FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: Anorexia, decreased appetite, dehydration Frequency not known: Hyponatremia
Maltese: Komuni: Anoreksja, nuqqas t'aptit, deidratazzjoni
English: Before enrolling in the trial, 58 of the 61 patients (95%) had received 2 to 4 different induction regimens and 18/61 (30%) of these patients had undergone at least 1 prior haematological stem cell transplant (HSCT).
Maltese: Qabel ma nkitbu għal din il-prova, 58 minn 61 pazjent (95%) kienu rċevew minn 2 sa 4 reġimeni differenti ta' induzzjoni u 18/61 (30%) minn dawn il-pazjenti kienu rċevew minn qabel tal-anqas trapjant wieħed ta' ċelluli steminali ematoloġikali (HSCT).
English: Grade 3 or 4 elevated creatinine occurred in 8% of patients.
Maltese: Żieda fil-livell tal-krejatinina ta' grad 3 jew 4 seħħet fi 8% tal-pazjenti.
English: • - (Number of patients with a CR + Number of patients with a CRp) ÷ Number of eligible patients who received clofarabine
Maltese: • (Numru ta' pazjenti b'RK + Numru ta' pazjenti li għandhom RKp) ÷ Numru ta' pazjenti eliġibbli li rċevew il-clofarabine
English: Bleeding events have been observed in the setting of thrombocytopaenia.
Maltese: Episodji ta' fsada ġew osservati fl-isfond ta' tromboċitopenija.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 1 mg of clofarabine.
Maltese: U KWANTITATTIVA Kull ml ta' konċentrat fih 1 mg ta' clofarabine.
English: The concomitant use of medicinal products that have been associated with renal toxicity and those eliminated by tubular secretion such as NSAIDs, amphotericin B, methotrexate, aminosides, organoplatines, foscarnet, pentamidine, cyclosporin, tacrolimus, acyclovir and valganciclovir, should be avoided particularly during the 5 day clofarabine administration period; preference should be given to those medicinal products that are not known to be nephrotoxic (see sections 4.5 and 4.8).
Maltese: cyclosporin, tacrolimus, acyclovir u valganciclovir, għandhom ikunu evitati speċjalment matul ilperijodu ta' għoti ta' 5 ijiem ta' clofarabine; preferenza għandha tingħata lil dawk il-prodotti mediċinali li mhumiex magħrufa li huma nefrotossiċi (ara sezzjonijiet 4.5 u 4.8).
English: Haemorrhage, including cerebral, gastrointestinal and pulmonary haemorrhage, has been reported and may be associated with a fatal outcome (see section 4.4).
Maltese: Ġiet irrapportata l-emorraġija, li tinkludi l-emorraġija ċerebrali, gastrointestinali u pulmunarja u din jista' jkollha konsegwenzi fatali (ara sezzjoni 4.4).
English: In the event of a second clinically significant infection, clofarabine treatment should be withheld until the infection is clinically controlled and may be reinitiated at a 25% dose reduction.
Maltese: Jekk ikun hemm infezzjoni oħra sinifikanti klinikalment, it-trattament bil-clofarabine għandu jitwaqqaf sakemm l-infezzjoni tkun klinikalment ikkontrollata u tista' terġa'
English: Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis (see section 5.1).
Maltese: pazjenti ta' ≤ 21 sena fid-dijanjosi inizjali (ara sezzjoni 5.1).
English: In this regard, patients should be closely monitored when clofarabine is used in combined regimens.
Maltese: kien osservat f'pazjenti kkurati bi clofarabine.
English: Common: Haematuria*, renal failure, acute renal failure
Maltese: (AST)* aminotransferases, insuffiċjenza epatika
English: Dose related toxicities on male reproductive organs were observed in mice, rats and dogs.
Maltese: Tossiċitajiet marbuta mad-doża fuq organi riproduttivi maskili kienu osservati fil-ġrieden, firien u klieb.
English: The patients were enrolled into a single phase I (n = 12) or two phase II (n = 14 / n = 14) safety and efficacy studies, and received multiple doses of clofarabine by intravenous infusion (see section 5.1).
