FrancophonIA/ELRC3.0 huggingface dataset:
English: Vyndaqel is a medicine which treats a disease called Transthyretin (TTR) amyloid polyneuropathy, also known as TTR familial amyloid polyneuropathy (TTR-FAP).
Maltese: Vyndaqel huwa mediċina li jitratta l-marda tal-polinewropatija amyloid tat-tip Transthyretin (TTR), magħrufa wkoll bħala polinewropatija amyloid tat-tip TTR familjali (TTR-FAP).
English: The folded monomers undergo partial denaturation to produce alternatively folded monomeric amyloidogenic intermediates.
Maltese: Il-monomers milwijin jgħaddu minn bdil parzjali fin-natura tagħhom biex jiproduċu intermedji folded monomeric amyloidogenic alternattivi.
English: The adverse reactions were generally mild or moderate in severity.
Maltese: Ir-reazzjonijiet avversi ġeneralment kienu ħfief jew moderati fis-severità.
English: These intermediates then misassemble into soluble oligomers, profilaments, filaments, and amyloid fibrils.
Maltese: Dawn l-intermedji jinqatgħu minn ma' xulxin biex isiru oligomers li jinħallu, profilamenti, filamenti, u fibrilli tal-amyloid.
English: Therequirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq ilportal elettroniku Ewropew tal-mediċini.
English: Each soft capsule contains 20 mg of micronized tafamidis meglumine equivalent to 12.2 mg tafamidis.
Maltese: Kull kapsula ratba fiha 20 mg ta' tafamidis meglumine mikronizzat ekwivalenti għal 12.2 mg ta' tafamidis.
English: There is no relevant use of tafamidis in the paediatric population.
Maltese: M'hemm l-ebda użu relevanti ta' tafamidis fil-popolazzjoni pedjatrika.
English: Based on population PK results, subjects older than 60 years old had an average 19% lower estimate of clearance at steady-state compared to subjects less than 60 years old.
Maltese: Fuq bażi tar-riżultati PK tal-popolazzjoni, suġġetti li għandhom aktar minn 60 sena kellhom medja ta 19% stima aktar baxxa tat-tneħħija fl-istat fiss meta mqabbla mas-suġġetti li għandhom anqas minn 60 sena.
English: See section 4.
Maltese: (ara sezzjoni 4).
English: 4.5 Interaction with other medicinal products and other forms of interaction In a clinical study in healthy volunteers, tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4.
Maltese: Fi studju kliniku f'voluntiera b'saħħithom, tafamidis meglumine m'induċiex jew m'inibixxiex lenżima taċ-ċitokromu P450 CYP3A4 .
English: The primary outcome measures were the Neuropathy Impairment Score of the Lower Limb (NIS-LL - a physician assessment of the neurologic exam of the lower limbs) and the Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN - a patient reported outcome, total quality of life score [TQOL]).
Maltese: Ir-riżultati primarji kienu l-Punteġġ tal-Indeboliment Newropatiku tar-Riġlejn (NIS-LLvalutazzjoni minn tabib tal-eżami newroloġiku tar-riġlejn) u Kwalità tal-Ħajja ta' NorfolkNewropatija tad-Dijabete (Norfolk QOL-DN - riżultat rrapurtat minn pazjent, il-punteġġ tal-kwalità tal-ħajja totali [TQOL].
English: The dissociation of the transthyretin tetramer to monomers is the rate limiting step in the pathogenesis of TTR amyloid polyneuropathy, also known as TTR familial amyloid polyneuropathy (TTR-FAP).
Maltese: Tafamidis meglumine għandu jiżdied mal-istandard tal-kura għall-kura ta' pazjent b'polinewropatija amilojde familjali transtiretin (TTR-FAP, transthyretin familial amyloid polyneuropathy).
English: Pre-specified ITT Analysis
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Other medicines and Vyndaqel
Maltese: Kif taħżen Vyndaqel
English: Following daily administration of a 20 mg dose of tafamidis meglumine for 14 days in healthy subjects, mean steady-state half-life was 59 h and mean total clearance was 0.42 l/h.
