FrancophonIA/ELRC3.0 huggingface dataset:
English: Ziextenzo is a clear, colourless to slightly yellowish solution for injection in a pre-filled syringe (6 mg/0.6 mL).
Maltese: Ziextenzo huwa soluzzjoni ċara u bla kulur sa ħarira safranija, għall-injezzjoni ġo siringa mimlija għal lest (6 mg/0.6 mL).
English: Excipients with known effect Each pre-filled syringe contains 30 mg sorbitol (E420).
Maltese: Kull siringa mimlija għal-lest fiha 30 mg sorbitol (E 420).
English: This will allow quick identification of new safety information.
Maltese: Informazzjoni ta' sigurtà importanti
English: In a second study (n = 310), which used a weight-adjusted dose (100 µg/kg), the mean duration of grade 4 neutropenia for the pegfilgrastim group was 1.7 days, compared with 1.8 days in the filgrastim group (difference 0.03 days, 95% CI-0.36, 0.30).
Maltese: Fi studju ieħor (n = 310), fejn intużat doża maħduma skont il-piż (100 µg/kg), id-dewmien medju tan newtropenija ta' grad 4 għall-grupp b'pegfilgrastim kienet ta' 1.7 ijiem, imqabbel ma' 1.8 ijiem filgrupp ta' filgrastim (differenza ta' 0.03 ijiem, CI ta' 95% -0.36, 0.30).
English: In two randomised, double-blind, pivotal studies in patients with high-risk stage II-IV breast cancer undergoing myelosuppressive chemotherapy consisting of doxorubicin and docetaxel, use of pegfilgrastim, as a single once per cycle dose, reduced the duration of neutropenia and the incidence of febrile neutropenia similarly to that observed with daily administrations of filgrastim (a median of 11 daily administrations).
Maltese: F'żewġ studji randomised, double-blind, ewlenin, f'pazjenti b'kanċer tas-sider ta' riskju għoli ta' stadju II-IV li kienu qed jingħataw kimoterapija majelosoppressiva li tikkonsisti minn doxorubicin u docetaxel, l-użu ta' pegfilgrastim, bħala doża waħda f'kull ċiklu, naqqset id-dewmien tan-newtropenija u linċidenza ta' newtropenija bid-deni b'mod simili għal dak osservat bl-għoti ta' kuljum ta' filgrastim (medjan ta' 11-il għoti kuljum).
English: Human granulocyte colony stimulating factor (G-CSF) is a glycoprotein, which regulates the production and release of neutrophils from the bone marrow.
Maltese: Il-fattur uman li jistimula l-kolonja ta' granuloċiti (G-CSF - granulocyte-colony stimulating factor) huwa glikoproteina li tirregola l-produzzjoni u r-reħa ta' newtrofili mill-mudullun.
English: The injections should be given into the thigh, abdomen or upper arm. For instructions on handling of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq l-immaniġġar talprodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: With the exception of the youngest age group (0-5 years), the mean AUC in paediatric subjects appeared similar to that for adult patients with high-risk stage II-IV breast cancer and receiving 100 mcg/kg pegfilgrastim after the completion of doxorubicin/docetaxel (see sections 4.8 and 5.1).
Maltese: II-IV ta' riskju għoli li kienu qed jirċievu 100µg/kg pegfilgrastim wara li temmew doxorubicin/docetaxel (ara sezzjonijiet 4.8 u 5.1).
English: Rare side effects (may affect up to 1 in 1,000 people):
Maltese: Effetti sekondarji rari (jistgħu jaffetwaw sa pazjent wieħed minn kull 1,000 persuna):
English: The safety and efficacy of pegfilgrastim have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g. nitrosoureas.
Maltese: Is-sigurtà u l-effikaċja ta' pegfilgrastim ma ġewx evalwati f'pazjenti li kienu qed jirċievu kimoterapija assoċjata ma' majelosoppressjoni ittardjata eż. nitrosoureas.
English: In the absence of growth factor support, this regimen has been reported to result in a mean duration of grade 4 neutropenia of 5 to7 days, and a 30-40% incidence of febrile neutropenia.
