FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommended replacement doses of hydrocortisone are 8-10 mg/m2/day for patients with adrenal insufficiency alone and 10-15 mg/m2/day in patients with congenital adrenal hyperplasia (CAH), typically in three or four divided doses.
Croatian: Preporučene nadomjesne doze hidrokortizona su 8-10 mg/m2/dan u bolesnika samo s adrenalnom insuficijencijom i 10-15 mg/m2/dan u bolesnika s kongenitalnom adrenalnom hiperplazijom (KAH),
English: If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy which have been reported after use of systemic and topical corticosteroids.
Croatian: Ako bolesnik ima simptome kao što su zamućen vid ili neki drugi poremećaji vida, treba razmotriti potrebu da ga se uputi oftalmologu radi procjene mogućih uzroka, koji mogu uključivati kataraktu, glaukom ili rijetke bolesti kao što je centralna serozna korioretinopatija koja je zabilježena nakon sistemske i topikalne uporabe kortikosteroida.
English: Historical cohorts of adults treated from childhood for CAH have been found to have reduced bone mineral density and increased fracture rates and growth retardation (see section 4.4) - it is unclear if these relate to hydrocortisone therapy using current replacement regimens.
Croatian: U povijesnim kohortama odraslih osoba liječenih od djetinjstvu zbog kongenitalne adrenalne hiperplazije utvrđeno je smanjenje gustoće minerala u kostima i povišena stopa prijeloma te zastoj rasta (vidjeti dio 4.4) - nije jasno je li to povezano s terapijom hidrokortizonom u skladu s trenutačnim režimima nadomještanja.
English: Alkindi contains a medicine called hydrocortisone.
Croatian: Alkindi sadrži lijek naziva hidrokortizon.
English: Alkindi comes in high density polyethylene plastic bottles containing 50 capsules.
Croatian: Lijek Alkindi dostupan je u polietilenskim plastičnim bocama visoke gustoće koje sadrže 50 kapsula.
English: There is no information on any effects of Alkindi on fertility.
Croatian: Nema podataka o učincima lijeka Alkindi na plodnost.
English: 0.5 mg (red)
Croatian: 0,5 mg (crvena)
English: The coadministration of Alkindi with soft food (yoghurt and fruit puree) has been studied in vitro with no significant effect on dissolution seen.
Croatian: Istodobna primjena lijeka Alkindi i kašaste hrane (jogurt i voćni pire) ispitivana je in vitro te nije uočen značajan učinak na otapanje.
English: - Stomach pains (gastritis) or feelings of sickness (nausea).
Croatian: - Bol u želucu (gastritis) ili mučnina.
English: It may harm them, even if their signs of illness are the same as those of the child for whom this medicine has been prescribed - If your child gets any side effects, talk to your doctor or pharmacist.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolesti jednaki onima u djeteta za kojeg je ovaj lijek propisan.
English: Patients with dysphagia or premature infants where oral feeding has not been established.
Croatian: Bolesnici s disfagijom ili prijevremeno rođena djeca koja se još ne hrane oralnim putem.
English: Hydrocortisone belongs to a group of medicines known as corticosteroids.
Croatian: Hidrokortizon pripada skupini lijekova koji se nazivaju kortikosteroidi.
English: The granules may sometimes be seen in stools since the centre of the granule is not absorbed in the gut after it has released the active substance.
Croatian: Granule se ponekad mogu opaziti u stolici jer se središte granula ne apsorbira u crijevima nakon oslobađanja djelatne tvari.
English: The following adverse reactions have been reported in the scientific literature in adult patients for other hydrocortisone medicinal products when given as adrenal insufficiency replacement therapy with frequency not known (cannot be estimated from the available data).
Croatian: U znanstvenoj literaturi zabilježene su sljedeće nuspojave u odraslih bolesnika pri primjeni drugih lijekova s hidrokortizonom u nadomjesnoj terapiji adrenalne insuficijencije, uz kategoriju učestalosti nepoznato (ne može se procijeniti na temelju dostupnih podataka).
English: - The capsule is made from hypromellose.
Croatian: - Kapsula se sastoji od hipromeloze.
