FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final report for the medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate and concerned by the PASS final report , the scientific conclusions are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni završnog izvješća zatraženog neintervencijskog ispitivanja sigurnosti primjene lijeka nakon stavljanja u promet (engl. post-authorization safety study, PASS) za lijek(ove) koji sadrži(e) djelatne tvari magnezijev sulfat heptahidrat, bezvodni natrijev sulfat i kalijev sulfat, a koje su obuhvaćene završnim izvješćem PASS-a, znanstveni zaključci su sljedeći:
English: Changes to be made to the conditions of the marketing authorisation(s) of medicinal product(s) containing the active substance magnesium sulphate heptahydrate, sodium sulphate anhydrous, potassium sulphate concerned by the non-interventional imposed PASS final report
Croatian: Izmjene uvjeta odobrenja za stavljanje lijeka u promet za lijek(ove) koji sadrži(e) djelatne tvari magnezijev sulfat heptahidrat, bezvodni natrijev sulfat i kalijev sulfat, a koje su obuhvaćene završnim izvješćem zatraženog neintervencijskog PASS-a
English: Annex II Conditions of Marketing Authorisation
Croatian: Uvjeti odobrenja za stavljanje lijeka u promet
English: • Wearing appropriate protective clothing.
Croatian: Nositi odgovarajuću zaštitnu odjeću.
English: • Loss of appetite.
Croatian: • Gubitak apetita.
English: • Shaking of your body which you cannot control.
Croatian: Drhtanje tijela koje ne možete kontrolirati.
English: It may also be harmful if this medicine is given to children.
Croatian: Mogao bi biti štetan i ako se ovaj lijek daje djeci.
English: • If you forget to take a dose, take it as soon as you remember it.
Croatian: Ako zaboravite uzeti dozu, uzmite je čim se sjetite.
English: However, other drinks, such as soft drinks, can be used accordingly to individual taste.
Croatian: Međutim, mogu se koristiti i druga pića, primjerice bezalkoholna pića, prema individualnom ukusu.
English: • Tell your doctor if you are pregnant or intend to become pregnant.
Croatian: Obavijestite svog liječnika ako ste trudni ili namjeravate zatrudnjeti.
English: • Your doctor will monitor you more closely for a short time.
Croatian: Liječnik će Vas kratko vrijeme pažljivije motriti.
English: • Swelling at the back of the eye.
Croatian: Oticanje pozadine oka.
English: To do this, your doctor may need to do some blood tests.
Croatian: Da bi to učinio, liječnik će Vam možda morati obaviti neke krvne pretrage.
English: Examples are:
Croatian: Primjeri su:
English: • Often applying a sunscreen with a high protection factor.
Croatian: Često nanositi kremu za sunčanje s visokim zaštitnim faktorom.
English: Minor flakes or slight sediment may still be observed.
Croatian: Manje pahuljice ili lagani talog se i dalje mogu vidjeti.
English: Do not store below 20°C for more than 1 month.
Croatian: Ne čuvati na temperaturi ispod 20°C dulje od mjesec dana.
English: This is because this medicine contains alcohol (see section below “Sandimmun Neoral contains ethanol”).
Croatian: Razlog tome je što ovaj lijek sadrži alkohol (vidjeti dio u nastavku „Sandimmun Neoral sadrži etanol“).
English: {Name of the Member State} {Name of the medicinal product} This leaflet was last revised in {MM/YYYY} {month YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG} {mjesec GGGG}.
English: It may also affect your sight because of the higher pressure inside your head (benign intracranial hypertension).
Croatian: Moglo bi i utjecati na Vaš vid zbog višeg tlaka u glavi (dobroćudna intrakranijska hipertenzija).
English: • Do not store your capsules in a hot place (maximum temperature 25°C).
Croatian: Ne čuvajte kapsule na vrućem mjestu (maksimalna temperatura 25°C).
English: This will give you the chance to talk to your doctor about your treatment and talk about any problems you may be having.
Croatian: To će Vam dati priliku da razgovarate sa svojim liječnikom o svom liječenju te o tegobama koje eventualno imate.
