FrancophonIA/ELRC3.0 huggingface dataset:
English: • Weakening of the bones - this may cause bone fractures
Croatian: • slabljenje kostiju - to može prouzročiti lomove kostiju
English: Frequencies of these possible side effects are not known (frequency cannot be estimated from the available data).
Croatian: Učestalosti tih mogućih nuspojava nisu poznate (iz dostupnih podataka nije moguće procijeniti učestalost).
English: The dose is specific for you and is decided by your doctor.
Croatian: Doza je prilagođena posebno Vama i o njoj odlučuje liječnik.
English: You should then take the second dose of this medicine 6 to 10 hours after the morning dose.
Croatian: Tada biste trebali uzeti drugu dozu ovog lijeka 6 do 10 sati nakon jutarnje doze.
English: Plenadren is not recommended for use in children and adolescents under 18 years old as it has not been studied in these patients.
Croatian: Ne preporučuje se primjena Plenadrena u djece i adolescenata mlađih od 18 godina jer nije ispitana u tih bolesnika.
English: What you need to know before you take Plenadren
Croatian: Što morate znati prije nego počnete uzimati Plenadren
English: This may occur during commencement of treatment and during dose adjustments.
Croatian: One se mogu pojaviti na početku liječenja i tijekom prilagodbe doze.
English: Do not take this medicine with grapefruit juice as the juice will conflict with the action of this medicine.
Croatian: Nemojte uzimati ovaj lijek sa sokom od grejpa jer je utjecaj soka u suprotnosti s djelovanjem ovog lijeka.
English: When your illness is over, return to your normal maintenance dose of this medicine.
Croatian: Kada Vam bolest prestane, vratite se na svoju uobičajenu dozu održavanja ovog lijeka.
English: An increased dose is necessary occasionally in order for the body to cope with increased stress such as fever.
Croatian: Povećana doza povremeno je potrebna kako bi se tijelo moglo boriti s povećanim stresom kao što je vrućica.
English: Glucocorticoids occur naturally in the body, and help to maintain your general health and well-being.
Croatian: Glukokortikoidi se u tijelu javljaju prirodno, a pomažu u održavanju Vašeg općeg zdravlja i dobrobiti.
English: If extra doses are needed frequently and regularly, you should contact your doctor for re-evaluation of your maintenance dose.
Croatian: Ako su dodatne doze potrebne često i redovito, morate se obratiti liječniku da Vam ponovno procijeni Vašu dozu održavanja.
English: If used with mifepristone, a treatment used to end a pregnancy, the effect of Plenadren may be reduced.
Croatian: Ako se primjenjuje s mifepristonom, terapijom koja se koristi za okončanje trudnoće, učinak Plenadrena može biti smanjen.
English: It belongs to a group of medicines called corticosteroids.
Croatian: Pripada skupini lijekova koji se nazivaju kortikosteroidi.
English: It is therefore important to continue taking this medicine as prescribed by your doctor.
Croatian: Stoga je važno da nastavite uzimati ovaj lijek onako kako Vam je propisao liječnik.
English: 40 mg is the highest maintenance dose studied.
Croatian: Doza od 40 mg najviša je ispitana doza održavanja.
English: Events have been reported in patients treated with Plenadren.
Croatian: Zabilježeni su događaji u bolesnika liječenih Plenadrenom.
English: This may require dose individualisation.
Croatian: To može zahtijevati individualizaciju doze.
English: Your blood pressure may increase, you may gain extra weight and your blood sugar may become too high.
Croatian: Može Vam se povećati krvni tlak, možete dobiti na težini a vrijednost šećera u krvi može postati previsoka.
English: Plenadren contains a substance called hydrocortisone (sometimes called cortisol).
Croatian: Plenadren sadrži tvar koja se naziva hidrokortizon (ponekad se naziva kortizol).
English: What Plenadren contains
Croatian: Što Plenadren sadrži
English: In addition they modify the body's immune responses to diverse stimuli.
Croatian: Nadalje, oni mijenjaju imunosni odgovor organizma na različite podražaje.
