FrancophonIA/ELRC3.0 huggingface dataset:
English: Vaxelis suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine (adsorbed).
Maltese: Vaxelis suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin ikkonjugat għal difterite, tetnu, pertussi (komponent aċellulari), epatite B (rDNA), poljomelite (inattivat) u Haemophilus tip b (adsorbit).
English: A history of febrile convulsions, a family history of convulsions, or Sudden Infant Death Syndrome (SIDS) do not constitute a contraindication for the use of Vaxelis.
Maltese: Passat mediku ta' aċċessjonijiet bid-deni, storja familjari ta' konvulżjonijiet jew is-Sindrome ta' Mewt f'Daqqa fi Trabi (SIDS - Sudden Infant Death Syndrome) ma jikkostitwixxux kontraindikazzjoni għall-użu ta' Vaxelis.
English: Common (1/100 to <1/10)
Maltese: (≥1/100 sa <1/10)
English: Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate)
Maltese: (Polyribosylribitol Phosphate)
English: th doses.
Maltese: Tliet dożi
English: The persistence of antibody to hepatitis B surface antigen (anti-HBsAg) was measured in children 4 or 5 years of age who had received Vaxelis either at 2, 4 and 11-12 months or at 2, 3, 4 and 12 months of age.
Maltese: Il-persistenza tal-antikorp għall-antiġen tas-superfiċje tal-epatite B (anti-HBsAg) tkejlet fi tfal ta' 4 jew 5 snin li kienu rċivew Vaxelis jew fl-eta ta' 2, 4 u 11-12-il xahar jew inkella fl-età ta' 2, 3, 4 u 12il xahar.
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), without needle - multipack of 5 packs of 10.
Maltese: 0.5 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ tip I) b'tapp planġer (butyl) u għatu fit-tarf (butyl), mingħajr labra - pakkett multiplu ta' 5 pakketti ta' 10.
English: There may be some circumstances, such as high incidence of pertussis, when the potential benefits outweigh possible risks.
Maltese: Jista jkun hemm ċirkostanzzi, bħal inċidenza għolja ta pertussis, fejn il-benefiċċji potenzjali huma akbar mir-riskji possibbli.
English: Vaxelis will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Maltese: Vaxelis tingħata lit-tifel/tifla tiegħek minn tabib jew infermier li huma mħarrġa fl-użu ta' vaċċini u li huma mgħammra biex jittrattaw ma' kull reazzjoni allerġika severa mhux komuni għall-injezzjoni (ara sezzjoni 4 Effetti sekondarji possibbli).
English: • Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours of vaccination
Maltese: • huwa/hija allerġika/allerġiku (għandu/għandha sensittività eċċessiva)
English: Suspension for injection 10 pre-filled syringes (0.5 ml) without needle
Maltese: U KONTENUT Suspensjoni għall-injezzjoni 10 siringi mimlijin għal-lest (0.5 ml) mingħajr labra
English: Vaxelis will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Maltese: Clostridium tetani, Bordetella pertussis, il-virus ta' epatite B, poljovirus jew Haemophilus influenzae tip b. Madankollu, jista' jkun mistenni li l-epatite D ser tiġi mxekkla mill-immunizzazzjoni peress li lepatite D (ikkawżata mill-aġent delta) ma sseħħx fl-assenza ta' infezzjoni b'epatite B.
English: 2, 4 months
Maltese: 2, 4 xhur
English: The most frequently reported adverse reactions after Vaxelis administration were irritability, crying, somnolence, injection site reactions (pain, erythema, swelling), pyrexia (≥38
Maltese: L-iktar reazzjonijiet avversi rrapportati b'mod frekwenti b'Vaxelis kienu irritabilità, biki, ngħas, reazzjonijiet fis-sit tal-injezzjoni (uġigħ, eritema, nefħa), deni (≥ 38 oC), nuqqas ta' aptit, u rimettar .
English: Booster vaccination:
Maltese: Kategorija farmakoterapewtika:
English: For instructions on handling of the medicinal product before administration, see section 6.6.
Maltese: Għall-istruzzjonijiet dwar l-immaniġġar tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: N = 319-609 % N = 498-550 % N = 2455-2696
Maltese: N = 2455-2696
English: MSD Polska Sp. z o.o.
