FrancophonIA/ELRC3.0 huggingface dataset:
English: 2-4-6 months; 3-4-5 months and 3-4½-6 months
Maltese: 6-10-14 -il-ġimgħa 2-4-6 xhur; 3-4-5 xhur u 34½-6 xhur
English: Tritanrix HepB - Suspension for injection
Maltese: Tritanrix HepB - Suspensjoni għall-injezzjoni,
English: For this reason, the vaccinee should remain under medical supervision for 30 minutes after vaccination.
Maltese: Għal din ir-raġuni, min qed jiġi mlaqqam għandu jibqa' taħt superviżjoni medika għal 30 minuta wara t-tilqim.
English: • if after previously having Tritanrix HepB or another vaccine against pertussis (whooping cough) disease, your child had any problems, especially: ♦ A high temperature (over 40°C) within 48 hours of vaccination ♦ A collapse or shock-like state within 48 hours of vaccination ♦ Persistent crying lasting 3 hours or more within 48 hours of vaccination ♦ Seizures/fits with or without a high temperature within 3 days of vaccination
Maltese: ♦ Deni għoli (‘l fuq minn 40° C) fi żmien 48 siegħa mit-tilqim ♦ Kollass jew stat bħal f'xokk fi żmien 48 siegħa mit-tilqim ♦ Biki persistenti li jdum tliet sigħat jew aktar fi żmien 48 siegħa mit-tilqim ♦ Aċċessjonijiet/ konvulżjonijiet b`deni għoli jew mingħajr deni għoli fi żmien 3 ijiem mit-tilqim
English: There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
Maltese: Jista' jkun hemm ċirkustanzi, bħal inċidenza għolja ta' pertussis, fejn il-benefiċċji tat-tilqima jkunu akbar mir-riskji possibbli.
English: The HBsAg assembles spontaneously, in the absence of chemical treatment, into spherical particles of 20 nm in average diameter containing non-glycosylated HBsAg polypeptide and a lipid matrix consisting mainly of phospholipids.
Maltese: L-HBsAg jinbidel spontanjament, mingħajr trattament kimiku, f'partiċelli sferiċi ta' dijametru medju ta' 20 nm, li fihom polipeptide ta' l-HBsAg mhux glikosilat u matriċi lipidu li hu magħmul l-aktar minn fosfolipidi.
English: The expected immunological response may not be obtained after vaccination of immunosuppressed patients, e.g. patients on immunosuppressive therapy.
Maltese: Ir-rispons immunoloġiku mistenni jista' ma jinkisibx wara t-tilqim ta' pazjenti immunosoppressi, e.ż.. pazjenti fuq kura immunosoppressiva. .
English: Tritanrix HepB can be mixed with the lyophilised Hib vaccine (Hiberix).
Maltese: Tritanrix HepB jista' jitħallat mal-vaċċin lajofilizzat Hib (Hiberix).
English: HOW TO STORE TRITANRIX HepB
Maltese: KIF TAĦŻEN TRITANRIX HepB
English: Store in a refrigerator (2°C - 8°C) Store in the original package in order to protect from light.
Maltese: Aħżen fi friġġ (2°C - 8°C) Żommu fil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: Each injection is given on a separate visit.
Maltese: Kull injezzjoni tingħata f'vista separata.
English: In a prospective comparative study, which compared the administration of the combined DTPw-HBV vaccine with the simultaneous separate administration of DTPw and HBV vaccine, higher incidences of pain, redness, swelling and fever were reported in the group receiving the combined vaccine.
Maltese: Fi studju prospettiv kumparattiv, li qabbel l-amministrazzjoni tal-vaċċin kombinat DTPw HBV ma' lamministrazzjoni separata iżda fl-istess ħin tal-vaċċin DTPw u HBV, ġiet irrappurtata inċidenza ogħla ta' uġigħ, ħmura, nefħa u deni fil-grupp li ħadu il-vaċċin kombinat.
