FrancophonIA/ELRC3.0 huggingface dataset:
English: NR: Non-responder defined as serum/plasma HCV-RNA positive at the end of a minimum of 12 weeks of treatment.
Maltese: NR: Ma wrewx rispons definit bħala HCV-RNA fis-serum/plażma pożittiv fi tmiem it-12-il ġimgħa ta' kura.
English: (-0.3 for Metavir and -1.2 for Ishak) and stable (-0.1 for Metavir and -0.2 for Ishak) among non-responders.
Maltese: Dan it-tnaqqis kien sinifikanti fost dawk li wrew rispons (-0.3 għal Metavir u -1.2 għal Ishak) u stabbli (-0.1 għal Metavir u -0.2 għal Ishak) fost dawk li ma kellhomx rispons.
English: - Genotoxicity: Rebetol induces genotoxicity (see section 5.3).
Maltese: Rebetol jikkawża effett tossiku fuq il-ġeni (ara sezzjoni 5.3).
English: In a non-comparative trial, 2,293 patients with moderate to severe fibrosis who failed previous treatment with combination alpha interferon/ribavirin were retreated with peginterferon alfa-2b, 1.5 microgram/kg subcutaneously, once weekly, in combination with weight adjusted Rebetol.
Maltese: Fi prova mhux kumparattiva, 2,293 pazjent b'fibrożi moderata għal severa li kienu fallew għall-kura li ngħataw qabel b'taħlita ta' interferon alfa/ribavirin kienu kkurati mill-ġdid b'peginterferon alfa-2b, 1.5 mikrogramma/kg mogħtija taħt il-ġilda, darba fil-ġimgħa, flimkien ma' Rebetol mogħti skont il-piż tal-pazjent.
English: In a juvenile rat toxicity study, pups dosed from postnatal day 7 to 63 with 10, 25 and 50 mg/kg of ribavirin demonstrated a dose-related decrease in overall growth, which was subsequently manifested as slight decreases in body weight, crown-rump length and bone length.
Maltese: Fi studju fuq il-firien dwar l-effett tossiku fil-frieħ, frieħ li ġew iddożati minn jum 7 sa jum 63 wara t-twelid b'10, 25 u 50 mg/kg ta' ribavirin urew tnaqqis ġenerali fit-tkabbir skont id-doża, li wara deher bħala tnaqqis żgħir fil-piż tal-ġisem, fit-tul mill-qorriegħa sal-warrani u fit-tul tal-għadam.
English: Injury, poisoning and procedural complications Common:
Maltese: Korriment, avvelenament u komplikazzjonijiet ta' xi proċedura Komuni:
English: - Men:
Maltese: c:
English: Non-responders to prior therapy with pegylated interferon alpha/ribavirin were less likely to achieve a week 12 response to retreatment than non-responders to non-pegylated interferon alpha/ribavirin (12.4 % vs. 28.6 %).
Maltese: Dawk li ma kellhomx rispons għat-terapija li ngħatat qabel b'interferon alfa pegilat/ribavirin kellhom anqas ċans li jiksbu rispons f'ġimgħa 12 għall-kura mill-ġdid minn dawk li ma kellhomx rispons għal interferon alfa mhux pegilat/ribavirin (12 % vs 28.6 %).
English: Epistaxis, respiratory disorder, respiratory tract congestion, sinus congestion, nasal congestion, rhinorrhea, increased upper airway secretion, pharyngolaryngeal pain, nonproductive cough
Maltese: Ħsibijiet ta' suwiċidju, psikożi, imġiba aggressiva, konfużjoni, aġitazzjoni, rabja, tibdil fil-burdata, imġiba anormali, nervosità, disturbi fl-irqad, tnaqqis fil-libido,
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common:
Maltese: Neoplażmi beninni, malinni u dawk mhux speċifikati (inklużi ċisti u polipi) Komuni:
English: Eleven percent of children (5/46) treated for 24 weeks and 13 % of children (6/48) treated for 48 weeks were observed to have a decrease from pre-treatment baseline > 30 height-for-age percentiles to the end of the 5 year long-term follow-up.