English: What Plenadren is and what it is used for
Croatian: Što je Plenadren i za što se koristi
English: Most reactions resolve after dose reduction, although specific treatment may be necessary.
Croatian: Većina se nuspojava povuče nakon smanjenja doze, iako ih može biti potrebno posebno liječiti.
English: If you are affected do not drive or use machines, until you have discussed the issue with your doctor.
Croatian: Ako osjećate takvo djelovanje, nemojte voziti ili rukovati strojevima dok niste o tome razgovarali s liječnikom.
English: This regimen has been documented in over 300 intercurrent illness episodes within the clinical study programme.
Croatian: Ovaj režim dokumentiran je u sklopu programa kliničkog ispitivanja u više od 300 epizoda istovremene bolesti.
English: Immune system disorders Activation of infection (tuberculosis, fungal and viral infections including herpes).
Croatian: Poremećaji imunološkog sustava Aktivacija infekcije (tuberkuloza, gljivične i virusne infekcije uključujući herpes).
English: A common maintenance dose is 20-30 mg per day, given once daily in the morning.
Croatian: Uobičajena doza održavanja iznosi 20-30 mg na dan, a daje se jedanput na dan i to ujutro.
English: A small amount of cortisol is excreted in the urine unchanged (<0.5% of the daily production), meaning that cortisol is eliminated completely by metabolism.
Croatian: Mala količina kortizola izluči se nepromijenjena mokraćom (<0,5% dnevne proizvodnje), što znači da se kortizol u potpunosti eliminira putem metabolizma.
English: Shire Services BVBA Rue Montoyer 47 B - 1000 Brussels Belgium
Croatian: Shire Services BVBA Rue Montoyer 47 B - 1000 Brussels Belgija
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 3
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: It is important that you continue treatment with Plenadren during pregnancy.
Croatian: Važno je da liječenje Plenadrenom nastavite i tijekom trudnoće.
English: The medicine delivers hydrocortisone to your body throughout the day.
Croatian: Lijek dostavlja hidrokortizon u Vaše tijelo tijekom cijeloga dana.
English: • When you wake up in the morning swallow Plenadren tablets whole with a glass of water at least 30 minutes before your breakfast, preferable between 6.00 am and 8.00 am in the morning.
Croatian: • Kada se ujutro probudite progutajte cijelu tabletu Plenadrena s čašom vode i barem 30 minuta prije doručka, a poželjno je da to bude između 6 i 8 sati ujutro.
English: The daily dose of Plenadren may have to be doubled or tripled in milder conditions such as a mild infection or stress.
Croatian: Možda ćete trebati dnevnu dozu Plenadrena povećati dvostruko ili trostruko u slučaju lakših stanja kao što je blaga infekcija ili stres.
English: Treatment of adrenal insufficiency in adults.
Croatian: Liječenje adrenalne insuficijencije u odraslih.
English: • Diabetes or problems with blood sugar levels (shown in blood tests)
Croatian: • šećerna bolest ili teškoće s razinama šećera u krvi (vidljivo u nalazima pretraga krvi)
English: A too high dose of this medicine for more than a few days may be harmful to your health.
Croatian: Ako uzmete više lijeka Plenadren nego što ste trebali Previsoka doza ovog lijeka dulje od nekoliko dana može biti štetna za Vaše zdravlje.
English: If it is not enough to double the daily dose, you should take a third dose 6 to 10 hours after the second dose (6-10 hour intervals between doses).
Croatian: Ako nije dovoljno to što ste udvostručili dnevnu dozu, 6 do 10 sati nakon druge doze morat ćete uzeti treću dozu (razmaci između doza od 6 do 10 sati).
English: It should be swallowed whole; tablets should not be divided, chewed or crushed.
Croatian: Tabletu treba progutati cijelu; tablete se ne smiju lomiti, žvakati ili drobiti.
English: The dose must therefore be increased temporarily and your doctor may advise you to use other hydrocortisone tablets instead of, or in addition to Plenadren.
