FrancophonIA/ELRC3.0 huggingface dataset:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 150 mg/25 ml
Maltese: Ż-ŻGĦAR EWLENIN KITBA FUQ IL-FJALA GĦAL PAXENE 150 mg/25 ml
English: The efficacy and safety of Paxene (175 mg/m² over 3 hours at 3-week intervals) in refractory metastatic breast cancer were investigated in 172 women in a multicentre, open-label Phase III trial.
Maltese: L-effikaċja u sigurtà ta' Paxene (175 mg/m² mogħtija fuq 3 sigħat f'intervalli ta' tliet ġimgħat) f'kanċer tas-sider fi stat metastatiku refrattorju ġie investigat f'172 mara fi prova ta' Fażi
English: • Painful sensation in the body
Maltese: • Sensazzjoni ta' uġigħ fil-ġisem
English: Patients should not be re-treated with subsequent cycles of paclitaxel until neutrophil counts recover to ≥ 1,500 cells/mm3 (≥ 1,000 cells/mm3 for AIDS-KS patients) and platelets recover to a level of ≥ 100,000 cells/mm3 (≥ 75,000 cells/mm3 for AIDS-KS patients).
Maltese: Pazjenti m'għandhomx jingħataw trattament mill-ġdid b'ċikli sussegwenti ta' paclitaxel sakemm lgħadd ta' newtrofili jirkupra għal livell ta' ≥1,500 ċellula/mm3 (≥1,000 ċellula/mm3 għal pazjenti b'KS-AIDS) u l-plejtlets jirkupraw għal livell ta' ≥100,000 ċellula/mm3 (≥75,000 ċellula/mm3 għal pazjenti b'AIDS-KS).
English: Mayne Pharma (France) SAS.
Maltese: S.A. Mayne Pharma (Benelux)
English: Animal studies showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Maltese: Studji fuq l-annimali wrew effetti tossiċi li m'humiex riversibbli fuq l-organi riproduttivi tar-raġel f'livelli ta' espożizzjoni klinikament rilevanti.
English: Additionally ileus, effects on creatinine clearance, abnormal electrolytes (e.g. hyponatraemia, hypomagnesaemia), hyperglycaemia, cough and pneumonia occurred very rarely.
Maltese: Barra minn hekk, ilejus, effetti fuq ir-rata ta' tneħħija tal-kreatinina, elettroliti anormali (p.e. iponatremja, ipomagnesemja) ipergliċemija, sogħla, u pulmonite kienu rari ħafna.
English: Myelosuppression appeared to be less frequent and severe with paclitaxel as a 3 hour infusion followed by cisplatin compared with ciclophosphamide followed by cisplatin.
Maltese: Il-majelosoppressjoni dehret li hi inqas frekwenti u sevea meta paclitaxel ingħata bħala infużjoni fuq tliet sigħat segwita b'cisplatin meta mqabbla ma' ciclophosphamide segwit b'cisplatin.
English: In patients treated with paclitaxel severe conduction abnormalities are rare.
Maltese: F'pazjenti li qed jingħataw kura b'paclitaxel abnormalitajiet fit-trasmissjoni huma rari.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 6 mg/ml of paclitaxel (300 mg of paclitaxel in 50 ml)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kunjett wieħed fih 6 mg/ml paclitaxel (300 mg ta' paclitaxel f'50 ml)
English: • Flu-like symptoms
Maltese: Komuni: sindromu tal-influwenza
English: Advanced ovarian carcinoma (first-line treatment)
Maltese: Kanċer tal-ovarju avvanzat (il-kura preferuta)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/113/002
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦALL-KUMMERĊ EU/1/99/113/002
English: Take special care with Paxene
Maltese: Oqgħod attenta ħafna b'Paxene
English: However, Grade 3 neurotoxicity was significantly more common in the high-dose paclitaxel arm vs. etoposide/cisplatin (40 % vs. 21 %).
Maltese: Madankollu, in-newrotossiċità ta Grad 3 kienet sinifikament aktar komuni fil-fergħa tal-istudju fejn ingħatat doża għolja ta' paclitaxel meta paragunati ma' etoposide/cisplatin (40 % vs 21 %).
English: When administered as a 3 hour infusion for the first-line chemotherapy of ovarian cancer, neurotoxicity, arthralgia/myalgia, and hypersensitivity were reported as more frequent and severe by patients treated with paclitaxel followed by cisplatin than patients treated with ciclophosphamide followed by cisplatin.
Maltese: Meta mogħti bħala infużjoni ta' 3 sigħat bħala l-kimoterapija fil-kura preferuta għal kanċer tal- ovarju, il-frekwenza ta' rapporti minn pazjenti għal newrotossiċità, artralġja/majalġja u sensittività eċċessiva kienu ogħla u kienu aktar serji meta dawn kienu kkurati b'paclitaxel segwit minn cisplatin aktar milli għal pazjenti kkurati b'ciclophosphamide segwit minn cisplatin.
English: The following discussion refers to two major trials for the first-line chemotherapy of ovarian cancer (paclitaxel plus cisplatin: over 1,050 patients) and two Phase III trials for the treatment of advanced NSCLC (paclitaxel plus cisplatin: over 360 patients) (see section 5.1).
Maltese: III għall-kura avvanzata ta' NSCLC (paclitaxel flimkien ma' cisplatin: aktar minn 360 pazjent) (ara sezzjoni 5.1).
English: Paxene belongs to a group of medicines known as antineoplastic agents.
Maltese: Paxene jappartjeni għal grupp ta' mediċini magħrufa bħala sustanzi antineoplastiċi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON TEXT FOR PAXENE 30 mg/5 ml
Maltese: Ż-ŻGĦAR EWLENIN KITBA FUQ IL-KUNJETT GĦAL PAXENE 30 mg/5 ml
English: Severe peripheral neuropathy occurred in 3 % of patients treated with the recommended dose and schedule of Paxene.
Maltese: Newropatija periferika serja seħħet fi 3 % tal-pazjenti kkurati bid-doża rakkomandata u skedata ta' Paxene.
English: Paediatric use:
Maltese: Tlf.:
English: Very common: neuropathy (mainly peripheral), paraesthesia, somnolence
Maltese: Komuni ħafna: newropatija (prinċipalment periferali),
English: • Shock
Maltese: • Xokk
English: Very common: alopecia
Maltese: • Nefħa lokalizzata tal-ġilda
English: Ear and labyrinth disorders
Maltese: Disturbi fil-widnejn u sistema labrintika
English: Median survival for each paclitaxel-containing arm was not significantly different compared to etoposide/cisplatin (p= 0.097 and 0.090 for high-dose paclitaxel and low-dose paclitaxel, respectively).
Maltese: Is-sopravivenza medjana għal kull fergħa ta l-istudju li fih kien hemm paclitaxel ma kinitx sinifikament differenti meta paragunata ma' etoposide/cisplatin (p=0.097 u 0.090 għal doża għolja ta' paclitaxel u għal doża baxxa ta'paclitaxel rispettivament).
English: Patients who experience severe neutropenia (neutrophils < 500 cells/mm3 for a week or longer) or severe peripheral neuropathy during Paxene therapy should have their dose reduced by 20 % (NSCLC and first-line treatment of ovarian cancer) or 25 % (MBC and MOC) for subsequent courses of Paxene.
Maltese: Newtropenja serja (<500 ċellula/mm3) seħħet f'20 % u f'39 % ta' pazjenti kkurati b'Paxene fl-ewwel kors ta' kura u għal tul il-perijodu kollu, rispettivament.
English: • Feeling faint
Maltese: • Uġigħ ta' ras
English: • Discolouration of stool
Maltese: • Tħossok stordut
English: In addition, paclitaxel induces bundles of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.
Maltese: Barra minn hekk, paclitaxel jissensitizza soror ta' mikrotubi waqt iċ-ċiklu taċ-ċellula u asters multipli ta' mikrotubi waqt il-mitosi.
English: Patients with severe hepatic dysfunction should not be treated with paclitaxel.
Maltese: Sintomi sensorjali ġeneralmet tjiebu jew irrisolvew fi ftit xhur minn meta jkun twaqqaf paclitaxel.
English: Neurotoxicity, mainly peripheral neuropathy, appeared to be more frequent and severe with a 175 mg/m2 3 hour infusion (85 % neurotoxicity, 15 % severe) than with a 135 mg/m2 24 hour infusion
Maltese: In-newrotossiċità, prinċipalment in-newropatija periferika dehret li hi aktar frekwenti u severa b'infużjoni ta'175 mg/m2 mogħtija fuq 3 sigħat (85 % newrotossiċità, 15 % severa) milli b'infużjoni ta' 135 mg/m2 mogħtija fuq 24 siegħa (25 % newropatija periferali, 3 % severa) meta paclitaxel ingħata flimkien ma'cisplatin.
English: Renal excretion plays a minor role in the elimination of paclitaxel, less than 10 % of the dose has been reported to be excreted in the urine as unchanged drug.
Maltese: Anqas minn 10 % tad-doża ġiet rappurtata li tiġi eliminata fl-awrina fi stat mhux mibdul.
English: One vial contains polyoxyl castor oil: 527 mg/ml and ethanol anhydrous; 49.7 v/v% For a full list of excipients, see section 6.1.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Fih ukoll: polyoxyl castor oil; citric acid (anidru) u 49.7% (v/v) ethanol.
English: Metastatic ovarian cancer (second-line treatment)
Maltese: Kanċer tal-ovarju fl-istat metastatiku (it-tieni kura preferuta)
English: Studies conducted in AIDS-KS patients who were taking Paxene and multiple concomitant medicinal products suggest that the systemic clearance of paclitaxel was significantly lower (p < 0.05) in the presence of nelfinavir and ritonavir, but not with indinavir.
Maltese: Studji mwettqa f'pazjenti li għandhom AIDS-KS li kienu qed jieħdu Paxene u prodotti mediċinali diversi jindikaw li r-rata ta' tneħħija sistematika ta' paclitaxel kienet sinifikament anqas (p < 0.05) filpreżenza ta' nelfinavir u ritonavir, imma mhux għal indinavir.
English: Patients with hepatic impairment may be at increased risk of toxicity, particularly Grade 3-4 myelosuppression.
Maltese: Pazjenti b'indeboliment fil-funzjoni tal-fwied jistgħu jkunu f'riskju ogħla ta' tossiċità, partikolarment trażżin tal-mudullun ta' Grad 3-4.
English: Consequently, Paxene should be administered with caution in patients receiving protease inhibitors as concomitant therapy.
Maltese: Sussegwentement, Paxene għandu jingħata b'attenzjoni f'pazjenti li qed jirċievu impedituri ta' protease bħala terapija konġunta.
English: Use by:
Maltese: Lott:
English: As Paxene contains ethanol (392 mg/ml), possible effects on the CNS and other effects should be considered (see section 4.7).
Maltese: Effetti possibbli fuq is-sistema nervuża ċentrali u effetti oħrajn għnandhom jiġu kkonsidrati billi Paxene fih l-ethanol (392 mg/ml) (ara sezzjoni 4.7).
English: Preparation for intravenous infusion
Maltese: Preparazzjoni għal infużjoni ġol-vina
English: Patients with impaired renal function:
Maltese: Effetti sekondarji rari huma elenkati taħt:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/113/004
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/113/004
English: Very rare*: acute encephalopathy, autonomic neuropathy (resulting in paralytic ileus and orthostatic hypotension),
Maltese: Rari ħafna*: enċefalopatija akuta; newropatija awtonomika (li tirriżulta f'ilju paralitiku u ipotensjoni ortostatika), aċċessjonijiet
English: The usual dose of Paxene is 100 mg/m2 of body surface area.
Maltese: Ġeneralment, id-doża ta' Paxene hija ta' 100 mg/m2 tal-erja superfiċjali tal-ġisem.
English: Rare side-effect are listed below:
Maltese: Effetti sekondarji rari ħafna huma elenkati isfel:
English: The following undesirable effects relate to 107 AIDS-KS patients treated with 100 mg/m2 Paxene administered as a 3 hour infusion as second-line chemotherapy in a clinical study, and were considered possibly or probably related to Paxene.
Maltese: Sarkoma ta' Kaposi relatata ma' AIDS Id-doża rakkomandata ta' Paxene hija ta' 100 mg/m2 mogħtija bħala infużjoni ta' 3 sigħat ġol-vina kull ġimagħtejn.
English: According to the duration of infusion, two dose regimes of Paxene are recommended: Paxene 175 mg/m2 administered as a 3-hour intravenous infusion, followed by cisplatin 75 mg/m2 every three weeks or Paxene 135 mg/m2 as a 24-hour infusion, followed by cisplatin 75 mg/m2 every three weeks.
Maltese: Paxene 175 mg/m2 mogħti bħala infużjoni ta' 3 sigħat, sussegwit b'cisplatin 75 mg/m2 kull tliet ġimgħat jew Paxene 135 mg/m2 bħala infużjoni ta' 24 siegħa, sussegwit b'cisplatin 75 mg/m2 kull tliet ġimgħat.
English: Very common: nausea, vomiting, diarrhoea, mucosal inflammation, constipation, stomatitis, abdominal pain
Maltese: Komuni ħafna: tqalligħ, rimettar, dijarea, infjammazzjoni talmukosa, stitikezza, stomatite, uġigħ fl-addome
English: The efficacy and safety of Paxene were investigated in a single, non-comparative study in 107 patients with advanced KS, previously treated with systemic chemotherapy.
Maltese: L-effikaċja u s-sigurtà ta' Paxene kienu mistħarġa fi studju uniku, mhux komparattiv li sar fuq 107 pazjenti b'KS avvanzata, li qabel kienu kkurati b'kimoterapija sistematika.
English: Severe cardiovascular events were observed more frequently in patients with NSCLC than breast or ovarian carcinoma.
Maltese: Każijiet kardjovaskulari severi ġew osservati bi frekwenza akbar f'pazjenti li għandhom NSCLC milli f'pazjenti b'karċinoma tas-sider jew tal-ovarju.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2)
English: MANUFACTURER'S BATCH NUMBER Batch Number:
Maltese: NUMRU TAL-LOTT Lott [numru]:
English: Paxene should be given before cisplatin when used in combination (see section 4.5).
Maltese: Paxene għandu jingħata qabel cisplatin meta dawn jintużaw flimkien (ara sezzjoni 4.5).
English: Do not use Paxene after the expiry date, which is stated on the vial label and outer carton after “use by”.
Maltese: Tużax Paxene wara d-data ta' skadenza li tidher fuq it-tikketta tal-kunjett u l-kartuna ta' barra wara “Uża sa”.
English: Like other genotoxic cytostatics, paclitaxel can have genotoxic effects.
Maltese: Karsinoġenesi, mutagenesi, indeboliment tal-fertilità:
English: In the first trial, over 650 patients with stage IIb-c, III or IV primary ovarian cancer received a maximum of 9 treatment courses of paclitaxel (175 mg/m2
Maltese: Fl-ewwel prova klinika, aktar minn 650 pazjent li kienu jbatu minn kanċer tal-ovarju primarju li kien jinsab fl-istadji IIb-ċ, III jew IV ġew mogħtija massimu ta' 9 korsijiet ta' kura ta' paclitaxel (175 mg/m2 mifruxa fuq 3 sigħat) segwit minn cisplatin
English: What Paxene looks like and contents of the pack
Maltese: Id-Dehra ta' Paxene u l-kontenuti tal-pakkett
English: Very rare*: hepatic necrosis, hepatic encephalopathy
Maltese: Rari ħafna*: xokk anafilattiku (li tinkludi sensittività
English: Paxene should be administered via an infusion control device (pump) using non-PVC tubing and connectors.
Maltese: Paxene għandu jingħata minn tagħmir ta' infużjoni ikkontrollat (pompa) fejn għandhom jintużaw tubi u konnetturi li mhumiex tal-PVC.
English: • Mild flaking of skin associated with dryness, rash and acne
Maltese: • Xedd tal-ġilda b'mod ħafif minħabba ġilda xotta, raxx u akne
English: MARKETING AUTHORISATION NUMBER(S) EU/1/99/113/001
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/99/113/003
English: EU (MA) Number
Maltese: EU/1/15/1064/001
English: It is available as an oral solution (100 mg/ml).
Maltese: Jiġi f'soluzzjoni orali (100 mg/ml).
English: The full EPAR for Levetiracetam Actavis Group can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Levetiracetam Actavis Group is a ‘generic medicine'.
Maltese: Levetiracetam Actavis Group huwa ‘mediċina ġenerika'.
English: The active substance in Levetiracetam Actavis Group, levetiracetam, is an anti-epileptic medicine.
Maltese: Is-sustanza attiva f'Levetiracetam Teva Group, il-levetiracetam, hija mediċina antiepilettika.
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Maltese: Il-mod preċiż kif taħdem illevetiracetam għadu mhux ċar iżda jidher li din tinterferixxi ma' proteina msejħa proteina sinaptika vexxili 2A, li tinstab fl-ispazji ta' bejn in-nervituri, u għandha sehem fir-rilaxx ta' messaġġiera kimiċi miċ-ċelloli tan-nervituri.
English: When Levetiracetam Actavis Group is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Maltese: Meta Levetiracetam Actavis Group jingħata flimkien ma' trattament antiepilettiku ieħor, id-doża talbidu f'pazjenti minn 12-il sena 'l fuq li jiżnu aktar minn 50 kg għandha tkun 500 mg darbtejn kuljum.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Actavis Group.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Levetiracetam Actavis Group.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Actavis Group has been shown to have comparable quality and to be bioequivalent to Keppra.
Maltese: Is-CHMP ikkonkluda li, b'konformità mar-rekwiżiti tal-UE, intwera li l-kwalità ta' Levetiracetam Actavis Group hija kumparabbli ma' Keppra u li l-prodott mediċinali huwa bijoekwivalenti għalih.
English: In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution.
Maltese: Fi trabi ta' bejn xahar u sitt xhur, id-doża inizjali hija 7 mg/kg darbtejn kuljum u għandha tingħata permezz tas-soluzzjoni orali.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Actavis Group on 5 December 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Levetiracetam Actavis Group fil-5 ta' Diċembru 2011.
English: Levetiracetam Actavis Group is a medicine that contains the active substance levetiracetam.
Maltese: Levetiracetam Actavis Group huwa mediċina li fiha s-sustanza attiva levetiracetam.
English: This means that Levetiracetam Actavis Group is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Maltese: Dan ifisser li Levetiracetam Actavis Group huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Keppra.
English: The most common side effects with Levetiracetam Actavis Group (seen in more than 1 patient in 10) are somnolence (sleepiness), and asthenia (weakness) or fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Levetiracetam Actavis Group (li dehru f'aktar minn pazjent 1 minn kull 10) huma somnolonza (ħedla) u astenja (dgħufija) jew għeja (telqa).
English: When Levetiracetam Actavis Group is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Maltese: Id-doża tal-bidu hija 250 mg darbtejn kuljum, u tiżdied ġimgħatejn wara għal 500 mg darbtejn kuljum.
English: Because Levetiracetam Actavis Group is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Maltese: Peress li Levetiracetam Actavis Group huwa mediċina ġenerika, l-istudji fuq il-pazjenti ġew limitati għal testitjiet li ddeterminaw jekk din il-mediċina kinitx bijoekwivalenti għall-mediċina ta' referenza Keppra.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from
Maltese: • aċċessjonijiet mijokloniċi (qosra, movimenti spażmodiċi donnhom xokkijiet ta' muskolu jew ta' grupp ta' muskoli) f'pazjenti minn tnax-il sena 'l fuq li jbatu bl-epilessija mijoklonika ġuvenili;
English: What is Levetiracetam Actavis Group?
Maltese: X'inhu Levetiracetam Actavis Group?
English: Other information about Levetiracetam Actavis Group
Maltese: Aktar tagħrif dwar Levetiracetam Actavis Group
English: Levetiracetam Actavis Group can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Maltese: Levetiracetam Actavis Group jista' jintuża waħdu f'pazjenti minn 16-il sena 'l fuq li ġew dijanjostikati għall-ewwel darba bl-epilessija, għall-kura ta' aċċessjonijiet parzjali tal-bidu (attakki ta' epilessija) b'ġeneralizzazzjoni sekondarja jew mingħajrha.
English: For the full list of all side effects reported with Levetiracetam Actavis Group, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Levetiracetam Actavis Group, ara l-fuljett ta' tagħrif.
English: Because Levetiracetam Actavis Group is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Levetiracetam Actavis Group huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Why has Levetiracetam Actavis Group been approved?
Maltese: Għaliex ġie approvat Levetiracetam Actavis Group?
English: Epilepsy is caused by excessive electrical activity in the brain.
Maltese: Lepilessija tiġi kkawżata minn attività elettrika eċċessiva fil-moħħ.
English: Levetiracetam Actavis Group must not be used in people who are hypersensitive (allergic) to levetiracetam, to other pyrrolidone derivatives (medicines with a similar structure to levetiracetam), or to any of the other ingredients.
Maltese: Levetiracetam Actavis Group ma għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal-levetiracetam jew għal kwalunkwe sustanza oħra misluta mill-pirrolidoniċi (mediċini bi struttura simili għal-levetiracetam), jew għal xi ingredjenti oħra tiegħu.
English: Further information on Vihuma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Vihuma.
Maltese: Aktar informazzjoni dwar Vihuma tinstab fis-sit elettroniku talAġenzija: ema.europa.eu/medicines/human/EPAR/Vihuma.
English: What are the risks associated with Vihuma?
Maltese: X'inhuma r-riskji assoċjati ma' Vihuma?
English: Other information about Vihuma
Maltese: Informazzjoni oħra dwar Vihuma
English: Vihuma received a marketing authorisation valid throughout the EU on 13 February 2017.
Maltese: Vihuma ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-13 ta' Frar 2017.
English: Treatment with Vihuma was rated ‘excellent' or ‘good' for 94% of bleeding episodes.
Maltese: Il-kura b'Vihuma ġiet ikklassifikata bħala “eċċellenti”jew “tajba” f'94 % tal-episodji ta' emorraġija.
English: Vihuma was effective at preventing and treating bleeding episodes in three main studies involving 113 patients with haemophilia A.
Maltese: Vihuma ntwera li hu effettiv fil-prevenzjoni u fil-kura ta' episodji ta' emorraġija fi tliet studji ewlenin li involvew 113-il pazjent b'emofilja A.
English: The company that makes Nuwiq has agreed that its scientific data can be used for Vihuma (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Nuwiq qablet li d-data xjentifika tagħha tista' tintuża għal Vihuma (“kunsens infurmat”).
English: Patients with haemophilia A lack factor VIII, and this causes blood clotting problems leading to events such as bleeding in the joints, muscles or internal organs.
Maltese: Pazjenti bl-emofilja A għandhom nuqqas tal-fattur VIII, u dan jikkawża problemi fil-koagulazzjoni li jwasslu għal avvenimenti bħal emorraġija fil-ġogi, fil-muskoli jew fl-organi interni.
English: When Vihuma was used for treatment, bleeding episodes resolved in 81% of cases following 1 or 2 injections.
Maltese: Meta Vihuma ntuża għall-kura, episodji ta' emorraġija ġew solvuti f'81 % tal-każijiet wara injezzjoni waħda jew tnejn.
English: A total of 986 bleeding episodes were recorded, most of which resolved with one injection of Vihuma.
Maltese: B'kollox, ġew irreġistrati 986 episodju ta' emorraġija, li l-parti l-kbira tagħhom issolvew b'injezzjoni waħda ta' Vihuma.
English: The second study involved 32 patients aged 12 years and above who were given Vihuma to prevent and treat bleeding events as well as to prevent bleeding during surgery.
Maltese: It-tieni studju involva 32 pazjent minn 12-il sena'l fuq li ngħataw Vihuma biex jipprevjeni u jikkura avvenimenti ta' emorraġija kif ukoll biex jipprevjeni emorraġija waqt il-kirurġija.
English: Vihuma corrects the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Maltese: Vihuma jikkoreġi d-defiċjenza tal-fattur VIII billi jissostitwixxi l-fattur VIII nieqes, u jagħti kontroll temporanju tad-disturb ta' emorraġija.