FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 10: Adverse reactions reported among paediatric patients infected with HCV and assigned to Pegasys plus ribavirin in study NV17424
Maltese: Reazzjonijiet avversi rrappurtati fost pazjenti pedjatriċi infettati b'HCV u assenjati għal Pegasys flimkien ma' ribavirin fi studju NV17424
English: Platelet <25,000 cells/mm3: discontinue treatment.
Maltese: Plejtlits <25,000 ċellula/mm3: waqqaf it-trattament għal kollox.
English: ● Insert the needle all the way into the pinched skin at an angle of 45° to 90° (6).
Maltese: ● Daħħal il-labra kollha fil-ġilda maqrusa b'angolu ta' 45° sa 90° (6).
English: 1 level reduction (mcg)
Maltese: Tnaqqis ta' tliet livelli (mcg)
English: Retinal haemorrhage
Maltese: Mard awtoimmuni
English: ● The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, sodium acetate,
Maltese: Fih ukoll sodium chloride, polysorbate 80, benzyl alcohol (għal aktar informazzjoni ara l-fuljett ta'
English: Hypertension, supraventricular arrhythmias, congestive heart failure, chest pain and myocardial infarction have been associated with alfa interferon therapies, including Pegasys.
Maltese: Pressjoni għolja, arritmija supraventrikolari, insuffiċjenza konġestiva tal-qalb, uġigħ fis-sider u infart mijokardijaku kienu assoċjati ma' terapiji b'alfa interferons, inkluż Pegasys.
English: Study WV16240 recruited patients who were positive for HBeAg, while study WV16241 recruited patients who were negative for HBeAg and positive for anti-HBe.
Maltese: irrekluta pazjenti li kienu pożittivi għal HBeAg, waqt li studju WV16241irrekluta pazjenti li kienu negattivi għal HBeAg u pożittivi għal anti-HBe.
English: Do not:
Maltese: ATTENZJONI:
English: 4 pre-filled syringes + 4 injection needles 180 micrograms/0.5 ml
Maltese: 4 siringi mimlija għal-lest + 4 labar għall-injezzjoni 180 mikrogramma/0.5 ml
English: 800 mg/day
Maltese: 800 mg/jum
English: Myocardial infarction, congestive heart failure, cardiomyopat hy, angina, arrhythmia, atrial fibrillation, pericarditis, supraventricu lar tachycardia
Maltese: arritmija, fibrillazzjoni atrijali, perikardite, takikardija supraventrikola ri
English: Genotype 2 or 3 HVL with RVR**
Maltese: Ġenotip 2 jew 3 HVL b'RVR**
English: In CHC clinical trials with adult patients, isolated increases in ALT (≥ 10x upper limit of normal [ULN], or ≥ 2x BL for patients with a BL ALT ≥ 10x ULN) which resolved without dose-modification were observed in 8 of 451 patients treated with combination therapy.
Maltese: Fi provi kliniċi dwar CHC b'pazjenti adulti, żidiet iżolati fl-ALT (≥ 10x l-ogħla limitu tan-normal [ULN], jew ≥ 2x BL għall-pazjenti li għandhom BL ALT ≥ 10x ULN) li waqfu mingħajr ebda tibdil fid-doża dehru fi 8 minn 451 pazjent ikkurati b'terapija kombinata.
English: For HIV-HCV patients receiving Pegasys and ribavirin combination therapy other undesirable effects have been reported in ≥ 1% to ≤ 2% of patients: hyperlactacidaemia/lactic acidosis, influenza, pneumonia,
Maltese: Għall-pazjenti b'HIV-HCV li qed jirċievu terapija kombinata b'Pegasys u ribavirin kienu rrappurtati effetti mhux mixtieqa oħra f'≥ 1% sa ≤ 2% tal-pazjenti: iperlattiċidemija/aċidożi lattika, influwenza,
English: Rhabdomyoly sis
Maltese: Ċirkustanzi soċjali
English: Patients with moderate renal impairment receiving Pegasys 180 mcg once weekly exhibited similar peginterferon alfa-2a plasma exposures compared to patients with normal renal function.
