FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of harm is reduced with low molecular weight povidone (e.g. K25 and K30) as this type of povidone is excreted from the body and is not expected to accumulate inside the cells as high molecular weight povidone does.
Slovenian: Tveganje za okvare je pri povidonu z majhno relativno molekulsko maso (npr. K25 in K30) so manjše, saj se tovrstni povidon izloči iz telesa in naj se v nasprotju s povidonom z veliko relativno molekulsko maso ne bi kopičil v celicah.
English: It followed the decision of NOMA, the Norwegian medicines agency, to suspend the only methadone-containing oral solution that contains high molecular weight povidone present on the national market, on the basis of reports of serious adverse events in former or current drug abusers in Norway.
Slovenian: Pregled se je začel, potem ko se je norveška agencija za zdravila odločila, da bo zaradi poročil o resnih neželenih dogodkih, opaženih pri nekdanjih ali trenutnih uporabnikih drog na Norveškem, začasno umaknila edino peroralno raztopino metadona na nacionalnem trgu, ki vsebuje povidon z veliko relativno molekulsko maso.
English: The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)1 has endorsed by consensus the recommendation to suspend the marketing authorisation of methadone oral (by mouth) solutions containing high molecular weight povidone.
Slovenian: F1P je soglasno podprla priporočilo o začasnem umiku dovoljenja za promet s peroralnimi raztopinami metadona (ki se dajejo skozi usta), ki vsebujejo povidon z veliko relativno molekulsko maso.
English: Date of first authorisation: 03 May 2019
Slovenian: Datum prve odobritve: 03. maj 2019
English: Do not inject more than one dose within 2 days.
Slovenian: Ne injicirajte več kot enega odmerka v 2 dneh.
English: NC = not calculated
Slovenian: NC = ni izračunano
English: Less than 50a, b
Slovenian: Manj kot 50a, b
English: If 1 visit was missing, then the other visit was used as the endpoint.
Slovenian: Če je 1. obisk manjkal, je bil kot končna točka uporabljen drugi obisk.
English: Other warming methods should not be used.
Slovenian: Drugi postopki segrevanja se ne smejo uporabljati.
English: You may not know that you have this condition until this point, or what might have caused it.
Slovenian: Do takrat morda ne boste vedeli, da imate to stanje ali kaj bi ga lahko povzročilo.
English: For all injections:
Slovenian: Za vse injekcije:
English: Instructions for use are provided at the end of this leaflet.
Slovenian: Navodila za uporabo so na voljo na koncu tega navodila.
English: Wash your hands thoroughly with soap (for at least 3 minutes) and dry them well.
Slovenian: Z milom si temeljito umijte roke (umivajte si jih vsaj tri minute) in jih dobro osušite.
English: Your doctor will tell you how often you should take this medicine.
Slovenian: Zdravnik vam bo povedal, kako pogosto morate jemati to zdravilo.
English: The applicant will ensure the long term follow-up of patients in the Registry.
Slovenian: Vlagatelj bo zagotovil dolgoročno spremljanje bolnikov v registru.
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavni del paketa, ni je mogoče prodati ločeno.
English: A risk to the newborn infant cannot be excluded.
Slovenian: Tveganja za novorojenčka/dojenčka ni mogoče izključiti.
English: The decrease was gradual, self-sustaining and did not decrease to adverse levels.
Slovenian: Zmanjšanje je bilo postopno, neodvisno in ni doseglo škodljivih ravni.
English: c The denominator for percentage calculation was the total number of patients in each treatment group.
Slovenian: c Imenovalec za odstotni izračun je bilo skupno število bolnikov v vsaki skupini zdravljenja.
English: It is recommended that you discuss breast-feeding with your doctor to see what is best for you and your child.
Slovenian: Priporočljivo je, da se o dojenju pogovorite z zdravnikom, da ugotovite, kaj je najbolje za vas in vašega otroka.
English: Do not use Waylivra until you completely understand the procedure described below.
Slovenian: Zdravila Waylivra ne uporabite, dokler v celoti ne razumete spodaj opisanega postopka.
English: Date of first removal from fridge:
Slovenian: Datum prve odstranitve iz hladilnika:
English: The most recent data of the ongoing Study CS7 is provided in Table 6.
Slovenian: Najnovejši podatki o potekajoči študiji CS7 so navedeni v preglednici 6.
English: This medicine is intended for patients aged 18 years and above.
Slovenian: To zdravilo je namenjeno bolnikom, starim 18 let ali več.
English: Do not warm syringe in any other way, such as by microwave or warm water.
Slovenian: Brizge ne smete na noben drug način segrevati, npr. tudi ne z mikrovalovi ali toplo vodo.
English: 50 to 74a
Slovenian: 50-74a
English: Do not use Waylivra if you are under 18 years old.
Slovenian: Ne uporabljajte zdravila Waylivra, če ste mlajši od 18 let.
English: Wash hands and gather supplies
Slovenian: Umijte si roke in pripravite potrebščine
English: You may notice this if you have an injury which causes bleeding and it takes a long time to stop (more than 5-6 minutes for a skin scratch).
Slovenian: To lahko opazite, če se poškodujete do krvavitve in je za ustavitev krvavitve potreben daljši čas (več kot od 5 do 6 minut pri opraskanini kože).
English: Every 2-3 days
Slovenian: Vsake 2-3 dni
English: Treatment and monitoring should be adjusted according to laboratory values in line with Table 1.
Slovenian: Zdravljenje in spremljanje je treba prilagajati laboratorijskim vrednostim skladno s preglednico 1.
English: If you do not have a sharps disposal container, you may use a household container that is:
Slovenian: Če nimate vsebnika za ostre odpadke, lahko uporabite gospodinjsko posodo, ki:
English: It is normal to see a large air bubble.
Slovenian: Normalno je, da je viden velik zračni mehurček.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni sistem 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: Patients should be instructed to give the injection on the same day of the week, according to medically determined frequency of administration.
Slovenian: Bolnikom je treba naročiti, da si dajejo injekcijo na isti dan v tednu, skladno z medicinsko določeno pogostnostjo dajanja.
English: Before using this medicine, it is important that you read, understand, and closely follow the instructions for use.
Slovenian: Pred uporabo tega zdravila je pomembno, da ta navodila za uporabo preberete, razumete in natančno upoštevate.
English: * p-value =0.0001 **p-value < 0.0001
Slovenian: * p-vrednost = 0,0001 **p-vrednost < 0,0001
English: Pharmacotherapeutic group:{Not yet assigned}, ATC code: {Not yet assigned} Mechanism of action
Slovenian: Farmakoterapevtska skupina:{še ni bila dodeljena}, oznaka ATC: {še ni bila dodeljena} Mehanizem delovanja
English: With treatment with Waylivra, LDL-C levels may rise but will usually remain within the normal range.
Slovenian: Pri zdravljenju z zdravilom Waylivra se lahko raven LDL-C zviša, vendar običajno ostane v normalnem območju.
English: The safety and efficacy of this medicinal product in children and adolescents below 18 years of age have not yet been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost tega zdravila pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
English: Monitoring Frequency
Slovenian: Pogostost spremljanja
English: Call your doctor or pharmacist to get a new supply.
Slovenian: Pokličite zdravnika ali farmacevta in si priskrbite novo zalogo.
English: - Medicines that may cause problems with your liver, such as paracetamol.
Slovenian: - zdravila, ki lahko povzročijo težave z jetri, npr. paracetamol.
English: These local reactions were mostly mild and typically consisted of 1 or more of the following: erythema, pain, pruritus, or local swelling.
Slovenian: Te lokalne reakcije so bile večinoma blage in so običajno obsegale enega ali več od naslednjih pojavov: eritem, bolečina, pruritus ali lokalno otekanje.
English: The safety and efficacy in patients with severe renal impairment has not been established and these patients should be closely observed.
Slovenian: Varnost in učinkovitost pri bolnikih s hudo okvaro ledvic nista bili dokazani, zato je treba te bolnike skrbno spremljati.
English: The needle should be inserted at a 45 degree angle to the skin surface (Figure J).
Slovenian: Iglo je treba vstaviti pod kotom 45 stopinj glede na površino kože (slika J).
English: This medicinal product is intended for subcutaneous use only.
Slovenian: To zdravilo je namenjeno samo za subkutano uporabo.
English: No overall differences in safety or effectiveness were observed between these patients and younger patients, however data are limited in this subpopulation.
Slovenian: Med temi in mlajšimi bolniki ni bila opažena nobena splošna razlika v varnosti ali učinkovitosti, vendar so podatki za to subpopulacijo omejeni.
English: Every 2 weeks
Slovenian: Vsaka dva tedna
English: You should avoid alcohol during treatment with this medicine due to risk of liver issues.
Slovenian: Med zdravljenjem s tem zdravilom se morate zaradi tveganja za težave z jetri izogibati alkoholu.
English: Pinch the skin
Slovenian: Stisnite kožo
English: Effects of Waylivra on lipid parameters
Slovenian: Učinki zdravila Waylivra na lipidne parametre
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganje, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: Symptoms of overdose are expected to be limited to constitutional symptoms and injection site reactions.
Slovenian: Simptomi prevelikega odmerjanja naj bi bili omejeni na konstitucionalne simptome in reakcije na mestu injiciranja.
English: Normal (≥140)
Slovenian: Normalno (> 140)
English: Steady-state was reached approximately 3 months after starting volanesorsen.
Slovenian: Stanje dinamičnega ravnovesja je bilo doseženo približno 3 mesece po uvedbi volanesorsena.
English: This can lead to inflammation of your pancreas, causing severe pain.
Slovenian: To lahko privede do vnetja trebušne slinavke, kar povzroča hude bolečine.
English: No clinical data on the effect of this medicinal product on human fertility are available.
Slovenian: Klinični podatki o učinku tega zdravila na plodnost pri človeku niso na voljo.
English: • The Guide for healthcare professionals shall contain the following key elements:
Slovenian: • Vodnik za zdravstvene delavce mora vsebovati naslednje ključne elemente:
English: After the Injection 12.
Slovenian: Po injiciranju 12.
English: 3 years
Slovenian: 3 leti.
English: Compliance with diet and alcohol restriction was reinforced through periodic counselling sessions during the study.
Slovenian: Upoštevanje diete in omejeno uživanje alkohola so med študijo krepili z rednim svetovanjem.
English: If you miss a dose, contact your doctor to ask when to take your next dose.
Slovenian: Če ste pozabili vzeti odmerek, se posvetujte z zdravnikom o tem, kdaj vzeti naslednji odmerek.
English: You will only be given Waylivra if genetic testing has confirmed you have FCS and your risk for pancreatitis is considered very high..
Slovenian: Zdravilo Waylivra boste prejeli le, če bo z genetskimi preiskavami potrjeno, da imate FCS in je vaše tveganje za pankreatitis ocenjeno kot zelo veliko.
English: Always keep your sharps container away from children and pets.
Slovenian: Vsebnik z ostrimi predmeti vedno hranite stran od otrok in hišnih živali.
English: Recommendations for adjustments to monitoring frequency and dosing are specified in Table 1 (see section 4.2).
Slovenian: Priporočila za prilagoditev pogostnosti spremljanja in odmerjanja so navedena v preglednici 1 (glejte poglavje 4.2).
English: If necessary, your doctor may change how often you use this medicine, or may stop it for a period.
Slovenian: Po potrebi lahko vaš zdravnik spremeni pogostost vašega jemanja tega zdravila ali zdravilo za določen čas ukine.
English: You or your caregiver will be trained on how to use Waylivra according to the instructions in this leaflet.
Slovenian: Vi ali vaš negovalec bodo usposobljeni za uporabo zdravila Waylivra po navodilih v tem navodilu za uporabo.
English: The effect of concomitant administration of this medicinal product with alcohol or medicinal products known to have potential for hepatotoxicity (e.g., paracetamol) is unknown.
Slovenian: Učinek sočasne uporabe tega zdravila z alkoholom ali zdravili, za katera je znano, da lahko povzročijo hepatotoksičnost (npr. paracetamolom), ni znan.
English: When your sharps disposal container is almost full, you will need to follow your community guidelines for proper disposal of the sharps container.
Slovenian: Ko je vsebnik za ostre odpadke skoraj poln, boste morali ravnati po smernicah za pravilno odstranjevanje vsebnika za ostre odpadke.
English: The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional.
Slovenian: Prvo injekcijo mora bolnik ali negovalec dati pod vodstvom ustrezno usposobljenega zdravstvenega delavca.
English: What you need to know before you use Waylivra 3.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Waylivra 3.
English: If signs and symptoms of hepatotoxicity develop, use of the hepatotoxic medicinal product should be discontinued.
Slovenian: Če se pojavijo znaki in simptomi hepatotoksičnosti, je treba zdravljenje s hepatotoksičnim zdravilom prekiniti.
English: Nineteen of the 33 patients in the volanesorsen group completed 12 months of study treatment.
Slovenian: Devetnajst od 33 bolnikov v skupini, zdravljeni z volanesorsenom, je zaključilo 12 mesecev študijskega zdravljenja.
English: An analysis of patients with a history of recurrent pancreatitis events (≥ 2 events in the 5 years prior to
Slovenian: Analiza bolnikov z anamnezo ponavljajočih se epizod pankreatitisa (≥ 2 dohodka v petih letih pred
English: Following 3 months, dose frequency should be reduced to 285 mg every 2 weeks.
Slovenian: Po 3 mesecih je treba pogostost odmerjanja zmanjšati na 285 mg vsaka 2 tedna.
English: Age, sex, weight, and race
Slovenian: Starost, spol, telesna masa in rasa
English: Injecting 6.
Slovenian: Injiciranje 6.
English: There is limited clinical data for patients aged 65 and over (see sections 5.1 and 5.2).
Slovenian: Klinični podatki pri bolnikih, starih 65 let ali več, so omejeni (glejte poglavji 5.1 in 5.2).
English: Observed Value
Slovenian: Opazova na vrednost
English: • Upright and stable during use,
Slovenian: • med uporabo stoji pokonci in je stabilna;
English: Store in a refrigerator (2 ° - 8 °C).
Slovenian: Shranjujte v hladilniku (2 °C-8 °C).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: What Waylivra is and what it is used for 2.
Slovenian: Kaj je zdravilo Waylivra in za kaj ga uporabljamo 2.
English: Talk to your doctor, pharmacist or nurse before using Waylivra if you have or have had any of the following medical problems: - Very high triglyceride levels which are not due to FCS.
Slovenian: Pred začetkom uporabe zdravila Waylivra se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, če imate ali ste imeli katero koli od naslednjih zdravstvenih težav: - Zelo visoko raven trigliceridov, ki ni posledica sindroma FCS.
English: The decrease in platelet counts was not acute and decreased to below 50,000 cells/μl.
Slovenian: Število trombocitov se ni akutno zmanjšalo in je padlo pod 50.000 celic/μl.
English: Waylivra should be injected under your skin in the way the doctor, nurse or pharmacist has shown you, and you should make sure you inject all of the liquid in the syringe.
Slovenian: Zdravilo Waylivra je treba injicirati pod kožo tako, kot so vam pokazali zdravnik, medicinska sestra ali farmacevt, vi pa morate poskrbeti, da injicirate vso tekočino iz brizge.
English: Do not use this medicine after the expiry date which is stated on the carton and syringe label after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki injekcijske brizge poleg oznake »EXP«.
English: o That patients should be made aware of the possibility of thrombocytopaenia and to seek medical attention immediately in case of signs of bleeding.
Slovenian: o Da morajo biti bolniki seznanjeni z možnostjo trombocitopenije in da morajo v primeru znakov krvavitve nemudoma poiskati zdravniško pomoč.
English: No evidence of altered safety profile or clinical response was associated with presence of anti-drug antibodies; however this is based on the limited long-term data (see section 4.4).
Slovenian: O povezanosti varnostnega profila ali kliničnega odziva s prisotnostjo protiteles proti zdravilu ni bilo nobenega dokaza, vendar pa to temelji na omejenih dolgoročnih podatkih (glejte poglavje 4.4).
English: The effect of taking Waylivra with alcohol is not known.
Slovenian: Učinek jemanja zdravila Waylivra z alkoholom ni znan.
English: Clear, colourless to slightly yellow solution with a pH of approximately 8 and osmolarity of 363-485 mOsm/kg.
Slovenian: Bistra, brezbarvna do rahlo rumena raztopina s pH približno 8 in osmolalnostjo 363-485 mOsm/kg.
English: Lipid Parameter (g/L for apoC-III, apoB, apoB-48; mmol/L for cholesterol, triglycerides)
Slovenian: Lipidni parameter (g/l za apoC-III, apoB, apoB-48; mmol/l za holesterol, trigliceride)
English: Do not administer intramuscularly or intravenously.
Slovenian: Ne injicirajte ga intramuskularno ali intravensko.
English: o Information about the FCS disease registry and the PASS study and the importance of contributing to those studies.
Slovenian: o Informacije o registru bolezni FCS in študiji PASS ter spodbudo k sodelovanju pri teh študijah.
English: Urine tests
Slovenian: Preiskave urina
English: Waylivra may be given after you have already received other medicines used to lower the levels of triglycerides in blood without them having much effect.
Slovenian: Zdravilo Waylivra se lahko daje po tem, ko ste že prejeli druga zdravila za zniževanje ravni trigliceridov v krvi in ta niso imela večjega učinka.
English: Contents of the pack and other information What Waylivra contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Waylivra
English: The European Medicines Agency has deferred the obligation to submit the results of studies with volanesorsen in one or more subsets of the paediatric population in the treatment of familial chylomicronemia syndrome (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z volanesorsenom za eno ali več podskupin pediatrične populacije pri zdravljenju sindroma družinske hilomikronemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In animals, elimination of volanesorsen was slow and occurred mainly via urinary excretion, reflecting rapid plasma clearance principally to tissues.
Slovenian: Pri živalih je bilo izločanje volanesorsena počasno in je pretežno potekalo z izločanjem prek sečil, kar odraža hiter plazemski očistek predvsem v tkiva.
English: Do not take out of the packaging or remove the needle cap until you are ready to inject.
Slovenian: Zdravila ne vzemite iz embalaže in ne odstranite pokrovčka igle, dokler niste pripravljeni za injiciranje.
English: If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
English: The concentrations in breast milk of mice were >800 fold lower than effective tissue concentrations in maternal liver.
Slovenian: Koncentracije v mleku doječih miši so bile več kot 800-krat nižje od efektivne tkivne koncentracije v jetrih matere.
English: Please note that the expiry date refers to the last day of that month.
Slovenian: Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Volanesorsen had no effect on fertility in mice.
Slovenian: Volanesorsen ni vplival na plodnost pri miših.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of very low amounts of volanesorsen in milk (see section 5.3).
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih so pokazali izločanje zelo majhnih ravni volanesorsena v mleko (glejte poglavje 5.3).
English: Monitoring of inflammation should be assessed through quarterly assessment of erythrocyte sedimentation rate (ESR).
Slovenian: Vnetje je treba spremljati s četrtletnim ocenjevanjem hitrosti sedimentacije eritrocitov (SR).
English: Pregnancy There are no data on the use of volanesorsen in pregnant women.
Slovenian: Podatkov o uporabi volanesorsena pri nosečnicah ni.
English: There are limited data available in subjects >75 years of age.
Slovenian: Za osebe, starejše od 75 let, so na voljo le omejeni podatki.
English: Table 6: Summary of Fasting Triglycerides (Mean (SD, SEM), mg/dL) Over Time in Study CS7
Slovenian: Preglednica 6: Povzetek ravni trigliceridov na tešče (povprečje (SD, SEM), mg/dl) skozi čas v študiji CS7
English: Discontinue treatment Glucocorticoids recommended
Slovenian: Prekinite zdravljenje Priporočajo se glukokortikoidi
English: Single- and multiple-dose pharmacokinetics of volanesorsen in healthy volunteers and patients with hypertriglyceridemia have shown that the Cmax of volanesorsen is dose-proportional over a dose range of 100 to 400 mg and the AUC is slightly more than dose-proportional over the same dose range.
Slovenian: Farrmakokinetika enkratnih in večkratnih odmerkov volanesorsena pri zdravih prostovoljcih in bolnikih s hipertrigliceridemijo je pokazala, da je Cmaks volanesorsena v območju od 100 do 400 mg sorazmeren odmerku in da je AUC v istem območju odmerkov nekoliko večja kot pa le sorazmerna odmerku.
English: Thighs - Front, middle area as shown (Figure E).
Slovenian: Stegna -sprednji, srednji del, kakor je prikazano (slika E).
English: Insert the needle into the injection site with a quick, firm motion without touching the plunger head.
Slovenian: Iglo vstavite v mesto injiciranja s hitrim in čvrstim gibom, ne da bi se dotaknili glave bata.
English: The median age at diagnosis was 27 years, with 23% shown to lack a known FCS genetic mutation.
Slovenian: Mediana starost ob postavitvi diagnoze je bila 27 let, 23 % pa jih ni imelo znane mutacije, povezane s sindromom FCS.
English: The date you first remove the pack from the refrigerator should be recorded on the outer carton in the space indicated.
Slovenian: Datum, ko paket prvič vzamete iz hladilnika, mora biti zapisan na škatli v označenem prostoru.
English: - Any liver or kidney problems.
Slovenian: - Kakršne koli težave z jetri ali ledvicami.