FrancophonIA/ELRC3.0 huggingface dataset:
English: The other ingredients of the powder contained in the hard capsule are: sodium laurilsulfate, lactose monohydrate, magnesium stearate and sodium starch glycolate.
Maltese: Il-qalba tal-kapsula: Sodium laurilsulfate, Lactose monohydrate, Magnesium stearate, Sodium starch glycolate.
English: The dose for adults is 600 mg once daily.
Maltese: Id-doża għall-adulti hija ta' 600 mg kuljum.
English: 7 Carefully pull the cap away from the body of the capsule (illustration c).
Maltese: 7 B'attenzjoni iġbed l-għatu mill-korp tal-kapsula (illustrazzjoni ċ).
English: Substantial decrease in lopinavir exposure.
Maltese: Parametri tal-piż u metaboliċi
English: The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
Maltese: Il-kapsuli huma stampati b'linka li fiha cochineal carminic acid (E120), indigo carmine (E132) u titanium dioxide (E171).
English: Simvastatin/Efavirenz (40 mg once daily/600 mg once daily)
Maltese: Simvastatin/Efavirenz (40 mg darba kuljum/600 mg darba kuljum)
English: Pravastatin/Efavirenz (40 mg once daily/600 mg once daily)
Maltese: Pravastatin/Efavirenz (40 mg darba kuljum/600 mg darba kuljum)
English: uncommon hepatitis acute rare hepatic failure‡,*
Maltese: mhux komuni epatite akuta rari insuffiċjenza tal-fwied
English: Voriconazole: AUC: ↓ 7% (↓ 23 to ↑ 13) *
Maltese: AUC: ↓ 7% (↓ 23 għal ↑
English: Cmax: ↓ 47% (↓ 9 to ↓ 51)
Maltese: Cmax: ↓ 51% (↓ 46 sa ↓
English: OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK OUTER CARTON TEXT FOR BLISTER PACK
Maltese: KLIEM FUQ IL-KARTUNA TA' BARRA U FUQ IT-TIKKETTA GĦALL-PAKKETT TALFLIXKUN
English: Paroxetine/Efavirenz (20 mg once daily/600 mg once daily)
Maltese: Paroxetine/Efavirenz (20 mg darba kuljum/600 mg darba kuljum)
English: Atazanavir/ritonavir/Efavirenz (400 mg once daily/200 mg once daily/600 mg once daily, all administered with food)
Maltese: Atazanavir/ritonavir/Efavirenz (400 mg darba kuljum/200 mg darba kuljum/600 mg darba kuljum, kollha mogħtija mal-ikel)
English: When efavirenz is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg twice daily and the efavirenz dose must be reduced by 50%, i.e., to 300 mg once daily.
Maltese: Meta efavirenz jingħata fl-istess ħin ma' voriconazole, id-doża ta' manteniment ta' voriconazole għandha tiżdied għal 400 mg darbtejn kuljum u d-doża ta' efavirenz għandha titnaqqas b'50%, jiġifieri għal 300 mg darba kuljum.
English: Capsule sprinkle: for patients at least 3 months old and weighing at least 3.5 kg who cannot swallow capsules, the capsule contents can be administered with a small amount of food using the capsule sprinkle method of administration (see section 6.6 for instructions).
Maltese: Traxxix tal-kapsula: għal pazjenti li għandhom tal-inqas 3 xhur u li jiżnu għallinqas 3.5 kg li ma jistgħux jibilgħu l-kapsuli, il-kontenut tal-kapsuli jista' jingħata ma' ammont żgħir ta' ikel permezz tal-metodu ta' għoti bi traxxix tal-kapsula (ara sezzjoni 6.6 għall-istruzzjonijiet).
English: Efavirenz is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 5.2) and not recommended in patients with moderate hepatic impairment because of insufficient data to determine whether dose adjustment is necessary.
Maltese: Efavirenz huwa kontraindikat f'pazjenti b'indeboliment qawwi tal-fwied (ara sezzjonijiet 4.3 u 5.2) u mhuwiex irrakkomandat f'pazjenti b'indeboliment tal-fwied moderat minħabba dejta insuffiċjenti biex wieħed jistabbilixxi jekk huwiex meħtieġ aġġustament fid-doża.
