FrancophonIA/ELRC3.0 huggingface dataset:
English: The Phase I environmental risk assessment following the VICH guideline results in Predicted Environmental Concentrations (PECs) in soil for Pharmasin 100% W/W Water Soluble Granules for all target species above 100 μg/kg, thus requiring a Phase II assessment.
Maltese: Il-valutazzjoni tar-riskju tal-Fażi I mwettqa skont il-linja gwida tal-VICH tirriżulta f'Konċentrazzjonijiet Ambjentali Previsti (PECs) fil-ħamrija għal Pharmasin 100% W/W Water Soluble Granules għall-ispeċi kollha fil-mira ta' aktar minn 100 μg/kg, u għalhekk jeħtieġ valutazzjoni ta' Fażi
English: At a later date data were presented in a form that enabled the comparison of nitrate production between control and treatment soils.
Maltese: F'data iktar tard, ġiet ippreżentata dejta f'forma li ppermettiet it-tqabbil tal-produzzjoni tan-nitrat bejn il-ħamrija ta' kontroll u l-ħamrija tattrattament.
English: Products
Maltese: MEMBRI
English: Anabaena flos-aquae was exposed to different concentrations of an aqueous solution of tylosin tartrate for 72 hours.
Maltese: Anabaena flos-aquae kienet esposta għal konċentrazzjonijiet differenti ta' soluzzjoni milwiema ta' tilosina tartrat għal 72 siegħa.
English: A comparison of the surface water concentrations obtained using the FOCUS models, with the established PNEC (4.2 μg/l) demonstrated that, for all but one of the scenarios investigated, predicted concentrations of tylosin were below the predicted no effect concentrations.
Maltese: Tqabbil tal-konċentrazzjonijiet tal-ilma tal-wiċċ miksuba bl-użu tal-mudelli FOCUS, bil-PNEC stabbilit (4.2 μg/l) wera li, għax-xenarji investigati kollha minbarra wieħed, il-konċentrazzjonijiet ta' tilosina mbassra kienu inqas mill-konċentrazzjonijiet imbassra bla effett.
English: The study was performed in line with OECD guideline 201.
Maltese: L-istudju twettaq f'konformità mal-linja gwida 201 tal-OECD.
English: The TWA PEC was calculated over 3 days as this corresponds to the duration of the blue-green algae (cyanobacteria) study.
Maltese: Il-valur ta' TWA PEC kien kkalkutat fuq 3 ijiem billi dawn jikkorrispondu għat-tul tal-istudju tal-alka blu-ħadra (ċjanobatterji).
English: Similarly the study with terrestrial plants was considered inadequate and due to the uncertainty regarding the NOECs derived in the study a risk for plants could not be excluded.
Maltese: Madankollu, skont l-informazzjoni pprovduta ma jistax jiġi eskluż riskju għaċ-ċjanobatterji.
English: Test fish were exposed to an aqueous solution of tylosin tartrate at a single concentration of 100 mg/l for a period of 96 hours at a temperature of approximately 14 ºC under semi-static test conditions.
Maltese: L-istudju sar f'konformità mal-linja gwida 203 tal-OECD. Il-ħut għat-test kien espost għal soluzzjoni milwiema ta' tilosina tartrat f'konċentrazzjoni waħda ta' 100 mg/l għal perjodu ta' 96 siegħa f'temperatura ta' madwar 14 ºC, f'kundizzjonijiet tat-test semistatiċi.
English: • no conclusion on long term influence on nitrogen transformation by soil microbes can be drawn;
Maltese: • ma tistax tinsilet konklużjoni dwar l-influwenza għal terminu twil dwar it-trasformazzjoni tan-nitroġenu bil-mikrorganiżmi tal-ħamrija;
English: The key omission in the report is the absence of tables for all endpoints determined in the study, for example the numbers of seeds germinating and the biomass (growth) is not reported for the control groups of any of the plants tested.
Maltese: In-nuqqas ewlieni fir-rapport huwa n-nuqqas ta' tabelli għall-endpoints kollha stabbiliti fl-istudju, pereżempju n-numru ta' żerriegħa li tfelles u l-bijomassa (tkabbir) mhumiex rapportati għall-gruppi ta' kontroll ta' xi waħda mill-pjanti ttestjati.
English: In order to follow VICH guidance when proceeding to Tier B the most sensitive species from the above experiment, i.e. radish, should have been retested together with two additional species from the same category.
