FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients aged between 18 and 50 years, who had a single symptomatic cartilage lesion between 1 and 5 cm2 of the femoral condyles met the inclusion criteria.
Maltese: Pazjenti ta' bejn 18 u 50 sena, li kellhom leżjoni sintomatika waħda fil-qarquċa ta' bejn 1 u 5 cm2 tal-kondili femorali ssodisfaw il-kriterji biex jidħlu fl-istudju.
English: Chondromalacia, Gonarthrosis
Maltese: Kif gћandek tuża ChondroCelect
English: Cartilage hypertrophy
Maltese: Flebite superfiċjali
English: ChondroCelect can only be prescribed and implanted by an orthopaedic surgeon in a hospital.
Maltese: ChondroCelect jista' jiġi ordnat u impjantat biss minn kirurgu ortopediku fi sptar.
English: Most of the reported adverse reactions were expected as related to the open-knee surgical procedure..
Maltese: Ħafna mir-reazzjonijiet avversi rrappurtati kienu mistennija li jkunu relatati mal-proċedura kirurġika bl-irkoppa miftuħa.
English: There was continuous improvement up to 36 months in the clinical outcome measure KOOS (the Knee Injury and Osteoarthritis Outcome Score) in both treatment arms.
Maltese: Kien hemm titjib kontinwu sa 36 xahar tal-kejl tal-eżitu kliniku KOOS (in-Knee Injury and Osteoarthritis Outcome Score)
English: In the compassionate use patients, a higher incidence of arthrofibrosis and decreased joint range of motion was observed in a subgroup of patients with a patellar lesion (8.2% and 13.1% respectively) compared to non-patellar lesions (0.6% and 2.6% respectively).
Maltese: rispettivament) meta mqabbla ma' leżjonijiet mhux fil-patella (0.6% u 2.6% rispettivament).
English: NAME OF THE MEDICINAL PRODUCT ChondroCelect 10,000 cells/microlitre implantation suspension
Maltese: IL-PRODOTT MEDIĊINALI ChondroCelect 10,000 ċellola/mikrolitru ta' suspensjoni għal impjant
English: Repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.
Maltese: Tiswija ta' difetti singoli sintomatiċi fil-qarquċa tal-kondil femorali tal-irkoppa (Soċjetà Internazzjonali għat-Tiswija tal-Qarquċa [ICRS] grad III jew IV) minn 2 cm² 'il quddiem fl-adulti.
English: Hyperesthesia, Migraine,
Maltese: Artrite, Artropatija,
English: Tabulated list of adverse reactions They are listed by System Organ Class and frequency.
Maltese: Huma elenkati skont is-Sistema tal-Klassifika tal-Organi u l-frekwenza.
English: Arthrofibrosis
Maltese: • artralġja
English: Uncommon side effects (affects in 1 to 10 users in 1,000 include: anxiety, dermal and visual hypersensitivity ), migraine, mini stroke (transient ischaemic attack), fat entering the circulatory system (fat embolism), vein blockage and inflammation (thrombophlebitis), blockage in a lung artery (lung embolism), itching scar, pain at the front of the knee (chondromalacia), breakdown of knee tissue (gonartrhosis, atrophy), discomfort, chronic inflammation (granulomatous lesion).
Maltese: sensittività eċċessiva dermali u viżiva), emigranja, puplesija ħafifa (attakk iskemiku temporanju), xaħam jidħol fis-sistema ċirkolatorja (emboliżmu tax-xaħam), imblokk u infjammazzjoni fil-vini (tromboflebite), imblokk f'arterja tal-pulmun (emboliżmu fil-pulmun), ċikatriċi bil-ħakk, uġigħ fin-naħa ta' quddiem tal-irkoppa (chondromalacia), kollass tat-tessuti tal-irkoppa (gonartrhosis, atrofija), skonfort, infjammazzjoni kronika (granulomatous lesion).
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot {lot number}
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT
English: Too early and vigorous activity may compromise the grafting and the durability of clinical benefit from ChondroCelect.
Maltese: Attività kmieni ħafna u vigoruża tista' tikkomprometti l-grafting u d-durabilità tal-benefiċċju kliniku minn ChondroCelect.
English: Each vial of product contains 4 million autologous human cartilage cells in 0.4 ml cell suspension, corresponding to a concentration of 10,000 cells/microlitre.
Maltese: Kull kunjett tal-prodott fih 4 miljun ċellola awtologa ta' qarquċa umana f'0.4 ml ta' suspensjoni ta' ċelloli, li jikkorrispondi għal konċentrazzjoni ta' 10,000 ċellola/mikrolitru.
English: The falcon tube is placed in a plastic screw top container together with surgery materials (one sterile syringe of 1 ml, one 18G intravenous catheter and two pieces of Vicryl 6.0) and a temperature monitor.
Maltese: Il-falcon tube jitqiegħed ġewwa kontenitur tal-plastik b'għatu bil-kamin flimkien ma' materjali kirurġiċi (siringa sterili waħda ta' 1 ml, kateter 18G wieħed għal ġol-vini u biċċtejn Vicryl 6.0) u
English: Haemarthrosis, Joint instability, Joint stiffness, Loose body in joint, Mobility decreased, Muscle atrophy, Osteoarthritis, Synovial cyst, Synovitis,
Maltese: Tnaqqis fil-mobilità, Atrofija tal-muskoli, Osteoartrite, Ċista sinovjali, Sinovite,
English: ChondroCelect 10,000 cells/microlitre implantation suspension.
Maltese: TAL-PRODOTT MEDIĊINALI ChondroCelect 10,000 ċellola/mikrolitru ta' suspensjoni għal impjant.
English: The product is packaged in several layers of packaging material which guarantee sterility and stable temperature conditions for 48 hours if stored at room temperature.
Maltese: Il-prodott huwa ppakkjat f'diversi saffi ta' materjali tal-imballaġġ li jiggarantixxu sterilità u temperatura stabbli għal 48 siegħa jekk jinħażen fit-temperatura tal-kamra.
English: The safety and efficacy in children and adolescents (aged less than 18) have not been established.
Maltese: Is-sigurtà u l-effikaċja fit-tfal u l-adoloxxenti (età ta' inqas minn 18-il sena) ma ġewx stabbiliti s'issa.
English: ChondroCelect should not be sterilised.
Maltese: ChondroCelect m'għandux jiġi sterilizzat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 4 million autologous human cartilage cells in 0.4 ml, corresponding to a concentration of 10,000 cells/microlitre.
Maltese: Kull kunjett fih 4 miljun ċellola awtologa ta' qarquċa umana f'0.4 ml, li tikkorrispondi għal konċentrazzjoni ta' 10,000 ċellola/mikrolitru.
English: The vials are placed in a sterile falcon tube with a plastic screw top.
Maltese: Il-kunjetti jitpoġġew ġo falcon tube sterili b'għatu tal-plastik bil-kamin.
English: No statistically significant difference could be observed in clinical benefit between ChondroCelect and microfracture at that point in time.
Maltese: Ma ġiet osservata l-ebda differenza statistikament sinifikanti fil benefiċċju kliniku bejn ChondroCelect u l-mikrofrattura f'dak il-ħin.
English: Elderly population The use of ChondroCelect has not been studied in this age group.
Maltese: Popolazzjoni anzjana L-użu ta' ChondroCelect ma ġiex studjat f'dan il-grupp ta' età.
English: Only 907 patients have been exposed up to now, including patients treated with ChondroCelect within the clinical trials conducted to support the MA of ChondroCelect.
Maltese: 907 pazjenti biss ġew esposti s'issa, inklużi pazjenti kkurati bi ChondroCelect fi ħdan il-provi kliniċi mwettqa sabiex isostnu l-MA ta' ChondroCelect.
English: ChondroCelect consists of autologous cultured cartilage cells.
Maltese: ChondroCelect jikkonsisti minn ċelloli awtologi kulturati tal-qarquċa.
English: The nature and intended clinical use of ChondroCelect are such that conventional studies on pharmacokinetics, absorption, distribution, metabolism and elimination are not applicable.
Maltese: In-natura u l-użu kliniku intenzjonati ta' ChondroCelect huma tali li studji konvenzjonali dwar il farmakokinetika, l-assorbiment, id-distribuzzjoni, il-metaboliżmu u l-eliminazzjoni mhumiex applikabbli.
English: What ChondroCelect looks like and contents of the pack ChondroCelect is a cell suspension (a fluid) for implantation.
Maltese: ChondroCelect huwa suspensjoni ta' ċelloli (fluwidu) għal impjant.