English: Collapse or shock-like state (hypotonic-hyporesponsive episode) Respiratory, thoracic and mediastinal disorders:
Maltese: Kollass u stat bħal f'xokk (episodju ipotoniku-iporisponsiv) Disturbi respiratorji, toraċiċi u medjastinali
English: • allergic reactions, including anaphylactic and anaphylactoid reactions.
Maltese: • reazzjonjiet allerġiċi inkluż reazzjonijiet anafilattiċi u anafilaktojd.
English: 3 Produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Maltese: 3 Manifatturat f'ċelluli tal-ħmira (Saccharomyces cerevisiae) b'teknoloġija rikombinanti tad-DNA
English: 1 ml of suspension in a vial (type I glass) for 2 doses with a plunger stopper (rubber butyl) - pack size of
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 1 ml ta' suspensjoni fi fjala (ħġieġ tat-tip I) għal 2 dożi magħluqa bi planġer (lastku butyl)- pakkett bi fjala
English: not less than 30 IU not less than 60 IU not less than 4 IU 10 micrograms
Maltese: UI mhux anqas minn 4 UI 10 mikrogrammi
English: GlaxoSmithKline d.o.o.
Maltese: GlaxoSmithKline ehf.
English: Тел.
Maltese: FIL-VINA.
English: The administration of a booster dose with trivalent DTP vaccine is recommended before the end of the second year of life.
Maltese: Huwa rakkommandat li tingħata doża ta' rinforz bil-vaċċin DTP trivalenti qabel mat-tarbija tagħlaq sentejn.
English: 0.26 milligrams Al3+
Maltese: 0.26 milligrammi Al3+
English: In clinical studies, Tritanrix HepB has been administered simultaneously with oral polio vaccine (OPV) and Haemophilus influenzae type b (Hib) vaccine.
Maltese: Waqt studji kliniċi, Tritanrix HepB ingħata flimkien ma' vaċċin orali tal-poljo (OPV) u vaċċin talHaemophilus influenzae tat-tip b (Hib).
English: 0.37 milligrams Al3+
Maltese: 0.37 milligrammi Al3+
English: Tel: + 420 2 22 00 11 11 gsk.czmail@gsk.com
Maltese: Tel: +421 (0)2 48 26 11 11 recepcia.sk@gsk.com
English: FURTHER INFORMATION What Tritanrix HepB contains - The active substances contained in 1 dose (0.5 ml) are:
Maltese: - Is-sustanza attiva li fiha doża waħda (0.5 ml) hija:
English: Belgium
Maltese: Polska
English: Side effects that occurred during clinical trials with Tritanrix HepB were as follows:
Maltese: Effetti sekondarji li ġraw waqt provi kliniċi bi Tritanrix HepB kienu kif ġej:
English: The coughing is often accompanied by a “whooping” sound, hence the common name “whooping cough”.
Maltese: Is-sogħla ħafna drabi ġġib magħha ħoss qawwi ta' tħarħir (whooping), mnejn ġie l-isem komuni ‘whooping cough' (sogħla konvulsiva).
English: Tritanrix HepB is indicated for active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks onwards (see section 4.2).
Maltese: Tritanrix HepB huwa indikat għal tilqim attiv kontra d-difterite, it-tetnu, il-pertussis u l-epatite B (HBV) fittrabi minn sitt ġimgħat 'l quddiem (ara sezzjoni 4.2).
English: MARKETING AUTHORISATION HOLDER GlaxoSmithKline Biologicals s.a. rue de l'Institut 89
Maltese: FIS-SUQ GlaxoSmithKline Biologicals s.a.
English: Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours.
Maltese: Kollass jew stat li jixbaħ lil xokk (episodju ipotoniku-iporisponsiv) fi żmien 48 siegħa.
English: Tritanrix HepB contains a hepatitis B component, to provide protection against disease caused by hepatitis B virus.