Maltese: Ħdax fil-mija tat-tfal (5/46) ikkurati għal 24 ġimgħa u 13% tat-tfal (6/48) ikkurati għal 48 ġimgħa kien osservat li kellhom tnaqqis ta' > 30 perċentwali tat-tul għall-età mil-linja bażi ta' qabel il-kura sal-aħħar tas-segwitu fit-tul ta' 5 snin.
English: 2220 Heist op den Berg Belgium
Maltese: Heist op den Berg
English: Based on published data, single-dose ribavirin pharmacokinetics was altered (increased AUCtf and Cmax) in patients with renal dysfunction compared with control subjects (creatinine clearance > 90 mL/minute).
Maltese: Abbażi ta' dejta ippublikata, il-farmakokinetika ta' doża waħda ta' ribavirin kienet mibdula (żieda fl-AUCtf u fis-Cmax) f'pazjenti b'funzjoni ħażina tal-kliewi meta mqabbla mal-individwi bħala kontroll (ir-rata li biha titneħħa l-kreatinina > 90 mL/minuta).
English: The pharmacokinetics of Rebetol (dose-normalized) in this trial was similar to those reported in a prior study of Rebetol in combination with interferon alfa-2b in children and adolescent patients and in adult patients.
Maltese: Il-farmakokinetika ta' Rebetol (miġjuba għan-normal skont id-doża) f'din il-prova kienet simili għal dawk irrappurtati fi studju ieħor b'Rebetol li sar qabel f'taħlita ma' interferon alfa-2b f'pazjenti tfal u adolexxenti u f'pazjenti adulti.
English: The overall sustained response rate after a 24-week treatment duration was 50 %.
Maltese: Ir-rata globali tar-rispons sostnut wara kura ta' 24 ġimgħa kienet 50 %.
English: Interferon alfa-2b 3 MIU/m 2 3 times a week (n = 54)
Maltese: 3 MIU/m2 3 darbiet fil-ġimgħa (n = 54)
English: Renal failure*, renal insufficiency*
Maltese: Indeboliment tal-kliewi, insuffiċjenza tal-kliewi*
English: Bitherapy with peginterferon alfa-2b or interferon alfa-2b The safety of Rebetol capsules is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied Rebetol in combination with interferon alfa-2b, two trials studied Rebetol in combination with peginterferon alfa-2b.
Maltese: Ma saru l-ebda studji dwar l-interazzjoni bejn Rebetol u prodotti mediċinali oħra, ħlief għall-peginterferon alfa-2b, interferon alfa-2b u mediċini kontra l-aċidu fl-istonku.
English: Conjunctival haemorrhage, eye pruritus, keratitis, vision blurred, photophobia
Maltese: Pressjoni baxxa, pressjoni għolja, fwawar
English: Commonly reported side effects(may affect up to1 in 10people): decrease in blood clotting cells called platelets (that may result in easy bruising and spontaneous bleeding), excess of triglycerides in the blood,excess of uric acid (as in gout) in the blood, increase in thyroid gland activity (which may cause nervousness, heat intolerance and excessive sweating, weight loss, palpitation, tremors), agitation, anger, aggressive behaviour,behaviour disorder, difficulty concentrating, emotional instability,fainting, feeling anxious or nervous, feeling cold, feeling confused,feeling of restlessness, feeling sleepy, lack of interest or attention, mood changes, pain,poor quality sleep, sleepwalking, suicide attempt, trouble sleeping, unusual dreams, wanting to harm yourself, bacterial infections,common cold,fungal infections, abnormal vision,dry or teary eyes, ear infection, eye irritation or pain or infection,change in taste,changes in yourvoice,cold sores, coughing, inflamed gums, nose bleed, nose irritation,oral pain,pharyngitis (sore throat), rapid breathing, respiratory infections, scaling lips and clefts in the corners of the mouth, shortness of breath, sinusitis, sneezing, sores in mouth, sore tongue, stuffy or runny nose, throat pain, toothache, tooth abscess, tooth disorder, vertigo (spinning feeling), weakness, chest pain, flushing, palpitations (pounding heart beat), rapid heart rate, abnormal liver function, acid reflux, back pain, bedwetting, constipation, gastroesophageal or rectal disorder, incontinence, increased appetite, inflammation of the membrane of the stomach and intestine, stomach upset, loose stools, urination disorders, urinary tract infection, difficult, irregular, or no menstrual period, abnormally heavy and prolonged menstrual periods, disorder of vagina, inflammation of the vagina, testis pain, development of male body traits, acne, bruising, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), increased or decreased sensitivity to touch, increased sweating, increase in muscle movement, tense muscle, limb pain, nail disorder, numbness or tingling feeling, pale skin, rash with raised spotted lesions, shaky hands, redness of skin or skin disorder, skin discolouration, skin sensitive to sunlight, skin wound, swelling due to a build-up of excess water, swollen glands (swollen lymph nodes), tremor, tumour (unspecified).
