FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pivotal studies of Spherox, patients were excluded if they had signs of chronic inflammatory diseases.
Slovenian: Če so bolniki v osrednjih študijah zdravila Spherox kazali znake kroničnih vnetnih bolezni, so bili izločeni.
English: Post-operative haemarthrosis occurs mainly in patients with a predisposition to haemorrhage or poor surgical haemorrhage control.
Slovenian: 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.
English: • If you get any side effects, talk to your doctor or physical therapist.
Slovenian: • Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali fizioterapevtom.
English: Spherox consists of so-called spheroids.
Slovenian: Zdravilo Spherox je sestavljeno iz t. i. sferoidov.
English: • SOC Skin and subcutaneous tissue disorder: scar pain (common)
Slovenian: • Organski sistem (SOC) Bolezni kože in podkožja: boleča brazgotina (pogosti)
English: OTHER For autologous use only.
Slovenian: Samo za avtologno uporabo.
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Slovenian: Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
English: The safety and efficacy of Spherox in patients aged over 50 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Spherox pri bolnikih, starejših od 50 let, še nista bili dokazani.
English: • uneasiness
Slovenian: • nelagodje;
English: 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).
Slovenian: 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).
English: It is packed in a sterile tube with a screw-type cap and additionally surrounded by an extra bag.
Slovenian: Pakirana je v sterilni cevki z navojnim zamaškom, poleg tega pa je ovita še z dodatno vrečko.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intraarticular use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA za intraartikularno uporabo Pred uporabo preberite priloženo navodilo!
English: The pre-filled syringe is packed in a sterile tube and additionally surrounded by an extra bag.
Slovenian: Napolnjena injekcijska brizga je pakirana v sterilni cevki, poleg tega pa je ovita še z dodatno vrečko.
English: BATCH NUMBER, DONATION AND PRODUCT CODES {Batch Number}
Slovenian: ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV {Številka serije}
English: In case of syringe as primary packaging unit: 1 syringe containing {Number of Spheroids} spheroids in a sterile tube
Slovenian: 1 injekcijska brizga, ki vsebuje (število sferoidov) v sterilni tubi.
English: 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).
Slovenian: 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).
English: • 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.
Slovenian: 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.
English: 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).
Slovenian: 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
English: Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX02
Slovenian: 5.1 Farmakodinamične lastnosti Farmakoterapevtska skupina: Druga zdravila za bolezni mišično-skeletnega sistema, oznaka ATC:
English: In the pivotal studies of Spherox, patients were excluded if they were under medical treatment with corticosteroids.
Slovenian: Če so bili bolniki v osrednjih študijah zdravila Spherox zdravljeni s kortikosteroidi, so bili izločeni.
English: • internal bleedings
Slovenian: • notranje krvavitve;
English: PARTICULARS TO APPEAR ON THE SECONDARY PACKAGING Tube
Slovenian: PODATKI NA SEKUNDARNI OVOJNINI Tuba
English: The safety and efficacy of Spherox in children aged less than 15 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Spherox pri otrocih, mlajših od 15 let, še nista bili dokazani.
English: How to use Spherox
Slovenian: Kako jemati zdravilo Spherox
English: The safety and efficacy of Spherox in children aged 15 to 18 years have not been established.
Slovenian: Pediatrična populacija Varnost in učinkovitost zdravila Spherox pri otrocih, starih od 15 do 18 let, še nista bili dokazani.
English: All parts of the pre-filled syringe are made of polypropylene, the sealing ring of isoprene.
Slovenian: Vsi deli napolnjene injekcijske brizge so izdelani iz polipropilena, tesnilni obroček pa iz izoprena.
English: LIST OF EXCIPIENTS Excipient: sodium chloride.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožna snov: natrijev klorid.
English: If you get any side effects, talk to your doctor or physical therapist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali fizioterapevtom.
English: 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).
Slovenian: ali IV po ICRS (Outerbridge 1961, ICRS Cartilage Injury Evaluation Package 2000).
English: The pre-filled syringe consists of a luer lock, a sealing ring and a cover cap.
Slovenian: Napolnjeno injekcijsko brizgo sestavljajo nastavek luer, tesnilni obroček in pokrovček.
English: • 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.
