natgillin/translations-raw huggingface dataset:
AUC: ↑ 1.8-fold
AUC:↑ 1,8-krat
AUC: ↑ 6.2-fold Cmax: ↑ 3.4-fold
AUC:↑ 6,2-krat Cmax:↑ 3,4-krat
Careful monitoring of adverse reactions (respiratory depression, sedation) is recommended.
Priporočljivo je skrbno spremljanje neželenih učinkov (respiratorne depresije, sedacije).Morda bo potrebno zmanjšati odmerek alfentanila in fentanila.
(CYP3A enzyme induction)
(indukcija encima CYP3A)
Within the first hour after ingestion gastric lavage may be performed.
V prvi uri po zaužitju se lahko opravi izpiranje želodca.
AUC: ↑ 1.4-fold
AUC:↑ 1,4-krat
Potential ↑in plasma concentrations of sertindole.
Morebitno ↑ koncentracij sertindola v plazmi.
↑in plasma concentrations of ebastine have been observed
Opazili so ↑ koncentracij ebastina v plazmi.
AUC: ↑ 1.3-fold
AUC:↑ 1,3-krat
Potential ↑in plasma concentrations of buspirone.
Morebitno ↑ koncentracij buspirona v plazmi.
AUC: ↑ 5.9-fold Cmax: ↑ 2.7-fold
AUC:↑ 5,9-krat Cmax:↑ 2,7-krat
• Diarrhoea • Skin reactions (pruritus, rash)
• kožne reakcije (srbenje, izpuščaj).
sunitinib, lapatinib, nilotinib, bortezomib, paclitaxel, vincristine, vinblastine, cabozantinib, dabrafenib,
- nekatera zdravila za zdravljenje raka, kot so alkaloidi rožnatega zimzelena, busulfan, docetaksel, erlotinib, imatinib, dasatinib, sunitinib, lapatinib, nilotinib, bortezomib, paklitaksel, vinkristin, vinblastin,
Potential ↑in plasma concentrations of clarithromycin
Morebitno ↑ koncentracij klaritromicina v plazmi.
AUC: ↑ 2.6-fold Cmax: ↑2.5-fold
AUC:↑ 2,6-krat Cmax:↑ 2,5-krat
Potential ↑in plasma concentrations of haloperidol.
Morebitno ↑ koncentracij haloperidola v plazmi.
AUC: ↑ 1.9-fold Cmax: ↑ 1.7-fold
AUC:↑ 1,9-krat Cmax:↑ 1,7-krat
Saxagliptin:
Saksagliptin:
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora neznana epistaksa
AUC: ↑ 1.7-fold Cmax: ↑ 1.3-fold
AUC:↑ 1,7-krat Cmax:↑ 1,3-krat
↑in plasma concentrations of tolterodine have been observed
AUC:↑ 3,0-krat Opazili so ↑ koncentracij tolterodina v plazmi.
They will be checked again after that in case your doctor increases your daily ketoconazole dose.
Če vam bo za tem zdravnik še povečal dnevni odmerek ketokonazola, bo preiskave jetrnih encimov znova preveril.
• Arthralgia (joint pain)
• artralgija (bolečina v sklepih),
↑in plasma concentrations of praziquantel have been observed
Opazili so ↑ koncentracij prazikvantela v plazmi.
↑in plasma concentrations of oxycodone have been observed
Opazili so ↑ koncentracij oksikodona v plazmi.
Ketoconazole at doses up to 40 mg/kg had no effects on female fertility in the rat, whilst doses of 75 mg/kg and higher decreased the pregnancy rate and the number of implantation sites.
