FrancophonIA/ELRC3.0 huggingface dataset:
English: BufloMed 'S.Med' 300 mg Filmtabletten 300 mg
Maltese: BufloMed 'S.Med' 300 mg Filmtabletten
English: Buflomedilratiopharm 300 mg Filmtabletten ratiopharm GmbH Graf-Arco-STr. 3 D-89079 Ulm Germany
Maltese: Buflomedilratiopharm 300 mg Filmtabletten ratiopharm GmbH Graf-Arco-STr.
English: FONZYLANE 150 mg, comprimé pelliculé 150 mg
Maltese: LOFTYL 150 mg, comprimé pelliculé 150 mg
English: AMDIPHARM LIMITED, IRELAND Temple Chambers 3 Burlington Road Dublin 4 Ireland
Maltese: LIMITED, IRELAND Temple Chambers 3 Burlington Road Dublin 4 Ireland
English: BufloMed 'S.Med' retard 600 mg Filmtabletten prolonged-release tablet oral use
Maltese: BufloMed 'S.Med' retard 600 mg Filmtabletten pillola li terħi l-mediċina fuq tul ta' żmien
English: AMDIPHARM LTD Temple Chambers 3 Burlington Road DUBLIN 4
Maltese: LTD Temple Chambers 3 Burlington Road DUBLIN 4
English: AMDIPHARM LTD
Maltese: Il-Lussemburgu AMDIPHARM
English: Portugal
Maltese: Greece
English: Annex I List of the invented names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Maltese: Anness I Lista tal-ismijiet ivvintati, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħataw, id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: VALAORITOU 10, METAMORFOSI ATTIKIS 144 54 Greece
Maltese: VALAORITOU 10, METAMORFOSI ATTIKIS 144 54
English: Belgium
Maltese: Italy
English: MARATHONOS AVENUE 95 PIKERMI ATTIKIS 19010 Greece
Maltese: MARATHONOS AVENUE 95 PIKERMI ATTIKIS 19010
English: Prolonged-release tablet oral use ratiopharm GmbH Graf-Arco-STr. 3 D-89079 Ulm Germany
Maltese: 3 D-89079 Ulm Germany
English: Strength Pharmaceutical form
Maltese: Qawwa Għamla farmaċewtika
English: MA (EU) number (Invented) name
Maltese: Numru ta' l-EU Isem (ivvintat)
English: Route of administration
Maltese: 14-il qartas
English: Pharmaceutical Form
Maltese: Għamla Farmaċewtika
English: MA (EU) number (Invented) name Strength
Maltese: Numru ta' l-EU Isem (Ivvintat) Qawwa
English: Pack size
Maltese: Mnejn għandu jingħata
English: 4.3 Contra-indications
Maltese: 4.3 Kontraindikazzjonijiet
English: 22 May 2012
Maltese: 22 ta' Mejju 2012
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Maltese: Riżultat ta' proċedura skont l-Artikolu 30 tad-Direttiva 2001/83/KE
English: What is Femara?
Maltese: X'inhu Femara?
English: Femara is a medicine that contains the active substance letrozole.
Maltese: Femara huwa mediċina li fiha s-sustanza attiva letrozole.
English: On 15 March 2012, the European Medicines Agency completed a review of Femara.
Maltese: Fil-15 ta' Marzu 2012, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Femara.
English: The active substance in Femara, letrozole, is an ‘aromatase inhibitor'.
Maltese: Is-sustanza attiva f'Femara, letrozole, hija ‘inibitur tal-aromatase'.
English: The CHMP also harmonised other sections of the SmPC including sections 4.6 (pregnancy and lactation) and 4.8 (side effects).
Maltese: Is-CHMP armonizza wkoll sezzjonijiet oħra tal-SmPC inklużi s-sezzjonijiet 4.6 (tqala u treddigħ) u 4.8 (effetti sekondarji).
English: Femara was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Femara instab li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Reċiproċi u Deċentralizzati - Bniedem (CMD(h)).
English: Why was Femara reviewed?
Maltese: Għalxiex ġie rivedut Femara?