Slovenian: 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.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: 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).
English: 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).
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake „EXP“.
English: 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.
Slovenian: 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.
English: • SOC Vascular disorders: lymphoedema (common), thrombophlebitis (uncommon), deep vein thrombosis (uncommon), haematoma (uncommon)
Slovenian: • Organski sistem (SOC) Žilne bolezni: limfedem (pogosti), tromboflebitis (občasni), globoka venska tromboza (občasni), hematom (občasni)
English: • 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)
Slovenian: • Organski sistem (SOC) Bolezni mišično-skeletnega sistema in vezivnega tkiva: efuzija sklepa (zelo pogosti), artralgija (zelo pogosti), zatekanje sklepa (zelo pogosti), tendonitis (pogosti),
English: Spherox is implanted into the cartilage defect in the joint during the next operation.
Slovenian: Med naslednjo operacijo je zdravilo Spherox implantirano v poškodovan hrustanec v sklepu.
English: Ask your doctor or physical therapist if you have any further questions about treatment with Spherox.
Slovenian: Če imate še kakšna vprašanja o zdravljenju z zdravilom Spherox, se obrnite na svojega zdravnika ali fizioterapevta.
English: 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.
Slovenian: Za odločitev o zdravljenju poškodb na nasprotni strani („obojestranskih lezij“, večjih od stopnje II po
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Spherox 10-70 spheroids/cm2 implantation suspension
Slovenian: IME ZDRAVILA IN POT(-I) UPORABE Spherox 10-70 sferoidov/cm2 suspenzija za implantacijo
English: Application system co.fix 150 mm or
Slovenian: Sistem za aplikacijo co.fix 150 mm ali injekcijska brizga
English: Pain, Gait disturbance
Slovenian: motnje hoje,
English: • 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)
Slovenian: • vnetje ven, združeno z nastankom krvnega strdka v bližini površine kože (simptomi: npr.
English: • pain
Slovenian: • bolečina;
English: 10-70 spheroids are applied per square centimetre defect.
Slovenian: Odmerjanje Na kvadratni centimeter poškodbe je nanesenih 10-70 sferoidov.
English: One applicator has a maximum capacity of 60 spheroids in a volume of up to 200 microlitre isotonic sodium chloride solution.
Slovenian: V enem aplikatorju je največ 60 sferoidov v izotonični raztopini natrijevega klorida s prostornino do
English: Implantation suspension.
Slovenian: FARMACEVTSKA OBLIKA suspenzija za implantacijo
English: 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,
Slovenian: 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.
English: 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.
Slovenian: 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.
English: During treatment with Spherox surgery-related (implantation) or Spherox-related adverse reactions may occur.
Slovenian: Med zdravljenjem z zdravilom Spherox se lahko pojavijo neželeni učinki, povezani s kirurškim posegom
English: Application of Spherox in obese patients is not recommended.
Slovenian: Uporaba zdravila Spherox pri bolnikih s čezmerno telesno maso ni priporočljiva.
English: Only resume physical activity when instructed by your doctor.
Slovenian: S telesno dejavnostjo ponovno začnite samo,
English: • Periodic safety update reports (PSURs)
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU
English: PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA suspenzija za implantacijo
English: • 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
Slovenian: o potrditev, da je bolnik, ki prejema zdravilo, pravi bolnik, ki prejema ustrezno zdravilo, o potrditev ustrezne strani implantacije,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1181/001
Slovenian: EU/1/17/1181/001 EU/1/17/1181/002
English: The surgical procedure will have a major influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Kirurški poseg ima pomemben vpliv na sposobnost vožnje in upravljanja strojev.
English: Spherox 10-70 spheroids/cm2 implantation suspension
Slovenian: Spherox 10-70 sferoidov/cm2 suspenzija za implantacijo
English: Visit 2: Spherox implantation
Slovenian: Drugi obisk: vsaditev zdravila Spherox
English: Spherox contains 10-70 spheroids per cm² of the cartilage defect.
Slovenian: Zdravilo Spherox vsebuje 10-70 sferoidov na cm² poškodbe hrustanca.
English: 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
Slovenian: {1 ali 2} sistem/-a za aplikacijo co.fix 150 mm, ki vsebuje/-ta {število sferoidov} v sterilni tubi.
