FrancophonIA/ELRC3.0 huggingface dataset:
English: All patients, especially children, should be up-to-date with all their vaccinations before they start treatment with RoActemra.
Slovenian: Vsi bolniki, še posebno otroci, morajo pred začetkom zdravljenja z zdravilom
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE CARTON (WITH BLUE BOX) - Multipack
Slovenian: ŠKATLA NAPOLNJENE INJEKCIJSKEGA PERESNIKA (S PODATKI MODREGA OKENCA) - skupno pakiranje
English: JIA ACR30 Response
Slovenian: JIA ACR 30 nenadno poslabšanje
English: Immune system disorders
Slovenian: Bolezni imunskega sistema anafilaksija
English: • If the patient weighs less than 30 kg: the dose is 162 mg (the content of 1 pre-filled syringe) once every 2 weeks
Slovenian: • Če bolnik tehta manj kot 30 kg: odmerek je 162 mg (vsebina ene napolnjene injekcijske brizge) enkrat na 2 tedna.
English: During the withdrawal phase (Part II), the percentage of patients achieving JIA ACR 30, 50, and 70 responses at Week 40 relative to baseline are shown in Table 8.
Slovenian: del) po 40 tednih dosegli odzive JIA ACR 30, 50 in 70 glede na izhodiščno vrednost.
English: If a patient misses a subcutaneous weekly injection of RoActemra within 7 days of the scheduled dose, he/she should be instructed to take the missed dose on the next scheduled day.
Slovenian: Če je od izpuščenega tedenskega odmerka subkutane injekcije zdravila RoActemra pri bolniku s sJIA minilo manj kot 7 dni, je treba bolniku naročiti, da izpuščeni odmerek vzame na dan naslednjega načrtovanega odmerka.
English: The proportion of patients with serious adverse events was balanced between the treatment groups (RoActemra 11.7% vs. adalimumab 9.9%).
Slovenian: (zdravilo RoActemra 11,7 % v primerjavi z adalimumabom 9,9 %).
English: Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in pJIA patients in the tables below.
Slovenian: V primeru nenormalnih laboratorijskih vrednosti je pri bolnikih s pJIA priporočljivo uporabo tocilizumaba prekiniti, kot je opisano v spodnjih preglednicah.
English: The pharmacokinetics of RoActemra were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with a one-hour infusion of 4 or 8 mg/kg RoActemra every 4 weeks for 24 weeks or with 162 mg RoActemra given subcutaneously either once a week or every other week for 24 weeks.
Slovenian: 3552 bolnikov z revmatoidnim artritisom, ki so 24 tednov na 4 tedne dobivali enourno infuzijo 4 ali 8 mg/kg zdravila RoActemra, ali 24 tednov 162 mg zdravila RoActemra subkutano bodisi enkrat tedensko ali vsak drugi teden.
English: Malignancies
Slovenian: Nevtrofilci
English: Hrvatska
Slovenian: urtikarija
English: During routine laboratory monitoring in the intravenous RoActemra study WA19977 3.4% and 10.4% of patients experienced a post-baseline elevation of their LDL-cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200 mg/dL at any time during the study treatment, respectively.
Slovenian: Vrednosti lipidov V študiji s subkutano obliko je imelo v katerem koli času med študijskim zdravljenjem (ne v izhodišču) 14,3 % bolnikov zvišano vrednost holesterola LDL na ≥ 130 mg/dl in 12,8 % bolnikov zvišano vrednost celokupnega holesterola na ≥ 200 mg/dl.
English: sJIA Patients
Slovenian: Pri štirih bolnikih
English: Doses of 4 or 8 mg/kg RoActemra or placebo were given every four weeks in combination with stable MTX (10 mg to 25 mg weekly).
Slovenian: Odmerke 4 ali 8 mg/kg zdravila RoActemra ali placebo so dobivali na štiri tedne v kombinaciji s stabilnim odmerkom metotreksata (od 10 do 25 mg na teden).
English: Before you use RoActemra, your doctor may do a blood test to measure your liver function.
Slovenian: Zdravnik lahko opravi preiskave krvi, da preveri jetrno delovanje, preden boste dobili zdravilo RoActemra.
