natgillin/translations-raw huggingface dataset:
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
Anti-platelet or other anti-coagulant medicinal products must not be used concomitantly with Glybera at the time of injection.
V času injiciranja se zdravilo Glybera ne sme uporabljati sočasno z antiagregacijskimi sredstvi in antikoagulanti.
It belongs to a group of medicines called lipid modifying agents.
Spada v skupino zdravil za zmanjšanje ravni serumskih lipidov.
A single intravenous bolus of methylprednisolone (1 mg/kg bodyweight) was given 30 minutes prior to alipogene tiparvovec administration.
Bolniki so 30 minut pred injiciranjem alipogentiparvoveka prejeli enkratni intravenski bolus metilprednizolona (1 mg/kg telesne mase).
Patient Code number:
Ime zdravnika: Tel. št. zdravnika: Številka bolnika:
Do not take oral contraceptives as they have the potential to worsen your disease; Use condoms so that as little Glybera as possible may be passed to/from your partner.
Uporabljajte kondome, tako da na/od vašega partnerja preide čim manj zdravila Glybera.
Glybera should not be administered to women who are breast-feeding as long as breastfeeding is ongoing.
Zdravilo Glybera se ne sme uporabljati pri doječih materah, dokler dojijo.
3) Educational materials for patients treated with Glybera including the following key safety elements:
1) Izobraževalno gradivo za farmacevte, vključno z naslednjimi ključnimi varnostnimi elementi:
Once thawed the medicinal product must be used immediately; if not used immediately, the vials should be stored in a refrigerator at 2ºC to 8ºC, and protected from light for a maximum of 8 hours.
Če se ne uporabi takoj, se sme viale shranjevati največ 8 ur v hladilniku pri temperaturi od 2 ºC do 8 ºC, pri čemer morajo biti zaščitene pred svetlobo.
A transient reduction of triglycerides for up to 12 weeks in some individual patients has been observed.
Pri nekaterih posameznikih so opazili prehodno zmanjšanje trigliceridov v trajanju do 12 tednov.
Pack size 3 vials
Velikost pakiranja po 3 viale
Patient-specific pack containing sufficient amount of vials to dose each patient Liquid absorbing sheet is also contained.
Za bolnika specifično pakiranje, ki vsebuje zadostno količino vial za odmerjanje pri posameznem bolniku.
Marketing Authorisation Holder uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Imetnik dovoljenja za promet z zdravilom uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, Nizozemska.
• Guidance on the selection of suitable patients for treatment with Glybera including: o the need for genetic testing to be performed prior to the initiation of treatment in order to identify the patients who are eligible for treatment o that patients should not be taking anti-platelet or other anti-coagulation medicinal products at the time of injection o the need to exclude infection before starting immunosuppressant treatment o the need for all patients to be entered into a long term surveillance programme
• Smernice o izbiri primernih bolnikov za zdravljenje z zdravilom Glybera, vključno s: o potrebo po genskih preiskavah, ki jih je treba opraviti pred začetkom zdravljenja, da se ugotovijo bolniki, primerni za zdravljenje;
Glybera is not usually recommended for use during pregnancy.
Uporaba zdravila Glybera med nosečnostjo ni priporočljiva.
For each injection site, one syringe of 1 ml with clear volume marks of 0.5 ml must be used.
Za vsako mesto injiciranja je treba uporabiti eno 1-ml injekcijsko brizgo z jasnimi oznakami za prostornino po 0,5 ml. Prostornina na mesto injiciranja ne sme preseči 0,5 ml. Brizge je dovoljeno uporabiti le enkrat.
• Guidance on the need for immunosuppressive administration prior to and after treatment
• Potreba po regionalni ali spinalni anesteziji • Smernice o potrebi po imunosupresivnem režimu pred zdravljenjem in po njem
• Advice on the need and duration of barrier contraception
• Svetovanje o potrebi po pregradni kontracepciji in trajanju njene uporabe • Prepoved darovanja organov, krvi in celic
Burning sensation, Dizziness, Formication, Presyncope
Bolezni živčevja glavobol pekoč občutek, omotica, mravljinčenje,
The patients enrolled in clinical studies (CT-AMT-010-01, CT-AMT 01101, CT-AMT 011-02) should be followed up in the LPLD registry.
01, CT-AMT 011-02), je treba izvajati sledenje v registru LPLD.
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Dyspnoea exertional, Pulmonary embolism
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja ob naporu, pljučna embolija
Assessment of each individual subject's risk profile prior to Glybera administration is advised.
Pred uporabo zdravila Glybera je priporočljiva ocena profila tveganja pri posameznem bolniku.
Number of vials (1 mL) Number of 1ml syringes (each filled with 0.5ml)
Primeri tipičnih razporedov odmerjanja na podlagi telesne mase bolnikov so prikazani v spodnji razpredelnici: Telesna masa (kg) Število vial (1 ml) Število 1-ml injekcijskih brizg (vsaka je napolnjena z 0,5 ml)
Glybera should under no circumstances be administered intravascularly.
Zdravilo Glybera se ne sme nikoli injicirati intravaskularno.
Very common (may affects more than 1 in 10 people)
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) • bolečina v nogi (nogah) (bolečina v okončini)
To avoid this, your doctor will also prescribe treatment that will suppress the immune system (known as immunosuppressants), starting 3 days before the day of injection with Glybera and for 12 weeks after.
Da se temu izognete, bo zdravnik predpisal zdravljenje, ki bo zavrlo imunski sistem (imenovano imunosupresivno zdravljenje).
The active substance is alipogene tiparvovec.
Zdravilna učinkovina je alipogentiparvovek.
Glybera 3 × 1012 genome copies/ml solution for injection
Glybera 3 × 1012 genomskih kopij/ml raztopina za injiciranje
o information on the signs and symptoms of a reduction/loss of efficacy o the use of the events diary and what should be recorded
o uporabo dnevnika za dogodke in kaj je treba beležiti vanj.
In particular, tell your doctor if you are taking the following before you are given Glybera:
Preden prejmete zdravilo Glybera, zdravnika obvestite predvsem, če jemljete kar koli od naslednjega:
Except for the site of injection, the highest vector DNA copy numbers were found in the liver and blood.
Z izjemo mesta injiciranja so največje število kopij DNK
How to store Glybera
Shranjevanje zdravila Glybera
• The need to provide the educational material to patients and request their informed consent to be enrolled into the registry prior to treatment o the need and duration of barrier contraception o not to donate organs nor blood nor cells o on the need to continue on a low-fat diet and avoid drinking alcohol o the necessity to carry the patient alert card, that is included in each pack, with them at o that enrolment is mandatory for patients treated with Glybera o that patients treated with Glybera in a clinical trial should be enrolled in the registry at o that, where possible, patients with familial LPLD who are not treated with Glybera o the need to obtain the patient's informed consent prior to treatment o how to enter patients in it - including those not treated with Glybera
o o da je vključitev obvezna za bolnike, ki se zdravijo z zdravilom Glybera; o da se morajo bolniki, ki se bodo zdravili z zdravilom Glybera v kliničnem preskušanju, na o da je treba v register vključiti bolnike z družinskim LPLD, ki se ne zdravijo z zdravilom o potreba po pridobivanju bolnikovega informiranega soglasja pred zdravljenjem;
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (3 vial pack)
PROZOREN, ZATESNJEN PLASTIČEN OVOJ (pakiranje s 3 vialami)
Disodium phosphate
Žilne bolezni hipertenzija
This product contains GMO.
To zdravilo vsebuje GSO.
