FrancophonIA/ELRC3.0 huggingface dataset:
English: At a median follow-up time of 77 months, acute leukaemia occurred in 1 of 532 (0.2%) patients who received docetaxel, doxorubicin, and cyclophosphamide in the GEICAM 9805 study.
Slovenian: Akutno levkemijo so po mediano 77 mesečnem spremljanju zabeležili pri 1 od 532 (0,2 %) bolnicah,
English: *un-adjusted log-rank test
Slovenian: CP je bilo značilno daljše (log-rang test, p =
English: Asthenia (G3/4: 10.0%); Pyrexia (G3/4: NA);
Slovenian: Letargija (S3/4: 4,0 %), pireksija (S3/4: 3,6 %),
English: • one single-dose powder vial with 80 mg docetaxel (plus 18% overfill: 94.4 mg) and
Slovenian: V vsakem pakiranju je : • ena viala z enim odmerkom praška z 80 mg docetaksela (plus 18 % dodatka celotni vsebini: 94,4 mg)
English: 4 ml (35.4% w/w ethanol in polysorbate 80)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 4 ml (35,4 % etanola v polisorbatu 80)
English: Median progression free survival (months) (95%CI)
Slovenian: Mediano preživetje brez napredovanja bolezni (meseci) (95 % IZ)
English: Docefrez 80 mg, Powder for Concentrate for Solution for Infusion
Slovenian: Docefrez, 80 mg, prašek in vehikel za pripravo koncentrata za raztopino za infundiranje
English: Sverige Sun Pharmaceutical Industries Europe B.V.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Sun Pharmaceutical Industries Europe B.V.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: (KRT) po protokolu (TPF/KRT).
English: PREPARATION GUIDE FOR USE WITH DOCEFREZ 80 MG, POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: NAVODILO ZA UPORABO DOCEFREZ 80 mg koncentrat in vehikel za raztopino za infundiranje docetaksel
English: Docefrez 80 mg powder and solvent for concentrate for solution for infusion
Slovenian: Docefrez 80 mg prašek in raztopilo za koncentrat infuzijske tekočine docetaksel
English: PREPARATION GUIDE FOR USE WITH DOCEFREZ 20 MG, POWDER AND SOLVENT FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Slovenian: NAVODILO ZA UPORABO Docefrez 20 mg koncentrat in vehikel za raztopino za infundiranje Docetaksel
English: Dysgeusia/Parosmia; Peripheral sensory neuropathy (G3/4: 0.6%)
Slovenian: periferna senzorična nevropatija (S3/4:0,6 %)
English: Lethargy (G3/4: 19.0%); Fever (G3/4: 2.3%);
Slovenian: Letargija (S3/4: 19,0 %), zvišana telesna temperatura (S3/4: 2,3 %),
English: Hypotension (G3/4: 0%) Phlebitis (G3/4: 0%)
Slovenian: Hipotenzija (S3/4: 0 %), vnetje žile (S 3/4: 0 %)
English: Batch:
Slovenian: do:
English: 1 ml colourless type 1 glass vial with grey bromobutyl rubber stopper sealed with dark blue flip-off with aluminium seal.
Slovenian: 1-mililitrska viala iz prozornega stekla tipa 1 s sivim brombutilnim zamaškom in temnomodro aluminijasto zaporko.
English: • The Docefrez 80 mg vial contains a white to off white lyophilised powder in a 15 ml tubular colourless glass vial with 20 mm grey rubber stopper and sealed with red flip-off aluminium seal.
