FrancophonIA/ELRC3.0 huggingface dataset:
English: Granulocyte colony stimulating factors may be administered for haematologic toxicity according to local standard practice.
Maltese: Fatturi stimulanti tal-kolonja ta' granuloċiti jistgħu jingħataw għal tossiċità ematoloġika skont il-prattika lokali standard.
English: Once the symptoms of the toxicity have resolved, Bortezomib Hospira treatment may be re-initiated at a 25% reduced dose (1.3 mg/m2 reduced to 1.0 mg/m2, 1.0 mg/m2 reduced to 0.7 mg/m2).
Maltese: Meta s-sintomi tat-tossiċità jkunu marru, il-kura b'Bortezomib Hospira tista' terġa' tibda tingħata b'doża mnaqqsa b'25% (1.3 mg/m2 imnaqqsa għal 1.0 mg/m
English: Type I glass 10 ml vial with a rubber stopper and an aluminium seal containing 2.5 mg, 3 mg or 3.5 mg bortezomib.
Maltese: Kunjett ta' 10 ml tal- ħġieg ta' tip I, b'tapp tal-lastku u siġill tal-aluminju li fih 2.5 mg, 3 mg jew 3.5 mg bortezomib
English: Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction*
Maltese: Insuffiċjenza kardijaka (inkluż ventrikulari tax-xellug u tallemin)*, Iskemija mijokardijaka, Funzjoni ħażina talventrikulu*
English: • Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg can be administered both intravenously and subcutaneously
Maltese: • Bortezomib Hospira 1 mg, 2.5 mg, 3 mg u 3.5 mg jista' jingħata kemm ġol-vina u anke taħt il-ġilda
English: Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex*
Maltese: Sepsi (inkluż xokk settiku)*, Herpes zozter (inkluż mifrux u tal-għajn), Infezzjoni bil-virus tal-herpes*, Infezzjonijiet bilbatterji*, Infezzjoni fil-passaġġ tan-naħa ta' fuq/taħt tan-nifs*, Infezzjoni bil-fungu*, Herpes simplex*
English: Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Maltese: Qed tintuża l-istima Mantel-Haenszel tal-proporzjon ta' probabilità komuni għal tabelli stratifikati, bir-riskji IPI u l-istadju tal-marda bħala fatturi ta' stratifikazzjoni.
English: Bortezomib Hospira therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL.
Maltese: It-terapija b'Bortezomib Hospira m'għandhiex tingħata sa ġimagħtejn sakemm il-pazjent ikollu ANC ta'  750 ċellula/μL u għadd ta' plejtlits ta'  25,000 ċellula/μL.
English: collapse
Maltese: Tqala
English: Each vial contains 2.5 mg bortezomib (as a mannitol boronic ester).
Maltese: Kull kunjett fih 2.5 mg ta' bortezomib (bħala mannitol boronic ester).
English: • Benign cysts
Maltese: • Ċesti beninni
English: Common Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality* Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*,
Maltese: Diżidrazzjoni, Ipokalemija*, Iponatremija*, Żokkor fid-demm abnormali*, Ipokalċemija*, Abnormalità fl-enzimi*
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
Maltese: Inċidenza ta' newtropatija periferali fl-istudju LYM-3002 skont it-tossiċità u l-waqfien tat-trattament minħabba newropatija periferali
English: #, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection*
Maltese: #, Bakteremja (anke ta' staphylococcus), Hordeolum, Influwenza, Ċellulite, Infezzjoni marbut mal-apparat, Infezzjoni tal-ġilda*, Infezzjoni tal-widna*, Infezzjoni ta' Staphylococcus *, Infezzjoni fis-snien*
English: Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Maltese: Immaġini tal-moħħ preferibbilment Immaġini bir-Riżonanza Manjetika (MRI, Magnetic Resonance Imaging), tintuża biex tikkonferma d-dijanjosi.
English: Limited information on bortezomib retreatment in relapsed multiple myeloma is available.
