natgillin/translations-raw huggingface dataset:
During those clinical trials in which patients were treated for one year, patients who failed to show a virological response after six months of treatment (HCV-RNA below lower limit of detection) were unlikely to become sustained virological responders (HCV-RNA below lower limit of detection six months after withdrawal of treatment).
V kliničnih preskušanjih, v katerih so bolnike zdravili eno leto, se je izkazalo, da je pri bolnikih, pri katerih po šestih mesecih zdravljenja ni virološkega odziva (serumska RNA- HCV pod spodnjo mejo detekcije), zelo malo verjetno, da bodo razvili trajen virološki odziv (serumska RNA - HCV pod spodnjo mejo detekcije šest mesecev po prekinitvi zdravljenja).
Treatment should be continued for another six month period (i. e., a total of one year) in patients who exhibit negative HCV-RNA after six months of treatment. • Genotypes Non-1:
Pri bolnikih, ki imajo po šestih mesecih zdravljenja negativno vrednost serumske • RNA- HCV, morate z zdravljenjem nadaljevati še šest mesecev (to je skupaj eno leto). • Genotipi ne- 1:
The decision to extend therapy to one year in patients with negative HCV- RNA after six months of treatment should be based on other prognostic factors (e. g., age > 40 years, male gender, bridging fibrosis).
Odločitev o podaljšanju terapije na eno leto pri bolnikih z negativno vrednostjo serumske RNA- HCV po šestih mesecih zdravljenja mora temeljiti na drugih prognostičnih dejavnikih (npr. starost > 40 let, moški spol, premostitvena fibroza).
In clinical studies performed in this population ribavirin and interferon alfa-2b were used in doses of 2 15 mg/ kg/ day and 3 MIU/ m three times a week respectively (Table 2).
V kliničnih študijah izvajanih s to populacijo sta se ribavirin in interferon alfa- 2b uporabljal v odmerku 15 mg/ kg/ dan in 3 mio i. e. / m2 trikrat na dan (preglednica 2).
Ribavirin Teva capsules are to be administered orally each day in two divided doses with food (morning and evening).
Kapsule zdravila Ribavirin Teva se uporabljajo peroralno vsak dan v dveh deljenih odmerkih s hrano (zjutraj in zvečer).
Ribavirin paediatric dose based on body weight
Odmerek zdravila Ribavirin Teva za otroke na podlagi telesne mase Dnevni odmerek zdravila Ribavirin
Number of 200 mg capsules 3 capsulesa 4 capsulesb
4 kapsuleb
> 65
50 - 65
Refer to adult dosing table (Table 1)
Glejte preglednico odmerjanja pri odraslih bolnikih (preglednica > 65 1) a:
1 morning, 2 evening b:
1 zjutraj, 2 zvečer b:
2 morning, 2 evening
2 zjutraj, 2 zvečer
Virological response is defined as absence of detectable HCV-RNA at Week 12 of treatment.
Virološki odziv je opredeljen kot odsotnost merljive vrednosti serumske RNA- HCV v 12. tednu zdravljenja.
Genotype 2 or 3:
4 Genotip 2 or 3:
Dose modification for all patients If severe adverse reactions or laboratory abnormalities develop during therapy with Ribavirin and peginterferon alfa-2b or interferon alfa-2b, modify the dosages of each product if appropriate, until the adverse reactions abate.
Prilagajanje odmerka za vse bolnike Če se med zdravljenjem z zdravilom Ribavirin Teva in peginterferonom alfa- 2b ali interferonom alfa - 2b pojavijo hudi neželeni učinki ali nenormalni izvidi laboratorijskih preiskav, odmerek vsakega zdravila po potrebi prilagajajte, dokler neželene reakcije ne izginejo.
Guidelines were developed in clinical trials for dose modification (see Dosage modification guidelines, Table 3).
Preglednica 3
As adherence might be of importance for outcome of therapy, the dose should be kept as close as possible to the recommended standard dose.
Smernice za prilagajanje odmerka
The potential negative impact of ribavirin dose reduction on efficacy results could not be ruled out.
