FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the available clinical data of parenteral amitriptyline administration to depressed patients as well as on pharmacokinetic parameters the recommended dosage is 50 - 150 mg/day, given in 1 to 3 ampoules daily.
Maltese: Abbażi tad-data klinika disponibbli dwar l-għoti parenterali ta' amitriptyline lil pazjenti dipressati kif ukoll dwar parametri farmakokinetiċi, id-dożaġġ rakkomandat huwa ta' 50 - 150 mg/jum, li jingħata f'1 sa 3 ampulli kuljum.
English: Taking into account current treatment guidelines and recent systematic reviews published in the literature, the CHMP endorsed an indication for amitriptyline in the treatment of major depressive disorder in adults.
Maltese: Wara li qies il-linji gwida ta' kura attwali u r-rieżamijiet sistematiċi riċenti ppubblikati fil-letteratura, is-CHMP approva indikazzjoni għal amitriptyline fil-kura ta' disturb dipressiv maġġuri fl-adulti.
English: Finally, based on current recommendations by national and international treatment guidelines and available literature, the use of amitriptyline for enuresis nocturna in children was restricted to third line therapy in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin-related products.
Maltese: Finalment, abbażi ta' rakkomandazzjonijiet attwali minn linji gwida ta' kura nazzjonali u internazzjonali u minn letteratura disponibbli, l-użu ta' amitriptyline għal enuresis nocturna fit-tfal ġie ristrett għal terapija tat-tielet linja fi tfal li jkollhom minn 6 snin ‘il fuq meta l-patoloġija organika, inkluż spina bifida u disturbi relatati, tkun ġiet eskluża u ma jkun inkiseb ebda rispons għall-kuri l-oħra kollha bil-mediċina u mhux bil-mediċina, inkluż prodotti relatati ma' antispażmodiċi u vasopressin.
English: It is authorised in the following Member States: AT, BE, CY, DK, DE, EE, EL, LU, NL, NO and SE. Other amitriptyline containing products are also authorised under different brand names in the EU.
Maltese: AT, BE, CY, DK, DE, EE, EL, LU, NL, NO u SE.
English: • the scope of the referral was the harmonisation of the product information,
Maltese: • il-kamp tal-applikazzjoni tar-riferiment kien l-armonizzazzjoni tal-informazzjoni dwar ilprodott,
English: Finally, section 5.3 on preclinical safety data has been modified according to the most recent and relevant information from literature to reflect current knowledge with regards to cardiac toxicity, genotoxic potential, embryotoxicity and effect on fertility.
Maltese: Finalment, is-sezzjoni 5.3 dwar tagħrif ta' qabel l-użu kliniku dwar is-sigurtà ġiet modifikata skont l-informazzjoni l-aktar riċenti u rilevanti mil-letteratura biex tirrifletti għarfien attwali fir-rigward ta' tossiċità kardijaka, potenzjal ġenotossiku u tossiċità tal-embriju u effett fuq il-fertilità Tikkettar
English: Its main metabolite, nortriptyline, is a more potent and selective norepinephrine reuptake inhibitor, although it still blocks serotonin uptake.
Maltese: Il-metabolit ewlieni tiegħu, nortriptyline, huwa inibitur aktar qawwi u selettiv tal-assorbiment mill-ġdid ta' norepinephrine, għalkemm xorta jimblokka l-assorbiment ta' serotonin.
English: For the treatment of pain (neuropathic pain, prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine) in adults doses are in general lower than in depression, with doses rarely exceeding 100 mg. Dosing should start with 10mg at bedtime and then titrated in 1025mg increments every 3-7 days.
Maltese: Għall-kura ta' uġigħ (uġigħ newropatiku, kura profilattika ta' uġigħ ta' ras ta' tip ta' tensjoni kronika u kura profilattika tal-migranja) fl-adulti, b'mod ġenerali, id-dożi jkunu aktar baxxi milli għad-dipressjoni, b'dożi li rarament jaqbżu 100 mg.
English: Section 5.1 was revised to include a short factual description of the mechanism of action and Section 5.2 was updated to include data supporting the pharmacokinetic properties, especially of the parenteral formulation have been presented and discussed.
Maltese: Is-sezzjoni 5.1 ġiet riveduta biex tinkludi deskrizzjoni fattwali qasira tal-mekkaniżmu ta' azzjoni u s-Sezzjoni 5.2 ġiet aġġornata biex tinkludi data li tappoġġa l-karatteristiċi farmakokinetiċi, speċjalment tal-formulazzjoni parenterali li ġew ippreżentati u diskussi.
