natgillin/translations-raw huggingface dataset:
Each vial of 1.0 ml solution contains 180 micrograms peginterferon alfa-2a.
Ena viala z 1,0 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a.
The recommended duration of therapy is 48 weeks in patients with CHB. Before initiating therapy for CHB, persistently elevated serum ALT levels should have been documented.
Pred začetkom zdravljenja CHB je treba dokumentirati dolgotrajno zvišane ravni ALT v serumu.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih preveliko odmerjanje učinkovine
Activation button
Sprožilni gumb 4.
D-79639 Grenzach- Wyhlen Germany
D-79639 Grenzach- Wyhlen Nemčija
HIV-HCV co-infected patients
Bolniki, sočasno okuženi s HIV in HCV
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 135 µg PRE-FILLED SYRINGES (WITH BLUE BOX) - Multipack
ZUNANJA OVOJNINA - 12 x 135 µg NAPOLNJENE INJEKCIJSKE BRIZGE (Z MODRIM OKENCEM) - skupno pakiranje
Never re-attach protective cap after removal.
Po odstranitvi pokrovčka ne poskušajte namestiti znova.
Hold the pre-filled pen comfortably in your hand.
V roki sproščeno držite napolnjeni injekcijski peresnik.
Pegasys 135 micrograms solution for injection in pre-filled pen Pegasys 180 micrograms solution for injection in pre-filled pen
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Pegasys 180 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku
Pegasys is administered subcutaneously in the abdomen or thigh.
Zdravilo Pegasys dajemo subkutano v trebuh ali stegno.
Pegasys 180 micrograms solution for injection in pre-filled syringe 4 years
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi 4 leta
Weight decreased
Znižanje do
Caution should be exercised when administering Pegasys in combination with other potentially myelosuppressive agents.
Pri dajanju zdravila Pegasys v kombinaciji z drugimi zdravili z možnim mielosupresivnim delovanjem je potrebna previdnost.
Bronchitis, upper respiratory infection, oral candidiasis, herpes simplex, fungal, viral and bacterial infections
Infekcijske in parazitske bolezni bronhitis, okužba zgornjih dihal, kandidaza v ustih, herpes simpleks,
No HBV-HIV co-infected patients were included in these clinical trials.
ta klinična preskušanja bolniki, sočasno okuženi s HBV in HIV, niso bili vključeni.
Pegasys is presented as a solution for injection in a pre-filled syringe (0.5 ml) with a separate injection needle.
Zdravilo Pegasys je na voljo v obliki raztopine za injiciranje v napolnjeni injekcijski brizgi (0,5 ml).
Specific recommendations for management of treatment-emergent anaemia in adults are as follows: ribavirin should be reduced to 600 milligrams/day (200 milligrams in the morning and 400 milligrams in the evening) if either of the following apply: (1) a patient without significant cardiovascular disease experiences a fall in haemoglobin to < 10 g/dl and ≥ 8.5 g/dl, or (2) a patient with stable cardiovascular disease experiences a fall in haemoglobin by ≥ 2 g/dl during any 4 weeks of treatment.
(1) se pri bolniku brez pomembnega srčnožilnega obolenja pojavi zmanjšanje hemoglobina na < 10 g/dl in ≥ 8,5 g/dl ali (2) če se pri bolniku s stabilnim srčnožilnim obolenjem pojavi padec hemoglobina za ≥ 2 g/dl kadar koli med štiritedenskim zdravljenjem.
Hyperglycaemia, type 1 diabetes mellitus
Bolezni endokrinega sistema hipotiroidizem, hipertiroidizem diabetes diabetična ketoacidoza
Benzyl alcohol Sodium acetate Acetic acid Water for injections
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi natrijev klorid polisorbat 80 benzilalkohol natrijev acetat ocetna kislina voda za injekcije
Ribavirin 1000/1200 mg 72 or 48 Weeks (N = 942) Pts with VR at Wk 12 a
1000/1200 mg 72 tednov (n = 473)
In the investigator sponsored CHIPS study (Chronic Hepatitis C International Paediatric Study), 65 children and adolescents (6-18 years) with chronic HCV infection were treated with Pegasys 100 mcg/m2 sc once weekly and ribavirin 15 mg/kg/day for 24 weeks (genotypes 2 and 3) or 48 weeks
V raziskovalčevi študiji CHIPS (Chronic Hepatitis C International Pediatric Study) so 65 otrok in mladostnikov (starih 6 do 18 let) s kronično okužbo s HCV zdravili z zdravilom Pegasys
Pegasys 180 micrograms solution for injection Peginterferon alfa-2a
Pegasys 180 mikrogramov raztopina za injiciranje peginterferon alfa-2a
Pegasys 90 micrograms solution for injection in pre-filled syringe Pegasys 135 micrograms solution for injection in pre-filled syringe Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Navodilo za uporabo Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
Liver and renal graft rejections have been reported with Pegasys, alone or in combination with ribavirin.
Pri zdravilu Pegasys, uporabljenem samostojno ali v kombinaciji z ribavirinom, so poročali o zavrnitvah jetrnih in ledvičnih presadkov.
Pegasys 180 micrograms solution for injection Each vial of 1 ml solution contains 180 micrograms peginterferon alfa-2a*.
Pegasys 180 mikrogramov raztopina za injiciranje Ena viala z 1 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a*.
