FrancophonIA/ELRC3.0 huggingface dataset:
English: The time to onset for occurrence of osteonecrosis also has similar pattern when compared to osteonecrosis of the jaw/external auditory canal.
Slovenian: Tudi čas do pojava osteonekroze sledi podobnemu vzorcu kot pri osteonekrozi čeljustnice/zunanjega slušnega kanala.
English: Treatment of TIH
Slovenian: Zdravljenje TIH
English: While being treated with Zoledronic acid medac, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
Slovenian: Med zdravljenjem z zdravilom Zoledronska kislina medac, morate skrbeti za dobro ustno higieno (vključno z rednim ščetkanjem zob) in hoditi na redne zobozdravstvene preglede.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic acid medac.
Slovenian: Vse bolnike je treba spodbujati, da skrbijo za dobro ustno higieno, imajo redne zobozdravstvene preglede in takoj poročajo o kakršnih koli ustnih simptomih, na primer majanju zob, bolečini ali otekanju, neceljenju ran ali izcedku med zdravljenjem z zdravilom Zoledronska kislina medac.
English: Other medicines and Zoledronic acid medac Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo Zoledronska kislina medac Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: * Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR Not reached
Slovenian: * zajema vertebralne in nevertebralne zlome ** velja za vse skeletne dogodke, tako za njihovo celotno število kot za trajanje vsakega dogodka med preskušanjem NR ni bil dosežen
English: Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
Slovenian: akutna odpoved ledvic, hematurija, proteinurija pridobljen Fanconijev sindrom
English: How much Zoledronic acid medac is given - The usual single dose given is 4 mg. - If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Slovenian: Koliko zdravila Zoledronska kislina medac se daje - Običajni posamezni odmerek je 4 mg. - Če imate težave z ledvicami, vam bo zdravnik dal manjši odmerek, ki bo odvisen od tega, kako hude so vaše težave z ledvicami.
English: The SRE rate (events/person year) was 0.628 for zoledronic acid and 1.096 for placebo.
Slovenian: Pogostnost SRE (dogodki/oseba-let) je bila 0,628 z zoledronsko kislino in 1,096 s placebom.
English: Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of zoledronic acid along with driving and operating of machinery.
Slovenian: Neželeni učinki, kot na primer vrtoglavost in somnolenca, lahko vplivajo na sposobnost vožnje in upravljanja s stroji, zato je ob uporabi zoledronske kisline potrebna previdnost pri vožnji in upravljanju strojev.
English: How often Zoledronic acid medac is given - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid medac every three to four weeks.
Slovenian: Kako pogosto se daje zdravilo Zoledronska kislina medac - Če prejemate zdravilo za preprečevanje zapletov na kosteh zaradi kostnih metastaz, boste prejeli eno infuzijo zdravila Zoledronska kislina medac vsake tri do štiri tedne.
English: Other medicinal products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Slovenian: Druga zdravila, ki vsebujejo zoledronsko kislino kot zdravilno učinkovino, so na voljo za osteoporozo in za zdravljenje Pagetove bolezni kosti.
English: - Low level of red blood cells (anaemia).
Slovenian: - konjunktivitis (vnetje očesne veznice), - nizka koncentracija rdečih krvnih celic (anemija).
English: Zoledronic acid medac belongs), or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zoledronska kislina medac) ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures (e.g. tooth extractions) and poorly fitting dentures.
Slovenian: • zobozdravstvene bolezni v anamnezi, slaba ustna higiena, peridontalne bolezni, invazivni zobozdravstveni postopki (npr. ekstrakcije zob) in slabo prileganje protez.
English: − In vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Slovenian: - In vivo: inhibicijo osteoklastne resorpcije kosti, ki spremeni mikrookolje kostnega mozga, tako da je le-to manj ugodno za rast tumorskih celic, protiangiogeno aktivnost in protibolečinsko aktivnost.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2)
English: After dilution of the concentrate the prepared solution should be clear, colourless and free of visible particles.
Slovenian: Po redčenju koncentrata mora biti pripravljena raztopina bistra, brezbarvna in brez vidnih delcev.
