FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad
English: Prior to launch of Spherox in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the training programme and the controlled distribution programme, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Maltese: (MAH, Marketing Authorisation Holder) għandu jaqbel fuq il-kontenut u l-format tal-programm ta᾽ taħriġ u tal-programm ta᾽ distribuzzjoni kkontrollata, inkluż, mezzi tal-komunikazzjoni, modalitajiet ta᾽ distribuzzjoni u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali.
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).
Maltese: KOOS ġenerali medju żdied minn 51.7 ± 16.5 għal 68.1 ± 18.6 wara 12-il xahar, 72.6 ± 19.5 wara
English: A tube may contain a maximum of two co.fix 150.
Maltese: It-tubu jista' jkun fih massimu ta' żewġ co.fix 150.
English: 10-70 spheroids are applied per square centimetre defect.
Maltese: 10-70 sferojdi huma applikati għal kull ċentimetru kwadru ta' difett.
English: Spherox 10-70 spheroids/cm2 implantation suspension spheroids of human autologous matrix-associated chondrocytes
Maltese: Spherox 10-70 sferojdi/cm2 sospensjoni għall-impjantazzjoni sferojdi ta' kondroċiti assoċjati mal-matriċi awtologi umani
English: Immune system disorders
Maltese: Disturbi fis-sistema immunitarja
English: • muscle weakness
Maltese: • indeboliment tal-mixi
English: Spheroids are spherical aggregates of ex vivo expanded human autologous chondrocytes and selfsynthesized extracellular matrix.
Maltese: 2.2 Għamla kwalitattiva u kwantitattiva Sferojdi huma aggregati sferiċi ta' kondroċiti awtologi umani estiżi ex vivo u matriċi extraċellulari awto-sintetizzata.
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.
Maltese: Problemi fil-ġogi fl-istes ħin bħal osteoartrite bikrija, difetti fl-għadam subchondral, insabbilità talġog, leżjonijiet tal-ligamenti jew tal-menisku, distribuzzjoni tal-piż mhux normali fil-ġog, allinjament ħażin tal-varus jew valgus, allinjament ħażin jew nuqqas ta' stabilità tal-galletta, u mard metaboliku,
English: The safety and efficacy of Spherox in children aged 15 to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Spherox fit-tfal ta' età bejn il-15 u t-18-il sena ma ġewx determinati s'issa.
English: • you are infected with HIV (the virus that causes AIDS), hepatitits B virus or with hepatitis C
Maltese: • inti infettat bl-HIV (il-virus li jikkawża l-AIDS), bil-virus tal-epatite B jew bil-virus tal-epatite
English: A GLP-compliant examination of biodistribution and tumourigenicity in NSG mice showed no signs of biodistribution and/or migration from implanted human spheroids.
Maltese: Eżaminazzjoni konformi mal-GLP ta' bijodistribuzzjoni jew tumuroġeniċità fi ġrieden NSG ma wriet l-ebda sinjali ta' bijodistribuzzjoni u/jew migrazzjoni mill-isferojdi umani impjantati.
English: Further follow-up assessments of up to 5 years will be performed to generate long-term efficacy data on the treatment with Spherox.
Maltese: Ser jitwettqu aktar valutazzjonijiet ta' segwitu sa 5 snin biex jiġġeneraw data dwar l-effikaċja fit-tul dwar it-trattament bi Spherox.
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.
Maltese: • Il-materjal ta᾽ taħriġ għal professjonisti tal-kura tas-saħħa oħra għandu jkun fih l elementi ewlenin li ġejjin: o Informazzjoni dwar Spherox, inkluż l-indikazzjoni li bħalissa hija approvata u l-bażi legali o Il-ħtieġa li d-donaturi jiġu skrinjati għal epatite B, epatite Ċ, HIV u sifilide o Deskrizzjoni dettaljata tal-immaniġġjar tal-ħsad tal-bijopsija u tal-prodott, elementi dwar il-preparazzjoni għall-impjantazzjoni, l-iskeda għas-segwitu tal-pazjent u fiżjoterapija rakkomandata.
English: No signs of inflammation, synovitis, infections, rejection, hypertrophy or immune toxicity, tumourigenicity or biodistribution were observed.
Maltese: L-ebda sinjal ta' infjammazzjoni, sinovite, infezzjoni, rifjut, ipertrofija jew tossiċità immunitarja,
English: The applicator (stem length 150 mm (co.fix 150)) is packed in a sterile tube and additionally surrounded by an extra bag.
Maltese: L-applikatur (tul taz-zokk 150 mm (co.fix 150)) huwa ppakkjat f'tubu sterili u, barra minn hekk, huwa mgeżwer f'borża addizzjonali.
English: Name and address of the manufacturer of the biological active substance
Maltese: MANIFATTUR TAS-SUSTANZA BIJOLOĠIKA ATTIVA U MANIFATTUR
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).
Maltese: Daqsijiet tal-pakketti In-numru ta' unitajiet ta' ppakkjar primarji mibgħuta jiddependi mit-tip tal-unità ta' ppakkjar primarju u n-numru ta' sferojdi neċessarji għad-daqs ta' difett speċifiku (10-70 sferojdi/cm²).
English: LIST OF EXCIPIENTS Excipient: sodium chloride.
Maltese: TA' EĊĊIPJENTI Eċċipjent: klorur tas-sodju
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Il-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta᾽ farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: There are no data on possible effects of Spherox treatment on fertility.
Maltese: Fertilità Ma hemm l-ebda data dwar effetti possibbli tal-kura bi Spherox fuq il-fertilità.
English: Spherox 10-70 spheroids/cm2 implantation suspension Syringe:
Maltese: Spherox 10-70 sferojdi/cm2 suspensjoni għall-impjantazzjoni.
English: • Measures to ensure the traceability of the product and guarantee the identification of: patient data; diagnosis leading to the treatment; information on biopsy including date of the operation, adverse events reported during the procedure and quality of the biopsy; information on the implant, including all in-process controls and final product controls.
Maltese: data dwar il-pazjent; dijanjożi li twassal għall-kura; informazzjoni dwar il-bijopsija inkluż id data tal-operazzjoni, avvenimenti avversi rrappurtati waqt il-proċedura u l-kwalità talbijopsija; informazzjoni dwar l-impjant, inkluż il-kontrolli tal-proċess u l-kontrolli tal-prodott finali kollha.
English: The applicator co.fix 150 is packed in a sterile tube and additionally surrounded by an extra bag.
Maltese: L-applikatur co.fix 150 huwa ppakkjat f'tubu sterili u, barra minn hekk huwa mgeżwer f'borża addizzjonali.
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:
Maltese: F'każ ta' sistema ta' applikazzjoni co.fix 150 mm bħala unità ta' ppakkjar primarja:
English: Chondromalacia, Osteochondrosis, Osteonecrosis, Extraskeletal ossification
Maltese: Mediċini oħrajn għal disturbi fis-sistema muskulo-skeletali, Kodiċi
English: • SOC General disorders and administration site conditions: pain (common), gait disturbance (common), discomfort (uncommon)
Maltese: • SOC Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata: uġigħ (komuni), disturbi fil-mixja
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
Maltese: {1 jew 2} sistema{i} ta' applikazzjoni co.fix 150 mm f'tubu sterili
English: Driving cars and using machines may be limited during the rehabilitation period.
Maltese: Is-sewqan ta' karozzi u t-tħaddim ta' magni jistgħu jkunu limitati waqt il-perjodu ta' riabilitazzjoni.
English: Visit 2: Spherox implantation
Maltese: Impjantazzjoni ta' Spherox
English: Pain, Gait disturbance
Maltese: Disturb fil-mixja
English: Fertility
Maltese: Siringa
English: • swelling due to obstructed flow of tissue fluid via the lymph vessels
Maltese: • nefħa kkawżata minn tal-fluss tal-fluwidu tat-tessut mill-kanali limfatiċi
English: The MAH shall ensure that in each Member State where Spherox is marketed, a system aimed to control access to the product beyond the level of control ensured by routine risk minimisation measures.
Maltese: Il-MAH għandu jiżgura li f᾽kull Stat Membru fejn jitqiegħed fis-suq Spherox, ikun hemm sistema mmirata biex tikkontrolla l-aċċess għall-prodott lill hinn mil-livell ta᾽ kontroll żgurat minn miżuri tal-minimizzazzjoni tar-riskji ta᾽ rutina.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: UŻU Prodott mediċinali li jingħata b᾽riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2). C.
English: Spherox consists of so-called spheroids.
Maltese: Spherox jikkonsisti minn hekk imsejħa sferojdi.
English: Pregnancy and breast-feeding
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: The safety and efficacy of Spherox in patients aged over 50 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Spherox f'pazjenti ta' età ta' aktar minn 50 sena ma ġewx determinati s'issa.
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.
Maltese: 78.7 ± 18.6 fil-viżta ta' segwitu 12-il xahar wara l-kura, tjieb sal-vista ta' wara 24 xahar għal 81.5 ± 17.3 u laħaq 83.2 ± 14.9 fil-vista ta' wara 36 xahar.
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,
Maltese: Għall-"gruppi tad-dożi kollha", il-medja globali tal-KOOS żdiedet fl-ewwel sena wara l-kura minn 57.0 ± 15.2 għal 73.4 ± 17.3 fuq skala minn 0 (l-agħar) għal 100 (l-aħjar) u kompliet tiżdied kemm kemm, sa ma laħqet 74.6 ± 17.6 wara 18-il xahar, 73.8 ± 18.4 wara sentejn, 77.0 ± 17.8 wara tliet snin, 77.1 ± 18.6 wara erba' snin u 76.9 ± 19.3 fis-segwitu finali wara ħames snin.
English: The adverse reactions related to Spherox are displayed by system organ class and frequency in Table 1
Maltese: Tabella 1: Effetti Mhux Mixtieqa konnessi ma' Spherox Sistema tal-Klassifika talOrgani (SOC)
English: Syringe: EXP {DD month YYYY} at {hours} CET
Maltese: U MNEJN GĦANDU JINGĦATA
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Spherox 10-70 spheroids/cm2 implantation suspension
Maltese: Sistema ta' applikazzjoni co.fix 150 mm: Spherox 10-70 sferojdi/cm2 suspensjoni għall-impjantazzjoni
English: Post-operative haemarthrosis occurs mainly in patients with a predisposition to haemorrhage or poor surgical haemorrhage control.
Maltese: Il-funzjonijiet emostatiċi tal-pazjent għandhom jiġu kkontrollati qabel il-kirurġija.
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).
Maltese: bil-faxxa t'isfel ta' CI ekwivalenti għal -1.0 fil-valutazzjoni ta' wara 12-il xahar, Δ ta' 6.1 bl-inqas valuri ta' CI ugwali għal -0.4 fil-valutazzjoni ta' wara 24 xahar, riżultati għal KOOS wara 36 xahar kienu konsistenti mal-punti ta' żmien preċedenti).
English: How to store Spherox
Maltese: X'fih Spherox
English: • Periodic safety update reports (PSURs)
Maltese: • Rapporti perjodiċi aġġornati dwar is-sigurtà (PSURs) Ir-rekwiżiti biex jiġu ppreżentati
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista᾽ twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar riskji).
English: • SOC Injury, poisoning and procedural complications: ligament sprain (common), suture-related complication (uncommon), wound dehiscence (uncommon)
Maltese: (komuni), komplikazzjoni relatata mal-punti (mhux komuni), ferita tinfetaħ (mhux komuni)
English: What Spherox contains
Maltese: Spherox.
English: Changes within each dose group were of similar magnitude, and the three between-group (pairwise) analyses did not reveal any statistically significant differences between the groups.
Maltese: Tibdiliet fi ħdan kull grupp tad-doża kienu ta' daqs simili, u t-tliet analiżi ta' bejn il-gruppi (f'sens ta' pari) ma żvelaw l-ebda differenza statistikament sinifikanti bejn il-gruppi.
English: Joint noise, Joint lock, Synovial cyst
Maltese: IL-KONTENUT SKONT IL-PIŻ, IL-VOLUM, JEW PARTI
English: • SOC Skin and subcutaneous tissue disorder: scar pain (common)
Maltese: • SOC Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda: uġigħ fiċ-ċikatriċi (komuni)
English: • accumulation of fluid in the joint
Maltese: • akkumulazzjoni ta' fluwidu fil-ġog
English: Spherox is not recommended in children or adolescents below 18 years.
Maltese: Tfal u adolexxenti Spherox mhuwiex rakkomandat fi tfal jew adolexxenti ta' taħt it-18-il sena.
