natgillin/translations-raw huggingface dataset:
It seems intuitive that for good prognosis patients who have also received treatment of curative intent, the addition of bicalutamide might confer less benefit than in other patients.
Zdi se samoumevno, da bi lahko imel dodatek bilakutamida pri bolnikih z dobro napovedjo, ki so prejemali tudi zdravljenje kurativnega značaja, manj koristnih učinkov kot pri drugih bolnikih.
- The Committee considered that bicalutamide 150 mg is effective in the treatment of locally advanced prostate cancer; however the CHMP considered that the therapeutic indication should be restricted to treatment of patients at high risk of disease progression.
- Odbor je upošteval, da je bikalutamid 150 mg učinkovit pri zdravljenju lokalno napredovalega raka prostate, vendar pa je bil CHMP mnenja, da bi morale biti indikacije za zdravljenje omejene na zdravljenje bolnikov z visokim tveganjem za napredovanje bolezni.
Regarding the heart failure deaths, the allocation of cause of death is known to be unreliable, and very few post-mortems were done.
Kar se tiče primerov smrti zaradi odpovedi srca, je ugotavljanje vzroka za smrt ugotovljeno nezanesljivo, opravili pa so tudi le majhno število obdukcij.
The EPC study was an empirical design, that is to say, it generally compared Casodex (bicalutamide) to the standard of care in each region involved.
Študija EPC je temeljila na empiričnem načrtu, kar pomeni, da je na splošno primerjala Casodex (bikalutamid) s standardno nego, značilno za vsako regijo, vključeno v študijo.
At the initial authorisation of the early prostate cancer indication, the data for overall survival were too immature to allow an analysis, however it makes sense to subsequently analyse this endpoint in the same subgroups, and there are favourable trends in overall survival for patients with locally advanced disease receiving Casodex (bicalutamide) alone, and for patients also receiving radiotherapy.
V času začetne odobritve za indikacijo zgodnjega raka prostate so bili podatki za celotno preživetje še preveč nerazviti, da bi omogočali analizo, vendar pa je naknadna analiza te končne točke v istih podskupinah smiselna, saj obstajajo koristni trendi pri celotnem preživetju bolnikov z lokalno napredovalo boleznijo, ki prejemajo zdravilo Casodex (bikalutamid) bodisi samostojno ali v kombinaciji z radioterapijo.
When the EPC programme was initiated more than 8 years ago, the aim was to document the benefit of early bicalutamide therapy versus placebo as monotherapy or adjuvant therapy to surgery or radiotherapy.
Ob začetku programa EPC pred več kot osmimi leti je bil cilj dokumentirati primerjavo koristnih učinkov zgodnjega zdravljenja z bikalutamidom glede na placebo, uporabljenega kot monoterapija ali adjuvantno zdravljenje h kirurgiji ali radioterapiji.
How does the company justify that the placebo arm did not receive an adequate treatment according to the present standard of care and why this is not taken into account in the analysis of the EPC results?
Kako družba utemeljuje dejstvo, da placebo skupina glede na veljavne standarde nege ni prejela ustreznega zdravljenja in zakaj to ni bilo upoštevano pri analizi rezultatov za zgodnji rak prostate?
Benefit is generally a function of risk progression and in patients with locally advanced disease; benefit is reduced after surgery or in cases where radiotherapy is likely to be curative.
Koristni učinki so navadno funkcija napredovanja tveganja in so opazni pri bolnikih z lokalno napredovalo boleznijo; koristni učinki se zmanjšajo po kirurškemu posegu ali tam, kjer bo radioterapija po vsej verjetnosti imela zdravilen učinek.
AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
SPREMEMBE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
In particular, there is a statistically significant and clinically meaningful improvement in progression-free survival in the patients with locally advanced prostate cancer who received Casodex (bicalutamide) as compared to placebo (58% versus 69% progressors in patients who were not receiving adjuvant surgery or radiotherapy).
Opaziti je statistično značilno in klinično pomembno izboljšanje preživetja brez napredovanja bolezni pri bolnikih z lokalno napredovalim rakom prostate, ki so prejemali zdravilo Casodex (bikalutamid), glede na tiste, ki so prejemali placebo (58 % napram 69 % bolnikov z napredovanjem bolezni in ki niso prejemali adjuvantne kirurgije ali radioterapije).
