natgillin/translations-raw huggingface dataset:
Excipient with known effect Each tablet contains 71.45 mg lactose monohydrate.
Svaka tableta sadrži 71,45 mg laktoze hidrat.
- The recommended starting dose in polycythaemia vera is 10 mg twice daily.
- Preporučena početna doza kod policitemije vere je 10 mg dvaput na dan.
The recommended starting dose for PV patients with ESRD on haemodialysis is a single dose of 10 mg or two doses of 5 mg given 12 hours apart, to be administered post-dialysis and only on the day of haemodialysis.
Preporučena početna doza za bolesnike s PV-om i terminalnim bubrežnim zatajenjem koji su na hemodijalizi je jednokratna doza od 10 mg ili dvije doze od 5 mg dane u razmaku od 12 sati, koje treba primijeniti nakon dijalize i to samo na dan hemodijalize.
- Each 20 mg Jakavi tablet contains 20 mg of ruxolitinib.
- Svaka tableta Jakavi 20 mg sadrži 20 mg ruksolitiniba.
How to store Jakavi
Kako čuvati Jakavi
Dose adjustment with concomitant strong CYP3A4 inhibitors or fluconazole When ruxolitinib is administered with strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole) the unit dose of ruxolitinib should be reduced by approximately 50%, to be administered twice daily (see section 4.5).
Kada se ruksolitinib primjenjuje sa snažnim CYP3A4 inhibitorima ili dvostrukim inhibitorima enzima CYP2C9 i CYP3A4 (npr. flukonazolom), jediničnu dozu ruksolitiniba treba smanjiti za otprilike 50% te je primjenjivati dvaput na dan (vidjeti dio 4.5).
Excipient with known effect Each tablet contains 142.90 mg lactose monohydrate.
Svaka tableta sadrži 142,90 mg laktoze hidrat.
Positive (N=110) n (%)
Pozitivan (N=110) n (%)
The concurrent use of haematopoietic growth factors and ruxolitinib has not been studied.
Istodobna primjena hematopoetskih čimbenika rasta i ruksolitiniba nije do sada ispitivana.
Positive (N=49) n (%)
Pozitivan (N=49) n (%)
Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets
Jakavi 10 mg tablete Jakavi 15 mg tablete Jakavi 20 mg tablete
Positive (N=113) n (%)
Pozitivan (N=113) n (%)
Bruising was reported in 10.3% of patients treated with ruxolitinib, 8.1% of patients receiving best available therapy in RESPONSE
Stvaranje modrica bilo je zabilježeno u 10,3% bolesnika liječenih ruksolitinibom, u 8,1% bolesnika koji su primali najbolju dostupnu terapiju u RESPONSE ispitivanju te u 2,7% bolesnika koji su primali najbolju dostupnu terapiju u RESPONSE 2 ispitivanju.
Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets ruxolitinib
Jakavi 10 mg tablete Jakavi 15 mg tablete Jakavi 20 mg tablete ruksolitinib
If you have any questions about how Jakavi works or why this medicine has been prescribed for you, ask your doctor.
Ako imate ikakvih pitanja o djelovanju Jakavija ili o tome zašto
A dose modification is recommended in patients with severe renal impairment and end-stage renal disease (see section 4.2).
U bolesnika s teškim oštećenjem bubrega i terminalnim bubrežnim zatajenjem preporučuje se prilagodba doze (vidjeti dio 4.2).
Excipient with known effect Each tablet contains 214.35 mg lactose monohydrate.
Svaka tableta sadrži 214,35 mg laktoze hidrat.
Jakavi 20 mg tablets
Jakavi 20 mg tablete
Gastrointestinal disorders Flatulence a
Flatulencija a
Tell your doctor if you are breast-feeding.
Obratite se svom liječniku ako dojite.
Negative (N=35) n (%)
Negativan (N=35) n (%)
Discontinuation of treatment because of thrombocytopenia occurred in 0.7% of patients receiving ruxolitinib and 0.9%
Do prekida liječenja zbog trombocitopenije došlo je kod 0,7% bolesnika koji su primali ruksolitinib te kod 0,9% bolesnika koji su primali kontrolne režime.
- Each 5 mg Jakavi tablet contains 5 mg of ruxolitinib.