Maltese: − infezzjonijiet bil-batterji, riħ komuni, infezzjonijiet tal-fungu, vista anormali, għajnejn xotti jew bi dmugħ, infezzjoni tal-widnejn, irritazzjoni jew uġigħ jew infezzjoni fl-għajnejn, bidla fit-togħma, bidliet fil-vuċi tiegħek, xofftejn jinqasmu, sogħla, ħanek iffjammat, tinfaraġ minn imnieħrek, irritazzjoni fl-imnieħer, uġigħ fil-ħalq, farinġite (grieżem misluħin), nifs mgħaġġel, infezzjonijiet tan-nifs, xofftejn bil-qxur u qsim fit-truf tal-ħalq, qtugħ ta' nifs, sinużite, għatis, selħiet fil-ħalq, ilsien misluħ, imneħer inblukkat jew iqattar, uġigħ fil-grieżem, uġigħ tas-snien, ħofor fis-snien, vertigo (tħoss kollox idur bik), dgħufija,
English: Adverse reactions reported with a > 10 % incidence in adult patients treated with Rebetol capsules in combination with interferon alfa-2b or pegylated interferon alfa-2b for one year have also been reported in children and adolescents.
Maltese: Reazzjonijiet avversi rrappurtati bi frekwenza ta' > 10 % f'pazjenti adulti kkurati b'kapsuli ta' Rebetol flimkien ma' interferon alfa-2b jew interferon alfa-2b pegilat għal sena kienu rrappurtati wkoll fit-tfal u fl-adolexxenti.
English: Table 11 Sustained virological response based on genotype after Rebetol in combination with peginterferon alfa-2b in HCV/HIV co-infected patients Study 1
Maltese: peginterferon alfa-2b f'pazjenti infettati fl-istess ħin b'HCV/HIV
English: Treatment group
Maltese: trattament
English: Interaction studies have only been performed in adults.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Studji ta' interazzjoni twettqu biss f'adulti.
English: Luxembourg/Luxemburg MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
Maltese: Sebgħin fil-mija (68/97) tal-individwi kollha li kienu ħadu sehem temmew dan l-istudju li minnhom 75 % (42/56) kellhom rispons sostnut.
English: Table 14 Sustained virological response in previously untreated children and adolescents Rebetol 15 mg/kg/day interferon alfa-2b 3 MIU/m2 3 times a week
Maltese: Rebetol 15 mg/kg/jum interferon alfa-2b 3 MIU/m2 3 darbiet fil-ġimgħa
English: The duration of therapy was 48 weeks with a follow-up period of 6 months except for patients infected with genotypes 2 or 3 and viral load < 800,000 IU/mL (Amplicor) who were treated for 24 weeks with a 6 month follow-up period.
