natgillin/translations-raw huggingface dataset:
In the majority of patients with urea cycle disorders or haemoglobinopathies receiving various doses of phenylbutyrate (300 - 650 mg/kg/day up to 20 g/day) no plasma level of phenylacetate could be detected after overnight fasting.
U većine bolesnika s poremećajima ciklusa ureje ili hemoglobinopatijama koji su primali različite doze fenilbutirata (300 - 650 mg/kg/dan do 20 g/dan) nije mogla biti utvrđena razina fenilacetata u plazmi nakon cjelonoćnog gladovanja.
Pheburane is contra-indicated during breast-feeding (see section 4.3).
Pheburane je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
Repeated dosing with phenylacetate showed evidence of an induction of clearance.
Ponavljanja doziranja fenilacetata pokazala su postojanje indukcije klirensa.
Do not use PHEBURANE after the expiry date which is stated on the carton and the bottle label after EXP.
PHEBURANE se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake „Rok valjanosti“.
Bottle: 174 g granules.
Bočica: 174 g granula.
PHEBURANE should be administered orally.
PHEBURANE se primjenjuje peroralno.
PHEBURANE contains the active substance sodium phenylbutyrate which is used to treat patients of all ages with urea cycle disorders.
PHEBURANE sadrži djelatnu tvar natrijev fenilbutirat koji se koristi za liječenje bolesnika svih starosnih skupina s poremećajima ciklusa ureje.
• PHEBURANE is considered high in sodium.
• PHEBURANE se smatra lijekom s visokim sadržajem natrija.
Common rash, abnormal skin odor
Često osip, nenormalni miris kože
These symptoms are consistent with the accumulation of phenylacetate, which showed dose-limiting neurotoxicity when administered intravenously at doses up to 400 mg/kg/day.
Jednaki simptomi javljaju se pri akumulaciji fenilacetata koji pokazuje dozno limitirajuću neurotoksičnost ako se primijeni intravenski u dozama višim od 400 mg/kg/dan.
Because of its slow dissolution, PHEBURANE should not be administered by nasogastric or gastrostomy tubes.
Zbog spore topivosti PHEBURANE se ne bi smio primjenjivati kroz nazogastričnu ili gastrostomsku sondu.
PHEBURANE has negligible influence on the ability to drive and use machines.
PHEBURANE zanemarivo utječe na sposobnost upravljanja vozilima i rada na strojevima.
This medicine contains 768 mg of sucrose per 1 g of sodium phenylbutyrate.
Ovaj lijek sadrži 768 mg saharoze po 1 g natrijevog fenilbutirata.
Clinical efficacy and safety Based on studies of phenylacetylglutamine excretion in patients with urea cycle disorders it is possible to estimate that, for each gram of sodium phenylbutyrate administered, between 0.12 and 0.15 g of phenylacetylglutamine nitrogen are produced.
Temeljeno na ispitivanjima izlučivanja fenilacetilglutamina u bolesnika s poremećajem ciklusa ureje može se procijeniti da se po svakom gramu primijenjenog natrijevog fenilbutirata stvara između 0,12 i 0,15 g fenilacetilglutaminskog dušika.
CARTON AND BOTTLE LABEL
OZNAKA NA KUTIJI I BOČICI
However PHEBURANE must be used along with a diet reduced in proteins, designed especially for you by the doctor and the dietician.
PHEBURANE se treba koristiti zajedno s dijetom s ograničenim unosom proteina, koju je Vaš liječnik ili dijetetičar posebno osmislio za Vas.
Studies with high intravenous doses of phenylacetate showed non-linear pharmacokinetics characterised by saturable metabolism to phenylacetylglutamine.
Ispitivanja s visokim intravenskim dozama fenilacetata pokazala su nelinearno farmakokinetičko svojstvo saturacijom njegovog metaboliziranja u fenilacetilglutamin.
Nutritional management PHEBURANE must be combined with dietary protein restriction and, in some cases, essential amino acid and carnitine supplementation.
PHEBURANE treba kombinirati s dijetom s ograničenim unosom proteina, u nekim slučajevima uz suplementaciju esencijalnim aminokiselinama i karnitinom.