English: Spheroids of human autologous matrix-associated chondrocytes for implantation suspended in isotonic sodium chloride solution.
Slovenian: 2.1 Splošen opis Sferoidi humanih avtolognih, na matriks nanesenih hondrocitov za implantacijo, suspendirani v izotonično raztopino natrijevega klorida.
English: Spherox 10-70 spheroids/cm2 implantation suspension Syringe:
Slovenian: Spherox 10-70 sferoidov/cm2 suspenzija za implantacijo Injekcijska brizga:
English: 6.1 List of excipients
Slovenian: 6.1 Seznam pomožnih snovi natrijev klorid
English: • SOC Injury, poisoning and procedural complications: ligament sprain (common), suture-related complication (uncommon), wound dehiscence (uncommon)
Slovenian: • Organski sistem (SOC) Poškodbe, zastrupitve in zapleti pri posegih: zvin (pogosti), zaplet,
English: Immune system disorders
Slovenian: Bolezni imunskega sistema občasni preobčutljivost
English: How to store Spherox
Slovenian: Shranjevanje zdravila Spherox
English: 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).
Slovenian: Velikosti pakiranj Število dobavljenih primarnih ovojnin je odvisno od vrste primarne ovojnine in števila sferoidov,
English: DATE OF REVISION OF THE TEXT
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: The pre-filled syringe is delivered with an application device (indwelling cannula or filter stem).
Slovenian: (vstavljeno kanilo ali filtrirno ročico).
English: The spheroids are provided in an applicator or a pre-filled syringe as primary packaging unit.
Slovenian: 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.
English: Precautions for use
Slovenian: Način uporabe
English: Tabulated list of adverse reactions
Slovenian: Preglednica z neželenimi učinki
English: Depending on the treated joint, you may have to wear a brace.
Slovenian: Morda boste morali uporabljati opornico, odvisno od zdravljenega sklepa.
English: Spherox 10-70 spheroids/cm2 implantation suspension spheroids of human autologous matrix-associated chondrocytes
Slovenian: Spherox 10-70 sferoidov/cm2 suspenzija za implantacijo sferoidi humanih avtolognih, na matriks nanesenih hondrocitov
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih občasni hipertrofija, delaminacija presadka
English: below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
Slovenian: Neželeni učinki, povezani z zdravilom Spherox, so prikazani v spodnji preglednici 1 glede na klasifikacijo organskih sistemov in pogostnost: zelo pogosti (≥ 1/10), pogosti (od ≥ 1/100 do < 1/10),
English: Syringe
Slovenian: ZDRAVILA
English: KOOS (Knee Injury and Osteoarthritis Outcome Score) after 12, 24, 36, 48 and 60 months compared to before treatment could be observed.
Slovenian: Pri vseh 3 skupinah odmerkov je bilo po 12, 24, 36, 48 in 60 mesecih v primerjavi z obdobjem pred zdravljenjem opaziti znatno izboljšanje (α < 0,05) glede na vprašalnik
English: NAME OF THE MEDICINAL PRODUCT Spherox 10-70 spheroids/cm2 implantation suspension spheroids of human autologous matrix-associated chondrocytes
Slovenian: Navodilo za uporabo Spherox 10-70 sferoidov/cm2 suspenzija za implantacijo sferoidi humanih avtolognih, na matriks nanesenih hondrocitov
English: Elderly
Slovenian: OVOJNINAH
English: • muscle weakness
Slovenian: • mišična oslabelost;
English: Graft delamination
Slovenian: Injekcijska brizga:
English: • wound-related complication
Slovenian: • zaplet, povezan z rano;
English: Spherox has been analysed in a prospective, randomized, uncontrolled open-label, multicentre Phase II clinical study including 75 patients with focal cartilage defects (ICRS grade III or IV) in the knee with a defect size of 4-10 cm2.
Slovenian: Zdravilo Spherox je bilo analizirano v prospektivni randomizirani nekontrolirani odprti multicentrični klinični študiji II.
English: What Spherox looks like and contents of the package
Slovenian: Izgled zdravila Spherox in vsebina pakiranja Suspenzija za implantacijo.
