FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypertrophy, Graft delamination
Danish: Hypertrofi, delaminering af implantatet
English: PARTICULARS TO APPEAR ON THE SECONDARY PACKAGING Tube
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN SEKUNDÆRE EMBALLAGE Rør
English: Do not use Spherox if
Danish: Brug ikke Spherox
English: BATCH NUMBER, DONATION AND PRODUCT CODES {Patient ID (including the Batch Number)}
Danish: BATCHNUMMER, DONATIONS- OG PRODUKTKODER {patientens ID (inklusive batchnummeret)}
English: The mean patient age was 34 years (range 19 to 48 years) with a mean body mass index (BMI) of 25.2.
Danish: Patienternes gennemsnitsalder var 34 år (variationsbredde 19 til 48 år) med et gennemsnitligt BMI på 25,2.
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).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Dette lægemiddel indeholder et specifikt antal sfæroider af humane autologe matrixassocierede chondrocytter, afhængigt af defektens størrelse (10-70 sfæroider/cm2).
English: OTHER SPECIAL WARNING(S), IF NECESSARY For autologous use only.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Udelukkende til autolog anvendelse.
English: Side effects appearing after the implantation of Spherox are mostly related to the surgery.
Danish: Bivirkningerne efter implantation af Spherox skyldes hovedsagelig operationen.
English: The surgical procedure will have a major influence on the ability to drive and use machines.
Danish: Det kirurgiske indgreb vil i væsentlig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Cases in which Spherox cannot be supplied
Danish: Tilfælde, hvor Spherox ikke kan leveres
English: Spherox is administered to patients by intraarticular implantation.
Danish: Spherox administreres ved intraartikulær implantation.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT {Number of spheroids} sph
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER {Antal sfæroider} sf.
English: LIST OF EXCIPIENTS Excipient: sodium chloride.
Danish: LISTE OVER HJÆLPESTOFFER Hjælpestof: natriumchlorid.
English: Other joint problems should be corrected before or at the time of Spherox implantation.
Danish: Andre ledproblemer bør rettes før implantation af Spherox eller på tidspunktet for implantationen.
English: The surgical procedure will have a major influence on your ability to drive and use machines.
Danish: Operationen vil i væsentlig grad påvirke din evne til at føre motorkøretøj og betjene maskiner.
English: Strictly follow the advice of your doctor or physical therapist.
Danish: Følg nøje anvisningerne fra lægen eller fysioterapeuten.
English: • increase in size of the cartilage cells, softening of cartilage, disorder of bone formation, death of bone tissue, bone formation outside the skeleton.
Danish: • øget størrelse af bruskcellerne, opblødning af brusken, forstyrrelse af knogledannelsen,
English: In the pivotal studies of Spherox, patients were excluded if they had signs of chronic inflammatory diseases.
Danish: I de pivotale studier med Spherox var patienter med tegn på kroniske betændelseslignende sygdomme ekskluderet.
English: The applicator co.fix 150 is packed in a sterile tube and additionally surrounded by an extra bag.
Danish: Applikatoren co.fix 150 er pakket i et sterilt rør og desuden beskyttet af en ekstra pose.
English: The risk of treatment failure may increase if you do not follow your rehabilitation schedule.
Danish: Hvis du ikke følger rehabiliteringsplanen, er der større risiko for, at behandlingen mislykkes.
English: Silicone oil serves as lubricant.
Danish: Som smøremiddel anvendes silikoneolie.
English: The applicator (stem length 150 mm (co.fix 150)) is packed in a sterile tube and additionally surrounded by an extra bag.
Danish: Applikatoren (skaftlængde 150 mm (co.fix 150)) er pakket i et sterilt rør og desuden anbragt i en ekstra pose.
English: (osteoarthritis)
Danish: (slidgigt)
English: In the pivotal studies of Spherox, patients were excluded if they were under medical treatment with corticosteroids.
Danish: I hovedundersøgelserne med Spherox var patienter, der var i medicinsk behandling med kortikosteroider, ekskluderet.
