natgillin/translations-raw huggingface dataset:
Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur when one of the following active substances is taken, for example:
Ob jemanju katere izmed naslednjih učinkovin se lahko zmanjša učinek na znižanje koncentracije glukoze v krvi, zato lahko v nekaterih primerih pride do hiperglikemije:
Alertness and reaction time may be impaired due to low or high blood sugar due to glimepiride, especially when beginning or after altering treatment, or when Tandemact is not taken regularly.
Na začetku ali pri spremembi zdravljenja ali ob nerednem jemanju zdravila Tandemact se lahko poslabša budnost in odzivni čas zaradi nizke ali visoke ravni sladkorja v krvi, ki jo povzroča glimepirid.
A decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Ob sočasnem dajanju gemfibrozila bo morda treba znižati odmerek pioglitazona.
Localised swelling (oedema) has also been experienced commonly (may affect up to 1 in 10 people) in patients taking Tandemact in combination with insulin.
Bolniki ki jemljejo zdravilo Tandemact skupaj z insulinom so pogosto (pri največ 1 od 10 bolnikov) izkusili lokalizirano oteklino (edem).
NAME OF THE MEDICINAL PRODUCT Tandemact 45 mg/4 mg tablets pioglitazone/glimepiride
IME ZDRAVILA Tandemact 45 mg/4 mg tablete pioglitazon/glimepirid
Tandemact
Zdravilo Tandemact
Each Tandemact 30 mg/2 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 2 mg glimepiride.
- Ena Tandemact 30 mg/2 mg tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida) in 2 mg glimepirida.
EU/1/06/366/005 14 tablets EU/1/06/366/006 28 tablets EU/1/06/366/007 30 tablets EU/1/06/366/008 50 tablets EU/1/06/366/009 90 tablets EU/1/06/366/010 98 tablets
EU/1/06/366/005 14 tablet EU/1/06/366/006 28 tablet EU/1/06/366/007 30 tablet EU/1/06/366/008 50 tablet EU/1/06/366/009 90 tablet EU/1/06/366/010 98 tablet
- weight gain - dizziness - gas - respiratory infection - numbness
Pogosti (pri največ 1 od 10 bolnikov) - povečanje telesne mase - omotica - vetrovi - okužba dihal - odrevenelost
EU/1/06/366/017 14 tablets EU/1/06/366/018 28 tablets EU/1/06/366/019 30 tablets EU/1/06/366/020 50 tablets EU/1/06/366/021 90 tablets EU/1/06/366/022 98 tablets
EU/1/06/366/017 14 tablet EU/1/06/366/018 28 tablet EU/1/06/366/019 30 tablet EU/1/06/366/020 50 tablet EU/1/06/366/021 90 tablet EU/1/06/366/022 98 tablet
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Tandemact and have also been reported in male patients (frequency cannot be estimated from the available data) taking Tandemact.
O zlomih so poročali tudi pri bolnikih, ki so se zdravili z zdravilom Tandemact (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
NAME OF THE MEDICINAL PRODUCT Tandemact 30 mg/2 mg tablets pioglitazone/glimepiride
IME ZDRAVILA Tandemact 30 mg/2 mg tablete pioglitazon/glimepirid
EU/1/06/366/011 14 tablets EU/1/06/366/012 28 tablets EU/1/06/366/013 30 tablets EU/1/06/366/014 50 tablets EU/1/06/366/015 90 tablets EU/1/06/366/016 98 tablets
EU/1/06/366/011 14 tablet EU/1/06/366/012 28 tablet EU/1/06/366/013 30 tablet EU/1/06/366/014 50 tablet EU/1/06/366/015 90 tablet EU/1/06/366/016 98 tablet
Each Tandemact 30 mg/4 mg tablet contains 30 mg pioglitazone (as hydrochloride) and 4 mg glimepiride.
- Ena Tandemact 30 mg/4 mg tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida) in 4 mg glimepirida.
HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
V večini kliničnih preskušanj so opažali znižane skupne plazemske koncentracije trigliceridov in prostih maščobnih kislin ter povišane ravni HDL holesterola v primerjavi s placebom, in majhna, statistično neznačilna povišanja ravni LDL holesterola.