English: In plasma, approximately 90% is bound to proteins, mostly lipoproteins.
Croatian: U plazmi se otprilike 90% veže na bjelančevine, uglavnom lipoproteine.
English: Make sure that the syringe does not touch the liquid in the glass.
Croatian: Pazite da štrcaljka ne dodiruje tekućinu u čaši.
English: Your doctor will make sure that you get the right dose for your individual needs.
Croatian: Vaš liječnik će se pobrinuti da dobijete odgovarajuću dozu za Vaše individualne potrebe.
English: • if this medicine is being prescribed for a child.
Croatian: ako je ovaj lijek propisan za dijete.
English: It can also be used to maintain steroid-induced remission, allowing withdrawal of steroids.
Croatian: Može se koristiti i za održavanje remisije inducirane steroidima, omogućujući ustezanje steroida.
English: This is because of the change in how ciclosporin is absorbed into your blood.
Croatian: Razlog tome je promjena u načinu apsorpcije ciklosporina u Vašu krv.
English: • Nifedipine.
Croatian: Nifedipin.
English: These phenomena do not affect the efficacy and safety of the product and the dosing by means of the pipette remains accurate.
Croatian: Ove pojave ne utječu na djelotvornost i sigurnost lijeka, a doziranje lijeka pomoću pipete i dalje ostaje točno.
English: • the levels of ciclosporin in your blood, especially if you have had a transplant,
Croatian: razine ciklosporina u krvi, osobito ako ste imali transplantaciju,
English: Take Sandimmun Neoral at the same time every day.
Croatian: Uzimajte Sandimmun Neoral u isto vrijeme svakoga dana.
English: In addition, clinical safety parameters such as renal function and blood pressure must be monitored during the first 2 months after the switch.
Croatian: Osim toga, parametri kliničke sigurnosti kao što su bubrežna funkcija i krvni tlak moraju se pratiti tijekom prva 2 mjeseca nakon prebacivanja.
English: Your doctor should monitor how well your kidneys work.
Croatian: Liječnik bi trebao pratiti koliko Vam dobro funkcioniraju bubrezi.
English: • Changes in menstrual cycle, breast enlargement in men.
Croatian: Promjene u menstrualnom ciklusu, povećanje grudi u muškaraca.
English: Two, 4 and 8 weeks after the switch, renal function and blood pressure should be monitored.
Croatian: 2, 4 i 8 tjedana nakon prebacivanja treba pratiti bubrežnu funkciju i krvni tlak.
English: This is because this product contains oils which can become solid at low temperatures.
Croatian: Razlog tome je što lijek sadrži ulja koja se mogu skrutnuti na niskim temperaturama.
English: If the syringe is to be cleaned, do not rinse it but wipe the outside with a dry tissue (see section 6.6).
Croatian: Ako treba očistiti štrcaljku, ne smije se ispirati već obrisati vanjski dio suhom maramicom (vidjeti dio 6.6).
English: However, there are no adequate and well-controlled studies in pregnant women and therefore Sandimmun Neoral should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the foetus.
Croatian: Međutim, nema odgovarajućih i dobro kontroliranih ispitivanja u trudnica pa se stoga Sandimmun Neoral ne smije koristiti tijekom trudnoće osim ako potencijalna korist za majku opravdava potencijalni rizik za plod.
English: Blister packs of double-sided aluminium consisting of aluminium foil on the bottom side and aluminium foil on the upper side.
Croatian: Blister pakovanja od obostranog aluminija koja se sastoje od aluminijske folije na donjoj strani i aluminijske folije na gornjoj strani.
English: Stir and drink the whole contents of the glass straight away.
Croatian: Promiješajte i odmah popijte cjelokupni sadržaj čaše.
English: • if you develop high blood pressure.
Croatian: ako razvijete visoki krvni tlak.
English: The terminal half-life ranged from 6.3 hours in healthy volunteers to 20.4 hours in patients with severe liver disease (see sections 4.2 and 4.4).