As regards the multiplicity issue raised, it is considered appropriate to look at subgroups from a statistical viewpoint, as they have helped to narrow the indication to patients with a more favourable benefit/risk balance for bicalutamide 150 mg.
Kar se tiče vprašanja multiplikativnosti, se zdi primerno pregledati podskupine iz statističnega stališča, saj so pri bikalutamidu 150 mg pomagale zožiti indikacijo na bolnike z bolj ugodnim razmerjem med koristmi in tveganji.
CASODEX (Bicalutamide) 150 mg was studied as a treatment for patients with localised (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer in a combined analysis of 3 placebo controlled double-blind studies in 8113 patients, where CASODEX was given as immediate hormonal therapy or as adjuvant to radical prostatectomy or radiotherapy, (primarily external beam radiation).
CASODEX (bikalutamid) 150 mg je bil preučevan kot terapija za bolnike z lokaliziranim (T1-T2, N0 ali NX, M0) ali lokalno napredovalim (T3-T4, katerikoli N, M0; T1-T2, N+, M0) nemetastatskim rakom prostate v kombinirani analizi treh s placebom kontroliranih, dvojno slepih študij pri 8113 bolnikih.
How does the company justify the indication of bicalutamide 150 mg for locally advanced prostate cancer knowing the absence of statistically significant overall survival and the important side effects?
Kako družba utemeljuje indikacijo bikalutamida 150 mg za lokalno napredovali rak prostate, če ve, da so statistično značilno celotno preživetje in pomembni neželeni učinki odsotni?
AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTION OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR BICALUTAMIDE 150MG CONTAINING MEDICINAL PRODUCTS
SPREMEMBE, KI BODO VKLJUČENE V USTREZEN ODSTAVEK POVZETKOV GLAVNIH ZNAČILNOSTI ZDRAVIL, KI VSEBUJEJO BIKALUTAMID 150 MG
With reference to the adequacy of treatment in the placebo group in the EPC studies, given that at the time of initiation of these studies there was no widely agreed standard of care in locally advanced prostate cancer (something which remains the case), the empirical design of the studies, which compared Casodex (bicalutamide) 150mg or placebo when given as an adjunct to “standard care” is considered reasonable.
Z ozirom na primernost zdravljenja v placebo skupini v študijah EPC in glede na dejstvo, da v času uvajanja teh študij ni bilo široko sprejetega standarda nege lokalno napredovalega raka prostate (to še vedno velja), velja empirična zasnova študij, v katerih so primerjali dajanje zdravila Casodex (bikalutamid) 150 mg ali placeba kot dodatek „standardni negi“, za sprejemljivo.
Its authorised indications include the treatment of patients with locally advanced prostate cancer, as an immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Odobrene indikacije vključujejo takojšnje zdravljenje bolnikov z lokalno napredovalim rakom prostate, bodisi samostojno bodisi kot adjuvans k zdravljenju z radikalno prostatektomijo ali radioterapijo.
The 4 issues raised in the referral concern the analyses of the Early Prostate Cancer Programme (EPC): - the lack of an overall survival benefit versus adverse events in ‘locally advanced prostate cancer'; - statistical concerns regarding multiplicity; - the standard of care for the placebo group in the relevant studies; - the number of deaths due to cardiac failure.
Štiri sporna vprašanja v napotitvenem postopku so bila: - pomanjkanje koristnega učinka za celotno preživetje napram neželenim učinkom pri „lokalno napredovalemu raku prostate“; - statistični zadržki glede multiplikativnosti; - standard oskrbe za skupino, ki je prejemala placebo, v zadevnih študijah; - število smrti zaradi odpovedi srca.
At that time, the RMS concluded that Casodex (bicalutamide) 150 mg should not be used in the treatment of ‘localised' prostate cancer, however, it was concluded that the benefit/risk balance remained positive for selected patients in ‘locally advanced' prostate cancer, as immediate therapy either alone or as adjuvant to treatment by radical prostatectomy or radiotherapy.
