natgillin/translations-raw huggingface dataset:
- samtidig indgift af Rebetol og didanosin ikke på grund af risiko for mitokondrietoksicitet (se
- co-administration of Rebetol and didanosine is not recommended due to the risk of
4. 5).
mitochondrial toxicity (see section 4.5).
- samtidig indgift af Rebetol og stavudin bør undgås for at begrænse risiko for overlappende
- co-administration of Rebetol and stavudine should be avoided to limit the risk of overlapping
mitokondrietoksicitet.
mitochondrial toxicity.
Patienter med samtidig HCV/ HIV infektion og fremskreden cirrose, som modtager HAART behandling kan have en øget risiko for nedsat leverfunktion og død.
Co-infected patients with advanced cirrhosis receiving HAART may be at increased risk of hepatic decompensation and death.
Tillæg af behandling med alfa interferoner alene eller i kombination med ribavirin kan øge risikoen hos denne patient undergruppe.
Adding treatment with alfa interferons alone or in combination with ribavirin may increase the risk in this patient subset.
Andre baseline- faktorer hos co- inficerede patienter, som kan associeres med en højere risiko for hepatisk dekompensering omfatter behandling med didanosin og forhøjet bilirubin.
Other baseline factors in co-infected patients that may be associated with a higher risk of hepatic decompensation include treatment with didanosine and elevated bilirubin serum concentrations.
Deres Child- Pugh score bør vurderes under behandling.
Co-infected patients receiving both antiretroviral (ARV) and anti-hepatitis treatment should be closely monitored, assessing their Child-Pugh score during treatment.
Hæmatologiske unormaliteter hos patienter med samtidig HCV/ HIV- infektion:
Haematological abnormalities in HCV/ HIV co-infected patients:
Patienter, der samtidig er inficeret med HCV/ HIV og som modtager peginterferon alfa- 2b/ ribavirin behandling og HAART kan have øget risiko for at udvikle hæmatologiske unormaliteter (som neutropeni, thrombocytopeni og anæmi) sammenlignet med HCV mono- inficerede patienter.
HCV/ HIV co-infected patients receiving peginterferon alfa-2b/ ribavirin treatment and HAART may be at increased risk to develop haematological abnormalities (as neutropenia, thrombocytopenia and anaemia) compared to HCV mono-infected patients.
4. 8).
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).
4. 5).
Patients treated with ribavirin and zidovudine are at increased risk of developing anaemia; therefore, the concomitant use of ribavirin with zidovudine is not recommended (see section 4.5).
Hos patienter, der er co- inficeret med HCV/ HIV, er begrænsede effekt - og sikkerhedsdata (N = 25) tilgængelige i patienter med CD4- tællinger mindre end 200 celler/ μl.
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.
Der er derfor grund til at udvise forsigtighed i behandlingen af patienter med lave CD4- tællinger.
Caution is therefore warranted in the treatment of patients with low CD4 counts.
For de antiretrovirale lægemidler, der skal tages samtidig med HCV- behandling, henvises der til disses respektive produktresuméer for kendskab og håndtering af toksicitet der er specifikke for det enkelte produkt samt potentialet for overlappende toksiciteter med Rebetol og peginterferon alfa- 2b.
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 Rebetol and peginterferon alfa-2b.
8 Dentale og parodontale lidelser:
Dental and periodontal disorders:
Dentale og parodontale lidelser, som kan føre til tab af tænder, er blevet rapporteret hos patienter, der fik Rebetol og peginterferon alfa- 2b eller interferon alfa- 2b kombinationsbehandling.
In addition, dry mouth could have a damaging effect on teeth and mucous
Herudover kan mundtørhed have en skadelig virkning på tænder og mundslimhinder under langtidsbehandling med kombinationen af Rebetol og peginterferon alfa- 2b eller interferon alfa- 2b.
8 membranes of the mouth during long-term treatment with the combination of Rebetol and peginterferon alfa-2b or interferon alfa-2b.
Laboratorieanalyser:
Laboratory tests:
Standard hæmatologiske tests og blodkemi (komplet blodtælling og differentialtælling, blodpladetal, elektrolytter, serum creatinin, leverfunktionsundersøgelser, urinsyre) skal udføres hos alle patienter før påbegyndelse af behandling.
