natgillin/translations-raw huggingface dataset:
The participants received two injections of Daronrix, containing one of four different amounts of haemagglutinin (a protein found in flu viruses), with or without the adjuvant, 21 days apart.
Udeleženci so prejeli dve injekciji zdravila Daronrix, ki sta vsebovali eno od štirih različnih količin hemaglutinina (beljakovine, ki se nahaja v virusih gripe) z adjuvansom ali brez njega v razmaku 21 dni.
A flu pandemic occurs when a new type (strain) of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Pandemija gripe nastopi, ko se pojavi nova vrsta (sev) virusa gripe, ki se lahko enostavno širi od človeka do človeka, ker ljudje nanj niso imuni (zaščiteni proti njemu).
Daronrix is a vaccine.
Zdravilo Daronrix je cepivo.
If a pandemic starts, the virus strain in Daronrix will be replaced by the strain causing the pandemic before the vaccine can be used.
V primeru izbruha pandemije bo sev virusa v zdravilu Daronrix nadomeščen s sevom, ki povzroča pandemijo, preden bo cepivo mogoče uporabljati.
What benefit has Daronrix shown during the studies?
Kakšne koristi je zdravilo Daronrix izkazalo med raziskavami?
If a pandemic is declared, and if the company that makes Daronrix decides to market the vaccine, they will include the flu strain responsible in the vaccine.
V primeru razglasitve pandemije in če se bo podjetje, ki izdeluje zdravilo Daronrix, odločilo za njegovo trženje, bodo v cepivo vključili pandemični sev virusa gripe.
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
V tem primeru lahko imunski sistem, če je ponovno izpostavljen virusu, hitreje tvori protitelesa.
For the full list of all side effects reported with Daronrix, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Daronrix, glejte Navodilo za uporabo.
Why has Daronrix been approved?
Zakaj je bilo zdravilo Daronrix odobreno?
Daronrix is a ‘mock-up' vaccine.
Zdravilo Daronrix je »modelno« cepivo.
What information is still awaited for Daronrix?
Katere informacije o zdravilu Daronrix še pričakujemo?
What is the risk associated with Daronrix?
Kakšna tveganja so povezana z zdravilom Daronrix?
The full EPAR for Daronrix can be found here.
Celotno javno poročilo o oceni zdravila (EPAR) za zdravilo Daronrix je na voljo tukaj.
What is Daronrix?
Kaj je zdravilo Daronrix?
How has Daronrix been studied?
Kako je bilo zdravilo Daronrix raziskano?
How does Daronrix work?
Kako zdravilo Daronrix deluje?
The main study of Daronrix included 387 healthy adults and compared the ability of different doses of Daronrix, with or without the adjuvant, to trigger the production of antibodies (immunogenicity).
V njej so preučevali učinkovitost različnih odmerkov zdravila Daronrix z adjuvansom ali brez njega pri sprožanju nastajanja protiteles (imunogenosti).
How is Daronrix used?
Kako se zdravilo Daronrix uporablja?
What is Daronrix used for?
Za kaj se zdravilo Daronix uporablja?
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
Pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki jih morajo uvesti države članice
NovoSeven has been approved in the European Union since 1996.
NovoSeven je v Evropski uniji odobren od leta 1996.
The Company submitted the results of three studies, involving a total of 486 patients.
Podjetje je predložilo rezultate treh raziskav, v katerih je sodelovalo skupaj 486 bolnikov.
The letter from the Company notifying the EMEA of the withdrawal of the application is available here.
Dopis, s katerim je podjetje obvestilo EMEA o umiku vloge, je na voljo tukaj.
QUESTIONS AND ANSWERS ON WITHDRAWAL OF THE APPLICATION FOR A CHANGE TO THE MARKETING AUTHORISATION for NOVOSEVEN
VPRAŠANJA IN ODGOVORI GLEDE UMIKA VLOGE ZA SPREMEMBO DOVOLJENJA ZA PROMET z zdravilom NOVOSEVEN
What is NovoSeven?
Kaj je zdravilo NovoSeven?
Following CHMP opinion, it usually takes around 6 weeks to the European Commission to update the licence.
Ko CHMP poda mnenje, Evropska komisija v približno 6 tednih posodobi dovoljenje.