Maltese: Wara amministrazzjoni ta' doża ta' 20 mg tafamidis meglumine kuljum għal 14-il ġurnata f'suġġetti b'saħħithom, il-half-life medja fi stat fiss kienet ta' 59 siegħa u t-tneħħija totali medja kienet ta' 0.
English: After oral administration of the soft capsule, the maximum plasma concentration (Cmax) is achieved at a median time (tmax) of 2 hours after dosing in the fasted state.
Maltese: Wara amministrazzjoni tal-kapsula ratba mill-ħalq, il-konċentrazzjoni massima fil-plażma (Cmax) hija milħuqa f'ħin medjan (tmax) ta' sagħtejn wara li d-dożaġġ ngħata lill-pazjenti li kienu sajmin.
English: Component of a multipack, can't be sold separately.
Maltese: Parti minn pakkett ta' ħafna, ma jistax jinbiegħ separatament.
English: Each soft capsule contains 20 mg tafamidis meglumine equivalent to 12.2 mg tafamidis
Maltese: Kull kapsula ratba fiha 20 mg tafamidis meglumine ekwivalenti għal 12.2 mg ta' tafamidis
English: As Vyndaqel works by stabilizing the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilized, and your disease may progress.
Maltese: Peress li Vyndaqel jaħdem billi jistabilizza il-proteina TTR, jekk tieqaf tieħu Vyndaqel, il-proteina ma tibqax aktar stabilizzata, u il-marda tiegħek tista' tmur għal-agħar.
English: Pack sizes: a pack of 30 x 1 soft capsules and a multipack containing 90 (3 packs of 30 x 1) soft capsules.
Maltese: Daqsijiet tal-pakkett: pakkett ta' 30 x1 kapsuli rotob u pakkett ta' hafna li fih 90 (3 pakketti ta' 30 x 1) kapsula rotob.
English: Printing ink (Opacode purple) Ethyl alcohol
Maltese: Linka ta' l-istampar (Opacode vjola)
English: Multipack of 90 (3 packs of 30 x 1) soft capsules - WITH BLUE BOX
Maltese: Pakkett ta' ħafna li fih 90 (3 pakketti ta' 30 x 1) kapsula rotob - BIL-KAXXA BLU
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Maltese: GĦAMLA KWALITATTIVA
English: Pack of 30 - for multipack of 90 (3 packs of 30 x 1) soft capsules - WITHOUT BLUE BOX
Maltese: Pakkett ta' 30 - għal pakkett ta' ħafna ta' 90 (3 pakketti ta' 30 x 1) kapsuli rotob - MINGĦAJR KAXXA BLU
English: Large Fiber change from BL LSMean (SE)
Maltese: Bidla tal-fibra kbira minn BL LSMean (SE)
English: 8 MARKETING AUTHORISATION NUMBER(S) EU/1/11/717/001
Maltese: EU/1/11/717/001 EU/1/11/717/002
English: 10 SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: Vyndaqel is for oral use.
Maltese: Vyndaqel huwa għal użu orali.
English: What Vyndaqel looks like and contents of the pack
Maltese: Id-Dehra ta' Vyndaqel u l-kontenuti tal-pakkett
English: In the rat peri- and post-natal development study with tafamidis, decreased pup survival and reduced pup weights were noted following maternal treatment during pregnancy and lactation at doses of 15 and 30 mg/kg.
Maltese: Fi studju b'tafamidis fil-far dwar l-iżvilupp ta' qabel u wara t-twelid, tnaqqis fis-sopravivenza talfriegħ u tnaqqis fil-piż tal-friegħ kienu osservati wara li l-omm kienet trattata waqt it-tqala u t-treddigħ b'dożi ta' 15 u 30 mg/kg.
English: Eighty-six of the 91 patients completing the 18 month treatment period subsequently enrolled in an open label extension study, where they all received once daily 20 mg tafamidis meglumine for an additional 12 months.
