FrancophonIA/ELRC3.0 huggingface dataset:
English: Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, night sweats, hyperhidrosis, dermatitis, acne, furuncule, erythema, urticaria, skin disorder, bruise, sweating increased, abnormal hair texture, nail disorder*
Slovenian: Pogosti psoriaza, poslabšanje psoriaze, ekcem, preobčutljivostna reakcija za svetlobo, makulopapulozni izpuščaj, eritematozni izpuščaj, nočno potenje, hiperhidroza, dermatitis, akne, furunkli, eritem, urtikarija, kožne bolezni, podplutbe, povečano potenje, nenormalna tekstura las, bolezni nohtov*
English: For weight, pre-treatment to end of long term follow up, weight for age percentiles decreased 1.3 and 5.5 percentiles among children treated for 24 weeks or 48 weeks, respectively.
Slovenian: Za telesno maso se je percentil telesne mase za starost od časa pred zdravljenjem do konca dolgoročnega spremljanja otrokom, zdravljenim 24 tednov, zmanjšal za 1,3 percentila in otrokom, zdravljenim 48 tednov, za 5,5 percentila.
English: Adult patients: Ribavirin Teva Pharma B.V. is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA (see section 4.4).
Slovenian: je indicirano v kombinaciji s interferonom alfa2b za zdravljenje odraslih bolnikov z vsemi tipi kroničnega hepatitisa C, razen genotipa 1, ki predhodno še niso bili zdravljeni, nimajo jetrne dekompenzacije, imajo zvišano vrednost alaninaminotransferaze (ALT) in so pozitivni na ribonukleinsko kislino virusa hepatitisa C RNA-HCV (glejte poglavje 4.4).
English: The Kaplan-Meier estimate for continued sustained response over 5 years is 98 % [95 % CI: 95 %, 100 %] for paediatric patients treated with interferon alfa-2b and ribavirin.
Slovenian: Kaplan-Meierjeva ocena ohranitve trajnega virološkega odziva v času 5 let pri pediatričnih bolnikih, zdravljenih z interferonom alfa-2b in ribavirinom, znaša 98 % [95 % IZ: 95 %, 100 %].
English: Mitochondrial toxicity and lactic acidosis have been reported in HIV-positive patients receiving NRTI regimen and associated-ribavirin for co-HCV infection (see section 4.4).
Slovenian: Pri HIV-pozitivnih bolnikih, ki so prejemali shemo NRTI skupaj z ribavirinom zaradi sočasne okužbe s HCV, so poročali o mitohondrijski toksičnosti in o laktacidozi (glejte poglavje 4.4).
English: Other medicines and Ribavirin Teva Pharma B.V.
Slovenian: Druga zdravila in zdravilo Ribavirin Teva Pharma B.V.
English: What Ribavirin Teva Pharma B.V. is and what it is used for What you need to know before you use Ribavirin Teva Pharma B.V. How to use Ribavirin Teva Pharma B.V.
Slovenian: in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Ribavirin Teva Pharma B.V.
English: Micturition frequency, polyuria, urine abnormality
Slovenian: pogosto uriniranje, poliurija, nenormalen seč
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).
Slovenian: Pri uporabi kombinacije tega zdravila in zdravil, ki vsebujejo interferon alfa, so poročali tudi o naslednjih neželenih učinkih: - nenormalne misli, slišanje ali videnje stvari, ki ji ni, spremenjeno duševno stanje, dezorientacija, - angioedem (otekanje dlani, stopal, gležnjev, obraza, ustnic, ust ali žrela, ki lahko povzroči težave pri požiranju ali dihanju), možganska kap (možganskožilni dogodki), - sindrom Vogt-Koyanagi-Harada (avtoimunska vnetna bolezen, ki prizadene oči, kožo in sluznice ušes ter ovojnice možganov in hrbtenjače), - bronhokonstrikcija in anafilaksija (huda alergijska reakcija po vsem telesu), neprekinjen kašelj, - očesne težave, vključno z okvaro mrežnice, zamašitvijo mrežnične arterije, vnetjem očesnega živca, otekanjem očesa in belimi lisami na mrežnici (na mrežnici se pojavijo bele usedline), - napihnjenost trebuha, zgaga, težave z odvajanjem blata ali boleče odvajanje blata, - akutne preobčutljivostne reakcije, vključno z urtikarijo (koprivnico), podplutbami, močnimi bolečinami v udih, bolečinami v nogah ali stegnih, zmanjšanjem obsega gibov, okorelostjo,
English: Abdominal pain, abdominal pain upper, vomiting , diarrhoea, nausea
Slovenian: bolečine v trebuhu, bolečine v zgornjem delu trebuha, bruhanje, diareja, naveza
English: There is a linear relationship between dose and AUCtf following single doses of 200-1,200 mg ribavirin.
Slovenian: Po enkratnih odmerkih od 200 do 1.200 mg ribavirina je odvisnost AUCtf od odmerka linearna.
English: Chest discomfort, facial pain
Slovenian: neugodje v prsih, obrazna bolečina
English: What you need to know before you use Ribavirin Teva Pharma B.V. Do not take Ribavirin Teva Pharma B.V.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Ribavirin Teva Pharma B.V.
English: Do not pass it on to others.
Slovenian: ne smete uporabljati samega.
English: An increase in uric acid and indirect bilirubin values associated with haemolysis was observed in some patients treated with Ribavirin Teva Pharma B.V. used in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials, but values returned to baseline levels by four weeks after the end of therapy.
Slovenian: Pri nekaterih bolnikih, ki so bili zdravljeni z ribavirinom v kombinaciji s peginterferonom alfa-2b ali interferonom alfa-2b v kliničnih preskušanjih, so opažali zvečanje vrednosti sečne kisline in indirektnega bilirubina v povezavi s hemolizo, vendar so se te vrednosti povrnile na začetno raven v štirih tednih po koncu terapije.
English: Pharmachemie B.V. Swensweg 5
Slovenian: Pharmachemie B.V.
English: Conjunctival haemorrhage, eye pruritus, keratitis, vision blurred, photophobia
Slovenian: krvavitev veznice, očesni pruritus, keratitis, zamegljen vid, fotofobija
English: Patients were randomized to receive either ribavirin (800-1,200 mg/day based on weight) plus peginterferon alfa-2b (100 or 150 µg/week based on weight) or ribavirin (8001,200 mg/day based on weight) plus interferon alfa-2b (3 MIU TIW).
Slovenian: Bolnike so naključno razporedili bodisi v skupino, ki bo prejemala ribavirin (800-1.200 mg/dan glede na telesno maso) in peginterferon alfa-2b (100 ali 150 µg/teden glede na telesno maso) ali pa ribavirin (800-1.200 mg/dan glede na telesno maso) in interferon alfa-2b (3 milijone i.e. trikrat na teden).
English: Ribavirin (800 mg/day) + interferon alfa2b (3 MIU TIW)
Slovenian: ribavirin (800 mg/dan) + interferon alfa-2b (3 mio i.e., TNT)
English: No pharmacokinetic interactions were noted between ribavirin and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
Slovenian: V farmakokinetični študiji večkratnih odmerkov niso beležili nobenih farmakokinetičnih interakcij med ribavirinom in peginterferonom alfa-2b ali interferonom alfa-2b.
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.
Slovenian: Otrokom, zdravljenim 24 tednov, se je percentil telesne višine za starost od časa pred zdravljenjem do konca dolgoročnega spremljanja zmanjšal za 1,3 percentila, zdravljenim 48 tednov pa za 9,0 percentilov.
English: 1,200 mg/day) d + peginterferon alfa-2b (100 or 150c µg/week)
Slovenian: peginterferon alfa-2b (100 or 150c µg/teden)
English: Please refer to the corresponding SmPC of medicinal products used in combination with Ribavirin Teva Pharma B.V..
Slovenian: Prosimo, glejte ustrezne povzetke glavnih značilnosti zdravil, uporabljenih v kombinaciji z zdravilom Ribavirin Teva Pharma B.V.
English: Thrombocytopenia, lymphadenopathy
Slovenian: trombocitopenija, limfadenopatija
English: Rarely reported side effects (may affect up to 1 in 1,000 people):
Slovenian: Redko prijavljeni neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov):
English: Very rarely reported side effects (may affect up to 1 in 10,000 people):
Slovenian: Zelo redko prijavljeni neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov):
English: You or your caregiver should call your doctor immediately if you have any of these side effects.
Slovenian: Če imate katerega od naštetih neželenih učinkov, morate vi ali vaš negovalec nemudoma poklicati zdravnika.
English: There are several serious adverse reactions associated with the combination therapy of ribavirin with (peg)interferon alfa.
Slovenian: Kombinirano zdravljenje z ribavirinom in (peg)interferonom alfa je povezano z več resnimi neželenimi učinki.
English: Cutaneous sarcoidosis
Slovenian: kožna sarkoidoza
English: Nervous system disorders
Slovenian: motnje delovanja jeter
English: Ulcerative stomatitis, stomatitis, mouth ulceration, colitis, upper right quadrant pain, dyspepsia, gastroesophageal reflux*, glossitis, cheilitis, abdominal distension, gingival bleeding, gingivitis, loose stools, tooth disorder, constipation, flatulence
Slovenian: ulcerozni stomatitis, stomatitis, razjede v ustih, kolitis, bolečine v zgornjem desnem kvadrantu trebuha, dispepsija, gastroezofagealni refluks*, glositis, heilitis, napihnjenost trebuha,krvavitve iz dlesni, gingivitis, mehko blato, zobne bolezni, zaprtje, napenjanje
English: decreases in the number of red blood cells (that may cause fatigue, shortness of breath, dizziness), decrease in neutrophils(that make you more susceptible to different infections), difficulty concentrating, feeling anxious or nervous, mood swings, feeling depressed or irritable, tired feeling, trouble falling asleep or staying asleep, cough, dry mouth, pharyngitis (sore throat), diarrhoea, dizziness, fever, flu-like symptoms, headache, nausea, shaking chills, virus infection, vomiting, weakness, loss of appetite, loss of weight, stomach pain, dry skin, irritation, hair loss, itching, muscle pain, muscle aches, pain in joints and muscles, rash.
Slovenian: - zmanjšanje števila rdečih krvničk (kar lahko povzroči utrujenost, kratko sapo in omotico); zmanjšanje števila nekaterih belih krvničk (zaradi katerega boste lahko bolj občutljivi za različne okužbe), - težave s koncentracijo, občutek tesnobe ali živčnosti, nihanje razpoloženja, občutek depresivnosti ali razdražljivosti, občutek utrujenosti, težave z uspavanjem ali zbujanje, - kašelj, suha usta, faringitis (vnetje žrela), - driska, omotica, zvišana telesna temperatura, gripi podobni simptomi, glavobol, slabost, mrzlica s tresenjem, virusna okužba, bruhanje, občutek šibkosti, - izguba apetita, izguba telesne mase, bolečine v želodcu, suha koža, draženje, izpadanje las/dlak, srbenje, mišične bolečine, bolečine v sklepih in mišicah, izpuščaj
English: Vertigo, hearing impaired/loss, tinnitus, ear pain
Slovenian: vrtoglavica, poslabšanje/izguba sluha, tinitus, bolečine v ušesih
English: Polyvinyl alcohol - partly hydrolysed Macrogol / Polyethylene glycol 3350 Titanium dioxide (E171) Talc
Slovenian: Obloga tablete opadry II 85F23470 delno hidroliziran polivinilalkohol makrogol/polietilenglikol 3350 titanov dioksid (E171) smukec rdeči železov oksid rumeni železov oksid črni železov oksid
English: Packs of 14, 28, 42, 56, 84, 112, 140 and 168 tablets Not all pack sizes may be marketed.
Slovenian: Škatle s 14, 28, 42, 56, 84, 112, 140 in 168 tabletami.
