FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Quadramet: If you are allergic to ethylene diamine tetramethylene phosphonic acid (EDTMP) or similar phosphonate compounds or any of the other ingredients of this medicine (listed in section 6), If you are pregnant, If you have received chemotherapy or hemibody field external radiation therapy in a preceding period of 6 weeks.
Croatian: Ako ste alergični na etilen diamin tetrametilen fosfonsku kiselinu (EDTMP) ili slične fosfonate, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6),
English: Radiation dose to the body can be limited by increasing fluid intake and frequent voiding of urine.
Croatian: Doza ozračivanja tijela može biti smanjena povećanim unosom tekućine i učestalim mokrenjem.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOðAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Quadramet has a high affinity for skeletal tissue.
Croatian: Quadramet ima visoku sposobnost vezanja za kost.
English: CIS bio international, Boîte Postale 32,
Croatian: Boîte Postale 32,
English: How to store Quadramet
Croatian: Kako čuvati Quadramet
English: Do not use Quadramet after the expiry date which is stated on the label.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na pakovanju.
English: The undesirable effects due to Quadramet administration are linked with a decrease of red and white blood cells, and platelets.
Croatian: Nuspojave pri primjeni Quadrameta povezane su sa smanjenjem broja eritrocita, leukocita i trombocita.
English: Quadramet is delivered frozen in dry ice. Store in a freezer at -10°C to -20°C in the original package.
Croatian: Čuvati u zamrzivaču u originalnom pakovanju na -10 do -20 °C.
English: Quadramet should not be diluted before use.
Croatian: Prije primjene ne treba ga razrjeñivati.
English: Store at -10°C to -20°C in a freezer in its original packaging.
Croatian: Čuvati u zamrzivaču u originalnom pakovanju na -10 °C do -20 °C.
English: The other ingredients are total EDTMP (as EDTMP.H2O), calcium-EDTMP sodium salt (as Ca), total sodium (as Na), water for injections.
Croatian: Pomoćne tvari su: ukupni EDTMP (u obliku EDTMP.H2O), kalcij-EDTMP natrijeva sol (u obliku Ca), ukupni natrij (u obliku Na), voda za injekcije.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1.3 GBq Samarium (153Sm) lexidronam pentasodium at the reference date (corresponding to 20 to 80 µg/ml of samarium per vial) Samarium specific activity is approximately 16 - 65 MBq/µg of samarium.
Croatian: Svaki ml otopine sadrži 1,3 GBq samarijevog (153Sm) leksidronama, u obliku pentanatrijeve soli, na referentni datum (što odgovara 20 do 80 µg/ml samarija po bočici).
English: NAME OF THE MEDICINAL PRODUCT Quadramet 1.3 GBq/mL solution for injection.
Croatian: Quadramet 1,3 GBq/ml otopina za injekciju.
English: Each vial contains 1.5 ml (2 GBq at reference) to 3.1 ml (4 GBq at reference) of solution for injection.
Croatian: Jedna bočica sadrži 1,5 ml (2 GBq u referentno vrijeme) do 3,1 ml (4 GBq u referentno vrijeme) otopine za injekciju.
English: Total EDTMP (as EDTMP.H2O) Calcium-EDTMP sodium salt (as Ca) Total sodium (as Na) Water for Injections
Croatian: ukupni EDTMP (u obliku EDTMP.H2O) kalcij-EDTMP natrijeva sol (u obliku Ca) ukupni natrij (u obliku Na) voda za injekcije
English: F-91192 GIF-SUR-YVETTE Cedex FRANCE
Croatian: F-91192 GIF-SUR-YVETTE
English: The operator should be careful to protect the eyes while inspecting the solution for clarity.
Croatian: Prilikom pregleda bistrosti otopine, osoba koja pregledava otopinu mora zaštiti oči.
English: 91192 GIF-SUR-YVETTE Cedex, FRANCE
Croatian: 91192 GIF-SUR-YVETTE
English: PHARMACOLOGIC PROPERTIES
Croatian: FARMAKOLOŠKA SVOJSTVA
English: MINIMUM PARTICULARS TO APPEAR ON SMALL INTERMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKOVANJE STAKLENA BOČICA
English: What Quadramet looks like and contents of the pack Quadramet is a solution for injection.
