natgillin/translations-raw huggingface dataset:
Keep the vial in the outer carton in order to protect from light.
Vialo shranjujte v škatli za zagotovitev zaščite pred svetlobo.
Human Papillomavirus
L1 protein humanega papilomavirusa
In the clinical study in women 24 to 45 years, 98.4%, 98.1%, 98.8%, and 97.4% of individuals who received Silgard became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
V kliničnih študijah pri ženskah, starih od 24 do 45 let, je bilo 1 mesec po prejemu tretjega odmerka cepiva Silgard anti-HPV 6 seropozitivnih 98,4 % oseb, anti-HPV 11 seropozitivnih 98,1 % oseb, anti-HPV 16 seropozitivnih 98,8 % oseb in anti-HPV 18 seropozitivnih 97,4 % oseb.
In the clinical studies in women 16 to 26 years of age, 99.8%, 99.8%, 99.8%, and 99.5% of individuals who received Silgard became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18-seropositive, respectively, by 1 month Postdose 3.
V kliničnih študijah pri ženskah, starih 16 do 26 let, je bilo 1 mesec po prejemu tretjega odmerka cepiva Silgard anti-HPV 6 seropozitivnih 99,8 % oseb, anti-HPV 11 seropozitivnih 99,8 % oseb, anti-HPV 16 seropozitivnih 99,8 % oseb in anti-HPV 18 seropozitivnih 99,5 % oseb.
• the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
• učinkovitost cepiva Silgard proti s HPV 6, 11, 16 in 18 povezanimi bradavicami 99,0 %
Clinical Trials
primeri primeri
In the clinical study in men 16 to 26 years, 98.9%, 99.2%, 98.8%, and 97.4% of individuals who received Silgard became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 seropositive, respectively, by 1 month Postdose 3.
V klinični študiji pri moških, starih od 16 do 26 let, je med tistimi, ki so prejeli cepivo Silgard, postalo v 1 mesecu po 3. odmerku anti-HPV 6 seropozitivnih 98,9 %, anti-HPV 11 seropozitivnih 99,2 %, anti-HPV 16 seropozitivnih 98,8 % in anti-HPV 18 seropozitivnih 97,4 %.
In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.1 years (median follow-up of 8.7 years).
V PPE populaciji v obdobju 10,1 leta (mediani čas spremljanja 8,7 let) niso odkrili primerov bolezni zaradi HPV (s HPV tipi 6/11/16/18 povezana CIN katere koli stopnje in bradavice na spolovilih).
The efficacy of Silgard against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 84.7%
Učinkovitost cepiva Silgard proti kombinirani pojavnosti s HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 84,7 % (95-odstotni IZ: 67,5; 93,7)
Silgard, suspension for injection.
Silgard suspenzija za injiciranje i.m.
N Number of cases HPV 6/11/16/18-related external genital lesions
N število primerov s HPV 6/11/16/18 povezane lezije na zunanjih spolovilih lezije na zunanjih spolovilih bradavice na spolovilih 1394 PIN1/2/3
The efficacy of Silgard in 16- through 26-year-old women was assessed in 4 placebo-controlled, double-blind, randomised Phase II and III clinical studies including a total of 20,541 women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Učinkovitost cepiva Silgard pri ženskah, starih 16 do 26 let, je bila ovrednotena v 4-ih s placebom nadzorovanih, dvojno slepih, randomiziranih kliničnih študijah II.
Discard the product if particulates are present or if it appears discoloured.
V primeru prisotnosti delcev ali spremembe barve morate cepivo zavreči.
Silgard, suspension for injection - pre-filled syringe with 1 needle, pack of 1, 10, 20
Silgard suspenzija za injiciranje - napolnjena injekcijska brizga z 1 iglo, pakiranje po 1, 10, 20
The efficacy of Silgard against the combined incidence of HPV 16- or 18-related persistent infection, genital warts, vulvar and vaginal lesions, CIN of any grade, AIS, and cervical cancers was 41.6%
Učinkovitost cepiva Silgard proti kombinirani pojavnosti s HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 41,6 % (95-odstotni IZ: 24,3; 55,2).
In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related External Genital Lesions) were observed through 10.6 years (median follow-up of
V PPE populaciji v obdobju 10,6 leta (mediani čas spremljanja 9,9 leta) niso odkrili primerov bolezni zaradi HPV (s HPV tipi 6/11/16/18 povezane lezije na zunanjih spolovilih).
The efficacy of Silgard in 16- through 26-year-old men was assessed in 1 placebo-controlled, doubleblind, randomised Phase III clinical study (Protocol 020) including a total of 4,055 men who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
Učinkovitost cepiva Silgard pri moških v starosti od 16 do 26 let so ocenili v 1 s placebom kontrolirani, dvojno slepi randomizirani klinični študiji faze III (Protokol 020).
Therefore Silgard can be used during breast-feeding.
Doječe matere se zato lahko cepi s cepivom Silgard.
Patients were followed
Opazovani dogodek
• Inject immediately using the intramuscular (IM) route, preferably in the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
aplikacijo, najbolje v deltoidni predel nadlakti.
Anti-HPV levels in placebo individuals who had cleared an HPV infection (seropositive and PCR
Pri osebah, ki so prejemale placebo in so okrevale po okužbi s HPV (seropozitivne in PCR negativne) so bile vrednosti anti-HPV bistveno manjše od vrednosti, induciranih s cepivom.
In these studies, individuals who were seronegative for anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 in the cLIA were still protected against clinical disease after a follow-up of 9 years for 16-23 year-old women, 10 years for 24-45 year-old women, and 10 years for 16-26 year-old men.
V teh študijah so bile po 9-letnem spremljanju žensk, starih od 16 do 23 let, 10-letnem spremljanju žensk, starih od 24 do 45 let in 10-letnem spremljanju moških, starih od 16 do 26 let, osebe, ki so bile po metodi cLIA seronegativne za anti-HPV 6, anti-HPV 11, anti-HPV 16 in anti-HPV 18, še vedno
Silgard, suspension for injection - pre-filled syringe with 2 needles, pack of 1, 10, 20
Silgard suspenzija za injiciranje - napolnjena injekcijska brizga z 2 iglama, pakiranje po 1, 10,
Keep the pre-filled syringe in the outer carton in order to protect from light.
Napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred
• Two needles of different lengths are provided in the pack, choose the appropriate needle to ensure an intramuscular (IM) administration depending on your patient's size and weight.
Glede na bolnikovo velikost in telesno maso izberite ustrezno iglo za intramuskularno (i.m.)
In the PPE population, no cases of HPV diseases (HPV types 6/11/16/18 related CIN any grade and Genital Warts) were observed through 10.7 years (median
V PPE populaciji v obdobju 10,7 leta (mediani čas spremljanja 10,0 leta) niso odkrili primerov bolezni zaradi HPV (s HPV tipi 6/11/16/18 povezana CIN katere koli stopnje in bradavice na spolovilih).
PHARMACEUTICAL PARTICULARS
Imetnik dovoljenja za promet z zdravilom
This population approximates to the general population of women with respect to prevalence of HPV infection or disease at enrolment.
Glede na prevalenco okužb s HPV in bolezni ob vključitvi ta populacija približno ustreza splošni populaciji žensk.
The efficacy of Silgard against HPV 6-, 11-, 16-, 18-related external genital warts was 68.1% (95% CI: 48.8, 79.3).
Učinkovitost cepiva Silgard proti kombinirani pojavnosti s HPV 6, HPV 11, HPV 16 ali HPV 18 povezane persistentne okužbe, bradavic na spolovilih, sprememb na vulvi in nožnici, CIN katere koli stopnje, AIS in raka na materničnem vratu je bila 88,7 % (95-odstotni IZ: 78,1; 94,8).
Silgard induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Pri brejih podganah je cepivo Silgard po enkratnem ali večkratnem intramuskularnem injiciranju sprožilo odziv v obliki pojava specifičnih protiteles proti tipom 6, 11, 16 in 18 HPV.
At the injection site: hematoma, pruritus Not known Asthenia*, chills*, fatigue*, malaise*
Neznana celulitis na mestu injiciranja* Neznana idiopatska trombocitopenična purpura*,
• Inspect the suspension visually for particulate matter and discolouration prior to administration.
• Pred uporabo cepivo preglejte glede delcev in spremembe barve.
Efficacy in women naïve to the relevant vaccine HPV type(s)
Učinkovitost pri ženskah, ki še niso bile v stiku z relavantnim tipom (relavantnimi tipi) HPV, ki jih vsebuje cepivo
This gives the medicine a long duration of action.
To omogoča dolgotrajno delovanje zdravila.
The name of the medicine was changed to Trevicta on 26 May 2016.
Ime zdravila je bilo 26. maja 2016 spremenjeno v Trevicto.
1 Previously known as Paliperidone Janssen.
1 Predhodno znano kot Paliperidone Janssen.
What measures are being taken to ensure the safe and effective use of Trevicta?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Trevicta?
Trevicta is available as a prolonged-release suspension for injection in pre-filled syringes (175 mg, 263 mg, 350 mg and 525 mg).
Zdravilo Trevicta je na voljo v obliki suspenzije za injiciranje s podaljšanim sproščanjem v predhodno napolnjenih injekcijskih brizgah (175 mg, 263 mg, 350 mg in 525 mg).
The full EPAR and risk management plan summary for Trevicta 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) in povzetek načrta obvladovanja tveganj za zdravilo Trevicta sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The Committee therefore decided that Trevicta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zato zaključil, da so koristi zdravila Trevicta večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
This is a summary of the European public assessment report (EPAR) for Trevicta.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Trevicta.
Other information about Trevicta
Druge informacije o zdravilu Trevicta
In the brain, paliperidone attaches to several different receptors on the surface of nerve cells.
V možganih se paliperidon veže na več različnih receptorjev na površini živčnih celic.
The European Commission granted a marketing authorisation valid throughout the European Union for Paliperidone Janssen on 5 December 2014.
Evropska komisija je dovoljenje za promet z zdravilom Paliperidone Janssen, veljavno po vsej Evropski uniji, izdala 5. decembra 2014.
A risk management plan has been developed to ensure that Trevicta is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Trevicta je bil pripravljen načrt obvladovanja tveganj.
By blocking these receptors, paliperidone helps to normalise the activity of the brain and reduce symptoms of the disease.
Z zaviranjem teh receptorjev paliperidon pripomore k normalizaciji dejavnosti možganov in olajša simptome bolezni.
It is given every 3 months by slow injection into the upper part of the shoulder (deltoid muscle) or the buttocks.
Daje se vsake tri mesece s počasnim injiciranjem v zgornji del ramena (deltoidno mišico) ali zadnjico.
It is not intended to provide practical advice on how to use Trevicta.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Paliperidone acts mainly by blocking the receptors for the neurotransmitters dopamine and 5hydroxytryptamine (also called serotonin).
Paliperidon deluje predvsem tako, da zavira receptorje za živčna prenašalca dopamin in 5-hidroksitriptamin (imenovan tudi serotonin).
This authorisation was based on the authorisation granted to Xeplion in 2011 (‘informed consent').
Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Xeplion, ki je bilo izdano leta 2011 („uporaba dokumentacije s soglasjem“).
In the second study (in 305 patients) Trevicta was more effective than placebo (a dummy treatment), with 9% of patients given the medicine suffering a relapse of their condition compared with 29% of those on placebo.
V drugi študiji (pri 305 bolnikih) je bilo zdravilo Trevicta učinkovitejše kot placebo (zdravilo brez zdravilne učinkovine), pri čemer je relaps doživelo 9 % bolnikov, ki so prejemali zdravilo, v primerjavi z 29 % bolnikov, ki so prejemali placebo.
What benefits of Trevicta have been shown in studies?
Kakšne koristi je zdravilo Trevicta izkazalo v študijah?
Two studies have been conducted with Trevicta given every 3 months.
Z zdravilom Trevicta sta bili izvedeni dve študiji, pri katerih so zdravilo Trevicta dajali vsake tri mesece.
The most common side effects with Trevicta (seen in at least 5 in 100 patients) are insomnia (difficulty sleeping), headache, anxiety, upper respiratory tract infections (such as colds), reactions at the site of injection and increased weight.
Najpogostejši neželeni učinki zdravila Trevicta (opaženi pri vsaj 5 od 100 bolnikov) so nespečnost (težave s spanjem), glavobol, anksioznost, okužba zgornjih dihal (kot so prehladi), reakcija na mestu injiciranja in povečana telesna masa.
The symptoms of schizophrenia include disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Simptomi shizofrenije vključujejo neorganizirano razmišljanje in nepovezan govor, halucinacije (bolnik ima privide in prisluhe), sumničavost ter blodnje (zmotna prepričanja).
What is Trevicta and what is it used for?
Kaj je zdravilo Trevicta in za kaj se uporablja?
What are the risks associated with Trevicta?
Kakšna tveganja so povezana z zdravilom Trevicta?
Why is Trevicta approved?
Zakaj je bilo zdravilo Trevicta odobreno?
The Agency's Committee for Medicinal Products for Human Use (CHMP) noted that paliperidone injections are effective in treating schizophrenia symptoms.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je menil, da so injekcije paliperidona učinkovite pri zdravljenju simptomov shizofrenije.
For more information on the use of Trevicta, see the summary of product characteristics (also part of the EPAR).
Za več informacij o uporabi zdravila Trevicta glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
The 3-monthly injection is expected to be more convenient to patients and improve their adherence to treatment, and no new safety concerns were raised with this formulation compared with the known safety profile of paliperidone.
Injiciranje vsake tri mesece naj bi bilo za bolnike priročnejše in naj bi izboljšalo njihovo sodelovanje pri zdravljenju, poleg tega pa se pri tej formulaciji v primerjavi z znanim varnostnim profilom paliperidona niso pojavili nobeni novi varnostni pomisleki.
Because paliperidone for use by monthly injections has already been authorised in the EU as Xeplion, the company also used data from Xeplion to support the use of Trevicta.
Ker je paliperidon za uporabo v obliki mesečnih injekcij v EU že odobren pod imenom Xeplion, je družba v podporo uporabi zdravila Trevicta uporabila nekatere podatke o zdravilu Xeplion.
This disrupts signals transmitted between brain cells by ‘neurotransmitters', substances that nerve cells use to communicate with neighbouring cells.
S tem se prekine prenos signalov med možganskimi celicami prek živčnih prenašalcev, tj. snovi, ki omogočajo komunikacijo med bližnjimi celicami.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Trevicta, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Trevicta in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Paliperidone is an active breakdown product (metabolite) of risperidone, another antipsychotic medicine that has been used in the treatment of schizophrenia since the 1990s.
Paliperidon je aktivni presnovek (metabolit) risperidona, drugega antipsihotičnega zdravila, ki se za zdravljenje shizofrenije uporablja od devetdesetih let prejšnjega stoletja.
The active substance in this medicine, paliperidone, is an antipsychotic medicine.
Zdravilna učinkovina v tem zdravilu, paliperidon, je antipsihotično zdravilo.
Trevicta is given by a healthcare professional.
Zdravilo Trevicta sme dajati samo zdravstveni delavec.
It has also been authorised as Xeplion since 2011 for use by monthly injections for the maintenance treatment of schizophrenia.
Od leta 2011 je pod imenom Xeplion odobren tudi za uporabo v obliki mesečnih injekcij za vzdrževalno zdravljenje shizofrenije.
For practical information about using Trevicta, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Trevicta naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The dose of Trevicta is 3.5 times the dose of the monthly injections of paliperidone the patient was previously receiving.
Odmerek zdravila Trevicta je 3,5kratnik odmerka mesečnih injekcij paliperidona, ki jih je bolnik prejemal.
Trevicta must not be given to people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.
Zdravila Trevicta ne smejo jemati bolniki, ki so preobčutljivi za (alergični na) paliperidon, katero koli drugo sestavino zdravila ali risperidon.
For the full list of all side effects reported with Trevicta, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Trevicta, glejte navodilo za uporabo.
Prolonged-release means that the active substance, paliperidone, is released slowly over a few months after being injected.
Podaljšano sproščanje pomeni, da se zdravilna učinkovina, paliperidon, po injiciranju počasi sprošča več mesecev.
Trevicta is an antipsychotic medicine used for the maintenance treatment of schizophrenia in adults whose disease has been stable on treatment with once-monthly injections of paliperidone.
Zdravilo Trevicta je antipsihotično zdravilo, ki se uporablja za vzdrževalno zdravljenje shizofrenije pri odraslih, pri katerih je bolezen ob zdravljenju z injekcijami paliperidona enkrat mesečno stabilna.
Paliperidone has been authorised in the European Union (EU) as Invega since 2007 for use by mouth to treat schizophrenia.
Paliperidon je v Evropski uniji (EU) odobren za peroralno zdravljenje shizofrenije od leta 2007 pod imenom Invega.
For more information about treatment with Trevicta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Trevicta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
In Trevicta as in Xeplion, paliperidone has been attached to a fatty acid that allows it to be released slowly after being injected.
V zdravilu Trevicta je paliperidon tako kot v zdravilu Xeplion vezan na maščobno kislino, ki omogoča njegovo počasno sproščanje po vbrizganju.