Standard haematologic tests and blood chemistries (complete blood count [CBC] and differential, platelet count, electrolytes, serum creatinine, liver function tests, uric acid) must be conducted in all patients prior to initiating therapy.
Acceptable baselineværdier, der kan betragtes som en vejledning før initiering af Rebetol behandling:
Acceptable baseline values that may be considered as a guideline prior to initiation of Rebetol therapy:
Voksne: ≥ 12 g/ dl (kvinder); ≥ 13 g/ dl (mænd) Pædiatrisk: ≥ 11 g/ dl (kvinder); ≥ 12 g/ dl (mænd)
Adult: ≥ 12 g/dl (females); ≥ 13 g/dl (males) Paediatric: ≥ 11 g/dl (females); ≥ 12 g/dl (males)
Blodplader Neutrofil tal
Platelets Neutrophil Count
≥ 100. 000/ mm3 ≥ 1. 500/ mm3
≥ 100,000/mm3 ≥ 1,500/mm3
For fertile kvinder:
For females of childbearing potential:
Kvindelige patienter skal have en rutine graviditetstest udført hver måned under behandling og i fire måneder derefter.
Female patients must have a routine pregnancy test performed monthly during treatment and for four months thereafter.
4. 6).
Female partners of male patients must have a routine pregnancy test performed monthly during treatment and for seven months thereafter (see section 4.6).
Anvendelse hos patienter med sjældne arvelige lidelser:
Use in patients with rare hereditary disorders:
Hver Rebetol kapsel indeholder 40 mg lactose.
Each Rebetol capsule contains 40 mg of lactose.
Patienter med sjældne arvelige lidelser med galaktose intolerance, total laktase mangel eller glucose- galaktose malabsorption bør ikke anvende dette lægemiddel.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
Resultater af in vitro undersøgelser med både humane og rotte levermikrosompræparater viste ingen cytokrom P450 enzymmedieret metabolisme af ribavirin.
Results of in vitro studies using both human and rat liver microsome preparations indicated no cytochrome P450 enzyme mediated metabolism of ribavirin.
Ribavirin hæmmer ikke cytokrom P450 enzymer.
Ribavirin does not inhibit cytochrome P450 enzymes.
Der er således minimal mulighed for P450 enzymbaserede interaktioner.
Therefore, there is a minimal potential for P450 enzyme-based interactions.
Ingen interaktionsundersøgelser er udført med Rebetol og andre lægemidler med undtagelse af peginterferon alfa- 2b, interferon alfa- 2b og antacida.
No interaction studies have been conducted with Rebetol and other medicinal products, except for peginterferon alfa-2b, interferon alfa-2b and antacids.
Der sås ingen farmakokinetiske interaktioner mellem Rebetol og peginterferon alfa - 2b eller interferon alfa- 2b i en flerdosis farmakokinetisk undersøgelse.
No pharmacokinetic interactions were noted between Rebetol and peginterferon alfa-2b or interferon alfa-2b in a multiple-dose pharmacokinetic study.
Bioavailabiliteten af ribavirin 600 mg blev reduceret ved samtidig indtagelse af et antacidum indeholdende magnesium, aluminium og simeticon; AUCtf faldt 14%.
The bioavailability of ribavirin 600 mg was decreased by co-administration with an antacid containing magnesium aluminium and simethicone; AUCtf decreased 14%.
Nukleosidanaloger:
Nucleoside analogs:
4. 4).
The concomitant use of
9 Til trods for at den nøjagtige mekanisme stadig mangler at blive belyst, er der set forværring af anæmi som følge af ribavirin, når zidovudin er en del af de lægemidler, der anvendes til behandling af HIV.
9 ribavirin with zidovudine is not recommended due to an increased risk of anaemia (see section 4.4).
5. 2).
Any potential for interactions may persist for up to two months (five half-lives for ribavirin) after cessation of Rebetol therapy due to the long half-life (see section 5.2).
Der er ingen tegn på, at ribavirin har interaktion med ikke- nukleosid reverse transcriptase- hæmmere eller proteasehæmmere.
The re is no evidence that ribavirin interacts with non-nucleoside reverse transcriptase inhibitors or protease inhibitors.
Anvendelsen af Rebetol er kontraindiceret under graviditet.
The use of Rebetol is contraindicated during pregnancy.
- Fertilitet:
- Fertility:
I dyrestudier gav ribavirin reversible virkninger på spermatogenese (se pkt.