English: For the 162 mg every week dose, the predicted mean (±SD) steady-state AUC1week, Cmin and Cmax of RoActemra were
Slovenian: Za odmerek 162 mg vsak drugi teden je bila pričakovana povprečna (± SD) površina pod krivuljo
English: Pack sizes of 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes.
Slovenian: Na voljo je pakiranje s 4 napolnjenimi injekcijskimi brizgami in skupno pakiranje, ki vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih brizg.
English: In the RoActemra subcutaneous weekly group, one patient (1.1%, 1/95) developed positive neutralizing anti-RoActemra antibodies, though not of the IgE isotype.
Slovenian: 1/95) pojavila pozitivna nevtralizirajoča protitelesa proti zdravilu RoActemra, ki pa niso bila izotipa IgE.
English: Of the 46 patients (1.6%) who developed anti-RoActemra antibodies, 6 had an associated medically significant hypersensitivity reaction, of which 5 led to permanent discontinuation of treatment.
Slovenian: jih je 6 imelo spremljajočo klinično pomembno preobčutljivostno reakcijo, ki je v 5 primerih vodila v ukinitev zdravljenja.
English: During routine laboratory monitoring in the RoActemra 6 month controlled clinical trial SC-I, 19% of patients experienced sustained elevations in total cholesterol > 6.2 mmol/L (240 mg/dl), with 9% experiencing a sustained increase in LDL to ≥ 4.1 mmol/L(160 mg/dL) on the subcutaneous weekly dose.
Slovenian: Vrednosti lipidov V okviru rutinskega laboratorijskega spremljanja v šestmesečnem kontroliranem kliničnem preskušanju zdravila RoActemra SC-I se je pri 19 % bolnikov, ki so prejemali subkutani tedenski odmerek, pojavilo dolgotrajno zvišanje celotnega holesterola na > 6,2 mmol/l (240 mg/dl), pri 9 %
English: Exploratory efficacy results showed that RoActemra SC improved all exploratory efficacy parameters including Juvenile Arthritis Disease Activity Score (JADAS)-71, for TCZ naïve patients and maintained all exploratory efficacy parameters for patients who switched from RoActemra IV to RoActemra SC treatment over the entire course of the study for patients in both body weight groups
Slovenian: Eksploratorni rezultati učinkovitosti so pokazali, da je zdravilo RoActemra v subkutani obliki izboljšalo vse eksploratorne parametre učinkovitosti, vključno z indeksom za juvenilni artritis
English: The pharmacokinetics of tocilizumab in pJIA patients was characterized by a population pharmacokinetic analysis which included 237 patients who were treated with 8 mg/kg IV every 4
Slovenian: Farmakokinetiko tocilizumaba so proučili s populacijsko farmakokinetično analizo podatkov 3552
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of decreases in platelet counts remained consistent with what was seen in the 6-month controlled clinical trials.
Slovenian: V obdobju dvojno slepe kontrole ter pri dolgoročni izpostavljenosti sta vzorec in incidenca zmanjšanja števila trombocitov ostala skladna s tem, kar so opazili v šestmesečnih kontroliranih kliničnih preskušanjih.
English: Similarly the proportion of patients achieving a DAS 28 remission (DAS28 < 2.6) was significantly higher (31% vs. 16% respectively) in patients receiving RoActemra 8 mg/kg plus DMARD than in patients receiving RoActemra 4 mg/kg plus DMARD (p< 0.0001).
Slovenian: (DAS28 < 2,6) značilno večji delež bolnikov, ki so dobivali 8 mg/kg zdravila RoActemra skupaj z imunomodulirajočimi antirevmatičnimi zdravili, kot bolnikov, ki so dobivali 4 mg/kg zdravila RoActemra skupaj z imunomodulirajočimi antirevmatičnimi zdravili (31 % v prim.
English: Figure E
Slovenian: Slika E
English: Significant reduction in DAS28 from baseline (mean improvement) of 3.1-3.4 were observed in tocilizumab-treated patients compared to control patients (1.3-2.1).
