natgillin/translations-raw huggingface dataset:
154 oral contraceptives ("the Pill") any medicines used to treat diseases related to the acid in the stomach (e. g. antacids, H2- blockers and proton pump inhibitors) medicines to lower blood pressure, to slow heart rate, or to correct heart rhythm simvastatin, lovastatin, and atorvastatin (used to lower blood cholesterol) nevirapine and efavirenz (used to treat HIV) cyclosporin, tacrolimus, and sirolimus (medicines to decrease the effects of body's immune system) certain antibiotics (rifabutin, clarithromycin) ketoconazole, itraconazole, and voriconazole (antifungals) warfarin (anticoagulant, used to reduce the blood clots) irinotecan (used to treat cancer) sedative agents (e. g. midazolam administered by injection) buprenorphine (used to treat opioid addiction and pain).
Posebno pomembno je omeniti naslednje: druga zdravila za zdravljenje okužbe z virusom HIV, sildenafil (zdravilo za zdravljenje moške impotence (erektilna disfunkcija)), peroralni kontraceptivi, vsa zdravila, ki jih uporabljamo za zdravljenje bolezni, povezanih z želodčno kislino (npr. antacidi, antagonisti histaminskih receptorjev H2 in zaviralci protonske črpalke), zdravila za znižanje zvišanega krvnega tlaka, za upočasnitev srčnega utripa ali za uravnavanje srčnega ritma, simvastatin, lovastatin in atorvastatin (znižujejo holesterol v krvi), nevirapin in efavirenz (zdravila za zdravljenje okužbe z virusom HIV), ciklosporin, takrolimus in sirolimus (zdravila, ki zavirajo imunski sistem), nekateri antibiotiki (rifampicin, klaritromicin), ketokonazol, itrakonazol in vorikonazol (antimikotiki), varfarin (antikoagulant za preprečevanje krvnih strdkov), irinotekan (zdravilo za zdravljenje raka) pomirjevala (npr. midazolam, ki ga uporabljamo v obliki injekcij) buprenorfin (uporabljamo ga za zdravljenje zasvojenosti z opioidi in lajšanje bolečine).
No studies on the effect of effects on the ability to drive and use machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
This medicine contains a sweetening agent called aspartame.
Zdravilo vsebuje sladilo, ki se imenuje aspartam.
Aspartame provides a source of phenylalanine that may not be suitable for persons with phenylketonuria.
Aspartam je vir fenilalanina in ni primerno za tiste, ki imajo fenilketonurijo.
REYATAZ oral powder contains 7.3 g sucrose per 300 mg daily dose.
REYATAZ peroralni prašek vsebuje v 300- mg dnevnem odmerku 7, 3 g saharoze.
This should be taken into account in patients with diabetes mellitus.
To je treba upoštevati pri bolnikih, ki imajo sladkorno bolezen.
The usual adult dose of REYATAZ is 300 mg oral powder once daily with 100 mg ritonavir once daily and with food, in combination with other anti-HIV medicines.
Običajni odmerek zdravila REYATAZ za odrasle je 300 mg peroralnega praška enkrat na dan s 100 mg ritonavirja enkrat na dan in skupaj s hrano, v kombinaciji z drugimi zdravili proti HIV.
300 mg REYATAZ oral powder equals to 6 level measuring spoons of powder (each spoon makes 50 mg of atazanavir).
300 mg REYATAZ peroralnega praška je 6 merilnih žličk peroralnega praška (vsaka žlička vsebuje
There is not enough information to recommend a dose in children.
Na voljo ni dovolj podatkov, da bi lahko priporočili odmerjanje pri otrocih.
155 Take REYATAZ with food (a meal or a substantial snack).
Vzemite zdravilo REYATAZ s hrano (s kosilom ali z obilnejšim obrokom).
Scoop an overfilled spoon of loose powder from the bottle using the measuring spoon provided (see picture below).
Napolnite merilno žličko s praškom (glejte spodnjo sliko).
Then gently level the powder in the spoon by scraping the extra powder back into the bottle using a flat edge of a knife or spatula.
Nežno odstranite odvečni prašek z žličke nazaj v plastenko s ploščatim delom noža ali loparčka.
