natgillin/translations-raw huggingface dataset:
Not all pack sizes may be available.
Na trgu morda ni vseh navedenih pakiranj.
Clarithromycin has been reported to double the exposure of ciclosporin.
Klaritromicin, kot poročajo, podvoji izpostavljenost ciklosporinu.
After use, wipe the syringe on the outside only with a dry tissue.
Po uporabi obrišite brizgo samo z zunanje strani s suho krpo.
Of the many drugs reported to interact with ciclosporin, those for which the interactions are adequately substantiated and considered to have clinical implications are listed below.
Izmed številnih zdravil, za katera so poročali, da medsebojno delujejo s ciklosporinom, so spodaj našteta tista, za katera so interakcije s ciklosporinom ustrezno dokazane in štejejo za klinično pomembne.
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
V okviru vsakega organskega sistema so neželeni učinki razvrščeni po skupinah glede na pogostnost, najpogostejši najprej.
The glass must be rinsed well with some more diluent to ensure that all of the dose is taken.
Kozarec je treba dobro izprati z dodatno količino tekočine in jo zaužiti, s čimer je mogoče zagotoviti vnos celotnega odmerka.
If you have any questions about how Sandimmun works or why this medicine has been prescribed for you, ask your doctor.
Če vas zanima, kako zdravilo Sandimmun deluje ali zakaj so vam predpisali to zdravilo, se obrnite na svojega zdravnika.
In patients in whom within a given time (for specific information see below) no adequate response is achieved or the effective dose is not compatible with the established safety guidelines, treatment with Sandimmun should be discontinued.
Bolnikom, pri katerih po določenem času (specifični podatki so navedeni spodaj) ne pride do zadostnega odziva ali pa za njih učinkovit odmerek ne ustreza uveljavljenimi smernicam za varno uporabo zdravila, je treba zdravljenje z zdravilom Sandimmun ukiniti.
To achieve full effectiveness, up to 12 weeks of Sandimmun therapy may be required.
Da bi dosegli največjo možno učinkovitost zdravila Sandimmun, je lahko potrebnih 12 tednov zdravljenja.
Within the therapeutic dose range the peak plasma concentration and the area under the plasma concentration/time curve are proportional to the dose; for whole blood, however, the relationship is non-linear.
V okviru terapevtskih odmerkov sta najvišja koncentracija in površina pod krivuljo časovnega poteka koncentracije v plazmi sorazmerni z danim odmerkom, razmerje v polni krvi pa ni linearno.
However, due to its nephrotoxic potential (see section 4.8), careful monitoring of renal function is recommended (see section 4.4).
Zaradi nefrotoksičnega potenciala ciklosporina (glejte poglavje 4.8) je priporočeno skrbno spremljanje ledvične funkcije (glejte poglavje 4.4).
Psoriasis Treatment of severe psoriasis in patients in whom conventional therapy is inappropriate or ineffective.
Zdravljenje hude psoriaze pri bolnikih, pri katerih je običajno zdravljenje neprimerno ali neučinkovito.
When concurrently administered with ciclosporin, the dosage of the statins should be reduced and concomitant use of certain statins should be avoided according to their label recommendations.
Pri sočasni uporabi s ciklosporinom je treba odmerke statinov znižati, sočasni uporabi določenih statinov pa se je treba v celoti izogniti v skladu s priporočili v označevanju teh zdravil.
If you have questions about how long to take Sandimmun, talk to your doctor or your pharmacist.
Če vas zanima, kako dolgo je treba jemati zdravilo Sandimmun, se pogovorite s svojim zdravnikom ali farmacevtom.
Then, take the syringe out of the bottle
Nato vzemite brizgo iz steklenice.
• You may have some side effects.
• Morda boste imeli neželene učinke.
Patients with malignant or pre-malignant alterations of the skin should be treated with Sandimmun only after appropriate treatment of such lesions, and if no other option for successful therapy exists.
Bolnike z maligno spremembo ali predstopnjo maligne spremembe se sme zdraviti z zdravilom Sandimmun samo po ustreznem zdravljenju take kožne lezije in v primeru, da za uspešno zdravljenje ni nobene druge možnosti.
• if you have kidney problems (except for nephrotic syndrome).