English: • Neo-adjuvant (pre-surgery) treatment of hormone receptor positive, HER-2 negative breast cancer where chemotherapy is not suitable and immediate surgery not indicated.
Maltese: • Kura neo-awżiljarja (qabel operazzjoni) ta' kanċer tas-sider negattiv għall-HER-2, pożittiv għar riċetturi tal-ormoni, fejn il-kemjoterapija ma tkunx adatta u operazzjoni immedjata ma tkunx indikata.
English: Femara is authorised in the EU via national procedures.
Maltese: Femara huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The company that markets these medicines is Novartis.
Maltese: Il-kumpanija li tbiegħ dawn il-mediċini hija Novartis.
English: Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets)
Maltese: (letrozole, pilloli ta' 2.5 mg)
English: Femara is marketed in all EU Member States and is also available under other trade names: Femar, Fémara, and Loxifan.
Maltese: Femara jinbiegħ fl-Istati Membri kollha tal-UE u huwa wkoll disponibbli taħt ismijiet kummerċjali oħrajn: Femar, Fémara, u Loxifan.
English: In harmonising the contraindications, the CHMP decided against including two contraindications that were in the SmPCs of some EU countries: liver impairment and pre-operative use in patients whose receptor status is negative or unknown.
Maltese: Fl-armonizzazzjoni tal-kontraindikazzjonijiet, is-CHMP iddeċieda li ma jinkludix żewġ kontraindikazzjonijiet li kienu fl-SmPCs ta' ċerti pajjiżi tal-UE: indeboliment tal-fwied u użu qabel loperazzjoni f'pazjenti li l-istatus tar-riċetturi tagħhom huwa negattiv jew mhux magħruf.
English: This means that it works by blocking the action of an enzyme called ‘aromatase', which is involved in the production of the hormone oestrogen.
Maltese: Dan ifisser li taħdem billi timblokka l-azzjoni ta' enzima li tissejjaħ ‘aromatase', li hija involuta fil-produzzjoni tal-ormon estroġenu.
English: • Adjuvant (post-surgery) treatment of hormone receptor positive invasive early breast cancer.
Maltese: • Kura awżiljarja (wara operazzjoni) ta' kanċer invażiv bikri tas-sider pożittiv għar-riċetturi tal ormoni.
English: Questions and answers on Femara and associated names (letrozole, 2.5 mg tablets) EMA/180824/2012
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fit-22 ta' Mejju 2012.
English: The main areas harmonised include:
Maltese: L-oqsma ewlenin armonizzati jinkludu:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Femara in the European Union (EU).
Maltese: Il-Kumitat għallProdotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li hemm il-ħtieġa li tiġi armonizzata l-informazzjoni tal-preskrizzjoni għal Femara fl-Unjoni Ewropea (UE).
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses, duration of treatment and use of Femara in patients with reduced kidney or liver function.
Maltese: Wara li armonizza l-indikazzjonijiet, is-CHMP armonizza wkoll ir-rakkomandazzjonijiet dwar id-dożi, ittul tal-kura u l-użu ta' Femara f'pazjenti b'funzjoni mnaqqsa tal-kliewi jew tal-fwied.
English: The CHMP was of the view that it was more appropriate to include relevant warnings in section 4.4.
Maltese: Is-CHMP kien tal-fehma li kien aktar xieraq li jiddaħħlu twissijiet rilevanti fis-sezzjoni 4.4.
English: 4.2 Posology and method of administration
Maltese: .2 Posoloġija u metodu ta' kif għandu jingħata
English: On 31 August, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Femara in the EU.
Maltese: Fil-31 ta' Awwissu, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Femara fl-UE.
English: By blocking the activity of aromatase and thereby reducing the amount of oestrogen produced, the medicine slows or stops the growth and spread of the cancer.
Maltese: Bl-imblokkar tal-attività talaromatase li allura tnaqqas l-ammont ta' estroġenu prodott, il-mediċina tnaqqas jew twaqqaf l-iżvilupp u t-tixrid tal-kanċer.
