natgillin/translations-raw huggingface dataset:
Neofordex should not be used with live attenuated vaccines (see section 4.5).
Zdravilo Neofordex se ne sme uporabljati skupaj z živimi oslabljenimi cepivi (glejte poglavje 4.5).
− Increased blood sugar levels, constipation;
− zvišane ravni sladkorja v krvi, zaprtost;
Other MDR transporters may also have a role in dexamethasone transport.
Določeno vlogo pri prenašanju deksametazona lahko imajo tudi drugi prenašalci MDR.
You must not breast-feed during treatment.
Med zdravljenjem ne smete dojiti.
Post-natal development assessment of animals treated prenatally presented decreased glucose tolerance and insulin sensitivity, behavioural alterations and decrease in brain and body weight.
Pri ocenjevanju postnatalnega razvoja živali, ki so prejemale učinkovino pred skotitvijo, so ugotovili zmanjšano toleranco za glukozo in občutljivost za insulin, vedenjske spremembe ter zmanjšanje mase možganov in telesne mase.
The benefit from dexamethasone treatment should be carefully and continuously weighed against actual and potential risks.
V rednih intervalih je treba skrbno oceniti koristi zdravljenja z deksametazonom v primerjavi z dejanskimi in možnimi tveganji.
Neofordex should not be taken if you are pregnant unless clearly indicated by your doctor.
Zdravila Neofordex ne smete jemati, če ste noseči, razen če vam ga je izrecno svetoval zdravnik.
This is particularly important if you notice signs of pneumonia: cough, fever, shortness of breath and chest pain.
To je še posebno pomembno, če opazite znake pljučnice: kašelj, vročino, kratko sapo in bolečine v prsnem košu.
The efficacy and safety of dexamethasone combination treatment in multiple myeloma has been confirmed in numerous clinical studies in newly diagnosed patients and in patients with relapsed or refractory disease.
Učinkovitost in varnost kombinacij z deksametazonom pri zdravljenju multiplega mieloma so potrdili v številnih kliničnih študijah pri bolnikih z na novo diagnosticirano boleznijo in bolnikih z recidivno ali proti zdravilom odporno boleznijo.
Please inform any doctor, dentist or person who may prescribe a treatment for you that you are currently taking or have recently taken dexamethasone.
Povejte zdravniku, zobozdravniku ali drugi osebi, ki bi vam lahko predpisala zdravljenje, da jemljete ali da ste pred kratkim jemali deksametazon.
Glucocorticoid therapy may reduce the effect of anti-diabetic and antihypertensive treatment.
Zdravljenje s glukokortikoidi lahko zmanjša učinek antidiabetičnih in antihipertenzivnih zdravil.
Potassium levels should be monitored and corrected as necessary.
Treba je spremljati ravni kalija in po potrebi ustrezno ukrepati.
When thalidomide, lenalidomide or pomalidomide is used, particular attention to pregnancy testing and prevention requirements is needed.
Pri uporabi talidomida, lenalidomida ali pomalidomida je treba posebno pozornost nameniti opravljanju testov za ugotavljanje nosečnosti in ukrepom za preprečevanje nosečnosti.
If you forget to take Neofordex If you forget to take Neofordex at the usual time and - if you are less than 12 hours late: take the tablet immediately.
Če ste pozabili vzeti zdravilo Neofordex Če ste pozabili vzeti zdravilo Neofordex ob običajni uri in - če je od pozabljenega odmerka preteklo manj kot 12 ur: takoj vzemite tableto; - če je od pozabljenega odmerka preteklo več kot 12 ur: ne vzemite tablete, ki ste jo pozabili, ampak vzemite naslednjo tableto ob običajni uri.
Dexamethasone may cause confusional state, hallucinations, dizziness, somnolence, fatigue, syncope and blurred vision (see section 4.8).
Deksametazon lahko povzroči zmedenost, halucinacije, omotico, somnolenco, utrujenost, sinkopo in zamegljen vid (glejte poglavje 4.8).
If your treatment is to be stopped follow your doctor's advice.