Slovenian: • Viala Docefrez 80 mg vsebuje bel do sivo bel liofoliziran prašek, v 15 ml cevasti brezbarvni viali z
English: Fever (G3/4: 1.2%)
Slovenian: (S3/4: 1,2 %)
English: In a phase III study, 1218 patients with unresectable stage IIIB or IV NSCLC, with KPS of 70% or greater, and who did not receive previous chemotherapy for this condition, were randomised to either Docetaxel (T) 75 mg/m2 as a 1 hour infusion immediately followed by cisplatin (Cis) 75 mg/m2 over 30-60 minutes every 3 weeks (TCis), docetaxel 75 mg/m2 as a 1 hour infusion in combination with carboplatin (AUC 6 mg/ml.min) over 30-60 minutes every 3 weeks, or vinorelbine (V) 25 mg/m2 administered over 6-10 minutes on days 1, 8, 15, 22 followed by cisplatin 100 mg/m2 administered on day 1 of cycles repeated every 4 weeks (VCis).
Slovenian: Druga je na 3 tedne dobivala docetaksel 75 mg/m2 v 1-urni infuziji v kombinaciji s karboplatinom (AUC 6 mg/ml«min) v 30-60 minutah, tretja pa na 4 tedne (VCis) vinorelbin (V) 25 mg/m2 v 6-10 minutah 1.,
English: Hearing impaired (G3/4: 0%).
Slovenian: Okvara sluha (S3/4: 0 %)
English: • Induction chemotherapy followed by chemoradiotherapy (TAX 324) MedDRA system organ classes
Slovenian: Indukcijska kemoterapija in nato kemoradioterapija (TAX324)
English: Constipation (G3/4:
Slovenian: Nevtropenija (S3/4:
English: Immune system disorders Metabolism and nutrition disorders
Slovenian: Presnovne in prehranske motnje anoreksija
English: Stomatitis/Pharyngitis (G3/4:
Slovenian: Motnja solzenja (S3/4:
English: Arrhythmia (G3/4:
Slovenian: Pruritični izpuščaj (S3/4:
English: Docefrez 80 mg powder and solvent for concentrate for solution for infusion Docetaxel
Slovenian: Docefrez 80 mg prašek in raztopilo za koncentrat infuzijske tekočine docetaksel intravenska uporaba
English: The overfill ensures that after dilution with the entire extractable volume of the accompanying solvent vial for Docefrez, there is a minimal extractable reconstituted solution of 3.36 ml containing 80 mg docetaxel (anhydrous).
Slovenian: Docefrez, minimalni izločljivi volumen 3,36 ml, ki vsebuje 80 mg docetaksela (brez vode).
English: Fatigue/weakness (G3/4: 5%); Oedema peripheral (G3/4: 1%)
Slovenian: Astenija (S3/4: 3 %), pireksija (S3/4: 1 %), utrujenost/šibkost (S3/4: 5 %), periferni edemi (S3/4: 1 %),
English: Exfoliative rash (G3/4: 0.3%)
Slovenian: Eksfoliacijski izpuščaj (S3/4: 0,3
English: Infection (G3/4: 3.3%)
Slovenian: Okužba (S3/4: 6,3 %),
English: Alopecia; Erythema; Rash; Nail disorders
Slovenian: Alopecija, eritem, izpuščaj,
English: Stomatitis (G3/4: 6.0%);
Slovenian: Omotica (S3/4: 2,0 %),
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription 15.
Slovenian: Shranjevanje zdravila Docefrez 12.
English: If Docefrez powder, reconstituted solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.
Slovenian: Če pride koncentrat, osnovna raztopina ali raztopina za infundiranje Docefrez v stik s kožo, jo je treba takoj in temeljito umiti z milom in vodo.
English: Infections (G3/4;5.7%; including sepsis and pneumonia, fatal in
Slovenian: Okužba, povezana z bolezni vključno s sepso in pljučnico, s smrtnim izidom v 1,7 %)
English: 1 ml (35.4% w/w ethanol in polysorbate 80)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1 ml (35,4 % etanola v polisorbatu 80)
English: Nausea (G3/4: 3.3%);
Slovenian: Utrujenost (S3/4: 3,9 %),
English: In patients treated with docetaxel in combination with doxorubicin and cyclophosphamide (TAC), febrile neutropenia and/or neutropenic infection occurred at lower rates when patients received primary G-CSF prophylaxis.