- Svaka tableta Jakavi 5 mg sadrži 5 mg ruksolitiniba.
- Each 15 mg Jakavi tablet contains 15 mg of ruxolitinib.
- Svaka tableta Jakavi 15 mg sadrži 15 mg ruksolitiniba.
Other bleeding events (including events such as epistaxis, post-procedural haemorrhage, gingival bleeding) were reported in 8.7% of patients treated with ruxolitinib, 6.3% of patients treated with best available therapy in RESPONSE study and 6.7% of patients treated with best available therapy in RESPONSE 2 study.
U jednog bolesnika liječenog ruksolitinibom došlo je do događaja krvarenja stupnja 3 (postproceduralno krvarenje); nije zabilježeno nijedno krvarenje stupnja 4. Drugi događaji krvarenja (uključujući događaje kao što su epistaksa, postproceduralno krvarenje, gingivalno krvarenje) bili su zabilježeni u 8,7% bolesnika liječenih ruksolitinibom, u 6,3% bolesnika liječenih najboljom dostupnom terapijom u RESPONSE ispitivanju te u 6,7% bolesnika koji su primali najbolju dostupnu terapiju u RESPONSE 2 ispitivanju.
Jakavi 10 mg tablets EU/1/12/773/014-016
Jakavi 10 mg tablete EU/1/12/773/014-016
Jakavi 20 mg tablets EU/1/12/773/010-012
Jakavi 20 mg tablete EU/1/12/773/010-012
Jakavi 5 mg tablets EU/1/12/773/004-006
Jakavi 5 mg tablete EU/1/12/773/004-006
Jakavi 15 mg tablets EU/1/12/773/007-009
Jakavi 15 mg tablete EU/1/12/773/007-009
Negative (N=27) n (%)
Negativan (N=27) n (%)
Negative (N=20) n (%)
Negativan (N=20) n (%)
Negative (N=40) n (%)
Negativan (N=40) n (%)
Jakavi 10 mg tablets
Jakavi 10 mg tablete
Jakavi 20 mg tablets are white to almost white elongated tablets with “NVR” debossed on one side and “L20” debossed on the other side.
Jakavi 20 mg tablete su bijele do gotovo bijele duguljaste tablete s oznakom „NVR“ utisnutom na jednoj strani i oznakom „L20“ utisnutom na drugoj strani.
was 0-2 mmHg on ruxolitinib versus a decrease of 2-5 mmHg in the placebo arm.
U ispitivanju COMFORT-I (bolesnici s MF-om) srednje povišenje sistoličkog krvnog tlaka od početnog bilo je 0-2 mmHg na terapiji ruksolitinibom u usporedbi sa smanjenjem od 2-5 mmHg u kraku koji je primao placebo.
Jakavi 15 mg tablets
Jakavi 15 mg tablete
Strong CYP3A4 inhibitors (such as, but not limited to, boceprevir, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole) In healthy subjects co-administration of ruxolitinib (10 mg single dose) with a strong CYP3A4 inhibitor, ketoconazole, resulted in ruxolitinib Cmax and AUC that were higher by 33% and 91%, respectively, than with ruxolitinib alone.
Snažni CYP3A4 inhibitori (kao što su, između ostalih, boceprevir, klaritromicin, indinavir, itrakonazol, ketokonazol, lopinavir/ritonavir, ritonavir, mibefradil, nefazodon, nelfinavir, posakonazol, sakvinavir, telaprevir, telitromicin, vorikonazol)
Jakavi 5 mg tablets
Jakavi 5 mg tablete
- Each 10 mg Jakavi tablet contains 10 mg of ruxolitinib.
Jakavi 10 mg sadrži 10 mg ruksolitiniba.
Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Sodium starch glycolate (Type A) Povidone K30
6.1 Popis pomoćnih tvari celuloza, mikrokristalična magnezijev stearat silicijev dioksid, koloidni, bezvodni natrijev škroboglikolat, vrste A povidon K30 hidroksipropilceluloza 300 do 600 cps laktoza hidrat
Round curved white to almost white tablets of approximately 9.3 mm in diameter with “NVR” debossed on one side and “L10” debossed on the other side.
