FrancophonIA/ELRC3.0 huggingface dataset:
English: However, certain monkey species, eg, rhesus monkeys, are susceptible to pharmacodynamic stimulation upon exposure to human type 1 interferons.
Maltese: Madankollu, ċerti speċi ta' xadini, eż. ix-xadini tarrazza rhesus, huma suxxettibbli għal stimulazzjoni farmakodinamika meta jkunu esposti għal interferoni umani ta' tip 1.
English: Epistaxis, respiratory disorder, nasal congestion, rhinorrhea, cough nonproductive Pulmonary infiltrates
Maltese: Epistassi, disturbi respiratorji, konġestjoni fl-imnieħer, rinoreja, sogħla mhux produttiva
English: The most commonly reported potentially life-threatening or fatal adverse events include mucositis, diarrhoea, neutropaenia, renal impairment, and electrolyte disturbance.
Maltese: Laktar avvenimenti avversi komuni rrappurtati li huma potenzjalment ta' theddida għall-ħajja jew fatali jinkludu mukożite, dijarea, newtropenija, indeboliment tal-kliewi, u disturbi fl-elettroliti.
English: Multiple-dose pharmacokinetic properties for IntronA injection and ribavirin capsules in children and adolescents with chronic hepatitis C, between 5 and 16 years of age, are summarized in Table 7.
Maltese: Il-propjetajiet tal-farmakokinetika ta' dożi multipli għal injezzjoni ta' IntronA u kapsuli ta' ribavirin fi tfal u adolexxenti b'epatite Ċ kronika, li kellhom bejn 5 u 16-il sena, qed jintwerew fil-qosor f'Tabella 7.
English: IntronA has been classified as recombinant interferon alfa-2b.
Maltese: IntronA kien ikklassifikat bħala interferon alfa-2b rikombinanti.
English: The population enrolled mainly consisted of children with mild to moderate hepatitis C. Due to the lack of data in children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of peginterferon alfa-2b with ribavirin needs to be carefully considered in this population (see peginterferon alfa-2b and ribavirin SPCs section 4.4).
Maltese: Minħabba nuqqas ta' dejta fi tfal bi progressjoni severa tal-marda, u l-potenzjal għal effetti mhux mixtieqa, il-benefiċċju/riskju tal-kombinazzjoni ta' peginterferon alfa-2b ma' ribavirin jeħtieġ li jiġi kkunsidrat b'attenzjoni f'din il-popolazzjoni (ara l-SPC ta' peginterferon alfa-2b u ribavirin, sezzjoni 4.4).
English: Intravenous infusion:
Maltese: Infużjoni ġol-vini:
English: The appropriate dose of IntronA is withdrawn from the vial(s), added to 50 mL of 9 mg/mL (0.9 %) sodium chloride solution for injection in a PVC bag or glass bottle for intravenous use and administered over 20 minutes.
Maltese: Id-doża adattata ta' IntronA tinġibed mill-kunjett(i), tiżdied ma' 50 mL ta' 9 mg/mL (0.9 %) sodium chloride soluzzjoni għall-injezzjoni f'borża tal-PVC jew flixkun tal-ħġieġ għal użu għal ġol-vini u mogħtija fuq medda ta' 20 minuta.
English: Prompt discontinuation of interferon alpha administration and treatment with corticosteroids appear to be associated with resolution of pulmonary adverse events.
Maltese: It-twaqqif minnufih tal-għoti ta' interferon alpha, u kura b'kortikosterojdi jidher li huma assojati mal-fejqan ta' avvenimenti avversi pulmonari.
English: Hairy Cell Leukaemia: 2 million IU/m 2, 3 times a week (every other day) injected subcutaneously (under the skin).
Maltese: Lewkimja tal-Hairy Cell: 2 miljun IU/m², 3 darbiet fil-ġimgħa (darba kull jumejn) injettati taħt ilġilda.
English: Fungal infection, bacterial infection, pulmonary infection, otitis media, tooth abscess, herpes simplex, urinary tract infection, vaginitis, gastroenteritis
Maltese: Infezzjonijiet fungali, infezzjoni batterjali, infezzjoni pulmonari, otite medja, axxess fis-snien, herpes simplex, infezzjoni filpassaġġ tal-awrina, gastroenterite
English: IntronA is available in twelve different pack sizes:
Maltese: IntronA jiġi f'tnax-il daqs differenti ta' pakketti:
English: Chronic hepatitis C in children and adolescent population Three clinical trials have been conducted in children and adolescents; two with standard interferon and ribavirin and one with pegylated interferon and ribavirin.