Če morate prekiniti zdravljenje, upoštevajte napotke zdravnika.
Glucocorticoids are excreted in human milk and effects have been shown in breastfed newborns/infants of treated women.
Glukokortikoidi se izločajo v materino mleko in imajo dokazano neželene učinke na novorojenčke/dojenčke, ki jih dojijo zdravljene matere.
In case of active infectious disease, appropriate antiinfective treatment must be added to the treatment with Neofordex.
Pri bolnikih z aktivno infekcijsko boleznijo je treba ob zdravljenju z zdravilom Neofordex uvesti tudi ustrezno antiinfektivno zdravljenje.
Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected.
Bolnikom/negovalcem je treba svetovati, naj poiščejo zdravniško pomoč, če opazijo zaskrbljujoče psihološke simptome, še zlasti znake depresivnega razpoloženja ali samomorilnih misli.
The patient populations studied included a wide range of ages, as well as patients considered eligible or ineligible for autologous stem cell transplantation.
Populacija bolnikov v študijah je zajela bolnike zelo različnih starosti ter bolnike, ki so bili bodisi primerni ali neprimerni za avtologno presaditev krvotvornih matičnih celic.
However, both incidence and severity of peripheral neuropathy increase with concomitant bortezomib or thalidomide administration.
Vendar pa se tako incidenca kot stopnja resnosti periferne nevropatije povečata pri sočasni uporabi bortezomiba ali talidomida.
This risk is increased by concomitant use of fluoroquinolones and in patients undergoing dialysis with secondary hyperparathyroidism or after renal transplantation.
Tveganje je večje ob sočasni uporabi fluorokinolonov in pri bolnikih na dializi s sekundarnim hiperparatiroidizmom ali po presaditvi ledvic.
Dexamethasone is transported by the P-glycoprotein (also known as MDR1).
Deksametazon se prenaša s P-glikoproteinom (ki je znan tudi kot MDR1).
It is characterized by excessive numbers of abnormal plasma cells in the bone marrow and overproduction of intact monoclonal immunoglobulin (IgG, IgA, IgD, or IgE) or Bence-Jones protein only (free immunoglobulin monoclonal κ and λ light chains).
Zanjo sta značilna preveliko število nenormalnih plazemskih celic v kostnem mozgu ter čezmerna proizvodnja intaktnega monoklonskega imunoglobulina (IgG, IgA, IgD ali IgE) ali samo Bence-Jonesove beljakovine (monoklonske proste lahke verige κ in λ).
- The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica (see section 2).
- Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza, magnezijev stearat in koloidni brezvodni silicijev dioksid (glejte poglavje 2).
Less common but serious adverse reactions include: pneumonia and other infections and psychiatric disorders (see section 4.4).
Med manj pogostimi, vendar resnimi neželenimi učinki pa so: pljučnica in druge okužbe ter duševne motnje (glejte poglavje 4.4).
Patients and/or carers should be warned that potentially severe psychiatric adverse reactions may occur with systemic steroids (see section 4.8).
Bolnike in/ali negovalce je treba opozoriti, da se lahko pri uporabi sistemskih steroidov pojavijo psihiatrični neželeni učinki, ki so lahko hudi (glejte poglavje 4.8).
They act together by killing cancerous white blood cells.
Ta zdravila nato skupaj uničijo rakave bele krvne celice.
Once the patient has been stabilised on the anticoagulation treatment and any complications of the thromboembolic event have been managed, the treatment with dexamethasone and thalidomide or its analogues may be restarted at the original dose dependent upon a benefit risk assessment.
Ko je bolnik stabiliziran z antikoagulacijskim zdravljenjem in so morebitni zapleti, povezani s trombemboličnim dogodkom, pod nadzorom, se lahko ponovno uvede zdravljenje z deksametazonom in talidomidom ali njegovimi analogi z začetnim odmerkom in ob upoštevanju ocene razmerja med tveganji in koristmi.
The dose of insulin, oral anti-diabetics and anti-hypertensive medicinal products may have to be increased.
Zato je odmerek insulina, peroralnih antidiabetikov in antihipertenzivnih zdravil včasih treba povečati.
Hepatic impairment or renal insufficiency
Okvara jeter ali ledvična insuficienca
Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma.
Zdravljenje mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem multiplega mieloma.
The combination of dexamethasone with lenalidomide or pomalidomide may cause a decrease in normal white blood cells (blood cells that help fight infection) and/or blood platelets (which help prevent bleeding).
Kombinacija deksametazona in lenalidomida ali pomalidomida lahko povzroči zmanjšanje normalnega števila belih krvnih celic (krvnih celic, ki pomagajo pri premagovanju okužb) in/ali trombocitov (ti pomagajo pri preprečevanju krvavitev).
In cases of prior tuberculosis with major radiological sequelae or if it is not certain that a full 6-month rifampicin treatment course has been followed, a prophylactic anti-tuberculosis treatment is required.
Pri bolnikih, ki so imeli v preteklosti tuberkulozo z večjimi radiološkimi spremembami ali pri katerih ni gotovo, da so ustrezno zaključili 6-mesečno zdravljenje z rifampicinom, je treba uvesti profilaktično zdravljenje tuberkuloze.
There is a linear relationship between administered and bioavailable doses.
Med uporabljenim in biološko razpoložljivim odmerkom obstaja linearna povezava.
If you notice any of these symptoms talk to a doctor straight away.
Če opazite katerega koli od teh simptomov, se takoj posvetujte z zdravnikom.
Based on human experience, dexamethasone is suggested to cause congenital malformations, particularly intra-uterine growth retardation and rarely neonatal adrenal insufficiency, when administered during pregnancy.
Na podlagi izkušenj pri ljudeh se domneva, da deksametazon povzroča kongenitalne malformacije, zlasti intrauterini zastoj rasti, v redkih primerih pa tudi insuficienco nadledvične žleze pri novorojenčkih, če ga jemljejo nosečnice.
At doses ≥ 500 mg per dose or < 3 g per day, precautions are required due to increased risk of haemorrhage, ulcerations and gastro-intestinal perforation.
Pri odmerkih ≥ 500 mg na odmerek ali < 3 g na dan so potrebni previdnostni ukrepi zaradi povečanega tveganja za krvavitve, razjede in predrtje prebavil.
Neofordex should not be used during pregnancy unless the clinical condition of the woman requires treatment with dexamethasone.
Zdravila Neofordex ne smete uporabljati pri nosečnicah, razen če klinično stanje nosečnice zahteva zdravljenje z deksametazonom.
Particular care is needed when treating patients with renal impairment, hypertension or congestive heart failure.
Posebna previdnost je potrebna pri zdravljenju bolnikov z okvaro ledvic, hipertenzijo ali kongestivnim srčnim popuščanjem.
Water and sodium retention is common and can lead to hypertension.
Pogosto se pojavi zastajanje vode in natrija, ki lahko povzroči hipertenzijo.
Dexamethasone can suppress skin reaction to allergy testing.
Deksametazon lahko zavre kožno reakcijo pri testiranju alergij.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Bolniki z redkimi dednimi motnjami, kot so intoleranca za galaktozo, laponska oblika zmanjšane aktivnosti laktaze ali malabsorpcija glukoze/galaktoze, tega zdravila ne smejo jemati.
Certain viral diseases (varicella, measles) can be aggravated in patients receiving glucocorticoid treatment or who have received glucocorticoid treatment within the previous 3 months.
Določene virusne bolezni (npr. norice in ošpice) se lahko pri bolnikih, ki se zdravijo z glukokortikoidi ali ki so prejemali zdravljenje z glukokortikoidi v zadnjih 3 mesecih, pojavijo v težji obliki.
− Cataract, blurred vision;
− katarakta, zamegljen vid;
Note: It is important that while you are taking Neofordex you avoid contact with anyone who is suffering from chickenpox, measles or shingles.
Opomba: Pomembno je, da se med jemanjem zdravila Neofordex izogibate stiku z osebami, ki imajo norice, ošpice ali pasovec.
No data are available on the biotransformation of dexamethasone in hepatically impaired patients.
Podatki o biotransformaciji deksametazona pri bolnikih z okvaro jeter niso na voljo.
These are common (may affect up to 1 in 10 people) and may include: - feeling depressed (including thinking about suicide) - feeling high (mania), very happy (euphoria) or moods that go up and down, - feeling anxious, having difficulty in concentrating and memory loss, - feeling, seeing or hearing things that do not exist or believing in things that are not real, having gloomy thoughts, changing how you act.
Te so pogoste (pojavijo se lahko pri največ 1 od 10 bolnikov) in lahko vključujejo: - depresivnost (vključno z razmišljanjem o samomoru); - privzdignjeno razpoloženje (manija), pretirano dobro razpoloženje (evforija) ali nihanje razpoloženja; - občutek tesnobe, težave s koncentracijo in izguba spomina; - občutenje, videnje ali slišanje stvari, ki jih ni, ali prepričanost v obstoj stvari, ki niso resnične, temačne misli in spremembe vedenja.
Corticosteroids can favour the development of tendonitis and, in exceptional cases, rupture of the affected tendon.
Kortikosteroidi lahko spodbudijo razvoj tendinitisa, v izjemnih primerih pa tudi pretrganje prizadete kite.
FN was associated with dose interruption in 3.7% of patients, and with dose reduction in 1.3% of patients, and with no treatment discontinuations.
FN je bila povezana s prekinitvijo odmerjanja pri 3,7 % bolnikov in z zmanjšanjem odmerka pri 1,3 % bolnikov; v nobenem primeru ni prišlo do prenehanja zdravljenja.
Dexamethasone has been shown to induce multiple myeloma cell death (apoptosis) via a down-regulation of Nuclear Factor-κB activity and an activation of caspase-9 through second mitochondria-derived activator of caspase (Smac; an apoptosis promoting factor) release.
Deksametazon dokazano sproži propad (apoptozo) celic multiplega mieloma, tako da zavira delovanje nuklearnega dejavnika κB in aktivira kaspazo-9, s tem ko omogoči, da se iz mitohondrija sprosti pomožni aktivator kaspaze (t. i. Smac - dejavnik, ki spodbuja apoptozo).
The side effects listed below were seen when dexamethasone was taken for the treatment of multiple myeloma and for the treatment of other diseases.
Neželene učinke, navedene spodaj, so opazili pri jemanju deksametazona za zdravljenje multiplega mieloma in za zdravljenje drugih bolezni.
Patients receiving Neofordex in combination with products containing thalidomide, lenalidomide or pomalidomide should adhere to the pregnancy prevention programmes of those products.
Bolnice, ki jemljejo zdravilo Neofordex v kombinaciji z zdravili, ki vsebujejo talidomid, lenalidomid ali pomalidomid, se morajo držati programov preprečevanja nosečnosti za ta zdravila.
• With fluoroquinolones, due to possibly increased risk of tendonitis and, in exceptional cases, rupture of the affected tendon, particularly after long-term treatment.
• s fluorokinoloni, saj bi se lahko povečalo tveganje za tendinitis, v izjemnih primerih pa tudi za pretrganje prizadete kite, zlasti v primeru dolgotrajnega zdravljenja;
However, antithrombotic prophylaxis with low-dose acetylsalicylic acid is possible.
Antitrombotično profilaktično zdravljenje z majhnimi odmerki acetilsalicilne kisline pa je dopustno;
Data are derived from historical experience and clinical studies in multiple myeloma patients in which dexamethasone was used as monotherapy or in combination with placebo.
Podatki so bili pridobljeni iz izkušenj v preteklosti in kliničnih študij pri bolnikih z multiplim mielomom, v katerih so deksametazon uporabili v monoterapiji ali v kombinaciji s placebom.
Individual tablets in intact packaging should be separated from the blister using the perforation, e.g. for use in multi-compartment compliance aids.
Posamezne tablete v nedotaknjeni ovojnini od pretisnega omota ločite po perforaciji, npr. za uporabo v večpredelnih organizatorjih za zdravila.
