natgillin/translations-raw huggingface dataset:
In patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.2 and 4.4). 
Pri bolnikih s hudo okvaro ledvic je treba zdravilo Arimidex uporabljati previdno (glejte poglavji 4.2 in 4.4).
Tamoxifen (N=3,094) 
Tamoksifen (n = 3.094)
Pharmacotherapeutic group: Enzyme inhibitors, ATC code: L02B G03 
Oznaka ATC: L02BG03
Very rare side effects (affect less than 1 person in 10,000 people) 
Zelo redki neželeni učinki (pojavijo se pri manj kot 1 od 10.000 bolnikov)
Adjuvant treatment of early invasive breast cancer for hormone receptor-positive patients 
Adjuvantno zdravljenje zgodnjega invazivnega raka dojke pri bolnicah pozitivnimi hormonskimi receptorji
What Arimidex contains 
Kaj vsebuje zdravilo Arimidex
A total of 764 patients were randomised to receive either a single daily dose of 1 mg or 10 mg of Arimidex or megestrol acetate 40 mg four times a day. 
Skupaj 764 bolnic so randomizirali bodisi na enkratni dnevni odmerek 1 mg ali 10 mg zdravila Arimidex ali na 40 mg megestrolacetata štirikrat na dan. Primarni spremenljivki učinkovitosti sta bili čas do napredovanja in objektivni delež odziva.
For postmenopausal women with hormone receptor-positive early invasive breast cancer, the recommended duration of adjuvant endocrine treatment is 5 years. 
Priporočeno trajanje adjuvantnega endokrinega zdravljenja žensk po menopavzi z zgodnjim invazivnim rakom dojke in pozitivnimi hormonskimi receptorji je 5 let.
In patients with severe renal impairment, administration of Arimidex should be performed with caution (see section 4.4 and 5.2). 
Pri bolnicah s hudo okvaro ledvic je treba zdravilo Arimidex uporabljati previdno (glejte poglavji 4.4 in 5.2).
p-value Time to recurrencec 
vrednost p Čas do ponovitvec
Caution is advised in patients with moderate to severe hepatic impairment (see section 4.4). 
Pri bolnikih z zmerno do hudo okvaro jeter je priporočljiva previdnost (glejte poglavje 4.4).
MARKETING AUTHORISATION NUMBER(S) [To be completed nationally] 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET [Izpolni država članica]
Adjuvant treatment of early invasive breast cancer for hormone receptor-positive patients being treated with adjuvant tamoxifen 
Adjuvantno zdravljenje zgodnjega invazivnega raka dojke pri bolnicah s pozitivnimi hormonskimi receptorji, zdravljenih z adjuvantnim tamoksifenom
0.78 to 0.97 
0,78 do 0,97
Fatigue/asthenia 
Utrujenost/astenija
This study provides evidence that the use of bisphosphonates could be considered in the management of possible bone mineral loss in postmenopausal women with early breast cancer scheduled to be treated with Arimidex. 
Ta študija dokazuje, da pride pri ženskah po menopavzi, ki imajo zaradi zgodnjega raka dojke predvideno zdravljenje z zdravilom Arimidex, v poštev uporaba difosfonatov za obvladanje morebitnega zmanjšanja mineralne gostote kosti.
NAME OF THE MEDICINAL PRODUCT Arimidex and associated names (see Annex I) 1 mg film-coated tablets 
IME ZDRAVILA Arimidex in z njim povezana imena (glejte Dodatek I) 1 mg filmsko obložene tablete
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1 mg anastrozole. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 1 mg anastrozola.
0.83 to 1.14 
0,83 do 1,14
This is because these medicines may stop Arimidex from working properly. 
Ta zdravila namreč lahko preprečijo pravilno delovanje zdravila
A greater magnitude of benefit was observed for disease free survival in favour of Arimidex versus tamoxifen for the prospectively defined hormone receptor-positive population. 
V prospektivno opredeljeni populaciji s pozitivnimi hormonskimi receptorji so z zdravilom Arimidex ugotovili večjo korist glede preživetja brez bolezni kot s tamoksifenom.
Diarrhoea Vomiting 
Žilne bolezni
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - izpolni država članica]
0.83 to 1.06 
0,83 do 1,06
Fracture rates of 22 per 1,000 patient-years and 15 per 1,000 patient-years were observed for the Arimidex and tamoxifen groups, respectively, after a median follow-up of 68 months. 
Po mediano 68-mesečnem spremljanju je bil delež zlomov v skupini z zdravilom Arimidex 22 na 1.000 bolnic-let in v skupini s tamoksifenom 15 na 1.000 bolnic-let.
0.39 to 0.89 
0,39 do 0,89
Batch release sites 
Mesta sproščanja serij
Arimidex works by cutting down the amount of the hormone called estrogen that your body makes. 
Zdravilo Arimidex deluje tako, da zmanjša nastajanje hormona estrogena v telesu.
Vaginal dryness Vaginal bleeding *** 
Pogosti suhost nožnice krvavitev iz nožnice ***
0.74 to 0.99 
0,74 do 0,99
Very common side effects (affect more than 1 in 10 people) 
Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov)
Uncommon side effects (affect 1 to 10 people in 1,000) 
Občasni neželeni učinki (pojavijo se pri 1 do 10 od 1.000 bolnikov)
Time to any recurrence Hazard ratio 2-sided 95% CI 
Čas do oddaljene ponovitve Razmerje ogroženosti 2-stranski 95 % IZ
0.73 to 0.94 
0,73 do 0,94
• Treatment of hormone receptor-positive advanced breast cancer in postmenopausal women. 
• Zdravljenje napredovalega raka dojke s pozitivnimi hormonskimi receptorji pri ženskah po menopavzi.
No significant difference in the number of patients who had a 50% or greater reduction in total breast volume after 6 months of treatment was observed between the Arimidex 1 mg treated group and the placebo group. 
Med skupino, zdravljeno z 1 mg zdravila Arimidex, in skupino, ki je dobivala placebo, niso ugotovili značilne razlike v številu bolnikov, ki se jim je po 6 mesecih zdravljenja volumen dojk zmanjšal za 50 % ali več.
First-line therapy in postmenopausal women with advanced breast cancer Two double-blind, controlled clinical studies of similar design (Study 1033IL/0030 and Study 1033IL/0027) were conducted to assess the efficacy of Arimidex compared with tamoxifen as first-line therapy for hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer in postmenopausal women. 
Zdravljenje prve linije pri ženskah z napredovalim rakom dojke Za oceno učinkovitosti zdravila Arimidex v primerjavi s tamoksifenom kot zdravljenjem prve linije pri ženskah po menopavzi, ki so imele raka dojke s pozitivnimi hormonskimi receptorji ali lokalno napredovalega ali metastatskega raka dojke z neznanim stanjem hormonskih receptorjev, sta bili opravljeni dve dvojno slepi, kontrolirani klinični študiji s podobnim načrtom (študija 1033IL/0030 in študija 1033IL/0027).
• Adjuvant treatment of hormone receptor-positive early invasive breast cancer in postmenopausal women. 
• Adjuvantno zdravljenje zgodnjega invazivnega raka dojke s pozitivnimi hormonskimi receptorji pri ženskah po menopavzi.
The enzymes mediating metabolism of anastrozole have not been identified. 
Encimi, s katerimi se presnovi anastrozol, niso ugotovljeni.
• Thinning of your hair (hair loss). 
• razredčenje las (izpadanje las)
Hazard ratio 2-sided 95% CI 
Razmerje ogroženosti 2-stranski 95 % IZ
No dose change is recommended in patients with mild or moderate renal impairment. 
Bolnikom z blago ali zmerno okvaro ledvic odmerka ni treba spremeniti.
The primary endpoint was change from baseline in lumbar spine bone mass density at 12 months. 
Primarni opazovani dogodek je bila sprememba gostote kosti v ledveni hrbtenici po 12 mesecih v primerjavi z izhodiščem.
Rare side effects (affect 1 to 10 people in 10,000) 
Redki neželeni učinki (pojavijo se pri 1 do 10 od 10.000 bolnikov)
• Diarrhoea. 
• zaspanost
Very common Asthenia 
Zelo pogosti glavobol
New contralateral breast cancer Odds ratio 
Nov kontralateralni rak dojke Razmerje obetov 2-stranski 95 % IZ
Overall survival Hazard ratio 2-sided 95% CI 
Celotno preživetje Razmerje ogroženosti 2-stranski 95 % IZ
Trigger finger 
Občasni sprožilni prst
0.30 to 0.76 
0,30 do 0,76
NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte Dodatek I - izpolni država članica]
• Hives or nettle rash. 
• koprivke ali koprivnica
Hot flushes 
Valovi vročine
HOW TO STORE ARIMIDEX 
SHRANJEVANJE ZDRAVILA ARIMIDEX
There are no data on the use of Arimidex during lactation. 
O uporabi zdravila Arimidex med obdobjem dojenja ni podatkov.
Common side effects (affect 1 to 10 people in 100) 
Pogosti neželeni učinki (pojavijo se pri 1 do 10 od 100 bolnikov)
• Hot flushes. 
• valovi vročine
NAME OF THE MEDICINAL PRODUCT Arimidex and associated names (see Annex I) 1 mg film-coated tablets [See Annex I - To be completed nationally] anastrozole 
NAVODILO ZA UPORABO Arimidex in z njim povezana imena (glejte Dodatek I) 1 mg filmsko obložene tablete [Glejte Dodatek I - izpolni država članica] anastrozol
Spine fractures 
Zlomi kolka
NAME OF THE MEDICINAL PRODUCT Arimidex and associated names (see Annex I) 1 mg film-coated tablets [See Annex I - To be completed nationally] 
Arimidex in z njim povezana imena (glejte Dodatek I) 1 mg filmsko obložene tablete [Glejte Dodatek I - izpolni država članica]
Stop Arimidex if you become pregnant and talk to your doctor. 
Če zanosite, nehajte jemati zdravilo Arimidex in se posvetujte z zdravnikom.
BATCH NUMBER Lot 
ŠŠKKA AT
Hypercholesterolaemia Very common Headache 
Pogosti anoreksija hiperholesterolemija
Disease-free survivala Hazard ratio 2-sided 95% CI 
Preživetje brez boleznia Razmerje ogroženosti 2-stranski 95 % IZ
Lactose monohydrate 
Mineralna gostota kosti
In a phase III trial (Austrian Breast and Colorectal Cancer Study Group [ABCSG] 8) conducted in 2,579 postmenopausal women with hormone receptor-positive early breast cancer who had received surgery with or without radiotherapy and no chemotherapy (see below), switching to Arimidex after 2 years adjuvant treatment with tamoxifen was statistically superior in disease-free survival when compared to remaining on tamoxifen, after a median follow-up of 24 months. 
Pri 2.579 ženskah po menopavzi z zgodnjim rakom dojke in pozitivnimi hormonskimi receptorji je bilo opravljeno preskušanje III. faze (ABCSG [Austrian Breast and Colorectal Cancer Study Group] 8).
Joint pain/stiffness 
Bolečine v sklepih/togost
Fractures 
Odmerjanje
Hepatic impairment 
• izguba teka
BEFORE YOU TAKE ARIMIDEX 
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO ARIMIDEX
• Being sick (vomiting). 
• slabost v želodcu (siljenje na bruhanje)
This normally takes several seconds. 
Za to je običajno potrebnih nekaj sekund.
You could put yourself or others at risk of serious injury or death. 
V nasprotnem primeru lahko sebe ali druge spravite v nevarnost za resno poškodbo ali smrt.
c p-value for PGI-C is nominal. 
c Vrednost p za PGI-C je nominalna.
Results are presented in Table 2. 
Rezultati so predstavljeni v preglednici 2.
For more information see section 4. 
Za več informacij glejte poglavje 4.
Do not push the handle and mouthpiece together more than once. 
Ustnika in držaja ne stisnite skupaj več kot enkrat.
Most of the gender difference is accounted for by differences in body weight. 
Večina razlike med spoloma je razložljiva z razlikami v telesni masi.
Find a clean and dry surface. 
Poiščite čisto in suho površino.
Godfried Bomansstraat 31 6543 JA Nijmegen Netherlands 
Godfried Bomansstraat 31 6543 JA Nijmegen
This may cause difficulties in breathing or swallowing. 