Maltese: Epatite Ċ kronika fil-popolazzjoni ta' tfal u adolexxenti Tliet provi kliniċi saru fuq tfal u adolexxenti; tnejn b'interferon standard u ribavirin u wieħed b'interferon pegilat u ribavirin.
English: Collect necessary items before you begin: - a vial of IntronA solution for injection; - a syringe (for example 1 mL); - a needle for the subcutaneous injection (for example 0.4 x 13 mm [27 gauge 0.5 inch]); - a cleansing swab.
Maltese: Preparazzjoni Iġbor l-affarijiet kollha li għandek bżonn qabel tibda: kunjett ta' IntronA soluzzjoni għall-injezzjoni; siringa (pereżempju 1 mL); labra biex tinjetta taħt il-ġilda (pereżempju 0.4 x 13 mm [27 gauge 0.5 pulzieri]; tajjara għat-tindif.
English: Musculoskeletal and connective tissue disorders Very common:
Maltese: Disturbi muskolu-skeletriċi u tattessuti konnettivi Komuni ħafna:
English: Patients were randomized to receive either pegylated interferon alfa-2b (1.5 µg/kg/week) plus ribavirin (800 mg/day) or IntronA (3 MIU TIW) plus ribavirin (800 mg/day) for 48 weeks with a follow-up period of 6 months.
Maltese: Il-pazjenti ntgħażlu b'mod każwali biex jirċievu jew interferon alfa-2b pegilat (1.5 µg/kg/ġimgħa) flimkien ma' ribavirin (800 mg/jum) jew inkella IntronA (3 MIU TIW) flimkien ma' ribavirin (800 mg/jum) għal 48 ġimgħa b'perjodu ta' follow-up ta' 6 xhur.
English: IntronA is a sterile, stable, formulation of highly purified interferon alfa-2b produced by recombinant DNA techniques.
Maltese: IntronA huwa formulazzjoni sterili u stabbli ta' interferon alfa-2b ippurifikat sa grad għoli ħafna magħmul b'tekniki ta' DNA rikombinanti.
English: Chronic myelogenous leukaemia The recommended dose of IntronA is 4 to 5 million IU/m2 administered daily subcutaneously.
Maltese: Lewkimja tal-Mudullun Kronika: 4-5 miljun IU/m² kuljum injettati taħt il-ġilda.
English: Depression, emotional lability, insomnia Suicidal ideation, aggressive reaction, confusion, behaviour disorder, agitation, somnambulism, anxiety, nervousness, sleep disorder, abnormal dreaming, apathy
Maltese: Ħsibijiet li tagħmel suwiċidju, reazzjoni aggressiva, konfużjoni, disturb fl-imġiba, aġitazzjoni, ħmar il-lejl, ansjetà, nervożità, disturb fl-irqad, ħolm anormali, apatija
English: Treatment of adult patients with Philadelphia chromosome or bcr/abl translocation positive chronic myelogenous leukaemia.
Maltese: Kura ta' pazjenti adulti bil-kromosoma ta' Philadelphia jew lewkimja kronika majeloġena pożittiva għat-traslokazzjoni bcr/abl.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: EU/1/99/127/027 EU/1/99/127/028 EU/1/99/127/029 EU/1/99/127/030 EU/1/99/127/043 EU/1/99/127/044 EU/1/99/127/048 EU/1/99/127/049 EU/1/99/127/050 EU/1/99/127/051 EU/1/99/127/052 EU/1/99/127/053
Maltese: EU/1/99/127/027 EU/1/99/127/028 EU/1/99/127/029 EU/1/99/127/030 EU/1/99/127/043 EU/1/99/127/044
English: EU/1/99/127/029 2 multiple dose vials
Maltese: EU/1/99/127/029 2 kunjetti b'ħafna dożi
English: All Genotypes
Maltese: erythema multiforme
English: Daily dosing of cynomolgus monkeys with 20 x 10
Maltese: Dożaġġ ta' kuljum ta' 20 x 106
English: For storage conditions of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-ewwel ftuħ tal-prodott mediċinali, ara sezzjoni 6.3.
English: IntronA 10 million IU/mL solution for injection or infusion
Maltese: IntronA 10 miljun IU/mL soluzzjoni għall-injezzjoni jew infużjoni
English: One mL of solution contains 6 million IU of interferon alfa-2b.
Maltese: Millilitru wieħed fih 6 miljun IU interferon alfa-2b.
