FrancophonIA/ELRC3.0 huggingface dataset:
English: Via Palermo, 26/A, Parma, 43122, Italy Phone: +39 0521 2791
Maltese: Via Palermo, 26/A, Parma, 43122, l-Italja Telefon:
English: In vitro studies have revealed no evidence of anchorage-independent growth indicative of tumorigenic potential.
Maltese: Studji in vitro ma wrew l-ebda evidenza ta' tkabbir indipendenti mill-ankraġġ li huwa indikattiv ta' potenzjal tumoriġeniku.
English: An incision of 2 x 2 mm is made to remove the biopsy.
Maltese: Issir inċiżjoni ta' 2 x 2 mm biex tittieħed il-bijopsija.
English: • Replace it with Holoclar
Maltese: Mediċini oħra u Holoclar
English: By taking some healthy limbal cells, a new layer of healthy tissue is grown in the laboratory on a supporting layer of fibrin, a protein scaffold.
Maltese: Billi tieħu xi ċelluli limbali f'saħħithom, saff ġdid ta' tessut f'saħħtu jitkabbar fil-laboratorju fuq saff ta' appoġġ ta' fibrin, li huwa qafas ta' proteini.
English: - There are two excipients: one is fibrin - a clear supportive layer used to keep Holoclar intact, the other one is a liquid containing amino acids, vitamins, salts and carbohydrates to store the cells in the vial called Dulbecco's Modified Eagles Medium supplemented with L-glutamine.
Maltese: - Hemm żewġ eċċipjenti: wieħed huwa fibrin - saff ċar ta' appoġġ użat biex iżomm Holoclar intatt, l-ieħor huwa likwidu li fih aċidi amminiċi, vitamini, melħ u karboidrati biex jaħżen iċ ċelluli fil-kunjett imsejjaħ Dulbecco's Modified Eagles Medium supplementat b'L-glutamine.
English: The container is put in a secondary plastic container which is then put in a sealed sterile plastic bag.
Maltese: Il-kontenitur jitpoġġa f'kontenitur sekondarju tal-plastik li mbagħad jitqiegħed f'borża tal-plastik sterili ssiġillata.
English: Implantation
Maltese: Manifattur
English: Treatment of adult patients with moderate to severe limbal stem cell deficiency (defined by the presence of superficial corneal neovascularisation in at least two corneal quadrants, with central corneal involvement, and severely impaired visual acuity), unilateral or bilateral, due to physical or chemical ocular burns.
Maltese: Kura ta' pazjenti adulti b'nuqqas moderat sa sever ta' ċelluli staminali limbali (definit mill-preżenza ta' neovaskularizzazzjoni superfiċjali tal-kornea f'mill-inqas żewġ kwadranti tal-kornea, b'involviment tal-kornea ċentrali, u b'akutezza viżiva indebolita b'mod sever), unilaterali jew bilaterali, minħabba ħruq okulari fiżiku jew kimiku.
English: Post-biopsy treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: BATCH NUMBER, DONATION AND PRODUCT CODES Batch:
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT LOTT:
English: For implantation.
Maltese: Għall-impjant.
English: The proportion of patients with improvement in visual acuity was higher among those without a scar of the corneal stroma (15/18 patients, 83.3%) than in those with scarring (36/81 patients, 44.4%).
Maltese: Il-proporzjon ta' pazjenti b'titjib fl-akutezza viżiva kien ogħla fost dawk mingħajr ċikatriċi tal-istroma tal-kornea (15/18-il pazjent, 83.3%) milli f'dawk b'ċikatriċi (36/81 pazjent, 44.4%).
English: BATCH NUMBER, DONATION AND PRODUCT CODES Batch
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT Lott
English: Other anaesthesiology procedures may be followed at the discretion of the surgeon.
Maltese: Jistgħu jiġu segwiti proċeduri anestesjoloġiċi oħra fid-diskrezzjoni tal-kirurgu.
English: Marketing Authorisation Holder Chiesi Farmaceutici S.p.A.
Maltese: Chiesi Farmaceutici S.p.A.
English: See the educational material for further information.
Maltese: Ara l-materjal edukattiv għal aktar informazzjoni.
English: The most serious side effects are problem with cornea (erosion) and perforation of the cornea, which may occur within the 3 months from Holoclar implantation.
Maltese: L-aktar effetti sekondarji serji huma problema fil-kornea (tħaffir) u perforazzjoni tal-kornea, li jistgħu jseħħu fi żmien 3 xhur mill-impjantazzjoni ta' Holoclar.
English: Holoclar is intended solely for use in autologous limbal stem cell regeneration in line with the approved therapeutic indication and should be administered under aseptic conditions in conjunction with limbal peritomy, undermining of the conjunctiva and excision of the corneal fibrovascular tissue in preparation of the defect bed.
Maltese: Tqegħid tal-Impjant Holoclar huwa maħsub biss għall-użu fir-riġenerazzjoni awtologa ta' ċelluli limbali staminali f'konformità mal-indikazzjoni terapewtika approvata u għandu jingħata taħt kondizzjonijiet asettiċi flimkien ma' peritomija limbali, taħfir taħt il-konġuntiva u qtugħ tat-tessut fibrovaskulari tal-kornea bħala preparazzjoni tas-sit tad-difett.
English: Syncope vasovagal
Maltese: Kif jingħata Holoclar
English: Prior to implantation the patient's name should be carefully checked with the patient/donor identification on the shipment documentation and product container.
Maltese: Qabel ma jiġi impjantat l-isem tal-pazjent għandu jiġi ċċekkjat b'attenzjoni mal-identifikazzjoni tal-pazjent/donatur fuq id-dokumentazzjoni tal-kunsinna u fuq il-kontenitur tal-prodott.
English: Conjunctival adhesion, conjunctival hyperaemia, corneal oedema, corneal
Maltese: Oftalmoloġiċi, oftalmoloġiċi oħra, Kodiċi ATC:
English: Pharmacotherapeutic group: Ophthalmologicals, other ophthalmologicals, ATC code: S01XA19 Mechanism of action and pharmacodynamic effects The mechanism of action of Holoclar is the replacement of corneal epithelium and lost limbal stem cells in patients in which the limbus has been destroyed by ocular burns.
Maltese: Każijiet oħra meta ma jkunx jista' jintuża Holoclar Anke jekk il-kirurgu diġà ħa kampjun żgħir ta' ċelluli limbali (bijopsija) meħtieġ biex tiġi manifatturata l-mediċina, huwa possibbli li ma tkunx tista' tiġi kkurat b'Holoclar.
English: • Bleeding from the eye lid skin
Maltese: .8 Effetti mhux mixtieqa
English: When possible, concomitant eye problems should be corrected prior to Holoclar implantation.
Maltese: Meta possibbli, problemi oħra fl-għajnejn għandhom jiġu kkoreġuti qabel jitqiegħed l-impjant Holoclar.
English: The efficacy of the medicinal product was evaluated in a multi-centre, case-series, non-controlled, retrospective cohort study in 106 patients (HLSTM01 study) of both genders, treated for the presence of a moderate to severe limbal stem cell deficiency (LSCD).
Maltese: L-effikaċja tal-prodott mediċinali kienet evalwata fi studju ta' koorti retrospettiv, b'aktar minn ċentru wieħed, serje ta' każijiet u mhux ikkontrollat f'106 pazjenti (studju HLSTM01) taż-żewġ sessi, ikkurati għall-preżenza ta' nuqqas moderat sa sever ta' ċelluli staminali limbali (LSCD - limbal stem cell deficiency).
English: Visit 2: Holoclar implantation
Maltese: Vista 2: Tqegħid tal-impjant Holoclar Fit-tieni vista l-kirurgu se:
English: Holoclar contains lethally-irradiated murine 3T3 fibroblast cells and may contain traces of foetal bovine serum.
Maltese: 3T3 tal-ġrieden irradjati b'mod letali u jista' jkun fih traċċi tas-serum tal-feti tal-bovini.
English: Following implantation, an appropriate regimen of topical and systemic anti-inflammatory and prophylactic antibiotic treatment must be given.
Maltese: Wara t-tqegħid tal-impjant, għandu jingħata kors xieraq ta' kura b'anti-infjammatorju topiku u sistemiku u antibijotiku profilattiku.
English: Uncommon perforation, eye irritation, photophobia
Maltese: Adeżjoni tal-konġuntiva, iperimija tal-konġuntiva, edima tal-kornea, perforazzjoni talkornea, irritazzjoni fl-għajn, fotofobija
English: What Holoclar contains - The active substance consists of 300,000 - 1,200,000 of your living eye cells, on average 3.5% of which are stem cells.
Maltese: X'fih Holoclar - Is-sustanza attiva tikkonsisti minn 300,000 - 1,200,000 ċellula ħajja tal-għajn tiegħek, li medja ta' 3.5% minnhom huma ċelluli staminali.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PLASTIC BAG (TERTIARY)
Maltese: BORŻA TAL-PLASTIK (TERZJARJA)
English: At the time of product administration, the mean duration of the condition since the injury was 18 years (median 10 years), 99% of patients had corneal opacity and 90% of them had a severe impairment in visus (1/10th or less at Snellen chart).
Maltese: Fil-ħin tal-għoti tal-prodott, il-medja tat-tul tal-kondizzjoni sa minn meta saret il-ħsara kienet 18-il sena (medjan 10 snin), 99% tal-pazjenti kellhom opaċità tal-kornea u 90% minnhom kellhom indeboliment sever in visus (1/10th jew inqas fiċ ċart ta' Snellen).
English: NAME OF THE MEDICINAL PRODUCT Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent
Maltese: Holoclar ekwivalenti għal 79,000 - 316,000 ċellula/ċm2 ta' tessut ħaj
English: Although the risk is considered to be low and controlled in the manufacturing.
Maltese: Għalkemm ir-riskju huwa meqjus bħala baxx u kkontrollat waqt il-manifattura.
English: The product is implanted locally.
Maltese: Il-prodott huwa impjantat lokalment.
English: Conjunctival haemorrhage, eye haemorrhage, corneal epithelium defect, eye pain, glaucoma/intraocular pressure increased, ulcerative keratitis
Maltese: Emorraġija fil-konġuntiva, emorraġija fl-għajn, difett flepitelju tal-kornea, uġigħ flgħajn, glawkoma/żieda filpressjoni ta' ġewwa l-għajn, keratite ulċerattiva
English: Keep Holoclar within the steel container in the plastic bag until surgery.
Maltese: Żomm Holoclar fil-kontenitur tal-azzar fil-borża tal-plastik sal-kirurġija.
English: Educational material for patients and/or carers to address the following key elements: - Contraindicated use of eye drops containing benzalkonium chloride - Side effects of post-transplant treatment with antibiotics and corticosteroids - Inform patients of the registry - Reporting suspected side effects
Maltese: - Effetti sekondarji ta' kura wara t-trapjant b'antibijotiċi u kortikosterojdi - Jgħarraf lill-pazjenti dwar ir-reġistru - Rappurtar ta' effetti sekondarji suspettati
English: No interactions between Holoclar and the post-biopsy/post-operative treatment suggested in section 4.2 have been reported.
Maltese: Ma kinux irrappurtati interazzjonijiet bejn Holoclar u l-kura ta' wara l-bijopsija/wara l-operazzjoni issuġġeriti f'sezzjoni 4.2. 4
English: After surgery, you will be prescribed a course of medicines to ensure full healing: antibiotics to reduce the chance of an infection and steroids to reduce swelling and irritation.
Maltese: Wara l-kirurġija, se tiġi preskritt kors ta' mediċini biex jiġi żgurat fejqan komplut: antibijotiċi biex inaqqsu iċ-ċans ta' infezzjoni u sterojdi biex inaqqsu in-nefħa u l-irritazzjoni.
English: Do not store above 25°C or below 15°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C jew inqas minn 15°C.
English: The treatment may be repeated if considered indicated by the treating physician.
Maltese: Dan ifisser li għad trid tingħata aktar evidenza dwar din il-mediċina.
English: The proportion of patients with symptoms (pain, burning or photophobia) significantly decreased from pre-surgery (40 patients with at least one symptom; 38.5%) to one year after the procedure (12 patients; 11.5%).
Maltese: Il-proporzjon ta' pazjenti b'sintomi (uġigħ, ħruq jew fotofobija) naqas b'mod sinifikanti minn qabel ilkirurġija (40 pazjent b'mill-inqas sintomu wieħed; 38.5%) sa sena wara l-proċedura (12-il pazjent;
English: NAME OF THE MEDICINAL PRODUCT Holoclar 79,000 - 316,000 cells/cm2 living tissue equivalent.
Maltese: Holoclar ekwivalent għal 79,000 - 316,000 ċellula/ċm2 ta' tessut ħaj.
English: A minimum of 1 - 2 mm2 of undamaged limbus is required for biopsy.
Maltese: Huwa meħtieġ mill-inqas 1 - 2mm2 ta' limbus bla ħsara għall-bijopsija.