Maltese: Wara li sitta u tmenin minn 91 pazjent lestew it-trattament fuq tul ta' 18-il xahar, dawn bdew jagħmlu parti minn studju ta' estensjoni open-label fejn kollha rċevew 20 mg tafamidis meglumine darba kuljum għal 12il xahar oħra.
English: 5 PHARMACOLOGIC PROPERTIES
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI
English: Pharmacokinetic parameters were similar after single and repeated administration of 20 mg dose, indicating a lack of induction or inhibition of tafamidis metabolism.
Maltese: Parametri farmakinetiċi kienu simili wara doża waħda ta' 20 mg jew amministrazzjoni repetuta ta' doża ta' 20 mg.
English: The recommended dose of tafamidis meglumine is 20 mg orally once daily.
Maltese: Pożoloġija Id-doża rakkomandata ta' tafamidis meglumine hi 20 mg orali darba kuljum.
English: Very Common
Maltese: Komuni ħafna
English: Although data are limited, (one open label study in 21 patients), taking into account the mechanism of action of tafamidis and the results on TTR stabilisation, tafamidis meglumine is expected to be beneficial in patients with stage 1 TTR amyloid polyneuropathy due to mutations other than V30M.
Maltese: Għalkemm id-dejta hija limitata, (studju wieħed open-label fuq 21 pazjent), u meta tiġi kkunsidrata lazzjoniji tal-mekkaniżmu ta' tafamidis u jiġu kkunsidrati r-riżultati tal-istabilizzazjoni ta' TTR, huwa mistenni li tafamidis meglumine jkun ta' beneffiċju f'pazjenti bil-polinewropatija amyloid tat-tip TTR fi stadju 1, minħabba tibdiliet oħra li mhumiex V30M.
English: Results of once-daily dosing with tafamidis meglumine 20 mg for 14 days demonstrated that steadystate was achieved by Day 14.
Maltese: Riżultati tad-dożaġġ ta' darba kuljum b'tafamidis meglumine 20 mg għal 14-il ġurnata wrew li l-istat fiss jista' jiġi milħuq sa Ġurnata 14.
English: NIS-LL change from BL LSMean (SE)
Maltese: Bidla tal-fibra żgħira minn BL LSMean (SE)
English: In clinical trials of healthy volunteers, the highest dose of tafamidis given was 480 mg in a single dose and 60 mg once daily for two weeks.
Maltese: Fi provi kliniċi f'voluntiera b'saħħithom, logħla doża ta' tafamidis li ngħatat kienet 480 mg bħala doża waħda u 60 mg darba kuljum għal ġimgħatejn.
English: Based on repeated measures analysis of variance with change from baseline as the dependent variable, an unstructured covariance matrix, treatment, month and treatment-by-month as fixed effects, and subject as a random effect in the model.
Maltese: Fuq bażi ta' analiżi ta' miżuri ripetuti ta' varjanza mal-bidla mil-linja bażi bħala l-varjabbli dipendenti, matriċi ta' kovarjanza mhux strutturata, trattament, xahar u trattament skont ix-xahar bħala effetti fissi, u suġġett bħala effett każwali fil-mudell.
English: In the open-label extension study, the rate of change in the NIS-LL during the 12 months of treatment was similar to that observed in those patients randomised and treated with tafamidis in the previous double blind 18 month period.
Maltese: Fl-istudju ta' estensjoni open-label, ir-rata tal-bidla tal-NIS-LL matul it-12-il xahar ta' trattament kienet simili ta' dik osservata f'dawk il-pazjenti magħżulin bl-addoċċ u trattati b'tafamidis fil-perjodu double-blind ta' 18-il xahar ta' qabel.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measure: Description
Maltese: Peress li din hi awtorizzazzjoni taħt ċirkustanzi eċċezzjonali skont l-Artiklu 14 (8) tal-Regolament (KE) 726/2004, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jagħmel, fiżżmien stipulat, il-miżuri li gejjin:
English: This medicine has been prescribed for you only.
Maltese: Mediċini oħra u Vyndaqel
English: The secondary endpoints demonstrated that tafamidis meglumine treatment resulted in less deterioration of neurologic function and improved nutritional status (mBMI) compared with placebo, as shown in the following table.