In animal studies, ribavirin produced reversible effects on spermatogenesis (see section
5. 3).
5.3).
- Teratogenecitet:
- Teratogenicity:
Betydeligt teratogent og/ eller embryocidt potentiale er vist for ribavirin i alle
Significant teratogenic and/or embryocidal potential have been demonstrated for
5. 3).
ribavirin in all animal species in which adequate studies have been conducted, occurring at doses as low as one twentieth of the recommended human dose (see section 5.3).
- Genotoksicitet:
- Genotoxicity:
5. 3).
Ribavirin induces genotoxicity (see section 5.3).
4. 3, 4. 4 og 5. 3).
Rebetol must not be used by females who are pregnant (see sections 4.3, 4.4 and 5.3).
Den yderste forsigtighed skal udvises for at undgå graviditet hos kvindelige patienter.
Extreme care must be taken to avoid pregnancy in female patients.
Rebetol behandling må ikke initieres før et negativt resultat fra en graviditetstest er opnået umiddelbart før behandlingsstart.
Rebetol therapy must not be initiated until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.
4. 4).
Females of childbearing potential and their partners must each 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).
Det er uvist, om ribavirin optaget i sædvæske vil udøve de potentielle teratogene eller genotoksiske virkninger på det humane embryo/ foster.
It is unknown whether the ribavirin that is contained in sperm will exert its potential teratogenic or genotoxic effects on the human embryo/foetus.
Mænd, hvis partnere er gravide, skal underrettes om at anvende kondom for at mindske overførsel af ribavirin til partneren.
Although data on approximately 300 prospectively followed pregnancies with paternal exposure to ribavirin have not shown an increased risk of malformation compared to the general population, nor any specific pattern of malformation, male patients and their female partners of childbearing age must be counseled to each use an effective contraceptive during treatment with Rebetol and for seven months after treatment Men whose partners are pregnant must be instructed to use a condom to minimise delivery of ribavirin to the partner.
Af hensyn til muligheden for bivirkninger hos de ammede børn, skal amning afbrydes før påbegyndelse af behandling.
Because of the potential for adverse reactions in nursing infants, nursing must be discontinued prior to initiation of treatment.
Rebetol har ingen eller ubetydelig indflydelse på evnen til at føre bil og betjene maskiner; peginterferon alfa- 2b eller interferon alfa- 2b anvendt i kombination kan imidlertid have en virkning.
Rebetol has no or negligible influence on the ability to drive and use machines; however, peginterferon alfa-2b or interferon alfa-2b used in combination may have an effect.
10 Sikkerheden ved Rebetol kapsler er vurderet på basis af data fra tre kliniske undersøgelser hos patienter uden tidligere eksponering for interferon (interferon- naive patienter): to undersøgelser vurderede Rebetol i kombination med interferon alfa- 2b, en undersøgelse vurderede Rebetol i kombination med peginterferon alfa- 2b.
10 The safety of Rebetol capsules is evaluated from data from three clinical trials in patients with no previous exposure to interferon (interferon-naïve patients): two trials studied Rebetol in combination with interferon alfa-2b, one trial studied Rebetol in combination with peginterferon alfa-2b.
Patienter, som behandles med interferon alfa- 2b og ribavirin efter tidligere relaps efter interferon behandling, eller som behandles i en kortere periode, har sandsynligvis en bedre sikkerhedsprofil end den nedenfor beskrevne.
Patients who are treated with interferon alfa-2b and ribavirin after previous relapse from interferon therapy or who are treated for a shorter period are likely to have an improved safety profile than that described below.
Et givet antal bivirkninger tilskrevet interferonbehandling, men som har været rapporteret i sammenhæng med hepatitis C- behandling (i kombination med ribavirin) er også listet i Tabel 4.
A certain number of adverse reactions, generally attributed to interferon therapy but that have been reported in the context of hepatitis C therapy (in combination with ribavirin) are also listed for reference in Table 4.
Desuden refererer SPCet for peginterferon alfa- 2b og interferon alfa- 2b til bivirkninger, der kan tilskrives interferonmonoterapi.
Also, refer to peginterferon alfa-2b and interferon alfa-2b SPCs for adverse reactions that may be attributable to interferon monotherapy.
Indenfor systemorganklasserne er bivirkningerne opført under overskrifter for hyppighed ved brug af følgende kategorier: meget almindelig (≥1/ 10); almindelig (≥1/ 100 til < 1/ 10); ikke almindelig (≥1/ 1. 000 til < 1/ 100); sjælden (≥1/ 10. 000 til < 1/ 1. 000); meget sjælden (< 1/ 10. 000); ikke kendt.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known.
Bivirkninger set i kliniske undersøgelser og efter markedsføring af Rebetol med pegyleret interferon alfa- 2b eller interferon alfa- 2b injektion Systemorganklasse Bivirkninger
Adverse reactions reported during clinical trials or following the marketing use of Rebetol with pegylated interferon alfa-2b or interferon alfa-2b injection
og parasitære sygdomme
Adverse Reactions
Meget almindelig Almindelig
Common:
Virusinfektion, pharyngitis Svampeinfektion, otitis media, herpes simplex, urinvejsinfektion
Viral infection, pharyngitis Fungal infection, otitis media, herpes simplex, urinary tract infection
Lungebetændelse‫٭ ‬
Pneumonia*
Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper) Almindelig Blod og lymfesystem
Blood and lymphatic system disorders
Meget almindelig Almindelig Meget sjælden Ikke kendt Immunsystemet
Immune system disorders
Anæmi, neutropeni Thrombocytopeni, lymfadenopati, lymfopeni Aplastik anæmi‫٭ ‬ Pure red cell- aplasi, idiopatisk thrombocytopenisk purpura, thrombotisk thrombocytopenisk purpura
Anaemia, neutropenia Thrombocytopenia, lymphadenopathy, lymphopenia Aplastic anaemia* Pure red cell aplasia, idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura
Meget sjælden Ikke kendt Det endokrine system
Endocrine disorders
Sarcoidosis‫٭ ‬ Vogt- Koyanagi- Harada syndrom, systemisk lupus erythematosus, reumatoid artritis (ny eller forværret), vaskulitis, akutte overfølsomhedsreaktioner herunder urticaria, angioødem, forsnævring af bronkierne, anafylaksi
Sarcoidosis* Vogt-Koyanagi-Harada syndrome, systemic lupus erythematosus, rheumatoid arthritis (new or aggravated), vasculitis, acute hypersensitivity reactions including urticaria, angioedema, bronchoconstriction, anaphylaxis
Almindelig Sjælden Metabolisme og ernæring
Metabolism and nutrition disorders
Hypothyreoidisme, hyperthyreoidisme Diabetes
Hypothyroidism, hyperthyroidism Diabetes
Meget almindelig Almindelig
Very common:
Anoreksi Hyperglykæmi, hyperuricæmi, hypokalcæmi, dehydrering, øget appetit, tørst
Hyperglycaemia, hyperuricaemia, hypocalcaemia, dehydration, increased appetite, thirst
Meget sjælden Psykiske forstyrrelser
Psychiatric disorders
Hypertriglyceridæmi‫٭ ‬
Hypertriglyceridemia*
Depression, søvnløshed, angst, emotionel labilitet Selvmordstanker, psykose, aggresiv opførsel,
Depression, insomnia, anxiety, emotional lability Suicidal ideation, psychosis, aggressive behaviour, confusion, agitation, nervousness, sleep disorder, abnormal dreaming, abnormal crying, apathy, decreased libido
11
Rare:
Selvmordsforsøg Hallucinationer Selvmord‫٭ ‬ Ændring i mental status
Suicide attempts Hallucination 11
Hovedpine, svimmelhed, mundtørhed, nedsat koncentration
Suicide* Mental status change
Almindelig
Very common:
Ataksi, tremor, parestesier, dysfoni, tab af smagssans, hypoæstesi, hyperæstesi, somnolens, migræne, hypertoni, smagsforstyrrelser
Headache, dizziness, dry mouth, concentration impaired Ataxia, tremor, paresthaesia, dysphonia, taste loss, hypoaesthesia, hyperaesthesia, somnolence, migraine, hypertonia, dysgeusia
Sjælden Meget sjælden
Very rare:
