natgillin/translations-raw huggingface dataset:
If not, the next higher dose should be selected.
Če ni, je treba izbrati naslednji večji odmerek.
DATE OF FIRST AUTHORISATION 20 November 2015
DATUM PRVE PRIDOBITVE 20. november 2015
The physician's educational material should contain the following key elements:
Izobraževalno gradivo za zdravnike mora vsebovati naslednje ključne elemente:
Use within 3 months of opening.
Uporabite v 3 mesecih po odprtju.
Elderly patients (older than 65 years)
Starejši bolniki (> 65 let)
Liver parameters should also be monitored.
Spremljati je treba tudi jetrne parametre.
Take the next dose as soon as you remember, as long as it is more than 12 hours until the next dose.
Vzemite naslednji odmerek, takoj ko se spomnite, če je do naslednjega odmerka preostalo še več kot 12 ur.
Dublin 2, Ireland Tel: +353 86 803 8014 info@retrophin.com
Tel: +353 86 803 8014 info@retrophin.com
This medicine is intended for long-term use.
To zdravilo je namenjeno dolgotrajni uporabi.
In the event of overdose the patient should be monitored and treated symptomatically.
V primeru prevelikega odmerjanja je treba bolnika spremljati in simptomatsko zdraviti.
Ask your doctor for advice.
Za nasvet se obrnite na zdravnika.
Do not take more capsules than your doctor has advised you.
Ne vzemite več kapsul, kot vam je naročil zdravnik.
For additional information, see section 6.6.
Za dodatne informacije glejte poglavje 6.6.
The mixture should be given immediately after preparation.
Mešanico je treba uporabiti takoj po pripravi.
A total of 85 patients took part in the clinical study.
V klinični študiji je sodelovalo skupno 85 bolnikov.
What you need to know before you use Kolbam 3.
Kaj morate vedeti, preden boste uporabili zdravilo Kolbam 3.
Patients should be monitored initially every 3 months during the first year then 6 monthly during the subsequent three years and annually thereafter.
V prvem letu je treba bolnike spremljati vsake tri mesece, v naslednjih treh letih vsakih šest mesecev, potem pa enkrat na leto.
Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Zdravnik vam bo povedal, koliko kapsul morate vzeti in kdaj.
It is recommended that cholic acid is taken with food (see section 4.5) at approximately the same time each day, in the morning and/or evening.
Priporočeno je, da se holna kislina jemlje s hrano (glejte poglavje 4.5) ob približno istem času vsak dan, zjutraj in/ali zvečer.
Some of the primary defects include but are not limited to:
Nekatere od primarnih okvar med drugim vključujejo:
Cholic acid also promotes normal growth of children.
Holna kislina spodbuja tudi normalno rast pri otrocih.
Additional or more frequent investigations should be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Dodatne ali pogostejše preiskave je treba opraviti za spremljanje zdravljenja v obdobju hitre rasti, sočasne bolezni ali nosečnosti (glejte poglavje 4.6).
The dose should be subsequently titrated to the desired effect but should not exceed a maximum of 15 mg/kg/day.
Potem je treba odmerek titrirati do želenega učinka, vendar ne sme preseči največjega odmerka 15 mg/kg/dan.
In all studies, a dose of 10-15 mg/kg/day was administered.
V vseh študijah so uporabili odmerek od 10 do 15 mg/kg/dan.
• oral contraceptives,
• peroralna kontracepcijska sredstva,
Try to ensure that if any of the dose is spat out or refused, it is given again.
Poskušajte zagotoviti, da odmerek, ki ga otrok izpljune ali zavrne, daste znova.