Citrulline or arginine supplementation is required for patients diagnosed with neonatal-onset form of carbamyl phosphate synthetase or ornithine transcarbamylase deficiency at a dose of 0.17 g/kg/day or 3.8 g/m2/day.
Suplementacija citrulina ili arginina potrebna je u bolesnika kod kojih se deficijencija karbamilfosfat sintetaze i ornitin transkarbamilaze pojavila u novorođenačkoj dobi u dozi 0,17 g/kg/dan ili 3,8 g/m2/dan,
Only use the calibrated measuring spoon provided.
Koristiti samo priloženu kalibriranu mjernu žličicu.
• Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium.
• Tijekom liječenja potrebno je nadzirati razinu kalija u serumu budući da izlučivanje fenilacetilglutamina putem bubrega može inducirati gubitak kalija urinom.
This medicine contains 124 mg (5.4 mmol) of sodium per 1 g of sodium phenylbutyrate.
Ovaj lijek sadrži 124 mg (5,4 mmol) natrija po 1 g natrijevog fenilbutirata.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Unutar svakog grupiranja po učestalosti nuspojave se navode prema svojoj težini, od težih prema manje teškima.
PHEBURANE contains sodium and sucrose
PHEBURANE sadrži natrij i sukrozu
There are no or limited amount of data from the use of sodium phenylbutyrate in pregnant women.
Nema podataka ili su podaci o primjeni natrijevog fenilbutirata u trudnica ograničeni.
The disposition of phenylbutyrate and its metabolites has also been studied in cancer patients following intravenous infusion of sodium phenylbutyrate (up to 2 g/m²) or phenylacetate.
Raspoloživost fenilbutirata i njegovih metabolita također je ispitivana na onkološkim bolesnicima koji su primili intravensku infuziju natrijevog fenilbutirata (do 2 g/m²) ili fenilacetata.
Uncommon side effects (may affect more than 1 in 1,000 people): deficiency in red blood cells due to failure of the bone marrow, bruising, altered heart rhythm, rectal bleeding, inflammation of the stomach, stomach ulcer, inflammation of the pancreas.
Manje česte nuspojave (mogu se javiti kod više od 1 na 1000 ljudi): nedostatak eritrocita zbog zatajivanja koštane srži, stvaranje modrica, promjena srčanog ritma, krvarenje iz rektuma, upala želuca (gastritis), čir želuca, upala gušterače.
Common abdominal pain, vomiting, nausea, constipation, dysgeusia Uncommon pancreatitis, peptic ulcer, rectal haemorrhage, gastritis
Često bol u abdomenu, povraćanje, mučnina, konstipacija, disgeuzija Manje često pankreatitis, peptički ulkus, krvarenje iz rektuma, gastritis
Phenylbutyrate is rapidly absorbed under fasting conditions.
Fenilbutirat se brzo apsorbira na tašte.
The active substance is sodium phenylbutyrate.
Djelatna tvar je natrijev fenilbutirat.
Phenylacetate is a metabolically active compound that conjugates with glutamine via acetylation to form phenylacetylglutamine which is then excreted by the kidneys.
Fenilacetat je metabolički aktivni spoj koji se acetilacijom konjugira s glutaminom i tvori fenilacetilglutamin, koji se potom izlučuje putem bubrega.
The daily dose of PHEBURANE will be based on your body weight or body surface and adjusted according to your protein tolerance and diet. You will need regular blood tests to determine the correct daily dose.
Dnevna doza PHEBURANEA temeljit će se na Vašoj tjelesnoj težini i tjelesnoj površini i bit će prilagođena prema Vašoj toleranciji na proteine i dijeti.
PHEBURANE is unlikely to affect your ability to drive and use machines.
Malo je vjerojatno da PHEBURANE utječe na sposobnost upravljanja vozilima i rada na strojevima.
A calibrated measuring spoon is provided.
Priložena je kalibrirana mjerna žličica.
More frequent monitoring of plasma ammonia levels is advised when these medicinal products have to be used.