Maltese: Il-punti tat-tmiem sekondarji wrew li t-trattament b'tafamidis meglumine rriżulta f'inqas deterjorazzjoni tal-funzjoni newroloġika u titjib tal-istat ta' nutrizzjoni (mBMI) meta mqabbla malplaċebo, kif jidher fit-tabella li ġejja.
English: 3 LIST OF EXCIPIENTS
Maltese: KLASSIFIKAZZJONI ĠENERALI
English: There is no explicit evidence of biliary excretion of tafamidis in humans.
Maltese: M'hemm l-ebda evidenza ċara ta' eliminazzjoni biljarja fil-bnedmin.
English: The inhibition of transthyretin tetramer dissociation forms the rationale for the use of tafamidis to slow disease progression.
Maltese: Dan jindika nuqqas ta' induzzjoni jew inibizzjoni tal-metaboliżmu ta' tafamidis.
English: In patients with this disease, TTR breaks up and may form fibres called amyloid.
Maltese: F'pazjenti b'din il-marda, TTR titkisser u tifforma fibri msejjħa amyloid.
English: Further information on Riximyo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Riximyo.
Maltese: Aktar informazzjoni dwar Riximyo tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/Riximyo.
English: The cancer improved in just over 87% of those given Riximyo (271 of 311 patients), and in similar numbers of those given MabThera (274 of 313 patients).
Maltese: Il-kanċer ma aggravax fi ftit aktar minn 87 % ta' dawk li ngħataw Riximyo (271 minn 311-il pazjent), u f'numri simili għal dawk li ngħataw MabThera (274 minn 313-il pazjent).
English: Other information about Riximyo
Maltese: Informazzjoni oħra dwar Riximyo
English: Riximyo contains the active substance rituximab.
Maltese: Riximyo fih is-sustanza attiva rituksimab.
English: Riximyo received a marketing authorisation valid throughout the EU on 15 June 2017.
Maltese: Riximyo rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-15 ta' Ġunju 2017.
English: The reference medicine for Riximyo is MabThera.
Maltese: Il-mediċina ta' referenza għal Riximyo hija MabThera.
English: The medicine is available for infusion (drip) into a vein.
Maltese: Il-mediċina tiġi bħala infużjoni (dripp) ġo vina.
English: The active substance in Riximyo, rituximab, is a monoclonal antibody designed to attach to a protein called CD20, which is present on B cells.
Maltese: Is-sustanza attiva f'Riximyo, ir-rituksimab, hija antikorp monoklonali mfassal biex jeħel ma' proteina msejħa CD20, li hija preżenti fuq iċ-ċelloli B.
English: Laboratory studies comparing Riximyo with the reference medicine MabThera have shown that the active substance in Riximyo is highly similar to that in MabThera in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorji li jqabblu Riximyo mal-mediċina ta' referenza MabThera wrew li s-sustanza attiva f'Riximyo hija simili ħafna għal dik f'MabThera f'termini ta' struttura, purità u attività bijoloġika.
English: What are the risks associated with Riximyo?
Maltese: X'inhuma r-riskji assoċjati ma' Riximyo?
English: It will also provide doctors and patients using the medicine for GPA, MPA or pemphigus with educational material on the risk of infection including that of a rare severe infection, progressive multifocal leukoencephalopathy (PML).
Maltese: Din se tipprovdi wkoll lit-tobba u lill-pazjenti li jużaw il-mediċina għal GPA, MPA jew pemfigus materjal edukattiv dwar ir-riskju ta' infezzjoni inkluż dak dwar infezzjoni severa rari, lewkoenċefalopatija multifokali progressiva (PML).
English: In addition, Riximyo was as effective as MabThera in one main study involving 629 patients with advanced, untreated follicular lymphoma, where Riximyo or MabThera were added to other chemotherapy for part of the treatment.
Maltese: Barra minn hekk, Riximyo kien effettiv daqs MabThera fi studju ewlieni wieħed li involva 629 pazjent b'linfoma follikulari avvanzata u mhux ikkurata, fejn Riximyo jew MabThera ġew miżjuda ma' kimoterapija oħra għal parti mill-kura.