Hypersensitivity reactions of the skin may occur as itching, rash, and urticaria.
Pojavijo se lahko preobčutljivostne reakcije kože, npr. srbenje,
Tandemact 45 mg/4 mg tablets White to off-white, round, flat and debossed ‘4833 G' on one face and ‘45/4' on the other.
Tandemact 45 mg/4 mg tablete Tablete so bele do sivobele barve, okrogle, ploske z oznako ‘4833 G' na eni in ‘45/4' na drugi strani.
Each tablet contains 45 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
Ena tableta vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida) in 4 mg glimepirida.
- Tandemact 45 mg/4 mg tablets are white to off-white, round, flat and debossed ‘4833 G' on one face and ‘45/4' on the other.
Tablete Tandemact 45 mg/4 mg so bele do sivobele barve, okrogle, ploske, z oznako ‘4833 G' na eni in ‘45/4' na drugi strani.
NAME OF THE MEDICINAL PRODUCT Tandemact 30 mg/4 mg tablets pioglitazone/glimepiride
IME ZDRAVILA Tandemact 30 mg/4 mg tablete pioglitazon/glimepirid
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Pri bolnikih s sladkorno boleznijo tipa 2 in obstoječo težjo makrovaskularno boleznijo, starih manj kot 75 let, so izvajali študijo kardiovaskularnega izida.
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride.
Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida) in 2 mg glimepirida.
- Tandemact 30 mg/4 mg tablets are white to off-white, round, convex and debossed ‘4833 G' on one face and ‘30/4' on the other.
Tablete Tandemact 30 mg/4 mg so bele do sivobele barve, okrogle, izbočene, z oznako ‘4833 G' na eni in ‘30/4' na drugi strani.
Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida) in 4 mg glimepirida.
This can lead to a risk of hypoglycaemia (low blood sugar): - gemfibrozil and fibrates (to lower high cholesterol level) - insulin, metformin or other medicines to treat diabetes mellitus - phenylbutazone, azapropazone, oxyphenbutazone, aspirin-like medicines (to treat pain and inflammation) - long acting sulphonamides, tetracyclines, chloramphenicol, fluconazole, miconazole,
To lahko povzroči tveganje za hipoglikemijo (nizka raven sladkorja v krvi): - gemfibrozil in fibrati (za zniževanje visoke ravni holesterola) - insulin, metformin ali druga zdravila za zdravljenje sladkorne bolezni
Tandemact is contraindicated during pregnancy (see section 4.3).
Zdravilo Tandemact je kontraindicirano med nosečnostjo (glejte poglavje 4.3) Če pride do zanositve, je treba zdravljenje z zdravilom Tandemact prekiniti.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 45 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 45 mg pioglitazona (v obliki pioglitazonijevega klorida) in 4 mg glimepirida.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 4 mg of glimepiride.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida) in 4 mg glimepirida.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg of pioglitazone (as hydrochloride) and 2 mg of glimepiride.
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 30 mg pioglitazona (v obliki pioglitazonijevega klorida) in 2 mg glimepirida.
particularly when pioglitazone is used in combination with insulin (see section 4.4 Fluid retention and cardiac failure).
Zdravniki morajo začeti zdravljenje z najnižjim odmerkom, ki je na voljo in odmerek zviševati postopoma, še posebej, ko se pioglitazon uporablja v kombinaciji z insulinom (glejte poglavje 4.4 Zastajanje tekočine in srčno popuščanje).
This treatment should be assessed after 12 months.
To zdravljenje je treba oceniti po 12 mesecih.
Martina Weise (Germany)
Martina Weise (Nemčija)
The European Commission issued a decision on 27 July 2010.
Evropska komisija je odločbo izdala 27. julija 2010.
Company responses provided on: 6 April 2009, 11 September 2009, 14 January 2010 and 19 March 2010
6. aprila 2009, 11. septembra 2009, 14. januarja 2010 in 19. marca 2010
Jens Ersboll (Denmark)
Jens Ersbøll (Danska)
The company that markets these medicines is Novartis.
