natgillin/translations-raw huggingface dataset:
• Because of the potential harm that could derive from such a misuse (injection into a vein), methadone solutions containing povidone K90 will be suspended.
• Zaradi možnih okvar, ki jih lahko povzroči tovrstna napačna uporaba (injiciranje v veno), bodo raztopine metadona, ki vsebujejo povidon K90, začasno umaknjene s trga.
• Since no measures could be identified to minimise the potential harm with methadone oral solutions containing high molecular weight povidone, these solutions will be suspended.
• Ker ni bilo mogoče opredeliti nobenih ukrepov za zmanjšanje možnih okvar, povezanih s peroralnimi raztopinami metadona, ki vsebujejo povidon z veliko relativno molekulsko maso, bodo te raztopine začasno umaknjene s trga.
The safety of oral methadone medicines containing povidone was reviewed by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), following reports of serious adverse events in former or current drug abusers in Norway, which led to the suspension of methadone oral solutions containing povidone K90 from the Norwegian market.
Varnost peroralnih zdravil, ki vsebujejo metadon in povidon, je ocenil Odbor za oceno tveganja na področju farmakovigilance (PRAC) pri Evropski agenciji za zdravila, potem ko so se na Norveškem pojavila poročila o resnih neželenih dogodkih pri nekdanjih ali trenutnih uporabnikih drog, zaradi česar so bile peroralne raztopine metadona, ki vsebujejo povidon K90, začasno umaknjene z norveškega trga.
Methadone tablets containing low molecular weight povidone remain on the market, but their product information will be amended to reinforce the recommendation that these medicines are for oral administration only and must not be used in any other way.
Tablete metadona, ki vsebujejo povidon z majhno relativno molekulsko maso, ostajajo na trgu, vendar bodo informacije o zdravilu za ta zdravila spremenjene tako, da se bo okrepilo opozorilo, da so ta zdravila namenjena samo za peroralno uporabo in se ne smejo uporabljati na noben drug način.
• Some oral methadone solutions contain high molecular weight povidone (K90), which can be harmful if injected as it is retained in the body and may cause tissue damage.
• Nekatere peroralne raztopine metadona vsebujejo povidon z veliko relativno molekulsko maso (K90), ki je lahko škodljiv, če se injicira, saj se ohrani v telesu in lahko povzroči poškodbe tkiv.
• Patients taking methadone oral solutions with povidone K90 as part of their rehabilitation program will be switched to other methadone medicines, which do not pose the same risk of povidone accumulating inside vital organs.
• Bolnikom, ki uporabljajo peroralne raztopine metadona, ki vsebujejo povidon K90, v okviru programa za zdravljenje odvisnosti, bodo predpisana druga zdravila, ki vsebujejo metadon in ne predstavljajo tveganja, da bi se povidon kopičil v vitalnih organih.
Oral methadone medicines are available as solutions or tablets, and should only be taken by mouth.
Peroralna zdravila, ki vsebujejo metadon, so na voljo v obliki raztopin ali tablet in se lahko jemljejo samo skozi usta.
Povidone is used in oral solutions as a suspending and dispersing agent, or as a binding agent for tablets.
Povidon se v peroralnih raztopinah uporablja kot suspendirajoče sredstvo in dispergent, v tabletah pa kot vezivno sredstvo.
Some oral formulations of methadone also contain the additive povidone, which is available in different molecular weights.
Nekatere peroralne farmacevtske oblike metadona vsebujejo tudi dodatek povidon z različnimi relativnimi molekulskimi masami.
The povidone contained in oral methadone solutions has a high molecular weight (known as K90), while the povidone used in methadone tablets has a low molecular weight (e.g. K25 and K30).
Povidon, ki ga vsebujejo peroralne raztopine metadona, ima veliko relativno molekulsko maso (imenujemo ga K90), medtem ko ima povidon v tabletah metadona majhno relativno molekulsko maso (npr. K25 in K30).
For methadone tablets containing povidone of lower molecular weight (e.g. K25 and K30), the available data showed that this kind of povidone is excreted from the body and does not accumulate inside the cells as high molecular weight povidone does.
Za tablete metadona, ki vsebujejo povidon z manjšo relativno molekulsko maso (npr. K25 in K30), so razpoložljivi podatki pokazali, da se ta vrsta povidona izloči iz telesa in se v nasprotju s povidonom z veliko relativno molekulsko maso ne kopiči v celicah.
• The risk of harm is reduced with low molecular weight povidone since it is expected to be readily excreted and not to accumulate inside cells.
• Pri povidonu z majhno relativno molekulsko maso je tveganje za okvare manjše, saj naj bi se hitro izločil in naj se ne bi kopičil v celicah.
If methadone oral solutions containing high molecular weight povidone (K90) are misused by injection instead of being taken by mouth as they are intended, the povidone accumulates inside vital organs and may cause serious harm, with possible fatal consequences.
Če se peroralne raztopine metadona, ki vsebujejo povidon z veliko relativno molekulsko maso (K90), napačno uporabijo z injiciranjem, namesto da bi se dale skozi usta, kot je predvideno, se povidon kopiči v vitalnih organih in lahko povzroči resne okvare, ki imajo lahko usodne posledice.
Oral methadone medicines are available as solutions or tablets; only oral methadone products containing povidone were concerned by this review.
Peroralna zdravila, ki vsebujejo metadon, so na voljo v obliki raztopin ali tablet; v tem pregledu so bila obravnavana samo peroralna zdravila, ki vsebujejo metadon in povidon.
• Cases of povidone deposits and serious adverse reactions (e.g. anaemia and pathological fractures) have been reported in intravenous drug abusers.
• Pri uporabnikih intravenskih drog so poročali o primerih nalaganja povidona in resnih neželenih učinkih (npr. anemija in patološki zlomi).
market and changes will be made to the product information (SmPC and package leaflet) to reinforce the message that tablets are for oral administration only and must not be taken in any other way.
Ta zdravila bodo zato ostala na trgu, informacije o zdravilu (povzetek glavnih značilnosti zdravila in navodilo za uporabo) pa bodo spremenjene tako, da se bo okrepilo opozorilo, da so tablete namenjene samo za peroralno uporabo in se ne smejo dajati na noben drug način.
If a medicine containing high molecular weight povidone (known as K90) is misused in this way, the povidone is not excreted from the body and accumulates inside the cells of vital organs, which may cause serious harm.
Če se na ta način napačno uporabi zdravilo, ki vsebuje povidon z veliko relativno molekulsko maso (imenovan K90), se povidon ne izloči iz telesa, temveč se kopiči v celicah vitalnih organov, s čimer lahko povzroči resne okvare.
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.
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.
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.
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.
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.
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.
Date of first authorisation: 03 May 2019
Datum prve odobritve: 03. maj 2019
Do not inject more than one dose within 2 days.
Ne injicirajte več kot enega odmerka v 2 dneh.
NC = not calculated
NC = ni izračunano
Less than 50a, b
Manj kot 50a, b
If 1 visit was missing, then the other visit was used as the endpoint.
Če je 1. obisk manjkal, je bil kot končna točka uporabljen drugi obisk.
Other warming methods should not be used.
Drugi postopki segrevanja se ne smejo uporabljati.
You may not know that you have this condition until this point, or what might have caused it.
Do takrat morda ne boste vedeli, da imate to stanje ali kaj bi ga lahko povzročilo.
For all injections:
Za vse injekcije:
Instructions for use are provided at the end of this leaflet.
Navodila za uporabo so na voljo na koncu tega navodila.
Wash your hands thoroughly with soap (for at least 3 minutes) and dry them well.
Z milom si temeljito umijte roke (umivajte si jih vsaj tri minute) in jih dobro osušite.
Your doctor will tell you how often you should take this medicine.
Zdravnik vam bo povedal, kako pogosto morate jemati to zdravilo.
The applicant will ensure the long term follow-up of patients in the Registry.
Vlagatelj bo zagotovil dolgoročno spremljanje bolnikov v registru.
Component of a multipack, can't be sold separately.
Sestavni del paketa, ni je mogoče prodati ločeno.
A risk to the newborn infant cannot be excluded.
Tveganja za novorojenčka/dojenčka ni mogoče izključiti.
The decrease was gradual, self-sustaining and did not decrease to adverse levels.
Zmanjšanje je bilo postopno, neodvisno in ni doseglo škodljivih ravni.
c The denominator for percentage calculation was the total number of patients in each treatment group.
c Imenovalec za odstotni izračun je bilo skupno število bolnikov v vsaki skupini zdravljenja.
It is recommended that you discuss breast-feeding with your doctor to see what is best for you and your child.
Priporočljivo je, da se o dojenju pogovorite z zdravnikom, da ugotovite, kaj je najbolje za vas in vašega otroka.
Do not use Waylivra until you completely understand the procedure described below.
Zdravila Waylivra ne uporabite, dokler v celoti ne razumete spodaj opisanega postopka.
Date of first removal from fridge:
Datum prve odstranitve iz hladilnika:
The most recent data of the ongoing Study CS7 is provided in Table 6.
Najnovejši podatki o potekajoči študiji CS7 so navedeni v preglednici 6.
This medicine is intended for patients aged 18 years and above.
To zdravilo je namenjeno bolnikom, starim 18 let ali več.
Do not warm syringe in any other way, such as by microwave or warm water.
Brizge ne smete na noben drug način segrevati, npr. tudi ne z mikrovalovi ali toplo vodo.
Do not use Waylivra if you are under 18 years old.
Ne uporabljajte zdravila Waylivra, če ste mlajši od 18 let.
Wash hands and gather supplies
Umijte si roke in pripravite potrebščine
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).
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).
Every 2-3 days
Vsake 2-3 dni
Treatment and monitoring should be adjusted according to laboratory values in line with Table 1.
Zdravljenje in spremljanje je treba prilagajati laboratorijskim vrednostim skladno s preglednico 1.
If you do not have a sharps disposal container, you may use a household container that is:
Če nimate vsebnika za ostre odpadke, lahko uporabite gospodinjsko posodo, ki:
It is normal to see a large air bubble.
Normalno je, da je viden velik zračni mehurček.
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.
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.
Patients should be instructed to give the injection on the same day of the week, according to medically determined frequency of administration.
Bolnikom je treba naročiti, da si dajejo injekcijo na isti dan v tednu, skladno z medicinsko določeno pogostnostjo dajanja.
Before using this medicine, it is important that you read, understand, and closely follow the instructions for use.
Pred uporabo tega zdravila je pomembno, da ta navodila za uporabo preberete, razumete in natančno upoštevate.
* p-value =0.0001 **p-value < 0.0001
* p-vrednost = 0,0001 **p-vrednost < 0,0001
Pharmacotherapeutic group:{Not yet assigned}, ATC code: {Not yet assigned} Mechanism of action
Farmakoterapevtska skupina:{še ni bila dodeljena}, oznaka ATC: {še ni bila dodeljena} Mehanizem delovanja
With treatment with Waylivra, LDL-C levels may rise but will usually remain within the normal range.
Pri zdravljenju z zdravilom Waylivra se lahko raven LDL-C zviša, vendar običajno ostane v normalnem območju.
The safety and efficacy of this medicinal product in children and adolescents below 18 years of age have not yet been established.
Pediatrična populacija Varnost in učinkovitost tega zdravila pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
Monitoring Frequency
Pogostost spremljanja
Call your doctor or pharmacist to get a new supply.
Pokličite zdravnika ali farmacevta in si priskrbite novo zalogo.
- Medicines that may cause problems with your liver, such as paracetamol.
- zdravila, ki lahko povzročijo težave z jetri, npr. paracetamol.
These local reactions were mostly mild and typically consisted of 1 or more of the following: erythema, pain, pruritus, or local swelling.
Te lokalne reakcije so bile večinoma blage in so običajno obsegale enega ali več od naslednjih pojavov: eritem, bolečina, pruritus ali lokalno otekanje.
The safety and efficacy in patients with severe renal impairment has not been established and these patients should be closely observed.
Varnost in učinkovitost pri bolnikih s hudo okvaro ledvic nista bili dokazani, zato je treba te bolnike skrbno spremljati.
The needle should be inserted at a 45 degree angle to the skin surface (Figure J).
Iglo je treba vstaviti pod kotom 45 stopinj glede na površino kože (slika J).
This medicinal product is intended for subcutaneous use only.
To zdravilo je namenjeno samo za subkutano uporabo.
No overall differences in safety or effectiveness were observed between these patients and younger patients, however data are limited in this subpopulation.
Med temi in mlajšimi bolniki ni bila opažena nobena splošna razlika v varnosti ali učinkovitosti, vendar so podatki za to subpopulacijo omejeni.
Every 2 weeks
Vsaka dva tedna
You should avoid alcohol during treatment with this medicine due to risk of liver issues.
Med zdravljenjem s tem zdravilom se morate zaradi tveganja za težave z jetri izogibati alkoholu.
Pinch the skin
Stisnite kožo
Effects of Waylivra on lipid parameters
Učinki zdravila Waylivra na lipidne parametre
• 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.
• 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).
Symptoms of overdose are expected to be limited to constitutional symptoms and injection site reactions.
Simptomi prevelikega odmerjanja naj bi bili omejeni na konstitucionalne simptome in reakcije na mestu injiciranja.
Normal (≥140)
Normalno (> 140)
Steady-state was reached approximately 3 months after starting volanesorsen.
Stanje dinamičnega ravnovesja je bilo doseženo približno 3 mesece po uvedbi volanesorsena.
This can lead to inflammation of your pancreas, causing severe pain.
To lahko privede do vnetja trebušne slinavke, kar povzroča hude bolečine.
No clinical data on the effect of this medicinal product on human fertility are available.
Klinični podatki o učinku tega zdravila na plodnost pri človeku niso na voljo.
• The Guide for healthcare professionals shall contain the following key elements:
• Vodnik za zdravstvene delavce mora vsebovati naslednje ključne elemente:
After the Injection 12.
Po injiciranju 12.
3 years
3 leti.
Compliance with diet and alcohol restriction was reinforced through periodic counselling sessions during the study.
Upoštevanje diete in omejeno uživanje alkohola so med študijo krepili z rednim svetovanjem.
If you miss a dose, contact your doctor to ask when to take your next dose.
Če ste pozabili vzeti odmerek, se posvetujte z zdravnikom o tem, kdaj vzeti naslednji odmerek.
You will only be given Waylivra if genetic testing has confirmed you have FCS and your risk for pancreatitis is considered very high..
Zdravilo Waylivra boste prejeli le, če bo z genetskimi preiskavami potrjeno, da imate FCS in je vaše tveganje za pankreatitis ocenjeno kot zelo veliko.
Always keep your sharps container away from children and pets.
Vsebnik z ostrimi predmeti vedno hranite stran od otrok in hišnih živali.
Recommendations for adjustments to monitoring frequency and dosing are specified in Table 1 (see section 4.2).
Priporočila za prilagoditev pogostnosti spremljanja in odmerjanja so navedena v preglednici 1 (glejte poglavje 4.2).
If necessary, your doctor may change how often you use this medicine, or may stop it for a period.
Po potrebi lahko vaš zdravnik spremeni pogostost vašega jemanja tega zdravila ali zdravilo za določen čas ukine.
You or your caregiver will be trained on how to use Waylivra according to the instructions in this leaflet.
Vi ali vaš negovalec bodo usposobljeni za uporabo zdravila Waylivra po navodilih v tem navodilu za uporabo.
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.
Učinek sočasne uporabe tega zdravila z alkoholom ali zdravili, za katera je znano, da lahko povzročijo hepatotoksičnost (npr. paracetamolom), ni znan.
When your sharps disposal container is almost full, you will need to follow your community guidelines for proper disposal of the sharps container.
Ko je vsebnik za ostre odpadke skoraj poln, boste morali ravnati po smernicah za pravilno odstranjevanje vsebnika za ostre odpadke.
The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified health care professional.
Prvo injekcijo mora bolnik ali negovalec dati pod vodstvom ustrezno usposobljenega zdravstvenega delavca.
What you need to know before you use Waylivra 3.
Kaj morate vedeti, preden boste uporabili zdravilo Waylivra 3.
If signs and symptoms of hepatotoxicity develop, use of the hepatotoxic medicinal product should be discontinued.
Če se pojavijo znaki in simptomi hepatotoksičnosti, je treba zdravljenje s hepatotoksičnim zdravilom prekiniti.
Nineteen of the 33 patients in the volanesorsen group completed 12 months of study treatment.
Devetnajst od 33 bolnikov v skupini, zdravljeni z volanesorsenom, je zaključilo 12 mesecev študijskega zdravljenja.
An analysis of patients with a history of recurrent pancreatitis events (≥ 2 events in the 5 years prior to
Analiza bolnikov z anamnezo ponavljajočih se epizod pankreatitisa (≥ 2 dohodka v petih letih pred
Following 3 months, dose frequency should be reduced to 285 mg every 2 weeks.
Po 3 mesecih je treba pogostost odmerjanja zmanjšati na 285 mg vsaka 2 tedna.
Age, sex, weight, and race
Starost, spol, telesna masa in rasa
Injecting 6.
Injiciranje 6.
There is limited clinical data for patients aged 65 and over (see sections 5.1 and 5.2).
Klinični podatki pri bolnikih, starih 65 let ali več, so omejeni (glejte poglavji 5.1 in 5.2).
Observed Value
Opazova na vrednost
• Upright and stable during use,
• med uporabo stoji pokonci in je stabilna;
Store in a refrigerator (2 ° - 8 °C).
Shranjujte v hladilniku (2 °C-8 °C).
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.
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.
What Waylivra is and what it is used for 2.
Kaj je zdravilo Waylivra in za kaj ga uporabljamo 2.
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.
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.
The decrease in platelet counts was not acute and decreased to below 50,000 cells/μl.
Število trombocitov se ni akutno zmanjšalo in je padlo pod 50.000 celic/μl.
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.
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.
Do not use this medicine after the expiry date which is stated on the carton and syringe label after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki injekcijske brizge poleg oznake »EXP«.
o That patients should be made aware of the possibility of thrombocytopaenia and to seek medical attention immediately in case of signs of bleeding.
o Da morajo biti bolniki seznanjeni z možnostjo trombocitopenije in da morajo v primeru znakov krvavitve nemudoma poiskati zdravniško pomoč.
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).
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).
The effect of taking Waylivra with alcohol is not known.
Učinek jemanja zdravila Waylivra z alkoholom ni znan.
Clear, colourless to slightly yellow solution with a pH of approximately 8 and osmolarity of 363-485 mOsm/kg.
Bistra, brezbarvna do rahlo rumena raztopina s pH približno 8 in osmolalnostjo 363-485 mOsm/kg.
Lipid Parameter (g/L for apoC-III, apoB, apoB-48; mmol/L for cholesterol, triglycerides)
Lipidni parameter (g/l za apoC-III, apoB, apoB-48; mmol/l za holesterol, trigliceride)
Do not administer intramuscularly or intravenously.
Ne injicirajte ga intramuskularno ali intravensko.
o Information about the FCS disease registry and the PASS study and the importance of contributing to those studies.
o Informacije o registru bolezni FCS in študiji PASS ter spodbudo k sodelovanju pri teh študijah.
Urine tests
Preiskave urina
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.
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.
Contents of the pack and other information What Waylivra contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Waylivra