Zmanjšajte le dnevni Zmanjšajte le odmerek
4 Table 3
Prekinite
Dosage modification guidelines
vrednosti
Laboratory Values
odmerek zdravila
Reduce only Ribavirin Reduce only
peginterferona alfa- 2b
daily dose adult to
Ribavirin Teva za
peginterferon alfa-2b
zdravljenje, če:
combination therapy
alfa- 2b (odrasli in otroci)
600 mg/ day*, paediatric to 7.5 mg/ kg, if:
600 mg/ dan *, za
(adult) or interferon alfa- 2b dose (adult and paediatric) to one-half dose, if:
na polovico odmerka, če:
if:
otroke na 7, 5 mg/ kg, če:
Haemoglobin in: patients with history of stable cardiac disease Paediatric: not applicable (see section 4.4)
Hemoglobin
≥ 2 g/ dl decrease in haemoglobin during any 4 week period during treatment (permanent dose reduction)
≥ 2 g/ dl zmanjšanje vrednosti hemoglobina med
< 12 g/ dl after 4 weeks of dose reduction
stabilno srčno boleznijo v anamnezi Otroci: navedba smiselno ni potrebna (glejte poglavje 4. 4)
White blood cells Neutrophils
Bele krvne celice Nevtrofilci
< 1.0 x 109/ l < 0.5 x 109/ l
1, 0 x 109/ l 0, 5 x 109/ l
Adult < 50 x 109/ l
Odrasli < 50 x Otroci < 80 x
Adult < 25 x 109/ l
109/ l 109/ l
80 x 109/ l
Odrasli < 25 x 109/ l Otroci < 50 x 109/ l
Paediatric < 50 x 109/ l
2, 5 x ZMN **
Bilirubin – Indirect
Bilirubin –
Adult > 4 mg/ dl
Odrasli > 4 mg/ dl
Paediatric > 5 mg/ dl (for > 4 weeks) Creatinine
Otroci > 5 mg/ dl (za > 4 tedne)
Alanine aminotransferase/ aspartate aminotransferase (ALT/ AST)
Kreatinin Alanin - aminotransferaza / aspartat - aminotransferaza (ALT/ AST)
2 x baseline and > 10 x ULN**
> 2, 0 mg/ dl 2 x začetna vrednost in > 10 x ZMN **
* Administered in two divided doses, in the morning and in the evening. ** Upper limit of normal
* Dajanje v dveh deljenih odmerkih zjutraj in zvečer. ** Zgornja meja normale
Therefore, it is recommended that renal function be evaluated in all patients prior to initiation of Ribavirin.
Zato je priporočljivo, da pri vseh bolnikih pred pričetkom jemanja zdravila Ribavirin Teva ovrednotite
Patients with creatinine clearance < 50 ml/ minute must not be treated with Ribavirin (see section 4.3).
Bolnikov, pri katerih je očistek kreatinina < 50 ml/ min, ne smete zdraviti z zdravilom Ribavirin Teva (glejte poglavje 4. 3).
If serum creatinine rises to > 2 mg/ dl (Table 3), Ribavirin and peginterferon alfa- 2b/ interferon alfa-2b must be discontinued.
Če se vrednost kreatinina v serumu zviša nad 2 mg/ dl (preglednica 3), morate zdravljenje z zdravili Ribavirin Teva in peginterferon alfa- 2b oz. interferon alfa- 2b prekiniti.
Therefore, no dose adjustment of Ribavirin is required in patients with hepatic impairment.
Med ribavirinom in delovanjem jeter ni prihafarmakokinetičnih interakcij (glejte poglavje 5. 2), zato pri bolnikih z jetrno okvaro ni potrebno prilagajanje odmerka zdravila Ribavirin Teva.
Use in the elderly (≥ 65 years of age):
Uporaba pri starejših bolnikih (starost ≥ 65 let):
However, as in younger patients, renal function must be determined prior to administration of Ribavirin (see section 5.2).
Kot pri mlajših bolnikih pa morate pred začetkom uporabe zdravila Ribavirin Teva opraviti preiskave delovanja ledvic (glejte poglavje 5. 2).
Ribavirin may be used in combination with interferon alfa-2b in children (3 years of age and older) and adolescents.
Zdravilo Ribavirin Teva v obliki kapsul ali peroralne raztopine se lahko uporablja v kombinaciji z interferonom alfa- 2b pri otrocih (starost 3 leta in več) in mladostnikih.
5 with pegylated or other forms of interferon (i. e. not alfa-2b) in these patients have not been evaluated.
Varnosti in učinkovitosti zdravila Ribavirin Teva s pegilirano ali drugo obliko interferona (tj. ne alfa- 2b) pri teh bolnikih niso ovrednotili.