English: Therefore, due to the divergent national decisions taken by Member States concerning the authorisation of amitriptyline-containing products, Greece notified the Agency on 17 December 2015 of a referral under Article 30 of Directive 2001/83/EC for Saroten and associated names, in order to resolve divergences amongst the nationally authorized SmPCs for the above-mentioned product and thus to harmonise its divergent SmPCs across the EU.
Maltese: Għalhekk, minħabba d-deċiżjonijiet nazzjonali diverġenti meħudin mill-Istati Membri fir-rigward talawtorizzazzjoni ta' prodotti li fihom amitriptyline, fis-17 ta' Diċembru 2015, il-Greċja nnotifikat lillAġenzija dwar riferiment skont l-Artikolu 30 tad-Direttiva 2001/83/KE għal Saroten u ismijiet assoċjati sabiex jiġu riżolti diverġenzi fost l-SmPCs awtorizzati b'mod nazzjonali għall-prodott imsemmi hawn fuq u għaldaqstant biex l-SmPCs diverġenti tiegħu jiġu armonizzati fl-UE kollha.
English: Therapeutic Indications
Maltese: Indikazzjonijiet Terapewtiċi
English: The MAHs have performed an analysis of their databases and considered all available information in the literature including classical textbooks such as Martindale (Martindale 2014), in order to justify the inclusion of adverse drug reactions, for which a causal relationship is at least a reasonable possibility.
Maltese: L-MAHs wettqu analiżi tal-bażijiet ta' data tagħhom u kkunsidraw l-informazzjoni kollha disponibbli fil-letteratura inkluż f'kotba klassiċi bħal Martindale (Martindale 2014), sabiex tiġi ġġustifikata linklużjoni ta' reazzjonijiet avversi għal mediċina, li għalihom hemm possibbiltà raġonevoli ta' relazzjoni każwali.
English: Amitriptyline is a well-known tricyclic antidepressant with an established mechanism of action and use (Brunton 2011)1.
Maltese: Amitriptyline huwa antidipressant triċikliku magħruf sew b'mekkaniżmu ta' azzjoni u użu stabbilit (Brunton 2011).
English: A maximum daily dosage of 150 mg amitriptyline given by injection/infusion should not be exceeded.
Maltese: M'għandux jinqabeż dożaġġ massimu ta' kuljum ta' 150 mg amitriptyline li jingħata b'injezzjoni/infużjoni.
English: In addition, the CHMP concluded that the totality of the data provided by the MAHs was supportive of a first line treatment for amitriptyline in the prophylactic treatment of chronic tension type headache (CTTH) and migrane in adults, although a specific indication in fibromyalgia was not agreed.
Maltese: Barra minn hekk, is-CHMP ikkonkluda li t-totalità tad-data pprovduta mill-MAHs appoġġat kura talewwel linja għal amitriptyline fil-kura profilattika ta' uġigħ ta' ras ta' tip ta' tensjoni kronika (CTTH,
English: Although the use of amitriptyline in a broad indication in chronic pain was not agreed by the CHMP, the use of amitriptyline in the treatment of neuropathic pain in adults was considered supported by recent systematic reviews and meta-analysis of pharmacological treatments of this condition.
Maltese: Għalkemm is-CHMP ma qabilx dwar l-użu ta' amitriptyline f'indikazzjoni wiesgħa fl-uġigħ kroniku, lużu ta' amitriptyline fil-kura ta' uġigħ newropatiku fl-adulti ġie kkunsidrat bħala appoġġat minn rieżamijiet sistematiċi riċenti u metaanaliżi ta' kuri farmakoloġiċi ta' din il-kundizzjoni.
English: • The committee reviewed the totality of the data submitted by the MAHs as well as relevant available literature in support of the proposed harmonisation of the product information, the CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Saroten and associated names (see Annex I).
Maltese: • l-informazzjoni dwar il-prodott proposta mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fisSuq ġiet evalwata fuq il-bażi tad-dokumentazzjoni ppreżentata u d-diskussjoni xjentifika fi ħdan il-Kumitat;
English: Amitriptyline is a tertiary amine that acts primarily as a serotonin-norepinephrine reuptake inhibitor.
Maltese: Prodotti oħrajn li fihom amitriptyline wkoll huma awtorizzati taħt ismijiet ta' ditti differenti fl-UE.
English: The maintenance dose is the lowest effective dose and doses above 150 mg daily are not recommended.
Maltese: Id-doża ta' manteniment hija d-doża l-aktar effettiva baxxa u mhumiex rakkomandati dożi ‘l fuq minn 150 mg kuljum.
English: The current SmPCs approved in the EU Member States differ significantly in the approved indications, posology and recommendations for use.
Maltese: L-SmPCs attwali approvati flIstati Membri tal-UE għandhom differenzi sinifikanti fl-indikazzjonijiet, fil-pożoloġija u firrakkomandazzjonijiet approvati għall-użu.
English: Amitriptyline has potent anticholinergic, antihistaminergic, and sedative properties and it potentiates the effects of catecholamines.
Maltese: Amitriptyline għandu karatteristiċi antikolinerġiċi, antiistaminerġiċi u sedattivi qawwijin u dan isaħħaħ l-effetti tal-katekolamini.
English: With regards to fertility, pregnancy and lactation, section 4.6 of the SmPC was updated based on the review and analysis of all the available data provided by MAHs including literature, and post marketing data from the MAH Global Safety database.
Maltese: Fir-rigward tal-fertilità, it-tqala u t-treddigħ, is-sezzjoni 4.6 tal-SmPC ġiet aġġornata abbażi tarrieżami u l-analiżi tad-data kollha disponibbli pprovduta mill-MAHs inkluż, letteratura u data ta' wara t-tqegħid fis-suq mill-bażi ta' data tas-Sigurtà Globali tal-MAH. Amitriptyline mhuwiex rakkomandat matul it-tqala sakemm ma jkunx meħtieġ b'mod ċar u biss wara li tkun saret kunsiderazzjoni bir-reqqa tar-riskju/tal-benefiċċju.
English: For the elderly patients over 65 years of age and patients with cardiovascular disease it is generally recommended to initiate treatment in the lower dose range as recommended for adult, as these populations are particularly susceptible to the known adverse reactions and in particular cardiac toxicity.
Maltese: Għall-pazjenti anzjani ta' aktar minn 65 sena u pazjenti b'mard kardjovaskulari, ġeneralment huwa rakkomandat li tinbeda kura fil-medda ta' doża aktar baxxa kif huwa rakkomandat għall-adulti, peress li dawn il-popolazzjonijiet huma partikolarment suxxettibbli għar-reazzjonijiet avversi magħrufa u b'mod partikolari għal tossiċità kardijaka.
English: A warning was added in section 4.4 of the SmPC on the risk of QT prolongation.
Maltese: Fis-sezzjoni 4.4 tal-SmPC żdiedet twissija dwar ir-riskju ta' titwil tal-QT.
English: The recommended starting dose for the treatment of pain in the elderly and patients with cardiovascular disease is 10 mg to 25 mg in the evening.
Maltese: Id-doża tal-bidu rakkomandata għall-kura ta' uġigħ fl-anzjani u f'pazjenti b'mard kardjovaskulari hija ta' 10 mg sa 25 mg filgħaxija.
English: Intravenous use vial (glass)
Maltese: Użu għal ġol-vini kunjett (ħġeiġ)
English: Strength Pharmaceutical Form
Maltese: Numru ta' l-EMA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: 36 hours.
Maltese: 36 siegħa.
English: Date of latest renewal: 11/12/2017
Maltese: Data tal-aħħar tiġdid: 11/12/2017
English: Via Glauco Gottardi,100, Modena, 41100, Italy
Maltese: Via Glauco Gottardi,100, Modena, 41100, L-Italja
English: Holostem Terapie Avanzate S.R.L, presso Centro di Medicina Rigenerativa “Stefano Ferrari”, Via Glauco Gottardi 100, 41100 Modena, Italy
Maltese: Holostem Terapie Avanzate S.R.L, presso Centro di Medicina Rigenerativa “Stefano Ferrari”, Via Glauco Gottardi 100, 41100
English: Fibrin support.