English: Pulmonary infiltrates, pneumonitis, and pneumonia, occasionally resulting in fatality, have been observed rarely in interferon alpha treated patients, including those treated with IntronA.
Maltese: Infiltrati pulmonarji, pulmonite, u pnewmonja, li kultant wasslu għall-mewt, ġew osservati b'mod rari f'pazjenti kkurati b'interferon alpha, inklużi dawk ikkurati b'IntronA.
English: Subcutaneous use:
Maltese: Rappreżentant Awtorizzat:
English: One vial of solution for injection or infusion contains 18 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 3 mL of solution.
Maltese: U KWANTITATTIVA Kunjett wieħed ta' soluzzjoni għall-injezzjoni jew infużjoni fih 18-il miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 3 mL ta' soluzzjoni.
English: Collect necessary items before you begin: - a vial of IntronA solution for injection; - a syringe (for example 2 mL); - a needle for the subcutaneous injection (for example 0.4 x 13 mm [27 gauge 0.5 inch]); - a cleansing swab.
Maltese: Preparazzjoni Iġbor l-affarijiet kollha li għandek bżonn qabel tibda: kunjett ta' IntronA soluzzjoni għall-injezzjoni; siringa (pereżempju ta' 2 mL); labra biex tinjetta taħt il-ġilda (pereżempju 0.4 x 13 mm [27 gauge 0.5 pulzieri]; tajjara għat-tindif.
English: One mL of solution contains 10 million IU of interferon alfa-2b.
Maltese: Millilitru wieħed fih 10 miljun IU interferon alfa-2b.
English: Very commonly reported side effects: pain, swelling and redness or skin damage at site of injection, hair loss, dizziness, changes in appetite, stomach or abdominal pains, diarrhoea, nausea (feeling sick), viral infection, depression, emotional lability, insomnia, anxiety, sore throat and painful swallowing, fatigue, chills/rigors, fever, flu-like reaction, feeling of general discomfort, headaches, weight loss, vomiting, irritability, weakness, mood swings, coughing (sometimes severe), shortness of breath, itching, dry skin, rash, sudden and severe muscle pain, joint pain, musculoskeletal pain, changes in laboratory blood values including decreased white blood cell count.
Maltese: Effetti sekondarji rrappurtati komuni ħafna: uġigħ, nefħa u ħmura jew ħsara fil-ġilda fis-sit mnejn tingħata l-injezzjoni, telf ta' xagħar, sturdament, tibdil fl-aptit, weġgħat fl-istonku jew fl-addome, dijarea, tqalligħ (tħossok imdardar), infezzjoni virali, dipressjoni, reazzjonijiet emozzjonali eċċessivi u tibdil ta' spiss fil-burdata, nuqqas ta' rqad, ansjetà, gerżuma misluħa u wġigħ biex tibla, għeja, dehxiet/tregħid, deni, reazzjoni bħal tal-influwenza, tħossok skomdu b'mod ġenerali, uġigħ ta' ras, telf tal-piż, rimettar, irritabilità, dgħufija, tibdil filburdati, sogħla (kultant qawwija), qtugħ ta' nifs, ħakk, ġilda xotta, raxx, uġigħ muskolari sever f'daqqa, uġigħ fil-ġogi, uġigħ muskoluskeletriku, tibdil fil-valuri tal-laboratorju inkluż tnaqqis flgħadd taċ-ċelluli bojod tad-demm.
English: Hyperkinesia, tremor, dysphonia, paresthaesia, hypoaesthesia, hyperaesthesia, concentration impaired, somnolence
Maltese: Iperkinesija, tregħid, disfonija, parasteżija, ipoaesteżija, iperaesteżija, indeboliment tal-konċentrazzjoni, ngħas
English: A five-year long-term, observational, follow-up study enrolled 97 paediatric chronic hepatitis C patients after treatment in the standard interferon multicentre trials.
Maltese: Fi studju follow-up li dam ta' ħames snin, osservazzjonali, 97 pazjent pedjatriku b'epatite Ċ kronika kienu rreġistrati wara kura fil-provi multiċentriċi bi standard interferon.
English: IntronA 18 million IU/3 mL solution for injection or infusion
Maltese: IntronA 18-il miljun IU/3 mL soluzzjoni għall-injezzjoni jew infużjoni
English: Due to the lack of data in these two multicentre trials for children with severe progression of the disease, and the potential for undesirable effects, the benefit/risk of the combination of ribavirin and interferon alfa-2b needs to be carefully considered in this population (see sections 4.1, 4.4 and 4.8).