Družba, ki zdravilo trži, je Novartis.
Famvir is authorised in the EU via national procedures.
Zdravilo Famvir je v EU odobreno z nacionalnimi postopki.
Other sections harmonised include the sections on special warnings, pregnancy and lactation and side effects.
Druga usklajena poglavja so poglavja s posebnimi opozorili, o nosečnosti in dojenju ter neželenih učinkih.
Famvir is also available in the EU under other trade names: Famciclovir-Sandoz, Famciclovir-SB, Famciclovir-SB Zoster, Famvir Zoster and Oravir.
Zdravilo Famvir je na voljo v EU tudi pod drugimi imeni: Famciclovir-Sandoz, Famciclovir-SB, Famciclovir-SB Zoster, Famvir Zoster in Oravir.
Why was Famvir reviewed?
Zakaj je bilo zdravilo Famvir pregledano?
The European Medicines Agency has completed a review of Famvir.
Evropska agencija za zdravila je zaključila pregled zdravila Famvir.
The CHMP agreed that Famvir should be used for:
CHMP je potrdil, da se zdravilo Famvir uporablja za:
The blocking of the production of DNA leads to the viruses being unable to multiply.
Zaradi zaviranja tvorbe DNK se virusi ne morejo razmnoževati.
It is used to treat infection with herpes viruses including varicella zoster which causes shingles, and herpes simplex (HSV) which can cause cold sores or genital herpes.
Uporablja se za zdravljenje okužbe z virusi herpesa, vključno z virusom varicella zoster, ki povzroča pasovec, in herpesom simpleks (HSV), ki lahko povzroča kožne mehurčke ali genitalni herpes.
This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
To je v različnih državah članicah privedlo do razhajanj glede uporabe zdravila, kakor je razvidno iz povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo v državah, v katerih je zdravilo v prometu.
The Committee recommended that the doses of Famvir should be adjusted in patients with impaired kidney function.
Odbor je priporočil, da je treba odmerke zdravila Famvir prilagoditi pri bolnikih z oslabljenim delovanjem ledvic.
Famvir should not be used in people who may be hypersensitive (allergic) to famciclovir, penciclovir or to any of the other ingredients.
Zdravila Famvir ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) famciklovir, penciklovir ali katero koli drugo sestavino zdravila.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Famvir in the European Union (EU).
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Famvir.
Penciclovir is an antiviral.
Penciklovir je protivirusna učinkovina.
Recurrent episodes should be treated with 125 mg twice a day for five days.
Pri nadaljnjih ponovitvah je treba dajati 125 mg dvakrat dnevno pet dni.
What is Famvir?
Kaj je zdravilo Famvir?
The active substance in Famvir, famciclovir, is converted in the body into a substance called penciclovir.
Zdravilna učinkovina zdravila Famvir, famciklovir, se v telesu pretvori v snov, imenovano penciklovir.
Famvir is an antiviral medicine that contains the active substance famciclovir.
Famvir je protivirusno zdravilo, ki vsebuje zdravilno učinkovino famciklovir.
• the treatment of herpes zoster (shingles) and ophthalmic zoster (shingles around the eye) in immunocompetent adults (patients with an immune system that works normally);
• zdravljenje herpesa zoster (pasavca) in oftalmičnega herpesa zoster (pasavca okrog oči) pri imunsko kompetentnih odraslih (bolnikih, pri katerih imunski sistem deluje normalno);
It works by blocking the production of DNA by herpes viruses.
Deluje tako, da zavira tvorbo DNK, ki jo tvorijo virusi herpesa.
• the treatment of herpes zoster in immunocompromised adults (reduced activity of the immune system);
• zdravljenje herpesa zoster pri imunsko kompromitiranih bolnikih (zmanjšano delovanje imunskega sistema);
On 27 November 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Famvir and associated names in the EU.
Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Famvir in povezanimi imeni v EU, je 27. novembra 2008 zadevo napotila na CHMP.
For herpes zoster, the recommended dose is 500 mg three times a day, for seven days in immunocompetent adults and for ten days in immunocompromised adults.
Pri herpesu zoster je priporočeni odmerek 500 mg trikrat dnevno sedem dni pri imunsko kompetentnih odraslih oziroma deset dni pri imunsko kompromitiranih odraslih.
For genital herpes in immunocompetent adults, the recommended dose for the first episode is 250 mg three times a day for five days.
Pri genitalnemu herpesu pri imunsko kompetentnih odraslih je priporočeni odmerek pri prvem pojavu 250 mg trikrat dnevno pet dni.
• the suppression of recurrence of genital herpes in immunocompetent and immunocompromised adults.
• supresijo ponovitev genitalnega herpesa pri imunsko kompetentnih in imunsko kompromitiranih
• treatment of recurrent episodes of genital herpes in immunocompromised adults;
• zdravljenje nadaljnjih ponovitev genitalnega herpesa pri imunsko kompromitiranih odraslih;
For the suppression of the recurrence of genital herpes, the recommended dose is 250 mg twice a day in immunocompetent adults and 500 mg twice a day in immunocompromised adults.
Pri supresiji ponovitev genitalnega herpesa je priporočeni odmerek 250 mg dvakrat dnevno pri imunsko kompetentnih odraslih oziroma 500 mg dvakrat dnevno pri imunsko kompromitiranih odraslih.
Famvir was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Famvir potrebno usklajevanje.
For recurrent genital herpes in immunocompromised adults, the recommended dose is 500 mg twice a day for seven days.
Pri ponovitvah genitalnega herpesa pri imunsko kompromitiranih odraslih je priporočeni odmerek 500 mg dvakrat dnevno sedem dni.
• treatment of first and recurrent episodes of genital herpes in immunocompetent adults;
• zdravljenje prvega pojava in nadaljnjih ponovitev genitalnega herpesa pri imunsko kompetentnih
Subcutaneous use pre-filled syringe (glass) in prefilled pen (VarioJect)
45 mg/0,45 ml raztopina za injiciranje v napolnjeni brizgi napolnjen injekcijski peresnik (steklo) (VarioJect)
The treatment is usually short-term.
Po navadi je zdravljenje kratkoročno.
Your doctor will have prescribed the strength most suitable for you.
Zdravnik vam bo predpisal za vas ustrezno jakost.
BLISTER (PVC/PVDC/PVC//Alu)
PRETISNI OMOT (PVC/PVDC/PVC//Al)
Do not give this medicine to children under the age of 18 because the safety and efficacy have not been established.
Otroci in mladostniki Zdravila ne dajajte otrokom, starim manj kot 18 let, saj varnost in učinkovitost nista bili dokazani.
Blister (PVC/PVDC/PVC//Alu): 14, 28, 56 or 84 film-coated tablets, in a box.
Pretisni omot (PVC/PVDC/PVC//Al): 14, 28, 56 ali 84 filmsko obloženih tablet, v škatli.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni "brez natrija".
Not everyone gets flares, but you could get a flare-up even if you are taking Febuxostat Krka, and especially during the first weeks or months of treatment.
Do izbruha ne pride pri vseh ljudeh, vendar se lahko pojavi tudi, če jemljete zdravilo Febuksostat Krka, še zlasti v prvih tednih ali mesecih zdravljenja.
BL 2 4 6 8 12 16 20 24 28 32 36 40 44 48 52
BL 2 4 6 8 12 16 20 24 28 32 36 4b 44 48 52
Prophylaxis against gout flares was obligatory over the 26-week period.
Preventivno zdravljenje zagonov protina je bilo obvezno v času 26 tednov.
* p < 0.001 vs allopurinol, # p < 0.001 vs 80 mg
* p < 0,001 v primerjavi z alopurinolom, # p < 0,001 v primerjavi z 80 mg
Over time, gout flares will occur less often and be less painful if you keep taking Febuxostat Krka every day.
Čez čas se bodo izbruhi protina pojavljali manj pogosto in bodo manj boleči, če boste nadaljevali z jemanjem zdravila Febuksostat Krka vsak dan.
Rare (may affect up to 1 in 1,000 people): - muscle damage, a condition which on rare occasions can be serious.