− Fast or irregular heart rhythm, too high or too low blood pressure, formation of blood clots that may clog blood vessels (for example in legs or lungs), swelling of arms or legs, reddening of the skin of the face or body;
− hiter ali nepravilen srčni utrip, previsok ali prenizek krvni tlak, nastajanje krvnih strdkov, ki lahko zamašijo krvne žile (na primer v nogah ali pljučih), otekanje rok ali nog, pordelost kože na obrazu ali telesu;
Systemic treatment with glucocorticoids can induce chorioretinopathy which may result in impaired vision including loss of vision.
Sistemsko zdravljenje z glukokortikoidi lahko povzroči horioretinopatijo, ki lahko privede do okvare vida, vključno z izgubo vida.
Studies in animals have shown reductions in female fertility (see Section 5.3).
Študije na živalih so pokazale zmanjšanje plodnosti pri samicah (glejte poglavje 5.3).
In males, fertility may be decreased through germ cell apoptosis and spermatogenic defects.
Pri samcih se lahko zmanjša plodnost zaradi apoptoze zarodnih celic in motene spermatogeneze.
High-dose (40 mg or 20 mg) oral dexamethasone has been studied in the therapy of multiple myeloma in combination with chemotherapy in the VAD regimen (vincristine, adriamycin/doxorubicin and dexamethasone) or in association with novel agents, including thalidomide and its analogues as well as proteasome inhibitors.
Velike odmerke (40 mg ali 20 mg) peroralnega deksametazona so proučevali pri zdravljenju multiplega mieloma v kombinaciji s kemoterapijo po shemi VAD (vinkristin, adriamicin/doksorubicin in deksametazon) ali v povezavi z novimi učinkovinami, vključno s talidomidom in njegovimi analogi ter zaviralci proteasoma.
− Heart attack, abnormally slow heartbeat;
− srčna kap, nenormalno počasen srčni utrip;
When Neofordex is used in combination with known teratogens (e.g. thalidomide, lenalidomide, pomalidomide, plerixafor), particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Kadar se zdravilo Neofordex uporablja v kombinaciji z znanimi teratogeni (npr. s talidomidom, lenalidomidom, pomalidomidom ali pleriksaforjem), je treba posebno pozornost nameniti opravljanju testov nosečnosti in ukrepom za preprečevanje nosečnosti (glejte poglavje 4.6).
The following combinations require precautions due to safety concerns:
Iz varnostnih razlogov so potrebni previdnostni ukrepi pri naslednjih kombinacijah:
You should tell your doctor if you have symptoms of tumour lysis syndrome such as muscle cramping, muscle weakness, confusion, visual loss or disturbances and shortness of breath
Obvestite zdravnika, če imate simptome sindroma lize tumorja, kot so mišični krči, šibkost mišic, zmedenost, izguba ali motnje vida in zasoplost.
In Pom + LD-Dex treated patients neutropenia was infrequently serious (2.0% of patients), did not lead to treatment discontinuation, and was associated with treatment interruption in 21.0% of patients, and with dose reduction in 7.7% of patients.
Pri bolnikih, zdravljenih s Pom + LD-dex, je bila nevtropenija občasno resna (2,0 % bolnikov), ni vodila k prenehanju zdravljenja in je bila pri 21,0 % bolnikov povezana s prekinitvijo zdravljenja ter pri 7,7 % bolnikov z zmanjšanjem odmerka.
If such patients have been in contact with people with chickenpox or measles, a preventive treatment with intravenous normal immunoglobulin or passive immunisation with varicella zoster immunoglobulin (VZIG) must be started as appropriate.
Če so bili ti bolniki v stiku z osebami, ki so imele norice ali ošpice, je treba uvesti bodisi preventivno zdravljenje z intravenskim polispecifičnim imunoglobulinom ali pasivno imunizacijo z imunoglobulini proti noricam in pasovcu.
At the end of dexamethasone treatment, the dose should be tapered in a stepwise fashion until a complete stop.