Maltese: Il-pazjenti kienu miktuba f'fażi waħda I (n = 12) jew żewġ fażijiet II (n = 14/ n = 14) ta' studji tas-sigurtà u effikaċja, u rċevew aktar minn doża waħda ta' clofarabine permezz ta' infużjoni għal ġol-vini (ara sezzjoni 5.1).
English: This means that due to the rarity of the disease it has not been possible to obtain complete information on the reference medicinal product.The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary accordingly to the reference medicinal product SmPC.
Maltese: Dan ifisser li minħabba li l-marda hija rari ma kienx possibbli li tinkiseb informazzjoni kompluta dwar il-prodott mediċinali ta' referenza.
English: Neoplasms benign and malignant (including cysts and polyps)
Maltese: Neoplażmi beninni u malinni (li jinkludu ċesti u polipi)
English: Neoplasms benign and malignant (including cysts and polyps) and Immune systems disorders Administration of clofarabine results in a rapid reduction in peripheral leukaemia cells.
Maltese: Neoplażmi beninni u malinni (inklużi ċesti u polipi) u Disturbi fis-sistema immuni L-għoti ta' clofarabine jirriżultata fi tnaqqis mgħaġġel taċ-ċelluli periferali tal-lewkimja.
English: There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity (see sections 4.3 and 4.4).
Maltese: Indeboliment epatiku M'hemmx esperjenza dwar l-użu f'pazjenti b'indeboliment epatiku (serum bilirubin > 1.5 x ULN kif ukoll AST u ALT > 5 x ULN) u l-fwied hu organu potenzjali bersall għat-tossiċità (ara sezzjonijiet 4.3
English: A 25% dose reduction may be warranted in patients experiencing significant toxicities (see below).
Maltese: Jista' jkun hemm bżonn ta' tnaqqis ta' 25% fid-doża f'pazjenti li qegħdin jesperjenzaw tossiċitajiet sinifikanti (ara hawn taħt).
English: A multi-centre, phase II, open-label, non-comparative study of clofarabine was conducted to determine the overall remission (OR) rate in heavily pretreated patients (≤ 21 years old at initial diagnosis) with relapsed or refractory ALL defined using the French-American-British classification.
Maltese: II, open-label, mhux-komparattiv ta' clofarabine sar biex jiddetermina r rata tar-remissjoni totali (RT) f'pazjenti li ngħataw trattament intensiv minn qabel (≤ 21 sena meta saret dijanjosi inizjali) b'ALL rikaduta jew refrattorja definit permezz tal-użu tal-klassifika Franċiża
English: These infections may lead to septic shock, respiratory failure, renal failure, and/or multi-organ failure.
Maltese: insuffiċjenza renali, u/jew insuffiċjenza f'diversi organi.
English: ALT and AST occurred within 10 days of clofarabine administration and returned to ≤ grade 2 within 15 days.
Maltese: Il biċċa l-kbira ta' elevazzjonijiet f'ALT u AST ġraw fi żmien 10 ijiem min meta ngħata l-clofarabine u reġgħu lura għal ≤≤ grad 2 fi żmien 15-il jum.
English: Ivozall is a potent antineoplastic agent with potentially significant haematological and non-haematological adverse reactions (see section 4.8).
Maltese: 4.4 Twissijiet speċjali u prekawzjonijiet għall-użu Ivozall hu aġent antineplastiku qawwi u għandu reazzjonijiet avversi ematoloġikali u nonematoloġikali li huma potenzjalment sinifikanti (ara sezzjoni 4.8).
English: For instructions on dilution of the medicinal product before administration (see section 6.6).
Maltese: Għal istruzzjonijiet dwar il-dilwizzjoni talproduct mediċinali qabel ma jingħata (ara sezzjoni 6.6).
English: Clofarabine is contraindicated in patients with severe renal insufficiency (see section 4.3) and should be used with caution in patients with mild to moderate renal insufficiency (see section 4.4).
Maltese: Clofarabine hu kontra-indikat f'pazjenti li jbatu minn insuffiċjenza severa renali (ara sezzjoni 4.3) u għandu jintuża bir-reqqa f' pazjenti b'insuffiċjenza renali ħafifa għal moderata (ara sezzjoni 4.4).
