FrancophonIA/ELRC3.0 huggingface dataset:
English: Untreated bone oedema corresponding with the cartilage defect to be treated may adversely affect the success of the procedure.
Slovenian: Nezdravljeni kostni edem, ki ustreza poškodbi hrustanca, predvidenega za zdravljenje, lahko negativno vpliva na uspeh postopka.
English: Also, during the rehabilitation period, the ability to drive and use machines may be restricted due to reduced mobility.
Slovenian: Tudi v obdobju rehabilitacije je zaradi zmanjšane mobilnosti ta sposobnost vožnje in upravljanja strojev lahko omejena.
English: The MAH shall ensure that in each Member State where Spherox is marketed, all surgeons and other health professionals who are expected to prescribe and administer the product have access to the educational materials including:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora poskrbeti, da imajo v vsaki državi članici, v kateri se zdravilo Spherox trži, vsi kirurgi in drugi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali in dajali zdravilo, dostop do izobraževalnega gradiva, ki vključuje:
English: • blood clot in a deep vein (symptoms: e.g. swelling, pain, increased warmth in the affected area)
Slovenian: • krvni strdek v globoki veni (simptomi: npr. otekanje, bolečina, občutek povečane toplote na prizadetem območju).
English: • partial or complete detachment of the tissue beneath the bone and surrounding cartilage
Slovenian: • delna ali popolna oddvojitev tkiva pod kostjo in sosednjim hrustancem;
English: Side effects appearing after the implantation of Spherox are mostly related to the surgery.
Slovenian: Neželeni učinki, ki se pojavijo po vsaditvi zdravila Spherox, so večinoma povezani z operacijo.
English: • Advanced osteoarthritis of the affected joint (exceeding grade II according to Kellgren and
Slovenian: • Napredovali osteoartritis prizadetega sklepa (ki presega stopnjo II po Kellgrenu in Lawrenceu).
English: Due to the nature and intended clinical use of Spherox, conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Slovenian: Zaradi lastnosti zdravila Spherox in njegove klinične uporabe običajne študije farmakokinetike, absorpcije, porazdelitve, presnove in izločanja niso smiselne.
English: Prior to launch of Spherox in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the training programme and the controlled distribution programme, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravila Spherox na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki programa usposabljanja in programa nadzorovanega razdeljevanja, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
English: Driving cars and using machines may be limited during the rehabilitation period.
Slovenian: V rehabilitacijskem obdobju bosta vožnja in upravljanje strojev morda omejeni.
English: Autologous chondrocyte implantation (ACI) is based on the extraction of the patient's own chondrocytes isolated from healthy cartilage, their culture in vitro and their subsequent implantation into the cartilage defect.
Slovenian: Implantacija avtolognih hondrocitov (ACI- Autologous chondrocyte implantation) temelji na ekstrakciji bolnikovih lastnih hondrocitov, izoliranih iz zdravega hrustanca, njihovi vzgoji in vitro ter njihovi kasnejši implantaciji v poškodovan hrustanec.
English: Spherox is not recommended for pregnant or breast-feeding women, as it is applied during surgery.
Slovenian: Zdravilo Spherox ni priporočljivo za ženske, ki so noseče ali dojijo, saj je dano med operacijo.
English: • Forms for documentation
Slovenian: • obrazce za dokumentacijo.
English: The MAH shall ensure that in each Member State where Spherox is marketed, a system aimed to control access to the product beyond the level of control ensured by routine risk minimisation measures.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je v vsaki državi članici, v kateri se zdravilo Spherox trži, vzpostavljen sistem nadzorovanega dostopa do zdravila, ki je obsežnejši od nadzora, zagotovljenega z rednimi ukrepi za zmanjševanje tveganj.
English: On the first visit, the doctor will evaluate your cartilage defect during an exploratory operation.
Slovenian: Ob prvem obisku bo zdravnik z raziskovalno operacijo ocenil poškodbo hrustanca pri vas.