Croatian: Dozu stoga treba privremeno povećati i liječnik Vam može savjetovati da uzimate druge tablete hidrokortizona umjesto Plenadrena, ili kao dodatak
English: Therefore, patients should be advised of the signs and symptoms of acute adrenal insufficiency and of adrenal crisis and the need to seek immediate medical attention.
Croatian: Stoga bolesnike treba upozoriti na znakove i simptome akutne adrenalne insuficijencije te adrenalne krize i na potrebu da odmah potraže liječničku pomoć.
English: OTHER Shire Services BVBA
Croatian: DRUGO Shire Services BVBA
English: Plenadren is given as maintenance therapy.
Croatian: Doziranje Plenadren se daje kao terapija održavanja.
English: Therefore, there is no reason to believe that replacement doses of hydrocortisone will exacerbate any systemic infection or worsen the outcome of such an infection.
Croatian: Stoga nema razloga smatrati da će nadomjesne doze hidrokortizona pogoršati bilo koju sistemsku infekciju ili ishod takve infekcije.
English: This may require dose adjustment of hydrocortisone.
Croatian: Zbog toga može biti potrebna prilagodba doze hidrokortizona.
English: • Salt and water retention causing swelling and raised blood pressure (shown on medical examination) and low potassium level in the blood
Croatian: • zadržavanje soli i vode što uzrokuje oticanje i povišeni krvni tlak (vidljivo u nalazima pretraga) i niska razina kalija u krvi
English: Plenadren replaces the natural cortisol that is missing in adrenal insufficiency.
Croatian: Plenadren zamjenjuje prirodni kortizol koji u nedostaje u adrenalnoj insuficijenciji.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici boce i kutiji iza oznake EXP.
English: • St. John's wort - used to treat depression and other conditions
Croatian: • gospina trava - koristi se za liječenje depresije i drugih stanja
English: Paediatric population No pharmacokinetic data are available in children or adolescents.
Croatian: Nema farmakokinetičkih podataka za djecu ili adolescente.
English: - if you are allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Plenadren - ako ste alergični na hidrokortizon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: The following signs and symptoms may suggest that you need to take additional doses of Plenadren or other forms of hydrocortisone: fatigue, weight loss, stomach discomfort, feeling light headed when you change from sitting to standing or dizziness when standing, darkening of your skin particularly skin creases and exposed areas.
Croatian: Sljedeći znakovi i simptomi mogu ukazivati na to da su Vam potrebne dodatne doze Plenadrena ili drugi oblici hidrokortizona: umor, gubitak težine, nelagoda u trbuhu, osjećaj ošamućenosti pri promjeni položaja iz sjedećeg u stojeći ili omaglica kada stojite, tamnjenje kože, osobito nabora i izloženih područja.
English: If more than one daily administration is required the morning dose should be given as instructed, additional doses given later during the day can be given with or without food.
Croatian: Ako je primjena lijeka češća od jednom dnevno, za jutarnju se dozu treba pridržavati uputa dok se dodatne doze, koje se uzimaju kasnije tijekom dana, mogu uzeti s hranom ili bez nje.
English: Reproductive studies in animals have shown that glucocorticoids can cause foetal abnormalities and reproductive toxicity, see section 5.3.
Croatian: Ispitivanja reprodukcije na životinjama pokazala su da glukokortikoidi mogu prouzročiti nepravilnosti fetusa i reproduktivnu toksičnost, vidjeti dio 5.3.
English: Patients suffering from long-term (chronic) adrenal insufficiency need a replacement therapy to survive.
Croatian: Bolesnicima koji pate od dugotrajne (kronične) adrenalne insuficijencije potrebna je nadomjesna terapija kako bi preživjeli.
English: Talk to your doctor if you experience any of these side effects:
Croatian: Obratite se liječniku ako primijetite bilo koju od ovih nuspojava:
English: If divided, crushed or chewed this may prevent the hydrocortisone dose in the tablet to cover the whole day, as it should.
Croatian: Ako ih razlomite, drobite ili žvačete možete spriječiti da doza hidrokortizona u tableti djeluje cijeloga dana onako kako bi trebala.