Maltese: It-tul tat-terapija kien ta' 48 ġimgħa b'perijodu ta' follow up ta' 6 xhur ħlief għall-pazjenti infettati b'ġenotip 2 jew 3 u viral load < 800,000 IU/mL (Amplicor) li kienu kkurati għal 24 ġimgħa b'perijodu ta' follow up ta' 6 xhur
English: Histological response
Maltese: Rispons globalia
English: Failure to prior therapy was defined as relapse or non-response (HCV-RNA positive at the end of a minimum of 12 weeks of treatment).
Maltese: Falliment għal terapija li tkun ingħatat qabel kien definit bħala rkadar jew nuqqas ta' rispons (HCV-RNA pożittiv fi tmiem mill-anqas 12-il ġimgħa ta' kura).
English: Rebetol oral solution is supplied in a concentration of 40 mg/mL.
Maltese: Soluzzjoni orali ta' Rebetol tiġi f'konċentrazzjoni ta' 40 mg/mL.
English: In patients of African American origin (which is known to be a poor prognostic factor for HCV eradication), treatment with peginterferon alfa-2b (1.5 µg/kg)/Rebetol combination therapy resulted in a higher sustained virologic response rate compared to peginterferon alfa-2b 1 µg/kg dose.
Maltese: F'pazjenti ta' nisel Afrikan-Amerikan (li huwa magħruf bħala fattur ta' pronjożi batut għas-suċċess tat-tneħħija tal-HCV), kura b'terapija kombinata ta' peginterferon alfa-2b (1.5 µg/kg)/Rebetol wasslet għal rispons viroloġiku sostnut ogħla meta mqabbel ma' doża ta' peginterferon alfa-2b 1µg/kg.
English: Commonly reported side effects(may affect up to1 in 10people): decrease in certainwhite blood cells called leukocytes that help fight infection, excess of sugar in the blood, low calcium level in the blood, amnesia, crying, bleeding gums, feeling faint, anger, memory impaired, mental disorder, cardiac murmur (abnormal heart beat sounds), difficult breathing, low or high blood pressure, blurred vision, changes in yourhearing, ringing in ears, earache, bloating, burning sensation on tongue, change in taste, taste loss, dry mouth, migraine,nonproductive cough, thirst, abnormal urine, passing more urine than usual, irritated colon, irritation of prostate gland, intestinal gas (flatus), jaundice (yellow skin), disorder of ovary, breast pain, lack of interest in sex or inability to perform, erectile problem, abnormal hair texture, arthritis, psoriasis, muscle spasm, puffy or swollen hands and ankles, swollen face, unsteady when walking,water impairment.
Maltese: − għamla tax-xagħar mhux normali, akne, artrite, tbenġil, ekżema (ġilda ffjammata, ħamra, bil-ħakk u xotta u jista' jkun hemm ukoll xi feriti li jnixxu), ħorriqija, sensittività li tħoss tiżdied jew tonqos, disturbi tad-dwiefer, spażmi tal-muskoli, sensazzjoni ta' tnemnim jew tingiż, uġigħ fid-dirgħajn jew riġlejn, uġigħ fil-ġogi, idejn jirtodu, psorajiżi, idejn u għekiesi mLaħħmin jew minfuħin, sensittività għad-dawl tax-xemx, raxx b'feriti mgħollijin b'tikek, ħmura tal-ġilda jew disturbi tal-ġilda, wiċċ minfuħ, glandoli jintefħu (glandoli tal-limfa minfuħin), muskoli miġbudin, tumur (mhux speċifikat), mixi mhux stabbli, indeboliment tal-ilma.
English: - Breast-feeding.
