FrancophonIA/ELRC3.0 huggingface dataset:
English: Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine.
Maltese: Abacavir huwa primarjament metabolizzat mill-fwied u bejn wieħed u ieħor 2% ta' abacavir jitneħħa mingħajr ma jinbidel fl-urina.
English: Logistic regression modelling of the predictive value for genotype (adjusted for baseline plasma HIV-1 RNA [vRNA], CD4+ cell count, number and duration of prior antiretroviral therapies), showed that the presence of 3 or more NRTI resistance-associated mutations was associated with reduced response at Week 4 (p=0.015) or 4 or more mutations at median Week 24 (p≤0.012).
Maltese: (addattat għall-livell bażiku fil-plażma ta' HIV-1 RNA [vRNA], l-għadd ta' ċelloli CD4+, in numru ta' drabi u t-tul ta' terapiji antiretrovirali fil-passat), wera li l-preżenza ta' 3 jew aktar mutazzjonijiet assoċċjati ma' reżistenza b'NRTI, kellhom x'jaqsmu ma' reazzjoni mnaqqsa fir-4
English: In the intent-to-treat (ITT) population, 70% of patients in the abacavir group, compared to 69% of patients in the zidovudine group, achieved a virologic response of plasma HIV-1 RNA ≤50 copies/ml by Week 48 (point estimate for treatment difference: 0.8, 95% CI -6.3, 7.9).
Maltese: Fil-popolazzjoni bl-intenzjoni ta' kura (intent-to-treat jew ITT), 70% tal-pazjenti filgrupp ta' abacavir mqabbla ma' 69% tal-pazjenti fil-grupp ta' zidovudine, laħqu livell viroloġiku ta' HIV-1 RNA fil-plażma ta' ≤50kopji/ml sat-48 ġimgħa (point estimate ta' differenza fil-kura: 0.8, 95% CI- 6.3, 7.9). Fl-analiżi kif trattat (as treated jew AT), id-differenza bejn iż-żewġ friegħi kienet aktar ċara (88% fil-grupp ta' abacavir mqabbla ma' 95% tal-pazjenti fil-grupp ta' zidovudine (point estimate ta' differenza fil-kura:
English: After a median follow-up of 32 weeks, the tritherapy with the three nucleosides ZDV/3TC/ABC was shown to be virologically inferior to the two other arms regardless of baseline viral load (< or > 100 000 copies/ml) with 26% of subjects on the ZDV/3TC/ABC arm, 16% on the ZDV/3TC/EFV arm and 13% on the 4 drug arm categorised as having virological failure (HIV RNA >200 copies/ml).
Maltese: ZDV/3TC/EFV u 13% fuq il-fergħa ta' erbgħa mediċini li kienu kkatergoriżżati bħala falliment viroloġiku (HIV RNA >200 kopji kull ml. Fit-48 ġimgħa il-proporzjon ta' suġġetti b'HIV RNA <50 kopja kull ml kienu 63%, 80% u 86% għallfergħat ZDV/3TC/ABC, ZDV/3TC/EFV U ZDV/3TC/ABC/EFV rispettivament.
English: Ziagen contains abacavir (which is also an active substance in Kivexa, Triumeq and Trizivir).
Maltese: Ziagen fih abacavir (li huwa wkoll is-sustanza attiva f'Kivexa, Triumeq u Trizivir).
English: Sorbitol can have a mild laxative effect.
Maltese: Sorbitol jista jkollu effett lassativ ħafif.
English: Do not store above 30°C.
Maltese: Taħżinx f`temperatura 'l fuq minn 30°C.
English: In adults treated with abacavir in combination with lamivudine and zidovudine the proportion of patients with undetectable viral load (<400 copies/ml) was approximately 70% (intention to treat analysis at 48 weeks) with corresponding rise in CD4 cells.
Maltese: F'pazjenti adulti li qed jingħataw abacavir ma' lamivudine u zidovudine il-proporzjon ta` pazjenti b'viral load li ma jitkejjilx (<400 copies/ml) kien bejn wieħed u ieħor ta` 70% (l-analiżi intent-totreat fi żmien 48 ġimgħa) b`żieda korrispondenti f`ċelloli CD4.
English: Ziagen 300 mg film-coated tablets
Maltese: Ziagen 300 mg Pilloli Miksija b'Rita
English: In a pharmacokinetic study (PENTA 15), four virologically controlled subjects less than 12 months of age switched from abacavir plus lamivudine oral solution twice daily to a once daily regimen.