Slovenian: Pri bolnikih, zdravljenih s tocilizumabom, so ugotovili značilno znižanje (povprečno izboljšanje) DAS28 za 3,1 do 3,4 od izhodišča v primerjavi s kontrolnimi bolniki
English: Tell your doctor immediately if you feel unwell.
Slovenian: Če se ne počutite dobro, morate to nemudoma povedati zdravniku.
English: Reduction of tocilizumab dose due to laboratory abnormalities has not been studied in sJIA patients.
Slovenian: Zmanjšanja odmerka tocilizumaba zaradi nenormalnih laboratorijskih vrednosti pri bolnikih s sJIA
English: Elevations of ALT/AST > 5 x ULN were observed in 0.7% of tocilizumab monotherapy patients and 1.4% of tocilizumab plus DMARD patients, the majority of whom were discontinued permanently from tocilizumab treatment.
Slovenian: bolnikov, ki so dobivali tocilizumab v monoterapiji, in pri 1,4 % bolnikov, ki so tocilizumab dobivali v kombinaciji z imunomodulirajočimi antirevmatičnimi zdravili; pri večini teh so zdravljenje s tocilizumabom ukinili.
English: Keep the pre-filled syringes in the outer carton in order to protect from light and moisture.
Slovenian: Napolnjene injekcijske peresnike shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo in vlago.
English: • Patient Information Pack
Slovenian: • izobraževalno gradivo za bolnike.
English: Skin and subcutaneous tissue disorders
Slovenian: prsnega koša in mediastinalnega prostora kašelj, dispneja
English: Because RoActemra is given in one pre-filled syringe, it is unlikely that you will receive too much.
Slovenian: Če ste uporabili večji odmerek zdravila RoActemra, kot bi smeli Ker je zdravilo RoActemra pripravljeno v eni napolnjeni injekcijski brizgi, ni verjetno, da bi uporabili prevelik odmerek.
English: Leukopenia, Neutropenia, Hypofibrinogenae mia
Slovenian: Bolezni živčevja glavobol, omotica
English: Doses of 4 or 8 mg/kg RoActemra or placebo were given every four weeks, in combination with stable MTX (10 mg to 25 mg weekly).
Slovenian: 8 mg/kg zdravila RoActemra ali placebo so dobivali na štiri tedne v kombinaciji s stabilnim odmerkom metotreksata (od 10 do 25 mg na teden).
English: • Do not try to take apart the pre-filled pen at any time.
Slovenian: • Ne poskušajte odpreti ali razstaviti napolnjene injekcijske brizge.
English: cholesterol value to ≥ 130 mg/dL and total cholesterol value to ≥ 200 mg/dL at any time during study treatment, respectively.
Slovenian: ≥ 130 mg/dl in 35,4 % bolnikov zvišano vrednost celokupnega holesterola na ≥ 200 mg/dl.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 162 mg tocilizumab
Slovenian: 1 napolnjena injekcijska brizga vsebuje 162 mg tocilizumaba.
English: Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to slightly yellowish, or any part of the pre-filled syringe appears to be damaged.
Slovenian: Ne uporabite zdravila, če je raztopina motna ali vsebuje lebdeče delce, če je barva zdravila drugačna od brezbarvne do rahlo rumenkaste in če ste opazili, da je kateri koli del napolnjene injekcijske brizge poškodovan.
English: • If a dose is missed within 7 days, inject a dose as soon as you remember and give the next dose at the regular scheduled time.
Slovenian: • Če je od izpuščenega odmerka minilo manj kot 7 dni, odmerek injicirajte takoj, ko se spomnite,
English: For MCS, the mean change from baseline to week 52 for both RoActemra weekly and every other weekly dose groups [7.28, 6.12, respectively] were higher than the placebo plus 52 weeks prednisone taper group [2.84] (although the differences were not statistically significant [weekly p=0.0252 for weekly, p=0.1468 for every other weekly]) and similar to the placebo plus 26 weeks prednisone taper group [6.67].
Slovenian: MCS od izhodišča do 52. tedna je bila tako z zdravilom RoActemra vsak teden [7,28] kot vsaka dva tedna [6,12] večja kakor s placebom v kombinaciji z 52-tedenskim zmanjševanjem prednizona [2,84]
English: Treatment should be initiated by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or CRS.
