FrancophonIA/ELRC3.0 huggingface dataset:
English: taste loss, bleeding gums or sores in mouth, burning sensation on tongue, sore tongue, inflamed gums, tooth problem, migraine, respiratory infections, sinusitis, nose bleed, nonproductive cough, rapid or difficult breathing, stuffy or runny nose, thirst, tooth disorder, cardiac murmur (abnormal heart beat sounds), chest pain or discomfort, feeling faint, feeling unwell, flushing, increased sweating, heat intolerance and excessive sweating, low or high blood pressure, palpitations (pounding heart beat), rapid heart rate, bloating, constipation, indigestion, intestinal gas (flatus), increased appetite, irritated colon, irritation of prostate gland, jaundice (yellow skin), loose stools, pain on the right side around your ribs, enlarged liver, stomach upset, frequent need to urinate, passing more urine than usual, urinary tract infection, abnormal urine, difficult, irregular, or no menstrual period, abnormally heavy and prolonged menstrual periods, painful menstruation, disorder of ovary or vagina, breast pain, erectile problem, abnormal hair texture, acne, arthritis, bruising, eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), hives, increased or decreased sensitivity to touch, nail disorder, muscle spasms, numbness or tingling feeling, limb pain, pain in joints, shaky hands, psoriasis, puffy or swollen hands and ankles, sensitivity to sunlight, rash with raised spotted lesions, redness of skin or skin disorder, swollen face, swollen glands (swollen lymph nodes), tense muscles, tumour (unspecified), unsteady when walking, water impairment.
Maltese: - nefħa, stitikezza, indiġestjoni, gass fl-imsaren (flatus), żieda fl-aptit, kolon irritat, irritazzjoni filglandola tal-prostata, suffejra (ġilda safranija), ippurgar maħlul, uġigħ fuq in-naħa tal-lemin madwar il-kustilji, fwied minfuħ, stonku mqallgħa' bżonn tagħmel pipi ta' spiss, tgaħddi aktar urina mis-soltu, infezzjoni fl-apparat urinarju, urina anormali. - pirjid menstruwali diffiċli, irregolari jew nieqes, pirjids menstruwali anormali qawwija u li jdumu, menstruwazzjoni bl-uġigħ, disturbi tal-ovarji jew vaġina, uġigħ fis-sider, problemi ta' impotenza, - għamla tax-xagħar anormali, akne, artrite, tbenġil, ekżema (infjammata, ħamra, bil-ħakk u ġilda xotta, bil-possibilita ta' feriti li jnixxu), urtikarja, żieda jew tnaqqis fis-sensittività għal mess, uġigħ fil-ġogi, idejn jitregħdu, psorjasi, idejn u l-għakkiesi minfuħin, sensitivita għad-dawl taxxemx, raxx bi ġrieħi mtebbgħa, ħmura tal-ġilda jew disturbi tal-ġilda, wiċċ minfuħ, glandoli minfuħin (għoqiedi linfatiċi minfuħin), muskoli mwebbsa, tumur (mhux speċifikat), żbilanċ meta timxi, indeboliment tal-ilma.
English: Package leaflet: Information for the user Ribavirin Teva Pharma B.V. 400 mg film-coated tablets ribavirin
Maltese: Informazzjoni għall-utent Ribavirin Teva Pharma B.V. 400 mg pilloli miksija b'rita ribavirin
English: Single-dose pharmacokinetics of ribavirin in patients with mild, moderate or severe hepatic dysfunction (Child-Pugh Classification A, B or C) is similar to those of normal controls.
Maltese: Il-farmakokinetika ta' doża waħda ta' ribavirin f'pazjenti b'każi ħfief, moderati jew severi ta' fwied mhux qed jaħdem normali (Klassifikazzjoni Child-Pugh A, B jew Ċ) tixbaħ lil dawk tal-kontrolli normali.
English: Some data suggest that HIV/HCV co-infected patients receiving abacavir-containing ART may be at risk of a lower response rate to pegylated interferon/ribavirin therapy.
Maltese: Xi tagħrif jissuġerixxi li pazjenti koinfettati b'HIV/HCV li qed jirċievu abacavir li fih ART jista' jkun f'rata ta' riskju iżgħar ta' rispons għal terapija b'pegylated interferon/ribavirin.
English: If you are a HCV/HIV co-infected adult patient receiving anti-HIV treatment, the addition of this medicine and peginterferon alfa-2b may increase your risk of worsening liver function combined antiretroviral therapy (cART) and increase your risk of lactic acidosis, liver failure, and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets) (NRTI).
Maltese: F'pazjenti koinfettati b'HCV/HIV li qed jirċievu cART, effetti kollaterali oħra li ġejjin seħħew bil-kombinazzjoni ta' ribavirin u peginterferon alfa-2b (mhux elenkat hawn fuq fl-effetti sekondarji tal-adulti): - tnaqqis fl-aptit - uġigħ fid-dahar - tnaqqis fl-għadd ta' limfoċiti ta' CD4 - metaboliżmu difettuż tax-xaħam,
English: Adult patients: Ribavirin Teva Pharma B.V. is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed (see section 5.1).
Maltese: Ribavirin Teva Pharma B.V. hu indikat għall-użu biex jingħata flimkien ma' interferon alfa-2b, għat-trattament ta' pazjenti adulti b'epatite Ċ kronika li qabel kienu wrew rispons (bin-normalizzazzjoni ta' ALT fi tmiem il-kura) għal monoterapija ta' interferon alfa, iżda li wara rkadew (ara sezzjoni 5.1).
English: This medicine in combination with peginterferon alfa-2b or interferon alfa-2b may also cause: dark, cloudy or abnormally coloured urine, difficulty breathing, changes in the way your heart beats, chest pain, pain down left arm, jaw pain, loss of consciousness, loss of use, drooping or loss of power of facial muscles, loss of feeling sensation, loss of vision.
Maltese: Din il-mediċina flimkien ma' peginterferon alfa-2b jew interferon alfa-2b tista' tikkawża wkoll: - urina skura, mċajpra jew mhux ta' kulur normali, - diffikultà biex tieħu n-nifs, bidliet fil-mod kif il-qalb tħabbat, uġigħ lejn 'l isfel tad-dirgħan tax xellug, uġigħ fix-xdaq, - telf ta' koxjenza, - telf ta' użu, tbaxxija jew nuqqas ta' saħħa fil-muskoli tal-wiċċ, nuqqas ta' sensazzjoni tal-mess, - nuqqas ta' vista.
English: Homicidal ideation*, mania*, mental status change
Maltese: Ħsibijiet ta' suwiċidju*, manija*, tibdil fl-istat mentali
English: Anaemia, neutropenia
Maltese: Anemija, newtropenija
English: Haemoglobin levels dropped below 10 g/dL in up to 14 % of adult patients and 7 % of children and adolescents treated with ribavirin in combination with either peginterferon alfa-2b or interferon alfa-2b.
Maltese: Il-livelli ta' emoglobina niżlu għal inqas minn 10 g/dL f'14 % ta' pazjenti adulti u 7 % fi tfal u adoloxxenti ttrattati b'ribavirin flimkien ma' jew peginterferon alfa-2b (adulti biss) jew interferon alfa-2b.
English: Please refer to the SmPC of (peg)interferon alfa for details on the recommendations of monitoring and management regarding the adverse reactions listed below before initiating therapy and other precautions associated with (peg)interferon alfa.
Maltese: Jekk jogħġbok irreferi għall-SmPC ta' (peg)interferon alfa għal dettalji dwar ir-rakkomadazzjonijiet ta' monitoraġġ u mmaniġġjar ta' dak li għandu x'jaqsam mar-reazzjonijiet avversi elenkati taħt qabel tinbeda t-terapija u prekawzjonijiet oħra assoċjati ma' (peg)interferon alfa.