Maltese: Fin-nuqqas ta' appoġġ ta' fattur tat-tkabbir, ġie rrappurtat li dan il-kors ta' dożaġġ iwassal għal newtropenija ta' grad 4 li ddum medja ta' 5 sa 7 ijiem, u inċidenza ta' 30-40% ta' newtropenija bid-deni.
English: Sodium hydroxide (for pH adjustment) Water for injections
Maltese: Sodium hydroxide (għal aġġustament tal-pH)Ilma għall-injezzjonijiet
English: Thrombocytopenia1 Leukocytosis1
Maltese: Tromboċitopenija1 Lewkoċitosi1
English: Consistent with the clinical effects and the potential for leukocytosis, a WBC count should be performed at regular intervals during therapy.
Maltese: Konsistenti mal-effetti kliniċi u l-potenzjal għal lewkoċitosi,
English: The overall rate of febrile neutropenia was 9% of patients treated with pegfilgrastim and 18% of patients treated with filgrastim (difference 9%, 95% CI of -16.8%, -1.1%).
Maltese: Ir-rata totali ta' newtropenija biddeni kienet ta' 9% tal-pazjenti ttrattati b'pegfilgrastim u 18% tal-pazjenti ttrattati b'filgrastim (differenza ta' 9%, CI ta' 95% ta' -16.
English: Studies in rats indicated that reproductive performance, fertility, oestrous cycling, days between pairing and coitus, and intrauterine survival were unaffected by pegfilgrastim given subcutaneously.
Maltese: Studji fil-frien indikaw li l-ħila riproduttiva, fertilità, ċiklu oestrous, ġranet bejn it-tqabbil u l-kopulazzjoni, u s-sopravivenza fil-ġuf ma ġewx affettwati minn Pegfilgrastim mogħti taħt il-ġilda.
English: There is insufficient information on the excretion of pegfilgrastim/metabolites in human milk, a risk to the newborns/infants cannot be excluded.
Maltese: M'hemmx informazzjoni suffiċjenti dwar l-eliminazzjoni ta' pegfilgrastim/metaboliti fil-ħalib tas-sider tal-bniedem, u riskju għat-trabi ta' twelid/trabi ma jistax jiġi eskluż.
English: Musculoskeletal pain (myalgia, arthralgia, pain in extremity, back pain, musculoskeletal pain, neck pain)
Maltese: (majalġja, artralġja, uġigħ flestremitajiet, uġigħ fid-dahar, uġigħ muskoluskeletriku,
English: In a placebo-controlled, double blind study in patients with breast cancer the effect of pegfilgrastim on the incidence of febrile neutropenia was evaluated following administration of a chemotherapy regimen associated with a febrile neutropenia rate of 10-20% (docetaxel 100 mg/m2 every 3 weeks for 4 cycles).
Maltese: Fi studju double blind, ikkontrollat bil-plaċebo, f'pazjenti b'kanċer tas-sider ġie evalwat l-effett ta' pegfilgrastim fuq l-inċidenza tan-newtropenija bid-deni wara l-għoti ta' kors ta' kimoterapija assoċjat ma' rata ta' newtropenija bid-deni ta' 10-20% (docetaxel 100 mg/m2 kull 3 ġimgħat għal 4 ċikli).
English: Ziextenzo may be exposed to room temperature (not above 35 °C) for a maximum single period of up to 120 hours.
Maltese: Ziextenzo jista' jiġi espost għal temperatura ambjentali (mhux aktar minn 35°C) għal perjodu wieħed ta' massimu ta' 120 siegħa.
English: • Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.
Maltese: • Sindrome ta' Stevens-Johnson, li tista' tidher bħala rqajja' ċirkulari ħomor li jixbhu l-bersalli, ħafna drabi b'infafet ċentrali fuq it-torso, tqaxxir tal-ġilda, ulċeri fil-ħalq, il-griżmejn, l-imnieħer, il-ġenitali u l-għajnejn u li tista' tibda b'deni u sintomi li jixbhu l-influwenza.
English: • if you have any of the following or combination of the following side effects: - swelling or puffiness, which may be associated with passing water less frequently, difficulty breathing, abdominal swelling and feeling of fullness, and a general feeling of tiredness These could be symptoms of condition called “Capillary Leak Syndrome” which causes blood to leak from the small blood vessels into your body.