Maltese: Pazjenti b'indeboliment moderat tal-kliewi li kienu qed jirċievu Pegasys 180 mcg darba fil-ġimgħa urew esponimenti fil-plażma għal peginterferon alfa-2a simili meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali.
English: A clinical trial evaluated 50 CHC patients with either moderate (creatinine clearance 30 to 50 mL/min) or severe (creatinine clearance less than 30 mL/min) renal impairment, or with end stage renal disease (ESRD) requiring chronic hemodialysis (HD).
Maltese: Prova klinika evalwat 50 pazjent b'CHC b'indeboliment moderat (tneħħija tal-krejatinina 30 sa 50 mL/min) jew sever (tneħħija tal-krejatinina inqas minn 30 mL/min) tal-kliewi, jew b'marda talkliewi tal-aħħar stadju (ESRD - end stage renal disease) li kienu jeħtieġu emodijalisi (HDhemodialysis) kronika.
English: The occurrence of anaemia (haemoglobin <10 g/dl) has been observed in up to 15% of CHC patients in clinical trials on the combined treatment of Pegasys with ribavirin.
Maltese: L-okkorrenza ta' anemija (emoglobina <10 g/dl) deheret f'mhux aktar minn 15% tal-pazjenti b'CHC fi provi kliniċi fuq il-kura kombinata ta' Pegasys ma' ribavirin.
English: HIV-HCV co-infection
Maltese: Pazjenti ko-infettati b'HIV-HCV
English: Sarcoidosis, thyroiditis
Maltese: Ipotirojdiżmu, ipertirojdiżmu
English: (N=444) 48 weeks
Maltese: (N=453) 48 ġimgħa
English: HCV patients with normal ALT
Maltese: Pazjenti b'HCV li għandhom ALT normali
English: ● a 1 ml syringe
Maltese: • siringa ta' 1 ml
English: Available in packs of 1, 4 or a multipack of 12 (2 packs of 6) pre-filled syringes.
Maltese: Disponibbli f'pakketti ta' 1, 4 jew pakkett multiplu ta' 12-il siringa mimlija għal-lest (2 pakketti ta' 6).
English: NPV= negative predictive value; Sensitivity = % of all responders not meeting the stopping rule; Specificity = % of all non-responders meeting stopping rule (a)
Maltese: DNA ta' HBV > 6.5 log10 NPV= valur ta' tbassir negattiv (negative predictive value); Sensittività = % ta' dawk kollha li rrispondew li ma jissodisfawx ir-regola ta' waqfien (stopping rule); Speċifiċità = % ta' dawk kollha li ma rrispondewx li jissodisfaw ir regola ta' waqfien (a)
English: The “Instructions for the User”, provided in the carton, must be followed carefully by the patient.
Maltese: L-“Istruzzjonijiet għall-Utent”, ipprovduti fil-kaxxa, għandhom jiġu segwiti b'attenzjoni mill-pazjent.
English: Moderate (ANC: 0.749 - 0.5 x 109/l) and severe (ANC: < 0.5 x 109/l) neutropenia was observed respectively in 24% (216/887) and 5% (41/887) of patients receiving Pegasys 180 micrograms and ribavirin 1000/1200 milligrams for 48 weeks.
Maltese: 9/l) kienet osservata rispettivament f'24% (216/887) u f'5% (41/887) tal-pazjenti li rċevew Pegasys 180 mikrogramma u ribavirin 1000/1200 milligramma għal 48 ġimgħa.
English: ● an injection needle Not included in the pack:
Maltese: Neoplażmi beninni u malinni:
English: Interferon alfa-2a 3 MIU
Maltese: Interferon alfa-2a
English: Elderly
Maltese: Ieħor
English: There are no data in paediatric patients coinfected with HCV/HIV or with renal impairment.
Maltese: M'hemmx dejta dwar pazjenti pedjatriċi ko-infettati b'HCV/HIV jew b'indeboliment renali.
English: Ischaemic colitis, tongue pigmentation
Maltese: Kolite iskemika, pigmentazzjon i tal-ilsien
English: Roche Latvija SIA Tel: +371 - 6 7 039831
Maltese: Tel: +371 - 6 7039831
English: Table 22: Serological, virological and biochemical responses in paediatric patients with chronic hepatitis B
Maltese: Tabella 22: Risponsi seroloġiċi, viroloġiċi u bijokimiċi f'pazjenti pedjatriċi b'epatite B kronika
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il- mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: ● Remove the needle guard from the syringe needle (5).
Maltese: ● Neħħi l-għatu protettiv tal-labra mill-labra tas-siringa (5).
English: ● if you have had a severe nervous or mental disorder.
Maltese: • jekk kellek disturb nervuż jew mentali sever.
English: Pegasys 180 micrograms solution for injection in pre-filled syringe The syringe contains graduation marks corresponding to 180 micrograms (mcg), 135 mcg and 90 mcg.
Maltese: Is-siringa fiha marki ta' gradwazzjoni li jikkorrispondu għal 180 mikrogramma (mcg), 135 mcg u 90 mcg.
English: Available data for patients infected with genotype 5 or 6 are limited; therefore combination treatment with 1,000/1,200 mg of ribavirin for 48 weeks is recommended.
Maltese: Dejta disponibbli għall-pazjenti infettati b'ġenotip 5 jew 6 hija limitata; għalhekk kura kombinata b'1,000/1,200 mg ta' ribavirin għal 48 ġimgħa hija rakkomandata.
English: Educational problem
Maltese: Problema fl-edukazzjoni
English: Treatment for 24 weeks may be considered in patients infected with - genotype 1 with low viral load (LVL) (≤ 800,000 IU/ml) at baseline or
Maltese: Kura għal 24 ġimgħa tista' tkun ikkunsidrata f'pazjenti infettati b' - ġenotip 1 b'viral load baxxa (LVL - low viral load) (≤ 800,000
English: Optic neuropathy, papilloedema, retinal vascular disorder, retinopathy, corneal ulcer
Maltese: Infjammazzjoni u nefħa tan-nerv ottiku, infjammazzjoni tar-retina, ulċerazzjoni tal-korneja
English: Modified Assessment
Maltese: Stima Modifikata
English: Predictability of response Please refer to section 4.2, in Table 2.
Maltese: Jekk jogħġbok ara sezzjoni 4.2, f'Tabella 2.
English: Patients receiving zidovudine in combination with ribavirin and alfa interferons are at increased risk of developing anaemia.
Maltese: Pazjenti li qed jirċievu zidovudine flimkien ma' ribavirin u alfa interferons għandhom riskju akbar li jiżviluppaw anemija.
English: Overall Sustained Response
Maltese: Sostenut Globali
English: Hepatic dysfunction
Maltese: Indeboliment Epatiku
English: HBeAg Seroconversion HBV DNA < 20,000 IU/mL* HBV DNA < 2,000 IU/mL ALT Normalization HBsAg Seroconversion Loss of HBsAg
Maltese: Għall-pazjenti negattivi għal HBeAg b'infezzjoni bil-ġenotip D tal-HBV, HBsAg ta' > 20,000 IU/mL jew DNA ta' HBV ta' > 6.5 log10 IU/mL f'Ġimgħa 12 wara bidu tat-trattament huma assoċjati ma'
English: For HBeAg-negative patients with HBV genotype D infection, HBsAg > 20,000 IU/mL or HBV DNA > 6.5 log10 IU/mL at Week 12 following commencement of treatment is associated with high likelihood of failure to achieve HBV-DNA <2,000 IU/mL and ALT normalization at Week 24 post treatment.
Maltese: Għall-pazjenti negattivi għal HBeAg b'infezzjoni bil-ġenotip D tal-HBV, HBsAg ta' > 20,000 IU/mL jew DNA ta' HBV ta' > 6.5 log10 IU/mL f'Ġimgħa 12 wara bidu tat-trattament huma assoċjati ma' probabbiltà għolja ta' falliment biex tintlaħaq DNA ta' HBV ta' <2,000 IU/mL u normalizzazzjoni talALT f'Ġimgħa 24 wara t-trattament.
English: Dysuria, incontinence, urinary tract disorder
Maltese: Disurja, inkontinenza, disturb flapparat tal-awrina
English: In general, the safety profile observed in paediatric patients was similar to that seen in adults.
Maltese: B'mod ġenerali, il-profil ta' sigurtà osservat f'pazjenti pedjatriċi kien simili għal dak osservat fl-adulti.
English: Skin disorders: Toxic epidermal necrolysis/Stevens Johnson Syndrome/erythema multiforme (a spectrum of rashes with varying degrees of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin), angioedema (swelling in the skin and mucosa)
Maltese: Nekrolisi tossika tal-epidermide/Sindrome Stevens Johnson/eritema multiforme (firxa ta' raxxijiet bi gradi varji ta' severità inkluż mewt li tista' tkun assoċjata ma' nfafet fil-ħalq, imnieħer, għajnejn u membrani tal-mukuża oħrajn u tqaxxir tal-parti affettwata tal-ġilda), anġjoedima (nefħa fil-ġilda u fil-mukuża)
English: Patients who achieved undetectable levels of HCV RNA after 20 weeks of treatment remained on Pegasys plus ribavirin combination therapy for a total of 48 weeks and were then followed for 24 weeks after the end of treatment.
Maltese: Pazjenti li laħqu livelli ta' RNA ta' HCV li ma kinux osservati wara 20 ġimgħa ta' kura baqgħu fuq terapija kombinata ta' Pegasys flimkien ma' ribavirin għal total ta' 48 ġimgħa u wara kienu segwiti għal 24 ġimgħa wara t-tmiem tal-kura.
English: The probabilities of achieving a sustained virological response with 48 or 72 weeks of treatment if viral suppression was achieved at week 12 were 35% (20 of 57) and 57% (57 of 100), respectively.
Maltese: Il-probabbiltajiet li jintlaħaq rispons viroloġiku sostenut b'48 jew 72 ġimgħa ta' kura jekk tkun intlaħqet sopressjoni virali f'ġimgħa 12 kienu ta' 35% (20 minn 57) u 57% (57 minn 100), rispettivament.
English: Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml *Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 w vs. Pegasys 180 mcg & ribavirin 800 mg, 48 w: Odds Ratio (95% CI) = 1.52 (1.07 to 2.17), P-value (stratified Cochran-Mantel-Haenszel test) = 0.020 *Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 w vs. Pegasys 180 mcg & ribavirin 1000/1200 mg, 24 w: Odds Ratio (95% CI) = 2.12 (1.30 to 3.46), P-value (stratified Cochran-Mantel-Haenszel test) = 0.002.
Maltese: Pegasys 180 mcg & ribavirin 800 mg, 48 ġ: Odds Ratio (CI ta' 95%) = 1.52 (1.07 sa 2.17) Valur p (test Cochran-Mantel-Haenszel stratifikat) = 0.020 * Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 ġ vs.
English: Genotype 4 with RVR*
Maltese: Ġenotip 4 b'RVR*
English: Psychiatric and nervous system disorders: Mood /emotion changes, aggression, nervousness, decreased sexual desire, poor memory, fainting, decreased muscle strength, migraine, numbness, tingling, burning sensation, tremor, changes in the sense of taste, nightmares, sleepiness Eye disorders: Blurry vision, eye pain, eye inflammation and dry eyes Ear disorders: ear pain
Maltese: Disturbi psikjatriċi u fis-sistema nervuża: Tibdil fil-burata/emozzjonali, aggressjoni, nervi, tnaqqis fix xewqa sesswali, memorja ħażina, ħass ħażin, tnaqqis tas-saħħa fil-muskoli, emigranja, tnemnim, tingiż, sensazzjoni ta' ħruq, rogħda, tibdil fis-sens tat-togħma, inkubi, ngħas Disturbi fl-għajnejn:
English: (copies/mL) / 5.26) ** Patients switched to Pegasys treatment post-principal observation period and before Week 24 follow-up were counted as non-responders.