Do not try to pack the powder into the spoon or attempt to level the powder by shaking or tapping the spoon.
Ne polnite žličke s praškom s stresanjem iz plastenke.
REYATAZ oral powder should be taken at about the same time each day with a meal.
Peroralni prašek REYATAZ jemljemo ob isti uri, vsak dan, s hrano.
It may be mixed with water, milk, infant formula, applesauce, or yoghurt.
Lahko ga mešamo z vodo, mlekom, tekočimi pripravki za dojenčke, čežano ali jogurtom.
Once the powder is mixed, it must be consumed within 6 hours.
Ko ga zmešate, ga morate uporabiti v 6 urah.
Do not mix the powder inside the bottles of REYATAZ.
Ne mešajte praška v plastenki REYATAZ.
If you accidentally take more REYATAZ oral powder than your doctor recommended, contact your HIV doctor at once or contact the nearest hospital for advice.
Če ste po nesreči vzeli prevelik odmerek zdravila REYATAZ, se takoj posvetujte z zdravnikom ali se oglasite v najbližji bolnišnici.
Patients treated with REYATAZ have reported the following side effects:
se zdravili z zdravilom REYATAZ, so poročali o naslednjih neželenih učinkih:
Common: headache ocular icterus (presence of jaundice seen in the white part of the eyes) vomiting, diarrhoea, abdominal pain (stomach pain of discomfort), nausea, dyspepsia (indigestion) jaundice (yellowing of the skin and/ or eyes) rash lipodistrophy syndrome (body changes due to fat redistribution, accumulation, or loss of body fat), fatigue (extreme tiredness) Uncommon:
očesni ikterus (zlatenica, ki se kaže kot rumeno obarvanje beločnic); bruhanje, driska, bolečine v trebuhu (bolečine ali neugodje v želodcu), siljenje na bruhanje, dispepsija (prebavne motnje); zlatenica (rumeno obarvanje kože in/ ali oči); kožni izpuščaj;
156 peripheral neuropathy (numbness, weakness, tingling or pain in the arms and legs) hypersensitivity (allergic reaction) asthenia (unusual tiredness or weakness) weight decreased, weight gain, anorexia (loss of appetite), appetite increased depression, anxiety, sleep disorder disorientation, amnesia (loss of memory), dizziness, somnolence (sleepiness), abnormal dream syncope (fainting), hypertension (high blood pressure) dyspnoea (shortness of breath) pancreatitis (inflammation of the pancreas), gastritis (inflammation of the stomach), stomatitis aphthous (mouth ulcers and cold sores), dysgeusia (impairment of the sense of taste), flatulence (wind), dry mouth, abdominal distension hepatitis (inflammation of the liver) urticaria (itchy rash), alopecia (unusual hair loss or thinning), pruritus (itching) muscle atrophy (muscle shrinkage), arthralgia (joint pain), myalgia (aching muscles) nephrolithiasis (formation of kidney stones), hematuria (blood in the urine), proteinuria (excess protein in the urine), pollakiuria (increased frequency of urination) gynaecomastia (breast enlargement in men) chest pain, malaise (generally feeling unwell), fever insomnia (difficulty sleeping) Rare: gait disturbance (abnormal manner of walking) oedema (swelling), palpitation (fast or irregular heart beat) hepatosplenomegaly (enlargement of the liver and spleen) vesiculobullous rash (visible accumulation of fluid under the skin), eczema (skin rash), vasodilatation (widening of blood vessels) myopathy (aching muscles, muscle tenderness of weakness, not caused by exercise) kidney pain Not known:
Redki: motnje hoje (nenormalen način hoje); edem (oteklina), palpitacije (hitro in nepravilno utripanje srca); hepatosplenomegalija (povečanje jeter in vranice); vezikobulozen izpuščaj (vidno nakopičenje tekočine pod kožo), ekcem (kožni izpuščaj), vazodilatacija (razširjenost žil); miopatija (bolečina, občutljivost ali slabost mišic, ki ni posledica telesnega napora); bolečine v ledvicah.
Keep out of the reach and sight of children.
162 Zdravilo shranjujte nedosegljivo otrokom!
Do not use REYATAZ after the expiry date stated on the package and on the bottle label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini in nalepki plastenke.
Do not use REYATAZ oral powder if you notice the product has turned into a dark yellow or brown powder aggregated into one clump.
Zdravila ne uporabljajte, če opazite, da je prašek postal temno rumene ali rjave barve in se skepil.
157 Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
The active substance in REYATAZ is atazanavir.
Zdravilna učinkovina zdravila REYATAZ je atazanavir.
One measuring spoon of 1.5 g oral powder contains 50 mg of atazanavir (as sulphate).
Ena merilna žlička 1, 5 g peroralnega praška vsebuje 50 mg atazanavirja (v obliki sulfata).
The other ingredients are aspartame (E951), sucrose, and orange vanilla flavour.
Pomožne snovi so aspartam (E951), saharoza in aroma pomaranče in vanilije.
REYATAZ oral powder is supplied in bottles containing 180 g of powder together with a plastic measuring spoon.
REYATAZ peroralni prašek je na voljo v plastenkah, ki vsebujejo 180 g praška skupaj s plastično merilno žličko.
The colour of the powder is off-white to pale yellow.
Prašek je sivobelkaste do bledorumene barve.
REYATAZ also exists in capsules.
Zdravilo REYATAZ je na voljo tudi v obliki kapsul.
However, not all pack sizes may be marketed in all countries.
Na trgu ni vseh navedenih pakiranj.
The marketing authorisation holder of REYATAZ is:
Imetnik dovoljenja za promet z zdravilom REYATAZ:
The manufacturer of REYATAZ is:
Izdelovalec zdravila REYATAZ:
This leaflet was last approved in {MM/ YYYY}
164 Navodilo je bilo odobreno {MM/ LLLL}.
Ribavirin Teva is a medicine containing the active substance ribavirin.
Ribavirin Teva je zdravilo, ki vsebuje zdravilno učinkovino ribavirin.
Ribavirin Teva is a ‘ generic medicine’.
Ribavirin Teva je „ generično zdravilo “.
This means that it is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Rebetol.
To pomeni, da je podobno „ referenčnemu zdravilu “, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Rebetol.
Ribavirin Teva is used to treat adults and children aged three years and older who have chronic (long- term) hepatitis C (a disease of the liver due to an infection with the hepatitis C virus).
Zdravilo Ribavirin Teva se uporablja za zdravljenje odraslih in otrok, starih tri leta ali več, ki imajo kronični (dolgotrajni) hepatitis C (bolezen jeter zaradi okužbe z virusom hepatitisa C).
Ribavirin Teva must never be used on its own but only together with an interferon (another type of medicine used in hepatitis).
Zdravilo Ribavirin Teva se ne sme nikoli uporabljati samostojno, temveč samo v kombinaciji z interferonom (drugo vrsto zdravila, ki se uporablja pri hepatitisu).
In adults, Ribavirin Teva can be used in ‘ naïve’ patients (who have not been treated before) or in patients in whom previous treatment including any type of interferon alfa, with or without ribavirin, did not work.
Pri odraslih se zdravilo Ribavirin Teva lahko uporablja pri bolnikih, ki še nikoli niso bili zdravljeni ali pri bolnikih, pri katerih prejšnja zdravljenja, vključno z zdravljenjem s katero koli vrsto interferona alfa, z ribavirinom ali brez njega, niso bila uspešna.
Ribavirin Teva is used either in combination with interferon alfa-2b or peginterferon alfa-2b (including for adults also infected with human immunodeficiency virus [HIV]).
Zdravilo Ribavirin Teva se uporablja ali v kombinaciji z interferonom- 2b ali peginterferonom alfa- 2b (tudi pri odraslih, ki so okuženi tudi z virusom humane imunske pomanjkljivosti [HIV]).
In children and adolescents, Ribavirin Teva can only be used in naïve patients without HIV infection and only in combination with interferon alfa-2b.
Pri otrocih in mladostnikih se zdravilo Ribavirin Teva lahko uporablja samo pri nezdravljenih bolnikih, ki niso okuženi s HIV, in samo v kombinaciji z interferonom alfa- 2b.
The dose of Ribavirin Teva is based on the patient’ s body weight, and ranges from three to seven capsules a day.