Ketokonazol v odmerkih do 40 mg/kg ni imel nobenega učinka na plodnost podganjih samic,
AUC: ↑2.2-fold Cmax: ↑1.7-fold
AUC: ↑2,2-krat Cmax: ↑1,7-krat
AUC: ↔ Cmax: ↔
Cmax:↔
AUC: ↑ 2-fold Cmax: ↑1.6-fold
AUC:↑ 2-krat Cmax:↑ 1,6-krat
AUC: ↑ 2.3-fold Cmax: ↑ 2.0-fold
AUC:↑ 2,3-krat Cmax:↑ 2,0-krat
Talk to your doctor or pharmacist before taking Ketoconazole HRA.
Pred začetkom jemanja zdravila Ketokonazol HRA se posvetujte z zdravnikom ali farmacevtom.
Cmax: ↑ 6 fold
Cmax: ↑ 1,6-krat
AUC: ↑ 10-fold Cmax: ↑ 4-fold
AUC:↑ 10-krat Cmax:↑ 4-krat
AUC: ↑ 2.6-fold Cmax: ↑1.7-fold
AUC:↑ 2,6-krat Cmax:↑ 1,7-krat
Exacerbation or development of inflammatory/autoimmune disorders has been described after Cushing's syndrome remission, including after treatment with ketoconazole.
Po remisiji Cushingovega sindroma, vključno po zdravljenju s ketokonazolom, so opazili poslabšanje ali razvoj vnetnih/avtoimunskih motenj.
Nausea, abdominal pain, vomiting, diarrhoea
povišana telesna temperatura, anoreksija, navzea in bruhanje.
A dose reduction of ketoconazole should be considered when coadministered with ritonavir dosed as an antiretroviral medicinal product or as a pharmacokinetic enhancer.
Pri sočasni uporabi z ritonavirjem, odmerjanim kot protivirusnim zdravilom ali farmakokinetičnim ojačevalcem, je treba razmisliti o zmanjšanju odmerka ketokonazola.
Endocrine disorders Common
Bolezni endokrinega sistema pogosti adrenalna insuficienca
Edoxaban
Aprepitant
Dasatinib ↑in plasma concentrations of Dasatinib have been observed Dabrafenib
Opazili so ↑ koncentracij dasatiniba v plazmi.
Nervous system disorders
Alfaadrenergični antagonisti
How to take Ketoconazole HRA
Kako jemati zdravilo Ketokonazol HRA
Contraindicated due to the risk of serious cardiovascular events including QT prolongation (see section 4.3).
Kontraindicirano zaradi tveganja resnih kardiovaskularnih dogodkov, vključno s podaljšanjem intervala QT
Cmax ↑ 9.6 fold
Cmax:↑ 1,6-krat
AUC: ↑ 1.5-fold Cmax: ↑1.7-fold
AUC:↑ 1,5-krat Cmax:↑ 1,7-krat
Potential ↑in plasma concentrations of warfarin
Morebitno ↑ koncentracij varfarina v plazmi.
Ketoconazole has not been demonstrated to induce its own metabolism.
Spodbujanja lastne presnove pri ketokonazolu niso dokazali.
AUC: ↑ 3.6-fold
AUC:↑ 1,6-krat
↑in plasma concentrations of colchicine have been observed
Opazili so ↑ koncentracij kolhicina v plazmi.
No change in plasma concentration were shown with paclitaxel concentrate.
Pri koncentratu paklitaksela niso opazili nobene spremembe v plazmi.Z
(CYP3A enzyme inhibition)
(zaviranje encima CYP3A)
Musculoskeletal and connective tissue disorder
Bolezni mišično skeletnega sistema in vezivnega tkiva neznana mialgija, artralgija
AUC: ↑ 2.7-fold Cmax:↑ 1.5-fold
AUC:↑ 2,7-krat Cmax: ↑ 1,5-krat
AUC: ↑ 1.6-fold Cmax: ↑ 1.4-fold
AUC:↑ 1,6-krat Cmax:↑ 1,4-krat
- This medicine does not require any special storage conditions - Do not throw away any medicines via wastewater or household waste.
- Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.Taki ukrepi pomagajo varovati okolje.
