FrancophonIA/ELRC3.0 huggingface dataset:
English: It is available as round, orange tablets (50 and 150 mg).
Maltese: Jiġi bħala pilloli tondi, oranġjo (50 u 150 mg).
English: Other information about Masivet:
Maltese: Informazzjoni oħra dwar Masivet:
English: The active substance in Masivet, masitinib, is a protein-tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Masivet, masitinib, hija impeditur ta' protein-tyrosine kinase.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Masivet to AB Science S.A. on 17 November 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea, għal Masivet lil AB Science S.A. fi 17 ta' Novembru 2008.
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ benefiċċju-riskju jista' jinstab f'modulu 6 ta' dan l-EPAR.
English: What is Masivet?
Maltese: X'inhu Masivet?
English: The main study compared the effectiveness of Masivet at the recommended dose of 12.5 mg per kilogramme bodyweight once a day with placebo (a dummy treatment).
Maltese: L-istudju prinċipali qabbel l-effikaċja ta' Masivet fid-doża rrakkomandata ta' 12.5 mg kull kilogramm tal-piż tal-ġisem darba kuljum ma' plaċebo (kura finta).
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Masivet exceed the risks for the treatment of non-resectable mast cell tumours (grade 2 or 3) that have a confirmed mutated c-kit tyrosine kinase receptor and recommended that Masivet be given a marketing authorisation.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Masivet jisbqu r-riskji għall-kura ta' tumuri taċ-ċelluli mast li ma jistgħux jitneħħew (bilkirurġija) (grad 2 jew 3) li għandhom riċettur c-kit tyrosine kinase mibdul b'mod ġenetiku kkonfermat u rrakkomanda li Masivet jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What benefit has Masivet shown during the studies?
Maltese: Liema benefiċċju wera Masivet waqt l-istudji mwettqa?
English: The most common side effects with Masivet are gastrointestinal reactions (diarrhoea and vomiting) and hair loss.
Maltese: L-iktar effetti sekondarji komuni b'Masivet huma reazzjonijiet gastrointestinali (dijarea u rimettar) u telf tal-pil.
English: If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni abbażi tar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: How has Masivet been studied?
Maltese: Kif ġie studjat Masivet?
English: What is the risk associated with Masivet?
Maltese: X'inhu r-riskju assoċjat ma' Masivet?
English: Page 2/2© EMEA 2009
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 05/2009.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) MASIVET Sommarju tal-EPAR għall-pubbliku
English: These reactions are usually mild to moderate and temporary, last for up to four weeks.
Maltese: Dawn ir-reazzjonijiet huma ġeneralment ħfief għal moderati u temporanji, ġeneralment idumu sa erba' ġimgħat.
English: The study included dogs of various breeds and both sexes with mast-cell tumours that had come back after surgery or could not be removed with surgery.
Maltese: L-istudju inkluda klieb ta' diversi razez u taż-żewġ sessi b'tumuri taċ-ċelloli mast li rritornaw wara l-kirurġija jew li ma setgħux jitneħħew permezz tal-kirurġija.
English: For a full list of all side-effects reported with Masivet, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati ma' Masivet, ara lFuljett ta' Tagħrif.
English: Masivet contains masitinib, which belongs to a class of medicines having an anticancer action.
Maltese: Masivet fih masitinib, li jagħmel parti mill-klassi ta' mediċini li għandhom azzjoni kontra lkanċer.
English: It is used for tumours which are severe in character (grade 2 or 3) and which cannot be removed with surgery.
Maltese: Huwa jintuża għal tumuri li huma serji fin-natura tagħhom (grad 2 jew 3) u li ma jistgħux jitneħħew bil-kirurġija.
English: Why has Masivet been approved?
Maltese: Għaliex ġie approvat Masivet?
English: In the dogs whose tumours contained mutated c-kit receptors, it took longer for the tumour to get worse when dogs received Masivet (median of 241 days) than in those receiving placebo (median of 83 days).
Maltese: Fil-klieb lit-tumuri tagħhom kien fihom riċetturi c-kit mibdula b'mod ġenetiku, it-tumur ħa aktar żmien biex imur għall-agħar meta l-klieb irċievew Masivet (medjan ta' 241-il jum) milli f'dawk li kienu qegħdin jirċievu plaċebo (medjan ta' 83-il jum).
English: The study population included dogs whose tumours contained mutated or normal (‘wild-type') c-kit receptors.