English: Previous treatment failure patients
Slovenian: Predhodno nezdravljeni bolniki
English: Contusion
Slovenian: zmedenost
English: Ribavirin monotherapy must not be used.
Slovenian: ne smete uporabljati v monoterapiji.
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..
Slovenian: Za dodatne informacije o predpisovanju posameznih zdravil in za dodatna priporočila o odmerjanju pri sočasni uporabi z zdravilom Ribavirin Teva Pharma B.V., prosimo, glejte ustrezne povzetke glavnih značilnosti zdravil, ki se uporabljajo v kombinaciji z zdravilom Ribavirin Teva Pharma B.V.
English: Magnesium stearate
Slovenian: ishemični kolitis
English: Mouth ulceration, stomatitis ulcerative, stomatitis, aphthous stomatitis, dyspepsia, cheilosis, glossitis, gastroesophageal reflux, rectal disorder, gastrointestinal disorder, constipation, loose stools, toothache, tooth disorder, stomach discomfort, oral pain
Slovenian: razjede v ustih, ulcerozni stomatitis, stomatitis, aftičen stomatitis, dispepsija, heiloza, glositis, gastroezofagealni refluks, bolezen danke, bolezen prebavil, zaprtje, mehko blato, zobobol, zobna bolezen, neugodje v trebuhu, bolečine v ustih
English: Seminal transfer of ribavirin has been studied.
Slovenian: Proučevali so prehajanje ribavirina v semensko tekočino.
English: Uncommonly reported side effects (may affect up to 1 in 100 people):
Slovenian: Občasno prijavljeni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Immediate packaging (blister foil)
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Pain in extremity, back pain, muscle contracture
Slovenian: artritis, bolečine v hrbtu, mišični krči, bolečine v udih
English: Females of childbearing potential must use an effective contraceptive during treatment and for four months after treatment has been concluded; routine monthly pregnancy tests must be performed during this time (see section 4.4).
Slovenian: V tem času morajo vsak mesec rutinsko opravljati teste nosečnosti (glejte poglavje 4.4).
English: Each tablet contains 200 mg of ribavirin
Slovenian: Ena tableta vsebuje 200 mg ribavirina.
English: 1,200 mg/day) d + interferon alfa-2b (3 MIU TIW)
Slovenian: ribavirin 1.200 mg/dan) d + interferon alfa-2b (3 mio i.e., TNT)
English: The following side effects have been reported with the combination of ribavirin and an alpha interferon product in adults:
Slovenian: in zdravil, ki vsebujejo interferon alfa, pri odraslih so poročali o naslednjih neželenih učinkih:
English: Very commonly reported side effects (may affect more than 1 in 10 people):
Slovenian: Zelo pogosto prijavljeni neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Pruritus, photosensitivity reaction, maculopapular rash, hyperhidrosis, eczema, acne, skin disorder, nail disorder, skin discolouration, dry skin, erythema, bruise
Slovenian: Pogosti pruritus, preobčutljivostna reakcija za svetlobo, makulopapulozni izpuščaj, ekcem, hiperhidroza, akne, kožne bolezni, bolezni nohtov, obarvanje kože, suha koža, eritem, podplutbe
English: If you are not sure, talk to your doctor or pharmacist before taking Ribavirin Teva Pharma B.V. if you: - are allergic to ribavirin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden začnete jemati zdravilo Ribavirin Teva Pharma B.V.
English: Ribavirin Teva Pharma B.V. 400 mg film-coated tablets ribavirin
Slovenian: 400 mg filmsko obložene tablete ribavirin
English: Each tablet contains 400 mg of ribavirin
Slovenian: Ena tableta vsebuje 400 mg ribavirina.
English: Dyspnoea, tachypnea, epistaxis, coughing, nasal congestion, nasal irritation, rhinorrhoea, sneezing, pharyngolaryngeal pain
Slovenian: dispneja, tahipneja, epistaksa, kašelj, zamašen nos, draženje nosne sluznice, rinoreja, kihanje, faringolaringealne bolečine
English: Laboratory values for HCV/HIV co-infected patients
Slovenian: Laboratorijske vrednosti pri bolnikih, sočasno okuženih s HCV in HIV:
English: Vasculitis
Slovenian: vaskulitis
English: • Ribavirin (1,000/1,200 mg/day) + peginterferon alfa-2b (1.5 micrograms/kg/week for one month followed by 0.5 microgram/kg/week for 11 months) (n = 514).