Maltese: Informazzjoni ristretta disponibbli dwar it-trattament mill-ġdid bi bortezomib f'majeloma multipla li rkadiet
English: Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of bortezomib in dual and triple combinations with other chemotherapeutic agents, as induction therapy prior to stem cell transplantation in patients with previously untreated multiple myeloma.
Maltese: III, bit-tikketta tingħaraf (IFM2005-01, MMY-3010) saru biex juru s-sigurtà u l-effikaċja ta' bortezomib f'kombinazzjonijiet doppji u trpliċi ma' sustanzi kimoterapewtiċi oħra, bħala terapija ta' induzzjoni qabel it-trapjant ta' ċelluli steminali f'pazjenti b'majeloma multipla li ma ġietx trattata qabel.
English: Although in patients aged ≥ 75 years, both BR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Maltese: Għalkemm f'pazjenti li kellhom ≥ 75 sena, kemm BR-CAP kif ukoll R-CHOP kienu ttollerati anqas, ir-rata ta' każijiet avversi serji fil-gruppi ta' BR-CAP kienet ta' 68%, meta mqabbla ma' 42 % fil-grupp ta' R-CHOP.
English: Common Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic
Maltese: Pankreatite (anke kronika)*, Ematemesi, Nefħa tax-xofftejn*, Sadd gastrointestinali (li jinkludi sadd tal-musrana ż-żgħira , l-ileju)*, Skonfort fladdoma, Postumetti*, Enterite*, Gastrite*, Emorraġija ġenġivali, Mard ta' refluss gastroesofaġeali*, Kolite (li jinkludi clostridium difficile colite)*, Kolite iskemika
English: Median survival for the B+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Maltese: B+M+P kienet 56.4 xhur ikkumparat ma' 43.1 fil-grupp ta' kura
English: Bortezomib combination treatment with dexamethasone In the absence of any direct comparison between bortezomib and bortezomib in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of bortezomib in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the bortezomib monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Maltese: Trattament ta' kombinazzjoni ta' bortezomib ma' dexamethasone Fin-nuqqas ta' tqabbil dirett bejn bortezomib u bortezomib f'kombinazzjoni ma' dexamethasone f'pazjenti b'majeloma multipla progressiva, saret analiżi statistika ta' tqabbil bejn pari sabiex jitqabblu riżultati mill-grupp mhux magħżul b'mod każwali ta' bortezomib flimkien ma' dexamethasone (l-istudju b'tikketta li tingħaraf ta' Fażi
English: #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
Maltese: #, Akne*, Infafet, Disturb fil-piġmentazzjoni*
English: Very Common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Maltese: Sintomi ta' nawsja u rimettar*, Dijarea*, Stomatite*, Stitikezza
English: Hepatitis B Virus (HBV) reactivation and infection
Maltese: Riattivazzjoni tal-Virus tal-Epatite B u infezzjoni fil-Virus tal-Epatite B (HBV - Hepatitis B Virus) Limfoma taċ-ċellola ‘mantle'
English: Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded.
Maltese: Pazjenti bi grad ta' linja bażi ta' newropatija periferali ta' ≥ 2 jew b'għadd ta' plejtlits ta' <50,000/µl kienu esklużi.
English: Lymphadenopathy, Haemolytic anaemia
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: 9/l or ANC ≤ 0.75 x Bortezomib Hospira therapy should be withheld • If platelet counts ≤ 30 x 10
Maltese: • Jekk l-għadd tal-plejtlits ikun 30  109/l jew l-ANC ikun 0.75 x 10
English: 1.1 Preparation of the 1 mg vial: carefully add 0.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: 1.1. Preparazzjoni tal-kunjett ta' 1 mg: b'attenzjoni żid 0.4 mL ta' 9 mg/mL (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab Bortezomib Hospira billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: VIAL
Maltese: Kunjett
English: Each carton of 1 mg Bortezomib Hospira contains a glass 5 ml siliconised vial with a rubber stopper and an aluminium seal.