• če imate težave z ledvicami, razen nefrotskega sindroma,
The intravenous LD50 is 148 mg/kg in mice, 104 mg/kg in rats, and 46 mg/kg in rabbits.
Intravenska LD50 pri miših je 148 mg/kg, pri podganah 104 mg/kg in pri kuncih 46 mg/kg.
If the concentrate for solution for infusion is used, careful consideration should be given to administering an adequate intravenous dose that corresponds to the oral dose.
Pri uporabi koncentrata za raztopino za infundiranje je treba skrbno pretehtati apliciranje primernega intravenskega odmerka, ki ustreza peroralnemu odmerku.
• if you have high blood pressure (hypertension) which is not under control with medication.
• če imate visok krvni tlak (hipertenzijo), ki ni urejen z zdravili.
Blister packs of double-sided aluminium consisting of aluminium foil on the bottom side and aluminium foil on the upper side.
Pretisni omoti iz obojestranske aluminijaste folije, in sicer je ena folija na spodnji, druga pa na zgornji strani pretisnega omota.
Sandimmun capsules should be swallowed whole.
Peroralna uporaba Sandimmun kapsule je treba pogoltniti cele.
If you think you have been given too much Sandimmun, tell your doctor immediately.
Če menite, da ste prejeli preveč zdravila Sandimmun, takoj obvestite zdravnika.
Live-attenuated vaccines
Živa atenuirana cepiva
In some cases, mainly in transplant patients, fatal outcomes have been reported (see section 4.4).
V nekaterih primerih, predvsem pri bolnikih po presaditvi, so poročali o smrtnem izidu (glejte poglavje 4.4).
Atopic dermatitis Sandimmun is indicated in patients with severe atopic dermatitis when systemic therapy is required.
Uporaba zdravila Sandimmun je indicirana pri bolnikih s hudim atopijskim dermatitisom, kadar je potrebno sistemsko zdravljenje.
Cases reporting chronic morphological changes included arteriolar hyalinosis, tubular atrophy and interstitial fibrosis (see section 4.4).
Primeri poročil o kroničnih morfoloških spremembah pa vključujejo hialino degeneracijo arteriol, tubularno atrofijo in intersticijsko fibrozo (glejte poglavje 4.4).
In two published research studies, rabbits exposed to ciclosporin in utero (10 mg/kg/day subcutaneously) demonstrated reduced numbers of nephrons, renal hypertrophy, systemic hypertension, and progressive renal insufficiency up to 35 weeks of age.
V dveh objavljenih raziskovalnih študijah so pri kuncih, izpostavljenih ciklosporinu in utero (10 mg/kg/dan subkutano) ugotavljali zmanjšano število nefronov, hipertrofijo ledvic, sistemsko hipertenzijo in progresivno insuficienco ledvic do 35. tedna starosti.
How to store Sandimmun Contents of the pack and other information
Shranjevanje zdravila Sandimmun Vsebina pakiranja in dodatne informacije
In a study of 7 renal transplant patients aged 2-16 years, the ciclosporin clearance ranged from 9.8 to15.5 ml/min/kg.
V študiji s 7 bolniki s presajeno ledvico, starimi 2-16 let, se je očistek ciklosporina gibal od 9,8-15,5 ml/min/kg.
Detailed information on this medicinal product is available on the website of {name of MS/Agency}
Podrobne informacije o zdravilu so objavljene na spletni strani {Ime države članice/Agencije}
The increase in the bioavailability of diclofenac is most probably caused by a reduction of its high first-pass effect.
Povečano biološko uporabnost diklofenaka najverjetneje povzroča zmanjšanje njegovega obsežnega metabolizma prvega prehoda.
You will be switched to ciclosporin in the form of capsules or oral solution (both of which are taken by mouth) as soon as possible.
Takoj ko bo mogoče, boste prešli na uporabo ciklosporina v obliki kapsul ali peroralne raztopine (obe navedeni obliki zdravila zaužijete).
The oral LD50 of ciclosporin is 2,329 mg/kg in mice, 1,480 mg/kg in rats and > 1,000 mg/kg in rabbits.
Peroralna LD50 ciklosporina je pri miših 2.329 mg/kg, pri podganah 1.480 mg/kg in pri kuncih > 1.000 mg/kg.