English: Date of latest renewal: 8
Croatian: Datum posljednje obnove odobrenja: 8. kolovoza 2016.
English: Adrenal insufficiency occurs when your adrenal glands (just above your kidneys) do not produce enough of the hormone cortisol.
Croatian: Adrenalna insuficijencija nastupa kada nadbubrežne žlijezde (smještene neposredno iznad bubrega) ne proizvode dovoljno hormona kortizola.
English: This terminal half-life is similar to the pharmacokinetics of endogenous cortisol that also is secretion-controlled.
Croatian: Taj terminalni poluvijek sličan je farmakokinetici endogenog kortizola pri kojem je također kontrolirano izlučivanje.
English: In plasma, cortisol is bound to corticosteroid-binding globulin (CBG, also called transcortin) and albumin.
Croatian: U plazmi je kortizol vezan za globulin koji veže kortikosteroide (CBG, naziva se i transkortin) i za albumin.
English: If you stop taking Plenadren
Croatian: Ako prestanete uzimati Plenadren
English: Signs include high blood pressure, elevated plasma glucose levels and hypokalaemia.
Croatian: Znakovi uključuju visoki krvni tlak, povišene koncentracije glukoze u plazmi i hipokalijemiju.
English: MedDRA System Organ Class
Croatian: MedDRA - klasifikacije organskih sustava
English: When the oral dose is increased the total plasma exposure of cortisol increased less than proportional.
Croatian: Kada se poveća peroralna doza, ukupna izloženost kortizola u plazmi povećava se manje nego proporcionalno.
English: In patients with some remaining endogenous cortisol production a lower dose may be sufficient.
Croatian: U bolesnika u kojih još donekle postoji proizvodnja endogenog kortizola, može biti dovoljna niža doza.
English: Ask your doctor promptly for information on how you should handle these situations.
Croatian: Upitajte liječnika što prije za savjet kako riješiti takve situacije.
English: Poorly treated or untreated adrenal insufficiency reduces your ability to concentrate and will affect your ability to drive and use machines.
Croatian: Loše liječena ili neliječena adrenalna insuficijencija umanjuje sposobnost koncentracije i utjecat će na Vašu sposobnost vožnje i upotrebe strojeva.
English: The absorption rate of hydrocortisone was reduced after food intake resulting in a delay in the time to maximal concentration in plasma from on average less than 1 hour to over 2.5 hours.
Croatian: Brzina apsorpcije hidrokortizona smanjila se nakon unosa hrane, što je rezultiralo kašnjenjem u postizanju maksimalne koncentracije u plazmi koje je prosječno iznosilo manje od 1 sata pa do više od
English: Plenadren is used in adults to treat a condition known as adrenal insufficiency, or cortisol deficiency.
Croatian: Plenadren se upotrebljava u odraslih za liječenje stanja poznatog kao adrenalna insuficijencija ili nedostatak kortizola.
English: In situations when the body is exposed to excessive physical and/or mental stress, patients may need additional substitution of immediate release hydrocortisone tablets especially in the afternoon/evening, see also section ‘Use in intercurrent illness' where other ways of temporarily increasing the dose of hydrocortisone is described.
Croatian: U situacijama u kojima je tijelo izloženo prekomjernom fizičkom i/ili psihičkom stresu, bolesnicima može biti potrebna dodatna zamjenska tableta hidrokortizona s neposrednim/trenutnim oslobađanjem osobito poslije podne/uvečer, vidjeti također dio 'Primjena u slučaju istovremene bolesti' gdje su opisani drugi načini privremenog povećanja doze hidrokortizona.
English: Since severe renal impairment may affect medicinal products completely eliminated via metabolism, dose adjustment may be needed.
Croatian: Budući da teško oštećenje bubrežne funkcije može utjecati na lijekove koji se u potpunosti izlučuju metabolizmom, može biti potrebna prilagodba doze.
English: Symptoms may range from excitement/arousal to mania or psychosis.
Croatian: Simptomi mogu biti različiti; od uzbuđenosti/opće pobuđenosti do manije ili psihoze.