Maltese: Minħabba nuqqas ta' dejta f'dawn iż-żewġ provi multiċentriċi għal tfal bi progressjoni severa tal-marda, u l-potenzjal għal effetti mhux mixtieqa, il-benefiċċju/riskju tal-kombinazzjoni ta' ribavirin u interferon alfa-2b għandha tiġi kkunsidrata bl-attenzjoni f'din il-popolazzjoni (ara sezzjonijiet 4.1, 4.4 u 4.8).
English: Hepatobiliary disorders Common:
Maltese: Limfoma follikulari:
English: IntronA 25 million IU/2.5 mL solution for injection or infusion
Maltese: 25 miljun IU/2.5 mL soluzzjoni għall injezzjoni jew infużjoni
English: 3 mL of solution (corresponding to 18 MIU) is contained in a multidose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
Maltese: Soluzzjoni ta' 3 ml (li tikkorrispondi għal 18 MIU) miżmuma f'kunjett b'doża waħda (ħġieġ ta' tip I) b'tapp (lasktu tal-halobutyl) f'siġill flip-off (aluminju) b'bonnet (polypropylene).
English: HCV/HIV Co-infected patients
Maltese: Pazjenti koinfettati b'HCV/HIV
English: Genotype 1 (n=92)
Maltese: (n = 17)
English: Diarrhoea, vomiting, nausea, abdominal pain Mouth ulceration, stomatitis ulcerative, stomatitis, right upper quadrant pain, dyspepsia, glossitis, gastroesophageal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder
Maltese: Dijarea, rimettar, tqalligħ, uġigħ fl-addome Ulċera fil-ħalq, stomatite ulċerattiva, stomatite, uġigħ fil-parti tallemin ta' fuq, dispepsja, glossite, rifluss gastroesofagali, disturb fir-rektum, disturb gastrointestinali, stitikezza, ippurgar maħlul, uġigħ fis-snien, disturb fis-snien
English: Patients who fail to achieve virological response at 12 weeks are highly unlikely to become sustained virological responders (negative predictive value 96 %).
Maltese: Pazjenti li ma jiksbux rispons viroloġiku sat12-il ġimgħa x'aktarx li ma jsirux responders viroloġiċi sostnuti (valur ta' tbassir negattiv 96 %).
English: Retinal haemorrhages
Maltese: Laċerazzjoni tal-ġilda
English: Patients who also have HIV infection: Lactic acidosis and worsening liver function are side effects associated with Highly Active Anti-Retroviral Therapy (HAART), an HIV treatment.
Maltese: Pazjenti li għandhom ukoll infezzjoni tal-HIV: Aċidożi lattika u funzjoni tal-fwied li teħżien huma effetti sekondarji assoċjati ma' Terapija AntiRetrovirali Attiva Ħafna (HAART), li hija kura għallHIV.
English: Pregnancy, breast-feeding and fertility
Maltese: Effett fuq il-fertilità
English: For example, in a trial of high-dose adjuvant IntronA treatment in patients with melanoma, incidences of fatigue, pyrexia, myalgia, neutropaenia/anaemia, anorexia, nausea and vomiting, diarrhoea, chills, flulike symptoms, depression, alopecia, altered taste, and dizziness were greater than in the hepatitis C trials.
Maltese: Pereżempju, fi provi ta' kura addizzjonali b'doża għolja ta' IntronA f'pazjenti b'melanoma, inċidenzi ta' għeja, denia, uġigħ fil-muskoli, newtropenija/anemija, anoreksja, tqalligħ u rimettar, dijarea, tertir ta' bard, sintomi li jixbhu l-influwenza, dipressjoni, alopeċja, tibdil fit-togħma, u sturdament kienu akbar milli fil-provi tal-epatite Ċ.
English: One vial of solution for injection or infusion contains 25 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 2.5 mL of solution.
Maltese: U KWANTITATTIVA Kunjett wieħed ta' soluzzjoni għall-injezzjoni jew infużjoni fih 25 miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 2.5 mL ta' soluzzjoni.
English: 2.5 mL of solution (corresponding to 25 MIU) is contained in a multidose vial (type I glass) with a stopper (halobutyl rubber) in a flip-off seal (aluminium) with a bonnet (polypropylene).
Maltese: Soluzzjoni ta' 2.5 mL (li tikkorrispondi għal 25 MIU) miżmuma f'kunjett b'doża waħda (ħġieġ ta' tip I) b'tapp (lasktu tal-halobutyl) f'siġill flip-off (aluminju) b'bonnet (polypropylene).
English: §, rash maculopapular, rash erythematous, eczema, erythema, skin disorder Stevens Johnson syndrome, toxic epidermal necrolysis, erythema multiforme
Maltese: Alopeċja, ħakk*, ġilda xotta*, raxx*, żieda fl-għaraq Psorjasi (ġdida jew taggrava) §, raxx makulopapulari, raxx erimatuż, ekżema, eritema, disturb tal-ġilda Sindrome ta' Stevens Johnson, nekrolisi epidermali tossika, erythema multiforme
English: During combination therapy for up to 48 weeks with IntronA and ribavirin, growth inhibition was observed that resulted in reduced final adult height in some patients.
Maltese: Waqt terapija kombinata li damet sa 48 ġimgħa b'IntronA u ribavirin, ġiet osservata inibizzjoni tat-tkabbir dehret li f'xi pazjenti wasslet għal tnaqqis fit-tul finali bħala adulti.
English: As maintenance therapy in patients who have achieved objective remission (more than 50 % reduction in myeloma protein) following initial induction chemotherapy.
Maltese: Bħala terapija ta' manteniment f'pazjenti li rnexxielhom jiksbu tnaqqis fil-mard oġġettiv (aktar minn 50 % tnaqqis fil-proteina tal-majeloma) wara kimoterapija ta' induzzjoni inizjali.
English: Once opened, the medicine may be stored for a maximum of 28 days at 2ºC - 8ºC.
Maltese: Ladarba jinfetaħ, il-mediċina tista' tinħażen għal mhux aktar minn 28 jum bejn 2ºC - 8ºC.
English: Hypertension Peripheral ischaemia, hypotension
Maltese: Iskemija periferali, pressjoni baxxa§
English: One vial of solution for injection or infusion contains 10 million IU of recombinant interferon alfa-2b produced in E. coli by recombinant DNA technology, in 1 mL of solution.
Maltese: U KWANTITATTIVA Kunjett wieħed ta' soluzzjoni għall-injezzjoni jew infużjoni fih 10 miljun IU ta' interferon alfa-2b rikombinanti magħmul fl-E. coli bit-teknoloġija ta' DNA rikombinanti, ġo 1 mL ta' soluzzjoni.
English: IntronA 18 million IU/3 mL solution for injection or infusion interferon alfa-2b
Maltese: IntronA 18-il miljun IU/3 mL soluzzjoni għall-injezzjoni jew infużjoni interferon alfa-2b
English: However, this does not preclude the occurrence of hepatic events in patients with cirrhosis (including hepatocarcinoma).
Maltese: Madankollu dan ma jipprekludix l-okkorrenza ta' avvenimenti epatiċi f'pazjenti b'ċirrożi (inkluża epatokarċinoma).
English: Patients who received IntronA plus ribavirin were less likely to respond than patients who received pegylated interferon alfa-2b and ribavirin.
Maltese: Pazjenti li rċivew IntronA ma' ribavirin kellom anqas probabbiltà li jkollhom rispons minn pazjenti li rċivew interferon pegilat alfa-2b u ribavirin.
English: - One mL of solution contains 6 million IU of interferon alfa-2b.
Maltese: - Millilitru wieħed tas-soluzzjoni fih 6 miljun IU ta' interferon alfa-2b.
English: This enhancement in efficacy included loss of serum HCV (< 100 copies/mL by PCR), improvement in hepatic inflammation, and normalisation of ALT, and was sustained when measured 6 months after the end of treatment.
Maltese: Dan it-titjib fl-effikaċja kien jinkludi t-tnaqqis ta' HCV fis-serum (< 100 kopja/mL bil-PCR), titjib fl infjammazzjoni epatika, u normalizzazzjoni tal-ALT, u kien sostnut meta tkejjel 6 xhur wara t-tmiemtal-kura.
English: During clinical trials, patients who failed to show a virologic response after 6 months of treatment (HCV-RNA below lower limit of detection) did not become sustained virologic responders (HCVRNA below lower limit of detection six months after withdrawal of treatment).
Maltese: Waqt il-provi kliniċi, il-pazjenti li ma wrewx rispons viroloġiku wara 6 xhur ta' kura (HCV-RNA inqas mil-limitu li jista' jkun imkejjel) ma sarux responders sostnuti viroloġiċi (HCV-RNA inqas millimitu li jista' jkun imkejjel sitt xhur wara l-waqfien tal-kura).
English: Obtundation, coma and encephalopathy
Maltese: Obtundation, koma u anormalitajiet kardijaċi
English: - IntronA in combination with ribavirin
Maltese: - IntronA flimkien ma' ribavirin
English: Patients co-infected with HIV and receiving Highly Active Anti-Retroviral Therapy (HAART) may be at increased risk of developing lactic acidosis.
Maltese: Pazjenti koinfettati bl-HIV u li qed jirċievu Terapija AntiRetrovirali Attiva Ħafna (HAART) jistgħu jkunu f'riskju akbar li jiżviluppaw aċidożi lattika.
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-terapija damet 48 ġimgħa b'perjodu ta' follow-up ta' 6 xhur ħlief għall-pazjenti li kienu infettati b'ġenotipi 2 jew 3 u ammont virali ta' < 800,000 IU/mL (Amplicor) li kienu kkurati għal 24 ġimgħa b'perjodu ta 6 xhur follow-up.
English: - The active substance is recombinant interferon alfa-2b.
Maltese: X'fih IntronA - Is-sustanza attiva hi interferon alfa-2b rikombinanti.
English: IntronA 25 million IU/2.5 mL solution for injection or infusion Interferon alfa-2b
Maltese: IntronA 25 miljun IU/2.5 mL soluzzjoni għall-injezzjoni jew infużjoni Interferon alfa-2b
English: Additionally, Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes of the ears, brain and spinal cord), thoughts about threatening the life of others, mania (excessive or unreasonable enthusiasm), bipolar disorders (mood disorders characterized by alternating episodes of sadness and excitement), congestive heart failure, pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), pulmonary fibrosis (scarring of the lungs), and hepatitis B reactivation in HCV/HBV co-infected patients (recurrence of hepatitis B disease) have been reported with IntronA use.
Maltese: Minbarra hekk, bl-użu ta' IntronA kien ġie rrappurtat is-sindrome ta' Vogt-Koyanagi-Harada (marda awtoimmunitarja infjammatorja li taffettwa lill-għajnejn, il-ġilda u l-membrani tal-widnejn, moħħ u sinsla), ħsibijiet dwar li thedded il-ħajja ta' nies oħra, manija (entużjażmu eċċessiv jew mhux raġonevoli), disturbi bipolari (disturbi fil-burdati li l-karatteristika tagħhom hija episodji li jalternaw bejn dwejjaq u eċċitament), insuffiċjenza konġestiva tal-qalb u effużjoni perikardijaka (jinġabar fluwidu bejn il-perikardju (il-kisja tal-qalb) u l-qalb innifisha) fibrożi tal-pulmun (ċikatriċi tal-pulmun) u riattivazzjoni tal-epatite B f'pazjenti koinfettati b'HCV/HBV (rikorrenza tal-marda epatite B).
English: For all patients, if no improvement on serum HBV-DNA is observed after 3 to 4 months of treatment (at the maximum tolerated dose), discontinue IntronA therapy.
Maltese: Għall-pazjenti kollha, jekk ma jidhirx titjib tal-HBV-DNA fis-serum wara 3 sa 4 xhur ta' kura (biddoża massima ttollerata), waqqaf it-terapija b'IntronA.
English: EXP
Maltese: BD
English: IntronA contains less than 1 mmol sodium (23 mg) per 2.5 mL, i.e., essentially "sodium-free".
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) kull 2.5 mL, i.e., jista' jitqies “mingħajr sodium”.
English: EU/1/99/127/030 12 multiple dose vials
Maltese: EU/1/99/127/030 12-il kunjett b'ħafna dożi
English: After intravenous administration, serum interferon levels peaked (135 to 273 IU/mL) by the end of the infusion, then declined at a slightly more rapid rate than after subcutaneous or intramuscular administration of medicinal product, becoming undetectable four hours after the infusion.
Maltese: Wara l-għoti ġol-vina, il-livelli ta' interferon fis-serum laħqu l-ogħla livell (135 sa 273 IU/mL) sattmiem tal-infużjoni, imbagħad naqsu b'rata ftit aktar mgħaġġla milli wara l-għoti tal-prodott mediċinali taħt il-ġilda jew ġol-muskoli, u ma setgħux jitkejlu aktar erba' sigħat wara l-infużjoni.
English: Uncommonly reported side effects: bacterial infection, feeling of pins and needles, and pericarditis (inflammation of the lining of the heart).
Maltese: infezzjoni batterjali, sensazzjoni ta' tingiż, u perikardite (infjammazzjoni tal-kisja tal-qalb).