English: The most common side effects with Riximyo are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heartrelated problems.
Maltese: L-effetti sekondarji l-aktar komuni b'Riximyo huma reazzjonijiet relatati mal-infużjoni (bħal deni, sirdat u rogħda) filwaqt li l-effetti sekondarji serji l-aktar komuni huma reazzjonijiet għall-infużjoni, infezzjonijiet u problemi relatati mal-qalb.
English: When rituximab attaches to CD20, it causes the B cells to die, which helps in lymphoma and CLL (where B cells have become cancerous) and in pemphigus (where B cells are involved in inflammation).
Maltese: Meta r-rituksimab teħel ma' CD20, dan jikkawża l-mewt taċ-ċelloli B, li jgħin fil-linfoma u fis-CLL (fejn iċ-ċelloli B ikunu saru kanċerużi) u fil-pemfigus (fejn iċċelloli B huma involuti fl-infjammazzjoni).
English: Riximyo is a ‘biosimilar medicine'.
Maltese: Riximyo jista' jinkiseb biss b'riċetta ta' tabib.
English: This means that Riximyo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Maltese: Dan ifisser li Riximyo huwa simili ħafna għal mediċina bijoloġika oħra (il-'mediċina ta' referenza') li diġà hija awtorizzata fl-UE.
English: Studies have also shown that giving Riximyo produces similar levels of the active substance in the body to giving MabThera.
Maltese: Listudji wrew wkoll li l-għoti ta' Riximyo jipproduċi livelli simili tas-sustanza attiva fil-ġisem bħall-għoti ta' MabThera.
English: The safety of Riximyo has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Maltese: Is-sigurtà ta' Riximyo ġiet evalwata, u abbażi tal-istudji kollha li saru, l-effetti sekondarji tal-mediċina jitqiesu li huma komparabbli ma' dawk tal-mediċina ta' referenza MabThera.
English: An overview of Riximyo and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Riximyo u għalfejn huwa awtorizzat fl-UE
English: How does Riximyo work?
Maltese: Kif jintuża Riximyo?
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Riximyo has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li, b'mod konformi mar-rekwiżiti tal-UE għal mediċini bijosimili, Riximyo għandu struttura, purità u attività bijoloġika simili ħafna għal MabThera u jiġi distribwit bl-istess mod fil-ġisem.
English: For the full list of side effects and restrictions of Riximyo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Riximyo, ara l-fuljett ta' tagħrif.
English: Riximyo is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Maltese: Riximyo huwa mediċina li tintuża fl-adulti għall-kura tal-kanċers tad-demm u tal-kundizzjonijiet infjammatorji li ġejjin:
English: Riximyo must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients or in patients with a severe infection or a severely weakened immune system (the body's defences).
Maltese: Riximyo m'għandux jintuża minn persuni li huma ipersensittivi (allerġiċi) għal rituksimab, proteini talġrieden jew għal kwalunkwe sustanza oħra tiegħu jew f'pazjenti b'infezzjoni severa jew b'sistema immunitarja mdgħajfa b'mod sever (id-difiżi tal-ġisem).
English: What measures are being taken to ensure the safe and effective use of Riximyo?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Riximyo?
English: Depending on the condition it is used to treat, Riximyo may be given on its own, or with chemotherapy (cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).
Maltese: Skont il-kundizzjoni li jintuża biex jikkura, Riximyo jista' jingħata waħdu, jew flimkien ma' kimoterapija (mediċini tal-kanċer) jew ma' mediċini li jintużaw għal disturbi infjammatorji (methotrexate jew kortikosterojd).
English: Riximyo (rituximab)
Maltese: Kif jaħdem Riximyo?
English: All these data were considered sufficient to conclude that Riximyo will behave in the same way as MabThera in terms of effectiveness and safety in its authorised uses.
