FrancophonIA/ELRC3.0 huggingface dataset:
English: If you vomit more than 4 hours after taking EDURANT you do not need to take another tablet until your next regularly scheduled tablet.
Slovenian: Če bruhate več kot 4 ure po tem, ko ste vzeli zdravilo EDURANT, pred vašim običajnim naslednjim odmerkom, ni potrebno vzeti še ene tablete.
English: No dose adjustment is suggested but caution is advised in patients with moderate hepatic impairment.
Slovenian: Pri bolnikih z zmerno okvaro jeter prilagajanje odmerkov ni priporočeno, priporočljiva pa je previdnost.
English: Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4,786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
Slovenian: 62% od 4.786 rekombinantnih kliničnih izolatov HIV-1, ki so bili rezistentni na efavirenz in/ali nevirapin, je ohranilo občutljivost na rilpivirin (stopnja razlike občutljivosti (FC) ≤ biološki zgornji meji občutljivosti (BCO)).
English: Rilpivirine has tested negative in the absence and presence of a metabolic activation system in the in vitro Ames reverse mutation assay and the in vitro clastogenicity mouse lymphoma assay.
Slovenian: Rezultati rilpivirina pri in vitro Amesovem testu povratnih mutacij in pri in vitro testu mišjega limfoma (testu klastogenosti) so bili negativni tako v prisotnosti sistema aktivacije presnove kot brez njega.
English: By baseline viral load (copies/ml)
Slovenian: Glede na začetno virusno breme (št. kopij/ml)
English: There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
Slovenian: Novih izsledkov o varnosti v primerjavi z znanim varnostnim profilom rilpivirina pri odraslih, okuženih s HIV-1, ni bilo.
English: This observation was the same in the efavirenz arm.
Slovenian: Enako so opažali v skupini bolnikov, ki so prejemali efavirenz.
English: Baseline disease characteristics Median baseline plasma HIV-1 RNA (range), log10 copies/ml
Slovenian: Osnovni podatki o bolezni srednja izhodiščna vrednost plazemske koncentracije RNK HIV-1 (obseg), log10 kopij/ml srednja izhodiščna vrednost števila celic CD4+ (obseg), x 10
English: There were no new safety concerns identified in the Week 240 analysis of the TMC278-C213 trial in adolescents.
Slovenian: V analizi podatkov študije TMC278-C213 pri mladostnikih se po 240 tednih niso pojavila nobena nova vprašanja glede varnosti zdravila.
English: N=number of subjects per treatment group; ND=not determined.
Slovenian: N = število preiskovancev v posamezni zdravljeni skupini; ND = ni bilo določeno populacija z namenom zdravljenja (intent-to-treat, ITT) - čas do izgube virološkega odziva (time to loss of virologic response, TLOVR).
English: In rats, there were no drug-related neoplasms.
Slovenian: Pri podganah zdravilo ni povzročilo razvoja neoplazem.
English: Antacids should only be administered either at least 2 hours before or at least 4 hours after rilpivirine.
Slovenian: Antacide se sme odmerjati samo najmanj 2 uri pred odmerjanjem rilpivirina ali najmanj 4 ure po njem.
English: Your doctor may evaluate how severe your liver or kidney disease is before deciding if you can take EDURANT.
Slovenian: Zdravnik bo morda ovrednotil, kako hudo bolezen jeter ali ledvic imate, preden se bo odločil, ali lahko jemljete zdravilo EDURANT ali ne. - Takoj obvestite zdravnika, če opazite kakršnekoli simptome okužbe (na primer vročino, mrazenje, potenje).
English: Study TMC278-C204 was a randomised, active-controlled, Phase IIb trial in antiretroviral treatment-naïve HIV-1 infected adult patients consisting of 2 parts: an initial partially blinded dose-finding part [(rilpivirine) doses blinded] up to 96 weeks, followed by a long-term, open label part.
Slovenian: Študija TMC278-C204 je bila randomizirana, aktivno nadzorovana študija faze IIb, v katero so bili vključeni odrasli bolniki, okuženi s HIV-1 in predhodno niso prejemali protiretrovirusnih zdravil.
English: Make sure that you check the following points and tell your doctor if any of these apply to you.
Slovenian: Premislite, ali imate oziroma ste opazili katero od spodaj navedenih težav oziroma sprememb in o tem obvestite svojega zdravnika.
