FrancophonIA/ELRC3.0 huggingface dataset:
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Slovenian: Ker gre za pogojno dovoljenje za promet z zdravilom in ob upoštevanju člena 14(7) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: It is very important that you take all the medicines prescribed by your surgeon, otherwise Holoclar may not work.
Slovenian: Zelo pomembno je, da jemljete vsa zdravila, ki vam jih kirurg predpiše, sicer se lahko zgodi, da zdravilo Holoclar ne bo delovalo.
English: If you are allergic to either of these ingredients, you will not be able to be given this medicine (see above under ‘You must not be given Holoclar').
Slovenian: Če ste alergični na katero koli od teh sestavin, tega zdravila ne boste smeli dobiti (glejte zgoraj pod naslovom »Zdravila Holoclar vam ne smejo dati«).
English: Exceptions include non-topical antibiotics for prophylaxis and corticosteroids during the immediate post-operative period.
Slovenian: Izjeme vključujejo netopikalne antibiotike za profilakso in kortikosteroide v obdobju takoj po operaciji.
English: Treatment with Holoclar is a two-step procedure.
Slovenian: Zdravljenje z zdravilom Holoclar je dvostopenjski postopek.
English: Any shaking, inverting or other mechanical stress of the Holoclar container should be avoided.
Slovenian: Vsakršno tresenje, obračanje ali druge mehanske obremenitve vsebnika z zdravilom Holoclar je treba preprečiti.
English: For implantation.
Slovenian: za implantiranje
English: Very common: may affect more than 1 in 10 people • Inflammation of the eyelids (blepharitis)
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov • vnetje očesnih vek (blefaritis)
English: See the educational material for further information.
Slovenian: Za več informacij preberite izobraževalno gradivo.
English: The cells are kept alive in a small sterile container.
Slovenian: Celice se ohranjajo žive v majhnem sterilnem vsebniku.
English: Patient's Forename and Surname:
Slovenian: Ime in priimek bolnika:
English: The surgeon will be informed as early in the process as possible and should hence select an alternative treatment for the patient.
Slovenian: Kirurg bo o tem obveščen takoj, ko bo mogoče in bo moral poiskati drugo obliko zdravljenja za bolnika.
English: If the temperature monitored in the insulated box deviates from the storage conditions, contact the manufacturer.
Slovenian: Če izmerjene vrednosti temperature v izolirni škatli odstopajo od priporočenih pogojev shranjevanja, se posvetujte z izdelovalcem.
English: Any unused medicinal product or waste material must be returned to the manufacturer.
Slovenian: Neuporabljeno zdravilo ali odpadni material morate vrniti izdelovalcu.
English: Prior to implantation the patient's name should be carefully checked with the patient/donor identification on the shipment documentation and product container.
Slovenian: Pred implantacijo je treba skrbno preveriti bolnikovo ime in ga primerjati z identifikacijo bolnika/darovalca na prevoznih listinah in na vsebniku z zdravilom.
English: Via Glauco Gottardi,100, Modena, 41100, Italy
Slovenian: Via Glauco Gottardi,100, Modena, 41100, Italija
English: The other ingredient is a special kind of inactivated mouse cell which is used to grow your limbal cells.
Slovenian: Druga sestavina je posebna vrsta inaktiviranih mišjih celic, ki se uporablja za gojenje limbusnih celic.
English: There have been no formal compatibility studies with Holoclar therefore this medicinal product should not be used with other medicinal products during the post-surgical period until the corneal epithelium integrity is fully restored.
Slovenian: Formalnih študij kompatibilnosti z zdravilom Holoclar niso opravili, zato tega zdravila ne smemo uporabljati z drugimi zdravili v obdobju po operaciji, dokler ni vzpostavljena popolna celovitost roženičnega epitelija.
English: Blepharitis (10.5%), and corneal epithelium defect (3.5%) were the most common individual adverse reactions not related to the surgical procedure.
Slovenian: Blefaritis (10,5 %) in okvara roženičnega epitelija (3,5 %) sta bila najpogostejša posamična neželena učinka, ki nista bila povezana s kirurškim postopkom.