English: • Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Slovenian: • sočasna zdravljenja: kemoterapija, inhibitorji angiogeneze (glejte poglavje 4.5), radioterapija glave in vratu, kortikosteroidi.
English: The reports of osteonecrosis at other sites with zoledronic acid suggest similarity in reporting frequency (femur>knee>humerus) as compared to the commonly affected sites of osteonecrosis based on anatomical factors.
Slovenian: Poročila o osteonekrozi v povezavi z zoledronsko kislino na drugih lokacijah kažejo podobno pogostnost (stegnenica>koleno>nadlahtnica) kot pri z osteonekrozo običajno prizadetih lokacijah zaradi anatomskih dejavnikov.
English: Additional information on handling of Zoledronic acid medac, including guidance on preparation of reduced doses, is provided in section 4.2.
Slovenian: Nadaljnje informacije o ravnanju z zdravilom Zoledronska kislina medac, vključno z navodili za pripravo nižjih odmerkov, so navedene v poglavju 4.2.
English: Can't be sold separately.
Slovenian: Prodaja posamezne enote ni možna.
English: 0.5 mg/dl or 44 µmol/l;
Slovenian: zvišanje za 0,5 mg/dl ali 44 µmol/l;
English: Patients receiving zoledronic acid 4 mg reported less increase in pain than those receiving placebo, and the difference reached significance at months 3, 9, 21 and 24.
Slovenian: so poročali o manjšem porastu bolečin kot tisti, ki so dobivali placebo, ta razlika pa je dosegla statistično značilnost v 3., 9., 21. in 24. mesecu.
English: Healthcare professionals are advised not to dispose of unused Zoledronic acid medac via the domestic sewage system.
Slovenian: Zdravstvenim delavcem svetujemo, da neporabljenega zdravila Zoledronska kislina medac ne izlijejo v gospodinjske odplake.
English: Zoledronic acid treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Slovenian: Zdravljenje z zoledronsko kislino pri bolnikih s TIH, ki imajo tudi težko ledvično okvaro, lahko pride v poštev šele po oceni nevarnosti in koristnih učinkov zdravljenja.
English: After first opening: Chemical and physical in-use stability has been demonstrated for 4 days at 2 - 8°C and 25°C.
Slovenian: Po prvem odprtju: dokazana je bila 4-dnevna kemična in fizična stabilnost razredčenega zdravila pri 2-8 °C in 25 °C.
English: There are no site specific risk factors for osteonecrosis apart from additional oral risk factors for osteonecrosis of the jaw.
Slovenian: Dejavniki tveganja za osteonekrozo niso specifični glede na lokacijo z izjemo dodatnih oralnih dejavnikov tveganja za osteonekrozo čeljustnice.
English: • Potency of the bisphosphonate (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bisphosphonate.
Slovenian: • potentnost difosfonatov (večje tveganje pri visoko potentnih učinkovinah), pot uporabe (večje tveganje pri parenteralni uporabi) in kumulativni odmerek difosfonata.
English: Increasing the infusion time from 5 to 15 minutes caused a 30 % decrease in zoledronic acid concentration at the end of the infusion, but had no effect on the area under the plasma concentration versus time curve.
Slovenian: Podaljšanje časa infundiranja s 5 na 15 minut je povzročilo 30-odstotno znižanje koncentracije zoledronske kisline ob koncu infuzije, ni pa vplivalo na površino pod krivuljo plazemske koncentracije proti času.
English: Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw.
Slovenian: Pri bolnikih, ki se zdravijo s kemoterapijo in/ali obsevanjem, jemljejo steroide, imajo operativen poseg na zobeh, niso deležni redne zobozdravstvene oskrbe, imajo bolezen dlesni, kadijo ali so se prej zdravili z difosfonati (ki se uporabljajo za zdravljenje ali preprečevanje bolezni kosti), je lahko tveganje nastanka osteonekroze čeljustnic večje.