Slovenian: (TAC), sta se febrilna nevtropenija in/ali nevtropenična okužba redkeje pojavili pri bolnicah, ki so prejemale primarno profilakso z G-CSF.
English: G3/4 Blood bilirubin increased
Slovenian: zvečanje bilirubina v krvi S3/4
English: Docetaxel in combination with platinum agents in chemotherapy-naïve patients
Slovenian: Docefrez v kombinaciji s platinskimi zdravili pri bolnikih, ki še niso bili zdravljeni s kemoterapijo
English: Efficacy of docetaxel in the treatment of patients with gastric adenocarcinoma
Slovenian: Rezultate učinkovitosti povzema spodnja tabela: Učinkovitost docetaksela pri zdravljenju bolnikov z adenokarcinomom želodca Končna točka
English: Dizziness (G3/4: 2.3%); Peripheral motor neuropathy
Slovenian: Aritmija (S3/4: 2,0 %) Miokardna ishemija
English: G-CSF was administered as secondary prophylaxis to patients who experienced complicated neutropenia (febrile neutropenia, prolonged neutropenia, or infection).
Slovenian: docetaksel so aplicirali v 1-urni infuziji, vsa ostala zdravila pa v intravenskem bolusu prvi dan. Bolnice, ki so doživele zapleteno nevtropenijo (febrilna nevtropenija, dolgotrajna nevtropenija ali okužba), so kot sekundarno profilakso dobile G
English: Constipation (G3/4: 1.0%); Gastrointestinal pain (G3/4:
Slovenian: (S3/4: 1,2 %), gastrointestinalna krvavitev (S3/4: 0,4 %)
English: Positive
Slovenian: učinki
English: (95% CI) ***p-value
Slovenian: (95 % IZ) Razmerje tveganja (95 % IZ) *vrednost p
English: Epistaxis (G3/4: 0%);
Slovenian: (S3/4: 0 %)
English: Venous disorder (G3/4:
Slovenian: Venska bolezen (S3/4:
English: Docefrez 20 mg powder and solvent for concentrate for solution for infusion
Slovenian: Docefrez 20 mg prašek in vehikel za pripravo koncentrata za raztopino za infundiranje
English: Docetaxel 100 mg/m² single agent
Slovenian: Docetaksel 100 mg/m2 v monoterapiji Organski sistemi po
English: EU Procedure number
Slovenian: Številka EU
English: Invented name Strengths Pharmaceutical Form Route of administration
Slovenian: Izmišljeno ime Jakost
English: Packaging Content
Slovenian: Vsebina
English: Package size blister (PVC/alu) 336 (4 packs of 84) hard capsules blister (PVC/alu) 84 hard capsules
Slovenian: 336 (4 pakiranja po 84) trdih kapsul
English: (Invented) name Strength Pharmaceutical Form Route of Administration
Slovenian: Pot uporabe Ovojnina
English: Within 1 month of Commission Decision.
Slovenian: V enem mesecu po sklepu Komisije.
English: These should be submitted to the National Competent Authorities:
Slovenian: Predložiti jih je treba pristojnim nacionalnim organom.
English: The clinical study report should be submitted to the relevant National Competent Authorities:
Slovenian: Poročilo o klinični študiji je treba predložiti ustreznemu pristojnemu nacionalnemu organu.
English: The details of the visual reminder should be agreed at national level further to a user test taking into account input from local patient representatives.
Slovenian: O podrobnostih vizualnega opomnika se je treba dogovoriti na nacionalni ravni, poleg tega pa je potreben uporabniški preskus, pri čemer je treba upoštevati pripombe lokalnih predstavnikov bolnikov.
English: The study design should aim to evaluate and quantify the effectiveness of the Risk Management Measures, and should include a pre- and post-implemented analysis and assessment.
Slovenian: Študija bi morala biti zasnovana tako, da bi se z njo ocenila in izmerila učinkovitost ukrepov za obvladovanje tveganja, ter bi morala vključevati analizo in oceno pred zdravljenjem in po njem.
