FrancophonIA/ELRC3.0 huggingface dataset:
English: • A reminder to use contraception, that upadacitinib is contraindicated during pregnancy, and to notify their HCPs if they become pregnant while taking upadacitinib o Description of signs/symptoms of deep venous thrombosis or pulmonary embolism which the patient needs to be aware of, so that they can seek attention from an HCP.
Maltese: • Tfakkira biex tuża kontraċettiv, li upadacitinib m'għandux jingħata waqt it-tqala, u biex jgħarrfu lil-HCPs tagħhom jekk joħorġu tqal waqt li jkunu qed jieħdu upadacitinib o Deskrizzjoni ta' sinjali/sintomi ta' trombożi fil-vini tal-fond jew emboliżmu pulmonari li l-pazjenti jeħtieġ li jkunu konxju tagħhom, sabiex ikunu jistgħu jfittxu attenzjoni minn HCP.
English: As there is a higher incidence of infections in the elderly ≥ 75 years of age, caution should be used when treating this population.
Maltese: Minħabba li hemm inċidenza ogħla ta' infezzjonijiet fl-anzjani ta' ≥ 75 sena, għandu jkun hemm kawtela meta jingħata trattament lil din il-popolazzjoni.
English: Malignancies were observed in clinical studies of upadacitinib.
Maltese: Id-data klinika attwalment hi limitata u għadhom għaddejjin studji fit-tul.
English: • you have had a herpes zoster infection (shingles), because RINVOQ may allow it to come back.
Maltese: • kellek infezzjoni ta' herpes zoster (ħruq ta' Sant'Antin), għaliex tista' tirritorna b'RINVOQ.
English: Lymphocytes
Maltese: MEDIĊINALI
English: Upadacitinib Cmax was unchanged in subjects with mild hepatic impairment and 43% higher in subjects with moderate hepatic impairment compared to subjects with normal liver function.
Maltese: Is-Cmax ta' upadacitinib baqgħet mhux mibdula f'individwi b'indeboliment ħafif tal-fwied u 43% ogħla f'individwi b'indeboliment moderat tal-fwied meta mqabbla ma' individwi b'funzjoni normali tal-fwied.
English: 30 prolonged-release tablets 90 prolonged-release tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 pillola li jerħu l-mediċina bil-mod
English: RINVOQ 15 mg prolonged-release tablets
Maltese: IL-PRODOTT MEDIĊINALI RINVOQ 15 mg pilloli li jerħu l-mediċina bil-mod
English: Consider alternatives to strong CYP3A4 inhibitor medications when used in the long-term.
Maltese: Ikkunsidra alternattivi għal mediċini li huma inibituri qawwija ta' CYP3A4 meta użati fit-tul.
English: improvement; ADA = adalimumab; CDAI = Clinical Disease Activity Index; CR = Clinical Remission; CRP = C-Reactive Protein, DAS28 = Disease Activity Score 28 joints; IR = inadequate responder; LDA = Low Disease Activity; MTX = methotrexate; PBO = placebo; UPA= upadacitinib a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE e multiplicity controlled p≤0.001upadacitinib vs placebo or MTX comparison f multiplicity controlled p≤0.01 upadacitinib vs placebo or MTX comparison g nominal p≤0.001 upadacitinib vs placebo or MTX comparison h nominal p≤0.001upadacitinib vs adalimumab comparison i nominal p≤0.01 upadacitinib vs adalimumab comparison j nominal p<0.05 upadacitinib vs adalimumab comparison k nominal p≤0.01 upadacitinib vs placebo or MTX comparison l nominal p<0.05 upadacitinib vs MTX comparison
Maltese: e upadacitinib ikkontrollat għall-multipliċità p≤0.001 vs paragun bi plaċebo jew b'MTX f upadacitinib ikkontrollat għall-multipliċità p≤0.01 vs paragun bi plaċebo jew b'MTX g upadacitinib nominali p≤0.001 vs paragun bi plaċebo jew b'MTX
English: In clinical trials, upadacitinib was administered without regard to meals (see section 4.2).
Maltese: Fil-provi kliniċi, upadacitinib ingħata mingħajr ma ngħata kas tal ikel (ara sezzjoni 4.2).
English: Patients who were positive for hepatitis B surface antigen or hepatitis B virus DNA were excluded from clinical studies.
Maltese: Pazjenti li kellhom riżultat pożittiv għall-antiġen tal-wiċċ tal-Epatite B jew DNA tal-virus tal-epatite B ġew esklużi mill-istudji kliniċi.
English: RINVOQ is available in packs containing 28 or 98 prolonged-release tablets and in multipacks of 84 comprising 3 cartons, each containing 28 prolonged-release tablets.
Maltese: RINVOQ huwa disponibbli f'pakketti li fihom 28 jew 98 pillola li jerħu l-mediċina bil-mod u f'pakketti multipli ta' 84 li fihom 3 kartuni, kull waħda b'28 pillola li jerħu l-mediċina bil-mod.
English: All studies included long-term extensions for up to 5 years.
Maltese: L-istudji kollha kienu jinkludu estensjonijiet fit-tul sa 5 snin.
English: Treatment should be interrupted if ANC is < 1,000 cells/mm3 and may be restarted once ANC returns above this value
Maltese: It-trattament għandu jiġi interrott jekk l-ANC huwa ta' < 1,000 ċellula/mm3 u jista' jerġa' jinbeda ladarba l-ANC
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of 98 tablets
Maltese: Kartuna ta' barra ta' 98 pillola
English: HDPE bottles with desiccant and polypropylene cap in carton containing 30 prolonged-release tablets.
Maltese: Flixken tal-HDPE b'dessikant u b'għatu tal-polypropylene f'kartuna li fihom 30 pillola li jerħu l mediċina bil-mod.
English: Upadacitinib is a selective and reversible JAK inhibitor.
Maltese: Upadacitinib hu inibitur selettiv u riversibbli ta' JAK.
English: Note: Week 48-data derived from analysis on Full Analysis set (FAS) by randomised group using NonResponder Imputation
Maltese: Nota: Id-data ta' ġimgħa 48 li nkisbet mill-analiżi tas-sett ta' Analiżi Sħiħ (FAS - Full Analysis set) minn grupp li ntgħażel b'mod każwali permezz tal-Imputazzjoni tal-Persuni li Ma Wrewx Rispons
English: Upadacitinib partitions similarly between plasma and blood cellular components, as indicated by the blood to plasma ratio of 1.0.
Maltese: Upadacitinib jitqassam b'mod simili bejn ilplażma u l-komponenti ċellulari tad-demm kif indikat mil-proporzjon tad-demm mal-plażma ta' 1.0.
English: • The patient alert card shall contain the following key messages: o Contact details of the upadacitinib prescriber o Language that the PAC should be carried by the patient at any time and to share it with HCPs involved in their care (i.e., non-upadacitinib prescribers, emergency room HCPs, etc.) o Description of signs/symptoms of infections the patient needs to be aware of, so that they can seek attention from their HCP:
Maltese: • Il-kartuna ta' allert għall-pazjent għandu jkun fiha l-messaġġi ewlenin li ġejjin: o Dettalji tal-kuntatt tal-persuna li tkun tat riċetta għal upadacitinib o Lingwaġġ li l-PAC għandha tinġarr mill-pazjent fi kwalunkwe ħin u tinqasam malHCPs involuti fil-kura tagħhom (jiġifieri persuni li ma jkunux taw ir-riċetta għal upadictinib, HCPs fit-taqsima tal-emerġenza, eċċ.) o Deskrizzjoni ta' sinjali/sintomi ta' infezzjonijiet li l-pazjent irid ikun konxju tagħhom, sabiex ikunu jistgħu jfittxu attenzjoni mill-HCP tagħhom.
English: Malignancy
Maltese: Limfoċiti
English: • infection of the lung (pneumonia), which may cause shortness of breath, fever, and a cough with mucus
Maltese: • infezzjoni tal-pulmun (pnewmonja), li tista' tikkawża qtugħ ta' nifs, deni, jew sogħla bil-mukus
English: Each prolonged-release tablet contains upadacitinib hemihydrate, equivalent to 15 mg upadacitinib
Maltese: Informazzjoni għall-pazjent RINVOQ 15 mg pilloli li jerħu l-mediċina bil-mod upadacitinib
English: In methotrexate (MTX)-controlled studies, the frequency of infection over 12/14 weeks in the upadacitinib 15 mg monotherapy group was 19.5% compared to 24.0% in the MTX group.
Maltese: 12/14-il ġimgħa fil-grupp ta' upadacitinib 15 mg mogħti waħdu kienet ta' 19.5% mqabbla ma' 24.0%
English: 1 vial + 1 vial
Maltese: 1 fjala + 1 fjala
English: 1 vial + 1 pre-filled syringe powder: 450 IU; solvent: 0.75 ml (600 IU/ml)
Maltese: 1 pinna mimlija għal-lest + 15 il-siringa għal injezzjoni li jintremew wara li jintużaw syringes trab: 450IU; solvent: 0.75 ml (600
English: Subcutaneous use powder: vial (glass); solvent: vial (glass)
Maltese: trab: fjala (ħġieġ); solvent: fjala (ħġieġ)
English: Packaging
Maltese: IU/ml)
English: Lorviqua is available as tablets (25 and 100 mg) and the recommended dose is 100 mg once a day.
Maltese: Lorviqua jiġi bħala pilloli (25 u 100 mg) u d-doża rakkomandata hija 100 mg darba kuljum.
English: Lorviqua contains the active substance lorlatinib.
Maltese: Lorviqua fih is-sustanza attiva lorlatinib.
English: Lorviqua received a conditional marketing authorisation valid throughout the EU on 6 May 2019 Further information on Lorviqua can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Lorviqua.
Maltese: ema.europa.eu/medicines/human/EPAR/Lorviqua.
English: Other information about Lorviqua
Maltese: Informazzjoni oħra dwar Lorviqua
English: Lorviqua has been given ‘conditional authorisation'.
Maltese: Lorviqua ngħata ‘awtorizzazzjoni kondizzjonali'.
English: The most common side effects with Lorviqua (which may affect more than 1 in 5 people) are hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridaemia (high blood levels of triglycerides, a type of fat), oedema (build-up of fluid), peripheral neuropathy (nerve damage in the hands and feet), problems with thinking, learning and memory, tiredness, weight gain and effects on mood.
Maltese: L-effetti sekondarji l-aktar komuni b'Lorviqua (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma iperkolesterolemija (livelli għoljin ta' kolesterol fid-demm), ipertrigliċeridemija (livelli għoljin ta' trigliċeridi, tip ta' xaħam), edema (akkumulazzjoni ta' fluwidu), newropatija periferika (ħsara fin nervituri fl-idejn u fis-saqajn), problemi bil-ħsieb, tagħlim u memorja, għeja, żieda fil-piż u effetti fuq il-burdata.
English: The active substance in Lorviqua, lorlatinib, is a tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Lorviqua, il-lorlatinib, hija “inibitur tat-tirożina kinażi”.
English: What are the risks associated with Lorviqua?
Maltese: X'inhuma r-riskji assoċjati ma' Lorviqua?
English: What information is still awaited for Lorviqua?
Maltese: Liema informazzjoni għadha mistennija għal Lorviqua?
English: How is Lorviqua used?
Maltese: Lorviqua?
English: Lorviqua must not be used together with medicines known as ‘strong CYP3A4/5 inducers' because the combined medicines could have an effect on the liver.
Maltese: Lorviqua m'għandhux jintuża flimkien ma' mediċini magħrufin bħala “indutturi CYP3A4/5 qawwija” għax il-mediċini kkombinati jista' jkollhom effett fuq il-fwied.
English: As for all medicines, data on the use of Lorviqua are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Lorviqua hija ssorveljata kontinwament.
English: Lorviqua is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC), when the disease is advanced and ‘ALK-positive', which means that the cancer cells have certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
Maltese: Lorviqua huwa mediċina kontra l-kanċer li tintuża biex tikkura adulti b'kanċer tal-pulmun b'ċelloli mhux żgħar (NSCLC), meta l-marda tkun avvanzata u “pożittiva għall-ALK”, li jfisser li ċ-ċelloli tal-kanċer għandhom ċerti bidliet li jaffettwaw lill-ġene responsabbli għal proteina msejħa ALK (kinażi tal-linfoma anaplastika).
English: Lorviqua was effective at treating ALK-positive NSCLC in one main study which included 139 patients whose disease had worsened despite treatment with either alectinib or ceritinib or with crizotinib and another ALK tyrosine kinase inhibitor.
Maltese: Lorviqua kien effettiv fil-kura ta' NSCLC pożittiv għall-ALK fi studju ewlieni wieħed li inkluda 139 pazjent li l-marda tagħhom aggravat minkejja l-kura jew b'alektinib jew b'ċeritinib jew bi kriżotinib u b'inibitur tat-tirożina kinażi ta' ALK ieħor.
English: Out of patients who had been previously treated with crizotinib and another ALK tyrosine kinase inhibitor, around 40% had a complete or partial response to the medicine.
Maltese: Minn pazjenti li qabel kienu ġew ikkurati bi kriżotinib u b'inibitur ta' tirożina kinażi ta' ALK ieħor, madwar 40 % kellhom rispons komplet jew parzjali għall-mediċina.
English: Lorviqua is used on its own when the disease has worsened despite treatment with other medicines of the same class known as ALK tyrosine kinase inhibitors (TKIs), including alectinib, ceritinib and crizotinib.
Maltese: Lorviqua jintuża waħdu meta l-marda tmur għall-agħar minkejja kura b'mediċini oħra tal-istess klassi magħrufa bħala inibituri tat-tirożina kinażi ta' ALK (TKIs), inkluża l-alektinib, iċ-ċeritinib u l-kriżotinib.
English: For the full list of side effects and restrictions with Lorviqua, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u rrestrizzjonijiet b'Lorviqua, ara l-fuljett ta' tagħrif.
English: Side effects reported with Lorviqua are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Lorviqua huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Since Lorviqua has been given conditional authorisation, the company that markets Lorviqua will conduct a study with the medicine in patients whose disease has worsened after treatment with alectinib or ceritinib.
Maltese: Minħabba li Lorviqua ngħata awtorizzazzjoni kondizzjonali, il-kumpanija li tqiegħed Lorviqua fis-suq se twettaq studju bil-mediċina f'pazjenti li l-marda tagħhom marret għall-agħar wara l-kura b'alektinib jew b'ċeritinib.
English: Response to treatment was assessed using body scans and standardised criteria for assessing solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Maltese: Ir-rispons għall-kura ġie vvalutat permezz ta' skenns tal-ġisem u kriterji standardizzati użati għal tumuri solidi, u r-rispons komplet seħħ meta l-pazjent ma kien baqagħlu l-ebda sinjal tal-kanċer.
English: Around 43% of patients who had been previously treated with alectinib or ceritinib were considered by their doctors to have had a complete or partial response to the medicine.
Maltese: Madwar 43 % tal-pazjenti li qabel kienu ġew ikkurati b'alektinib jew ċeritinib kienu kkunsidrati mittobba tagħhom li kellhom rispons komplet jew parzjali għall-mediċina.
English: 224 (4 x 56) capsules
Maltese: 224 (4 x 56) kapsula
English: Pack size blister (PA/Alu/PVC/Alu)
Maltese: Daqs tal-pakkett folja (PA/Alu/PVC/Alu
English: 240 capsules
Maltese: Flixkun tal-HDPE 240 kapsula
English: HDPE bottle
Maltese: Il-pakkett li jmiss malprodott
English: Ref.: EMEA/711149/2009 EMEA/H/C/219
Maltese: EMEA/703045/2009 EMEA/H/C/219
English: It is available as white oval tablets (500 mg) and as granules (940 mg/g).
Maltese: Hija disponibbli f'pilloli bojod ovali (500 mg) u fi granuli (940 mg/g).
English: The marketing authorisation holder is Swedish Orphan International AB.
Maltese: Is-sid tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Swedish Orphan International AB.
English: Ammonaps sodium phenylbutyrate EPAR summary for the public
Maltese: Ammonaps sodium phenylbutyrate Sommarju tal-EPAR għall-pubbliku
English: Ammonaps is a medicine that contains the active substance sodium phenylbutyrate.
Maltese: Ammonaps huwa mediċina li fiha s-sustanza attiva sodium phenylbutyrate.
English: The marketing authorisation was renewed on 8 December 2004 and on 8 December 2009.
Maltese: L-awtorizzazzjoni għat-tqegħid fis-suq ġiet imġedda fit8 ta' Diċembru 2004 u fit-8 ta' Diċembru 2009.
English: Other information about Ammonaps:
Maltese: Informazzjoni oħra dwar Ammonaps:
English: As the company had supplied the additional information requested, the ‘Exceptional Circumstances' ended on 6 July 2004.
Maltese: Peress li l-kumpanija pprovdiet l-informazzjoni addizzjonali mitluba, iċ-‘ Ċirkostanzi Eċċezzjonali' ntemmu fis-6 ta' Lulju 2004.
English: What is Ammonaps?
Maltese: X'inhu Ammonaps?
English: The most common side effects with Ammonaps (seen in more than 1 patient in 10) are amenorrhoea (absence of periods) and irregular menstruation (irregular periods), but these only occur in fertile female patients.
Maltese: L-effett sekondarji l-aktar komuni b'Ammonaps (li dehru f'aktar minn pazjent 1 minn kull 10) huma amenorrhoea (nuqqas ta' ċikli) u mestrwazzjoni irregolari (ċikli irregolari), iżda dawn iseħħu biss f'pazjenti tas-sess femminili li jkunu fertili.
English: What is the risk associated with Ammonaps?
Maltese: X'inhu r-riskju assoċjat ma' Ammonaps?
English: Ammonaps was authorised under ‘Exceptional Circumstances', because, as the disease is rare, limited information was available at the time of approval.
Maltese: Ammonaps ġie awtorizzat taħt ‘Ċirkostanzi Eċċezzjonali', għax, peress li l-marda hija rari, linformazzjoni disponibbli kienet limitata fiż-żmien tal-approvazzjoni.
English: The active substance in Ammonaps, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body.
Maltese: Issustanza attiva f'Ammonaps, sodium phenylbutyrate, tinbidel f'sustanza msejħa phenylacetate filġisem.
English: Early diagnosis and immediate treatment are important to reduce the risk of disability.
Maltese: Dijanjożi bikrija u trattament immedjat huma importanti għat-tnaqqis tar-riskju ta' diżabilità.
English: Ammonaps has been studied in 82 patients with urea cycle disorders who were treated with Ammonaps and had not received other treatments for their disease before.
Maltese: Ammonaps ġie studjat fi 82 pazjent b'disturbi fiċ-ċiklu tal-urea li ġew trattati b'Ammonaps u li ma kienux irċevew trattamenti oħrajn għall-marda tagħhom qabel.
English: • ‘late-onset' disease in patients who show a partial lack of an enzyme after the age of one month and have had brain damage caused by high blood ammonia levels.
Maltese: • ‘bidu tard' marda fil-pazjenti li juru nuqqas parzjali ta' enżim wara l-età ta' xahar u li kellhom ħsara fil-moħħ minħabba l-livelli għoljin ta' ammonia fid-demm.
English: Phenylacetate combines with the amino acid glutamine, which contains nitrogen, to form a substance that can be removed from the body by the kidneys.
Maltese: Phenylacetate jingħaqad mal-aċidu amino glutamine, li fih in-nitroġenu, biex jifforma sustanza li tista' titneħħa mill-ġisem mill-kliewi.
English: The overall survival rate was about 80% in newborn babies who received Ammonaps.
Maltese: Ir-rata ta' sopravivenza ġenerali kienet madwar 80% fit-trabi tat-twelid li rċevew Ammonaps.
English: Ammonaps is used to treat patients who have urea cycle disorders.
Maltese: Ammonaps jintuża għat-trattament ta' pazjenti li għandhom disturbi fiċ-ċiklu tal-urea.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that urea cycle disorders are a serious disease with few treatments available, and that Ammonaps has been shown to prevent ammonia levels becoming too high.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) innota li d-disturbi fiċ-ċiklu tal-urea huma marda serja bi ftit trattamenti disponibbli, u li Ammonaps wera li jista' jimpedixxi llivelli ta' ammonia milli jilħqu livelli għoljin wisq.
English: Therefore, despite the limited information available, the CHMP decided that Ammonaps's benefits are greater than its risks as adjunctive therapy in the chronic management of urea cycle disorders.
Maltese: Għalhekk, minkejja l-informazzjoni limitata disponibbli, is-CHMP iddeċieda li l-benefiċċji ta' Ammonaps huma akbar mir-riskji tiegħu bħala terapija aġġuntiva fil-kura kronika tad-disturbi fiċ-ċiklu tal-urea.
English: The main measure of effectiveness was survival, but the study also looked at the number of hyperammonaemic episodes (periods of very high blood ammonia levels), cognitive development (development of the ability to think, learn and remember), growth, and blood ammonia and glutamine levels.
Maltese: Il-kejl ewlieni tal-effikaċja kien is-sopravivenza, iżda l-istudju eżamina wkoll innumru ta' episodji iperammonemiċi (perijodi ta' livelli għoljin ħafna ta' ammonia fid-demm), liżvilupp konjittiv (l-iżvilupp tal-abbiltà li taħseb, titgħallem u tiftakar), l-iżvilupp tal-ġisem, u l-livelli ta' ammonia u ta' glutamine fid-demm.
English: In the body, waste nitrogen is in the form of ammonia, which is toxic, especially for the brain.
Maltese: Fil-ġisem, in-nitroġenu żejjed huwa fil-forma ta' ammonia, li hija tossika, speċjalment għall-moħħ.
English: The full EPAR for Ammonaps is available here.
Maltese: Għaliex ġie approvat Ammonaps?
English: How has Ammonaps been studied?
Maltese: Kif ġie studjat Ammonaps?
English: What benefit has Ammonaps shown during the studies?
Maltese: Liema benefiċċju wera Ammonaps waqt l-istudji mwettqa?
English: Ammonaps is used as an add-on to other treatments and with a special low-protein diet to reduce the intake of nitrogen.
Maltese: Ammonaps jintuża bħala addittiv ma' trattamenti oħrajn u flimkien ma' dieta speċjali bi ftit proteini sabiex jonqos it-teħid tan-nitroġenu.
English: This allows the levels of nitrogen in the body to decrease, reducing the amount of ammonia produced.
Maltese: Dan jippermetti li jonqsu l-livelli tan-nitroġenu fil-ġisem, u għalhekk jonqos l-ammont ta' ammonia prodotta.
English: The tablets are for adults and children, and the granules are used in babies and in patients who cannot swallow tablets.
Maltese: Il-pilloli huma għall-adulti u għat-tfal, u l-granuli jintużaw għat-trabi u għall-pazjenti li ma jistgħux jibilgħu l-pilloli.
English: How does Ammonaps work?
Maltese: Għalxiex jintuża Ammonaps?
English: Ammonaps was not compared with any other treatments.
Maltese: Ammonaps ma ġiex imqabbel ma' trattamenti oħrajn.
English: Ammonaps is used in patients who lack one or more of the following enzymes: carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase.
Maltese: Ammonaps jintuża f'pazjenti li jonqoshom wieħed jew aktar mill-enżimi li ġejjin: carbamylphosphate synthetase, ornithine transcarbamylase, jew argininosuccinate synthetase.
English: Erythema multiforme
Maltese: Erytema multiforme
English: EU/1/01/192/001 10 tablets EU/1/01/192/002 14 tablets EU/1/01/192/003 20 tablets EU/1/01/192/004 100 tablets EU/1/01/192/005 5x2 tablets
Maltese: EU/1/01/192/001 10 pilloli EU/1/01/192/002 14-il pillola EU/1/01/192/003 20 pillola
English: (see sections 4.7 and 4.8).
Maltese: (ara sezzjoni 4.3).
English: Commonly susceptible species
Maltese: Speci komunement sensittivi
English: Pharmacotherapeutic group: macrolides, lincosamides and streptogramins, ATC Code: J01FA15.
Maltese: Kategorija farmakoterapewtika: makrolidi, linkosamidi u streptogramini, Kodiċi ATC: J01FA15.
English: Legionella pneumophila Moraxella catarrhalis* Other
Maltese: Legionella pneumophila Moraxella catarrhalis
English: INFORMATION IN BRAILLE Levviax
Maltese: INFORMAZZJONI BIL-BRAILLE Levviax
English: They are available in packs of 10, 5x2, 14, 20 and 100 tablets.
Maltese: Huma disponibbli f'pakketti ta' 10, 5x2, 14, 20 u 100 pillola.
English: -Renal impairment
Maltese: - Indeboliment renali
English: Musculoskeletal, connective tissue
Maltese: Disturbi muskoluskeletrali u talconnective tissue
English: Increase in liver enzymes (AST, ALT, alkaline phosphatase)
Maltese: Żidiet fl-enżimi tal-fwied (AST, ALT, alkaline phosphatase)
English: EXPIRY DATE EXP {month/year}
Maltese: DATA TA' META JISKADI EXP {XX/SSSS}
English: Aventis Pharma S.p.A. Strada Statale No 17, km22 67019 Scoppito (L'Aquila) Italy
Maltese: Strada Statale No 17, km22 67019 Scoppito (L'Aquila)
English: Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 and 2E1.
Maltese: Telithromycin huwa impeditur ta' CYP3A4 u CYP2D6, iżda jew m'għandux effett jew għandu wieħed limitat fuq CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 u 2E1.
English: • ketoconazole (anti fungal treatment)
Maltese: • ketoconazole (kura kontra l-infezzjonijiet tal-fungu)
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 July 2001
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI / TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 9 ta' Lulju 2001
English: Rash, urticaria, pruritus
Maltese: Raxx, urtikarja, ħakk
English: Oral anticoagulants
Maltese: Antikoagulanti
English: Reproductive system disorders
Maltese: Disturbi tassistema riproduttiva
English: Impaired renal function:
Maltese: Indeboliment fil-funzjoni renali:
English: Ελλάδα sanofi-aventis AEBE Τηλ.
Maltese: Jekk tiġi fid-dubju kellem lit-tabib jew l-ispiżjar tiegħek.