English: Too early and vigorous activity may compromise the grafting and the durability of clinical benefit from Spherox.
Slovenian: Dejavnosti, ki se jih bolnik loti prekmalu in preveč intenzivno, lahko ogrozijo presadek in trajanje kliničnih koristi zdravila Spherox.
English: If the manufacturing of spheroids has failed or if the release criteria are not fulfilled, e.g. due to insufficient biopsy quality, the medicinal product cannot be delivered.
Slovenian: Primeri, pri katerih dobava zdravila Spherox ni mogoča Če proizvodnja sferoidov ni uspešna ali če niso izpolnjeni pogoji sprostitve, npr. zaradi nezadostne kakovosti biopsije, zdravila ni mogoče dobaviti.
English: • swelling due to obstructed flow of tissue fluid via the lymph vessels
Slovenian: • otekanje zaradi oviranega pretoka tkivne tekočine prek limfnih žil.
English: In a sheep study, also no biodistribution was observed after injection of spheroids into the knee joint.
Slovenian: Tudi v študiji, ki je vključevala ovce, biološka porazdelitev po vbrizganju sferoidov v kolenski sklep ni bila opažena.
English: • increase in size of the cartilage cells, softening of cartilage, disorder of bone formation, death of bone tissue, bone formation outside the skeleton.
Slovenian: • povečana velikost celic hrustanca; mehčanje hrustanca, motnje nastajanja kosti, odmiranje kostnega tkiva, nastajanje kosti zunaj okostja.
English: CO.DON AG Warthestraße 21 14513 Teltow Germany
Slovenian: CO.DON AG, Warthestraße 21, 14513 Teltow, Nemčija
English: As Spherox is used to repair cartilage defects of the joint and is therefore implanted during a surgical procedure, it is not recommended for use in pregnant or breast-feeding women.
Slovenian: Ker se zdravilo Spherox uporablja za popravljanje poškodb sklepnega hrustanca in je implantirano med kirurškim posegom, ni priporočljivo za uporabo pri ženskah, ki so noseče ali dojijo.
English: What Spherox is and what it is used for 2.
Slovenian: Kaj je zdravilo Spherox in za kaj ga uporabljamo 2.
English: The implantation must be performed during a surgical procedure (preferably an arthroscopy or miniarthrotomy).
Slovenian: Implantacijo je treba izvesti med kirurškim posegom (najbolje med artroskopijo ali mini artrotomijo).
English: A spheroid looks like a tiny pearl made of cartilage cells and cartilage material derived from your own body.
Slovenian: Sferoid je videti kot droben biser iz hrustančnih celic in hrustančnega materiala, ki izvirajo iz vašega lastnega telesa.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: • The patient should document the receipt and understanding of the information on the product
Slovenian: • bolnik mora podpisati, da je prejel informacije o zdravilu in jih razume,
English: 14513 Teltow, Germany Tel.: +49 3328 43460 Fax: +49 3328 434643 E-mail: info@codon.de
Slovenian: Tel. št.: +49 (0)3328 43 46 0, faks: +49 (0)3328 43 46 43, e-pošta: info@codon.de
English: Your cartilage cells are extracted from this sample in a laboratory and are then grown to make the spheroids that constitute Spherox.
Slovenian: V laboratoriju iz tega vzorca pridobijo celice vašega hrustanca in jih nato gojijo za izdelavo sferoidov, ki sestavljajo zdravilo Spherox.
English: Spherox is cultured and implanted as three-dimensional spheroids.
Slovenian: Zdravilo Spherox je vzgojeno in implantirano v obliki tridimenzionalnih sferoidov.
English: The patient's haemostatic functions should be screened prior to surgery.
Slovenian: Pred operacijo je treba preveriti hemostatične funkcije pri bolniku.
English: The catheter of the applicator is made of thermoplastic polyurethane, the sealing plug on one side of acrylonitrile butadiene styrene and a silicone stopper on the other side.