Maltese: • jekk għandek xi wieħed minn dawn li ġejjin jew kombinazzjoni tal-effetti sekondarji li ġejjin: nefħa jew tħossok mimli, li jistgħu jkunu assoċjati ma li jgħaddi l-awrina inqas frekwenti, diffikultà biex tieħu nifs, nefħa addominali u tħossok mimli, u sensazzjoni ġenerali ta' għeja Dawn jistgħu jkunu sintomi ta' kondizzjoni msejħa “Sindrome ta' Tnixxija Kapillari” li tikkawża demm li jnixxi mill-vini ż-żgħar fil-ġisem tiegħek.
English: Uncommon pulmonary adverse reactions including interstitial pneumonia, pulmonary oedema, pulmonary infiltrates and pulmonary fibrosis have been reported.
Maltese: Kienu rrappurtati reazzjonijiet avversi mhux komuni relatati mal-pulmun, fosthom pulmonite tal interstizju, edima fil-pulmun, infiltrati fil-pulmun u fibrożi fil-pulmun.
English: The onset of pulmonary signs such as cough, fever, and dyspnoea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function along with increased neutrophil count may be preliminary signs of Acute Respiratory Distress Syndrome (ARDS).
Maltese: Bidu ta' sinjali pulmonari bħal sogħla, deni u qtugħ ta' nifs flimkien ma' sinjali radjuloġiċi ta' infiltrati fil-pulmun, u deterjorazzjoni tal-funzjoni tal-pulmun flimkien ma' żieda fl-għadd ta' newtrofili jistgħu jkunu sinjali tal-bidu tas-Sindrome ta' Tbatija Respiratorja Akuta (ARDS - Acute Respiratory Distress
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza ddettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Hypersensitivity-type reactions, including skin rash, urticaria, angioedema, dyspnoea, erythaema, flushing, and hypotension occurred on initial or subsequent treatment with pegfilgrastim (uncommon [≥ 1/1,000 to < 1/100]).
Maltese: Reazzjonijiet tat-tip ta' sensittività eċċessiva, inkluż raxx tal-ġilda, urtikarja, anġjoedima, qtugħ ta' nifs,
English: This medicinal product contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg / mL.
Maltese: Din il-mediċina fiha 30 mg sorbitol f'kull siringa mimlija għal-lest li hu ekwivalenti għal 50 mg / mL.
English: Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL solution for injection.
Maltese: Kull siringa mimlija għal-lest fiha 6 mg ta' *pegfilgrastim f'0.6 mL ta' soluzzjoni għall-injezzjoni.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: • spleen rupture.
Maltese: • tqalligħ u uġigħ ta' ras.
English: Do not shake Ziextenzo vigorously as this may affect its activity.
Maltese: Jekk tmisshom, il-protezzjoni tal-labra tista' tiġi attivata kmieni wisq.
English: • bone pain.
Maltese: Aħżen fi friġġ.
English: If you experience a loss of response or failure to maintain a response with pegfilgrastim treatment, your doctor will investigate the reasons why, including whether you have developed antibodies which neutralise pegfilgrastim's activity.
Maltese: Jekk ikollok telf ta' rispons jew falliment li jinżamm rispons bi trattament ta' pegfilgrastim, it-tabib tiegħek se jinvestiga r-raġunijiet għaliex, inkluż jekk żviluppajtx antikorpi li jinnewtralizzaw l-attività ta' pegfilgrastim.
English: A higher frequency of serious adverse reactions in younger children aged 0-5 years (92%) has been observed compared to older children aged 6-11 and 12-21 years respectively (80% and 67%) and adults.
Maltese: Kienet osservata frekwenza ogħla ta' reazzjonijiet avversi serji fi tfal żgħar b'età ta' 0-5 snin (92%) meta mqabbla ma' tfal akbar b'età ta' 6-11 u 12-21 sena rispettivament
English: For more information, see section 5.1
Maltese: Għal aktar informazzjoni, are sezzjoni 5.1. Eċċipjenti b'effett magħruf
English: LEK Pharmaceuticals d.d.
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI 5
English: Cutaneous vasculitis1,2
Maltese: Reazzjonijiet fis-sit tal-injezzjoni2
English: Capillary leak syndrome has been reported after granulocyte-colony stimulating factor administration and is characterised by hypotension, hypoalbuminaemia, oedema and haemoconcentration.