English: Rilpivirine should not be used in combination with systemic dexamethasone (except as a single dose) as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Slovenian: Rilpivirina se ne sme uporabljati v kombinaciji s sistemskim deksametazonom (razen če gre za en sam odmerek), saj bi pri lahko prišlo do izgube terapevtskega učinka rilpivirina (glejte poglavje 4.3).
English: Dosing recommendations for paediatric patients less than 12 years of age cannot be made due to insufficient data (see section 4.2).
Slovenian: Zaradi nezadostnih podatkov še ni mogoče dati priporočil za odmerjanje pri pediatričnih bolnikih, mlajših od 12 let.
English: Only adolescents deemed likely to have good adherence to antiretroviral therapy should be treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.
Slovenian: Nezadostno upoštevanje navodil lahko vodi v razvoj odpornosti in v izgubo nadaljnih možnosti zdravljenja.
English: Resistance to efavirenz % (n/N) * The number of patients with virologic failure and paired genotypes (baseline and failure) were 71, 11, and 4 for rilpivirine and 30, 10,
Slovenian: Število virološko neuspešnih bolnikov in enakim genotipom (ob začetku zdravljenja in ob ugotovitvi neuspešnosti), je bilo v skupini, ki je prejemala rilpivirin 71, 11 in 4 ter 30, 10 in 2 v skupini, ki je prejemala efavirenz za vsako shemo (tenofovir/emtricitabin, zidovudin/lamivudin, abakavir/lamivudin) posebej.
English: BOTTLE LABEL
Slovenian: NALEPKA NA VSEBNIKU
English: Tabulated summary of adverse reactions
Slovenian: Povzetek neželenih učinkov zdravila v preglednici
English: 6 cells/l Percentage of subjects with: hepatitis B/C virus co-infection Percentage of patients with the following background regimens: tenofovir disoproxil fumarate plus emtricitabine zidovudine plus lamivudine abacavir plus lamivudine
Slovenian: Odstotek bolnikov z naslednjimi osnovnimi shemami zdravljenja: tenofovir dizoproksil fumarat in emtricitabin zidovudin in lamivudin abakavir in lamivudin
English: EDURANT should be used with caution in patients with moderate hepatic impairment.
Slovenian: Pri bolnikih z zmerno okvaro jeter je treba zdravilo EDURANT uporabljati previdno.
English: No dose adjustment is needed for patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic prilagajanje odmerkov ni potrebno.
English: 6 cells/l in the efavirenz arm in the pooled analysis of the ECHO and THRIVE trials [estimated treatment difference (95% CI): 11.3 (-6.8; 29.4)].
Slovenian: Po rezultatih združene analize podatkov iz študij ECHO in THRIVE po 96 tednih [z ocenjeno spremembo zaradi zdravljenja (s 95% IZ): 11,3 (-6,8; 29,4)] je bila v skupini z rilpivirinom povprečna sprememba števila celic CD4+ od izhodišča +228 x 10
English: 6 cells/l)
Slovenian: celic/l)
English: Cardiovascular
Slovenian: Kardivaskularni učinki
English: The mean increase from baseline in CD4+ counts was 146 × 10
Slovenian: Pri bolnikih, ki so prejemali 25 mg rilpivirina, se je število celic CD4+ v povprečju zvečalo za 146 x 10
English: Tell your doctor about your situation
Slovenian: Zagotovo se pogovorite z zdravnikom
English: Treatment with rilpivirine resulted in an early small increase of mean serum creatinine levels which remained stable over time and is not considered clinically relevant (see section 4.8).
Slovenian: V začetku zdravljenja z rilpivirinom je prišlo do majhnega zvečanja povprečne koncentracije kreatinina v serumu, ki je v nadaljevanju zdravljenja ostala konstantna.
English: Patients with a baseline viral load > 100,000 HIV-1 RNA copies/ml who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class.
Slovenian: Stopnja z zdravljenjem povezane odpornosti na zaviralce ne-nukleozidne reverzne transkriptaze (NNRTI) je bila večja pri virološko neuspešnih bolnikih z začetnim virusnim bremenom > 100.000 kopij RNK HIV-1/ml.
English: Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than the rilpivirine arm.
Slovenian: Po 96 tednih je do prekinitve zdravljenja zaradi neželenih učinkov prišlo pri večjem številu bolnikov, zdravljenih z efavirenzom v primerjavi s skupino, zdravljeno z rilpivirinom.
English: Hepatobiliary disorders very common increased transaminases common increased bilirubin
Slovenian: Bolezni jeter, žolčnika in žolčevodov zelo pogosti zvečana koncentracija aminotransferaz pogosti zvečana koncentracija bilirubina
English: Tenofovir/emtricitabine
Slovenian: tenofovir/emtricitabi zidovudin/lamivudin 87,1%
English: Rilpivirine must not be used in combination with these anticonvulsants as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Slovenian: Rilpivirina se ne sme uporabljati v kombinaciji z navedenimi antikonvulzivi, saj bi lahko prišlo do izgube terapevtskega učinka rilpivirina (glejte poglavje 4.3).
English: No dose adjustment of rilpivirine is required in patients with mild or moderate renal impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro ledvic prilagajanje odmerka rilpivirina ni potrebno.
English: - low white blood cell and/or platelet count, decrease in haemoglobin in your blood, increase in triglycerides, lipase and/or bilirubin in your blood
Slovenian: - utrujenost - bruhanje - zaspanost - zmanjšan apetit - motnje spanja - neprijeten občutek v želodcu - depresivno razpoloženje - suha usta - zmanjšano število belih krvničk in/ali trombocitov, zmanjšana koncentracija hemoglobina v krvi, zvečana koncentracija trigliceridov, lipaze in/ali bilirubina v krvi
English: PROTON PUMP INHIBITORS Omeprazole*
Slovenian: ZAVIRALCI PROTONSKE ČRPALKE omeprazol*
English: Rilpivirine must not be used in combination with rifampicin as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Slovenian: Rilpivirina se ne sme uporabljati v kombinaciji z rifampicinom, saj lahko pride do izgube terapevtskega učinka rilpivirina (glejte poglavje 4.3).
English: Rilpivirine must not be used in combination with rifapentine as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Slovenian: Rilpivirina se ne sme uporabljati v kombinaciji z rifapentinom, saj lahko pride do izgube terapevtskega učinka rilpivirina (glejte poglavje 4.3).
English: 25-O-desacetyl-rifabutin AUC ↔ 25-O-desacetyl-rifabutin Cmin ↔ 25-O-desacetyl-rifabutin Cmax ↔
Slovenian: 300 mg enkrat na dan rifabutin AUC ↔ rifabutin Cmin ↔ rifabutin Cmax ↔ 25-O-deacetil-rifabutin AUC ↔ 25-O-deacetil-rifabutin Cmin ↔ 25-O-deacetil-rifabutin Cmax ↔ rilpivirin AUC ↓ 46% rilpivirin Cmin ↓ 49% rilpivirin Cmax ↓ 35%
English: Some patients may experience tiredness, dizziness or drowsiness during treatment with EDURANT.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med zdravljenjem z zdravilom EDURANT se pri nekaterih bolnikih lahko pojavi utrujenost, omotica ali zaspanost.
English: No dose adjustment of EDURANT is required in patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter prilagajanje odmerka zdravila EDURANT ni potrebno.
English: Therefore, EDURANT is not recommended in patients with severe hepatic impairment (see section 4.2).
Slovenian: Uporabe zdravila EDURANT pri bolnikih s hudo okvaro jeter (Child-Pugh stopnje C) niso preučevali, zato zdravila EDURANT ni priporočeno uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.2).
English: Antiretroviral treatment-naïve HIV-1 infected patients were enrolled who had a plasma HIV-1 RNA ≥ 5,000 copies/ml and were screened for susceptibility to N(t)RTIs and for absence of specific NNRTI resistance-associated mutations.
Slovenian: V obe študiji so vključevali bolnike, okužene s HIV-1, ki še niso prejemali protiretrovirusnih zdravil, poleg tega pa so imeli v plazmi ≥ 5.000 kopij RNK HIV-1/ml.
English: ORAL CONTRACEPTIVES Ethinylestradiol* 0.035 mg once daily Norethindrone* 1 mg once daily ethinylestradiol AUC ↔ ethinylestradiol Cmin ↔ ethinylestradiol Cmax ↑ 17% norethindrone AUC ↔ norethindrone Cmin ↔ norethindrone Cmax ↔ rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * based on historic controls
Slovenian: 1 mg enkrat na dan etinilestradiol AUC ↔ etinilestradiol Cmin ↔ etinilestradiol Cmax ↑ 17% noretindron AUC ↔ noretindron Cmin ↔ noretindron Cmax ↔ rilpivirin AUC ↔* rilpivirin Cmin ↔* rilpivirin Cmax ↔* * na podlagi podatkov kontrolnih oseb iz preteklih študij
English: Pharmacokinetic Results of Total Rilpivirine After Administration of Rilpivirine 25 mg Once Daily as Part of an Antiretroviral Regimen, During the 2
Slovenian: Rezultati farmakokinetike celokupnega rilpivirina po uporabi 25 mg rilpivirina enkrat na dan, kot del protiretrovirusnega zdravljenja med drugim in tretjim trimesečjem nosečnosti ter v obdobju po porodu farmakokinetika celokupnega rilpivirina (povprečna vrednost ± SD, tmax: mediana [razpon])
English: EDURANT should be used with caution in this population (see section 4.2).
Slovenian: Pri starejših bolnikih prilagajanje odmerkov zdravila EDURANT ni potrebno, vendar je pri uporabi zdravila EDURANT pri tej populaciji potrebna previdnost (glejte poglavje 4.2).
English: Rilpivirine must not be used in combination with proton pump inhibitors as co-administration is likely to result in loss of therapeutic effect of rilpivirine (see section 4.3).
Slovenian: Rilpivirina se ne sme uporabljati v kombinaciji z zaviralci protonske črpalke, saj lahko pride do izgube terapevtskega učinka rilpivirina (glejte poglavje 4.3).
English: Contact your doctor if uncertain about what to do if you miss a dose or vomit.
Slovenian: Če ste negotovi kako ukrepati, če izpustite odmerek ali če bruhate, se obrnite na svojega zdravnika.
English: Lactose monohydrate Croscarmellose sodium Povidone K30
Slovenian: Jedro tablete laktoza monohidrat premrežen natrijev karmelozat povidon K30 polisorbat 20 silicificirana mikrokristalna celuloza magnezijev stearat
English: Rilpivirine must not be used in combination with products containing St John's wort as co-administration may result in loss of therapeutic effect of rilpivirine (see section 4.3).
Slovenian: Rilpivirina se ne sme uporabljati v kombinaciji s pripravki, ki vsebujejo šentjanževko, saj lahko pride izgube terapevtskega učinka rilpivirina (glejte poglavje 4.3).
English: Outcome in the week 96 analysis
Slovenian: Izid po 96 tednih zdravljenja rilpivirin +
English: The bottle comes with a child resistant cap.
Slovenian: Vsebnik je zaprt z za otroke varno zaporko.
English: It can be used in patients of all ages.
Slovenian: Uporablja se lahko pri bolnikih vseh starosti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Idelvion's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Idelvion večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Idelvion?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Idelvion?
English: This is a summary of the European public assessment report (EPAR) for Idelvion.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Idelvion.
English: Idelvion albutrepenonacog alfa
Slovenian: Idelvion albutrepenonakog alfa
English: In a study in 80 adults and adolescents and another study in 27 children aged less than 12 years, Idelvion was effective at preventing bleeding, with most patients experiencing no bleeding while on preventive treatment.
Slovenian: V študiji z 80 odraslimi in mladoletniki in v drugi študiji s 27 otroki, mlajšimi od 12 let, je zdravilo Idelvion učinkovito preprečevalo krvavitve in pri večini bolnikov na preventivnem zdravljenju se krvavitve niso pojavile.
English: Hypersensitivity (allergic) reactions can occur rarely with Idelvion and include: swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a fast heartbeat, tightness of the chest and wheezing.
Slovenian: Preobčutljivostne (alergijske) reakcije se pri zdravilu Idelvion redko pojavijo in vključujejo: oteklost, pekoč občutek in zbadanje na mestu injiciranja, mrzlico, vročinske oblive, srbeč izpuščaj, glavobol, koprivnico, nizek krvni tlak, letargijo, slabost in bruhanje, nemir, hiter srčni utrip, stiskanje v prsnem košu in sopenje.
English: It must also not be used in patients allergic to hamster proteins.
Slovenian: Ne sme se uporabljati pri bolnikih z alergijo na proteine hrčka.
English: Other information about Idelvion
Slovenian: Druge informacije o zdravilu Idelvion
English: A risk management plan has been developed to ensure that Idelvion is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Idelvion je bil pripravljen načrt obvladovanja tveganj.
English: Furthermore, Idelvion was effective in treating bleeding episodes when they did occur; around 93% of the bleeding episodes resolved with one Idelvion injection.
Slovenian: Poleg tega je bilo zdravilo Idelvion učinkovito pri zdravljenju epizod krvavitev, ko so se pojavile; približno 93 % epizod krvavitev so obvladali s samo eno injekcijo zdravila Idelvion.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Idelvion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Idelvion je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Because the number of patients with haemophilia B is low, the disease is considered ‘rare', and Idelvion was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 February 2010.
