FrancophonIA/ELRC3.0 huggingface dataset:
English: Adults (18 years or above) Median 95% CI* Median 95% CI Median 95% CI Terminal half-life (days) 41.3 20.2 to 86.8 45.1 27.3 to 89.3 31.9 29.6 to 36.1 Cmin (mg/dl)/(mg/kg) (trough level)
Slovenian: Odrasli (18 let ali več) Mediana 95 % IZ* Mediana 95 % IZ Mediana 95 % IZ
English: Do not use KIOVIG:
Slovenian: Ne uporabljajte zdravila KIOVIG:
English: Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Slovenian: Pri bolnikih, ki so prejemali zdravljenje z i.v.
English: Only clear to slightly opalescent and colourless to pale yellow solutions are to be administered.
Slovenian: Infundirati smete le bistre ali rahlo opalescentne in brezbarvne do bledo rumene raztopine.
English: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Slovenian: Kronična vnetna demielinizacijska poliradikulonevropatija (CIPD)
English: Headache, high blood pressure, nausea, rash, local reactions (e.g. pain and swelling or other reactions at the infusion site), fever, tiredness.
Slovenian: • Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 1 od 10 bolnikov): glavobol, visok krvni tlak, slabost s siljenjem na bruhanje, izpuščaj, lokalne reakcije (npr. bolečine in otekanje ali druge reakcije na mestu infundiranja), zvišana telesna temperatura, utrujenost.
English: Cough, rhinorrhoea, asthma, nasal congestion, oropharyngeal pain, dyspnea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj, izcedek iz nosu, astma, zamašen nos, orofaringealna bolečina, dispneja pogosti orofaringealno otekanje občasni
English: In case of renal impairment, IVIg discontinuation should be considered.
Slovenian: V primeru ledvične okvare po potrebi prekinite zdravljenje z i.v.
English: Oropharyngeal swelling
Slovenian: Diuretiki Henlejeve zanke
English: Renal parameters should be assessed prior to infusion of IVIg, particularly in patients judged to have a potential increased risk for developing acute renal failure, and again at appropriate intervals.
Slovenian: Zlasti pri bolnikih, pri katerih se oceni, da imajo morebitno povečano tveganje za pojav akutne ledvične odpovedi, je treba pred infuzijo i.v.
English: starting dose: 2 g/kg maintenance dose: 1 g/kg or 2 g/kg given over 2-5 days every 2-4 weeks or every 4-8 weeks over 2-5 days
Slovenian: začetni odmerek: 2 g/kg vzdrževalni odmerek: 1 g/kg razdeljeno na več odmerkov v obdobju 2-5 dni vsake 3 tedne v obdobju 1-2 dni
English: In all patients, IVIg administration requires:
Slovenian: Pri vseh bolnikih je pri uporabi i.v.
English: In patients at risk for acute renal failure, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Slovenian: Pri bolnikih, pri katerih obstaja tveganje za akutno ledvično odpoved, je treba pripravke i.v.
English: Insomnia, anxiety
Slovenian: Psihiatrične motnje nespečnost, anksioznost pogosti razdražljivost občasni
English: Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced red blood cells (RBC) sequestration.
Slovenian: Hemolitična anemija se lahko pojavi kot posledica zdravljenja z i.v.
English: In patients at risk, the use of IVIg products that do not contain these excipients may be considered.
Slovenian: imunoglobulinske pripravke, ki ne vsebujejo teh pomožnih snovi.
English: Table 2 Post-Marketing Adverse Reactions (ARs)
Slovenian: Preglednica 2 Pogostnost neželenih učinkov zdravil (AR), ugotovljenih po pridobitvi dovoljenja za promet z zdravilom
English: In patients at risk for thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable.
Slovenian: Pri bolnikih, ki so ogroženi zaradi možnosti tromboemboličnih neželenih učinkov, morate i.v.
English: Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment (see also Section 4.4).
Slovenian: imunoglobulinov pojavi hemolitična anemija (glejte poglavje 4.4).
English: In divided doses over 2-5 days every 3 weeks over 1-2 days
Slovenian: vsake 2 do 4 tedne oz. vsakih 4 do 8 tednov v obdobju 2-5 dni.
English: Vertigo, fluid in middle ear
Slovenian: Ušesne bolezni, vključno z motnjami labirinta vrtoglavica, tekočina v srednjem ušesu občasni
English: Psychiatric disorders
Slovenian: Povzročitelji nalezljivih bolezni
English: 48 hours.
Slovenian: 48 ur
English: Please inform your doctor if you are pregnant or think you may be pregnant.
