FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the patient Vylaer Spiromax 160 micrograms/4.5 micrograms, inhalation powder
Maltese: Informazzjoni għall-pazjent Vylaer Spiromax 160 mikrogramma/4.5 mikrogrammi, trab li jittieħed man-nifs
English: Vylaer Spiromax 320 micrograms/9 micrograms inhalation powder
Maltese: Vylaer Spiromax 320 mikrogramma/9 mikrogrammi trab li jittieħed man-nifs
English: Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with Vylaer Spiromax.
Maltese: Ladarba s-sintomi tal-ażma jiġu kkontrollati, tista' tingħata kunsiderazzjoni sabiex gradwalment titnaqqas id-doża ta' Vylaer Spiromax.
English: Inhalation powder
Maltese: Disturbi gastro-intestinali
English: Vylaer Spiromax 160 micrograms / 4.5 micrograms inhalation powder
Maltese: Vylaer Spiromax 160 mikrogramma/4.5 mikrogrammi trab li jittieħed man-nifs.
English: Vylaer Spiromax is NOT indicated for use in children 12 years of age and younger or adolescents 13 to 17 years of age.
Maltese: Vylaer Spiromax MHUWIEX indikat għall-użu fi tfal, ta' 12-il sena jew iżgħar jew f'adolexxenti, ta' 13 sa 17-il sena.
English: Budesonide is excreted in breast milk.
Maltese: Budesonide hu eliminat fil-ħalib tas-sider tal-bniedem.
English: The most common adverse reactions are pharmacologically predictable adverse reactions of β2 adrenoceptor agonist therapy, such as tremor and palpitations.
Maltese: L-aktar reazzjonijiet avversi komuni huma r-reazzjonijiet avversi farmakoloġikament prevedibbli ta' terapija bl-agonisti tal-adrenoriċetturi β2, bħat-tregħid u l-palpitazzjonijiet.
English: The prophylactic use of Vylaer Spiromax, e.g. before exercise, has not been studied.
Maltese: L-użu profilattiku ta' Vylaer Spiromax, eż. qabel leżerċizzju, ma ġiex studjat.
English: Package leaflet: Information for the patient Vylaer Spiromax 320 micrograms/9 micrograms, inhalation powder
Maltese: Informazzjoni għall-pazjent Vylaer Spiromax 320 mikrogramma/9 mikrogrammi, trab li jittieħed man-nifs
English: How to store Vylaer Spiromax
Maltese: Jekk tinsa tuża Vylaer Spiromax
English: Vylaer Spiromax is an inhalation powder.
Maltese: Tużax Vylaer Spiromax biex tittratta dawn is-sintomi tal-ażma.
English: Vylaer Spiromax should be used correctly in order to achieve effective treatment.
Maltese: Vylaer Spiromax jista' jiġi ordnat f'żewġ modi differenti.
English: • Do not use this medicine after the expiry date which is stated on the carton or on the label of your inhaler after EXP.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna jew fuq it-tikketta talinalatur tiegħek wara JIS/EXP.
English: Do not use Vylaer Spiromax if:
Maltese: Għal Vylaer Spiromax hemm żewġ approċċi differenti ta' kura:
English: If either of these symptoms occur, stop using Vylaer Spiromax straightaway and use your ‘reliever inhaler'.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali imniżżla f'Appendiċi V.
English: Candida infections in the oropharynx, pneumonia (in COPD patients)
Maltese: Infezzjonijiet b'candida fl-orofarinġi, Pulmonite (f'pazjenti b'COPD)
English: Budesonide has a high systemic clearance (approximately 1.2 L/min) and the plasma elimination half-life after i.v.
Maltese: Budesonide għandu tneħħija sistemika għolja (madwar 1.2 L/min) u l-half-life tal-eliminazzjoni mill-plażma wara għoti fil-vini hija bħala medja ta' 4 sigħat.
English: If these effects occur, they are usually mild and usually disappear as you continue to use Vylaer Spiromax.
Maltese: Jekk iseħħu dawn l-effetti, dawn ġeneralment ikunu ħfief u ġeneralment jitilqu malli tkompli tuża Vylaer Spiromax.
English: If either of these symptoms occur, stop using Vylaer Spiromax straightaway and use your 'reliever inhaler' Contact your doctor immediately as you may need to have your treatment changed.
Maltese: Il-qawwiet aktar baxxi ta' Vylaer Spiromax huma disponibbli għar-reġim tat-terapija ta' manteniment u ta' solljiev.