English: • Rifampicin or rifabutin - used to treat tuberculosis
Croatian: • rifampicin ili rifabutin - koristi se za liječenje tuberkuloze
English: INFORMATION IN BRAILLE Plenadren 20 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Plenadren 20 mg
English: During long-term prophylactic treatment with any of the antibiotics, adjustment of the hydrocortisone dosage should be considered.
Croatian: Tijekom dugotrajnog profilaktičkog liječenja bilo kojim antibiotikom potrebno je razmisliti o prilagodbi doze hidrokortizona.
English: Hydrocortisone interactions listed below have been reported after therapeutic doses of glucocorticoids.
Croatian: Interakcije hidrokortizona navedene u nastavku, zabilježene su nakon terapijskih doza glukokortikoida.
English: Infants of mothers taking high doses of systemic glucocorticoids for prolonged periods may be at risk of adrenal suppression.
Croatian: Djeca majki koje uzimaju visoke doze sistemskih glukokortikoida tijekom duljeg razdoblja mogu biti izložena riziku od adrenalne supresije.
English: INFORMATION IN BRAILLE Plenadren 5 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Plenadren 5 mg
English: During short-term or temporary illnesses such as infection, fever, or physical stress such as surgery you will need more hydrocortisone since the body cannot produce the additional amount of cortisol required in these situations.
Croatian: Za vrijeme kratkotrajne ili privremene bolesti kao što su infekcija, vrućica ili tjelesni stres poput kirurškog zahvata, bit će Vam potrebno više hidrokortizona jer tijelo ne može proizvesti dodatne količine kortizola potrebne u takvim situacijama.
English: Moreover, there is no reason to believe that doses of hydrocortisone used for replacement therapy in adrenal insufficiency may reduce the response to vaccines and increase the risk of generalised infection with live vaccines.
Croatian: Nadalje, nema razloga smatrati da bi doze hidrokortizona, primjenjivane kao nadomjesna terapija pri adrenalnoj insuficijenciji, mogle smanjiti odgovor na cjepiva i povećati rizik od generalizirane infekcije živim cjepivima.
English: If you forget to take Plenadren
Croatian: Ako ste zaboravili uzeti Plenadren
English: Treatment of primary adrenal insufficiency often warrants addition of a mineralocorticoid.
Croatian: U liječenju primarne adrenalne insuficijencije često je nužno dodati mineralokortikoid.
English: This may happen when you have stomach problems involving vomiting and/or diarrhoea.
Croatian: To se može dogoditi ako imate želučanih tegoba uključujući povraćanje i/ili proljev.
English: A total of 80 patients (173 patient-years of data) have been treated with modified-release hydrocortisone in clinical studies.
Croatian: U kliničkim ispitivanjima ukupno 80 bolesnika (podaci za 173 bolesnik-godina) liječeno je hidrokortizonom s prilagođenim oslobađanjem.
English: If you are changing treatment from other hydrocortisone tablets to Plenadren you may experience side effects during the first weeks.
Croatian: Ako mijenjate terapiju i prelazite s drugih tableta hidrokortizona na Plenadren, prvih tjedana uzimanja možete opaziti nuspojave.
English: However, talk to your doctor if you plan to breast-feed your baby.
Croatian: Ipak, obratite se liječniku ako planirate dojiti.
English: • Pain in the joints
Croatian: • bol u zglobovima
English: Hydrocortisone is given as replacement therapy aimed at restoring normal cortisol levels.
Croatian: Hidrokortizon se daje kao nadomjesna terapije radi uspostave normalnih koncentracija kortizola.
English: During long term treatment with medicines treating infections (antibiotics) the dose of Plenadren may need adjustment by your doctor.
Croatian: Tijekom dugotrajnog uzimanja lijekova protiv infekcija (antibiotici) možda će Vam liječnik morati prilagoditi dozu Plenadrena.
English: The cortisol levels in your blood increase rapidly to a maximum level, about 1 hour after taking the tablet in the morning, and then gradually decrease over the day with no or almost no cortisol level in the blood in the late evening and night when the levels should be low.