Slovenian: Prosimo, obvestite vašega zdravnika, če ste noseči ali menite, da bi lahko bili noseči.
English: The product is implanted locally.
Slovenian: Izdelek se implantira lokalno.
English: Your surgeon will give you more information.
Slovenian: Vaš kirurg vam bo dal več informacij.
English: Grounds for one additional renewal
Slovenian: Osnova za eno dodatno podaljšanje
English: Ask your doctor for more information as to which pain medication you can safely use.
Slovenian: Vašega zdravnika prosite za več informacij o tem, katera protibolečinska zdravila lahko varno uporabljate.
English: Patients had to agree to actively participate in a strict rehabilitation protocol and follow-up program.
Slovenian: Bolniki so se morali strinjati z aktivnim sodelovanjem v strogem rehabilitacijskem protokolu in programu spremljanja.
English: If you do not follow your rehabilitation schedule, the risk of treatment failure may increase.
Slovenian: Če ne boste izvajali svojega rehabilitacijskega programa, se lahko poveča tveganje za neuspešno zdravljenje.
English: Do not expose to radioactive irradiation (X-rays).
Slovenian: Ne izpostavljajte radioaktivnemu sevanju (rentgenskim žarkom).
English: Driving cars and using machines may be limited during the rehabilitation period.
Slovenian: Vožnjo avtomobila in upravljanje strojev bo morda v obdobju rehabilitacije treba omejiti.
English: Store between 15°C - 25°C.
Slovenian: Shranjujte pri temperaturi od 15 °C do 25 °C.
English: You should be very cautious when bending and putting weight on your treated knee.
Slovenian: Zelo previdni morate biti pri upogibanju in obremenjevanju vašega zdravljenega kolena.
English: The safety and efficacy in children and adolescents (aged less than 18) have not been established.
Slovenian: Varnost in učinkovitost pri otrocih in mladostnikih (starih manj kot 18 let) še nista bili dokazani.
English: Fibrin sealant products differ significantly in their quantitative and qualitative composition.
Slovenian: Fibrinska tesnilna sredstva se zelo razlikujejo po svoji količinski in kakovostni sestavi.
English: • Cartilage is a tissue that is present in every joint.
Slovenian: • Hrustanec je tkivo, prisotno v vsakem sklepu.
English: To protect your knee, you will have to wear a brace.
Slovenian: Za zaščito vašega kolena boste morali nositi opornik.
English: It is very important to carefully observe the recommendations of your doctor and/or physical therapist.
Slovenian: Zelo pomembno je, da dosledno upoštevate priporočila vašega zdravnika in/ali fizioterapevta.
English: If, based on the benefit/risk assessment of the responsible surgeon treatment of patients below 18 years is considered, special attention should be given to ensure that the growth plate is completely closed.
Slovenian: Če se na podlagi ocene koristi/tveganj odgovornega kirurga premišljuje o zdravljenju bolnikov pod 18 let, je treba posebno pozornost posvetiti temu, da je rastna plošča povsem zaprta.
English: A defect can be caused by acute trauma, such as a fall.
Slovenian: Okvaro lahko povzroči akutna travma, kot je padec.
English: Your doctor or physical therapist will give you more details on your rehabilitation.
Slovenian: Vaš zdravnik ali fizioterapevt vam bosta dala več podatkov o vaši rehabilitaciji.
English: Dispose of in accordance with local requirements.
Slovenian: Odstranite v skladu z lokalnimi predpisi.
English: It protects the ends of our bones and allows our joints to function smoothly.
Slovenian: Ščiti konce kosti in omogoča nemoteno delovanje sklepov.
English: The adverse reactions listed are those that occurred most frequently, with treatment failure and delamination being the most serious.
Slovenian: Neželeni učinki, ki so navedeni, so tisti, do katerih je prišlo bolj pogosto, med njimi pa sta najresnejša neuspešno zdravljenje in delaminacija.
English: Therefore the treated knee should be protected according to the recommendations as outlined in the appropriate rehabilitation schedule, to avoid early damage which might lead to graft failure.
Slovenian: Zato je treba zdravljeno koleno zaščititi v skladu s priporočili ustreznega rehabilitacijskega programa, da bi se izognili zgodnjim poškodbam, ki bi lahko vodile k neuspehu vsaditve.
English: During the rehabilitation period, the level of weight-bearing will increase gradually, depending on your weight and the size of the cartilage defect.
Slovenian: Med rehabilitacijo se bo stopnja obremenitve postopno povečevala v odvisnosti od vaše teže in velikosti okvare hrustanca.
English: Do not irradiate.
Slovenian: Ne izpostavljajte sevanju.
English: Frequencies are defined according to the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Slovenian: Frekvence so opredeljene skladno z naslednjo konvencijo: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000).
English: The marketing authorisation holder shall submit the periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora redno posodobljena poročila o varnosti zdravila za to zdravilo predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: Treatment with ChondroCelect: a two-step procedure.
Slovenian: Zdravljenje z zdravilom ChondroCelect: postopek v dveh korakih.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/563/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/563/001
English: Pain relief medicinal products should be used according to the recommendations of the responsible surgeon.
Slovenian: Protibolečinska zdravila je treba uporabljati v skladu s priporočili odgovornega kirurga.
English: - The use of ChondroCelect is generally not recommended when you are overweight (i.e. a Body Mass Index over 30) because it could compromise the result of the treatment.
Slovenian: - Uporaba zdravila ChondroCelect na splošno ni priporočljiva, če imate prekomerno telesno maso (tj. indeks telesne mase nad 30), ker lahko ogrozi rezultat zdravljenja.
English: The product is packaged in several layers of packaging material which guarantee sterility and stable temperature conditions for 48 hours if stored at room temperature.
Slovenian: Zdravilo je pakirano v več plasteh embalaže, ki zagotavljajo sterilnost in stabilne temperaturne pogoje 48 ur ob shranjevanju na sobni temperaturi.
English: Although it is thought that these reactions are mostly surgery-related, a potential influence of the expanded chondrocytes cannot be completely excluded.
Slovenian: Čeprav se meni, da so te reakcije večinoma povezane z operacijo, ni mogoče povsem izključiti morebitnega vpliva ekspandiranih hondrocitov.
English: The cells are kept alive in a small sterile vial.
Slovenian: Celice se ohranja žive v majhni sterilni viali.
English: For the group with a longer time since onset of symptoms there were no apparent differences between the 2 groups.
Slovenian: Za skupino, pri kateri je od pojava simptomov preteklo več časa, med 2 skupinama ni bilo opaznih razlik.
English: Date of latest renewal: 22 August 2014
Slovenian: Datum prve odobritve: 5 oktober 2009 Datum zadnjega podaljšanja: 22 avgust 2014
English: • Obligation to conduct post-authorisation measures Not applicable.
Slovenian: • Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet Navedba smiselno ni potrebna.
English: The surgeon will be informed as early in the process as possible, and should hence select an alternative treatment for the patient concerned.
Slovenian: Kirurg bo med postopkom obveščen tako hitro, kot je to mogoče, in mora nato za zadevnega bolnika izbrati drug način zdravljenja.
English: In a study in sheep, the majority of animals showed penetration of the transplanted cells in subchondral bone; in two of these cases complete penetration of underlying bone marrow was observed.
Slovenian: Študija na ovcah je pri večini živali pokazala penetracijo transplantiranih celic v subhondralno kost; v dveh izmed teh primerov je bila opažena popolna penetracija kostnega mozga.
English: After surgery, you will have to follow a rehabilitation program for approximately one year, to allow your knee to heal well.
Slovenian: Po operaciji boste morali približno eno leto izvajati rehabilitacijski program, da bi omogočili dobro zdravljenje vašega kolena.
English: Further clinical data in patients with larger lesions are foreseen to be collected in the future.
Slovenian: V prihodnosti se napoveduje zbiranje nadaljnjih kliničnih podatkov pri bolnikih z večjimi lezijami.
English: • Training material for other healthcare professionals
Slovenian: • gradivo za usposabljanje drugih zdravstvenih delavcev
English: The efficacy of ChondroCelect was studied in a phase III, multicenter, randomized, controlled trial (TIG/ACT/01/2000) and the first two years of its 4-year extension phase (TIG/ACT/01/2000EXT).
Slovenian: Učinkovitost zdravila ChondroCelect je bila preučevana v multicentrični, randomizirani, kontrolirani študiji III. faze (TIG/ACT/01/2000) in prvih dveh letih njegove štiriletne faze razširitve (TIG/ACT/01/2000EXT).
English: According to current literature the incidence of cartilage hypertrophy can be reduced by using a collagen membrane to cover the lesion site instead of using a periosteal flap (Gooding et al., 2006; Niemeyer et al., 2008).
Slovenian: Glede na trenutno literaturo se lahko pogostnost hipertrofije hrustanca zmanjša z uporabo kolagenske membrane za pokritje mesta lezije namesto uporabe zaplate periosta (Gooding et al., 2006; Niemeyer et al., 2008).
English: ChondroCelect is an autologous product and should under no circumstances be administered to other patients.
Slovenian: Zdravilo ChondroCelect je avtologen proizvod in se v nobenem primeru ne sme dajati drugim bolnikom.
English: The purpose is to repair the defect with healthy and functional cartilage over time.
Slovenian: Namen je zdravljenje okvare z zdravim in funkcionalnim hrustancem v daljšem obdobju.
English: Please tell your doctor or physical therapist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali fizioterapevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: PharmaCell Cell Manufacturing Facility B.V., Urmonderbaan 20B, 6167 RD Geleen, Netherlands
Slovenian: Izdelovalec: PharmaCell Cell Manufacturing Facility B.V., Urmonderbaan 20B, 6167 RD Geleen, Nizozemska
English: • The need for screening of donors using patient questionnaire and laboratory tests for hepatitis C,
Slovenian: • potrebo po testiranju darovalcev z uporabo vprašalnikov laboratorijskih preskusov za hepatitis
English: For information on preparation and handling of ChondroCelect, please refer to section 6.6.
Slovenian: Glede informacij o pripravi in ravnanju z zdravilom ChondroCelect glejte poglavje 6.6.
English: The use of fibrin glue inside the cartilage defect bed is not recommended as this may result in a significantly poorer outcome (see section 5.3).
Slovenian: Uporaba fibrinskega lepila v poškodovanem hrustancu ni priporočljiva, ker je rezultat lahko veliko slabši (glejte odsek 5.3).
English: Patients with femoral epiphyseal growth plate that is not fully closed
Slovenian: Bolniki s femoralno epifizno rastno ploščo, ki ni povsem zaprta.
English: The safety data obtained in these patients do not indicate a particular safety concern, and confirm a lower incidence of hypertrophy as suggested by scientific literature on the use of collagen membranes versus periost.
Slovenian: Varnostni podatki, pridobljeni pri teh bolnikih, ne nakazujejo posebnih težav z varnostjo in potrjujejo manjšo pogostnost hipertrofije, kot nakazuje znanstvena literatura o uporabi kolagenskih membran v primerjavi s periostom.
English: This finding might be related to the inability to perform a progressive loading under nonweight bearing conditions post-surgery in these models and therefore cannot be fully extrapolated as such to the human situation.
Slovenian: Ugotovitve so morda povezane z nezmožnostjo postopnega obremenjevanja v pogojih pooperativne neobremenitve pri teh modelih in jih zato ni mogoče v celoti ekstrapolirati na situacijo človeka.
English: Hypersensitivity to any of the excipients listed in section 6.1, or to bovine serum.
Slovenian: Preobčutljivost na katero koli pomožno snov, navedeno v poglavju 6.1, ali goveji serum.
English: The nature and intended clinical use of ChondroCelect are such that conventional studies on pharmacokinetics, absorption, distribution, metabolism and elimination are not applicable.
Slovenian: Narava in načrtovana klinična uporaba zdravila ChondroCelect sta takšni, da običajne študije farmakokinetike, absorpcije, porazdelitve, presnove in izločanja niso potrebne.
English: The safety data obtained in these patients do not indicate a particular safety concern.
Slovenian: Varnostni podatki, dobljeni pri teh bolnikih, ne nakazujejo posebnih težav z varnostjo.
English: Post-marketing experience with respect to patient number, i.e. 444 patients and duration of follow-up is still quite limited, and doesn't warrant granting a renewal with unlimited validity.
Slovenian: Izkušnje z zdravilom po začetku trženja glede na število bolnikov, kar pomeni 444 bolnikov, in trajanje spremljanja so še vedno precej omejene in ne upravičujejo odobritve dovoljenja z neomejeno veljavnostjo.
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of ChondroCelect remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Slovenian: Na podlagi podatkov, ki so postali razpoložljivi od izdaje prvega dovoljenja za promet z zdravilom, Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da razmerje med koristmi in tveganji pri uporabi zdravil ChondroCelect ostaja pozitivno, vendar je njegov varnostni profil je treba pozorno spremljati zaradi naslednjih razlogov:
English: In the pivotal study there was no influence of Body Mass Index (BMI) on outcome but bibliographic data shows that a BMI over 30 may adversely affect the success of the procedure.
Slovenian: V glavni študiji ni bilo vpliva indeksa telesne mase (ITM) na rezultat, vendar pa bibliografski podatki kažejo, da lahko ITM nad 30 negativno vpliva na uspeh postopka.
English: Fax: +32-(0)16 39 60 70 info@tigenix.com
Slovenian: Faks: +32-(0)16 39 60 70 info@tigenix.com
English: Prior to implantation match the patient name to the patient/donor identification on the shipment documentation and product vial.
Slovenian: Pred implantacijo preverite ujemanje imena bolnika z identifikacijo bolnika/darovalca v dokumentaciji o pošiljki in na viali zdravila.
