natgillin/translations-raw huggingface dataset:
Graft delamination describes the partial or complete detachment of the formed tissue from the subchondral bone and the surrounding cartilage. 
Delaminacija presadka Delaminacija presadka pomeni delno ali popolno oddvojitev ustvarjenega tkiva od subhondralne kosti in okoliškega hrustanca.
Other cases in which Spherox cannot be supplied 
Drugi primeri, pri katerih dobava zdravila Spherox ni mogoča
Spherox is used to repair cartilage defects of knee in adults. 
Zdravilo Spherox se uporablja za popravljanje poškodb hrustanca v kolenu pri odraslih.
BATCH NUMBER, DONATION AND PRODUCT CODES Pt Name, Pt ID: {Patient Name}, {Patient ID} Lot {Batch Number} 
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV Ime bolnika, ID bolnika: {Ime bolnika}, {ID bolnika} Številka serije {številka serije}
Do not irradiate. 
Ne obsevajte.
OTHER SPECIAL WARNING(S), IF NECESSARY For autologous use only. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA
• accumulation of fluid in the joint 
• kopičenje tekočine v sklepu;
• tissue lump that may occur in the joint 
• oteklina tkiva, ki se lahko pojavi v sklepu;
• The active substance of Spherox are spheroids that consist of cartilage cells and cartilage material derived from your own body. 
• Učinkovina v zdravilu Spherox so sferoidi iz hrustančnih celic in hrustančnega materiala, ki izvirajo iz vašega lastnega telesa.
What Spherox is and what it is used for 
Kaj je zdravilo Spherox in za kaj ga uporabljamo
Name and address of the manufacturer responsible for batch release 
NEMČIJA Ime in naslov izdelovalca, odgovornega za sproščanje serij
• The Summary of Product Characteristics 
• povzetek glavnih značilnosti zdravila,
Common: may affect up to 1 in 10 people 
pogosti: pojavijo se lahko pri največ 1 od 10 bolnikov
Each pre-filled syringe or applicator contains a specific number of spheroids according to the defect size (10-70 spheroids/cm2) to be treated. 
Vsaka napolnjena injekcijska brizga ali aplikator vsebuje določeno število sferoidov glede na velikost poškodbe (10-70 sferoidov/cm2), ki bo zdravljena.
The applicator (stem length 150 mm (co.fix 150)) is packed in a sterile tube and additionally surrounded by an extra bag. 
Aplikator (z dolžino ročice 150 mm (co.fix 150)) je pakiran v sterilni tubi, poleg tega pa je ovit še z dodatno vrečko.
Other joint problems should be corrected before or at the time of Spherox implantation. 
Druge težave s sklepi je treba popraviti pred vsaditvijo zdravila Spherox ali v času njegove vsaditve.
No clinical data on exposed pregnancies are available for autologous chondrocytes or spheroids from autologous chondrocytes. 
Kliničnih podatkov o nosečnostih, pri katerih je prišlo do izpostavljenosti avtolognim hondrocitom ali sferoidom iz avtolognih hondrocitov, ni.
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. 
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.
Silicone oil serves as lubricant. 
Kot mazivo je uporabljeno silikonsko olje.
A symptomatic hypertrophy of the transplant may occur during treatment with Spherox resulting in pain. 
Hipertrofija vsadka Med zdravljenjem z zdravilom Spherox lahko pride do simptomatske hipertrofije vsadka, kar lahko povzroča bolečino.
A debridement of the defect area is required. 
Zahteva se debridement področja poškodbe.
For information on preparation and handling of Spherox, please refer to section 6.6. 
Informacije o pripravi zdravila Spherox in ravnanju z njim si oglejte v poglavju 6.6. 4.3 Kontraindikacije
Spherox should preferably be implanted into an otherwise healthy joint. 
Najbolje je, če je zdravilo Spherox implantirano v sicer zdrav sklep.
If the primary or secondary packaging is damaged and therefore unsterile, Spherox must not be applied. 
Če je primarna ali sekundarna ovojnina poškodovana in s tem nesterilna, zdravilo Spherox ne sme biti uporabljeno.
Do not open the outer packaging before use to prevent microbial contamination. 
Da preprečite okužbo z mikrobi, zunanje ovojnine pred uporabo ne odpirajte.
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. 
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.
• you have advanced joint and bone inflammation with degeneration in the affected joint 
• če imate napredovalo vnetje sklepov in kosti z degeneracijo v prizadetem sklepu (osteoartritis);
Spherox is intended for autologous use only. 
Zdravilo Spherox je namenjeno le avtologni uporabi.
Uncommon: may affect up to 1 in 100 people 
občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Application system co.fix 150 mm: 
IME ZDRAVILA IN POT(-I) UPORABE Sistem za aplikacijo co.fix 150 mm:
This may also be carried out by keyhole surgery. 
Tudi to je mogoče izvesti z endoskopsko operacijo.
By surgery the spheroids are implanted to the defected cartilage area and stick to the defect site. 
Z operacijo se sferoidi vsadijo na poškodovano območje hrustanca in namestijo na mesto poškodbe.
Defect sizes ranged from 0.5 to 4 cm2. 
Poškodbe so bile velike od 0,5 do
The following adverse reactions considered surgery-related have been reported during the course of the clinical trials and/or from spontaneous sources: 
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:
• pain in the joint 
• bolečina v sklepu;
White to yellowish spheroids of matrix-associated autologous chondrocytes in a clear, colourless solution. 
Beli do rumenkasti sferoidi avtolognih, na matriks nanesenih hondrocitov v bistri, brezbarvni tekočini.
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. 
(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.
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. 
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.
One pre-filled syringe has a maximum capacity of 100 spheroids in a volume of up to 1000 microlitre isotonic sodium chloride solution. 
V eni napolnjeni injekcijski brizgi je največ 100 sferoidov v izotonični raztopini natrijevega klorida s prostornino do 1.000 mikrolitrov.
UNIQUE IDENTIFIER - 2D BARCODE Not applicable. 
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
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. 
Analizirana populacija je zajemala 102 bolnika (41 žensk, 61 moških) s povprečno starostjo 37 let (v razponu od
The application of Spherox in patients with cartilage defects outside the knee joint is not recommended. 
Uporaba zdravila Spherox pri bolnikih s poškodbami hrustanca zunaj kolenskega sklepa ni priporočljiva.
Table 1: Undesirable Effects related to Spherox 
Preglednica 1: Neželeni učinki, povezani z zdravilom Spherox Organski sistem (SOCSystem Organ Class)
• The product will only be available to surgeons certified to prescribe and administer Spherox 
• zdravilo bo na voljo le kirurgom, ki imajo potrdilo, da lahko predpisujejo in dajejo zdravilo
Pack sizes 
Vreča
In the pivotal studies of Spherox, patients were excluded if they had signs of chronic inflammatory diseases. 
Če so bolniki v osrednjih študijah zdravila Spherox kazali znake kroničnih vnetnih bolezni, so bili izločeni.
Post-operative haemarthrosis occurs mainly in patients with a predisposition to haemorrhage or poor surgical haemorrhage control. 
Pooperativna hemartroza se pojavlja v glavnem pri bolnikih, ki so nagnjeni h krvavitvam, ali pa do nje pride zaradi slabega nadzora nad krvavitvijo med operacijo.
• If you get any side effects, talk to your doctor or physical therapist. 
• Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali fizioterapevtom.
Spherox consists of so-called spheroids. 
Zdravilo Spherox je sestavljeno iz t. i. sferoidov.
• SOC Skin and subcutaneous tissue disorder: scar pain (common) 
• Organski sistem (SOC) Bolezni kože in podkožja: boleča brazgotina (pogosti)
OTHER For autologous use only. 
Samo za avtologno uporabo.
• Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description 
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
The safety and efficacy of Spherox in patients aged over 50 years have not been established. 
Varnost in učinkovitost zdravila Spherox pri bolnikih, starejših od 50 let, še nista bili dokazani.
• uneasiness 
• nelagodje;
STATEMENT OF ACTIVE SUBSTANCE(S) This medicine contains a specific number of spheroids of human autologous matrix-associated chondrocytes according to the defect size (10-70 spheroids/cm2). 
NAVEDBA ENE ALI VEČ UČINKOVIN To zdravilo vsebuje določeno število sferoidov humanih avtolognih, na matriks nanesenih hondrocitov glede na velikost poškodbe (10-70 sferoidov/cm2).
It is packed in a sterile tube with a screw-type cap and additionally surrounded by an extra bag. 
Pakirana je v sterilni cevki z navojnim zamaškom, poleg tega pa je ovita še z dodatno vrečko.
METHOD AND ROUTE(S) OF ADMINISTRATION For intraarticular use. 
POSTOPEK IN POT(I) UPORABE ZDRAVILA za intraartikularno uporabo Pred uporabo preberite priloženo navodilo!
The pre-filled syringe is packed in a sterile tube and additionally surrounded by an extra bag. 
Napolnjena injekcijska brizga je pakirana v sterilni cevki, poleg tega pa je ovita še z dodatno vrečko.
BATCH NUMBER, DONATION AND PRODUCT CODES {Batch Number} 
ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV {Številka serije}
In case of syringe as primary packaging unit: 1 syringe containing {Number of Spheroids} spheroids in a sterile tube 
1 injekcijska brizga, ki vsebuje (število sferoidov) v sterilni tubi.
For patients treated by microfracture the mean overall KOOS increased from 51.7 ± 16.5 to 68.1 ± 18.6 after 12 months, 72.6 ± 19.5 after 24 months and 76.3 ± 17.1 after 36 months (p < 0.0001 in all three cases). 
KOOS povečala z 51,7 ± 16,5 na 68,1 ± 18,6 po 12 mesecih, 72,6 ± 19,5 po 24 mesecih in 76,3 ± 17,1 po 36 mesecih (v vseh treh primerih je p < 0,0001).
• The training material for other health professionals shall contain the following key elements: o Information on Spherox, including the indication currently approved and legal basis o The need to screen donors for hepatitis B, hepatitis C, HIV and syphilis o Detailed description of the handling of the biopsy harvest and of the product, elements on the preparation for the implantation, the schedule for the patient follow-up and recommended physiotherapy. 
o informacije o zdravilu Spherox, vključno s trenutno odobreno indikacijo in pravno podlago, o zahtevo po presejanju darovalcev za hepatitis B, hepatitis C, HIV in sifilis, o podroben opis ravnanja z vzorci, odvzetimi z biopsijo, in z zdravilom, elemente o pripravi za implantacijo, časovni načrt za kontrolne preglede bolnika in priporočeno fizioterapijo ter o zahtevo po uradni potrditvi izvedbe usposabljanja pred biopsijo.
With regard to the between-group analysis, the treatment with Spherox passed the test of non-inferiority compared with microfracture (Δ of 5.7 with lower bound of CI equal to -1.0 at the 12 months assessment, Δ of 6.1 with lower bound of CI equal to -0.4 at the 24 months assessment, results for KOOS at 36 months were consistent with the earlier time points). 
Glede na analizo med skupinami je zdravljenje z zdravilom Spherox opravilo preskus neinferiornosti v primerjavi z mikrofakturiranjem (Δ = 5,7 pri čemer je spodnja meja CI enaka -1,0 pri oceni ob 12 mesecih oz. Δ = 6,1 pri čemer je spodnja meja CI
Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX02 
5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Druga zdravila za bolezni mišično-skeletnega sistema, oznaka ATC:
In the pivotal studies of Spherox, patients were excluded if they were under medical treatment with corticosteroids. 
Če so bili bolniki v osrednjih študijah zdravila Spherox zdravljeni s kortikosteroidi, so bili izločeni.
• internal bleedings 
• notranje krvavitve;
PARTICULARS TO APPEAR ON THE SECONDARY PACKAGING Tube 
PODATKI NA SEKUNDARNI OVOJNINI Tuba
The safety and efficacy of Spherox in children aged less than 15 years have not been established. 
Varnost in učinkovitost zdravila Spherox pri otrocih, mlajših od 15 let, še nista bili dokazani.
How to use Spherox 
Kako jemati zdravilo Spherox
The safety and efficacy of Spherox in children aged 15 to 18 years have not been established. 
Pediatrična populacija Varnost in učinkovitost zdravila Spherox pri otrocih, starih od 15 do 18 let, še nista bili dokazani.
All parts of the pre-filled syringe are made of polypropylene, the sealing ring of isoprene. 
Vsi deli napolnjene injekcijske brizge so izdelani iz polipropilena, tesnilni obroček pa iz izoprena.
LIST OF EXCIPIENTS Excipient: sodium chloride. 
SEZNAM POMOŽNIH SNOVI Pomožna snov: natrijev klorid.
If you get any side effects, talk to your doctor or physical therapist. 
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali fizioterapevtom.
Since 2004, Spherox has been available on a named patient basis for the treatment of cartilage defects classified as Outerbridge grade 3 or 4 or ICRS grade III or IV (Outerbridge 1961, ICRS Cartilage Injury Evaluation Package 2000). 
ali IV po ICRS (Outerbridge 1961, ICRS Cartilage Injury Evaluation Package 2000).
The pre-filled syringe consists of a luer lock, a sealing ring and a cover cap. 
Napolnjeno injekcijsko brizgo sestavljajo nastavek luer, tesnilni obroček in pokrovček.
• The training material for surgeons and surgical staff shall contain the following key elements: o Information on Spherox, including the indication currently approved and legal basis o Detailed description of the biopsy harvest procedure and the administration procedure, the implantation by knee-joint arthrotomy and the follow-up protocol o Preparation of the patient for the procedure and subsequent monitoring o The need to officially confirm that training has been conducted prior to the biopsy. 
o informacije o zdravilu Spherox, vključno s trenutno odobreno indikacijo in pravno podlago, o podroben opis postopka odvzemanja vzorcev z biopsijo in postopka dajanja, implantacijo z artrotomijo kolena ter kontrolni protokol, o pripravo bolnika na postopek in naknadno spremljanje, o zahtevo po uradni potrditvi izvedbe usposabljanja pred biopsijo, o pomembnost izpolnjevanja kontrolnega seznama, o priporočila o rehabilitaciji po biopsiji in presaditvi.
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2). 
POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Do not use this medicine after the expiry date which is stated on the label after EXP. Store and transport refrigerated (1 °C to 10 °C). 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake „EXP“.
For the patients treated with Spherox the mean overall KOOS (scale of 0-100 ± SD) increased from 56.6 ± 15.4 at baseline to 78.7 ± 18.6 at the follow-up visit 12 months after treatment, improved up to the 24 months visit to 81.5 ± 17.3 and reached 83.2 ± 14.9 at the 36 months visit. 
do 100 ± SD) povečala od 56,6 ± 15,4 v izhodišču na 78,7 ± 18,6 ob kontrolnem obisku 12 mesecev po zdravljenju, izboljševala do obiska pri 24 mesecih na 81,5 ± 17,3 in dosegla 83,2 ± 14,9 ob obisku pri 36 mesecih.
• SOC Vascular disorders: lymphoedema (common), thrombophlebitis (uncommon), deep vein thrombosis (uncommon), haematoma (uncommon) 
• Organski sistem (SOC) Žilne bolezni: limfedem (pogosti), tromboflebitis (občasni), globoka venska tromboza (občasni), hematom (občasni)
• SOC Musculoskeletal and connective tissue disorders: joint effusion (very common), arthralgia (very common), joint swelling (very common), tendonitis (common), muscular weakness (common), patellofemoral pain syndrome (common), osteonecrosis (uncommon) 
• Organski sistem (SOC) Bolezni mišično-skeletnega sistema in vezivnega tkiva: efuzija sklepa (zelo pogosti), artralgija (zelo pogosti), zatekanje sklepa (zelo pogosti), tendonitis (pogosti),
Spherox is implanted into the cartilage defect in the joint during the next operation. 
Med naslednjo operacijo je zdravilo Spherox implantirano v poškodovan hrustanec v sklepu.
Ask your doctor or physical therapist if you have any further questions about treatment with Spherox. 
Če imate še kakšna vprašanja o zdravljenju z zdravilom Spherox, se obrnite na svojega zdravnika ali fizioterapevta.
For decision on treatment of facing defects (“kissing lesions” larger than ICRS grade II) the degree of overlap and location of the defects in the joint have to be taken into consideration. 
Za odločitev o zdravljenju poškodb na nasprotni strani („obojestranskih lezij“, večjih od stopnje II po
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Spherox 10-70 spheroids/cm2 implantation suspension 
IME ZDRAVILA IN POT(-I) UPORABE Spherox 10-70 sferoidov/cm2 suspenzija za implantacijo
Application system co.fix 150 mm or 
Sistem za aplikacijo co.fix 150 mm ali injekcijska brizga
Pain, Gait disturbance 
motnje hoje,
• inflammation of veins combined with the formation of a blood clot located near the surface of the skin (symptoms: e.g. redness and/or warmth of the skin along the vein, tenderness, pain) 
• vnetje ven, združeno z nastankom krvnega strdka v bližini površine kože (simptomi: npr.
• pain 
• bolečina;
10-70 spheroids are applied per square centimetre defect. 
Odmerjanje Na kvadratni centimeter poškodbe je nanesenih 10-70 sferoidov.
One applicator has a maximum capacity of 60 spheroids in a volume of up to 200 microlitre isotonic sodium chloride solution. 
V enem aplikatorju je največ 60 sferoidov v izotonični raztopini natrijevega klorida s prostornino do
Implantation suspension. 
FARMACEVTSKA OBLIKA suspenzija za implantacijo
For ‘all dose groups' the mean overall KOOS increased in the first year after treatment from 57.0 ± 15.2 to 73.4 ± 17.3 on a scale from 0 (worst) to 100 (best) and continued to increase slightly, reaching 74.6 ± 17.6 after 18 months, 73.8 ± 18.4 after two years, 
Za vse skupine odmerkov se je povprečna skupna vrednost KOOS v prvem letu po zdravljenju na lestvici od 0 (najslabše) do 100 (najboljše) zvišala s 57,0 ± 15,2 na 73,4 ± 17,3 in je nato še naprej rahlo zvečevala, pri čemer je po 18 mesecih dosegla 74,6 ± 17,6, po dveh letih 73,8 ± 18,4, po treh letih 77,0 ± 17,8, 77,1 ± 18,6 po štirih letih in 76,9 ± 19,3 pri končnem spremljanju po petih letih.
The container may be a syringe or a special application system called co.fix that is a catheter with a stem length of 150 mm. 
Vsebnik je lahko injekcijska brizga ali poseben sistem za dajanje, imenovan co.fix, ki je kateter z dolžino ročice 150 mm.Aplikator co.fix 150 je pakiran v sterilni cevki, poleg tega pa je ovit še z dodatno vrečko.
During treatment with Spherox surgery-related (implantation) or Spherox-related adverse reactions may occur. 
Med zdravljenjem z zdravilom Spherox se lahko pojavijo neželeni učinki, povezani s kirurškim posegom
Application of Spherox in obese patients is not recommended. 
Uporaba zdravila Spherox pri bolnikih s čezmerno telesno maso ni priporočljiva.
Only resume physical activity when instructed by your doctor. 
S telesno dejavnostjo ponovno začnite samo,
• Periodic safety update reports (PSURs) 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU
PHARMACEUTICAL FORM AND CONTENTS 
FARMACEVTSKA OBLIKA IN VSEBINA suspenzija za implantacijo
• The Prescriber checklist shall contain the following key messages: o Corroboration that the patient receiving the product is the right patient receiving the appropriate product o Confirmation of the appropriate side of the implantation o A reference to the fact that the patient has been informed and understands the benefits and risks of the product and the associated procedures 
o potrditev, da je bolnik, ki prejema zdravilo, pravi bolnik, ki prejema ustrezno zdravilo, o potrditev ustrezne strani implantacije,
The surgical procedure will have a major influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Kirurški poseg ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
Spherox 10-70 spheroids/cm2 implantation suspension 
Spherox 10-70 sferoidov/cm2 suspenzija za implantacijo
Visit 2: Spherox implantation 
Drugi obisk: vsaditev zdravila Spherox
Spherox contains 10-70 spheroids per cm² of the cartilage defect. 
Zdravilo Spherox vsebuje 10-70 sferoidov na cm² poškodbe hrustanca.
In case of application system co.fix 150 mm as primary packaging unit: {1 or 2} application system{s} co.fix 150 mm containing {Number of Spheroids} spheroids in a sterile tube 
{1 ali 2} sistem/-a za aplikacijo co.fix 150 mm, ki vsebuje/-ta {število sferoidov} v sterilni tubi.
Spheroids of human autologous matrix-associated chondrocytes for implantation suspended in isotonic sodium chloride solution. 
2.1 Splošen opis Sferoidi humanih avtolognih, na matriks nanesenih hondrocitov za implantacijo, suspendirani v izotonično raztopino natrijevega klorida.
Spherox 10-70 spheroids/cm2 implantation suspension Syringe: 
Spherox 10-70 sferoidov/cm2 suspenzija za implantacijo Injekcijska brizga:
6.1 List of excipients 
6.1 Seznam pomožnih snovi natrijev klorid
• SOC Injury, poisoning and procedural complications: ligament sprain (common), suture-related complication (uncommon), wound dehiscence (uncommon) 
• Organski sistem (SOC) Poškodbe, zastrupitve in zapleti pri posegih: zvin (pogosti), zaplet,
Immune system disorders 
Bolezni imunskega sistema občasni preobčutljivost
How to store Spherox 
Shranjevanje zdravila Spherox
The number of primary packaging units delivered depends on the type of the primary packaging unit and the number of spheroids necessary for the specific defect size (10-70 spheroids/cm²). 
Velikosti pakiranj Število dobavljenih primarnih ovojnin je odvisno od vrste primarne ovojnine in števila sferoidov,
DATE OF REVISION OF THE TEXT 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
The pre-filled syringe is delivered with an application device (indwelling cannula or filter stem). 
(vstavljeno kanilo ali filtrirno ročico).
The spheroids are provided in an applicator or a pre-filled syringe as primary packaging unit. 
6.5 Vrsta ovojnine in vsebina ter posebna oprema za uporabo, dajanje ali implantacijo Sferoidi so na voljo v aplikatorju ali napolnjeni injekcijski brizgi kot primarni ovojnini.
Precautions for use 
Način uporabe
Tabulated list of adverse reactions 
Preglednica z neželenimi učinki