natgillin/translations-raw huggingface dataset:
Pharmacotherapeutic group: Corticosteroids for systemic use; Glucocorticoids.
Farmakoterapevtska skupina: kortikosteroidi za sistemsko uporabo; glukokortikoidi.
As Alkindi is replacing the normal hormone your child lacks, side effects are uncommon, however:
Ker zdravilo Alkindi nadomešča običajni hormon, ki ga vašemu otroku primanjkuje, so neželeni učinki redki, vendar:
Where parenteral hydrocortisone is required, the patient should be treated in a facility with resuscitation facilities in case of evolving adrenal crisis.
Če je potrebno parenteralno dajanje hidrokortizona, mora biti bolnik zdravljen v ustanovi, ki ima na voljo opremo za oživljanje za primer napredujoče adrenalne krize.
The capsule shell must not be swallowed but carefully be opened as follows:
Ovoj kapsule se ne sme pogoltniti, ampak ga je treba previdno odpreti po naslednjem postopku:
Undesirable effects of corticosteroid replacement therapy Most undesirable effects of corticosteroids are dose and duration of exposure related.
Neželeni učinki nadomestnega zdravljenja s kortikosteroidi Večina neželenih učinkov kortikosteroidov je povezana z odmerkom in trajanjem izpostavljenosti.
One, corticosteroid-binding globulin is a glycoprotein; the other is albumin.
Prva - globulin, ki veže kortikosteroid -, je glikoprotein, druga pa albumin.
The study used a single dose of Alkindi granules equivalent to the previous morning's dose of each patient's usual glucocorticoid treatment.
V študiji je bil uporabljen en odmerek zrnc zdravila Alkindi, ki je bil enakovreden prejšnjemu jutranjemu odmerku pri običajnem zdravljenju posameznega bolnika z glukokortikoidi.
Corticosteroids may cause growth retardation in infancy, childhood and adolescence; this may be irreversible.
Kortikosteroidi lahko v obdobju zgodnjega otroštva, otroštva in adolescence upočasnijo rast; ta proces je lahko nepovraten.
Frequency: not known
Neznana pogostnost
Stopping the medicine suddenly could quickly make your child very unwell.
Nenadno prenehanje dajanja zdravila bi otrokovo stanje lahko hitro zelo poslabšalo.
Contents of the pack and other information What Alkindi contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Alkindi
- Stomach pains (gastritis) or feelings of sickness (nausea).
- Bolečine v želodcu (gastritis) ali siljenje na bruhanje (navzea).
Other medicines and Alkindi
Druga zdravila in zdravilo Alkindi
Sudden discontinuation of therapy with Alkindi risks triggering an adrenal crisis and death.
Pri nenadnem prenehanju zdravljenja z zdravilom Alkindi obstaja tveganje adrenalne krize in smrti.
The granules must be given orally and should not be chewed.
Zrnca je treba dajati peroralno in se ne smejo žvečiti.
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).
Treba je spremljati klinični odziv in pri bolnikih pozorno opazovati znake, zaradi katerih bi bilo morda treba prilagoditi odmerek, vključno s spremembami kliničnega stanja zaradi remisij ali izbruhov bolezni, individualno odzivnostjo na zdravilo in učinkom stresa (npr. operacija, okužba, travma).
In patients with some remaining endogenous cortisol production a lower dose may be sufficient.
Pri bolnikih, ki v manjši meri še tvorijo endogeni kortizol, bo morda zadostoval nižji odmerek.
Warning Alkindi granules come in a capsule that must be opened before use, discard the empty capsule after use out of reach of children.
Opozorilo Zrnca zdravila Alkindi so v kapsuli, ki jo je treba pred uporabo odpreti; Prazno kapsulo po uporabi zavrzite tako, da je nedosegljiva otrokom.
Alkindi has no influence on a child's ability to perform skilled tasks (e.g. riding a bicycle) or using machines.
Zdravilo Alkindi ne vpliva na otrokovo sposobnost izvajanja veščin (npr. vožnje s kolesom) ali uporabe strojev.