Maltese: Biex tiġi segwita l-linja gwida tal-VICH meta wieħed jgħaddi għal-livell B, l-aktar speċijiet sensittivi millesperiment t'hawn fuq, jiġifieri r-ravanell, misshom reġgħu ġew ittestjati ma' żewġ speċijiet oħra mill-istess kategorija.
English: A soil nitrogen transformation study was provided; the study was conducted based on OECD Guideline 216, however not according to GLP specifications and with some modifications to the test protocol.
Maltese: Ġie ppreżentat studju dwar it-trasformazzjoni tan-nitroġenu fil-ħamrija; l-istudju twettaq skont ilLinja Gwida 216 tal-OECD, madankollu mhux skont l-ispeċifikazzjonijiet tal-GLP u b'xi modifiki għall-protokoll tat-test.
English: 23.4 g
Maltese: Ġell. 23.4 g
English: Table 1: Adverse reactions reported in clinical trials System organ class
Maltese: Tabella 1: Reazzjonijiet avversi rraportati fi provi kliniċi Sistema tal-klassifika talorgani
English: Date of first authorisation: 14 January 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 14 Jannar 2016
English: Rash pruritic Purpura
Maltese: Raxx pruritiku Purpura
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1069/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ UE/1/15/1069/001
English: 75223 Niefern-Öschelbronn Germany tel +49 (0) 7233 9749 - 0 fax+49 (0) 7233 9749 - 210
Maltese: 75223 Niefern-Öschelbronn Il-Ġermanja tel +49 (0) 7233 9749 - 0 fax +49 (0) 7233 9749 - 210
English: Of the patients with a between-treatment difference in wound healing (N=35), the percentage of patients who showed earlier healing (primary endpoint) of their Episalvan treated wound half (85.7% [95% CI: 69.7%, 95.2%]) was higher than those who showed earlier healing of their standard of care control treated wound half (14.3% [95% CI: 4.8%, 30.3%]) (p < 0.0001, binomial test).
Maltese: Mill-pazjenti b'differenza ta' bejn il-kura fil-fejqan tal-ġerħa (N=35), ilpersentaġġ ta' pazjenti li wrew fejqan aktar kmieni (punt aħħari primarju) fin-nofs tal ġerħa kkurata b'Episalvan (85.7% [95% CI: 69.7%, 95.2%]) kien ogħla minn dawk liwrew fejqan aktar kmieni ta' nofs il-ġerħa ikkurata b'kura standard (14.3% [95% CI: 4.8%, 30.3%]) (p < 0.0001, test binomali).
English: Pack size:1 tube of 23.4 g gel.
Maltese: Daqs tal-pakkett: tubu wieħed ta' 23.4 g ta' ġell.
English: Interactions with topical products have not been investigated in clinical trials.
Maltese: Interazzjonijiet ma' prodotti topiċi ma ġewx investigati fi provi kliniċi.
English: Sunflower oil, refined.
Maltese: Żejt tal-ġirasol, raffinat.
English: INFORMATION IN BRAILLE Episalvan gel (carton only)
Maltese: INFORMAZZJONI BIL-BRAILLE Episalvan gel (kartuna biss)
English: Intention-to-treat (ITT) data set.
Maltese: Sett tad-dejta ta' intenzjoni ta' kura (ITT).
English: Extraction solvent: n-heptane.
Maltese: Solvent ta' estrazzjoni n-heptane.
English: 75223 Niefern-Öschelbronn GERMANY
Maltese: 75223 Niefern-Öschelbronn
English: The Phase III studies were blindly evaluated, prospective, intra-individually controlled, randomised, multicentre trials.
Maltese: L-istudji tal-Fażi III kienu provi vvalutati fl-agħma, prospettivi, ikkontrollati intraindividwalment, randomizzati, multiċentriċi.
English: OUTER CARTON and TUBE
Maltese: KARTUNA TA' BARRA u TUBU
English: Extraction solvent: n-Heptane
Maltese: Solvent ta' estrazzjoni n-Heptane
English: Episalvan gel is sterile.
Maltese: Episalvan gel hu sterili.
English: -1.0 days (CI: -1.4, -0.6) faster wound closure with Episalvan, p<0.0001a
Maltese: -1.0 ijiem (CI: -1.4, -0.6) għeluq aktar malajr talġerħa b'Episalvan, p<0.