To lahko povzroči težave pri dihanju ali požiranju.
This reaction will not be altered by boiling the urine specimen. 
Ta reakcija se ne spremeni s prevretjem vzorca urina.
This is because the medicine may affect the results of some tests. 
To je zato, ker lahko to zdravilo vpliva na rezultate nekaterih preiskav.
Make sure your hands are clean and dry. 
Poskrbite, da bodo vaše roke čiste in suhe.
Your doctor may need to review your treatments. 
Zdravnik bo morda moral znova oceniti vaše zdravljenje.
Patients should be monitored and supportive care should be provided. 
Bolnike je treba spremljati in jim zagotoviti podporno oskrbo.
Take in a deep, comfortable breath until your lungs feel full. 
Globoko in udobno vdihnite, dokler ne začutite, da so se vaša pljuča napolnila.
• Make sure your hands are clean and dry when using the inhaler and capsules. 
• Poskrbite, da bodo vaše roke čiste in suhe, ko uporabljate inhalator in kapsule.
Much improved % (n) Improved % (n) Little improved % (n) Not improved % (n) p-value 
% z velikim izboljšanjem (n) % z izboljšanjem (n) % z majhnim izboljšanjem (n) % brez izboljšanja (n)
Other side effects you may experience of which the frequency is not known include: 
Drugi neželeni učinki, ki se lahko pojavijo, njihova pogostnost pa ni znana, vključujejo:
- Your doctor or pharmacist will show you how to use your medicine correctly. 
- Zdravnik ali farmacevt vam bo pokazal, kako pravilno uporabljati vaše zdravilo.
2 doses a Observed cases. 
2 odmerka a Opaženi primeri.
Patients who are taking these medicinal products should be monitored closely. 
Bolnike, ki jemljejo ta zdravila, je treba natančno spremljati.
You may feel confused or agitated, and your heart rate may be slower or faster than normal. 
Morda se boste počutili zmedene ali nemirne in vaš srčni utrip bo morda hitrejši ali počasnejši kot običajno.
After 12 months, the average reduction in FEV1 from baseline was the same in both groups (-0.1 L). 
Po 12 mesecih je bilo povprečno zmanjšanje FEV1 v primerjavi z izhodiščem v obeh skupinah enako (-0,1 l).
During off periods your usual medicine does not control the condition well enough and movement is likely to be more difficult. 
obdobjih izklopa pa vaše običajno zdravilo ne obvladuje bolezni dovolj dobro in vaše gibanje je verjetno oteženo.
• It is normal for some powder to remain on the inhaler. 
• Normalno je, da na inhalatorju ostane nekaj praška.
There is only limited data available in very elderly patients (≥75 years). 
Podatki za zelo stare bolnike (≥ 75 let) so omejeni.
The mouthpiece will spring back and stay attached. 
Ustnik bo zdrsnil nazaj in ostal pritrjen.
Daily doses (median) 
Dnevni odmerki (mediana)
% (n) Diff. p-value 
% (n) Razlika vrednost p
Do not use any capsule that looks crushed, damaged or wet. 
Nikoli ne uporabite kapsule, če je videti zdrobljena, poškodovana ali vlažna.
If the off period has passed, do not use Inbrija until the next off period. 
Če je obdobje izklopa že minilo, ne uporabljajte zdravila Inbrija do naslednjega obdobja izklopa.
You can use 2 capsules up to five times a day. 
Dve kapsuli smete uporabiti največ petkrat na dan.
do not drive or use tools or machines. 
Če se to zgodi vam, ne vozite in ne uporabljajte orodij ali strojev.
Please see the “Instructions for use” at the end of this leaflet on how to use your medicine with the provided inhaler. 
Glejte poglavje »Navodila za uporabo« na koncu tega navodila za uporabo, kjer je razloženo, kako morate uporabljati svoje zdravilo s priloženim inhalatorjem.
Subjects had to be able to recognise OFF periods and to handle the device. 
Udeleženci so morali biti sposobni prepoznati epizode izklopa in ravnati s pripomočkom.
Important: If you did not hear or feel the capsule “whirl” while inhaling you may need to take a deeper, longer breath. 