Takrat je referenčna država članica zaključila, da zdravila Casodex (bikalutamid) 150 mg ne bi smeli uporabljati za zdravljenje „lokaliziranega“ raka prostate, vendar pa je zaključila tudi, da je razmerje med koristmi in tveganji ostalo pozitivno za izbrane bolnike z „lokalno napredovalim“ rakom prostate in pri uporabi za takojšnje zdravljenje bodisi samostojno ali kot adjuvans k zdravljenju z radikalno prostatektomijo ali radioterapijo.
The aim of the study should be to estimate the incidence of heart failure, cardiovascular morbidity and mortality in patients with prostate cancer, compared to the general population.
Cilj te študije bi moral biti ocenjevanje pojavnosti odpovedi srca, kardiovaskularne obolevnosti in smrtnosti pri bolnikih z rakom prostate v primerjavi s splošno populacijo.
The aim of the study is to estimate the incidence of heart failure, cardiovascular morbidity and mortality in patients with prostate cancer, compared to the general population.
Cilj te študije je oceniti pojavnost odpovedi srca, kardiovaskularne obolevnosti in smrtnosti pri bolnikih z rakom prostate v primerjavi s splošno populacijo.
4.1 Therapeutic indications [Invented name] 150mg is indicated either alone or as adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk for disease progression (see section 5.1).
[Izmišljeno ime zdravila] 150 mg je indiciran bodisi kot monoterapija ali kot adjuvantna terapija poleg radikalne prostatektomije ali radioterapije pri bolnikih z lokalno napredovalim rakom prostate z visokim tveganjem za napredovanje bolezni (glejte poglavje 5.1).
The results should be reported to the RMS and the NCAs where bicalutamide 150 mg is authorised.
O rezultatih mora poročati RMS in nacionalnim pristojnim organom, kjer je bikalutamid 150 mg odobren.
How can the company rule out any role of bicalutamide 150 mg in the increased mortality due to heart failure in the Casodex arm of the EPC trial?
Kako lahko družba izključi kakršnokoli vlogo bikalutamida 150 mg v povišani smrtnosti zaradi odpovedi srca v skupini, ki je v preizkušanju za zgodnji rak prostate prejemala zdravilo Casodex?
The SPC has been amended accordingly and notes in section 5.1 that, for patients with locally advanced disease “A reduction in risk of objective disease progression… was most evident in those at highest risk of disease progression.
Povzetek glavnih značilnosti zdravila je bil ustrezno dopolnjen, tako da poglavje 5.1 vsebuje opombo, da je bilo pri bolnikih z lokalno napredovalo boleznijo „znižanje tveganja objektivnega napredovanja bolezni... najbolj očitno pri tistih, katerih tveganje za napredovanje bolezni je bilo največje.
In view of this, the benefit-risk profile for the use of CASODEX is not considered favourable in this group of patients.
Razmerje med koristjo in tveganjem uporabe zdravila CASODEX v tej skupini zato velja za neugodno.
0.56 (0.40 to 0.78)
0,56 (0,40 do 0,78)
Locally advanced prostate cancer refers to larger tumours or tumours with spread to lymph nodes, but not involving spread to other organs.
Izraz lokalno napredovali rak prostate se nanaša na velike tumorje, ki so se razširili na bezgavke, ne pa tudi na druge organe.
Further, the study should include prostate cancer subgroups to include those on bicalutamide, and those treated with LHRH analogues, orchidectomy, and other hormonal therapies.
Poleg tega bi morala študija vključevati podskupine bolnikov z rakom prostate, vključno s tistimi, ki prejemajo bikalutamid, in tistimi, ki se zdravijo z LHRH analogi, so prestali orhidektomijo in druge hormonske načine zdravljenja.
However, the EPC study was positive for the primary progression free survival (PFS) endpoint, both overall and in the locally advanced subgroups.
Kljub temu pa je bila študija pozitivno ovrednotena na primarni točki preživetja brez napredovanja bolezni, tako v celoti kot tudi pri podskupinah z lokalnim napredovanjem bolezni.