Croatian: Kako Quadramet izgleda i sadržaj pakovanja
English: Urinary bladder wall Uterus
Croatian: Stijenka mokraćnog mjehura Maternica
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Quadramet 1.3 GBq/mL solution for injection Samarium (153Sm) lexidronam pentasodium
Croatian: NAZIV GOTOVOG LIJEKA I PUT(EVI) PRIMJENE LIJEKA Quadramet 1,3 GBq/ml otopina za injekciju. samarijev (153Sm) leksidronam, pentanatrijeva sol
English: NAME OF THE MEDICINAL PRODUCT Quadramet 1.3 GBq/mL solution for injection Samarium (153Sm) lexidronam pentasodium
Croatian: Quadramet 1,3 GBq/ml otopina za injekciju samarijev (153Sm) leksidronam, pentanatrijeva sol
English: Radiation dose to the body can be limited by promoting a diuresis and frequent voiding of urine.
Croatian: Doza ozračivanja tijela može se smanjiti forsiranom diurezom i učestalim mokrenjem.
English: Ovaries
Croatian: Miokard
English: Verification of the dose to be administered and patient identification are necessary prior to administration of Quadramet.
Croatian: Prije primjene Quadrameta potrebno je potvrditi dozu planiranu za primjenu te identitet bolesnika.
English: The active substance is samarium (153Sm) lexidronam pentasodium.
Croatian: Djelatna tvar je samarijev (153Sm) leksidronam u obliku pentanatrijeve soli.
English: Chest
Croatian: Timus
English: GLASS VIAL
Croatian: Žučni mjehur
English: Frequency of administration
Croatian: Vrsta zračenja
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET CIS bio international,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Samarium (153Sm) lexidronam pentasodium :
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI samarijev (153Sm) leksidronam, pentanatrijeva sol
English: Decreases in white blood cell and platelet counts and anaemia were observed in patients receiving Quadramet.
Croatian: U bolesnika koji su primali Quadramet primijećeno je smanjenje broja leukocita i trombocita i anemija.
English: Quadramet being supplied as a single-dose vial, an accidental overdose is unlikely to occur.
Croatian: Ako primijenite više Quadrameta nego što ste trebali Budući da se Quadramet isporučuje u bočicama za pojedinačne doze, malo je vjerojatno da se to dogodi.
English: This medicinal product is a clear, colourless to light amber solution which is packed in a 15 ml colourless European Pharmacopoeia Type I drawn glass vial closed with Teflon-coated chlorobutyl/natural rubber stopper and aluminium flip-off overseal.
Croatian: Ovaj je lijek bistra, bezbojna do svijetlo jantarna otopina pakirana u bočici od bezbojnog stakla tipa
English: Gallbladder Ascending colon wall Descending colon wall Small intestine Myocardial wall Kidneys
Croatian: Stijenka uzlaznog debelog crijeva 0,005 Stijenka silaznog debelog crijeva 0,010 Tanko crijevo
English: 1 produced in E. coli cells by recombinant DNA technology 2 adsorbed on aluminium hydroxide (0.5 mg Al3+)
Croatian: 1 proizvedeno u stanicama E. coli tehnologijom rekombinantne DNK 2 adsorbirano na aluminijevu hidroksidu (0,5 mg Al3+)
English: 3 NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
Croatian: 3 NHBA (Neisserial heparin vezujući antigen), NadA (Neisseria adhezin A), fHbp (faktor H vezujući protein)
English: Immediate Packaging
Croatian: Put primjene Pakovanje
English: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 2
Croatian: soj NZ98/254 izmjereno kao količina ukupnih proteina koji sadrže PorA P1.4 2
English: --1 One dose (0.5 ml) contains: Recombinant Neisseria meningitidis group B NHBA fusion protein 1, 2, 3
Croatian: --1 Jedna doza (0,5 ml) sadrži: Rekombinantni fuzijski protein NHBA iz Neisseria meningitidis grupe B 1, 2, 3
English: 10 pre-filled syringes without needles
Croatian: 10 napunjenih štrcaljki bez igala
English: 1.2 Annex to Application Form List of all authorised product presentations
Croatian: Opinion of the committee for medicinal products for human use on the granting of a marketing authorisation for Bexsero
English: 10 pre-filled syringes with needles
Croatian: 10 napunjenih štrcaljki s iglama
English: 1 pre-filled syringe without needles
Croatian: 1 napunjena štrcaljka bez igala
English: 1 pre-filled syringe with needles
Croatian: 1 napunjena štrcaljka s iglama
English: Treatment is usually continued for 2 years.
Croatian: Liječenje se najčešće nastavlja tijekom 2 godine.