English: Non-clinical data based on implantation of expanded cartilage cells in goats and mice did not reveal special hazard for humans.
Slovenian: Neklinični podatki na podlagi implantacije ekspandiranih hrustančnih celic pri kozah in miših niso pokazali posebnega tveganja za človeka.
English: The Marketing Authorisation Holder (MAH) shall ensure that the medicinal product will be distributed only to Healthcare Establishments that meet criteria described in the Risk Management Plan.
Slovenian: Imetnik dovoljenja za promet z zdravilom zagotovi, da se zdravilo priskrbi le zdravstvenim ustanovam, ki izpolnjujejo merila, opisana v načrtu za obvladovanje tveganj.
English: Depending on the location, the size of the lesion and the patient's profile, appropriate rehabilitation instructions have been developed.
Slovenian: Glede na mesto, velikost lezije in profil bolnika so bila pripravljena ustrezna navodila za rehabilitacijo.
English: In the majority of the 370 patients included in the Compassionate Use Program, a collagen membrane instead of a periosteal flap was used to seal the defect.
Slovenian: Pri večini izmed 370 bolnikov, vključenih v program sočutne uporabe, je bila za tesnjenje okvare uporabljena kolagenska membrana namesto zaplate periosta.
English: In studies in goats, mild signs of synovitis were observed in the majority of the animals, including controls at 10 weeks post surgery.
Slovenian: Pri študijah na kozah so bili opaženi blagi znaki sinovitisa pri večini živali, vključno pri kontrolah pri 10 tednih po operaciji.
English: Synovitis and subchondral bone injuries have been reported in animal models and are possible risks with the use of ChondroCelect.
Slovenian: O sinovitisu in subhondralnih poškodbah kosti so poročali pri živalskih modelih in predstavljajo morebitna tveganja pri uporabi zdravila ChondroCelect.
English: It can also be caused by repetitive trauma, as a result of overweight or due to incorrect weight-bearing on the knee as a result of a knee deformity.
Slovenian: Povzroči jo lahko tudi ponavljajoča se travma, ki je posledica prevelike telesne mase, ali dolgotrajno nepravilno prenašanje telesne mase na koleno, kar je posledica deformacije kolena.
English: These studies have demonstrated that this type of fibrin sealant can be safely used with ChondroCelect.
Slovenian: Te študije so pokazale, da se lahko to vrsto fibrinskega tesnilnega sredstva varno uporablja z zdravilom ChondroCelect.
English: Each pack contains an individual treatment dose consisting of 1 to 3 vials, depending on the number of cells needed to treat the specific lesion size.
Slovenian: Vsak paket vsebuje individualen odmerek za zdravljenje, ki ga sestavlja od 1 do 3 viale, odvisno od števila celic, potrebnih za zdravljenje specifične velikosti lezije.
English: The amount of cells to be administered is dependent on the size (surface in cm²) of the cartilage defect.
Slovenian: Količina uporabljenih celic je odvisna od velikosti (površina v cm2) okvare hrustanca.
English: The product is made from a small sample of cartilage cells (a biopsy) taken from your knee.
Slovenian: Izdelek je narejen iz majhnega vzorca hrustančnih celic (biopta), vzetega iz vašega kolena.
English: The estimated benefit was larger in the ChondroCelect group but the results did not reach statistical significance.
Slovenian: Ocenjene koristi so bile večje v skupini, ki je jemala zdravilo ChondroCelect, vendar izid ni bil statistično pomemben.
English: If the ChondroCelect vial is damaged or its sterility has been compromised, the product must not be used and must be shipped back to TiGenix.
Slovenian: Če je viala zdravila ChondroCelect poškodovana ali je ogrožena njena sterilnost, se zdravilo ne sme uporabiti in ga je treba poslati podjetju TiGenix.
English: There are no data on possible effects of ChondroCelect treatment on fertility.
Slovenian: Ni podatkov o možnih učinkih zdravljenja z zdravilom ChondroCelect na plodnost.
English: In vitro interaction studies were performed with a commercially available fibrin glue containing aprotinin (a fibrinolysis inhibitor of bovine origin).
Slovenian: Izvedene so bile interakcijske študije in vitro s komercialno razpoložljivim fibrinskim lepilom, ki vsebuje aprotinin (inhibitor fibrinolize govejega izvora).
English: A decision should be made whether to discontinue breast-feeding taking into account the potential benefits of the treatment for the woman and the potential risk to the infant.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z zdravilom, pri čemer je treba pretehtati možne prednosti zdravljenja za mater in možna tveganja za otroka.