AUC: ↑ 5-fold
AUC:↑ 5-krat
Potential ↑in plasma concentrations of digoxine
Morebitno ↑ koncentracij digoksina v plazmi.
AUC: ↑ 2.1-fold
AUC:↑ 2,1-krat
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; - Hypersensitivity to any imidazole antifungal medicinal product; - Acute or chronic liver disease and/or if pre-treatment liver enzymes levels are above 2 times the upper limit of normal (see sections 4.2 and 4.4): - Pregnancy (see section 4.6); - Breastfeeding (see section 4.6); - Congenital or documented acquired QTc prolongation ; - Concomitant therapy with any of the following medicinal products which may interact and result in potentially life-threatening adverse reactions (see section 4.5): o CYP3A4 metabolised HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin and lovastatin) due to an increased risk of skeletal muscle toxicity including rhabdomyolysis; o eplerenone due to an increased risk of hyperkalemia and hypotension; o substances that may have their plasma concentrations increased and have QT prolonging potential: methadone, disopyramide, quinidine, dronedarone, pimozide, sertindole, saquinavir (saquinavir/ritonavir 1000/100 mg bid), ranolazine, mizolastine, halofantrine; o dabigatran due to an increased bleeding risk; o triazolam, oral midazolam and alprazolam due to potential for prolonged or increased sedation and respiratory depression; o ergot alkaloids (eg dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) due to an increased risk of ergotism and other serious vasospastic adverse reactions; o lurasidone; o quetiapine due to an increased risk of toxicity; o telithromycin and clarithromycin in patients with severe renal impairment due to an increased risk of hepatotoxicity and QT interval prolongation; o felodipine, nisoldipine due to an increased risk of oedema and congestive heart failure;
o zaviralci reduktaze HMG-CoA, ki jih presnavlja CYP3A4 (npr. simvastatin, atorvastatin in lovastatin), zaradi povečanega tveganja mišičnoskeletne toksičnosti, vključno z rabdomiolizo, o eplerenon zaradi povečanega tveganja hiperkaliemije in hipotenzije, o učinkovine, katerih koncentracija v plazmi se lahko poveča in ki imajo potencial za podaljšanje intervala QT: metadon, dizopiramid, kinidin, dronedaron, pimozid, sertindol, sakvinavir (sakvinavir/ritonavir 1000/100 mg dvakrat na dan), ranolazin, mizolastin, halofantrin,
Potential ↑ in plasma concentrations of methadone
Morebitno ↑ koncentracij metadona v plazmi.
AUC: ↑ 1.5-fold Cmax: ↑ 1.5-fold
AUC:↑ 1,5-krat Cmax:↑ 1,5-krat
Not recommended due to the increased risk of QT prolongation and extrapyramidal symptoms.
Ni priporočljivo zaradi povečanega tveganja podaljšanja intervala QT in ekstrapiramidnih simptomov.Morda bo potrebno zmanjšati odmerek haloperidola.
AUC: ↑ 5-fold Cmax: ↑ 1.1 -fold
AUC: ↑ 5-krat Cmax: ↑ 1,1-krat
Buprenorphine IV and sublingual
Buprenorfin i.v.
Dose adjustment of paclitaxel may be required.
Morda bo potrebna prilagoditev odmerka paklitaksela.
Patients with Cushing's syndrome and coexisting inflammatory/autoimmune disorders should be supervised after normalisation of cortisol levels on ketoconazole.
Po normalizaciji ravni kortizola med jemanjem ketokonazola je treba bolnike s Cushingovim sindromom in sočasnimi vnetnimi/avtoimunskimi motnjami nadzorovati.