Kramper‫, ٭ ‬perifer neuropati‫٭ ‬ Cerebrovaskulær blødning‫, ٭ ‬cerebrovaskulær iskæmi‫ ٭ ‬hjernebetændelse‫, ٭ ‬polyneuropati‫٭ ‬
Seizure (convulsion)*, peripheral neuropathy* Cerebrovascular haemorrhage*, cerebrovascular ischaemia*, encephalopathy*, polyneuropathy*
Ikke kendt Øjne
Eye disorders
Ansigtslammelse, neuropati (herunder mononeuropati)
Facial palsy, neuropathies (including mononeuropathies)
Sløret syn, konjunktivitis, øjensmerter, abnormt syn, tårekirtellidelse
Blurred vision, conjunctivitis, eye pain, abnormal vision, lacrimal gland disorder
Sjælden Øre og labyrint
Rare:
Blødninger i nethinden‫, ٭ ‬retinopati (herunder macula ødem) ‫, ٭ ‬nethindearterieobstruktion‫, ٭ ‬ nethindeveneobstruktion‫, ٭ ‬optisk neuropati‫, ٭ ‬ papilødem‫, ٭ ‬synstab eller tab af synsfelt‫, ٭ ‬ ekksudater‫٭ ‬
Retinal haemorrhages*, retinopathies (including macular oedema)*, retinal artery obstruction*, retinal vein obstruction*, optic neuritis*, papilloedema*, loss of visual acuity or visual field*, cotton wool spots*
Almindelig Hjerte
Ear and labyrinth disorders
Vertigo, nedsat hørelse/ høretab, tinnitus, ørepine
Cardiac disorders
Almindelig Sjælden Meget sjælden Vaskulære sygdomme
Vertigo, hearing impairment/loss, tinnitus, earache
Hjertebanken, takykardi Kardiomyopati‫, ٭ ‬arytmi‫, ٭ ‬ Hjerteinfarkt‫, ٭ ‬iskæmisk hjertesygdom‫٭ ‬
Palpitation, tachycardia Cardiomyopathy*, arrhythmia* Myocardial infarction*, cardiac ischaemia*
Almindelig Meget sjælden Luftveje, thorax og mediastinum
Respiratory, thoracic and mediastinal disorders
Hypotension, hypertension, synkope, rødme Perifer iskæmi‫٭ ‬
Hypotension, hypertension, syncope, flushing Peripheral ischaemia*
Dyspnø, hoste Bihulebetændelse, bronkitis, næseblod, næsekatar, respiratorisk lidelse, næsetæthed, næseflåd, tør hoste
Dyspnoea, coughing Sinusitis, bronchitis, epistaxis, rhinitis, respiratory disorder, nasal congestion, rhinorrhea, nonproductive cough
Meget sjælden Mave- tarm- kanalen
Very rare:
Lungeinfiltration‫, ٭ ‬pneumoni‫, ٭ ‬interstitial pneumonitis‫٭ ‬
Pulmonary infiltrates*, pneumonitis*, interstitial pneumonitis*
Meget almindelig Almindelig
Gastro-intestinal disorders
Diarre, opkastning, kvalme, abdominal smerte Ulcerøs stomatitis, stomatitis, colitis, smerte i højre øvre kvadrant, dyspepsi, gastro- øsofageal refluks‫, ٭ ‬glossitis, tandkødsblødning, tandkødsbetændelse, løse afføringer, forstoppelse, flatulens
Diarrhoea, vomiting, nausea, abdominal pain Ulcerative stomatitis, stomatitis, colitis, upper right quadrant pain, dyspepsia, gastroesophogeal reflux*, glossitis, gingival bleeding, gingivitis, loose stools, constipation, flatulence
Sjælden Meget sjælden Ikke kendt Lever og galdeveje
Hepatobiliary disorders
Pancreatitis‫٭ ‬ Iskæmisk colitis‫, ٭ ‬colitis ulcerosa‫٭ ‬ Rodbetændelse, tandlidelse
Pancreatitis* Ischaemic colitus*, ulcerative colitus* Periodontal disorder, dental disorder
Almindelig Meget sjælden Hud og subkutane væv
Very rare:
Leverforstørrelse, gulsot, hyperbilirubinæmi‫٭ ‬ Hepatoxicitet (herunder dødelig) ‫٭ ‬
Hepatomegaly, jaundice, hyperbilirubinemia* Hepatotoxicity (including fatalities)*
12 Meget almindelig Almindelig
Alopecia, pruritus, skin dry, rash Psoriasis, aggravated psoriasis, eczema, photosensitivity reaction, maculopapular rash, erythematous rash, dermatitis, acne, furunculosis*, erythema, skin disorder, bruise, sweating increased, abnormal hair texture, nail disorder* 12
Alopeci, pruritus, tør hud, udslæt Psoriasis, forværret psoriasis, eksem, lysoverfølsomhedsreaktion, maculopapuløst udslæt, erythematøst udslæt, dermatitis, akne, furunkulose‫, ٭ ‬erythem, hudlidelse, blå mærker, øget svedtendens, unormal hårstruktur, neglelidelse‫٭ ‬
Very rare:
Meget sjælden Knogler, led, muskler og bindevæv
Stevens Johnson syndrome*, toxic epidermal necrolysis*, erythema multiforme*
Stevens Johnson syndrom‫, ٭ ‬toksisk epidermal nekrolyse‫, ٭ ‬erythema multiforme‫٭ ‬
Musculoskeletal and connective tissue disorders
Meget almindelig Almindelig Sjælden Nyrer og urinveje
Rare:
Arthralgi, myalgi, muskoloskeletal smerte Arthritis Rhabdomyolyse‫, ٭ ‬myositis‫٭ ‬
Arthralgia, myalgia, musculoskeletal pain Arthritis Rhabdomyolysis*, myositis*
Almindelig Sjælden Meget sjælden Det reproduktive system og mammae
Very rare:
Øget vandladningsfrekvens, polyuri Nyresvigt‫, ٭ ‬nyreinsufficiens‫٭ ‬ Nefrotisk syndrom‫٭ ‬
Micturition frequency, polyuria Renal failure*, renal insufficiency* Nephrotic syndrome*
Almindelig
Reproductive system and breast disorders
Kvinder:
Common:
Mænd:
Female: amenorrhea, menorrhagia, menstrual disorder, dysmenorrhea, breast pain, ovarian disorder, vaginal disorder.
Impotens, prostatitis Sexuel dysfunktion (ikke specificeret) ‫٭ ‬
Male: impotence, prostatitis Sexual dysfunction (not specified)*
Almene symptomer og reaktioner på administrationsstedet Meget almindelig
Very common:
Inflammation på injektionsstedet, reaktion på injektionsstedet, træthed, rigor, feber, influenzalignende symptomer, astheni, irritabilitet
Injection site inflammation, injection site reaction, fatigue, rigors, fever, flu-like symptoms, asthenia, irritability
Brystsmerter, perifere ødemer, utilpashed, smerte på injektionsstedet, ansigtsødem‫٭ ‬
Chest pain, peripheral oedema, malaise, injection site pain, face oedema*
Meget sjælden Undersøgelser
Investigations
Nekrose på injektionsstede‫٭ ‬
Injection site necrosis
Meget almindelig almindelig
Common:
Vægtfald Hjertemislyd, unormal urin
Weight decrease Cardiac murmur, urine abnormal
‫ ٭ ‬Ovenstående frekvenser er fra kliniske forsøg med ribavirin i kombination med interferon alfa- 2b (pegyleret eller non - pegyleret), da ribavirin altid udskrives samtidig med et alfa- interferon produkt, og de listede bivirkninger, som inkluderede reflekterende erfaring efter markedsføring, ikke tillader præcis kvantificering af frekvens.
* Since ribavirin is always prescribed with an alpha interferon product, and the listed adverse drug reactions included reflecting post-marketing experience do not allow precise quantification of frequency, the frequency reported above is from clinical trials using ribavirin in combination with interferon alfa-2b (pegylated or nonpegylated).
Et fald i hæmoglobinkoncentration på > 4g/ dl blev set hos 30% af patienter behandlet med Rebetol og peginterferon alfa- 2b og 37% af patienter behandlet med Rebetol + interferon alfa- 2b.
A reduction in haemoglobin concentrations by > 4 g/dl was observed in 30% of patients treated with Rebetol and peginterferon alfa-2b and 37% of patients treated with Rebetol + interferon alfa-2b.
Hæmoglobinværdierne faldt til under 10 g/ dl hos op til 14% voksne patienter og 7% børn og unge behandlet med Rebetol i kombination med enten peginterferon alfa- 2b (kun voksne) eller interferon alfa- 2b.
Haemoglobin levels dropped below 10 g/dl in up to 14% of adult patients and 7% of children and adolescents treated with Rebetol in combination with either peginterferon alfa-2b (adults only) or interferon alfa-2b.