English: Withdraw an appropriate volume of the concentrate needed, as follows: - 4.4 ml for 3.5 mg dose
Slovenian: Odvzemite ustrezni volumen potrebnega koncentrata, kot sledi: 4,4 ml za odmerek 3,5 mg,
English: • Breast-feeding (see section 4.6).
Slovenian: • Dojenje (glejte poglavje 4.6)
English: - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Slovenian: • Preprečevanje z okostjem povezanih dogodkov (patološki zlomi, spinalna kompresija, obsevanje ali operacija kosti ali tumorsko povzročena hiperkalciemija) pri odraslih bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti.
English: - Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Slovenian: - Osteonekrozo so zelo redko opažali tudi na drugih kosteh in ne le na čeljustnici, še posebej na kolku in stegnu.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Slovenian: Intravensko dana zoledronska kislina se odstranjuje iz telesa s trifaznim procesom: hitro dvofazno izginotje iz sistemskega krvnega obtoka z razpolovnima časoma t1/2α 0,24 ure in t1/2β 1,87 ure, ki mu sledi dolga eliminacijska faza s terminalnim eliminacijskim razpolovnim časom t1/2γ 146 ur.
English: Therefore, the product information should be updated to reflect in sections 4.4 and 4.8 of the SmPC a warning on osteonecrosis of other anatomical sites and add this adverse reaction with a frequency very rare.
Slovenian: Informacije o zdravilu je zato treba posodobiti z vključitvijo opozorila o pojavu osteonekroze na drugih anatomskih lokacijah in dodatkom tega neželenega učinka s pogostnostjo zelo redek v poglavji 4.4 in 4.8 povzetka glavnih značilnosti zdravila.
English: The cases from safety database did report multiple risk factors including underlying malignancy, bone metastases; concomitant therapy with steroids, angiogenesis inhibitors, radiotherapy but the exact underlying cause for the osteonecrosis was not ascertained.
Slovenian: Primeri iz podatkovne baze o varnosti zdravila kažejo več dejavnikov tveganja vključno z osnovno rakavo boleznijo, kostnimi zasevki, sočasnim zdravljenjem s steroidi, zaviralci angiogeneze ali radioterapijo, vendar pa natančen vzrok za pojav osteonekroze ni ugotovljen.
English: - have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Slovenian: - imate ali ste imeli bolečino, oteklino ali odrevenelost čeljusti, občutek pritiska v čeljusti ali če se vam maje zob.
English: Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Slovenian: Študije razmnoževanja pri živalih z zoledronsko kislino so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
English: • From a microbiological point of view, the solution for infusion should be used immediately, after first opening.
Slovenian: • Z mikrobiološkega stališča je raztopino za infundiranje najbolje uporabiti takoj po prvem odpiranju.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje zoledronsko kislino za vse podskupine pediatrične populacije glede zdravljenja tumorsko povzročene hiperkalciemije in preprečevanja z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajamejo kosti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: On the basis of the scientific conclusions for zoledronic acid (indicated for cancer and fractures) the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing zoledronic acid (indicated for cancer and fractures) is unchanged subject to the proposed changes to the product information
Slovenian: Podlaga za spremembe pogojev dovoljenja (dovoljenj) za promet z zdravilom Na podlagi znanstvenih zaključkov za zoledronsko kislino (indicirano za zdravljenje raka in zlomov) odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil(-a), ki vsebuje(-jo) zoledronsko kislino (indicirano za zdravljenje raka in zlomov) nespremenjeno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
English: Furthermore, there is evidence of an association between hypocalcaemia and secondary neurological events reported in these cases including convulsions, hypoaesthesia and tetany (see section 4.4).
Slovenian: Poleg tega obstajajo dokazi o povezanosti hipokalciemije in posledičnih nevroloških dogodkov, o katerih so poročali v teh primerih in so vključevali konvulzije, hipestezijo in tetanijo (glejte poglavje 4.4).
English: Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of a condition called osteonecrosis of the jaw.
Slovenian: Takoj obvestite zdravnika in zobozdravnika, če se pri vas pojavijo kakršne koli težave v zvezi z usti ali zobmi, na primer majanje zob, bolečina ali otekanje, neceljenje ran ali izcedek, ker so to lahko znaki stanja, ki se imenuje osteonekroza čeljustnic.