English: If you stop giving Alkindi
Croatian: Ako prestanete davati Alkindi
English: During illnesses, at times of surgical operations and during times of serious stress, your endocrinologist may recommend additional doses of Alkindi and may also advise that your child receives other forms of hydrocortisone instead of, or as well as, Alkindi.
Croatian: Tijekom bolesti, kod kirurških zahvata i u vrijeme ozbiljnog stresa endokrinolog može predložiti uzimanje dodatnih doza lijeka Alkindi te preporučiti da Vaše dijete dobiva druge oblike hidrokortizona umjesto lijeka Alkindi ili u kombinaciji s lijekom Alkindi.
English: Glucocorticoids are adrenocortical steroids, both naturally-occurring and synthetic, which are readily absorbed from the gastro-intestinal tract.
Croatian: Glukokortikoidi su adrenokortikalni steroidi, i prirodno prisutni i sintetski, koji se lako apsorbiraju iz probavnog sustava.
English: Euphoria
Croatian: Euforija
English: Let your endocrinologist know if you are worried about your child's growth (see section 4).
Croatian: Obavijestite svog endokrinologa ako ste zabrinuti zbog rasta svog djeteta (vidjeti dio 4.).
English: Of these 24 patients, 23 had a diagnosis of CAH and 1 had a diagnosis of hypopituitarism including hypothyroidism.
Croatian: Od tih 24 bolesnika, 23 bolesnika imalo je dijagnozu kongenitalne adrenalne hiperplazije, a jedan bolesnik imao je dijagnozu hipopituitarizma i hipotireoidizma.
English: If you forget to give Alkindi
Croatian: Ako ste zaboravili dati Alkindi
English: A total of 30 healthy (but dexamethasone-suppressed) adult male subjects in two phase 1 studies and 24 paediatric patients with adrenal insufficiency in two phase 3 studies have been treated with Alkindi.
Croatian: Lijekom Alkindi liječeno je ukupno 30 zdravih (ali deksametazonom suprimiranih) odraslih muških ispitanika u dvama ispitivanjima faze I i 24 pedijatrijska bolesnika s adrenalnom insuficijencijom u dvama ispitivanjima faze III.
English: Your endocrinologist will monitor your child's potassium levels to check for any changes.
Croatian: Endokrinolog će pratiti razine kalija u Vašeg djeteta kako bi uočio bilo kakve promjene.
English: Pack sizes: 1 bottle containing 50 capsules
Croatian: Jedna boca sadrži 50 kapsula
English: Medicines that may mean your endocrinologist will decrease your child's dose of Alkindi include: - Medicines used to treat fungal diseases: itraconazole, posaconazole, and voriconazole.
Croatian: Lijekovi zbog kojih endokrinolog može smanjiti dozu lijeka Alkindi koju Vaše dijete dobiva uključuju: - Lijekove koji se primjenjuju za liječenje gljivičnih oboljenja: itrakonazol, posakonazol i vorikonazol.
English: No studies have been conducted in patients with hepatic or renal impairment.
Croatian: Nisu provedena ispitivanja u bolesnika s oštećenjem jetre ili bubrega.
English: The pivotal study was an open-label single-dose single-centre trial in 24 paediatric patients aged less than 6 years requiring replacement therapy for adrenal insufficiency due to CAH, primary adrenal failure or hypopituitarism.
Croatian: Pedijatrijska populacija Ključno ispitivanje bilo je otvoreno, monocentrično ispitivanje primjene jedne doze u 24 pedijatrijska bolesnika mlađa od šest godina kojima je trebala nadomjesna terapija adrenalne insuficijencije uzrokovane kongenitalnom adrenalnom hiperplazijom, primarnim zatajenjem nadbubrežnih žlijezda ili hipopituitarizmom.
English: Parenteral administration of hydrocortisone is warranted during transient illness episodes such as severe infections, in particular gastroenteritis associated with vomiting and/or diarrhoea, high fever of any aetiology or extensive physical stress, such as for instance serious accidents and surgery under general anaesthesia.
Croatian: Parenteralna primjena hidrokortizona nužna je tijekom prolaznih epizoda bolesti kao što su teške infekcije, posebice gastroenteritis povezan s povraćanjem i/ili proljevom, visoka vrućica bilo koje etiologije ili velik tjelesni stres prouzročen primjerice ozbiljnom nesrećom i kirurškim zahvatom pod općom anestezijom.