Croatian: Razina kortizola u krvi brzo se poveća do najviše razine otprilike 1 sat otkako ste ujutro uzeli tabletu, a zatim se postupno smanjuje tijekom dana s tim da kasno navečer i noću, kada razine trebaju biti niske, uopće nema ili gotovo nema razine kortizola u krvi.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS BOTTLE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BOCA
English: • The active substance is hydrocortisone.
Croatian: • Djelatna tvar je hidrokortizon.
English: Psychiatric disorders Euphoria and psychosis, insomnia.
Croatian: Euforija i psihoza, nesanica.
English: Following oral administration, hydrocortisone is rapidly and well absorbed from the gastrointestinal tract and the absorption has been reported to be more than 95% for an oral 20 mg dose (tablets).
Croatian: Nakon peroralne primjene hidrokortizon se brzo i dobro apsorbira iz probavnog sustava pa je za jednu peroralnu dozu od 20 mg (tableta) zabilježena apsorpcija iznad 95%.
English: Plenadren can be used during pregnancy.
Croatian: Plenadren se smije primjenjivati u trudnoći.
English: Animal experiments have shown that prenatal exposure to very high doses of glucocorticoids can induce malformations (cleft palate, skeletal malformations).
Croatian: Pokusi na životinjama pokazali su da prenatalna izloženost vrlo visokim dozama glukokortikoida može prouzročiti malformacije (rascjep nepca, malformacije kostura).
English: Animal studies have also shown that prenatal exposure to high doses of glucocorticoids (but lower than teratogenic doses) may be associated with increased risk of intrauterine growth retardation, cardiovascular disease in adulthood and permanent changes in glucocorticoid receptor density, neurotransmitter turnover and behaviour.
Croatian: Ispitivanja na životinjama također su pokazala da prenatalna izloženost visokim dozama glukokortikoida (ali nižim od teratogenih) može biti povezana s povećanim rizikom od intrauterinog zastoja rasta, kardiovaskularnom bolešću u odrasloj dobi i s trajnim promjenama u gustoći receptora glukokortikoida, metabolizmu živčanih prijenosnika i ponašanju.
English: CYP 3A4 is involved in the clearance of cortisol by the formation of 6β-hydroxycortisol which is excreted in urine.
Croatian: CYP 3A4 uključen je u klirens kortizola stvaranjem 6β-hidrokortizola koji se izlučuje putem mokraće.
English: Glucocorticoids are important steroids for intermediary metabolism, immune function, musculoskeletal and connective tissue and the brain.
Croatian: Glukokortikoidi su steroidi važni u intermedijarnom metabolizmu, funkciji imunosti, važni za mišićno-koštani sustav i vezivno tkivo te mozak.
English: - if for any other reason your general health is declining although you take your medicine as prescribed; seek immediate medical care.
Croatian: Ako se Vaše zdravlje pogoršava iz nekog drugog razloga, iako uzimate lijek kako je propisano,
English: However, seek immediate medical help if you notice any of the following: severe weakness, fainting, abdominal pain, nausea, vomiting, back pain, confusion, reduced consciousness, delirium (very confused state).
Croatian: Međutim, bez odlaganja potražite liječničku pomoć ako opazite nešto od sljedećeg: teška slabost, nesvjestica, bol u trbuhu, mučnina, povraćanje, bol u leđima, smetenost, smanjena svijest, delirij
English: Hydrocortisone is eliminated completely by metabolism by 11ßHSD type 1 and type 2 enzymes and CYP 3A4 in the liver and in peripheral tissue.
Croatian: Hidrokortizon se potpuno eliminira metabolički putem enzima 11ßHSD tip 1 i tip 2 i enzima CYP 3A4
English: In case of severe hepatic impairment, the functional liver mass decreases and thus the metabolising capacity for hydrocortisone.
Croatian: U slučaju teškog oštećenja funkcije jetre, smanjuje se funkcionalna masa jetre a time i sposobnost metabolizacije hidrokortizona.