English: Handle with care, avoid any shaking, inverting or other mechanical stress.
Maltese: Immaniġġja b'attenzjoni, evita' li jiġi mħawwad, li jinqaleb ta' taħt fuq u kwalunkwe stress mekkaniku ieħor.
English: As a precautionary measure, and in light of the requirement of the post-operative pharmacological treatment, it is preferable to avoid the use of Holoclar during pregnancy.
Maltese: Bħala prekawzjoni, minħabba l-ħtieġa ta' kura farmakoloġika wara l-operazzjoni, hu preferribli li ma jintużax Holoclar waqt it-tqala.
English: What Holoclar looks like and contents of the pack Holoclar is a layer of cells for implantation into your eye.
Maltese: Kull preparazzjoni ta' Holoclar hija maħsuba bħala kura waħda.
English: • Uneven eyelids
Maltese: Komuni ħafna
English: Do not use eye-drops containing benzalkonium chloride and/or other preservatives.
Maltese: Tużax qtar għall-għajnejn li fihom benzalkonium chloride u/jew preservattivi oħra.
English: Patient's Date of Birth:
Maltese: DATA TA' SKADENZA JIS:
English: Ask your surgeon if you have any further questions about the treatment with Holoclar.
Maltese: Kellem lill-kirurgu tiegħek qabel ma tingħata Holoclar.
English: EXPIRY DATE EXP : Day / Month / Year At time: Hour / Minute (CET)
Maltese: Siegħa / Minuta (CET)
English: Fifty-seven patients underwent a keratoplasty after the use of the product with a success rate of 42.1% (N=24) one year after the corneal transplantation (i.e. with a stable corneal epithelium without significant recurrence of neovascularisation).
Maltese: Sebgħa u ħamsin pazjent għamlu keratoplastija wara l-użu tal-prodott b'rata ta' suċċess ta' 42.1% (N =24) sena waħda wara t-trapjant tal-kornea (jiġifieri b'epitelju tal-kornea stabbli mingħajr rikorrenza sinifikanti ta'neovaskularizzazzjoni).
English: Skin and subcutaneous tissue disorders
Maltese: Holoclar fih ċelluli fibroblasti
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Holoclar in one or more subsets of the paediatric population in the treatment of limbal stem cell deficiency due to ocular burns (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini iddifferiet l-obbligu li jiġu ppreżentati riżultati tal-istudji b'Holoclar f'wieħed jew iktar settijiet tal-popolazzjoni pedjatrika fil-kura ta' defiċjenza ta' ċelluli staminali limbali kkawżata minn ħruq okulari (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The nature and intended clinical use of Holoclar are such that conventional pharmacokinetic studies on absorption, biotransformation and elimination are not applicable.
Maltese: In-natura u l-użu kliniku maħsub ta' Holoclar huma tali li studji farmakokinetiċi konvenzjonali fuq l assorbiment, bijotrasformazzjoni u eliminazzjoni mhumiex applikabbli.
English: Immunohistochemical analysis of cornea taken from patients receiving keratoplasty after Holoclar treatment demonstrated that the transplanted stem cells establish a normal layer of stratified corneal epithelium, which do not migrate or invade basal ocular structures.
Maltese: L-aktar reazzjoni frekwenti relatata mal proċedura kirurġika kienet emorraġija fil-konġuntiva (5%) osservata l-aktar matul l-ewwel ġurnata wara l-kirurġija u hemm tendenza li tkun ħafifa fl-intensità u tisparixxi wara ftit ġranet mingħajr kura.
English: This being a conditional marketing authorisation and pursuant to Article 14(7) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Maltese: KONDIZZJONALI Peress li din hi Awtorizzazzjoni għat-Tqegħid fis-Suq kondizzjonali u skont l-Artikolu 14(7) tar
English: The eye is subjected to ocular surface lavage with sterile balanced salt solution for eye irrigation followed by detachment of the conjunctiva from the limbus to expose the sample collection site of the cornea.
Maltese: 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: Other cytotoxic agents must be avoided.
Maltese: Il-kirurgu tiegħek se jinfurmak dwar dan.
English: These tests included cell karyotype, cell growth in soft agar and growth factor-dependent proliferation.
Maltese: Dawn it-testijiet inkludew karjotip taċ-ċellula, tkabbir taċċelluli f'agar artab u proliferazzjoni dipendenti mill-fattur tat-tkabbir.
English: - If you get any side effects, talk to your surgeon.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lill-kirurgu tiegħek.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Potentially infected biological material.
Maltese: OĦRA, JEKK MEĦTIEĠA Materjal bijoloġiku potenzjalment infettat.
English: Each container contains 3.8 cm2 of autologous human corneal epithelium attached to a fibrin support and immersed in transport medium.
Maltese: Kull kontenitur fih 3.8 ċm2 ta' epitelju awtologu tal-kornea umana imwaħħal ma' appoġġ ta' fibrin u mgħaddas f'sustanza tat-trasport.
English: Concomitant eyelids malposition, conjunctival scarring with fornix shortening, corneal anaesthesia and/or conjunctival anaesthesia or severe hypoaesthesia, pterygium and severe dry eye are potential complicating factors.
Maltese: Pożizzjoni ħażina taż-żewġ kpiepel tal-għajnejn, ċikatriċi fil-konġuntiva b'fornix imqassar, anestesija tal-kornea u/jew anestesija tal-konġuntiva jew ipoesteżija severa, pterigium u għajn xotta ħafna huma fatturi potenzjali ta' kumplikazzjoni.
English: Each container contains 3.8 cm2 of autologous human corneal epithelium attached on a fibrin support and covered with transport medium.
Maltese: Kull kontenitur fih 3.8 ċm2 ta' epitelju awtologu tal-kornea umana imwaħħla fuq appoġġ ta' fibrin u mgħottija b'sustanza tat-trasport.
English: The biopsy is performed using topical anaesthesia.
Maltese: Il-bijopsija ssir b'anestesija topika.
English: Two weeks after surgery, a topical corticosteroid treatment should be started with preservative-free dexamethasone 0.1% eye-drops, 1 drop three times per day for 2 weeks, then reduced to 1 drop twice daily for 1 week and 1 drop once daily for a further week.
Maltese: Ġimagħtejn wara l-kirurġija, għandha tinbeda kura ta' kortikosterojd topiku bi qtar għall-għajnejn ta' dexamethasone 0.1% bla preservattivi, qatra waħda tliet darbiet kuljum għal ġimagħtejn, imbagħad imnaqqsa għal qatra waħda darbtejn kuljum għal ġimgħa u qatra waħda darba kuljum għal ġimgħa oħra.
English: Breast-feeding As a precautionary measure, Holoclar is not recommended for implant during breast-feeding.
Maltese: Treddigħ Bħala prekawzjoni, Holoclar mhux rakkomandat biex jigi impjantat waqt it-treddigħ.
English: General disorders and administration site conditions Metaplasia of the implant
Maltese: Metaplasja tal-impjant
English: Adverse reactions reported in patients implanted with Holoclar are provided in the table.
Maltese: Lista ta' reazzjonijiet avversi f'tabella Reazzjonijiet avversi rrappurtati f'pazjenti li sarilhom impjant ta' Holoclar huma pprovduti fit-tabella.
English: Elderly
Maltese: WARA
English: Your eyelid will be taped closed for three days and your eye will be bandaged for 10 to 15 days after the implantation.
Maltese: Il-kappell t'għajnek se jiġi magħluq bi stikk għal tlett ijiem u għajnek se tkun infaxxata għal 10 sa 15-il ġurnata wara t-tqegħid tal-impjant.
English: (see section 4.6).
Maltese: (ara sezzjoni 4.6).
English: • valproate (an antiepileptic medicine),
Maltese: • valproate (mediċina anti-epilettika),
English: Common depression, irritability
Maltese: Komuni dipressjoni, irritabilità
English: Date of first authorisation: 31 July 2013 Date of latest renewal: 23 March 2018
Maltese: Data tal-aħħar tiġdid: 23 ta' Marzu 2018
English: Granules.
Maltese: Granuli.
English: Decreased blood potassium, albumin, total protein and phosphate.
Maltese: Tnaqqis fil-potassju, albumina, proteina totali u fosfat fid-demm.
English: Adverse reactions mainly involved the reproductive and gastrointestinal system.
Maltese: Reazzjonijiet avversi involvew primarjament is-sistema riproduttiva u gastro-intestinali.
English: Content of clinically important electrolytes
Maltese: Il-kontenut ta' elettroliti klinikament importanti
English: • 9.9 - 13.0 g/m2/day in children weighing more than 20 kg, adolescents and adults.
Maltese: • 9.9 - 13.0 g/m2/kuljum fi tfal li jiżnu aktar minn 20 kg, adoloxxenti u adulti.
English: • haloperidol (used in certain psychotic disorders),
Maltese: • haloperidol (użat f'ċerti disturbi psikotiċi),
English: info@frostpharma.com info@frostpharma.com
Maltese: info@frostpharma.com
English: Distribution The volume of distribution of phenylbutyrate is 0.2 l/kg.
Maltese: Distribuzzjoni Il-volum ta' distribuzzjoni ta' phenylbutyrate hu ta' 0.2 l/kg.
English: Common anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis
Maltese: Komuni anemija, tromboċitopenja, lewkopenja, lewkoċitożi, tromboċitożi
English: The other ingredients are: sugar spheres (sucrose and maize starch, see section 2 ‘PHEBURANE contains sucrose), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
Maltese: Is-sustanzi l-oħra huma: sugar spheres (sukrosju u maize starch, ara sezzjoni 2 ‘PHEBURANE fih sukrosju), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
English: The patient recovered within 48 hours after symptomatic treatment.
Maltese: Il-pazjent irkupra wara 48 siegħa ta' kura sintomatika.
English: PHEBURANE 483 mg/g granules sodium phenylbutyrate
Maltese: PHEBURANE 483 mg/g granuli sodium phenylbutyrate
English: Very common amenorrhea, irregular menstruation
Maltese: Komuni ħafna amenorrea, mestrwazzjoni irregolari
English: The active substance is sodium phenylbutyrate.
Maltese: Is-sustanza attiva hija sodium phenylbutyrate.
English: FrostPharma AB Tel: +46 775 86 80 02
Maltese: Tel: +46 775 86 80 02
English: In normal volunteers gender differences were found in the pharmacokinetic parameters of phenylbutyrate and phenylacetate (AUC and Cmax about 30 - 50 % greater in females), but not phenylacetylglutamine.
Maltese: F'voluntiera normali, differenzi fis-sess instabu fil-parametri farmakokinetiċi ta' phenylbutyrate u phenylacetate (AUC u Cmax madwar 30 - 50% akbar fin-nisa) iżda mhux phenylacetylglutamine.
English: Plasma glutamine should be maintained at levels less than 1,000 μmol/L.
Maltese: Glutamine talplażma għandha tinżamm f'livelli ta' anqas minn 1,000 μmol/L.
English: Tabulated list of adverse reactions
Maltese: Lista tabulata ta'reazzjonijiet avversi
English: Common metabolic acidosis, alkalosis, decreased appetite
Maltese: Komuni aċidożi metabolika, alkalosi, nuqqas ta' aptit
English: A probable case of toxic reaction to sodium phenylbutyrate (450 mg/kg/d) was reported in an 18year old anorectic female patient who developed a metabolic encephalopathy associated with lactic acidosis, severe hypokalaemia, pancytopaenia, peripheral neuropathy, and pancreatitis.
Maltese: Każ probabbli ta' reazzjoni tossika għal sodium phenylbutyrate (450 mg/kg/kuljum) kien irrappurtat f'pazjenta anorettika ta' 18-il sena li żviluppat enċefalopatija metabolika assoċjata ma' aċidożi lattika, ipokalemija severa, panċitopenja, newropatija periferali, u pankreatite.
English: Plasma levels of ammonia, arginine, essential amino acids (especially branched chain amino acids), carnitine and serum proteins should be maintained within normal limits.
Maltese: Il-livelli fil-plażma ta' ammonia, arginine, l-amino aċidi essenzjali (speċjalment branched chain amino acids), carnitine u proteini tas-serum għandhom jinżammu fil-limiti normali.
English: Bottle: 174 g granules.
Maltese: Flixkun: 174 g ta' granuli.
English: <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: (≥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 tiġi stmata mit-tagħrif disponibbli).
English: • PHEBURANE contains 124 mg (5.4 mmol) of sodium per gram of sodium phenylbutyrate, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose.
Maltese: • PHEBURANE fih 124 mg (5.4 mmol) ta' sodium għal kull gramma ta' sodium phenylbutyrate, korrispondenti għal 2.5 g (108 mmol) ta' sodium kull 20 g ta' sodium phenylbutyrate, li hi l-għola doża ta' kuljum.
English: EU/1/13/822/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/822/001
English: The elimination half-life was estimated to be 1.3 and 2.4 hours, respectively.
Maltese: Il-half-life tal-eliminazzjoni kienet stmata li kienet ta' 1.3 u 2.4 siegħat,