Maltese: Fi studju farmakokinetiku (PENTA 15), erba' individwi kkontrollati viroloġikament li kellhom anqas minn 12-il xahar qalbu minn abacavir flimkien ma' soluzzjoni orali ta' lamivudine darbtejn kuljum għal reġimen ta' darba kuljum.
English: Plasma HIV-1 RNA <80 c/ml
Maltese: HIV-1 RNA fil-plasma <80 c/ml Differenza fir-riskju (darba kuljum-darbtejn
English: The scored tablets are yellow, biconvex, capsule shaped and are engraved with ‘GX 623' on both sides.
Maltese: Il-pilloli b'sinjal imnaqqax biex tkun tista' taqsamhom huma sofor, ibbuzzati fuq iż-żewġ naħat, b`forma ta` kapsoli u huma mnaqqxa b'GX 623 fuq iż-żewġ naħat.
English: When taken according to the dosage recommendations each 15 ml dose contains approximately 5 g of sorbitol.
Maltese: Meta tittiehed skond id-doża rrakkomandata, kull doża ta` 15 ml fiha madwar 5g ta` sorbitol.
English: Ziagen is not recommended in patients with moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Maltese: Ziagen mhuwiex rakkomandat lill-pazjenti b`indeboliment moderat jew sever tal-fwied (ara sezzjonijiet 4.2 u 5.3).
English: Results indicate that the FDC group was associated with a similar virologic outcome (non-inferior) compared to the abacavir plus lamivudine group, based on proportions of subjects with HIV-1 RNA < 50 copies/ml (90% and 85% respectively, 95% CI -2.7, 13.5).
Maltese: Ir-riżultati indikaw li l-grupp FDC kien assoċjat ma' riżultat viroloġiku simili mhux inferjuri, paragunat mall-grupp ta' abacavir u lamivudine, bażati fuq proporzjonijiet ta' individwi b' HIV-1 RNA < 50 kopji/ml (90% u 85%
English: • a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis)
Maltese: • raxx mifrux bi bżieżaq u tqaxxir tal-ġilda, speċjalment madwar il-ħalq, imnieħer, għajnejn u ġenitali (sindrome Stevens-Johnson), u forma aktar severa li tikkawża tqaxxir tal-ġilda f'aktar minn 30% tas-superfiċje tal-ġisem (nekrolisi epidermali tossika)
English: Infomed@viivhealthcare.com
Maltese: • diffikultà biex tiċċaqlaq.
English: In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART) an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
Maltese: F'pazjenti infettati bl-HIV, b'defiċjenza immunitarja severa fiż-żmien li tkun inbdiet it-terapija antiretrovirali kombinata (TARK), jista' jkun hemm reazzjoni nfjammatorja għall-mikrobi opportunistiċi asintomatiċi jew residwali.
English: Single doses up to 1200 mg and daily doses up to 1800 mg of Ziagen have been administered to patients in clinical studies.
Maltese: F'studji kliniċi ngħataw dożi waħdiet ta` 1200 mg sa 1800 mg kuljum ta` Ziagen lill-pazjenti.
English: Ziagen contains abacavir (which is also an active substance in medicines such as Kivexa,Triumeq and Trizivir).
Maltese: Ziagen fih abacavir (li huwa wkoll sustanza attiva f'mediċini bħal Kivexa, Triumeq u Trizivir).
English: Studies in HIV infected patients have shown good penetration of abacavir into the CSF, with a CSF to plasma AUC ratio of between 30 to 44%.
Maltese: (AUC) ta' CSF għal plażma ta` bejn 30 u 44%.
English: Following intravenous administration, the apparent volume of distribution was about 0.8 l/kg, indicating that abacavir penetrates freely into body tissues.
Maltese: Distribuzzjoni Wara li jkun ingħata fil-vina, il-volum ta` distribizzjoni apparenti kien ta` madwar 0.8 l/kg, li juri li abacavir jidħol liberament fit-tessuti tal-ġisem.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL - ORAL SOLUTION
Maltese: PAKKETT TA' BARRA - SOLUZZJONI ORALI
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Maltese: Filwaqt li ngħatat prova li t-trażżin virali effettiv b'terapija antiretrovirali jnaqqas b'mod sostanzjali r-riskju ta' trasmissjoni sesswali, riskju residwu ma jistax jiġi eskluż.
English: Results indicate that the FDC group was associated with a similar virologic outcome (noninferior) compared to the abacavir plus lamivudine group, based on proportions of subjects with HIV1 RNA < 50 copies/ml (90% and 85% respectively, 95% CI -2.7, 13.5).
Maltese: Ir-riżultati indikaw li l-grupp ta' Kivexa kien assoċjat ma' riżultat viroloġiku simili mhux inferjuri, paragunat mall-grupp ta' abacavir u lamivudine, bażati fuq proporzjonijiet ta' individwi b' HIV-1 RNA < 50 kopji/ml (90% u 85%
English: Children from three months to one year of age: The recommended dose is 8 mg/kg twice daily.
Maltese: Id-doża rrakkomandata hija ta' 8 mg/kg darbtejn kuljum.
English: There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues ; these have predominantly concerned treatment with regimens containing zidovudine.The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Maltese: Ir-reazzjonijiet avversi l-aktar komuni li kienu rrappurtati jinkludu mard tad-demm (anemija, newtropenja) u mard metaboliku (iperlaktejtimja,
English: See sections 4.4 and 4.8.
Maltese: (ara sezzjoni 4.4).
English: It also increases the CD4 cell count in your blood.
Maltese: Ċelluli CD4 huma tip ta'
English: The abacavir + lamivudine once daily dosing group was demonstrated to be non-inferior to the twice daily group according to the pre-specified non-inferiority margin of -12%, for the primary endpoint of <80 c/mlat Week 48 as well as at Week 96 (secondary endpoint) and all other thresholds tested (<200c/ml, <400c/ml, <1000c/ml), which all fell well within this non-inferiority margin.
Maltese: 12%, għall-punt tat-tmiem primarju ta' <80 c/ml fil-Ġimgħa 48 kif ukoll fil-Ġimgħa 96 (punt tattmiem sekondarju) u għal-limiti stabbiliti l-oħra kollha ttestjati (<200c/ml, <400c/ml, <1000c/ml),
English: The systemic exposures were equivalent to 7 to 24 times the expected systemic exposure in humans.
Maltese: L-esponimenti sistemiċi kienu ekwivalenti għal 7 sa 24 darba ta` l-esponiment sistemiku li jkun mistenni fil-bnedmin.
English: Ziagen contains abacavir (which is also an active substance in Trizivir , Triumeq and Kivexa).
Maltese: Ziagen fih abacavir (li huwa wkoll is-sustanza attiva f'Trizivir, Triumeq u Kivexa).
English: • In order to avoid restarting abacavir, patients who have experienced a suspected HSR should be instructed to dispose of their remaining Ziagen tablets
Maltese: • Sabiex jiġi evitat li jerġgħu jibdew abacavir, pazjenti li jkunu esperjenzaw HSR suspettat għandhom jingħataw struzzjonijiet biex jarmu l-bqija tal-pilloli tagħhom ta' Ziagen
English: Methadone: in a pharmacokinetic study, co-administration of 600 mg abacavir twice daily with methadone showed a 35% reduction in abacavir Cmax and a one hour delay in tmax but the AUC was unchanged.
Maltese: Methadone: waqt studji farmakokinetiċi, meta 600 mg ta` abacavir darbtejn kuljum ingħata ma'
English: One randomised, double blind, placebo controlled clinical study in adults has compared the combination of abacavir, lamivudine and zidovudine to the combination of indinavir, lamivudine and zidovudine.
Maltese: Studju kliniku fl-adulti randomised, double blind, kontrollat bil-plaċebo, qabbel l-użu ta'
English: Excipients
Maltese: Ġilda
English: The pack also includes a polyethylene syringe-adapter and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.
Maltese: Il-pakkett jinkludi wkoll adapter tal-polyethylene għas-siringa u siringa ta' 10 ml biex tingħata d doża mill-ħalq li hija magħmula minn bettija tal-polypropylene (b'marki tal-kejl bil-ml) u planġer tal-polyethylene.
English: This can be taken either as 300 mg (15 ml) twice a day or 600 mg (30 ml) once a day.
Maltese: (15 ml) darbtejn kuljum jew 600 mg (30 ml) darba kuljum.
English: Other symptoms include:
Maltese: Jekk ikollok xi sintomi ta' infezzjoni waqt li tkun qed tieħu Ziagen:
English: • presence of skin rash; OR
Maltese: • il-preżenza ta' raxx tal-ġilda; JEW
English: The exception was the preputial gland tumour which occurred at a dose of 110 mg/kg in mice.
Maltese: L-eċċezzjoni kienet filkaż tat-tumur tal-glandola prepuzzjali li deher f`doża ta` 110 mg/kg fil-ġrieden.
English: If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).
Maltese: Jekk it-tabib tiegħek ma jkunx dispost, għandek tfittex għajnuna medika oħra immedjatament (e.z. id-dipartiment ta` l-emergenza fl-eqreb sptar).
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy, and should be monitored according to standard practice.
Maltese: Pazjenti b'disfunzjoni tal-fwied pri-eżistenti, li tinkludi epatite kronika u attiva, għandhom numru akbar ta' abnormalitajiet fil-funzjoni tal-fwied meta jingħataw ukoll terapija antiretrovirali, u għandhom jiġu monitorjati skond il-prattika stàndard.
English: Based on the results of in vitro experiments and the known major metabolic pathways of abacavir, the potential for P450 mediated interactions with other medicinal products involving abacavir is low.
Maltese: Fuq il-bażi ta' riżultati ta' esperimenti in vitro u r-reazzjonijiet metaboliċi prinċipali magħrufa ta' abacavir, il-possibiltà ta` interazzjonijiet permezz ta' P450 ma' prodotti mediċinali li fihom abacavir hija baxxa.
English: Artificial strawberry and banana flavours Purified water
Maltese: Togħma artifiċjali tal-frawli u tal-banana
English: In pregnant women, more than 800 outcomes after first trimester exposure and more than 1000 outcomes after second and third trimester exposure indicate no malformative and foetal/neonatal effect of abacavir.
Maltese: 1000 riżultat wara espożizzjoni fit-tieni u fit-tielet trimestru ma jindikaw ebda effett malformattiv u feto/neonatali ta' abacavir.
English: Sodium citrate
Maltese: Sustanzi attivi
English: Clinical diagnosis of suspected hypersensitivity to ABC remains the basis for clinical decision making.
Maltese: Id-dijanjożi klinika ta' suspett ta' sensittività eċċessiva għal ABC tibqa' l-bażi għat-teħid ta' deċiżjoni klinika.
English: Dosing according to weight bands is recommended for Ziagen tablets.
Maltese: Huwa rrakkomandat dożaġġ skond kategoriji ta' piż għal pilloli ta' Ziagen.
English: The once daily regimen of abacavir is supported by a 48 weeks multi-centre, double-blind, controlled study (CNA30021) of 770 HIV-infected, therapy-naïve adults.
Maltese: Studju kkontrollat double-blind ta' 48 ġimgħa b'770 adult infettati bl-HIV li qatt ma ingħatalhom kura qabel, f'aktar minn ċentru wieħed (CAN 30021), wera li d-doża ta' darba kuljum ta' abacavir hija effettiva.
English: Some people taking Ziagen for HIV are more at risk of serious side effects.
Maltese: Xi persuni li qed jieħdu Ziagen għall-HIV huma f'riskju akbar ta' effetti sekondarji serji.
English: The systemic exposure at the no effect level in mice and rats was equivalent to 3 and 7 times the human systemic exposure during therapy.
Maltese: L-esponiment tas sistema għall-livell ta' bla effett fil-ġrieden u fil-firien kienet ekwivalenti għal minn 3 u 7 darbiet ta` l-esponiment sistemiku uman li jkun hemm waqt it-terapija.
English: This can be taken either as one 300 mg tablet twice a day or two 300 mg tablets once a day.
Maltese: 300 mg darbtejn kuljum jew bħala żewġ pilloli ta' 300 mg darba kuljum.
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Maltese: Pazjenti b'epatite B jew Ċ kronika u li jkunu qed jiġu kkurati b'terapija antiretrovirali kombinata għandhom riskju ogħla ta' reazzjonijiet avversi fil-fwied severi u potenzjalment fatali.
English: Marketing Authorisation Holder:
Maltese: Detentur tal-Awtorizzazzjoni għat-tqegħid fis-suq:
English: Abacavir should not be used in patients known to carry the HLA-B*5701 allele
Maltese: Qabel ma tinbeda kura b'abacavir, għanda ssir investigazzjoni għall-ġarr ta' l-allel HLA-B*5701
English: Late onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Maltese: Rarament ġew irrappurtati disturbi newroloġiċi li ma tfaċċawx mill-ewwel (ipertonja, aċċessjoni, imġiba mhux normali).
English: The study Data Safety Monitoring Board stopped the ZDV/3TC/ABC arm at this time based on the higher proportion of patients with virologic failure.
Maltese: ZDV/3TC/EFV ġew kategoriżżati li kellhom falliment viroloġiku.
English: General disorders and administration site conditions Common: fever, lethargy, fatigue
Maltese: Mard ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni: deni, letarġija, għejja.
English: • skin rash
Maltese: OĦRAJN
English: • nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness Other symptoms include:
Maltese: • dardir (tħossok se tirremetti), rimettar (tirremetti), dijarea, uġigħ ta' żaqq (fl-istonku),
English: The mean (CV) AUC over a dosing interval of 12 hours was 6.02 µg.h/ml (29%), equivalent to a daily AUC of approximately 12.0 µg.h/ml.
Maltese: L-AUC medju (CV) meqjus fuq perjodu ta' 12-il siegħa kien 6.02 µg.h/ml.
English: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti li jbgħatu minn fructose intolerance ereditarja m'għandhomx jieħdu din il-mediċina.
English: 1206 paediatric patients aged 3 months to 17 years enrolled in the ARROW Trial (COL105677) and were dosed according to the weight - band dosing recommendations in the World Health Organisation treatment guidelines (Antiretroviral therapy of HIV infection in infants and children, 2006).
Maltese: Fi studju randomizzat, multiċentriku u kkontrollat ta' pazjenti pedjatriċi, infettati bl-HIV sar tqabbil randomizzat ta' skema li kienet tinkludi dożaġġ ta' abacavir u lamivudine darba kuljum kontra darbtejn kuljum. 1206 pazjenti pedjatriċi li l-età tagħhom kienet tvarja minn 3 xhur sa 17-il sena ħadu sehem fil-Prova ARROW (COL105677) u ngħataw dożi skont ir-rakkomandazzjonijiet tad-dożaġġ skont il-kategorija ta' piż fil-linji gwida dwar it-trattament tal-Organizzazzjoni Dinjija tas-Saħħa (Terapija antiretrovirali ta' infezzjoni tal-HIV fit-trabi u t-tfal, 2006).
English: This medicine contains the sweetener sorbitol (approximately 5g in each 15 ml dose), which may have a mild laxative effect.
Maltese: Din il-mediċina fiha sorbitol (madwar 5 g f`kull doża ta'15 ml) biex jagħti togħma ħelwa, li jista' jkollu effett lassattiv ħafif.
English: 28 June 2013 EMA/384191/2013
Maltese: 13 ta' Settembru 2013 EMA/563900/2013
English: Flupirtine works as a ‘selective neuronal-potassium-channel opener'.
Maltese: Flupirtine jaħdem bħala “selective neuronal potassium channel opener”.
English: Flupirtine-containing medicines have been authorised since the 1980s and are currently available in the following EU Member States: Bulgaria, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Romania and Slovakia.
Maltese: Il-mediċini li fihom flupirtine ilhom awtorizzati mit-tmeninijiet u fil-preżent huma disponibbli fl-Istati Membri li ġejjin: il-Bulgarija, l-Estonja, il-Ġermanja, l-Ungerija, l-Italja, il-Latvja, il-Litwanja, il-Polonja, il-Portugall, ir-Rumanija u s-Slovakkja.
English: Flupirtine is available as 100-mg immediate-release capsules, 400-mg extended-release tablets, 75mg and 150-mg suppositories and as a solution for injection (100 mg).
Maltese: Flupirtine huwa disponibbli bħala kapsuli b'rilaxx immedjat ta' 100 mg, pilloli b'rilaxx estiż ta' 400 mg, suppożitorji ta' 75 mg u 150 mg u bħala soluzzjoni għal injezzjoni (100 mg).
English: The review of flupirtine-containing medicines was initiated in March 2013 at the request of Germany, under Article 107i of Directive 2001/83/EC.
Maltese: Ir-reviżjoni tal-mediċini li fihom flupirtine nbdiet f'Marzu 2013 fuq talba mill-Ġermanja, skont lArtikolu 107i tad-Direttiva 2001/83/KE. Segwiet il-passi proċedurali stabbiliti fl-Artikolu 107i tadDirettiva 2011/83, magħrufa wkoll bħala l-proċedura urġenti tal-Unjoni.
English: With regard to the evidence of efficacy, the review highlighted a lack of sufficient data on the benefits of flupirtine in chronic pain.
Maltese: Fir-rigward tal-evidenza tal-effikaċja, ir-reviżjoni enfasizzat nuqqas ta' dejta suffiċjenti dwar ilbenefiċċji ta' flupirtine f'uġigħ kroniku.
English: The recommendations follow a review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) which looked into reported liver problems with flupirtine, ranging from high liver-enzyme levels to liver failure.
Maltese: Ir-rakkomandazzjonijiet segwew reviżjoni mill-Kumitat Konsultattiv dwar il-Valutazzjoni tar-Riskji talFarmakoviġilanza (PRAC) li ta daqqa t'għajn lejn il-problemi fil-fwied irrappurtati bi flupirtine, li jvarjaw minn livelli għoljin ta' enzimi fil-fwied sa insuffiċjenza tal-fwied.
English: A review of the safety data from the EU adverse reaction database revealed 330 cases of adverse liver events suspected to be linked to flupirtine.
Maltese: Informazzjoni għall-professjonisti fil-kura tas-saħħa Reviżjoni tad-dejta dwar is-sigurtà mid-database tal-UE tar-reazzjonijiet avversi żvelat 330 każ ta' avvenimenti avversi fil-fwied li hemm suspett li huma marbuta ma' flupirtine.
English: Flupirtine is a non-opioid painkiller that has been used to treat pain, such as pain associated with muscle tension, cancer pain, menstrual pain and pain following orthopaedic surgery or injuries.
Maltese: Flupirtine huwa analġesiku mhux opjojdu biex jiġi kkurat l-uġigħ, bħall-uġigħ assoċjat mat-tensjoni talmuskoli, l-uġigħ tal-kanċer, l-uġigħ mestrwali u uġigħ wara kirurġija ortopedika jew korrimenti.
English: The PRAC recommendations were sent to the CMDh, which adopted a final position.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lis-CMDh, li adotta pożizzjoni finali.
English: Subsequently, multiple other actions such as muscle relaxation were identified.
Maltese: Sussegwentement, ġew identifikati diversi azzjonijiet oħra bħar-rilassament tal-muskoli.
English: Restrictions in the use of flupirtine-containing medicinesCMDh endorses PRAC recommendation
Maltese: Id-dożi l-oħra u l-forom farmaċewtiċi huma disponibbli biss fil-Ġermanja.
English: The 100-mg immediate-release capsules are available in the 11 EU Member States listed above.
Maltese: Il-kapsuli b'rilaxx immedjat huma disponibbli fil-11-il Stat Membru elenkati hawn fuq.
English: • Because flupirtine may have effects on the liver in some patients, your doctor will test your liver function during treatment and stop treatment if there are any signs of liver problems.
Maltese: • Peress li flupirtine jista' jkollu effetti fuq il-fwied f'xi pazjenti, it-tabib tiegħek se jittestja l-funzjoni tal-fwied tiegħek matul il-kura u jwaqqaf il-kura jekk ikun hemm sinjali ta' problemi fil-fwied.
English: Flupirtine was first introduced as an alternative painkiller to opioids and NSAIDs.
Maltese: Fil-bidu, flupirtine ġie introdott bħala analġesiku alternattiv għall-opjojdi u l-NSAIDs.
English: • Healthcare professionals should review the treatment of patients taking flupirtine taking into account the recommendations above.
Maltese: • Il-professjonisti fil-kura tas-saħħa għandhom jirrevedu l-kura tal-pazjenti li jieħdu flupirtine filwaqt li jqisu r-rakkomandazzjonijiet ta' hawn fuq.
English: • Oral flupirtine medicines and suppositories should only be used to treat adults with acute pain and only if treatment with other painkillers (such as NSAIDs and weak opioids) is contraindicated.
Maltese: • Il-mediċini orali u s-suppożitorji ta' flupirtine għandhom jintużaw biss biex jikkuraw adulti b'uġigħ akut u f'każ biss li l-kura b'analġesiċi oħrajn (bħal NSAIDs u oppjojdi dgħajfa) tkun kontraindikata.
English: The CMDh agreed with the PRAC's conclusions and has endorsed the PRAC's recommendations on the use of flupirtine-containing medicines.
Maltese: Is-CMDh qabel mal-konklużjonijiet tal-PRAC u approva r-rakkomandazzjonijiet tal-PRAC dwar l-użu talmediċini li fihom flupirtine.