FrancophonIA/ELRC3.0 huggingface dataset:
English: If possible, concomitant joint problems should be corrected prior to or at the latest at the time of Spherox implantation.
Croatian: Konkomitantne probleme sa zglobom potrebno je izliječiti prije ili najkasnije u vrijeme implantacije lijeka Spherox ako je moguće.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Croatian: Nakon dobivanja odobrenja za lijek važno je prijavljivanje sumnji na njegove nuspojave.
English: Other cases in which Spherox cannot be supplied
Croatian: Drugi slučajevi u kojima ne možete dobiti Spherox
English: Store at temperatures between 1 °C and 10 °C.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Čuvati na temperaturi između 1 °C i 10 °C.
English: • The product will only be available to surgeons certified to prescribe and administer Spherox
Croatian: • lijek Spherox bit će dostupan samo kirurzima koji su ga ovlašteni propisivati i primjenjivati
English: Spheroids of human autologous matrix-associated chondrocytes for implantation suspended in isotonic sodium chloride solution.
Croatian: Sferoidi ljudskih autolognih, na matriks vezanih, hondrocita za implantaciju, suspendiranih u izotoničnoj otopini natrijeva klorida.
English: The safety and efficacy of Spherox in patients aged over 50 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Spherox u bolesnika starijih od 50 godina još nisu ustanovljene.
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava Manje često
English: The pre-filled syringe is packed in a sterile tube and additionally surrounded by an extra bag.
Croatian: Unaprijed napunjena štrcaljka pakira se u sterilnu tubu i obložena je dodatnom vrećicom.
English: It is packed in a sterile tube with a screw-type cap and additionally surrounded by an extra bag.
Croatian: Pakira se u sterilnu tubu s poklopcem s navojem i obložena je dodatnom vrećicom.
English: Twenty-five patients were treated with 10-30 spheroids/cm² defect, 25 with 40-70 spheroids/cm² defect and 25 with 3-7 spheroids/cm² defect.
Croatian: bolesnika odgovarajuće oštećenje liječeno je s 10-30 sferoida/cm² oštećenja, 25 s 40-70 sferoida/cm²
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGINGUNITS Application system co.fix 150 mm or
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Sustav za primjenu „co.fix 150 mm” ili
English: The safety and efficacy of Spherox in children aged 15 to 18 years have not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost lijeka Spherox u djece u dobi od 15 do 18 godina nisu još ustanovljene.
English: Application of Spherox in obese patients is not recommended.
Croatian: Primjena lijeka Spherox ne preporučuje se u pretilih bolesnika.
English: EXPIRY DATE EXP {DD month YYYY} at {hours} CET
Croatian: ROK VALJANOSTI EXP {DD mjesec GGGG} u {sati} SEV
English: Dispose of in accordance with local requirements.
Croatian: Zbrinuti sukladno nacionalnim propisima.
English: Depending on the treated joint, you may have to wear a brace.
Croatian: Možda ćete morati nositi ortoze, ovisno o liječenom zglobu.
English: Store between 1 °C and 10 °C, do not freeze, do not irradiate, do not open the outer packaging before use to prevent microbial contamination.
Croatian: POSEBNE MJERE ČUVANJA Čuvati na temperaturi između 1 °C i 10 °C, ne zamrzavati, ne izlagati zračenju.
English: After implantation, the patient should follow an appropriate rehabilitation schedule.
Croatian: Bolesnik treba slijediti odgovarajući program rehabilitacije nakon implantacije.
English: Spherox contains 10-70 spheroids per cm² of the cartilage defect.
Croatian: Spherox sadrži 10-70 sferoida po cm² oštećene hrskavice.
English: In all 3 dose groups a significant improvement (α < 0.05) of the
Croatian: U svim trima doznim skupinama zabilježena su znatna poboljšanja (α < 0,05) prema ljestvici KOOS (rezultat ishoda za ozljedu koljena i osteoartritis, engl.
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Delaminacija presatka
English: How to use Spherox
Croatian: Kako primjenjivati Spherox
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).
Croatian: Klinička djelotvornost Od 2004. lijek Spherox dostupan je po principu za svakog bolesnika poimence, za liječenje oštećenja hrskavice klasificiranih kao 3. ili 4. stupanj prema Outerbridgeu ili III. ili IV. stupanj prema ICRS-u
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)
Croatian: artralgija (vrlo često), oticanje zgloba (vrlo često), tendinitis (često), slabost u mišićima (često), patelofemoralni bolni sindrom (često), osteonekroza (manje često)
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
Croatian: Ako je sustav za primjenu „co.fix 150 mm” primarno pakiranje: {1 ili 2} sustav{a} za primjenu „co.fix 150 mm” koji sadrži{avaju} {broj sferoida} sferoida u sterilnoj tubi
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.
Croatian: nestabilnost zgloba, lezije ligamenata ili meniska, abnormalna raspodjela pritiska težine u zglobu, varusna ili valgusna deformacija, nepravilnog patelarno poravnanja ili nestabilnosti te metaboličke,
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).
Croatian: Ovaj lijek sadrži određen broj sferoida ljudskih autolognih hondrocita vezanih na matricu, sukladno veličini oštećenja (10-70 sferoida/cm2).
English: 77.0 ± 17.8 after three years, 77.1 ± 18.6 after four years and 76.9 ± 19.3 at final follow-up after five years.
Croatian: 68,1 ± 18,6 nakon 12 mjeseci, na 72,6 ± 19,5 nakon 24 mjeseci i na 76,3 ± 17,1 nakon 36 mjeseci
English: The safety and efficacy of Spherox in children aged less than 15 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka Spherox u djece mlađe od 15 godina nisu još ustanovljene.
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.
Croatian: o podatke o lijeku Spherox, uključujući trenutačno odobrene indikacije i zakonsku osnovu o potrebu za probirom na hepatitis B, hepatitis C, HIV i sifilis u donatora o detaljan opis provedbe postupka biopsijske žetve i rukovanja lijekom, sastavnice postupka pripreme za implantaciju, raspored praćenja bolesnika i preporučenu fizioterapiju o potrebu službenog potvrđivanja da je osoba završila obuku prije same biopsije.
English: Syringe
Croatian: Nuspojave
English: The patient's haemostatic functions should be screened prior to surgery.
Croatian: Prije operacije potrebno je provjeriti bolesnikove hemostatske funkcije.
English: Cartilage tissue is present in every joint as a hard smooth layer on the surface of bone ends.
Croatian: Hrskavično tkivo prisutno je u svakom zglobu kao tvrd glatki sloj na površini krajeva kostiju, koji štiti kosti i omogućuje nesmetan rad zglobova.
English: LIST OF EXCIPIENTS Excipient: sodium chloride.
Croatian: POPIS POMOĆNIH TVARI Pomoćna tvar: natrijev klorid
English: The application of Spherox in patients with cartilage defects outside the knee joint is not recommended.
Croatian: Primjena lijeka Spherox ne preporučuje se u bolesnika s oštećenjima hrskavice izvan područja zgloba koljena.
English: How to store Spherox
Croatian: Kako čuvati Spherox
English: • SOC Injury, poisoning and procedural complications: ligament sprain (common), suture-related complication (uncommon), wound dehiscence (uncommon)
Croatian: • SOC Ozljede, trovanja i proceduralne komplikacije: istegnuće ligamenta (često), komplikacije povezane sa šavom (manje često), dehiscencija rane (manje često) • SOC Poremećaji kože i potkožnog tkiva: bolni ožiljak (često)
English: Posology
Croatian: Opis
English: • scar tissue pain
Croatian: • bol • upala tetive
English: • SOC Vascular disorders: lymphoedema (common), thrombophlebitis (uncommon), deep vein thrombosis (uncommon), haematoma (uncommon)
Croatian: • SOC Krvožilni poremećaji: limfedem (često), tromboflebitis (manje često), duboka venska tromboza (manje često), hematom (manje često)
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,
Croatian: Za sve dozne skupine prosječan rezultat prema ljestvici KOOS porastao je u prvoj godini nakon liječenja s 57,0 ± 15,2 na 73,4 ± 17,3 na ljestvici od 0 (najgore) do 100 (najbolje) te je nastavio s blagim porastom dosegnuvši vrijednost 74,6 ± 17,6 nakon 18 mjeseci, 73,8 ± 18,4 nakon dvije godine, 77,0 ± 17,8 nakon tri godine, 77,1 ± 18,6 nakon četiri godine i 76,9 ± 19,3 na zadnjem praćenju nakon pet godina.
English: If you get any side effects, talk to your doctor or physical therapist.
Croatian: • Ako primijetite bilo koju nuspojavu, trebate obavijestiti liječnika ili fizioterapeuta.
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.
Croatian: 0-100 ± SD) povećao se s početne vrijednosti od 56,6 ± 15,4 na 78,7 ± 18,6 u vrijeme posjete u okviru praćenja bolesnika 12 mjeseci nakon liječenja i poboljšao se na posjeti nakon 24 mjeseci do vrijednosti 81,5 ± 17,3 i dosegao je 83,2 ± 14,9 u vrijeme posjete tijekom 36. mjeseca.
English: Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX02
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Ostali lijekovi za liječenje poremećaja mišićno-koštanog sustava, ATK
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.
Croatian: bodova pri drugoj posjeti (3 mjeseca nakon liječenja) na 75,0 boda u skupini bolesnika liječenih s 3-7 sferoida/cm² oštećenja, sa 64,5 boda pri drugoj posjeti na 76,4 bodova u doznoj skupini liječenoj s 10-30 sferoida/cm² oštećenja i sa 64,7 bodova pri drugoj posjeti na 73,6 boda u doznoj skupini liječenoj s 40-70 sferoida/cm² oštećenja.
English: below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
Croatian: Nuspojave povezane s lijekom Spherox su prikazane prema klasifikaciji organskih sustava i učestalosti u tablici 1 u nastavku: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100);
English: Spherox 10-70 spheroids/cm2 implantation suspension spheroids of human autologous matrix-associated chondrocytes
Croatian: Spherox 10-70 sferoida/cm2 suspenzija implantata sferoidi ljudskih autolognih hondrocita vezanih na matricu
English: • uneasiness
Croatian: • uznemirenost
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.
Croatian: o podatke o lijeku Spherox, uključujući trenutačno odobrene indikacije i zakonsku osnovu o detaljan opis postupka biopsijske žetve (engl. biopsy harvest procedure) i postupka primjene lijeka, implantacije artrotomijom koljena te protokola za praćenje o pripremu bolesnika za postupak i naknadno praćenje o potrebu službenog potvrđivanja da je osoba završila obuku prije same biopsije o važnost ispunjavanja kontrolnog popisa o preporuke za oporavak nakon biopsije i nakon transplantacije.
English: What Spherox looks like and contents of the package
Croatian: Kako Spherox izgleda i sadržaj pakiranja Suspenzija implantata.
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)
Croatian: • Preosjetljivost (alergija) (simptomi: npr. reakcije na koži, nizak krvni tlak, suženje dišnih putova,
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER CO.DON AG, Warthestraße 21, 14513 Teltow, Germany Tel: +49 (0)3328 43 46 0, Fax: +49 (0)3328 43 46 43, Email: info@codon.de
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET CO.DON AG, Warthestraße 21, 14513 Teltow, Njemačka Tel:.
English: Graft delamination
Croatian: Oticanje zgloba
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Spherox 10-70 spheroids/cm2 implantation suspension
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Spherox 10 - 70 sferoida/cm2 suspenzija implantata
English: 6.5 Nature and contents of container and special equipment for use, administration or implantation
Croatian: 6.5 Vrsta i sadržaj spremnika i posebna oprema za uporabu, primjenu ili implantaciju Sferoidi dolaze u aplikatoru ili napunjenoj štrcaljki kao primarnom pakiranju.
English: Further patient scores, e.g. the International Knee Documentation Committee (IKDC; subjective evaluation of the knee) and the Lysholm score showed after 12, 24, 36, 48 and 60 months also a significant improvement in comparison to the value before treatment.