English: They should be given a total of 150 mg per kilogram body weight every day, split into two doses.
Croatian: Moraju primiti ukupno 150 mg po kilogramu tjelesne mase svaki dan, podijeljeno u dvije doze.
English: The recommended dose for adults is one sachet three times a day.
Croatian: Preporučena doza za odrasle osobe je jedna vrećica triput na dan.
English: In children and adolescents, the daily dose depends on their weight.
Croatian: U djece i adolescenata dnevna doza ovisi o njihovoj tjelesnoj težini.
English: The first of these involved 166 patients with tuberculosis aged between 15 to 30 years.
Croatian: Prvo od ova dva ispitivanja obuhvatilo je 166 bolesnika oboljelih od tuberkuloze u dobi od 15 do 30 godina.
English: A risk management plan has been developed to ensure that Granupas is used as safely as possible.
Croatian: Razvijen je plan upravljanja rizikom kako bi se osiguralo da se Granupas koristi što je sigurnije moguće.
English: Other information about Granupas
Croatian: Druge informacije o lijeku Granupas
English: A dosing spoon is used to measure small doses for young children.
Croatian: Žlica za doziranje koristi se za mjerenje malih doza za djecu.
English: Granupas must not be taken by patients with severely reduced kidney function.
Croatian: Granupas ne smiju uzimati bolesnici s ozbiljno smanjenom funkcijom bubrega.
English: What is Granupas and what is it used for?
Croatian: Što je Granupas i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Granupas?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Granupas?
English: The benefits in combination with other tuberculosis treatments were shown in published studies presented by the company, two of which were considered to be the main studies for the application.
Croatian: Koristi od kombinacije s drugim terapijama protiv tuberkuloze dokazane su u objavljenim ispitivanjima koje je tvrtka dostavila, od kojih se dva smatraju glavnim ispitivanjima za primjenu.
English: This is a summary of the European public assessment report (EPAR) for Granupas.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Granupas.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Para-aminosalicylic acid Lucane on 7 April 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje za para-aminosalicilatnu kiselinu Lucane vrijedi na prostoru Europske unije od 7. travnja 2014.
English: It is used in combination with other medicines to treat adults and children from 28 days of age who have multi-drug resistant tuberculosis when combinations without this medicine cannot be used, either because the disease is resistant to them or because of their side effects.
Croatian: Koristi se u kombinaciji s drugim lijekovima za liječenje odraslih osoba i djece u dobi od 28 dana starosti koji boluju od tuberkuloze rezistentne na više lijekova, u slučaju kada se kombinacije bez ovog lijeka ne mogu koristiti, zato što je bolest otporna na njih ili zbog njihovih nuspojava.
English: Why is Granupas approved?
Croatian: Zašto je Granupas odobren?
English: The most common side effects with Granupas (which may affect up to 1 in 10 people) are abdominal pain (stomach ache), vomiting, nausea, bloating, diarrhoea and soft stools, giddiness, disturbance in gait and balance, and allergic skin reactions and rash.
Croatian: Najčešće nuspojave lijeka Granupas (kod više od 1 na 10 osoba) su abdominalna bol (bol u želucu), povraćanje, mučnina, napuhavanje, proljev i mekana stolica, omaglica, poremećaj u hodanju i ravnoteži, alergijske reakcije kože i osip.
English: It is not intended to provide practical advice on how to use Granupas.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Granupas.
English: The name of the medicine was changed to Granupas on 15 May 2014.
Croatian: Naziv lijeka je promijenjen 15. svibnja
English: PAS is similar to a chemical (para-aminobenzoic acid) that is used by the bacteria to make folic acid needed for new bacteria to grow.
Croatian: PAS je sličan kemikaliji (para-aminobenzojevoj kiselini) koju bakterije koriste za stvaranje folne kiseline potrebne za rast nove bakterije.
English: Because the number of patients with tuberculosis is low in the EU, the disease is considered ‘rare', and Granupas was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 December
Croatian: Budući da je broj bolesnika oboljelih od tuberkuloze u EU-u nizak, dotična se bolest smatra „rijetkom” te je Granupas 17. prosinca 2010. označen kao lijek za liječenje rijetkih bolesti.
English: The active substance, PAS, is a ‘bacteriostatic agent', which means that it works by stopping the growth of M. tuberculosis bacteria.
Croatian: Djelatna tvar, PAS, je „bakteriostatičko sredstvo”, što znači da djeluje tako što zaustavlja rast bakterije M. tuberculosis.
English: Granupas is a tuberculosis medicine that contains the active substance para-aminosalicylic acid (PAS).
Croatian: Granupas je lijek protiv tuberkuloze koji sadrži djelatnu tvar para-aminosalicilatnu kiselinu (PAS).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Granupas's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za ljudsku uporabu (CHMP) Agencije zaključio je da su dobrobiti lijeka Granupas veće od rizika lijeka, te je preporučio da se lijek odobri za uporabu u EU-u.
English: PAS has been used for many years in the EU for the combination treatment of tuberculosis.
Croatian: PAS se u Europskoj uniji koristi mnogo godina u kombiniranom liječenju tuberkuloze.
English: What are the risks associated with Granupas?
Croatian: Koji su rizici povezani s lijekom Granupas?
English: PAS had been widely used in the past for combination treatment but was largely discontinued due to adverse effects on the stomach.
Croatian: PAS se često koristio tijekom prošlosti za kombinirano liječenje, no njegova je primjena uvelike prekinuta zbog negativnog djelovanja na želudac.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Granupas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Granupas možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The patients were treated for 3 months with either PAS or another medicine called streptomycin, or with a combination of PAS and streptomycin, and then followed up for 3 extra months.
Croatian: Bolesnici su liječeni tijekom 3 mjeseca PAS-om ili drugim lijekom naziva streptomicin ili kombinacijom PAS-a i streptomicina, te su zatim praćeni tijekom dodatna 3 mjeseca.
English: Multi-drug resistance is when the bacteria causing tuberculosis (Mycobacterium tuberculosis) are resistant to treatment with at least isoniazid and rifampicin, two standard tuberculosis medicines.
Croatian: Rezistencija na više lijekova je prisutna u slučajevima kada je bakterija koja uzrokuje tuberkulozu (Mycobacterium tuberculosis) otporna na liječenje s barem izoniazidom i rifampicinom, dva standardna lijeka za liječenje tuberkuloze.
English: Previously known as Para-aminosalicylic acid Lucane
Croatian: Prije poznato pod nazivom para-aminosalicilatna kiselina Lucane
English: In the second main study involving 341 patients aged over 12 years, PAS in combination with isoniazid was compared with isoniazid alone.
Croatian: U drugom glavnom ispitivanju koje je obuhvatilo 341 bolesnika u dobi starijoj od 12 godina, PAS u kombinaciji s izoniazidom uspoređen je samo s izoniazidom.
English: The applicant also provided published data on the doses of PAS to be used in children.
Croatian: Podnositelj zahtjeva dostavio je i objavljene podatke o dozama PAS-a koje će se koristiti u djece.
English: The Committee also noted that the World Health Organization continues to recommend PAS as an option to be used in combination with other medicines for treating multi-drug resistant tuberculosis.
Croatian: Povjerenstvo je također zaključilo da Svjetska zdravstvena organizacija i dalje preporuča PAS kao opciju za liječenje u kombinaciji s drugim lijekovima za liječenje tuberkuloze otporne na više lijekova.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Granupas, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku za Granupas uključene su sigurnosne informacije uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: The full EPAR and risk management plan summary for Granupas can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito Europsko javno izvješće o ocjeni dokumentacije (EPAR) za lijek Granupas kao i plan upravljanja rizikom nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Granupas can only be obtained with a prescription.
Croatian: Granupas se izdaje samo na liječnički recept.
English: In addition, the PAS-isoniazid combination helped reduce the emergence of resistance to isoniazid: after 1 year, while 47% of patients in the isoniazid-only group had resistant bacteria the figure was only 8% in the combination group.
Croatian: Nadalje, kombinacija PAS-a i izoniazida pomogla je u smanjivanju pojavljivanja rezistencije na izoniazid: nakon 1 godine, iako je 47% bolesnika u grupi koja je primala samo izoniazid imala otpornu bakteriju, u grupi koja je primala kombinirano liječenje brojka je bila 8%.
English: For more information about treatment with Granupas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Granupas pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: PAS in combination with streptomycin also helped reduce the emergence of resistance to streptomycin: in 89% of patients receiving the combination the bacteria remained responsive to streptomycin, compared with 21% of patients who were given only streptomycin.
Croatian: PAS u kombinaciji sa streptomicinom također je pomogao u smanjivanju nastupanja rezistencije na streptomicin: u 89% bolesnika koji su primali kombinaciju, bakterija je odgovarala na streptomicin, u usporedbi s 21% bolesnika koji su primili samo streptomicin.
English: para-aminosalicylic acid
Croatian: Granupas para-aminosalicilatna kiselina
English: After 12 months, 90% of patients in the combination group did not have the bacteria in their phlegm compared with 51% of patients given a comparable dose of isoniazid alone.
Croatian: Nakon 12 mjeseci, 90% bolesnika u grupi koja je primala kombiniranu terapiju nije imalo bakteriju u ispljuvku u usporedbi s 51% bolesnika koji su primali usporedivu dozu samo izoniazida.
English: The Committee noted that the active substance, PAS, has been shown to be beneficial when used in combination with other medicines to treat tuberculosis and that it helps reduce the emergence of resistance to other medicines.
Croatian: Povjerenstvo je zaključilo kako je dokazano da je djelatna tvar, PAS, korisna ako se koristi u kombinaciji s drugim lijekovima za liječenje tuberkuloze te da pomaže smanjivanju pojavljivanja rezistencije na druge lijekove.
English: At the end of the 6 months, 87% of patients on the combination had improvements in their chest x-rays compared with 56% of patients in the group taking PAS alone.
Croatian: Po završetku 6 mjeseci, u 87% bolesnika koji su primali kombinirano liječenje zabilježeno je poboljšanje u njihovim rendgenskim snimkama prsa u usporedbi s 56% bolesnika u grupi koja je uzimala samo PAS.
English: It is available as 4 g sachets containing ‘gastroresistant' granules that allow the active substance to reach the intestine without being released in the stomach, thus reducing side effects in the stomach.
Croatian: Lijek je dostupan u vrećicama od 4 g koje sadrže „gastro rezistentne” granule koje omogućuju djelatnoj tvari da dospije u crijeva bez otpuštanja u želucu, te se na taj način smanjuju nuspojava u želucu.
English: In addition,33% of patients in the combination group had no bacteria detected in their phlegm (sputum) compared with 8% in the PAS group.
Croatian: Nadalje, u 33% bolesnika u grupi koja je primala kombinirano liječenje nije otkrivena bakterija u ispljuvku (sputumu) u usporedbi s 8% u grupi koja je liječena PAS-om.
English: What benefits of Granupas have been shown in studies?
Croatian: Koje su koristi lijeka Granupas dokazane u ispitivanjima?
English: How does Granupas work?
Croatian: Kako Granupas djeluje?
English: The CHMP noted that Granupas contains gastro-resistant granules, designed to allow PAS to reach the intestine without being released in the stomach, and thus reduce the potential for side effects.
Croatian: CHMP je zaključio da lijek Granupas sadrži želučanootporne granule, koje su razvijene kako bi omogućile PAS-u da dosegne crijeva bez prethodnog otpuštanja u želucu, te tako smanji moguće nuspojave.
English: For the full list of all side effects reported with Granupas, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Granupas potražite u uputi o lijeku.
English: For practical information about using Granupas, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Granupas pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: How is Granupas used?
Croatian: Kako se Granupas koristi?
English: By interfering and taking the place of this chemical in the processes that make folic acid, para-aminosalicylic acid reduces the amount of folic acid produced and thereby stops or slows the growth of M. tuberculosis.
Croatian: Para-aminosalicilatna kiselina smanjuje količinu folne kiseline koja se stvara i time zaustavlja ili usporava rast M. tuberculosis, tako što interferira i preuzima ulogu ove kemikalije u procesu umjesto folne kiseline.
English: These include loss of coordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, decreased muscle tone, fits and learning difficulties.
Croatian: To uključuje gubitak koordinacije, probleme u vezi sa „sakadnim” (brzim) pokretima očiju koji mogu dovesti do oštećenja vida, kašnjenja u razvoju, otežanog gutanja, smanjenog tonusa mišića, napadaja i poteškoća pri učenju.
English: The recommended starting dose for type-1 Gaucher disease is one capsule three times a day.
Croatian: Preporučena početna doza za Gaucherovu bolest tipa 1 je jedna kapsula triput dnevno.
English: For Niemann-Pick type-C disease, it is two capsules three times a day for patients aged 12 years and over; in younger patients, the dose depends on their weight and height.
Croatian: Za Niemann-Pickovu bolest tipa C doza je dvije kapsule triput dnevno za bolesnike u dobi od 12 godina i starije, a u mlađih bolesnika doza ovisi o tjelesnoj težini i visini.