English: Patients who underwent transplant after alternative therapy or relapse*
Maltese: Pazjenti li kellhom trapjant wara terapija alternattiva jew rikaduta* CRp
English: Common: Hyperbilirubinaemia, jaundice, veno-occlusive disease, increases in alanine (ALT)* and aspartate (AST)* aminotransferases, hepatic failure Uncommon: Hepatitis
Maltese: Għalhekk, clofarabine hu kontra-indikat f'pazjenti b'indeboliment epatiku sever (ara sezzjoni 4.3) u għandu jintuża bir-reqqa f'pazjenti b'indeboliemt epatiku ħafif għal moderat (ara sezzjoni 4.4).
English: The safety profile of clofarabine has not been established in patients with severe renal insufficiency or patients receiving renal replacement therapy (see section 4.3).
Maltese: Il-profil tas-sigurtà ta' clofarabine ma ġiex stabbilit f'pazjenti b'insuffiċjenza severa tal-kliewi jew f'pazjenti li kienu qed jirċievu terapija tas-sostituzzjoni tal-kliewi (ara sezzjoni 4.3).
English: Further treatment with clofarabine, generally at a lower dose, can be considered when patients are stabilised and organ function has returned to baseline.
Maltese: Aktar trattament bi clofarabine, ġeneralment b'doża aktar baxxa, jista' jitqies meta l-pazjenti ikunu stabilizzati u l-funzjoni tal-organu tkun marret lura għal-linja bażi.
English: NAME OF THE MEDICINAL PRODUCT Ivozall 1 mg/ml concentrate for solution for infusion clofarabine
Maltese: Informazzjoni għall-utent Ivozall 1 mg/ml konċentrat għal solużjoni għall-infużjoni clofarabine
English: However, for patients with a body surface area > 0.38 m2, the contents of between 1 to 7 vials will be required to produce the recommended daily dosage of clofarabine.
Maltese: Madankollu, għal pazjenti li għandhom erja ta' superfiċje tal-ġisem > 0.38 m2, il kontenuti ta' bejn 1 sa 7 kunjetti ser ikunu meħtieġa biex jipproduċu d-dożaġġ irrakkomandat ta' kuljum ta' clofarabine.
English: *ITT = intention to treat.
Maltese: Ma saru ebda studji ta' interazzjoni.
English: If a patient experiences one or more severe toxicities (US National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Grade 3 toxicities excluding nausea and vomiting), treatment should be delayed until the toxicities resolve to baseline parameters or to the point where they are no longer severe and the potential benefit of continued treatment with clofarabine outweighs the risk of such continuation.
Maltese: Jekk il-pazjent jesperjenza wieħed jew aktar tossiċitajiet severi (tossiċitajiet Grad 3 tal-Kriterja tatTossiċità Komuni (CTC) tal-Istitut Nazzjonali tal-Kanċer (NCI) tal-US u liema tossiċitajiet jeskludu dardir u ramettar); it-trattament għandu jkun postpost sakemm it-tossiċitajiet jirrisolvu sal-parametri tal-linjabażi jew sal-punt fejn ma għadhomx severi aktar u l-benefiċċji potenzjali tat-trattament kontinwu b'clofarabine ikun akbar mir-riskju tat-tali kontinwazzjoni.
English: However, as clofarabine is not detectably metabolised by the cytochrome P450 (CYP) enzyme system, pathways of non-renal elimination currently remain unknown.
Maltese: Biss, peress li clofarabine mhux metabolizzat b'mod li jidher bis-sistema tal enżim cytochrome P450 (CYP), s'issa għadna ma nafux fejn huma l-passaġġi tat-tneħħija li ma jinvolvux il-kliewi.
English: If a patient experiences a hematologic toxicity of Grade 4 neutropaenia (ANC < 0.5 x 10
Maltese: L-użu konkomitanti ta' prodotti mediċinali li kienu assoċjati mat-tossiċità epatika għandu jkun evitat kemm jista' jkun (ara sezzjonijiet 4.5 u 4.8).
English: Cytotoxic medicinal products should be handled with caution.
Maltese: Tarmix mediċini mal-ilma tad-dranaġġ .