- Contact your endocrinologist if your child experiences blurred vision or other visual disturbances.
- obvestite endokrinologa, če se pri vašem otroku pojavi zamegljen vid ali druge motnje vida.
The coadministration of Alkindi with soft food (yoghurt and fruit puree) has been studied in vitro with no significant effect on dissolution seen.
Sočasno dajanje zdravila Alkindi z mehko hrano (jogurtom in sadno kašo) je bilo preučeno v študiji in vitro, pri čemer ni bil ugotovljen noben pomemben učinek na raztapljanje.
Alkindi is therapeutically equivalent to conventional hydrocortisone tablets.
Zdravilo Alkindi je terapevtsko enakovredno običajnim tabletam hidrokortizona.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake „Uporabno do“.
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.
Pri bolnikih z adrenalno insuficienco obstaja med okužbo tveganje smrtno nevarne adrenalne krize, zato mora biti klinični sum na okužbo močan, s specialistom pa se je treba posvetovati dovolj zgodaj.
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.
Prav tako morajo biti bolniki/skrbniki pozorni na možne duševne motnje, ki se lahko pojavijo med postopnim zmanjševanjem odmerka/ukinjanjem sistemskih steroidov ali takoj po tem, čeprav so o teh neželenih učinkih poročali redko.
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.
Zdravljenje za reakcije, katerih vzrok je kronična zastrupitev, verjetno ni indicirano, razen če ima bolnik stanje, zaradi katerega bi postal nenavadno dovzeten za neželene učinke hidrokortizona.
Hydrocortisone is a synthetic version of the hormone cortisol.
Hidrokortizon je sintetična različica hormona kortizola.
Pre-operatively, anaesthetists must be informed if the patient is taking corticosteroids or has previously taken corticosteroids.
Anesteziologi morajo biti pred operacijo obveščeni o tem, ali bolnik jemlje ali je jemal kortikosteroide.
Your endocrinologist will monitor your child's growth and bones (see section 2).
Endokrinolog bo spremljal otrokovo rast in razvoj kosti (glejte poglavje 2).
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.
Sočasno dajanje zdravil, ki so zaviralci ali induktorji citokroma CYP3A4, lahko zato povzroči neželene spremembe koncentracij zdravila Alkindi v serumu, hkrati s tem pa tveganje neželenih učinkov, še posebej adrenalne krize.
What you need to know before you give Alkindi Do not give Alkindi:
Kaj morate vedeti, preden boste dali zdravilo Alkindi Ne dajajte zdravila Alkindi:
No studies have been conducted in patients with hepatic or renal impairment.
Pri bolnikih z okvaro jeter ali ledvic niso izvedli nobene študije.
Once the bottle has been opened, use the capsules within 60 days.
Ko odprete plastenko, kapsule uporabite v 60 dneh.
Excessive weight gain with decreased height velocity or other symptoms or signs of Cushing syndrome indicate excessive glucocorticoid replacement.
Prekomerno zvečanje telesne mase ob počasnejši rasti ali drugih simptomih ali znakih Cushingovega sindroma lahko kaže na prekomerno nadomestno zdravljenje z glukokortikoidi.
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.
Pri otrocih, ki lahko uživajo mehko hrano, zrnca posujte po žlici hladne mehke hrane ali mehke hrane sobne temperature (npr. jogurta ali sadne kaše) in jih otroku dajte takoj.
Hydrocortisone can be used during pregnancy and breast-feeding when the body is not making enough cortisol.
Nosečnost, dojenje in plodnost Hidrokortizon je mogoče uporabljati med nosečnostjo in dojenjem, če telo ne tvori dovolj kortizola.
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.
Če se pri bolniku pojavijo simptomi, kot so zamegljen vid ali druge motnje vida, ga je treba napotiti k oftalmologu zaradi ovrednotenja možnih vzrokov, ki lahko vključujejo katarakto, glavkom ali redke bolezni, kot je centralna serozna horioretinopatija, o katerih so poročali po sistemski in topikalni uporabi kortikosteroidov.
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.
