FrancophonIA/ELRC3.0 huggingface dataset:
English: If your capsules are out of date, take them to your pharmacist who will get rid of them safely.
Slovenian: Če je rok uporabnosti vaših kapsul že potekel, jih vrnite svojemu farmacevtu, ki bo poskrbel za njihovo varno uničenje.
English: Women who take celecoxib should not breastfeed.
Slovenian: Ženske, ki jemljejo celekoksib, ne smejo dojiti.
English: As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report
Slovenian: V skladu s smernicami CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen RMP predložen hkrati z naslednjim rednim posodobljenim poročilom
English: Caution should be used as there is no experience in such patients at doses higher than 200 mg.
Slovenian: Potrebna je previdnost, kajti pri takšnih bolnikih ni izkušenj z odmerki, večjimi od 200 mg.
English: Thirteen patients had the attenuated FAP phenotype.
Slovenian: Trinajst bolnikov je imelo atenuiran fenotip FAP.
English: The inter-subject variability in the exposure of celecoxib is about 10-fold.
Slovenian: Interindividualna variabilnost izpostavljenosti celekoksibu je približno 10-kratna.
English: The MAH will submit a progress report for the CHIP trial, including an update on safety data, in the 8th annual reassessment and will submit a full study report for the completed study when available.
Slovenian: Imetnik dovoljenja za promet bo predložil poročilo o napredku preskušanja- CHIP, vključno s posodobljenimi podatki o varnosti v 8. vsakoletni ponovni oceni, ter celotno poročilo o zaključeni študiji, ko bo le-to na voljo.
English: Effects of celecoxib on other medicinal products
Slovenian: Vplivi celekoksiba na druga zdravila
English: The clinical significance of this in vitro finding is unknown.
Slovenian: Klinični pomen tega izsledka in vitro ni znan.
English: What Onsenal is and what it is used for
Slovenian: KAJ JE ZDRAVILO ONSENAL IN ZA KAJ GA UPORABLJAMO
English: If you take more ONSENAL than you should If you accidentally take too many capsules, tell your doctor or pharmacist as soon as possible.
Slovenian: Če ste vzeli večji odmerek zdravila Onsenal, kot bi smeli Če pomotoma vzamete preveč kapsul, čim prej obvestite svojega zdravnika ali farmacevta.
English: The PreSAP trial did not demonstrate a statistically significant increased risk for the same composite endpoint.
Slovenian: Preskušanje PreSAP ni pokazalo statistično pomembno večjega tveganja za isti sestavljeni opazovani dogodek.
English: NSAIDs may reduce the effect of diuretics and antihypertensive medicinal products.
Slovenian: NSAID-i lahko zmanjšajo učinek diuretikov in antihipertenzivov.
English: The usual dose is 400 mg twice a day.
Slovenian: Običajni odmerek je 400 mg dvakrat na dan.
English: It is estimated that the frequency of the homozygous *3/*3 genotype is 0.3-1.0% among different ethnic groups.
Slovenian: Ocenjena pogostnost homozigotnosti genotipa *3/*3 je v različnih etničnih skupinah od 0,3 do 1,0 %.
English: Steady state plasma concentrations are reached within 5 days of treatment.
Slovenian: Stanje dinamičnega ravnovesja koncentracije v plazmi je doseženo po 5 dneh zdravljenja.
English: Patients appear to be at highest risk for these reactions early in the course of therapy; the onset of the reaction occurring in the majority of cases within the first month of treatment.
Slovenian: Kaže, da je tveganje za te reakcije največje kmalu po začetku zdravljenja; v večini primerov so reakcije nastopile v prvem mesecu zdravljenja.
English: The progress report will include full documentation of efforts to achieve the target for yearly recruitment: an increased number of 30 patients/year is expected.
Slovenian: Poročilo o napredku bo vključevalo popopolno dokumentacijo o prizadevanjih za dosego ciljnega letnega vključevanja novih bolnikov; pričakovano je povečano
English: Caution is also required in patients taking diuretic treatment or otherwise at risk of hypovolaemia.
Slovenian: Previdnost je potrebna tudi pri bolnikih, ki prejemajo diuretike ali jih kako drugače ogroža hipovolemija.
English: If during treatment, patients deteriorate in any of the organ system functions described above, appropriate measures should be taken and discontinuation of celecoxib therapy should be considered.
Slovenian: Če se med zdravljenjem poslabša delovanje kateregakoli organskega sistema, opisanega zgoraj, je treba uvesti ustrezne ukrepe in razmisliti o ukinitvi zdravljenja s celekoksibom.
English: Cyclooxygenase is responsible for generation of prostaglandins.
Slovenian: Ciklooksigenaza je odgovorna za nastajanje prostaglandinov.
English: A.
Slovenian: B.
English: Onsenal is packed in blisters and supplied in boxes of 10 or 60 capsules.
Slovenian: Zdravilo Onsenal je pakirano v pretisnih omotih in je na voljo v škatlicah po 10 in 60 kapsul.
English: In particular, the frequency of routine endoscopic surveillance should not be decreased and FAP-related
Slovenian: Še zlasti se ne sme zmanjšati pogostnosti rutinskih endoskopskih kontrol ali odložiti operacij, ki so povezane s FAP.
English: • Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease
Slovenian: • Potrjena ishemična bolezen srca, bolezen perifernih arterij in/ali cerebrovaskularna bolezen
English: A randomized double-blind placebo controlled study was conducted in 83 patients with FAP.
Slovenian: Randomizirano, dvojno slepo s placebom nadzorovano študijo so opravili pri 83 bolnikih s FAP.
English: Dosing with food (high fat meal) delays absorption by about 1 hour with an increase in total
Slovenian: Zaužitje s hrano (zelo masten obrok) upočasni absorpcijo za približno 1 uro, celotna absorpcija (AUC)
English: Do not take the capsule after the ‘expiry date' shown on the blister and carton.
Slovenian: Kapsul ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in škatlici.
English: In addition, an updated RMP should be submitted:
Slovenian: Poleg tega je treba posodobljen načrt za obvladovanje tveganja predložiti:
English: Administration of celecoxib to a limited number of lactating women has shown a very low transfer of celecoxib into breast milk.
Slovenian: Uporaba celekoksiba pri majhnem številu doječih žensk je pokazala zelo majhno prehajanje celekoksiba v materino mleko.
English: • Patients with renal insufficiency with estimated creatinine clearance <30 ml/ min.
Slovenian: • Bolniki z ledvično insuficienco z ocenjenim očistkom kreatinina < 30 ml/min.
English: • In pregnancy and in women who can become pregnant unless using an effective method of contraception (see sections 4.5, 4.6 and 5.3)
Slovenian: • V nosečnosti in pri ženskah, ki lahko zanosijo, če ne uporabljajo učinkovite kontracepcijske zaščite (glejte poglavja 4.5, 4.6 in 5.3)
English: Celecoxib has been shown to reduce the number and size of adenomatous colorectal polyps.
Slovenian: Ugotovljeno je, da celekoksib zmanjša število in velikost adenomatoznih kolorektalnih polipov.
English: worsening of inflammation of the stomach or intestine.
Slovenian: poslabšanje vnetja želodca ali črevesa.
English: Celecoxib is well absorbed reaching peak plasma concentrations after approximately 2-3 hours.
Slovenian: Celekoksib se dobro absorbira in doseže največjo koncentracijo v plazmi po približno 2-3 urah.
English: The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/risk profile.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednji program študij, katerih rezultati služijo kot osnova za vsakoletno ponovno oceno razmerja med koristmi in tveganji.
English: • Breast feeding (see sections 4.6 and 5.3)
Slovenian: • Dojenje (glejte poglavji 4.6 in 5.3).
English: − If you have heart problems such as pain in the chest
Slovenian: - če imate težave s srcem, npr. bolečine v prsih
English: Therefore, antiplatelet therapies should not be discontinued (see section 5.1).
Slovenian: Zato antiagregacijske terapije ne smemo ukiniti (glejte poglavje 5.1).
English: Cyclo-oxygenase-2 is an enzyme that increases at inflammatory sites and in abnormally growing cells.
Slovenian: Ciklooksigenaza-2 je encim, katerega raven se zveča na mestih vnetja in v nenormalno rastočih celicah.
English: For any information about this medicine, please contact the local representative of the Marketing
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika
English: The metabolic capacity in patients with mild to moderate impairment was best correlated to their albumin values.
Slovenian: Presnovna zmogljivost bolnikov z blago do zmerno okvaro je najbolje korelirala z vrednostjo albumina.
English: • Hypersensitivity to the active substance or to any of the excipients (see section 6.1).
Slovenian: • Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavje 6.1).
English: Therefore, the combination should be administered with caution, especially in the elderly.
Slovenian: Zato je treba takšno kombinacijo posebno še pri starejših osebah aplicirati zelo previdno.
English: The maximum recommended daily dose is 800 mg.
Slovenian: Največji priporočeni dnevni odmerek je 800 mg.
English: Onsenal works by inhibiting COX-2, to which such dividing cells are sensitive.
Slovenian: Zdravilo Onsenal deluje tako, da zavre COX-2, na katerega so takšne deleče se celice občutljive.
English: Make sure that your doctor knows before you start taking Onsenal: - if you have conditions which increase your risk of heart disease such as high blood pressure,
Slovenian: Preden začnete jemati Onsenal, poskrbite, da bo zdravnik vedel: - če imate bolezni, ki povečujejo tveganje za bolezen srca, kot naprimer visok krvni tlak,
English: - if you have had a serious allergic reaction or a serious skin reaction to any medicines
Slovenian: - če ste imeli resno alergijsko reakcijo ali resno kožno reakcijo na katerokoli zdravilo
English: Two isoforms, COX-1 and COX-2, have been identified.
Slovenian: Ugotovljeni sta dve izoobliki, COX-1 in COX-2.
English: What ONSENAL looks like and contents of the pack
Slovenian: Izgled zdravila Onsenal in vsebina pakiranja
English: The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 2.0, predstavljeni v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v
English: As a result, the frequencies of these adverse drug reactions cannot be reliably determined.
Slovenian: Zaradi tega pogostnosti teh neželenih učinkov ni mogoče zanesljivo ugotoviti.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the version dated 28 February 2005 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance, ki je bil sprejet v različici z dne, 28. februarja 2005 načrta za obvladovanje tveganja (RMP), predstavljenem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
English: Plasma protein binding is about 97% at therapeutic plasma concentrations and celecoxib is not preferentially bound to erythrocytes.
Slovenian: Pri terapevtskih plazemskih koncentracijah je vezava na beljakovine v plazmi približno 97-odstotna; celekoksib se ne veže prednostno na eritrocite.
English: Celecoxib was excreted in rat milk.
Slovenian: Celekoksib se je izločal v mleko podgan.
English: Like all medicines, ONSENAL can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Onsenal neželene učinke, ki pa se ne pojavijo pri vseh
English: Celecoxib is a weak inhibitor of CYP2D6.
Slovenian: Celekoksib je šibek zaviralec CYP2D6.
English: Celecoxib is excreted in the milk of lactating rats at concentrations similar to those in plasma.
Slovenian: Celekoksib se izloča v mleku doječih podgan v koncentraciji, ki je podobna koncentraciji v plazmi.
English: In animals, exposure to celecoxib during early embryonic development resulted in pre-implantation and post-implantation losses.
Slovenian: Pri živalih je izpostavljenost celekoksibu med zgodnjim embrionalnim razvojem povzročila izgube zarodkov pred ugnezdenjem in po njem.
English: The main metabolites found in the circulation have no detectable COX-1 or COX-2 activity.
Slovenian: Glavni presnovki v obtoku nimajo ugotovljive aktivnosti na COX-1 ali COX-2.
English: COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function).
Slovenian: COX-2 je vpletena tudi v ovulacijo, ugnezdenje zarodka in zaprtje arterioznega duktusa, uravnavanje delovanja ledvic in funkcije centralnega živčnega sistema (indukcija zvišane telesne temperature, zaznavanje bolečine in kognitive funkcije).
English: Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with celecoxib after careful consideration (see section 5.1).
Slovenian: Bolnike s pomembnimi dejavniki tveganja za srčnožilne dogodke (npr. hipertenzija, hiperlipidemija, diabetes mellitus, kajenje) lahko s celekoksibom zdravimo le po skrbnem premisleku (glejte poglavje
English: Celecoxib is a diaryl-substituted pyrazole, chemically similar to other non-arylamine sulfonamides (e.g. thiazides, furosemide) but differing from arylamine sulfonamides (e.g. sulfamethoxizole and
Slovenian: Celekoksib je diaril-substituiran pirazol, kemično podoben drugim nearilaminskim sulfonamidom (npr. tiazidom, furosemidu), a drugačen od arilaminskih sulfonamidov (npr. sulfametoksazola in
English: Diaphragmatic hernia was also seen in a peri-post natal toxicity study in rats, which included exposure during the organogenetic period.
Slovenian: Diafragmalno hernijo so ugotovili tudi v peri-/postnatalni študiji toksičnih učinkov na podganah, v kateri so bile živali izpostavljene zdravilu tudi med obdobjem organogeneze.
English: In the event of elderly patients with mild to moderate cardiac dysfunction requiring therapy, special care and follow up is warranted.
Slovenian: Pri starejših bolnikih z blago do zmerno disfunkcijo srca, ki zahteva zdravljenje, sta potrebna posebna skrb in spremljanje.
English: In the event of suspected overdose, appropriate supportive medical care should be provided e.g. by eliminating the gastric contents, clinical supervision and, if necessary, the institution of symptomatic treatment.
Slovenian: Če obstaja sum na preveliko odmerjanje, je treba zagotoviti ustrezno podporno medicinsko oskrbo, npr. izpiranje želodca, kliničen nadzor in, če je treba, simptomatsko zdravljenje.
English: The greatest reduction was observed in patients treated with celecoxib 16 mg/kg/day, which corresponds to the recommended adult FAP dose of 800 mg daily.
Slovenian: Največje zmanjšanje so zabeležili pri bolnikih, ki so dobivali celekoksib v odmerku 16 mg/kg/dan, kar ustreza priporočenemu odmerku za odrasle s FAP, ki je 800 mg na dan.
English: Celecoxib is contraindicated in pregnancy and in women who can become pregnant unless using an effective method of contraception (see section 4.3).
Slovenian: Celekoksib je kontraindiciran med nosečnostjo in pri ženskah, ki bi lahko zanosile, če ne bi uporabljale učinkovite kontracepcijske zaščite (glejte poglavje 4.3).
English: Cardiovascular Safety - Long-Term Studies Involving Subjects With Sporadic Adenomatous Polyps: Two studies involving subjects with sporadic adenomatous polyps were conducted with celecoxib i.e., the APC trial (Adenoma Prevention with Celecoxib) and the PreSAP trial (Prevention of Spontaneous Adenomatous Polyps).
Slovenian: Srčnožilna varnost - dolgoročne študije preiskovancev s sporadičnimi adenomatoznimi polipi: S celekoksibom sta bili izvedeni dve študiji preiskovancev s sporadičnimi adenomatoznimi polipi: preskušanje APC (Adenoma Prevention with Celecoxib) in preskušanje PreSAP (Prevention of Spontaneous Adenomatous Polyps).
English: Studies in animals (rats and rabbits) have shown reproductive toxicity (see sections 4.3 and 5.3).
Slovenian: Študije na živalih (podganah in kuncih) so pokazale učinke na sposobnost razmnoževanja (glejte poglavji 4.3 in 5.3).
English: There is no clinical experience of overdose in clinical trials.
Slovenian: Kliničnih izkušenj s prevelikim odmerjanjem iz kliničnih preskušanj ni.
English: In clinical studies where Onsenal was taken for up to 3 years to prevent spontaneous colon polyps, the following additional side effects have been observed (side effects marked with an asterisk were more common in these studies than in arthritis studies):
Slovenian: V kliničnih študijah, v katerih so bolniki do 3 leta dobivali zdravilo Onsenal za preprečevanje spontanih polipov na debelem črevesu, so zabeležili naslednje dodatne neželene učinke (z zvezdico označeni neželeni učinki so bili v teh študijah pogostejši kot v študijah pri artritisu):
English: The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions.
Slovenian: Razlika v antitrombocitni aktivnosti med nekaterimi NSAID, ki zavirajo COX-1, in selektivnimi zaviralci COX-2 bi lahko bila klinično pomembna pri bolnikih, ki jih ogrožajo trombembolične reakcije.
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMA) http://www.ema.europa.eu/, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: diabetes, high cholesterol or if you smoke you should discuss with your doctor whether Onsenal is suitable for you
Slovenian: sladkorno bolezen, visok holesterol, ali če kadite, se morate z zdravnikom posvetovati, ali je
English: Familial Adenomatous Polyposis (FAP) is a genetic disease resulting from an autosomal dominant genetic alteration of a tumor suppressor gene, the adenomatous polyposis coli (APC) gene.
Slovenian: Familiarna adenomatozna polipoza (FAP) je genetska bolezen; njen vzrok je avtosomna dominantna sprememba gena za supresijo tumorjev, t. i. gena adenomatozne polipoze kolona (APK).
English: Onsenal is indicated for the reduction of the number of adenomatous intestinal polyps in familial adenomatous polyposis (FAP), as an adjunct to surgery and further endoscopic surveillance (see
Slovenian: Onsenal je indiciran za zmanjšanje števila adenomatoznih intestinalnih polipov pri familiarni adenomatozni polipozi (FAP) kot dodatek operaciji in nadaljnjemu endoskopskemu nadzoru (glejte
English: Do not store your capsules above 30°C.
Slovenian: Kapsule shranjujte pri temperaturi do 30 °C.
English: As with all NSAIDS, celecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.
Slovenian: Kot vsa nesteroidna protivnetna zdravila lahko tudi celekoksib povzroči pojav hipertenzije ali poslabšanje obstoječe hipertenzije; oboje lahko pripomore k večji incidenci srčnožilnih dogodkov.
English: - if you have had an allergic reaction to any of the ingredients of Onsenal - if you have had an allergic reaction to a group of medicines called “sulphfonamides”.
Slovenian: - če ste kdaj imeli alergijsko reakcijo na katerokoli sestavino zdravila Onsenal - če ste kdaj imeli alergijsko reakcijo na zdravila, ki jih imenujemo "sulfonamidi".
English: Examples of medicinal products which are metabolised by CYP2C19 are diazepam, citalopram and imipramine.
Slovenian: Zgledi zdravil, ki se presnavljajo s CYP2C19, so diazepam, citalopram in imipramin.
English: Stop taking the capsules and tell your doctor immediately… If you have an allergic reaction such as skin rash, swelling of the face, wheezing or difficulty breathing
Slovenian: Nehajte jemati kapsule in zdravniku takoj povejte ... - če dobite alergijsko reakcijo, npr. izpuščaj na koži, oteklost obraza, piskajoče dihanje ali težave
English: The MAH has previously committed to undertake a “Phase III placebo-controlled trial with celecoxib in genotype positive subjects with Familial Adenomatous Polyposis” (CHIP trial, Protocol A3191193) to generate further efficacy and safety data.
Slovenian: Imetnik dovoljenja za promet se je predhodno zavezal, da izvede “S placebom nadzorovano preskušanje III. faze s celekoksibom pri genotipsko pozitivnih preiskovancih s familiarno adenomatozno polipozo” (preskušanje CHIP , protokol A3191193), s katero pridobi dodatne podatke o
English: Therefore, blood pressure should be monitored closely during the initiation of therapy with celecoxib and throughout the course of therapy.
Slovenian: Zato je treba med uvedbo celekoksiba in ves čas zdravljenja natančno kontrolirati krvni tlak.
English: Onsenal can be taken with low dose acetylsalicylic acid (aspirin).
Slovenian: Zdravilo Onsenal lahko jemljete z majhnimi odmerki acetilsalicilne kisline (Aspirina).
English: However, patients who experience dizziness, vertigo or somnolence while taking celecoxib should refrain from driving or operating machinery.
Slovenian: Vendar naj bolniki, ki med jemanjem celekoksiba doživljajo omotico, vrtoglavico ali zaspanost, ne vozijo in ne upravljajo strojev.
English: The adverse reactions observed with celecoxib in these additional studies were consistent with those for osteoarthritis and rheumatoid arthritis patients listed in Table 1.
Slovenian: Neželeni učinki, opaženi s celekoksibom v teh dodatnih študijah, so se skladali s tistimi pri bolnikih z osteoartritisom in revmatoidnim artritisom, naštetimi v preglednici 1.
English: The European Medicines Agency (EMA) will review any new information on the medicine every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila (EMA) bo vsako leto ponovno pregledala vse nove podatke o zdravilu in posodobila navodilo za uporabo, če bo potrebno.
English: As for NSAIDs, the risk of acute renal insufficiency, which is usually reversible, may be increased in some patients with compromised renal function (e.g. dehydrated patients or elderly patients) when ACE inhibitors or angiotensin II receptor antagonists are combined with NSAIDs, including celecoxib.
Slovenian: Za NSAID-e velja, da se tveganje akutne ledvične insuficience, ki je običajno reverzibilna, lahko pri nekaterih bolnikih s prizadeto funkcijo ledvic (npr. dehidrirani ali starejši bolniki) poveča v primeru, da kombiniramo zaviralce ACE ali antagoniste receptorjev angiotenzina II z NSAID-i, vključno s celekoksibom.
English: − Oedema (water retention that can cause swelling) − Enlarged or inflamed prostate, prostate specific antigen increased (lab test)
Slovenian: - edemi (zastajanje vode, ki lahko povzroči otekanje) - povečanje ali vnetje prostate, zvišanje za prostato specifičnega antigena (laboratorijska
English: Onsenal 400 mg capsules contain lactose (99.6 mg).
Slovenian: Kapsule Onsenal 400 mg vsebujejo laktozo (99,6 mg).