Patients taking NRTI treatment in association with ribavirin and interferon alfa-2b or peginterferon alfa-2b may be at increased risk of mitochondrial toxicity, lactic acidosis and hepatic decompensation (see section 4.4).
Bolniki, ki prejemajo terapijo NRTI skupaj z ribavirinom in interferonom alfa- 2b ali peginterferonom alfa- 2b, imajo lahko povečano tveganje za nastanek toksičnost za mitohondrie, laktacidoze in jetrne dekompenzacije (glejte poglavje 4. 4).
- Hypersensitivity to the active substance or to any of the excipients.
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov;
- Pregnant women (see sections 4.4, 4.6 and 5.3).
noseče ženske (glejte poglavja 4. 4, 4. 6 in 5. 3).
Ribavirin must not be initiated until a report of
Zdravljenja z zdravilom Ribavirin Teva ne smete
a negative pregnancy test has been obtained immediately prior to initiation of therapy.
uvesti, dokler ne dobite negativnega izvida testa nosečnosti tik pred začetkom zdravljenja; doječe matere;
- Women who are breast-feeding.
-
- A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac
hude obstoječe srčne bolezni v anamnezi, vključno z nestabilno ali nenadzorovano srčno
disease, in the previous six months (see section 4.4).
-
- Severe, debilitating medical conditions, including patients with chronic renal failure, patients
boleznijo v preteklih šestih mesecih (glejte poglavje 4. 4); hude bolezni, ki bolnika onesposobijo, vključno s kronično ledvično odpovedjo in očistkom
with creatinine clearance < 50 ml/ minute and/ or on haemodialysis.
kreatinina < 50 ml/ min in/ ali hemodializo; hude motnje delovanja jeter ali dekompenzirana jetrna ciroza;
- Severe hepatic dysfunction or decompensated cirrhosis of the liver.
-
- Haemoglobinopathies (e. g., thalassemia, sickle-cell anaemia).
hemoglobinopatije (npr. talasemija, anemija srpastih celic);
- Initiation of peginterferon alfa-2b is contraindicated in HCV/ HIV patients with cirrhosis and a
uvedba peginterferona alfa- 2b je kontraindicirana pri bolnikih, ki so sočasno okuženi s HCV in
- Existence of, or history of severe psychiatric condition, particularly severe depression, suicidal
Obstoječa huda duševna bolezen ali huda duševna bolezen v anamnezi, še posebej huda
Because of co-administration with peginterferon alfa-2b or interferon alfa-2b:
Zaradi sočasne uporabe peginterferona alfa- 2b ali interferona alfa- 2b pa še: avtoimunski hepatitis ali avtoimunska bolezen v anamnezi.
- Autoimmune hepatitis; or history of autoimmune disease.
-
Severe CNS effects, particularly depression, suicidal ideation and attempted suicide have been observed in some patients during Ribavirin combination therapy with peginterferon alfa-2b or interferon alfa-2b, and even after treatment discontinuation mainly during the 6-month follow-up period.
Pri nekaterih bolnikih so med kombinirano terapijo z zdravilom Ribavirin Teva in peginterferonom alfa- 2b ali interferonom alfa- 2b opažali hude učinke na CŽS, še posebej depresijo, samomorilne misli in tudi poskus samomora, celo po ukinitvi zdravljenja, predvsem v 6- mesečnem obdobju spremljanja.
Among children and adolescents, treated with Ribavirin in combination with interferon alfa-2b, suicidal ideation or attempts were reported more frequently compared to adult patients (2.4% versus 1%) during treatment and during the 6-month follow-up after treatment.
Tako kot pri odraslih bolnikih so tudi pri otroci
As in adult patients, children and adolescents experienced other psychiatric adverse events (e. g., depression, emotional lability, and somnolence).
6 in mladostniki opazili druge psihiatrične neželene dogodke (npr. depresijo, čustveno labilnost in zaspanost).
If psychiatric symptoms persist or worsen, or suicidal ideation is identified, it is recommended that treatment with Ribavirin and peginterferon alfa-2b or interferon alfa-2b be discontinued, and the patient followed, with psychiatric intervention as appropriate.
Če psihiatrični simptomi ne prenehajo ali se celo poslabšajo, ali če ugotovite, da ima bolnik samomorilne misli, je priporočljivo, da prekinete zdravljenje z zdravilom Ribavirin Teva in peginterferonom alfa- 2b ali interferonom alfa- 2b in bolnika spremljate, po potrebi tudi s psihiatrično intervencijo.
If treatment with Ribavirin in combination with peginterferon alfa-2b or interferon alfa-2b is judged necessary in adult patients with existence or history of severe psychiatric conditions, this should only be initiated after having ensured appropriate individualised diagnostic and therapeutic management of the psychiatric condition.
Če ocenite, da je potrebno zdravljenje z zdravilom Ribavirin Teva v kombinaciji s peginterferonom alfa- 2b ali interferonom alfa- 2b pri odraslih bolnikih z obstoječimi hudimi psihiatričnimi motnjami ali s hudimi psihijatričnimi motnjami v anamnezi, ga smete uvesti šele potem, ko ste zagotovili ustrezno individualno diagnostično in terapevtsko obravnavo psihiatrične motnje.
The use of Ribavirin and interferon alfa-2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see section 4.3).
Uporaba zdravila Ribavirin Teva in interferona alfa- 2b pri otrocih in mladostnikih z obstoječimi hudimi psihiatričnimi motnjami ali s hudimi psihijatričnimi motnjami v anamnezi je kontraindicirana (glejte poglavje 4. 3).
6 Based on results of clinical trials, the use of ribavirin as monotherapy is not effective and Ribavirin must not be used alone.
Na podlagi izsledkov kliničnih preskušanj vemo, da ribavirin v obliki monoterapije ni učinkovit, zato ga ne smete uporabljati samostojno.
The safety and efficacy of this combination have been established only using ribavirin capsules together with peginterferon alfa-2b or interferon alfa-2b solution for injection.
Varnost in učinkovitost te kombinacije je bila ugotovljena le pri uporabi kapsul ribavirina skupaj z raztopino za injiciranje peginterferona alfa- 2b ali interferona alfa - 2b.
All patients in the chronic hepatitis C studies had a liver biopsy before inclusion, but in certain cases (i. e. patients with genotype 2 and 3), treatment may be possible without histological confirmation.
Pri vseh bolnikih v študijah kroničnega hepatitisa C so opravili jetrno biopsijo pred vključitvijo v študijo, toda v nekaterih primerih (to je pri bolnikih z genotipoma 2 in 3), je lahko zdravljenje možno brez histološke potrditve.
Ribavirin must not be used by women who are pregnant (see section 4.3).
Nosečnice ne smejo uporabljati zdravila Ribavirin Teva (glejte poglavje 4. 3).
Extreme care must be taken to avoid pregnancy in partners of male patients taking Ribavirin (see sections 4.6 and 5.3).
Izjemno skrbno moramo paziti, da preprečimo zanositev pri partnerkah moških bolnikov, ki jemljejo zdravilo Ribavirin Teva (glejte poglavji 4. 6 in 5. 3).
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 (adults only) or interferon alfa-2b (adults and children or adolescents) in clinical trials.
V kliničnih preskušanjih so pri do 14% odraslih bolnikov in 7% otrok in mladostnikov, zdravljenih z zdravilom Ribavirin Teva v kombinaciji s peginterferonom alfa- 2b (samo odrasli) ali interferonom alfa- 2b (odrasli in otroci ali mladostniki), opažali zmanjšanje vrednosti hemoglobina na < 10 g/ dl.
Although ribavirin has no direct cardiovascular effects, anaemia associated with Ribavirin may result in deterioration of cardiac function, or exacerbation of the symptoms of coronary disease, or both.
Čeprav ribavirin nima neposrednih srčnožilnih učinkov, lahko anemija zaradi zdravila Ribavirin Teva povzroči poslabšanje delovanja srca, poslabšanje simptomov koronarne bolezni ali oboje.
Thus, Ribavirin must be administered with caution to patients with pre-existing cardiac disease (see section 4.3).
Zato morate zdravilo Ribavirin Teva pri bolnikih z obstoječo boleznijo srca uporabljati previdno (glejte poglavje 4. 3).
Adult patients with a history of congestive heart failure, myocardial infarction and/ or previous or current arrhythmic disorders must be closely monitored.
Odrasle bolnike s kongestivnim srčnim popuščanjem ali miokardnim infarktom v anamnezi oziroma s predhodnimi ali obstoječimi motnjami srčnega ritma morate strogo nadzorovati.
If an acute hypersensitivity reaction (e. g., urticaria, angioedema, bronchoconstriction, anaphylaxis) develops, Ribavirin must be discontinued immediately and appropriate medical therapy instituted.
Če se razvije akutna preobčutljivostna reakcija (npr. urtikarija, angioedem, bronhokonstrikcija, anafilaksa), morate jemanje zdravila Ribavirin Teva takoj prekiniti in uvesti
Any patient complaining of decrease or loss of vision must have a prompt and complete eye examination.
Pri vseh bolnikih je treba opraviti osnovni pregled očesa, pri tistih bolnikih, ki tožijo zaradi poslabšana vida ali zaradi izgube vida, pa je treba takoj opraviti celoten pregled očesa.
Combination therapy with alpha interferons should be discontinued in patients who develop new or worsening ophthalmologic disorders
Kombinirano terapijo z interferoni alfa je treba ukiniti pri bolnikih, ki se jim pojavijo ali poslabšajo očesne težave.
Supplemental monitoring specific for children and adolescents
Dodatno spremljanje posebej za otroke in mladostnike
7 Growth and Development:
Rast in razvoj:
During a 1-year course of therapy there was a decrease in the rate of linear growth (mean percentile decrease of 9%) and a decrease in the rate of weight gain (mean percentile decrease of 13%).
V času 1- letne terapije je prišlo do zmanjšanja hitrosti linearne rasti (srednje odstotno zmanjšanje 9%) in zmanjšanja hitrosti pridobivanja telesne mase (srednje odstotno zmanjšanje 13%).
However, based on interim data from a long-term follow-up study, 12 (14%) of 84 children had a > 15 percentile decrease in rate of linear growth, of whom 5 (6%) children had a > 30 percentile decrease despite being off treatment for more than 1 year.
Vendar pa je na podlagi vmesnih podatkov iz dolgoročne študije spremljanja bolnikov po zdravljenju imelo 12 (14%) od 84 otrok > 15- odstotno zmanjšanje hitrosti linearne rasti, od tega je imelo 5 (6%) otrok > 30 - odstotno zmanjšanje kljub temu, da terapije niso prejemali že več kot 1 leto.
In addition, preclinical juvenile toxicity results have demonstrated a minor, dose-related decrease in overall growth in neonatal rats dosed with ribavirin (see section 5.3).
Predklinični podatki o toksičnosti zdravila za podganje mladiče so pri novorojenih podganjih mladičih, ki so jim dajali odmerke ribavirina, kažejo od odmerka odvisno splošno zmanjšanje rasti, ki se je kasneje pokazalo kot rahlo zmanjšanje telesne mase, razdalje od temena do trtice in dolžine kosti (glejte poglavje 5. 3).
Therefore, the risk/ benefit of the combined use of Ribavirin and interferon alfa-2b should be assessed in young children prior to the initiation of therapy.
Zato je treba pred začetkom zdravljenja oceniti razmerje med tveganji in koristmi kombinirane uporabe zdravila Ribavirin Teva in interferona alfa- 2b pri majhnih otrocih.
Physicians are advised to monitor the growth of children taking Ribavirin in combination with interferon alfa-2b.
Zdravnikom torej svetujemo, naj spremljajo rast otrok, ki jemljejo zdravilo Ribavirin Teva v kombinaciji z interferonom alfa- 2b.
Approximately 12% of children treated with Ribavirin and interferon alfa-2b developed increase in TSH.
Pri približno 12% otrok, zdravljenih z zdravilom Ribavirin Teva in interferonom alfa- 2b, se je pojavilo povečanje TSH.
Thyroid dysfunction during treatment with Ribavirin and interferon alfa-2b has been observed.
Med zdravljenjem z zdravilom Ribavirin Teva in interferonom alfa- 2b so opažali motnje delovanja žleze ščitnice.
Caution should be taken in HIV-positive subjects co- infected with HCV who receive nucleoside reverse transcriptase inhibitor (NRTI) treatment (especially ddI and d4T) and associated interferon alfa-2b/ ribavirin treatment.
Pri bolnikih s pozitivnim izvidom na HIV in sočasno okužbo s HCV, ki prejemajo zaviralce nukleozidne reverzne transkriptaze (NRTI - » nucleoside reverse transcriptase inhibitor «) v povezavi z zdravljenjem z interferonom alfa- 2b in ribavirinom, je potrebna previdnost (posebno ddI in d4T).
In particular:
Pri bolnikih, pozitivnih na HIV, ki se zdravijo po shemi NRTI, mora zdravnik skrbno spremljati pokazatelje toksičnost za mitohondrije in laktacidoze pri sočasnem zdravljenju z ribavirinom, še posebej: zaradi možnosti razvoja toksičnosti za mitohondrije ni priporočljivo sočasno dajanje zdravila
- co-administration of Ribavirin and didanosine is not recommended due to the risk of
-
mitochondrial toxicity (see section 4.5).
Ribavirin Teva z didanozinom (glejte poglavje 4. 5). se je treba izogibati sočasni uporabi zdravila Ribavirin Teva in stavudina, da omejimo tveganje
- co-administration of Ribavirin and stavudine should be avoided to limit the risk of overlapping
-
mitochondrial toxicity.
toksičnosti za mitohondrije zaradi prekrivanja učinkov obeh zdravil.
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
8 Sočasno okuženi bolniki z napredovalo cirozo, ki prejemajo terapijo HAART, imajo lahko povečano tveganje za nastanek jetrne dekompenzacije in smrt.
Although, the majority of them could be managed by dose reduction, close monitoring of haematological parameters should be undertaken in this population of patients (see section 4.2 and below “ Laboratory tests” and section 4.8).
Čeprav bi lahko pri večini teh bolnikov stanje obvladali z zmanjšanjem odmerka, je pri tej skupini bolnikov potrebno skrbno spremljanje hematoloških parametrov (glejte poglavje 4. 2, » Laboratorijske preiskave « v nadaljevanju in poglavje 4. 8).
8 Patients with low CD4 counts:
Bolniki z majhnim številom celic CD4:
In patients co-infected with HCV/ HIV, limited efficacy and safety data (N = 25) are available in subjects with CD4 counts less than 200 cells/ µl.
Pri bolnikih sočasno okuženi s HCV in HIV, ki imajo število celic CD4 manjše od 200 celic/ μl, so na voljo omejeni podatki o učinkovitosti in varnosti zdravila (N = 25).
Please refer to the respective 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 and peginterferon alfa-2b.
Preberite si tudi ustrezne Povzetke glavnih značilnosti zdravila za protiretrovirusna zdravila, ki jih bo bolnik jemal skupaj s terapijo za HCV, da bi se bolj zavedali toksičnih učinkov vsakega od teh zdravil ter da bi se zavedali potencialnega prekrivanja njihovih toksičnih učinkov z zdravilom Ribavirin Teva v kombinaciji s peginterferonom alfa- 2b.
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Ribavirin and peginterferon alfa-2b or interferon alfa-2b combination therapy.
Pri bolnikih, ki so prejemali zdravilo Ribavirin Teva in peginterferon alfa- 2b ali interferon alfa- 2b v kombinirani terapiji, so poročali o zobnih boleznih in boleznih parodoncija, ki lahko vodijo do izgube zob.
In addition, dry mouth could have a damaging effect on teeth and mucous membranes of the mouth during long-term treatment with the combination of Ribavirin and peginterferon alfa-2b or interferon alfa-2b.
Poleg tega bi lahko med dolgotrajnim zdravljenjem s kombinacijo zdravila Ribavirin Teva in peginterferona alfa- 2b ali interferona alfa- 2b imela škodljiv vpliv na zobe in ustno sluznico tudi suha usta.
Acceptable baseline values that may be considered as a guideline prior to initiation of Ribavirin therapy:
Sprejemljive začetne vrednosti, ki lahko služijo kot smernice pred uvedbo terapije z zdravilom Ribavirin Teva:
Haemoglobin
Hemoglobin Krvne ploščice Število nevtrofilcev
Adult: ≥ 12 g/ dl (females); ≥ 13 g/ dl (males) Paediatric: ≥ 11 g/ dl (females); ≥ 12 g/ dl (males)
Odrasli ≥12 g/ dl (ženske); ≥13 g/ dl (moški) Otroci ≥11 g/ dl (ženske); ≥12 g/ dl (moški) ≥100. 000/ mm3 ≥1. 500/ mm3
Female patients must have a routine pregnancy test performed monthly during treatment and for four months thereafter.
Bolnice morajo rutinsko opravljati nosečnostni test vsak mesec med zdravljenjem
Uric acid may increase with Ribavirin due to haemolysis; therefore, the potential for development of gout must be carefully monitored in pre-disposed patients.
Zato morate pri k temu nagnjenih bolnikih skrbno spremljati možnost nastanka protina.