Slovenian: Zdravljenje mora vpeljati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem revmatoidnega artritisa, sJIA, poliartikularnega juvenilnega idiopatskega poliartritisa (pJIA) ali sindromom sproščanja citokinov.
English: During the double-blind controlled period and with long-term exposure, the pattern and incidence of elevations in lipid parameters remained consistent with what was seen in the 6-month controlled trials.
Slovenian: V obdobju dvojno slepe kontrole ter pri dolgoročni izpostavljenosti sta vzorec in incidenca zvišanja vrednosti lipidov ostala skladna s tem, kar so opazili v šestmesečnih kontroliranih kliničnih preskušanjih.
English: Keep the pre-filled syringe in the outer carton in order to protect from light and moisture.
Slovenian: Napolnjene injekcijske brizge shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo in vlago.
English: Mild renal impairment
Slovenian: Bolezni sečil nefrolitiaza
English: Predicted mean ± SD PK parameters at steady-state after IV dosing in sJIA RoActemra PK Parameter
Slovenian: Predvideno povprečje ± std. odklon farmakokinetičnih parametrov v stanju dinamičnega ravnovesja po intravenskem odmerjanju pri bolnikih s Sjia
English: Doses of 8 mg/kg of RoActemra were given every four weeks as monotherapy.
Slovenian: RoActemra so uporabljali kot monoterapijo v odmerku 8 mg/kg na štiri tedne.
English: Eligible patients received RoActemra dosed according to body weight (BW), with patients weighing
Slovenian: Bolniki, primerni za vključitev v študijo, so prejemali zdravilo RoActemra glede na telesno maso;
English: • Do not fan or blow on the clean area.
Slovenian: • Očiščene površine ne sušite s fenom in nanjo ne pihajte.
English: Endocrine disorders
Slovenian: Bolezni endokrinega sistema hipotiroidizem
English: The risk of malignancy is increased in patients with RA.
Slovenian: Bolniki z revmatoidnim artritisom imajo večje tveganje za malignome.
English: • Caution should be exercised when considering initiation of tocilizumab treatment in patients with elevated transaminases ALT or AST above 1.5x ULN.
Slovenian: • Pri odločitvi o uvedbi zdravljenja pri bolnikih, ki imajo vrednost ALT ali AST več kot 1,5-krat višjo od zgornje meje normalne vrednosti (ZMN), je potrebna previdnost.
English: The pharmacokinetics of tocilizumab were determined using a population pharmacokinetic analysis on a database composed of 3552 RA patients treated with a one-hour infusion of 4 or 8 mg/kg tocilizumab every 4 weeks for 24 weeks or with 162 mg tocilizumab given subcutaneously either once a week or every other week for 24 weeks.
Slovenian: bolnikov z revmatoidnim artritisom, ki so 24 tednov na 4 tedne dobivali enourno infuzijo 4 ali 8 mg/kg tocilizumaba, ali 24 tednov 162 mg tocilizumaba subkutano bodisi enkrat tedensko ali vsak drugi teden.
English: In general, side effects in sJIA patients were of a similar type to those in adults with RA.
Slovenian: Otroci s sJIA V splošnem so neželeni učinki, opaženi pri bolnikih s sJIA, podobni tistim pri bolnikih z revmatoidnim artritisom.
English: What RoActemra looks like and contents of the pack RoActemra is a concentrate for solution for infusion.
Slovenian: Zdravilo RoActemra je koncentrat za raztopino za infundiranje.
English: Interrupt RoActemra dosing.
Slovenian: RoActemra za bolnikov odmerek.
English: MTX naïve, Early RA Study VII (WA19926), a 2 year study with the planned primary analysis at week 52 evaluated 1162
Slovenian: Študija VII (WA19926) je bila dveletna študija z načrtovano primarno analizo v 52. tednu; ocenila je 1162 odraslih bolnikov z zmernim do hudim, aktivnim, zgodnjim revmatoidnim artritisom (povprečno trajanje bolezni ≤ 6 mesecev), ki se še niso zdravili z metotreksatom.
English: In paediatric patients with pJIA, the central volume of distribution was 1.97 L, the peripheral volume of distribution was 2.03 L, resulting in a volume of distribution at steady state of 4.0 L.
Slovenian: Pri pediatričnih bolnikih je bil centralni volumen porazdelitve 1,97 l in periferni volumen porazdelitve
English: NAME OF THE MEDICINAL PRODUCT RoActemra 20 mg/mL concentrate for solution for infusion.
Slovenian: RoActemra 20 mg/ml koncentrat za raztopino za infundiranje
English: Predicted mean ± SD PK parameters at steady-state after subcutaneous dosing in GCA Subcutaneous
Slovenian: Predvideno povprečje ± std. odklon farmakokinetičnih parametrov v stanju dinamičnega ravnovesja po subkutanem odmerjanju pri bolnikih s sJIA
English: At week 24, a significant reduction in DAS28 from baseline (mean improvement) of 3.5 was observed on both treatment arms, and a comparable proportion of patients had achieved DAS28 clinical remission (DAS28 < 2.6) on the subcutaneous (38.4%) and IV (36.9%) arms.
Slovenian: Tudi delež bolnikov, ki so dosegli klinično remisijo glede na DAS28 (DAS28 < 2,6) v subkutani (38,4 %) in intravenski skupini (36,9 %), je bil primerljiv.
English: (See Fig.
Slovenian: in pJIA.
English: Platelet count decreased sJIA
Slovenian: zmanjšanje števila trombocitov sJIA
English: You are not to be given RoActemra
Slovenian: Kako boste prejeli zdravilo RoActemra
English: • Hold the syringe comfortably in your hand.
Slovenian: • Sproščeno držite napolnjeno injekcijsko brizgo.
English: Paediatric population sJIA Patients
Slovenian: Uporaba pri pediatrični populaciji
English: Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in sJIA patients in the tables below.
Slovenian: V primeru nenormalnih laboratorijskih vrednosti je pri bolnikih s sJIA priporočljivo uporabo tocilizumaba prekiniti, kot je opisano v spodnjih preglednicah.
English: Cmean (µg/mL)
Slovenian: Csrednja (µg/ml)
English: Upper respiratory tract infections
Slovenian: Preiskave zvišanje jetrnih transaminaz,
English: In Study IV, RoActemra was administered intravenously every 4 weeks in combination with other DMARDs vs. placebo and other DMARDs.
Slovenian: RoActemra dajali intravensko na 4 tedne v kombinaciji z drugimi imunomodulirajočimi antirevmatičnimi zdravili; primerjava je bila kombinacija placeba in imunomodulirajočih antirevmatičnih zdravil.
English: These may affect up to 1 in every 1,000 users
Slovenian: Ti se lahko pojavijo pri največ 1 od 1000 bolnikov.
English: Roche Registration GmbH Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
Slovenian: Roche Registration GmbH Emil-Barell-Strasse 1
English: 162 mg QW ≥ 30 kg
Slovenian: ≥ 30 kg
English: An elevation in AST > 3 ULN occurred in 1% of patients in the RoActemra subcutaneous weekly group, compared to no patients in either of the placebo plus prednisone taper groups.
Slovenian: bolnikov, ki so prejemali zdravilo RoActemra subkutano vsak teden, in pri nobenem bolniku v skupinah s placebom in postopnim zmanjševanjem prednizona.
English: PHARMACEUTICAL FORM Solution for injection in pre-filled pen (ACTPen).
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku (ACTPen) Bistra do rahlo rumenkasta raztopina.
English: Do not use if the medicine is cloudy or contains particles, is any colour besides colourless to yellowish, or any part of the pre-filled pen appears to be damaged.
Slovenian: Ne uporabite zdravila, če je raztopina motna ali vsebuje lebdeče delce, če je barva zdravila drugačna od brezbarvne do rahlo rumenkaste in če ste opazili, da je kateri koli del napolnjenega injekcijskega peresnika poškodovan.
English: Withdraw a volume of sterile, non-pyrogenic sodium chloride 9 mg/mL (0.9%) solution for injection from a 50 mL infusion bag, equal to the volume of RoActemra concentrate required for the patients dose, under aseptic conditions.
Slovenian: (9 mg/ml) raztopine natrijevega klorida za injiciranje, kot je potrebni volumen koncentrata zdravila
English: Rotate Injection Site
Slovenian: Menjava mest injiciranja
English: Date of first authorisation: 15 May 2009 Date of latest renewal: 21 March 2014
Slovenian: Datum prve odobritve:15. maj 2009 Datum zadnjega podaljšanja: 21. marec 2014
English: You should do a pregnancy test right away.
Slovenian: Takoj morate opraviti test nosečnosti.
English: The sooner you take emergency contraception, the better the chance of avoiding pregnancy.
Slovenian: Prej ko vzamete nujno kontracepcijo, boljša je možnost, da se boste izognili nosečnosti.
English: However, it is important that you see your doctor.
Slovenian: Vendar je pomembno, da obiščete svojega zdravnika.
English: All patient data collected will remain anonymous.
Slovenian: Vsi zbrani podatki o bolnicah bodo ostali anonimni.
English: The tablet can be taken with or without food.
Slovenian: Tableta se lahko zaužije s hrano ali brez nje.
English: The effect on newborn/infants has not been studied.
Slovenian: Učinka na novorojenčke/dojenčke niso preučevali.
English: A risk to the breastfed child cannot be excluded.
Slovenian: Tveganja za dojenega otroka ni mogoče izključiti.
English: *Symptom which could also be related to an undiagnosed pregnancy (or related complications)
Slovenian: * Simptom, ki bi lahko bil povezan tudi z nediagnosticirano nosečnostjo (ali povezanimi zapleti).
English: Emergency contraception is not effective in every case.
Slovenian: Nujna kontracepcija ni učinkovita v vseh primerih.
English: There are no antidotes and further treatment should be symptomatic.
Slovenian: Na voljo ni nobenega antidota, nadaljnje zdravljenje pa mora biti simptomatsko.
English: • Risk Management Plan (RMP)
Slovenian: Načrt za obvladovanje tveganj (RMP)
English: NS: non statistically significant †: compared to placebo
Slovenian: NS: ni statistično značilno †: v primerjavi s placebom
English: Of 100 women who take this medicine approximately 2 will become pregnant.
Slovenian: Od 100 žensk, ki vzamejo to zdravilo, zanosita približno dve.
English: There are many different types of contraception available, and you should be able to find the right method for you.
Slovenian: Na voljo je veliko različnih vrst kontracepcije in zagotovo vam bo uspelo najti pravo zase.
English: Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program.
Slovenian: Varnost ulipristalacetata je bila ocenjena na vzorcu 4.718 žensk v času razvojnega kliničnega programa.
English: The adverse reactions reported in the phase III program of 2,637 women are provided in the table below.
Slovenian: Neželeni učinki, o katerih so poročali v III. fazi programa na vzorcu 2.637 žensk, so podani v spodnji preglednici.
English: Biotransformation/elimination
Slovenian: Biotransformacija/izločanje
English: If your menstrual period is late, there is a possibility that you may be pregnant.
Slovenian: Če vam menstruacija zamuja, obstaja možnost, da ste noseči.
English: Meta- analysis
Slovenian: Meta-analiza
English: At these repeated doses, the safety for a human embryo is unknown.
Slovenian: Pri teh ponavljajočih se odmerkih varnost za človeški zarodek ni znana.
English: Only condoms can protect you from sexually transmitted infections.
Slovenian: Samo kondomi vas lahko zaščitijo pred spolno prenosljivimi okužbami.
English: Therefore it is important you use condoms until your next period.
Slovenian: Zato je pomembno, da do naslednje menstruacije uporabljate kondome.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih
English: Do not throw away any medicines via waste water.
Slovenian: Zdravila ne smete odvreči v odpadne vode.
English: - Ask your pharmacist if you need more information or advice.
Slovenian: - Posvetujte se s farmacevtom, če potrebujete dodatne informacije ali nasvet.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Adolescents:
Slovenian: Mladostnice: