FrancophonIA/ELRC3.0 huggingface dataset:
English: Action should be taken to try to minimize all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Slovenian: Sprejeti je treba ukrepe za zmanjšanje vseh dejavnikov tveganja, ki jih je mogoče spremeniti (npr. kajenje, hipertenzija in hiperlipidemija).
English: At high doses (e.g. 40 mg), it reduces the immune response.
Slovenian: Veliki odmerki (npr. 40 mg) zmanjšajo imunski odziv.
English: 30 to 40% are conjugated to glucuronic acid or sulphated in the human liver and excreted in this form in the urine.
Slovenian: Od 30 do 40 % se v človeških jetrih konjugira z glukuronsko kislino ali sulfatira in se v tej obliki izloči z urinom.
English: Your doctor may change the dose and frequency of administration based on certain parameters including your blood analyses, your general condition, other medicines prescribed to you and your response to the treatment.
Slovenian: Zdravnik lahko spremeni odmerek in pogostnost jemanja na podlagi določenih parametrov, kot so krvne analize, vaše splošno stanje, druga zdravila, ki so vam jih predpisali, in vaš odziv na zdravljenje.
English: In extremely rare cases, a tendon may rupture.
Slovenian: V izjemno redkih primerih se lahko kita pretrga.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh poznejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: Do not exceed or take less than the prescribed dose.
Slovenian: Ne vzemite večjega ali manjšega odmerka od predpisanega.
English: You may also feel a ‘withdrawal symptom'.
Slovenian: Poleg tega lahko nastopijo „odtegnitveni simptomi“.
English: You should also tell your doctor if you have recently received a vaccination or are planning to be vaccinated.
Slovenian: Zdravnika prav tako obvestite, če ste bili pred kratkim cepljeni ali če načrtujete cepljenje.
English: No differences were found in dexamethasone pharmacokinetics between subjects of European and Asian (Indonesian and Japanese) descent.
Slovenian: Med farmakokinetiko deksametazona pri osebah evropskega in azijskega (indonezijskega in japonskega) porekla niso zabeležili razlik.
English: Exposed patients should be advised to seek medical attention without delay.
Slovenian: Izpostavljenim bolnikom je treba svetovati, naj takoj poiščejo zdravniško pomoč.
English: Data on female fertility are contradictory.
Slovenian: Podatki o plodnosti pri samicah so si nasprotujoči.
English: You should also tell your doctor if you have had tuberculosis or if you have stayed in regions where roundworm infections are common.
Slovenian: Zdravniku prav tako povejte, če ste imeli tuberkulozo ali če ste bili na območjih, kjer so pogoste okužbe z glistami.
English: Email: ctrs@ctrs.fr
Slovenian: E-mail: ctrs@ctrs.fr
English: − Inability of the heart to pump enough blood round the body (heart failure);
Slovenian: − nezmožnost srca, da bi črpalo dovolj krvi po telesu (srčno popuščanje);
English: − if you are allergic to dexamethasone or one of the other ingredients of this medicine (listed in section 6),
Slovenian: − če ste alergični na deksametazon ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: Due to possible stability issues affecting half tablets stored after division, half-tablets that are not taken immediately should be discarded in agreement with local precautions for environmental protection (see also 6.4).
Slovenian: Zaradi možnih težav s stabilnostjo razpolovljenih tablet, hranjenih po delitvi, je treba polovice tablet, ki jih bolnik ne vzame takoj, zavreči v skladu z lokalnimi previdnostnimi ukrepi za varovanje okolja (glejte tudi poglavje 6.4).
English: • Oral contraceptives, as it cannot be excluded that the efficacy of oral contraceptives may be reduced during treatment.
Slovenian: • peroralni kontraceptivi, saj ni mogoče izključiti možnosti, da bi se med zdravljenjem zmanjšala njihova učinkovitost.
English: − Increased need for diabetes medicine, salt imbalance, potassium loss due to low carbon dioxide levels (a condition called metabolic alkalosis);
Slovenian: − povečana potreba po zdravilih za sladkorno bolezen, neravnovesje soli, izguba kalija zaradi nizkih ravni ogljikovega dioksida (stanje, ki ga imenujemo presnovna alkaloza);
English: No interaction study has been performed with oral contraceptives.
Slovenian: Študij medsebojnega delovanja s peroralnimi kontraceptivi niso izvedli.
English: If you become ill or are involved in an accident, or if you need surgery (even at the dentist) or require a vaccination (particularly “live virus” vaccines) you should inform the doctor treating you that you are taking or have recently taken high-dose corticosteroids.
Slovenian: Če zbolite, če ste bili udeleženi v nesreči ali če potrebujete kirurški poseg (tudi pri zobozdravniku) ali cepljenje (zlasti s cepivi z „živimi virusi“), povejte zdravniku, ki vas zdravi, da jemljete ali da ste pred kratkim jemali velike odmerke kortikosteroidov.
English: • With anti-hypertensive medicinal products, due to a reduction of their effect (water and sodium retention).
Slovenian: • z antihipertenzivnimi zdravili, saj se zmanjša njihov učinek (zastajanje vode in natrija).
English: Throw away half tablets that you have not taken.
Slovenian: Polovice tablet, ki jih ne uporabite, zavrzite.
English: Multiple myeloma is a progressive rare haematologic disease.
Slovenian: Multipli mielom je redka napredujoča hematološka bolezen.
English: Patients should be monitored clinically, including by endoscopy.
Slovenian: Bolnike je treba klinično spremljati, vključno z endoskopijo.
English: Swallow the prescribed dose of one tablet (40 mg) or half a tablet (20 mg) in the morning with a glass of water.
Slovenian: Predpisani odmerek, eno tableto (40 mg) ali polovico tablete (20 mg), pogoltnite zjutraj s kozarcem vode.
English: It the combination is required, monitoring should be reinforced and coagulation parameters controlled after one week and then every other week of treatment as well as after the end of treatment.
Slovenian: Če je ta kombinacija nujna, je treba okrepiti spremljanje bolnika in preveriti koagulacijske parametre po enem tednu in nato vsak drugi teden zdravljenja, prav tako pa tudi po koncu zdravljenja;
English: A dose reduction of lenalidomide or pomalidomide may be required.
Slovenian: Morda bo treba zmanjšati odmerek lenalidomida ali pomalidomida.
English: Neofordex has moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo Neofordex ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: • With live attenuated vaccines, due to risk of vaccine-related illness with risk of death.
Slovenian: • z živimi oslabljenimi cepivi, saj obstaja tveganje za bolezni, povezane s cepivom, ki se lahko končajo s smrtjo.
English: If your dose is half a tablet (20 mg), the tablet should be divided into two equal halves.
Slovenian: Če je vaš odmerek polovica tablete (20 mg), morate tableto razdeliti na dve enaki polovici.
English: The decision to take antithrombotic prophylactic measures should be made after careful assessment of an individual patient's underlying risk factors.
Slovenian: Odločitev o uporabi antitrombotičnih profilaktičnih ukrepov je treba sprejeti po temeljiti oceni obstoječih dejavnikov tveganja pri posameznem bolniku.
English: If you have difficulties taking the tablet out of the blister or breaking the tablet, ask somebody for help.
Slovenian: Če težko vzamete tableto iz pretisnega omota ali razdelite tableto, prosite nekoga, da vam pomaga.
English: At very high doses the majority of dexamethasone circulates unbound in the blood.
Slovenian: Pri zelo velikih odmerkih večina deksametazona prosto kroži po krvnem obtoku.
English: Keep tablets in the blister packaging until you take them.
Slovenian: Tablete hranite v pretisnem omotu, dokler jih ne vzamete.
English: Prophylactic antithrombotic treatment should be recommended, especially in patients with additional thrombotic risk factors.
Slovenian: Priporočiti je treba profilaktično antitrombotično zdravljenje, zlasti pri bolnikih z dodatnimi dejavniki tveganja za trombotične dogodke.
English: Then, keep the spare half tablet in a safe place, out of the sight and reach of children, until you can throw it away properly, as you should not throw away any medicines in wastewater or household waste.
Slovenian: Nato drugo polovico razpolovljene tablete hranite na varnem, zunaj dosega otrok, dokler nimate priložnosti, da jo pravilno zavržete, saj zdravil ne smete odlagati v odpadno vodo ali med gospodinjske odpadke.
English: If you need tests (in particular for infections) you should inform the person performing the tests as dexamethasone may interfere with the results.
Slovenian: Če potrebujete preiskave (zlasti za okužbe), obvestite osebo, ki opravlja preiskave, o jemanju deksametazona, saj ta lahko vpliva na izide preiskav.
English: In elderly and/or frail patients, the daily dose may be reduced to 20 mg of dexamethasone, according to the appropriate treatment regimen.
Slovenian: Pri starejših in/ali slabotnih bolnikih je odmerek včasih treba zmanjšati na 20 mg deksametazona v skladu z ustreznim režimom zdravljenja.
English: Neofordex may cause serious mental health problems.
Slovenian: Zdravilo Neofordex lahko povzroči resne težave z duševnim zdravjem.
English: Pack size of 10 tablets.
Slovenian: Velikost pakiranja: 10 tablet.
English: High-dose corticosteroids, including dexamethasone, can cause psychological problems that may sometimes be serious.
Slovenian: Veliki odmerki kortikosteroidov, vključno z deksametazonom, lahko povzročijo psihične težave, ki so včasih lahko resne.
English: In particular, pneumonia occurs commonly.
Slovenian: Še posebno pogosto se pojavi pljučnica.
English: Patients from endemic areas (tropical and sub-tropical regions, southern Europe) should have a stool examination and if required an eradication of the parasite before initiating dexamethasone treatment.
Slovenian: Pri bolnikih z endemičnih območij (tropskih in subtropskih predelov, južne Evrope) je treba pregledati blato in po potrebi odpraviti parazite, preden se uvede zdravljenje z deksametazonom.
English: Genotoxicity findings have been shown to be artefactual.
Slovenian: Ugotovitve o genotoksičnosti so se izkazale za netočne.
English: Excipient with known effect: Each tablet contains 98.1 mg lactose (as monohydrate).
Slovenian: Pomožne snovi z znanim učinkom: ena tableta vsebuje 98,1 mg laktoze (v obliki monohidrata).
English: Smoking has no influence on dexamethasone pharmacokinetics.
Slovenian: Kajenje ne vpliva na farmakokinetiko deksametazona.
English: This risk is increased by treatment with certain antibiotics and by kidney problems.
Slovenian: To tveganje se poveča pri zdravljenju z nekaterimi antibiotiki in v primeru težav z ledvicami.
English: Bioavailability of dexamethasone is approximately 80%.
Slovenian: Biološka uporabnost deksametazona je približno 80-odstotna.
English: Patients with hepatic impairment or renal insufficiency require appropriate monitoring; patients with hepatic impairment should be dosed with caution as there are no data for this patient population (see sections 4.4 and
Slovenian: Bolnike z okvaro jeter ali ledvično insuficienco je treba ustrezno spremljati; pri bolnikih z okvaro jeter je treba zdravilo odmerjati previdno, saj podatki za to populacijo bolnikov niso na voljo (glejte poglavji 4.4 in
English: In case of neutropenia, the physician should consider the use of growth factors in patient management.
Slovenian: Če se pojavi nevtropenija, mora zdravnik razmisliti o uporabi rastnih dejavnikov pri zdravljenju bolnika.
English: The tablet can be divided into two equal halves.
Slovenian: Tableta se lahko deli na dve enaki polovici.
English: The following combinations require precautions due to changes in dexamethasone pharmacokinetics:
Slovenian: Pri naslednjih kombinacijah so potrebni previdnostni ukrepi zaradi sprememb farmakokinetike deksametazona:
English: Prescribing physicians should carefully evaluate which dose of dexamethasone to use, taking into account the condition and disease status of the patient.
Slovenian: Zdravniki, ki predpisujejo zdravilo, morajo skrbno pretehtati, kakšen odmerek deksametazona naj se uporabi, pri čemer morajo upoštevati stanje bolnika in njegove bolezni.
English: During treatment, patients should be closely monitored for the appearance of infections.
Slovenian: V času zdravljenja je treba bolnike natančno spremljati zaradi morebitnega pojava okužb.
English: If you have had blood clots in the past you should inform your doctor before taking Neofordex.
Slovenian: Če ste v preteklosti imeli krvne strdke, o tem obvestite svojega zdravnika, preden vzamete zdravilo Neofordex.
English: Treatment with a high-dose corticosteroid may reduce your body's ability to fight infection.
Slovenian: Zdravljenje z velikim odmerkom kortikosteroidov lahko zmanjša sposobnost telesa, da se bori proti okužbam.
English: Risks may be higher with high doses (see also section 4.5 for pharmacokinetic interactions that can increase the risk of adverse reactions), although dose levels do not allow prediction of the onset, type severity or duration of reactions.
Slovenian: Tveganje se lahko poveča pri večjih odmerkih (glejte tudi poglavje 4.5 za farmakokinetične interakcije, ki lahko povečajo tveganje za neželene učinke), čeprav na podlagi velikosti odmerkov ni mogoče predvideti nastopa, vrste, stopnje resnosti ali trajanja neželenih učinkov.
English: Halved tablets that are not taken immediately should be disposed of (see section 6.6).