English: The mean wound size treated with Episalvan in clinical studies in split-thickness skin graft donor site wounds was 40.7 cm² (range 8-300 cm²).
Maltese: Id-daqs medju tal-ġerħa kkurata b'Episalvan fi studji kliniċi fi ġrieħi ta' grafts tal-ġilda tas-sit tad-donatur fi ħxuna maqsuma kien ta' 40.7 cm² (medda 8-300 cm²).
English: -1.1 days (CI: -1.5, -0.7) faster wound closure with Episalvan, p<0.0001a
Maltese: -1.1 ijiem (CI: -1.5, -0.7) għeluq aktar malajr talġerħa b'Episalvan, p<0.
English: Observer-blinded photo assessment (blinded read), mean expert evaluation primary blinded read / very conservative calculation (primary endpoint for STSG studies)
Maltese: Valutazzjoni fotografika fl-agħma mill-osservatur (qari agħma), evalwazzjoni esperta medja qari agħma primarju / kalkolazzjoni konservattiva ħafna (punt aħħari primarju għal studji
English: The frequency of adverse reactions is defined as follows: 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), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita kif ġej: 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The 219 patients with split-thickness skin graft donor site wounds had a mean age of 53 years; their donor site mean wound size was 81.5 cm2.
Maltese: Il-219-il pazjent bi ġrieħi tas-sit donatur tat-trapjant tal-ġilda bi ħxuna maqsuma kellhom età medja ta' 53 sena; id-daqs medju tal-ġerħa tas-sit donatur kien ta' 81.5 cm2.
English: Uncommon side effects (may affect up to 1 in 100 people): - wound infection - allergic reaction (hypersensitivity) - skin irritation (dermatitis) - itchy rash - purple coloured rash - pain
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100): - infezzjonijiet tal-ġrieħi - reazzjoni allerġika (sensittività eċċessiva) - irritazzjoni tal-ġilda (dermatite) - raxx bil-ħakk - raxx ta' kulur vjola - uġigħ
English: NAME OF THE MEDICINAL PRODUCT Episalvan gel
Maltese: TAL-PRODOTT MEDIĊINALI Episalvan gel
English: In the following table, adverse reactions are listed by MedDRA system organ class and preferred term.
Maltese: Fit-tabella li jmiss, ir-reazzjonijiet avversi huma elenkati permezz tas-sistema talklassifika tal-organi MedDRA u t-terminu ppreferut.
English: Mechanism of action and pharmacodynamic effects The active substance accelerated re-epithelialization in an in vitro wound scratch assay using human primary keratinocytes at the dosage of 1 μg/ml, and in a porcine ex vivo wound healing model at the dosage of 10 µg/ml.
Maltese: Is-sustanza attiva aċċellerat epitelizzazzjoni mill-ġdid f'assaġġ tal-grif tal-ġerħa in vitro bl-użu ta' keratinotiċi primarji umani fid-dożaġġ ta' 1 μg/ml, u f'mudell ta' fejqan ta' ġerħa ex vivo porċina ta' 10 µg/ml.
English: In the Grade 2a burn wound study, the mean wound size treated with Episalvan was 108 cm² (range 23-395 cm²).
Maltese: Fl-istudju Grad 2a dwar il-ġrieħi tal-ħruq, id-daqs medju tal-ġrieħi ikkurati b'Episalvan kien ta' 108 cm² (range 23-395 cm²).
English: See section 4.4 and 5.1 with respect to type of wounds studied.
Maltese: Ara sezzjoni 4.4 u 5.1 rigward it-tip ta' ġrieħi studjati.
English: Episalvan is for single use only.
Maltese: Episalvan jista' jintuża waqt it-tqala.
English: The most frequently observed adverse reactions were wound complication (in 2.9% of patients), pain of skin (2.5%) and pruritus (1.3%).
Maltese: L-aktar reazzjonijiet avversi osservati b'mod frekwenti kienu kumplikazzjoni tal-ġerħa (fi 2.9% tal-pazjenti), uġigħ tal-ġilda (2.5%) u prurite (1.3%).
English: Hypersensitivity to the active substance or to the excipient listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjent elenkat fis-sezzjoni 6.1.
English: Episalvan gel is packed in white collapsible aluminium tubes.
Maltese: Episalvan gel huwa ppakkjat f'tubi tal-aluminju abjad kollassabbli.