BG - Bulgaria AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire, LU1 3LU, UK
BG - Bolgarija AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire, LU1 3LU, UK
Further, the study will include prostate cancer subgroups to include those on Casodex (bicalutamide), and those treated with luteinizing hormone-releasing hormone (LHRH) analogues, orchidectomy, and other hormonal therapies.
Poleg tega bo študija vključevala podskupine bolnikov z rakom prostate, vključno s tistimi, ki prejemajo zdravilo Casodex (bikalutamid), in tistimi, ki se zdravijo z analogi LHRH, orhidektomijo in drugimi hormonskimi načini zdravljenja.
The lack of broad consensus in the standard of care for early prostate cancer makes it difficult to study.
Ker širše soglasje glede standardne nege zgodnjega raka prostate ne obstaja, je taka študija zelo otežena.
B-1180 Brussel
B-1180
PT - Portugal Generis Farmacêutica, S.A. Office Park da Beloura - Edifício 4
PT - Portugalska Generis Farmacêutica, S.A. Office Park da Beloura - Edifício 4 Quinta da Beloura 2710-444 Sintra
Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.
Zato se lahko zdravniki odločijo, da je optimalna medicinska strategija pri bolniku z majhnim tveganjem za napredovanje bolezni (zlasti v adjuvantnih okoliščinah po radikalni prostatektomiji) odložitev hormonskega zdravljenja, dokler se ne pojavijo znaki napredovanja bolezni.
- The CHMP concluded that the benefit/risk balance of bicalutamide 150 mg containing medicinal products in the agreed restricted indication is favourable.
- CHMP je zaključil, da je pri zdravilih, ki vsebujejo biklautamid 150 mg, in ob dogovorjeni omejeni indikaciji razmerje med koristmi in tveganji ugodno.
Reports concerning pregnancy in partners of patients taking bicalutamide
odpoved srca odpoved jeter intersticijsko bolezen pljuč raka na prsih poročila o nosečnosti partneric bolnikov, ki jemljejo bikalutamid
EL - Greece Genepharm SA 18th klm Marathon Ave 153 44 Pallini Attiki
18th klm Marathon Ave 44 Pallini Attiki
Deaths (%) in placebo patients
Smrti (%) pri bolnikih na placebu
It is acknowledged that overall there is no statistically significant survival benefit in locally advanced prostate cancer.
Znano je, da pri lokalno napredovalem raku prostate niso opazili statistično značilnega koristnega učinka na preživetje.
Progression-free survival in locally advanced disease by therapy sub-group
Preživetje brez napredovanja pri lokalno napredovali bolezni po terapevtskih podskupinah
A new pharmacoepidemiological study will be undertaken as part of an agreed Risk Management Plan (RMP), a post-opinion commitment to get a better understanding of cardiovascular risk.
Za boljše razumevanje kardiovaskularnih tveganj se bo kot del dogovorjenega načrta za obvladovanje tveganja začela izvajati farmakoepidemiološka študija za boljše razumevanje kardiovaskularnega tveganja, kot se je po pridobljenem mnenju odbora zavezal imetnik.
PT - Portugal Farma-APS, Produtos Farmacêuticos, S.A.
PT - Portugalska Farma-APS, Produtos Farmacêuticos, S.A. Rua João de Deus, 19
It is difficult to obtain overall survival data in patients with early prostate cancer due to its insidious course.
Zaradi zahrbtnosti bolezni je podatke o celotnem preživetju bolnikov z zgodnjim rakom prostate težko dobiti.
27472 Cuxhaven, Germany
Heinz-Lohmann-Strasse 5 27472 Cuxhaven, Germany tableta
Events (%) in placebo patients
Dogodki (%) pri bolnikih na placebu
HU - Hungary AstraZeneca KFt. Park u. 3
HU - Madžarska AstraZeneca KFt.
Albert-Schweitzer Gasse 3
Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer Gasse 3
Events (%) in Casodex patients
Dogodki (%) pri bolnikih, ki so prejemali zdravilo Casodex
SL - Slovenia AstraZeneca UK Limited
SL - Slovenija AstraZeneca UK Limited filmsko obložena
Member State Marketing Authorisation Holder
Država članica Imetnik dovoljenja za promet z zdravilom Izmišljeno ime
Section 5.1 of the SPC was amended to note that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, might be to defer hormonal therapy until signs that the disease is progressing.