English: Vylaer Spiromax 320 micrograms/9 micrograms should be used as maintenance therapy only.
Maltese: Vylaer Spiromax 320 mikrogramma/9.0 mikrogrammi għandu jintuża bħala terapija ta' manteniment biss.
English: Asthma Using Vylaer Spiromax and a separate ‘reliever inhaler'
Maltese: Użu ta' Vylaer Spiromax u inalatur ta' solljiev separat'.
English: In pharmacokinetic studies with and without a charcoal blockage, Vylaer Spiromax was evaluated by comparing it with an alternative authorised fixed-dose combination inhaled product containing the same active substances, budesonide and formoterol and has been shown to be equivalent in both systemic exposure (safety) and pulmonary deposition (efficacy).
Maltese: Mekkaniżmu ta' azzjoni u effetti farmakodinamiċi Vylaer Spiromax fih formoterol u budesonide, li għandhom modi ta' azzjoni differenti u juru effetti addittivi f'termini tat-tnaqqis fit-taħrix tal-ażma.
English: • Use within 6 months of removing from the foil wrapping.
Maltese: • Uġigħ ħafif fil-gerżuma, sogħla u vuċi maħnuqa.
English: Vylaer Spiromax pharmacokinetic profile
Maltese: Uża Vylaer Spiromax tiegħek kuljum.
English: During transfer from oral therapy to a budesonide/formoterol fumarate fixed-dose combination therapy, a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain.
Maltese: Matul it-trasferiment minn terapija orali għal terapija kombinata b'doża fissa ta' budesonide/formoterol fumarate, se tkun esperjenzata azzjoni ġeneralment aktar baxxa tal-isterojdi sistemiċi li tista' twassal għat-tfaċċar ta' sintomi allerġiċi jew artritiċi bħal rinite, ekżema u wġigħ filmuskoli u fil-ġogi.
English: EU/1/15/1050/001 IONSYS 40 µg/dose
Maltese: EU/1/15/1050/001 IONSYS 40 µg/doża
English: Transdermal use sachet (nylon/alu/copoly mer of polyethylene and polymethacrylic acid)
Maltese: Użu minn fuq il ġilda qartas (nylon/alu/copoly mer ta' polyethylene u polymethacrylic acid)
English: Strength
Maltese: Kontenut
English: 80 doses per transdermal system
Maltese: 80 doża għal kull sistema li tgħaddi l-mediċina minn ġol-ġilda
English: Pack size
Maltese: Għamla
English: 6 transdermal systems
Maltese: 6 sistemi li jgħaddu l-mediċina minn ġol-ġilda
English: • Liver function tests.
Maltese: • Testijiet tal-funzjoni tal-fwied.
English: • Product information (Summary of Product Characteristics (SPC) and Package Leaflet)
Maltese: • Informazzjoni fuq il-Prodott (Sommarju tal-Karatteristiċi tal-Prodott (SPC) u Fuljett tal
English: • Adverse drug reaction reporting forms
Maltese: • Formoli biex tirraporta effetti avversi ta' mediċina
English: • That Volibris is potentially hepatotoxic o Contraindication in patients with severe hepatic impairment (with or without cirrhosis) and in patients with baseline values of hepatic aminotransferases (AST and/or ALT) > 3X ULN.
Maltese: • Li Volibris huwa potenzjalment tossiku għall-fwied o Mhux indikat f'pazjenti b'indeboliment sever tal-fwied (bi jew mingħajr ċirrożi) u f'pazjenti li għandhom il-valuri l-linja bażi ta'aminotransferases tal-fwied (AST u/jew ALT)
English: Physician checklist
Maltese: Informazzjoni għall-pazjent
English: • Pregnancy reporting forms
Maltese: • Formoli biex tirraporta waqt it-tqala
English: The effect of Volibris on human testicular function and male fertility is not known.
Maltese: Mhux magħruf l-effett ta' Volibris fuq il-funzjoni tat-testikola umana u l-fertilita' ta' l-uman maskil.
English: • That hypersensitivity reactions, although uncommon, have been reported with Volibris.
Maltese: • Li ġew irrapurtati reazzjonijiet ta' sensittività eċċessiva, għalkemm mhux komuni, b'Volibris.
English: • That Volibris is teratogenic o Volibris is contraindicated in pregnancy and in women of child bearing potential who are not using reliable contraception.
Maltese: • Li Volibris huwa teratoġeniku o Volibris huwa kontraindikat fit-tqala u f'nisa li jista' jkollhom it-tfal u li ma humiex qegħdin jużaw kontraċezzjoni ta' min joqgħod fuqha.
