FrancophonIA/ELRC3.0 huggingface dataset:
English: In case of renal impairment, IVIg discontinuation should be considered.
Maltese: F'każ ta' indeboliment renali, għandu jitqies it-twaqqif tal-IVIg.
English: Peripheral coldness, phlebitis
Maltese: Kesħa fl-estremitajiet, flebite
English: Immune system disorders Hypersensitivity, anaphylactic reaction
Maltese: Sensittività eċċessiva, reazzjoni anafilattika
English: Elderly
Maltese: Emolisi
English: Cough, rhinorrhoea, asthma, nasal congestion, oropharyngeal pain, dyspnea
Maltese: Sogħla, rinorea, ażżma, konġestjoni fl-imnieħer, uġigħ faringolarinġali, dispneja
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Maltese: Miżuri standard għall-prevenzjoni ta' infezzjonijiet li jirriżultaw mill-użu ta' prodotti mediċinali imħejjija minn demm uman jew mill-plażma umana jinkludu għażla ta' donaturi, skrining ta' donazzjonijiet individwali u kollezzjoniet ta' plażma għal markers speċifiċi ta' infezzjoni u l-inklużjoni ta' passi effettivi fil-manifattura għall-inattivazzjoni/tneħħija ta' viri.
English: Oropharyngeal swelling
Maltese: Ż-ŻGĦAR EWLENIN
English: Muscle twitching
Maltese: Ġbid tal-muskoli
English: Immunomodulation in adults, and children and adolescents (0-18 years) in:
Maltese: Immunomodulazzjoni f'persuni adulti, tfal u adolexxenti (li jkollhom minn 0 sa 18-il sena) fi:
English: • assessment of blood viscosity in patients at risk for hyperviscosity
Maltese: • evalwazzjoni tal-viskożità tad-demm f'pazjenti f'riskju għal viskożità eċċessiva
English: Chronic sinusitis, fungal infection, infection, kidney infection, sinusitis, upper respiratory tract infection, urinary tract infection, bacterial urinary tract infection, meningitis aseptic
Maltese: Sinusite kronika, infezzjoni fungali, infezzjoni, infezzjoni tal-kliewi, sinusite, infezzjoni fil-parti ta' fuq tas-sistema respiratorja, infezzjoni fis-sistema ta' l-awrina, infezzjoni batterjoloġika fis-sistema ta' l-awrina, meninġite asettika
English: Patients who suffer from a rare condition characterized by slow progressive asymmetrical weakness of limbs without sensory loss (multifocal motor neuropathy, MMN).
Maltese: Pazjenti li jbatu minn kundizzjoni rari kkaratterizzata minn dgħufija tad-dirgħajn/riġlejn assimetrika progressiva mingħajr telf sensorjali (newropatija multifokali tal-moviment, MMN).
English: Transfusion-related acute lung injury
Maltese: Ferita akuta fil-pulmun relatata mat-trasfużjoni
English: How to store KIOVIG
Maltese: KIOVIG huwa użat għal
English: 0.2-0.4 g/kg every 3-4 weeks to obtain IgG trough level above 5g/l
Maltese: 0.2-0.4 g/kg kull 3-4 ġimgħat biex jinkiseb livell minimu ta' IgC ta' aktar minn 5 g/l
English: Chronic inflammatory demyelinating polyneuropathy (CIDP)
Maltese: Polinewropatija bi ħsara fil-majlin infjammatorja kronika (CIDP - chronic inflammatory demyelinating polyneuropathy)
English: Dizziness, migraine, paresthesia, hypoesthesia
Maltese: Sturdament, emigranja, parestesija, ipoestesija
English: For further precautions for use see section 4.4.
Maltese: Għal prekawzjonijiet addizzjonali dwar l-użu ara sezzjoni 4.4.
English: Chills, edema, influenza-like illness, chest discomfort, chest pain, asthenia, malaise, rigors
Maltese: Tertir ta' bard, edema, marda simili għall-influwenza, skonfort fis-sider, uġigħ fis-sider, astenja, tħossok ma tiflaħx, tertir
English: The recommended dose is 0.2-0.4 g/kg every three to four weeks.
Maltese: Id doża rakkomandata hi ta' 0.2-0.4 g/kg kull tlieta sa erba' ġimgħat.
English: Patients with a disease which results in multiple inflammations of several organs of the body (Kawasaki disease).