In the event of increased lipids being found, restriction of dietary fat and, if appropriate, a dose reduction, should be considered.
V primeru ugotovljenega zvišanja koncentracije lipidov je treba razmisliti o omejitvi maščob v prehrani in, če je primerno, o znižanju odmerka zdravila.
• Muscle weakness, loss of muscle strength, pain in muscles of the legs or hands or anywhere in the body.
• oslabelost mišic, izguba mišične moči, bolečine v mišicah nog, rok ali drugje po telesu
After use, wipe the syringe on the outside only with a dry tissue and replace it in its cover.
Po uporabi obrišite brizgo samo na zunanji strani s suho krpo in jo spravite nazaj v tulec.
• Do not store your capsules in a hot place (maximum temperature 30°C).
Kapsul ne shranjujte na toplem (pri temperaturi nad 30 °C).
Atorvastatin 10-80 mg Simvastatin 10-80 mg Fluvastatin 20-80 mg Lovastatin
Večkratnik spremembe izpostavljenosti pri sočasni uporabi s ciklosporinom atorvastatin 10-80 mg simvastatin 10-80 mg fluvastatin 20-80 mg lovastatin
Expel any large bubbles by depressing and withdrawing the plunger a few times before removing the syringe containing the prescribed dose from bottle.
Odstranite morebitne velike mehurčke, tako da bat nekajkrat potisnete gor in dol, preden odstranite brizgo, ki vsebuje predpisano količino raztopine, iz steklenice.
In rheumatoid arthritis clinical trials with ciclosporin, patients aged 65 or older were more likely to develop systolic hypertension on therapy, and more likely to show serum creatinine rises ≥50% above the baseline after 3 to 4 months of therapy.
V kliničnih študijah s ciklosporinom pri revmatoidnem artritisu so bili bolniki v starosti 65 let ali več bolj dovzetni za razvoj sistolične hipertenzije in zvišanje koncentracije kreatinina v serumu za ≥50 % nad izhodiščno vrednost po 3 do 4 mesecih zdravljenja.
Table 1 Summary of exposure changes of commonly used statins with ciclosporin
Preglednica 1 Povzetek sprememb izpostavljenosti pogosto uporabljanih statinov pri sočasni uporabi s ciklosporinom
The absolute oral bioavailability following administration of Sandimmun is 20 to 50%.
Absolutna peroralna biološka uporabnost ciklosporina po odmerjanju zdravila Sandimmun je 20 do 50 %.
Once mixed it should be taken immediately after preparation.
Raztopino je treba uporabiti takoj po pripravi.
This is very important if you have had a transplant.
To je zelo pomembno za bolnike po presaditvi.
If you are over 65 and have psoriasis or atopic dermatitis, you should only be treated with Sandimmun if your condition is particularly severe.
Če ste stari več kot 65 let in imate luskavico ali atopijski dermatitis, smete prejemati zdravilo Sandimmun samo v primeru, da imate zelo hudo obliko bolezni.
All metabolites identified so far contain the intact peptide structure of the parent compound; some possess weak immunosuppressive activity (up to one-tenth that of the unchanged drug).
Vsi do zdaj odkriti presnovki vsebujejo nespremenjeno peptidno strukturo matične učinkovine, nekateri med njimi pa kažejo tudi šibko imunosupresivno aktivnost (z največ eno desetino aktivnosti nespremenjene učinkovine).
Dose reduction may be necessary in patients with severe liver impairment to maintain blood levels within the recommended target range (see sections 4.4 and 5.2) and it is recommended that ciclosporin blood levels are monitored until stable levels are reached.
Pri bolnikih s hudo okvaro jeter je za vzdrževanje koncentracije ciklosporina v krvi v priporočenem okviru ciljnih vrednosti v nekaterih primerih treba znižati odmerjanje (glejte poglavji 4.4 in 5.2), koncentracije ciklosporina v krvi pa je priporočljivo spremljati, dokler se ne stabilizirajo.
At the cellular level it inhibits production and release of lymphokines including interleukin 2 (T-cell growth factor, TCGF).
Ciklosporin na celični ravni zavira nastajanje in sproščanje limfokinov, med drugim tudi interlevkina 2 (rastnega dejavnika celic T, angl. T-cell growth factor, TCGF).
Patients with abnormal baseline renal function should initially be treated with 2.5 mg/kg/day and must be monitored very carefully.
Bolnike, ki imajo pred zdravljenjem okvarjeno delovanje ledvic, je treba sprva zdraviti z odmerkom 2,5 mg/kg/dan in jih zelo skrbno spremljati.
In addition the corresponding frequency category for each adverse drug reaction is based on the following convention (CIOMS III): very common (≥1/10); common (≥1/100,
Ustrezna kategorija pogostnosti pri posameznem neželenem učinku temelji na naslednjem dogovoru (CIOMS III): zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10);
Control of serum magnesium levels is therefore recommended in the peri-transplant period, particularly in the presence of neurological symptom/signs.
Zato je v tem obdobju priporočeno spremljanje koncentracij magnezija v serumu, zlasti če ima bolnik nevrološke simptome/znake.
{Name and Address} <{tel}> <{fax}> <{e-mail}>
{Ime in naslov} <{tel.}> <{faks}> <{e-pošta}>
Switching between oral ciclosporin formulations The switch from one oral ciclosporin formulation to another should be made under physician supervision, including monitoring of blood levels of ciclosporin for transplantation patients.
Prehod z ene peroralne oblike ciklosporina na drugo Prehod z ene peroralne oblike ciklosporina na drugo je treba izvajati pod zdravnikovim nadzorom, kar pri bolnikih po presaditvi vključuje spremljanje koncentracije ciklosporina v krvi.
Ciclosporin may increase the plasma concentrations of repaglinide and thereby increase the risk of hypoglycaemia.
Ciklosporin lahko zviša koncentracijo repaglinida v plazmi in tako poveča tveganje za hipoglikemijo.
The elimination half-life in kidney-transplanted patients was approximately 11 hours, with a range between 4 and 25 hours.
Pri bolnikih po presaditvi ledvice je bil razpolovni čas izločanja približno 11 ur, v obsegu od 4 do 25 ur.
• Medicines which may increase or decrease the level of ciclosporin (the active substance of Sandimmun) in your blood.
• zdravila, ki zvišujejo ali znižujejo koncentracijo ciklosporina (zdravilne učinkovine v zdravilu Sandimmun) v krvi.
In very severe cases, rapid and adequate control of the disease is more likely to occur with a starting dose of 5 mg/kg/day.
V zelo hudih primerih je več možnosti za hitro in ustrezno izboljšanje pri uporabi začetnega odmerka 5 mg/kg/dan.
The syringe should not be rinsed, but wiped on the outside with a dry tissue to remove remaining drops of the solution (see section 6.6).
Brizge se ne sme izpirati, primerno pa je s suho krpo obrisati kapljice raztopine, ki ostanejo na zunanji strani brizge (glejte poglavje 6.6).
Due to the variability of this condition, treatment must be individualised.
Zaradi variabilnosti te bolezni je treba zdravljenje prilagoditi vsakemu bolniku posamezno.
Ciclosporin was tested in a number of in vitro and in vivo tests for genotoxicity with no evidence for a clincally relevant mutagenic potential.
Ciklosporin so testirali s številnimi in vitro in in vivo testi za ugotavljanje genotoksičnosti in z nobenim niso odkrili klinično pomembnega mutagenega potenciala ciklosporina.
Lymphadenopathy observed on treatment with ciclosporin should be regularly monitored.
Limfadenopatijo, do katere pride med zdravljenjem s ciklosporinom, je treba redno opazovati.
Sandimmun can be given in combination with low-dose corticosteroids and/or non-steroidal antiinflammatory drugs (NSAIDs) (see section 4.4).
Zdravilo Sandimmun je mogoče odmerjati v kombinaciji z nizkimi odmerki kortikosteroidov in/ali z nesteroidnimi protivnetnimi zdravili (glejte poglavje 4.4).
Regular monitoring of blood pressure is required.
Potrebne so redne meritve krvnega tlaka.
Transplantation
Presaditev
If this happens, tell your doctor or pharmacist.
Če pride do tega, obvestite svojega zdravnika ali farmacevta.
If a significant impairment of renal function occurs, the dosage of the co-administered medicinal product should be reduced or alternative treatment considered.
Če pride do pomembne okvare ledvične funkcije, je treba znižati odmerjanje sočasno uporabljanega zdravila ali razmisliti o drugem načinu zdravljenja.