English: Gastrointestinal disorders common abdominal pain, diarrhoea, nausea, vomiting uncommon pancreatitis
Maltese: Disturbi gastro-intestinali komuni uġigħ fiż-żaqq, dijarea, dardir, rimettar mhux komuni pankreatite
English: UNIQUE IDENTIFIED - HUMAN READABLE DATA Outer carton
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Cmin: ↓ 8% (↑ 14 to ↓ 25) Norelgestromin (active metabolite): AUC: ↓ 64% (↓ 62 to ↓ 67)
Maltese: Cmin: ↓ 8 % (↑ 14 għal Norelgestromin (metabolit attiv):
English: Fluconazole/Efavirenz (200 mg once daily/400 mg once daily)
Maltese: Fluconazole/Efavirenz (200 mg darba kuljum/400 mg darba kuljum)
English: Skin rash was considered treatment related in 18% of patients treated with efavirenz.
Maltese: Ir-raxx fil-ġilda tqies li kien marbut mal-kura fi 18 % tal-pazjenti kkurati b'efavirenz.
English: When efavirenz is coadministered with an anticonvulsant that is a substrate of CYP450 isoenzymes, periodic monitoring of anticonvulsant levels should be conducted.
Maltese: Meta efavirenz jingħata fl-istess ħin ma' antikonvulsiv li jkun substrat ta' isoenzimi CYP450, għandu jsir monitoraġġ perjodiku tal-livelli tal-antikonvulsiv.
English: Resistance
Maltese: ANTISTAMINI
English: SUSTIVA is recommended to be taken on an empty stomach preferably at bedtime.
Maltese: Huwa rakkomandat li SUSTIVA jittieħed fuq stonku vojt preferibbilment qabel l-irqad.
English: Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz.
Maltese: Ġie rrapportat raxx qawwi marbut ma' nfafet, tqaxxir umdu tal-ġilda u ulċeri f'inqas minn 1 % mill-pazjenti kkurati b'efavirenz.
English: Telaprevir (relative to 750 mg q8h): AUC: ↓ 18% (↓ 8 to ↓ 27) Cmax: ↓ 14% (↓ 3 to ↓ 24)
Maltese: AUC: ↓ 18% (↓ 8 sa ↓ Cmax: ↓ 14% (↓ 3 sa ↓ 24) Cmin: ↓ 25% (↓ 14 sa ↓ Efavirenz:
English: Bristol-Myers Squibb Pharma EEIG
Maltese: Bristol-Myers Squibb Pharmaceuticals Ltd.
English: Five of these NNRTI-resistant isolates were found to have K103N or a valine-toisoleucine substitution at position 108 (V108I) in RT. Three of the efavirenz treatment failure isolates tested remained sensitive to efavirenz in cell culture and were also sensitive to nevirapine and delavirdine.
Maltese: Tlieta mill-iżolati tal-falliment tal-kura b'efavirenz li ġew ittestjati baqgħu sensittivi għal efavirenz fil-kulturi taċ-ċelluli u kienu sensittivi wkoll għal nevirapine u delavirdine.
English: The median increase from baseline in CD4+ count at 48 weeks was 215 cells/mm and the median increase in CD4+ percentage was 6%.
Maltese: Iżżieda medjana mil-linja bażi fl-għadd ta' CD4+ fil-ġimgħa 48 kienet ta' 215 ċellula/mm u ż-żieda medjana fil-perċentwali ta' CD4+ kienet ta' 6%.
English: Efavirenz has been shown to induce CYP3A4 and CYP2B6, resulting in the induction of its own metabolism, which may be clinically relevant in some patients.
Maltese: Efavirenz intwera li jinduċi CYP3A4 u CYP2B6, bir-riżultat li induċa l-metaboliżmu tiegħu stess u dan jista' jkun rilevanti b'mod kliniku f'xi pazjenti.
English: Risk to the infant can not be excluded.
Maltese: Ma jistax jiġi eskluż riskju għat-tarbija.
English: The pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.4).