Slovenian:  ribavirin (1.000/1.200 mg/dan) + peginterferon alfa-2b (1,5 mikrogramov/kg na teden en mesec,
English: Fatigue, rigors, pyrexia, influenza like illness, asthenia, irritability
Slovenian: utrujenost, mrzlica, zvišana telesna temperatura, gripi podobna bolezen, astenija, razdražljivost
English: Bone pain, muscle weakness
Slovenian: bolečine v kosteh, mišična šibkost
English: A decrease in haemoglobin levels to < 10 g/dL was observed in up to 14 % of adult patients and 7 % of children and adolescents treated with ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b in clinical trials.
Slovenian: V kliničnih preskušanjih so pri do 14 % odraslih bolnikov in 7 % otrok in mladostnikov, zdravljenih z ribavirinom v kombinaciji s peginterferonom alfa-2b ali interferonom alfa-2b, opažali znižanje vrednosti hemoglobina na < 10 g/dl.
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).
Slovenian: jemljete tega zdravilo v kombinaciji z interferonom alfa in zdravilom proti virusu HIV lahko poveča tveganje za pojav laktacidoze, odpovedi jeter in razvoja krvnih nepravilnosti (zmanjšanje števila rdečih krvničk, ki prenašajo kisik po telesu, določenih belih krvničk, ki služijo za boj proti okužbam, in celic za strjevanje krvi, ki jim pravimo trombociti).
English: Fatigue, rigors, pyrexia, influenza-like illness, asthenia, malaise, irritability
Slovenian: utrujenost, mrzlica, zvišana telesna temperatura, gripi podobna bolezen, astenija, splošno slabo počutje, razdražljivost
English: How to use Ribavirin Teva Pharma B.V.
Slovenian: Kako jemati zdravilo Ribavirin Teva Pharma B.V.
English: - are pregnant or planning to become pregnant (see section “Pregnancy and breast-feeding”).
Slovenian: - če ste alergični na ribavirin ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste noseči ali načrtujete nosečnost (glejte poglavje “Nosečnost in dojenje ”), - če dojite,
English: Ribavirin Teva Pharma B.V. 200 mg film-coated tablets ribavirin
Slovenian: 200 mg filmsko obložene tablete ribavirin
English: Pancytopenia: Ribavirin Teva Pharma B.V. can cause a decrease in your platelet and red and white blood cell count when used in combination with peginterferon.
Slovenian: lahko v kombinaciji s peginterferonom povzroči zmanjšanje števila krvnih ploščic (trombocitov) in rdečih ter belih krvnih celic.
English: Visual disturbance, blurred vision, conjunctivitis, eye irritation, eye pain, abnormal vision, lacrimal gland disorder, dry eye
Slovenian: motnje vida, zamegljen vid, konjunktivitis, draženje očesa, bolečine v očeh, motnje vida, bolezni solzne žleze, suho oko
English: If needed, 2nd dose reduction of Ribavirin Teva Pharma B.V. is by an additional 200 mg/day.
Slovenian: Če je potrebno, lahko opravite tudi drugo zmanjšanje odmerka zdravila Ribavirin Teva Pharma B.V.
English: Haematological abnormalities in HCV/HIV co-infected patients:
Slovenian: Hematološke motnje pri bolnikih, sočasno okuženih s HCV in HIV:
English: Usual daily Ribavirin Teva Pharma B.V. dose
Slovenian: Običajni dnevni odmerek zdravila Ribavirin Teva Pharma B.V.
English: Haemolysis: Ribavirin Teva Pharma B.V. can cause a break down in red blood cells causing anaemia which may impair your heart function or worsen symptoms of heart disease.
Slovenian: lahko povzroči razgradnjo rdečih krvnih celic in posledično anemijo, kar lahko poslabša delovanje srca ali poslabša simptome bolezni srca.
English: abnormal behaviour, emotional disorder, fear, nightmare, bleeding of the mucous membrane that lines the inner surface of the eyelids, blurred vision, drowsiness, intolerance to light, itchy eyes, facial pain, inflamed gums, chest discomfort, difficult breathing, lung infection, nasal discomfort, pneumonia,wheezing, low blood pressure, enlarged liver, painful menstruation, itchy anal area (pinworms or ascarids), blistering rash (shingles), decreased sensitivity to touch, muscle twitching, pain in skin, paleness, peeling of skin, redness, swelling.
Slovenian: neprenašanje svetlobe, srbenje oči, obrazne bolečine, vnetje dlesni, - tiščanje v prsih, težko dihanje, pljučne okužbe, neprijeten občutek v nosu, pljučnica, piskanje v pljučih, - nizek krvni tlak, - povečana jetra, - boleče menstruacije, - srbenje v predelu zadnjika (podančice ali askaride), izpuščaj z mehurji (herpes zoster ali pasovec),
English: For complete information be sure to read the “How to use” section of the Package Leaflet for the other medicines used in combination with Ribavirin Teva Pharma B.V..
Slovenian: “Kako uporabljati zdravilo” v navodilih za uporabo za druga zdravila, uporabljena v kombinaciji z zdravilom Ribavirin Teva Pharma B.V..
English: severe rashes which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes (erythema multiforme, Stevens Johnson syndrome), toxic epidermal necrolysis (blistering and peeling of the top layer of skin).
Slovenian: (multiformni eritem, Stevens-Johnsonov sindrom), toksično epidermalno nekrolizo (mehurjenje in luščenje povrhnje plasti kože).
English: EU/1/09/527/001 (14 tablets) EU/1/09/527/002 (28 tablets) EU/1/09/527/003 (42 tablets) EU/1/09/527/004 (56 tablets) EU/1/09/527/005 (84 tablets) EU/1/09/527/006 (112 tablets) EU/1/09/527/007 (140 tablets) EU/1/09/527/008 (168 tablets)
Slovenian: EU/1/09/527/001 (14 tablet) EU/1/09/527/002 (28 tablet) EU/1/09/527/003 (42 tablet) EU/1/09/527/004 (56 tablet) EU/1/09/527/005 (84 tablet) EU/1/09/527/006 (112 tablet) EU/1/09/527/007 (140 tablet) EU/1/09/527/008 (168 tablet)
English: Drug hypersensitivity
Slovenian: preobčutljivost za zdravila
English: The active substance is Ribavirin.
Slovenian: - Zdravilna učinkovina je ribavirin.
English: EU/1/09/527/009 (14 tablets) EU/1/09/527/010 (28 tablets) EU/1/09/527/011 (42 tablets) EU/1/09/527/012 (56 tablets) EU/1/09/527/013 (84 tablets) EU/1/09/527/014 (112 tablets) EU/1/09/527/015 (140 tablets) EU/1/09/527/016 (168 tablets)
Slovenian: EU/1/09/527/009 (14 tablet) EU/1/09/527/010 (28 tablet) EU/1/09/527/011 (42 tablet) EU/1/09/527/012 (56 tablet) EU/1/09/527/013 (84 tablet) EU/1/09/527/014 (112 tablet) EU/1/09/527/015 (140 tablet) EU/1/09/527/016 (168 tablet)
English: Ribavirin Teva Pharma B.V. dose based on body weight when used in combination with interferon alfa-2b or peginterferon alfa-2b in children above 3 years of age and adolescents
Slovenian: na podlagi telesne mase pri otrocih, starejših od 3 let, in mladostnikih, če je zdravilo uporabljeno v kombinaciji z interferonom alfa-2b ali peginterferonom alfa-2b
English: Ribavirin Teva Pharma B.V. must be used in combination therapy as described in section 4.1.
Slovenian: je treba uporabljati v kombinaciji z drugimi zdravili, kot je opisano v poglavju 4.1.