Maltese: Appoġġ ta' fibrin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/987/001
Maltese: EU/1/14/987/001
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17/02/2015
Maltese: Data tal-ewwel awtorizzazzjoni: 17/02/2015
English: Telephone: +3905212791 Telefax: +390521 774468 E-Mail: info@chiesigroup.com
Maltese: +390521 774468 E-Mail: info@chiesigroup.com
English: OTHER M.A.H: CHIESI FARMACEUTICI S.P.A
Maltese: M.A.H: CHIESI FARMACEUTICI
English: Store between 15°C - 25°C
Maltese: Aħżen f'temperatura bejn 15°C - 25 °C
English: Store between 15 °C - 25 °C
Maltese: Aħżen f'temperatura bejn 15°C - 25°C
English: Visit 1: Biopsy taken
Maltese: Vista 1: Teħid tal-bijopsija
English: Final CSR December
Maltese: CSR Finali
English: Biopsy
Maltese: Bijopsija
English: DATE:
Maltese: JIS: DATA:
English: Holoclar is generally implanted under topical retrobulbar or parabulbar anaesthesia.
Maltese: Holoclar ġeneralment jiġi impjantat taħt anestesija topika retrobulbari jew parabulbari.
English: There is only limited information in elderly (n=12, >65 year old) and very elderly (n= 2, 75-84 year old) patients.
Maltese: Hemm biss informazzjoni limitata f'pazjenti anzjani (n=12, età ta' >65 sena) u anzjani ħafna (n = 2, età ta' 75-84 sena).
English: Transport medium (Dulbecco's Modified Eagles Medium supplemented with L-glutamine).
Maltese: Sustanza tat-trasport (Dulbecco's Modified Eagles Medium supplimentat b'L-glutamine).
English: Additional clinically-relevant parameters were evaluated as secondary efficacy assessments.
Maltese: Parametri klinikament rilevanti addizzjonali ġew evalwati bħala valutazzjonijiet sekondarji taleffikaċja.
English: UNIQUE IDENTIFIER - 2D BARCODE <Not applicable.>
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D <Mhux applikabbli.>
English: Name and address of the manufacturer of the biological active substance Holostem Terapie Avanzate S.R.L.
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva Holostem Terapie Avanzate S.R.L.
English: Do not irradiate (e.g. X-rays)
Maltese: Tirradjax (eż. raġġi X)
English: In the paediatric patients included in the studies HLSTM01 (age 13, 14 and 16 years) and HLSTM02 (age 8 and 14 years) the profile of adverse reactions was not different from the adult population.
Maltese: Fil-pazjenti pedjatriċi inklużi fl-istudji HLSTM01 (età ta' 13, 14 u 16-il sena) u HLSTM02 (età ta' 8 u 14-il sena) il-profil tar-reazzjonijiet avversi ma kienx differenti mill-popolazzjoni adulta.
English: Holoclar consists of a transparent circular sheet of 300,000 to 1,200,000 viable autologous human corneal epithelial cells (79,000 - 316,000 cells/cm2), including on average 3.5% (0.4 to 16%) limbal stem cells, and stem cell-derived transient amplifying and terminally differentiated cells, attached on a supportive 2.2 cm diameter fibrin layer and maintained in the transport medium.
Maltese: Holoclar jikkonsisti minn folja tonda trasparenti ta' 300,000 sa 1,200,000 ċellula awtologa u vijabbli tal-epitelju tal-kornea umana (79,000 - 316,000 ċellula/ċm2), inkluż medja ta' 3.5% (0.4 sa 16%) ċelluli staminali limbali, u ċelluli derivati minn ċelluli staminali li jamplifikaw temporanjament u differenzjati b'mod terminali, imwaħħla fuq saff fibrin ta' sapport ta' dijametru ta' 2.2 ċm u miżmuma fis-sustanza tat-trasport.
English: Holoclar must be applied no later than 15 minutes after opening the primary container.
Maltese: Holoclar għandu jiġi applikat mhux aktar tard minn15-il minuta wara li jinfetaħ il-kontenitur primarju.
English: Holoclar could contain potentially infected biological material.
Maltese: Holoclar jista' jkun fih materjal bijoloġiku potenzjalment infettat.
English: • Problems with cornea (erosion)
Maltese: • Problemi bil-kornea (tħaffir)
English: Hypersensitivity to any of the excipients listed in section 6.1 or to bovine serum and murine 3T3-J2 cells.
Maltese: Sensittività eċċessiva għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1 jew għal serum tal-bovini u ċelluli 3T3-J2 tal-ġrieden.
English: The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Maltese: Il-kategoriji li ġejjin huma wżati biex jikklassifikaw ir-reazzjonijiet avversi skont il-frekwenza talokkorrenza: 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 magħrufa (ma tistax tittieħed stima mid dejta disponibbli).
English: Glaucoma (3.5%) was the most frequent adverse reaction considered related to the corticosteroid treatment (see sections 4.2 and 4.4).
Maltese: Glawkoma (3.5%) kienet l-aktar reazzjoni avversa frekwenti kkunsidrata bħala relatata ma' kura b'kortikosterojdi (ara sezzjonijiet 4.2 u 4.4).
English: • The limbus is part of the eye.
Maltese: • Il-limbus huwa parti mill-għajn.
English: After 2 weeks the systemic antibiotic administration should be stopped and the daily dose of prednisone should be tapered to 0.25 mg/kg (maximum 12.5 mg) per day for 1 week, to 0.125 mg/kg (maximum 5.0 mg) per day for the following week and then stopped.
Maltese: Wara ġimagħtejn l-għoti ta' antibijotiku sistemiku għandu jitwaqqaf u d-doża ta' kuljum ta' prednisone għandha titnaqqas bil-mod għal 0.25 mg/kg (massimu ta' 12.5 mg) kuljum għall-ġimgħa waħda, 0.125 mg/kg (massimu ta' 5.0 mg) kuljum għall-ġimgħa ta' wara u wara titwaqqaf.
English: The procedure of Holoclar administration include the use of antibiotics and corticosteroids (see section 4.2).
Maltese: Il-proċedura tal-għoti ta' Holoclar tinkludi l-użu ta' antibijotiċi u kortikosterojdi (ara sezzjoni 4.2).
English: Each square centimetre of Holoclar contains 79,000 - 316,000 cells.
Maltese: Kull ċentimetru kwadru ta' Holoclar fih 79,000 - 316,000 ċellula.
English: There is no information on the safety of Holoclar in children up to 7 years of age and only limited information in patients 8 - 17 years of age.
Maltese: M'hemm l-ebda informazzjoni dwar is-sigurtà ta' Holoclar fi tfal b'età sa 7 snin u hemm biss informazzjoni limitata f'pazjenti b'età ta' 8 - 17-il sena.
English: No recommendation on posology can be made (see sections 4.8 and 5.1).
Maltese: Ma tista' tingħata lebda rakkomandazzjoni dwar il-pożoloġija (ara sezzjonijiet 4.8 u 5.1).
English: A total of 75 (72.1%) treatments were reported with a successful outcome.
Maltese: Kienu rrappurtati total ta' 75 (72.1%) kura b'riżultat ta' suċċess.
English: Fertility No clinical data on the effects of Holoclar on fertility are available.
Maltese: Fertilità M'hemmx dejta klinika disponibbli dwar l-effetti ta' Holoclar fuq il-fertilità.
English: Holoclar must not be sterilised.
Maltese: Holoclar m'għandux jiġi sterilizzat.
English: A total of 104 patients, aged between 13 and 79 years (mean 46.8 years) were included in the primary efficacy analysis.
Maltese: Total ta' 104 pazjenti, ta' età bejn 13 u 79 sena (medja 46.8 snin) kienu inklużi fl-analiżi primarja tal-effikaċja.
English: • Infection of the cornea
Maltese: • Infezzjoni tal-kornea
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Chiesi Farmaceutici S.P.A, Via Palermo 26/A 43122 Parma, Italy
Maltese: Chiesi Farmaceutici S.P.A, Via Palermo 26/A 43122 Parma, L-Italja
English: Transparent, circular sheet.
Maltese: Folja tonda u trasparenti.
English: EXP:
Maltese: Telefax:
English: The safety and efficacy of Holoclar in children and adolescents aged 0 to 18 years has not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Holoclar fi tfal u adolexxenti b'età minn 0 sa 18-il sena ma ġewx determinati s'issa.
English: For the manufacture of Holoclar, a biopsy of 1 - 2 mm2 of undamaged limbus is required.
Maltese: Għall-manifattura ta' Holoclar, hija meħtieġa bijopsija ta' 1 - 2 mm2 ta' limbus bla ħsara.
English: When categorical values for visual acuity were converted into the Logarithm of the Minimum Angle of Resolution (LogMAR), 47% of cases (40 over 85 with non-missing values) experienced an improvement equal or greater than 3 Snellen line equivalents.
Maltese: Logarithm of the Minimum Angle of Resolution), 47% tal-każijiet (40 minn 85 b'valuri mhux nieqsa)
English: The HLSTM01 study enrolled a total of seven patients (6.7% of the study population) with an age at baseline of 65 years or above, and seven additional patients (24.1%) were included in HLSTM02.
Maltese: L-istudju HLSTM01 irreġistra total ta' seba' pazjenti (6.7% tal-popolazzjoni tal-istudju) b'età fil-linja bażi ta' 65 sena jew aktar, u seba' pazjenti oħra (24.1%) kienu inklużi f'HLSTM02.
English: Currently available data are described in section 4.8 and 5.1, but no recommendation on posology can be made.
Maltese: Dejta disponibbli bħalissa hi deskritta fis-sezzjoni 4.8 u 5.1, imma ma tista' tingħata l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: PHARMACEUTICAL FORM Living tissue equivalent.
Maltese: GĦAMLA FARMAĊEWTIKA Ekwivalenti għal tessut ħaj.
English: • Growth of the conjunctiva over the cornea (pterygium)
Maltese: • Tkabbir tal-konġuntiva fuq il-kornea (pterigium)
English: Conventional pharmacodynamic studies for Holoclar have not been performed Clinical efficacy and safety
Maltese: Ma twettqux studji farmakodinamiċi konvenzjonali għal Holoclar
English: Benzalkonium chloride (as well as other quaternary ammonium compounds) is cytotoxic and eyedrops containing this preservative may damage the newly-regenerated corneal epithelium.
Maltese: Benzalkonium chloride (kif ukoll sustanzi ta' quaternary ammonium oħra) huwa ċitotossiku u qtar għall-għajnejn li fihom dan il-preservattiv jistgħu jagħmlu ħsara lill-epitelju tal-kornea li għadu kif ġie riġenerat.
English: The safety of Holoclar is demonstrated in the results obtained from the two retrospective clinical studies.
Maltese: Is-sigurtà ta' Holoclar intweriet fir-riżultati miksuba miż-żewġ studji kliniċi retrospettivi.
English: Other medicines and Holoclar Some eye-drops contain a preservative called ‘benzalkonium chloride'.
Maltese: Xi qtar għall-għajnejn fihom preservattiv imsejjaħ ‘benzalkonium chloride'.
English: Multinational, multicentre, prospective, open-label, uncontrolled interventional study (HLSTM03) to assess the efficacy and safety of autologous cultivated limbal stem cells grafting for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns
Maltese: Studju multinazzjonali, multiċentriku, prospettiv, open-label, mhux ikkontrollat ta' intervent (HLSTM03) biex jevalwa l-effikaċja u s-sigurtà ta' trapjant ta' ċelluli staminali limbali awtologi kkultivati għar-restawr tal epitelju tal-kornea f'pazjenti b'defiċjenza ta' ċelluli staminali limbali kkawżata minn ħruq okulari
English: The following regimen is suggested: Doxycycline 100 mg tablets twice daily (or amoxicillin 500 mg twice daily) and prednisone orally at a daily dose of 0.5 mg/kg (to a maximum dose of 25 mg) per day should be administered from the day of surgery for 2 weeks.
Maltese: Huwa rakkomandat il-kors li ġej: Pilloli doxycycline100 mg darbtejn kuljum (jew amoxicillin 500 mg darbtejn kuljum) u prednisone mill-ħalq b'doża ta' kuljum ta' 0.5 mg/kg (sa doża massima ta' 25 mg) kuljum għandhom jingħataw mill-ġurnata tal-kirurġija għal ġimagħtejn.
English: • Overgrowth around the implant (metaplasia)
Maltese: • Tkabbir żejjed madwar l-impjant (metaplasja)
English: The medicine is put in several layers of packaging which protect the medicine from bacteria and ensures that Holoclar is kept at a stable temperature for 36 hours, if stored at room temperature.
Maltese: Il-mediċina titqiegħed f'diversi saffi ta' ippakkjar li jipproteġu lmedicina minn batterja u jiżguraw li Holoclar jinżamm f'temperatura stabbli għal 36 siegħa, jekk jiġi maħżun f'temperatura tal-kamra.
English: Blepharitis (10.5%), and corneal epithelium defect (3.5%) were the most common individual adverse reactions not related to the surgical procedure.
Maltese: 5%), u difett fl-epitelju tal-kornea (3.5%) kienu l-aktar reazzjonijiet avversi individwali komuni mhux relatati mal-proċedura kirurġika.
English: Moderate to severe LSCD was defined according to an invasion of at least two quadrants of the corneal surface by superficial neo vessels.
Maltese: LSCD moderat sa sever kien definit skont invażjoni ta' mill-inqas żewġ kwadranti tas-superfiċje tal-kornea minn neokanali superfiċjali.