Redki (pojavijo se pri 1 od 1.000 bolnikov) so: - okvara mišic, stanje, ki je lahko v redkih primerih resno.
Your doctor will often prescribe other medicines, if they are needed, to help prevent or treat the symptoms of flares (such as pain and swelling in a joint).
Zdravnik vam bo pogosto predpisal druga zdravila, če bodo potrebna za preprečevanje ali zdravljenje simptomov izbruhov protina (kot so bolečine in oteklost sklepov).
Long-term, open label extension studies
Dolgotrajne, odprte podaljšane raziskave
*** See section 5.1 for incidences of gout flares in the individual Phase 3 randomized controlled studies.
*** Glejte poglavje 5.1 za incidenco izbruhov protina v posameznih randomiziranih kontroliranih študijah 3. faze
The patients should be closely monitored and the dose of mercaptopurine/azathioprine should be subsequently adjusted based on the evaluation of the therapeutic response and the onset of eventual toxic effects.
Bolnike je treba skrbno nadzirati, odmerek merkaptopurina/azatioprina pa mora biti posledično prilagojen glede na oceno terapevtskega odgovora in pojava morebitnih toksičnih učinkov.
Treatment of chronic hyperuricaemia
Zdravljenje kronične hiperuikemije
Do not take Febuxostat Krka - if you are allergic to febuxostat or any of the other ingredients of this medicine (listed in section
Ne jemljite zdravila Febuksostat Krka - če ste alergični na febuksostat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
In clinical studies the use of naproxen or other NSAIDs/Cox-2 inhibitors was not related to any clinically significant increase in adverse events.
V kliničnih študijah uporaba naproksena ali drugih NSAID/zaviralcev COX-2 ni bila povezana z nobenim klinično pomembnim povečanjem neželenih učinkov.
Tumour Lysis Syndrome: in the pivotal Phase III trial (FLORENCE) only subjects with severe hepatic insufficiency were excluded from trial participation.
Sindrom tumorske lize: v ključni študiji 3. faze (FLORENCE) so bili samo bolniki s hudo jetrno insuficienco izključeni iz študije.
Concomitant ingestion of an antacid containing magnesium hydroxide and aluminium hydroxide has been shown to delay absorption of febuxostat (approximately 1 hour) and to cause a 32% decrease in Cmax, but no significant change in AUC was observed.
Pokazalo se je, da sočasno zaužitje antacida, ki vsebuje magnezijev hidroksid in aluminijev hidroksid, zakasni absorpcijo febuksostata (za približno 1 uro) in povzroči 32 % znižanje Cmax, toda značilne spremembe AUC niso opazili.
Excipient(s) with known effect - lactose: 73 mg
Pomožna snov z znanim učinkom: - laktoza: 73 mg
If you take more Febuxostat Krka than you should In the event of an accidental overdose ask your doctor what to do, or contact your nearest accident and emergency department.
Če ste vzeli večji odmerek zdravila Febuksostat Krka, kot bi smeli V primeru nenamerno vzetega prevelikega odmerka se o tem, kaj morate storiti, posvetujte z zdravnikom ali pojdite v najbližji urgentni oddelek za nezgode in nujne primere.
Incidence of overall treatment-emergent signs and symptoms and adverse drug reactions was 67.6% vs 64.7% and 6.4% vs 6.4% with febuxostat and allopurinol respectively.
Incidenca z zdravljenjem povezanih znakov in simptomov ter neželenih učinkov je bila 67,6 % proti 64,7 % in 6,4 % za febuksostat v primerjavi s 6,4 % pri alopurinolu.
Febuxostat Krka should be started two days before the beginning of cytotoxic therapy and continued for a minimum of 7 days; however treatment may be prolonged up to 9 days according to chemotherapy duration as per clinical judgment.
Zdravljenje z zdravilom Febuksostat Krka je treba začeti dva dni pred pričetkom terapije s citotoksičnimi kemoterapevtiki in ga nadaljevati najmanj 7 dni; vendar se lahko zdravljenje podaljša do 9 dni, odvisno od trajanja kemoterapije kot tudi klinične presoje.
