FrancophonIA/ELRC3.0 huggingface dataset:
English: - class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide) - class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide) - some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
Maltese: (eż. quinidine, disopyramide, amiodarone, sotalol), Mediċini li jintużaw għal disturbi mentali (eż. thioridazine, chlorpromazine, levomepromazine) u mediċini oħrajn bħal ċerti antibijotiċi (eż. sparfloxacine, pentamidine) jew ċerti mediċini għall-kura ta' reazzjonijiet allerġiċi (eż.
English: Hepatobiliary disorders Not known:
Maltese: Kanċer tal-ġilda mhux melanoma:
English: In patients taking telmisartan alone the following additional side effects have been reported:
Maltese: F'pazjenti li kienu qed jieħdu telmisartan waħdu, l-effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
English: Plasma concentrations of telmisartan are generally 2-3 times higher in females than in males.
Maltese: Il-konċentrazzjonijiet ta' telmisartan fil-plażma huma ġeneralment 2-3 darbiet ogħla fin-nisa milli flirġiel.
English: Package leaflet: Information for the user Actelsar HCT 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Maltese: Informazzjoni għall-utent Actelsar HCT 80 mg/25 mg pilloli telmisartan/hydrochlorothiazide
English: EU/1/13/817/045 EU/1/13/817/029 EU/1/13/817/046 EU/1/13/817/030 EU/1/13/817/031 EU/1/13/817/032 EU/1/13/817/033
Maltese: EU/1/13/817/030 EU/1/13/817/031 EU/1/13/817/032 EU/1/13/817/033 EU/1/13/817/034
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin or other medicinal products such as heparin sodium).
Maltese: Prodotti mediċinali li jistgħu jżidu l-livelli tal-potassium jew jikkaġunaw iperkalemija (eż. inibituri ta' ACE, dijuretiċi potassium-sparing, supplimenti tal-potassium, sostituti tal-melħ li fihom il-potassium, cyclosporin jew prodotti mediċinali oħrajn, bħal heparin sodium).
English: Hydrochlorothiazide: Following oral administration of telmisartan/hydrochlorothiazide, peak concentrations of hydrochlorothiazide are reached in approximately 1.0-3.0 hours after dosing.
Maltese: Wara l-għoti ta' telmisartan/hydrochlorothiazide mill-ħalq, il-konċentrazzjonijiet massimi ta' hydrochlorothiazide jintlaħqu wara madwar 1.0 - 3.0 sigħat wara d-dożaġġ.
English: Experience with telmisartan/hydrochlorothiazide is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Maltese: L-esperjenza b' telmisartan/hydrochlorothiazide hi modesta f'dawk il-pazjenti b'indeboliment renali minn ħafif sa moderat, u għalhekk, monitoraġġ pejodiku tallivelli tal-potassium, tal-krejatinina u ta' l-uric acid serum hu rakkomandat.
English: - Heart trouble.
Maltese: Disturbi vaskulari
English: Diarrhoea, dry mouth, flatulence
Maltese: Suffejra epatoċellulari, suffejra kolestatika
English: Package leaflet: Information for the user Actelsar HCT 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: Informazzjoni għall-utent Actelsar HCT 40 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: Upper respiratory tract infection, urinary tract infection including cystitis
Maltese: Ngħas Disturbi respiratorji, toraċiċi u medjastinali
English: Slow heartbeat, dizziness, vomiting, reduced kidney function including kidney failure, have also been reported.
Maltese: Taħbit bil-mod tal-qalb, sturdament, rimettar, tnaqqis fil-funzjoni tal-kliewi li jinkludi insuffiċjenza tal-kliewi, ġew irrappurtati wkoll.
English: Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Maltese: It-thiazides jistgħu jnaqqsu it-tneħħija ta' kalċju ma' l-awrina u jikkawżaw żieda żgħira u intermittenti ta' kalċju fis-serum fl-assenza ta' disturbi magħrufa tal-metaboliżmu tal-kalċju.
