natgillin/translations-raw huggingface dataset:
The following uncommon side effect may affect up to 1 in 100 people:
Naslednji občasni neželeni učinki se lahko pojavijo pri največ 1 od 100 bolnikov:
A total graft delamination is a serious complication and the patient may experience locking, pain, and swelling after an acute distortion of the knee.
Celotna razslojitev presadka je resen zaplet, pri katerem lahko bolnik doživi blokado, bolečino in oteklino po akutni deformaciji kolena.
Please inform your doctor or surgeon if you are pregnant or think you may be pregnant.
Obvestite zdravnika, če ste noseči, ali menite, da bi lahko bili noseči.
The following rare side effects may affect up to 1 in 1,000 people:
Naslednji redki neželeni učinki se lahko pojavijo pri največ 1 od 1.000 bolnikov:
The biopsy will be sent to the cell processing facility.
Vzorec biopsije se nato pošlje v laboratorij za obdelavo celic.
Your doctor will discuss with you the specific rehabilitation programme that follows your surgery.
S kirurgom se boste posvetovali o posebnem rehabilitacijskem programu, ki sledi operaciji.
The defect bed should be debrided only down to the subchondral plate and not through it.
Debriment ležišča okvare naredimo do subhondralne plošče in ne skozi njo.
• The need for rehabilitation following articular cartilage repair
• Potreba po rehabilitaciji po popravilu sklepnega hrustanca.
Subsequently, the marketing authorisation holder shall submit 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.
Zatem jih mora 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
• Graft delamination (complete or partial, possibly leading to loose bodies in the joint or graft failure)
• razslojitev presadka (popolna ali delna, kar lahko povzroči prosta telesa v sklepu ali neuspeh
Ask your doctor or surgeon for more information as to which pain medicine you can safely use.
Svojega zdravnika ali kirurga vprašajte, katera protibolečinska zdravila lahko varno uporabljate.
• Guidance on the selection of suitable patients for MACI treatment and the importance of using MACI only in the approved indication
• Navodila za izbiro primernih bolnikov za zdravljenje z zdravilom MACI in pomen uporabe zdravila MACI samo v odobreni indikaciji.
The amount of MACI administered is dependent upon the size (surface in cm2) of the cartilage defect.
Količina uporabljenega zdravila MACI je odvisna od velikosti (površina v cm2) okvare hrustanca.
Non-clinical in vitro investigations have shown that the collagen membrane is non-cytotoxic, nonmutagenic, non-reactive (short- and long-term implantation), non-sensitising, a negligible irritant, and non-toxic (acute systemic).
Neklinične raziskave in vitro kažejo, da kolagenska membrana ni citotoksična, ni mutagena, ni reaktivna (kratkoročna in dolgoročna vsaditev), ne povzroča senzibilizacije, da povzroča zanemarljivo draženje in da ni toksična (akutna sistemska).
Each dish contains 1 implantation matrix, held in place by a green polycarbonate x-ring and closed with a green polycarbonate cover for shipment.
V vsaki posodi je 1 matriks za implantacijo, ki je pritrjen z zelenim x-obročkom iz polikarbonata, zaprta pa je z zelenim pokrovom iz polikarbonata za transport.
Following implantation, the patient should follow an appropriately controlled, phased rehabilitation programme as recommended by the treating physician based on the MACI Rehabilitation Manual.
Po vsaditvi se mora bolnik udeležiti ustrezno nadziranega rehabilitacijskega programa, razdeljenega v faze, kot priporoča lečeči zdravnik na podlagi rehabilitacijskega priročnika za zdravilo MACI.
Marketing Authorisation Holder Vericel Denmark ApS, Amaliegade 10, DK-1256 Copenhagen K, Denmark
Imetnik dovoljenja za promet z zdravilom Vericel Denmark ApS, Amaliegade 10, DK-1256 Kopenhagen K, Danska
Due to limited experience, the use of MACI in joints other than the knee is not recommended.
Zaradi omejenih izkušenj se uporaba zdravila MACI pri drugih sklepih, razen za koleno, ne priporoča.
Based on the exposure of more than 6,000 patients to MACI treatment in the knee, complications may be related to the arthrotomy procedure, general complications related to surgical intervention, other knee pathology (such as ligamentous or meniscal pathology), or the biopsy procurement.
Na podlagi izpostavljenosti zdravljenju kolena z zdravilom MACI pri več kot 6.000 bolnikih so lahko zapleti povezani s postopkom artrotomije, splošnimi zapleti, povezanimi s kirurškim posegom, drugimi patologijami kolena (kot je patologija vezi ali meniskusov) ali postopkom biopsije.
MACI is shipped following a validated rapid microbial sterility assay to determine absence of microbial growth.
Zdravilo MACI se pošlje po potrjenem hitrem testu mikrobne sterilnosti, s katerim se potrdi odsotnost mikrobne rasti.
The MAH shall ensure the traceability of each implant by using unique identification numbers assigned to each biopsy (Biopsy ID number), membrane and final MACI product (MAH ID number), as described in the Risk Management Plan.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti sledljivost vsakega vsadka s pomočjo edinstvene identifikacijske številke, dodeljene vsaki biopsiji (ID-številka biopsije), membrani in končnemu zdravilu MACI (ID-številka MAH), kot je opisano v načrtu obvladovanja tveganja.
The pharmacokinetic behaviour of MACI is related to the resorption of the collagen membrane, a proteolytic process performed by cells in the vicinity of the defects.
Farmakokinetično vedenje zdravila MACI je povezano z resorpcijo kolagenske membrane, kar je proteolitični proces, ki ga izvajajo celice v bližini okvare.
Details on the receipt, storage and handling of MACI and its preparation for implantation, including cross checks of patient details and Biopsy ID and MACI product ID numbers
Podrobnosti o prejemu, shranjevanju in ravnanju z zdravilom MACI in o njegovi pripravi za implantacijo, vključno z navzkrižnim preverjanjem podatkov bolnikov, IDštevilko biopsije in ID-številko zdravila MACI.
The median age of patients was 34 to 35 years (age range: 18 to 54), and the mean body mass index was 26.
Povprečna starost bolnikov je bila 34 do 35 let (razpon: 18 do 54), povprečni indeks telesne mase je bil 26.Večina bolnikov je imela vsaj 1 predhodno ortopedsko operacijo kolena.
Non-clinical data based on implantation of MACI in rabbits and horses did not reveal any special hazard
Neklinični podatki na osnovi vsaditve zdravila MACI kuncem in konjem ne kažejo posebnega
Like all medicines, MACI can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo MACI neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The patient's haemostatic functions should be screened prior to surgery.
Bolnikove hemostatske funkcije je treba preveriti pred kirurškim posegom.
This means that other problems in the joint should be corrected before or during MACI implantation.
To pomeni, da je treba vse druge težave sklepa popraviti pred ali med vsaditvijo zdravila MACI.
• Malalignment: the tibio-femoral joint should be properly aligned.
• Neporavnanost: tibiofemoralni sklep mora biti pravilno poravnan.
By 6 months, these signals had subsided, resulting in a normal synovial appearance.
Pri 6 mesecih so ti znaki izzveneli, sinovija pa je dobila normalen videz.
Implantation of MACI is to be performed during arthrotomy under sterile conditions.
Vsaditev zdravila MACI se izvede med artrotomijo v sterilnih pogojih.
Your surgeon will organise the date for implantation.
Kirurg bo določil datum za
The safety and efficacy of MACI in children less than 18 years of age have not been established.
Varnost in učinkovitost zdravila MACI pri otrocih, starih do 18 let, nista bili dokazani.
• have a growth plate of the knee that is not fully closed.
• če rastna plošča v kolenu še ni povsem zaprta.
What MACI is and what it is used for What you need to know before you use MACI How to use MACI
Kaj je zdravilo MACI in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo MACI
Your MACI implant has been manufactured specifically for you and cannot be administered to any other patient.