English: Anorexia, increased appetite, decreased appetite
Maltese: Anoreksja, żieda fl-aptit, tnaqqis fl-aptit
English: Package leaflet: Information for the user Ribavirin Teva Pharma B.V. 200 mg film-coated tablets ribavirin
Maltese: Informazzjoni għall-utent Ribavirin Teva Pharma B.V. 200 mg pilloli miksija b'rita ribavirin
English: The following other side effects have also been reported with the combination of this medicine and an alpha interferon product: abnormal thoughts, hearing or seeing images that are not present, altered mental status, disorientation, angioedema (swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing), stroke (cerebrovascular events), Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes 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: L-effetti kollaterali li ġejjin ġew irrapportati wkoll bil-kombinazzjoni ta' din il-mediċina u prodott ta' alpha interferon: - ħsibijiet anormali, tisma' jew tara xbiehat li ma jkunux preżenti, stat mentali mibdul, diżorjentazzjoni - anġjoedema (nefħa tal-idejn, ir-riġlejn, għakkiesi, wiċċ, xofftejn jew griżmejn li jistgħu jikkawżaw diffikultà biex tibla' jew tieħu n-nifs, puplesija (każijiet ċerebrovaskulari), - sindromu ta' Vogt-Koyanagi (disturb infjammatorju awtoimmuni li jaffettwa l-għajnejn, il-ġilda u r-riti tal-widnejn, il-moħħ u l-ispina dorsali), - tidjieq tal-bronki u anafilassi (reazzjoni allerġika severa li taffettwa l-ġisem kollu), sogħla b'mod kostanti, - problemi tal-għajnejn li jinkludu ħsara lir-retina, arterja retinali mxekkla, infjammazzjoni tan-nerv ottiku, nefħa tal-għajnejn u dbabar tat-tajjar(depożiti bojod fuq ir-retina), - erja addominali mkabbra, uġigħ fl-istonku, problemi biċ-ċaqlieq tal-imsaren, jew ċaqlieq talimsaren bl-uġigħ, - reazzjonijiet akuti ta' sensittività eċċessiva li jinkludu urtikarja (ħorriqija), tbenġil, uġigħ qawwi fid-dirgħajn/riġlejn, riġel jew koxxa, ċaqlieq ristrett, ebusija, sarkojdosi (marda karaterizzata b'deni persistenti, telf fil-piż, uġigħ fil-ġog u nefħa, ġrieħi fil-ġilda u glandoli minfuħin)
English: Laboratory values for HCV/HIV co-infected patients
Maltese: Valuri tal-laboratorju għall pazjenti li jkunu infettati b'HCV/HIV fl-istess ħin
English: No pharmacokinetic interaction appears between ribavirin and hepatic function (see section 5.2).
Maltese: Ma tidher l-ebda interazzjoni farmakokinetika bejn ribavirin u l-funzjoni tal-fwied (ara sezzjoni 5.2).
English: - anti-Human Immunodeficiency Virus (HIV) medicines - [nucleoside reverse transcriptase inhibitor (NRTI), and/or combined anti-retroviral therapy (cART)]: Taking this medicine in combination with an alpha interferon and an anti-HIV medicine may increase the risk of lactic acidosis, liver failure, and blood abnormalities development (reduction in number of red blood cells which carry oxygen, certain white blood cells that fight infection, and blood clotting cells called platelets).
Maltese: - mediċini kontra l-Virus tal-Immunodefiċjenza Umana (Human Immunodeficiency Virus - HIV) [inibitur nukleosid ta' reverse transcriptase (NRTI -nucleoside reverse transcriptase inhibitor), u/jew terapija b'kombinazzjoni ta' mediċini antiretrovirali (cART - combined anti-retroviral therapy)]:
English: The mechanism by which ribavirin in combination with other medicinal products exerts its effects against HCV is unknown.
Maltese: Il-mekkaniżmu li bih Ribavirin flimkien ma' prodotti mediċinali oħra jeżerċita l-effetti tiegħu kontra HCV mhux magħruf.
English: Not known side effects (frequency cannot be estimated from the available data):
Maltese: Effetti kollaterali mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-dejta disponibbli):
English: Prior to initiation of treatment with ribavirin the physician must comprehensively inform both male and female patients of the teratogenic risk of ribavirin, the necessity of effective and continuous contraception, the possibility that contraceptive methods may fail and the possible consequences of pregnancy should it occur during or following treatment with ribavirin (see section 4.6).
Maltese: Qabel il-bidu ta' trattament b'ribavirin it-tabib għandu jinforma b'mod komprensiv kemm pazjenti rġiel kif ukoll nisa dwar ir-riskju teratoġeniku ta' ribavirin, il-ħtieġa ta' kontraċezzjoni effettiva u kontinwa, il-possibbiltà li l-metodi ta' kontraċezzjoni jistgħu jfallu u l-konsegwenzi possibbli ta' tqala jekk din isseħħ waqt jew wara trattament b'ribavirin (ara sezzjoni 4.6).
English: From pre-treatment to end of long-term follow up among children treated for 24 or 48 weeks, height for age percentiles decreased 1.3 and 9.0 percentiles, respectively.
Maltese: Minn qabel il-kura sat-tmiem tal-perjodu ta' segwitu fit-tul fost tfal ikkurati għal 24 jew 48 ġimgħa, il-perċentwali tat-tul għall-età naqsu b'1.3 u 9.0 perċentwali, rispettivament.
English: Haematological abnormalities were more frequently reported in patients receiving ribavirin in combination with peginterferon alfa-2b when compared to patients receiving ribavirin in combination with interferon alfa-2b.
Maltese: Anormalitajiet ematoloġiċi kienu rappurtati b'mod aktar frekwenti f'pazjenti li kienu qed jirċievu Ribavirin f'kombinazzjoni ma' peginterferon alfa-2b meta mqabbla ma' pazjenti li kienu qed jirċievu Ribavirin f'kombinazzjoni ma' interferon alfa-2b.
English: Cardiac status must be assessed before start of therapy and monitored clinically during therapy; if any deterioration occurs, therapy must be stopped (see section 4.2).
Maltese: L-istat kardijaku għandu jkun eżaminat qabel tinbeda t-terapija u osservat klinikament waqt it-terapija; jekk iseħħ xi deterjorament, it-terapija għandha titwaqqaf (ara sezzjoni 4.2).
English: Ribavirin must be used in combination with other medicinal products (see section 5.1).
Maltese: Ribavirin għandu jintuża flimkien ma' prodotti mediċinali oħra (ara sezzjoni 5.1).
English: Table 2.
Maltese: (Tabella 2).
English: Vertigo, hearing impaired/loss, tinnitus, ear pain
Maltese: Vertiġini, impediment/telf tas-smiegħ, tinnite, uġigħ fil-widnejn
English: Read the package leaflet before use.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu għal skop kummerċjali.
English: Ribavirin Teva Pharma B.V. must be used in combination therapy as described in section 4.1.
Maltese: Ribavirin Teva Pharma B.V. għandu jintuża f'terapija flimkien ma' mediċini oħra kif deskritt fissezzjoni 4.1.
English: The recommended dose of Ribavirin Teva Pharma B.V. combined with interferon alfa-2b, is shown in the below table.
Maltese: Id-doża rrakkomandata ta' Ribavirin Teva Pharma B.V. mogħti flimkien ma' interferon alfa-2b, qed tintwera fit-tabella taħt.
English: Abnormal behaviour, depressed mood, emotional disorder, fear, nightmare
Maltese: Mġieba anormali, burdata depressa, disturbi emozzjonali, biża', ħmar il-lejl
English: Thrombocytopenia, lymphadenopathy
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Face oedema
Maltese: U LUŻU
English: If pregnancy does occur during treatment or within four months from stopping treatment, the patient must be advised of the significant teratogenic risk of ribavirin to the foetus (see section 4.4).
Maltese: Jekk it-tqala sseħħ waqt it-trattament, jew sa erba' xhur minn wara li jintemm it-trattament, il-pazjenta għandha tkun infurmata bir-riskju sinifikanti għal teratoġeniċità ta' ribavirin għall-fetu (ara sezzjoni 4.4).
English: Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin Teva Pharma B.V. (see sections 4.3, 4.4 and 5.3).
Maltese: Fi studji qabel l-użu kliniku intwera li ribavirin huwa teratoġeniku u tossiku għall-ġeni (ara sezzjonijiet 4.4 u 5.3).
English: Pruritus, photosensitivity reaction, maculopapular rash, hyperhidrosis, eczema, acne, skin disorder, nail disorder, skin discolouration, dry skin, erythema, bruise
Maltese: Ħakk, reazzjoni ta' fotosensittività, raxx makulopapulari, ekżema, iperidrosi, akni, disturbi tal-ġilda, disturbi taddwiefer, tibdil fil-kulur tal-ġilda, ħakk, ġilda xotta, eritema, tbenġil,
English: Both the Metavir score and Ishak grade decreased among subjects treated with ribavirin in combination with peginterferon alfa-2b.
Maltese: Kemm-il punteġġ Metavir u l-grad Ishak naqsu fost l-individwi ttrattati b'ribavirin f'kombinazzjoni ma' peginterferon alfa-2b.
English: Please refer to the corresponding Summary of Product Characteristics (SmPC) of medicinal products used in combination with Ribavirin Teva Pharma B.V. for prescribing information particular to that product and for further dosage recommendations on co-administration with Ribavirin Teva Pharma B.V..
Maltese: Jekk jogħġbok irreferi għall-SmPC korrispondenti tal-prodotti mediċinali użati flimkien ma' Ribavirin Teva Pharma B.V. għal rakkomandazzjonijiet dwar twaqqif jew bidla fid-doża.
English: Uncommon
Maltese: Komuni
English: The purpose of the study was to annually evaluate the durability of sustained virologic response (SVR) and assess the impact of continued viral negativity on clinical outcomes for patients who were sustained responders 24 weeks post-treatment of the 48-week interferon alfa-2b and ribavirin treatment.
Maltese: L-iskop tal-istudju kien li kull sena tiġi evalwata d-durabilità tar-rispons viroloġiku sostnut (SVR) u sabiex tiġi assessjata l-impatt negattiv virali li ssokta fuq pazjenti li rrispondew b'mod sostnut għal 24 ġimgħa wara l-kura ta' 48 ġimgħa bit-trattament ta' interferon alfa-2b u ribavirin.
English: seizure (convulsions) pneumonia, rheumatoid arthritis, kidney problems, dark or bloody stools, intense abdominal pain sarcoidosis (a disease characterised by persistent fever, weight loss, joint pain and swelling, skin lesions and swollen glands), vasculitis.
Maltese: - puplesija (konvulżjonijiet) - pnewmonja, - artrite rewmatojdi, problemi bil-kliewi - ippurgar skur jew bid-demm, uġigħ addominali qawwi - sarkojdosi (marda kkaraterizzata b'deni persistenti, telf fil-piż, uġigħ fil-ġogi u nefħa, ġrieħi fuq il ġilda u glandoli minfuħa) - vaskulite.
English: 1,200 mg/day) d + interferon alfa-2b (3 MIU TIW)
Maltese: Ribavirin (8001,200 mg/jum) d + interferon alfa-2b (3 MIU TIW)
English: The use of ribavirin 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' ribavirin f'kombinazzjoni ma' peginterferon alfa-2b ma deherx li kellu impatt negattiv fuq il-kontroll ta' viraemja bl-HIV waqt it-terapija jew fiż-żmien ta' follow-up.
English: SVR after treatment of chronic HCV with interferon alfa-2b (pegylated and nonpegylated, with or without ribavirin) results in long-term clearance of the virus providing resolution of the hepatic infection and clinical 'cure' from chronic HCV.
Maltese: SVR wara kura b'HCV kroniku b'interferon alfa-2b (pegilat u mhux pegilat, bi jew mingħajr ribavirin) wassal għal tneħħija fuq terminu ta' żmien twil tal-virus b'hekk tgħaddi linfezzjoni epatika ‘b'kura' klinika minn HCV kronika.
English: p valuea
Maltese: OĦRAJN
English: Please refer to the corresponding Summary of Product Characteristics of the antiretroviral medicinal products that are to be taken concurrently with HCV therapy for awareness and management of toxicities specific for each product and the potential for overlapping toxicities with Ribavirin Teva Pharma B.V in combination with other medicinal products.
Maltese: Jekk jogħġbok irreferi għall-SmPC korrispondenti ta' prodotti mediċinali li jintużaw flimkien ma' ribavirin għal effetti addizzjonali mhux mixtieqa rrappurtati b'dawn il-prodotti.
English: The pharmacokinetics of ribavirin is altered in patients with renal dysfunction due to reduction of apparent creatinine clearance in these patients (see section 5.2).
Maltese: Il-farmakokinetika ta' ribavirin tinbidel f'pazjenti b'funzjoni ħażina tal-kliewi minħabba tnaqqis fittneħħija apparenti tal-kreatinina f'dawn il-pazjenti (ara sezzjoni 5.2).
English: If the abnormality is reversed, ribavirin 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, ribavirin 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: Most cases of anaemia, neutropenia, and thrombocytopenia were mild (WHO grades 1 or 2).
Maltese: Il-maġġoranza tal-każijiet ta' anemija, newtropenija, u tromboċitopenija kienu ħfief (gradi 1 jew 2 tal-WHO).
English: In the HIV-positive population receiving an NRTI regimen, physicians should carefully monitor markers of mitochondrial toxicity and lactic acidosis when ribavirin is administered.
Maltese: Fil-popolazzjoni pożittiva għal HIV li qed jirċievu programm ta' trattament ta' NRTI, it-tobba għandhom josservaw b'attenzjoni l-markers ta' tossiċità mitokondrijali u aċidosi lattika meta jingħata ribavirin.
English: In addition, in a 26 week carcinogenicity study using the heterozygous p53(+/-) mouse model, ribavirin did not produce tumours at the maximally tolerated dose of 300 mg/kg (plasma exposure factor approximately 2.5 compared to human exposure).
Maltese: Barra minn hekk, fi studju dwar il-karċinoġeniċità fuq 26 ġimgħa bl-użu tal-mudell heterozygous p53(+/-) tal-ġurdien, ribavirin ma kkawżax tumuri fid-doża massima ttollerata ta' 300 mg/kg (fattur tal-espożizzjoni tal-plażma ta' madwar 2.5 meta mqabbel ma' l-espożizzjoni għal bniedem).
English: Due to substantial increases in ribavirin plasma concentrations in patients with moderate and severe renal impairment, ribavirin dose adjustments are recommended in adult patients with creatinine clearance < 50 mL/minute.
Maltese: Minħabba żidiet sostanzjali fil-konċentrazzjonijiet ta' ribavirin fil-plażma f'pazjenti b'indeboliment moderat u sever tal-kliewi, huma rrakkomandati aġġustamenti fid-doża ta' ribavirin f'pazjenti adulti bi tneħħija tal-kreatinina ta' < 50 mL/minuta.
English: The safety of ribavirin is evaluated from data from four clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied ribavirin in combination with interferon alfa-2b, two trials studied ribavirin in combination with peginterferon alfa-2b.
Maltese: Is-sigurtà ta' ribavirin hija evalwata minn tagħrif miġbur minn erba' studji kliniċi f'pazjenti li ma kellhom ebda esponiment għal interferon (pazjenti inkonsapevoli dwar interferon): żewġ provi studjaw ribavirin flimkien ma' interferon alfa-2b, żewġ provi studjaw ribavirin flimkien ma' peginterferon alfa-2b.
English: Daily ribavirin dose
Maltese: Doża ta' ribavirin
English: Ribavirin has been shown to produce high inter and intra subject pharmacokinetic variability following single oral doses (intrasubject variability of approximately 30 % for both AUC and Cmax), which may be due to extensive first pass metabolism and transfer within and beyond the blood compartment.
Maltese: Ribavirin intwera li jipproduċi varjabilità farmakokinetika għolja bejn u fl-individwi wara dożi waħidhom mill-ħalq (b'varjabilità ta' bejn l-individwi ta' madwar 30 % kemm għal AUC u għal Cmax), li għandha mnejn tkun minħabba l-metaboliżmu estensiv tal-ewwel passaġġ u t-trasferiment ġo u 'l barra mill-komportament tad-demm.
English: EXP
Maltese: Lott
English: Paediatric patients (children 3 years of age and older and adolescents: Ribavirin Teva Pharma B.V. is indicated in a combination regimen with interferon alfa2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA.
Maltese: Ribavirin Teva Pharma B.V. huwa indikat għall-użu, fi programm ta' terapija kkombinat ma' interferon alfa-2b, għal trattament fi tfal u adoloxxenti minn 3 snin 'il fuq, li għandhom kull tip ta' epatite Ċ kronika, ħlief ġenotip 1. li ma kienux ikkurati qabel, mingħajr fwied mhux kompensat, u li huma pożittivi għal HCV-RNA.
English: urinary FSH (n = 116)
Maltese: FSH urinarju (n = 116)
English: • The active substance is follitropin alfa.
Maltese: • Is-sustanza attiva hija follitropin alfa.
English: The pH of the solution is 6.7 - 7.3.
Maltese: Il-pH tas-soluzzjoni hu 6.7 - 7.3.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance Polymun Scientific Immunbiologische Forschung GmbH Donaustraße 99
Maltese: Polymun Scientific Immunbiologische Forschung GmbH Donaustraße 99