Okrugle, zaobljene, bijele do gotovo bijele tablete promjera približno 9,3 mm, s oznakom „NVR“ utisnutom na jednoj strani i oznakom „L10“ utisnutom na drugoj strani.
Elongated curved white to almost white tablets of approximately 16.5 x 7.4 mm with “NVR” debossed one one side and “L20” debossed on the other side.
Izdužene, zaobljene, bijele do gotovo bijele tablete veličine približno 16,5 x 7,4 mm, s oznakom „NVR“ utisnutom na jednoj strani i oznakom „L20“ utisnutom na drugoj strani.
Jakavi 15 mg tablets are white to almost white oval tablets with “NVR” debossed on one side and “L15” debossed on the other side.
Jakavi 15 mg tablete su bijele do gotovo bijele ovalne tablete s oznakom „NVR“ utisnutom na jednoj strani i „L15“ utisnutom na drugoj strani.
Jakavi 20 mg tablets ruxolitinib
Jakavi 20 mg tablete ruksolitinib
Ovaloid curved white to almost white tablets of approximately 15.0 x 7.0 mm with “NVR” debossed on one side and “L15” debossed on the other side.
Ovalne, zaobljene, bijele do gotovo bijele tablete veličine približno 15,0 x 7,0 mm, s oznakom „NVR“ utisnutom na jednoj strani i oznakom „L15“ utisnutom na drugoj strani.
A complete blood cell count, including a white blood cell count differential, must be performed before initiating therapy with Jakavi.
Prije početka liječenja Jakavijem mora se napraviti kompletna krvna slika, uključujući i diferencijalnu krvnu sliku leukocita.
Round curved white to almost white tablets of approximately 7.5 mm in diameter with “NVR” debossed on one side and “L5” debossed on the other side.
Okrugle, zaobljene, bijele do gotovo bijele tablete promjera približno 7,5 mm, s oznakom „NVR“ utisnutom na jednoj strani i oznakom „L5“ utisnutom na drugoj strani.
Jakavi 10 mg tablets are white to almost white round tablets with “NVR” debossed on one side and “L10” debossed on the other side.
Jakavi 10 mg tablete su bijele do gotovo bijele okrugle tablete s oznakom „NVR“ utisnutom na jednoj strani i oznakom „L10“ utisnutom na drugoj strani.
Each tablet contains 20 mg ruxolitinib (as phosphate).
Svaka tableta sadrži 20 mg ruksolitiniba (u obliku ruksolitinibfosfata).
Vascular disorders Hypertensiona
Krvožilni poremećaji Hipertenzija a
Jakavi 10 mg tablets ruxolitinib
Jakavi 10 mg tablete ruksolitinib
Follow all the doctor's instructions carefully.
Što morate znati prije nego počnete uzimati Jakavi Pažljivo slijedite sve liječničke upute.
Common
Kod
Jakavi 5 mg tablets ruxolitinib
Jakavi 5 mg tablete ruksolitinib
Each tablet contains 15 mg ruxolitinib (as phosphate).
Svaka tableta sadrži 15 mg ruksolitiniba (u obliku ruksolitinibfosfata).
The frequency of grade 3-4 events was similar for patients treated with ruxolitinib or reference treatments
Učestalost događaja stupnja 3-4 bila je slična za bolesnike liječene ruksolitinibom ili referentnim terapijama (4,7% u odnosu na 3,1%).
Each tablet contains 5 mg ruxolitinib (as phosphate).
Svaka tableta sadrži 5 mg ruksolitiniba (u obliku ruksolitinibfosfata).
bruising and other bleeding events) were reported in 32.6% of patients exposed to ruxolitinib and
U ključnim ispitivanjima MF-a faze 3 događaji krvarenja (uključujući intrakranijalno i gastrointestinalno, modrice i druge događaje krvarenja) bili su prijavljeni u 32,6% bolesnika koji su bili izloženi ruksolitinibu te u 23,2% bolesnika koji su bili izloženi referentnim terapijama (placebu ili najboljoj dostupnoj terapiji).
Jakavi 15 mg tablets ruxolitinib
Jakavi 15 mg tablete ruksolitinib
Each tablet contains 10 mg ruxolitinib (as phosphate).
Svaka tableta sadrži 10 mg ruksolitiniba (u obliku ruksolitinibfosfata).
CLINICAL PARTICULARS
Bolesnici s
c grade 1
CTCAEc stupanj 1
Therefore, you should not stop taking Jakavi without discussing it with your doctor.
Jakavi ako se prethodno ne posavjetujete s liječnikom.
Thrombocytopenia b
Trombocitopenija b
This means that it is similar to a ‘reference medicine' containing the same active substance.
To znači da je sličan „referentnom lijeku” koji sadrži istu djelatnu tvar.
Every year, the European Medicines Agency will review any new information that becomes available and this summary will be updated as necessary.
Svake godine Europska agencija za lijekove procjenjuje sve nove informacije koje postanu dostupne te se ovaj sažetak po potrebi ažurira.
For small children and children who cannot swallow capsules, the contents of the capsules can be mixed with sodium bicarbonate solution 8.4% to make a liquid.
Za malu djecu i djecu koja ne mogu progutati kapsule, sadržaj kapsula može se pomiješati s otopinom natrijeva bikarbonata od 8,4 % da bi se dobila tekućina.
Nevertheless, studies have shown that the medicine benefits patients and has no significant side effects.
Ispitivanja su pokazala da lijek koristi bolesnicima i nema značajnih nuspojava.
Most patients also had improvements in symptoms of the disease: all reported an improvement in diarrhoea, 89% of patients showed an improvement in their mental ability, 60% of patients showed improvement in mobility, and 85% and 77% of patients showed psychiatric improvement based on two different scores.
U većine bolesnika došlo je do ublažavanja simptoma bolesti: u svih je zabilježeno ublažavanje proljeva, u 89 % bolesnika došlo je do poboljšanja mentalnih sposobnosti, u 60 % bolesnika došlo je do poboljšane mobilnosti, a u 85 % i 77 % bolesnika došlo je do psihijatrijskog poboljšanja na temelju dvije različite ocjene.
Chenodeoxycholic acid Leadiant is available as capsules (250 mg) which are taken 3 times a day at approximately the same time every day.
Lijek Kenodeoksikolna kiselina Leadiant dostupan je u obliku kapsula (250 mg) koje se uzimaju 3 puta dnevno približno u isto vrijeme svakog dana.
This helps to reduce the production of abnormal substances and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the disease.
To pomaže u smanjivanju stvaranja abnormalnih tvari i doprinosi normalnoj aktivnosti žuči u probavnom sustavu, čime se ublažavaju simptomi ove bolesti.
They were mild or moderate in severity and did not last.
Nuspojave su bile blage ili umjerene i nisu dugo trajale.
The daily dose is chosen and adjusted during treatment for each patient depending on the patient's age, liver function and levels of bile acids in their blood and urine.
Dnevna se doza odabire za svakog bolesnika i prilagođava mu se tijekom liječenja ovisno o dobi bolesnika, funkciji jetre i razinama žučnih kiselina u krvi i urinu.
Among 23 patients for whom data on blood levels of bile acids were available, all had reductions in their levels (average reduction of 56-69 µmol/l).
U svih 23 bolesnika za koje su bili dostupni podatci o razini žučne kiseline u krvi zabilježeno je smanjenje tih razina (prosječno smanjenje 56-69 µmol/l).
However, due to the rarity of the disease, there are still limited data available on the use of the medicine.
Međutim, budući da je ta bolest rijetka, podatci o primjeni tog lijeka i dalje su ograničeni.
This summary was last updated in 06-2017.
Sažetak je posljednji put ažuriran: 06. 2017.
Among 14 patients for whom data on urine levels of bile acids were available, 79% (11 out of 14) had reduced levels at their most recent test.
Od 14 bolesnika za koje su bili dostupni podatci o razini žučnih kiselina u mokraći, u 79 % njih (11 od 14) zabilježeno je smanjenje razine prilikom posljednje pretrage.
When primary bile acids are lacking, the body produces abnormal bile acids and other substances instead which accumulate throughout the body, causing damage.
Ako postoji manjak primarnih žučnih kiselina, tijelo proizvodi abnormalne žučne kiseline i druge tvari koje se nakupljaju u tijelu i uzrokuju štetu.
Since Chenodeoxycholic acid Leadiant has been approved under exceptional circumstances, the company that markets this medicine will set up a registry to monitor the benefits and safety of the medicine.
Budući da je lijek Kenodeoksikolna kiselina Leadiant dobio odobrenje u iznimnim okolnostima, tvrtka koja stavlja lijek u promet uspostavit će registar za praćenje koristi i sigurne primjene lijeka.
These patients cannot produce enough of the primary bile acid chenodeoxycholic acid due to genetic abnormalities that result in a lack of the liver enzyme sterol 27 hydroxylase.
Ti bolesnici ne mogu proizvesti dovoljno primarne žučne kiseline, odnosno kenodeoksikolne kiseline, zbog genetskih poremećaja koji rezultiraju nedostatkom jetrenog enzima sterola 27 hidroksilaze.
The full EPAR for Chenodeoxycholic acid Leadiant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za lijek Kenodeoksikolna kiselina Leadiant nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
However, Xenbilox differs from Chenodeoxycholic acid Leadiant in that it is authorised for a different use (to dissolve cholesterol gallstones).
Međutim, Xenbilox se razlikuje od lijeka Kenodeoksikolna kiselina Leadiant jer je odobren za drugu upotrebu (za otapanje žučnih kamenaca).
The name of the product was changed to Chenodeoxycholic acid Leadiant on 12 May 2017.
Naziv lijeka izmijenjen je u Kenodeoksikolna kiselina Leadiant 12. svibnja 2017.
This is because it has not been possible to obtain complete information about Chenodeoxycholic acid Leadiant due to the rarity of the disease.
Razlog za to je nemogućnost dobivanja potpunih informacija o lijeku Kenodeoksikolna kiselina Leadiant zbog rijetkosti bolesti.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Chenodeoxycholic acid Leadiant's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi lijeka Kenodeoksikolna kiselina Leadiant nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
Chenodeoxycholic acid has been used to treat cerebrotendinous xanthomatosis for about 40 years, although it was not licensed for this use.
Kenodeoksikolna kiselina koristi se za liječenje cerebrotendinozne ksantomatoze otprilike 40 godina iako nije licencirana za tu primjenu.
The summary of the opinion of the Committee for Orphan Medicinal Products for Chenodeoxycholic acid Leadiant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Kenodeoksikolna kiselina Leadiant dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Chenodeoxycholic acid Leadiant have been included in the summary of product characteristics and the package leaflet.
Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Kenodeoksikolna kiselina Leadiant nalaze se u sažetku opisa svojstava i u uputi o lijeku.
Chenodeoxycholic acid Leadiant has been authorised under ‘exceptional circumstances'.
Lijek Kenodeoksikolna kiselina Leadiant odobren je u „iznimnim okolnostima”.
Because the number of patients with this condition is low, the disease is considered ‘rare', and Chenodeoxycholic acid Leadiant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 December 2014.
Budući da je broj bolesnika s tim stanjem nizak, bolest se smatra „rijetkom” te se lijek Kenodeoksikolna kiselina Leadiant označava kao „lijek za liječenje rijetkih bolesti” od 16. prosinca ranije poznat pod nazivom Kenodeoksikolna kiselina sigma-tau
This is a ‘primary bile acid', which is a main component of bile (a fluid produced by the liver that helps to digest fats).
To je „primarna žučna kiselina” koja je glavni sastojak žuči (tekućine koju proizvodi jetra radi probavljanja masnoća).
The European Commission granted a marketing authorisation valid throughout the European Union for Chenodeoxycholic acid sigma-tau on 10 April 2017.
Europska komisija izdala je odobrenje za stavljanje lijeka Kenodeoksikolna kiselina sigma-tau u promet koje vrijedi na prostoru Europske unije od 10. travnja 2017.
Chenodeoxycholic acid Leadiant can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cerebrotendinous xanthomatosis or other diseases of primary bile acid production.
Kenodeoksikolna kiselina Leadiant izdaje se samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik koji ima iskustva u liječenju cerebrotendinozne ksantomatoze ili drugih bolesti proizvodnje primarne žučne kiseline.
For more information about treatment with Chenodeoxycholic acid Leadiant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o liječenju lijekom Kenodeoksikolna kiselina Leadiant pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
Chenodeoxycholic acid is one of the main primary bile acids produced by the liver.