Croatian: Terminalni poluvijek imao je raspon od 6,3 sati u zdravih dobrovoljaca do 20,4 sati u bolesnika s teškom bolešću jetre (vidjeti dijelove 4.2 i 4.4).
English: • how well your liver and kidneys are working,
Croatian: koliko dobro Vam funkcioniraju jetra i bubrezi,
English: Do not take Sandimmun Neoral with grapefruit or grapefruit juice.
Croatian: Nemojte uzimati Sandimmun Neoral s grejpom ili sokom od grejpa.
English: • your blood pressure before the start of your treatment and regularly during treatment,
Croatian: krvni tlak prije početka liječenja te redovito tijekom liječenja,
English: Sandimmun Neoral with food and drink
Croatian: Sandimmun Neoral s hranom i pićem
English: This will get rid of any large air bubbles.
Croatian: Tako ćete izbaciti velike mjehure zraka.
English: If considered necessary, magnesium supplementation should be given.
Croatian: Ako se smatra potrebnim, treba dati magnezij u obliku dodatka.
English: The lower part of the plunger ring needs to be in front of the mark on the syringe which shows the amount of medicine.
Croatian: Donji dio klipa treba biti ispred oznake na štrcaljki koja pokazuje količinu lijeka.
English: Sandimmun Neoral can be used to induce and maintain remissions.
Croatian: Sandimmun Neoral se može koristiti za induciranje i održavanje remisija.
English: If NSAIDs with a low first-pass effect (e.g. acetylsalicylic acid) are given together with ciclosporin, no increase in their bioavailability is to be expected.
Croatian: Ako se NSAIL-ovi s niskim učinkom prvog prolaza (npr. acetilsalicilna kiselina) daju zajedno s ciklosporinom, ne očekuje se nikakvo povećanje njihove bioraspoloživosti.
English: This can lead to symptomatic hypomagnesaemia, especially in the peri-transplant period.
Croatian: To može dovesti do simptomatske hipomagnezemije, osobito u peritransplantacijskom razdoblju.
English: When a blister is opened, a characteristic smell is noticeable.
Croatian: Kada se otvori blister, zamjetan je karakterističan miris.
English: • if you have high blood pressure (hypertension) which is not under control with medication.
Croatian: ako imate visoki krvni tlak (hipertenziju) koja se ne kontrolira lijekom.
English: To achieve full effectiveness, up to 12 weeks of Sandimmun Neoral therapy may be required.
Croatian: Da bi se postigla potpuna učinkovitost moglo bi biti potrebno do 12 tjedana terapije Sandimmun Neoralom.
English: In many patients, however, higher peak concentrations (Cmax) and increased exposure to the active substance (AUC) may occur.
Croatian: U mnogo bolesnika, međutim, mogu se javiti najviše vršne koncentracije (Cmax) i povećana izloženost djelatnoj tvari (AUC).
English: In nontransplant patients the relationship between blood level and clinical effects is less well established.
Croatian: U netransplantacijskih bolesnika odnos između razine u krvi i kliničkih učinaka nije tako dobro utvrđen.
English: If hypertension develops, appropriate antihypertensive treatment must be instituted.
Croatian: Ako se razvije hipertenzija, mora se započeti odgovarajuće antihipertenzivno liječenje.
English: {Name and Address} {tel} {fax} {e-mail}
Croatian: {Naziv i adresa} {tel} {fax} {e-mail}
English: • These medicines all contain ciclosporin as the active ingredient.
Croatian: Ti lijekovi svi sadrže ciklosporin kao djelatni sastojak.
English: In a small percentage of patients these changes are more marked and may be of clinical significance.
Croatian: U malom postotku bolesnika te su promjene izraženije i mogu biti klinički značajne.
English: Control of serum magnesium levels is therefore recommended in the peri-transplant period, particularly in the presence of neurological symptom/signs.
Croatian: Stoga se preporučuje kontroliranje razina magnezija u pertitransplantacijskom razdoblju, osobito ako su prisutni neurološki simptomi/znakovi.
English: • If you have an autoimmune disease, in which your body's immune response attacks your body's own cells, Sandimmun Neoral stops this immune reaction.
Croatian: Ako imate autoimunu bolest, u kojoj imunološki odgovor Vašeg tijela napada vlastite stanice Vašeg tijela, Sandimmun Neoral zaustavlja tu imunološku reakciju.
English: A jelly-like formation may occur below 20°C, which is however reversible at temperatures up to 30°C.
Croatian: Na temperaturi ispod 20°C mogu se pojaviti želatinozne tvorevine, no one su reverzibilne na temperaturama do 30°C.
English: Your dose may need to be lowered.
Croatian: Vašu će dozu možda trebati smanjiti.
English: After 6 months of therapy, renal function needs to be assessed every 4 to 8 weeks depending on the stability of the disease, its co- medication, and concomitant diseases.
Croatian: Nakon 6 mjeseci terapije bubrežnu je funkciju potrebno ocjenjivati svakih 4 do 8 tjedana ovisno o stabilnosti bolesti, istodobno primijenjenim lijekovima i pridruženim bolestima.
English: • Gum tissue overgrowing and covering your teeth.
Croatian: Desni koje prekomjerno rastu i prekrivaju Vam zube.
English: The increase in the bioavailability of diclofenac is most probably caused by a reduction of its high first-pass effect.
Croatian: Povećanje bioraspoloživosti diklofenaka najvjerojatnije je uzrokovano smanjenjem njegovog učinka prvog prolaza.
English: 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 Neoral should be discontinued.
Croatian: U bolesnika u kojih se u određenom razdoblju (za specifične informacije vidjeti u nastavku) ne postigne primjereni odgovor ili učinkovita doza nije kompatibilna s utvrđenim smjernicama za sigurnost primjene, liječenje Sandimmun Neoralom potrebno je prekinuti.
English: In particular tell your doctor or pharmacist if you are taking any of the following medicines before or during Sandimmun Neoral treatment:
Croatian: Osobito obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova prije ili tijekom liječenja Sandimmun Neoralom:
English: If you are over 65 and have psoriasis or atopic dermatitis, you should only be treated with Sandimmun Neoral if your condition is particularly severe.
Croatian: Ako ste stariji od 65 godina i imate psorijazu ili atopijski dermatitis, smijete se liječiti Sandimmun Neoralom samo ako Vam je stanje osobito teško.
English: The syringe should not come in contact with the diluent.
Croatian: Štrcaljka ne smije doći u kontakt s razrjeđivačem.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Moguće nuspojave Kao i svi drugi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće razviti kod svakoga.
English: In the event of unexpected toxicity or inefficacy of ciclosporin, blood trough levels should also be monitored.
Croatian: U slučaju neočekivane toksičnosti ili neučinkovitosti ciklosporina potrebno je također pratiti najniže razine u krvi.
English: Sandimmun Neoral capsules may be stored at room temperature not exceeding 25°C.
Croatian: Sandimmun Neoral treba čuvati na sobnoj temperaturi koja ne prelazi 25°C.
English: The determination of bilirubin and parameters that assess hepatic function are required prior to starting therapy and close monitoring during treatment is recommended.
Croatian: Određivanje bilirubina i parametara kojima se ocjenjuje funkcija jetre potrebno je prije početka terapije, a tijekom terapije se preporučuje pažljivo praćenje.
English: Your doctor will discuss with you the potential risks of taking Sandimmun Neoral during pregnancy.
Croatian: Liječnik će razgovarati s Vama o potencijalnim rizicima uzimanja Sandimmun Neorala tijekom trudnoće.
English: • High blood pressure.
Croatian: Visoki krvni tlak.
English: When using Sandimmun Neoral in any of the established non-transplantation indications, the following general rules should be adhered to:
Croatian: Kada se Sandimmun Neoral koristi u bilo kojoj od utvrđenih netransplantacijskih indikacija, potrebno je pridržavati se sljedećih općih pravila:
English: There is a high variability in the data reported on the terminal half-life of ciclosporin depending on the assay applied and on the target population.