Slovenian: Razpolovljene tablete, ki jih bolnik ne vzame takoj, je treba zavreči (glejte poglavje 6.6).
English: In some cases, the combination of several medicines can increase the side effects of one or the other of these medicines taken separately.
Slovenian: V nekaterih primerih lahko kombinacija več zdravil okrepi neželene učinke, ki se pojavijo pri jemanju samo enega ali drugega zdravila.
English: Laboratoires CTRS 63, rue de l'Est 92100 Boulogne-Billancourt France
Slovenian: Laboratoires CTRS 63, rue de l'Est 92100 Boulogne-Billancourt Francija
English: The administration of such medicinal products and Neofordex should be separated by at least two hours.
Slovenian: Med uporabo teh zdravil in zdravila Neofordex morata preteči najmanj dve uri;
English: Patients/carers should also be alert to possible psychiatric disturbances that may occur either during, or immediately after, dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Slovenian: Prav tako morajo biti bolniki/negovalci pozorni na možne duševne motnje, ki se lahko pojavijo med postopnim zmanjševanjem odmerka/ukinjanjem sistemskih steroidov ali takoj po tem, čeprav so o teh neželenih učinkih poročali redko.
English: In particular, the requirements of the pregnancy prevention programme for combination treatment with thalidomide or its analogues must be followed.
Slovenian: Predvsem morajo upoštevati zahteve programa preprečevanja nosečnosti za kombinirano zdravljenje s talidomidom ali njegovimi analogi.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki na pretisnem omotu in škatli poleg oznake „EXP“.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Neofordex in all subsets of the paediatric population in multiple myeloma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Neofordex za vse podskupine pediatrične populacije z multiplim mielomom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Your doctor will advise on an appropriate diet, and may prescribe potassium, calcium or vitamin D supplements.
Slovenian: Zdravnik vam bo svetoval glede ustrezne prehrane in vam po potrebi predpisal dodatke kalija, kalcija ali vitamina D.
English: − Epileptic fits;
Slovenian: − epileptični napadi;
English: − Fever due to a lack of certain white blood cells, lack of all types of blood cells, diminished blood clotting, decreased magnesium or calcium levels in the blood;
Slovenian: − zvišana telesna temperatura zaradi pomanjkanja določenih belih krvnih celic, pomanjkanje vseh vrst krvnih celic, slabše strjevanje krvi, znižane ravni magnezija in kalcija v krvi;
English: If you notice blurring or distorted vision that lasts for several days, please contact your doctor.
Slovenian: Če opazite zamegljen ali popačen vid, ki traja več dni, se posvetujte z zdravnikom.
English: Women of childbearing potential and their male partners should take appropriate contraceptive measures.
Slovenian: Ženske v rodni dobi in njihovi partnerji morajo poskrbeti za ustrezno kontracepcijsko zaščito.
English: Such infections can also be caused by microorganisms that rarely cause disease under normal circumstances (opportunistic infections).
Slovenian: Povzročitelji tovrstnih okužb pa so lahko tudi mikroorganizmi, ki v običajnih okoliščinah redko povzročajo bolezni (oportunistične okužbe).
English: Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids, ATC code: H02AB02
Slovenian: Farmakoterapevtska skupina: kortikosteroidi za sistemsko zdravljenje, glukokortikoidi, oznaka ATC: H02AB02
English: Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Slovenian: Bolnikom in zdravnikom svetujemo, da so pozorni na znake in simptome trombembolije.
English: Patients should be made aware of this risk and self-monitoring of blood and urine should be reinforced, especially during the initiation of treatment.
Slovenian: Bolnike je treba seznaniti s tem tveganjem in okrepiti spremljanje vrednosti v krvi in urinu, ki ga bolniki opravljajo sami, zlasti med uvajanjem zdravljenja.
English: Dexamethasone is similar to glucocorticoids which are naturally produced in the body.
Slovenian: Deksametazon je podoben glukokortikoidom, ki se naravno tvorijo v telesu.
English: Patient at high risk of TLS, such as patients with high proliferative rate, high tumour burden, and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precaution taken.
Slovenian: Bolnike z velikim tveganjem za TLS, kot so tisti z veliko hitrostjo proliferacije celic, visokim tumorskim bremenom in veliko občutljivostjo za citotoksična zdravila, je treba skrbno spremljati in uvesti ustrezne previdnostne ukrepe.
English: This can sometimes lead to infections caused by germs that rarely cause infection under normal circumstances (called opportunistic infections).
Slovenian: To lahko včasih privede do okužb, ki jih povzročajo mikrobi, ki v običajnih okoliščinah redko povzročajo okužbe (t. i. oportunistične okužbe).
English: Patients should be monitored for haematological adverse reactions, especially neutropenia.
Slovenian: Bolnike je treba spremljati glede hematoloških neželenih učinkov, predvsem nevtropenije.
English: If you are using a pill organiser box, use the perforation to separate individual tablets from the blister without opening the packaging.
Slovenian: Če uporabljate organizator za zdravila, posamezne tablete ločite od pretisnega omota po perforaciji, ne da bi odprli ovojnino.
English: − Lack of body water (dehydration) with thirst or headache;
Slovenian: − pomanjkanje vode v telesu (dehidracija), ki se kaže z žejo ali glavobolom;
English: Patients and physicians are advised to be observant for signs and symptoms of bleeding, including petechiae and epistaxes, especially in case of concomitant treatment susceptible to induce bleeding.
Slovenian: Bolnikom in zdravnikom svetujemo, naj bodo pozorni na znake in simptome krvavitev, vključno s petehijami in epistaksami, zlasti v primeru sočasnega jemanja zdravil, ki lahko povzročijo krvavitev.
English: A haemoglobin concentration above 12 g/dl should lead to discontinuation of erythropoietic medicinal products.
Slovenian: Če koncentracija hemoglobina preseže 12 g/dl, je treba uporabo eritropoetičnih zdravil prekiniti.
English: The incidence rate of certain adverse reactions varies depending on the combination treatment used.
Slovenian: Incidenca nekaterih neželenih učinkov je odvisna od uporabljenega kombiniranega zdravljenja.
English: There is a risk of severe strongyloidiasis.
Slovenian: Obstaja tveganje za hudo strongiloidozo.
English: Advise patients to not dispose of unused tablets through household waste or wastewater.
Slovenian: Bolnike poučite, naj neuporabljenih tablet ne mečejo med gospodinjske odpadke ali v odpadne vode.
English: Elimination The plasma half-life of dexamethasone is approximately 250 minutes.
Slovenian: Plazemski razpolovni čas deksametazona je približno 250 minut.
English: If the patient experiences any thromboembolic events, treatment must be discontinued and standard anticoagulation therapy started.
Slovenian: Če se pri bolniku pojavijo kateri koli trombembolični dogodki, je treba zdravljenje prekiniti in uvesti standardno antikoagulacijsko zdravljenje.
English: Treatment with high-dose dexamethasone increases the risk of developing serious infections, in particular due to bacteria, yeasts and/or parasites.
Slovenian: Zdravljenje z velikimi odmerki deksametazona poveča tveganje za razvoj resnih okužb, ki jih povzročajo predvsem bakterije, kvasovke in/ali paraziti.
English: Most reactions recover after either dose reduction or withdrawal, although specific treatment may be necessary.
Slovenian: Večina neželenih učinkov izgine po zmanjšanju odmerka ali prekinitvi zdravljenja, vendar pa je včasih potrebno specifično zdravljenje.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Neofordex therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Neofordex, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: If you take more Neofordex than you should If you take too much Neofordex contact your doctor or hospital immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Neofordex, kot bi smeli Če ste vzeli prevelik odmerek zdravila Neofordex, se takoj obrnite na svojega zdravnika ali bolnišnico.
English: Acute toxicity of dexamethasone is weak and toxic effects have rarely been observed after an acute overdose.
Slovenian: Akutna toksičnost deksametazona je majhna in le redko so po akutnem prevelikem odmerjanju opazili toksične učinke.
English: These would include depressive or manic-depressive illness and previous steroid psychoses.
Slovenian: Med te motnje sodijo depresija ali manična depresija ter steroidne psihoze v preteklosti.
English: Patients should be advised to promptly report febrile episodes.
Slovenian: Bolnikom je treba svetovati, naj o epizodah febrilne nevtropenije takoj obvestijo zdravnika.
English: The major part is hydrogenated or hydroxylated in humans, the major metabolites being hydroxy-6-dexamethasone and dihydro-20-dexamethasone.
Slovenian: Večji del se pri ljudeh hidrogenira ali hidroksilira, pri čemer sta glavna presnovka hidroksi-6-deksametazon in dihidro-20deksametazon.
English: Dexamethasone is bound by plasma proteins, principally albumin, up to about 80%, depending on the administered dose.
Slovenian: Deksametazon se veže na beljakovine v plazmi, zlasti na albumin, pri čemer je vezava do 80-odstotna in je odvisna od uporabljenega odmerka.