<1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
(< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
- PSURs - Annual Reassessments
PSUR - letne ponovne ocene
Side effects of unknown frequency (cannot be estimated from the available data):
Neželeni učinki z neznano pogostnostjo (ni mogoče oceniti iz razpoložljivih podatkov):
• Information on: o Calculation of the correct dose and the need to instruct caregivers on how to administer the product correctly o Symptoms and signs of an overdose and the management of this
• informacije o: o izračunu pravilnega odmerka in potrebi po dajanju navodil skrbnikom, kako pravilno uporabljati zdravilo, o simptomih in znakih prevelikega odmerjanja ter njegovi obravnavi.
There are several enzyme defects described in the literature.
V literaturi je opisanih več okvar encimov.
Co-administration should be avoided.
Sočasnemu jemanju se je treba izogniti.
Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu France
Patheon France 40 boulevard de champaret 38300 Bourgoin-Jallieu Francija
To monitor the long term safety and efficacy in patients treated with Kolbam from a patient registry for which details are reflected in the risk management plan.
Spremljati dolgoročno varnost in učinkovitost pri bolnikih, zdravljenih z zdravilom Kolbam, v registru bolnikov, katerega podrobnosti so navedene v načrtu za obvladovanje tveganja.
Once the bottle is opened, the medicinal product must be used within 3 months.
Po odprtju plastenke je treba zdravilo uporabiti v 3 mesecih.
In this set of patients, about one quarter were below or at most 6 months of age at diagnosis, and about one third were between 7 and 36 months.
Pri tem nizu bolnikov jih je bila približno četrtina v času diagnoze mlajših od šest mesecev ali starih šest mesecev, približno tretjina pa od sedem do 36 mesecev.
During your treatment, your doctor will carry out various blood and urine tests at different times to see how your body is handling this medicine and to help work out the dose that you need.
Med zdravljenjem bo zdravnik opravil različne krvne in urinske preiskave v različnih obdobjih, s katerimi bo ugotovil, kako vaše telo prenaša to zdravilo in kakšen odmerek potrebujete.
Kolbam can be used from the age of one month and patients affected by these conditions will need treatment for the rest of their life.
Zdravilo Kolbam se lahko uporablja od starosti enega meseca naprej, bolniki s temi okvarami pa bodo zdravljenje potrebovali do konca življenja.
• AMACR deficiency
• pomanjkanje AMACR;
Treatment should be stopped earlier if there are clear indicators of severe hepatic failure.
Zdravljenje je treba prekiniti prej, če obstajajo jasni pokazatelji hude odpovedi jeter.
Clinical features were limited to pruritus and diarrhoea.
Klinični znaki so bili omejeni na pruritus in diarejo.
In Study CAC-002-01, the mean age of patients at baseline was 9.0 years, with ages ranging from 0.1 to 35.6 years.
V študiji CAC-002-01 je bila povprečna starost bolnikov 9,0 leta z razponom od 0,1 do 35,6 let.
Cholic acid is one of the primary bile acids in man on which essential physiological functions depend.
Holna kislina je ena od primarnih žolčnih kislin pri človeku, od katere so odvisne esencialne fiziološke funkcije.
In the absence of clinical experience in such patients, no recommendations on dosage adjustment can be made.
Ker ni kliničnih izkušenj s temi bolniki, ni mogoče priporočiti prilagoditve odmerka.
Your doctor will advise you if for any reason you have to stop treatment with cholic acid.
Zdravnik vam bo svetoval, če morate zaradi kakršnega koli razloga prekiniti zdravljenje s holno kislino.
Do not chew the capsule.
Kapsule ne žvečite.
Of these 85 patients, 52 presented with disorders in primary bile acid synthesis including the following 3 single enzymes:
Od teh 85 bolnikov jih je imelo 52 motnje v sintezi primarnih žolčnih kislin, vključno z naslednjimi tremi posamičnimi encimimi:
Progress and results from the registry will form the basis of the annual reassessments of the benefit/risk profile of Kolbam.
Napredek in rezultati v zvezi z registrom bodo podlaga za letno ponovno oceno profila razmerja med tveganji in koristmi zdravila Kolbam.