Maltese: (kopji/mL) / 5.26) ** Pazjenti li qalbu għal trattament b'Pegasys wara l-perjodu prinċipal ta' osservazzjoni u qabel Ġimgħa 24 ta' segwitu kienu magħduda bħala li ma rrispondewx.
English: Pegasys 180 micrograms solution for injection Peginterferon alfa-2a
Maltese: Pegasys 180 mcg injezzjoni Peginterferon alfa-2a SC
English: Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml RVR = rapid viral response (HCV RNA undetectable) at week 4
Maltese: IU/ml; Viral load għolja = > 800,000 IU/ml RVR = rispons virali rapidu (RNA ta' HCV mhux osservata) f'ġimgħa 4
English: A full listing of adverse reactions reported in this treatment group (n=55) is provided in Table 10.
Maltese: Lista sħiħa ta' reazzjonijiet avversi rrappurtati f'dan il-grupp ta' kura (n=55) hija pprovduta f'Tabella 10.
English: Use with ribavirin
Maltese: Ribavirin
English: Treatment response for HBeAg-positive patients was defined as HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) + HBV DNA <2,000 IU/mL at 6 months post-treatment and treatment response for HBeAg-negative patients was defined as HBV DNA < 2,000 IU/mL + ALT normalization at 6 months posttreatment.
Maltese: (definit bħala telf ta' HBeAg u preżenza ta' anti-HBe) + DNA ta' HBV ta' <2,000 IU/mL 6 xhur wara t-trattament u rispons għat-trattament ta' pazjenti negattivi għal HBeAg kien definit bħala DNA ta' HBV ta' < 2,000
English: Retinopathy including retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy and retinal artery or vein obstruction which may result in loss of vision have been reported in rare instances with Pegasys.
Maltese: Retinopatija inkluż emorraġiji fir-retina, cotton wool spots, papilloedima, newropatija ottika u sadd tal-vina jew arterja tar-retina li jistgħu jwasslu għal telf tal-vista kienu rrappurtati f'okkażjonijiet rari b'Pegasys.
English: - genotype 4 who become HCV RNA negative at week 4 and remain HCV RNA negative at week 24.
Maltese: - ġenotip 4 li jsiru negattivi għall-RNA ta' HCV f'ġimgħa 4 u jibqgħu negattivi għall-RNA ta' HCV f'ġimgħa 24.
English: Pegasys 90 micrograms solution for injection in pre-filled syringe The syringe contains graduation marks corresponding to 90 micrograms (mcg), 65 mcg, 45 mcg, 30 mcg, 20 mcg and 10 mcg.
Maltese: Pegasys 90 mikrogramma soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest Is-siringa fiha marki ta' gradwazzjoni li jikkorrispondu għal 90 mikrogramma (mcg), 65 mcg, 45 mcg,
English: In clinical trials of 48 weeks treatment and 24 weeks follow-up, the safety profile for Pegasys in CHB was similar to that seen in CHC.
Maltese: Fi provi kliniċi ta' 48 ġimgħa ta' trattament u 24 ġimgħa ta' segwitu, il-profil ta' sigurtà ta' Pegasys f'CHB kien simili għal dak osservat f'CHC.
English: Renal impairment
Maltese: Assenti Ftit
English: Very rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 10,000 people) are:
Maltese: Effetti sekondarji rari ħafna bit-taħlita ta' Pegasys u ribavirin (jistgħu jaffettwaw sa persuna waħda minn kull 10,000) huma:
English: (N=478) 48 weeks
Maltese: (N=478)
English: Genotype 4 non RVR
Maltese: Ġenotip 4 mhux RVR
English: Roche Eesti OÜ Tel: + 372 - 6 177 380
Maltese: Tel: + 372 - 6 177 380
English: Pegasys is presented as a solution for injection in a vial (1 ml).
Maltese: Pegasys huwa ppreżentat bħala soluzzjoni għall-injezzjoni f'kunjett (1 ml).