English: White to yellowish spheroids of matrix-associated autologous chondrocytes in a clear, colourless solution.
Danish: Hvide til let gullige sfæroider af matrixassocierede autologe chondrocytter i klar, farveløs opløsning.
English: Post-operative haemarthrosis occurs mainly in patients with a predisposition to haemorrhage or poor surgical haemorrhage control.
Danish: Postoperativ hæmartrose forekommer hovedsagelig hos patienter med prædisposition for blødning eller med ikke velkontrolleret postoperativ blødning.
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)
Danish: • SOC Knogler, led, muskler og bindevæv: ledeffusion (meget almindelig), artralgi (meget almindelig), ledhævelse (meget almindelig), tendinitis (almindelig), muskelsvaghed (almindelig), patellofemoralt smertesyndrom (almindelig), osteonekrose (ikke almindelig)
English: What you need to know before you are given Spherox
Danish: Det skal du vide, før du får Spherox
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.
Danish: Opbevares mellem 1 °C og 10 °C, må ikke nedfryses, må ikke bestråles.
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelig: (kan forekomme hos op til 1 ud af 100 personer):
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.
Danish: • Kursusmaterialet til andre sundhedspersoner skal indeholde følgende hovedelementer: o information om Spherox, herunder den aktuelt godkendte indikation og det retlige grundlag o nødvendigheden af at screene donorer for hepatitis B, hepatitis C, HIV og syfilis o detaljeret beskrivelse af håndteringen af biopsitagningen og af produktet, elementer vedrørende forberedelsen til implantationen, tidsplan for patientopfølgning og anbefalet fysioterapi o nødvendigheden af officielt at bekræfte, at der er udført træning før biopsien
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.
Danish: Hver fyldt sprøjte eller applikator indeholder et specifikt antal sfæroider (10-70 sfæroider/cm2) i henhold til størrelsen af den defekt, der skal behandles.
English: • wound-related complication
Danish: • sårrelateret komplikation
English: In case of syringe as primary packaging unit: EU/1/17/1181/002
Danish: Hvis sprøjte er indre emballage: EU/1/17/1181/002
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).
Danish: For de patienter, der var behandlet med mikrofrakturer, steg det gennemsnitlige overordnede KOOS fra 51,7 ± 16,5 til 68,1 ± 18,6 efter 12 måneder, 72,6 ± 19,5 efter 24 måneder og 76,3 ± 17,1 efter 36 måneder (p < 0,0001 i alle tre tilfælde).
English: You may in that case notice symptoms, for example swelling or pain of the tissues around the joint.
Danish: for eksempel hævelse eller smerter i vævet rundt om leddet.
English: What Spherox contains
Danish: Spherox indeholder:
English: Application of Spherox in obese patients is not recommended.
Danish: Anvendelse af Spherox hos adipøse patienter frarådes.
English: EXPIRY DATE EXP {DD month YYYY} at {hours} CET
Danish: UDLØBSDATO EXP {DD måned ÅÅÅÅ} klokken {klokkeslæt} CET
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).
Danish: Ved analyse mellem grupperne viste testningen non inferioritet af behandling med Spherox i forhold til mikrofrakturer (Δ på 5,7 med en nedre grænse for konfidensintervallet på -1,0 ved vurderingen efter 12 måneder, Δ på 6,1 med en nedre grænse for konfidensintervallet på -0,4 efter 24 måneder, resultater for KOOS ved 36 måneder var konsistente med tidligere tidspunkter.
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.
Danish: For de patienter, der var behandlet med Spherox, øgedes det gennemsnitlige overordnede KOOS (skala 0-100 ± SD) fra 56,6 ± 15,4 ved baseline til 78,7 ± 18,6 ved opfølgningsbesøget 12 måneder efter behandlingen, viste forbedring op til besøget ved 24 måneder til 81,5 ± 17,3, og det nåede op på 83,2 ± 14,9 ved besøget ved 36 måneder.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Pt Name, Pt ID: {Patient Name}, {Patient ID} Lot {Batch Number}
Danish: FREMSTILLERENS BATCHNUMMER, DONATIONS- OG PRODUKTKODER Patientens navn, patientens ID: {patientens navn}, {patientens ID} Batch {batchnummer}
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.