Zdravilo MACI je bilo izdelano posebej za vas, zato se ga ne sme dati drugim bolnikom.
Your surgeon will explain what arthrotomy and athroscopy
Kirurg vam bo razložil postopek artrotomije in atroskopije.
If positive sterility results are obtained, the treating physician will be contacted to discuss either cancellation of the implantation or a plan of action based on the patient-specific circumstances and risk assessment.
Če so rezultati sterilnost pozitivni, bo lečeči zdravnik o tem obveščen in se bo odločil za odpoved vsaditve ali za načrt ravnanja na podlagi okoliščin, specifičnih za bolnika, in ocene tveganj.
The following important risks have been identified related to either MACI or peri-operative complications:
Opredelili so naslednja pomembna tveganja, ki so povezana bodisi z zdravilom MACI bodisi z zapleti po operaciji:
• Details of appropriate disposal of MACI implant trimmings or unused MACI implants
• Podrobnosti o ustreznem odstranjevanju obrezlin vsadka MACI ali neuporabljenih vsadkov
You may also be given antibiotics or pain-killers to help reduce some of the side effects.
Morda boste prejeli antibiotike ali zdravila proti bolečinam, ki vam bodo pomagala lajšati nekatere neželene učinke.
Both anterior and posterior cruciate ligaments should be stable or undergo reconstruction to reduce shearing forces and rotation stresses across the joint.
Anteriorna in posteriorna križna vez morata biti stabilni ali pa ju je treba rekonstruirati, da se zmanjšajo strižne sile in napetost pri kroženju sklepa.
MACI is an implant consisting of a porcine derived (derived from pigs) collagen membrane which contains your own cartilage cells (called autologous chondrocytes) and is implanted into your knee.
Zdravilo MACI je vsadek, sestavljen iz kolagenske membrane (pridobljen iz prašičev), ki vsebuje vaše lastne hrustančne celice (imenovane avtologni hondrociti), ki se vsadi v vaše koleno.
During the rehabilitation period that follows MACI treatment patients should refer to their treating physician and follow their advice.
V obdobju rehabilitacije, ki sledi zdravljenju z zdravilom MACI, je treba bolnike napotiti k lečečemu zdravniku po nasvet, ki ga morajo upoštevati.
How to use MACI
Kako uporabljati zdravilo MACI
• the graft may detach completely or partially from the defect in the joint.
• vsadek se lahko povsem ali delno odcepi od okvare v sklepu.
Graft delamination refers to a loosening, either partial or total, of the graft from the subchondral bone and from the surrounding cartilage.
Razslojitev presadka pomeni zrahljanje, bodisi delno ali v celoti, presadka od subhondralne kosti in od okoliškega hrustanca.
Other complications have been identified as causally related to MACI.
Ugotovili so druge zaplete, ki so vzročno povezani z zdravilom MACI.
MACI is intended for autologous use only.
Zdravilo MACI je namenjeno samo za avtologno uporabo.
Visit 10 (Week 104) Unstratified
10. obisk (104. teden) Stratificirano glede na center Odzivni Neodzivni Manjkajoči 10. obisk (104. teden)
MACI will be released following successful results from assays which assess chondrocyte viability, identity, potency, minimum cell number, endotoxin, pre-release sterility, and mycoplasma.
Zdravilo MACI sprostijo za uporabo po uspešnih rezultatih testov, ki ocenjujejo viabilnost hondrocitov, identiteto, zmožnost, minimalno število celic, endotoksine, sterilnost pred sprostitvijo in
Adverse reactions are listed by System Organ Class and frequency.
Neželeni učinki so našteti po organskih sistemih in pogostnosti.
MACI is not recommended for pregnant women.
Zdravilo MACI se ne priporoča za nosečnice.
However as MACI will be implanted using invasive surgical techniques, it is not recommended during pregnancy.
Vendar pa vsaditev zdravila MACI poteka z uporabo invazivne kirurške tehnike, zato se je med nosečnostjo ne priporoča.
If you have a sudden occurrence or recent history of bone or joint infections, your MACI treatment should be temporarily delayed until your doctor considers that you have recovered.
Če se vam nenadno pojavi ali ste pred kratkim imeli okužbo kosti ali sklepa, bo zdravljenje z zdravilom MACI začasno preloženo, dokler zdravnik ne oceni, da ste okrevali.
The membrane is resorbed over the months following implantation.
Membrana se v nekaj mesecih po vsaditvi
For information on preparation and handling of MACI, please refer to section 6.6.
Za informacije o pripravi zdravila MACI in ravnanju z njim glejte poglavje 6.6.
Your surgeon will give you more information on any special considerations for your particular case.
Kirurg vam bo posredoval nadaljnje informacije o posebnih zadevah, ki se nanašajo na vas osebno.
Please consult the Surgical Technique Manual for further information.
Za nadaljnje informacije glejte priročnik s kirurškimi tehnikami.
Symptomatic graft hypertrophy is acomplication that may occur with MACI.
Simptomatska hipertrofija presadka je zaplet, ki se lahko pojavi pri uporabi zdravila MACI.
MACI must be administered by a surgeon specifically trained and qualified in the use of MACI.
Zdravilo MACI mora vsaditi kirurg, ki je posebej izurjen in usposobljen za uporabo zdravila MACI.
Cartilage is a tissue that is present in every joint in the body; it protects the ends of bones and allows joints to function smoothly.
Hrustanec je tkivo, ki ga najdemo v vsakem sklepu v telesu; ščiti skrajne dele kosti in omogoča gladko
MACI should be implanted in a reasonably healthy joint.
Zdravilo MACI se vsadi v sorazmerno zdrav sklep.
Four patients were treatment failures in the microfracture treatment arm, versus one in the MACI treatment arm.
Pri štirih bolnikih zdravljenje ni uspelo v kraku zdravljenja s postopkom mikrofrakture, v primerjavi z enim v kraku zdravljenja z zdravilom MACI.
The MAH shall ensure, prior to the distribution of the product to a particular Healthcare Establishment, that all surgeons and other healthcare professionals involved in the handling and administration of MACI or its components, as well as those involved in follow-up of patients treated with MACI in the Healthcare Establishment, receive the educational pack.
Imetnik dovoljenja za promet bo pred razdeljevanjem zdravila zdravstveni ustanovi zagotovil, da bodo vsi kirurgi in drugi strokovnjaki zdravstvene nege, ki uporabljajo zdravilo MACI in njegove sestavne dele, kot tudi vsi tisti, ki sodelujejo v postopku spremljanja bolnikov, ki so se zdravili z zdravilom MACI v zdravstveni ustanovi, prejeli ustrezen izobraževalni paket.
Tell your doctor or surgeon if you know you have a predisposition for bleeding or poor bleeding control following surgical procedures.
Povejte zdravniku ali kirurgu, če veste, da ste nagnjeni h krvavitvam ali se krvavitve po kirurškem posegu pri vas težko obvladajo.
• Details on biopsy procurement, and storage and handling of the biopsy harvest
• Podrobnosti o naročilu biopsije, skladiščenju in ravnanju z rezultati biopsije.
• bleeding in the joint
• krvavitev v sklepu,
“Autologous” means that your own cells are used which have been taken from your knee (through a biopsy) and grown outside the body.
»Avtologno« pomeni, da se uporabi vaše lastne celice, odvzete iz vašega kolena (z biopsijo).
Risks involved with implantation of MACI:
Tveganja, povezana z vsaditvijo zdravila MACI:
Due to the surgical nature of the underlying procedure, implantation with MACI has a major influence on the ability to drive and use machines.
Zaradi kirurške narave osnovnega procesa ima vsaditev zdravila MACI pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
• Meniscal pathology: unstable or torn meniscus requires repair, replacement, or partial meniscectomy.