Maltese: Il-farmakokinetika ta' efavirenz għadha ma ġietx studjata f'pazjenti b'insuffiċjenza tal-kliewi; madankollu, anqas minn 1 % tad-doża ta' efavirenz jitneħħa mhux mibdul fl-awrina, għalhekk l-impatt ta' indeboliment tal-kliewi fuq l-eliminazzjoni ta' efavirenz għandu jkun mill-inqas (ara sezzjoni 4.4).
English: The dose for children weighing 40 kg or more is 600 mg once daily.
Maltese: Id-doża għall-adulti, hija ta' 600 mg kuljum.
English: Sertraline (a medicine used to treat depression): your doctor may need to change your dose of sertraline.
Maltese: Sertraline (mediċina użata biex tikkura d-dipressjoni): it-tabib tiegħek jista'jirrakkomanda kura alternattiva.
English: At baseline, median plasma HIV-1 RNA was 4.8 log10 copies/mL, median CD4+ cell count was 367 cells/mm3, and median CD4+ percentage was 18%.
Maltese: Fil-linja bażi, il-medjan tal-RNA tal-HIV-1 fil-plażma kien 4.8 log10 kopja/mL, il-medjan tal-għadd ta' ċelluli CD4+ kien 367 ċellula/mm
English: The pharmacokinetic parameters for efavirenz at steady state in paediatric patients were predicted by a population pharmacokinetic model and are summarized in Table 5 by weight ranges that correspond to the recommended doses.
Maltese: Il-parametri farmakokinetiċi għal efavirenz fi stat fiss f'pazjenti pedjatriċi kienu mbassra b'mudell farmakokinetiku tal-popolazzjoni u huma miġbura fil-qosor fit-Tabella 5 b'meded ta' piżijiet li jikkorrispondu għad-dożi rakkomandati.
English: Co-administration with elbasvir (EBR) and grazoprevir (GZR) due to the potential for significant decreases in plasma concentrations of EBR and GZR (see section 4.5).
Maltese: L-għoti flimkien ma' elbasvir (EBR) u grazoprevir (GZR) minħabba l-potenzjal għal tnaqqis sinifikanti fil-konċentrazzjonijiet ta' EBR u GZR fil-plażma (ara sezzjoni 4.5). Preparazzjonijiet ta' ħxejjex li fihom St.
English: Dark yellow, printed with "SUSTIVA" on the body and "200 mg" on the cap.
Maltese: SUSTIVA 200 mg kapsuli ibsin Lewn isfar skur, b'”SUSTIVA” stampata fuqha u "200 mg” fuq il-kappa
English: Cmax: ↓ 45%
Maltese: Cmin : ↓ 40%
English: You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy.
Maltese: Xorta tista' tgħaddi l-HIV lil ħaddieħor meta tkun qed tieħu din il-mediċina, għalkemm irriskju huwa mnaqqas b'terapija antiretrovirali.
English: ‡These adverse reactions were identified through post-marketing surveillance but not reported as drugrelated events for efavirenz-treated patients in 16 clinical trials.
Maltese: Dawn ir-reazzjonijiet avversi kienu identifikati permezz ta' sorveljanza ta' wara t-tqegħid fis-suq iżda ma ġewx irrapportati bħala każijiet marbuta mal-mediċina fil-pazjenti kkurati b'efavirenz f'16il prova klinika.
English: Cmin: ↓ 37% (↓ 17 to ↓ 52) Efavirenz:
Maltese: ↓ 37% (↓ 17 għal ↓ Cmax: ↓ 28% (↓ 7 għal ↓ Cmin: ↓ 37% (↓ 17 għal ↓ Efavirenz:
English: Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms.
Maltese: Xi pazjenti li bi żball ħadu 600 mg darbtejn kuljum irrappurtaw żieda fis-sintomi tas-sistema nervuża.
English: In a single-dose study, half life was doubled in the single patient with severe hepatic impairment (Child Pugh Class C), indicating a potential for a much greater degree of accumulation.
Maltese: Fi studju ta' doża singola, il-half-life irduppjat f'pazjent wieħed b'indeboliment qawwi tal-fwied (Child-Pugh Klassi Ċ), li jindika possibbiltà ta' akkumulazzjoni sa grad ferm ogħla.
English: Efavirenz in combination with darunavir/ritonavir 800/100 mg once daily may result in suboptimal darunavir Cmin.
Maltese: Efavirenz flimkien ma' darunavir/ritonavir 800/100 mg darba kuljum jista' jwassal għal Cmin ta' darunavir subottimali.
English: Lorazepam: AUC: ↑ 7% (↑ 1 to ↑ 14)
Maltese: AUC : ↑21% Cmin: ↑17%
English: if you have a history of convulsions (fits or seizures) or if you are being treated with anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin.
Maltese: - jekk għandek storja ta' konvulżjonijiet (attakki jew aċċessjonijiet) jew jekk tkun qed tiġi kkurat/a b'terapija antikonvulsanti bħal carbamazepine, phenobarbital u phenytoin.
English: Rash was more common in children than in adults treated with SUSTIVA.
Maltese: Ir-raxx kien iktar komuni fittfal milli f'adulti kkurati bi SUSTIVA.
English: Propylene glycol
Maltese: SUSTANZI KARDJOVASKULARI
English: If efavirenz is to be used in combination with darunavir/ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used.
Maltese: Jekk efavirenz ser jintuża flimkien ma' darunavir/ritonavir, għandu jintuża l-kors ta' dożaġġ ta' darunavir/ritonavir 600/100 mg darbtejn kuljum.
English: Cmax: ↓ 61%
Maltese: AUC: ↓ 77% Cmax: ↓ 61%
English: Number of Capsules or Tablets and Strength to Administer kg
Maltese: Numru ta' Kapsuli jew Pilloli u Saħħa li Għandhom Jingħataw kg
English: AUC: ↓ 34% (↓ 21 to ↓ 41)
Maltese: ↓ 34% (↓ 21 sa
English: You must not take SUSTIVA with certain medicines.
Maltese: Ma għandekx tieħu SUSTIVA ma' ċerti mediċini.
English: Among co-infected patients, 3% of those treated with efavirenz and 2% in the control arm discontinued because of liverdisorders (see section 4.4).
Maltese: Fost il-pazjenti koinfettati, 3% minn dawk ikkurati b'efavirenz u 2% fil-fergħa ta' kontroll ma komplewx l-istudju minħabba disturbi fil-fwied (ara sezzjoni 4.4).
English: SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens.
Maltese: SUSTIVA ma ġiex studjat b'mod adegwat f'pazjenti b'mard avvanzat tal-HIV, u speċifikament pazjenti b'għadd CD4 < 50 ċellula/mm3, jew wara li jkunu fallew kuri li jkun fihom l-impeditur ta' protease (PI).
English: Mean change from baseline-CD4 cell count
Maltese: Bidla medja mill- linja bażi talgħadd taċċelluli CD4
English: Two of three delavirdineresistant clinical isolates examined were cross-resistant to efavirenz and contained the K103N substitution.
Maltese: Tnejn minn tliet iżolati kliniċi reżistenti għal delavirdine li ġew eżaminati kellhom reżistenza inkroċjata għal efavirenz u kellhom is-sostituzzjoni K103N.
English: CCR5 antagonist Maraviroc/Efavirenz (100 mg twice daily/600 mg once daily)
Maltese: Maraviroc/Efavirenz (100 mg darbtejn kuljum/600 mg darba kuljum)
English: Undesirable effects in children were generally similar to those of adult patients.
Maltese: L-effetti mhux mixtieqa fit-tfal kienu ġeneralment simili għal dawk tal-pazjenti adulti.
English: Rash was reported in 59 of 182 children (32%) treated with efavirenz and was severe in six patients.
Maltese: Ġie rrapportat raxx f'59 minn 182 tifel u tifla (32%) li ġew ikkurati b'efavirenz, u kien qawwi f'sitt pazjenti.
English: False-positive urine cannabinoid test results have been reported with some screening assays in uninfected and HIV-infected subjects receiving efavirenz.
Maltese: Riżultati pożittivi-foloz għal test għal kannabinojdi tal-awrina ġew irrapportati b'xi assaġġi ta' skrinjar f'individwi mhux infettati u f'individwi infettati bl-HIV li kienu qed jirċievu efavirenz.
English: Patients who are receiving concomitant anticonvulsant medicinal products primarily metabolised by the liver, such as phenytoin, carbamazepine and phenobarbital, may require periodic monitoring of plasma levels.
Maltese: Għal pazjenti li qed jirċievu fl-istess ħin prodotti mediċinali antikonvulżivi li jiġu metabolizzati primarjament fil-fwied, bħal phenytoin, carbamazepine u phenobarbital, jista' jkun hemm bżonn li l-livelli tagħhom fil-plażma jiġu mmonitorjati.
English: Cmin: ↓ 43% (↓ 18 to ↓ 60) Efavirenz:
Maltese: Cmin: ↓ 43% (↓ 18 għal ↓
English: AUC: ↑ 21% Cmin: ↑ 17% Cmax: ↑ 15% (CYP3A4 inhibition)
Maltese: Cmax: ↑ 15% (inibizzjoni ta' CYP3A4)
English: For patients at least 3 months old and weighing at least 3.5 kg who cannot swallow capsules, the capsule contents can be administered with a small amount (1-2 teaspoons) of food using the capsule sprinkle method of administration.
Maltese: Għal pazjenti li għandhom mill-inqas 3 xhur u li jiżnu mil-inqas 3.5 kg li ma jistgħux jibilgħu lkontenut tal-kapsuli jistgħu jingħataw ammont żgħir ta' ikel (eż. 1-2 kuċċarini) ta' ikel permezz talmetodu ta' amministrazzjoni ta' traxxix tal-kapsuli.
English: It is recommended that efavirenz be taken on an empty stomach, preferably at bedtime.
Maltese: Huwa rakkomandat li efavirenz jittieħed fuq stonku vojt, preferibbilment qabel l-irqad.
English: Concomitant administration of simeprevir with efavirenz resulted in significantly decreased plasma concentrations of simeprevir due to CYP3A induction by efavirenz, which may result in loss of therapeutic effect of simeprevir.
Maltese: L-għoti konkomitanti ta' simeprevir ma' efavirenz irriżulta fi tnaqqis fil-konċentrazzjonijiet fil-plażma ta' simeprevir minħabba induzzjoni ta' CYP3A minn efavirenz, li jista' jirriżulta f'telf tal-effett terapewtiku ta' simeprevir.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Maltese: TAD-DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Bristol-Myers Squibb Pharma EEIG
English: The frequency of this is unknown (see section 4.4).
Maltese: Il-frekwenza ta' dan mhix magħrufa (ara sezzjoni 4.4).
English: Lipid disorders should be managed as clinically appropriate.
Maltese: Dawn il-bidliet mhumiex meqjusa bħala klinikament sinifikanti.
English: Each SUSTIVA film-coated tablet contains 600 mg of the active substance efavirenz.
Maltese: Kull pillola SUSTIVA miksija b'rita fiha 600 mg tas-sostanza attiva efavirenz.
English: This loss is due to significant decreases in elbasvir and grazoprevir plasma concentrations caused by CYP3A4 induction.
Maltese: Dan it-telf jiġri minħabba tnaqqis sinifikanti fil-konċentrazzjonijiet ta' elbasvir u grazoprevir fil-plażma kkawżat minn induzzjoni ta' CYP3A4
English: Each hard capsule contains 50 mg of efavirenz.
Maltese: Kull kapsula iebsa fiha 50 mg ta' efavirenz.
English: The capsule shell contains: gelatine, sodium laurilsulfate, yellow iron oxide (E172), titanium dioxide (E171) and silicon dioxide.
Maltese: • Il-qoxra tal-kapsula fiha: gelatine, sodium laurilsulfate, yellow iron oxide (E172), titanium dioxide (E171) u silicon dioxide (E551).
English: Diltiazem or similar medicines (called calcium channel blockers which are medicines typically used for high blood pressure or heart problems): when you start taking SUSTIVA, your doctor may need to adjust your dose of the calcium channel blocker.