English: ChondroCelect is supplied as one individual treatment dose (falcon tube) contained in 1 to 3 Type I glass vials of 1 ml.
Maltese: ChondroCelect jiġi bħala doża ta' trattament individwali waħda (tubu Falcon) kontenuta f'wieħed sa tliet kunjetti tal-ħġieġ ta' Tip I ta' 1 ml.
English: Fibrin sealant products differ significantly in their quantitative and qualitative composition.
Maltese: Il-prodotti siġillanti tal-fibrin ivarjaw ħafna fl-għamla kwantitattiva u kwalitattiva tagħhom.
English: Hypersensitivity to any of the excipients listed in section 6.1, or to bovine serum.
Maltese: Sensittività eċċessiva għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 jew għas serum tal-ifrat.
English: This is the case if the biopsy is of insufficient quality to make ChondroCelect, or in some instances, it may be the cells cannot be grown in the laboratory or that the cells after expansion do not meet all the quality requirements Your surgeon will be informed and might have to select an alternative treatment for you.
Maltese: Il-kirurgu jiġi infurmat kemm jista' jkun kmieni fil-proċess, u biex ikun jista' jagħżel trattament alternattiv għall-pazjent ikkonċernat.
English: Fat embolism, Thrombophlebitis
Maltese: Emboliżmu fil-pulmun
English: Wound dehiscence, Wound secretion
Maltese: Tqarmiċ tal-ġogi, Nefħa tal-ġogi
English: Scar pain,
Maltese: Skumdità,
English: In vitro interaction studies were performed with a commercially available fibrin glue containing aprotinin (a fibrinolysis inhibitor of bovine origin).
Maltese: Studji in vitro dwar l-effett ta' mediċini jew ta' affarijiet oħra fuq l-effett farmaċewtiku tal prodott twettqu b'kolla tal-fibrin disponibbli kummerċjalment li fiha l-aprotinin (inibitur tal fibrinolisi ta' oriġini bovina).
English: Very common side effects (affects more than 1 user in 10) include: joint pain (arthralgia), overgrowth of cartilage cells (cartilage hypertrophy), crackling or clicking sensation when articulating the knee (joint crepitation), and joint swelling.
Maltese: Effetti sekondarji komuni (jaffettwaw minn 1 sa 10 utenti f'kull 100) jinkludu: restrizzjoni filmoviment tal-irkoppa (artrofibrosi, tnaqqis fil-medda ta' movement tal-ġogi, tnaqqis fil-mobilità),
English: Rehabilitation
Maltese: riabilitazzjoni..
English: Too early and vigorous activity may compromise the implant and the durability of clinical benefit from ChondroCelect.
Maltese: L-attività kmieni ħafna u vigoruża tista' tikkomprometti l-impjant u d-durabilità tal-benefiċċju kliniku minn ChondroCelect.
English: Concomitant knee problems like early osteoarthritis, osteochondritis dissecans (OCD), instability of the knee, cartilage lesions at other locations than the femoral condyle, lesions of knee ligaments or of the meniscus, varus or valgus malalignment (abnormal weight distribution in the knee), and inflammatory joint disease are potential complicating factors.
Maltese: Problemi konkomitanti fl-irkoppa bħal bidu ta'osteoartrite, osteokondrite dessikanti (OCD), instabilità tal-irkoppa, leżjonijiet tal-qarquċa f'postijiet oħra differenti mill-kondil femorali,
English: Deep vein thrombosis, Haematoma, Superficial phlebitis
Maltese: Viżta 1: evalwazzjoni tad-difett fil-qarquċa u bijopsija
English: According to current literature the incidence of cartilage hypertrophy can be reduced by using a collagen membrane to cover the lesion site instead of using a periosteal flap (Gooding et al., 2006; Niemeyer et al., 2008).
Maltese: Skont illetteratura preżenti, l-inċidenza ta' ipertrofija tal-qarquċa tista' titnaqqas billi tintuża membrana tal-collagen biex tgħatti l-post tal-leżjoni minflok ma jintuża ġewnaħ periosteali (Gooding et al., 2006;
English: Arthroscopy
Maltese: Tromboflebite
English: - You should resume physical activity according to the rehabilitation plan recommended by the physical therapist.
Maltese: - Inti għandek terġa' tibda l-attività fiżika skont il-pjan ta' riabilitazzjoni rrakkomandat mit terapista fiżiku.