English: Therefore, do not drive or use machines after having Holoclar put in your eye until your surgeon tells you that it is safe to do so.
Slovenian: Zato ne smete voziti po tem, ko vam v oko vsadijo zdravilo Holoclar, dokler vam kirurg ne pove, da je to varno.
English: In some cases it may be possible that the source limbal stem cells of the patient are not expandable or that the release criteria are not met, due to poor biopsy quality, patient characteristics, or manufacturing failure.
Slovenian: V nekaterih primerih je možno, da izvornih limbusnih matičnih celic bolnika ne bo mogoče ekspandirati ali da kriteriji za sprostitev zdravila zaradi slabe kakovosti biopsije, bolnikovih značilnosti ali napake v izdelavi, ne bodo izpolnjeni.
English: By taking some healthy limbal cells, a new layer of healthy tissue is grown in the laboratory on a supporting layer of fibrin, a protein scaffold.
Slovenian: Z odvzemom nekaj zdravih limbusnih celic se v laboratoriju vzgoji nova plast zdravega tkiva na podporni fibrinski plasti, beljakovinskem ogrodju.
English: The amount of cells to be administered is dependent on the size (surface in cm²) of the corneal surface.
Slovenian: Količina celic, ki jih je treba aplicirati, je odvisna od velikosti površine roženice (površina v cm˛).
English: Ask your doctor or pharmacist for advice.
Slovenian: Posvetujte se s svojim zdravnikom ali farmacevtom.
English: Holoclar is implanted to repair the damaged surface of the eye in adults.
Slovenian: Zdravilo Holoclar se vsadi z namenom, da popravi poškodovano površino očesa pri odraslih.
English: Damage to the limbus stops normal healing, which means that the damage to your eye is never properly repaired.
Slovenian: Poškodba limbusa ustavi običajno celjenje, kar pomeni, da se poškodba očesa nikoli prav ne popravi.
English: Most side effects affect the eye, some of which are caused by the surgery.
Slovenian: Večina neželenih učinkov zadeva oko, nekatere pa povzroči tudi operacija.
English: A total of 75 (72.1%) treatments were reported with a successful outcome.
Slovenian: (72,1 %) zdravljenj poročajo o uspešnem izidu.
English: If you have an acute eye infection or swollen, red (inflamed) eyes, your treatment should be delayed until you have recovered.
Slovenian: Če imate akutno okužbo očesa ali oteklo, rdeče (vneto) oko, je treba z zdravljenjem počakati, dokler ne okrevate.
English: In the paediatric patients included in the studies HLSTM01 (age 13, 14 and 16 years) and HLSTM02 (age 8 and 14 years) the profile of adverse reactions was not different from the adult population.
Slovenian: Pri pediatričnih bolnikih, vključenih v študiji HLSTM01 (starosti 13, 14 in 16 let) in HLSTM02 (starosti 8 in 14 let) se profil neželenih učinkov ni razlikoval od profila pri odrasli populaciji.
English: Patients with a known hypersensitivity to mice or foetal bovine serum must not be treated (see section 4.3).
Slovenian: Bolnikov z znano preobčutljivostjo na mišji ali fetalni goveji serum se ne sme zdraviti (glejte poglavje 4.3).
English: Success of the procedure was evaluated based on the presence of a stable corneal epithelium (i.e. absence of epithelial defects) without significant recurrence of neovascularisation (no more than one quadrant without central corneal involvement) at 12 months post-intervention.
Slovenian: Uspeh postopka so ocenili na podlagi prisotnosti stabilnega roženičnega epitelija (tj. odsotnosti epitelijskih okvar) brez znatnega ponovnega pojava neovaskularizacije (ne več kot en kvadrant brez vpletenosti osrednjega dela roženice) 12 mesecev po posegu.
English: Therefore, following treatment with Holoclar, driving and using machines must be limited and patients should follow the advice of their treating physician.
Slovenian: Zato je treba po zdravljenju z zdravilom Holoclar vožnjo in upravljanje s stroji omejiti, bolnik pa mora upoštevati nasvet lečečega zdravnika.
English: On the first visit, the surgeon will carry out a biopsy, which means removing a very small amount of tissue containing limbal cells (from your eye).
Slovenian: Ob prvem obisku bo kirurg opravil biopsijo, kar pomeni, da vam bo odstranil zelo majhen košček tkiva, ki vsebuje limbusne celice (iz očesa).
English: If you are pregnant, think you might be pregnant or you are breast-feeding, treatment with this medicine should be delayed.
Slovenian: Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, je treba odložiti zdravljenje s tem zdravilom.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Holoclar
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Holoclar
English: After surgery, you will be prescribed a course of medicines to ensure full healing: antibiotics to reduce the chance of an infection and steroids to reduce swelling and irritation.
Slovenian: Po posegu vam bodo predpisali zdravila, da bi zagotovili popolno okrevanje: antibiotike za zmanjšanje možnosti okužbe in steroide za zmanjšanje otekline in draženja.
English: The nature and intended clinical use of Holoclar are such that conventional pharmacokinetic studies on absorption, biotransformation and elimination are not applicable.
Slovenian: Zaradi narave in nameravane klinične uporabe zdravila Holoclar običajne študije farmakokinetike glede absorpcije, biotransformacije in izločanja ne pridejo v poštev.
English: The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Slovenian: Za razvrstitev neželenih učinkov po pogostnosti so uporabljene naslednje kategorije: 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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: If the Holoclar primary container is damaged, the visual appearance of the product is affected, visual particulates are identified, the product must not be used and must be returned to the manufacturer.
Slovenian: Če je primarni vsebnik zdravila Holoclar poškodovan, če je okvarjen vizualni izgled zdravila ali najdete vidne delce, zdravila ne smete uporabiti in ga morate vrniti izdelovalcu.
English: The procedure of Holoclar administration include the use of antibiotics and corticosteroids (see section 4.2).
Slovenian: Postopek apliciranja zdravila Holoclar vključuje uporabo antibiotikov in kortikosteroidov (glejte poglavje 4.2).
English: The biopsy must be received by the manufacturer within 24 hours from the procurement.
Slovenian: Izdelovalec mora bioptični vzorec prejeti v 24 urah po odvzemu.
English: These results were confirmed in a sensitivity analysis where superficial neovascularisation was evaluated by an independent assessor from blinded photos of patients' eyes taken before and after Holoclar implantation.
Slovenian: Te rezultate so potrdili v analizi občutljivosti, v kateri je površinsko neovaskularizacijo ocenil neodvisni ocenjevalec na anonimiziranih fotografijah oči bolnikov, narejenih pred implantacijo zdravila Holoclar in po njej.
English: Other cytotoxic agents must be avoided.
Slovenian: Izogniti se je treba uporabi drugih citotoksičnih učinkovin.
English: The HLSTM01 study enrolled a total of seven patients (6.7% of the study population) with an age at baseline of 65 years or above, and seven additional patients (24.1%) were included in HLSTM02.
Slovenian: V študijo HLSTM01 je bilo vključenih skupaj sedem bolnikov (6,7 % študijske populacije) z izhodiščno starostjo 65 let ali več; sedem dodatnih bolnikov (24,1 %) je bilo vključenih v študijo HLSTM02.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Holoclar in one or more subsets of the paediatric population in the treatment of limbal stem cell deficiency due to ocular burns (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Holoclar za eno ali več podskupin pediatrične populacije za zdravljenje pomanjkanja limbusnih matičnih celic zaradi opeklin očesa (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The medicine is put in several layers of packaging which protect the medicine from bacteria and ensures that Holoclar is kept at a stable temperature for 36 hours, if stored at room temperature.
Slovenian: Zdravilo je pakirano v številne plasti zaradi zaščite pred bakterijami in pa zaradi zagotavljanja zdravilu Holoclar 36 ur stabilne temperature - pod pogojem, da je shranjeno na sobni temperaturi.