Croatian: Postoji velika varijablinost u podacima zabilježenima o terminalnom poluvijeku ciklosporina ovisno o primijenjenom testu i ciljanoj populaciji.
English: Increases in temperatures up to 30°C for a total maximum of 3 months do not affect the quality of the product.
Croatian: 30°C tijekom maksimalno 3 mjeseca ne utječe na kakvoću lijeka.
English: Sandimmun Neoral oral solution should be stored between 15 and 30°C, but preferably not below 20°C for more than 1 month as it contains oily components of natural origin which tend to solidify at low temperatures.
Croatian: Sandimmun Neoral oralnu otopinu treba čuvati na temperaturi od 15 do 30°C, ali po mogućnosti ne ispod 20°C dulje od 1 mjesec budući da sadrži uljne komponente prirodnog porijekla koje se lako skrutnu pri niskim temperaturama.
English: Except for the treatment of nephrotic syndrome, there is no adequate experience available with Sandimmun Neoral.
Croatian: Osim za liječenje nefrotskog sindroma, nema odgovarajućeg iskustva sa Sandimmun Neoralom.
English: The relationship between administered dose and exposure (AUC) of ciclosporin is linear within the therapeutic dose range.
Croatian: Odnos između primijenjene doze i izloženosti (AUC) ciklosporinu je linearan unutar terapijskog raspona doze.
English: If the ciclosporin trough blood levels are beyond the therapeutic range, and/or worsening of the clinical safety parameters occurs, the dosage must be adjusted accordingly.
Croatian: Ako su najniže razine ciklosporina u krvi izvan terapijskog raspona i/ili dođe do pogoršanja parametara kliničke sigurnosti, doza se mora sukladno tome prilagoditi.
English: This is because these can affect how Sandimmun Neoral works.
Croatian: To je zato što oni mogu utjecati na djelovanje Sandimmun Neorala.
English: Examples of drugs that decrease ciclosporin levels are:
Croatian: Primjeri lijekova koji smanjuju razine ciklosporina su:
English: Since the switch from Sandimmun to Sandimmun Neoral may result in increased exposure to ciclosporin, the following rules must be observed:
Croatian: Budući da prebacivanje sa Sandimmuna na Sandimmun Neoral može rezultirati povećanon izloženošću ciklosporinu, moraju se poštivati sljedeća pravila:
English: In addition, the absorption of ciclosporin from Sandimmun Neoral is less variable and the correlation between ciclosporin trough concentrations and exposure (in terms of AUC) is stronger than with Sandimmun.
Croatian: Osim toga, apsorpcija ciklosporina iz Sandimmun Neorala manje je varijabilna, a povezanost između najnižih koncentracija ciklosporina i izloženosti (u smislu AUC-a) jača je nego sa Sandimmunom.
English: It provides a more consistent absorption profile with less influence from concomitant food intake or from diurnal rhythm than Sandimmun.
Croatian: Ona omogućuje dosljedniji profil apsorpcije s manje utjecaja konkomitantnog unosa hrane ili dnevnog ritma nego Sandimmun.
English: If you have questions about how long to take Sandimmun Neoral, talk to your doctor or your pharmacist.
Croatian: Ako imate pitanja o tome koliko dugo uzimati Sandimmun Neoral, obratite se svom liječniku ili ljekarniku.
English: • Leave your capsules in the foil.
Croatian: Ostavite kapsule u foliji.
English: Some side effects could be serious Tell your doctor straight away if you notice any of the following serious side effects:
Croatian: Odmah se obratite liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: However, due to its nephrotoxic potential (see section 4.8), careful monitoring of renal function is recommended (see section 4.4).
Croatian: Međutim, zbog njegovog nefrotoksičnog potencijala (vidjeti dio 4.8), preporučuje se pažljivo motrenje bubrežne funkcije (vidjeti dio 4.4).
English: The intersubject and intrasubject variability for AUC and Cmax is approximately 10-20%.
Croatian: Varijabilnost među ispitanicima i u pojedinačnih ispitanika za AUC i Cmax iznosi otprilike 10-20%.