Odmerek zdravila Ribavirin Teva je odvisen od bolnikove telesne mase in znaša od tri do sedem kapsul na dan.
It can only be taken by patients weighing at least 47 kg.
Jemljejo ga lahko le bolniki, ki tehtajo več kot 47 kg.
RNA, which are needed for viruses to survive and multiply.
Zdravilna učinkovina zdravila Ribavirin Teva, ribavirin, je protivirusna učinkovina, ki spada v razred nukleozidnih analogov.
Ribavirin Teva on its own has no effect on eliminating the hepatitis C virus from the body.
Zdravilo Ribavirin Teva kot samostojno zdravilo nima nikakršnega učinka na odstranitev virusa hepatitisa C iz telesa.
Because Ribavirin Teva is a generic medicine, studies have been limited to tests to demonstrate that it is bioequivalent to the reference medicine (i. e. that the two medicines produce the same levels of the active substance in the body).
Ker je zdravilo Ribavirin Tevan generično zdravilo, so bile študije omejene na preskuse, s katerimi se dokazuje, da je biološko enakovredno referenčnemu zdravilu (tj. da zdravili dosegata enake ravni zdravilne učinkovine v telesu).
Because Ribavirin Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Glede na to, da je Ribavirin Teva generično zdravilo in je biološko enakovredno referenčnemu zdravilu, se upošteva, da ima enake koristi in tveganja kot referenčno zdravilo.
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva has been shown to have comparable quality and to be bioequivalent to Rebetol.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Ribavirin Teva primerljivo raven kakovosti kot zdravilo Rebetol ter da mu je biološko enakovredno.
Therefore, the CHMP’ s view was that, as for Rebetol, the benefit outweighs the identified risk.
Zato je CHMP menil, da njegove koristi, tako kot pri zdravilu Rebetol, odtehtajo znana tveganja.
The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Teva to Teva Pharma B. V. on 31 March 2009.
Evropska komisija je dovoljenje za promet z zdravilom Ribavirin Teva, veljavno po vsej Evropski uniji, odobrila družbi Teva Pharma BV dne 31. marca 2009.
EMEA Number EU/ 1/ 09/ 509/ 001 EU/ 1/ 09/ 509/ 002 EU/ 1/ 09/ 509/ 003 EU/ 1/ 09/ 509/ 004
številka EU EU/ 1/ 09/ 509/ 001
Name Ribavirin Teva Ribavirin Teva Ribavirin Teva Ribavirin Teva
ime Ribavirin Teva
Strength 200 mg 200 mg 200 mg 200 mg
jakost 200 mg
Pharmaceutical Form Capsule, hard Capsule, hard Capsule, hard Capsule, hard
farmacevtska oblika trda kapsula
Route of Administration Oral use Oral use Oral use Oral use
pot uporabe peroralna uporaba
Packaging blister (PVC/ PE/ PVdC) blister (PVC/ PE/ PVdC) blister (PVC/ PE/ PVdC) blister (PVC/ PE/ PVdC)
ovojnina pretisni omot (PVC/ PE/ PVdC)
Package size 84 capsules 112 capsules 140 capsules 168 capsules
velikost pakiranja 84 kapsul
Each Ribavirin Teva capsule contains 200 mg of ribavirin For a full list of excipients, see section 6.1.
Ena kapsula zdravila Ribavirin Teva vsebuje 200 mg ribavirina.
White, opaque and imprinted with blue ink.
trda kapsula Bele, neprozorne in imajo natisnjen napis z modrim črnilom.
Ribavirin Teva is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b (adults) or interferon alfa-2b (adults, children (3-years of age or older), and adolescents).
Zdravilo Ribavirin Teva je indicirano za zdravljenje kroničnega hepatitisa C in ga morate uporabljati izključno v kombinaciji s peginterferonom alfa- 2b (odrasli) ali interferonom alfa- 2b (odrasli, otroci (3 leta in starejši) in mladostniki).
There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i. e., not alfa-2b), or on the use of Ribavirin with peginterferon alfa-2b in children or adolescents.
Ni podatkov o varnosti ali učinkovitosti uporabe zdravila Ribavirin Teva skupaj z drugimi oblikami interferona (to je ne alfa- 2b) ali uporabe zdravila Ribavirin Teva a z peginterferonom alfa- 2b pri otrocih ali mladostnikih.
Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA (see section 4.4).
Zdravilo Ribavirin Teva je indicirano v kombinaciji s interferonom alfa- 2b za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki predhodno še niso bili zdravljeni, nimajo jetrne dekompenzacije, imajo zvišano vrednost alanin- aminotransferaze (ALT) in so pozitivni na serumsko RNA- HCV (glejte poglavje 4. 4).
Additionally, Ribavirin Teva is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA, including patients with clinically stable HIV co-infection (see section 4.4).
Poleg tega je zdravilo Ribavirin Teva v kombinaciji s peginterferonom alfa- 2b indicirano za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki pred tem niso bili zdravljeni in nimajo jetrne dekompenzacije, imajo pa zvišane vrednosti alanin - aminotransferaze (ALT) in pozitiven izvid na serumsko RNA - HCV, vključno z bolniki, ki imajo klinično stabilno okužbo s HIV (glejte poglavje 4. 4).
Ribavirin Teva is intended for use, in a combination regimen with interferon alfa2b, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Zdravilo Ribavirin Teva je namenjeno uporabi v kombinirani terapiji z interferonom alfa- 2b za zdravljenje otrok, starih 3 leta ali več, ki imajo predhodno nezdravljen kronični hepatitis C brez jetrne dekompenzacije in pozitiven izvid na serumsko RNA- HCV.
Additionally, Ribavirin Teva is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have failed previous treatment with interferon alpha
Zdravilo Ribavirin Teva je indicirano v kombinaciji z interferonom alfa- 2b za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki so se predhodno odzvali (z normalizacijo
2 (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
2 vrednosti ALT na koncu zdravljenja) na monoterapijo z interferonom alfa, a se je bolezen kasneje ponovila.
Dose to be administered The dose of Ribavirin Teva is based on patient body weight (Table 1).
Odmerjanje Odmerek zdravila Ribavirin Teva se določi na podlagi bolnikove telesne mase (preglednica 1).
Ribavirin capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Kapsule zdravila Ribavirin Teva naj jemlje bolnik peroralno vsak dan v dveh deljenih odmerkih (zjutraj in zvečer) s hrano
Ribavirin Teva must be used in combination with either peginterferon alfa-2b (1.5 micrograms/ kg/ week) or interferon alfa-2b (3 million international units [MIU] three times a week).
Zdravilo Ribavirin Teva morate uporabljati v kombinaciji bodisi s peginterferonom alfa- 2b (1, 5 mikrograma/ kg na teden) ali z interferonom alfa- 2b (3 milijone mednarodnih enot (mio i. e.) trikrat na teden).
Ribavirin dose based on body weight
Ribavirin Teva na podlagi telesne mase Dnevni odmerek zdravila
Patient
Ribavirin Teva
Number of 200 mg capsules 4a
1. 200 mg
a: b: c: d:
> 105 a:
86 – 105 > 105 2 morning, 2 evening 2 morning, 3 evening 3 morning, 3 evening 3 morning, 4 evening
3 zjutraj, 3 zvečer d:
1,200 mg 1,400 mg
3 zjutraj, 4 zvečer
6c 7d
1. 400 mg
Ribavirin Teva Capsules in combination with pegylated interferon alfa-2b:
Kapsule zdravila Ribavirin Teva v kombinaciji s pegiliranim interferonom alfa- 2b:
Duration of treatment – Naïve patients Predictability of sustained virological response:
Dolžina zdravljenja - Nezdravljeni bolniki Predvidljivost trajnega virološkega odziva:
Patients infected with virus genotype 1 who fail to achieve virological response at Week 12 are highly unlikely to become sustained virological responders (see also section 5.1).
Pri bolnikih, okuženih z virusom genotipa 1, ki ne dosežejo virološkega odziva v 12. tednu, je verjetnost, da bodo razvili trajen virološki odziv, izredno majhna (glejte tudi poglavje 5. 1).
• Genotype 1:
Genotip 1:
For patients who exhibit virological response at week 12, treatment should be continued for another nine month period (i. e., a total of 48 weeks).
Pri bolnikih, ki imajo virološki odziv v 12. tednu, nadaljujte z zdravljenjem še eno 9 - • mesečno obdobje (to je skupaj 48 tednov).
In the subset of patients with genotype 1 infection and low viral load (< 600,000 IU/ ml) who become HCV-RNA negative at treatment week 4 and remain HCV-RNA negative at week 24, the treatment could either be stopped after this 24 week treatment course or pursued for an additional 24 weeks (i. e. overall 48 weeks treatment duration).
V podskupini bolnikov, ki so okuženi z virusom genotipa 1 in imajo majhno virusno obremenitev (< 600. 000 i. e. / ml) ter katerih izvidi na serumsko RNA- HCV postanejo negativni v 4. tednu zdravljenja in so še vedno negativni v 24. tednu zdravljenja, lahko zdravljenje bodisi ustavite po ciklusu terapije v 24. tednu, ali pa ga nadaljujete še za dodatnih 24 tednov (tako da bo skupno trajanje zdravljenja 48 tednov).
However, an overall 24 weeks treatment duration may be associated with a higher risk of relapse than a 48 weeks treatment duration (see section 5.1). • Genotypes 2 or 3:
Skupna dolžina zdravljenja 24 tednov pa je lahko povezana z večjim tveganjem za ponovitev bolezni kot pri skupni dolžini zdravljenja 48 tednov (glejte poglavje 5. 1).
It is recommended that all patients be treated for 24 weeks, except for HCV/ HIV co-infected patients who should receive 48 weeks of treatment. • Genotype 4:
Priporočljivo je, da vse bolnike zdravite 24 tednov, razen pri tistih, ki imajo • sočasno okužbo s HCV in HIV.
HCV/ HIV Co-infection The recommended duration of dosing for HCV/ HIV co-infected patients is 48 weeks, regardless of genotype.
3 Priporočena dolžina zdravljenja pri bolnikih, ki so sočasno okuženi s HCV in HIV, znaša 48 tednov, ne glede na genotip.
The negative predictive value for sustained response in HCV/ HIV co-infected patients treated with Ribavirin in combination with
Napovedovanje odziva oziroma odsotnosti odziva na zdravljenje pri bolnikih, ki imajo sočasno okužbo s HCV in HIV Raziskave so pokazale, da je zgodnji virološki odziv do 12. tedna zdravljenja, ki je opredeljen kot zmanjšanje virusnega bremena za 2- log ali doseganje nemerljive količine serumske RNA- HCV v serumu, dober napovednik stalnega odziva na zdravljenje.
A positive predictive value of 50% (52/ 104; Study 1) was observed for HCV/ HIV co-infected patients receiving combination therapy.
Negativna napovedna vrednost stalnega virološkega odziva pri bolnikih, ki so bili sočasno okuženi s HCV in HIV in so se zdravili z zdravilom Ribavirin Teva v kombinaciji s peginterferonom alfa- 2b, je bila 99% (67/ 68, študija 1) (glejte poglavje 5. 1), medtem ko so 50% pozitivno napovedno vrednost (52/ 104, študija 1) opazili pri bolnikih, ki so bili sočasno okuženi s HCV in HIV in so prejemali kombinirano terapijo.
Duration of treatment - Retreatment Predictability of sustained virological response:
Trajanje zdravljenja - Ponovno zdravljenje Predvidljivost stalnega virološkega odziva:
All patients, irrespective of genotype, who have demonstrated serum HCV-RNA below the limits of detection at Week 12 should receive 48 weeks of therapy.
Vsi bolniki ne glede na genotip, ki so imeli v 12. tednu serumsko vrednost RNA- HCV pod mejo detekcije, morajo prejemati terapijo 48 tednov.
Retreatment duration greater than 48 weeks in non-responder patients with genotype 1 has not been studied with pegylated interferon alfa-2b and ribavirin combination therapy.
Ponovnega zdravljenja s kombinacijo peginterferona alfa- 2b in ribavirina, daljšega od 48 tednov, pri neodzivnih bolnikih z genotipom 1 niso proučevali.
Ribavirin Capsules in combination with interferon alfa-2b:
Kapsule zdravila Ribavirin Teva v kombinaciji z interferonom alfa- 2b: