FrancophonIA/ELRC3.0 huggingface dataset:
English: • two packs containing 25 vials of 2.5 ml emulsion (adjuvant) Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a.
Maltese: • żewġ pakketti li fihom 25 kunjett ta' emulsjoni ta' 2.5 ml (stimulant) Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur
English: This is as long as medical treatment is available straight away, in case you have an allergic reaction.
Maltese: Dejjem jekk ikun hemm disponibbli kura medika immedjata, f'każ li jkollok reazzjoni allerġika.
English: Full dose N=42
Maltese: N=42
English: • one pack containing 50 vials of 2.5 ml suspension (antigen)
Maltese: Pakkett wieħed ta' Pumarix fih: • pakkett wieħed li fih 50 kunjett ta' suspensjoni ta' 2.5 ml (antiġen)
English: In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
Maltese: Fi studju kliniku ieħor, 39 individwu b'età minn 18 sa 60 sena irċevew doża ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Indonesia/5/2005 erbatax-il xahar wara li rċevew żewġ dożi ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Vietnam/1194/2004 mogħti f'ġurnata 0 u f'ġurnata 21.
English: A clinical study (D-H5N1-009), evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of another Pandemic influenza vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany).
Maltese: snin u s-6 u d-9 snin li jew irċivew żewġ dożi (i.e. 0.5 ml) sħaħ tal-adulti jew żewġ nofsijiet tad-doża (i.e. 0.25 ml) tal-adulti (21 jum bogħod minn xulxin) ta' vaċċin tal-influwenza Pandemika ieħor
English: In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
Maltese: Fi studju kliniku (D-Pan-H5N1-012), individwi b'età minn 18 sa 60 sena irċevew doża ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Vietnam/1194/2004 jew minn Indonesia/5/2005
English: In another clinical study (Q-Pan-H5N1-001), the anti-haemagglutinin (anti-HA) antibody responses in subjects aged 18-64 years were as follows:
Maltese: Fi studju kliniku ieħor (Q-Pan-H5N1-001), ir-rispons għall-antikorpi anti-haemagglutinin (anti-HA)
English: Uncommon: may affect up to 1 in 100 people
Maltese: Mhux Komuni: jistgħu jaffettwaw sa persuna waħda minn kull 100
English: Seroprotection rate1 Seroconversion rate2
Maltese: 1 rata ta' seroprotezzjoni:
English: In a consistency study (Q-Pan-H5N1-002), the anti-haemagglutinin (anti-HA) antibody responses twenty-one days and six months after the second dose were as follows:
Maltese: Fi studju ta' konsistenza (Q-Pan-H5N1-002), ir-rispons tal-antikorpi anti-haemagglutinin (anti-HA)
English: Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) manufactured using a different process Paediatric population
Maltese: Għoti ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Vietnam/1194/2004
English: They may also happen with Pumarix.
Maltese: X'għandek tkun taf qabel ma tingħata Pumarix
English: On the basis of the scientific conclusions for Pumarix, the CHMP is of the opinion that the benefitrisk balance of the medicinal product containing the active substance purified antigen fractions of inactivated split virion A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 is favourable subject to the proposed changes to the product information.
Maltese: Fuq il-bażi tal-konklużjonijiet xjentifiċi għal Pumarix, is-CHMP huwa tal-opinjoni li l-bilanċ bejn ilbenefiċċju u r-riskju tal-prodotti mediċinali li fihom is-sustanza attiva frazzjonijiet ta' antiġeni purifikati tal-virjon maqsum inattivat A/Indonesia/05/2005 (H5N1)/PR8-IBCDC-RG2 huwa wieħed favorevoli soġġett għat-tibdiliet proposti għall-informazzjoni dwar il-prodott.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Antigen suspension for Pumarix
Maltese: KUNJETT TA' SUSPENSJONI (ANTIĠEN)
English: Pumarix can only be marketed when there is an official WHO/EU declaration of an influenza pandemic, on the condition that the Marketing Authorisation Holder for Pumarix takes due account of the officially declared pandemic strain.
Maltese: Pumarix jista' jitqiegħed fis-suq biss meta jkun hemm dikjarazzjoni uffiċjali ta' influwenza pandemika mill-WHO/EU, bil-kondizzjoni li d-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għal Pumarix jikkunsidra sew it-tip ta' influwenza pandemika uffiċjalment dikjarata.
English: - However, in a pandemic situation, you may still be given the vaccine.
Maltese: Madankollu, f'sitwazzjoni ta' influwenza pandemika, xorta tista' tingħata l-vaċċin.
English: After two priming doses
Maltese: Twissijiet u prekawzjonijiet
English: In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing four different doses of H5N1 antigen (3.75, 1.5, 0.6 and 0.24 µg of HA antigen) adjuvanted with half dose of AS03.
Maltese: - Sfida b'razza eterologa ta' H5N1 pandemika (A/Hong Kong/156/97) F'dan l-esperiment ta' protezzjoni, l-inmsa (sitt inmsa/grupp) kienu mlaqqma fil-muskoli b'vaċċin kandidat li fih erba' dożi differenti tal-antiġen H5N1 (3.75, 1.5, 0.6 u 0.24 µg tal-antiġen HA) stimulat b'nofs doża ta' AS03.
English: Immune response to A/Vietnam/1194/2004 3 to 5 years
Maltese: Rispons immuni għal A/Vietnam/1194/2004 21 ġurnata wara t-tieni doża
English: • Itching, rash
Maltese: • Għaraq
English: At day 42 and six months after the second dose, the anti-HA antibody responses were as follows:
Maltese: F'ġurnata 42 u sitt xhur wara t-tieni doża, ir-rispons tal-antikorpi anti-HA kienu kif ġej:
English: µg HA derived from A/Vietnam/1194/2004 (H5N1) at 0 and 21 days.
Maltese: HA derivati minn A/Indonesia/5/2005 (H5N1):
English: 2seroconversion rate (i.e. proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and 3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT) Twenty-one days after the second dose, a 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in 94.4% of subjects aged 18-60 years and in 80.4% of subjects over 60 years of age.
Maltese: Wieħed u għoxrin ġurnata wara t-tieni doża, inkisbet żjieda ta' 4 darbiet aktar fl-antikorpi li jinnewtralizzaw fis-serum kontra A/Indonesia/5/2005 f'94.4% tal-individwi b'età minn 18 sa 60 sena u f'80.
English: See section 6.5 for the
Maltese: Ara sezzjoni 6.5 għan-numru ta' dożi li fih kull kunjett.
English: During the pandemic, the applicant will conduct a prospective cohort study as identified in the
Maltese: Waqt il-pandemija, l-applikant ser iwettaq studju ta' koorti prospettiv kif identifikat fil-pjan ta'
English: 2seroconversion rate (i.e. proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and 3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT) A 4-fold increase in serum neutralising antibody titres against A/Indonesia/5/2005 was achieved in 76.6% of subjects at day 21, 97.9% at day 42 and 91.5% at day 180 and 100% of subjects had a titre of
Maltese: 1 rata ta' seroprotezzjoni (i.e. proporzjon ta' individwi b'titre HI ≥ 1:40); 2rata ta' serokonverżjoni (i.e. proporzjon ta' individwi li kienu seronegattivi qabel it-tilqim u għandhom titre protettiv ta' ≥1:40 wara t-tilqim, jew li kienu seropożittivi qabel it-tilqim u għandhom
English: It should be noted that the adverse reactions may be intensified.
Maltese: Wieħed għandu jinnota li r-reazzjonijiet avversi jistgħu jkunu aktar qawwija.
English: There is limited information available on the use of vaccine very similar to Pumarix (but manufactured in a different facility) to children aged from 3-9 years who received either two adult doses or two half adult doses given three weeks apart.
Maltese: Hemm informazzjoni limitata disponibbli dwar l-użu ta' vaċċin simili ħafna għal Pumarix (iżda manifatturat f'faċilità differenti) għal tfal b'età minn 3 snin sa 9 snin li rċevew żewġ dożi jew żewġ nofs dożi tal-adulti mogħtija tliet ġimgħat bogħod minn xulxin.
English: Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not suggest malformations or fetal or neonatal toxicity.
Maltese: Dejta minn nisa tqal imlaqqma b'vaċċini differenti, inattivati, mhux stimulati tal-istaġun ma tissuġerix malformazzjonijiet jew tossiċità fil-fetu jew wara t-twelid.
English: IB Biomedical Corporation of Quebec doing business as GlaxoSmithKline Biologicals North America 2323 du parc Technologique Blvd.
Maltese: Il-vaċċin tal-influwenza pandemika għandu jintuża skont gwidi uffiċjali.
English: Uncommon: abdominal pain, vomiting, dyspepsia, stomach discomfort
Maltese: Mhux komuni: uġigħ addominali, rimettar, dispepsja, skomdu fl-istonku
English: Adverse reactions from clinical trials with the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up vaccines).
Maltese: Reazzjonijiet avversi minn provi kliniċi bil-vaċċin mock-up huma elenkati hawn taħt (ara sezzjoni 5.1
English: In other clinical studies where children 6 months to 17 years received another pandemic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose
Maltese: (H5N1 A/Indonesia/05/2005 immanifatturat fi Dresden, il-Ġermanja) dehru żidiet fil-frekwenza ta' xi effetti sekondarji (inkluż uġigħ fis-sit tal-injezzjoni, ħmura u deni) wara t-tieni doża fi tfal li
English: Such situation requires rapid notification of safety information that may have the greatest implications for risk-benefit balance in a pandemic.
Maltese: Sitwazzjoni bħal din tirrikjedi notifikazzjoni ta' malajr ta' informazzjoni dwar is-sigurtà li jista' jkollha l-akbar implikazzjonijiet għal bilanċ tal-benefiċċju u r-riskju f'pandemija.
English: In addition, one group of six ferrets were immunized with vaccine candidate containing 3.75 µg H5N1 + full dose of AS03 and one control group included ferrets immunized with non-adjuvanted vaccine (3.75 micrograms HA).
Maltese: Barra dan, grupp wieħed ta' sitt inmsa kienu mlaqqma b'vaċċin kandidat li fih 3.75 µg ta' H5N1 + doża sħiħa ta'AS03 u grupp ta' kontroll wieħed kien jinkludi inmsa mlaqqma b'vaċċin mhux stimulat (3.75 mikrogramma ta' HA).
English: Tell the doctor requesting these tests that you have recently been given Pumarix.
Maltese: L-ebda każ ta' doża eċċessiva ma ġie rrappurtat.
English: Potassium dihydrogen phosphate (KH2PO4)
Maltese: • Glandoli minfuħin fl-għonq
English: A/Indonesia/5/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
Maltese: Bl-użu ta' razza li tixbaħ lil A/Indonesia/5/2005 (H5N1) (PR8-IBCDC-RG2)
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2 of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet ta' farmakovigilanza kif deskrit fil-Pjan ta' Farmakoviġilanza kif inhu maqbul fil-RMP ppreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti tal-RMP kif maqbul mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill
English: The safety and efficacy of Pumarix in children aged less than 3 years and in children and adolescents aged 10 to 17 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Pumarix fi tfal b'età inqas minn 3 snin u fi tfal u adoloxxenti b'età minn 10 snin sa 17-il sena ma ġewx determinati s'issa.
English: - Tables 1 to 4 will be based on events reported from healthcare professionals only.
Maltese: - Tabelli 1 sa 4 ser ikunu bbażati fuq avvenimenti rrappurtati biss minn professjonisti fil-kura tas
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 30°C.
Maltese: Waqt l-użu, l-istabbiltà kimika u fiżika ġiet ipprovata għal perijodu ta' 24 siegħa f'temperatura ta' 30°C.
English: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection.
Maltese: Sinkope (ħass ħażin) jista' jseħħ wara, jew saħansitra qabel, kwalunkwe tilqima bħala rispons psikoġeniku għall-injezzjoni b'labra.
English: Induration Pain
Maltese: KUNJETT TA' EMULSJONI
English: When a dose of 0.5 ml of a similar vaccine was given to children aged 3-9 years, fever occurred more often than when half of this dose (0.25 ml of vaccine) was given.
Maltese: Meta doża ta' 0.5 ml ta' vaċċin simili ingħatat lil tfal b'età minn 3 snin sa 9 snin, id-deni kien osservat aktar frekwenti minn meta ngħatat nofs din id-doża (0.25 ml tal-vaċċin).
English: In addition, from post-marketing surveillance with interpandemic trivalent vaccines, the following
Maltese: Minbarra sorveljanza ta' wara t-tqegħid fis-suq b'vaċċini trivalenti interpandemiċi, kienu rappurtati r
English: Regardless of whether one or two doses of priming vaccine had been given 6 months earlier, the seroprotection rates against A/Indonesia were >80% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 and the seroprotection rates against A/Vietnam were >90% after a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005.
Maltese: 3.75 ug ta' HA derivati minn A/Vietnam/1194/2004 u ir-rati ta' seroprotezzjoni kontra A/Vietnam kienu ta' >90% wara doża ta' vaċċin stimulat b'AS03 li fih 3.75 ug ta' HA derivat minn
English: One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 administered after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from Indonesia/5/2005
Maltese: Doża waħda ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Turkey/Turkey/1/2005
English: 1seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;
Maltese: Fattur booster3 1 rata ta' seroprotezzjoni: proporzjon ta' individwi b'titre ta' inibizzjoni tal-emagglutinazzjoni (HI) ≥
English: 2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4
Maltese: 2rata ta' serokonverżjoni: proporzjon ta' individwi li kienu seronegattivi qabel it-tilqim u għandhom titre protettiv ta' ≥1:40 wara t-tilqim, jew li kienu seropożittivi qabel it-tilqim u għandhom żjieda ta' 4
English: GlaxoSmithKline d.o.o.
Maltese: GlaxoSmithKline Oy Puh/Tel:
English: Cross-reactive immune responses elicited by AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 (H5N1):
Maltese: Hemm dejta ta' sigurtà u immunoġeniċità limitata ħafna disponibbli dwar l-għoti ta' vaċċin stimulat b'AS03 li fih 3.75 µg HA derivati minn A/Vietnam/1194/2004
English: Taking into account the PRAC Assessment Report on the PSUR for Pumarix, the scientific conclusions of the PRAC are as follows:
Maltese: Meta wieħed iqis ir-Rapport tal-Valutazzjoni tal-PRAC dwar il-PSURs għal Pumarix, il konklużjonijiet xjentifiċi tal-PRAC huma kif ġejjin:
English: Serological testing indicated a direct correlation between vaccines induced HI and neutralising antibody titres in protected animals compared to antigen and adjuvant controls.
Maltese: antikorpi newtralizzanti f'annimali protetti meta mqabbel ma' kontrolli b'antiġeni u bi stimulant.
English: • They will give Pumarix as an injection into a muscle
Maltese: • Se jagħtuk Pumarix bħala injezzjoni ġewwa muskolu
English: EU/1/09/566/001 EU/1/09/566/002 EU/1/09/566/003 EU/1/09/566/004 EU/1/09/566/005
Maltese: EU/1/09/566/001 EU/1/09/566/002 EU/1/09/566/003 EU/1/09/566/004
English: Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Tablet container (HDPE)
Maltese: Folja (PVC/PVdC/alu) Folja (PVC/PVdC/alu) Folja (PVC/PVdC/alu) Folja (PVC/PVdC/alu) Kontenitur tal pilloli(HDPE)
English: 28 tablets 30 tablets 84 tablets 100 tablets 60 tablets
Maltese: 28 pillola 30 pillola 84 pillola 100 pillola 60 pillola
English: Oral use Oral use Oral use Oral use Oral use
Maltese: Użu orali Użu orali Użu orali Użu orali Użu orali
English: Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Maltese: Pillola miksija b'rita Pillola miksija b'rita Pillola miksija b'rita Pillola miksija b'rita Pillola miksija b'rita
English: Muscular and Joint System Very rare:
Maltese: Sistema Muskolari u tal-ġogi Rari ħafna:
English: Muscle rigidity Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Maltese: Riġidità tal-muskoli Aggravar ta' sintomi ta' myasthenia gravis (ara sezzjoni 4.4)
English: [Invented name] is an antibiotic belonging to the quinolone family.
Maltese: [Isem ivvintat] huwa antibijotiku li jagħmel parti mill-familja ta' quinolones.
English: Liver Very rare:
Maltese: Fwied Rari ħafna:
English: 4.1 Therapeutic indications [Invented name] 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older (see section 4.4, 4.8 and 5.1): - Acute bacterial sinusitis (ABS) - Acute exacerbations of chronic bronchitis (AECB)
Maltese: [Isem ivvintat] 400 mg, pilloli miksija b'rita huma ndikati għall-kura ta' l-infezzjonijiet mill-batterja li ġejjin f'pazjenti b'età ta' 18-il sena jew akbar (ara sezzjoni 4.4, 4.8 u 5.1): - Sinożite akuta kkawżata minn batterja (ABS) - Irkadar akut ta' bronkite kronika (AECB)
English: 7 days
Maltese: 7 ġranet
English: Cardiac and Vascular Disorders
Maltese: Disturbi fil-Qalb u Vaskulari
English: [Invented name] contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones.
Maltese: [Isem ivvintat] fih moxifloxacin bħala sustanza attiva li tagħmel parti minn grupp ta' antibijotiċi msejħa fluoroquinolones.
English: There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: transient loss of vision, hypernatraemia, hypercalcaemia, haemolysis, rhabdomyolysis, photosensitivity reactions (see section 4.4).
Maltese: Kien hemm każijiet rari ħafna ta' l-effetti sekondarji li ġejjin irrapportati wara kura b'fluoroquinolones oħrajn, li possibilment jistgħu jseħħu wkoll waqt kura b' moxifloxacin: telf temporanju tal-vista, ipernatrimija, iperkalċimija, emolisi, rabdomijolisi, reazzjonijiet ta' fotosensittività (ara sezzjoni 4.4).
English: Musculoskeletal, Connective Tissue and Bone Disorders
Maltese: Disturbi Muskoluskeltrali, talConnective Tissue u tal-Għadam
English: When taking [Invented name] 400 mg film-coated tablets
Maltese: IVVINTAT] 400MG PILLOLI MIKSIJA
English: Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially lifethreatening, see section 4.4)
Maltese: Reazzjonijiet bullużi tal-ġilda bħassindrome StevensJohnson jew Nekrolisi epidermika tossika (b'potenzjal ta' periklu għall-ħajja, ara sezzjoni 4.4)
English: HOW TO TAKE [INVENTED NAME] 400 MG FILM-COATED TABLETS -Sudden worsening of chronic bronchitis (acute exacerbation of chronic bronchitis) 5 - 10 days
Maltese: -Irkadar f'daqqa ta' bronkite kronika (aggravar akut ta' bronkite kronika) 5 - 10 ġranet
English: Hepatobiliary Disorders
Maltese: TASSOMMARJU TAL-KARATTERISTIĊI
English: - Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see section 4.8).
Maltese: - B'moxifloxacin ġew irrapportati każijiet ta' epatite fulminanti (inkluż każijiet fatali) li potenzjalment iwasslu għall-insuffiċjenza tal-fwied (ara sezzjoni 4.8).
English: fatal cases, see section
Maltese: SEKONDARJI LI JISTA' JKOLLU
English: [Invented name] is used in patients of 18 years and older for treating the following bacterial infections when caused by bacteria against which moxifloxacin is active: infection of the sinuses, sudden worsening of long term inflammation of the airways or infection of the lungs (pneumonia) acquired outside the hospital (except severe cases).
Maltese: [Isem ivvintat] jintuża f'pazjenti b'età ta' 18-il sena jew akbar għall-kura ta' l-infezzjonijiet millbatterja meta dawn huma kkawżati minn batterja li moxifloxacin huwa attiv kontra tagħhom: infezzjoni tas-sinusis, irkadar f'daqqa ta' infjammazzjoni fit-tul tal-passaġġi tan-nifs jew infezzjoni tal-pulmun (pulmonite) miksuba minn barra l-isptar (minbarra każijiet severi).
English: 4.7 Effects on ability to drive and use machines (…) However, fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness, see section 4.8) or acute and short lasting loss of consciousness (syncope, see section 4.8).
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni (…) Madankollu, fluoroquinolones inkluż moxifloxacin jistgħu jwasslu għall-indeboliment filħila tal-pazjent li jsuq jew iħaddem magni minħabba reazzjonijiet fis-CNS (e.ż. sturdament, ara sezzjoni 4.8) jew telf akut ta' koxjenza għal tul ta' ħin qasir (sinkope, ara sezzjoni 4.8).
English: Please contact your doctor before you continue the treatment if you develop signs such as rapidly feeling unwell and/or being sick associated with yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or liver induced disease of the brain (symptoms of a reduced liver function or a rapid and severe inflammation of the liver).
Maltese: Jekk jogħġbok ikkuntattja t-tabib tiegħek qabel tkompli l-kura jekk tiżviluppa sinjali inkluż li tħossok ma tiflaħx f'daqqa u/jew tirremetti assoċjata ma' sfurija ta' labjad ta' l-għajnejn, awrina skura, ħakk fil-ġilda, tendenza ta' fsada jew marda tal-moħħ ikkawżata mill-fwied (sintomi ta' funzjoni tal-fwied imnaqqsa jew infjammazzjoni rapida u severa tal-fwied).
English: Elderly patients may also be more susceptible to drug-associated effects on the QT interval.
Maltese: Pazjenti anzjani wkoll jistgħu ikunu aktar suxxettibli għall-effetti assoċjati mal-mediċina fuq l-intervall QT.
English: Furthermore, there have been very rare cases of the following side effects reported following treatment with other quinolone antibiotics, which might possibly also occur during treatment with [Invented name]: transient loss of vision, increased blood sodium levels, increased blood calcium levels, increased breakdown of red blood cells, muscle reactions with muscle cell damage, increased sensitivity of the skin to sunlight or UV light.
Maltese: Barra dan, kien hemm każijiet rari ħafna ta' l-effetti sekondarji li ġejjin, irrapportati wara kura b'antibijotiċi quinolone oħra, li possibilment jistgħu jseħħu wkoll waqt kura b'[Isem ivvintat]: telf temporanju tal-vista, żjieda fil-livelli ta' sodju fid-demm, żjieda fil-livelli ta' kalċju fid-demm, żjieda fid-disintegrazzjoni ta' ċelluli ħomor tad-demm, reazzjonijiet fil-muskoli bi ħsara fiċ-ċelluli talmuskoli, żjieda fis-sensittività tal-ġilda għad-dawl tax-xemx jew dawl UV.
English: As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTcprolonging medications.
Maltese: Peress li n-nisa għandhom tendenza li jkollhom intervall QTc fil-linja bażi itwal meta mqabbel ma' l-irġiel, huma jistgħu jkunu aktar sensittivi għall-medikazzjonijiet li jtawwlu QTc.