Trevicta, which is given by injection every 3 months, is more effective than placebo and as effective as paliperidone monthly injection in preventing relapses of schizophrenia.
Zdravilo Trevicta, ki se daje z injiciranjem vsake tri mesece, je pri preprečevanju relapsov shizofrenije učinkovitejše od placeba in enako učinkovito kot mesečno injiciranje paliperidona.
Trevicta contains the active substance paliperidone.
Zdravilo Trevicta vsebuje zdravilno učinkovino paliperidon.
How is Trevicta used?
Kako se zdravilo Trevicta uporablja?
In one of them (involving 1,016 patients) Trevicta was as effective as paliperidone monthly injections in preventing relapses of schizophrenia.
V prvi študiji (pri 1 016 bolnikih) je bilo zdravilo Trevicta pri preprečevanju relapsov shizofrenije enako učinkovito kot mesečne injekcije paliperidona.
How does Trevicta work?
Kako zdravilo Trevicta deluje?
Results will be provided on a yearly basis.
Rezultati bodo letno predloženi.
Probability of survival (%)
Verjetnost preživetja (%)
In the overall population, 72.7 % of the patients were male.
Pri splošni populaciji je bilo kar 72,7 % bolnikov moških.
Safety data for Black and African American patients are limited.
Podatki o varnosti za črnce in Afroameričane so omejeni.
(see section 4.4)
(glejte poglavje 4.8).
Date of latest renewal: 26 August 2019
Datum zadnjega podaljšanja: 26. avgust 2019
If you do not take this medicine as prescribed by your doctor, this cancer treatment may not work properly.
Če tega zdravila ne jemljete, kot vam ga je predpisal zdravnik, zdravljenje raka morda ne bo uspešno.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 November 2014
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 21. november 2014
If you are allergic to peanut or soya, do not use this medicine.
Če ste alergični na arašide ali sojo, tega zdravila ne uporabljajte.
Therefore close monitoring is recommended in patients weighing < 50 kg.
Zato je priporočljivo skrbno spremljanje bolnikov, ki tehtajo < 50 kg.
wrapped in plastic foil).
kapsul, zaviti v plastično folijo).
This medicine has not been studied in children or adolescents and is therefore not to be taken by children and adolescents below the age of 18 years.
Otroci in mladostniki Tega zdravila niso proučevali pri otrocih ali mladostnikih, zato ga mlajši od 18 let ne smejo jemati.
This medicine can interact with certain other medicines.
To zdravilo lahko medsebojno deluje z drugimi zdravili.
Based on this information your doctor may carry out some blood tests, for example to check your liver function and to determine how fast your blood can clot.
Na podlagi teh podatkov lahko zdravnik opravi nekatere krvne preiskave, na primer preveri delovanje vaših jeter, in ugotovi, kako hitro se strjuje vaša kri.
The age range covered by the analysis was 29 to 85 years; approximately 5 % of the population were older than 75 years.
Obravnavani razpon starosti v analizi je bil 29 do 85 let; približno 5 % populacije je bilo starejše od 75 let.
Do not take more than this dose.
Ne jemljite večjega odmerka od tega.
* CTCAE: Common Terminology Criteria for Adverse Events
* CTCAE - enotna terminološka merila za poimenovanje neželenih dogodkov (Common Terminology Criteria for Adverse Events)
Your doctor will decide when to resume your treatment with this medicine - if you have cancer that has spread to the brain
Vaš zdravnik se bo odločil, kdaj boste lahko zdravljenje s tem zdravilom nadaljevali; - če imate raka, ki se je razširil v možgane;
• Periodic safety update reports
• Redno posodobljena poročila o varnosti zdravila
In the majority of patients, elevations of liver parameters were reversible.
Pri večini bolnikov so bila povečanja jetrnih parametrov reverzibilna.
Data from black individuals was very limited but in the same range as for Caucasians.
Podatki za črnce so zelo omejeni, vendar v enakem razponu kot za belce.
The overall recovery was considered complete (above 90 %) within 4 days after dosing.
Skupno izločanje je veljalo za končano (nad 90 %) v 4 dneh po odmerjanju.
HR: hazard ratio; CI: confidence interval
RO: razmerje ogroženosti; IZ: interval zaupanja
Do not take this medicine during pregnancy, as it can harm your unborn baby and cause birth defects.
Med nosečnostjo ne jemljite tega zdravila, ker lahko škodi vašemu nerojenemu otroku in povzroči prirojene okvare.