English: What Holoclar is and what it is used for
Slovenian: Kaj je zdravilo Holoclar in za kaj ga uporabljamo
English: Since this medicine will be used during your surgery, the hospital staff are responsible for the correct storage of the medicine before and during its use, as well as for the correct disposal.
Slovenian: Ker se zdravilo uporablja med operacijo, je za pravilno shranjevanje zdravila pred uporabo in med njo ter za pravilno odstranjevanje odgovorno osebje bolnišnice.
English: Hypersensitivity to any of the excipients listed in section 6.1 or to bovine serum and murine 3T3-J2 cells.
Slovenian: Preobčutljivost na katero koli pomožno snov, navedeno v poglavju 6.1 ali na goveji serum in celice 3T3-J2 glodalcev.
English: Holoclar is prepared individually from your own cells to match you, and must not be used for anyone other than yourself.
Slovenian: Zdravilo Holoclar je pripravljeno posebej za vas iz vaših lastnih celic, zato se ga ne sme uporabiti za nikogar drugega.
English: When Holoclar is made, two ingredients from animals are used.
Slovenian: Pri izdelavi zdravila Holoclar se uporabita dve živalski sestavini.
English: • Problems with cornea (erosion)
Slovenian: • težave z roženico (erozija)
English: Holostem Terapie Avanzate S.R.L, presso Centro di Medicina Rigenerativa “Stefano Ferrari”, Via Glauco Gottardi 100, 41100 Modena, Italy
Slovenian: Holostem Terapie Avanzate S.R.L, presso Centro di Medicina Rigenerativa “Stefano Ferrari”, Via Glauco Gottardi 100, 41100 Modena, Italija
English: Data on the use of Holoclar in elderly populations are limited.
Slovenian: Podatki o uporabi zdravila Holoclar pri starejši populaciji so omejeni.
English: These tests included cell karyotype, cell growth in soft agar and growth factor-dependent proliferation.
Slovenian: Testi so vključevali karotip celic, celično rast v gojišču mehkega agarja in od rastnega faktorja odvisno proliferacijo.
English: EXP:
Slovenian: EXP: DATUM:
English: Holoclar is an autologous product and should under no circumstances be administered to anyone other than the donor patient.
Slovenian: Zdravilo Holoclar je avtologno zdravilo, ki se ga ne sme v nobenih okoliščinah dajati nikomur drugemu, kot bolniku dajalcu.
English: There is only limited information in elderly (n=12, >65 year old) and very elderly (n= 2, 75-84 year old) patients.
Slovenian: Informacije pri starejših (n = 12, > 65 let starosti) in zelo starih bolnikih (n = 2, 75 do 84 let starosti) so omejene.
English: The proportion of patients with improvement in visual acuity was higher among those without a scar of the corneal stroma (15/18 patients, 83.3%) than in those with scarring (36/81 patients, 44.4%).
Slovenian: Delež bolnikov z izboljšano ostrino vida je bil višji pri tistih, ki niso imeli brazgotine roženične strome (15/18 bolnikov, 83,3 %), kot pri tistih z brazgotino (36/81 bolnikov, 44,4 %).
English: The administration should be followed by an appropriate antibiotic and anti-inflammatory treatment schedule, as recommended by the physician (see section 4.4).
Slovenian: Aplikacijo mora spremljati ustrezen režim antibiotičnega in protivnetnega zdravljenja, kot ga priporoča zdravnik (glejte poglavje 4.4).
English: Most side effects are mild and disappear in the weeks after surgery.
Slovenian: Večina neželenih učinkov je blaga in izginejo v nekaj tednih po operaciji.
English: As a precautionary measure, and in light of the requirement of the post-operative pharmacological treatment, it is preferable to avoid the use of Holoclar during pregnancy.
Slovenian: Iz previdnostnih razlogov in zaradi potrebnega farmakološkega zdravljenja po operaciji se je med nosečnostjo uporabi zdravila Holoclar bolje izogibati.
English: Even if the surgeon has already taken a small sample of limbal cells (a biopsy) needed to produce the medicine, it is possible that you will not be able to have treatment with Holoclar.
Slovenian: Četudi je kirurg že naredil biopsijo, se pravi odvzel majhen vzorec limbusnih celic, ki je potreben za gojenje zdravila, se morda z zdravilom Holoclar ne boste mogli zdraviti.
English: Telephone: +3905212791 Telefax: +390521 774468 E-Mail: info@chiesigroup.com
Slovenian: Italija telefon: +3905212791 telefaks: +390521 774468 e-pošta: info@chiesigroup.com
English: Non-clinical safety data were limited to in vitro testing of tumorigenicity of the human autologous cell cultures.
Slovenian: Predklinični podatki o varnosti so bili omejeni na testiranje tumorogenosti humanih avtolognih celičnih kultur in vitro.
English: One is foetal bovine serum which is from cows and is used to help grow your cells.
Slovenian: Ena je fetalni goveji serum iz krav, ki pomaga pri rasti vaših celic.
English: Patients with acute ocular inflammation or infections should be deferred until recovery has been documented since inflammation may compromise treatment success.
Slovenian: Pri bolnikih z akutnim vnetjem ali okužbami očesa je treba počakati na dokumentirano okrevanje, saj lahko vnetje vpliva na uspeh zdravljenja.
English: Do not irradiate (e.g. X-rays)
Slovenian: Ne obsevajte (npr. z rentgenskimi žarki).
English: Visit 1: Biopsy taken
Slovenian: 1. obisk: Biopsija
English: Holoclar is generally implanted under topical retrobulbar or parabulbar anaesthesia.
Slovenian: Zdravilo Holoclar se načeloma vsadi v topikalni retrobulbarni ali parabulbarni anesteziji.
English: Glaucoma (3.5%) was the most frequent adverse reaction considered related to the corticosteroid treatment (see sections 4.2 and 4.4).
Slovenian: Glavkom (3,5 %) je bil najpogostejši neželeni učinek, ki naj bi bil povezan z zdravljenjem s kortikosteroidi (glejte poglavji 4.2 in 4.4).
English: This ingredient can damage the cells of which Holoclar is made.
Slovenian: Ta sestavina lahko poškoduje celice, ki sestavljajo zdravilo Holoclar.
English: Follow their advice carefully.
Slovenian: Natančno upoštevajte kirurgov nasvet.
English: Other cases in which Holoclar cannot be used
Slovenian: Drugi razlogi, zakaj se zdravila Holoclar ne more uporabiti
English: In such a case, please contact your surgeon.
Slovenian: V tem primeru se obrnite na kirurga.
English: When the eye is badly damaged by physical or chemical burns, lots of scarring can occur and the limbus can be damaged.
Slovenian: Pri hudih poškodbah očesa zaradi fizikalnih ali kemijskih opeklin lahko pride do močnega brazgotinjenja in poškodovanja limbusa.
English: Fifty-seven patients underwent a keratoplasty after the use of the product with a success rate of 42.1% (N=24) one year after the corneal transplantation (i.e. with a stable corneal epithelium without significant recurrence of neovascularisation).
Slovenian: Pri sedeminpetdesetih bolnikih je bila eno leto po uporabi zdravila opravljena keratoplastika s stopnjo uspeha 42,1 % (N = 24) (tj. s stabilnim roženičnim epitelijem brez znatnega ponovnega pojava neovaskularizacije).
English: Biopsy
Slovenian: Biopsija
English: • The limbus is part of the eye.
Slovenian: • Limbus ali roženični rob je del očesa.
English: Full technical details on the procedures associated with the use of Holoclar are provided in the educational manual.
Slovenian: Način uporabe za implantiranje Celovite tehnične podrobnosti o postopku, povezanim z uporabo zdravila Holoclar, so na voljo v izobraževalnem priročniku.
English: Post-biopsy treatment
Slovenian: Zdravljenje po biopsiji
English: PHARMACEUTICAL FORM AND CONTENTS Living tissue equivalent.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA ekvivalent živega tkiva
English: Educational material for patients and/or carers to address the following key elements: - Contraindicated use of eye drops containing benzalkonium chloride - Side effects of post-transplant treatment with antibiotics and corticosteroids - Inform patients of the registry - Reporting suspected side effects
Slovenian: Izobraževalno gradivo za bolnike in/ali negovalce, ki bo obravnavalo naslednje ključne elemente: - kontraindicirano uporabo kapljic za oči, ki vsebujejo benzalkonijev klorid - neželene učinke zdravljenja po presaditvi z antibiotiki in kortikosteroidi - obveščanje bolnikov o registru - poročanje o stranskih učinkih
English: No interactions between Holoclar and the post-biopsy/post-operative treatment suggested in section 4.2 have been reported.
Slovenian: O interakcijah med zdravilom Holoclar in zdravili, priporočenimi za zdravljenje po biopsiji in po operaciji, ki so omenjene v poglavju 4.2, niso poročali.
English: Holoclar is given by surgery on your eye and this will impact on your ability to drive and use machines.
Slovenian: Zdravilo Holoclar se vsadi v oko s pomočjo kirurškega posega, kar vpliva na vašo sposobnost vožnje in upravljanja strojev.
English: The efficacy of the medicinal product was evaluated in a multi-centre, case-series, non-controlled, retrospective cohort study in 106 patients (HLSTM01 study) of both genders, treated for the presence of a moderate to severe limbal stem cell deficiency (LSCD).
Slovenian: Učinkovitost zdravila so ocenili v multicentrični, nenadzorovani, retrospektivni kohortni študiji primerov pri 106 bolnikih (študija HLSTM01) obeh spolov, zdravljenih zaradi zmernega do hudega pomanjkanja limbusnih matičnih celic (LSCD - limbal stem cell deficiency).
English: Holoclar could contain potentially infected biological material.
Slovenian: Zdravilo Holoclar lahko vsebuje potencialno kužni biološki material.
English: The biopsy is performed using topical anaesthesia.
Slovenian: Biopsija se opravi z uporabo topikalne anestezije.
English: Each preparation of Holoclar contains an individual treatment dose with sufficient number of cells to cover the entire corneal surface.
Slovenian: Vsak pripravek zdravila Holoclar vsebuje individualni odmerek za zdravljenje z zadostnim številom celic za pokrivanje celotne površine roženice.
English: Keep the steel primary container tightly closed to protect from bacterial, fungal and viral contamination.
Slovenian: Primarni jekleni vsebnik shranjujte tesno zaprt za zagotovitev zaščite pred bakterijsko, glivično in virusno kontaminacijo.
English: When possible, concomitant eye problems should be corrected prior to Holoclar implantation.
Slovenian: Če je mogoče, je treba pred implantacijo zdravila Holoclar sočasne težave z očesom odpraviti.
English: For the manufacture of Holoclar, a biopsy of 1 - 2 mm2 of undamaged limbus is required.
Slovenian: Za izdelavo zdravila Holoclar je treba z biopsijo odvzeti 1 - 2 mm2 nepoškodovanega limbusa.
English: The container is put in a secondary plastic container which is then put in a sealed sterile plastic bag.
Slovenian: Vsebnik je položen v sekundarni plastični vsebnik, vse skupaj pa je zaprto v sterilni plastični vreči.
English: Do not use eye-drops containing benzalkonium chloride and/or other preservatives.
Slovenian: Ne uporabljajte kapljic, ki vsebujejo benzalkonijev klorid in/ali druge konzervanse.
English: The treatment may be repeated if considered indicated by the treating physician.
Slovenian: Zdravljenje se lahko ponovi, če lečeči zdravnik presodi, da obstaja indikacija za to.
English: Each preparation of Holoclar is made individually and is for a single treatment only, although treatments can be repeated.
Slovenian: Vsak pripravek zdravila Holoclar je narejen posebej in je namenjen samo za enkratno zdravljenje, vendar pa se lahko zdravljenje ponovi.