Maltese: MSD Belgium BVBA/SPRL
English: See section 4.8 for how to report adverse reactions.
Maltese: Ara sezzjoni 4.8 dwar kif għandhom jiġu rapportati reazzjonijiet avversi.
English: Hepatitis B surface antigen
Maltese: Antiġen tas-superfiċje tal-epatite B
English: The recommended dose is as follows:
Maltese: DATA TA' SKADENZA JIS:
English: Vaxelis does not protect against disease caused by Haemophilus influenzae other than type b or by other microorganisms that cause invasive disease such as meningitis or sepsis, including N. meningitidis.
Maltese: Vaxelis ma jipproteġix kontra mard ikkawżat minn Haemophilus influenzae li mhuwiex tat-tip b jew minn mikro-organiżmi oħrajn li jikkawżaw mard invażiv bħal meninġite jew sepsis, inkluż N.
English: • Haemophilus influenzae type b infections (often just called Hib infections ): serious bacterial infections causing meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness.
Maltese: • Infezzjonijiet ta' Haemophilus influenzae tip b (ta' spiss msejħa Hib): huma infezzjonijiet serji kkawżati minn batterji li jikkawżaw meninġite (infjammazzjoni tal-membrana li tipproteġi l moħħ), ji jista' jwassal għal ħsara fil-moħħ, truxija, epilessija, u għama parzjali.
English: Serious allergic reactions are a very rare possibility (may affect up to 1 in 10,000 people) after receiving any vaccine.
Maltese: Reazzjonijiet allerġiċi serji huma possibiltà rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000) wara t-teħid ta' xi tilqima.
English: Disposal
Maltese: Dijarea
English: Name and address of the manufacturers of the biological active substances Merck Sharp and Dohme Corporation 770 Sumneytown Pike
Maltese: Merck Sharp and Dohme Corporation 770
English: Table 2: Seroprotection/Vaccine Response Rates One Month After the Primary Vaccination Series
Maltese: Tabella 2: Rati ta' Seroprotezzjoni/Rispons għat-Tilqima Xahar Wara s-Serje ta' Tilqim Primarju
English: The immune responses to Vaxelis in these infants were generally similar to those of the overall study population.
Maltese: Ir-risponsi immuni għal Vaxelis f'dawn it-trabi kienu ġeneralment simili għal dawk tal-popolazzjoni globali tal-istudju.
English: The primary vaccination schedules used in clinical studies were: 2, 4 months of age without hepatitis B vaccination at birth; 2, 3, 4 months of age without hepatitis B vaccination at birth; and 2, 4, 6 months of age with and without hepatitis B vaccination at birth.
Maltese: L-iskedi ta' tilqim primarju użati fl-istudji kliniċi kienu: fl-età ta' xahrejn, 4 xhur mingħajr tilqim talepatite B fit-twelid; fl-età ta' 2, 3, 4 xhur mingħajr tilqim tal-epatite B fit-twelid; u fl-età ta' 2, 4, 6 xhur b'tilqim u mingħajr tilqim tal-epatite B fit-twelid.
English: How to store Vaxelis
Maltese: X'inhu Vaxelis u għalxiex jintuża
English: • Temperature of 40.5°C within 48 hours, not attributable to another identifiable cause
Maltese: − kellhom deni ta' 40.5°C jew aktar fi żmien 48 siegħa li ma jkunx dovut għal xi ħaġa oħra identifikabbli.
English: • was born very prematurely (at or before 28 weeks of gestation).
Maltese: • ikunu twieldu b'mod prematur ħafna (fi jew qabel 28 ġimgħa ta' tqala).
English: The vaccine may contain traces of glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B which are used during the manufacturing process (see section 4.3).
Maltese: Il-vaċċin jista' jkun fih traċċi ta', glutaraldehyde, formaldehyde, neomycin, streptomycin u polymyxin B li jintużaw waqt il-proċess ta' produzzjoni (ara sezzjoni 4.3).
English: The safety and efficacy of Vaxelis in infants less than 6 weeks of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Vaxelis fit-trabi li għandhom inqas minn età ta' 6 ġimgħat għadhom ma ġewx determinati s'issa.
English: Vaxelis suspension for injection in pre-filled syringe.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni.
English: PC:
Maltese: huma:
English: Other side effects not listed above have been reported with other diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines:
Maltese: Effetti sekondarji oħra mhux elenkati hawn fuq kienu rrappurtati b'vaċċini oħra li fihom difterja, tetnu, pertussis, poljomelite, epatite B jew Hib:
English: MCM Vaccine B.V.
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott MCM Vaccine B.V.
English: As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Maltese: Bħal kull vaċċin ieħor, jista' jkun li mhux kull min jitlaqqam ikollu rispons immuni protettiv.
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), with 1 separate needle - pack size of 1 or 10.
Maltese: 0.5 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ tip I) b'tapp planġer (butyl) u għatu fit-tarf (butyl), b'labra waħda separata - daqs tal-pakkett ta' 1 jew 10.
English: Additional injections (booster)
Maltese: Poljovirus (Inattivat)4
English: Diphtheria Toxoid
Maltese: Kif taħżen Vaxelis
English: Vaccine response: If pre-Dose 1 antibody concentration < lower limit of quantification (LLOQ), then the post-vaccination series antibody concentration was ≥ LLOQ; if pre-Dose 1 antibody concentration ≥ LLOQ, then the post-vaccination series antibody concentration was ≥ pre-Dose 1 levels.
Maltese: Jekk il-konċentrazzjoni ta' antikopri ta' qabel id-Doża 1 < limitu il-baxx tal-kwantifikazzjoni (LLOQ), allura l-konċentrazzjoni ta' antikorpi wara s-serje ta' tilqim kienet ≥ LLOQ; jekk il-konċentrazzjoni ta' antikorpi ta' qabel id-Doża 1 ≥ LLOQ, allura l-konċentrazzjoni ta' antikorpi wara s-serje ta' tilqim kienet ≥ livelli ta' qabel id-Doża 1.
English: • Uncommon side effects (may affect up to 1 in 100 people) are: rash warmth, rash at the injection site increased appetite stomach pain excessive sweating cough nasal congestion and runny nose paleness sleep disorders including inability to get adequate sleep restlessness swollen glands in the neck, armpit or groin feeling tired floppy
Maltese: • Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10) huma: dijarea massa iebsa, għoqda fis-sit tal-injezzjoni tbenġil fis-sit tal-injezzjoni
English: Considerable study data suggest that individuals who have ever had a seroprotective response to hepatitis B vaccination will have a memory response that is protective against clinical disease if exposed to the hepatitis B virus.
Maltese: Dejta konsiderevoli tal-istudji tissuġġerixxi li individiwi li xi darba kellhom rispons seroprottettiv għattilqim tal-epatite B se jkollhom rispons ta' memorja li jkun protettiv kontra mard kliniku jekk jiġu esposti għall-virus tal-epatite B.
English: Genetic Polymorphism Immune responses to the vaccine have not been studied in the context of genetic polymorphism.
Maltese: Polimorfiżmu Ġenetiku Ir-risponsi immuni għall-vaċċin ma ġiex studjat fil-kuntest ta' polimorfiżmu ġenetiku.
English: Excipients:
Maltese: Tilqim primarju:
English: Carton for prefilled syringes without needle.
Maltese: Sodium phosphate, ilma għall-injezzjonijiet
English: • As with any vaccine, Vaxelis may not protect 100% of children who receive the vaccine.
Maltese: • Bħal b'kull vaċċin ieħor, jista' jkun li Vaxelis ma jipproteġix 100% tat-tfal li jirċievu l-vaċċin.
English: • Pertussis (often called whooping cough): a highly infectious illness that affects the airways.
Maltese: • Pertussis (ħafna drabi msejħa sogħla konvulsiva): marda infettiva ħafna, li taffettwa il-passaġġi tan-nifs.
English: Vaxelis suspension for injection in pre-filled syringe
Maltese: U KONTENUT Suspensjoni għall-injezzjoni
English: • Persistent crying lasting ≥3 hours, occurring within 48 hours of vaccination
Maltese: • Biki persistenti li jdum ≥ 3 sigħat u li jseħħ fi żmien 48 siegħa mit-tilqima
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), without needle - pack size of 1 or 10.
Maltese: 0.5 ml ta' suspensjoni f'siringa mimlija għal-lest (ħġieġ tip I) b'tapp planġer (butyl) u għatu fit-tarf (butyl), b'żewġ labar separati - daqs tal-pakkett ta' 1 jew 10.
English: Table 3: Seroprotection/Vaccine Response Rates One Month After Booster Vaccination
Maltese: Tabella 3: Rati ta' Seroprotezzjoni/Rispons għat-Tilqima Xahar Wara Tilqim Ta' Riinforz
English: Vaxelis does not protect your child against diseases caused by other bacteria and viruses that may cause similar symptoms.
Maltese: Vaxelis ma jipproteġix it-tifel/tifla tiegħek kontra mard ikkawżat minn batterji u virusis oħrajn li jistgħu jikkawżaw sintomi simili.
English: Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia), fits, brain damage and even death.
Maltese: Is-sogħla konvulsiva tista' anke tikkawza infezzjonijiet fil-widna, infezzjonijiet fis-sider (bronkite) li jistgħu jdumu zmien twil, infezzjonijiet fil-pulmun (pulmonite), konvulzjonijiet, ħsara fil-moħħ u anke mewt.
English: • has had any of the following events after receiving a vaccine against pertussis (whooping cough), as the decision to give further doses of pertussis containing vaccine will need to be carefully considered: had a fever of 40.5°C or above within 48 hours not due to another identifiable cause.
Maltese: • isofru minn aċċessjonijiet meta jkollhom id-deni, jew hemm storja fil-familja ta' aċċessjonjiet li jseħħu meta jkun hemm id-deni.
English: Individuals with a history of febrile convulsions should be closely followed up as febrile convulsions may occur within 2 to 3 days post vaccination.
Maltese: Individwi b'passat mediku t'aċċessjonijiet bid-deni għandhom jiġu segwiti millqrib peress li aċċessjonijiet bid-deni jistgħu jseħħu fi żmien 2 sa 3 ijiem wara t-tilqima.
English: If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including Vaxelis, should be based on careful consideration of the potential benefits and possible risks.
Maltese: Jekk is-sindrome ta' Guillain-Barré tkun seħħet fi żmien 6 ġimgħat mit-teħid ta' vaċċin preċedenti li jkun fih tossojd tat-tetnu, id-deċiżjoni sabiex tingħata kwalunkwe tilqima li fiha tossojd tat-tetnu, inkluż Vaxelis, għandha tkun ibbażata fuq konsiderazzjoni attenta tal-benefiċċji potenzjali u r-riskji possibbli.
English: 1 pre-filled syringe in a blister + 2 alcohol pads
Maltese: Daqs tal-pakkett siringa waħda mimlija għal-lest f'folja + 2 imsielaħ bl-alkoħol pinna waħda mimlija għal-lest f'folja + 2 imsielaħ bl-alkoħol
English: 1 pre-filled pen in a blister + 2 alcohol pads
Maltese: Numru tal-MA (EU) Isem Qawwa Għamla pakkett li
English: 1316 BN, Almere The Netherlands
Maltese: 1316 BN, Almere L-Olanda
English: Study results Study GOG-0179
Maltese: Riżultati tal-istudju ta' Studju GOG-0179
English: EU/1/10/633/001 - Single pack EU/1/10/633/002 - 5 pack
Maltese: EU/1/10/633/001 - Pakkett wieħed EU/1/10/633/002 - Pakkett ta' 5
English: In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A, nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Maltese: In vitro, topotecan ma inpedixxiex l-enżimi P450 umani CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A ta' CYP4A, u lanqas ma impedixxa lenżimi ċistoliċi umani dihydropyrimidine jew xanthine oxidase.