Swallow each capsule whole with water, either just before or just after food.
Kapsule pogoltnite cele z vodo, tik pred obrokom ali tik po njem.
Where the dose calculated is not a multiple of 50, the nearest dose below the maximum of 15 mg/kg/day should be selected, provided that is sufficient to suppress urinary bile acids.
Kadar izračunani odmerek ni večkratnik števila 50, je treba izbrati najbližji odmerek pod največjim odmerkom 15 mg/kg/dan, če je to zadostno za zaviranje žolčnih kislin v urinu.
What Kolbam is and what it is used for 2.
Kaj je zdravilo Kolbam in za kaj ga uporabljamo 2.
The recommended dose is based on your body weight (10-15 mg per kg) taken either as a single dose, once a day, or divided into two doses, one in the morning and one in the evening.
Priporočeni odmerek temelji na vaši telesni masi (od 10 do 15 mg na kg), vzame pa se kot enkratni odmerek enkrat na dan ali razdeljen v dva odmerka, eden zjutraj in eden zvečer.
Should the use of a preparation containing one of these substances be necessary, it must be taken at least 5 hours before or after cholic acid.
Če je uporaba pripravka, ki vsebuje te učinkovine, nujna, ga je treba uporabiti vsaj pet ur pred zaužitjem holne kisline ali po njem.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh podatkov o zdravilu.
Your doctor will advise you to take cholic acid at least 5 hours before or after taking the other medicine.
Zdravnik vam bo svetoval, da holno kislino vzamete vsaj pet ur pred uporabo drugega zdravila ali pet ur po njej.
The dose of cholic acid should be adjusted individually.
Odmerek holne kisline je treba prilagajati individualno.
The remaining 5 patients were treatment naïve.
Preostalih 5 bolnikov je bilo predhodno nezdravljenih.
See above under ‘Do not take Kolbam'.
Glejte zgornje poglavje „Ne jemljite zdravila Kolbam“.
Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State.
Pred prihodom zdravila na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom v zadevni državi članici dogovoriti glede končnega izobraževalnega gradiva.
Mixing of the capsule contents is designed to mask any unpleasant taste which results from the capsules being opened but no data on the compatibility or palatability are available.
Vsebina kapsule je zasnovana tako, da ob mešanju prikrije neprijeten okus, ki je posledica odprtja kapsule, vendar podatki o združljivosti ali okusnosti niso na voljo.
This mixing of the capsule contents with food should mask any unpleasant taste of the medicine.
Mešanje vsebine kapsule s hrano prikrije neprijeten okus zdravila.
The relevance of animal data with regards to cholic acid therapy safety is uncertain due to the known high inter-animal variability of bile acid homeostasis.
Pomembnost podatkov o živalih glede varnosti zdravljenja s holno kislino je negotova zaradi znane velike variabilnosti homeostaze žolčnih kislin med živalmi.
Other medicines and Kolbam
Druga zdravila in zdravilo Kolbam
Never take a double dose to make up for a forgotten dose.
Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Available data in animals have shown excretion of cholic acid in milk (see section 5.3).
Razpoložljivi podatki pri živalih so pokazali izločanje holne kisline v mleko (glejte poglavje 5.3).
The MAH shall ensure that at launch all physicians expected to prescribe the product are provided with information on the correct and safe use of the product.
Imetnik dovoljenja za promet z zdravilom mora ob prihodu zdravila na trg zagotoviti, da bodo vsi zdravniki, za katere se pričakuje, da bodo predpisovali to zdravilo, prejeli informacije o njegovi pravilni in varni uporabi.
The events were transitory and generally did not interfere with the therapy.
Neželeni učinki so bili prehodni in navadno niso ovirali zdravljenja.
If you stop taking it the abnormal substances in your bile may build up again to the levels before treatment was started, potentially causing damage to your liver.
Če ga prenehate jemati, se lahko nenormalne snovi v žolču ponovno nakopičijo do ravni pred začetkom zdravljenja, kar lahko poškoduje jetra.
At therapeutic doses, no effects on the breastfed newborn infant are anticipated since the systemic exposure of the breastfeeding mother to cholic acid is negligible (see section 5.2).
Pri terapevtskih odmerkih ni pričakovati učinkov na dojenega novorojenčka, saj je sistemska izpostavljenost matere holni kislini zanemarljiva (glejte poglavje 5.2).
Episodes of symptomatic overdose (or excessive dosing regimen) have been reported, including accidental overdose.
Poročali so o epizodah simptomatskega prevelikega odmerjanja (ali režimu čezmernega odmerjanja), vključno z nenamernim prevelikim odmerjanjem.
• AMACR deficiency (n=1)
• pomanjkanje AMACR (n = 1);
Gallstones have been reported after long-term therapy.
O žolčnih kamnih so poročali po dolgotrajnem zdravljenju.
No interaction studies with cholic acid and concomitantly administered medicinal products or food have been carried out.
Študij medsebojnega delovanja med holno kislino in sočasnimi zdravili ali hrano niso izvedli.
WHAT KOLBAM IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO KOLBAM IN ZA KAJ GA UPORABLJAMO
• CYP7A1 deficiency
• pomanjkanje CYP7A1.
The clinical experience reported is from a patient population with disorders in primary bile acid synthesis that includes principally infants from the age of one month, children and adolescents.
Klinične izkušnje, o katerih so poročali, izhajajo iz populacije bolnikov z motnjami sinteze primarnih žolčnih kislin, ki vključuje predvsem dojenčke, stare en mesec ali več, otroke in mladostnike.
No formal preclinical safety studies have been conducted; however, data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Opravili niso nobenih uradnih predkliničnih varnostnih študij, vendar podatki v literaturi na podlagi študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti,
On average, patients in this subgroup were 3 years at treatment start, minimum and maximum ages were 0 and 14 years, respectively.
Bolniki v tej podskupini so bili povprečno stari tri leta, pri čemer je bila najmanjša starost 0 let, največja pa 14 let.
Printing ink
Tiskarsko črnilo:
These are some of the medicines that may affect the way in which Kolbam works:
Nekatera zdravila, ki lahko vplivajo na delovanje zdravila Kolbam, so:
If you stop taking Kolbam
Če ste prenehali jemati zdravilo Kolbam
90 capsules.
90 kapsul
By replacing the missing cholic acid it stimulates the production of normal bile and helps prevent the build-up of the abnormal substances in the liver.
Z nadomeščanjem manjkajoče holne kisline spodbuja tvorbo normalnega žolča in pomaga preprečevati kopičenje nenormalnih snovi v jetrih.
The capsule contents will remain as fine granules in the milk or food.
Vsebina kapsule bo v mleku ali hrani ohranila obliko zrnc.
There is a theoretical possibility that administration of food may increase cholic acid bioavailability and improve tolerability.
Obstaja teoretična možnost, da lahko jemanje s hrano poveča biološko uporabnost holne kisline in izboljša prenašanje zdravila.
It is recommended that cholic acid is taken with food (see section 4.2).
Priporočeno je, da se holna kislina jemlje s hrano (glejte poglavje 4.2).
The capsules contain a white powder.
Kapsule vsebujejo bel prašek.
The effect of food on the bioavailability of cholic acid has not been studied.
Učinka hrane na biološko uporabnost holne kisline niso proučili.
You can continue to breastfeed your baby whilst being treated with cholic acid, as levels in breast milk are considered too low to harm your baby.
Med zdravljenjem s holno kislino lahko nadaljujete dojenje, saj so ravni v materinem mleku prenizke, da bi lahko škodovale vašemu otroku.
In the liver, cholic acid is extracted from portal blood by multiple mechanisms, including passive diffusion and transporters.
V jetrih se holna kislina iz portalne krvi izloči z več mehanizmi, vključno s pasivno difuzijo in prenašalci.
Pack sizes: 90 capsules.
Velikost pakiranja: 90 kapsul.
More frequent tests will be needed if you are growing fast, if you are ill (e.g., if you have liver problems) or if you are pregnant.
Če hitro rastete, ste bolni (npr. če imate težave z jetri) ali noseči, bodo potrebne pogostejše preiskave.
A total of 79 patients received cholic acid treatment, 49 of these suffered from a primary enzyme defect.
Zdravljenje s holno kislino je prejelo skupno 79 bolnikov, od katerih jih je 49 imelo okvaro primarnih encimov.
At therapeutic doses, no effect on fertility is anticipated.
Pri terapevtskih odmerkih se ne pričakujejo učinki na plodnost.
• lipid-lowering medicines such as clofibrate
• zdravila za zniževanje ravni lipidov, kot je klofibrat.
Height and weight showed similar improvements.
Rezultati za telesno višino in maso so se podobno izboljšali.
Do not use after the expiry date which is stated on the carton and bottle label after “EXP''.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na plastenki poleg oznake „Uporabno do:“.
There are limited safety data from the use of cholic acid in pregnant women.
Varnostni podatki o uporabi holne kisline pri nosečnicah so omejeni.
No data are available for patients with renal impairment.
Podatki o bolnikih z ledvično okvaro niso na voljo.
If you have a condition called familial hypertriglyceridaemia, your doctor may have to increase your dose of cholic acid.
Če imate bolezen, imenovano družinska hipertrigliceridemija, bo zdravnik morda moral povečati odmerek holne kisline.
Ciclosporin may affect the levels of cholic acid.
Ciklosporin lahko vpliva na ravni holne kisline.
General improvements in the degree of atypical urine bile acids were also seen in individual defect groups.
Splošno izboljšanje ravni atipičnih žolčnih kislin v urinu so prav tako opazili pri skupinah s posameznimi okvarami.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
MOŽNI NEŽELENI UČINKI Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
For young infants the contents may be mixed with infant formula, expressed breast milk or fruit puree and for infants and children under 6 years, mixed with soft food such as mashed potatoes or apple puree.
Pri majhnih dojenčkih se lahko vsebina zmeša z otroško formulo, iztisnjenim materinim mlekom ali sadno kašico, pri dojenčkih in otrocih, mlajših od šest let, pa z mehko hrano, kot je krompirjev pire ali jabolčna čežana.
Slightly increased blood pressure was evident in rats after 30 days of cholic acid at approximately 4-fold therapeutic dose with increased vasoconstrictor responses to noradrenaline, together with decreased levels of aldosterone and increased corticosterone, but no adverse clinical signs were observed.
Pri podganah so po 30 dneh uporabe holne kisline v odmerkih, približno 4-krat večjih od terapevtskega, ugotovili rahlo povišan krvni tlak s povečanimi vazokonstriktornimi odzivi na noradrenalin, skupaj z znižanimi ravnmi aldosterona in povišanimi ravnmi kortikosterona, vendar niso opazili nobenih neželenih kliničnih znakov.
Treatment with cholic acid in patients with pre-existing hepatic impairment should be given under close monitoring and, for all patients should be stopped in case of abnormal hepatocellular function, as measured by prothrombin time, if hepatocellular function does not improve within 3 months of the initiation of cholic acid treatment.
Zdravljenje s holno kislino pri bolnikih z obstoječo jetrno okvaro mora potekati pod skrbnim nadzorom, pri vseh bolnikih pa je treba zdravljenje prekiniti pri nenormalni hepatocelularni funkciji, ki se izmeri s protrombinskim časom, če se ne izboljša v treh mesecih po uvedbi zdravljenja s holno kislino.
Phenobarbital has been shown to increase the pool size and turnover of cholic acid and therefore has an antagonistic effect to the desired action of cholic acid in patients.
Pokazali so, da fenobarbital poveča velikost zaloge in premeno holne kisline, zato ima antagonistični učinek na želeno delovanje holne kisline pri bolnikih.
Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki
If your doctor considers it necessary that you keep taking ciclosporin, he will closely monitor the levels of bile acids in your blood and urine and adjust the dose of cholic acid accordingly.
Če zdravnik meni, da je nujno, da še naprej jemljete ciklosporin, bo skrbno spremljal ravni žolčnih kislin v krvi ter urinu in ustrezno prilagodil odmerek holne kisline.
It is recommended that the capsules are taken with food, as this may help to make the cholic acid more effective, and also reduces the likelyhood of diarrhoea.
Priporočljivo je, da kapsule vzamete skupaj s hrano, saj lahko to pomaga pri učinkovitejšem delovanju holne kisline in zmanjša verjetnost driske.
Cholic acid is not mutagenic; however, co-administration of cholic acid with known carcinogens has shown increased tumour formation compared to the known carcinogen alone.
Holna kislina ni mutagena, vendar so pokazali, da sočasna uporaba holne kisline z znanimi kancerogeni poveča tvorbo tumorjev v primerjavi z uporabo samega kancerogena.
INFORMATION IN BRAILLE Kolbam 50 mg
PODATKI V BRAILLOVI PISAVI Kolbam 50 mg
Transient elevations of transaminases at the initiation of cholic acid treatment have been observed and do not indicate the need for a dose reduction if Gamma GT is not elevated and if serum bile acid levels are falling or in the normal range.
Opazili so prehodno povečanje vrednosti transaminaz med uvajanjem zdravljenja s holno kislino, kar pa ne pomeni, da je treba zmanjšati odmerek, če ravni GGT niso zvišane in če ravni žolčnih kislin v serumu padajo oziroma so v normalnem razponu.
Among the subgroup of patients with CTX (n=8), 3 transitioned from CAC-91-10-10 and were on cholic acid treatment at study start.
V podskupini bolnikov s CTX (n = 8) so 3 prešli s CAC-91-10-10 in so se na začetku študije zdravili s holno kislino.
In the body cholic acid is naturally produced in the liver and is part of the bile, a fluid that helps digestion and absorbs fat and vitamins from the food.
V telesu holno kislino naravno tvorijo jetra in je del žolča, tekočine, ki pomaga pri prebavi in absorbira maščobe ter vitamine iz hrane.
Medicines for lowering cholesterol levels in the blood, such as cholestyramine, colestipol or colesevelam, and certain antacids which contain aluminium (e.g. indigestion relief products) may affect the absorption of cholic acid.
Zdravila za zniževanje ravni holesterola v krvi, kot so holestiramin, holestipol ali holesevelam, in nekateri antacidi, ki vsebujejo aluminij (npr. zdravila za lajšanje zgage), lahko vplivajo na absorpcijo holne kisline.
A total of 53 patients took part in the clinical study and received at least one dose of cholic acid; 22 (42%) were treatment naive, i.e., received their first dose of cholic acid during study CAC002-01.
V klinični študiji je sodelovalo skupno 53 bolnikov, ki so prejeli vsaj en odmerek holne kisline; 22 (42 %) je bilo predhodno nezdravljenih, tj. med študijo CAC-002-01 so prejeli svoj prvi odmerek holne kisline.
In repeated dose studies, frequently reported effects of cholic acid have included decreased body weight, diarrhoea and liver damage with elevated transaminases although are considered to be associated with the pharmacological effects of bile acid metabolism.
V študijah z večkratnimi odmerki so pogosti učinki holne kisline vključevali zmanjšano telesno maso, diarejo in jetrno okvaro s povišanimi ravnmi transaminaz, čeprav menijo, da so ti povezani s farmakološkimi učinki presnove žolčnih kislin.