English: How to store Sandimmun Neoral Contents of the pack and other information
Croatian: Kako čuvati Sandimmun Neoral Sadržaj pakovanja i druge informacije
English: When Sandimmun Neoral is given with other immunosuppressants (e.g. with corticosteroids or as part of a triple or quadruple medicinal product therapy), lower doses (e.g. 3 to 6 mg/kg given in 2 divided doses for the initial treatment) may be used.
Croatian: Kada se Sandimmun Neoral daje s drugim imunosupresivnim lijekovima (npr. s kortikosteroidima ili kao dio trostruke ili četverostruke terapije), mogu se primjenjivati niže doze (npr. 3 do 6 mg/kg dano u 2 podijeljene doze za uvođenje liječenja).
English: • Like other medicines that act on the immune system, ciclosporin may influence your body's ability to fight against infection and may cause tumours or other cancers, particularly of the skin.
Croatian: Kao i drugi lijekovi koji djeluju na imunološki sustav, ciklosporin može utjecati na sposobnost Vašeg tijela da se bori protiv infekcije i može uzrokovati tumore ili druge vrste raka, osobito kože.
English: Ciclosporin is extensively metabolised to approximately 15 metabolites.
Croatian: Ciklosporin se u velikoj mjeri biotransformira na približno 15 metabolita.
English: {Name and address} {tel} {fax} {e-mail}
Croatian: {Ime I adresa} {tel} {fax} {e-mail}
English: This explains why, in rare cases, Sandimmun Neoral-associated structural kidney alterations have been observed without increases in serum creatinine.
Croatian: To objašnjava zašto su, u rijetkim slučajevima, uočene stukturne promjene bubrega povezane sa Sandimmun Neoralom bez povišenja serumskog kreatinina.
English: When Sandimmun Neoral is used in transplant patients, routine monitoring of ciclosporin blood levels is an important safety measure.
Croatian: Kada se Sandimmun Neoral koristi u transplantiranih bolesnika, rutinsko praćenje razina ciklosporina u krvi važna je sigurnosna mjera.
English: The combination of Sandimmun Neoral with low doses of oral corticosteroids is recommended if the effect of Sandimmun Neoral alone is not satisfactory, especially in steroid-resistant patients.
Croatian: Kombinacija Sandimmun Neorala s niskim dozama oralnih kortikosteroida preporučuje se ako učinak samog Sandimmun Neorala nije zadovoljavajući, osobito u bolesnika rezistentnih na steroide.
English: Each mark on the syringe is 0.05 ml.
Croatian: Svaka oznaka na štrcaljki je 0,05 ml.
English: Patients with malignant or pre-malignant alterations of the skin should be treated with Sandimmun Neoral only after appropriate treatment of such lesions, and if no other option for successful therapy exists.
Croatian: Bolesnike s malignim ili predmalignim promjenama na koži smije se liječiti Sandimmun Neoralom samo nakon odgovarajućeg liječenja takvih lezija te ako ne postoji druga mogućnost za uspješnu terapiju.
English: Sandimmun Neoral contains approximately 12.0 vol. % ethanol (alcohol), which corresponds to up to 500 mg per dose used in transplant patients.
Croatian: Sandimmun Neoral sadrži otprilike 12,0 vol. % etanola (alkohola), što odgovara količini do 500 mg po dozi u transplantiranih bolesnika.
English: The elimination half-life in kidney-transplanted patients was approximately 11 hours, with a range between 4 and 25 hours.
Croatian: Poluvijek eliminacije u bolesnika s bubrežnim presatkom bio je otprilike 11 sati, s rasponom između 4 i 25 sati.
English: The name of your medicine is Sandimmun Neoral.
Croatian: Naziv Vašeg lijeka je Sandimmun Neoral.
English: Sandimmun Neoral 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.
Croatian: Sandimmun Neoral smiju propisivati samo liječnici koji imaju iskustva s imunosupresivnom terapijom i mogu osigurati odgovarajuće naknadno praćenje, koje uključuje redovne potpune fizikalne preglede, mjerenje krvnog tlaka i kontrolu laboratorijskih sigurnosnih parametara.