English: Combination therapy (cervical carcinoma):
Maltese: Terapija ta' kombinazzjoni (karċinoma ċervikali):
English: BN:
Maltese: SN:
English: (platelets between 25.0 and 50.0 x 10
Maltese: 25.0 u 50.0 x 10
English: Febrile neutropenia, neutropenia (see “Gastrointestinal disorders”), thrombocytopenia, anaemia, leucopenia
Maltese: Newtropenija bid-deni, newtropenija (ara “Disturbi gastrointestinali”), tromboċitopenija, anemija, lewkopenija
English: • High body temperature (fever).
Maltese: • Temperatura għolja tal-ġisem (deni).
English: Moderate to severe (Hb ≤8.0 g/dl) in 37 % of patients (14 % of courses).
Maltese: Moderati sa qawwija (Hb ≤ 8.0 g/dl) f'37 % tal-pazjenti (14 % tal-korsijiet).
English: Anaphylactic reaction, angioedema, urticaria
Maltese: Reazzjoni anafilattika, anġoedema, urtikarja
English: Median (95% CI.)
Maltese: Medjan (95 % C.I.)
English: 9/l) in 25 % of patients (8 % of courses); moderate
Maltese: 9/l plejtlets) f'25 % tal-pazjenti (8 % ta' korsijiet); moderata (bejn
English: Anorexia (which may be severe)
Maltese: Anoreksja (li tista' tkun serja)
English: Respiratory, thoracic and mediastinal disorders Rare
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Rari
English: Date of first authorisation: 10 June 2010 Date of latest renewal: 28 May 2015
Maltese: Data tal-aħħar tiġdid: 28 ta' Mejju 2015
English: Frequently reported non-haematological effects were gastrointestinal, such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Maltese: Effetti mhux ematoloġiċi li ġew irrappurtati b'mod frekwenti kienu dawk gastrointestinali, bħal dardir (52 %), rimettar (32 %), dijarea (18 %), stitikezza (9 %) u mukosite (14 %).
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were < 2.0 %.
Maltese: L-ammont ta' topotecan-O-glucuronide u N-desmethyl topotecan-O-glucuronide fl-awrina kien inqas minn 2.0 %.
English: the platelet count is ≥ 100 x 10
Maltese: plejtlets jilħaq ≥ 100 x 10
English: Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Hydrochloric acid (E507) (għal aġġustament ta' pH) Sodium hydroxide (għal aġġustament ta' pH)
English: 9/l) in 25 % of patients (15 % of courses).
Maltese: 9/l plejtlets) u 25 % ta' pazjenti (15 % ta' korsijiet).
English: Gastrointestinal perforation
Maltese: Disturbi gastrointestinali Komuni ħafna
English: Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %.
Maltese: L-eliminazzjoni ta' topotecan totali fl-ippurgar kienet ta' 18 % filwaqt li l-eliminazzjoni ta' N-desmethyl topotecan fl-ippurgar kienet ta' 1.7 %.
English: Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Maltese: Alopeċja kompleta jew serja ġiet osservata f'30 % tal-pazjenti u alopeċja parzjali f'15 % tal-pazjenti.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to ˂1/100); rare (≥1/10,000 to ˂1/1,000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Hazard ratio (95% CI) Response rate (%) (95% CI) Difference in response rate (95% CI) Median time to progression (weeks) (95% CI)
Maltese: Sopravivenza medjana (ġimgħat) (95 % CI) Proporzjon ta' periklu (95 % CI) Rata ta' rispons (%) (95 % CI) Differenza fir-rata ta' rispons (95 % CI) Żmien medjan għal progressjoni (ġimgħat) (95 % CI) Proporzjon ta' periklu (95 % CI) N = Numru totali ta' pazjenti li rċievew trattament.
English: Extravasation
Maltese: Extravażazzjoni
English: For storage conditions of the diluted medicinal product, see section 6.3.
Maltese: Għal kundizzjonijiet ta' ħażna tal-prodott mediċinali dilwit, ara sezzjoni 6.3.
English: Topotecan also had a high volume of distribution, about 132l (SD 57), and a relatively short half-life of 2-3 hours.
Maltese: Topotecan ukoll kellu volum għoli ta' distribuzzjoni, madwar 132 1, (SD 57), u half-life relattivament qasira ta' 2-3 sigħat.