English: Musculoskeletal and connective tissue disorders
Maltese: skeletriċi u tat-tessuti konnettivi
English: Visit 2: ChondroCelect implantation
Maltese: It-trattament b'ChondroCelect: proċedura f'żewġ passi
English: Marketing Authorisation Holder: TiGenix N.V.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (Marketing Authorisation Holder (MAH))
English: Visit 1: evaluation of the cartilage defect and biopsy On the first visit, the surgeon will evaluate your cartilage defect during an exploratory operation (arthroscopy).
Maltese: Fl-ewwel viżta, il-kirurgu se jevalwa d-difett fil-qarquċa tiegħek waqt operazzjoni esploratorja (artroskopija).
English: Pharmacotherapeutic group: Other drugs for disorders of the musculo-skeletal system, ATC code: M09AX02
Maltese: Mediċini oħra għal disturbi tas-sistema muskolu-skeletriku,
English: Fertility
Maltese: Dardir
English: Where possible, concomitant knee problems should be corrected prior to or at the latest at the time of ChondroCelect implantation.
Maltese: Fejn ikun possibbli, problemi konkomitanti fl-irkoppa għandhom jiġu rranġati qabel jew mhux aktar tard
English: Within each frequency grouping,
Maltese: Indeboliment tal-fejqan,
English: In the pivotal study there was no influence of Body Mass Index (BMI) on outcome but bibliographic data shows that a BMI over 30 may adversely affect the success of the procedure.
Maltese: Fl-istudju msemmi fuq ma kien hemm ebda influwenza tal-Indiċi tal-Massa tal-Ġisem (BMI) fuq ir-riżultat iżda dejta biblijografika turi li BMI ogħla minn 30 jista' jkollu effett ħażin fuq is
English: The MAH must ensure that the system of pharmacovigilance presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Maltese: farmakoviġilanza ppreżentata f'Modulu 1.8.1 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq tkun fis seħħ u tiffunzjona qabel u waqt li l-prodott mediċinali jkun fis-suq.
English: However, ChondroCelect has not been evaluated in combination with collagen membranes in clinical studies, although a commercially available collagen membrane has been used in patients treated with ChondroCelect under compassionate use.
Maltese: Madankollu, ChondroCelect ma ġiex evalwat f'kombinazzjoni ma' membrani talcollagen fi studji kliniċi, għalkemm membrane tal-collagen kummerċjalment disponibbli ntużat f'pazjenti ttrattati b'ChondroCelect bħala kura mingħajr ħlas.
English: Scientific publications have shown that commercially available collagen membranes can be used as an alternative to the periost in ACI procedures.
Maltese: Pubblikazzjonijiet xjentifiċi wrew li membrane kummerċjalment disponibbli tal-collagen tista' tintuża bħala alternattiva għall-perjosteum fi proċeduri ACI.
English: ChondroCelect was compared to the procedure of microfracture in the repair of symptomatic single cartilage lesions of the femoral condyles of the knee.
Maltese: ChondroCelect u 49 ġew evalwati fil-grupp tal-mikrofrattura.
English: Discomfort, Granulomatous lesion
Maltese: Ferita granulomatuża xi proċedura
English: Implantation suspension.
Maltese: Tesponix għall-irradjazzjoni.
English: ChondroCelect is used to repair single symptomatic cartilage defects in the femoral condyle of the knee in adults.
Maltese: ChondroCelect jintuża biex isewwi difett singolu sintomatiku tal-qarquċa fil-kondil femorali tal-irkoppa fl-adulti.
English: Photophobia, Transient ischaemic attack
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM
English: Post-marketing experience with respect to patient number, i.e. 444 patients and duration of follow-up is still quite limited, and doesn't warrant granting a renewal with unlimited validity.
Maltese: L-esperjenza ta' kliniċi mwettqa sabiex jappoġġaw l-immonitorjar ta' pazjenti, jiġifieri 444 pazjent u t-tul ta' follow-up għadu pjuttost limitat, u ma jsostnix tiġdid b'validità bla limitu.
English: Sixteen patients below 18 years have been treated with ChondroCelect under compassionate use.
Maltese: Il-kirurgu tiegħek se jiġi infurmat u għandu mnejn ikollu jfittixlek trattament alternattiv.
English: How to store ChondroCelect
Maltese: bbenefikaw l-aktar minn ChondroCelect.