International Non-proprietary Name (INN): eptacog alfa (activated)
Mednarodno nelastniško ime (INN): eptakog alfa (aktiviran)
The data submitted show that NovoSeven has an effect on the volume of the haemorrhage, but it is not clear how this effect translates into a better outcome for the patient, especially at the dose selected for this indication.
Predloženi podatki kažejo, da zdravilo NovoSeven vpliva na volumen krvavitve, vendar ni jasno, kako je ta učinek povezan z boljšim izidom za bolnika, zlasti pri odmerku, izbranem za to indikacijo.
What are the consequences of the withdrawal for patients undergoing clinical trials / compassionate use programmes with NovSeven?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preizkušanjih / programih sočutne uporabe zdravila NovoSeven?
In addition, there were concerns on the thromboembolic side effects (excessive clotting) for this indication, but the number of patients treated was too small for the CHMP to be able to balance this risk against the potential benefit.
Poleg tega obstajajo zadržki v zvezi s tromboemboličnimi stranskimi učinki (prekomerno strjevanje) za to indikacijo, vendar je bilo število zdravljenih bolnikov premajhno, da bi CHMP lahko ovrednotil to tveganje glede na morebitne koristi.
The main study was carried out in 399 patients (aged 66 on average), and compared the effectiveness of three dosages of NovoSeven to that of a placebo (dummy treatment).
V glavno raziskavo je bilo vključenih 399 bolnikov (povprečne starosti 66 let), v njej pa so primerjali učinkovitost treh odmerkov zdravila NovoSeven s placebom (zdravilom brez zdravilne učinkovine).
On 3 April 2006, Novo Nordisk A/S has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a new indication for NovoSeven, in the treatment of acute intracerebral haemorrhage (ICH) in adults for limiting haemorrhage growth and improving clinical outcome.
Podjetje Novo Nordisk A/S je 3.aprila 2006 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo NovoSeven, in sicer zdravljenje akutne znotrajmožganske krvavitve (ZMK) pri odraslih za omejitev krvavitve in za izboljšanje kliničnega izida.
The application was at Day 157 when the Company withdrew it.
Ko je podjetje vlogo umaknilo, je bila le-ta v postopku 157. dan.
There are no consequences for NovoSeven's use in the indications for which it is already authorised, where the known benefit and risk remain unchanged.
Omenjeno nima posledic za uporabo zdravila NovoSeven za indikacije, za katere je bilo zdravilo že odobreno, in pri katerih ostaja razmerje med koristmi in tveganji nespremenjeno.
Therefore, at the time of the withdrawal, the CHMP's view was that the benefit had not been sufficiently demonstrated and did not outweigh the identified risks.
Posledično je CHMP v času umika menil, da koristi niso bile dokazane v zadostni meri in niso večje od znanih tveganj.
It increases the production of thrombin, another coagulation factor, on the surface of the particles that make up blood clots (the platelets), and this helps producing a stable ‘plug' at the site of bleeding.
Poveča proizvodnjo trombina, še enega koagulacijskega faktorja, na površini delcev, ki tvorijo krvne strdke (trombocitov), kar pripomore k nastanku stabilnega “zamaška” na mestu krvavitve.
What documentation has been presented by the Company to support the application to the CHMP?
Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi?
It is also used in patients with acquired haemophilia, in patients with congenital factor VII deficiency, and in patients with Glanzmann's thrombasthenia (a rare bleeding disorder) who cannot be treated by a transfusion of platelets.
Uporablja se tudi pri bolnikih s pridobljeno hemofilijo, pri bolnikih s prirojenim pomanjkanjem faktorja VII in pri bolnikih z Glanzmannovo trombastenijo (redko motnjo strjevanja krvi), ki jih ni mogoče zdraviti s transfuzijo trombocitov.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that NovoSeven could not be approved for the treatment of acute intracerebral haemorrhage.
Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da zdravila NovoSeven ni mogoče odobriti za zdravljenje akutne znotrajmožganske krvavitve.
The main concern of the CHMP was that the data were too limited to evaluate the benefit and the potential risks of NovoSeven in intracerebral haemorrhage.
Glavni zadržek CHMP je bil, da je podatkov premalo, da bi lahko ovrednotili koristi in morebitna tveganja zdravila NovoSeven pri znotrajmožganski krvavitvi.
The effectiveness of NovoSeven was assessed by looking at its effect on the volume of the haemorrhage inside the brain, measured using a scan (percentage change in the volume after 24 hours of treatment with NovoSeven or placebo).