English: Side effects of unknown frequency (frequency cannot be estimated from the available data) Inflammation of the salivary gland, skin and lip cancer (Non-melanoma skin cancer), decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count, serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body's immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling , fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.
Maltese: tnaqqis fin-numru (jew anke nuqqas) ta' ċelluli fid-demm, li jinkludu għadd baxx taċ-ċelluli tad-demm ħomor u taċ-ċelluli tad-demm bojod, reazzjonijiet allerġiċi serji (eż. sensittività eċċessiva, reazzjoni anafilattika), tnaqqis jew telf tal-aptit, nuqqas ta' kwiet f'ġismek, sturdament, vista mċajpra jew tara kollox isfar, tnaqqis fil-vista u wġigħ fl- għajnejn (sinjali possibbli ta' mijopja akuta jew glawkoma ta' angolu magħluq), infjammazzjoni tal-vini jew arterji (vaskulite nekrotizzanti), frixa infjammata, stonku mqalleb, sfurija tal-ġilda jew ta' l-għajnejn (suffejra), sindrome qisu lupus (kundizzjoni li tixbah ħafna lil marda msejħa lupus erythematosus sistemiku fejn is-sistema immuni tal-ġisem tattakka lill-ġisem); disturbi tal-ġilda bħal vini jew arterji infjammati, żieda fis-sensittività għad-dawl tax-xemx, raxx, ħmura tal-ġilda, infafet fix-xufftejn, għajnejn jew ħalq, tqaxxir tal-ġilda, deni (sinjali possibbli ta'
English: Actelsar HCT 80 mg/25 mg tablets are white or almost white, 9.0 x 17.0 mm oval-shaped and biconvex tablets marked with “TH” on one side and “25” on the other side.
Maltese: x 17.0 mm, pilloli ovali u konvessi mmarkati b' “TH” fuq naħa waħda u “25” fuq in-naħa l-oħra.
English: In patients taking hydrochlorothiazide alone the following additional side effects have been reported:
Maltese: F'pazjenti li kienu qed jieħdu hydrochlorothiazide waħdu, l-effetti sekondarji addizzjonali li ġejjin kienu rrappurtati:
English: Contents of the pack and other information What Actelsar HCT contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Actelsar HCT
English: Package leaflet: Information for the user Actelsar HCT 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Maltese: Informazzjoni għall-utent Actelsar HCT 80 mg/12.5 mg pilloli telmisartan/hydrochlorothiazide
English: - Amantadine (medicine used to treat Parkinson's disease and also used to treat or prevent certain illnesses caused by viruses).
Maltese: - Amantadine (mediċina użata biex tikkura l-marda ta' Parkinson u tintuża wkoll biex tikkura jew tipprevjeni ċertu mard ikkawżat mill-viruses).
English: Light-headedness
Maltese: Iperkalemija
English: Sepsis including fatal outcome3 Blood and lymphatic system disorders Uncommon:
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni:
English: When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Maltese: Meta jkun klinikament xieraq, bidla diretta minn monoterapija għat-taħlita tista tkun ikkunsidrata.
English: Co-administration of thiazide may increase the incidence of hypersensitivity reactions of allopurinol.
Maltese: Sindrome qisu tal-lupus, reazzjonijiet ta' sensittività għad- dawl,
English: Nephritis interstitial, renal dysfunction, glycosuria General disorders and administration site conditions Not known:
Maltese: Nefrite interstizjali, disfunzjoni renali, glikosurja
English: pentamidine, sparfloxacine, terfenadine, vincamine IV)
Maltese: lassattivi, kortikosterojdi, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid u derivattivi tiegħu)
English: Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of Actelsar HCT, hyperkalaemia might occur.