Danish: • Kursusmaterialet til kirurger og operationspersonale skal indeholde følgende hovedelementer: o information om Spherox, herunder den aktuelt godkendte indikation og det retlige grundlag o detaljeret beskrivelse af proceduren ved biopsitagning og administration, implantationen ved knæledsartrotomi og opfølgningsprotokollen o forberedelse af patienten til proceduren og den efterfølgende overvågning o nødvendigheden af officielt at bekræfte, at der er udført træning før biopsien o vigtigheden af at udfylde tjeklisten o anbefalinger om rehabilitering efter biopsi og efter transplantation
English: The application of Spherox in patients with cartilage defects outside the knee joint is not recommended.
Danish: Anvendelse af Spherox til patienter med bruskdefekter uden for knæleddet frarådes.
English: • Prescriber checklist
Danish: • tjekliste for den ordinerende
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:
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER Hvis applikationssystemet co.fix 150 mm er indre emballage: {1 or 2} applikationssystem{er} co.fix 150 mm i et sterilt rør Hvis sprøjte er indre emballage:
English: The safety and efficacy of Spherox in patients aged over 50 years have not been established.
Danish: Ældre Spheroxs sikkerhed og virkning hos patienter over 50 år er ikke klarlagt.
English: Other medicines and Spherox
Danish: Brug af anden medicin sammen med Spherox
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
Danish: Hvis applikationssystemet co.fix 150 mm er indre emballage: {1 or 2} applikationssystem{er} co.fix 150 mm indeholdende {antal sfæroider} sfæroider i et sterilt rør
English: The safety and efficacy of Spherox in children aged 15 to 18 years have not been established.
Danish: Pædiatrisk population Spheroxs sikkerhed og virkning hos børn fra 15 til 18 år er ikke klarlagt.
English: • uneasiness
Danish: • ubehag
English: • SOC Skin and subcutaneous tissue disorder: scar pain (common)
Danish: • SOC Hud og subkutane væv: arsmerter (almindelig)
English: The pre-filled syringe is packed in a sterile tube and additionally surrounded by an extra bag.
Danish: Den fyldte sprøjte er pakket i et sterilt rør og desuden beskyttet af en ekstra pose.
English: Interim reports:
Danish: Interimrapporter:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Pouch
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Pose
English: Spherox contains 10-70 spheroids per cm² of the cartilage defect.
Danish: Spherox indeholder 10-70 sfæroider pr cm² af bruskdefekten.
English: • SOC General disorders and administration site conditions: pain (common), gait disturbance (common), discomfort (uncommon)
Danish: • SOC Almene symptomer og reaktioner på administrationsstedet: smerter (almindelig), gangforstyrrelse (almindelig), ubehag (ikke almindelig)
English: See the end of section 4 for how to report side effects.
Danish: 4, hvordan du indberetter bivirkninger.
English: • pain
Danish: • smerter
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.
Danish: For at fremstille sfæroiderne tages et lille stykke brusk fra en del af et af dine led ved et lille indgreb.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Spherox 10-70 spheroids/cm2 implantation suspension
Danish: LÆGEMIDLETS NAVN OG ADMINISTRATIONSVEJ(E) Spherox, suspension til implantation, 10-70 sfæroider/cm2
English: It is packed in a sterile tube with a screw-type cap and additionally surrounded by an extra bag.
Danish: Den er pakket i et sterilt rør med skruelåg og desuden anbragt i en ekstra pose.
English: The safety and efficacy of Spherox in children aged less than 15 years have not been established.
Danish: Spheroxs sikkerhed og virkning hos børn under 15 år er ikke klarlagt.
