natgillin/translations-raw huggingface dataset:
The primary endpoint was the combined remission at Week 24 after study treatment, defined as clinical closure of all treated fistulas (absence of draining despite gentle finger compression) and absence of collection (> 2 cm) confirmed by blinded central MRI.
Primarna mjera ishoda bila je kombinirana remisija u 24. tjednu nakon ispitivanog liječenja, koja je definirana kao kliničko zatvaranje svih liječenih fistula (odsustvo drenažnog sadržaja usprkos blagom pritisku prstom) i odsustvo nakupljanja sadržaja (> 2 cm) što je potvrdio zaslijepljeni središnji centar za MR.
The proportion of patients with clinical remission at Week 52 was 59% in the Alofisel group and 41% in the control group (p = 0.012) and corresponding figures for response were 66% and 55% (p = 0.114).
Udio bolesnika s kliničkom remisijom u 52. tjednu bio je 59% u Alofisel skupini i 41% u kontrolnoj skupini (p = 0,012), a odgovarajući postoci za odgovor bili su 66% i 55% (p = 0,114).
Keep the product within the outer carton and inside the shipping container at all times until its administration, to maintain the required temperature.
Čuvati lijek u vanjskom pakiranju i unutar originalnog spremnika u kojem je isporučen cijelo vrijeme sve do njegove primjene, kako bi se održala željena temperatura.
Alofisel must not be irradiated or otherwise sterilised.
Alofisel se ne smije zračiti niti bilo kako sterilizirati.
BATCH NUMBER, DONATION AND PRODUCT CODES
BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA
The vials are placed inside a cardboard box.
Bočice su pakirane u kartonskoj kutiji.
Pharmacodynamic effect
Farmakodinamički učinci
Results of the key secondary endpoints show that the proportion of patients with clinical remission at Week 24 was 55% in the Alofisel group and 42% in the control group (p = 0.052) and the corresponding figures for response were 69% and 55% (p = 0.039).
Rezultati ključnih sekundarnih mjera ishoda pokazuju da je udio bolesnika s kliničkom remisijom u 24. tjednu bio 55% u Alofisel skupini i 42% u kontrolnoj skupini (p = 0,052) a odgovarajući postoci za odgovor bili su 69% i 55% (p = 0,039).
After gentle re-suspension, the product is a white to yellowish homogeneous suspension.
Nakon nježne resuspenzije, lijek je bijela do žućkasta homogena suspenzija.
If you are allergic to Alofisel, bovine serum or to any of the ingredients of this medicine (listed in section6).
Ne smijete primiti Alofisel: ako ste alergični na Alofisel, goveđi serum ili neki sastojak ovog lijeka (naveden u dijelu 6).
After the cells have been resuspended (by gentle manual tapping), Alofisel is a white to yellowish homogenous suspension.
Nakon što se stanice resuspendiraju (blagim kucanjem prstima), Alofisel postaje bijela do žućkasta homogena suspenzija.
Immediately before use, Alofisel must be re-suspended by gently tapping the bottom of the vial until a homogeneous suspension is obtained, avoiding bubble formation.
Neposredno prije primjene Alofisel se mora resuspendirati nježnim kuckanjem po dnu bočice do postizanja homogene suspenzije, uz izbjegavanje stvaranja mjehurića.
An individual dose of Alofisel comprises 4 glass vials each containing 6 millilitres of Alofisel contained within a cardboard box.
Pojedinačna doza Alofisela sadrži 4 staklene bočice, od kojih svaka sadrži 6 mililitara Alofisela, koje su pakirane u kartonske kutije.
Proctalgia*
Proktalgija*
Then inject the content of the second vial in small deposits into the tissue around the second internal opening.
Zatim injicirajte sadržaj druge bočice u malim depozitima u tkivo oko drugog unutarnjeg otvora.
• stitch up the inner openings of the fistulas.
• zašiti unutarnje otvore fistula,
a) Injection around the internal openings of the fistulas tracts: insert the needle through the anus and proceed as follows: - If there is a single internal opening, inject the content of each of the two vials (one after the other) in small deposits into the tissue surrounding the single internal opening.
a) Injiciranje oko unutarnjih otvora fistularnih kanala: uvedite iglu kroz anus i postupite kako slijedi: - Ako postoji samo jedan unutarnji otvor, injicirajte sadržaj obje bočice (jednu za drugom) u malim depozitima u tkivo koje okružuje jedan unutarnji otvor.