Proti koncu zdravljenja z deksametazonom je treba odmerek postopoma zmanjševati do popolne prekinitve zdravljenja.
Dexamethasone is a synthetic glucocorticoid; it combines high anti-inflammatory effects with low mineralocorticoid activity.
Deksametazon je sintetični glukokortikoid, ki združuje močan protivnetni učinek s šibkim mineralokortikoidnim učinkom.
• Clarithromycin, erythromycin, telithromycin, itraconazole, ketoconazole, posaconazole, voriconazole, nelfinavir, ritonavir: Increased dexamethasone plasma concentration due to reduction of its hepatic metabolism by these enzyme inhibitors.
• klaritromicin, eritromicin, telitromicin, itrakonazol, ketokonazol, posakonazol, vorikonazol, nelfinavir in ritonavir: ti zaviralci encimov povzročijo zmanjšanje jetrne presnove deksametazona, zato se poveča njegova koncentracija v plazmi.
Prolonged use of corticosteroids may produce subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.
Daljša uporaba kortikosteroidov lahko povzroči nastanek subkapsularnih katarakt ali glavkoma z možno poškodbo vidnih živcev in lahko spodbudi razvoj sekundarnih očesnih okužb, ki jih povzročajo glivice ali virusi.
Talk to your doctor before taking Neofordex if you or a member of your immediate family have suffered, or currently suffer from severe depression or manic attacks.
Pred začetkom jemanja zdravila Neofordex se posvetujte z zdravnikom, če imate ali ste imeli vi ali kateri koli član ožje družine hudo depresijo ali manične napade.
Patients should be informed of the signs and symptoms of pneumonia and be advised to seek medical attention in case of their appearance.
Bolnike je treba poučiti o znakih in simptomih pljučnice in jih opozoriti, da morajo, če se ti pojavijo, poiskati zdravniško pomoč.
• With erythropoietic medicinal products or other medicinal products that may increase the risk of thrombosis, such as hormone replacement therapy, in patients receiving thalidomide or its analogues with Neofordex (see sections 4.4 and 4.8).
• z eritropoetičnimi zdravili ali drugimi zdravili, ki lahko povečajo tveganje za trombozo (na primer zdravila za hormonsko nadomestno zdravljenje), pri bolnikih, ki prejemajo talidomid ali njegove analoge skupaj z zdravilom Neofordex (glejte poglavji 4.4 in 4.8);
After oral administration of Neofordex, dexamethasone peak plasma levels are reached at a median of three hours.
Po peroralni uporabi zdravila Neofordex je največja koncentracija deksametazona v plazmi dosežena po mediano treh urah.
− Inflammation of the eye and/or eyelids, increased tearing;
− vnetje očesa in/ali očesnih vek, povečano solzenje;
Particular care is needed when treating patients with glaucoma (or family history of glaucoma) as well as when treating patients with ocular herpes simplex, because of possible corneal perforation.
Posebna previdnost je potrebna pri zdravljenju bolnikov z glavkomom (ali z družinsko anamnezo glavkoma) in pri zdravljenju bolnikov s herpesom simpleks na očesu, saj lahko pride do predrtja roženice.
The adverse reactions observed in patients treated with dexamethasone are listed below by system organ class and frequency.
Neželeni učinki, ki so jih opazili pri bolnikih, zdravljenih z deksametazonom, so navedeni spodaj glede na organski sistem in pogostnost.
Insomnia may be minimised by administering Neofordex in the morning.
Tveganje za nespečnost je mogoče zmanjšati, tako da se zdravilo Neofordex vzame zjutraj.
Dexamethasone may cause congenital malformations (see section 5.3).
Deksametazon lahko povzroči kongenitalne malformacije (glejte poglavje 5.3).
In controlled studies, combination treatment with dexamethasone consistently showed better outcomes in terms of survival and response than single-agent dexamethasone.
V nadzorovanih študijah so pri kombiniranem zdravljenju z deksametazonom dosledno beležili boljše izide pri parametrih preživetja in odziva kot pri zdravljenju s samim deksametazonom.