Maltese: Din id-data kollha ġiet meqjusa biżżejjed sabiex jiġi konkluż li Riximyo ser jaġixxi bl-istess mod bħal MabThera f'termini ta' effikaċja u sigurtà fl-użi awtorizzati tiegħu.
English: In GPA and MPA, destroying B cells lowers the production of antibodies thought to play an important role in attacking the blood vessels and causing inflammation.
Maltese: Pazjenti b'GPA, b'MPA jew b'pemfigus vulgaris m'għandhomx jingħataw Riximyo jekk ikollhom problemi tal-qalb severi.
English: As for all medicines, data on the use of Riximyo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Riximyo hija ssorveljata kontinwament.
English: The full EPAR and risk management plan summary for Episalvan 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: The respective times were 16.0 and 15.1 days respectively in the second study.
Maltese: Iżżminijiet rispettivi kienu 16.0 u 15.
English: Other information about Episalvan
Maltese: Informazzjoni oħra dwar Episalvan
English: The average time to wound closure was 8.8 days for the wounds treated with standard disinfectant gel and 7.6 days for the wounds treated with Episalvan.
Maltese: Iż-żmien medju għall-għeluq tal-ġerħa kien ta' 8.8 jiem għall-ġrieħi kkurati b'ġell disinfettant standard u 7.6 jiem għall-ġrieħi li ġew ikkurati b'Episalvan.
English: This is a summary of the European public assessment report (EPAR) for Episalvan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Episalvan.
English: Episalvan was studied in two main studies involving 217 patients with partial-thickness skin wounds in patients who underwent skin graft surgery.
Maltese: Episalvan ġie studjat f'żewġ studji prinċipali li involvew 217-il pazjent bi ġrieħi tal-ġilda ta' ħxuna parzjali f'pazjenti li kellhom kirurġija ta' graft tal-ġilda.
English: The most common side effects with Episalvan are wound complications, pain in the skin (both of which may affect more than 3 in 100 people) and pruritus (itching) (which may affect more 1 in 100 people).
Maltese: L-effetti sekondarji l-aktar komuni b'Episalvan huma kumplikazzjonijiet tal-ġrieħi, uġigħ fil-ġilda (ittnejn li huma jistgħu jaffettwaw aktar minn 3 persuni minn kull 100) u prurite (ħakk) (li tista' taffettwa aktar minn persuna 1 minn kull 100).
English: Episalvan birch bark extract
Maltese: Episalvan estratt taz-zokk tal-betula
English: Why is Episalvan approved?
Maltese: Għaliex ġie approvat Episalvan?
English: A risk management plan has been developed to ensure that Episalvan is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Episalvan jintuża bl-aktar mod sigur possibbli.
English: What are the risks associated with Episalvan?
Maltese: X'inhuma r-riskji assoċjati ma' Episalvan?
English: A third study involved 57 patients with partial-thickness burn wounds who had half their wound treated with Episalvan and the other half with a standard disinfectant gel.
Maltese: It-tielet studju involva 57 pazjent bi ġrieħi ta' ħruq ta' ħxuna parzjali li kellhom nofs il-ġerħa tagħhom ikkurata b'Episalvan u n-nofs l-ieħor b'ġell disinfettant standard.
English: It is thought that the active substance in Episalvan, birch bark extract, helps the cells that make up the outer layer of the skin (keratinocytes) grow and move quickly towards the gap created by the wound, therefore helping wounds to heal faster.
Maltese: Fir-rigward tas-sikurezza, ma ġiet identifikata ebda kwistjoni maġġuri u l-effetti sekondarji kienu maniġġevoli.
English: The exact way Episalvan works is not fully understood.
Maltese: Episalvan ġell intwera li jnaqqas il-ħinijiet tal-fejqan tal-ġrieħi.
English: Episalvan is available as a gel that should be applied as a thin layer (1 mm in thickness) to the wound, which should then be covered by a wound dressing.
Maltese: Episalvan jiġi bħala ġell li għandu jiġi applikat bħala saff irqiq (ħxuna ta' 1 mm) fuq il-ġerħa, li mbagħad għandha titgħatta b'faxxa għall-ġrieħi.