English: • SOC Vascular disorders: lymphoedema (common), thrombophlebitis (uncommon), deep vein thrombosis (uncommon), haematoma (uncommon)
Danish: • SOC Vaskulære sygdomme: lymfødem (almindelig), tromboflebitis (ikke almindelig), dyb venetrombose (ikke almindelig), hæmatom (ikke almindelig)
English: • pain in the joint
Danish: • smerter i arvæv
English: • SOC Injury, poisoning and procedural complications: ligament sprain (common), suture-related complication (uncommon), wound dehiscence (uncommon)
Danish: • SOC Traumer, forgiftninger og behandlingskomplikationer: forstrækning af ledbånd (almindelig), suturrelateret komplikation (ikke almindelig), sårdehiscens (ikke almindelig)
English: • tissue lump that may occur in the joint
Danish: • der kan forekomme en klump af væv i leddet
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.
Danish: (bedste), fortsatte med at stige let og nåede op på 74,6 ± 17,6 efter 18 måneder, 73,8 ± 18,4 efter to år, 77,0 ± 17,8 efter tre år, 77,1 ± 18,6 efter fire år og 76,9 ± 19,3 ved den afsluttende opfølgning efter 5 år.
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).
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP.
English: Spherox 10-70 spheroids/cm2 implantation suspension spheroids of human autologous matrix-associated chondrocytes
Danish: Spherox, suspension til implantation, 10-70 sfæroider/cm2 sfæroider af humane autologe matrixassocierede chondrocytter
English: Spherox is implanted into the cartilage defect in the joint during the next operation.
Danish: Ved næste operation implanteres Spherox i bruskdefekten i leddet.
English: See section 4.
Danish: Virkning og anvendelse 2.
English: Your doctor or physical therapist will advise you.
Danish: Det får du besked om af lægen eller fysioterapeuten.
English: Joint effusion, Arthralgia, Joint swelling
Danish: Effusion i leddet, artralgi, hævede led
English: KOOS (Knee Injury and Osteoarthritis Outcome Score) after 12, 24, 36, 48 and 60 months compared to before treatment could be observed.
Danish: I alle 3 dosisgrupper kunne der efter 12, 24, 36, 48 og 60 måneder iagttages en signifikant forbedring (α < 0,05) af KOOS (Knee Injury and Osteoarthritis Outcome Score) i forhold til før behandling.
English: Joint noise, Joint lock, Synovial cyst
Danish: Lydefra led, låsning af led, synovialcyste
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.
Danish: Anvendelse af Spherox frarådes til gravide eller ammende kvinder, da det anvendes til at reparere bruskdefekter i leddet og derfor implanteres under et operativt indgreb.
English: How to use Spherox
Danish: Sådan skal du bruge Spherox
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Graft delamination
Danish: Delaminering af implantatet
English: Spherox 10-70 spheroids/cm2 implantation suspension Syringe:
Danish: Spherox, suspension til implantation, 10-70 sfæroider/cm2 Sprøjte:
English: Posology
Danish: Beskrivelse
English: • internal bleedings
Danish: • indvendige blødninger
English: • ligament disorder
Danish: • låsning af led
English: Spherox 10-70 spheroids/cm2 implantation suspension
Danish: Spherox, suspension til implantation, 10-70 sfæroider/cm2
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,
Danish: For alle dosisgrupperne steg den gennemsnitlige samlede KOOS det første år efter behandlingen fra 57,0 ± 15,2 til 73,4 ± 17,3 på en skala fra 0 (værste) til 100
English: Resuming vigorous activity too soon may reduce the benefit and durability of Spherox.
Danish: Genoptag ikke fysisk aktivitet, før lægen instruerer dig om det. For tidlig genoptagelse af fysisk aktivitet kan nedsætte fordelen ved Spherox og bevirke, at behandlingen ikke virker så længe.