Maltese: Tritanrix HepB fiha komponent ta' l-epatite B biex tagħti protezzjoni kontra l-marda ikkawżata permezz talvirus ta' l-epatite B.
English: Hypersensitivity after previous administration of diphtheria, tetanus, pertussis or hepatitis B vaccines.
Maltese: Sensittività eċċessiva wara amministrazzjoni preċedenti ta' vaċċini tad-difterite, tetnu, pertussis jew epatite
English: • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination
Maltese: • fi trabi mwieldin ħafna qabel iż-żmien (fi jew qabel it-28 ġimgħa ta' tqala) jista' jkun hemm perjodi itwal minn normal bejn nifs u ieħor għal 2-3 ijiem wara t-tilqim
English: Tritanrix HepB suspension for injection Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Maltese: Titanrix HepB suspensjoni għall-injezzjoni Vaċċin (adsorbit) tad-difterite (D), tetnu (T), pertussis (ċellula sħiħa) (Pw) u epatite B (rDNA) (HBV)
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Maltese: Ir-riskju potenzjali ta' waqfien tan-nifs għal xi ħin u l-bżonn ta' monitoraġġ respiratorju għal 48-72 siegħa, għandhom jiġu kkunsidrati meta l-kors ta' tilqim primarju jingħata lit-trabi mwieldin ħafna qabel iż-żmien (twieldu ≤ 28 ġimgħa ta' tqala) u speċjalment f'dawk li diġà kellhom immaturità respiratorja.
English: 0.5 ml of suspension in a vial (type I glass) with a plunger stopper (rubber butyl) - pack size of 1.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 0.5 ml ta' suspensjoni fi fjala (ħġieġ tat-tip I) magħluqa bi planġer (lastku butyl)- pakkett bi fjala waħda.
English: Tritanrix HepB is for deep intramuscular injection, preferably in the anterolateral thigh.
Maltese: Tritanrix HepB qiegħed għal injezzjoni ġol-muskolu fil-fond, preferibbilment fil-koxxa anterolaterali.
English: Tritanrix HepB suspension for injection, multidose Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Maltese: Titanrix HepB suspensjoni għall-injezzjoni, ħafna dożi Vaċċin (adsorbit) tad-difterite (D), tetnu (T), pertussis (ċellula sħiħa) (Pw) u epatite B (rDNA) (HBV)
English: The incidences are presented below:
Maltese: Tilqim ta' rinforz:
English: DTPw-HBV vaccine
Maltese: TA' PRODOTTI MEDIĊINALI MHUX
English: Diphtheria (D), tetanus (T), pertussis (whole cell) (Pw) and hepatitis B (rDNA) (HBV) vaccine (adsorbed)
Maltese: Vaċċin (adsorbit) tad-difterite (D), tetnu (T), pertussis (ċellula sħiħa) (Pw) u epatite B (rDNA) (HBV)
English: Tritanrix HepB is available in pack of 1.
Maltese: Tritanrix HepB huwa disponibbli f'pakkett bi fjala waħda.
English: Method of administration
Maltese: A MANIFATTURI
English: Important information about some of the ingredients of Tritanrix HepB This medicinal product contains thiomersal as a preservative and it is possible that your child may experience an allergic reaction.
Maltese: Informazzjoni importanti dwar xi wħud mill-ingredjenti ta' Tritanrix HepB Dan il-prodott mediċinali fih thiomersal bħala preservattiv u huwa possibbli li ibnek/bintek ikollu/ikollha reazzjoni allerġika.
English: EXP: MM/YYYY
Maltese: TWISSIJA(IET) SPEĊJALI
English: Make sure your child finishes the complete vaccination course of three injections.
Maltese: Jista jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għall-skop kummerċjali.
English: EXPIRY DATE
Maltese: TAL-PRODOTT
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/014/001
Maltese: NUMRU(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/014/002
English: What Tritanrix HepB looks like and contents of the pack
Maltese: Id-Dehra ta' Tritanrix HepB u l-kontenuti tal-pakkett:
English: HIV infection is not considered as a contra-indication for diphtheria, tetanus, pertussis and HBV vaccination.
Maltese: Infezzjoni ta' l-HIV m'hijiex meqjusa bħala kontra-indikazzjoni għat-tilqim kontra d-difterite, tetnu, pertussis u l-HBV.
English: • serum sickness like disease (a hypersensitivity reaction to the administration of a foreign serum with symptoms like fever, swelling, skin rash, enlargement of the lymph nodes)
Maltese: • marda tixbaħ lil serum sickness (reazzjoni ta' ipersensittività għall-amministrazzjoni ta' serum barrani b'sintomi ta' deni, nefħa, raxx fil-ġilda u tkabbir tal-glandoli limfatiċi)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONODOSE VIAL
Maltese: Aħżen fil-pakkett oriġinali sabiex tilqa' mid-dawl
English: EMA/467741/2019 EMEA/H/C/004162
Maltese: EMA/425446/2019 EMA/H/C/004162
English: Further information on Ebymect can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ebymect.
Maltese: ema.europa.eu/medicines/human/EPAR/ebymect.
English: Ebymect received a marketing authorisation valid throughout the EU on 15 November 2015.
Maltese: Ebymect ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-15 ta' Novembru 2015.
English: Ebymect is used:
Maltese: Ebymect jintuża:
English: Other information about Ebymect
Maltese: Informazzjoni oħra dwar Ebymect
English: Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
Maltese: Id-dapagliflożina ilha awtorizzata fl-Unjoni Ewropea (UE) bħala Forxiga sa mill-2012;
English: Ebymect is available as tablets containing 5 mg of dapagliflozin with 850 mg of metformin and as 5 mg of dapagliflozin with 1,000 mg of metformin.
Maltese: Ebymect jiġi bħala pilloli li fihom 5 mg ta' dapagliflożina b' 850 mg ta' metformina u bħala 5 mg ta' dapagliflożina b' 1.000 mg ta' metformina.
English: What are the risks associated with Ebymect?
Maltese: X'inhuma r-riskji assoċjati ma' Ebymect?
English: It contains the active substances dapagliflozin and metformin.
Maltese: Fih iż-żewġ sustanzi attivi, id-dapagliflożina u l-metformina.
English: • dapagliflozin blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Maltese: id-dapagliflożina taħdem billi timblokka proteina fil-kliewi msejħa kotrasportatur 2 ta' sodium-glucose (SGLT2).
English: Ebymect contains two different active substances, which work in different ways:
Maltese: Ebymect fih żewġ sustanzi attivi differenti, li jaħdmu b'modi differenti:
English: In one main study, when dapagliflozin was used at a dose of 5 mg twice a day in addition to metformin (the same combination as in Ebymect), it decreased HbA1c (glycosylated haemoglobin) levels by 0.65% after 16 weeks, compared with a reduction of 0.30% with placebo (a dummy treatment) and metformin.
Maltese: Fi studju ewlieni wieħed, meta d-dapagliflożina ntużat f'doża ta' 5 mg darbtejn kuljum flimkien malmetformina (l-istess kombinazzjoni bħal f'Ebymect), hija naqqset il-livelli ta' HbA1c (emoglobina glikosilata) b'0.65 % wara 16-il ġimgħa, meta mqabbel ma' tnaqqis ta' 0.30 % bi plaċebo (kura finta) u l-metformina.
English: Further studies confirmed that different doses of dapagliflozin with metformin decreased HbA1c more than placebo plus comparable doses of metformin, and that dapagliflozin plus metformin was at least as effective in reducing HbA1c levels as the diabetes medicine glipizide (a type of medicine known as a sulphonylurea).
Maltese: Studji oħrajn kkonfermaw li dożi differenti tad-dapagliflożina mal-metformina naqqsu HbA1c iktar minn plaċebo flimkien ma' dożi komparabbli tal-metformina, u li d-dapagliflożina flimkien mal-metformina kienet tal-inqas effikaċi daqs il-mediċina kontra d-dijabete glipizide (tip ta' mediċina magħrufa bħala sulfonilurea) fit-tnaqqis tal-livelli ta' HbA1c.
English: Two other studies showed that dapagliflozin taken with metformin and another diabetes medicine, sitagliptin or insulin, for 24 weeks, further decreased HbA1c: the dapagliflozin combination decreased HbA1c levels by 0.40% more than placebo and metformin when added to sitagliptin, and by 0.61% more than placebo and metformin when added to insulin.
Maltese: Żewġ studji oħrajn urew li d-dapagliflożina meta tittieħed mal-metformina u mediċina oħra kontra ddijabete, sitagliptin jew l-insulina, għal 24 ġimgħa, naqqset iktar HbA1c: il-kombinazzjoni taddapagliflożina naqqset il-livelli ta' HbA1c b'0.40 % iktar minn plaċebo u l-metformina meta miżjuda ma' sitagliptin, u b'0.61 % iktar minn plaċebo u l-metformina meta miżjuda mal-insulina.
English: Dapagliflozin in combination with metformin was evaluated in 6 main studies involving 3,200 adults with type 2 diabetes.
Maltese: Id-dapagliflożina flimkien mal-metformina kienet evalwata f'sitt studji ewlenin li fihom ħadu sehem 3,200 adult b'dijabete tat-tip 2.
English: As for all medicines, data on the use of Ebymect are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Ebymect hija ssorveljata kontinwament.
English: A long-term study, involving over 17,000 patients with type 2 diabetes, looked at the effects of dapagliflozin on cardiovascular (heart and circulation) disease.
Maltese: Studju fit-tul, li jinvolvi aktar minn 17,000 pazjent bid-dijabete tat-tip 2, ħares lejn l-effetti ta' dapagliflożina fuq mard kardjovaskulari (tal-qalb u taċ-ċirkolazzjoni).
English: • patients with any form of acute metabolic acidosis (build up of acid in the blood), such as diabetic ketoacidosis (high blood levels of acids called ketones) or lactic acidosis (build-up of lactic acid in the body);
Maltese: f'pazjenti li jbatu minn kwalunkwe forma ta' aċidożi metabolika akuta (akkumulazzjoni ta' aċidu fiddemm), bħal ketoaċidożi dijabetika (livelli ta' aċidi fid-demm għoljin imsejħa ketoni) jew aċidożi lattika (akkumulazzjoni ta' aċidu lattiku fil-ġisem);
English: • patients with diabetic pre-coma (a dangerous condition that can occur in diabetes);
Maltese: f'pazjenti bi prekoma dijabetika (kondizzjoni perikoluża li tista' sseħħ fid-dijabete);
English: Ebymect is a diabetes medicine that is used, together with diet and exercise in adults with type 2 diabetes.
Maltese: Ebymect huwa mediċina kontra d-dijabete li tintuża, flimkien ma' dieta u eżerċizzju f'adulti bid-dijabete tat-tip 2.
English: • patients with reduced liver function;
Maltese: f'pazjenti b'funzjoni tal-fwied mnaqqsa;
English: Ebymect (dapagliflozin / metformin)
Maltese: Għaliex Ebymect ġie awtorizzat fl-UE?
English: The most common side effects with Ebymect (which may affect more than 1 in 10 people) are hypoglycaemia (when used together with insulin or a sulphonylurea) and gastrointestinal symptoms (symptoms affecting the stomach and gut).
Maltese: L-effetti sekondarji l-aktar komuni b'Ebymect (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma ipogliċemija (meta jintuża flimkien mal-insulina jew ma' sulfonilurea) u sintomi gastrointestinali (sintomi li jaffettwaw l-istonku u l-imsaren).
English: For the full list of side effects with Ebymect, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Ebymect, ara lfuljett ta' tagħrif.
English: How is Ebymect used?
Maltese: Kif jaħdem Ebymect?
English: As blood is filtered by the kidneys, SGLT2 stops glucose in the bloodstream from being passed out into the urine.
Maltese: Hekk kif id-demm jiġi ffiltrat mill-kliewi, SGLT2 iwaqqaf lill-glukożju fil-fluss tad-demm milli jgħaddi fl-urina.
English: HbA1c is a substance in the blood which gives an indication of how well the blood glucose is controlled.
Maltese: HbA1c hija sustanza fid-demm li tagħti indikazzjoni ta' kemm il-glukożju fid-demm ikun ikkontrollat tajjeb.
English: By blocking the action of SGLT2, dapagliflozin causes the kidneys to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Maltese: Billi timblokka l-azzjoni ta' SGLT2, id-dapagliflożina tikkawża lill-kliewi biex jgħaddu aktar glukożju fl-urina, u b'hekk jitnaqqsu l-livelli ta' glukożju fid-demm.
English: This authorisation was based on the authorisation granted to Xigduo in 2014 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija għal Xigduo fl-2014 (“kunsens infurmat”).
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Blitzima.
Maltese: Qabel ma tingħata Blitzima, inti se tingħata mediċini oħra (medikazzjoni ta' qabel) sabiex jiġu evitati jew jitnaqqsu l-effetti sekondarji possibbli.
English: Egis Gyógyszergyár Zrt.
Maltese: Magyarország Egis Gyógyszergyár Zrt.
English: EGIS SLOVAKIA spol.
Maltese: Slovenská republika EGIS SLOVAKIA spol.
English: Ελλάδα ΒΙΑΝΕΞ Α.Ε.
Maltese: ΒΙΑΝΕΞ Α.Ε.
English: Τηλ: +30 210 8009111 - 120
Maltese: Τηλ: +30 210 8009111 - 120 España
English: ORR, % CR,%
Maltese: ORR,%
English: Azathioprine 59 56 52 50 47 47 44 44 42 41 40 39 36 34 0 Rituximab 58 56 56 56 55 54 54 54 54 54 54 54 52 50 0
Maltese: Rituximab 58 56 56 56 55 54 54 54 54 54 54 54 52 50 0
English: p-value (Wald test, not adjusted)
Maltese: valur p (test ta'Wald, mhux aġġustat)
English: Astro-Pharma GmbH Tel: +43 1 97 99 860
Maltese: Ö sterreich Astro-Pharma GmbH Tel: +43 1 97 99 860
English: Blitzima contains the active substance “rituximab”.
Maltese: Blitzima fih is-sustanza attiva “rituximab”.
English: 2 vials
Maltese: 2 Kunjetti
English: Table 12 Clinical response outcomes at primary endpoint in Trial 1 (ITT population) Outcome†
Maltese: Tabella 12 Riżultati tar-rispons kliniku fil-ħin tal-punt finali primarju fi Prova 1 (popolazzjoni ITT) Riżultat†
English: Musculoskeletal disorders arthralgia / musculoskeletal pain, osteoarthritis, bursitis
Maltese: Disturbi muskoluskeletriċi artralġja / uġigħ muskolu-skeletrali, osteoartrite, bursite
English: Blitzima is indicated in adults for the following indications:
Maltese: Blitzima huwa indikat f'adulti għall-indikazzjonijiet li ġejjin:
English: Duration of response * Disease free survival (DFS)**
Maltese: Tul tar-rispons* Sopravivenza ħielsa mill-marda (DFS)**
English: • The active ingredient in Blitzima is called rituximab.
Maltese: • Is-sustanza attiva fi Blitzima hija msejħa rituximab.
English: Mundipharma CVA Tél/Tel: + 32 15 45 1180
Maltese: Luxembourg/Luxemburg Mundipharma CVA Tél/Tel: + 32 15 45 1180
English: Median EFS: 36 Not reached p < 0.0001
Maltese: EFS medjan: 36 Ma ntlaħaqx p < 0.0001
English: Event free survival Response rate (CR, nPR, or PR)
Maltese: Sopravivenza mingħajr avveniment Rata ta' rispons (CR, nPR, jew PR)
English: Concentrate for solution for infusion 500 mg / 50 mL
Maltese: Konċentrat għal soluzzjoni għal infużjoni 500 mg / 50 mL
English: However, the possible risk for the development of solid tumours cannot be excluded at this time.
Maltese: riskju għall-iżvilupp ta' tumuri solidi ma jistax jiġi eskluż.
English: Blitzima is a biosimilar medicinal product.
Maltese: Blitzima huwa prodott mediċinali bijoloġiku simili.
English: Azathioprine 0 0 3 3 5 5 8 8 9 9 9 10 13 15 17 Rituximab 0 0 0 0 1 1 1 1 1 1 1 1 3 3 3 Number of subjects at risk
Maltese: Rituximab 0 0 0 0 1 1 1 1 1 1 1 1 3 3 3
English: Rituximab + Prednisone N=38
Maltese: Rituximab + doża baxxa ta' prednisone (n = 38)
English: % SF‐36 PHS MCID Mean change in SF‐36 MHS
Maltese: PHS SF-36 PHS MCID% Bidla medja f'SF-36
English: Persistent depressive disorder Major depression Irritability
Maltese: Disturbi Psikjatriċi Disturb depressiv persistenti Depressjoni kbira Irritabilità
English: Granulomatosis with polyangiitis and microscopic polyangiitis Blitzima, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener's) (GPA) and microscopic polyangiitis (MPA).
Maltese: Granulomatosi b'polianġite u polianġite mikroskopika Blitzima, flimkien ma' glukokortikojdi, huwa indikat għat-trattament ta' pazjenti adulti bi granulomatosi b'polianġite (ta' Wegener) (GPA - granulomatosis with polyangiitis) attiva u severa u polianġite mikroskopika (MPA - microscopic polyangiitis).
English: A total of 6/34 (18%) of rituximab-treated patients from the maintenance therapy clinical trial developed ADA.
Maltese: Total ta' 6/34 (18%) tal-pazjenti ttrattati b'rituximab mill-prova klinika dwar terapija ta' manteniment żviluppaw ADA.
English: • respiratory failure
Maltese: Sistema respiratorja
English: Concentrate for solution for infusion 100 mg / 10 mL
Maltese: Konċentrat għal soluzzjoni għal infużjoni 100 mg / 10 mL
English: Number of responders (response rate [%]) a p-value is from Fisher's exact test with mid-p correction b 95% confidence interval is corrected Newcombe interval
Maltese: Numru ta' individwi li rrispondew (rata ta' rispons [%]) valur p huwa minn test eżatt ta' Fisher b'korrezzjoni mid-p b intervall ta' kunfidenza ta' 95% huwa intervall ta' Newcombe kkoreġut
English: Blitzima is indicated for the treatment of patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.
Maltese: Blitzima huwa indikat għall-kura ta' pazjenti b'limfoma mhux ta' Hodgkin ta ċ-ċellula B kbira mifruxa pożittiva għal CD20 flimkien ma' kimoterapija CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone).
English: The mean Cmax (N=15) was 408 µg/mL (range, 97 - 764 µg/mL) after the fifth 500 mg/ m2 infusion and the mean terminal half-life was 32 days (range, 14 - 62 days).
Maltese: Cmax medja (N = 15) kienet ta' 408 µg/mL (firxa, 97-764 µg/mL) wara l-ħames infużjoni ta' 500 mg/ m u l-half-life terminali medja kienet ta' 32 ġurnata (firxa, 14-62 ġurnata).