English: During treatment with Spherox surgery-related (implantation) or Spherox-related adverse reactions may occur.
Maltese: Effetti sekondarji li jidhru wara l-impjantazzjoni ta' Spherox huma l-aktar relatati mal kirurġija.
English: EXPIRY DATE EXP {DD month YYYY} at {hours} CET
Maltese: TIKKETTAR U FULJETT TA' TAGĦRIF
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.
Maltese: o Informazzjoni dwar Spherox, inkluż l-indikazzjoni li bħalissa hija approvata u l-bażi legali o Deskrizzjoni ddettaljata tal-proċedura tal-bijopsija tal-ħsad u l-proċedura ta᾽ għoti, limpjantazzjoni permezz ta᾽ artrotomija tal-ġog tal-irkoppa u l-protokoll ta᾽ segwitu o Preparazzjoni tal-pazjent għall-proċedura u monitoraġġ sussegwenti o Il-ħtieġa li jiġi kkonfermat b᾽mod uffiċjali li t-taħriġ ikun twettaq qabel il-bijopsija.
English: Spherox is not recommended for pregnant or breast-feeding women, as it is applied during surgery.
Maltese: Spherox mhuwiex rakkomandat f'nisa tqal jew li qed ireddgħu, għaliex jiġi applikat waqt kirurġija.
English: • The active substance of Spherox are spheroids that consist of cartilage cells and cartilage material derived from your own body.
Maltese: • Is-sustanza attiva ta' Spherox huma sferojdi li jikkonsistu minn ċelloli tal-qarquċa u minn materjal tal-qarquċa li ġej minn ġismek stess.
English: • Prescriber checklist
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: This will allow quick identification of new safety information.
Maltese: Dan ser jippermetti identifikazzjoni ta' malajr ta' informazzjoni ġdida dwar is-sigurtà.
English: The analysis population comprised 102 patients (41 women, 61 men) aged 37 years on average (range from 18 to 49 years) with a mean body mass index (BMI) of 25.8.
Maltese: Il-popolazzjoni tal-analiżi kienet magħmula minn 102 pazjenti (41 mara, 61 raġel) ta' età medja ta' 37 sena (firxa ta'
English: • blood clot in a deep vein (symptoms: e.g. swelling, pain, increased warmth in the affected area)
Maltese: • ċappa tad-demm f'vina profonda (sintomi: eż. nefħa, uġigħ, sħana miżjuda fiż-żona affettwata)
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux komuni: jistgħu jaffettwaw sa persuna 1 minn kull 100
English: In the pivotal studies of Spherox, patients were excluded if they were under medical treatment with corticosteroids.
Maltese: Fl-istudji pivotali ta' Spherox, il-pazjenti ġew esklużi jekk kienu taħt kura medika bil-kortikosteroidi.
English: In cases where the recommended dose was significantly exceeded (up to 170 spheroids/cm² in an investigator-initiated trial with a follow-up period of 12 months), no negative effects were observed.
Maltese: F'każijiet fejn id-doża rakkomandata tinqabeż b'mod sinifikanti (sa 170 sferojdi/cm² fi prova mibdija mill-investigatur b'perjodu ta' segwitu ta' 12-il xahar), ma ġie osservat l-ebda effett negattiv.
English: Spherox is implanted into the cartilage defect in the joint during the next operation.
Maltese: Spherox jiġi impjantat fid-difett tal-qarquċa fil-ġog waqt l-operazzjoni li jmiss.
English: Veterinary Medicines Division
Maltese: Diviżjoni tal-Mediċini Veterinarji
English: Article 34 of Directive 2001/82/EC, as amended
Maltese: L-Artikolu 34 tad-Direttiva 2001/82/KE, kif emendata
English: 11 July 2014
Maltese: 11 ta' Lulju 2014
English: International non-proprietary name (INN): lincomycin and spectinomycin
Maltese: Denominazzjoni internazzjonali komuni (INN): lincomycin u spectinomycin
English: The Committee appointed B. Urbain as rapporteur and C. Muñoz Madero as co-rapporteur.
Maltese: Muñoz Madero bħala ko-rapporteur.
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.
Maltese: Linco-Spectin 100 huwa trab għal soluzzjoni orali li fih 33.3 g ta' lincomycin (bħala lincomycin hydrochloride) u 66.7 g ta' spectinomycin (bħala spectinomycin sulphate) għal kull pakkett ta' 150 g. Lincomycin huwa antibijotiku linkosamidi, relatat mill-qrib mal-antimikrobiċi makrolidi u streptogramin B. Spectinomycin huwa klassifikat bħala antibijotiku aminocyclitol, qrib l-aminoglikosidi.
English: Opinion following an Article 341 referral for Linco-Spectin 100 and associated names
Maltese: Opinjoni wara riferiment skont l-Artikolu 340F għal Linco-Spectin 100 u ismijiet assoċjati
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.
Maltese: Minħabba deċiżjonijiet nazzjonali diverġenti li ttieħdu minn Stati Membri fir-rigward tal-ispeċi fil-mira, l-indikazzjonijiet, il-pożoloġija u l-perjodi ta' tiżmim fir-rigward tal-awtorizzazzjonijiet ta' Linco-Spectin 100 u l-ismijiet assoċjati tiegħu, fit-28 ta' Settembru 2012 il-Belġju rrefera l-kwistjoni lis-CVMP skont lArtikolu 34(1) tad-Direttiva 2001/82/KE, sabiex jiġu riżolti d-diverġenzi fl-informazzjoni nazzjonalment awtorizzata dwar il-prodott madwar l-Unjoni Ewropea.
English: Written explanations were provided by the marketing authorisation holders on 10 September 2013 and 10 February 2014.
Maltese: Spjegazzjonijiet bil-miktub ġew ipprovduti mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl10 ta' Settembru 2013 u fl-10 ta' Frar 2014.
English: Opinion following an Article 340F referral for Linco-Spectin 100 and associated names EMA/431244/2014
Maltese: L-opinjoni finali ġiet konvertita f'Deċiżjoni mill-Kummissjoni Ewropea fil-11 ta' Lulju 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.
Maltese: Abbażi tal-valutazzjoni tad-dejta attwalment disponibbli, is-CVMP qies li l-profil tal-benefiċċju-riskju ta' Linco-Spectin 100 u l-ismijiet assoċjati tiegħu jibqa' pożittiv, soġġett għal varjazzjoni talawtorizzazzjonijiet għat-tqegħid fis-suq skont l-informazzjoni rakkomandata dwar il-prodott.
English: Strength Pharmaceutical Form Route of Administration
Maltese: Qawwa Għamla farmaċewtika
English: EU Number
Maltese: Numru ta' l-EU Numru tal-MA
English: (Invented) name
Maltese: Kontenut (konċentrazzjoni)
English: TachoSil fibrinogen / thrombin
Maltese: TachoSil fibrinoġen / trombina
English: This summary was last updated in 03-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 03-2016.
English: The full EPAR for TachoSil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: TachoSil is used in adults:
Maltese: TachoSil jintuża f'adulti:
English: In the first study, the average time until bleeding stopped was 3.9 minutes with TachoSil compared with 6.3 minutes with the argon beamer, and in the second study, these values were 3.6 and 5.0 minutes, respectively.
Maltese: Fl-ewwel studju, il-ħin medju sakemm waqfet il-fsada kien ta' 3.9 minuti b'TachoSil meta mqabbel ma' 6.3 minuti bl-argon beamer, u fit-tieni studju, dawn il-valuri kienu ta' 3.6 u 5.0 minuti, rispettivament.
English: TachoSil is a sealant patch coated with the active substances human fibrinogen and human thrombin.
Maltese: TachoSil huwa kumpressa siġillanti miksija bis-sustanzi attivi fibrinoġen uman u trombina umana.
English: This is a summary of the European public assessment report (EPAR) for TachoSil.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal TachoSil.
English: Other information about TachoSil
Maltese: Informazzjoni oħra dwar TachoSil
English: In the study in neurological surgery, TachoSil was comparable to current techniques: around 7% (25 out of 361) of patients treated with TachoSil had a leak of CSF, compared with around 8% (30 out of 365) of patients on current techniques.
Maltese: Fl-istudju fl-intervent kirurġiku newroloġiku, TachoSil kien komparabbli ma' tekniki attwali: madwar 7% (25 minn 361) tal-pazjenti kkurati b'TachoSil kellhom tnixxija ta' FĊS, meta mqabbla ma' madwar 8% (30 minn 365) tal-pazjenti b'tekniki attwali.