Kenodeoksikolna kiselina jedna je od glavnih primarnih žučnih kiselina koje proizvodi jetra.
This is a summary of the European public assessment report (EPAR) for Chenodeoxycholic acid Leadiant.
Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Kenodeoksikolna kiselina Leadianit.
Chenodeoxycholic acid Leadiant has been investigated in a study which looked at the records of 35 patients with cerebrotendinous xanthomatosis who received chenodeoxycholic acid for around 9 years.
Lijek Kenodeoksikolna kiselina Leadiant ispitivan je u ispitivanju tijekom kojega su pregledani podatci o 35 bolesnika s cerebrotendinoznom ksantomatozom koji su primali kenodeoksikolnu kiselinu otprilike 9 godina.
What measures are being taken to ensure the safe and effective use of Chenodeoxycholic acid Leadiant?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Kenodeoksikolna kiselina Leadiant?
Chenodeoxycholic acid Leadiant is used to treat adults and children from one month of age with cerebrotendinous xanthomatosis.
Kenodeoksikolna kiselina Leadiant koristi se u liječenju odraslih i djece u dobi od jednog mjeseca nadalje koji boluju od cerebrotendinozne ksantomatoze.
Chenodeoxycholic acid Leadiant is a ‘hybrid medicine'.
Kenodeoksikolna kiselina Leadianit je „hibridni lijek”.
For practical information about using Chenodeoxycholic acid Leadiant, patients should read the package leaflet or contact their doctor or pharmacist.
Praktične informacije o primjeni lijeka Kenodeoksikolna kiselina Leadianit bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
It is not intended to provide practical advice on how to use Chenodeoxycholic acid Leadiant.
Svrha sažetka nije davati praktične savjete o primjeni lijeka Kenodeoksikolna kiselina Leadianit.
The reference medicine for Chenodeoxycholic acid Leadiant is Xenbilox.
Referentni lijek za lijek Kenodeoksikolna kiselina Leadianit je Xenbilox.
What is Chenodeoxycholic acid Leadiant and what is it used for?
Što je Kenodeoksikolna kiselina Leadianit i za što se koristi?
Other information about Chenodeoxycholic acid Leadiant
Ostale informacije o lijeku Kenodeoksikolna kiselina Leadiant
The chenodeoxycholic acid contained in this medicine replaces the patient's missing chenodeoxycholic acid.
Kenodeoksikolna kiselina sadržana u ovom lijeku nadomješta kenodeoksikolnu kiselinu koja nedostaje bolesniku.
What are the risks associated with Chenodeoxycholic acid Leadiant?
Koji su rizici povezani s lijekom Kenodeoksikolna kiselina Leadiant?
Chenodeoxycholic acid Leadiant is a medicine that contains the active substance chenodeoxycholic acid.
Kenodeoksikolna kiselina Leadianit je lijek koji sadrži djelatnu tvar kenodeoksikolnu kiselinu.
For the list of restrictions, see the package leaflet.
Potpuni popis ograničenja potražite u uputi o lijeku.
Why is Chenodeoxycholic acid Leadiant approved?
Zašto je lijek Kenodeoksikolna kiselina Leadiant odobren?
What information is still awaited for Chenodeoxycholic acid Leadiant?
Koje se još informacije očekuju o lijeku Kenodeoksikolna kiselina Leadiant?
What benefits of Chenodeoxycholic acid Leadiant have been shown in studies?
Koje su koristi lijeka Kenodeoksikolna kiselina Leadiant dokazane u ispitivanjima?
How is Chenodeoxycholic acid Leadiant used?
Kako se Kenodeoksikolna kiselina Leadiant koristi?
chenodeoxycholic acid
Kenodeoksikolna kiselina Leadiant kenodeoksikolna kiselina
How does Chenodeoxycholic acid Leadiant work?
Kako djeluje Kenodeoksikolna kiselina Leadiant?
The side effects seen with Chenodeoxycholic acid Leadiant are constipation and abnormal liver test values; however their frequency could not be reliably estimated from the available limited data.
Nuspojave lijeka Kenodeoksikolna kiselina Leadiant su zatvor i abnormalne vrijednosti jetrenih proba.
MA(EU) Number
Broj (EU) odobrenja