Maltese: Sindrome ta' tnixxija tal-kapillari ġie rrappurtat wara għoti tal-fattur li jistimula l-kolonja ta' granuloċiti u huwa kkaratterizzat minn pressjoni baxxa, ipoalbuminemija, edima u emokonċentrazzjoni.
English: There were no adverse effects observed in offspring from pregnant rats given pegfilgrastim subcutaneously, but in rabbits pegfilgrastim has been shown to cause embryo/foetal toxicity (embryo loss) at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose.
Maltese: Ma kien hemm l-ebda effett avvers osservat fil-frieħ ta' firien tqal li ngħataw pegfilgrastim taħt il-ġilda, iżda fil-fniek pegfilgrastim intwera li jikkawża tossiċità fl-embriju/fetu (telfien tal-embriju) b'dożi kumulattivi bejn wieħed u ieħor 4 darbiet id-doża rakkomandata għall-bniedem, li ma dehrux meta fniek tqal ġew esposti għad-doża rakkomandata fil-bniedem.
English: • inflammation of the aorta (the large blood vessel which transports blood from the heart to the body), see section 2.
Maltese: • infjammazzjoni tal-aorta (l-arterja l-kbira tad-demm li tittrasporta d-demm mill-qalb għall-ġisem) ara sezzjoni 2.
English: The symptoms experienced included fever, abdominal pain, malaise, back pain and inflammatory markers (e.g. C-reactive protein and white blood cell count) were raised.
Maltese: Issintomi li ħassew kienu jinkludu deni, uġigħ fl-addome, telqa, uġigħ fid-dahar u żieda fil-markaturi infjammatorji (eż.proteina C-reattiva u għadd ta' ċelloli bojod tad-demm).
English: EU/1/98/081/006 EU/1/98/081/007
Maltese: EU/1/98/081/003 EU/1/98/081/005 EU/1/98/081/006 EU/1/98/081/007
English: 200 mg 200 mg
Maltese: 200 mg 200 mg 200 mg 200 mg
English: Comtan Comtan
Maltese: Comtan Comtan Comtan Comtan
English: 100 tablets 60 tablets
Maltese: 100 pillolla 30 pillolla 100 pillolla 60 pillolla
English: Oral use Oral use bottle (HDPE) bottle (HDPE)
Maltese: Flixkun (tal-ħġieġ) Flixkun (HDPE) Flixkun (HDPE) Flixkun (HDPE)
English: Film-coated tablet Film-coated tablet
Maltese: Użu orali Użu orali Użu orali Użu orali
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/EU311932.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/medicines/human/orphan-designations/EU311932.
English: The maximum dose is 500 micrograms every two weeks.
Maltese: Id-doża massima hija 500 mikrogramma kull ġimagħtejn.
English: Further information on Besremi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/besremi.
Maltese: ema.europa.eu/medicines/human/EPAR/besremi.
English: Ropeginterferon alfa-2b is a type of 'interferon', a natural substance produced by the body.
Maltese: Ropeginterferon alfa-2b hija tip ta' “interferon”, sustanza naturali prodotta mill-ġisem.
English: In this study, 43% of patients receiving Besremi had normal red blood cell counts after one year of treatment; 46% of patients receiving another medicine, hydroxycarbamide, had similar improvements.
Maltese: F'dan l-istudju, 43 % tal-pazjenti li rċevew Besremi kellhom għadd normali taċ-ċelloli ħomor tad-demm wara sena ta' kura; 46 % tal-pazjenti li rċevew mediċina oħra, hydroxycarbamide, kellhom titjib simili.
English: Polycythaemia vera is rare, and Besremi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 December 2011.
Maltese: Poliċitemija vera hija rari, u Besremi ġie denominat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) fid-9 ta' Diċembru 2011.
English: What are the risks associated with Besremi?
Maltese: X'inhuma r-riskji assoċjati ma' Besremi?
English: Besremi contains the active substance ropeginterferon alfa-2b.
Maltese: Besremi fih is-sustanza attiva ropeginterferon alfa-2b.
English: Other information about Besremi
Maltese: Informazzjoni oħra dwar Besremi
English: How does Besremi work?
Maltese: Kif jaħdem Besremi?