AUC: ↑ 3.0-fold
AUC:↑ 3,0-krat
AUC: ↑ 3.2-fold Cmax: ↑ 1.4-fold
AUC: ↑ 3,2-krat Cmax: ↑ 1.4-krat
AUC: ↑ 3.0 fold Cmax: ↑ 3.0 fold
AUC:↑ 3,0-krat Cmax:↑ 3,0-krat
Ebastine
Irinotekan
AUC: ↑ 5-fold Cmax: ↑ 3.4-fold
AUC:↑ 5-krat Cmax:↑ 3,4-krat
Cmax: ↑ 2-fold
AUC:↑ 2-krat Cmax:↑ 2-krat
Dose adjustment of praziquantel may be required.
Morda bo potrebna prilagoditev odmerka prazikvantela.
You should stop your treatment and contact your doctor immediately if you feel unwell or experience symptoms such as lack of appetite, nausea, vomiting, fatigue, jaundice, abdominal pain or dark urine.
Če se ne počutite dobro ali imate simptome, kot so pomanjkanje apetita, slabost, bruhanje, utrujenost, zlatenica, bolečina v trebuhu ali temen urin, morate prekiniti zdravljenje in se takoj posvetovati z zdravnikom.
• Skin redness, drying, itching
• pordelost, suhost, srbenje kože,
Contraindicated due to the increased risk of adverse reactions (see section
Kontraindicirano zaradi povečanega tveganja neželenih učinkov (glejte poglavje 4.3).
• Hot flush
flutikazon,
Before starting the treatment, it is mandatory: - to measure liver enzymes (ASAT, ALAT, gammaGT and alkaline phosphatase) and bilirubin - to inform the patients about the risk of hepatotoxicity, including to stop the treatment and to contact their doctor immediately if they feel unwell or in the event of symptoms such as anorexia, nausea, vomiting, fatigue, jaundice, abdominal pain or dark urine.
- bolnike obvestiti o tveganju hepatotoksičnosti, vključno s prekinitvijo zdravljenja in takojšnjem posvetu z zdravnikom, če se ne počutijo dobro ali se pojavijo simptomi, kot so anoreksija, navzea, bruhanje, utrujenost, zlatenica, bolečina v trebuhu ali temen urin.Če se pojavijo taki simptomi, je treba zdravljenje takoj prekiniti in opraviti preiskave delovanja jeter.
Your adrenal function will be monitored at regular intervals as this is the standard care in the follow-up of Cushing's syndrome therapy and since adrenal insuficiency can occur during the treatment.
Pri vas bodo redno spremljali delovanje nadledvične žleze, saj je to standardna oskrba pri spremljanju zdravljenja Cushingovega sindroma in ker se lahko med zdravljenjem pojavi nezadostno delovanje nadledvične žleze (adrenalna insuficienca).Takoj se posvetujte z zdravnikom, če imate simptome, kot so šibkost, utrujenost, pomanjkanje apetita, slabost, bruhanje ali nizek krvni tlak.
AUC: ↑ 1.2-fold Cmax: ↑ 1.2-fold
AUC:↑ 1,2-krat Cmax:↑ 1,2-krat
• Dry mouth
vročinski oblivi
AUC: ↑ 15.3-fold Cmax: ↑ 4.1-fold
AUC:↑ 15,3-krat Cmax:↑ 4,1-krat Sirolimus (rapamicin): AUC:↑ 10,9-krat
Anticoagulants and antiplatelet drugs Dabigatran
Antikoagulanti in antitrombotiki
Microcrystalline cellulose Silica colloidal Magnesium stearate
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi koruzni škrob laktoza monohidrat povidon mikrokristalna celuloza koloidni silicijev dioksid magnezijev stearat
mostly produced in the testes
krat v primerjavi z zgodovinskimi kontrolami
Dizziness or somnolence have been reported during treatement with Ketoconazole HRA.
Med zdravljenjem z zdravilom Ketokonazol HRA so poročali o omotici in somnolenci (zaspanosti).