English: A visual reminder on the outer package to warn patients about the harm to unborn baby and the need for effective contraception when using the medicinal product should be implemented in all medicinal products-containing oral retinoids acitretin, alitretinoin and isotretinoin.
Slovenian: Vizualni opomnik na zunanji ovojnini za opozorilo bolnici o škodi za nerojenega otroka in potrebi po učinkoviti kontracepciji pri uporabi zdravila je treba uvesti pri vseh zdravilih, ki vsebujejo peroralne retinioide acitretin, alitretinoin in izotretinoin.
English: The marketing authorisation holder(s) for oral retinoids acitretin, alitretinoin and isotretinoin shall complete the below conditions, within the stated timeframe, and competent authorities shall ensure that the following is fulfilled:
Slovenian: Imetniki dovoljenja za promet z zdravilom za peroralne retinioide acitretin, alitretinoin in izotretinoin izpolnijo naslednje pogoje v navedenem roku, pristojni organi pa zagotovijo, da je izpolnjeno naslednje:
English: The MAHs of oral retinoids containing acitretin, alitretinoin or isotretinoin shall develop and submit educational materials according to the agreed key elements.
Slovenian: Imetniki dovoljenja za promet z zdravilom, ki vsebujejo peroralne retinioide acitretin, alitretinoin ali izotretinoin, pripravijo in predložijo izobraževalno gradivo v skladu z dogovorjenimi ključnimi elementi.
English: In order to assess the effectiveness of the updated risk minimisation measures in women of childbearing potential resulting from this referral procedure, MAH(s) of oral retinoids acitretin, alitretinoin and isotretinoin should conduct and submit the results of a drug utilisation study (DUS).
Slovenian: Da bi se ocenila učinkovitost posodobljenih ukrepov za zmanjšanje tveganja pri ženskah v rodni dobi na podlagi tega napotitvenega postopka, morajo imetniki dovoljenja za promet z zdravilom, ki vsebujejo peroralne retinioide acitretin, alitretinoin in izotretinoin, izvesti študijo o uporabi zdravil ter predložiti njene rezultate.
English: These materials should ensure that prescribers are informed and the patients understand and acknowledge the risks associated with oral retinoids acitretin, alitretinoin and isotretinoin in-utero exposure.
Slovenian: in bolnice poučeni ter razumejo tveganja, povezana z izpostavljenostjo peroralnim retinioidom acitretin, alitretinoin in izotretinoin v maternici, in potrjujejo seznanjenost z njimi.
English: 25 mg Film-coated tablet
Slovenian: Jakost Farmacevtska oblika Pot uporabe Stična ovojnina
English: EU/1/07/383/001 Januvia
Slovenian: Številka (EU) dovoljenja za promet
English: Page 2 of 2
Slovenian: Velikost pakiranja
English: The programme may last up to approximately a year.
Slovenian: Program lahko traja do približno enega leta.
English: However, knowledge on the long-term effect of the medicine is limited.
Slovenian: Vendar je znanje o dolgoročnih učinkih tega zdravila omejeno.
English: The European Commission granted a marketing authorisation valid throughout the European Union for ChondroCelect on 5 October 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom ChondroCelect, veljavno po vsej Evropski uniji, izdala 5. oktobra 2009.
English: The full EPAR for ChondroCelect can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo ChondroCelect je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The company is also performing an observational study to obtain more information about the safety and effectiveness of ChondroCelect.
Slovenian: Družba izvaja tudi opazovalno študijo, da bi pridobila več informacij o varnosti in učinkovitosti zdravila ChondroCelect.
English: Cartilage in the knee can be damaged because of an accident, such as a fall, or because they wear off.
Slovenian: Hrustanec v kolenu se lahko poškoduje pri nezgodi, kot je denimo padec, ali zaradi obrabe.
English: What measures are being taken to ensure the safe and effective use of ChondroCelect?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila ChondroCelect?
English: This is a summary of the European public assessment report (EPAR) for ChondroCelect.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo ChondroCelect.
English: A risk management plan has been developed to ensure that ChondroCelect is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila ChondroCelect je bil pripravljen načrt obvladovanja tveganj.
English: The defects were on the femoral condyle and were between 1 and 5 cm2 in size.
Slovenian: Okvare so bile na femoralnem kondilu, velikosti od 1 do 5 cm2.
English: For more information about treatment with ChondroCelect, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom ChondroCelect preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: ChondroCelect is a medicine that is prepared specially for each individual patient and can only be used to treat the particular patient it was prepared for.
Slovenian: Zdravilo ChondroCelect se pripravi za vsakega bolnika posebej in ga je mogoče uporabljati samo za zdravljenje bolnika, za katerega je bilo pripravljeno.
English: Patients treated with ChondroCelect should follow specific rehabilitation programme, including physiotherapy.
Slovenian: Bolniki, ki se zdravijo z zdravilom ChondroCelect, morajo opraviti poseben rehabilitacijski program, ki vključuje tudi fizioterapijo.
English: Other information about ChondroCelect
Slovenian: Druge informacije o zdravilu ChondroCelect
English: The main measures of effectiveness were how well the defects had healed after one year and the change in the patients' Knee Injury and Osteoarthritis Outcome Score (KOOS) after one and three years of treatment.
Slovenian: Glavni merili učinkovitosti sta bili dejstvo, kako dobro so se okvare popravile po enem letu, in sprememba v bolnikovem KOOS (Knee Injury and Osteoarthritis Outcome Score - merjenje izida ob poškodbi kolena in osteoartritisu) po enem in po treh letih od zdravljenja.
English: What benefit has ChondroCelect shown during the studies?
Slovenian: Kakšne koristi je zdravilo ChondroCelect izkazalo med študijami?
English: ChondroCelect must not be used in people who are hypersensitive (allergic) to any of the other ingredients or to bovine serum (cow's blood).
Slovenian: Zdravila ChondroCelect ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) katero koli drugo sestavino zdravila ali na goveji serum (kravjo kri).
English: The CHMP considered that ChondroCelect was shown to be effective at treating defects in the knee cartilage between 1 and 5 cm2 in size, and that the safety profile was considered acceptable.
Slovenian: CHMP je menil, da je zdravilo ChondroCelect učinkovito pri zdravljenju okvar kolenskega hrustanca velikosti od 1 do 5 cm2 in da je njegov varnostni profil sprejemljiv.
English: It must also not be used in patients with advanced osteoarthritis of the knee (a disease causing swelling and pain in the knee) and those with the femoral growth plate (the end part of the thighbone) that is not fully closed.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih z napredovalim osteoartritisom kolena (boleznijo, ki povzroča otekanje in bolečine v kolenu) in osebah s femoralno rastno ploščo (zaključnim predelom stegnenice), ki ni še povsem zaprta.
English: The KOOS was measured by patients rating the severity of their symptoms.
Slovenian: Izid KOOS so bolniki izmerili sami in pri tem ocenjevali resnost simptomov.
English: The cartilage cells are then grown and expanded in the laboratory to provide enough cells to make up a suspension of cells that can be used to treat the cartilage defect.
Slovenian: Hrustančne celice se nato vzgojijo in razmnožijo v laboratoriju v količini, ki zadostuje za pripravo celične suspenzije, ki se uporablja za zdravljenje okvar hrustanca.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ChondroCelect.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: In addition, the company that makes ChondroCelect will ensure that all surgeons and other healthcare professionals involved in the handling or use of ChondroCelect receive training materials on how to use the product.
Slovenian: Poleg tega bo družba, ki izdeluje zdravilo ChondroCelect, vsem kirurgom in drugim zdravstvenim delavcem, ki rokujejo z zdravilom ChondroCelect ali ga uporabljajo, zagotovila izobraževalno gradivo o uporabi zdravila.
English: This means that they are cells taken from the patient, grown outside the body and can be used for implantation into the patient's cartilage.
Slovenian: To pomeni, da se odvzamejo bolniku, se vzgojijo izven telesa in se nato uporabijo za vsadek v bolnikov hrustanec.
English: ChondroCelect is a suspension for implantation that contains cartilage cells.
Slovenian: ChondroCelect je suspenzija za implantacijo, ki vsebuje hrustančne celice.
English: The most common side effects with ChondroCelect (seen in more than 1 patient in 10) are arthralgia (joint pain), cartilage hypertrophy (overgrowth), joint crepitation (unusual crackling sounds) and swelling of the joint.
Slovenian: Najpogostejši neželeni učinki zdravila ChondroCelect (opaženi pri več kot 1 bolniku od 10) so artralgija (bolečine v sklepih), hipertrofija hrustanca (prekomerna rast), občutek prasketanja ali pokanja ob premikanju kolena (nenavadni pokajoči zvoki) in otekanje sklepa.
English: During surgery on the knee, the suspension is placed into the defect in the patient's cartilage.
Slovenian: Med operacijo kolena se suspenzija nanese na mesto okvare bolnikovega hrustanca.
English: Based on the assessment performed by the CAT, the CHMP decided that ChondroCelect's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Na podlagi ocene tega odbora je CHMP zaključil, da so koristi zdravila ChondroCelect večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Because ChondroCelect is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Slovenian: Ker je zdravilo ChondroCelect zdravilo za napredno zdravljenje, ga je ocenjeval Odbor za napredno zdravljenje.
English: After one year, when scans were performed and samples of cartilage were examined, patients who were treated with ChondroCelect showed better structural repair of their cartilage than patients treated with microfracture.
Slovenian: Po enem letu se je ob pregledu slik in vzorcev hrustanca izkazalo, da se je bolnikom, ki so bili zdravljeni z zdravilom ChondroCelect, hrustanec zacelil bolje kot bolnikom, zdravljenim s postopkom mikrofrakture.
English: ChondoCelect is a type of advanced therapy medicine called a ‘tissue engineered product'.
Slovenian: Zdravilo ChondroCelect spada v skupino zdravil za napredno zdravljenje, ki se imenujejo „zdravila, izdelana s tkivnim inženiringom“.
English: ChondroCelect was also as effective as microfracture at improving symptoms.
Slovenian: Zdravilo ChondroCelect je bilo pri izboljšanju simptomov enako učinkovito kot postopek mikrofrakture.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ChondroCelect, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: ChondroCelect must be administered by a qualified surgeon in a hospital.
Slovenian: Zdravilo ChondroCelect lahko odmeri samo ustrezno usposobljen kirurg v bolnišnici.
English: These cells are ‘characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins'.
Slovenian: To so karakterizirane viabilne avtologne hrustančne celice, ekspandirane ex vivo, ki izražajo specifične markerske proteine.
English: For the full list of all side effects reported with ChondroCelect, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila ChondroCelect, glejte navodilo za uporabo.
English: ChondroCelect characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Slovenian: ChondroCelect karakterizirane viabilne avtologne hrustančne celice, ekspandirane ex vivo, ki izražajo specifične markerske proteine
English: The active substance in ChondroCelect is the patient's own cartilage cells.
Slovenian: Zdravilna učinkovina zdravila ChondroCelect so bolnikove lastne hrustančne celice.
English: The training materials for surgeons will include information on how to collect the cartilage biopsy from patients, perform the operation and follow patients up.
Slovenian: Izobraževalno gradivo za kirurge bo vsebovalo informacije o tem, kako bolniku odvzeti biopsijo hrustanca, kako opraviti operacijo in kako po njej spremljati bolnika.
English: What is the risk associated with ChondroCelect?
Slovenian: Kakšna tveganja so povezana z zdravilom ChondroCelect?
English: First, a biopsy (a small sample) is taken from the patient's cartilage in the knee.
Slovenian: Najprej se iz bolnikovega kolenskega hrustanca vzame biopsija (majhen vzorec).