Maltese: − infjammazzjoni tal-frixa,
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or sucrose-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose,
English: Ulcerative stomatitis, stomatitis, mouth ulceration, colitis, upper right quadrant pain, dyspepsia, gastroesophoageal reflux*, glossitis, cheilitis, abdominal distension, gingival bleeding, gingivitis, loose stools, tooth disorder, constipation, flatulence
Maltese: Stomatite ulċerattiva, stomatite, ulċera fil-ħalq, kolite, uġigħ ta' żaqq fil-kwadrant ta' fuq fin-naħa tal-lemin, dispepsja, ittella' mill-istonku*, glossite, kejlite, nefħa addominali, fsada fil-ħanek, ġinġivite, purgar maħlul, disturbi fis-snien, stitikezza, gass fl-istonku
English: Table 7 Sustained response rates with Rebetol + peginterferon alfa-2b
Maltese: Rebetol f'taħlita ma' peginterferon alfa-2b
English: Chest pain, chest discomfort, peripheral oedema, malaise, feeling abnormal, thirst
Maltese: Uġigħ tas-sider, skumdità fis-sider, edima periferali, tħossok ma tiflaħx, tħossok anormali, għatx
English: Genotype 1* By Week 4*** (n= 950) HCV-RNA negative
Maltese: HCV-RNA negattiv 508 HCV-RNA negattiv jew
English: Twenty-four percent of children (11/46) treated for 24 weeks and 40 % of children (19/48) treated for 48 weeks had a > 15 percentile height-for-age decrease from pre-treatment to the end of 5 year long-term follow-up compared to pre-treatment baseline percentiles.
Maltese: Erbgħa u għoxrin fil-mija tat-tfal (11/46) ikkurati għal 24 ġimgħa u 40% tat-tfal (19/48) ikkurati għal 48 ġimgħa kellhom tnaqqis ta' > 15-il perċentwali fit-tul għall-età minn qabel il-kura sal-aħħar tas-segwitu fit-tul ta' 5 snin meta mqabbel mal-perċentwali fil-linja bażi ta' qabel il-kura.
English: Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and themembranes of the ears, brain and spinal cord), bronchoconstriction and anaphylaxis (a severe, whole-body allergic reaction), constant cough, eye problems including damage to the retina, obstruction of the retinal artery, inflammation of the optic nerve, swelling of the eye and cotton wool spots (white deposits on the retina), enlarged abdominal area, heartburn, trouble having bowel movement or painful bowel movement, acute hypersensitivity reactions including urticaria (hives), bruises, intense pain in a limb, leg or thigh pain, loss of range of motion, stiffness, sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands).
Maltese: − akne, tbenġil, ekżema (ġilda iffjammata, ħamra, tħokkok u xotta li tista' tkun b'feriti li jnixxu), żieda jew tnaqqis fis-sensittività biex tħoss, żieda fl-għaraq, żieda fil-movimenti tal-muskoli, muskoli ibsin, uġigħ fid-dirgħajn jew riġlejn, disturbi tad-dwiefer, sensazzjoni ta' tnemnim jew tingiż, ġilda pallida, raxx b'feriti mgħollijin u bi dbabar, idejn jirtogħdu, ħmura tal-ġilda jew disturbi tal-ġilda, ġilda titlef il-kulur, ġilda sensittiva għad-dawl, ferita fil-ġilda, nefħa minħabba li jakkumula l-ilma żejjed, glandoli minfuħin (glandoli tal-limfa minfuħin), tregħid, tumur (mhux speċifikat).
English: Conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Maltese: apatija, ħolm anormali, biki
English: Among 480 patients with > 2 log viral reduction but detectable virus at week 12, altogether 188 patients continued therapy.
Maltese: Fost 480 pazjent b'>2 log tat-tnaqqis virali iżda b'ammont ta' vajrus li jista' jiġi mkejjel ma' ġimgħa 12, b'kollox 188 pazjent komplew it-terapija.
English: Not applicable.
Maltese: − vaskulite.
English: Growth rate decrease (height and/or weight decrease for age)
Maltese: Tnaqqis fir-rata tat-tkabbir (tnaqqis fit-tul u/jew piż għall-età)
English: Response to the treatment was measured by Sustained Virologic Response (SVR) which is defined as undetectable HCV-RNA at 24 weeks post-treatment (see Table 9).
Maltese: Ir-rispons għall-kura kien imkejjel bħala Rispons Viroloġiku Sostnut (SVR) li huwa definit bħala HCV-RNA li jista' jitkejjel sa' 24 ġimgħa wara l-kura (ara Tabella 9).
English: Ninety-four of 107 children enrolled in the 5 year long-term follow-up trial.
Maltese: Erbgħa u disgħin minn 107 itfal kienu rreġistrati fil-prova ta' segwitu fit-tul ta' 5 snin.
English: The population enrolled mainly consisted in children with mild to moderate hepatitis C. The population enrolled mainly consisted in children with mild to moderate hepatitis C. In the two multicentre trials, sustained virological response rates in children and adolescents were similar to those in adults (see Table 7).
Maltese: F'żewġ provi multiċentriċi r-rati ta' rispons viroloġiku sostnut fi tfal u adolexxenti kienu simili għal dawk tal-adulti (ara Tabella 7).
English: Furthermore, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4 % vs. 1 %) during treatment and during the 6 month follow-up after treatment.
Maltese: Minbarra hekk, ħsibijiet dwar suwiċidju jew attentati ta' suwiċidju kienu rrappurtati aktar ta' spiss meta mqabbla ma' pazjenti adulti (2.4 % vs 1 %) waqt il-kura u fis-6 xhur tal-follow-up wara l-kura.
English: If the abnormality is reversed, Rebetol may be restarted at 600 mg daily, and further increased to 800 mg daily at the discretion of the treating physician.
Maltese: Jekk l-anormalità titranġa, Rebetol jista' jinbeda mill-ġdid b'600 mg kuljum, u jiżdied aktar għal 800 mg kuljum skont id-diskrezzjoni tat-tabib li jkun qed jikkura.
English: The use of Rebetol in combination with peginterferon alfa-2b had no observable negative impact on the control of HIV viraemia during therapy or follow-up.
Maltese: L-użu ta' Rebetol f'kombinazzjoni ma' peginterferon alfa-2b ma deherx li kellu impatt negattiv fuq il-kontroll ta' virimja bl-HIV waqt it-terapija jew fiż-żmien ta' follow up.
English: As in adult patients, children and adolescents also experienced other psychiatric adverse reactions (e.g., depression, emotional lability, and somnolence) (see section 4.4).
Maltese: Bħal f'pazjenti adulti, tfal u adolexxenti kellhom każijiet psikjatriċi avversi oħrajn (eż. dipressjoni, burdati emozzjonali, u ngħas) (ara sezzjoni 4.4).
English: If week 12 HCV-RNA is positive and decreased ≥ 2 log10 from baseline, then retest HCV-RNA at week 24 and if positive, patients to stop therapy.
Maltese: Jekk l-HCV-RNA ta' ġimgħa 12 huwa pożittiv u hemm tnaqqis ta' < 2log10 mil-linja bażi, pazjenti jkollhom iwaqqfu t-terapija.
English: In HCV/HIV co-infected patients receivingcART, the following other side effects have occurred with the combination of Rebetol hard capsules and peginterferon alfa-2b (not listed above in adults side effects): appetite decreased, back pain, CD4 lymphocytes decreased, defective metabolism of fat, hepatitis, limb pain, oral candidiasis (oral thrush), various laboratory blood values abnormalities.
Maltese: − raxxijiet severi li jistgħu jkunu assoċjati ma' bżieżaq fil-ħalq, imnieħer, għajnejn jew membrani mukużi oħrajn (eritema multiforme, sindrome ta' Stevens Johnson), nekrolisi tossika tal-epidermide (bżieżaq u tqaxxir tas-saff ta' fuq tal-ġilda).
English: EU/01/13/878/001 Defitelio
Maltese: UE/01/13/878/001 Defitelio
English: 2.5 ml
Maltese: 80 mg / ml
English: Intravenous use vial (glass)
Maltese: L-ewwel Ippakkjar
English: 80 mg/mL Concentrate for solution for infusion
Maltese: Konċentrat għal soluzzjoni għal infużjoni
English: Date of latest renewal: 23 March 2010
Maltese: Data tal-aħħar tiġdid: 23 ta' Marzu, 2010
English: ATC code: A04AA05
Maltese: A04AA05
English: p-value c
Maltese: valur p c
English: Significance levels at alpha 0.0167 (adjusted for multiple comparisons).
Maltese: Livelli ta' sinifikat f'alpha 0.0167 (aġġustati għal paraguni multipli).
English: (as hydrochloride).
Maltese: (bħala hydrochloride).
English: Glycerol Titanium dioxide
Maltese: Titanium dioxide
English: 5 soft capsules.
Maltese: 5 kapsuli rotob.
English: 12 to <17 y µg/kg
Maltese: 12 sa <17-il sena µg/kg
English: Glycerol Monocaprylocaproate (type I) Polyglycerol oleate
Maltese: Glycerol Monocaprylocaproate (tip I) Polyglycerol oleate Glycerol
English: It may harm them,
Maltese: Ngħas, nuqqas ta' rqad,
English: Dolasetron 100 milligrams (n= 191)
Maltese: Dolasetron 100 milligramma (n= 191)
English: b PK parameters expressed as Arithmetic mean (SD)
Maltese: b Parametri PK espressi bħala Medja Aritmetika (SD)
English: Republic of Ireland
Maltese: L-Irlanda
English: Significance level at α=0.05.
Maltese: Livell sinifikanti ta' α=0.05.
English: t½, hours
Maltese: t½, sigħat
English: Approximately 62 % of palonosetron is bound to plasma proteins.
Maltese: Madwar 62 % ta' palonosetron jintrabat mal-proteini tal-plażma.
English: 1 x 5 ml vial
Maltese: Kunjett 1 x 5 ml
English: Clearance c, L/h/kg Volume of distribution c, d, L/kg 6.08
Maltese: Volum ta' distribuzzjoni ċ, d, L/kg 6.08
English: Very rare ARs°
Maltese: ARs° rari ħafna
English: INFORMATION IN BRAILLE Aloxi 500 micrograms
Maltese: INFORMAZZJONI BIL-BRAILLE Aloxi 500 mikrogramma
English: • medicines for heart problems such as amiodarone, nicardipine, quinidine
Maltese: • mediċini għal problemi tal-qalb bħal amiodarone, nicardipine, quinidine
English: Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15 Ireland
Maltese: Damastown, Mulhuddart, Dublin 15 L-Irlanda
English: ondansetron.
Maltese: ondansetron ġol-vini.
English: Tachycardia, bradycardia, extrasystoles, myocardial ischaemia, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles
Maltese: Takikardija, bradikardija, extrasystoles, iskemija mijokardjali, takikardija tas-sinus, arritmija tassinus, extrasystoles supraventrikulari
English: Common ARs
Maltese: ARs Komuni
English: In the palonosetron 10 µg/kg, 20 µg/kg and ondansetron groups, the proportion of patients with CR0-24h was 54.2%, 59.4% and 58.6%.
Maltese: Fil-gruppi ta' palonosetron 10 µg/kg, 20 µg/kg u ta' ondansetron, il-proporzjon ta' pazjenti b'CR0-24 siegħa kien ta' 54.2%, 59.4% u 58.6%.
English: • The maximum dose is 1500 micrograms.
Maltese: • Id-doża massima hu ta' 1500 mikrogramma.
English: PC:
Maltese: ATC:
English: Aloxi is normally given by a doctor or nurse.
Maltese: Aloxi normalment jingħata minn tabib jew infermier.
English: Very rare (<1/10,000) adverse reactions were reported post-marketing.
Maltese: Reazzjonijiet avversi rari ħafna (<1/10,000) kienu rrappurtati wara t-tqegħid fis-suq.
English: • You will normally take the capsule about 60 minutes before the start of your chemotherapy.
Maltese: • Normalment inti ser tieħu l-kapsula madwar 60 minuta qabel il-bidu tal-kimoterapija tiegħek.
English: Doses of up to 6 mg have been used in clinical trials.
Maltese: Dożi sa 6 mg intużaw fi provi kliniċi.