English: *Doses have been calculated assuming target AUC of 0.66 (mg•hr/l) (CLcr=75 ml/min).
Slovenian: * Odmerke so izračunali tako, da so predpostavili tarčno AUC 0,66 (mg•hr/l) (CLcr=75 ml/min).
English: - 4.1 ml for 3.3 mg dose
Slovenian: 4,1 ml za odmerek 3,3 mg,
English: In an in vitro study, zoledronic acid showed low affinity for the cellular components of human blood, with a mean blood to plasma concentration ratio of 0.59 in a concentration range of 30 ng/ml to 5,000 ng/ml.
Slovenian: V študiji in vitro je imela zoledronska kislina nizko afiniteto za celične sestavine humane krvi, pri čemer je znašala povprečna vrednost razmerja med koncentracijo v krvi in koncentracijo v plazmi 0,59 v razponu koncentracij od 30 ng/ml do 5.000 ng/ml.
English: The safety margins relative to renal effects were narrow in the long-term repeat-dose parenteral animal studies but the cumulative no adverse event levels (NOAELs) in the single dose (1.6 mg/kg) and multiple dose studies of up to one month (0.06 - 0.6 mg/kg/day) did not indicate renal effects at doses equivalent to or exceeding the highest intended human therapeutic dose.
Slovenian: Varno območje, glede na učinke na ledvici, je bilo v dolgoročnih študijah večkratnih parenteralnih odmerkov na živalih ozko, vendar kumulativne koncentracije brez neželenih učinkov (NOAEL) pri enkratnih odmerkih (1,6 mg/kg) in pri do en mesec trajajočih študijah večkratnih odmerkov (0,060,6 mg/kg/dan) niso kazale na učinke na ledvici v odmerkih, ki so bili enakovredni največjemu nameravanemu človeškemu terapevtskemu odmerku ali ki so le-tega presegali.
English: What you need to know before you are given Zoledronic acid medac
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo Zoledronska kislina medac
English: Temporary interruption of zoledronic acid treatment should be considered until the condition resolves and contributing risk factors are mitigated where possible.
Slovenian: Začasna prekinitev zdravljenja z zoledronsko kislino pride v poštev, dokler se stanje ne razreši in se dejavniki tveganja, ki prispevajo z razvoju bolezni, ne ublažijo, če je to mogoče.
English: − In vitro: Inhibition of osteoblast proliferation, direct cytostatic and pro-apoptotic activity on tumour cells, synergistic cytostatic effect with other anti-cancer medicinal products, antiadhesion/invasion activity.
Slovenian: - In vitro: inhibicijo proliferacije osteoblastov, neposredno citostatično in pro-apoptotično aktivnost pri tumorskih celicah, sinergističen citostatični učinek z drugimi zdravili proti raku,
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid medac.
Slovenian: Če imate hipokalciemijo, jo je treba odpraviti preden prejmete prvi odmerek zdravila Zoledronska kislina medac.
English: The analysis of the individual safety reports from clinical trials, spontaneous reports and literature retrieved 62 cases of osteonecrosis of other anatomical sites in association with zoledronic acid, with the majority of events occurring in the hip/femur (46).
Slovenian: Analiza posameznih poročil o varnosti iz kliničnih študij, spontanih poročil in literature je razkrila 62 primerov osteonekroze v povezavi z zoledronsko kislino na drugih anatomskih lokacijah.
English: • Since no data are available on the compatibility of Zoledronic acid medac with other intravenously administered substances, Zoledronic acid medac must not be mixed with other medications/substances and should always be given through a separate infusion line.
Slovenian: • Ker o združljivosti zdravila Zoledronska kislina medac z drugimi intravensko dajanimi snovmi ni na voljo nikakršnih podatkov, zdravila Zoledronska kislina medac ne smete mešati z drugimi zdravili ali snovmi in jo morate vedno dajati po ločenem infuzijskem sistemu.
English: Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with zoledronic acid outweighs the possible risk.
Slovenian: Bolnike s tumorsko povzročeno hiperkalciemijo (TIH) in znaki poslabšanja ledvične funkcije, moramo ustrezno ovrednotiti in pri tem pretehtati, ali možna korist zdravljenja z zoledronsko kislino odtehta možno tveganje.
English: The following risk factors should be considered when evaluating an individual's risk of developing ONJ:
Slovenian: Pri oceni tveganja za razvoj osteonekroze čeljustnic pri posamezniku je treba upoštevati naslednje dejavnike tveganja:
English: To assess the effects of 4 mg zoledronic acid versus pamidronate 90 mg, the results of two pivotal multicentre studies in patients with TIH were combined in a pre-planned analysis.
Slovenian: Za oceno učinkov 4 mg zoledronske kisline v primerjavi s pamidronatom 90 mg so v vnaprej načrtovani analizi združili rezultate dveh ključnih multicentričnih študij pri bolnikih s tumorsko povzročeno hiperkalciemijo (TIH).
English: The solution must be allowed to reach 20°C to 23.5°C before administration.
Slovenian: Pred dajanjem mora raztopina doseči temperaturo med 20 °C in 23,5 °C.
English: Withdraw an appropriate volume of the solution needed, as follows: - 4.4 ml for 3.5 mg dose
Slovenian: Odvzemite ustrezni volumen potrebne raztopine, kot sledi: 4,4 ml za odmerek 3,5 mg,
English: In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Slovenian: V združeni analizi podatkov o varnosti zdravila iz registracijskih preskušanj zoledronske kisline pri preprečevanju z okostjem povezanih dogodkov pri bolnikih z napredovalimi malignimi boleznimi, ki zajemajo kosti, so bile pogostnosti neželenih dogodkov, ki so vključevali okvaro ledvic in pri katerih je obstajal sum, da so povezani z zoledronsko kislino (torej neželenih učinkov), naslednje: multipli mielom (3,2 %), rak prostate (3,1 %), rak dojke (4,3 %), tumor na pljučih in drugi čvrsti tumorji (3,2 %).
English: - 3.8 ml for 3.0 mg dose
Slovenian: 3,8 ml za odmerek 3,0 mg.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Dilute before use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo razredčite.
English: • Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Slovenian: • rak, sočasne druge bolezni (npr. anemija, koagulopatije, infekcija), kajenje.
English: - Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Slovenian: • Zdravljenje odraslih bolnikov s tumorsko povzročeno hiperkalciemijo (TIH - tumour-induced hypercalcaemia).
English: The effects of intravenous zoledronic acid in the treatment of paediatric patients (age 1 to 17 years) with severe osteogenesis imperfecta (types I, III and IV) were compared to intravenous pamidronate in one international, multicentre, randomised, open-label study with 74 and 76 patients in each treatment group, respectively.
Slovenian: 17 let) s hudo obliko osteogenesis imperfecta (tipov I, III in IV) so primerjali z intravenskim pamidronatom v eni mednarodni, multicentrični, randomizirani, odprti študiji s 74 oziroma 76 bolniki v vsaki od zdravljenih skupin.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, tj. zdravilo je v bistvu "brez natrija".
English: The results demonstrated that zoledronic acid 4 mg showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Slovenian: Rezultati so dokazali, da je zoledronska kislina 4 mg pokazala učinkovitost za preprečevanje z okostjem povezanih dogodkov (SRE), ki je bila primerljiva z učinkovitostjo 90 mg pamidronata.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic acid medac and will check your response to treatment at regular intervals.
Slovenian: Preden začnete zdravljenje z zdravilom Zoledronska kislina medac, vam bo zdravnik opravil preiskave krvi in v rednih presledkih preverjal vaš odziv na zdravljenje.
English: - Difficulty in breathing with wheezing or coughing.
Slovenian: - oteženo dihanje s piskanjem ali kašljem,
English: Anxiety, sleep disturbance Confusion
Slovenian: anksioznost, motnje spanja redki: