden talidomidu, za katerega je znano, da inducira hudo periferno nevropatijo.
At this time, the neurotoxic potential of lenalidomide associated with long-term use cannot be ruled out.
Trenutno ni možno izključiti nevrotoksičnega potenciala lenalidomida v povezavi z dolgoročno uporabo.
Tumour Lysis Syndrome Because lenalidomide has anti-neoplastic activity the complications of tumour lysis syndrome may occur.
Sindrom tumorske lize Ker lenalidomid deluje antineoplastično, se lahko pojavijo zapleti v obliki sindroma tumorske lize.
The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Bolniki s tveganjem sindroma tumorske lize imajo pred zdravljenjem veliko tumorsko breme.
Lactose intolerance Revlimid capsules contain lactose.
Intoleranca za laktozo Kapsule Revlimid vsebujejo laktozo.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redko dedno intoleranco za glukozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
Unused capsules Patients should be advised never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of the treatment.
Neporabljene kapsule Bolnikom je treba svetovati, da nikoli ne dajo svojega zdravila drugim in da po koncu zdravljenja vrnejo neporabljene kapsule farmacevtu.
Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as hormone replacement therapy, should be used with caution in multiple myeloma patients receiving lenalidomide with dexamethasone (see sections 4.4 and 4.8).
Eritropoetska zdravila ali druga zdravila, ki lahko povečajo tveganje za trombozo, kot je hormonsko nadomestno zdravljenje, je treba pri bolnikih z multiplim mielomom, ki prejemajo lenalidomid v kombinaciji z deksametazonom, uporabljati previdno (glejte poglavji 4. 4 in 4. 8).
Oral contraceptives No interaction study has been performed with oral contraceptives.
Peroralna kontracepcijska sredstva S peroralnimi kontraceptivi niso opravili študij interakcij.
Therefore, induction leading
V študiji in vitro s humanimi hepatociti lenalidomid ob različnih koncentracijah, na katerih je bil testiran, ni spodbujal CYP1A2, CYP2B6, CYP2C9, CYP2C19 in CYP3A4/ 5.
7 to reduced efficacy of drugs, including hormonal contraceptives, is not expected if lenalidomide is administered alone.
Zato se ne pričakuje spodbujanja, ki bi znižalo učinek zdravila, vključno s hormonskimi kontraceptivi, če se lenalidomid daje sam.
It may not be excluded that the efficacy of oral contraceptives may be reduced during treatment.
Zmanjšanja učinkovitosti peroralnih kontracepcijskih sredstev med zdravljenjem ni mogoče izključiti.
Effective measures to avoid pregnancy must be taken (see sections 4.4 and 4.6).
Uporabiti je treba učinkovite ukrepe za preprečevanje nosečnosti (glejte poglavji 4. 4 in 4. 6).
Results from human in vitro metabolism studies indicate that lenalidomide is not metabolised by cytochrome P450 enzymes suggesting that administration of lenalidomide with drugs that inhibit cytochrome P450 enzymes is not likely to result in metabolic drug interactions in man.
Rezultati študij presnove pri človeku in vitro kažejo, da lenalidomida ne presnavljajo encimi citokroma P450, kar kaže, da ni verjetno, da bi uporaba lenalidomida z zdravili, ki zavirajo encime citokroma P450, pri človeku povzročila presnovne interakcije med zdravili.
In vitro studies indicate that lenalidomide has no inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A.
Študije in vitro kažejo, da lenalidomid nima zaviralnega učinka na CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ali CYP3A.
Warfarin Co-administration of multiple doses of 10 mg of len alidomide had no effect on the single dose pharmacokinetics of R- and S- warfarin.
Varfarin Sočasna uporaba večkratnih odmerkov po 10 mg lenalidomida ni imela učinka na farmakokinetiko enkratnih odmerkov R - in S- varfarina.
Co-administration of a single 25 mg dose of warfarin had no effect on the pharmacokinetics of lenalidomide.
Sočasna uporaba enkratnega 25- miligramskega odmerka varfarina ni imela učinka na farmakokinetiko lenalidomida.
Digoxin Concomitant administration with lenalidomide 10 mg/day increased the plasma exposure of digoxin (0.5 mg, single dose) by 14% with a 90% CI (confidence interval) [0.52%-28.2%].
Digoksin Sočasna uporaba z 10 mg/ dan lenalidomida je povečala izpostavljenost digoksina v plazmi (0, 5 mg, enkratni odmerek) za 14% z 90- odstotnim IZ (interval zaupanja) [0, 52– 28, 2%].
Pregnancy (see also sections 4.3 and 4.4) Lenalidomide is structurally related to thalidomide.
Nosečnost (glejte tudi poglavji 4. 3 in 4. 4) Lenalidomid je strukturno soroden talidomidu.
Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see section 5.3).
Lenalidomid je povročil pri opicah deformacije, ki so podobne deformacijam opisanim pri talidomidu (glejte poglavje 5. 3).
Therefore, a teratogenic effect of lenalidomide is expected and lenalidomide is contraindicated during pregnancy (see section 4.3).
Zato se pričakuje teratogeni učinek lenalidomida in lenalidomid je med nosečnostjo kontraindiciran (glejte poglavje 4. 3).
Women of childbearing potential should use effective method of contraception.
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijsko metodo.
If pregnancy occurs in a woman treated with lenalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Če ženska, ki se zdravi z lenalidomidom, zanosi, je treba zdravljenje prekiniti, bolnico pa napotiti k zdravniku specialistu za teratologijo ali z izkušnjami v teratologiji na oceno in posvet.
If pregnancy occurs in a partner of a male patient taking lenalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Če zanosi partnerka moškega bolnika, ki se zdravi z lenalidomidom, je priporočljivo, da napotiti partnerko k zdravniku specialistu za teratologijo ali z izkušnjami v teratologiji na oceno in posvet.
Therefore male patients taking lenalidomide should use condoms if their partner is of childbearing potential and has no contraception.
Zato morajo moški bolniki, ki prejemajo lenalidomid, uporabljati kondome, če so njihove partnerice v rodni dobi in če ne uporabljajo kontracepcije.
Lactation It is not known whether lenalidomide is excreted in human milk.
8 Dojenje Ni znano, ali se lenalidomid izloča v materino mleko.
Lenalidomide may have minor or moderate influence on the ability to drive and use machines.
Lenalidomid ima lahko blag ali zmeren vpliv na sposobnost vožnje in upravljanja s stroji.
Fatigue, dizziness, somnolence and blurred vision have been reported with the use of lenalidomide.
Pri uporabi lenalidomida so poročali o utrujenosti, vrtoglavici, somnolenci in zamegljenem vidu.
In two Phase III placebo-controlled studies, 353 patients with multiple myeloma were exposed to the lenalidomide/dexamethasone combination and 351 to the placebo/dexamethasone combination.
V dveh s placebom nadzorovanih študijah III. faze je 353 bolnikov z multiplim mielomom prejemalo kombinacijo lenalidomida in deksametazona, 351 bolnikov pa kombinacijo placeba in deksametazona.
The median duration of exposure to study treatment was significantly longer (44.0 weeks) in the lenalidomide/dexamethasone group as compared to placebo/dexamethasone (23.1 weeks).
Mediana trajanja izpostavljenosti zdravljenju v študiji je bila bistveno daljša (44, 0 tedna) v skupini, ki je prejemala lenalidomid/ deksametazon, kot pri skupini, ki je prejemala placebo/ deksametazon (23, 1 tedna).
The difference was accounted for by a lower rate of discontinuation from study treatment due to lower progression of disease in patients exposed to lenalidomide/dexamethasone (39.7%) than in placebo/dexamethasone patients (70.4%).
Razliko so pripisali manjši stopnji prekinitve zdravljenja v študiji zaradi počasnejšega napredovanja bolezni pri bolnikih, ki so prejemali lenalidomid/ deksametazon (39, 7%), kot pri bolnikih, ki so prejemali placebo/ deksametazon (70, 4%).
325 (92%) of the patients in the lenalidomide/dexamethasone group experienced at least one adverse reaction compared to 288 (82%) in the placebo/dexamethasone group.
325 (92%) bolnikov v skupini, ki je prejemala lenalidomid/ deksametazon, je imelo vsaj en neželeni učinek, v primerjavi z 288 (82%) v skupini, ki je prejemala placebo/ deksametazon.
The most serious adverse reactions were: • Venous thromboembolism (deep vein thrombosis, pulmonary embolism) (see section 4.4) • Grade 4 neutropenia (see section 4.4).
Najresnejši neželeni učinki so bili: • venska trombembolija (globoka venska tromboza in pljučna embolija (glejte poglavje 4. 4)); • nevtropenija 4. stopnje (glejte poglavje 4. 4).
The most frequently observed adverse reactions which occurred significantly more frequently in the lenalidomide/dexamethasone group compared to the placebo/dexamethasone group were neutropenia (39.4%), fatigue (27.2%), asthenia (17.6%), constipation (23.5%), muscle cramp (20.1%), thrombocytopenia (18.4%), anaemia (17.0%), diarrhoea (14.2%) and rash (10.2%).
Najpogostejši neželeni učinki, ki so se v skupini, ki je prejemala lenalidomid/ deksametazon, pojavljali bistveno pogosteje kakor pri skupini, ki je prejemala placebo/ deksametazon, so bili nevtropenija (39, 4%), utrujenost (27, 2%), astenija (17, 6%), konstipacija (23, 5%), mišični krči (20, 1%), trombocitopenija (18, 4%), anemija (17, 0%), diareja (14, 2%) in izpuščaj (10, 2%).
The adverse reactions observed in patients treated with lenalidomide/dexamethasone are listed below by system organ class and frequency.
Neželeni učinki, ki so jih opazili pri bolnikih, ki so prejemali lenalidomid/ deksametazon, so razvrščeni po organskem sistemu in pogostnosti.
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 including isolated reports).
Njihova pogostnost je določena 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), zelo redki (< 1/ 10. 000, vključno s posameznimi poročili).
In the majority of cases, there was no significant difference in the incidence of specific adverse events between the two treatment arms.
V večini primerov ni bilo pomembne razlike med pogostnostjo posameznih neželenih dogodkov med obema vejama zdravljenja.
Only those adverse reactions marked with * occurred significantly more frequently in the lenalidomide/dexamethasone arm compared to the placebo/dexamethasone arm.
Samo neželeni učinki, označeni z zvezdico, so se pojavljali pogosteje v veji, ki je prejemala lenalidomid/ deksametazon, kot v veji, ki je prejemala placebo/ deksametazon.
The following adverse reactions have been observed in clinical trials and postmarketing experience: † Reports from post-marketing experience are marked with
Poročila iz postmarketinških izkušenj so označena z †.
Pneumonia*, lower respiratory tract infection, Herpes Zoster, Herpes Simplex, urinary tract infection, upper respiratory tract infection, sinusitis, oral candidiasis, oral fungal infection
pnevmonija *, okužbe spodnjih dihal, herpes zoster, herpes simplex, okužba sečil, okužba zgornjih dihal, sinusitis, oralna kandidoza, glivična okužba ust