If there is no improvement after 1 month, the daily dose may be gradually increased, but should not exceed 5 mg/kg.
Če po enem mesecu ne pride do izboljšanja, je mogoče dnevni odmerek postopoma zviševati, vendar ne sme preseči 5 mg/kg.
Psoriasis and atopic dermatitis
Psoriaza in atopijski dermatitis
What Sandimmun looks like and contents of the pack Sandimmun concentrate for solution for infusion is supplied in ampoules containing 1 ml or 5 ml concentrate.
Izgled zdravila Sandimmun in vsebina pakiranja Zdravilo Sandimmun koncentrat za raztopino za infundiranje je na voljo v ampulah, ki vsebujejo 1 ml ali 5 ml koncentrata.
Metabolism mainly takes place in the liver via cytochrome P450 3A4 (CYP3A4), and the main pathways of metabolism consist of mono- and dihydroxylation and N-demethylation at various positions of the molecule.
Njegova presnova večinoma poteka v jetrih s citokromom P450 3A4 (CYP3A4), poglavitne presnovne poti pa so monohidroksilacija, dihidroksilacija in N-demetilacija na različnih položajih v molekuli.
Pregnant rats which received 12 mg/kg/day of ciclosporin intravenously (twice the recommended human intravenous dose) had foetuses with an increased incidence of ventricular septal defect.
Breje podgane, ki so prejemale po 12 mg/kg/dan ciklosporina intravensko (dvakrat večji odmerek od priporočenega intravenskega odmerka za človeka), so imele zarodke z zvečano incidenco defekta prekatnega pretina.
Ciclosporin gave no evidence of mutagenic or teratogenic effects in the standard test systems with oral application (rats up to 17 mg/kg/day and rabbits up to 30 mg/kg/day orally).
Ciklosporin ni učinkoval mutageno ali teratogeno v standardnih poskusnih sistemih s peroralno uporabo (podgane do 17 mg/kg/dan in kunci do 30 mg/kg/dan peroralno).
If you accidentally take too much of your medicine, tell your doctor immediately or go to your nearest hospital emergency unit.
Če ste vzeli večji odmerek zdravila Sandimmun, kot bi smeli Če ste pomotoma vzeli preveč zdravila, takoj obvestite zdravnika ali pojdite v najbližjo bolnišnično enoto nujne medicinske pomoči.
For the initial monitoring of liver transplant patients, either the specific monoclonal antibody should be used, or parallel measurements using both the specific monoclonal antibody and the non-specific monoclonal antibody should be performed, to ensure a dosage that provides adequate immunosuppression.
Za začetno spremljanje bolnikov po presaditvi jeter je treba uporabljati bodisi metodo s specifičnimi monoklonskimi protitelesi ali pa izvajati vzporedne meritve tako s specifičnimi kot z nespecifičnimi monoklonskimi protitelesi, kar je potrebno za izbiro odmerka, ki zagotavlja ustrezno imunosupresijo.
Danazol has been reported to increase ciclosporin blood concentrations by approximately 50%.
Poročajo, da danazol zviša koncentracijo ciklosporina v krvi za približno 50 %.
Too much of the medicine can affect your kidneys.
Prevelika količina zdravila bi lahko škodovala vašim ledvicam.
If dose reduction is not successful in improving eGFR within one month, Sandimmun treatment should be discontinued (see section 4.4).
Če znižanje odmerka ne uspe izboljšati ocenjene stopnje glomerulne filtracije v enem mesecu, je treba prekiniti zdravljenje z zdravilom Sandimmun (glejte poglavje 4.4).
Sandimmun should be prescribed only by physicians who are experienced in immunosuppressive therapy and can provide adequate follow-up, including regular full physical examination, measurement of blood pressure and control of laboratory safety parameters.
Zdravilo Sandimmun smejo predpisovati samo zdravniki, ki imajo izkušnje z imunosupresivnim zdravljenjem in lahko zagotovijo ustrezno spremljanje bolnika, kar vključuje redne preglede celega telesa, merjenje krvnega tlaka in laboratorijske preiskave varnostnih parametrov.
Tabulated summary of adverse drug reactions from clinical trials Adverse drug reactions from clinical trials (Table 1) are listed by MedDRA system organ class.
Tabelaričen prikaz neželenih učinkov iz kliničnih študij Neželeni učinki zdravila iz kliničnih študij (preglednica 1) so navedeni po organskih sistemih MedDRA klasifikacije.
Experience with acute overdosage of ciclosporin is limited.
Izkušenj z akutnim prevelikim odmerjanjem ciklosporina je malo.
The capsules should be left in the blister pack until required for use and stored at a temperature not exceeding 30°C.
Kapsule Sandimmun je treba vzeti iz pretisnega omota šele tik pred uporabo in jih shranjevati pri temperaturi do 30 °C.
The concentrate is a clear brown/yellow oily liquid.
Koncentrat je bistra rjavo rumena oljna tekočina.
Your doctor will work out the correct dose of Sandimmun for you.
Vaš zdravnik bo določil pravi odmerek zdravila Sandimmun za vas.
Other medicines and Sandimmun
Druga zdravila in zdravilo Sandimmun
If any of these drugs are used concurrently with ciclosporin, close clinical observation is required in order to enable early detection of toxic manifestations of the medicinal products, followed by reduction of its dosage or its withdrawal.
Pri sočasni uporabi katere od navedenih učinkovin skupaj s ciklosporinom je potrebno natančno klinično opazovanje, s čimer je mogoče zgodaj odkriti toksično delovanje zdravila in nato znižati odmerjanje ali ukiniti zdravilo.
Additional precautions in endogenous uveitis
Dodatna opozorila pri endogenem uveitisu
Pull up the plunger until you have drawn up the correct amount of medicine.
Vlecite bat, dokler ne potegnete predpisane količine zdravila v brizgo.
During long-term treatment, some patients may develop structural changes in the kidney (e.g. interstitial fibrosis) which, in renal transplant patients, must be differentiated from changes due to chronic rejection.
Pri nekaterih bolnikih lahko pri dolgotrajnem zdravljenju pride do strukturnih sprememb v ledvicah (na primer do intersticijske fibroze), ki jih je pri bolnikih po presaditvi ledvice treba razlikovati od sprememb, ki so posledica kronične zavrnitve presadka.
If any of these affects you severely, tell your doctor.
Če vas kateri koli od teh učinkov huje prizadene, obvestite svojega zdravnika.
For inducing remission, initially 5 mg/kg/day orally given in 2 divided doses are recommended until remission of active uveal inflammation and improvement in visual acuity are achieved.
Za indukcijo remisije je priporočeni začetni odmerek 5 mg/kg/dan peroralno v dveh deljenih odmerkih, dokler se aktivno vnetje žilnice ne umiri in ne pride do izboljšanja ostrine vida.
A decision should be made whether to abstain from breast-feeding or to abstain from using the medicinal drug, taking into account the importance of the medicinal product to the mother.
Odločiti se je treba med prenehanjem dojenja ali prenehanjem zdravljenja z zdravilom, pri čemer je treba pretehtati prednosti zdravljenja za mater.
PHARMACEUTICAL FORM AND CONTENTS Capsule, soft [To be completed nationally]
FARMACEVTSKA OBLIKA IN VSEBINA kapsula, mehka
In such cases an initial oral loading dose of 10 to 12.5 mg/kg should be given, followed by daily oral administration of the maintenance dose previously found to be satisfactory.
V takih primerih je priporočljivo začeti s polnitvenim peroralnim odmerkom 10 do 12,5 mg/kg, nato pa nadaljevati z dnevnim peroralnim vzdrževalnim odmerkom, ki se je že prej izkazal kot zadovoljiv.
In view of the potential risk of skin malignancy, patients on Sandimmun, in particular those treated for psoriasis or atopic dermatitis, should be warned to avoid excess unprotected sun exposure and should not receive concomitant ultraviolet B irradiation or PUVA photochemotherapy.
Glede na možnost razvoja malignih obolenj kože je treba bolnike, še posebno tiste, ki uporabljajo zdravilo Sandimmun za zdravljenje psoriaze ali atopijskega dermatitisa, opozoriti, naj se nezaščiteni izogibajo čezmernemu izpostavljanju sončni svetlobi in da se ne smejo sočasno zdraviti z ultravijoličnimi žarki B ali fotokemoterapijo PUVA.