English: - Anti-fungals: itraconazole, posaconazole, voriconazole - Antibiotics: erythromycin and clarithromycin - Antiretroviral medicinal products: ritonavir - Grapefruit juice
Croatian: - Antimikotici: itrakonazol, posakonazol, vorikonazol - Antibiotike: eritromicin i klaritromicin - Antiretrovirusne lijekove: ritonavir - Sok od grejpa
English: - Changes in blood potassium levels, leading to excessive alkalinity of body tissues or fluids (hypokalaemic alkalosis).
Croatian: - Promjene u razini kalija u krvi koje uzrokuju pretjeranu lužnatost tjelesnih tkiva ili tekućina
English: Following oral administration, hydrocortisone is rapidly absorbed from the gastro-intestinal tract and the oral Alkindi 4x5 mg was approximately 87 % bioavailable when compared to intravenous hydrocortisone in dexamethasone-suppressed healthy adult male volunteers.
Croatian: Nakon peroralne primjene, hidrokortizon se brzo apsorbira iz probavnog sustava te je lijek Alkindi 4 x 5 mg za peroralnu primjenu bio otprilike 87 % bioraspoloživ u usporedbi s intravenskom primjenom hidrokortizona u zdravih, deksametazonom suprimiranih odraslih muških dobrovoljaca.
English: Medicines used to treat AIDS: efavirenz and nevirapine.
Croatian: Lijekove koji se primjenjuju za liječenje AIDS-a: efavirenz i nevirapin.
English: Taking Alkindi should not stop your child being vaccinated.
Croatian: Uzimanje lijeka Alkindi ne smije onemogućiti cijepljenje Vašeg djeteta.
English: Dosage must be individualised according to the response of the individual patient.
Croatian: Doziranje mora biti prilagođeno pojedincu sukladno odgovoru u pojedinog bolesnika.
English: Medicines used to treat infections (antibiotics): rifampicin and rifabutin.
Croatian: Lijekove za liječenje infekcija (antibiotici): rifampicin i rifabutin.
English: Tell your endocrinologist straight away if your child has any reaction like swelling or shortness of breath after being given Alkindi (see section 4).
Croatian: Odmah obavijestite svog endokrinologa ako Vaše dijete ima reakcije kao što su oticanje ili nedostatak zraka nakon dobivanja lijeka Alkindi (vidjeti dio 4.)
English: Hypokalaemic alkalosis
Croatian: Hipokalemička alkaloza
English: - Some adult patients taking hydrocortisone (similar to Alkindi) became anxious, depressed or confused.
Croatian: Neki odrasli bolesnici koji su uzimali hidrokortizon (sličan lijeku Alkindi) postali su tjeskobni,
English: Sudden discontinuation of therapy with Alkindi risks triggering an adrenal crisis and death.
Croatian: U slučaju naglog prekida liječenja lijekom Alkindi postoji rizik od izazivanja adrenalne krize i smrtnog ishoda.
English: How to give Alkindi
Croatian: Kako davati Alkindi
English: - The printing ink on the capsules contains shellac, propylene glycol, and concentrated ammonia solution.
Croatian: - Tinta za označavanje na kapsulama sadrži šelak, propilenglikol i koncentriranu otopinu amonijaka.
English: Changing from conventional oral glucocorticoid treatment to Alkindi When changing patients from conventional oral hydrocortisone replacement therapy to Alkindi, an identical total daily dose may be given.
Croatian: Prijelaz s konvencionalnog peroralnog liječenja glukokortikoidima na liječenje lijekom Alkindi Pri prijelazu bolesnika s konvencionalne peroralne nadomjesne terapije hidrokortizonom na liječenje lijekom Alkindi može se davati jednaka ukupna dnevna doza.
English: Replacement schedules of corticosteroids for people with adrenal insufficiency do not cause immunosuppression and are not, therefore, contraindications for administration of live vaccines.
Croatian: Raspored davanja nadomjesne terapije kortikosteroidima ne uzrokuje imunosupresiju u osoba s adrenalnom insuficijencijom te stoga ne predstavlja kotraindikaciju za primjenu živih cjepiva.