Procedural pain*
Bol uzrokovana postupkom*
No association between DSA results and safety or efficacy up to Week 52 was seen in the subset tested.
U ispitanoj podgrupi nije postojala povezanost između DSA statusa i sigurnosti i djelotvornosti do 52. tjedna.
Alofisel is supplied as one treatment dose contained in 4 Type I glass vials.
Alofisel je dostupan kao doza za jedno liječenje u 4 staklene bočice tipa I.
Data on the use of darvadstrocel in the elderly population are limited, however, given the cell-based nature of darvadstrocel and its local administration route it is not expected that the benefit-risk profile of darvadstrocel in elderly patients will differ from that observed in non-elderly patients.
Podaci o primjeni darvadstrocela u starijoj populaciji su ograničeni, međutim, s obzirom na staničnu prirodu darvadstrocela i lokalni put primjene, ne očekuje se da će se profil koristi i rizika darvadstrocela kod starijih bolesnika razlikovati od onog uočenog kod bolesnika koji nisu starije dobi.
- If there are two internal openings, inject the content of the first of two vials in small deposits into the tissue around one internal opening.
- Ako postoje dva unutarnja otvora, injicirajte sadržaj prve od dvije bočice u malim depozitima u tkivo koje okružuje jedan unutarnji otvor.
• clean the fistulas with salt water and remove any scar tissue.
• očistiti fistule fiziološkom otopinom i ukloniti tkivo s ožiljcima,
For further information on the use of Alofisel see section 4.2.
Za dalje informacije o primjeni lijeka Alofisel vidjeti dio 4.2.
Alofisel is injected by a surgeon in the fistula tract tissue.
Alofisel injicira kirurg u tkivo fistularnog kanala.
If you have any further questions, ask your doctor or surgeon.
Ako imate dodatnih pitanja, obratite se liječniku ili kirurgu.
Darvadstrocel is an expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells - eASC).
Darvadstrocel su ekspandirane ljudske alogene mezenhimalne matične stanice odraslih ljudi ekstrahirane iz adipoznog tkiva (ekspandirane adipozne matične stanice - eASC).
c) Perform a vigorous curettage of all fistula tracts, with special emphasis in the internal openings areas, using a metallic curette.
c) Metalnom kiretom napravite snažnu kiretažu svih fistularnih kanala, s posebnim naglaskom na zone unutarnjih otvora.
In the inflamed area, there is infiltration of activated lymphocytes and local release of inflammatory cytokines.
Na upaljenom području infiltriraju se aktivirani limfociti i lokalno se otpuštaju upalni citokini.
The injection of any other substance through the fistula tracts, such as hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions is not allowed, as these agents compromise the viability of the cells to be injected (see section 4.4 and section 4.5).
Injiciranje bilo kakve druge tvari kroz fistularne kanale kao što je vodikov peroksid, metilensko modrilo, otopine joda ili hipertonične otopine glukoze nije dozvoljeno, jer ti agensi kompromitiraju vijabilnost stanica koje će se injicirati (vidjeti dio 4.4 i dio 4.5).
A single dose of Alofisel consists of 120 million cells supplied in 4 vials.
Jedna doza lijeka Alofisel sadrži 120 milijuna stanica koje dolaze u 4 bočice.
At Week 12, 23/63 (36%) showed anti-donor antibody production.
U 12. tjednu rezultati su u 23/63 (36%) ispitanika pokazali nastanak DSA.
How to store Alofisel
Kako čuvati Alofisel
Final Report to EMA: 2Q/3Q 2022
Konačni izvještaj za EMA-u: 2./3. kvartal 2022.
The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) (see section 4.2 and section 4.5) through the fistula tracts is not allowed before, during, or after the injection of Alofisel as these may compromise the viability of the cells and, therefore, may affect the effectiveness of the treatment.
Injiciranje bilo koje druge tvari osim otopine natrijevog klorida 9 mg/ml (0,9%) (npr. vodikovog peroksida, metilenskog modrila, otopine joda ili hipertonične otopine glukoze) (vidjeti dio 4.2 i dio 4.5) kroz fistularne kanale nije dozvoljena prije, za vrijeme ili poslije injiciranja Alofisela jer to može kompromitirati vijabilnost stanica i stoga može utjecati na učinkovitost liječenja.
Each vial contains 30 million cells in 6 mL of suspension.
Svaka bočica sadrži 30 milijuna stanica u 6 ml suspenzije.
In vitro interaction studies have shown that the cell viability and immunomodulatory function of Alofisel is not affected by the presence of clinically-relevant concentrations of conventional therapies for Crohn's disease (infliximab, methotrexate and azathioprine).
In vitro ispitivanja interakcija pokazala su da klinički relevantne koncentracije konvencionalnih terapija za Crohnovu bolest (infliksimab, metotreksat i azatioprin) ne utječu na vijabilnost stanica i imunomodulatornu funkciju Alofisela.
The most common treatment-emergent adverse events were anal abscess (Alofisel: 19.4% patients; control group: 13.7% patients), proctalgia (Alofisel: 14.6% patients; control group: 11.8% patients) and anal fistula (Alofisel: 10.7% patients; control group: 7.8% patients).
Najčešće nuspojave povezane s primjenom lijeka su analni apsces (Alofisel: 19,4% bolesnika; kontrolna skupina: 13,7% bolesnika), proktalgija (Alofisel: 14,6% bolesnika; kontrolna skupina:
b) Re-suspend the cells by gently tapping the bottom of the vials until a homogeneous suspension is obtained, avoiding bubble formation.
b) Resuspendirajte stanice laganim kuckanjem po dnu bočice dok ne postignete homogenu suspenziju, ali izbjegavajte stvaranje mjehurića.
2.2 Qualitative and quantitative composition Each vial contains a suspension of 30 million cells (eASC) in 6 mL solution, corresponding to a concentration of 5 million cells/mL.
Svaka bočica sadrži suspenziju 30 milijuna stanica (eASC) u 6 ml otopine, što odgovara koncentraciji od 5 milijuna stanica/ml.
Each vial contains 6 mL of a suspension of 30 million of darvadstrocel.
Svaka bočica sadrži 6 ml suspenzije 30 milijuna darvadstrocela.
Data on the use of darvadstrocel in patients with hepatic or renal impairment are not available, however, given the cell-based nature of darvadstrocel and its local administration route it is not expected that the benefit-risk profile of darvadstrocel in hepatically or renally impaired patients will differ from that observed in non-hepatically or non-renally impaired patients.
Podaci o primjeni darvadstrocela kod bolesnika s oštećenjem jetre ili bubrega nisu dostupni, međutim, s obzirom na staničnu prirodu darvadstrocela i lokalni put primjene, ne očekuje se da će se profil koristi i rizika darvadstrocela kod osoba s oštećenjem jetre ili bubrega razlikovati od onog uočenog kod bolesnika koji nemaju oštećenje jetre ili bubrega.
Local anaesthesia is not recommended due to the unknown effect of local anaesthetics on the injected cells (see section 4.2).
Radi nepoznatog utjecaja lokalnih anestetika na injicirane stanice, lokalna anestezija se ne preporučuje (vidjeti dio 4.2).
The suspension of cells may have settled in the bottom of the vial forming a sediment.
Suspenzija stanica možda se slegnula na dnu bočice i formirala talog.
Therefore, no dose adjustment is required in hepatically or renally impaired patients.
Stoga nije potrebna prilagodba doze kod bolesnika s oštećenjem jetre ili bubrega.
• anal fistula
• analna fistula
GLASS VIAL
STAKLENA BOČICA
If you have any further questions on the use of this medicine, ask your doctor or surgeon.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili kirurgu.
Alofisel 5 million cells/mL suspension for injection
Alofisel 5 milijuna stanica/ml suspenzija za injekciju
Alofisel 5 million cells/mL suspension for injection Darvadstrocel
ALOFISEL 5 milijuna stanica/ml suspenzija za injekciju darvadstrocel
Up to Week 52, 20 (19.4%) and 14 (13.7%) patients developed 21 and 19 anal abscess adverse events in the Alofisel and control groups, respectively, of which 4 and 5 adverse events in respective groups (3.9% patients in both groups) were of severe intensity.
Do 52. tjedna, 20 (19,4%), odnosno 14 (13,7%) bolesnika razvilo je 21, odnosno 19 analnih apscesa kao nuspojavu u Alofisel skupini, odnosno u kontrolnoj skupini, od čega je 4 odnosno 5 nuspojava (3,9% bolesnika o obje skupine) bilo jakog intenziteta.
The active ingredient of Alofisel is darvadstrocel which consists of stem cells which are taken from the fat tissue of a healthy adult donor (so-called allogenic stem cells) and then grown in a laboratory.
Djelatni sastojak Alofisela je darvadstrocel koji se sastoji od matičnih stanica uzetih iz masnog tkiva zdravogodraslogdonora(tzv.alogenematičnestanice),kojesezatimuzgajajuulaboratoriju.
Adverse reactions System Organ Class
Tablica 1. Nuspojave Klasifikacija organskih sustava Učestalost
Up to Week 104, 5 (4.9%) and one (< 1.0%) patients developed 5 and 1 anal fistula serious adverse events in the Alofisel and control groups, respectively.
Do 104. tjedna, 5 (4,9%), odnosno jedan (< 1,0%) bolesnik razvili su 5, odnosno 1 nuspojavu analne fistule u Alofisel, odnosno kontrolnoj skupini.
ALOFISEL 5 million cells/mL suspension for injection Darvadstrocel
Alofisel 5 milijuna stanica/ml, suspenzija za injekciju darvadstrocel
Up to Week 52, 15 (14.6%) and 12 (11.8%) patients developed 20 and 17 proctalgia adverse events in the Alofisel and control groups, respectively, none of these events being serious in any group up to Week 104.
Do 52. tjedna, 15 (14,6%), odnosno 12 (11,8%) bolesnika razvilo je 20, odnosno 17 nuspojava proktalgije u Alofisel skupini i kontrolnoj skupini, a nijedan od tih događaja nije bio ozbiljan ni u jednoj skupini do 104. tjedna.
Preparation a) The expiry time: date of Alofisel should be re-confirmed; vials should then be removed from the outer packaging.
Nakon kondicioniranja fistularnih kanala, Alofisel treba primijeniti prema sljedeća dva koraka: Priprema a) Rok valjanosti: morate potvrditi datum valjanosti lijeka Alofisel; bočice se tada vade iz vanjskog pakiranja.
How Alofisel is given
Kako se primjenjuje Alofisel
Driving and using machines Alofisel is not likely to affect your ability to drive or use tools or machines.
Nije vjerojatno da će Alofisel utjecati na upravljanje vozilima ili strojevima.
Alofisel is indicated only for injection in the fistula tract tissue as described in section 4.2.
Alofisel je indiciran samo za injiciranje u tkivo fistularnog kanala kao što je opisano u dijelu 4.2. Alofisel se ne smije davati kroz iglu tanju od 22G.
In Alofisel group, the number of patients who had combined remission at Week 24 and subsequently developed anal abscess/anal fistula by Week 52 was 2.9% (3/103), whereas the number of patients without combined remission at Week 24 who subsequently developed anal abscess/anal fistula by Week 52 was 9.7% (10/103).
Alofisel skupini, 2,9% (3/103) bolesnika imalo je kombiniranu remisiju u 24. tjednu i naknadno razvilo analni apsces/analnu fistulu do 52. tjedna, dok je 9,7% (10/103) bolesnika bez kombinirane remisije u 24. tjednu naknadno razvilo analni apsces/analnu fistulu do 52. tjedna.
Up to Week 52, 11 (10.7%) and 8 (7.8%) patients developed 12 and 8 anal fistula adverse events in the Alofisel and control groups, respectively, none of these being of severe intensity.
Do 52. tjedna, 11 (10,7%), odnosno 8 (7,8%) bolesnika razvilo je 12, odnosno 8 nuspojava analnih fistula Alofisel skupini, odnosno kontrolnoj skupini, ali nijedna nije bila jakog intenziteta.
In control group, the number of patients who had combined remission at Week 24 who developed anal abscess/anal fistula by Week 52 was 4.9% (5/102), whereas the number of patients without combined remission at Week 24 who developed anal abscess/anal fistula by Week 52 was 2.9% (3/102).
U kontrolnoj skupini, 4,9% (5/102) bolesnika koji su imali kombiniranu remisiju u 24. tjednu razvili su analni apsces/analnu fistulu do 52. tjedna, dok je 2,9% (3/102) bolesnika bez kombinirane remisije u 24. tjednu naknadno razvilo analni apsces/analnu fistulu do 52. tjedna.
• anal abscess
• analni apsces
Vigorous curettage of all fistula tracts is recommended, with special emphasis in the internal openings area, using a metallic curette.
Preporučuje se metalnom kiretom snažno kiretirati sve fistularne kanala, a posebice područja unutarnjeg otvora.
Up to Week 104, 15 (14.6%) and 8 (7.8%) patients developed 15 and 9 serious adverse events of anal abscess in the Alofisel and control groups, respectively.
Do 104. tjedna, 15 (14,6%), odnosno 8 (7,8%) bolesnika razvilo je 15, odnosno 9 događaja ozbiljnih nuspojava analnog apscesa u Alofisel skupini, odnosno kontrolnoj skupini.
P value
vrijednost
e) Repeat steps (b), (c) and (d) for each of the vials in turn after the cells from one vial have been injected.
Na primjer, potrebna je igla za spinalnu anesteziju duljine oko 90 mm. e) Ponovite korake (b), (c) i (d) za svaku bočicu nakon što su injicirane stanice iz prethodne bočice.
OTHER
OSTALO
Hepatic or renal impairment
Oštećenje jetre ili bubrega
Keep the product within the outer carton.
Čuvati lijek u vanjskom pakiranju.
The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) (see section 4.2 and section 4.4) through the fistula tracts and use of local anaesthesia is not recommended due to the unknown effect on the injected cells (see section 4.4).
Injiciranje bilo koje druge tvari osim otopine natrijevog klorida 9 mg/ml (0,9%) (npr. vodikovog peroksida, metilenskog modrila, otopine joda ili hipertonične otopine glukoze) (vidjeti dio 4.2 i dio
Proctalgia
Nuspojave
Anal abscess
Analni apsces
What Alofisel looks like and contents of the pack Alofisel is a suspension for injection.
Alofisel je suspenzija za injekciju.
If you get any side effects, talk to your surgeon or doctor.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti kirurga ili liječnika.
See the end of Section 4 for how to report side effects.
Za postupak prijavljivanja nuspojava, pogledajte dio 4.
Takeda Pharma Ges.m.b.H.
Takeda Pharma sp. z o.o tel.
Takeda Pharma sp. z o.o tel. + 48 22 608 13 00
Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 600
Adverse Reactions
Upozorenjaimjereopreza
Anal fistula
Analna fistula
Date of first authorisation: 26 July 2018
Datum prvog odobrenja: 26. srpnja 2018.
It is not possible to advise on a minimum effective/safe dose in this population.
Nije moguće dati savjet o minimalnoj učinkovitoj/sigurnoj dozi u ove populacije.
The trials included 2,690 patients with the age of 18 years to 65 years.
Ispitivanja su uključila 2690 bolesnika u dobi od 18 godina do 65 godina.
If you forget to take a dose, take it as soon as you remember it.
Ako ste zaboravili uzeti dozu, uzmite je čim se sjetite.
The safety and effectiveness in these patients were not evaluated.
Sigurnost i učinkovitost u tih bolesnika nisu procijenjene.
• dementia (loss of memory and other mental abilities) especially if you are elderly.
• demenciju (gubitak pamćenja i drugih mentalnih sposobnosti), osobito ako ste starije dobi.
• or had low or high blood pressure.
• ili ste imali nizak ili visok krvni tlak.
• pain in arms or legs or both,
• bol u rukama ili nogama ili oboje
Suicidal thoughts and behaviours are more likely at the beginning of the treatment.
Samoubilačke misli i ponašanja vjerojatnija su na početku liječenja.
Remember to take the medicine pack with you so that it is clear what you have taken.
Ne zaboravite ponijeti pakiranje lijeka sa sobom tako da bude jasno što ste uzeli.
Alcohol should be avoided as it can influence how this medicine works.
Alkohol je potrebno izbjegavati jer može utjecati na to kako djeluje ovaj lijek.
Close medical supervision and monitoring should continue until the patient recovers.
Pažljiv medicinski nadzor i praćenje moraju trajati sve do oporavka bolesnika.
What RXULTI is and what it is used for
Što je RXULTI i za što se koristi
Tell your doctor immediately if you
Odmah obavijestite liječnika ako
• medicines having an effect on the central nervous system.
• lijekove koji utječu na središnji živčani sustav.
Treatment group n
Terapijska skupina n
Do not over-exercise and drink plenty of water.
Izbjegavajte pretjeranu tjelovježbu i pijte puno vode.
• withdrawal symptoms in new-born babies if the mother has taken this medicine during pregnancy.
• simptomi ustezanja u novorođenčadi ako je majka uzimala ovaj lijek tijekom trudnoće
This leaflet was last revised in MM/YYYY.
Ova uputa je zadnji puta revidirana u {MM/GGGG}.
It does not matter whether you take your medicine with or without food.
Nije važno uzimate li ovaj lijek s hranom ili bez nje.
It is not recommended to take RXULTI during your pregnancy.
Ne preporučuje se uzimati RXULTI tijekom trudnoće.
Caution should be exercised when prescribing with other medicinal products.
Potreban je oprez kad se propisuje s drugim lijekovima.
Even if you feel better, do not alter or stop your daily dose of RXULTI unless told to do so by your doctor as your symptoms may return.
Čak i ako se osjećate bolje, nemojte mijenjati ili prestati uzimati svoju dnevnu dozu lijeka RXULTI, osim ako Vam liječnik ne kaže da to učinite, jer se simptomi mogu vratiti.
Your doctor will consider the benefit of the therapy for you and the benefit of breast-feeding for your baby.
Liječnik će razmotriti korist terapije za Vas i korist dojenja za dijete.
Your medicine will usually be given to you in increasing doses as follows:
Lijek će Vam obično davati u sve višoj dozi na sljedeći način:
A risk to the new-borns/infants cannot be excluded.
Ne može se isključiti rizik za novorođenče/dojenče.
• an electrolyte imbalance (problems with the amount of salts in your blood).
• neravnotežu elektrolita (probleme s količinom soli u krvi).
• have or had a low number of white blood cells in your blood and get a fever or any other sign of infection.
• imate ili ste imali nizak broj bijelih krvnih stanica u krvi i dobijete vrućicu ili neki drugi znak infekcije.
• if you are allergic to brexpiprazole or any of the other ingredients of this medicine (listed in section 6).
• ako ste alergični na brekspiprazol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
The CGI-S was also assessed in trials 3 and 5 as secondary endpoint.
CGI-S je bio procijenjen i u ispitivanjima 3 i 5 kao sekundarna mjera ishoda.
Please check that you are not feeling dizzy or sleepy before you start driving or handling machines.
Provjerite da ne osjećate omaglicu ili pospanost prije nego što počnete upravljati vozilom ili rukovati strojevima.
Thus, DM-3411 is considered not to contribute to the therapeutic effects of brexpiprazole.
Stoga se smatra da DM-3411 ne pridonosi terapijskim učincima brekspiprazola.
RXULTI can be taken with or without food.
RXULTI se može uzimati s hranom ili bez nje.
Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.
Obavezno obavijestite liječnika ako uzimate lijek koji Vam drži krvni tlak pod kontrolom.
Leukopenia, neutropenia and agranulocytosis
Leukopenija, neutropenija i agranulocitoza
These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Ovi se simptomi mogu privremeno pogoršati ili čak pojaviti nakon prekida liječenja.
2500 Valby Denmark
2500 Valby Danska
However, your doctor may prescribe a lower or higher dose to a maximum of 4 mg once a day.
Međutim, liječnik Vam može propisati nižu ili višu dozu do maksimalno 4 mg jedanput na dan.
RXULTI with food and alcohol
RXULTI s hranom i alkoholom
At the beginning of treatment the lipid profile should be assessed.
Na početku liječenja potrebno je procijeniti lipidni profil.
Pharmacokinetics in special populations
Farmakokinetika u posebnih populacija
These symptoms may occur early during treatment.
Ti se simptomi mogu pojaviti rano tijekom liječenja.