Ključna študija je bila odprta študija, izvedena v enem centru in z enim odmerkom pri 24 pediatričnih bolnikih, starih manj kot šest let, ki so potrebovali nadomestno zdravljenje za adrenalno insuficienco kot posledico KAH, primarne odpovedi nadledvične žleze ali hipopituitarizma.
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.
V manj resnih situacijah, pri katerih ni potrebna parenteralna uporaba hidrokortizona, na primer pri okužbah nizke stopnje, zmerno zvišani telesni temperaturi ne glede na vzrok in stresnih situacijah, kot so manjši kirurški posegi, se je treba še posebej zavedati tveganja za razvoj akutne adrenalne insuficience, in je treba običajen dnevni nadomestni odmerek začasno povečati.Celotni dnevni odmerek zdravila Alkindi je treba povečati na dva- do trikratni običajni odmerek.
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.
Nadomestno zdravljenje pri primarni in sekundarni adrenalni insuficienci Zdravilo Alkindi se uporablja za nadomestno zdravljenje s peroralnim dajanjem zrnc v skladu s klinično prakso v odmerku, titriranim glede na klinični odziv posameznika.
What Alkindi is and what it is used for
Kaj je zdravilo Alkindi in za kaj ga uporabljamo
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).
V znanstveni literaturi so pri odraslih bolnikih za druga zdravila s hidrokortizonom, dana kot nadomestno zdravljenje adrenalne insuficience, poročali o naslednjih neželenih učinkih z neznano pogostnostjo (pogostnostjo, ki je iz razpoložljivih podatkov ni mogoče oceniti).
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.
ob kirurških operacijah in med zelo stresnimi obdobji endokrinolog lahko priporoči dodatne odmerke zdravila Alkindi in tudi svetuje, da vaš otrok prejme druge oblike hidrokortizona namesto zdravila Alkindi ali skupaj z njim.
Do not swallow the capsule, risk of choking.
Kapsule ne pogoltnite, lahko se zadušite.
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.
Dajanje kortikosteroidov brejim živalim lahko povzroči nepravilnosti pri razvoju ploda, vključno z volčjim žrelom, zastojem rasti v maternici ter vplivom na rast in razvoj možganov.
Distribution 90% or more of circulating hydrocortisone is reversibly bound to protein.
Porazdelitev Na beljakovine je reverzibilno vezanega 90 % krožečega hidrokortizona ali več.
Taking Alkindi should not stop your child being vaccinated.
Jemanje zdravila Alkindi ni razlog, da vaš otrok ne bi bil cepljen.
1 mg (blue)
1 mg (modra)
- Whichever method is used, the capsule is tapped to ensure all the granules are removed.
- Ne glede na uporabljeni način dajanja zdravila je treba po kapsuli potrkati, da so iz nje zagotovo odstranjena vsa zrnca.
Capsule Hypromellose
Kapsula hipromeloza
Psychosis with hallucinations and delirium Mania
Psihiatrične motnje psihoza s halucinacijami in delirijem manija evforija
0.5 mg (red)
0,5 mg (rdeča)
Detailed pictograms on how to administer the granules are provided in the package leaflet.
Piktogrami s podrobnostmi glede dajanja zrnc so v navodilu za uporabo.
Hydrocortisone belongs to a group of medicines known as corticosteroids.
Hidrokortizon spada v skupino zdravil, ki jih imenujemo kortikosteroidi.
Your endocrinologist will monitor your child's potassium levels to check for any changes.
Endokrinolog bo spremljal ravni kalija pri vašem otroku, da preveri, ali so se morda spremenile.
- 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.
- Kapsulo držite tako, da se natisnjena jakost nahaja na vrhu, in potrkajte po njej, tako da se bodo vsa zrnca zbrala v njenem spodnjem delu.
Dosage must be individualised according to the response of the individual patient.
Odmerek mora biti prilagojen posameznemu bolniku glede na njegov odziv.
There is no information on any effects of Alkindi on fertility.
Podatkov o možnih učinkih zdravila Alkindi na plodnost ni.