English: Capsule Hypromellose
Croatian: Kapsula Hipromeloza
English: Excretion of granules
Croatian: Izlučivanje granula
English: Detailed pictograms on how to administer the granules are provided in the package leaflet.
Croatian: Piktogrami s pojedinostima o načinu primjene granula nalaze se u uputi o lijeku.
English: Distribution 90% or more of circulating hydrocortisone is reversibly bound to protein.
Croatian: Hidrokortizon u krvi se reverzibilno vezuje (90 % ili više) na proteine.
English: 2 mg (green)
Croatian: 2 mg (zelena)
English: The granules are white to off-white and contained in a transparent colourless (size 00el) hard capsule.
Croatian: Granule su bijele do bjelkaste i nalaze se u prozirnoj tvrdoj kapsuli (veličine 00el) bez boje.
English: Medicinal products inducing CYP3A4, requiring a potential increase in Alkindi dosing, include but are not limited to:
Croatian: Lijekovi koji induciraju CYP3A4 i kod kojih može trebati povećanje doze lijeka Alkindi uključuju, ali nisu ograničeni na:
English: - Medicines used to treat infections (antibiotics): erythromycin and clarithromycin.
Croatian: - Lijekove za liječenje infekcija (antibiotici): eritromicin i klaritromicin.
English: The ink on the 1 mg strength capsule also contains indigotine (E132).
Croatian: Tinta na kapsuli jačine 1 mg također sadrži indigotin (E132).
English: The study used a single dose of Alkindi granules equivalent to the previous morning's dose of each patient's usual glucocorticoid treatment.
Croatian: U ispitivanju je primijenjena jedna doza granula lijeka Alkindi koja je bila ekvivalent dozi uobičajenog glukokortikoida kojeg je pojedini bolesnik dobio prethodnog jutra.
English: Infection should not be more likely at a replacement dose of hydrocortisone, but all infections should be treated seriously and stress dosing of steroid initiated early (see section 4.2).
Croatian: no svim infekcijama treba pristupiti ozbiljno i u ranoj fazi započeti s doziranjem steroida prilagođenim razini stresa (vidjeti dio 4.2).
English: Hydrocortisone is a synthetic version of the hormone cortisol.
Croatian: Hidrokortizon je sintetski oblik hormona kortizol.
English: Contact your endocrinologist if your child complains of these.
Croatian: Obratite se svojem endokrinologu ako se dijete žali na navedene poteškoće.
English: This is because the centre of the granule is not absorbed in the gut after it has released the medicine.
Croatian: To je zbog toga što središte granula nije apsorbirano u crijevima nakon oslobađanja djelatne tvari.
English: Where a child is vomiting or acutely unwell parenteral hydrocortisone should be started without delay, carers should be trained in adminstering this in an emergency.
Croatian: Ako dijete povraća ili se izrazito loše osjeća, treba bez odgađanja započeti s parenteralnom primjenom hidrokortizona, a njegovatelje treba osposobiti za takvu primjenu lijeka u hitnim situacijama.
English: Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate, intrauterine growth retardation and effects on brain growth and development.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Primjena kortikosteroida u gravidnih životinja može prouzročiti abnormalnosti u razvoju fetusa, uključujući rascjep nepca, intrauterini zastoj rasta i učinke na rast i razvoj mozga.
English: These include: - Grapefruit juice.
Croatian: - Sok od grejpa.
English: Your endocrinologist will decide on the right dose of Alkindi based on your child's weight or size (body surface area) and then adjust the dose of Alkindi as your child grows.
Croatian: Vaš će endokrinolog odrediti pravu dozu lijeka Alkindi na temelju tjelesne težine ili veličine (površine tijela) Vašeg djeteta te će kasnije, kako dijete raste, prilagođavati i dozu lijeka.
English: Fertility There are no data available for possible effects of Alkindi on fertility.
Croatian: Nema dostupnih podataka o mogućim učincima lijeka Alkindi na plodnost.
English: Do not stop giving your child Alkindi without asking your endocrinologist first.
Croatian: Nemojte prestati s davanjem lijeka Alkindi djetetu bez prethodnog savjetovanja s endokrinologom.
English: Replacement therapy in primary and secondary adrenal insufficiency Alkindi is given as replacement therapy by oral administration of granules according to clinical practice, in a dose to be titrated against individual clinical response.
Croatian: Lijek Alkindi daje se kao nadomjesna terapija peroralnom primjenom granula u skladu s kliničkom praksom, u dozi koju treba titrirati prema pojedinačnom kliničkom odgovoru.
English: 1 mg (blue)
Croatian: 1 mg (plava)
English: - The top of the capsule is twisted off. - The granules are either poured directly onto the child's tongue, or the granules are poured onto a spoon and placed in the child's mouth.
Croatian: - Granule sipajte izravno na jezik djeteta ili u žlicu koju potom stavite u usta djeteta.
English: White to off-white granules which are contained in a transparent colourless hard capsule for opening; the strength is printed on the capsule.
Croatian: Granule su bijele do bjelkaste i nalaze se u prozirnoj i bezbojnoj tvrdoj kapsuli za otvaranje: jačina je otisnuta na kapsuli.
English: Medicinal product-induced secondary adrenocortical insufficiency may result from too rapid a withdrawal of corticosteroids and may be minimised by gradual reduction of dosage.
Croatian: Prebrza obustava liječenja kortikosteroidima može prouzročiti sekundarnu adrenokortikalnu insuficijenciju induciranu lijekom koja se može ublažiti postupnim smanjenjem doze.
English: Alkindi was positively assessed in terms of palatability.
Croatian: U pogledu palatabilnosti, lijek Alkindi pozitivno je ocijenjen.
English: The lowest appropriate dose of steroid according to the response of the individual patient should be used.
Croatian: Sukladno odgovoru u pojedinog bolesnika, treba primjenjivati najnižu odgovarajuću dozu steroida.
English: Microcrystalline cellulose Hypromellose Magnesium stearate Ethyl cellulose
Croatian: Hipromeloza Magnezijev stearat Etilceluloza
English: Some food and drink may affect the way Alkindi works, and may mean that your endocrinologist needs to decrease your child's dose.
Croatian: Neke vrste hrane i pića mogu utjecati na način djelovanja lijeka Alkindi, što može značiti da će endokrinolog morati smanjiti dozu lijeka koju Vaše dijete dobiva.
English: - Too much Alkindi can affect your child's bones so your endocrinologist will adjust the dose depending on your child's size.
Croatian: - Prevelike količine lijeka Alkindi mogu utjecati na kosti Vašeg djeteta, stoga će endokrinolog prilagoditi dozu ovisno o veličini djeteta.
English: It is not known if this would happen with children, but tell your endocrinologist if your child develops any unusual behaviour after starting Alkindi (see section 4).
Croatian: Nije poznato može li se to dogoditi i djeci, ali obratite se svojem endokrinologu ako se Vaše dijete počne neuobičajeno ponašati nakon početka liječenja lijekom
English: The capsules are provided in highdensity polyethylene bottles with polypropylene closure with integrated desiccant.
Croatian: Kapsule se nalaze u polietilenskim bocama visoke gustoće s polipropilenskim zatvaračem koji ima umetnuto sredstvo za sušenje.
English: Breast-feeding Hydrocortisone for replacement therapy can be used during breast-feeding.
Croatian: Dojenje Nadomjesna terapija hidrokortizonom se može primjenjivati tijekom dojenja.
English: Indigotine (E132), Yellow iron oxide (E172), Titanium dioxide (E171)
Croatian: Indigotin (E132), žuti željezov oksid (E172), titanijev dioksid (E171)
English: Red iron oxide (E172), Potassium hydroxide
Croatian: Crveni željezov oksid (E172), kalijev hidroksid
English: - Whichever method is used, the capsule is tapped to ensure all the granules are removed.
Croatian: - Bez obzira na način primjene, kapsulu treba kucnuti prstom kako bi se u potpunosti ispraznila.
English: Hydrocortisone for replacement therapy can be used during pregnancy The ability of corticosteroids to cross the placenta varies between the different types of corticosteroids, however, hydrocortisone readily crosses the placenta.
Croatian: Mogućnost prijenosa kortikosteroida preko posteljice varira između različitih vrsta kortikosteroida, međutim, hidrokortizon s lakoćom prolazi kroz posteljicu.