Kada se oni koriste savjetuje se češća kontrola razine amonijaka u plazmi.
PHEBURANE is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
PHEBURANE je indiciran kao pomoćna terapija u dugotrajnom liječenju poremećaja ciklusa ureje, uključujući nedostatak karbamilfosfat sintetaze, ornitin transkarbamilaze ili argininosukcinat sintetaze.
PHEBURANE 483 mg/g granules
PHEBURANE 483 mg/g granule
PHEBURANE 483 mg/g {For carton only}
PHEBURANE 483 mg/g {Samo na kutiji}
• Even on therapy, acute hyperammonaemic encephalopathy may occur in a number of patients.
• Unatoč liječenju kod određenog broja bolesnika može se pojaviti hiperamonijemijska encefalopatija.
In the table below all adverse reactions are listed below, by system organ class and by frequency.
U sljedećoj tablici sve nuspojave navedene su prema klasifikaciji organskih sustava i učestalosti.
A calibrated dosing spoon is provided which dispenses up to 3g of sodium phenylbutyrate by graduation of 250 mg.
S lijekom se isporučuje kalibrirana mjerna žličica kojom se može dozirati do 3 g natrijevog fenilbutirata, graduirana po 250 mg.
After a single oral dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylbutyrate were detected 15 minutes after dosing.
Nakon jednokratne peroralne doze od 5 g natrijevog fenilbutirata, u obliku granula, mjerljive razine fenilbutirata u plazmi utvrđene su nakon 15 minuta.
• Pregnancy.
• Dojenje.
PHEBURANE 483 mg/g granules sodium phenylbutyrate
PHEBURANE 483 mg/g granule natrijev fenilbutirat
After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine were detected 30 and 60 minutes respectively after dosing.
Nakon jednokratne doze od 5 g natrijevog fenilbutirata, u obliku granula, mjerljive razine fenilacetata i fenilacetilglutamina u plazmi utvrđene su nakon 30 odnosno 60 minuta.
In case of any doubt, ask your doctor or pharmacist.
U slučaju ikakve dvojbe obratite se svom liječniku ili ljekarniku.
How to take PHEBURANE
Kako uzimati PHEBURANE
Only use this measuring spoon to measure out the dose.
Za doziranje koristite samo ovu mjernu žličicu.
Carton: One bottle with 174 g granules.
Kutija: Jedna bočica sa 174 g granula.
Sodium phenylbutyrate was negative in 2 mutagenicity tests, i.e. the Ames test and the micronucleus test.
Natrijev fenilbutirat bio je negativan u 2 testa mutagenosti, tj.
In case of mixture of the granules with solid foods or liquid it is important that it is taken immediately after mixing.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom U slučaju da se granule miješaju s krutom hranom ili tekućinom važno je pripremljeno uzeti odmah nakon miješanja.
How to store PHEBURANE
Kako čuvati PHEBURANE
Granules.
OBLIK Granule.
• are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati PHEBURANE: ako ste alergični na natrijev fenilbutirat ili neki drugi sastojak ovog lijeka (naveden u dijelu ako ste trudni ako dojite.
Each bottle contains 174g of granules.
Jedna bočica sadrži 174 g granula.
PHEBURANE granules are white to off-white.
Kako PHEBURANE izgleda i sadržaj pakiranja PHEBURANE granule su bijele do gotovo bijele boje.
Carcinogenicity and fertility studies have not been conducted with sodium phenylbutyrate.
Ispitivanja kancerogenosti i ispitivanja utjecaja fenilbutirata na plodnost nisu provedena.
It is unknown whether sodium phenylbutyrate/metabolites are excreted in human milk.
Nema dovoljno podataka o izlučivanju natrijevog fenilbutirata/metabolita u majčino mlijeko.
As the body breaks down protein after eating, waste nitrogen, in the form of ammonia, accumulates because the body cannot eliminate it. Ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma.
Nakon što se bjelančevine unesene hranom u tijelu razgrade, suvišni se dušik nakuplja u organizmu u obliku amonijaka jer ne može biti izlučen.
Concurrent administration of probenecid may affect renal excretion of the conjugation product of sodium phenylbutyrate.
Istovremena primjena probenecida može utjecati na izlučivanje produkata konjugacije s natrijevim fenilbutiratom putem bubrega.
Each gram of granules contains 483 mg of sodium phenylbutyrate.
Jedan gram granula sadrži 483 mg natrijevog fenilbutirata.
Phenylbutyrate is known to be oxidised to phenylacetate which is enzymatically conjugated with glutamine to form phenylacetylglutamine in the liver and kidney.
Poznato je da fenilbutirat u bubrezima i jetri oksidira u fenilacetat koji se potom s glutaminom enzimatski konjugira i tvori fenilacetilglutamin.
info@frostpharma.com info@frostpharma.com
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• suffer from congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body) or a decrease in your kidney function.
Obratite se svom liječniku ili ljekarniku prije nego uzmete PHEBURANE ako: patite od kongestivne insuficijencije srca (oblik srčane bolesti u kojoj srce ne može dovoljno dobro pumpati krv u organizmu) ili oslabljene funkcije bubrega. imate oslabljenu funkciju bubrega ili jetre budući da se PHEBURANE iz tijela izlučuje putem bubrega i jetre.
A calibrating measuring spoon which dispenses up to 3 g of sodium phenylbutyrate is provided with the medicine.
S lijekom se isporučuje kalibrirana mjerna žličica kojom se može dozirati do 3 g natrijevog fenilbutirata.
Excretion
Eliminacija
PHARMACEUTICAL FORM AND CONTENTS
OBLIK I SADRŽAJ Granule.
Name and address of the manufacturer(s) responsible for batch release Lucane Pharma
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
Uncommon arrhythmia
Manje često aritmija
General considerations
Opća upozorenja
(see Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept. (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2).
What PHEBURANE looks like and contents of the pack
Što PHEBURANE sadrži
Method of administration
Nutricijski menadžment
Eurocept International BV
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eurocept International BV
As a consequence, sodium phenylbutyrate reduces elevated plasma ammonia and glutamine levels in patients with urea cycle disorders.
Kao posljedica ovoga, u bolesnika s poremećenim ciklusom ureje natrijev fenilbutirat snizuje povišene razine amonijaka i glutamina.
Mechanism of action and pharmacodynamic effects Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate.
Natrijev fenilbutirat je neaktivni lijek koji se brzo metabolizira u djelatnu tvar fenilacetat.
To measure the dose:
Kako dozirati:
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Lucane Pharma Tél/Tel: + 33 153 868 750 info@lucanepharma.com
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Common oedema
Često edem
Lucane Pharma Tél: + 33 153 868 750 info@lucanepharma.com
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Lucane Pharma Τηλ: + 33 153 868 750 info@lucanepharma.com
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However, the relevance to humans is unknown.
Međutim, značaj ovog nalaza za ljude nije poznat.
Response was assessed every 4 weeks until disease progression.
Odgovor je procjenjivan svaka 4 tjedna do napredovanja bolesti.
The doctor may also adjust the doses of the other medicines.
Liječnik također može prilagoditi dozu drugih lijekova.
Median overall survival was not reached in either regimen.
Medijan ukupnog preživljenja nije dostignut ni u jednom režimu.
Second reduction to
Drugo smanjenje na
Prior to initiating a new cycle of therapy:
Prije početka novog ciklusa terapije:
Each blister contains one capsule).
Svaki blister sadrži jednu kapsulu).
Median (months) p-value*
Medijan (mjeseci) p-vrijednost*
The other ingredients are:
• Ostali sastojci su:
Age, gender, race
Dob, spol, rasa
PFS results are summarised in Table 4 and Figure 1.
Rezultati za PFS sažeti su u tablici 4 i na slici 1.
It should not be crushed, chewed, or opened (see section 6.6).
Ne smije se lomiti, žvakati niti otvarati (vidjeti dio 6.6).
NINLARO is taken once a week (on the same day of the week) for the first 3 weeks of this cycle.
NINLARO se uzima jedanput tjedno (istog dana u tjednu) tijekom prva 3 tjedna tog ciklusa.
Recommended actions
Preporučeni postupci
4.5 Interaction with other medicinal products and other forms of interaction
4.5 Interakcije s lijekovima i drugi oblici interakcija
A risk to newborns/infants cannot be excluded and therefore breast-feeding should be discontinued.
Ne može se isključiti rizik za novorođenče/dojenče, stoga dojenje treba prekinuti.
The median age was 66 years, range 38-91 years; 58% of patients were older than 65 years.
Medijan dobi iznosio je 66 godina, u rasponu od 38 do 91 godina; 58% bolesnika bilo je starije od 65 godina.
You should read the Package Leaflets of these other medicines for further information on their use and effects.
Trebate pročitati upute o lijeku za te druge lijekove za više informacija o njihovoj uporabi i učincima.
Reproductive and embryo-foetal development
Reproduktivni i embriofetalni razvoj
Animal toxicology and/or pharmacology
Životinjska toksikologija i/ili farmakologija
Date of Last Renewal: 16 September 2019
Datum posljednje obnove odobrenja: 16. rujna 2019.
Before starting NINLARO and during treatment, you will have blood tests to check that you have enough blood cells.
Prije početka uzimanja lijeka NINLARO i tijekom terapije podvrgnut ćete se testiranju krvi kako bi se provjerilo imate li dovoljno krvnih stanica.
PVC-Aluminium /Aluminium blister sealed inside a wallet pack containing one capsule.
PVC-aluminij/aluminij blister zalijepljen unutar ovitka koji sadrži jednu kapsulu.
Consider adding G-CSF as per clinical guidelines.
Razmotrite dodavanje G-CSF prema kliničkim smjernicama.
Discontinue treatment regimen.
Prekinite režim liječenja.
Progression-Free Survival Events, n (%)
Preživljenje bez napredovanja bolesti Događaji, n (%)
Primary refractory, defined as best response of stable disease or disease progression on all prior therapies, was documented in 6% of patients.
Primarno refraktorna bolest, definirana kao najbolji odgovor stabilne bolesti ili napredovanje bolesti na svim prethodnim terapijama, dokumentirana je u 6% bolesnika.
Other medicines and NINLARO
Drugi lijekovi i NINLARO
If lenalidomide is taken during pregnancy, a teratogenic effect in humans is expected.
Ako se lenalidomid uzima tijekom trudnoće očekuje se teratogeni učinak na ljude.
Duration of the treatment with NINLARO You should continue treatment until your doctor tells you to stop.
Trajanje terapije lijekom NINLARO Morate nastaviti s liječenjem sve dok Vam liječnik ne kaže da prestanete.
The recommended dose is one 4 mg capsule taken by mouth.
Preporučena doza je jedna kapsula od 4 mg uzeta kroz usta.
Children and adolescents NINLARO is not recommended for use in children and adolescents aged under 18 years.
Djeca i adolescenti NINLARO se ne preporučuje za primjenu u djece i adolescenata u dobi do 18 godina.
Fifty seven percent of patients were male.
Pedeset i sedam posto bolesnika bili su muškarci.
The patient should be monitored for symptoms of peripheral neuropathy.
Bolesnika je potrebno nadzirati za simptome periferne neuropatije.
If you take more NINLARO than you should, talk to a doctor or go to a hospital straight away.
Ako uzmete više lijeka NINLARO nego što ste trebali, razgovarajte s liječnikom ili odmah otiđite u bolnicu.
The safety and efficacy of ixazomib in children below 18 years of age have not been established.
Sigurnost i djelotvornost iksazomiba u djece mlađe od 18 godina nisu ustanovljene.
Patients should be advised not to drive or operate machines if they experience any of these symptoms.
Bolesnike treba savjetovati da ne upravljaju vozilima i ne rade sa strojevima ako iskuse ijedan od tih simptoma.
The baseline demographics and disease characteristics were balanced and comparable between the study regimens.
Početne demografske karakteristike i karakteristike bolesti bile su uravnotežene i usporedive između ispitivanih režima.
These are structures inside the cell that digest proteins and are important for cell survival.
To su strukture unutar stanice koje razgrađuju proteine i važne su za preživljavanje stanice.
The patient should be evaluated for underlying causes and provide supportive care, as necessary.
U bolesnika je potrebno procijeniti podležeće uzroke i po potrebi pružiti potpornu skrb.
Direct contact with the capsule contents should be avoided.
Potrebno je izbjegavati izravan doticaj sa sadržajem kapsule.
• Do not let the contents of the capsule come into contact with your skin.
• Pazite da sadržaj kapsule ne dođe u dodir s Vašom kožom.
• Take NINLARO at least one hour before or at least two hours after food.
• Uzmite NINLARO barem jedan sat prije ili najmanje dva sata nakon obroka.
Eighty five percent of the population was White, 9% Asian and 2% Black.
Osamdeset i pet posto ispitanika bilo je bijele rase, 9% azijske i 2% crne rase.
If you vomit after taking a dose, do not take an extra dose.
Ako povraćate nakon primjene lijeka, ne smijete uzeti dodatnu dozu.
Of the 5 patients in the ixazomib regimen, one patient had a confirmed partial response and 3 confirmed stable disease (however 2 were unconfirmed partial response and 1 was an unconfirmed very good partial response).
Od 5 bolesnika na režimu s iksazomibom, jedan je bolesnik imao potvrđen djelomični odgovor, a njih 3 potvrđenu stabilnu bolest (međutim, 2 su bili nepotvrđeni djelomični odgovori i 1 je bio nepotvrđen vrlo dobar djelomični odgovor).
Note: ADRs included as preferred terms are based on MedDRA version 16.0.
Napomena: Nuspojave uključene kao preporučeni pojmovi temelje se na verziji 16.0 MedDRA-e.
Therefore, the weight of evidence indicates that ixazomib is not considered to present a genotoxic risk.
Stoga, težina dokaza ukazuje da se ne smatra da iksazomib predstavlja genotoksični rizik.
This is because other medicines can affect the way NINLARO works.
To je stoga jer drugi lijekovi mogu utjecati na način djelovanja lijeka NINLARO.
Do not take NINLARO if you are allergic to ixazomib or to any of the other any of the other ingredients of this medicine (listed in section 6).
Nemojte uzimati NINLARO ako ste alergični na iksazomib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Neutropenia*
Neutropenija*
Approximately 2-fold accumulation in AUC was observed with weekly oral dosing on Day 15.
Približno dvostruka akumulacija u AUC uočena je s tjednim peroralnim doziranjem na 15. dan.
The following convention is used for the classification of the frequency of an adverse drug reaction (ADR): very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Sljedeća konvencija je korištena za klasifikaciju učestalosti nuspojava: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Effect of ixazomib on other medicinal products
Učinak iksazomiba na druge lijekove
These medicines should be avoided as they may reduce the effectiveness of NINLARO.
Te lijekove treba izbjegavati jer mogu smanjiti učinkovitost lijeka NINLARO.
Peripheral motor neuropathy was not commonly reported in either regimen (< 1%).
Periferna motorička neuropatija nije često zabilježena ni u jednom režimu (< 1%).
If you take more NINLARO than you should
Ako uzmete više lijeka NINLARO nego što ste trebali
*Represents a pooling of preferred terms
*Prikazuje grupiranje preporučenih pojmova
Hazard Ratio†
Omjer hazarda†
This includes any medicines obtained without a prescription, such as vitamins or herbal remedies.
To uključuje i bilo koje druge lijekove bez recepta, poput vitamina ili biljnih pripravaka.
A double dose should not be taken to make up for a missed dose.
Ne smije se uzeti dvostruka doza kako bi se nadoknadila propuštena.
Your doctor will examine you and you will be monitored closely during treatment.
Tijekom terapije liječnik će Vas pregledati i pažljivo nadzirati.
In case of severe gastrointestinal events, monitoring of serum potassium level is recommended.
U slučaju teških gastrointestinalnih događaja, preporučuje se praćenje razine serumskog kalija.