English: Syringe
Danish: Sprøjte
English: • tendon inflammation
Danish: • senebetændelse
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)
Danish: (symptomer: f.eks. rødme og/eller varmefornemmelse i huden langs venen, ømhed og smerter)
English: • The Summary of Product Characteristics
Danish: • produktresuméet
English: Elderly
Danish: Dosering
English: Musculoskeletal and connective tissue disorders
Danish: Knogler, led, muskler og bindevæv
English: • muscle weakness
Danish: • muskelsvaghed
English: • accumulation of fluid in the joint
Danish: • væskeansamling i leddet
English: • If you get any side effects, talk to your doctor or physical therapist.
Danish: • Kontakt lægen eller fysioterapeuten, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: 11 July 2014
Danish: Den 11. juli 2014
English: Article 34 of Directive 2001/82/EC, as amended
Danish: Artikel 34 i direktiv 2001/82/EF, som ændret.
English: Veterinary Medicines Division
Danish: Afdelingen for veterinærlægemidler
English: Written explanations were provided by the marketing authorisation holders on 10 September 2013 and 10 February 2014.
Danish: Indehaverne af markedsføringstilladelse afgav skriftlige redegørelser den 10. september 2013 og den 10. februar 2014.
English: The final opinion was converted into a Decision by the European Commission on 11 July 2014.
Danish: Den endelige udtalelse blev den 11. juli 2014 omarbejdet til en beslutning af Europa-Kommissionen.
English: The referral procedure started on 10 October 2012.
Danish: Indbringelsesproceduren blev indledt den 10. oktober 2012.
English: The Committee adopted a positive opinion by consensus on 10 April 2014.
Danish: Udvalget vedtog enstemmigt en positiv udtalelse den 10. april 2014.
English: International non-proprietary name (INN): lincomycin and spectinomycin
Danish: Internationalt fællesnavn (INN): lincomycin og spectinomycin
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.
Danish: Linco-Spectin 100 er et pulver til oral opløsning, der indeholder 33,3 g lincomycin (som lincomycinhydrochlorid) og 66,7 g spectinomycin (som spectinomycinsulfat) i hver 150 g pakning.
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.
Danish: Som følge af, at medlemsstaterne havde truffet divergerende nationale afgørelser om måldyrearter, indikationer, dosering og tilbageholdelsestider ved godkendelse af Linco-Spectin 100 og relaterede navne, indbragte Belgien den 28. september 2012 sagen for CVMP i medfør af artikel 34, stk. 1, i direktiv 2001/82/EF for at ophæve divergenserne mellem de nationalt godkendte produktinformationer i EU.
English: The Committee appointed B. Urbain as rapporteur and C. Muñoz Madero as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget hhv. B. Urbain og C. Muñoz Madero.
English: Opinion following an Article 340F referral for Linco-Spectin 100 and associated names EMA/431244/2014
Danish: Udtalelse efter en artikel 34-henvisning0F for Linco-Spectin 100 og relaterede navne EMA/431244/2014
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.
Danish: Efter vurdering af de foreliggende data var CVMP af den opfattelse, at benefit/risk-forholdet for LincoSpectin 100 og relaterede navne fortsat er positivt, forudsat at markedsføringstilladelserne ændres i overensstemmelse med den anbefalede produktinformation.
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.
Danish: Listen over de berørte produktnavne fremgår af bilag I. De videnskabelige konklusioner fremgår af bilag II.
English: Lincomycin is a lincosamide antibiotic, closely related to macrolide and streptogramin B antimicrobials.
Danish: Lincomycin er et antibiotikum i lincosamidgruppen og er nært beslægtet med antibiotika af typen makrolider og streptogramin B. Spectinomycin er klassificeret som et antibiotikum i aminocyclitolgruppen og er nært beslægtet med aminoglykosider.
English: Opinion following an Article 341 referral for Linco-Spectin 100 and associated names
Danish: Linco-Spectin 100 og relaterede navne
English: Strength Pharmaceutical Form Route of Administration
Danish: Styrke Lægemiddelform Administration Emballage
English: Content
Danish: Pakningsstørrelse
English: (Invented) name
Danish: Indhold (Koncentration)