Maltese: Pazjenti b'marda li tirriżulta f'infjammazzjonijiet multipli ta' bosta organi tal-ġisem (il-marda ta' Kawasaki)
English: • If you have already received KIOVIG previously and received the last treatment recently, then you will only be observed during the infusion and for at least 20 minutes after your infusion.
Maltese: • Jekk inti diġà rċevejt KIOVIG qabel u rċevejt l-aħħar trattament dan l-aħħar, inti ser tiġi osservat/a biss matul l-infużjoni u għal mill-inqas 20 minuta wara l-infużjoni tiegħek.
English: The dose required to achieve a trough level of 5-6 g/L is of the order of 0.2-0.8 g/kg/month.
Maltese: Id-doża meħtieġa biex jintlaħaq livell minimu ta' 5-6 g/L hi ta' 0.2-0.8 g/kg/xahar.
English: Haemolytic anaemia can develop subsequent to IVIg therapy due to enhanced red blood cells (RBC) sequestration.
Maltese: Anemija emolitika tista' tiżviluppa wara terapija b'IVIg minħabba sekwestrazzjoni mtejba ta' ċelluli tad-demm ħomor (RBC).
English: The same indications, dose and frequency of infusion as for adults apply for children and adolescents (age 0 to 18).
Maltese: L-istess indikazzjonijiet, doża u frekwenza ta' infużjoni bħal dawk tal-adulti, japplikaw għat-tfal u adolexxenti (minn 0 sa 18-il sena).
English: No dose adjustment unless clinically warranted, see section 4.4.
Maltese: L-ebda aġġustament fid-doża sakemm ma jkunx klinikament iġġustifikat, ara sezzjoni 4.4.
English: These include acute renal failure, acute tubular necrosis, proximal tubular nephropathy and osmotic nephrosis.
Maltese: Dawn jinkludu insuffiċjenza akuta tal-kliewi, nekrosi tubulari akuta, nefropatija tubulari prossimali u nefrosi osmotika.
English: Hyperproteinemia, increased serum viscosity and subsequent relative pseudohyponatremia may occur in patients receiving IVIg therapy.
Maltese: Iperproteinemija, żieda fil-viskożità tas-serum u psewdoiponatremija relattiva sussegwenti jistgħu jseħħu f'pazjenti li jkunu qed jirċievu terapija b'IVIg.
English: Patients who suffer from chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
Maltese: Pazjenti li jbatu minn poliradikulonewropatija bi ħsara fil-majlin infjammatorja kronika (CIDPchronic inflammatory demyelinating polyradiculoneuropathy).
English: Cases of acute renal failure have been reported in patients receiving IVIg therapy.
Maltese: Każijiet ta' insuffiċjenza akuta tal-kliewi ġew irrapportati f'pazjenti li jirċievu terapija b'IVIg.
English: Caution should be exercised in prescribing and infusion of IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events (such as a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, hypertension, use of estrogens, diabetes mellitus and a history of vascular disease or thrombotic episodes, patients with acquired or inherited thrombophilic disorders, hypercoagulable disorders, patients with prolonged periods of immobilisation, severely hypovolaemic patients, patients with diseases which increase blood viscosity, patients with indwelling vascular catheters and patients with high dose and rapid infusion).
Maltese: Għandha tingħata attenzjoni meta tingħata preskrizzjoni għal IVIg u meta l-IVIg jingħata b'infużjoni f'pazjenti obeżi u f'pazjenti li diġa għandhom fatturi ta' riskju għal każijiet trombotiċi (bħal storja medika ta' aterosklerosi, fatturi multipli ta' riskju kardjovaskulari, età avvanzata, indeboliment fl-awtput kardijaku, pressjoni għolja, użu ta' estroġeni, dijabete mellitus u passat mediku ta' mard vaskulari jew episodji trombotiċi, disturbi ta' koagulazzjoni eċċessiva, pazjenti b'disturbi trombofiliċi akkwistati jew li ntirtu, pazjenti b'perijodi ta' immobilizzazzjoni, pazjenti ipovolemiċi serji, pazjenti b'mard li jżid il-viskożità tad-demm, pazjenti b'kateters vaskulari interni u pazjenti b'doża għolja u infużjoni mgħaġġla).
English: For example, if you have an immunoglobulin A deficiency, you may have antibodies against immunoglobulin A in your blood.
Maltese: Dan jista' jseħħ b'mod partikolari jekk inti tbati minn defiċjenza ta' l-immunoglobulina A.
English: If well tolerated (see section 4.4), the rate of administration may gradually be increased to a maximum of 6 ml/kg BW/hr.
Maltese: Jekk din tiġi ttollerata sewwa (ara sezzjoni 4.4), ir-rata ta' amministrazzjoni tista', bil-mod il-mod tiżdied għal massimu ta' 6 ml/kg BW/siegħa.
English: The measures taken for the manufacture of KIOVIG are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus and parvovirus B19.
Maltese: Il-miżuri meħudin għall-manifattura ta' KIOVIG huma meqjusin effettivi għal viri enveloped bħal vajrus ta' l-immunodefiċjenza umana (HIV), vajrus ta' l-epatite B u vajrus ta' l-epatite Ċ, u għall-vajrus ta' l-epatite A mhux enveloped u parvovirus B19.
English: Certain severe adverse reactions (e.g. headache, flushing, chills, myalgia, wheezing, tachycardia, lower back pain, nausea, and hypotension) may be related to the rate of infusion.
Maltese: Ċerti reazzjonijiet avversi severi (eż. uġigħ ta' ras, fwawar, tertir ta' bard, majalġja, tħarħir, takikardija, uġigħ fil-parti t'isfel tad-dahar, dardir, u pressjoni baxxa) jistgħu jkunu relatati mar-rata ta' infużjoni.
English: In most cases, risk factors have been identified, such as pre-existing renal insufficiency, diabetes mellitus, hypovolaemia, overweight, concomitant nephrotoxic medicinal products, age over 65, sepsis, hyperviscosity or paraproteinemia.
Maltese: Fil-biċċa l-kbira tal-każijiet, il-fatturi ta' riskju ġew identifikati, bħal insuffiċjenza renali pre-eżistenti, dijabete mellitus, ipovolemja, piż żejjed, prodotti mediċinali nefrotossiċi li jkunu qed jingħataw fl-istess ħin, età akbar minn 65 sena, sepsis, viskożità eċċessiva jew paraproteinimja
English: starting dose: 2 g/kg maintenance dose: 1 g/kg or 2 g/kg given over 2-5 days every 2-4 weeks or every 4-8 weeks over 2-5 days d = day
Maltese: 1 g/kg jew 2 g/kg mogħtija fuq 2-5 ijiem kull 2-4 ġimgħat jew kull 4-8 ġimgħat fuq 2-5 ijiem
English: TRALI is a potentially lifethreatening condition requiring immediate intensive-care-unit management.
Maltese: TRALI hija kondizzjoni potenzjalment ta' periklu għall-ħajja li teħtieġ ġestjoni immedjata f'unità ta' kura intensiva.
English: Certain adverse reactions may occur more frequently
Maltese: Ċerti reazzjonijiet avversi jistgħu jseħħu aktar frekwenti
English: Pack size: 1 vial
Maltese: Kull 3 ġimgħat fuq 1-2 jiem
English: Primary immune thrombocytopenia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Clinical data obtained from a limited number of patients also indicate that adult PID patients may tolerate an infusion rate of up to 8 ml/kg BW/hr.
Maltese: Informazzjoni klinika miksuba minn numru limitat ta' pazjenti tindika wkoll li pazjenti adulti b'PID jista' jkun li jittolleraw rata ta' infużjoni ta' mhux aktar minn 8 ml/kg BW/siegħa.
English: • The other ingredients (excipients) are glycine and water for injections.
Maltese: • Is-sustanzi l-oħra (eċċipjenti) huma glycine u ilma għall-injezzjonijiet.
English: • You will be carefully observed during the infusion period with KIOVIG to make sure that you do not suffer a reaction.
Maltese: • Inti se tiġi osservat/a b'attenzjoni matul il-perijodu ta' infużjoni b'KIOVIG sabiex jiġi aċċertat li inti ma ssofrix reazzjoni.
English: There is reassuring clinical experience regarding the lack of hepatitis A or Parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
Maltese: B19 permezz ta' immunoglobulini u huwa stmat ukoll li l-kontenut ta' antikorpi jagħmel kontribuzzjoni importanti għas-sigurtà virali.