Slovenian: Ker je bolnikov s hemofilijo B malo, velja ta bolezen za redko, zato je bilo zdravilo Idelvion 4. februarja 2010 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Idelvion must not be used in patients who are hypersensitive (allergic) to the active substance or other ingredients of the medicine.
Slovenian: Zdravila Idelvion ne smejo uporabljati bolniki, ki so preobčutljivi za (alergični na) zdravilno učinkovino ali katero koli drugo sestavino zdravila.
English: The active substance in Idelvion, albutrepenonacog alfa, works in the body in the same way as human factor IX.
Slovenian: Zdravilna učinkovina zdravila Idelvion, albutrepenonakog alfa, deluje v telesu enako kot humani faktor IX.
English: What are the risks associated with Idelvion?
Slovenian: Kakšna tveganja so povezana z zdravilom Idelvion?
English: Idelvion can only be obtained with a prescription, and treatment should be supervised by a doctor with experience in treating haemophilia.
Slovenian: Izdaja zdravila Idelvion je le na recept, zdravljenje pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem hemofilije.
English: The dose and the frequency of the injections depend on the patient's bodyweight and whether Idelvion is used to treat or prevent bleeding, as well as the severity of the patient's factor IX deficiency, the extent and location of the bleeding and the patient's age and health.
Slovenian: Odmerek in pogostnost injiciranja sta odvisna od tega, ali se zdravilo Idelvion uporablja za zdravljenje ali preprečevanje krvavitve, resnosti bolnikovega pomanjkanja faktorja IX, obsega in mesta krvavitve ter bolnikove starosti in telesne mase.
English: The full EPAR for Idelvion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Idelvion je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Idelvion and what is it used for?
Slovenian: Kaj je zdravilo Idelvion in za kaj se uporablja?
English: What benefits of Idelvion have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Idelvion izkazalo v študijah?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Idelvion, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Idelvion is available as powder and solvent that are mixed together to make a solution for injection into a vein.
Slovenian: Zdravilo Idelvion je na voljo v obliki praška in vehikla, ki se zmešata za pripravo raztopine za injiciranje v veno.
English: Why is Idelvion approved?
Slovenian: Zakaj je bilo zdravilo Idelvion odobreno?
English: Studies show that Idelvion is effective at preventing and treating bleeding episodes in patients with haemophilia B, and its safety is comparable to that of other factor IX products.
Slovenian: Študije so pokazale, da zdravilo Idelvion učinkovito preprečuje in zdravi epizode krvavitev pri bolnikih s hemofilijo B in da je varnost zdravila primerljiva z varnostjo drugih zdravil s faktorjem IX.
English: For more information about treatment with Idelvion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Idelvion preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Idelvion, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Idelvion naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: Idelvion is a medicine used to prevent and treat bleeding in patients with haemophilia B, an inherited bleeding disorder caused by lack of a clotting protein called factor IX.
Slovenian: Idelvion je zdravilo, ki se uporablja za preprečevanje in zdravljenje krvavitev pri bolnikih s hemofilijo B, prirojeno motnjo strjevanja krvi zaradi pomanjkanja koagulacijske beljakovine, imenovane faktor IX.
English: For the full list of side effects reported with Idelvion, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Idelvion, glejte navodilo za uporabo.
English: It is not intended to provide practical advice on how to use Idelvion.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: How does Idelvion work?
Slovenian: Kako zdravilo Idelvion deluje?
English: How is Idelvion used?
Slovenian: Kako se zdravilo Idelvion uporablja?
English: Idelvion contains the active substance albutrepenonacog alfa.
Slovenian: Vsebuje zdravilno učinkovino albutrepenonakog alfa.
English: The following medicines are particularly important:
Slovenian: Posebej pomembna so naslednja zdravila:
English: Give the child something to drink.
Slovenian: Otroku dajte piti.
English: • if you or your child are repeatedly sick, or
Slovenian: • če ste vi ali vaš otrok pogosto bolni, ali
English: Date of first authorisation: 22 May 2014 Date of latest renewal:
Slovenian: Datum prve odobritve: 22. maj 2014 Datum zadnjega podaljšanja:
English: Not recommended (no data available)
Slovenian: ni priporočljivo (podatki niso na voljo)
English: • if your immune system is not working
Slovenian: • če vaš imunski sistem ne deluje
English: • if you are allergic to other medicines
Slovenian: • če ste alergični na druga zdravila