English: In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Maltese: Fi studji kliniċi, raxx ġie rapportat f'4 % tal-pazjenti u ħakk f'1.5 % talpazjenti.
English: Haematological Neutropenia: Severe (neutrophil count <0.5 x 10
Maltese: Serja (numru ta' newtrofili < 0.5 x 10
English: Topotecan Hospira 4 mg/4 ml sterile concentrate topotecan
Maltese: Topotecan Hospira 4 mg/4 ml konċentrat sterili topotecan
English: In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum-based chemotherapy (n = 112 and 114, respectively), the response rate (95 % CI) was 20.5 % (13 %, 28 %) versus 14 % (8 %, 20 %) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, respectively.
Maltese: Fi studju kumparattiv bejn topotecan u paclitaxel f'pazjenti li diġà ġew ikkurati għal karċinoma flovarji permezz ta' kimoterapija ibbażata fuq il-platinum (n = 112 u 114, rispettivament,) ir-rata ta' rispons (95 % CI) kienet ta' 20.5 % (13 %, 28 %) kontra 14 % (8 %, 20 %) u ż-żmien medjan għal kontinwazzjoni kienet ta' 19-il ġimgħa versu 15-il ġimgħa (proporzjon ta periklu 0.7 [0.6, 1.0]), għal topotecan u paclitaxel rispettivament.
English: Pharmacotherapeutic group: antineoplastic agents: other antineoplastic agents, ATC code: L01XX17.
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, aġenti antineoplastiċi oħra, Kodiċi ATC:
English: The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95% CI: 0.78 - 1.40).
Maltese: Il-proporzjon ta' periklu għas-sopravivenza b'topotecan li jingħata fil-vina meta mqabbel ma' CAV kien ta' 1.04 (95 % CI: 0.78 - 1.40).
English: Topotecan is contraindicated during breast-feeding (see section 4.3).
Maltese: Topotecan huwa kontraindikat waqt it-treddigħ (ara sezzjoni 4.3).
English: ITT population Cisplatin 50 mg/m2 on day 1, every 2l days.
Maltese: Popolazzjoni ITT Cisplatin 50 mg/m2 fil-jum 1, kull 21 jum
English: When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12%, n=9) and Cmax (23%, n=11) was noted on day 5.
Maltese: Meta topotecan (0.75 mg/m2/ġurnata għal ħamest ijiem konsekuttivi) u cisplatin (60 mg/m2/ġurnata filġurnata 1) ġew amministrati lil 13-il pazjent b'kanċer tal-ovarji, żjieda żgħira fl-AUC (12 %, n=9) u Cmax (23 %, n=11) kienet innutata fil-ġurnata 5.
English: Overall, the N-desmethyl metabolite contributed a mean of < 7% (range 4-9 %) of the total topotecan-related material accounted for in the urine and faeces.
Maltese: Globalment, il-metabolit N-desmethyl ikkontribwixxa medja ta' anqas minn 7 % (firxa ta' 49 %) tat-total tal-materjal relatat ma' topotecan li nstab fl-awrina u fl-ippurgar.
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Maltese: Metaboliti ta' o-glucuronidation ta' topotecan u N-desmethyl topotecan ġew identifikati fl-awrina.
English: • Weight loss and loss of appetite (anorexia); tiredness; weakness.
Maltese: • Tnaqqis fil-piż u nuqqas t'aptit (anoressija); għeja; debbulizza
English: The approved diluents for the concentrate are sodium chloride 9 mg/ml (0.9%) solution for injection and glucose 50 mg/ml (5%) solution for injection.
Maltese: Iddiluwenti approvati għal konċentrat huma jew soluzzjoni ta' 9 mg/ml (0.9 %) sodium chloride għallinjezzjoni jew soluzzjoni ta' 50 mg/ml (5 %) glukosju għall-injezzjoni.
English: Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic reactions have been reported rarely.
Maltese: Reazzjonijiet ta' sensittività eċċessiva inkluż raxx, urtikarja, anġjodema u reazzjonijiet anafilattiċi ġew irrappurtati b'mod rari.
English: Concentrate for solution for infusion 4 mg/4 ml
Maltese: Konċentrat għal soluzzjoni għall-infużjoni 4 mg/4 ml