English: Each vial of 10 ml contains: 1 g of human normal immunoglobulin Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin Each vial of 50 ml contains: 5 g of human normal immunoglobulin Each vial of 100 ml contains: 10 g of human normal immunoglobulin Each vial of 200 ml contains: 20 g of human normal immunoglobulin Each vial of 300 ml contains: 30 g of human normal immunoglobulin
Maltese: Parametri farmakokinetiċi għal KIOVIG ġew stabbiliti fiż-żewġ studji kliniċi li saru fl-Ewropa u l-Istati Uniti f'pazjenti b'PID.F'dawn l-istudji, total ta' 83 individwu ta' sentejn jew akbar ġew trattati b'dożi ta' 300 sa 600 mg/kg piż tal-ġisem kull 21 sa 28 jum għal 6 sa 12-il xahar.Il-half life medjana ta' IgG wara l-għoti ta' KIOVIG kienet ta' 32.5 ġranet.
English: Treatment of patients who do not have sufficient antibodies (replacement therapy).
Maltese: Trattament ta' pazjenti li m'għandhomx biżżejjed antikorpi (terapija ta' sostituzzjoni).
English: Immunoglobulins are normal constituents of the human body.
Maltese: L-immunoglobulini huma kostitwenti normali tal-ġisem uman.
English: Coombs direct test positive, oxygen saturation decreased
Maltese: Test dirett ta' Coombs b'riżultat pożittiv, tnaqqis fis-saturazzjoni tal-ossiġnu
English: • Do not store above 25°C.
Maltese: • Taħżinx f'temperatura 'l fuq minn 25 C.
English: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
Maltese: Poliradikulonewropatija bi ħsara filmajlin infjammatorja kronika (CIDP)
English: Diarrhoea, vomiting, abdominal pain, dyspepsia
Maltese: Dijarea, rimettar, uġigħ addominali, dispepsja
English: Table 2 Post-Marketing Adverse Reactions (ARs)
Maltese: Tabella 2 Reazzjonijiet Avversi (ARs) ta' Wara t-Tqegħid fis-Suq Sistema tal-Klassifika tal-Organi (SOC) fid-database MedDRA
English: All other patients should be observed for at least 20 minutes after administration.
Maltese: Il-pazjenti l-oħra kollha għandhom jiġu osservati għal mill-inqas 20 minuta wara li jingħata l-prodott.
English: • in patients with an untreated infection or underlying chronic inflammation.
Maltese: • f'pazjenti b'infezzjoni mhux ittrattata jew infjammazzjoni kronika sottostanti.
English: Kawasaki Disease
Maltese: Il-Marda ta' Kawasaki
English: 1 g/kg over 1-2 consecutive days every 3 weeks.
Maltese: 1 g/kg fuq 1-2 jiem konsekuttivi kull 3 ġimgħat.
English: The syndrome usually begins within several hours to 2 days following IVIg treatment.
Maltese: Is-sindrome normalment jibda fi żmien diversi sigħat sa jumejn wara l-kura b'IVIg.
English: Gait disturbance,
Maltese: Oġġett mhux imwaħħal fil-ġogi,
English: Store between 15°C - 25°C.
Maltese: Aħżen f'temperatura bejn 15°C - 25°C.
English: PharmaCell Cell Manufacturing Facility B.V., Urmonderbaan 20B, 6167 RD Geleen, Netherlands
Maltese: PharmaCell Cell Manufacturing Facility B.V., Urmonderbaan 20B, 6167 RD Geleen, L-Olanda
English: Pt N° {patient number}
Maltese: JIS {JJ xahar SSSS} fi {ħin} CET
English: ≥1/100 to <1/10
Maltese: Komuni ≥1/100 sa <1/10
English: This is called ‘autologous chondrocyte implantation' (ACI).
Maltese: Dan jissejjaħ ‘autologous chondrocyte implantation' (ACI).
English: ≥1/1,000 to <1/100
Maltese: Mhux komuni ≥1/1,000 sa <1/100
English: Do not expose to radioactive irradiation (X-rays).
Maltese: Tesponix għall-irradjazzjoni radjuattiva (X-rays).
English: 1 falcon tube with 1, 2 or 3 vials (x 0.4 ml)
Maltese: 1 tubu falcon b'1, 2 jew 3 kunjetti (x 0.4 ml)
English: Adverse reactions occurred in 78.4% of the patients over a 36-months postoperative follow-up period..
Maltese: Reazzjonijiet avversi seħħew fi 78.4% tal-pazjenti fuq perijodu ta' 36 xahar wara l-operazzjoni.
English: Trendelenburg's symptom
Maltese: Trendelenburg
English: Romeinse straat 12/2 3001 LEUVEN Belgium
Maltese: TiGenix N.V., Romeinse straat 12/2, 3001 Leuven, Il-Belġju
English: Frequencies are defined according to the following convention: 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).