Maltese: Għal kuntrarju, minħabba l-antaġoniżmu tar-riċetturi ta' angiotensin II (AT1) mill-komponent ta' telmisartan ta' Actelsar HCT, tista' sseħħ l-iperkalemija.
English: Side effects of unknown frequency (frequency cannot be estimated from the available data) Inflammation of the salivary gland, skin and lip cancer (Non-melanoma skin cancer), decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count, serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body's immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling , fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in patients with a diagnosis of diabetes mellitus,or fat in the blood.
Maltese: Tnaqqis fil-livelli tal-potassium fid-demm, ansjetà, ħass ħażin (sinkope), sensazzjoni ta' tnemnim, sensazzjoni bħal qisu xi ħadd qed iniggżek bil-labar (parestesija), tħoss kollox idur bik (vertigo), taħbit tal-qalb mgħaġġel (takikardija), disturbi fir-ritmu tat-taħbit tal-qalb, pressjoni tad-demm baxxa, ilpressjoni tad-demm taqa' f'daqqa meta tkun bilwieqfa, qtugħ ta' nifs (dispneja), dijarea, ħalq xott, gass, uġigħ fid-dahar, spażmi fil-muskoli, uġigħ fil-muskoli, disfunzjoni erettili (ma tkunx kapaċi jkollok jew iżżomm erezzjoni), uġigħ fis-sider, żieda fil-livelli tal-uric acid fid-demm.
English: Metformin
Maltese: Treddigħ
English: Arthrosis, tendon pain
Maltese: Dijarea, ħalq xott, gass
English: Telmisartan: Following oral administration, peak concentrations of telmisartan are reached in 0.5-1.5 h after dosing.
Maltese: Wara l-għoti mill-ħalq, konċentrazzjonijiet massimi ta' telmisartan jintlaħqu wara 0.5-1.5 siegħa wara d-dożaġġ.
English: EU/1/13/817/014 EU/1/13/817/015 EU/1/13/817/044 EU/1/13/817/016 EU/1/13/817/017 EU/1/13/817/018 EU/1/13/817/019
Maltese: EU/1/13/817/035 EU/1/13/817/036 EU/1/13/817/037 EU/1/13/817/038 EU/1/13/817/039 EU/1/13/817/040
English: Ear and labyrinth disorders Uncommon:
Maltese: Disturbi fil-widnejn u fis- sistema labirintika Mhux komuni:
English: There is no clinical experience with Actelsar HCT in patients with hepatic impairment.
Maltese: M'hemm l-ebda esperjenza klinika b' Actelsar HCT f'pazjenti b'indeboliment epatiku.
English: Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart rate (faster than 100 beats per minute).
Maltese: Sintomi tipiċi ta' żbilanċ tal-fluwidu jew ta' l-elettroliti jinkludu ħalq xott, dgħufija, letarġija, ngħas, nuqqas ta' kwiet f'ġismek, uġigħ fil-muskoli jew bugħawwieġ, nawseja (tħossok ser tirremetti), rimettar, muskoli għajjenin, rata anormali ta' taħbit mgħaġġel tal-qalb (iktar minn 100 taħbita kull minuta).
English: Further information on Aflunov can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/aflunov.
Maltese: Aktar informazzjoni dwar Aflunov tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/aflunov.
English: Aflunov received a marketing authorisation valid throughout the EU on 29 November 2010.
Maltese: Aflunov irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fid-29 ta' Novembru 2010.
English: Other information about Aflunov
Maltese: Informazzjoni oħra dwar Aflunov
English: Aflunov contains a flu strain called A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1).
Maltese: Aflunov fih razza tal-influwenza msejħa A/turkey/Turkey/1/2005 razza simili għal (H5N1) (NIBRG-23) (clade 2.2.1).
English: Aflunov should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, including those found at trace (very low) levels (egg or chicken protein, ovalbumin [a protein in egg white], kanamycin or neomycin sulphate [antibiotics], barium sulphate, formaldehyde and cetyltrimethylammonium bromide).
Maltese: Aflunov ma għandux jingħata lil pazjenti li kellhom reazzjoni anafilattika (reazzjoni allerġika severa) għal kwalunkwe wieħed mill-komponenti tal-vaċċin, inklużi dawk li nstabu f'livelli ta' traċċi (baxxi ħafna) (proteina ta' bajd jew ta' tiġieġa, ovalbumina [proteina fl-abjad tal-bajd], kanamiċina jew sulfat tan-neomiċina [antibijotiċi], sulfat tal-barju, formaldeid u bromur taċ-ċetiltrimetilammonju).
English: In the first study, 21 days after the second injection, around 90% of people aged below 60 years and around 80% of those aged above 60 years had levels of antibodies that would protect them against H5N1.
Maltese: Fl-ewwel studju, 21 jum wara t-tieni injezzjoni, madwar 90 % tal-persuni li kellhom inqas minn 60 sena u madwar 80 % ta' dawk li kellhom aktar minn 60 sena kellhom livelli ta' antikorpi li jipproteġuhom kontra l-H5N1.
English: The study showed that 21 days after the second injection, around 70% of adults below 60 years and around 64% of adults above 60 years produced an acceptable antibody response.
Maltese: L-istudju wera li 21 jum wara t-tieni injezzjoni, madwar 70 % tal-adulti li kellhom inqas minn 60 sena u madwar 64 % tal-adulti li kellhom aktar minn 60 sena pproduċew rispons ta' antikorp aċċettabbli.
English: This vaccine contains some parts of the H5N1 virus.
Maltese: Dan il-vaċċin fih xi partijiet tal-virus H5N1.
English: A third study, using a vaccine with strain A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23), was carried out in 343 adults aged below and above 60 years.
Maltese: It-tielet studju, li uża vaċċin b'razza A/turkey/Turkey/1/2005 razza simili għal (H5N1) (NIBRG-23), twettaq fi 343 adult li kellhom inqas u aktar minn 60 sena.
English: What are the risks associated with Aflunov?
Maltese: X'inhuma r-riskji assoċjati ma' Aflunov?
English: It was noted that it is likely that a H5N1 strain of influenza will cause a pandemic in the future and Aflunov was shown to produce sufficient antibodies to stimulate an immune response and protect against H5N1.
Maltese: Ġie nnutat li huwa probabbli li razza H5N1 tal-influwenza tikkawża pandemija fil-futur u Aflunov intwera li jipproduċi biżżejjed antikorpi biex jistimula rispons immunitarju u jipproteġi kontra l-H5N1.
English: Aflunov is a vaccine used in adults to protect against flu caused by the H5N1 (‘bird flu') strain of the influenza A virus.
Maltese: Aflunov huwa vaċċin li jintuża fl-adulti biex jipproteġi kontra l-influwenza kkawżata mir-razza H5N1 (“influwenza tat-tjur”) tal-virus tal-influwenza A.
English: In the second study involving 240 people, subjects were given Aflunov using different vaccination schedules.
Maltese: Fit-tieni studju li fih ħadu sehem 240 persuna, is-suġġetti ngħataw Aflunov bl-użu ta' skedi ta' vaċċinazzjoni differenti.
English: Aflunov has been shown to produce sufficient antibodies to stimulate an immune response and protect against H5N1.
Maltese: Intwera li Aflunov jipproduċi biżżejjed antikorpi biex jistimula rispons immunitarju u jipproteġi kontra lH5N1.
English: The most common side effects with Aflunov (which may affect more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of injection (swelling, pain, induration and redness) and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Aflunov (li jistgħu jaffettwaw aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, mijalġija (uġigħ fil-muskoli), reazzjonijiet fil-post tal-injezzjoni (nefħa, uġigħ, ebusija u ħmura) u għeja (ħedla).