Slovenian: Kateter aplikatorja je izdelan iz termoplastičnega poliuretana, tesnilni čep na eni strani je izdelan iz akrilonitril butadien stirena, na drugi strani pa je silikonski zamašek.
English: • hypersensitivity (allergy) (symptoms: e.g. skin reactions, low blood pressure, constriction of airways, swollen tongue or throat, weak and rapid pulse, sickness, vomiting, diarrhoea, dizziness, fainting, fever)
Slovenian: • preobčutljivost (alergija) (simptomi: npr. kožne reakcije, nizek krvni tlak, zoženje dihalnih poti, otekel jezik ali grlo, šibak in hiter srčni utrip, siljenje na bruhanje, bruhanje, driska, omotica,
English: Spherox is administered to patients by intraarticular implantation.
Slovenian: Zdravilo Spherox se daje bolnikom z intraartikularno implantacijo.
English: The spheroids are provided in a pre-filled syringe or an applicator (stem length 150 mm (co.fix 150)).
Slovenian: Sferoidi so na voljo v napolnjeni injekcijski brizgi ali aplikatorju (dolžina ročice 150 mm (co.fix 150)).
English: The risk of treatment failure may increase if you do not follow your rehabilitation schedule.
Slovenian: Če ne boste sledili časovnemu načrtu svojega rehabilitacijskega programa, se tveganje za neuspeh zdravljenja lahko poveča.
English: Other medicines and Spherox
Slovenian: Druga zdravila in zdravilo Spherox
English: Spheroids are spherical aggregates of ex vivo expanded human autologous chondrocytes and selfsynthesized extracellular matrix.
Slovenian: Sferoidi so sferični skupki ex vivo ekspandiranih humanih avtolognih hondrocitov in samosintetiziranega zunajceličnega matriksa.
English: Thromboprophylaxis should be administered according to local guidelines.
Slovenian: Treba je uvesti tromboprofilakso v skladu z lokalnimi smernicami.
English: Ex vivo produced spheroids were implanted in mice (subcutaneous implantation of cartilage explants with human spheroids) or in minipigs (autologous spheroids implanted in cartilage defects).
Slovenian: Sferoidi, pripravljeni ex vivo, so bili implantirani v miši (s subkutano implantacijo humanih sferoidov v eksplantate hrustanca) ali v pritlikave prašiče (avtologni sferoidi, implantirani v poškodbe hrustanca).
English: 21 14513 Teltow GERMANY
Slovenian: 21 14513 Teltow
English: Locally applied antibiotics or disinfectants may have potential toxicity on articular cartilage and it is not recommended that Spherox comes into direct contact with those substances.
Slovenian: Lokalno dani antibiotiki ali razkužila so lahko za artikularni hrustanec strupeni in neposredni stik zdravila Spherox s temi snovmi ni priporočljiv.
English: Spherox contains so-called spheroids that consist of living cartilage cells with a non-cellular portion for the repair of cartilage defects.
Slovenian: Zdravilo Spherox vsebuje tako imenovane sferoide iz živih hrustančnih celic z neceličnim delom za popravilo poškodb hrustanca.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Slovenian: PODATKI V BRAILLOVI PISAVI Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
English: If possible, concomitant joint problems should be corrected prior to or at the latest at the time of Spherox implantation.
Slovenian: Če je mogoče, je treba sočasne težave s sklepi odpraviti pred implantacijo zdravila Spherox ali najkasneje v času implantacije.
English: A tube may contain a maximum of two co.fix 150.
Slovenian: Tuba lahko vsebuje največ dva aplikatorja co.fix 150.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT {Number of spheroids} sph
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT {Število sferoidov} sferoidov
English: To make the spheroids, a small cartilage sample is taken from part of one of your joints during a minor operation, and then grown in the laboratory to make the medicine.
Slovenian: Za izdelavo sferoidov je med manjšo operacijo iz dela enega od vaših sklepov odvzetega malo hrustančnega materiala, ki je nato za izdelavo zdravila vzgajan v laboratoriju.
English: 1 syringe in a sterile tube
Slovenian: 1 injekcijska brizga v sterilni tubi.
English: The safety and efficacy of Spherox in patients with cartilage defects outside the femoral condyle and the patella of the knee have not been established.
Slovenian: Varnost in učinkovitost zdravila Spherox pri bolnikih s poškodbo hrustanca zunaj femoralnega kondila in pogačice kolena še nista bili dokazani.
English: METHOD OF ADMINISTRATION For intraarticular use
Slovenian: POSTOPEK UPORABE za intraartikularno uporabo
English: Spherox is delivered to the doctor in a container ready for application.
Slovenian: Zdravilo Spherox je zdravniku dobavljeno v vsebniku in je pripravljeno za uporabo.
English: Magnetic resonance imaging (MRI) results according to the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scoring system (0 = worst result; 100 = best result) showed an improvement within the first 60 months from 59.8 at Visit 2 (3 months after treatment) up to 75.0 points in the group of patients treated with 3-7 spheroids/cm² defect, from 64.5 at Visit 2 up to 76.4 points in the dose group of 10-30 spheroids/cm² defect, and from 64.7 at Visit 2 up to 73.6 points in the dose group of 40-70 spheroids/cm² defect.
Slovenian: Rezultati slikanja z magnetno resonanco (MRI) so glede na sistem točkovanja glede na opazovanje popravljenega tkiva hrustanca z magnetno resonanco (MOCART - Magnetic Resonance Observation of Cartilage Repair Tissue) (0 = najslabši rezultat; 100 = najboljši rezultat) v prvih 60 mesecih pokazali izboljšanje v skupini bolnikov, zdravljenih s 3-7 sferoidi/cm² poškodbe, z 59,8 točke pri drugem obisku (3 mesece po zdravljenju) na 75,0 točke, v skupini bolnikov z odmerkom 1030 sferoidov/cm² poškodbe izboljšanje s 64,5 točke ob drugem obisku na 76,4 točke, v skupini bolnikov z odmerkom 40-70 sferoidov/cm² poškodbe pa izboljšanje s 64,7 točke ob drugem obisku na
English: Spherox is used to treat defects up to 10 cm² in size.
Slovenian: Zdravilo Spherox se uporablja za zdravljenje poškodb z velikostjo do 10 cm².
English: What you need to know before you are given Spherox
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Spherox
English: Graft delamination describes the partial or complete detachment of the formed tissue from the subchondral bone and the surrounding cartilage.
Slovenian: Delaminacija presadka Delaminacija presadka pomeni delno ali popolno oddvojitev ustvarjenega tkiva od subhondralne kosti in okoliškega hrustanca.
English: Other cases in which Spherox cannot be supplied
Slovenian: Drugi primeri, pri katerih dobava zdravila Spherox ni mogoča
English: Spherox is used to repair cartilage defects of knee in adults.
Slovenian: Zdravilo Spherox se uporablja za popravljanje poškodb hrustanca v kolenu pri odraslih.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Pt Name, Pt ID: {Patient Name}, {Patient ID} Lot {Batch Number}
Slovenian: ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV Ime bolnika, ID bolnika: {Ime bolnika}, {ID bolnika} Številka serije {številka serije}
English: Do not irradiate.
Slovenian: Ne obsevajte.
English: OTHER SPECIAL WARNING(S), IF NECESSARY For autologous use only.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
English: • accumulation of fluid in the joint
Slovenian: • kopičenje tekočine v sklepu;
English: • tissue lump that may occur in the joint
Slovenian: • oteklina tkiva, ki se lahko pojavi v sklepu;
English: • The active substance of Spherox are spheroids that consist of cartilage cells and cartilage material derived from your own body.
Slovenian: • Učinkovina v zdravilu Spherox so sferoidi iz hrustančnih celic in hrustančnega materiala, ki izvirajo iz vašega lastnega telesa.
English: What Spherox is and what it is used for
Slovenian: Kaj je zdravilo Spherox in za kaj ga uporabljamo
English: Name and address of the manufacturer responsible for batch release
Slovenian: NEMČIJA Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: • The Summary of Product Characteristics
Slovenian: • povzetek glavnih značilnosti zdravila,
English: Common: may affect up to 1 in 10 people
Slovenian: pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
English: Each pre-filled syringe or applicator contains a specific number of spheroids according to the defect size (10-70 spheroids/cm2) to be treated.
Slovenian: Vsaka napolnjena injekcijska brizga ali aplikator vsebuje določeno število sferoidov glede na velikost poškodbe (10-70 sferoidov/cm2), ki bo zdravljena.
English: The applicator (stem length 150 mm (co.fix 150)) is packed in a sterile tube and additionally surrounded by an extra bag.
Slovenian: Aplikator (z dolžino ročice 150 mm (co.fix 150)) je pakiran v sterilni tubi, poleg tega pa je ovit še z dodatno vrečko.
English: Other joint problems should be corrected before or at the time of Spherox implantation.
Slovenian: Druge težave s sklepi je treba popraviti pred vsaditvijo zdravila Spherox ali v času njegove vsaditve.
English: No clinical data on exposed pregnancies are available for autologous chondrocytes or spheroids from autologous chondrocytes.
Slovenian: Kliničnih podatkov o nosečnostih, pri katerih je prišlo do izpostavljenosti avtolognim hondrocitom ali sferoidom iz avtolognih hondrocitov, ni.
English: Talk to your doctor before you are given Spherox, if you have any other joint problems or excess weight, as this may reduce the success of the procedure.
Slovenian: Če imate kakršne koli druge težave s sklepi ali ste pretežki, se pred uporabo zdravila Spherox posvetujte s svojim zdravnikom, saj to lahko zmanjša uspešnost postopka.
English: Silicone oil serves as lubricant.
Slovenian: Kot mazivo je uporabljeno silikonsko olje.
English: A symptomatic hypertrophy of the transplant may occur during treatment with Spherox resulting in pain.
Slovenian: Hipertrofija vsadka Med zdravljenjem z zdravilom Spherox lahko pride do simptomatske hipertrofije vsadka, kar lahko povzroča bolečino.
English: A debridement of the defect area is required.
Slovenian: Zahteva se debridement področja poškodbe.
English: For information on preparation and handling of Spherox, please refer to section 6.6.
Slovenian: Informacije o pripravi zdravila Spherox in ravnanju z njim si oglejte v poglavju 6.6. 4.3 Kontraindikacije
English: Spherox should preferably be implanted into an otherwise healthy joint.
Slovenian: Najbolje je, če je zdravilo Spherox implantirano v sicer zdrav sklep.
English: If the primary or secondary packaging is damaged and therefore unsterile, Spherox must not be applied.
Slovenian: Če je primarna ali sekundarna ovojnina poškodovana in s tem nesterilna, zdravilo Spherox ne sme biti uporabljeno.
English: Do not open the outer packaging before use to prevent microbial contamination.
Slovenian: Da preprečite okužbo z mikrobi, zunanje ovojnine pred uporabo ne odpirajte.
English: In order to evaluate the long-term efficacy and safety of Spherox vs. microfracture in patients with cartilage defects of the knee with a defect size between 1 and < 4 cm2, the MAH should conduct and submit the results of the ongoing prospective, randomised, open label, multicentre study.
Slovenian: Spherox v primerjavi z mikrofrakturo pri bolnikih s poškodbo hrustanca v kolenu v obsegu med 1 in < 4 cm2 mora imetnik dovoljenja za promet z zdravilom izvesti potekajočo, prospektivno, randomizirano, odprto multicentrično študijo in predložiti njene rezultate.
English: • you have advanced joint and bone inflammation with degeneration in the affected joint
Slovenian: • če imate napredovalo vnetje sklepov in kosti z degeneracijo v prizadetem sklepu (osteoartritis);
English: Spherox is intended for autologous use only.
Slovenian: Zdravilo Spherox je namenjeno le avtologni uporabi.
English: Uncommon: may affect up to 1 in 100 people
Slovenian: občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Application system co.fix 150 mm:
Slovenian: IME ZDRAVILA IN POT(-I) UPORABE Sistem za aplikacijo co.fix 150 mm:
English: This may also be carried out by keyhole surgery.
Slovenian: Tudi to je mogoče izvesti z endoskopsko operacijo.
English: By surgery the spheroids are implanted to the defected cartilage area and stick to the defect site.
Slovenian: Z operacijo se sferoidi vsadijo na poškodovano območje hrustanca in namestijo na mesto poškodbe.
English: Defect sizes ranged from 0.5 to 4 cm2.
Slovenian: Poškodbe so bile velike od 0,5 do
English: The following adverse reactions considered surgery-related have been reported during the course of the clinical trials and/or from spontaneous sources:
Slovenian: Med kliničnimi preskušanji in/ali iz spontanih virov poročanja so poročali o naslednjih neželenih učinkih, za katere se meni, da so povezani s kirurškim postopkom:
English: • pain in the joint
Slovenian: • bolečina v sklepu;
English: White to yellowish spheroids of matrix-associated autologous chondrocytes in a clear, colourless solution.
Slovenian: Beli do rumenkasti sferoidi avtolognih, na matriks nanesenih hondrocitov v bistri, brezbarvni tekočini.
English: Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults.
Slovenian: (stopnje III ali IV po klasifikaciji Mednarodnega združenja za zdravljenje hrustanca (ICRSInternational Cartilage Regeneration & Joint Preservation Society)) s poškodbami, ki pri odraslih merijo do 10 cm2.
English: Concomitant joint problems like early osteoarthritis, subchondral bone defects, instability of the joint, lesions of ligaments or of the meniscus, abnormal weight distribution in the joint, varus or valgus malalignment, patellar malalignment or instability, and metabolic, inflammatory, immunological or neoplastic diseases of the affected joint are potential complicating factors.
Slovenian: lezije vezi ali meniskusa, nenormalna porazdelitev mase v sklepu, nepravilna poravnava v varus ali valgus, nepravilna poravnava ali nestabilnost pogačice ter presnovne, vnetne, imunološke ali neoplastične bolezni sklepa so dejavniki, ki lahko povzročijo zaplete.
English: One pre-filled syringe has a maximum capacity of 100 spheroids in a volume of up to 1000 microlitre isotonic sodium chloride solution.
Slovenian: V eni napolnjeni injekcijski brizgi je največ 100 sferoidov v izotonični raztopini natrijevega klorida s prostornino do 1.000 mikrolitrov.
English: UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: The analysis population comprised 102 patients (41 women, 61 men) aged 37 years on average (range from 18 to 49 years) with a mean body mass index (BMI) of 25.8.
Slovenian: Analizirana populacija je zajemala 102 bolnika (41 žensk, 61 moških) s povprečno starostjo 37 let (v razponu od
English: CO.DON AG Warthestraße 21
Slovenian: Warthestraße 21
English: The application of Spherox in patients with cartilage defects outside the knee joint is not recommended.
Slovenian: Uporaba zdravila Spherox pri bolnikih s poškodbami hrustanca zunaj kolenskega sklepa ni priporočljiva.
English: Table 1: Undesirable Effects related to Spherox
Slovenian: Preglednica 1: Neželeni učinki, povezani z zdravilom Spherox Organski sistem (SOCSystem Organ Class)
English: • The product will only be available to surgeons certified to prescribe and administer Spherox
Slovenian: • zdravilo bo na voljo le kirurgom, ki imajo potrdilo, da lahko predpisujejo in dajejo zdravilo
English: Pack sizes
Slovenian: Vreča