Preparation of Glybera for administration
Priprava zdravila Glybera za injiciranje
Investigations
Diagnozo
Glybera 3 × 1012 genome copies/ml solution for injection Alipogene tiparvovec
Glybera 3 × 1012 genomskih kopij/ml raztopina za injiciranje alipogentiparvovek
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (2 vial pack)
PROZOREN, ZATESNJEN PLASTIČEN OVOJ (pakiranje z 2 vialama)
After you have been given Glybera, you may notice that your legs have a yellow colour; this might occur in case iodine was used to clean (sterilise) your legs before you received the medicine.
Ko boste prejeli zdravilo Glybera, boste morda opazili, da so vaše noge rumenkaste.
Clinical trial CT-AMT-11-05
Klinično preskušanje CT-AMT-11-05
Name and address of the manufacturer(s) responsible for batch release uniQure biopharma B.V. Meibergdreef 61
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij uniQure biopharma B.V.
AAV1-LPLS447X was administered to 8 LPLD patients in a 12-week, open label dose escalating study (1 x 1011 gc to 3 x 1011 gc per kg body weight i.m.).
Klinično preskušanje CT-AMT-010-01 V 12-tedenski odprti študiji s povečevanjem odmerka so AAV1-LPLS447X dali 8 bolnikom z LPLD (1
• difficulty breathing, chest pain on breathing in and palpitations which may be caused by blockage of the main blood vessel of the lung
• mišične bolečine in bolečine ter togost v sklepih • težave z dihanjem, bolečina v prsnem košu pri vdihu in palpitacije, ki jih lahko povzroča
including the need for injections to be administered under ultrasound or electrophysiological guidance
• Smernice o preprečevanju tveganj, povezanih z intramuskularnim injiciranjem zdravila Glybera, vključno s potrebo, da se injiciranje izvede pod ultrazvočnim ali elektrofiziološkim nadzorom • Podrobna navodila o odmerku, številu in lokalizaciji injiciranja
Five eligible subjects were included in the study with all subjects receiving alipogene tiparvovec.
od katerih so vsi prejemali alipogentiparvovek.
Clinical trial CT-AMT-11-03
Klinično preskušanje CT-AMT-11-03
In addition methylprednisolone might be administered half an hour prior to the Glybera administration.
Poleg tega lahko pol ure pred injiciranjem zdravila Glybera prejmete metilprednizolon.
Clinical trial CT-AMT-011-02
Klinično preskušanje CT-AMT-011-02
Clinical trial CT-AMT-011-01
Klinično preskušanje CT-AMT-011-01
Sodium content and potassium content
Vsebnost natrija in kalija
After the amount of Glybera to be administered has been calculated (see section 4.2) remove the correct number of single use vials from the freezer to thaw at room temperature (15oC to 25oC), approximately 30-45 minutes in advance of syringe filling.
Priprava zdravila Glybera za injiciranje Ko se izračuna količina zdravila Glybera, ki jo je treba injicirati (glejte poglavje 4.2), vzemite ustrezno število vial za enkratno uporabo iz zamrzovalnika in počakajte, da se odtajajo na sobni temperaturi (15
Doctors shall be encouraged also to enrol patients with familial LPLD who are not treated with Glybera.
LPLD, ki se niso zdravili z zdravilom Glybera.
1) Educational material for Pharmacists including the following key safety elements: • Detailed guidelines for product receipt and storage, procedure for the preparation, handling
• Podrobne smernice za sprejem in shranjevanje zdravila, postopek priprave, ravnanje in • Smernice za zagotavljanje, da bolniki prejmejo kartico z opozorili za bolnika, priloženo
Breast-feeding
presinkopa
Injection site discomfort, Injection site oedema, Injection site pruritus
Poškodbe in zastrupitve in zapleti pri posegih neugodje na mestu injiciranja, edem na mestu injiciranja, pruritus na mestu
Abdominal pain.Nausea, Constipation
Bolezni prebavil bolečina v trebuhu, navzea, obstipacija
The treatment should be monitored by measuring neutralising antibodies and T-Cell response against AAV1 and LPLS447X and T-Cell response at baseline as well as 6 and 12 months after treatment.
LPLS447X in merjenjem odziva limfocitov T ob izhodišču ter 6 in 12 mesecev po zdravljenju.
Doctor Phone:
Datum zdravljenja:
No vector DNA could be detected in the foetuses after treatment of either the females or the males prior to mating.
Po zdravljenju samcev ali samic pred parjenjem pri plodih niso zaznali DNK vektorja.
Side effects from your immunosuppressants
Razpredelnica z neželenimi učinki
Glybera should be administered to you in one treatment session only.
Zdravilo Glybera morate prejeti v obliki enkratne terapije.
Each vial of alipogene tiparvovec contains 1 extractable ml of solution, containing 3 x 1012 genome copies (gc).
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka viala vsebuje 1 ml raztopine, ki ga je mogoče ekstrahirati, in vsebuje 3 x 1012 genomskih kopij
• injection site discomfort, swelling, rash and pain
• nelagodje na mestu injiciranja, oteklina, izpuščaj in bolečina Neželeni učinki imunosupresivnih sredstev
Store and transport vial frozen -25oC to -15oC.
Viale shranjujte in prevažajte zamrznjene pri temperaturi -25 °C do -15 °C.
Clear, to slightly opalescent, colourless solution.
raztopina za injiciranje Bistra do rahlo opalescentna brezbarvna raztopina
Dizziness was commonly observed after Glybera administration.
LPLD, ki so se zdravili z zdravilom Glybera.
12 mg Concentrate for solution for infusion
12 mg Koncentrat za raztopino za infundiranje
1.2 ml (10 mg/ml) 1 vial
Intravenska uporaba viala (steklena) 1,2 ml (10 mg/ml) 1 viala
Official languages:
Uradni jeziki:
The European Union - key facts
Evropska unija - ključna dejstva
Guidelines and scientific advice
Smernice in znanstveni nasveti
Supporting regulatory science outside the EU - the Article 58 procedure
Spodbujanje regulativne znanosti izven EU - postopek iz člena 58
• Right of initiative - it can propose new or amended legislation for the pharmaceutical sector;
• Pravica do pobude - lahko predlaga novo ali spremenjeno zakonodajo za farmacevtski sektor;
National Competent Authorities
Pristojni nacionalni organi
The European Commission can also take action concerning other aspects of medicine regulation:
Evropska komisija lahko ukrepa tudi v zvezi z drugimi vidiki regulacije zdravil:
Different authorisation routes: one set of common rules.
Različni načini pridobitve dovoljenja: enoten sklop skupnih pravil.
These guidelines reflect the latest thinking on developments in biomedical science.
Te smernice odražajo najnovejša dognanja glede razvoja v biomedicinski znanosti.
Pricing and reimbursement
Oblikovanje cen in povračilo
The European system offers different routes for such an authorisation.
Evropski sistem ponuja več načinov za pridobitev takšnega dovoljenja.
This process allows Member States to rely on each other's scientific assessments.
Ta postopek dopušča državam članicam, da se zanašajo na znanstvene ocene drugih držav članic.
primarily of innovative and high-technology medicines developed by pharmaceutical companies for use in the EU.
predvsem inovativnih in visokotehnoloških zdravil, ki jih razvijejo farmacevtska podjetja za uporabo v EU.
The role of the European Commission
Vloga Evropske komisije
Authorisation and supervision of manufacturers
Dovoljenja za proizvajalce in nadzor nad njimi
The regulatory authorities of each Member State are responsible for granting licences for such activities taking place within their respective territories.
Regulativni organi posamezne države članice so odgovorni za izdajanje licenc za dejavnosti, ki se odvijajo na njihovem ozemlju.
• Global outreach - it ensures appropriate collaboration with relevant international partners and promotes the EU regulatory system globally.
• Globalno delovanje - zagotavlja ustrezno sodelovanje z zadevnimi mednarodnimi partnerji in promovira regulativni sistem EU po svetu.
The European Commission plays an important role in the regulation of medicines in the EU.
Evropska komisija igra pomembno vlogo pri regulaciji zdravil v EU.
The use of the centrally authorised procedure is compulsory for most innovative medicines, including medicines for rare diseases.
Uporaba centraliziranega postopka je obvezna pri večini inovativnih zdravil, vključno z zdravili za redke bolezni.
When a company wants to authorise a medicine in several Member States, it can use one of the following procedures:
Ko podjetje želi pridobiti dovoljenje za promet z zdravilom v več državah članicah, lahko uporabi enega od naslednjih postopkov:
EMA is responsible for the scientific evaluation,
Agencija EMA je odgovorna za znanstveno vrednotenje,
A strategic forum at the level of global agencies has recently been established - the International Coalition of Medicines Regulatory Authorities (ICMRA).
Nedavno je bil ustanovljen strateški forum na ravni svetovnih agencij - Mednarodna koalicija regulativnih organov za zdravila (ICMRA).
Population: >500m
Število prebivalcev: več kot 500 milijonov
GDP: € 12.9tn
BDP: 12,9 trilijona evrov
The European regulatory system for medicines monitors the safety of all medicines that are available on the European market throughout their life span.
Evropski regulativni sistem za zdravila spremlja varnost vseh zdravil, ki so na voljo na evropskem trgu, skozi njihovo celotno življenjsko dobo.
Medicines eligible for this procedure, which is derived from Article 58 of the regulation founding the Agency, are used to prevent or treat diseases that impact global public health.
Zdravila, ki so upravičena do tega postopka, ki izhaja iz člena 58 ustanovitvene uredbe agencije, so namenjena preprečevanju ali zdravljenju bolezni, ki vplivajo na globalno javno zdravje.
The role of EMA
Vloga agencije EMA
There are also a number of bilateral cooperation agreements in place that facilitate the exchange of important information on medicines between regulators inside and outside the EU.
Obstajajo še številni dvostranski sporazumi o sodelovanju, ki olajšujejo izmenjavo pomembnih informacij glede zdravil med regulativnimi organi znotraj in izven EU.
• Implementation - it can adopt implementing measures as well as oversee the correct application of EU law on pharmaceuticals;
• Izvajanje - lahko sprejme izvedbene ukrepe in nadzoruje pravilno uporabo prava EU na področju zdravil;
Regulatory cooperation and exchange of information with international regulators is also assured through the International Pharmaceutical Regulators' Forum (IPRF).
Regulativno sodelovanje in izmenjava informacij z mednarodnimi regulativnimi organi se zagotavlja tudi prek Mednarodnega farmacevtskega regulativnega foruma (IPRF).
The EMA has seven scientific committees that carry out its scientific assessments:
Agencija EMA ima sedem znanstvenih odborov, ki opravljajo znanstvene ocene:
ICMRA is a voluntary, executive level entity of medicines regulatory authorities worldwide providing strategic coordination, advocacy and leadership.
ICMRA je prostovoljna svetovna organizacija regulativnih organov za zdravila na izvršilni ravni, ki nudi strateško usklajevanje, zagovorništvo in vodstvo.
EMA was established in 1995 to ensure the best use of scientific resources across Europe for the evaluation, supervision and pharmacovigilance of medicines.
Agencija EMA je bila ustanovljena leta 1995 z namenom, da zagotavlja najboljšo uporabo znanstvenih virov po vsej Evropi za vrednotenje, nadzor in farmakovigilanco zdravil.
Experts participate in the work of EMA as members of its scientific committees, working parties, scientific advisory groups and other ad hoc advisory groups, or as members of the national assessment teams that evaluate medicines.
Strokovnjaki z agencijo EMA sodelujejo kot člani znanstvenih odborov, delovnih skupin, znanstvenih svetovalnih skupin in drugih ad hoc svetovalnih skupin ali kot člani nacionalnih ocenjevalnih skupin, ki ocenjujejo zdravila.
These activities aim to foster the timely exchange of regulatory and scientific expertise and the development of best practices in the regulatory field across the world.
Namen teh dejavnosti je spodbujati pravočasno izmenjavo regulativnega in strokovnega znanja ter razvijati najboljše prakse na področju regulacije po vsem svetu.
EMA's scientific committees
Znanstveni odbori agencije EMA
To protect public health and ensure the availability of high quality, safe and effective medicines for European citizens, all medicines must be authorised before they can be placed on the market in the EU.
Da bi zaščitili javno zdravje in zagotovili dostop do visokokakovostnih, varnih in učinkovitih zdravil za vse evropske državljane, morajo v EU vsa zdravila prejeti dovoljenje, preden se lahko dajo na trg.
The European Commission and EMA, in close cooperation with Member States, work to forge close ties with partner organisations around the world.
Evropska komisija in agencija EMA tesno sodelujeta z državami članicami in skušata vzpostaviti trdne vezi s partnerskimi organizacijami po vsem svetu.
By working closely together, Member States reduce duplication, share the workload and ensure the efficient and effective regulation of medicines across the EU.
S tesnim sodelovanjem države članice zmanjšujejo možnost podvajanja, si porazdelijo delovno obremenitev in zagotavljajo učinkovito in uspešno regulacijo zdravil po vsej EU.
The EU has developed a single market through a standardised system of laws that apply to all its Member States.
Evropska unija (EU) je razvila enotni trg s pomočjo standardiziranega sistema zakonov, ki veljajo za vse države članice.
These data are continuously monitored by EMA and the Member States in order to identify any new safety information.
Agencija EMA in države članice nenehno spremljajo te podatke, da bi odkrile morebitne nove informacije o varnosti.
Public hearings are intended to support the committee's decision-making by providing perspectives, knowledge and insights into the way medicines are used in clinical practice.
Namen javnih predstavitev je podpreti odločitve odbora z zagotavljanjem perspektive, znanja in vpogleda v način, kako se zdravila uporabljajo v klinični praksi.
Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States.
Ko ga odobri Evropska komisija, je centralizirano dovoljenje za promet veljavno v vseh državah članicah EU.
EU Member States: 28
Evropska unija= 28 držav članic
The European Commission and EMA work with the World Health Organization (WHO) on a range of issues, including medicines intended for markets outside the EU (medicines reviewed under EMA's so-called ‘Article 58 procedure'), the quality of medicines and the development of international nonproprietary names.
Evropska komisija in agencija EMA sodelujeta s Svetovno zdravstveno organizacijo (SZO) pri številnih vprašanjih, kot so zdravila, namenjena trgom izven EU (zdravila, pregledana v skladu s EMA t.i. ‘postopkom iz člena 58'), kakovost zdravil in razvoj mednarodnih nelastniških imen.
Increasingly, patients and healthcare professionals are involved in the work of the Agency including in the evaluation of medicines.
V dejavnost agencije je vključenih vse več bolnikov in zdravstvenih delavcev, tudi pri ocenjevanju zdravil.
This is an important tool to help develop and make available high-quality, effective and safe medicines, for the benefit of patients.
To je pomemben način, kako olajšati razvoj in dostopnost visokokakovostnih, učinkovitih in varnih zdravil v korist bolnikov.
Once a marketing authorisation has been granted, decisions about price and reimbursement take place at the level of each Member State considering the potential role and use of the medicine in the context of the national health system of that country.
Po dodelitvi dovoljenja za promet se cena in povračilo določita na ravni posameznih držav članic, ob upoštevanju morebitne vloge in uporabe zdravila v nacionalnem zdravstvenem sistemu zadevne države.
This works because EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines.
Tak sistem je učinkovit, ker zakonodaja EU od vsake države članice zahteva, da ta deluje v skladu z istimi pravili in zahtevami, kar zadeva odobritev in nadzor zdravil.