• Patologija meniskusa: nestabilen ali strgan meniskus, ki ga je treba popraviti, zamenjati ali izvesti delno meniscektomijo.
Current clinical and nonclinical evidence suggests that delivery of autologous chondrocytes on the collagen membrane promotes proliferation and re-differentiation of seeded cells, and may result in synthesis of hyaline-like cartilage repair tissue.
Trenutni klinični in predklinični dokazi kažejo, da nanos avtolognih hondrocitov na kolagensko membrano spodbuja proliferacijo in ponovno diferenciacijo nacepljenih celic, in lahko povzroči sintezo hialinu podobnega tkiva, ki obnovi
Local treatment guidelines regarding the use of antibiotic prophylaxis around orthopaedic surgery should
Upoštevati je treba lokalne smernice zdravljenja glede uporabe antibiotične profilakse pri ortopedskem
In such situations, your surgeon will be informed and might have to select an alternative treatment for
V teh primerih vas bo vaš kirurg o tem obvestil in morda za vas izbral drugo zdravljenje.
Controlled physiotherapy, including early mobilisation, range-of-motion exercises, and partial weightbearing is recommended as soon as possible to promote graft maturation and to reduce the risk of postoperative thromboembolic events and joint stiffness.
Takoj ko je mogoče, se priporoča fizioterapija, vključno z zgodnjo mobilizacijo, vajami za izboljšanje gibljivosti in delnim obremenjevanjem, da se pospeši zorenje vsadka in zmanjša tveganje trombemboličnih dogodkov in otrdelosti sklepa po operaciji.
You will need to have two surgical procedures to receive this treatment:
V okviru tega zdravljenja boste imeli dva kirurška posega:
Patients with local inflammations or active infections in the bone, joint, and surrounding soft tissue should be temporarily deferred until documented recovery.
Pri bolnikih z lokalnim vnetjem ali aktivno okužbo kosti, sklepa ali okoliškega mehkega tkiva je treba postopek začasno odložiti, dokler bolnik ne okreva.
Limited clinical data on exposed pregnancies are available.
Podatki o uporabi pri nosečnicah so omejeni.
Store shipping box in an area below 37°C.
Transportno škatlo shranjujte pri temperaturi do 37 °C.
A fibrin sealant is a type of glue that is made from human blood-clotting
Fibrinsko lepilo je vrsta lepila, izdelanega iz človeških beljakovin, ki povzročajo
Risk factors for graft delamination can include but are not limited to poor patient selection, poor adherence to recommended surgical technique, failure to address concomitant pathologies, poor compliance with the rehabilitation protocol or post-operative trauma to the knee.
Dejavniki tveganja za razslojitev presadka lahko med drugim vključujejo neustrezno izbiro bolnika, neupoštevanje priporočene kirurške tehnike, neobravnavanje sočasnih patologij, neupoštevanje rehabilitacijskega protokola ali poškodbo kolena po operaciji.
• are allergic to any of the ingredients of MACI (listed in section 6), or porcine products (derived from pigs), bovine serum (a protein derived from cows) or gentamicin (an antibiotic)
• če ste alergični na katero koli sestavino zdravila MACI (navedeno v poglavju 6) ali na izdelke pridobljene iz prašičev, goveji serum (beljakovina, pridobljena iz krav) ali gentamicin
While oral use of pain medication is recommended for post-surgical pain relief, intra-articular administration of analgesics is not recommended as studies have shown adverse effects on articular cartilage and chondrocytes with exposure.
Medtem ko se za lajšanje bolečine po operaciji priporočajo peroralni analgetiki, se intraartikularno dajanje analgetikov ne priporoča, saj so študije pokazale neželene učinke na sklepni hrustanec in hondrocite.
Genzyme Biosurgery ApS, Oliefabriksvej 51B, DK-2770 Kastrup, Denmark This leaflet was last revised in MM/YYYY
Izdelovalec Genzyme Biosurgery ApS, Oliefabriksvej 51B, DK-2770 Kastrup, Danska
The safe use of MACI has not been demonstrated during pregnancy or breast-feeding.