English: Wound halves treated with Episalvan healed faster than the wound halves treated with standard of care (mean 1.1 days according to primary endpoints, p<0.0001, two-sided paired t-test).
Maltese: Nofsijiet tal-ġrieħi kkurati b'Episalvan fiequ aktar malajr min-nofsijiet ikkurati b'kura standard (medju 1.1 ijiem skont il-punti aħħari primarji, p<0.0001, test-t f'par fuq żewġ naħat).
English: The most frequently reported side effects are: Common side effects (may affect up to 1 in 10 people): - painful skin - itching - complications in the wound healing process
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10): - uġigħ tal-ġilda - ħakk - kumplikazzjonijiet fil-proċess tal-fejqan tal-ġerħa
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1g gel contains: 100 mg birch bark extract (as dry extract, refined) from Betula pendula/Betula pubescens, corresponding to 72-88 mg betulin.
Maltese: ATTIVA(I) 1g ta' ġell fiha: 100 mg ta' estratt tal-qoxra tal-betula (bħala estratt niexef, raffinat) minn Betula pendula/Betula pubescens, li jikkorespondi għal 72-88 mg betulin.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Rapportar ta' reazzjonijiet avversi suspettati Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara lawtorizzazzjoni tal-prodott mediċinali.
English: How to store Episalvan 6.
Maltese: Kif taħżen Episalvan 6.
English: Other medicines and Episalvan
Maltese: Mediċini oħra u Episalvan
English: The active substance was not genotoxic in in vitro assays.
Maltese: Is-sustanza attiva ma kinitx ġenotossika f'assaġġi in vitro.
English: Carcinogenicity and reproductive and developmental toxicity studies have not been performed.
Maltese: Ma sarux studji dwar it-tossiċità karċinoġenika u riproduttiva u tal-iżvilupp ma sarux.
English: < PC: {number} SN: {number} NN: {number}>
Maltese: Tipi oħra ta' ġrieħi
English: 1 g gel contains: 100 mg extract (as dry extract, refined) from birch bark from Betula pendula, Betula pubescens as well as hybrids of both species (equivalent to 0.5-1.0 g birch bark), corresponding to 72-88 mg betulin.
Maltese: 1 g ta' ġell fiha: 100 mg ta' estratt (bħala estratt niexef, raffinat) mill-qoxra tal-betula minn Betula pendula, Betula pubescens kif ukoll minn ibridi taż-żewġ speċi (ekwivalenti għal 0.5-1.0 g ta' qoxra tal-betula), li jikkorrespondu għal 72-88 mg betulin.
English: Wound complication* * Wound complication comprises different kinds of local complications such as post-procedural complications, wound necrosis, wound secretion, impaired healing, or inflammation of wound.
Maltese: * Komplikazzjoni tal-ġerħa tikkonsisti minn tipi differenti ta' komplikazzjonijiet lokali bħal komplikazzjonijiet ta' wara l-proċedura, nekrożi tal-ġerħa, tnixxija tal-ġerħa, fejqan imfixkel jew infjammazjoni tal-ġerħa.
English: Three Phase III studies were conducted to assess the efficacy and safety of Episalvan in the treatment of partial thickness wounds of the skin: two studies which investigated split-thickness skin graft donor site wounds, which included a total of 219 patients (ITT: N=217), and one further study in 61 patients with Grade 2a burn wounds (ITT: N=57).
Maltese: Saru tliet studji tal-Fażi III sabiex jivvalutaw l-effikaċja u s-sigurtà ta' Episalvan fil-kura ta' ġrieħi tal-ġilda bi ħxuna parzjali: żewġ studji li investigaw ġrieħi tas-sit tad-donatur tat-trapjant tal-ġilda bi ħxuna maqsuma, li inkludew total ta' 219-il pazjent (ITT: N=217), u studju ieħor f'61 pazjent bi ġrieħi tal-ħruq ta' Grad 2a (ITT: N=57). Pazjenti bi ġrieħi tal-ħruq aktar fondi (Grad 2b) ma kinux inklużi.
English: Mean intra-patient difference in time to wound closure (95% epithelialisation)
Maltese: Differenza medja bejn pazjent u ieħor fiż-żmien għall-għeluq talġerħa (95% epitelizzazzjoni)
English: Renal or hepatic impairment
Maltese: Indeboliment renali u epatiku
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, local tolerance, and phototoxicity.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, tolleranza lokali u fototossiċità, ma juri l-ebda periklu speċjali għall-bnedmin.
English: DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: DATA TA' REVIŻJONI TAT-TEST Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu
English: Split-thickness skin graft donor site wound studies
Maltese: Differenza bejn pazjent u ieħor fiż-żmien għall-għeluq tal-ġerħa
English: Overdosing with Episalvan is unlikely: in patients in which wound sizes >300 cm were repeatedly treated with Episalvan, no betulin plasma levels could be detected.
Maltese: Doża eċċessiva b'Episalvan hija improbabbli: f'pazjenti fejn id-daqsijiet tal-ġrieħi >300 cm kienu kkurati ripetutament b'Episalvan, l-ebda livell tal-plażma ta' betulin ma ġie osservat.
English: No data are available.
Maltese: Dejta mhux disponibbli
English: Median time to wound healing was 7.3 days.
Maltese: Iż-żmien medjan għall-fejqan tal-ġrieħi kien ta' 7.3 ijiem.
English: Birch pollen allergy
Maltese: GĦAMLA KWALITATTIVA
English: Other wound types
Maltese: Tul ta' żmien tal-użu
English: Based on data from three clinical studies with a total of 280 patients, application of Episalvan gel to open wounds did not lead to betulin plasma levels higher than natural background-levels originating e.g. from nutritional sources.
Maltese: Abbażi ta' dejta minn tliet studji kliniċi b'total ta' 280 pazjent, l-applikazzjoni ta' Episalvan gel fuq ġrieħi miftuħa ma wassalx għal livelli tal-plażma betulin ogħla minn livelli tal-isfond naturali li joriġinaw eż. minn sorsi nutrizzjonali.
English: Episalvan gel Birch bark extract
Maltese: Kif għandek tuża Episalvan
English: In the Grade 2a burn wound study an octenidine containing antiseptic wound gel and fatty gauze dressing were used as control.
Maltese: Fl-istudju Grad 2a talġrieħi tal-ħruq, ġell antisettiku għall-ġrieħi li fih octenidine u garżi xaħmija ntużaw bħala kontroll.
English: Discard after use.
Maltese: Mhux applikabbli.
English: Treatment of partial thickness wounds in adults.
Maltese: Kura ta' ġrieħi ta' ħxuna parzjali fl-adulti.
English: Grade 2a burn wound study
Maltese: Studju Grad 2a talġrieħi tal-ħruq
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għatTqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: The primary endpoint for the two split-thickness skin graft trials was the intra-individual difference in time to wound closure (at least 95% epithelialisation) based on blinded photo evaluations.
Maltese: Il-punt aħħari primarju għall-prova ta' Grad 2a tal-ġerħa tal-ħruq kien il-persentaġġ ta' pazjenti b'fejqan aktar kmieni (tal-inqas 95% epitelizzazzjoni) ibbażati fuq valutazzjonijiet fotografiċi fl-agħma.
English: There is no clinical experience from use of Episalvan for the treatment of chronic wounds, e.g. diabetic foot ulcers, venous leg ulcers or wounds in patients with epidermolysis bullosa.
Maltese: Ma hemm l-ebda esperjenza klinika mill-użu ta' Episalvan għall-kura ta' ġrieħi kroniċi, eż. ulċeri dijabetiċi tas-sieq, ulċeri venużi tar-riġel jew ġrieħi f'pazjenti b'epidermolysis bullosa.
English: If you use more Episalvan than you should Episalvan is applied to the skin and the absorption into the body is minimal.
Maltese: Episalvan jiġi applikat fuq il-ġilda u l-assorbiment ta' Episalvan fil-ġisem huwa minimu.
English: For cutaneous application.
Maltese: U KWANTITATTIVA
English: Other side effects include:
Maltese: 'sekondarju':
English: The safety and efficacy of Episalvan in children and adolescents under 18 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Episalvan fit-tfal u l-adolexxenti taħt it-18-il sena ma ġewx determinati s'issa.
English: Skin and subcutaneous tissue disorders
Maltese: Uġigħ tal-ġilda Dermatite Prurite
English: Fertility studies have not been conducted.
Maltese: Ma sarux studji ta' fertilità.
English: White collapsible aluminium tube, interior lacquered with epoxy phenolic coating, and with a sealing compound in the fold.
Maltese: Mhumiex antiċipati effetti matul it-tqala, peress li l-esponiment sistemiku huwa negliġibbli.