Maltese: Il-frekwenzi huma definiti skont il-konvenzjoni li ġejja: 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).
English: Date of latest renewal: 22 August 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 5 t'Ottubru 2009 Data tal-aħħar tiġdid: 22 t'Awwissu 2014
English: Tendon disorder, Tendonitis
Maltese: Disturb tat-tendini, Tendinite
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) of the biological active substance(s) PharmaCell Cell Manufacturing Facility B.V.
Maltese: Isem u indirizz tal-manifattur(i) tas-sustanza(i) bijoloġika(ċi) attiva(i) PharmaCell Cell Manufacturing Facility B.V.
English: Reporting of side effect
Maltese: Effetti sekondarji possibbli
English: Limited clinical data on exposed pregnancies are available.
Maltese: Hemm dejta klinika limitata fuq tqaliet esposti..
English: In the ChondroCelect group 77% of patients had a medial and 23% a lateral condyle defect.
Maltese: ChondroCelect, 77% tal-pazjenti kellhom difett fil-kondil tan-nofs u 23% fil-kondil laterali.
English: Conventional pharmacodynamic studies for ChondroCelect have not been performed.
Maltese: Ma sarux studji farmakodinamiċi konvenzjonali għal ChondroCelect.
English: Wound infection, Erysipelas, Erythema,
Maltese: Artroskopija Infezzjoni fil-ferita, Erisipelas, Eritema,
English: The recommended dose of ChondroCelect is 0.8 to 1 million cells/cm², corresponding with 80 to 100 microlitre of product/cm² of defect.
Maltese: Id-doża rrakkomandata ta' ChondroCelect hija 0.8 sa 1 miljun ċellola/cm², li tikkorrispondi għal 80 sa 100 mikrolitru ta'
English: Patient number (Pt N°) {patient number} Patient initials (Pt initials) {patient initials}
Maltese: Numru tal-pazjent (Nru Paz.) {numru tal-pazjent} Inizjali tal-pazjent (Inizjali Paz) {inizjali tal-pazjent}
English: Pain in extremity, Peripheral neuropathy, Syncope,
Maltese: Uġigħ fl-estremità, Newropatija periferali, Sinkope,
English: The marketing authorisation holder shall submit the periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Atrophy,
Maltese: Kondromalaċija,
English: Arthritis,
Maltese: Artrofibrożi,
English: Common side effects ( affects in 1 to 10 users in 100) include: restriction of knee motion (arthrofibrosis, decreased joint range of motion, decreased mobility), excessive amount of joint fluid in the joint (joint effusion), joint lock, joint inflammation (arthritis, bursitis, synovitis), cavity filled with fluid in the knee (bone cyst, synovial cyst), bone swelling, cartilage disorder (chondropathy), benign bony growth (exostosis), blood in a joint (haemarthrosis), joint instability, joint stiffness, loose body in joint, weakening of muscle (muscle atrophy, Trendelenburg's sign), degenerative joint disorder (osteoarthritis), tendon disorder, inflammation of the tendon (tendonitis), impaired healing, treatment failure, gait disturbance, implant site hypersensitivity, peripheral edema, fever (pyrexia), postoperative wound complication (wound site reaction) ,wound infection (including erysipelas), redness, scar overgrowth, itching, scar pain, wound loosening, wound secretion loosening of the graft or membrane (graft complication, graft delamination), injury (cartilage injury, joint injury), blood clot in the deep vein of the leg (deep vein thrombosis), large bruise (haematoma), superficial vein inflammation (phlebitis), nausea, pain or nerve disorder (pain in extremity, peripheral neuropathy, complex regional pain syndrome, autonomic neuropathy), syncope, apnea, arthroscopy.
Maltese: indeboliment tal-muskolu (atrofija tal-muskolu, sinjal ta' Trendelenburg), disturb deġenerattiv tal-ġogi (osteoartrite), disturb fl-għeruq, infjammazzjoni tal-għerq (tendonite), indeboliment talfejqan, falliment tat-trattament, disturb fil-mixja, sensittività eċċessiva fis-sit tal-impjant, edema periferali, deni, kumplikazzjoni fil-ferita wara l-operazzjoni (reazzjoni fis-sit tal-ferita), infezzjoni tal-ferita (inkluż erisipelas), ħmura, tkabbir żejjed ta' ċikatriċi, ħakk, uġigħ fiċ-ċikatriċi, tinħall il ferita, tnixxija mill-ferita, jinħall it-trapjant jew il-membrana (kumplikazzjoni fit-trapjant, delamination tat-trapjant), ferita fil-qarquċa jew fil-ġogi, embolu fil-vina fonda tas-sieq (trombożi fil-vina fonda), tbenġila kbira (ematoma), infjammazzjoni fil-vini superfiċjali (flebite), dardir,
English: EXPIRY DATE EXP {DD month YYYY} at {hours} CET SPECIAL STORAGE CONDITIONS Store between 15°C - 25°C.
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen f'temperatura bejn 15°C - 25°C.
English: In a randomized, controlled study in the target population, 51 patients were treated with ChondroCelect.
Maltese: Fi studju randomizzat, ikkontrollat fil-popolazzjoni fil-mira, 51 pazjent ġew ittrattati b'ChondroCelect.
English: Dulbecco's Modified Eagles Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates).
Maltese: Dulbecco's Modified Eagles Medium (DMEM) (li fih aċidi amminiċi, vitamini, tipi ta' melħ u
English: Patients with less than 3 years since onset of symptoms (n=27 in the ChondroCelect arm and n=32 in the microfracture arm) benefited most from ChondroCelect.
Maltese: Il-pazjenti b'inqas minn 3 snin mill-bidu tas-sintomi (n=27 fil-grupp ta' ChondroCelect u n=32 fil-grupp tal-mikrofrattura)
English: More patients in the ChondroCelect treatment group, compared to patients in the microfracture group, had undergone previous knee surgery (88% versus 77%).
Maltese: Numru akbar ta' pazjenti fil-grupp tat-trattament b'ChondroCelect, meta pparagunat mal-pazjenti fil-grupp tal mikrofrattura, kienu għamlu operazzjoni preċedenti fl-irkoppa (88% kontra 77%).
English: Your surgeon will give you more information.
Maltese: Il-kirurgu tiegħek jagħtik aktar informazzjoni.
English: When a collagen membrane was used to seal the lesion site after application of ChondroCelect, the incidence of cartilage hypertrophy was reported to be 1.8% compared to 25% in the randomized, controlled trial alone.
Maltese: Meta ntużat membrana tal-collagen biex tissiġilla s-sit tal-leżjoni wara l-applikazzjoni ta' ChondroCelect, l-inċidenza ta' ipertrofija tal-qarquċa ġiet irrappurtata għal 1.8% meta pparagunata ma' 25% fil-prova randomizzata, ikkontrollata, waħidha.
English: After the 5 year follow-up period, 37 patients were evaluated in the ChondroCelect arm and 40 in the microfracture arm.
Maltese: Wara perijodu ta' sorveljanza ta' ħames snin, 37 pazjent kienu evalwati fil-grupp ta' ChondroCelect u 40 fil-grupp ta' mikrofrattura.
English: There are no data on possible effects of ChondroCelect treatment on fertility.
Maltese: M'hemmx dejta dwar l-effetti possibbli ta' kura b'ChondroCelect fuq il-fertilità.
English: Each vial contains 0.4 ml of autologous human cartilage cells suspension and is closed with a chlorobutyl stopper and aluminium seal.
Maltese: Kull kunjett fih 0.4 ml ta' suspensjoni ta' ċelloli awtologi ta' qarquċa umana u huwa magħluq b'tapp tal-chlorobutyl u siġill tal-aluminju.
English: ChondroCelect 10,000 cells/microlitre implantation suspension Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Maltese: Ċelloli awtologi vijabbli karatterizzati tal-qarquċa mwessgħin ex vivo li jesprimu proteini markers
English: In clinical studies with ChondroCelect a periosteal flap was used as a biological membrane.
Maltese: Fi studji kliniċi b'ChondroCelect intużat falda periosteali bħala membrana bijoloġika.
English: Patients with patellofemoral cartilage lesion, OCD, depth of lesion >0.5 cm, prior meniscal transplant, prior mosaicplasty and prior microfracture within the last 12 month were excluded.
Maltese: Pazjenti ma ħadux sehem jekk kellhom leżjoni fil-qarquċa patellofemorali, OCD, fond tal-leżjoni >0.5 cm, trapjant preċedenti tal-menisku, mosaicplasty preċedenti jew mikrofrattura preċedenti fl-aħħar 12-il xahar..
English: Impaired healing, Implant site hypersensitivity, Peripheral edema, Pyrexia
Maltese: Sensittività eċċessiva fil post tal-impjant, Edema periferali, Deni