English: 9/l) lasting
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: This is equivalent to 3.08 mmol (or 70.77 mg) of sodium which is equivalent to 3.53% of the WHO recommended maximum daily intake of 2 g sodium for an adult and should be taken into consideration for patients on a controlled sodium diet.
Maltese: ta' sodju li huwa ekwivalenti għal 3.53 % tat-teħid massimu ta' kuljum rakkomandat mill-WHO ta' 2 g sodju għal adult u għandu jkun ikkonsidrat fil-każ ta' pazjenti li qegħdin fuq dieta kkontrollata tas sodju.
English: The maximum tolerated dose identified in the phase I study described above of 52 mg/m2/day clofarabine was administered by intravenous infusion for 5 consecutive days every 2 to 6 weeks.
Maltese: Id-doża massima ttolerata identifikata fl-istudju ta' fażi I deskritt hawn fuq ta' 52 mg/m2/kuljum ta' clofarabine ġiet mogħtija permezz ta' infużjoni għal ġol-vini għal 5 ġranet konsekuttivi minn kull 2 sa 6 ġimgħat.
English: Renal clearance
Maltese: Sopravivenza totali
English: Ivozall must not be mixed with or concomitantly administered using the same intravenous line as other medicinal products (see section 6.2).
Maltese: Ivozall ma għandux jitħallat ma' jew jingħata fl-istess ħin permezz tal-użu tal-istess linja minn ġolvina ma' prodotti mediċinali oħra (ara sezzjoni 6.2).
English: If you are pregnant or you become pregnant during treatment with clofarabine, get medical advice immediately.
Maltese: Jekk int tqila jew sirt tqila waqt it-trattament bil-clofarabine, ħu parir mediku minnufih.
English: • Patients who met all of the criteria for a CR except for recovery of platelet counts to > 100 x 109/l
Maltese: • Pazjenti li jissodisfaw il-kriterji kollha tal-RK barra milirkupru tal-kownts tal-plejtlits għal > 100 x 109/l
English: Treatment cycles should be repeated every 2 to 6 weeks (from the starting day of the previous cycle) following recovery of normal haematopoiesis (i.e. ANC ≥ 0.75 × 109/l) and return to baseline organ function.
Maltese: ANC ≥ 0.75 × 109/1) u għandna mmorru lura għall-funzjoni organika tal-linja bażi.
English: Patients taking medicinal products known to affect blood pressure or cardiac function should be closely monitored during treatment with clofarabine (see sections 4.4 and 4.8).
Maltese: Pazjenti li qed jieħdu prodotti mediċinali li huma magħrufa li jaffettwaw l-pressjoni tad-demm jew funzjoni kardijaka għandhom ikunu monitorjati sewwa matul it-trattament b'clofarabine (ara sezzjonijiet 4.4 u 4.8).
English: The full EPAR for Adjupanrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ għal Adjupanrix jista' jinstab fs-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The injections were given 21 days apart.
Maltese: Bejn injezzjoni u oħra kien hemm 21 jum.
English: What is Adjupanrix?
Maltese: X'inhu Adjupanrix?
English: Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Maltese: Vaċċin għall-Influwenza Pandemika (H5N1) (virjon maqsum, diżattivat, stimulat)
English: At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Maltese: Wara 21 jum wara t-tieni injezzjoni, 84% tan-nies li irċevew il-vaċċin kellhom livelli ta' antikorpi li jistgħu jipproteġuhom kontra l-H5N1.
English: Adjupanrix is a vaccine for use in adults to protect against ‘pandemic' flu.
Maltese: Adjupanrix huwa vaċċin għall-użu fl-adulti biex jipproteġi kontra l-influwenza ‘pandemika'.
English: This is a summary of the European public assessment report (EPAR) for Adjupanrix.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Adjupanrix.
English: Adjupanrix is a ‘mock-up' vaccine.
Maltese: Adjupanrix vaċċin tat-tip “finta”.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Adjupanrix on 19 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Adjupanrix valida fl-Unjoni Ewropea kollha fid-19 ta' Ottubru 2009.
English: Why has Adjupanrix been approved?
Maltese: Għaliex ġie approvat Adjupanrix?
English: The vaccine must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at very low levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Maltese: Il-vaċċin ma għandux jingħata lil pazjenti li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill-komponenti tal-vaċċin, jew għal kwalunkwe sustanza li tinsab f'livelli baxxi ħafna fil-vaċċin, bħal bajd, il-proteini tat-tiġieġ, l-ovalbumina (il-proteina fl-abjad tal-bajd), il-formaldeħajd, is-sulfat tal-gentamiċina (antibijotiku) u s-sodju deoksiċolat.
English: The vaccine contains a flu strain called ‘A/VietNam/1194/2004 NIBRG 14' (H5N1).
Maltese: Il-vaċċin fih razza tal-influwenza msejħa ‘A/VietNam/1194/2004
English: The most common side effects with the vaccine (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
Maltese: L-aktar effetti sekondarji bil-vaċċin (li dehru f'doża 1 minn 10 tal-vaċċin) huma wġigħ ta' ras, artralġija (uġigħ fil-ġogi), mijalġija (uġigħ fil-ġogi), reazzjonijiet fis-sit tal-injezzjoni (ebusija, nefħa, uġigħ u ħmura), deni u għeja (ħedla).
English: There are some data supporting the use of half-doses (0.25 ml) in children three to nine years of age.
Maltese: Hemm xi dejta li ssostni l-użu ta' nofs dożi (0.25 ml) fi tfal ta' bejn it-tliet u d-disa' snin.
English: A further study looked at the immunogenicity of single or double doses in 437 people aged over 60 years, and two studies looked at the effect of giving a single injection of the vaccine to adults who had previously been vaccinated with a prepandemic vaccine containing a related virus strain.
Maltese: Studju ieħor iffoka fuq l-immunoġeniċità ta' dożi singoli jew doppji f'437 persuna li kellhom minn 60 sena 'l fuq, u żewġ studji oħra analizzaw l-effett ta' injezzjoni singola tal-vaċċin f'adulti li kienu ġew imlaqqma qabel b'vaċċin prepandemiku li kien fih razza relatata tal-virus.
English: What benefit has this vaccine shown during the studies?
Maltese: Liema benefiċċju wera l-vaċċin waqt l-istudji mwettqa?
English: The main study showed that the 3.75 microgram dose of the adjuvanted vaccine produced an antibody response that met these criteria.
Maltese: L-istudju prinċipali wera li 3.75 mikrogrammi tal-vaċċin stimulat produċew reazzjoni b'antikorp li ssodisfat dawn il-kriterji.
English: The main study of the vaccine included 400 healthy adults aged between 18 and 60 years and compared the ability of different doses of the vaccine, with or without the adjuvant, to trigger the production of antibodies (‘immunogenicity').
Maltese: L-istudju prinċipali tal-vaċċin inkluda 400 adult f'saħħithom bl-etajiet ivarjaw minn 18 sa 60 sena u qabbel il-kapaċità ta' dożi differenti tal-vaċċin, bi jew mingħajr l-adjuvant, biex titqanqal il-produzzjoni ta' antikorpi (“immunoġeniċità”).
English: People who have not previously been vaccinated against the pandemic flu with a ‘prepandemic' vaccine should receive two single 0.5 ml doses of the vaccine at least three weeks apart.
Maltese: Il-persuni li ma ngħatawx tilqim kontra l-influwenza pandemika b'vaċċin “prepandemiku” qabel għandhom jingħataw żewġ dożi singoli tal-vaċċin ta' 0.5ml mill-inqas tliet ġimgħat 'il bogħod minn xulxin.
English: This vaccine is the same as the Pandemrix H5N1 mock-up vaccine, which was previously authorised in the European Union (EU).
Maltese: Dan il-vaċċin huwa l-istess bħall-vaċċin finta Pandemrix H5N1, li huwa diġà awtorizzat fl-Unjoni Europea (UE).
English: According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Maltese: Skont il-kriterji stabbiliti mis-CHMP, vaċċin finta jeħtieġ li joħloq livelli ta' protezzjoni ta' antikorpi f'mhux inqas minn 70 % tal-persuni biex jitqies adatt.
English: The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Maltese: Il-kejl ewlieni tal-effikaċja kien il-livell ta' antikorpi kontra l-virus tal-influwenza fid-demm fi tliet mumenti differenti: qabel ma ngħata l-vaċċin, fil-jum tat-tieni vaċċin (il-21 jum) u 21 jum wara (it-42 jum).
English: A study in 405 children three to nine years of age looked at the immunogenicity triggered by a vaccine containing half the amount of haemagglutinins compared with the vaccine containing the full amount.
Maltese: Studju f'405 itfal li jvarjaw fl-età bejn tliet snin sa disa' snin qabbel l-immunoġeniċità mibdija bil-vaċċin li kien fiha nofs l-ammont ta' emagglutinini mal-vaċċin li kien fih l-ammont kollu.
English: Other information about Adjupanrix
Maltese: Tagħrif ieħor fuq Adjupanrix
English: When the company that makes the vaccine includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Maltese: Meta l-kumpanija li tagħmel il-vaċċin tinkludi fil-vaċċin ir-razza tal-influwenza li tkun responsabbli għal pandemija, hija għandha tiġbor informazzjoni dwar is-sigurtà u l-effikaċja tal-vaċċin pandemiku finali, u tissottomettiha lis-CHMP għal evalwazzjoni.
English: The final two studies in adults showed that a single dose of the vaccine was sufficient to bring about protective levels of antibodies in people who had previously been vaccinated with a prepandemic vaccine containing a related flu strain.
Maltese: Iż-żewġ studji finali wrew li doża singola tal-vaċċin kienet biżżejjed biex twassal għal livelli protettivi ta' antikorpi f'persuni li ngħataw vaċċin prepandemiku li kien fih razza tal-influwenza relatata qabel.
English: In elderly people, single doses also met the CHMP's criteria, except for in the small number of patients aged over 80 years who did not have any protection against the virus at the start of the study.
Maltese: Fl-anzjani, dożi singoli wkoll issodisfaw il-kriterji tas-CHMP, għajr f'għadd żgħir ta' pazjenti ta' aktar minn 80 sena li ma kellhomx protezzjoni kontra l-virus fil-bidu tal-istudju.
English: The vaccine is given by injection into the shoulder or thigh muscle.
Maltese: Imbagħad is-sistema immunitarja tkun tista' tipproduċi antikorpi aktar malajr meta tkun esposta għall-virus mill-ġdid.
English: It should only be used once a flu pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU).
Maltese: Għandu jintuża biss ladarba tkun ġiet iddikjarata uffiċjalment pandemija tal-influwenza mill-Organizzazzjoni Dinjija tas-Saħħa (WHO) jew mill-Unjoni Ewropea (UE).
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Maltese: Pandemija tal-influwenza sseħħ meta titfaċċa razza ġdida tal-virus tal-influwenza li tista' tinfirex faċilment minn persuna għal oħra minħabba li nnies ma jkollhomx immunità (protezzjoni) kontriha.
English: EU number
Maltese: l-EU
English: Strength Pharmaceutical Form Route of administration Packaging
Maltese: Mnejn jingħata Il-pakkett
English: Invented name
Maltese: Isem inventat farmaċewtika
English: K.Valdemāra 33 - 30 LV-1010 Rīga
Maltese: K.Valdemāra 33 - 30 LV-1010
English: Hexal AG Industriestraße 25 83607 Holzkirchen Germany
Maltese: Hexal AG Industriestraße 25 83607 Holzkirchen
English: Temozolomide Hexal may cause permanent infertility.
Maltese: Temozolomide Hexal jista' jikkawża infertilità permanenti.
English: Do not swallow it.)
Maltese: Tibilgħux.)
English: Multipack: 20 (4 packs of 5) hard capsules
Maltese: Pakkett multiplu: 20 (4 pakketti ta' 5) kapsuli ibsin
English: • vaginal irritation
Maltese: • irritazzjoni vaġinali
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100); Rari (≥1/10,000 sa <1/1,000);
English: Multipack (bottles)
Maltese: Pakkett multiplu (fliexken)
English: PC: {number} SN: {number} NN: {number
Maltese: {numru} SN:
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, sepsis†
Maltese: infezzjoni bħal cytomegalovirus, virus tal-epatite B†, meningoenċefalite erpetika†, sepsis†