FrancophonIA/ELRC3.0 huggingface dataset:
English: INCIVO must be taken with peginterferon alfa and ribavirin to prevent treatment failure.
Maltese: INCIVO għandu jittieħed ma' peginterferon alfa u ribavirin biex jilqa' kontra falliment tal-kura.
English: On-treatment virologic failure was defined as meeting a virologic stopping rule and/or having viral breakthrough.
Maltese: Falliment viroloġiku waqt il-kura kien iddefinit bħala tintlaħaq regola ta' waqfien viroloġiku u/jew il-virus jitfaċċa
English: to treat schizophrenia, bipolar disorder and major depressive disorder midazolam (taken by mouth), triazolam (taken to help you sleep and/or relieve anxiety (sedatives/hypnotics)
Maltese: biex jikkura skizofrenija, disturb bipolari u disturb dipressiv maġġur midazolam (meta jittieħed mill-ħalq), triazolam biex jgħinuk torqod u/jew ittaffi l-ansjetà (sedattivi/ipnotiċi)
English: BOTTLE LABEL (1-bottle pack)
Maltese: KARTUNA TA' BARRA (pakkett b'flixkun wieħed)
English: It is not recommended to co-administer fosamprenavir/ritonavir and telaprevir (see section 4.4).
Maltese: Mhuwiex irrakkomandat li fosamprenavir/ritonavir jingħataw flimkien ma' telaprevir (ara sezzjoni 4.4).
English: In the description of Phase 3 study outcomes for Studies 108, 111, and C216, SVR, considered virologic cure, was defined based on the HCV RNA assessment in the study week 72 visit window, using the last measurement in the window.
Maltese: Fid-deskrizzjoni tar-riżultati għall-fażi 3 tal-istudji 108, 111, u C216, SVR, li huwa kkunsidrat bħala kura viroloġika, kien iddefinit skont l-istima ta' RNA ta' HCV fil-perjodu tal-viżti tal-ġimgħa ta' studju 72, permezz tal-aħħar kejl meħud fil-perjodu.
English: )/PR N = 369 % (n/N)
Maltese: T12(b.i.d.)/PR N = 369 % (n/N)
English: High density polyethylene (HDPE) bottle containing 42 film-coated tablets and fitted with polypropylene (PP) child resistant closure and induction seal liner.
Maltese: Flixkun tal-polyethylene ta' densità għolja (HDPE) li fih 42 pillola miksijin b'rita u għatu talpolypropylene (PP) li ma jistax jinfetaħ mit-tfal u folja li tissiġilla imwaħħla mal-flixkun b'induzzjoni.
English: Telaprevir may be less effective due to decreased concentrations.
Maltese: Telaprevir jista' jkun anqas effettiv minħabba tnaqqis filkonċentrazzjonijiet.
English: In that study, the following common adverse events were reported more frequently with the 1,875 mg every 8 hours regimen compared to the 750 mg every 8 hours regimen: nausea, headache, diarrhoea, decreased appetite, dysgeusia and vomiting.
Maltese: F'dak l-istudju, il-każijiet avversi komuni li ġejjin kienu rrappurtati b'mod aktar frekwenti bl-iskeda ta' għoti ta' 1,875 mg kull 8 sigħat meta mqabbla mal-iskeda ta' għoti ta' 750 mg kull 8 sigħat: nawsja, uġigħ ta' ras, dijarea, nuqqas t'aptit, disgewżja u rimettar.
English: T12/PR: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
Maltese: T12/PR: INCIVO għal 12-il ġimgħa b'peginterferon alfa-2a u ribavirin għal 24 jew 48 ġimgħa;
English: The use of INCIVO in combination with peginterferon alfa-2b The Phase 3 studies were all conducted with peginterferon alfa-2a in combination with INCIVO and ribavirin.
Maltese: L-użu ta' INCIVO flimkien ma' peginterferon alfa-2b L-istudji tal-Fażi 3 saru kollha b'peginterferon alfa-2a flimkien ma' INCIVO u ribavirin.
English: It is not recommended to co-administer lopinavir/ritonavir and telaprevir (see section 4.4).
Maltese: L-għoti ta' atorvastatin flimkien ma' telaprevir huwa kontraindikat (ara sezzjoni 4.4).
English: Telaprevir-resistant variants were tested for cross-resistance against representative protease inhibitors in the HCV replicon system.
Maltese: Varjanti reżistenti għal telaprevir kienu ttestjati għal reżistenza inkroċjata għal impedituri ta' protease rapreżentattivi fis-sistema ta' replikazzjoni ta' HCV minn oriġini singola.
English: IL28B genotype CC
Maltese: Tneħħix id
English: INCIVO has only been used in a limited number of patients of 65 years or older.
Maltese: INCIVO intuża biss f'numru limitat ta' pazjenti li għandhom 65 sena jew aktar.
English: Hepatic impairment
Maltese: Mediċini oħra u INCIVO
English: (e.g., CYP1A1, CYP1A2, BCRP, OATPs) regulated by the same nuclear receptors, the potential clinical impact is unknown.
Maltese: Mhuwiex magħruf l-impatt kliniku possibbli għal enzimi u trasportaturi oħra (eż., CYP1A1, CYP1A2, BCRP, OATPs) irregolati permezz tal-istess riċetturi nukleari.
English: Patients were randomised to 1 of 4 treatment groups: - INCIVO 750 mg every 8 hours with peginterferon alfa-2a 180 g/week and ribavirin
Maltese: - INCIVO 750 mg kull 8 sigħat ma' peginterferon alfa-2a 180 g/ġimgħa u ribavirin
English: In the placebo-controlled Phase 2 and 3 trials, transfusions were reported during the INCIVO/placebo treatment phase in 2.5% of patients receiving INCIVO combination treatment and 0.7% in patients receiving peginterferon alfa and ribavirin alone.
Maltese: Fil-provi tal-Fażi 2 u tal-Fażi 3 ikkontrollati bi plaċebo, trasfużjonijiet kienu rrappurtati waqt il-fażi ta' kura b'INCIVO/plaċebo f'2.5% tal-pazjenti li kienu qed jingħataw kura b'taħlita ta' kura li tinkludi INCIVO u f'0.7% f'pazjenti li ngħataw peginterferon alfa u ribavirin biss.
English: QT interval prolongation has been reported with telithromycin (see section 4.4).
Maltese: Titwil tal-intervall QT kien irrappurtat b'telithromycin (ara s-sezzjoni 4.4).
English: - Patients with undetectable hepatitis C virus ribonucleic acid (HCV RNA) (target not detected) at weeks 4 and 12 receive an additional 12 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 24 weeks.
Maltese: - Pazjenti b'RNA ta' aċidu ribonuklejku tal-virus tal-epatite Ċ (HCV RNA) ftit wisq biex jitkejjel (target ma jistax jitkejjel) fil-ġimgħat 4 u 12 jirċievu 12-il ġimgħa oħra ta' peginterferon alfa u ribavirin waħedhom għal tul ta' żmien totali ta' kura ta' 24 ġimgħa.
English: INCIVO must be administered with peginterferon alfa and ribavirin.
Maltese: INCIVO għandu jintuża flimkien ma' peginterferon alfa u ribavirin.
English: ANALGESICS alfentanil fentanyl
Maltese: Kif taħżen INCIVO
English: alfentanil, fentanyl to treat pain (analgesics) or used during surgery to induce sleep digoxin, intravenous lidocaine to treat certain heart disorders such as abnormal heart beat (antiarrhythmics)
Maltese: flecainide, propafenone għal kura ta' ċerti disturbi tal-qalb bħal taħbit tal-qalb mhux normali (antiarritmiċi)
English: Predominant baseline resistance to telaprevir does not preclude successful treatment with telaprevir, peginterferon alfa, and ribavirin.
Maltese: Kura b'INCIVO tlestiet Waqqaf għalkollox trattament b'INCIVO, peginterferon alfa u ribavirin.
English: Relapse was defined as having detectable plasma HCV RNA from planned end of treatment onwards after previous HCV RNA < 25 IU/ml at planned end of HCV treatment, and not achieving SVR12.
Maltese: Irkadar kien iddefinit bħala wieħed ikollu HCV RNA fil-plażma osservat waqt il-perjodu ta' segwitu wara li qabel kien hemm HCV RNA < 25 IU/ml fit-tmiem ippjanat ta' trattament għal HCV, u mingħajr ma nkiseb SVR12.
English: SJS, TEN, erythema multiforme
Maltese: Ia jew III, bl-eċċezzjoni ta'
English: The exposure (AUC) to telaprevir increased slightly greater than proportionally to the dose after single-dose administration of 375 up to 1,875 mg with food, possibly due to saturation of metabolic
Maltese: L-esponiment (AUC) għal telaprevir żdied kemxejn aktar minn fi proporzjon mad-doża wara għoti ta' doża waħda ta' 375 sa 1,875 mg mal-ikel, x'aktarx minħabba s-saturazzjoni tar-rotot metaboliċi jew trasportaturi ta' effluss.
English: T12/PR24: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 weeks; T12/PR48: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
Maltese: T12/PR48: INCIVO għal 12-il ġimgħa ma' peginterferon alfa-2a u ribavirin għal 48 ġimgħa;
English: Bridging fibrosis Cirrhosis
Maltese: INCIVO fih sodium
English: Patients with undetectable HCV RNA ( target not detected) at weeks 4 and 12 were randomised at week 20 to receive either 24 weeks or 48 weeks of peginterferon alfa-2a and ribavirin treatment.
Maltese: Pazjenti li l-RNA ta' HCV tagħhom kienet ftit wisq biex titkejjel (target ma jistax jitkejjel) fil-ġimgħat 4 u 12 kienu randomised fil-ġimgħa 20 biex jew jirċievu 24 ġimgħa jew inkella 48 ġimgħa ta' kura b'peginterferon alfa-2a u ribavirin.
English: T12/PR48: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
Maltese: T12/PR48: INCIVO għal 12-il ġimgħa b'peginterferon alfa-2a u ribavirin għal 48 ġimgħa
English: Additional methods of non-hormonal contraception should be used when hormonal contraceptives are co-administered with telaprevir.
Maltese: Metodi addizzjonali ta' kontraċezzjoni mhux tal-ormoni għandhom jintużaw meta kontraċettivi tal-ormoni jingħataw flimkien ma' telaprevir.
English: All patients received 12 weeks of treatment with INCIVO plus peginterferon alfa-2a and ribavirin followed by 36 weeks of treatment with peginterferon alfa-2a and ribavirin (total treatment duration of 48 weeks).
Maltese: Il-pazjenti kollha rċevew 12-il ġimgħa ta' trattament b'INCIVO flimkien ma' peginterferon-alfa-2a u ribavirin segwiti b'36 ġimgħa ta' trattament b'peginterferon alfa-2a u ribavirin (żmien ta' trattament totali ta' 48 ġimgħa).
English: metformin to treat diabetes (antidiabetics)
Maltese: IMPEDITURI PROTEASE TAL-HIV (PIs)
English: There is limited pharmacokinetic data on the use of INCIVO in HCV patients aged ≥ 65 years and no data in subjects > 70 years of age.
Maltese: Hemm dejta farmakokinetika limitata dwar l-użu ta' INCIVO f'pazjenti b'HCV li għandhom ≥ 65 sena, u l-ebda dejta dwar individwi li għandhom > 70 sena.
English: Liver transplant patients without cirrhosis
Maltese: IMMUNOSOPPRESSANTI cyclosporine* tacrolimus* sirolimus
English: Treatment-naive patients or prior relapsers who were non-cirrhotic and achieved extended rapid virologic response (eRVR) received 12 weeks of treatment with INCIVO plus peginterferon alfa-2a and ribavirin followed by 12 weeks of treatment with peginterferon alfa-2a and ribavirin (total treatment duration of 24 weeks).
Maltese: Pazjenti li qatt ma kienu ħadu kura qabel jew dawk li qabel kienu rkadew li ma kinux ċirrotiċi u kisbu rispons viroloġiku malajr u mtawwal (eRVR - extended rapid virologic response) irċivew 12-il ġimgħa ta' kura b'INCIVO flimkien ma' peginterferon alfa-2a u ribavirin segwiti minn 12-il ġimgħa ta' kura b'peginterferon alfa-2a u ribavirin (tul ta' żmien totali ta' 24 ġimgħa ta' kura).
English: Prior partial responders
Maltese: MANIFATTUR RESPONSABBLI
English: HIV-ANTIVIRAL AGENTS: REVERSE TRANSCRIPTASE INHIBITORS If co-administered, telaprevir 1,125 mg q8h should be used (see section 4.4).
Maltese: TA' REVERSE TRANSCRIPTASE Jekk jingħataw flimkien, għandu jintuża 1,125 mg telaprevir kull
English: Peginterferon alfa may be continued unless interruption is medically indicated.
Maltese: L-għoti ta' peginterferon alfa jista' jitkompla sakemm ittwaqqif ma jkunx indikat b'mod kliniku
English: Patients on an atazanavir/ritonavir-based
Maltese: darunavir/ritonavir*
English: ADRs to INCIVO are presented in table 3.
Maltese: Sommarju tar-reazzjonijiet avversi miġbura f'tabella ADRs ta' INCIVO huma ppreżentati f'tabella 3.
English: Use INCIVO with caution in patients with: - a history of acquired QT prolongation; - clinically relevant bradycardia (persistent heart rate < 50 bpm); - a history of heart failure with reduced left-ventricular ejection fraction; - a requirement for medicinal products known to prolong the QT interval but the metabolism of which is not mainly CYP3A4 dependent (e.g. methadone, see section 4.5).
Maltese: - storja passata ta' titwil tal-QT akkwiżit; - bradikardija klinikament rilevanti (rata persistenti ta' taħbit tal-qalb ta' < 50 taħbita kull
English: Study 107 was an open label, rollover study for patients who were treated in the control group (placebo, peginterferon alfa-2a, and ribavirin) of a Phase 2 study of telaprevir and who did not achieve SVR in the Phase 2 study.
Maltese: L-istudju 107 kien studju open label li fih iddaħħlu l-istess pazjenti li fi studju tal-Fażi 2 ta' telaprevir kienu kkurati fil-grupp ta' kontroll (plaċebo, peginterferon alfa-2a, u ribavirin) u li ma kisbux SVR f'dan l-istudju tal-Fażi 2.
English: Rash
Maltese: Hrvatska
English: Table 6: SVR rates for patient subgroups: Study C211 T12(b.i.d.
Maltese: Tabella 6: Rati SVR għas-sottogruppi tal-pazjenti:
English: INCIVO was given for the first 8 weeks of treatment (T8/PR regimen) or the first 12 weeks of treatment (T12/PR regimen) in combination with peginterferon alfa-2a and ribavirin for either 24 or 48 weeks.
Maltese: INCIVO 750 mg kull 8 sigħat [T12(q8h)/PR] jew INCIVO 1,125 mg darbtejn kuljum [T12(b.i.d.)/PR] flimkien ma' peginterferon alfa-2a u ribavirin.
English: Table 17: Treatment outcome in genotype 1 HCV-infected liver transplant recipients (Study HPC3006)
Maltese: Tabella 17: Eżitu ta' trattament f'reċipjenti ta' fwied trapjantat infettati b'HCV ta' ġenotip 1
English: BMI ≥ 30 kg/m Baseline HCV RNA ≥ 800,000 IU/ml HCV genotype 1a HCV genotype 1b Baseline liver fibrosis No fibrosis, minimal fibrosis, or portal fibrosis Bridging fibrosis Cirrhosis
Maltese: Ħamsa u ħamsin minn 60 pazjent rċevew ribavirin b'doża fissa ta' 800 mg/jum u l-bqija tal-5 pazjenti rċivew doża ta' ribavirin ibbażata fuq il-piż.
English: The 662 enrolled patients had a median age of 51 years (range: 21 to 70); 70% of the patients were male; 26% had a body mass index ≥ 30 kg/m2; 5% were Black; 11% were Hispanic or Latino; 89% had baseline HCV RNA levels > 800,000 IU/ml; 22% had bridging fibrosis; 26% had cirrhosis; 54% had HCV genotype 1a; and 46% had HCV genotype 1b.
Maltese: 11% kienu ta' dixxendenza Spanjola jew Latina; 89% kellhom livell ta' RNA ta' HCV ta' > 800,000 IU/ml fil-linja bażi; 22% kellhom fibrożi li tgħaqqad vini flimkien; 26% kellhom ċirrożi; 54% kellhom HCV tal-ġenotip 1a; u 46% kellhom HCV tal-ġenotip 1b.
English: The rash reported during INCIVO combination treatment was assessed as a typically pruritic, eczematous rash, and involved less than 30% of body surface area.
Maltese: Ir-raxx irrappurtat waqt il-kura bit-taħlita li tinkludi INCIVO kien stmat li huwa raxx tipikament bil-ħakk, ekżematuż u jinvolvi anqas minn 30% tas-superfiċje tal-ġisem.
English: All patients received ribavirin at a fixed dose of 800 mg/day.
Maltese: Ilpazjenti kollha rċivew ribavirin bid-doża fissa ta' 800 mg/jum.
English: Recommendations for Monitoring of Cutaneous Reactions and Discontinuation of INCIVO, Ribavirin and Peginterferon alfa for Severe Rash
Maltese: Rakkomandazzjonijiet għall-Monitoraġġ tarReazzjonijiet fil-Ġilda, u għat-twaqqif ta' INCIVO, Ribavirin u Peginterferon alfa f'każ ta' Raxx Qawwi
English: If INCIVO is discontinued for anaemia, patients may continue treatment with peginterferon alfa and ribavirin.
Maltese: Jekk ikun indikat b'mod kliniku, jista' jkun meħtieġ twaqqif aktar qabel ta' peginterferon alfa u ribavirin.
English: Study 106 was a randomised, double-blind, placebo-controlled, Phase 2 study that enrolled patients who had failed prior treatment with peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin.
Maltese: L-Istudju 106 kien studju randomised, double-blind, tal-Fażi 2 ikkontrollat bi plaċebo li fih iddaħħlu pazjenti li qabel kienu diġà fallew kura b'peginterferon alfa-2a u ribavirin jew peginterferon alfa-2b u ribavirin.
English: - Heart problems
Maltese: - deidratazzjoni.
English: HCV RNA levels should be monitored at weeks 4 and 12.
Maltese: Il-livelli tal-RNA ta' HCV għadhom jiġu mmonitorjati fil-ġimgħat 4 u 12.
English: Clostridium perfringens Type A alpha toxoid: ≥ 6.8 IU*
Maltese: Clostridium perfringens toksojd Tip A alpha: ≥ 6.8 IU*
English: Pharmacotherapeutic group: Immunologicals for aves, ATC vet code: QI01AB08
Maltese: Immunoloġiċi għat-tjur, Kodici ATĊ veterinarja QI01AB08
English: Store and transport refrigerated (2ºC - 8°C).
Maltese: Aħżen u ttrasporta refriġirat (2C - 8C).
English: Store and transport refrigerated (2ºC- 8ºC).
Maltese: Aħżen u ttrasporta refriġirat (2C - 8C)
English: Netvax emulsion for injection for chickens
Maltese: Netvax emulsjoni għall-injezzjoni għat-tiġieġ
English: INDICATION(S)
Maltese: <MANIFATTURA(I)
English: 500ml high density polyethylene (HDPE) flexible bottle closed with a chlorobutyl rubber closure held in place with an aluminium seal with centre hole.
Maltese: Flixkun artab tal-high density polyethylene (HDPE) ta' 500 ml magħluq b'tapp tal-gomma klorobutil miżmum f'postu b'siġill tal-Aluminjum b'toqba fin-nofs.
English: Pack Sizes
Maltese: Xejn granet
English: Following the second vaccination swelling may persist for at least 35 days.
Maltese: Wara t-tieni vaċċinazzjoni in-nefħa tista`ddum sa 35 ġurnata.
English: Vaccine against necrotic enteritis
Maltese: Tilqim kontra l-enterite` nekrotika.
English: One dose of 0.5 ml should be given at 10 to 14 weeks of age.
Maltese: Doża waħda ta'0.5ml għandha tingħata bejn 10 u l- 14 ġimgħa ta` ħajja.
English: According to Article 71 of Directive 2001/82/EC as amended, Member States prohibit or may prohibit the import, sale, supply and/or use of the veterinary medicinal product on the whole or part of their a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programme for the diagnosis, control and eradication of animal disease, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
Maltese: Skond l-Artikolu 71 tad-Direttiva 2001/82/KEE tal-Parlament Ewropew u tal-Kunsill, l-Istati Membri jipprojbixxu jew jistgħu jipprojbixxu l-importazzjoni, il-bejgħ, il-forniment u/jew l-użu tal-prodott mediċinali veterinarju fit-territorju sħiħ tagħhom jew parti minnu jekk jiġi stabbilit illi:
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
Maltese: TAS-SUSTANZA(I) BIOLOĠIKA(ĊI) ATTIVA(I) U> SID(/SSIDIEN TA') L-AWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI MILL
English: * International units per ml of rabbit serum determined by haemolysis inhibition assay
Maltese: * Unitajiet internazzjonali għall-kull ml ta'serum tal-fenek kif determinat minn assay tal- inħibizzjoni
English: For the active immunization of chickens to provide passive immunisation against necrotic enteritis to their progeny, during the laying period.
Maltese: Għall-immunita` attiva fit-tiġieġ biex tipprovdi immunita` passiva kontra l- enterite'nekrotika lillflieles tagħhom, waqt il-perjodu tat-tqegħied il-bajd.
English: To stimulate active immunity in chickens, in order to provide passive protection to the progeny against Clostridium perfringens Type A induced necrotic enteritis.
Maltese: Biex jistimola l-immunita' attiva fit-tiġieġ sabiex jagħti protezzjoni passiva lill-flieles tagħhom kontra l-enterite` nekrotika ikkawżata minn Clostridium perfringens Tip A.
English: Triethanolamine (at doses up to 0.25 mg/kg bw) is considered not within the scope of Council
Maltese: Triethanolamine (f`dożi sa 0.25mg/kg piż ħaj) ma jaqax taħt l-iskop tar- Regolamenti tal-kunsill (KE)
English: Veterinary medicinal product subject to prescription.
Maltese: Prodott mediċinali veterinarju li jingħata fuq preskrizzjoni veterinarja.
English: The second dose should be administered no later than 6 weeks before the onset of lay.
Maltese: It-tieni vaċċinazzjoni għandha tingħata mhux aktar tard minn 6 ġimgħat qabel jibdew ibidu.
English: None
Maltese: A.
English: The duration of passive transfer of immunity: 51 weeks following completion of the vaccination
Maltese: It-trasferiment passiv ta'immunita` idum: 51 gimgħa wara li tkun lesta l-proċedura ta'vaċċinazzjoni
English: Accidental injection is dangerous - read package leaflet before use.
Maltese: Tużax wara d-data ta'skadenza fuq il-pakett.
English: Read the package leaflet before use
Maltese: Mhux id-daqsijiet kollha tal-pakketti jistgħu qegħdin fis-suq.
English: To reduce mortality and the incidence and severity of lesions caused by Clostridium perfringens Type A induced necrotic enteritis.
Maltese: Biex tnaqqas l-imwiet u l-inċidenza u s-severita` tal-feriti tal-enterite` nekrotika ikawżati minn Clostridium perfringens tip A. .
English: To be supplied only on veterinary prescription.
Maltese: Għandu jingħata biss bi preskrizzjoni veterinarja.
English: Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
Maltese: Injezzjoni aċċidentali jew jekk tinjetta lilek innifsek, jista' jirriżulta f'uġigħ kbir u nefħa, speċjalment jekk tinjetta f'ġog jew subgħa u f'kazijiet rari jista' jkun il-kawża li jkollok taqta' subgħajk jekk ma tingħatax għajnuna medika mal-ewwel.
English: A second dose of 0.5 ml should be administered 4 to 10 weeks after the first vaccination.
Maltese: It-tieni doża ta'0.5ml għandha tingħata bejn 4 u l- 10 ġimgħa wara l-ewwel vaċċinazzjoni.
English: Intervet International B.V. Wim de Körverstraat 35 5831AN Boxmeer The Netherlands
Maltese: Kull speċi għall-ikel Aness II tar-Regolamenti talkunsill (KE) No.2377/90
English: Name and address of the manufacturer of the biological active substance(s)
Maltese: Isem u indirizz tal-manufattur(i) tas-sustanza(i) bioloġika(ċi) attiva(i)
English: EMA/664134/2011 EMEA/H/C/000682
Maltese: EMEA/H/C/000682
English: Other information about Savene:
Maltese: Informazzjoni oħra dwar Savene:
English: This summary was last updated in 08-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'08-2011.
English: This document is a summary of the European public assessment report (EPAR) for Savene.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Evalwazzjoni (EPAR) għal Savene.
English: It contains the active substance dexrazoxane.
Maltese: Huwa fih is-sustanza attiva dexrazoxane.
English: The active substance in Savene, dexrazoxane, is an antidote to anthracyclines.
Maltese: Is-sustanza attiva f'Savene, dexrazoxane, hija antidotu għall-anthracyclines.
English: Savene is used to treat extravasation of anthracyclines (a group of anticancer medicines).
Maltese: Savene jintuża għall-kura ta' ekstravażjoni ta' anthracyclines (grupp ta' mediċini kontra l-kanċer).
English: Savene has been tested in two main studies involving a total of 80 patients who had extravasation of anthracyclines such as epirubicin or doxorubicin.
Maltese: Savene ġie ttestjat f'żewġ studji prinċipali li nvolvew total ta' 80 pazjent li kellhom ekstravażjoni ta' anthrcyclines bħal epirubicin jew doxorubicin.
English: What is the risk associated with Savene?
Maltese: X'inhu r-riskju assoċjat ma' Savene?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Savene is available here.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Savene huwa disponibbli hawn.
English: Because the number of patients who have extravasation of anthracyclines is low, the condition is considered ‘rare', and Savene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 September 2001.
Maltese: Minħabba li n-numru ta' pazjenti li jkollhom ekstravażjoni ta' anthracyclines huwa baxx, il-kundizzjoni hija kkunsidrata ‘rari', u Savene ġie nnominat bħala ‘prodott mediċinali orfni' (prodott mediċinali użat f'mard rari) fid-19 ta' Settembru 2001.
English: How has Savene been studied?
Maltese: Kif ġie studjat Savene?
English: The most common side effects with Savene (seen in more than 1 patient in 10) are nausea (feeling sick), and pain and infection at the site of the injection.
Maltese: L-effetti sekondarji l-aktar komuni b'Savene (jinstabu f'aktar minn pazjent 1 minn kull 10) huma dardir (tħossok ma tiflaħx), u uġigħ u infezzjoni fis-sit tal-injezzjoni.