Učinkovitost zdravila NovoSeven je bila ocenjena glede na to, kakšen je njegov učinek na volumen krvavitve znotraj možganov, izmerjeno s slikanjem (sprememba volumna v odstotkih po 24 urah zdravljenja z zdravilom NovoSeven ali placebom).
NovoSeven was to be used to treat adult patients with intracerebral haemorrhage (bleeding inside the brain).
Zdravilo NovoSeven naj bi se uporabljalo za zdravljenje odraslih bolnikov z intracerebralno krvavitvijo (krvavitev znotraj možganov).
The CHMP normally takes up to 90 days (with the possibility to extend it to another 90 days) to adopt an opinion after it has received an application for a change to a marketing authorisation.
CHMP po prejemu vloge za spremembo dovoljenja za promet navadno potrebuje do 90 dni (z možnostjo podaljšanja za dodatnih 90 dni), da poda svoje mnenje.
The Company has informed the CHMP that the current clinical trial of NovoSeven in intracerebral haemorrhage will continue.
Podjetje je CHMP obvestilo, da se bodo trenutno potekajoča klinična preizkušanja z zdravilom NovoSeven pri znotrajmožganskih krvavitvah nadaljevala.
NovoSeven is currently used for the treatment and prevention of bleeding connected with surgery in patients with haemophilia who have developed ‘inhibitors' (antibodies) to factor VIII or IX.
Zdravilo NovoSeven se trenutno uporablja za zdravljenje in preprečevanje krvavitev pri operacijah bolnikov s hemofilijo, ki so razvili “inhibitorje” (protitelesa) faktorjev VIII ali IX.
NovoSeven contains eptacog alfa (activated), which is a blood coagulation factor protein.
NovoSeven vsebuje eptakog alfa (aktiviran), ki je beljakovinski krvni koagulacijski faktor.
In intracerebral haemorrhage, NovoSeven is expected to slow down the bleeding and the spread of the haemorrhage, thus improving the outcome for the patient.
Pri znotrajmožganski krvavitvi naj bi zdravilo NovoSeven upočasnilo krvavitev in njeno širjenje, s čimer naj bi se izboljšal izid za bolnika.
NovoSeven is a powder and solvent for injection that contains the active substance eptacog alfa (activated human recombinant coagulation factor VII).
Zdravilo NovoSeven je prašek in vehikel za raztopino za injiciranje, ki vsebuje zdravilno učinkovino eptakog alfa (aktivirani humani rekombinantni koagulacijski faktor VII).
NovoSeven was expected to limit the bleeding, and so reduce the consequences of the intracerebral haemorrhage.
Zdravilo NovoSeven naj bi omejilo krvavitev in tako zmanjšalo posledice znotrajmožganske krvavitve.
In the body, eptacog alfa acts like one of the substances involved in blood coagulation (clotting), Factor VII.
Eptakog alfa v telesu deluje na podoben način kot ena izmed snovi (faktor VII), ki sodelujejo pri koagulaciji (strjevanju) krvi.
What was NovoSeven expected to be used for this indication?
Za kaj naj bi se zdravilo NovoSeven uporabljalo pri tej indikaciji?
How is NovoSeven expected to work in this indication?
Kako naj bi se zdravilo NovoSeven uporabljalo pri tej indikaciji?
What is happening for NovoSeven used in other conditions?
Kaj to pomeni za uporabo zdravila NovoSeven pri drugih indikacijah?
London, 27 April 2006 Doc.Ref.
London, 27. april 2006 CHMP/154955/2006
The full EPAR for Entecavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Entekavir Mylan je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Entecavir Mylan?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Entekavir Mylan?
This is a summary of the European public assessment report (EPAR) for Entecavir Mylan.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Entekavir Mylan.
Because Entecavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Entekavir Mylan generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Entecavir Mylan is taken once a day.
Zdravilo Entekavir Mylan se jemlje enkrat na dan.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Baraclude, and do not need to be repeated for Entecavir Mylan.
Študije o koristih in tveganjih zdravilne učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Baraclude, zato jih ni treba ponoviti za zdravilo Entekavir Mylan.
As for every medicine, the company provided studies on the quality of Entecavir Mylan.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Entekavir Mylan.
This means that Entecavir Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Baraclude.
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Baraclude.
Entecavir Mylan can only be obtained with a prescription and is available as tablets (0.5 mg and 1 mg).
Predpisovanje in izdaja zdravila Entekavir Mylan je le na recept, na voljo pa je v obliki tablet (0,5 mg in 1 mg).
The Agency recommended that Entecavir Mylan be approved for use in the EU.
Priporočila je, da se zdravilo Entekavir Mylan odobri za uporabo v EU.
The European Medicines Agency concluded that, in accordance with EU requirements, Entecavir Mylan has been shown to have comparable quality and to be bioequivalent to Baraclude.
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Entekavir Mylan primerljivo raven kakovosti kot referenčno zdravilo Baraclude ter da mu je biološko enakovredno.
For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Entecavir Mylan (a nucleoside analogue, such as lamivudine).
Pri odraslih s kompenzirano boleznijo jeter je odmerek odvisen od tega, ali se je bolnik predhodno že zdravil z zdravilom iz skupine, v katero spada tudi zdravilo Entekavir Mylan (z nukleozidnim analogom, kot je lamivudin).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Entecavir Mylan have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Entekavir Mylan upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Entecavir Mylan is a medicine used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Zdravilo Entekavir Mylan se uporablja za zdravljenje kroničnega (dolgotrajnega) hepatitisa B (nalezljive bolezni jeter, ki jo povzroča virus hepatitisa B).
Treatment with Entecavir Mylan should be started by a doctor with experience in the management of chronic hepatitis B.
Zdravljenje z zdravilom Entekavir Mylan mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B.
What are the benefits and risks of Entecavir Mylan?
Kakšne so koristi in tveganja, povezani z zdravilom Entekavir Mylan?
For more information about treatment with Entecavir Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Entekavir Mylan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Entecavir Mylan entecavir
Entekavir Mylan entekavir
For practical information about using Entecavir Mylan, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Entekavir Mylan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Children weighing 32.6 kg and above can be given the 0.5 mg tablets, while an oral solution of entecavir should be used for children weighing less than 32.6 kg. For further information, see the package leaflet.
Otroci, ki tehtajo vsaj 32,6 kg, lahko prejmejo tablete z odmerkom 0,5 mg, za tiste, ki tehtajo manj od 32,6 kg, pa je priporočljiva uporaba peroralne raztopine entekavirja.
It is not intended to provide practical advice on how to use Entecavir Mylan.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What is Entecavir Mylan and what is it used for?
Kaj je zdravilo Entekavir Mylan in za kaj se uporablja?
The active substance in Entecavir Mylan, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Zdravilna učinkovina v zdravilu Entekavir Mylan, entekavir, je protivirusna učinkovina, ki spada v razred nukleozidnih analogov.
Other information about Entecavir Mylan
Druge informacije o zdravilu Entekavir Mylan
Entecavir Mylan contains the active substance entecavir and is a ‘generic medicine'.
Zdravilo Entekavir Mylan vsebuje zdravilno učinkovino entekavir in je „generično zdravilo“.
Why is Entecavir Mylan approved?
Zakaj je bilo zdravilo Entekavir Mylan odobreno?
The 0.5 mg dose can be taken with or without food, but the 1 mg dose must be taken at least 2 hours before or 2 hours after a meal.
Bolniki, ki se še niso zdravili z nukleozidnim analogom, prejmejo 0,5-miligramski odmerek, bolniki, ki so predhodno prejemali lamivudin, a se okužba nanj ne odziva več, pa prejmejo odmerek 1 mg. Odmerek v višini 0,5 mg se lahko vzame s hrano ali brez nje, odmerek v višini 1 mg pa je treba vzeti vsaj dve uri pred obrokom ali dve uri po njem.
How has Entecavir Mylan been studied?
Kako je bilo zdravilo Entekavir Mylan raziskano?
How is Entecavir Mylan used?
Kako se zdravilo Entekavir Mylan uporablja?
How does Entecavir Mylan work?
Kako zdravilo Entekavir Mylan deluje?
These serious skin reactions can be more common in:
Te resne kožne reakcije so lahko pogostejše pri:
Concomitant use which needs to be taken into consideration:
Sočasna uporaba, ki jo je treba upoštevati:
The recommended dose is 1 tablet once a day in the morning.
Priporočeni odmerek je ena tableta enkrat na dan, zjutraj.
Experience in very elderly patients (≥75 years) is limited.
Izkušnje z zelo starimi bolniki (≥ 75 let) so omejene.
The clinical relevance is not clear.
Klinična pomembnost tega ni jasna.
However, no data are available.
Vendar podatkov ni na voljo.
Most of the radioactivity recovered in urine (>60% of dose) occurred in the first 24 hours.
Večina radioaktivnosti v urinu (> 60% odmerka) se je pojavila v prvih 24 urah.
Estimates range from 13 to 30 hours in man.
Pri ljudeh ga ocenjujejo na 13 do 30 ur.
A specific antidote is unknown.
Specifični antidot ni poznan.
Alternative methods of contraception should be considered.
Priporočljiva je uporaba alternativnih metod kontracepcije.
Drink plenty of water during the day to reduce the risk of kidney stones.
Čez dan pijte veliko vode, da zmanjšate možnost za nastanek ledvičnih kamnov.
Swallow the tablet whole with water and after breakfast in the morning.
Tablete pogoltnite cele z vodo, zjutraj po zajtrku.
• people of Han Chinese, Thai or Korean origin
• ljudeh kitajskega (Hani), tajskega in korejskega porekla;
Coadministration of these 2 active substances is generally not recommended.
Sočasna uporaba teh dveh učinkovin se načeloma ne priporoča.
All patients receiving coumarin anticoagulants must be carefully monitored.
Vse bolnike, ki prejemajo kumarinske antikoagulante, moramo skrbno spremljati.
Wait and take your next dose of Duzallo the next morning.
Počakajte in vzemite naslednji odmerek zdravila Duzallo naslednje jutro.
- you have or have had heart failure or other heart problems - your gout gets worse
- če imate ali ste kdaj imeli srčno popuščanje ali druge težave s srcem - če se vam protin poslabša
The large discrepancies in these values may be accounted for by variations in study design and/or creatinine clearance in the patients.
Velike razlike v vrednostih so lahko posledica razlik v načrtovanju študij in/ali kreatininskem očistku bolnikov.
Studies in animals with lesinurad do not indicate direct or indirect harmful effects.
Študije na živalih z lesinuradom ne kažejo neposrednih ali posrednih škodljivih učinkov.
Lesinurad has no or negligible influence on the ability to drive and use machines.
Lesinurad nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Reported values for the elimination half-life range from 13.6 hours to 29 hours.
Razpolovni čas izločanja znaša od 13,6 do 29 ur.
Lesinurad is extensively bound to proteins in plasma (greater than 98%), mainly to albumin.
Lesinurad se v veliki meri veže na beljakovine v plazmi (več kot 98%), predvsem na albumin.
ATC code: M04AA51
Oznaka ATC: M04AA51
The highest risk for SJS and TEN, or other serious hypersensitivity reactions, is within the first weeks of treatment.
Največje tveganje za pojav SJS in TEN ali drugih resnih preobčutljivostnih reakcij je v prvih tednih zdravljenja.
Chronic kidney disease may increase the risk in these patients additionally.
Kronično obolenje ledvic lahko tveganje pri teh bolnikih še dodatno poveča.
Unchanged lesinurad in urine accounted for approximately 30% of the dose.
Nespremenjeni lesinurad v urinu je predstavljal približno 30% odmerka.
HLA-B*5801 allele
HLA-B*5801 alel
The safety and efficacy of Duzallo in children and adolescents under 18 years of age have not yet been established.
Varnost in učinkovitost zdravila Duzallo pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
If concomitant use is unavoidable, a dose reduction of didanosine may be required, and patients should be closely monitored.
Če je sočasna uporabi neizogibna, je morda potrebno znižati odmerek didanozina, in bolnike je treba skrbno spremljati.
Difference in proportion (95% C.I.)
Razlika v deležu (95% IZ)
Blood count monitoring should therefore be performed at regular intervals.
Krvno sliko je treba zato redno spremljati.
The use of genotyping has not been established in other patient populations.
Genotipizacija pri drugih populacijah bolnikov ni v uporabi.
The absolute bioavailability of lesinurad is approximately 100%.
Absolutna biološka uporabnost lesinurada je približno 100%.
These serum creatinine elevations generally resolved, most without treatment interruption.
Ta zvišanja kreatinina v serumu so na splošno izzvenela, večinoma brez prekinitve zdravljenja.
These effects usually occur in people with liver or kidney problems (agranulocytosis).
Taki učinki se običajno pojavijo pri ljudeh, ki imajo težave z jetri ali ledvicami (agranulocitoza).