English: The most common side effects with Besremi (which may affect more than 1 in 10 people) are low levels of white blood cells and platelets (blood components that help the blood to clot), muscle and joint pain, tiredness, flu-like symptoms and increased blood levels of gamma-glutamyl transferase (a sign of liver problems).
Maltese: L-effetti sekondarji l-aktar komuni b'Besremi (li jistgħu jaffettwaw aktar minn persuna waħda minn 10) huma livelli baxxi ta' ċelloli bojod tad-demm u pjastrini (komponenti tad-demm li jgħinu lid-demm biex jagħqad), uġigħ fil-muskoli u fil-ġogi, għeja, sintomi li jixbhu lill-influwenza u żieda fil-livelli tad-demm ta' trasferażi gamma-glutamyl (sinjal ta' problemi fil-fwied).
English: The active substance in Besremi, ropeginterferon alfa-2b, works by attaching to receptors (targets) on body cells called interferon alfa/beta receptors (IFNAR).
Maltese: Is-sustanza attiva f'Besremi, ir-ropeginterferon alfa-2b, taħdem billi teħel ma' riċetturi (miri) fuq iċċelloli tal-ġisem imsejħa riċetturi interferon alfa/beta (IFNAR).
English: A main study of 257 patients showed that Besremi is effective at reducing levels of red blood cells in patients with polycythaemia vera.
Maltese: Studju ewlieni fuq 257 pazjent wera li Besremi huwa effettiv fit-tnaqqis taċ-ċelloli ħomor tad-demm f'pazjenti b'poliċitemija vera.
English: As for all medicines, data on the use of Besremi are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Besremi hija ssorveljata kontinwament.
English: Besremi is a medicine used to treat polycythaemia vera in adults who do not have symptoms of an enlarged spleen.
Maltese: Besremi huwa mediċina li jintuża biex jikkura poliċitemija vera fl-adulti li ma għandhomx sintomi ta' milsa mkabbra.
English: Besremi must not be used together with telbivudine (a medicine for treating hepatitis B).
Maltese: Besremi ma għandux jintuża flimkien ma' telbivudine (mediċina għall-kura tal-epatite B).
English: Besremi can only be obtained with a prescription and treatment should only be started under the supervision of a doctor experienced in managing polycythaemia vera.
Maltese: Besremi jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda taħt superviżjoni ta' tabib esperjenzat fil-ġestjoni ta' poliċitemija vera.
English: It must not be used in patients with thyroid disease which is not controlled by standard treatment, patients who have had psychiatric illnesses such as severe depression, patients with severe problems affecting the heart and the blood vessels, patients who have recently had a heart attack or stroke, patients suffering from autoimmune diseases, patients who have had a transplant, and patients with very severe liver or kidney disease.
Maltese: Ma għandux jintuża f'pazjenti bil-marda tat-tirojde li mhijiex ikkontrollata b'kura standard, pazjenti li kellhom mard psikjatriku bħal dipressjoni serja, pazjenti bi problemi serji li jaffettwaw il-qalb u l-vażijiet, pazjenti li riċentement kellhom attakk tal-qalb jew puplesija, pazjenti li jsofru minn mard awtoimmuni, pazjenti li sarilhom trapjant, u pazjenti b'mard serju ħafna tal-fwied jew tal-kliewi.
English: As for its safety, the side effects of Besremi are considered manageable.
Maltese: Fir-rigward tas-sigurtà tiegħu, l-effetti sekondarji ta' Besremi huma kkunsidrati maniġġabbli.
English: What measures are being taken to ensure the safe and effective use of Besremi?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Besremi?
English: In addition, the fact that Besremi does not have the potential to cause gene mutations was considered an important benefit.
Maltese: Barra minn hekk, il-fatt li Besremi ma għandux il-potenzjal li jikkawża mutazzjonijiet tal-ġeni tqies bħala benefiċċju importanti.
English: Side effects reported with Besremi are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Besremi huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Via Fiorentina, 1 - 53100 Siena
Maltese: Via Fiorentina, 1 - 53100 Siena L-Italja
English: Siena, Italy.
Maltese: Siena, L-Italja.
English: c)
Maltese: I)°
English: • Supportive data in adults a)
Maltese: • Dejta ta' sostenn fl-adulti a) Kross-reattività
English: MN results yielded a GMR against A/turkey/Turkey/05 ranging from 1.59 to 2.95.
Maltese: MN ipproduċew GMR kontra A/turkey/Turkey/05 li kien ivarja minn 1.59 sa 2.95.
English: Injection 3
Maltese: Injezzjoni 3
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29 November 2010
Maltese: 29 ta' Novembru 2010
English: Immune response against A/Vietnam/1194/2004 (H5N1):
Maltese: Rispons immuni kontra A/Vietnam/1194/2004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/657/001-002
Maltese: EU/1/10/657/001-002
English: There were 3678 subjects 18-60 years of age, 264 subjects 61-70 years of age, and 41 subjects greater than 70 years of age.
Maltese: Kien hemm 3,678 persuna minn 18-60 sena, 264 persuna minn 61-70 sena, u 41 persuna ta' aktar minn 70 sena.
English: Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Sodium citrate
Maltese: Sodium chloride Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dihydrate Magnesium chloride hexahydrate Calcium chloride dihydrate Sodium citrate
English: 9.75 milligrams per 0.5 ml polysorbate 80
Maltese: 9.75 milligrammi għal kull 0.5 ml polysorbate 80
English: Adverse reactions from clinical trial in children (6 months to 17 years old) (Study V87P6)
Maltese: Reazzjonijiet avversi minn prova klinika fi tfal (6 xhur sa 17-il sena)(Studju V87P6)
English: Loc. Bellaria - 53018 Rosia Sovicille (SI), Italy.
Maltese: Bellaria - 53018 Rosia Sovicille (SI), L-Italja.
English: 1.175 milligrams per 0.5 ml sorbitan trioleate
Maltese: 1.175 milligrammi għal kull 0.5 ml sorbitan trioleate
English: Fever ≥ 38°C (≥ 40°C) Any Other Adverse Event
Maltese: Deni ≥ 38°C (≥ 40°C) Kwalunkwe Episodju Avvers Ieħor
English: adjuvanted) Novartis Vaccines and Diagnostics;
Maltese: NOVARTIS VACCINES AND DIAGNOSTICS
English: GMR (95% CI) Day 43 to Day 1 % SC (95% CI) Day 43
Maltese: GMR (95% CI) Jum 43 sa Jum 1 % SC (95% CI) Jum 43
English: Active immunisation against H5N1 subtype of Influenza A virus.
Maltese: Immunizzazzjoni attiva kontra s-sottotip H5N1 tal-virus tal-Influwenza A.
English: Novartis V&D S.r.l.
Maltese: Novartis V&D
English: MARKETING AUTHORISATION NUMBER EU/1/10/657/001 1 prefilled syringe EU/1/10/657/002 10 prefilled syringes
Maltese: EU/1/10/657/001 Siringa waħda mimlija għal-lest EU/1/10/657/002 10 siringi mimlijin għal-lest
English: The vaccine contains per 0.5ml 9.75 mg squalene, 1.175 mg polysorbate 80 and 1.175 mg
Maltese: Il-vaċċin fih għal kull 0.5 ml, 9.75 mg squalene, 1.175 mg polysorbate 80 u 1.175 mg sorbitan trioleate.
English: Novartis Vaccines and Diagnostics S.r.l.
Maltese: Novartis Vaccines and Diagnostics S.r.l. Loc.
English: Toddlers (6-<36 months) Children (3-<9 years) Adolescents (9-<18 years) N=91
Maltese: Tfal (3 -< 9 snin) Adoloxxenti (9 -< 18-il sena)
English: A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14)
Maltese: (H5N1) (NIBRG-14)
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Maltese: TAS-SUSTANZA BIJOLOĠIKA ATTIVA U
English: Animals were challenged by the intranasal route on day 42 with a lethal dose of A/Vietnam/1203/04 virus.
Maltese: L-annimali ġew esposti mill-imnieħer f'jum 42 għal doża letali tal-virus A/Vietnam/1203/04.
English: Two doses of vaccine containing H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/dose adjuvanted) were administered three weeks apart to 156 healthy adults.
Maltese: Ingħataw żewġ dożi tal-vaċċin li fih H5N1 (A/Vietnam/1194/2004; 7.5 µg HA/doża adjuvanted) tliet ġimgħat minn xulxin lil 156 persuna adulta b'saħħithom.