Varnost uporabe zdravila MACI med nosečnostjo ali dojenjem ni bila dokazana.
The educational pack for healthcare professionals shall contain the following components:
Izbraževalni paket za zdravstveno osebje mora vsebovati naslednje:
In the pivotal study of MACI, patients were excluded if they had a history of osteoarthritis (Kellgren-Lawrence Grade 3 or 4) in the target knee, or concomitant inflammatory disease.
V osrednji študiji z zdravilom MACI so bili bolniki izključeni, če so imeli v anamnezi osteoartritis (3. ali 4. stopnje po lestvici Kellgren-Lawrence) v ciljnem kolenu ali sočasno vnetno bolezen.
Patients may require debridement of the hypertrophic tissue
Bolniki bodo morda potrebovali presaditev hipertrofičnega tkiva z artroskopskim postopkom.
MACI was superior compared to microfracture regarding the improvement of pain and function according to the KOOS scale (Knee Injury and Osteoarthritis Outcome Score).
Zdravilo MACI je bilo v primerjavi s postopkom mikrofrakture boljše v smislu izboljšanja bolečine in funkcije po lestvici KOOS (angl. Knee Injury and Osteoarthritis Outcome Score - merjenje izida ob poškodbi kolena in osteoartritisu).
When you receive MACI, you may experience side effects soon after the implantation.
Ko boste prejeli zdravilo MACI, boste morda kmalu po vsaditvi začutili neželene učinke.
SPECIAL STORAGE CONDITIONS Do not refrigerate or freeze.
POSEBNA NAVODILA ZA SHRANJEVANJE Ne shranjujte v hladilniku ali zamrzujte.
The use of MACI in elderly with generalised degeneration of the cartilage or osteoarthritis is not recommended.
Uporaba zdravila MACI pri starejših bolnikih z generalizirano degeneracijo hrustanca ali osteoartritisom ni priporočljiva.
However as MACI will be implanted using invasive surgical techniques, a decision must be made whether to discontinue breastfeeding taking into account the benefits of treatment for the woman and the risk to the infant.
Ker pa poteka vsaditev zdravila MACI z uporabo invazivne kirurške tehnike, se je treba odločiti, ali naj mati z dojenjem preneha, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
MACI is not recommended in patients with a total menisectomy unless the meniscal deficiency can be addressed with a staged or concurrent meniscal graft.
Zdravila MACI se ne priporoča pri bolnikih s popolno meniscektomijo, razen če je mogoče okvaro meniskusa obravnavati z zaporednim ali sočasnim presadkom meniskusa.
MACI is an autologous implant and must only be administered to the patient for whom it was manufactured.
Zdravilo MACI je avtologni vsadek, ki ga lahko dobi le bolnik, za katerega je bil izdelan.
Abnormal varus or valgus loading of the tibio-femoral joint may jeopardise the implant and should be addressed with a corrective osteotomy or similar procedure.
Obremenitev tibiofemoralnega sklepa zaradi nenormalnega varusa ali valgusa lahko ogrozi vsadek, zato jo je treba obravnavati s korekcijsko osteotomijo ali podobnim postopkom.
There is limited experience with delivery of MACI to the knee via arthroscopy, however, arthroscopic techniques may be used to apply MACI at the discretion of the treating physician.
Izkušnje z vstavitvijo zdravila MACI v koleno z artroskopijo so omejene, vendar pa se po presoji lečečega zdravnika lahko uporabijo artroskopske tehnike za vsaditev zdravila MACI lahko uporabijo.
There were no indications of gross inflammatory
Znakov večje vnetne reakcije ni bilo.
INFORMATION IN BRAILLE Justification for not including Braille accepted
Sprejeta je utemeljitev, da Braillova pisava ni potrebna
• difficulty breathing, chest pain and palpitations • leg swelling, leg pain and redness
• težko dihanje, bolečine v prsih in razbijanje srca (palpitacije), • otekanje noge, bolečina v nogi in rdečica.