English: At the time of the initial marketing authorisation, two main studies using a strain called A/Vietnam/1194/2004 (H5N1)-like strain (NIBRG-14) provided data on vaccination with Aflunov in healthy adults aged below and above 60 years.
Maltese: Fiż-żmien tal-awtorizzazzjoni inizjali għat-tqegħid fis-suq, żewġ studji ewlenin bl-użu ta' razza msejħa A/Vietnam/1194/2004 razza simili għal (H5N1) (NIBRG-14) ipprovdew data dwar il-vaċċinazzjoni b'Aflunov f'adulti b'saħħithom li għandhom aktar jew inqas minn 60 sena.
English: In one study involving 3,372 people, subjects were given either a seasonal flu vaccine followed by two doses of Aflunov three weeks apart, or placebo (a dummy vaccine) followed by two doses of an adjuvanted seasonal vaccine three weeks apart.
Maltese: Fi studju wieħed li fih ħadu sehem 3,372 persuna, is-soġġetti ngħataw jew vaċċin kontra l-influwenza staġjonali segwit minn żewġ dożi ta' Aflunov bi tliet ġimgħat bejn doża u oħra, jew plaċebo (vaċċin finta) segwit minn żewġ dożi ta' vaċċin staġjonali aġġuvant bi tliet ġimgħat bejn doża u oħra.
English: As for all medicines, data on the use of Aflunov are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Aflunov hija ssorveljata kontinwament.
English: The studies looked at the ability of the vaccine to trigger the production of antibodies (‘immunogenicity') against the flu virus.
Maltese: L-istudji ħarsu lejn l-abbiltà tal-vaċċin li jiskatta l-produzzjoni tal-antikorpi (“immunoġeniċità”) kontra l-virus tal-influwenza.
English: For the full list of side effects of Aflunov, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Aflunov, ara l-fuljett ta' tagħrif.
English: A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people do not have immunity (protection) against it. Health experts are concerned that a future flu pandemic could be caused by the H5N1 strain of the virus, an infection that can spread from birds to humans (a ‘zoonotic' infection).
Maltese: L-esperti tas-saħħa huma mħassba li pandemija tal-influwenza filfutur tista' tiġi kkawżata mir-razza H5N1 tal-virus, infezzjoni li tista' tinfirex mill-għasafar għallbnedmin (infezzjoni “żoonotika”).
English: The vaccine contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Maltese: Il-vaċċin fih “aġġuvant” (kompost li fih iż-żejt) biex itejjeb ir-rispons immunitarju.
English: How does Aflunov work?
Maltese: Kif jintuża Aflunov?
English: Aflunov is a type of vaccine to be given before or during a flu pandemic to protect against a new strain of flu.
Maltese: Aflunov huwa tip ta' vaċċin li għandu jingħata qabel jew matul pandemija tal-influwenza biex jipproteġi kontra razza ġdida tal-influwenza.
English: When a person is given the vaccine, the immune system recognises the virus parts in the vaccine as ‘foreign' and makes antibodies against them.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf ilpartijiet tal-virus fil-vaċċin bħala “barranin” u tipproduċi antikorpi kontrihom.