English: No effects during pregnancy are anticipated, since systemic exposure to Episalvan is negligible.
Maltese: Mhumiex antiċipati effetti matul it-tqala, peress li lesponiment sistematiku huwa negliġibbli.
English: In follow-up visits at 3 months and 12 months after the day of surgery or of burn injury the treated wound halves were found to be equal in the majority of patients with regard to pigmentation, redness, texture and hair growth of the regenerated epidermis.
Maltese: Fil-viżti ta' segwitu fi 3 xhur u 12-il xahar wara l-jum tal-kirurġija jew tal-ġerħa tal-ħruq in-nofsijiet tal-ġrieħi kkurati nstabu li kienu ndaqs fil-maġġoranza tal-pazjenti firrigward ta' pigmentazzjoni, ħmura, struttura u tkabbir tax-xagħar tal-epidermis riġenerata.
English: Episalvan gel is a herbal medicinal product which contains dry extract from birch bark.
Maltese: Episalvan gel huma prodott mediċinali erbali li fih estratt niexef mill-qoxra tal-betula.
English: EXP
Maltese: STSG)
English: No data are available on possible interaction between Episalvan and other medicines applied to the skin.
Maltese: Mhemmx dejta disponibbli fuq l-interazzjoni possibbli bejn Episalvan u mediċini oħrajn użati fuq il-ġilda.
English: See section 4.4 with respect to wound size and duration of treatment.
Maltese: Ara sezzjoni 4.4 rigward id-daqs tal-ġerħa u d-dewmien tal-kura.
English: Marketing Authorisation Holder and Manufacturer Amryt AG
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET RIGWARD ILPROVVISTA
English: Since no biologically relevant levels of betulin were found in patients, no further studies related to distribution, biotransformation and elimination were performed.
Maltese: Minħabba li l-ebda livell ta' betulin bijoloġikament relevanti ma nstab fil-pazjenti, ma saru l-ebda studju relatat mad-distribuzzjoni, bijotrasformazzjoni u eliminazzjoni.
English: Additional standard treatment may be required (see section 4.5).
Maltese: Kura oħra standard tista' tkun meħtieġa (ara sezzjoni 4.5).
English: See section 4.2 for information on paediatric use.
Maltese: Ara sezzjoni 4.2 għal tagħrif dwar l-użu pedjatriku.
English: Apply Episalvan at the next planned change of the wound dressing, continuing with your normal routine.
Maltese: Applika Episalvan fil-bidla ppjanata li jmiss tal-garża tal-ġerħa, filwaqt li tkompli bir-rutina normali tiegħek.
English: • Episalvan should be applied to the wound surface at a thickness of approximately 1 mm and covered by a sterile wound dressing.
Maltese: • Episalvan għandu jiġi applikat fuq wiċċ il-ġerħa fi ħxuna ta' madwar 1 mm u għandu jinkesa b'garża sterili għall-ġrieħi.
English: In the burn wound study with 61 patients, the mean study wound area was 216 cm2; the total burn injury of these patients was larger and affected 5.8% of the total body surface area.
Maltese: Fl-istudju dwar il-ġrieħi tal-ħruq b'61 pazjent, l-erja medja tal-ġerħa tal-istudju kienet 216 cm2; il-korriment totali tal-ħruq kien akbar u affetwa 5.8% tal-erja tas-superfiċje tal-ġisem.
English: Adverse reactions were administration site reactions only.
Maltese: Ir-reazzjonijiet avversi kienu reazzjonijiet tal-post mnejn jingħata biss.
English: For a subset of patients blinded photo-evaluation indicated better results for Episalvan treated wound halves compared to standard of care in pigmentation, redness and texture of the former wound areas.
Maltese: Għal sottogrupp ta' pazjenti evalwazzjoni fotografika fl-agħma indikat riżultati aħjar għal nofsijiet tal-ġrieħi ikkurati b'Episalvan meta mqabbla ma' kura standard ta' pigmentazzjoni, ħmura u struttura tal-erjas tal-ġrieħi ta' qabel.
English: Difference in time to wound closure was set to 0 for photo series rated as ‘not evaluable'.
Maltese: Id-differenza fil-ħin tal-għeluq tal-ġerħa kien iffissat għal 0 għal serje fotografika ikklassifikata bħala 'ma jistgħux jiġu evalwati'.
English: Injury, poisoning and procedural complications
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura