FrancophonIA/ELRC3.0 huggingface dataset:
English: Always use this medicine exactly as your endocrinologist, nurse or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako Vam je rekao endokrinolog, medicinska sestra ili ljekarnik.
English: The binding is accounted for by two protein fractions.
Croatian: U vezivanju sudjeluju dvije frakcije proteina.
English: Contents of the pack and other information What Alkindi contains
Croatian: Sadržaj pakiranja i druge informacije Što Alkindi sadrži
English: Other medicines and Alkindi
Croatian: Drugi lijekovi i Alkindi
English: Risks may be higher with high doses/systemic exposure (see also section 4.5), although dose levels do not allow prediction of the onset, type, severity or duration of reactions.
Croatian: Rizici mogu biti povišeni pri velikim dozama / sistemskoj izloženosti (vidjeti također dio 4.5), iako razine doza ne omogućavaju predviđanje početka, vrste, ozbiljnosti ili trajanja reakcija.
English: - If your child has difficulties swallowing food, or is a premature baby who cannot yet be fed by mouth.
Croatian: - Ako Vaše dijete ima poteškoće s gutanjem hrane ili je nedonošče koje se još ne može hraniti kroz usta.
English: Treatment should be limited to the minimum dosage required to achieve desired clinical response and when reduction in dosage is possible, the reduction should be gradual.
Croatian: Liječenje treba ograničiti na najmanju dozu potrebnu za postizanje željenog kliničkog odgovora, a kada je moguće smanjenje doze, ono mora biti postupno.
English: Check with your endocrinologist, nurse or pharmacist if you are not sure.
Croatian: Provjerite sa svojim endokrinologom, medicinskom sestrom ili ljekarnikom ako niste sigurni.
English: This does not mean the medicine will not work and you do not need to give your child another dose.
Croatian: To ne znači da lijek neće djelovati i nema potrebe da djetetu dajete još jednu dozu lijeka.
English: Once the bottle has been opened, use the capsules within 60 days.
Croatian: Nakon otvaranja boce upotrijebiti kapsule unutar 60 dana.
English: Psychosis with hallucinations and delirium Mania
Croatian: Psihoza s halucinacijama i delirijem Manija
English: If you forget to give your child a dose, give your child that dose as soon as you remember as well as their next dose at the usual time even if this means that your child receives two doses at the same time.
Croatian: Ako ste zaboravili djetetu dati dozu lijeka, dajte mu dozu čim se sjetite, te sljedeću dozu u uobičajeno vrijeme, čak i ako to znači da će dijete dobiti dvije doze odjednom.
English: Immediately after administration a drink such as water, milk, breast-milk, or formula-milk should be given to help ensure all granules are swallowed.
Croatian: Neposredno nakon primjene djetetu treba dati piće kao što je voda, mlijeko, majčino mlijeko ili mliječna formula kako biste bili sigurni da je progutalo sve granule.
English: What Alkindi looks like and contents of the pack
Croatian: Kako Alkindi izgleda i sadržaj pakiranja
English: Do not swallow the capsule, risk of choking.
Croatian: Ne gutati kapsulu, rizik od gušenja.
English: - If your child is allergic to hydrocortisone or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ako je Vaše dijete alergično na hidrokortizon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, corticosteroid therapy should be reinstated.
Croatian: Ovakva vrsta relativne insuficijencije može trajati mjesecima nakon prekida liječenja, te bi stoga u slučaju bilo kakve stresne situacije tijekom tog razdoblja trebalo ponovno započeti liječenje kortikosteroidima.
English: This does not mean the medicinal product has been ineffective and the patient should not take another dose for this reason.
Croatian: To ne znači da je lijek bio neučinkovit i bolesnik ne smije zbog toga uzeti još jednu dozu.
English: Infants require frequent assessment and should be evaluated at a minimum every 3 to 4 months to assess growth, blood pressure, and general well-being.
Croatian: Potrebno je učestalo praćenje dojenčadi i provođenje evaluacije najmanje svaka tri do četiri mjeseca kako bi se ocijenio rast, krvni tlak i općenito zdravlje.
English: Glucocorticoids cause profound and varied metabolic effects.
Croatian: Glukokortikoidi uzrokuju snažne i različite metaboličke učinke.
English: The study consisted of three consecutive cohorts, the first including 12 patients aged 2 to less than 6 years, the second including 6 patients aged 28 days to less than 2 years, and the third including 6 neonates aged from birth to less than 28 days.
Croatian: Ispitivanje je obuhvatilo tri skupine s dobnim slijedom, od kojih je prva uključivala 12 bolesnika u dobi od dvije do manje od šest godina, druga šest bolesnika u dobi od 28 dana do manje od dvije godine, i treća šestoro novorođenčadi u dobi od rođenja do manje od 28 dana.
English: As this was a single-dose study, the primary efficacy assessment was serum cortisol at 60 minutes.
Croatian: Budući da je to bilo ispitivanje primjene jedne doze, primarna ocjena djelotvornosti bila je koncentracija kortizola u serumu nakon 60 minuta.
English: If the granules are sprinkled onto a spoonful of soft food this should be given immediately (within 5 minutes) and not stored for future use.
Croatian: Ako se granule posipaju na žlicu kašaste hrane, treba je odmah dati djetetu (unutar pet minuta), a ne ostavljati za kasniju uporabu.
English: Frequency: not known
Croatian: Učestalost: nepoznata
English: Among parents and carers asked about their child's experience of taking the medication (n=23), 82.6% agreed/strongly agreed that their child found swallowing Alkindi easy; 65.2% agreed/strongly agreed that their child showed a positive reaction after Alkindi administration; 95.5% would be happy to give their child Alkindi in the future; and 95.5% said that they would prefer Alkindi for their child's treatment over their usual hydrocortisone formulation.
Croatian: Između roditelja i njegovatelja kojima je postavljeno pitanje o iskustvu djeteta s uzimanjem lijeka (n = 23), 82,6 % složilo se / izrazito se složilo da je njihovom djetetu gutanje lijeka Alkindi bilo lagano; 65,2 % složilo se / izrazito se složilo da je njihovo dijete pozitivno reagiralo nakon primjene lijeka Alkindi; 95,5 % je izjavilo da bi voljeli svom djetetu u budućnosti davati lijek Alkindi; i 95,5 % je izjavilo da bi dali prednost liječenju svog djeteta lijekom Alkindi u odnosu na uobičajenu formulaciju hidrokortizona.
English: ≥50% subjects reported that the taste, feel in mouth and ease of swallowing were very good and that they were likely to take the medicinal product again.
Croatian: Zabilježeno je da je ≥ 50 % ispitanika prijavilo vrlo dobar okus, osjećaj u ustima i lakoću gutanja, te da bi vjerojatno ponovo uzeli taj lijek.
English: Hydrocortisone is metabolised by cytochrome P450 3A4 (CYP3A4).
Croatian: Hidrokortizon se metabolizira putem citokroma P450 3A4 (CYP3A4).
English: The granules should be given into the mouth and should not be chewed.
Croatian: Granule se moraju davati u usta i ne smiju se žvakati.
English: If your child is vomiting or seriously unwell, your child may need an injection of hydrocortisone.
Croatian: Ako Vaše dijete povraća ili mu je izrazito loše, možda mu je potrebna injekcija hidrokortizona.
English: Warning Alkindi granules come in a capsule that must be opened before use, discard the empty capsule after use out of reach of children.
Croatian: Upozorenje Granule Alkindi dolaze u kapsuli koja se mora otvoriti prije uporabe, a nakon uporabe odložite praznu kapsulu izvan dosega djece.
English: Alkindi has no or negligible influence on the ability to drive and use machines.
Croatian: Alkindi ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Hydrocortisone can be used during pregnancy and breast-feeding when the body is not making enough cortisol.
Croatian: Hidrokortizon se može primjenjivati tijekom trudnoće i dojenja, kada tijelo ne proizvodi dovoljno kortizola.
English: The capsule shell must not be swallowed but carefully be opened as follows:
Croatian: Ovojnica kapsule ne smije se progutati, nego je treba pažljivo otvoriti na sljedeći način:
English: Patients/carers should be encouraged to seek medical advice if worrying psychological symptoms develop, especially if depressed mood or suicidal ideation is suspected.
Croatian: Potrebno je potaknuti bolesnike/njegovatelje da potraže savjet liječnika ako dođe do razvoja zabrinjavajućih psiholoških simptoma, posebice ako se sumnja na depresivno raspoloženje ili suicidalna razmišljanja.
English: The need for dose adjustment when such medicinal products are used can be anticipated and patients should be closely monitored.
Croatian: Može se očekivati da će trebati prilagoditi dozu prilikom primjene takvih lijekova, a bolesnike treba pomno pratiti.
English: Stopping the medicine suddenly could quickly make your child very unwell.
Croatian: Nagli prekid uzimanja lijeka mogao bi brzo dovesti do toga da Vašem djetetu bude izrazito loše.
English: Pharmacotherapeutic group: Corticosteroids for systemic use; Glucocorticoids.
Croatian: Farmakoterapijska skupina: kortikosteroidi za sistemsku uporabu; glukokortikoidi.
English: Hard capsule for opening, containing a single dose of granules.
Croatian: Tvrda kapsula za otvaranje, sadrži jednu dozu granula.
English: 1 patient had renal hypoplasia, 1 patient atopic dermatitis and 1 patient had rhinitis.
Croatian: Jedan bolesnik imao je renalnu hipoplaziju, jedan bolesnik imao je atopijski dermatitis i jedan bolesnik imao je rinitis.
English: If you give more Alkindi than you should
Croatian: Ako ste dali više lijeka Alkindi nego što ste trebali
English: Where parenteral hydrocortisone is required, the patient should be treated in a facility with resuscitation facilities in case of evolving adrenal crisis.
Croatian: Ako je potrebna parenteralna primjena hidrokortizona, bolesnika treba liječiti u ustanovi u kojoj su dostupni uređaji za oživljavanje u slučaju razvoja adrenalne krize.
English: Patients/carers should also be alert to possible psychiatric disturbances that may occur either during or immediately after dose tapering/withdrawal of systemic steroids, although such reactions have been reported infrequently.
Croatian: Potrebno je upozoriti bolesnike/njegovatelje na moguće psihijatrijske poremećaje koji mogu nastupiti tijekom ili neposredno nakon smanjivanja/ustezanja doze sistemskih steroida, iako takve reakcije nisu često prijavljivane.
English: Medicines called barbiturates, which can be used to treat convulsions (including phenobarbital and primidone).
Croatian: Lijekove naziva barbiturati, koji se mogu primjenjivati u liječenju konvulzija (uključujući fenobarbital i primidon).
English: Do NOT swallow the capsule - small children may choke.
Croatian: NE gutati kapsulu - može doći do gušenja kod male djece.
English: Reports of acute toxicity and/or deaths following hydrocortisone overdose are rare.
Croatian: Akutna toksičnost i/ili smrtni slučajevi nakon predoziranja hidrokortizonom rijetko su prijavljeni.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji.
English: Studies in animals have shown reproductive toxicity of corticosteroids (see section 5.3)
Croatian: Ispitivanja provedena na životinjama dokazala su reproduktivnu toksičnost kortikosteroida (vidjeti dio
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 niža doza može biti dovoljna.
English: Granules in capsules for opening.
Croatian: Granule u kapsulama za otvaranje.
English: The granules must be given orally and should not be chewed.
Croatian: Granule se moraju davati peroralno i ne smiju se žvakati.
English: Patients/and or carers should be warned that potentially severe psychiatric adverse reactions; euphoria, mania, psychosis with hallucinations and delirium have been seen in adult patients at replacement doses of hydrocortisone (see section 4.8).
Croatian: Bolesnike i/ili njegovatelje treba upozoriti na potencijalno teške psihijatrijske nuspojave; euforija, manija, psihoza s halucinacijama i delirijem zabilježene su pri primjeni nadomjesnih doza hidrokortizona u odraslih bolesnika (vidjeti dio 4.8).
English: Corticosteroids may cause growth retardation in infancy, childhood and adolescence; this may be irreversible.
Croatian: Kortikosteroidi mogu prouzročiti zastoj rasta u ranom djetinjstvu, djetinjstvu i adolescenciji, koji može biti nepovratan.
English: Once the intercurrent illness episode is over, patients can return to the normal replacement dose of Alkindi.
Croatian: Kada epizoda istovremene bolesti završi, bolesnici se mogu vratiti na uobičajenu nadomjesnu dozu lijeka Alkindi.
English: unwell or has an infection.
Croatian: je Vašem djetetu loše ili ima infekciju.
English: There were no adverse reactions and no episodes of adrenal crisis seen in any of the studies.
Croatian: U tim ispitivanjima nisu zabilježene nuspojave niti epizode adrenalne krize.
English: Van Heuven Goedhartlaan 935 A 1181LD Amstelveen The Netherlands
Croatian: Van Heuven Goedhartlaan 935 A 1181LD Amstelveen Nizozemska
English: Long-term treatment with hydrocortisone may be associated with changes in the development of bones and reduced growth.
Croatian: Dugotrajno liječenje hidrokortizonom može biti povezano s promjenama u razvoju kostiju i usporenim rastom.
English: Talk to your endocrinologist or pharmacist before giving Alkindi if your child is:
Croatian: Obratite se svojem endokrinologu ili ljekarniku prije davanja lijeka Alkindi ako:
English: Naturally-occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.
Croatian: Prirodno prisutni glukokortikoidi (hidrokortizon i kortizon), koji imaju i svojstva zadržavanja soli, koriste se kao nadomjesna terapija u stanjima adrenokortikalne insuficijencije.
English: In severe situations, an increase in dose is immediately required and oral administration of hydrocortisone must be replaced with parenteral treatment.
Croatian: U težim situacijama potrebno je odmah povećati dozu, a peroralna primjena hidrokortizona mora se zamijeniti parenteralnim liječenjem.
English: - In some patients with allergies to other medicines, allergy to hydrocortisone has been seen.
Croatian: U nekih bolesnika koji su alergični na druge lijekove zabilježena je alergija na hidrokortizon.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Alkindi is used when the body is not making enough cortisol, because part of the adrenal gland is not working (adrenal insufficiency, often caused by an inherited condition called congenital adrenal hyperplasia).
Croatian: Lijek Alkindi primjenjuje se kada tijelo ne proizvodi dovoljno kortizola jer dio nadbubrežne žlijezde ne radi (adrenalna insuficijencija, koju često uzrokuje nasljedna bolest, koja se naziva kongenitalna adrenalna hiperplazija).
English: Treatment is probably not indicated for reactions due to chronic poisoning unless the patient has a condition that would render him/her unusually susceptible to ill effects from hydrocortisone.
Croatian: Liječenje vjerojatno nije indicirano za reakcije nastale zbog kroničnog trovanja, osim kada se u bolesnika radi o stanju koje ga čini neobično osjetljivim na štetne učinke hidrokortizona.
English: If your child has a dramatic change in behaviour, contact your endocrinologist (see section 2).
Croatian: Ako Vaše dijete izrazito promijeni ponašanje, obratite se svojem endokrinologu (vidjeti dio 2.).
English: Cortisol is made naturally by the adrenal glands in the body.
Croatian: Kortizol prirodno nastaje u nadbubrežnim žlijezdama u tijelu.
English: If you give your child more Alkindi than you should, contact your endocrinologist or pharmacist for further advice as soon as possible.
Croatian: Ako ste djetetu dali više lijeka Alkindi nego što ste trebali, što prije se obratite svojem endokrinologu ili ljekarniku radi daljnjih savjeta.
English: Excessive weight gain with decreased height velocity or other symptoms or signs of Cushing syndrome indicate excessive glucocorticoid replacement.
Croatian: Pretjerano povećanje tjelesne težine praćeno smanjenom brzinom rasta ili drugim simptomima ili znacima Cushingova sindroma ukazuju na pretjeranu nadomjesnu terapiju glukokortikoidima.
English: - Contact your endocrinologist if your child experiences blurred vision or other visual disturbances.
Croatian: Obratite se svojem endokrinologu ako Vaše dijete ima zamućen vid ili druge poremećaje vida.
English: Monitoring of the clinical response is necessary and patients should be observed closely for signs that might require dosage adjustment, including changes in clinical status resulting from remissions or exacerbations of the disease, individual responsiveness to the medicinal product, and the effect of stress (e.g. surgery, infection, trauma).
Croatian: Potrebno je praćenje kliničkog odgovora, a bolesnike treba pomno motriti radi uočavanja znakova koji ukazuju da je potrebna prilagodba doze, uključujući promjene u kliničkom statusu prouzročene remisijama ili pogoršanjima bolesti, individualni odgovor na lijek i učinak stresa (npr. krirurški zahvat, infekcija, trauma).
English: Tell your endocrinologist or pharmacist if your child becomes ill, suffers severe stress, gets injured or is about to have surgery because your endocrinologist may need to increase the dose of Alkindi in these circumstances (see section 2).
Croatian: Obavijestite svojeg endokrinologa ili ljekarnika ako se Vaše dijete razboli, doživi težak stres, ozljedu ili se treba podvrgnuti kirurškom zahvatu jer će endokrinolog u tim okolnostima možda morati povećati dozu lijeka Alkindi (vidjeti dio 2.).
English: What you need to know before you give Alkindi 3.
Croatian: Što morate znati prije nego počnete davati Alkindi
English: For children who are able to take soft food, the granules may be sprinkled onto a spoonful of cold or room temperature soft food (such as yoghurt or fruit puree) and given immediately.
Croatian: Kod djece koja mogu jesti kašastu hranu, granule možete posipati na žlicu kašaste hrane koja je hladna ili na sobnoj temperaturi (kao što je jogurt ili voćni pire) te je odmah dati djetetu.
English: You should not stop giving Alkindi without the advice of your endocrinologist as this could make your child seriously unwell very quickly.
Croatian: Ne smijete prestati s davanjem lijeka Alkindi bez savjetovanja sa svojim endokrinologom jer bi Vašem djetetu zbog toga vrlo brzo moglo biti izrazito loše.
English: The endocrinologist may need to increase the dose of Alkindi temporarily; talk to your endocrinologist if your child is unwell.
Croatian: Endokrinolog će možda privremeno morati povećati dozu lijeka Alkindi; obratite se svojem endokrinologu ako je Vašem djetetu loše.
English: Patients with adrenal insufficiency are at risk of life-threatening adrenal crisis during infection so clinical suspicion of infection should be high and specialist advice should be sought early.
Croatian: Bolesnici s adrenalnom insuficijencijom izloženi su tijekom infekcije riziku od adrenalne krize opasne po život, stoga klinička sumnja mora biti visokog stupnja te treba potražiti savjet specijalista u ranoj fazi.
English: Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol which are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.
Croatian: Hidrokortizon se metabolizira u jetri i u većini tjelesnih tkiva u hidrogenirane razgradne produkte kao što su tetrahidrokortizon i tetrahidrokortizol, koji se izlučuju putem mokraće, najvećim dijelom konjugirani kao glukuronidi, zajedno s vrlo malim udijelom hidrokortizona u nepromijenjenom obliku.
English: Alkindi is therapeutically equivalent to conventional hydrocortisone tablets.
Croatian: Lijek Alkindi terapijski je ekvivalentan konvencionalnim tabletama hidrokortizona.
English: One, corticosteroid-binding globulin is a glycoprotein; the other is albumin.
Croatian: Jedna je glikoprotein, globulin koji veže kortikosteroide, a druga je albumin.
English: Your endocrinologist will monitor your child's growth and bones (see section 2).
Croatian: Endokrinolog će pratiti rast Vašeg djeteta i njegove kosti (vidjeti dio 2.).
English: intense feeling of happiness and excitement (euphoria).
Croatian: osjećaj prevelike uzbuđenosti i prekomjernu aktivnost (manija). intenzivan osjećaj sreće i uzbuđenja (euforija).
English: In all 24 patients Alkindi was found to increase cortisol values from baseline as expected: median baseline cortisol 14.1 mmol/l (range 14.1 - 104.5), median Cmax 535.2 mmol/l (range 346.2 - 1445.1).
Croatian: medijan početne vrijednosti kortizola je bio 14,1 mmol/l (raspon 14,1 - 104,5), medijan vrijednost Cmaks 535,2 mmol/l (raspon 346,2 - 1445,1).
English: In less severe situations when parenteral administration of hydrocortisone is not required, for instance low grade infections, moderate fever of any aetiology and stressful situations such as minor surgical procedures, there should be high awareness of the risk of developing acute adrenal insufficiency, and the normal oral daily replacement dose should be increased temporarily; the Alkindi total daily dose should be increased by doubling or tripling the usual dose.
Croatian: U manje teškim situacijama kada nije potrebna parenteralna primjena hidrokortizona, na primjer kod manjih infekcija, umjerene vrućice bilo koje etiologije i stresnih situacija kao što su manji kirurški zahvati, potrebna je visoka razina svijesti o riziku od razvoja akutne adrenalne insuficijencije te treba privremeno povećati uobičajenu peroralnu primjenu dnevne nadomjesne doze; ukupnu dnevnu dozu lijeka Alkindi treba povećati tako da se udvostruči ili utrostruči uobičajena doza.
English: The terminal half-life of hydrocortisone is about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets and Alkindi in dexamethasone-suppressed healthy adult male volunteers.
Croatian: Terminalni poluvijek hidrokortizona iznosi oko 1,5 sata nakon intravenske i peroralne doze tableta hidrokortizona i lijeka Alkindi u zdravih, deksametazonom suprimiranih odraslih muških dobrovoljaca.
English: The granules must not be added to liquid as this can result in less than the full dose being given, and may affect the taste masking which will allow the bitter taste of hydrocortisone to become apparent.
Croatian: Granule se ne smiju dodavati u tekućinu jer to može rezultirati davanjem manje od pune doze, a može i utjecati na prikrivanje okusa, zbog čega bi se mogao osjetiti gorak okus hidrokortizona.
English: Concomitant administration of medicinal products that are inhibitors or inducers of CYP3A4 may therefore lead to unwanted alterations in serum concentrations of Alkindi with the risk of adverse effects, particularly adrenal crisis.
Croatian: Stoga istodobna primjena lijekova koji su inhibitori ili induktori CYP3A4 može uzrokovati neželjene izmjene u koncentracijama lijeka Alkindi u serumu i rizik od nuspojava, osobito adrenalne krize.