Maltese: Diltiazem jew mediċini simili (magħrufin bħala imblokkaturi tal-kanal tal-kalċju li huma mediċini li normalment jintużaw għal pressjoni għolja tad-demm jew problemi tal-qalb): tibda tieħu SUSTIVA, it-tabib tiegħek jista' jkollu bżonn jaġġusta d-doża tiegħek talimblokkatur tal-kanal tal-kalċju.
English: (See section 4.8.)
Maltese: (Ara sezzjoni 4.8).
English: MedDRA System Organ Class (SOC)
Maltese: Sistema tal-Klassifika talOrgani MedDRA (SOC)
English: Radiculopathy, Syncope
Maltese: Radikulopatija, Sinkope
English: See section 4.4.
Maltese: Ara sezzjoni 4.4.
English: 08150 Barcelona - Spain
Maltese: 08150 Barċellona - Spanja
English: Flebogamma DIF is isotonic, with an osmolality from 240 to 370 mOsm/kg.
Maltese: Flebogamma DIF hu isotoniku, b'osmolalità minn 240 sa 370 mOsm/kg.
English: Guillain Barré syndrome
Maltese: Sindrome ta' Guillain Barré
English: - 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: - komuni (>1/100 sa <1/10) - mhux komuni (>1/1,000 sa <1/100) - rari (>1/10,000 sa <1/1,000)
English: Secondary immunodeficiencies
Maltese: Immunodefiċjenzi sekondarji
English: Date of latest renewal: 24 April 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Awwissu, 2007 Data tal-aħħar tiġdid: 24 ta' April, 2017
English: There are two groups:
Maltese: Hemm ħames gruppi:
English: Aseptic meningitis syndrome (AMS)
Maltese: Sindrome ta' meninġite asettika (AMS)
English: ● urinary infection
Maltese: ● infezzjoni urinarja
English: Pack size of 1 vial.
Maltese: Daqs tal-pakkett ta' kunjett 1.
English: ● bronchitis
Maltese: ● bronkite
English: Fructose intolerance (see section 4.4).
Maltese: Intolleranza għall-fructose (ara sezzjoni 4.4).
English: Incompatibilities
Maltese: Inkompatibbiltajiet
English: Multifocal motor neuropathy (MMN)
Maltese: Multifocal motor neuropathy)
English: The percentage of IgG subclasses is approximately 66.6% IgG1, 28.5% IgG2, 2.7% IgG3 and 2.2% IgG4.
Maltese: Il-perċentwali ta' sottoklassijiet IgG hu ta' madwar 66.6% IgG1, 28.5% IgG2, 2.7% IgG3 u 2.2% IgG4.
English: The percentage of IgG subclasses is approximately 66.6% IgG1, 27.9% IgG2, 3.0% IgG3 and 2.5% IgG4.
Maltese: Il-perċentwali ta' sottoklassijiet IgG hu ta' madwar 66.6% IgG1, 27.9% IgG2, 3.0% IgG3 u 2.5% IgG4.
English: ● syncope vasovagal (temporary loss of consciousness)
Maltese: ● sinkope vasovagali (tintilef temporanjament minn sensik)
English: ● musculoskeletal discomfort
Maltese: ● skonfort muskuloskeletriku
English: Conjunctivitis, Maculopathy, Vision blurred
Maltese: Konġuntivite, Makulopatija, Vista mċajpra
English: Replacement therapy:
Maltese: Terapija ta' sostituzzjoni:
English: - The active substance is human normal immunoglobulin (IVIg).
Maltese: - Is-sustanza attiva hi immunoglobulina umana normali (IVIg).
English: Bicytopenia, Leukopenia
Maltese: Biċitopenija, Lewkopenija
English: Human normal immunoglobulin (IVIg)
Maltese: Immunoglobulina umana normali (IVIg)
English: It is usually prepared from pooled plasma from not fewer than 1000 donors.
Maltese: Tkun normalment ippreparata minn plażma miġbura minn mhux inqas minn 1000 donatur.
English: Instituto Grifols, S.A. Polígono Levante Can Guasc, 2
Maltese: Polígono Levante Can Guasc, 2
English: • oedema peripheral
Maltese: • edema periferali
English: Productive cough
Maltese: Sogħla produttiva
English: Flebogamma DIF contains sorbitol
Maltese: Flebogamma DIF fih sorbitol
English: Polígono Levante Can Guasc, 2, E-08150 Parets del Vallès Barcelona, Spain
Maltese: Instituto Grifols, S.A. Polígono Levante Can Guasc, 2, E-08150 Parets del Vallès
English: One ml contains 50 mg of D-sorbitol.
Maltese: 1 ml fih 50 mg ta' D-sorbitol.
English: • alanine aminotransferase (hepatic transaminase) increased
Maltese: • żieda fl-alanine aminotransferase (transaminase epatika)
English: • (very rarely) thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses
Maltese: • (rari ħafna) reazzjonijiet tromboemboliċi bħal infart mijokardijaku, puplesija, emboliżmu pulmonari, trombożi tal-vini profondi
English: ● postnasal drip (excessive mucus)
Maltese: ● dripp postnasali (mukus eċċessiv)
English: Pregnancy
Maltese: Emigranja
English: EU/1/07/404/002 EU/1/07/404/003 EU/1/07/404/004 EU/1/07/404/005
Maltese: EU/1/07/404/002 EU/1/07/404/003 EU/1/07/404/004
English: 0.4 g/kg/d on day 1, possibly repeated once within 3 days for 2 - 5 days
Maltese: 0.4 g/kg/kuljum f'jum 1, possibilment ripetuta fi żmien 3 ijiem għal 2 - 5 ijiem
English: 1 g/kg or
Maltese: 2 g/kg
English: Human normal immunoglobulin contains mainly immunoglobulin G (IgG) with a broad spectrum of antibodies against infectious agents.
Maltese: L-immunoglobulina umana normali primarjament fih immunoglobulin G (IgG) b'firxa wiesgħa ta' antikorpi kontra organiżmi infettivi.
English: Secondary immunodeficiencies (as defined in 4.1)
Maltese: Immunodefiċjenzi sekondarji (kif definiti f'4.1)
English: • productive cough
Maltese: ● sogħla produttiva
English: Immune system disorders Hypersensitivity
Maltese: Disturbi fis-sistema immuni Sensittività eċċessiva
English: • (rarely) transient cutaneous reactions (including cutaneous lupus erythematosus - frequency unknown)
Maltese: • (rarament) reazzjonijiet tal-ġilda temporanji (li jinkludu lupus erythematosus tal-ġilda - frekwenza mhux magħrufa)
English: Human normal immunoglobulin …………..100 mg (purity of at least 97% IgG)
Maltese: Immunoglobulina umana normali…………..100 mg (purità ta' mill-inqas 97% IgG)
English: • diseases which increase blood viscosity • age over 65
Maltese: • età ta' iktar minn 65 sena
English: ● lymphoedema
Maltese: • limfoedema
English: Human normal immunoglobulin ……….. 50 mg (purity of at least 97% of IgG)
Maltese: Immunoglobulina umana normali ……….. 50 mg (purità ta' mill-inqas 97% ta' IgG)
English: Adverse reactions caused by human normal immunoglobulins (in decreasing frequency) encompass (see also section 4.4):
Maltese: Reazzjonijiet avversi kkawżati minn immunoglobulini umani normali (f'ordni ta' frekwenza li tonqos) jinkludu (ara wkoll sezzjoni 4.4):
English: ● myalgia (muscle pain)
Maltese: ● mijalġja (uġigħ fil-muskoli)
English: ● urticaria
Maltese: ● urtikarja
English: One ml contains:
Maltese: 1 ml fih:
English: IVIg recipients should be monitored for clinical signs and symptoms of haemolysis.
Maltese: IVIg għandhom jiġu mmonitorjati għal sinjali kliniċi u sintomi ta' emolisi.
English: • dermatitis contact
Maltese: • dermatite tal-kuntatt
English: Neutropenia/Leukopenia
Maltese: Newtropenija/Lewkopenija