Maltese: Il-popolazzjoni tal-istudju inkludiet klieb li t-tumuri tagħhom kien fihom riċetturi c-kit mibdula b'mod ġenetiku jew normali (tip-selvaġġ).
English: Some types of mast-cell tumour are linked to a mutation that causes excessive action of c-kit and stimulates the mast cells to divide uncontrollably.
Maltese: Xi tipi ta' tumur taċ-ċelluli-mast huma marbutin ma' tibdil ġenetiku li jikkaġuna azzjoni eċċessiva ta' c-kit u jistimula liċ-ċelluli mast biex jinqasmu mingħajr kontroll.
English: A number of studies with Masivet were carried out either in laboratory dogs or in animal patients at veterinary practises in Europe and in the USA.
Maltese: Saru numru ta' studji b'Masivet kemm fi klieb tal-laboratorju kif ukoll fuq pazjenti annimali fi prattiċi veterinarji fl-Ewropa u fl-Istati Uniti.
English: Because this disease is a life threatening condition and the overall number of dogs affected is expected to be low, the CVMP guidelines on “Minor-Use-Minor-Species (MUMS) data requirements” were applied when assessing the dossier.
Maltese: Minħabba li din il-marda hija kundizzjoni li thedded il-ħajja u n-numru totali ta' klieb effettwati huwa mistenni li jkun baxx, il-linji gwida tas-CVMP fuq “rekwiżiti ta' dejta UżuMinuri-Speċi-Minuri (UMSM)” kienu applikati fl-ivvalutar tad-dossier.
English: Masivet is used to treat dogs with mast-cell tumours (a type of cancer).
Maltese: Masivet jintuża biex jikkura klieb b'tumuri taċ-ċelluli-mast (tip ta' kanċer).
English: It must not be used in dogs less than six months of age or less than 4 kg in weight, or bitches that are pregnant or lactating.
Maltese: Huwa m'għandux jintuża fi klieb ta' età inqas minn sitt xhur jew ta' piż inqas minn 4 kg, jew klieb nisa li huma tqal jew li qegħdin ireddgħu.
English: Date of last renewal: 18/04/2016
Maltese: Data tal-aħħar tiġdid: 18/04/2016
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 05 August 2011
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 05 Awwissu 2011
English: Potassium chloride
Maltese: Thiomersal Potassium chloride
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
Maltese: *(Valur cycling (Ct) ≥ 36 minn metodu RT_PCR validat, jindika li m'hemmx preżenza tal-ġenom virali)
English: PACKAGE SIZE 100 ml (50 doses) 240 ml (120 doses)
Maltese: 100 ml (50 doża) 240 ml (120 doża)
English: PACKAGE SIZE 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Maltese: 20 ml (10 dożi) 100 ml (50 doża) 240 ml (120 doża)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Zulvac 1 Ovis suspension for injection for sheep
Maltese: VETERINARJU Zulvac 1 Ovis suspensjoni għall-injezzjoni għan-nagħaġ
English: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 Aluminium hydroxide, saponin and thiomersal.
Maltese: Kull doża ta' 2 ml Virus Bluetongue inattivat, serotip 1, strejn BTV-1/ALG2006/01 E1 Aluminium hydroxide, saponin u thiomersal.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20ml, 1 x 100ml and 1 x 240 ml
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa tal-kartun 1 x 20 ml, 1 x 100 ml u 1 x 240 ml
English: Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 RP* ≥ 1 *Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
Maltese: BTV-1/ALG2006/01 E1 RP* ≥ 1 * Qawwa Relattiva skont test ta' qawwa fil-ġrieden imqabbel ma' tilqima ta' referenza li ntweriet li hija effikaċi fin-nagħaġ.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Maltese: Skont l-Artikolu 71 tad-Direttiva 2001/82/EC tal-Parlament Ewropew u tal-Kunsill kif emendata, Stat Membru jista, skont il-liġijiet nazzjonal tiegħu, jipprojbixxi l-manifattura, l-importazzjoni, pussess, ilbejgħ, il-forniment u/jew l-użu ta' prodotti mediċinali veterinarji immunoloġiċi fit-territorju sħiħ tiegħu jew parti minnu jekk jiġi stabbilit illi:
English: To stimulate active immunity against Bluetongue Virus, serotype 1 in sheep.
Maltese: Biex jistimula immunità attiva kontra l-Virus Bluetongue, serotip 1, fin-nagħaġ.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009
Maltese: Is-sustanza attiva li hija prinċipju ta' oriġini bioloġiku maħsuba sabiex tipproduċi immunità attiva ma taqgħax fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f‘sezzjoni 6.1 tal-Karatteristiċi tal-prodott fil-qosor huma sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma ikunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta wżati bħal f'dan il-prodott mediċinali veterinarju.
English: Cardboard box with one type II glass vial of either 100 ml (containing 50 doses) or 240 ml (containing 120 doses) with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Kaxxa tal-kartun b'kunjett wieħed tal-ħġieġ tat-Tip II ta' 100 ml (fih 50 doża) jew 240 ml (fih 120 doża) b'għeluq ta' chlorobutyl rubber u siġill tal-aluminjum.
English: Cardboard box with one type I glass vial of 20 ml (containing 10 doses) with a chlorobutyl rubber stopper and aluminium cap.
Maltese: Kaxxa tal-kartun b'kunjett wieħed tal-ħġieġ tat-Tip I ta' 20 ml (fih 10 dożi) b'għeluq ta' chlorobutyl rubber u siġill tal-aluminjum.
English: Lactation:
Maltese: Inkompatibilitajiet:
English: ATC vet code: QI04AA02.
Maltese: Vaċċini b'virus inattivat -Bluetongue virus Kodici ATC veterinarja: QI04AA02
English: 4.11 Withdrawal period(s)
Maltese: 4.11 Perijodu ta' tiżmim
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: A transient increase in rectal temperature, not exceeding 1.2 °C, may occur very commonly during the 24 hours following vaccination.
Maltese: Waqt l-ewwel 24 siegħa wara t-tilqima huwa komuni ħafna li sseħħ żjieda temporanja fit-temperatura tar-rektum ta' mhux aktar minn 1.2°C.
English: Any revaccination scheme should be agreed by the Competent Authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Maltese: Kull skema ta' tilqim mill-ġdid għandha tiġi miftehma mill-Awtorità Kompetenti jew mill-veterinarju responsabbli, filwaqt li titqies is-sitwazzjoni epidemjoloġika lokali.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Isem u indirizz tal-manufattur tas-sustanza(i) bijoloġika(ċi) attiva(i)
English: 1st injection: from 1.5 months of age.
Maltese: L-ewwel injezzjoni: minn 1.5 xhur 'l fuq.
English: For active immunisation of sheep from 1 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotypes 1.
Maltese: Għat-tilqim attiv ta' nagħaġ minn xahar u nofs 'l fuq għall-prevenzjoni* ta' viremija kkawżata millvirus Bluetongue (BTV), serotip 1.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue virus (BTV).
Maltese: F'din il-kategorija ta' annimali il-vaċċin għandu jintuża biss skont stima tal-benefiċċju/riskju mill-veterinarju responsabbli u/jew mill-Awtoritajiet Kompetenti skont il-politika kurrenti dwar tilqim kontra l-Virus Blue Tongue (BTV).
English: PACKAGE LEAFLET: Zulvac 1 Ovis suspension for injection for sheep
Maltese: Zulvac 1 Ovis suspensjoni għall-injezzjoni għan-nagħaġ
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 7 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 48 days).
Maltese: Fil-maġġoranza tal-każijiet dawn ir-reazzjonijiet jieħdu l-forma ta' nefħa ġenerali tas-sit tal-injezzjoni (li ddum mhux aktar minn 7 ijiem) jew bħala għoqiedi li jinħassu (granuloma taħt il-ġilda, li tista' tippersisti għal aktar minn 48 ġurnata).
English: These reactions take the form in most cases of a general swelling of the injection site (persisting for not more than 9 days) or of palpable nodules (subcutaneous granuloma, possibly persisting for more than 63 days).
Maltese: Fil-maġġoranza tal-każijiet dawn ir-reazzjonijiet iseħħu bħala nefħa ġenerali tas-sit tal-injezzjoni (li ma ddumx aktar minn 9 ijiem) jew bħala għoqiedi li jinħassu (granuloma taħt il-ġilda, li tista' tippersisti għal aktar minn 63 ġurnata).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains:
Maltese: Kull doża ta' 2 ml fiha:
English: A transient increase in rectal temperature, not exceeding 0.6 °C, may occur during the 24 hours following administration of a two-fold overdose.
Maltese: Wara li tingħata doża darbtejn ogħla min dik irrakkomandata, waqt l-ewwel 24 siegħa tista' sseħħ żjieda temporanja fit-temperatura tar-rektum ta' mhux aktar minn 0.6°C.
English: Vaccination may be followed very commonly by a local reaction at the injection site.
Maltese: Huwa komuni ħafna lit-tilqim jkun segwit minn reazzjoni lokali fis-sit ta' l-injezzjoni.
English: Disposal: read package leaflet.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label 20 ml
Maltese: Tikketta tal-kunjett 20 ml
English: a) The administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Maltese: a) L-għotja tal-prodott lill-annimali tinterferixxi ma' l-implimentazzjoni ta' programm nazzjonali għad-djanjosi, il-kontroll jew l-eradikazzjoni tal-mard ta' l-annimali, jew tikkawża diffikultajiet fiċ-ċertifikazzjoni ta' l-assenza tal-kontaminazzjoni f'annimali ħajjin jew fl-ikel jew prodotti oħrajn li jiġu minn annimali kkurati;
English: Adcetris 50 mg Powder for concentrate for solution for infusion
Maltese: 50 mg Trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Other information about Holoclar
Maltese: Informazzjoni oħra dwar Holoclar
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Holoclar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Holoclar jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: One year after Holoclar implantation, 75 out of 104 patients studied (72%) were judged to have had successful implants based on the presence of stable corneal surface with no surface defects and little or no ingrown blood vessels (a common feature of limbal stem-cell deficiency).
Maltese: Sena wara l-impjantazzjoni b'Holoclar, 75 minn 104 pazjenti studjati (72%) tqiesu li kellhom impjant li rnexxa abbażi tal-preżenza ta' superfiċje korneali stabbli mingħajr difetti fissuperfiċje u ftit jew ebda vini jikbru ‘l ġewwa (karatteristika komuni ta' nuqqas ta' ċelloli staminali limbali).
English: This is a summary of the European public assessment report (EPAR) for Holoclar.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Holoclar.
English: The full EPAR and risk management plan summary for Holoclar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Because the number of patients with limbal stem-cell deficiency due to burns to the eyes is low, the disease is considered ‘rare', and Holoclar was designated an ‘orphan medicine' (a medicine used in rare diseases) on 7 November 2008.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn nuqqas ta' ċelloli staminali limbali minħabba ħruq flgħajnejn huwa baxx, il-marda hija kkunsidrata ‘rari', u Holoclar ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis-7 ta' Novembru 2008.
English: Holoclar has therefore been given ‘conditional approval'.
Maltese: Holoclar għalhekk ingħata ‘approvazzjoni kondizzjonali'.
English: What information is still awaited for Holoclar?
Maltese: Liema informazzjoni għadha mistennija għal Holoclar?
English: Holoclar is a type of advanced therapy product called a ‘tissue engineered product'.
Maltese: Holoclar huwa tip ta' prodott ta' terapija avvanzata imsejħa ‘prodott tal-inġinerija tat-tessuti'.
English: The company is to provide data on the benefits and risks of Holoclar from a prospective clinical study.
Maltese: Il-kumpanija ser tipprovdi dejta fuq il-benefiċċji u r-riskji ta' Holoclar minn studju kliniku prospettiv.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Holoclar on 17 February 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Holoclar fis-17 ta' Frar 2015.
English: Why is Holoclar approved?
Maltese: Għaliex ġie approvat Holoclar?
English: The conclusion on the benefit-risk balance of Holoclar is based on results of two retrospective studies (using past medical records), and the company is to provide further data from a prospective study (that records outcomes during the course of the study).
Maltese: Il-konklużjoni dwar il-bilanċ benefiċċju-riskju ta' Holoclar huwa bbażat fuq riżultati minn żewġ studji retrospettivi (bl-użu ta' rekords mediċi tal-passat), u l-kumpanija ser tipprovdi iktar dejta minn studju prospettiv (li jirrekordja riżultati waqt l-istudju).
English: Holoclar was shown to be effective in restoring a stable corneal surface in patients with moderate or severe limbal stem-cell deficiency caused by burns in a retrospective study using patients' past medical records.
Maltese: Holoclar intwera li huwa effettiv fir-restawr ta' superfiċe korneali stabbli f'pazjenti b'nuqqas ta' ċelloli staminali limbali moderat sa sever ikkawżat minn ħruq fi studju retrospettiv bl-użu ta' rekords mediċi tal-passat tal-pazjenti.
English: What are the risks associated with Holoclar?
Maltese: X'inhuma r-riskji assoċjati ma' Holoclar?
English: Following the surgery, the patient should receive antibiotics and an appropriate antiinflammatory medicine.
Maltese: Wara l-operazzjoni, il-pazjent għandu jirċievi antibijotiċi u mediċina anti-infjammatorja xierqa.
English: Next, the cells in the tissue are grown in a laboratory and frozen until the date of surgery is confirmed.
Maltese: Imbagħad, iċ-ċelloli fit-tessut jiġu mkabbra f'laboratorju u jiġu ffriżati sakemm tiġi kkonfermata id-data tal-operazzjoni.
English: The Committee noted that that moderate to severe forms of limbal stem-cell deficiency are serious conditions which, if untreated, can lead to severe reduction or complete loss of vision.
Maltese: Il-Kumitat innota li forom moderati sa severi ta' nuqqas ta' ċelloli staminali limbali huma kundizzjonijiet serji li, jekk ma jiġux ikkurati, jistgħu iwasslu għal tnaqqis sever jew telf totali tal-viżta.
English: In the first stage of treatment, a small part of healthy limbal tissue (1−2 mm2 in size) is taken from the patient in hospital and sent to the manufacturer on the same day.
Maltese: Fl-ewwel stadju tal-kura, parti żgħira mit-tessut limbali b'saħħtu (1−2 mm2 fid-daqs) tittieħed millpazjent fl-isptar u tintbagħat lill-manifattur fl-istess ġurnata.
English: Since Holoclar has been granted a conditional approval, the company that markets Holoclar will provide further data on Holoclar.
Maltese: Minħabba li Holoclar ingħata approvazzjoni kondizzjonali, il-kumpanija li tqiegħed Holoclar fis-suq se tipprovdi iktar dejta dwar Holoclar.
English: A risk management plan has been developed to ensure that Holoclar is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Holoclar jintuża bl-aktar mod sigur possibbli.
English: Holoclar is a stem-cell treatment used in the eye to replace damaged cells on surface (epithelium) of the cornea, the transparent layer in front of the eye covering the iris (the coloured part).
Maltese: Jikkonsisti minn ċelloli meħudin mil-limbus (it-tarf tal-kornea) tal-pazjent li mbagħad jiġu mkabbra fillaboratorju sabiex ikunu jistgħu jintużaw biex tissewwa ħsara fis-superfiċje korneali bil-ħsara.
English: How is Holoclar used?
Maltese: Kif jaħdem Holoclar?
English: It is used in adult patients with moderate to severe limbal stem-cell deficiency caused by burns, including chemical burns, to the eyes.
Maltese: Jintuża f'pazjenti adulti b'nuqqas moderat sa sever ta' ċelloli staminali limbali ikkawżat minn ħruq, inkluż ħruq kimiku, fl-għajnejn.
English: Once implanted in the eye, the corneal cells of Holoclar help to replace the corneal surface, while the limbal stem cells serve as a reservoir of new cells that continuously replenish the cornea.
Maltese: Meta jiġu impjantati fl-għajn, iċ-ċelloli korneali ta' Holoclar jgħinu biex jissostitwixxu s-superfiċje korneali, filwaqt li ċ-ċelloli staminali limbali iservu bħala riżerva ta' ċelloli ġodda sabiex il-kornea tiġi rikostitwita b'mod kontinwu.
English: As the side effects of Holoclar treatment are generally manageable, the CHMP concluded that Holoclar's benefits outweigh its risks and recommended that it be approved for use in the EU.
Maltese: Minħabba li l-effetti sekondarji tal-kura b'Holoclar huma ġeneralment maniġġevoli, is-CHMP ikkonkluda li l-benefiċċji ta' Holoclar jegħlbu r-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: The active substance in Holoclar is the patient's own limbal cells, which include cells from the surface of the cornea and limbal stem cells grown in a laboratory.
Maltese: Is-sustanza attiva f'Holoclar huma ċ-ċelloli limbali tal-pazjent stess, li jinkludu ċelloli mis-superfiċje talkornea u ċelloli staminali limbali mkabbra f'laboratorju.
English: What measures are being taken to ensure the safe and effective use of Holoclar?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Holoclar?