English: Low viral load = ≤ 800,000 IU/ml; High viral load= > 800,000 IU/ml RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24
Maltese: IU/ml; Viral load għolja= > 800,000 IU/ml RVR = rispons virali rapidu (RNA ta' HCV mhux osservata) f'ġimgħa 4 u RNA ta' HCV mhux osservata f'ġimgħa 24
English: *RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24; **RVR = rapid viral response (HCV RNA negative) by week 4
Maltese: 24 ġimgħa *RVR = rispons virali rapidu (RNA ta' HCV mhux osservat) f'ġimgħa 4 u RNA ta' HCV mhux osservat f'ġimgħa 24; **RVR = rispons virali rapidu (negattiv għall-RNA ta' HCV) sa ġimgħa 4
English: 135 or 180 micrograms peginterferon alfa-2a.
Maltese: soluzzjoni fiha 90, 135 jew 180 mikrogramma peginterferon alfa-2a.
English: Pegasys 135 micrograms solution for injection in pre-filled syringe The syringe contains graduation marks corresponding to 135 micrograms (mcg), 90 mcg and 45 mcg.
Maltese: Is-siringa fiha marki ta' gradwazzjoni li jikkorrispondu għal 135 mikrogramma (mcg), 90 mcg u 45 mcg.
English: HIV-HCV co-infected adult patients
Maltese: Pazjenti adulti infettati b'HIV-HCV fl-istess waqt
English: Study NV15495 specifically recruited patients with a histological diagnosis of cirrhosis (about 80%) or transition to cirrhosis (about 20%).
Maltese: Fl-istudju NV15495 ħadu sehem speċifikament pazjenti b'dijanjosi istoloġika ta' ċirrożi (bejn wieħed u ieħor 80%) jew transizzjoni għal ċirrożi (bejn wieħed u ieħor 20%).
English: Table 6: Pegasys dose modification recommendations for toxicities in paediatric patients with chronic hepatitis B or chronic hepatitis C
Maltese: Tabella 6: Rakkomandazzjonijiet ta' modifikazzjoni fid-doża ta' Pegasys minħabba effetti tossiċi f'pazjenti pedjatriċi b'epatite B kronika jew epatite Ċ kronika
English: A prolongation of the menstrual cycle has been seen with peginterferon alfa-2a in female monkeys (see section 5.3).
Maltese: Kien osservat titwil fiċ ċiklu mestrwali b'peginterferon alfa-2a f'xadini femminili (ara sezzjoni 5.3).
English: • If your child has or has ever had a psychiatric disorder, talk to your doctor, who will monitor your child for signs or symptoms of depression (see section 4).
Maltese: • Jekk it-tifel/tifla tiegħek qatt kellu/ha disturb psikjatriku, kellem lit-tabib tiegħek, li se jissorvelja lit-tifel/tifla tiegħek għal sinjali jew sintomi ta' depressjoni (ara sezzjoni 4).
English: In the investigator sponsored CHIPS study (Chronic Hepatitis C International Paediatric Study), 65 children and adolescents (6-18 years) with chronic HCV infection were treated with Pegasys 100 mcg/m2 sc once weekly and ribavirin 15 mg/kg/day for 24 weeks (genotypes 2 and 3) or 48 weeks
Maltese: Fl-istudju CHIPS sponsorjat mill-investigatur (Studju Pedjatriku Internazzjonali dwar l-Epatite Ċ Kronika), 65 tfal u adolexxenti (6-18-il sena) b'infezzjoni kronika ta' HCV kienu kkurati b'Pegasys
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 June 2002
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Ġunju 2002
English: Skin and subcutaneous tissue disorders
Maltese: Doża eċċessiva tas-sustanza
English: Cerebral ischaemia
Maltese: Iskemija ċerebrali
English: HBeAg seroconversion rates
Maltese: Serokonverżjoni ta' HBeAg
English: Genotype 1 RVR Low viral load High viral load Genotype 1 non RVR
Maltese: Ġenotip 1 Viral load baxxa Viral load għolja
English: Table 11: Performance of individual biomarkers at Week 12 of therapy in CHB HBeAg-positive and HBeAg-negative patients according to genotype
Maltese: Tabella 11: Prestazzjoni ta' bijomarkaturi individwali f'Ġimgħa 12 tat-terapija f'pazjenti b'CHB pożittivi għal HBeAg u negattivi għal HBeAg skont il-ġenotip
English: Pegasys treatment was associated with decreases in absolute CD4+ cell counts within the first 4 weeks without a reduction in CD4+ cell percentage.
Maltese: Kura b'Pegasys kienet assoċjata ma' tnaqqis fl-għadd assolut ta' ċelluli CD4+ fl-ewwel 4 ġimgħat mingħajr tnaqqis fil-persentaġġ taċ-ċelluli CD4+.
English: Genotype 1 RVR Low viral load High viral load Genotype 4 RVR
Maltese: Ġenotip 4 RVR Ġenotip 4 mhux RVR
English: Headache
Maltese: Axxite
English: In study NR15961, patients concurrently treated with stavudine and interferon therapy with or without ribavirin, the incidence of pancreatitis and/or lactic acidosis was 3% (12/398).
Maltese: Fl-istudju NR15961, f'pazjenti kkurati fl-istess ħin b'stavudine u b'terapija b'interferon flimkien ma' ribavirin jew mingħajru, l-inċidenza ta' pankreatite u/jew aċidożi lattika kienet ta' 3% (12/398).
English: For adults, dose reduction is recommended if the absolute neutrophil count (ANC) is 500 to < 750 cells/mm3.
Maltese: Għall-adulti, tnaqqis fid-doża huwa rakkomandat jekk l-għadd assolut ta' newtrofili (ANC - Absolute Neutrophil Count) huwa 500 sa < 750 ċellula /mm3.
English: Pre-filled pen components
Maltese: Disturbi filfwied u filmarrara
English: 0.5 ml of solution for injection in pre-filled syringe (siliconised Type I glass) with a fixed needle (stainless steel), plunger stopper (butyl rubber laminated with fluororesin) and a needle shield (polyisoprene) in a pre-filled pen.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 0.5 ml ta' soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest (ħġieġ silikonizzat tat-Tip I) b'labra fissa (stainless steel), planġer stopper (lastku butyl laminat bi flororeżin) b'għatu ta' protezzjoni tallabra (polyisoprene) f'pinna mimlija għal-lest.
English: Other
Maltese: Il
English: NPV Sensitivity Specificity HBeAg-positive(a)
Maltese: NPV Sensittività Speċifiċità Pożittivi għal HBeAg
English: In study WV16240, the primary efficacy endpoints were HBeAg seroconversion and HBV-DNA below 105
Maltese: Flistudju WV16240, il-punti finali primarji tal-effikaċja kienu s-serokonverżjoni ta' HBeAg u DNA ta'
English: Patients who withdrew from previous therapy with pegylated interferon alfa-2b/ribavirin because of haematological toxicity were excluded from enrolling in this trial.
Maltese: Pazjenti li waqfu terapija ta' qabel b'interferon alfa-2b pegilat/ribavirin minħabba tossiċità ematoloġika kienu esklużi minn din il-prova.
English: Low viral load High viral load Genotype 4 (0/5)
Maltese: Viral load għolja Ġenotip 2/3
English: Measuring the dose of Pegasys
Maltese: Mediċini oħra u Pegasys
English: Pegasys Dose Modification
Maltese: Modifikazzjoni fid-doża ta' Pegasys
English: ● if you have been told you have VKH syndrome.
Maltese: • jekk ġejt mgħarraf li għandek is-sindrome VKH.
English: In study WV16241, the primary efficacy endpoints were ALT normalisation and HBVDNA below 2 x 104 copies/ml.
Maltese: Fl-istudju WV16241, il-punti finali primarji tal-effikaċja kienu normalizzazzjoni ta' ALT u DNA ta' HBV taħt 2 x 104 kopja/ml. DNA ta' HBV kienet imkejjla b'Analiżi COBAS AMPLICOR HBV MONITOR (limitu ta' kemm jista' jiġi mkejjel ta' 200 kopja/ml).