English: Keep the product vial(s) within the falcon tube in the outer plastic screw top container in order to protect from light and bacterial/fungal contamination.
Maltese: Żomm il-kunjett(i) fit-tubu falcon tal-prodott fil-kontenitur ta' barra tal-plastik b'għatu bil-kamin sabiex tilqa' mid-dawl u minn kontaminazzjoni batterika/fungali.
English: Prior to implantation match the patient name to the patient/donor identification on the shipment documentation and product vial.
Maltese: Qabel l-impjant, qabbel l-isem talpazjent mal-identifikazzjoni tal-pazjent/donator fuq id-dokumentazzjoni tal-konsenja u l-kunjett
English: Treatment failure in the ChondroCelect group was generally related to delamination of the graft.
Maltese: Il-falliment tal-kura fil-grupp ta' ChondroCelect kien ġeneralment relatat ma'
English: Do not use ChondroCelect if you: are allergic to any of the ingredients of ChondroCelect (listed in section 6) or to bovine serum suffer from advanced osteoarthritis (degenerative joint disease) in your knee.
Maltese: Tużax ChondroCelect jekk: - inti allerġiku għal xi sustanza ta' din il-mediċina (elenkati fis-sezzjoni 6), jew serum tal ifrat.
English: • Autologous means that your own cells are used to make ChondroCelect.
Maltese: • Obbligu biex jitwettqu miżuri ta' wara l-awtorizzazzjoni Mhux applikabbli.
English: Manufacturer:
Maltese: MANIFATTUR(I)
English: Bone swelling, Bursitis,
Maltese: Ċista fl-għadam, Nefħa fl-għadam, Burżite,
English: Most side effects of ChondroCelect implantation are side effects related to open-knee surgery.
Maltese: Ħafna mill-effetti sekondarji tal-impjant ta' ChondroCelect huma effetti sekondarji relatati ma'
English: TiGenix N.V.
Maltese: Tnixxija mill-ferita
English: Concomitant asymptomatic cartilage lesions (ICRS grade I or II) might be present.
Maltese: Jista' jkun hemm leżjonijiet konkomitanti mingħajr sintomi fil-qarquċa (ICRS grad I jew II).
English: Re-intervention on the treated lesion for graft delamination or periost loosening occurred in 2 of 51 patients within 36 months after ChondroCelect implantation, compared to 7 of 61 patients treated with microfracture having generally insufficient or inadequate cartilage repair.
Maltese: 36 xahar wara l-impjant ta' ChondroCelect, meta pparagunat ma' 7 minn 61 pazjent ittrattati b'mikrofrattura li kellhom tiswija tal-qarquċa ġeneralment insuffiċjenti jew inadegwata.
English: The MAH shall perform the pharmacovigilance activities as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates.
Maltese: L-MAH għandu jwettaq l-attivitajiet ta' farmakoviġilanza ddettaljati fl-RMP maqbula ippreżentati fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti.
English: Itching scar
Maltese: • ġogi iqarmċu
English: Synovitis and subchondral bone injuries have been reported in animal models and are possible risks with the use of ChondroCelect.
Maltese: Sinovite u ħsara fl-għadam subkondrali t-tnejn ġew irrappurtati f'mudelli tal-annimali u huma riskji possibbli bl-użu ta' ChondroCelect.
English: Hypertrophic scar, Postoperative wound complication, Pruritus,
Maltese: Kondropatija, Exostosis, Emartrożi, Instabbilità fil-ġogi, Ebusija fil-ġogi,
English: NAME OF THE MEDICINAL PRODUCT ChondroCelect
Maltese: PREKAWZJONIJIET SPEĊJALI GĦAR-RIMI TA' PRODOTTI MEDIĊINALI MHUX
English: For the group with a longer time since onset of symptoms there were no apparent differences between the 2 groups.
Maltese: ma ntwerewx differenzi apparenti bejn iż-żewġ gruppi.
English: Other medicines and ChondroCelect
Maltese: Kif taħżen ChondroCelect
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 If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi mmodifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r riskju
English: Skin and subcutaneous tissue disorders
Maltese: prodott/cm² tad-difett.
English: Chondropathy, Exostosis,
Maltese: Ħakk, Uġigħ fiċ-ċikatriċi,
English: However, the concomitant use of another type of fibrin glue with a synthetic fibrinolysis inhibitor (tranexamic acid) in the pivotal clinical trial did not reveal any safety signal.
Maltese: Madankollu, l-użu konkomitanti ta' tip ieħor ta' kolla tal fibrin b'inibitur sintetiku tal-fibrinolisi (aċidu traneksamiku) fl-istudju kliniku msemmi fuq ma wera l-ebda ħjiel ta' problema ta'sigurtà.
English: - The other ingredient is sterile, buffered Dulbecco's Modified Eagles Medium (DMEM), a liquid containing amino acids, vitamins, salts and carbohydrates to store the cells in the vial.
Maltese: - Is-sustanza l-oħra hija Dulbecco's Modified Eagles Medium (DMEM) sterili, bafferjat,
English: In patients with a longer time since onset of symptoms, both treatments performed equally.
Maltese: F'pazjenti bi żmien itwal mill-bidu tas-sintomi, ma kienx hemm differenza bejn iż-żewġ trattamenti.
English: Patients with acute or recent history of bone or joint infections should be temporary deferred until documented recovery.
Maltese: Pazjenti bi storja akuta jew reċenti ta' infezzjonijiet fl-għadam jew fil-ġogi għandhom jiġu differiti temporanjament sakemm ikun hemm titjib dokumentat.
English: Before administration, ChondroCelect should be resuspended by gently tapping the vial to bring the cells back into suspension.
Maltese: ChondroCelect, mhumiex mistennija reazzjonijiet avversi fuq it-tarbija li tkun qed terda'.
English: Romeinse straat 12/2, 3001 LEUVEN Belgium info@tigenix.com
Maltese: • Awtologi tfisser li jintużaw iċ-ċelloli tiegħek stess biex isir ChondroCelect.
English: • The need for screening of donors using patient questionnaire and laboratory tests for hepatitis C,
Maltese: • Il-ħtieġa ta' għazla tad-donaturi permezz ta' kwestjonarju lill-pazjenti u t-testijiet tallaboratorju għall-epatite Ċ, l-epatite B, l-HIV u s-sifilide
English: 45, 51, 68, 74, 76 and 80 New York Avenue Framingham, MA 01701
Maltese: 45, 51, 68, 74, 76 and 80 New York Avenue Framingham,
English: Date of first authorisation: 9 March 2000 Date of last renewal: 9 March 2010
Maltese: Data tal-aħħar tiġdid: 9 ta' Marzu 2010
English: Thyrogen (N=374) THW (N=378)
Maltese: THW (N=378)
English: The median follow-up was 6.5 years (4.5 to 7.6 years).
Maltese: Ilmedjan ta' segwitu kien ta' 6.5 snin (4.5 sa 7.6 snin).
English: The elimination halflife was 22 ± 9 hours.
Maltese: Il-half life ta' eliminazzjoni kienet ta' 22 ± 9 sigħat.
English: Low activity dose RAI (1.1 GBq)
Maltese: Doża b'attività baxxa RAI (1.1 GBq)
English: High activity dose RAI (3.7 GBq)
Maltese: Attività għolja RAI (3.7 GBq)
English: Infections and infestations influenza
Maltese: Infezzjonijiet u infestazzjonijiet influwenza
English: The HiLo study randomised 438 patients (tumour stages T1-T3, Nx, N0 and N1, M0) at 29 centres.
Maltese: L-istudju HiLo għażel b'mod każwali 438 pazjent (stadji tat-tumur T1-T3, Nx, N0 u N1, M0) f'29 ċentru.
English: 1105 BP Amsterdam The Netherlands
Maltese: BP Amsterdam, L-Olanda.
English: For the ESTIMABL1 study, 726 (97%) of the original 752 patients were followed up for disease recurrence.
Maltese: Għall-istudju ESTIMABL1, 726 (97%) mill-oriġinali 752 pazjent ġew segwiti għar-rikorrenza talmarda.
English: Use aseptic technique.
Maltese: Użu ta' teknika asettika.
English: The cDNAs encode for an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites, and a beta subunit of 118 residues containing one N-linked glycosylation site.
Maltese: L-encode cDNAs għal sottunità alfa ta' 92 residwu ta' amino acid li fihom żewġ N-linked glycosylation sites, u sottunità beta ta' 118-il residwu li fih N-linked glycosylation site wieħed.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Ir-rata ta' rappurtaġġ hi kklassifikata bħala 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 ħafnae (<1/10,000) u mhux magħruf