Maltese: Kull kartuna ta' 1 mg Bortezomib Hospira fiha kunjett silikonizzat tal-ħġieġ ta' 5 mL b'tapp tal-lastku u siġill tal-aluminju.
English: RR (Post-transplant) CR+nCR
Maltese: RR (Wara t-trapjant) CR+nCR
English: Common Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache*
Maltese: Newropatija motorili*,Telf ta' kuxjenza (li jinkludi sinkope), Sturdament*, Disgewsja*, Letarġija, Uġigħ ta' ras*
English: Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy
Maltese: L-inċidenza ta' newropatija periferali (PN- peripheral neuropathy) waqt it-trattament ta' induzzjoni skont it-tossiċità u l-waqfien tat-trattament minħabba newropatija periferali
English: • Shivering
Maltese: • Mewt
English: • Lump in the eyelid (chalazion), red and swollen eyelids
Maltese: • Boċċa fil-kappell tal-għajn (chalazion), kappell tal-għajn aħmar u minfuħ
English: • Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
Maltese: • Infezzjonijiet li jinkludu infezzjonijiet fl-apparat awrinarju, influwenza, infezzjonijiet bil-virus ta' herpes, infezzjonijiet fil-widnejn u ċellulite
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Maltese: Newropatija periferali ta' Grad  3 seħħ f'6 % tal-pazjenti fil-grupp li ngħata l-kura taħt il-ġilda meta mqabbel ma' 16 % fil-grupp li ngħata l-kura ġol-vina (p=0.0264).
English: You may also be given bortezomib together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Maltese: Tista' tingħata bortezomib flimkien ma' mediċini pegylated liposomal dxorubicin jew dexamethasone.
English: Bortezomib Hospira 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3.5 mg powder for solution for injection must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Bortezomib Hospira 3.5 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett ta' 10 ml ta' Bortezomib Hospira 3.5 mg trab għal soluzzjoni għall-injezzjoni jrid ikun rikostitwit b'attenzjoni bi 3.5 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni, billi tintuża siringa tad-daqs xieraq, mingħajr ma jitneħħa t-tapp tal-kunjett.
English: Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with Bortezomib Hospira.
Maltese: Persuni li jġorru l-epatite B u pazjenti bi storja ta' epatite B għandhom jiġu mmonitorati mill-qrib għal sinjali klinici u tal-laboratorju ta' infezzjoni attiva b'HBV waqt u wara trattament b'rituximab flimkien ma' Bortezomib Hospira.
English: Bortezomib Hospira therapy should be withheld when the platelet count is < 25,000/μl or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/μl (see section 4.2).
Maltese: Terapija b'Bortezomib Hospira għandha titwaqqaf meta l-għadd ta' plejtlits ikun < 25,000/l jew, filkaż ta' għoti flimkien ma' melphalan u prednisone meta l-għadd tal-plejtlits ikun ta' ≤ 30,000/l (ara sezzjoni 4.2).
English: Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Maltese: Reazzjonijiet avversi serji rrappurtati b'mod mhux komuni waqt trattament bi bortezomib jinkludu insuffiċjenza tal-qalb, sindromu ta' lisi tat-tumur, pressjoni għolja fil-pulmun, sindromu ta' enċefalopatija riversibbli posterjuri, disturbi pulmonari akuti diffużi u infiltrattivi, u b'mod rari newtropatija awtonomika.
English: Bortezomib Hospira 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3.5 mg powder for solution for injection must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Bortezomib Hospira 3.5 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett ta' 10 ml ta' Bortezomib Hospira 3.5 mg trab għal soluzzjoni għall-injezzjoni jrid ikun rikostitwit b'attenzjoni bi 1.4 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride għallinjezzjoni, billi tintuża siringa ta' 1 ml, mingħajr ma jitneħħa t-tapp tal-kunjett.
English: Intravenous use: Add 2.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Maltese: Żid 2.5 ml ta' 0.9% Sodium Chloride sabiex tagħmel konċentrazzjoni finali ta'1 mg/ml.
English: Such changes may be reversible upon discontinuation of bortezomib (see section 4.8).
Maltese: Ġew irrappurtati każijiet b'mod mhux komuni ta' sadd fil-musrana (ara sezzjoni 4.8).
English: • different reconstitution requirements for intravenous (IV) or subcutaneous (SC) use
Maltese: • ħtiġijiet ta' rikostituzzjoni differenti għall-użu ġol-vina (IV) jew taħt il-ġilda (SC)
English: You might receive up to 8 cycles (24 weeks).
Maltese: Tista' tirċievi sa 8 ċikli (24 ġimgħa)
English: The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Maltese: It-TTP medjan kien ta' 6.5 għall-monoterapija ta' bortezomib meta mqabbel ma' 9.3 xhur għall-pazjenti fuq terapija kkombinata ta' bortezomib flimkien ma' pegylated liposomal doxorubicin.
English: The other ingredient is mannitol (E421).
Maltese: Is-sustanza mhux attiva l-oħra hija mannitol (E 421).
English: Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each Bortezomib Hospira treatment cycle.
Maltese: Kemm melphalan kif ukoll prednisone għandhom jingħataw mill-ħalq fil-ġranet 1, 2, 3 u 4 tal-ewwel ġimgħa ta' kull ċiklu ta' kura ta' Bortezomib Hospira.
English: Intrathecal administration
Maltese: Infiltrazzjoni limfoċitika
English: Overall complete response (CR+CRu)
Maltese: Rispons sħiħ globali (CR+CRu)
English: • Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be
Maltese: absolute neutrophils count) għandu jkun ≥ 1,500 ċellula/ μL
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil tal-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: The following medicinal products are given on day 1 of each bortezomib 21-day treatment cycle as intravenous infusions:
Maltese: Il-prodotti mediċinali li ġejjin jingħataw fil-jiem 1 ta' kull wieħed miċ-ċiklu ta' trattament ta' 21 jum ta' bortezomib bħala infużjonijiet għal ġol-vini:
English: However, the chemical and physical in-use stability has been demonstrated for 8 hours at 5°C and 25°C stored in the original vial and/or a syringe.
Maltese: Madankollu, intwera li l-istabbiltà kimika u fiżika waqt l-użu tas-soluzzjoni rrikostitwita hija ta' 8 sigħat f'temperatura ta' 5°C u 25°C maħżuna fil-kunjett oriġinali u/jew ġo siringa.
English: Bortezomib Hospira 3 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3 mg powder for solution for injection must be carefully reconstituted with 1.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Bortezomib Hospira 3 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett ta' 10 ml ta' Bortezomib Hospira 3 mg trab għal soluzzjoni għall-injezzjoni jrid ikun rikostitwit b'attenzjoni bi 1.2 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni, billi tintuża siringa tad-daqs xieraq, mingħajr ma jitneħħa t-tapp tal-kunjett.
English: Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Maltese: Newtropenija periferika kienet tinkludi t-termini ppreferruti: newropatija tas-sensazzjoni periferali, newropatija periferali, newropatija mmotorili periferali, u newropatija sensimotorja periferali.
English: Bortezomib Hospira 2.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 2.5 mg powder for solution for injection must be carefully reconstituted with 2.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Bortezomib Hospira 2.5 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett ta' 10 ml ta' Bortezomib Hospira 2.5 mg trab għal soluzzjoni għall-injezzjoni jrid ikun rikostitwit b'attenzjoni bi 2.5 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni, billi tintuża siringa tad-daqs xieraq, mingħajr ma jitneħħa t-tapp tal-kunjett.
English: Each vial contains 3 mg bortezomib (as a mannitol boronic ester).
Maltese: Kull kunjett fih 3 mg ta' bortezomib (bħala mannitol boronic ester).
English: Preparation of the 3 mg vial: carefully add 1.2 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: Preparazzjoni tal-kunjett ta' 3 mg: b'attenzjoni żid 1.2 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab Bortezomib Hospira billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: Bortezomib Hospira 3 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 3 mg powder for solution for injection must be carefully reconstituted with 3 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Bortezomib Hospira 3 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett ta' 10 ml ta' Bortezomib Hospira 3 mg trab għal soluzzjoni għall-injezzjoni jrid ikun rikostitwit b'attenzjoni bi 3 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni, billi tintuża siringa tad-daqs xieraq, mingħajr ma jitneħħa t-tapp tal-kunjett.
English: Rare side effects (may affect up to 1 in 1,000 people) Blood clot in small blood vessels (thrombotic microangiopathy)
Maltese: Effetti sekondarji rari (li jistgħu jaffettwaw sa persuna 1 f'1,000)
English: Common Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough* Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage
Maltese: Emboliżmu pulmonarju, Effużjoni plewrali, Edema pulmonari (li tista' tkun akuta), Emorraġija alveolari pulmonari
English: Subcutaneous use: Add 0.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Maltese: Żid 0.4 mL ta' 0.9% Sodium Chloride sabiex tagħmel konċentrazzjoni finali ta' 2.5 mg/mL.
English: • In cycles 5 to 9, bortezomib is administered once weekly on days 1, 8, 22 and 29.
Maltese: Fiċ-ċikli minn 5 sa 9, bortezomib jingħata darba fil-ġimgħa fil-jiem 1, 8, 22 u 29.
English: Grade 2 with pain or Grade 3 (severe symptoms; limiting self care ADL***)
Maltese: Grad 2 bl-uġigħ jew Grad 3 (sintomi severi; jillimitaw lill-persuna milli tieħu ħsieb lilha nnifisha fl-ADL***)
English: Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal*
Maltese: Livelli ta' gassijiet fid-demm abnormali*, Abnormalità flelettrokardjogramma (li jinkludi żieda fit-titwil ta' QT)*, Proporzjon internazzjonali normalizzat abnormali*, Tnaqqis fil-pH tal-istonku, Aggregazzjoni ta' plejtlits ogħla, Żieda f'Troponin I, Identifikazzjoni u seroloġija tal-vajrus*, Valuri tal-analiżi tal-awrina awrina abnormali*
English: Bortezomib Hospira 3 mg powder for solution for injection Each vial contains 3 mg bortezomib (as a mannitol boronic ester).
Maltese: Bortezomib Hospira 3 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett fih 3 mg ta' bortezomib (bħala mannitol boronic ester).
English: Bortezomib Hospira 2.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Hospira 2.5 mg powder for solution for injection must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Bortezomib Hospira 2.5 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett ta' 10 ml ta' Bortezomib Hospira 2.5 mg trab għal soluzzjoni għall-injezzjoni jrid ikun rikostitwit b'attenzjoni bi 1 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni, billi tintuża siringa tad-daqs xieraq, mingħajr ma jitneħħa t-tapp tal-kunjett.
English: Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: Preparazzjoni tal-kunjett ta' 3.5 mg: b'attenzjoni żid 3.5 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab Bortezomib Hospira billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: Preparazzjoni tal-kunjett ta' 3.5 mg: b'attenzjoni żid 1.4 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab Bortezomib Hospira billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: • If local injection site reactions occur following Bortezomib Hospira injection subcutaneously, either a less concentrated Bortezomib Hospira solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Maltese: • Jekk reazzjonijiet fis-sit lokali tal-injezzjoni jseħħu wara injezzjoni taħt il-ġildab'Bortezomib Hospira huwa rakkomandat li jew tingħata soluzzjoni taħy il-ġilda inqas konċentrata ta' Bortezomib Hospira (1 mg/ml minflok 2.5 mg/ml) jew inkella li taqleb għall-injezzjoni ġol-vina.