English: • ligament disorder
Slovenian: • vnetje tetive;
English: Hypertrophy, Graft delamination
Slovenian: omedlevica, povišana telesna temperatura);
English: • scar tissue pain
Slovenian: • bolečina brazgotinastega tkiva.
English: What Spherox contains
Slovenian: Spherox,
English: • SOC General disorders and administration site conditions: pain (common), gait disturbance (common), discomfort (uncommon)
Slovenian: • Organski sistem (SOC) Splošne težave in spremembe na mestu aplikacije: bolečina (pogosti),
English: • Prescriber checklist
Slovenian: • kontrolni seznam za zdravnika, ki predpiše zdravilo, ter
English: Application system co.fix 150 mm: EXP {DD month YYYY} at {hours} CET
Slovenian: {1 ali 2} sistem/-a za aplikacijo co.fix 150 mm v sterilni tubi.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGINGUNITS Application system co.fix 150 mm or
Slovenian: Če je primarna ovojnina sistem za aplikacijo co.fix 150 mm
English: Adverse Reaction
Slovenian: Neželeni učinek
English: 11 July 2014
Slovenian: 11. julij 2014
English: Article 34 of Directive 2001/82/EC, as amended
Slovenian: Člen 34 Direktive 2001/82/ES, kakor je bila spremenjena.
English: The Committee appointed B. Urbain as rapporteur and C. Muñoz Madero as co-rapporteur.
Slovenian: Odbor je za poročevalca imenoval B. Urbaina, za soporočevalca pa C. Muñoz Madera.
English: The final opinion was converted into a Decision by the European Commission on 11 July 2014.
Slovenian: Končno mnenje je bilo 11. julija 2014 spremenjeno v Odločbo Evropske komisije.
English: The referral procedure started on 10 October 2012.
Slovenian: Napotitveni postopek se je začel 10. oktobra 2012.
English: Veterinary Medicines Division
Slovenian: Oddelek za veterinarsko medicino
English: Written explanations were provided by the marketing authorisation holders on 10 September 2013 and 10 February 2014.
Slovenian: Imetniki dovoljenj za promet z zdravilom so 10. septembra 2013 in 10. februarja 2014 predložili pisna pojasnila.
English: The Committee adopted a positive opinion by consensus on 10 April 2014.
Slovenian: Odbor je 10. aprila 2014 soglasno sprejel pozitivno mnenje.
English: International non-proprietary name (INN): lincomycin and spectinomycin
Slovenian: Mednarodno nelastniško ime (INN): linkomicin in spektinomicin
English: Due to divergent national decisions taken by Member States with respect to target species, indications, posology and withdrawal periods concerning the authorisations of Linco-Spectin 100 and its associated names, on 28 September 2012 Belgium referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve divergences in the nationally authorised product information across the European Union.
Slovenian: Zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice glede ciljnih vrst, indikacij, odmerjanja in karenc v zvezi z odobritvijo zdravila Linco-Spectin 100 in povezanih imen, je 28. septembra 2012 Belgija napotila zadevo Odboru CVMP v skladu s členom 34(1) Direktive 2001/82/ES, da razreši neskladja med nacionalno odobrenimi informacijami o zdravilu po vsej Evropski uniji.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics, labelling and package leaflet in Annex III.
Slovenian: Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki skupaj s spremenjenim povzetkom glavnih značilnosti zdravila so v Prilogi II, označevanje in navodilo za uporabo pa sta v Prilogi III.
English: Based on the evaluation of the currently available data, the CVMP considered that the benefit-risk profile of of Linco-Spectin 100 and its associated names remains positive, subject to variation of the marketing authorisations in accordance with the recommended product information.
Slovenian: Na podlagi ocene trenutno razpoložljivih podatkov je Odbor CVMP presodil, da razmerje med tveganji in koristmi za zdravilo Linco-Spectin 100 in povezana imena ostaja pozitivno, ob upoštevanju spremembe dovoljenj za promet z zdravilom v skladu s priporočenimi informacijami o zdravilu.
English: Opinion following an Article 340F referral for Linco-Spectin 100 and associated names EMA/431244/2014
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 340F za zdravilo Linco-Spectin 100 in povezana imena EMA/431244/2014