MARKETING AUTHORISATION NUMBER(S)
Študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS):
In most of the publications the maintenance dose varied between 600 mg/day and 800 mg/day; - When the effective dose of ketoconazole is established, monitoring of urinary free cortisol and/or plasma cortisol levels may be performed every 3 to 6 months (see section 4.4); - In the case of adrenal insufficiency and depending on the severity of the event, the dose of ketoconazole should be decreased by at least 200 mg/day or the treatment should be temporarily discontinued and/or a corticosteroid therapy should be added until the resolution of the event.
- Če pride do adrenalne insuficience, je treba glede na resnost dogodka odmerek ketokonazola zmanjšati za vsaj 200 mg/dan ali zdravljenje začasno prekiniti in/ali dodati zdravljenje s kortikosteroidi, dokler dogodek ne izzveni.
ergotamine and methylergometrine (methylergonovine) - certain medicines used in cancers: irinotecan, everolimus - sirolimus: used to prevent your body from rejecting a kidney transplant - tolvaptan used for a specific disease called “syndrome of inappropriate antidiuretic hormone secretion” - vardenafil in men older than 75 years - medicine to treat erectile dysfunction in adults men - certain medicines for HIV: saquinavir/ritonavir, saquinavir - certain medicines to treat long-term (chronic) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus): Paritaprevir/Ombitasvir (ritonavir) - methadone: medicine to treat dependence to drugs - In patients with renal disorders:
- vardenafil pri moških, starejših od 75 let - zdravilo za zdravljenje erektilne disfunkcije pri odraslih moških, - nekatera zdravila za zdravljenje HIV: sakvinavir/ritonavir, sakvinavir,
Ask your doctor or pharmacist for more information if you are taking Ketoconazole HRA with other medicines.
Če zdravilo Ketokonazol HRA jemljete sočasno z drugimi zdravili, se za več informacij obrnite na zdravnika ali farmacevta.
The SmPC for concomitantly used products must be consulted for the recommendations regarding coadministration with strong CYP3A4 inhibitors.
Za priporočila glede sočasnega dajanja z močnimi zaviralci CYP3A4 je treba preveriti povzetke glavnih značilnosti sočasno uporabljenih zdravil.
Cardiovascular Drugs, Miscellaneous Ranolazine
Kardiovaskularna zdravila, razno
o CYP3A4 metabolised HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin and lovastatin) due to an increased risk of skeletal muscle toxicity including rhabdomyolysis; o eplerenone due to an increased risk of hyperkalemia and hypotension; o substances that may have their plasma concentrations increased and have QT prolonging potential : methadone, disopyramide, quinidine, dronedarone, pimozide, sertindole, saquinavir (saquinavir/ritonavir 1000/100 mg bid), ranolazine, mizolastine, halofantrine; o dabigatran due to an increased bleeding risk; o triazolam, oral midazolam and alprazolam due to potential for prolonged or increased sedation and respiratory depression; o ergot alkaloids (eg dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine) due to an increased risk of ergotism and other serious vasospastic adverse reactionsevents o lurasidone; o quetiapine due to an increased risk of toxicity; o telithromycin and clarithromycin in patients with severe renal impairment due to an increased risk of hepatotoxicity and QT interval prolongation; o felodipine, nisoldipine due to an increased risk of oedema and congestive heart failure; o colchicine in patients with renal impairment due to an increased risk of severe adverse reactions; o irinotecan due to an alteration of the metabolism of this medicinal product; o everolimus, sirolimus (also known as rapamycin) due to an increase of the plasma concentrations of these medicinal products; o vardenafil in men older than 75-years due to increased risk of adverse reactions o paritaprevir/ombitasvir (ritonavir) due to increased risk of adverse reactions; o fesoterodine and solifenacin in patients with renal impairment; o tolvaptan used for a specific disease called “syndrome of inappropriate antidiuretic hormone secretion”.
(metilergonovin)) zaradi povečanega tveganja ergotizma in drugih resnih vazospastističnih neželenih učinkov, o lurasidon, o kvetiapin zaradi povečanega tveganja toksičnosti, o telitromicin in klaritromicin pri bolnikih s hudo ledvično okvaro zaradi povečanega tveganja hepatotoksičnosti in podaljšanja intervala QT, o felodipin, nizoldipin zaradi povečanega tveganja edema in kongestivnega srčnega popuščanja, o kolhicin pri bolnikih z ledvično okvaro zaradi povečanega tveganja hudih neželenih učinkov,
AUC: ↑ 4-fold Cmax: ↑ 1.2-fold
AUC:↑ 4-krat Cmax:↑ 1,2-krat
• Tongue discoloration
• sprememba barve jezika,
Dexamethasone, fluticasone, methylprednisolone
sertindol, lurasidon, kvetiapin,
Dose adjustment of risperidone may be required.
Morda bo potrebna prilagoditev odmerka aprepitanta.
Cabozantinib
Dabrafenib
Pregnancy, breast-feeding and fertility
Antipsihotiki, anksiolitiki in hipnotiki
Potential ↑in plasma concentrations of sildenafil
Morebitno ↑ koncentracij sildenafila v plazmi.
AUC: ↑ 1.8-fold Cmax: ↑ 1.8-fold
Cmax: ↑ 1,8-krat
Press down at 1 and at the same time pull at 2.
Pritisnite navzdol pri 1 in istočasno povlecite pri 2.
The patient alert card shall contain the following key elements:
Opozorilna kartica za bolnika mora vsebovati naslednje ključne elemente:
MN = Multiples of Normal
MN = večkratnik normalne vrednosti
Monitoring of clinical response
Spremljanje kliničnega odziva
Take one capsule in the morning and one capsule at night.
Eno kapsulo vzemite zjutraj in eno zvečer.
All patient number (N)= Per Protocol Population
Število vseh bolnikov (N) = populacija po protokolu
Take the next capsule at the usual time.
Naslednjo kapsulo vzemite ob istem času, kot običajno.
The majority of extension phase discontinuations were due to transition to commercial product from year 3 onwards.
Večina prenehanj v fazi podaljšanja je bila posledica prehoda bolnikov na komercialno zdravilo od 3. leta naprej.
Your doctor will determine which medicines you can use based on how fast your body breaks down eliglustat.
Zdravnik bo presodil, katera zdravila lahko uporabljate glede na to, kako hitro vaše telo razgrajuje eliglustat.
As a result the amount of this medicine in the blood can differ between patients which could affect how a patient would respond.
Posledično se lahko razlikuje tudi količina tega zdravila v krvi, kar lahko vpliva na to, kako se bo bolnik odzval.
Take one capsule at the same time every day.
Vzemite eno kapsulo ob istem času vsak dan.
Eliglustat is moderately bound to human plasma proteins (76 to 83%) and is mainly distributed in plasma.
Eliglustat se zmerno veže na človeške plazemske beljakovine (76 do 83 %) in se pretežno porazdeli v plazmi.
Eighteen patients completed 8 years of treatment.
Osemnajst bolnikov je dokončalo 8 let zdravljenja.
The size of the capsule is ‘size 2' (dimensions 18.0 x 6.4 mm).
Velikost kapsule je »velikost št. 2« (mere: 18,0 × 6,4 mm).
Date of first authorisation: 19 January 2015 Date of latest renewal:
Datum prve odobritve: 19. januar 2015
Standard Deviation
Standardni odklon
• have any other heart problems.
• če imate katere koli druge težave s srcem,
Results of study 304 indicate that skeletal improvements are maintained or continue to improve during at least 8 years of treatment with Cerdelga.
Rezultati študije 304 kažejo, da se skeletna izboljšanja ohranijo ali se še naprej izboljšujejo v teku vsaj 8 let zdravljenja z zdravilom Cerdelga.
Patients at start of year (N) Patients at end of year (N) Patients with available data (N)
Bolniki ob koncu leta (N) Bolniki, za katere so na voljo podatki (N)
If you are pregnant, think that you may be pregnant or are planning to have a baby, tell your doctor who will discuss with you whether you can take this medicine during your pregnancy.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, ali lahko to zdravilo jemljete med nosečnostjo.
Patients who are URMs may not achieve adequate concentrations to achieve a therapeutic effect.
Pri bolnikih, ki so URM, se lahko zgodi, da ne dosežejo zadostne koncentracije za terapevtski učinek.
There were no clinically meaningful differences between groups for any of the four individual disease parameters (see Table 4).
Med skupinama ni bilo opaženih nobenih klinično pomembnih razlik za katero koli od štirih posameznih parametrov bolezni (glejte Preglednico 4).
This may cause mild increases in the PR, QRS, and QTc intervals.
To lahko povzroči blaga podaljšanja intervalov PR, QRS in QTc.
The capsules should be swallowed whole, preferably with water, and should not be crushed, dissolved, or opened.
Kapsule je treba zaužiti cele, po možnosti z vodo, in se jih ne sme zdrobiti, raztopiti ali odpirati.
Each pack contains 14, 56 or 196 hard capsules.
Vsako pakiranje vsebuje 14, 56 ali 196 trdih kapsul.
In the event of acute overdose, the patient should be carefully observed and given symptomatic treatment and supportive care.
Če pride do akutno prevelikega odmerjanja, je treba bolnika natančno spremljati ter uvesti simptomatsko in podporno zdravljenje.
No dosing recommendation for URMs can be given.
Priporočil za odmerjanje pri URM ni mogoče dati.
Nineteen patients completed 4 years of treatment.
Devetnajst bolnikov je zaključilo štiri leta zdravljenja.
Characteristics in specific groups
Lastnosti specifičnih skupin
The build-up prevents these organs from working properly.
Kopičenje te snovi v organih preprečuje njihovo pravilno delovanje.
• Pain in arms, legs or back
• bolečine v rokah, nogah ali v križu
If you cannot swallow the capsule whole, tell your doctor.
Če kapsule ne morete pogoltniti cele, se obrnite na zdravnika.
Please tell your doctor or pharmacist if you are using, or have recently used, or might use, any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The capsules may be taken with or without food.
Kapsule se lahko vzame s hrano ali brez nje.
In these four studies a total of 393 patients between the ages of 16-75 years received eliglustat for a median duration of 3.5 years (up to 9.3 years).
V teh štirih študijah je 393 bolnikov, starih od 16 do 75 let, prejemalo eliglustat mediano 3,5 leta (do 9,3 leta).
Not all packs may be marketed in your country.
V vaši državi morda ni vseh navedenih pakiranj na trgu.
MN = Multiples of Normal, CI = confidence interval * Excludes patients with a total splenectomy.
MN = mnogokratniki normalne vrednosti, IZ = interval zaupanja * Izključuje bolnike s popolno splenektomijo.
Use of eliglustat in patients with pre-existing cardiac conditions has not been studied during clinical trials.
Uporaba eliglustata pri bolnikih z obstoječimi srčnimi obolenji ni bila raziskovana v kliničnih preskušanjih.
Effects of eliglustat in toxicology studies were reversible and exhibited no evidence of delayed or recurring toxicity.
Učinki eliglustata v toksikoloških študijah so bili reverzibilni in niso kazali na zapoznelo ali ponavljajočo se toksičnost.
During the open-label long term treatment period with Cerdelga (extension phase), all patients with complete data who continued to receive Cerdelga showed further improvements throughout the extension phase.
Med obdobjem odprtega dolgoročnega zdravljenja z zdravilom Cerdelga (faza podaljšanja) so vsi bolniki, ki so imeli popolne podatke in so še naprej prejemali zdravilo Cerdelga, med celotno fazo podaljšanja kazali še dodatno izboljšanje.
The safety and efficacy of Cerdelga in children and adolescents under the age of 18 years has not been established.
Varnost in učinkovitost zdravila Cerdelga pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.