Excipient(s) with known effect - lactose: 109 mg
Pomožna snov z znanim učinkom: - laktoza: 109 mg
Three years data showed a decrease in the incidence of gout flares with less than 4% of patients requiring treatment for a flare (i.e. more than 96% of patients did not require treatment for a flare) at Month 16-24 and at Month 30-36.
Triletni podatki so pokazali zmanjšanje napadov protina in manj kot 4 % bolnikov je potrebovalo nadaljnjo zdravljenje izbruhov protina (tj. več kot 96 % bolnikov ni bilo potrebno zdraviti zaradi izbruhov protina) v mesecih 16 - 24 in v mesecih 30 - 36.
Gout flares were commonly observed soon after the start of treatment and during the first months.
Izbruh protina se je pogosto pojavil takoj po začetku zdravljenja in v prvih mesecih.
Rosiglitazone/CYP2C8 substrates
Rosiglitazon/substrati CYP2C8
If you are having a gout attack at the moment (a sudden onset of severe pain, tenderness, redness, warmth and swelling in a joint), wait for the gout attack to subside before first starting treatment with Febuxostat Krka.
Če imate trenutno izbruh protina (nenadni občutek hude bolečine, napetosti, pordelosti, toplote in oteklosti sklepa), počakajte, da izbruh protina mine, preden začnete zdravljenje z zdravilom Febuksostat Krka.
Patients who had 3 consecutive sUA levels >6.0 mg/dL were withdrawn.
Bolnike, ki so imeli 3 zaporedne vrednosti sUA na ravni > 6,0 mg/dl, so iz raziskave izključili.
The efficacy of febuxostat was demonstrated in three Phase 3 pivotal studies (the two pivotal APEX and FACT studies, and the additional CONFIRMS study described below) that were conducted in 4101 patients with hyperuricaemia and gout.
Učinkovitost febuksostata je bila dokazana v treh ključnih študijah 3. faze (dve ključni študiji APEX in FACT ter dodatna študija CONFIRMS, ki so opisane v nadaljevanju) pri 4.101 bolnikih s hiperurikemijo in protinom.
See section 2 "Febuxostat Krka contains lactose and sodium".
Glejte poglavje 2 "Zdravilo Febuksostat Krka vsebuje laktozo in natrij".
What you need to know before you take Febuxostat Krka
Kaj morate vedeti, preden boste vzeli zdravilo Febuksostat Krka
Keeping uric acid levels low by taking Febuxostat Krka once every day stops crystals building up, and over time it reduces symptoms.
Jemanje zdravila Febuksostat Krka enkrat na dan ohranja nizko raven sečne kisline in prepreči nastanek kristalov, dolgoročno pa zmanjša simptome.
The safety and efficacy of Febuxostat Krka in children below the age of 18 years have not been established.
Varnost in učinkovitost zdravila Febuksostat Krka pri otrocih, starih do 18 let, še nista bili dokazani.
In the randomized, double-blind, Phase 3 pivotal FLORENCE (FLO-01) study comparing febuxostat with allopurinol (346 patients undergoing chemotherapy for haematologic malignancies and at intermediate-to-high risk of TLS), only 22 (6.4%) patients overall experienced adverse reactions, namely 11 (6.4%) patients in each treatment group.
V randomizirani, dvojno slepi, ključni študiji 3. faze FLORENCE (FLO-01), kjer so primerjali febuksostat z alopurinolom (346 bolnikov, zdravljenih s kemoterapijo zaradi hematološkega malignega obolenja in s srednje visokim do visokim tveganjem za TLS), je v celoti le 22 (6,4 %) bolnikov imelo neželene učinke, in sicer 11 (6,4 %) bolnikov v vsaki zdravljeni skupini.
Primary endpoints were serum uric acid area under the curve (AUCsUA1-8) and change in serum creatinine (sC) level both from baseline to Day 8.
Primarni cilji so bili površina serumske sečne kisline pod krivuljo (AUCsUA1-8) in sprememba vrednosti serumskega kreatinina (sC) na samem začetku in do dneva 8.