The endocrinologist may need to increase the dose of Alkindi temporarily; talk to your endocrinologist if your child is unwell.
Endokrinolog bo moral morda začasno povečati odmerek zdravila Alkindi; posvetujte se z njim, če se vaš otrok počuti slabo.
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.
Zrnca se ne smejo dajati v tekočino, saj lahko to privede do dajanja odmerka, manjšega od celotnega, poleg tega pa lahko povzroči, da nad okusom zrnc prevlada grenak okus hidrokortizona.
Each carton contains 1 bottle.
Ena škatla vsebuje eno plastenko.
Microcrystalline cellulose Hypromellose Magnesium stearate Ethyl cellulose
Zrnca mikrokristalna celuloza hipromeloza magnezijev stearat etilceluloza
This is because the centre of the granule is not absorbed in the gut after it has released the medicine.
To se zgodi zato, ker se središče zrnca po sprostitvi zdravila ne vsrka v črevesje.
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.
Razpon danih odmerkov zdravila Alkindi je znašal od 1 mg do 4 mg. Starši/skrbniki (in otroci, če je bilo to mogoče) so s petstopenjsko Likertovo lestvico ocenili sprejemljivost okusa zdravila Alkindi.
Pack sizes: 1 bottle containing 50 capsules
Velikosti pakiranj: Ena plastenka, ki vsebuje 50 kapsul.
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).
Zdravilo Alkindi se uporablja, če telo ne tvori dovolj kortizola, ker del nadledvične žleze ne deluje (adrenalna insuficienca, ki jo pogosto povzroča podedovana bolezen,
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.
Parenteralno dajanje hidrokortizona je upravičeno med epizodami prehodnih bolezni, kot so resne okužbe, še posebej gastroenteritis, povezan z bruhanjem in/ali drisko, visoka telesna temperatura ne glede na vzrok ali prekomeren telesni stres, kot so na primer hude nesreče in operacije v splošni anesteziji.
Glucocorticoids are adrenocortical steroids, both naturally-occurring and synthetic, which are readily absorbed from the gastro-intestinal tract.
Glukokortikoidi so naravni in sintetični adrenokortikalni steroidi, ki se brez težav absorbirajo iz prebavnega trakta.
What Alkindi looks like and contents of the pack
Izgled zdravila Alkindi in vsebina pakiranja
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).
14,1 mmol/l (razpon 14,1-104,5), srednja vrednost Cmax pa 535,2 mmol/l (razpon 346,2-1445,1).
Store in the original bottle in order to protect from light.
Za zaščito pred svetlobo shranjujte v originalni plastenki.
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.
Prehod z običajnega peroralnega zdravljenja z glukokortikoidi na zdravilo Alkindi Kadar bolniki preidejo z običajnega peroralnega nadomestnega zdravljenja s hidrokortizonom na zdravilo Alkindi, se jim lahko daje enak skupni dnevni odmerek.
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.
Končna razpolovna doba hidrokortizona znaša približno 1,5 ure po intravenskem in peroralnem odmerjanju tablet hidrokortizona in zdravila Alkindi pri zdravih odraslih moških prostovoljcih, katerih imunski sistem je bil zaviran z deksametazonom.
Breast-feeding Hydrocortisone for replacement therapy can be used during breast-feeding.
Dojenje Hidrokortizon kot nadomestno zdravljenje se lahko uporablja med dojenjem.
Excretion of granules
Izločanje zrnc
Naturally-occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.
Naravno tvorjeni glukokortikoidi (hidrokortizon in kortizon), ki imajo tudi lastnost zadrževanja soli, se uporabljajo kot nadomestno zdravljenje pri stanjih pomanjkljivega delovanja nadledvične skorje.
- If your child has any reaction like swelling or shortness of breath after being given Alkindi, get medical help straight away and tell your endocrinologist as soon as possible as these can be signs of an allergic reaction (see section 2).
- Če se pri vašem otroku, potem ko ste mu dali zdravilo Alkindi, pojavi kakršna koli reakcija, kot je otekanje ali zadihanost, takoj poiščite zdravniško pomoč in o tem čim prej obvestite endokrinologa, saj so to lahko znaki alergijske reakcije (glejte poglavje 2).
Alkindi comes in high density polyethylene plastic bottles containing 50 capsules.
Zdravilo Alkindi je v plastenkah iz polietilena visoke gostote, v katerih je 50 kapsul.
If you forget to give Alkindi
Če ste pozabili dati zdravilo Alkindi
You should not stop giving Alkindi without the advice of your endocrinologist as this could make your child seriously unwell very quickly.
Zdravila Alkindi ne smete prenehati dajati brez posveta z endokrinologom, saj bi se stanje vašega otroka lahko zelo hitro poslabšalo.
The granules are white to off-white and contained in a transparent colourless (size 00el) hard capsule.
Zrnca so bela do umazano bela in so v prosojni, brezbarvni trdi kapsuli (velikosti 00el).
1 patient had renal hypoplasia, 1 patient atopic dermatitis and 1 patient had rhinitis.
Pri enem bolniku je bila prisotna hipoplazija ledvice, pri enem atopični dermatitis in pri enem rinitis.
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.
Endokrinolog bo pravilen odmerek zdravila Alkindi določil na podlagi otrokove telesne mase ali velikosti (telesne površine) in nato odmerek zdravila Alkindi prilagodil rasti otroka.
- 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.
- Zrnca stresite neposredno na otrokov jezik ali na žlico, s pomočjo katere jih vstavite v otrokova usta.
Cortisol is made naturally by the adrenal glands in the body.
Kortizol se naravno tvori v telesu v nadledvičnih žlezah.
All inks contain Shellac, Propylene glycol, Concentrated ammonia solution
Vsa črnila vsebujejo šelak, propilenglikol, koncentrirano raztopino amoniaka
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.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne tistim pri otroku, za katerega je bilo to zdravilo predpisano.
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).
Bolnike in/ali skrbnike je treba opozoriti, da so pri odraslih bolnikih pri nadomestnih odmerkih hidrokortizona opazili psihiatrične neželene učinke: evforijo, manijo, psihozo s halucinacijami in delirij (glejte poglavje 4.8).
Granules in capsules for opening.
zrnca v kapsulah za odpiranje
Medicinal product-induced secondary adrenocortical insufficiency may result from too rapid a withdrawal of corticosteroids and may be minimised by gradual reduction of dosage.
Zaradi prehitre odtegnitve kortikosteroidov lahko pride do z zdravilom sprožene sekundarne adrenokortikalne insuficience; ublažiti jo je mogoče s postopnim zmanjševanjem odmerka.
- Too much Alkindi can affect your child's growth, so your endocrinologist will adjust the dose depending on your child's size and monitor your child's growth carefully.
- lahko preveč zdravila Alkindi vpliva na rast vašega otroka, zato bo endokrinolog prilagodil odmerek glede na otrokovo velikost in natančno spremljal njegovo rast.
Alkindi was positively assessed in terms of palatability.
Sprejemljivost okusa zdravila Alkindi je bila ocenjena pozitivno.
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.
Z zdravilom Alkindi je bilo zdravljenih 30 zdravih odraslih moških (pri katerih pa je bil imunski sistem zaviran z deksametazonom) v dveh študijah 1. faze in 24 pediatričnih bolnikov z adrenalno insuficienco v dveh študijah 3. faze.
If your child has a dramatic change in behaviour, contact your endocrinologist (see section 2).
Če se je vedenje otroka zelo spremenilo, o tem obvestite endokrinologa (glejte poglavje 2).
White to off-white granules which are contained in a transparent colourless hard capsule for opening; the strength is printed on the capsule.
Zrnca so bela do umazano bela, v prosojni, brezbarvni trdi kapsuli za odpiranje; jakost je natisnjena na kapsuli.
If you stop giving Alkindi
Če ste prenehali dajati zdravilo Alkindi
Alkindi contains a medicine called hydrocortisone.
Zdravilo Alkindi vsebuje učinkovino, imenovano hidrokortizon.