English: • Advanced breast cancer after relapse or disease progression, in women with natural or artificially induced postmenopausal endocrine status, who have previously been treated with anti-oestrogens.
Maltese: • Kanċer tas-sider avvanzat wara rikaduta jew progressjoni tal-marda, f'nisa fi stat ta' endokrina ta'
English: • Extended adjuvant treatment of hormone-dependent invasive breast cancer in women who have received prior standard adjuvant tamoxifen therapy for five years.
Maltese: • Kura awżiljarja estiża ta' kanċer invażiv tas-sider dipendenti fuq l-ormoni f'nisa li qabel ingħataw kura awżiljarja standard b'tamoxifen għal ħames snin.
English: The CHMP, in light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Maltese: Fid-dawl tad-data ppreżentata u d-diskussjoni xjentifika fi ħdan il-kumitat, is-CHMP kien tal-fehma li lSmPCs, it-tikkettar u l-fuljetti ta' tagħrif għandhom jiġu armonizzati fl-UE kollha.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Maltese: Dan wassal għal diverġenzi fost l-Istati Membri fil-mod kif tista' tintuża l-mediċina, kif jidher fid-differenzi fis-sommarji tal-karatteristiċi talprodott (SmPCs), it-tikkettar u l-fuljetti ta' tagħrif fil-pajjiżi fejn tinbiegħ il-mediċina.
English: Femara is used in postmenopausal women because aromatase is involved in producing most of the oestrogen in this population.
Maltese: Femara jintuża f'nisa li jkunu jinsabu wara l-menopawsa minħabba li aromatase huwa involut filproduzzjoni tal-parti l-kbira tal-estroġenu f'din il-popolazzjoni.
English: (osteoarthritis)
Maltese: (osteoartrite)
English: Hypertrophy, Graft delamination
Maltese: Ipertrofija, Graft delamination
English: 21 14513 Teltow GERMANY
Maltese: 14513 Teltow
English: Interim reports:
Maltese: Rapporti interim:
English: Summary of safety profile
Maltese: Sommarju tal-profil tas-sigurtà
English: 01-Mar-2021
Maltese: Rapport ta᾽ studju finali: 01-Mar-2021
English: • ligament disorder
Maltese: • disturbi fil-ligament
English: • Infection with the hepatitits B virus (HBV), hepatitis C virus (HCV) or HIV I/II viruses.
Maltese: • Infezzjoni bil-virus tal-epatite B (HBV), virus tal-epatite Ċ (HCV) jew virus tal-HIV I/II.
English: Defect sizes ranged from 0.5 to 4 cm2.
Maltese: Id-daqsijiet tad-difetti varjaw bejn 0.5 u 4 cm2.
English: Rehabilitation
Maltese: Riabilitazzjoni
English: CO.DON AG Warthestraße 21 14513 Teltow Germany
Maltese: CO.DON AG Warthestraße 21 14513 Teltow
English: Reporting side effects
Maltese: Rapportar ta' effetti sekondarji
English: 72 hours
Maltese: 73 pazjent.
English: Pack sizes
Maltese: Mekkaniżmu ta' azzjoni
English: ICRS grades were mostly IV A, followed by IIIB and IIIA (56, 23 and 10 patients respectively).
Maltese: Il-gradi ICRS kienu l-aktar IV A, segwiti minn IIIb u IIIA (56, 23 u 10 pazjenti rispettivament).
English: KOOS (Knee Injury and Osteoarthritis Outcome Score) after 12, 24, 36, 48 and 60 months compared to before treatment could be observed.
Maltese: KOOS (Knee Injury and Osteoarthritis Outcome Score) wara 12, 24, 36, 48 u 60 xahar meta imqabbel ma qabel il-kura.
English: Adverse reactions related to the surgical procedure:
Maltese: Reazzjonijiet avversi konnessi mal-proċedura kirurġika:
English: Sodium chloride
Maltese: Klorur tas-sodju
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).
Maltese: Mill-2004, Spherox kien disponibbli fuq bażi ta' pazjenti individwali għall-kura ta' difetti tal-qarquċa kklassifikati bħala grad 3 jew 4 ta' Outerbridge jew grad III jew IV ta' ICRS (Outerbridge 1961, ICRS Cartilage Injury Evaluation Package 2000).
English: Due to the nature and intended clinical use of Spherox, conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Maltese: Minħabba n-natura u l-użu kliniku intenzjonat ta' Spherox, studji konvenzjonali fuq farmakokinetika, assorbiment, distribuzzjoni, metaboliżmu, u eliminazzjoni mhumiex applikabbli.
English: The implantation must be performed during a surgical procedure (preferably an arthroscopy or miniarthrotomy).
Maltese: L-impjantazzjoni għandha ssir waqt proċedura kirurġika (preferibbilment artroskopija jew miniartrotomija).
English: It must be administered by a specialised orthopedic surgeon and in a medical facility.
Maltese: Għandu jingħata minn kirurgu ortopediku speċjalizzat u f'faċilità medika.
English: • Primary (generalised) osteoarthritis.
Maltese: • Osteoartrite (ġeneralizzata) primarja.
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
Maltese: CO.DON AG, Warthestraße 21, 14513 Teltow, Il-Ġermanja Tel: +49 (0)3328 43 46 0, Fax:
English: This may also be carried out by keyhole surgery.
Maltese: Dan jista' jsir ukoll permezz ta' "keyhole surgery".
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-eċċipjenti, ara s-sezzjoni 6.1.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: The total MOCART scores 3, 12, 18, 24 and 36 months after treatment did not differ substantially between the two treatment groups.
Maltese: Il-punteġġi MOCART totali 3, 12, 18, 24 u 36 xahar wara l-kura, ma kinux differenti b'mod sostanzjali bejn iż-żewġ gruppi ta' trattament.
English: Application system co.fix 150 mm or
Maltese: Sistema ta' applikazzjoni co.fix 150 mm jew
English: CO.DON AG Warthestr.
Maltese: CO.DON AG
English: CO.DON AG Warthestraße 21
Maltese: Warthestraße 21
English: Post-authorisation efficacy study (PAES): 60-month follow-up data for study cod 16 HS 13.
Maltese: Data ta᾽ segwitu ta᾽ 60 xahar għal studju cod 16 HS 13.
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)
Maltese: • SOC Disturbi muskoluskeletriċi u tat-tessuti konnettivi: effużjoni fil-ġogi (komuni ħafna), artralġja (komuni ħafna), nefħa fil-ġogi (komuni ħafna), tendonite (komuni), dgħufija fil muskoli (komuni), sindrome ta' uġigħ patellofemorali (komuni), osteonekrosi (mhux komuni)
English: 14513 Teltow, Germany Tel.: +49 3328 43460 Fax: +49 3328 434643 E-mail: info@codon.de
Maltese: +49 (0)3328 43 46 43, Email: info@codon.de
English: Additional statistical assessments were performed 24 and 36 months after treatment.
Maltese: Valutazzjonijiet statistiċi addizzjonali twettqet 24 u 36 xahar wara l-kura.
English: • Advanced osteoarthritis of the affected joint (exceeding grade II according to Kellgren and
Maltese: • Osteoartrite avvanzata tal-ġog affettwat (li taqbeż grad II skont Kellgren and Lawrence).
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).
Maltese: Din il-mediċina fiha numru speċifiku ta' sferojdi ta' kondroċiti awtologi umani assoċjati mal-matriċi skont id-daqs tad-difett (10-70 sferojdi/cm2).
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.
Maltese: Riżultati ta' immaġini b'reżonanza manjetika (MRI) skont is-sistema ta' punteġġ tal-Osservazzjoni b'Reżonanza Manjetika tat-Tessut ta' Tiswija tal-Qarquċa (Magnetic Resonance Observation of Cartilage Repair Tissue - MOCART) (0 = l-agħar riżultat; 100 = l-aħjar riżultat) urew titjib fi żmien l ewwel 60 xahar minn 59.8 f'Viżta 2 (3 xhur wara l-kura) sa 75.0 punt fil-grupp tal-pazjenti kkurati b'difett ta' 3-7 sferojdi/cm², minn 64.5 f'Viżta 2 sa 76.4 punti fil-grupp tad-doża ta' difett ta' 10-30 sferojdi/cm², u minn 64.7 f'Viżta 2 sa 73.6 punti fil-grupp tad-doża ta' difett ta' 40-70 sferojdi/cm².
English: Patients treated with Spherox have to undergo a specific rehabilitation program (see section 4.4).
Maltese: Pazjenti kkurati bi Spherox iridu jgħaddu minn programm ta' riabilitazzjoni speċifiku (ara sezzjoni 4.4).
English: Information on adverse reactions in 177 patients from pivotal clinical trials are available.
Maltese: Hemm disponibbli informazzjoni dwar reazzjonijiet avversi f'177 pazjent minn provi kliniċi pivitali.
English: • Patients with not fully closed epiphyseal growth plate in the affected joint.
Maltese: • Pazjenti b'epiphyseal growth plate li ma għalqitx kompletment fil-ġog affettwat.
English: 1 syringe in a sterile tube
Maltese: Siringa 1 f'tubu sterili
English: Repair of symptomatic articular cartilage defects of the femoral condyle and the patella of the knee (International Cartilage Regeneration & Joint Preservation Society [ICRS] grade III or IV) with defect sizes up to 10 cm2 in adults.
Maltese: (International Cartilage Regeneration & Joint Preservation Society [ICRS] grad III jew IV) b'qisien tad-difetti sa 10 cm2 fl-adulti.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Pt Name, Pt ID: {Patient Name}, {Patient ID} Lot {Batch Number}
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT Isem tal-Pazjent, ID tal-Pazjent {Isem tal-Pazjent}, {ID tal-Pazjent} Lott {Numru tal-Lott}
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.
Maltese: International Knee Documentation Committee (IKDC; evalwazzjoni suġġettiva tal-irkoppa) u l-punteġġ ta' Lysholm urew ukoll, wara 12, 24, 36, 48 u 60 xahar, titjib sinifikanti meta mqabbel mal-valur qabel il-kura.
English: Implantation suspension.
Maltese: Suspensjoni għall-impjantazzjoni.
English: • uneasiness
Maltese: • uġigħ
English: Follow the rehabilitation program, strictly, after implantation.
Maltese: Programm ta' riabilitazzjoni Segwi l-programm ta' riabilitazzjoni, strettament, wara l-impjantazzjoni.
English: • internal bleedings
Maltese: • fsad intern
English: Spherox is cultured and implanted as three-dimensional spheroids.
Maltese: Spherox huwa kkulturat u impjantat bħala sferojdi tridimensjonali.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 10th July 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 10 ta' Lulju 2017
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.
Maltese: II, open-label mhux ikkontrollat, prospettiv u fejn il-pazjenti ġew assenjati b'mod arbitrarju li inkluda 75 pazjent b'difetti fokali tal-qarquċa (grad III jew IV ta' ICRS) fl-irkoppa b'daqs tad-difett ta' 4-10 cm2.
English: The catheter of the applicator is made of thermoplastic polyurethane, the sealing plug on one side of acrylonitrile butadiene styrene and a silicone stopper on the other side.
Maltese: Il-katiter talapplikatur huwa magħmul minn polyurethane termoplastiku , it-tapp li jissiġilla ta' acrylonitrile butadiene styrene fuq naħa waħda u tapp tas-silikon fuq in-naħa l-oħra.
English: • SOC Vascular disorders: lymphoedema (common), thrombophlebitis (uncommon), deep vein thrombosis (uncommon), haematoma (uncommon)
Maltese: • SOC Disturbi vaskulari: limfoedima (komuni), tromboflebite (mhux komuni), trombożi fil-vini tal-fond (mhux komuni), ematoma (mhux komuni)
English: Syringe
Maltese: Pożoloġija
English: The mean patient age was 34 years (range 19 to 48 years) with a mean body mass index (BMI) of 25.2.
Maltese: bejn 18 sa 49 sena) b' medja ta' indiċi tal-massa tal-ġisem(BMI) ta' 25.8.
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.
Maltese: Ħamsa u għoxrin pazjent ġew ikkurati, b'difett ta' 10-30 sferojdi/cm2, 25 b'difett ta' 40-70 sferodji/cm2 u 25
English: For intraarticular use.
Maltese: Mhux applikabbli.
English: Spherox is used to treat defects up to 10 cm² in size.
Maltese: Spherox jintuża biex jikkura difetti sa 10 cm² fid-daqs.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1181/001
Maltese: EU/1/17/1181/001 EU/1/17/1181/002
English: Joint effusion, Arthralgia, Joint swelling
Maltese: Effużjoni tal-ġogi, Artralġja, Nefħa tal-ġogi
English: One applicator has a maximum capacity of 60 spheroids in a volume of up to 200 microlitre isotonic sodium chloride solution.
Maltese: Applikatur wieħed għandu kapaċità massima ta' 60 sferojdi f'volum sa massimu ta' 200 mikrolitry ta'
English: Silicone oil serves as lubricant.
Maltese: Żejt tas-silikon iservi bħala lubrikant.
English: below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
Maltese: Ir-reazzjonijiet avversi konnessi ma' Spherox huma murija bis-sistema tal-klassifika tal-organi u l frekwenza f'Tabella 1 hawn taħt: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000); u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Too early and vigorous activity may compromise the grafting and the durability of clinical benefit from Spherox.
Maltese: Attività bikrija jew qawwija wisq tista' tikkomprometti t-tlaqqim u d-dewmien tal-benefiċċju kliniku minn Spherox.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Application system co.fix 150 mm:
Maltese: DATA TA' SKADENZA Sistema ta' applikazzjoni co.fix 150 mm:
English: For information on preparation and handling of Spherox, please refer to section 6.6.
Maltese: Għal informazzjoni dwar il-preparazzjoni u l-ġestjoni ta' Spherox, jekk joħġbok irreferi għas sezzjoni 6.6.
English: BATCH NUMBER, DONATION AND PRODUCT CODES {Batch Number}
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT {Numru tal-Lott}
English: Other medicines and Spherox
Maltese: Mediċini oħra u Spherox
English: The following adverse reactions considered surgery-related have been reported during the course of the clinical trials and/or from spontaneous sources:
Maltese: Ir-reazzjonijiet avversi li ġejjin meqjusa bħala konnessi mal-kirurġija ġew irrappurtati matul il-provi kliniċi u/jew minn sorsi spontanji:
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)
Maltese: • sensittività eċċessiva (allerġija) (sintomi: eż. reazzjonijiet tal-ġilda, pressjoni tad-demm baxxa, għeluq tal-passaġġi tal-arja, ilsien jew griżmejn minfuħ/in, polz batut jew mgħaġġel, mard, remettar, dijarea, sturdament, ħass ħażin, deni)
English: Spherox 10-70 spheroids/cm2 implantation suspension
Maltese: Spherox 10-70 sferojdi/cm2 suspensjoni għall-impjantazzjoni
English: In all 3 dose groups a significant improvement (α < 0.05) of the
Maltese: Fit-3 gruppi tad-doża kollha, seta' jiġi osservat titjib sinifikanti (α < 0.05) tal
English: BATCH NUMBER, DONATION AND PRODUCT CODES {Patient ID (including the Batch Number)}
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT {ID tal-Pazjent (inkluż in-Numru tal-Lott)}
English: Spheroids of human autologous matrix-associated chondrocytes for implantation suspended in isotonic sodium chloride solution.
Maltese: Sferojdi ta' kondroċiti awtologi umani assoċjati mal-matriċi għall-impjantazzjoni sospiżi f'soluzzjoni iżotonika tal-klorur tas-sodju.
English: • The product will only be available to surgeons certified to prescribe and administer Spherox
Maltese: • Il-prodott se jkun disponibbli biss għal kirurgi ċċertifikati biex jippreskrivu u jagħtu Spherox