Poglavje 5.1 Povzetka glavnih značilnosti zdravila je bilo dopolnjeno z opozorilom, da je odložitev hormonskega zdravljenja do pojava znakov, ki nakazujejo na napredovanje bolezni, najboljša strategija zdravljenja bolnikov z majhnim tveganjem za napredovanje bolezni, še posebej če se ga namerava uporabiti kot adjuvans po radikalni prostatektomiji.
RO-Romania AstraZeneca UK Ltd, 600 Capability Green Luton, Bedfordshire,
RO - Romunija AstraZeneca UK Ltd 600 Capability Green Luton, Bedfordshire LU1 3LU, United Kingdom
SK - Slovakia AstraZeneca UK Limited Silk Road Business Park Macclesfield
SK - Slovaška AstraZeneca UK Limited Silk Road Business Park Macclesfield
GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS Whereas
RAZLOGI ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA
NV AstraZeneca SA 110 rue E. Van Ophem B-1180 Bruxelles Belgium
LU - Luksemburg NV AstraZeneca SA rue E. Van Ophem
LV - Latvia AstraZeneca UK Limited Silk Road Business Park Macclesfield
AstraZeneca UK Limited Silk Road Business Park Macclesfield
Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing.” Section 5.1 of the SPC also includes a summary of the efficacy results from the EPC study.
Zato se klinični zdravniki lahko odločijo, da je odložitev hormonskega zdravljenja do pojava znakov, ki nakazujejo na napredovanje bolezni, najboljša strategija zdravljenja za bolnike z majhnim tveganjem za napredovanje bolezni, še posebej če se načrtuje uporaba kot adjuvans po radikalni prostatektomiji“.
Overall survival in locally advanced disease by therapy sub-group Analysis population Deaths (%) in CASODEX patients
Analizirana populacija Smrti (%) pri bolnikih na zdravilu CASODEX
Progression-free survival in locally advanced disease by therapy sub-group Analysis population Events (%) in CASODEX patients
Preživetje brez napredovanja bolezni pri lokalno napredovalem raku po zdravljenih podskupinah
112 (4 x 28) tablets (multipack)
112 (4 x 28) tablet (večkratno pakiranje)
MA (EU) number (Invented) name
Številka dovoljenja za promet (EU)
Immediate Packaging Pack size
Pot uporabe Primarna ovojnina Pakiranje
Route of Administration
Lastniško ime Jakost
0.6 ml (10 mg/ml) 1 pre-filled syringe + on body injector (Onpro kit)
1 napolnjena injekcijska brizga + injektor, ki se pritrdi na telo (komplet Onpro)
Solution for injection Subcutaneous use pre-filled syringe (glass) without blister
Za subkutano uporabo napolnjena injekcijska brizga (steklena) brez pretisnega omota
Solution for injection Subcutaneous use Pre-filled syringe (glass) with on body-injector (Onpro kit)
Za subkutano uporabo napolnjena injekcijska brizga (steklena) z injektorjem, ki se pritrdi na telo (komplet Onpro)
Solution for injection Subcutaneous use pre-filled syringe (glass) with needle guard
Za subkutano uporabo napolnjena injekcijska brizga (steklena) s ščitnikom igle
Solution for injection Subcutaneous use pre-filled syringe (glass)
Za subkutano uporabo napolnjena injekcijska brizga (steklena)
Blister (PVC/alu foil)
Pretisni omot (PVC/alufolija)
MA (EU) number
Številka postopka EMA Številka (EU) dovoljenja za promet
Bottle (HDPE)
Steklenica (polietilenska)
60 tablets
300 mg Filmsko obložene tablete
20mg/mL Oral solution Oral use
60 tablet mg/ml
1 bottle + 1 dosing syringe + 1 adapter
Steklenica, plastični nastavek za steklenico, peroralna odmerna brizga
Film-coated tablet
Peroralna raztopina
This will make it easier for you to do more activities.
Zaradi tega boste lažje opravili več aktivnosti.
10 August 2006
10 Avgust 2006.
For your own safety, it is very important that you have regular blood tests.
Zaradi vaše lastne varnosti je zelo pomembno, da redno opravljate krvne preiskave.
These may be signs that your liver is not working properly.
To so lahko znaki, da vaša jetra ne delujejo pravilno.
24 months
24 mesecev.
• If you are a child or adolescent under 18 years old.
• Če ste otrok ali mladostnik, mlajši od 18 let.
The terminal elimination half-life (t½) is 10 hours.
Končni razpolovni čas izločanja (t½) je 10 ur.
It is important to have these tests every month during treatment, even if you do not have any symptoms at all.
Pomembno je, da se te preiskave opravijo vsak mesec zdravljenja, čeprav nimate nobenih simptomov.
Swallow the tablet whole with water.
Pogoltnite celo tableto skupaj z vodo.
Therefore an interaction with such a drug cannot be excluded.
Zato interakcije s takšnim zdravilom ne moremo izključiti.
Use in children and adolescents (< 18 years).
Otroci in mladostniki (< 18 let):
Your doctor will advise you about suitable contraception.
Vaš zdravnik vam bo svetoval o najbolj primerni metodi kontracepcije.
Patients in need of the combination should be closely monitored.
Bolnike, ki potrebujejo takšno kombinacijo, je treba natančno nadzirati.
• If you have or have had a serious liver problem;
• Če imate ali ste imeli resne težave z jetri.
The absolute bioavailability of Thelin is between 70 and 100%.
Absolutna biološka uporabnost zdravila Thelin je med 70 in 100 %.
Thelin is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Zdravilo Thelin ni priporočljivo za otroke in mladostnike, mlajše od 18 let, zaradi pomanjkanja podatkov o varnosti in učinkovitosti.
If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Če zdravnika ne morete obvestiti takoj, pojdite v najbližjo bolnišnico in vzemite škatlo s seboj.
Functional Class
Funkcionalni razred
If necessary, pregnancy testing should be undertaken.
Če je potrebno, naj se izvede test nosečnosti.
Do not take Thelin if you are taking Ciclosporin A.
Ne jemljite zdravila Thelin, če jemljete ciklosporin A.
Re-introduction of treatment:
Ponovna uvedba zdravljenja:
The reduction in mean pulmonary artery pressure of 3 mmHg (6%) was not statistically significant.
Znižanje povprečnega tlaka pljučne arterije za 3 mmHg (6 %) ni bilo statistično pomembno.
Frequencies are reported as very common ( 1/10), common (> 1/100, < 1/10), uncommon (> 1/1,000,  1/100), rare (> 1/10,000,  1/1,000), and very rare ( 1/10,000).
Pogostnosti neželenih učinkov so navedene kot zelo pogosti (1/10), pogosti (>1/100, <1/10), občasni (>1/1000, 1/100), redki (>1/10000, 1/1000) in zelo redki (1/10000).
Steady state in volunteers is reached within about 6 days.
Pri prostovoljcih je bilo stanje dinamičnega ravnovesja doseženo v približno 6 dneh.
Refer to section 4.3.
Glejte poglavje 4.3.
• yellow colouring of the skin and eyes (jaundice) Talk to your doctor immediately.
• rumeno obarvanje kože in oči (zlatenica), nemudoma obvestite svojega zdravnika.
• pain in the stomach (abdominal pain)
• bolečine v trebuhu (abdominalne bolečine),
The advice of a hepatologist is recommended.
Priporočljivo je mnenje hepatologa.
It does not matter whether you take it with or without food.
Ni pomembno, ali tableto vzamete s hrano ali brez.
To be written in braille at time of manufacture.
Se izpiše v Braillovi pisavi ob izdelavi.
• If you are taking a high dose of nifedipine.
• Če jemljete visoke odmerke nifedipina.
During clinical trials, these changes were usually reversible when monitoring and discontinuation guidelines were followed.
V kliničnih preskušanjih so bile te spremembe ponavadi reverzibilne ob upoštevanju smernic za spremljanje in prekinitev zdravljenja.