Croatian: Lysholmovoj ljestvici, također su pokazali značajno poboljšanje nakon 12, 24, 36, 48 i 60 mjeseci u odnosu na vrijednost prije liječenja.
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)
Croatian: • upala vena u kombinaciji sa stvaranjem krvnog ugruška u blizini površine kože (simptomi: npr.
English: They are transported in a clear colourless solution.
Croatian: Prenose se u bistroj, bezbojnoj otopini.
English: The surgical procedure will have a major influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Kirurški postupak imat će velik utjecaj na sposobnost upravljanja vozilima i strojevima.
English: • internal bleedings
Croatian: • unutarnja krvarenja
English: • Prescriber checklist
Croatian: Tablični popis nuspojava
English: • SOC General disorders and administration site conditions: pain (common), gait disturbance (common), discomfort (uncommon)
Croatian: • SOC Opći poremećaji i reakcije na mjestu primjene: bol (često), poremećaj hodanja (često) osjećaj neugode (manje često)
English: On the first visit, the doctor will evaluate your cartilage defect during an exploratory operation.
Croatian: Procjena oštećenja hrskavice, uzimanje uzorka i uzimanje krvi Tijekom prvog posjeta liječnik će procijeniti oštećenje vaše hrskavice tijekom ekspolorativne operacije.
English: Spherox 10-70 spheroids/cm2 implantation suspension
Croatian: Štrcaljka: Spherox 10 - 70 sferoida/cm2 suspenzija implantata
English: • SOC Skin and subcutaneous tissue disorder: scar pain (common)
Croatian: • SOC Poremećaji mišićno-koštanog sustava i vezivnog tkiva: izljev u zglob (vrlo često),
English: Common
Croatian: Općenito
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).
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake EXP.
English: Risk factors are in particular non-treatment of concomitant diseases, such as subchondral bone oedema.
Croatian: Izostanak liječenja konkomitantnih bolesti kao što je edem subhondralne kosti važan je čimbenik rizika.
English: What Spherox is and what it is used for 2.
Croatian: Što se nalazi u ovoj uputi: 1. Što je Spherox i za što se koristi
English: NAME OF THE MEDICINAL PRODUCT Spherox 10-70 spheroids/cm2 implantation suspension spheroids of human autologous matrix-associated chondrocytes
Croatian: Uputa o lijeku: Informacije za bolesnika Spherox 10-70 sferoida/cm2 suspenzija implantata sferoidi ljudskih autolognih hondrocita vezanih na matricu
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT In case of application system co.fix 150 mm as primary packaging unit: {1 or 2} application system{s} co.fix 150 mm in a sterile tube In case of syringe as primary packaging unit:
Croatian: Ako je sustav za primjenu „co.fix 150 mm” primarno pakiranje: {1 ili 2} sustav{a}za primjenu „co.fix 150 mm” u sterilnoj tubi
English: In the pivotal studies of Spherox, patients were excluded if they were under medical treatment with corticosteroids.
Croatian: Bolesnici koji su primali terapiju s kortikosteroidima bili su isključeni iz ključnih ispitivanja lijeka
English: System Organ Class (SOC)
Croatian: Tablica 1: Nuspojave povezane s lijekom Spherox Klasifikacija organskih sustava (SOC)
English: • cracking sounds in the joint
Croatian: Zvuk u zglobu
English: • muscle weakness
Croatian: • slabost u mišićima
English: General
Croatian: Učestalost
English: Paediatric population
Croatian: Stariji bolesnici
English: In the pivotal studies of Spherox, patients were excluded if they had signs of chronic inflammatory diseases.
Croatian: Bolesnici sa znakovima kroničnih upalnih bolesti bili su isključeni iz ključnih ispitivanja lijeka
English: Pain, Gait disturbance
Croatian: Poremećaj hodanja
English: virus
Croatian: LIJEKA
English: • tendon inflammation
Croatian: • ukočenost zgloba
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intraarticular use.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA
English: • pain of the front knee or kneecap
Croatian: • bol u prednjem dijelu koljena ili iveru • izraslina na tkivu koja se može javiti u zglobu
English: Do not use Spherox if
Croatian: Nemojte primjenjivati Spherox ako • kosti u zglobu još rastu
English: 11 July 2014
Croatian: 11. srpnja 2014.
English: Background information
Croatian: Temeljne informacije
English: Article 34 of Directive 2001/82/EC, as amended
Croatian: Direktive 2001/82/EZ
English: Committee for medicinal products for veterinary use (CVMP)
Croatian: Povjerenstvo za veterinarske lijekove (CVMP)
English: Veterinary Medicines Division
Croatian: Odjel za veterinarske lijekove
English: The final opinion was converted into a Decision by the European Commission on 11 July 2014.
Croatian: Europska Komisija pretvorila je konačno mišljenje u Odluku 11. srpnja 2014.
English: Written explanations were provided by the marketing authorisation holders on 10 September 2013 and 10 February 2014.
Croatian: Nositelji odobrenja podnijeli su napismena objašnjenja 10. rujna 2013. i 10. veljače 2014.
English: International non-proprietary name (INN): lincomycin and spectinomycin
Croatian: Međunarodni nezaštićeni naziv (INN): linkomicin i spektinomicin
English: Linco-Spectin 100 is a powder for oral solution containing 33.3 g lincomycin (as lincomycin hydrochloride) and 66.7 g spectinomycin (as spectinomycin sulphate) per 150 g pack.
Croatian: Linco-Spectin 100 je prašak za oralnu otopinu koji sadrži 33,3 g linkomicina (u obliku linkomicin hidroklorida) i 66,7 g spektinomicina (u obliku spektinomicin sulfata) po 150 g pakiranja.
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.
Croatian: Zbog različitih nacionalnih odluka koje su donijele države članice s obzirom na ciljne vrste, indikacije, doziranje i karencije, a u vezi odobrenja za Linco-Spectin 100 i njegove pridružene nazive, 28. Rujna 2012. godine Belgija je uputila predmet na arbitražu na CVMP u skladu s člankom 34. stavkom 1. Direktive 2001/82/EZ kako bi se riješile razlike u informacijama za nacionalno odobrene proizvode širom Europske unije.
English: The Committee appointed B. Urbain as rapporteur and C. Muñoz Madero as co-rapporteur.
Croatian: Urbaina kao ocjenitelja i C. Muñoza Madera kao suocjenitelja.
English: The referral procedure started on 10 October 2012.
Croatian: Postupak arbitraže započeo je 10. listopada 2012.
English: The Committee adopted a positive opinion by consensus on 10 April 2014.
Croatian: Povjerenstvo je usvojilo pozitivno mišljenje putem dogovora 10. travnja 2014.
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.
Croatian: Na temelju procjene trenutačno dostupnih podataka, CVMP je smatrao da profil rizika i koristi za LincoSpectin 100 i njegove pridružene nazive ostaje pozitivan, podložan promjenama odobrenja za stavljanje lijeka u promet u skladu s preporučenim informacijama o proizvodu.
English: Opinion following an Article 340F referral for Linco-Spectin 100 and associated names EMA/431244/2014
Croatian: Mišljenje nakon arbitraže u skladu s člankom 34.0F za Linco-Spectin 100 i pridružene nazive EMA/431244/2014
English: Spectinomycin is classified as an aminocyclitol antibiotic, close to aminoglycosides.
Croatian: Spektinomicin je klasificiran kao aminociklitolički antibiotik, sličan aminoglikozidima.
English: Lincomycin is a lincosamide antibiotic, closely related to macrolide and streptogramin B antimicrobials.
Croatian: Linkomicin je linkozamidni antibiotik jako sličan makrolidnim antimikrobnim lijekovima i streptograminu B.
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.
Croatian: Znanstveni zaključci nalaze se u Prilogu II. skupa sa Sažetkom opisa svojstava, označivanjem i uputom o VMP u Prilogu III.
English: Opinion following an Article 341 referral for Linco-Spectin 100 and associated names
Croatian: Linco-Spectin 100 i pridružene nazive
English: Strength Pharmaceutical Form Route of Administration
Croatian: Doza Farmaceutski oblik Put primjene Unutarnje pakovanje
English: Pack size
Croatian: Sastav (koncentracija)