English: The ink on the 0.5 mg strength capsule also contains potassium hydroxide and red iron oxide (E172).
Croatian: Tinta na kapsuli jačine 0,5 mg također sadrži kalijev hidroksid i crveni željezov oksid (E172).
English: The Alkindi dose range administered was 1 mg - 4 mg. Parents/carers (and where possible children) assessed the palatability of Alkindi after administration using a 5-item Likert scale.
Croatian: Roditelji/njegovatelji (i kada je to bilo moguće, djeca) ocijenili su nakon primjene palatabilnost lijeka Alkindi prema Likertovoj ljestvici od pet stupnjeva.
English: Alkindi granules are not suitable for giving through a nasogastric tube as the granules may block the tube.
Croatian: Lijek Alkindi u granulama nije prikladan za davanje putem nazogastrične sonde jer granule mogu začepiti sondu.
English: Do not administer via nasogastric tube as there is a risk of nasogastric tube blockage.
Croatian: Nemojte primjenjivati putem nazogastrične sonde jer postoji rizik od začepljenja nazogastrične sonde.
English: All inks contain Shellac, Propylene glycol, Concentrated ammonia solution
Croatian: Šelak, propilenglikol, koncentriranu otopinu amonijaka
English: Hydrocortisone is believed to be the principal corticosteroid secreted by the adrenal cortex.
Croatian: Smatra se da je hidrokortizon glavni kortikosteroid koji izlučuje kora nadbubrežne žlijezde.
English: Some medicines can affect the way that Alkindi works, and may mean that your endocrinologist needs to alter your child's dose of Alkindi.
Croatian: Neki lijekovi mogu utjecati na način djelovanja lijeka Alkindi, što može značiti da će endokrinolog morati promijeniti dozu lijeka Alkindi koju Vaše dijete dobiva.
English: Strength (ink colour) Also contains:
Croatian: Također sadrže:
English: 5 mg (grey)
Croatian: 5 mg (siva)
English: Alkindi 0.5 mg granules in capsules for opening Alkindi 1 mg granules in capsules for opening Alkindi 2 mg granules in capsules for opening Alkindi 5 mg granules in capsules for opening
Croatian: Alkindi 0,5 mg granule u kapsulama za otvaranje Alkindi 1 mg granule u kapsulama za otvaranje Alkindi 2 mg granule u kapsulama za otvaranje Alkindi 5 mg granule u kapsulama za otvaranje
English: Your endocrinologist will train you how to do this in an emergency.
Croatian: Vaš endokrinolog će vas osposobiti za takvu primjenu lijeka u hitnim situacijama. se Vaše dijete mora cijepiti.
English: Let the anaesthetist know your child is receiving Alkindi before your child has their operation.
Croatian: Prije operacije pravovremeno obavijestite anesteziologa da Vaše dijete dobiva lijek Alkindi.
English: - The bottom of the capsule is gently squeezed.
Croatian: - Nježno stisnite donji dio kapsule.
English: Titanium dioxide (E171), Black iron oxide (E172), Potassium hydroxide
Croatian: Titanijev dioksid (E171), crni željezov oksid (E172), kalijev hidroksid
English: The ink on the 2 mg strength capsule also contains indigotine (E132), yellow iron oxide (E172), and titanium dioxide (E171).
Croatian: Tinta na kapsuli jačine 2 mg također sadrži indigotin (E132), žuti željezov oksid (E172) i titanijev dioksid (E171).
English: - The capsule is held so that the printed strength is at the top, and tapped to ensure all the granules are in the lower half of the capsule.
Croatian: Ovojnica kapsule ne smije se progutati, nego je treba pažljivo otvoriti na sljedeći način: - Kapsulu držite tako da se otisnuta jačina nalazi na gornjem dijelu, potom kucnite prstom po kapsuli kako biste bili sigurni da se sve granule nalaze u donjem dijelu.
English: The ink on the 5 mg strength capsule also contains potassium hydroxide, titanium dioxide (E171), and black iron oxide (E172).
Croatian: Tinta na kapsuli jačine 5 mg također sadrži kalijev hidroksid, titanijev dioksid (E171) i crni željezov oksid (E172).