English: o The need to provide patients with the appropriate information booklet(s) and patient reminder card. o Should consider monthly prescription of 30 day supply to ensure that patients and key test results are reviewed prior to further prescription.
Maltese: o Li għanda tkun ikkonsidrata riċetta ta' xahar għal provediment ta' 30 ġurnata biex ikun assigurat li l-pazjenti u r-riżultati ta' testijiet importanti ikunu ċċekkjati qabel riċetti oħra jingħataw.
English: The Member States shall agree the details of a controlled distribution system with the MAH according to national regulations and healthcare systems and ensure that it is implemented nationally so that prior to prescribing (and at the discretion of the Member State, dispensing) all health care professionals who intend to prescribe (and where appropriate, dispense) Volibris have been provided with the following:
Maltese: L-Istati Membri għandhom jaqblu fuq id-dettalji ta'sistema ta' distribuzzjoni kontrollata ma' l-MAH skond ir-regolamenti nazzjonali u sistemi ta' kura tas-saħħa u jassiguraw li tkun implimentata fuq livell nazzjonali biex qabel ma jippreskrivuha (u fuq id-diskrezzjoni ta' lIstat Membru, jagħtu l-mediċina) il-professjonisti kollha fil-qasam tas-saħħa li jkollhom lintenzjoni li jippreskrievu (u fejn ikun xieraq, jagħtu l-mediċina) Volibris jkollhom dan li ġej:
English: • Healthcare professional information regarding Volibris
Maltese: • Informazzjoni fuq Volibris għall-professjonisti fil-qasam tas-saħħa
English: • That treatment with Volibris often causes a decrease in haemoglobin and haematocrit o Initiation of Volibris is not recommended for patients with clinically significant anaemia.
Maltese: • Il-kura b'Volibris ħafna drabi tikkawża nuqqas fl-emoglobina u l-ematokrit o M'huwiex rakkomandat bidu ta' kura b'Volibris f'pazjenti b'anemija klinikament sinifikanti.
English: • That chronic administration of Volibris in animals has been linked to testicular tubular atrophy and impaired fertility.
Maltese: • L-għoti kroniku ta' Volibris fl-annimali ġie assoċjat ma' atrofija tat-tubi tat-testikoli u nuqqas ta' fertilita'.
English: Patient information The information for patients should include the following information:
Maltese: L-informazzjoni għall-pazjenti għandha tinkludi l-informazzjoni li ġejja:
English: − The physician prescribing her contraception that she is taking Volibris
Maltese: − It-tabib li jippreskrivi l-kontraċezzjoni li qed tieħu Volibris
English: • That treatment with Volibris causes peripheral oedema and fluid retention o If a patient develops clinically significant peripheral oedema, with or without associated weight gain, carry out further evaluation to determine the cause and if appropriate consider discontinuation of Volibris.
Maltese: • Il-kura b'Volibris tagħmel edema periferali u ritenzjoni ta' fluwidu o Jekk pazjent jiżviluppa edema periferali klinikament sinifikanti bi jew mingħajr żieda assoċjata fil-piż, għamel aktar evalwazzjoni biex issib il-kawża u jekk ikun hemm bżonn ikkunsidra li twaqqaf Volibris.
English: o Discontinuation of ambrisentan therapy if patients develop sustained, unexplained clinically significant ALT and/or AST elevation or if ALT and/or AST elevation is accompanied by signs or symptoms of hepatic injury (e.g. jaundice).
Maltese: o Titwaqqaf il-kura b'ambrisentan jekk il-pazjenti jiżviluppaw żieda sostenuta, mhux spjegabbli u klinikament sinifikanti ta' ALT u/jew AST, jew jekk żieda f'ALT u/jew AST hija akkumpanjata b'sinjali jew sintomi ta' ħsara fil-fwied (e.ż. suffejra).
English: o Hepatic aminotransferases (ALT and/or AST) should be evaluated prior to initiation of ambrisentan.
Maltese: o Għalhekk għandhom jiġu evalwati l-aminotransferases tal-fwied (ALT u/jew AST) qabel jinbeda ambrisentan.
English: • That because of the potential for liver injury and anaemia, patients should have regular blood tests and also tell their doctor if experiencing any symptoms of liver injury.
Maltese: • Li minħabba il-possibilita' ta' ħsara fil-fwied u anemija, il-pazjenti għandu jkollhom testijiet regolari tad-demm u jgħidu lit-tabib tagħhom ukoll jekk jesperjenzaw xi sintomi ta' ħsara talfwied.
English: The healthcare professional information regarding Volibris should contain the following key elements:
Maltese: L-informazzjoni fuq Volibris għall-professjonisti fil-qasam tas-saħħa għandu jkollha dawn l-elementi kruċjali li ġejjin:
English: Microfracture N=72
Maltese: Mikrofrattura N=72
English: Matrix: 1/2
Maltese: Matriċi: 1/2
English: C-reactive protein increased
Maltese: Żieda fil-proteina C-reactive
English: DK-1256 Copenhagen K Denmark
Maltese: DK-1256 Kopenhagen K Id-Danimarka
English: 6 days.
Maltese: 6 ijiem.
English: • Thromboembolic events
Maltese: • Avvenimenti tromboemboliċi
English: Table 1: KOOS Response Rate*: Full Analysis Set n (%)
Maltese: Tabella 1: Rata ta' Rispons skont KOOS*: Sett ta' Analiżi Sħiħa n (%)
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: Ilfrekwenzi 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: Marketing Authorisation Holder Vericel Denmark ApS, Amaliegade 10, DK-1256 Copenhagen K, Denmark
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Vericel Denmark ApS, Amaliegade 10, DK-1256 Kopenhagen K, Id-Danimarka
English: DK - 2770 Kastrup
Maltese: DK - 2770 Kastrup Id-Danimarka
English: Infective arthritis Wound infection Localised infection
Maltese: Artrite infettiva Infezzjoni fil-ferita Infezzjoni lokalizzata
English: These include:
Maltese: JIS:
English: Dulbecco's Modified Eagles Medium (DMEM; Calcium Chloride anhydrous, Ferric Nitrate.9H2O, Potassium Chloride, Magnesium Sulphate anhydrous, Sodium Chloride, Sodium Bicarbonate, Potassium Phosphate Monobasic.H2O, D-Glucose, L-Arginine.HCl, L-Cystine.2HCl, L-Glutamine, Glycine, L-Histidine.HCl.H2O, L-Isoleucine, L-Leucine, L-Lysine.HCl, L-Methionine, L-Phenylalanine, L-Serine, L-Threonine, L-Tryptophan, L-Tyrosine.2Na.2H2O, L-Valine, D-Calcium Pantothenate, Choline Chloride, Folic Acid, i-Inositol, Niacinamide, Riboflavin, Thiamine.HCl, Pyridoxine.HCl) with 4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES) adjusted for pH with HCl or NaOH and osmality with NaCl.
Maltese: Dulbecco's Modified Eagles Medium (DMEM; Calcium Chloride anhydrous, Ferric Nitrate.9H2O, Potassium Chloride, Magnesium Sulphate anhydrous, Sodium Chloride, Sodium Bicarbonate, Potassium Phosphate Monobasic.H2O, D-Glucose, L-Arginine.HCl, L-Cystine.2HCl, L-Glutamine, Glycine, L-Histidine.HCl.H2O, L-Isoleucine, L-Leucine, L-Lysine.HCl, L-Methionine, LPhenylalanine, L-Serine, L-Threonine, L-Tryptophan, L-Tyrosine.2Na.
English: System organ class
Maltese: Klassi tas-Sistemi u talOrgani
English: The implantation should be followed by an appropriate rehabilitation schedule (see section 4.4).
Maltese: L-impjantazzjoni għandha tiġi segwita minn skeda adegwata ta' riabilitazzjoni (ara sezzjoni 4.4).
English: Related to MACI:
Maltese: Relatati ma' MACI:
English: Dulbecco's Modified Eagles Medium (DMEM) with 4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES)
Maltese: Dulbecco's Modified Eagles Medium (DMEM) b'4-(2-Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES)
English: EXP:
Maltese: Lott:
English: • have a growth plate of the knee that is not fully closed.
Maltese: • għandek growth plate tal-irkoppa li ma ngħalqitx kompletament.
English: Genzyme Biosurgery ApS, Oliefabriksvej 51B, DK-2770 Kastrup, Denmark This leaflet was last revised in MM/YYYY
Maltese: Manifattur Genzyme Biosurgery ApS, Oliefabriksvej 51B, DK-2770
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 June 2013
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 ta' Ġunju, 2013
English: The median age of patients was 34 to 35 years (age range: 18 to 54), and the mean body mass index was 26.
Maltese: L-età medjana tal-pazjenti kienet minn 34 sa 35 sena (medda tal-età: 18 sa 54), u l-medja tal-indiċi tal-massa tal-ġisem kienet ta' 26.
English: 1 to 2 implantation matrices.
Maltese: Matriċi 1 sa 2 għall-impjantazzjoni.
English: For information on preparation and handling of MACI, please refer to section 6.6.
Maltese: Għal informazzjoni dwar il-preparazzjoni u l-immaniġġjar ta' MACI, jekk jogħġbok irreferi għal sezzjoni 6.6.
English: • The need to screen donors using patient questionnaires and laboratory tests for hepatitis C, hepatitis B, HIV and syphilis
Maltese: • Il-ħtieġa li donaturi jiġu skrinjati permezz ta' kwestjonarji għall-pazjenti u testijiet tallaboratorju għall-epatite Ċ, epatite B, HIV u sifilide
English: Patient: (name - date of birth {DD.Mmm.YYYY}) Biopsy: {biopsy number} Matrix: 1/1
Maltese: {numru tal-bijopsija} Matriċi: 1/1
English: MACI is shipped in custom-designed, sterile, sealed, clear polystyrene dishes.
Maltese: MACI jiġi trasportat f'dixxijiet sterili, ssiġillati, tal-polystyrene trasparenti, iddisinjati apposta.
English: Biopsy: {biopsy number}
Maltese: {numru tal-bijopsija}
English: MACI is shipped following a validated rapid microbial sterility assay to determine absence of microbial growth.
Maltese: MACI jiġi kkunsinjat wara analiżi rapida validata ta' sterilità mikrobjali biex jiġi stabbilit li ma jkunx hemm tkabbir mikrobjali.
English: Store shipping box in an area below 37°C.
Maltese: Aħżen il-kaxxa li fih ikun ġie trasportat f'post f'temperatura taħt 37°C.
English: Your surgeon will organise the date for implantation.
Maltese: Il-kirurgu tiegħek se jorganizza d-data għall-impjantazzjoni.
English: 1 implantation matrix.
Maltese: Matriċi 1 għall-impjantazzjoni.
English: See responder rates in Table 1 below.
Maltese: Ara r-rati ta' dawk li rrispondew fit-Tabella 1 hawn taħt.
English: Lot: {lot number}
Maltese: {numru tal-lott }
English: A. LABELLING
Maltese: • Emartrożi
English: Risks involved with implantation of MACI:
Maltese: Riskji involuti bl-impjantazzjoni ta' MACI:
English: Other medicines and MACI
Maltese: Mediċini oħra u MACI
English: • Hypersensitivity to any of the excipients listed in section 6.1, or porcine products, or any residual component carried over from manufacture of MACI, including bovine serum, and gentamicin.
Maltese: • Sensittività eċċessiva għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1, jew għal prodotti tal-majjali, jew xi komponent residwu trasferit mill-manifattura ta' MACI, inkluż serum taċ-ċanga, u gentamicin.
English: • Symptomatic graft hypertrophy
Maltese: • Ipertrofija sintomatika tat-trapjant
English: The following important risks have been identified related to either MACI or peri-operative complications:
Maltese: Ir-riskji importanti li ġejjin ġew identifikati bħala relatati jew ma' MACI jew ma' komplikazzjonijiet wara l-operazzjoni:
English: There were no significant differences observed in the structural markers of cartilage repair between both treatments, as assessed by International Cartilage Repair Society (ICRS) II overall assessment histology scores of biopsies, and MRI defect fill scores.
Maltese: Ma kien hemm l-ebda differenza sinifikanti osservata fil-markaturi strutturali fittiswija tal-qarquċa bejn iż-żewġ kuri, kif evalwati mill-punteġġi globali tal-valutazzjoni tal-istoloġija ta' bijopsiji tal-International Cartilage Repair Society (ICRS) II, u mill-punteġġi tal-mili ta' difett fuq l-MRI.
English: Risks involved with arthrotomy or arthroscopy or MACI
Maltese: Riskji involuti b'artrotomija jew artroskopija jew b'MACI
English: Pharmacotherapeutic group: Other Medicines for Disorders of the Musculo-Skeletal system, ATC code: M09AX02
Maltese: Mediċini oħra għal Disturbi tas-Sistema Muskolu-Skeletrika, Kodiċi ATC:
English: Peri-operative complications related to surgical intervention of the knee:
Maltese: Kumplikazzjonijiet peri-operattivi relatati mal-intervent kirurġiku tal-irkoppa:
English: The other ingredients are Dulbecco's Modified Eagles Medium (DMEM) with 4-(2Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES).
Maltese: Is-sustanzi l-oħra huma Dulbecco's Modified Eagles Medium (DMEM) b'4-(2Hydroxyethyl)piperazine-1-ethanesulfonic acid sodium (HEPES).
English: Non-clinical in vitro investigations have shown that the collagen membrane is non-cytotoxic, nonmutagenic, non-reactive (short- and long-term implantation), non-sensitising, a negligible irritant, and non-toxic (acute systemic).
Maltese: Investigazzjonijiet mhux kliniċi in vitro urew li l-membrana tal-kollaġen mhijiex ċitotossika, mhijiex mutaġenika, mhijiex reattiva (impjantazzjoni fuq perjodu qasir jew fit-tul), mhijiex sensitizzanti, hija irritant negliġibbli, u mhux tossika (sistemika akuta).
English: For implantation.
Maltese: Għal impjantazzjoni.
English: Store below 37°C in the outer carton until ready to use.
Maltese: Aħżen f'temperatura taħt 37°C fil-kartuna ta' barra sakemm ikun lest għall-użu.
English: The use of MACI is not recommended in children and adolescents below 18 years.
Maltese: L-użu ta' MACI mhuwiex irrakkomandat fit-tfal u adolexxenti iżgħar minn 18-il sena.
English: • Graft delamination (complete or partial, possibly leading to loose bodies in the joint or graft failure)
Maltese: • Delaminazzjoni tat-trapjant (kompleta jew parzjali, li possibbilment twassal għal korpi maħlula fil-ġog jew falliment tat-trapjant)
English: The following rare side effects may affect up to 1 in 1,000 people:
Maltese: Dawn li ġejjin huma effetti sekondarji rari li jistgħu jaffettwaw sa persuna 1 minn kull 1,000:
English: Name and address of the manufacturer of the biological active substance Genzyme Biosurgery ApS
Maltese: Genzyme Biosurgery ApS
English: All surgical procedures carry a certain risk.
Maltese: Il-proċeduri kirurġiċi kollha jġorru ċertu riskju.
English: MACI 500,000 - 1,000,000 cells/cm implantation matrix Matrix applied characterised autologous cultured chondrocytes
Maltese: TAL-PRODOTT MEDIĊINALI MACI 500,000 - 1,000,000 ċellola/ċm Kondroċiti awtologi kulturati karatterizzati applikati f'matriċi
English: Each implant contains matrix applied characterised autologous cultured chondrocytes.
Maltese: Kull impjant fih kondroċiti awtologi kulturati karatterizzati applikati f'matriċi.
English: However as MACI will be implanted using invasive surgical techniques, it is not recommended during pregnancy.
Maltese: Madanakollu, peress li MACI sejjer jiġi impjantat permezz ta' tekniki kirurġiċi invażivi, huwa mhuwiex rakkomandat waqt ittqala.
English: Epinephrine or fibrin sealant (see section 4.5), applied sparingly directly to bleeding points, is a suitable haemostatic
Maltese: Epinephrine jew siġillant tal-fibrina (ara sezzjoni 4.5), applikat bil-qies direttament lill-punti fejn ikun hemm il-fsada, huwa sustanza emostatika xierqa.
English: MACI has been investigated in a parallel, randomised, open-label trial in 144 patients with Outerbridge Grade III or IV focal cartilage defects of the knee of 3-20 cm
Maltese: MACI ġie investigat fi prova parallela, każwali, b'tikketta miftuħa li fiha ħadu sehem 144 pazjent b'difetti fokali fil-qarquċa tal-irkoppa ta' 3-20 ċm2) tal-Grad III jew IV tal-klassifika
English: Risk factors for graft delamination can include but are not limited to poor patient selection, poor adherence to recommended surgical technique, failure to address concomitant pathologies, poor compliance with the rehabilitation protocol or post-operative trauma to the knee.
Maltese: Fatturi ta' riskju għal delaminazzjoni tat-trapjant jistgħu jinkludu imma mhumiex limitati għal għażla ħażina tal-pazjent, adeżjoni batuta mat-teknika kirurġika rakkomandata, nuqqas li jiġu indirizzati patoloġiji konkomittanti, nuqqas ta' konformità mal-protokoll ta' riabilitazzjoni jew trawma lillirkoppa wara l-operazzjoni.
English: When you receive MACI, you may experience side effects soon after the implantation.
Maltese: Meta tirċievi MACI, inti tista' tesperjenza effetti sekondarji immedjatament wara l-impjantazzjoni.