Pomembno: Če niste čutili ali slišali, da se kapsula med inhaliranjem »vrti«, boste morda morali narediti globlji in daljši vdih.
Detailed instructions for use for the patients are included in the package leaflet. 
Podrobna navodila za uporabo za bolnike so vključena v priloženo navodilo za uporabo.
Concurrent use can, however, cause a worsening of involuntary motor disorders. 
Vendar pa lahko sočasna uporaba povzroči poslabšanje nehotenih motoričnih motenj.
Malaise, 
srbenje,
Frequency categories are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), not known 
Kategorije pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 to <1/10), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The maximum daily dose of Inbrija should not exceed 10 capsules (330 mg). 
Največji dnevni odmerek zdravila Inbrija ne sme preseči 10 kapsul (330 mg).
Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population. 
Epidemiološke študije so pokazale, da imajo bolniki s Parkinsonovo boleznijo v primerjavi s splošno populacijo večje tveganje za razvoj melanoma (2-krat do približno 6-krat večje).
Prepare your dose 
Pripravite svoj odmerek
No dose adjustment is required based on smoking status. 
Prilagoditev odmerka glede na status kadilca ni potrebna.
Puncturing tines and springs are made from stainless steel. 
Igle in vzmeti za prebadanje so izdelane iz nerjavečega jekla.
2 doses 
2 odmerka
Do not breathe into mouthpiece. 
Ne dihajte v ustnik.
In addition, certain medicinal products used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of levodopa. 
Poleg tega lahko določena zdravila za zdravljenje psihoze poslabšajo simptome Parkinsonove bolezni in zmanjšajo učinkovitost levodope.
Duration PD 
Trajanje PB
Local or systemic pulmonary medicinal products 
Lokalna ali sistemska zdravila za pljuča
You must stop taking these medicines at least 14 days before starting treatment with Inbrija. 
Ta zdravila morate nehati jemati vsaj 14 dni pred začetkom zdravljenja z zdravilom Inbrija.
Line up the white arrows on the handle and mouthpiece. 
Poravnajte beli puščici na držaju in ustniku.
Dispose of used capsules in accordance with local requirements. 
Uporabljene kapsule odstranite v skladu z lokalnimi zahtevami.
Dispose of it and get a new capsule. 
Zavrzite jo in vzemite novo kapsulo.
UPDRS-III was assessed before and 30 minutes post dose administration. 
UPDRS-III so ocenili pred dajanjem odmerka in 30 minut po njem.
Central Nervous System (CNS) effects and mental disturbances 
Učinki na osrednji živčni sistem (OŽS) in duševne motnje
Patients selected for treatment with Inbrija should be able to recognize the onset of their 'OFF' symptoms and be capable of preparing the inhaler or else have a responsible care giver able to prepare the inhaler for them when required. 
Bolniki, ki so izbrani za zdravljenje z zdravilom Inbrija, morajo biti sposobni prepoznati nastop svojih simptomov »izklopa« in zmožni pripraviti inhalator oziroma morajo imeti odgovornega skrbnika, ki bo zanje pripravil inhalator, ko bo to potrebno.
Do not use Inbrija if you have taken medicines called non-selective MAO inhibitors for treating depression in the last 14 days. 
Ne uporabljajte zdravila Inbrija, če ste v zadnjih 14 dneh vzeli zdravila, imenovana neselektivni zaviralci MAO, za zdravljenje depresije.
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
The following side effects may happen with this medicine: Very common (may affect more than 1 in 10 people): - cough 
Pri tem zdravilu se lahko pojavijo naslednji neželeni učinki: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 oseb):
There are no data on the effects of levodopa on human fertility. 
Ni podatkov o vplivu levodope na plodnost pri človeku.
Tell your doctor or pharmacist if you are taking: 
Obvestite zdravnika ali farmacevta, če jemljete:
Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. 
Zelo redko so poročali o nenadnem nastopu spanca med dnevnimi dejavnostmi, v nekaterih primerih brez zavedanja ali opozorilnih znakov.
Furthermore, a reduction of dose or termination of therapy may be considered. 
Treba je tudi razmisliti o zmanjšanju odmerka ali ukinitvi zdravljenja.
These may be symptoms of “withdrawal-emergent hyperpyrexia”. 
To so lahko simptomi »hiperpireksije ob odtegnitvi«.
After administration of Inbrija the Cmax and AUC0-24 h was 11% to 12% higher for smokers than for non-smokers. 
Po aplikaciji zdravila Inbrija sta bili Cmax in AUC0-24 h pri kadilcih 11 % do 12 % večji kot pri nekadilcih.
The most frequent adverse reactions reported in the Inbrija clinical studies were cough (15.6%), fall (8.7%), upper respiratory tract infection (5.8%), dyskinesia (5.7%) and sputum discoloured (2.8%). 
Najpogostejši neželeni učinki, o katerih so poročali v kliničnih študijah z zdravilom Inbrija, so bili kašelj (15,6 %), padec (8,7 %), okužba zgornjih dihal (5,8 %), diskinezija (5,7 %) in sprememba barve sputuma (2,8 %).
If you cough or stop your dose, start again from the beginning of Step 7 using the same capsule. 
Če zakašljate ali prekinete svoj odmerek, ponovno začnite s 7. korakom, pri čemer uporabite isto kapsulo.
The European Medicines Agency has waived the obligation to submit the results of studies with Inbrija in all subsets of the paediatric population in the treatment of idiopathic Parkinson's disease (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Inbrija za vse podskupine pediatrične populacije za zdravljenje idiopatske Parkinsonove bolezni (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Tricyclic antidepressants 
Triciklični antidepresivi
The physician or other healthcare professional should instruct the patient how to administer the product correctly. 
Zdravnik ali drug zdravstveni delavec mora bolnika podučiti, kako se pravilno jemlje zdravilo.
Use one capsule at a time. 
Uporabite eno kapsulo naenkrat.
See also under “Other medicines and Inbrija”. 
Glejte tudi poglavje »Druga zdravila in zdravilo Inbrija«.
Your doctor will monitor you closely during start of treatment; - an ulcer in your stomach or intestines; - an eye condition called glaucoma, because the pressure in your eyes may need to be monitored; - severe problems with your kidneys; - severe problems with your liver. 
Zdravnik vas bo ob začetku zdravljenja natančno spremljal; - razjeda/čir v želodcu ali črevesju; - bolezen oči, imenovana glavkom, saj bo morda treba spremljati tlak v vaših očeh; - hude težave z ledvicami; - hude težave z jetri.
Any nonselective MAO inhibitors should be discontinued at least 14 days prior to initiating levodopa. 
Vse neselektivne zaviralce monoaminooksidaze je treba ukiniti vsaj 14 dni pred uvedbo levodope.
This may damage the capsule, and you may not get your full dose. 
To bi lahko povzročilo poškodbo kapsule in preprečilo, da bi prejeli celoten odmerek.
Alanine aminotransferase increased, 
povečana alanin aminotransferaza,
If you need to have surgery, tell your doctor that you are using Inbrija. 
Če boste potrebovali kirurški poseg, povejte zdravniku, da uporabljate zdravilo Inbrija.
Concomitant use of antipsychotics should be monitored carefully for worsening of Parkinson's motor symptoms especially when D2-receptor antagonists are used (see section 4.5). 
Pri sočasni uporabi antipsihotikov je potrebno skrbno spremljanje glede poslabšanja motoričnih simptomov Parkinsonove bolezni, še posebej, kadar se uporabljajo antagonisti receptorjev D2 (glejte poglavje 4.5).
Abnormalities in blood urea nitrogen (BUN) and positive Coombs test have also been reported. 
Poročali so tudi o anomalijah pri dušiku sečnine v krvi (BUNblood urea nitrogen) in o pozitivnem Coombsovem testu.
Levodopa is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes. 
Levodopa je povezana s somnolenco in so jo zelo redko povezali s prekomerno somnolenco v dnevnem času ter epizodami nenadnega nastopa spanca.
You will need it later to store the inhaler. 
Ponovno ga boste potrebovali, da boste pospravili inhalator.
Step 9: Hold breath for 5 seconds, then breathe out 
9. korak: Zadržujte dih v pljučih 5 sekund in nato izdihnite.