English: Side effects reported with Aflunov are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Aflunov huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Package size bottle (HDPE)
Maltese: Daqs tal-pakkett flixkun (HDPE)
English: Poligono Industrial Malpica 50016 Zaragoza Spain
Maltese: Poligono Industrial Malpica 50016 Zaragoza Spanja
English: Date of first authorisation: 31 March 2009 Date of latest renewal: 16 January 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 31 ta' Marzu 2009 Data tal-aħħar tiġdid: 16 ta' Jannar 2014
English: 3 capsulesa
Maltese: 3 kapsulia
English: Teva Pharma SLU C/C, no 4
Maltese: SLU C/C, no 4
English: EU/1/09/509/001 - 84 capsules EU/1/09/509/002 - 112 capsules EU/1/09/509/003 - 140 capsules EU/1/09/509/004 - 168 capsules
Maltese: EU/1/09/509/001 - 84 kapsula EU/1/09/509/002 - 112-il kapsula EU/1/09/509/003 - 140 kapsula EU/1/09/509/004 - 168 kapsula
English: Genotype 2/3/4 (n=26)
Maltese: Ġenotip 2/3/4 (n=26)
English: 84 hard capsules 112 hard capsules 140 hard capsules 168 hard capsules
Maltese: 84 kapsula 112 kapsula 140 kapsula 168 kapsula
English: Overall Responsea (n=118)
Maltese: Rispons Globalia (n=118)
English: EU/1/09/509/001 (84 capsules) EU/1/09/509/002 (112 capsules) EU/1/09/509/003 (140 capsules) EU/1/09/509/004 (168 capsules)
Maltese: EU/1/09/509/001 (84 kapsula) EU/1/09/509/002 (112-il kapsula) EU/1/09/509/003 (140 kapsula) EU/1/09/509/004 (168 kapsula)
English: Genotype 1 (n=92)
Maltese: Ġenotip 1 (n=92)
English: Capsule contents Calcium hydrogen phosphate Croscarmellose sodium Povidone
Maltese: Il-kontenut tal-kapsula Calcium hydrogen phosphate Croscarmellose sodium Povidone
English: The active substance is Ribavirin 200 mg
Maltese: Is-sustanza attiva hi Ribavirin 200 mg
English: Ribavirin Teva contains the active substance ribavirin.
Maltese: Ribavirin Teva fih is-sustanza attiva ribavirin.
English: Ribavirin dose (mg/kg)
Maltese: Doża ta' Ribavirin (mg/kg)
English: Patients with low CD4 counts:
Maltese: Tnaqqis fil-limfoċiti CD4:
English: Capsule imprint Shellac
Maltese: Impronta fuq il-kapsula Shellac
English: Ribavirin capsules are packaged in blisters consisting of polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC)-aluminium blister packs
Maltese: Il-kapsuli ribavirin huma ppakkjati ġo folji li jikkonsistu minn polyvinyl chloride (PVC)/polyethylene (PE)/polyvinylidene chloride (PVdC)-pakketti ta' folji tal-aluminju
English: Carrat F, Bani-Sadr F, Pol S et al. JAMA 2004; 292(23):
Maltese: Carrat F, Bani-Sadr F, Pol S et al.
English: Ribavirin is a synthetic nucleoside analogue which has shown in vitro activity against some RNA and DNA viruses.
Maltese: Ribavirin huwa analogu sintetiku ta' nucleosajd li wera attività in vitro kontra xi RNA u DNA talvirusis.
English: Genotype 1 > 600,000 IU/mL
Maltese: Ġenotip 1 ≤ 600,000 IU/mL Kollha Ġenotip 1 > 600,000 IU/mL Kollha
English: The other ingredients are calcium hydrogen phosphate, croscarmellose sodium, povidone, magnesium stearate.
Maltese: Is-sustazi l-oħra huma calcium hydrogen phosphate, croscarmellose sodium, povidone, magnesium stearate.
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne, East Sussex BN22 9AG UK
Maltese: Hampden Park Eastbourne, East Sussex BN22 9AG
English: − stroke (cerebrovascular events).
Maltese: - suwiċidju - puplesija (episodji ċerebrovaskulari).
English: In clinical trials of 118 children and adolescents 3 to 16 years of age treated with combination therapy of interferon alfa-2b and ribavirin, 6 % discontinued therapy due to adverse events.
Maltese: Fi provi kliniċi fuq 118-il tifel u tifla u adoloxxent bejn l-etajiet ta' 3 snin sa 16-il sena, ikkurati b'terapija kkombinata ta' interferon alfa-2b u riavirin, 6 % waqqfu t-terapija minħabba reazzjonijiet avversi.