Pegasys 90 micrograms solution for injection in pre-filled syringe EU/1/02/221/017
Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/02/221/017
Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml * Pegasys 180 mcg & ribavirin 800 mg vs. Interferon alfa-2a 3 MIU & ribavirin 800 mg: Odds Ratio (95% CI) = 5.40 (3.42 to 8.54), P-value (stratified Cochran-Mantel-Haenszel test) = < 0.0001 * Pegasys 180 mcg & ribavirin 800 mg vs. Pegasys 180 mcg:
*Zdravilo Pegasys 180 μg & ribavirin 800 mg v primerjavi z interferonom alfa-2a 3 mio i.e. & ribavirinom 800 mg: razmerje (95 % CI) = 5,40 (3,42 do 8,54), p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = < 0,0001 *Zdravilo Pegasys 180 μg & ribavirin 800 mg v primerjavi z zdravilom Pegasys 180 µg: razmerje (95 % CI) = 2,89 (1,93 do 4,32), p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = < 0,0001 *Interferon alfa-2a 3 mio i.e. & ribavirin 800 mg v primerjavi z zdravilom Pegasys 180 µg: razmerje (95 % CI) = 0,53 (0,33 do 0,85), p-vrednost (stratificiran Cochran-Mantel-Haenszlov test) = < 0,0084
Retinal haemorrhage
zamaščenost jeter
Table 9: Undesirable effects reported with Pegasys monotherapy for CHB or CHC or in combination with ribavirin for CHC patients in clinical trials and post marketing Body system Very common
Preglednica 9: Neželeni učinki, ki so se pojavili v kliničnih preskušanjih in po prihodu zdravila na trg pri samostojnem zdravljenju z zdravilom Pegasys pri bolnikih s CHB ali CHC ali v kombiniranem zdravljenju z ribavirinom pri bolnikih s CHC
Degree of abnormality Score Encephalopathy None Grade 1-2
Encefalopatija odsotna stopnja 1-2 stopnja 3-4*
Overall Sustained Response
Celokup en trajni odziv
Pegylated interferon Interferon plus ribavirin Pegylated interferon plus ribavirin
Pegasys 180 μg in ribavirin 1000/1200 mg 48 tednov interferon pegiliran interferon interferon in ribavirin pegiliran interferon in ribavirin
A total of 151 patients without advanced fibrosis were 2:1 randomized to Pegasys (group A, n=101) or untreated control (group B, n=50), respectively.
151 bolnikov brez napredovale fibroze v razmerju 2:1 na skupino, ki je prejemala zdravilo Pegasys
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 180 µg PRE-FILLED SYRINGES (WITH BLUE BOX) - Multipack
ZUNANJA OVOJNINA- 12 x 180 µg NAPOLNJENE INJEKCIJSKE BRIZGE (Z MODRIM OKENCEM) - skupno pakiranje
● Remove the needle guard from the syringe needle.
● Z injekcijske igle snemite zaščito.
Tachycardia, oedema peripheral, palpitations,
Srčne bolezni tahikardija, periferni edem, palpitacije miokardni infarkt, kongestivno srčno popuščanje,
Thyroid function abnormalities or worsening of pre-existing thyroid disorders have been reported with the use of alfa interferons, including Pegasys.
obstaja povečano tveganje za nastanek novih ali poslabšanje že obstoječih psihiatričnih motenj, če jih zdravimo z interferonom alfa.
NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection
Pegasys 180 mikrogramov raztopina za injiciranje
The mean changes from baseline in height and weight for age Z-scores at Week 48 of treatment in study YV25718 were -0.07 and -0.21 (n=108 and n= 106 respectively) for Pegasys-treated patients as compared to -0.01 and -0.08 (n=47 each) in untreated patients.
-0,07 in -0,21 (n = 108 in n = 106) v primerjavi z -0,01 in -0,08 (n = 47 za vsako) pri nezdravljenih bolnikih.
Pegasys 135 micrograms solution for injection in pre-filled syringe EU/1/02/221/005
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/02/221/005
Genotype 2 or 3 RVR Low viral load High viral load
Genotip 2 ali 3, nizko virusno breme in hiter virološki odziv**
1 pre-filled syringe + 1 injection needle 90 micrograms/0.5 ml
1 napolnjena injekcijska brizga + 1 injekcijska igla 90 mikrogramov/0,5 ml
● if you think you are getting an infection (such as pneumonia) as when receiving Pegasys you may temporarily have a greater risk of getting an infection.
• če mislite, da ste dobili okužbo (kot je pljučnica).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg VIALS
ZUNANJA OVOJNINA - 4 x 180 µg VIALE
● Hold the syringe with the needle in the vial pointing up, remove the syringe from the long needle while keeping the needle in the vial and without touching the tip of the syringe.
Snemite brizgo z dolge igle, igla pa naj ostane v viali.
Tooth extraction, cholecystectomy
Kirurški in drugi medicinski posegi ekstrakcija zoba, holecistektomija
Alopecia, dermatitis, pruritis, dry skin
Bolezni kože in podkožja alopecija, dermatitis, pruritus, suha koža psoriaza, urtikarija, ekcem,
4 pre-filled syringes + 4 injection needles 135 micrograms/0.5 ml
4 napolnjene injekcijske brizge + 4 injekcijske igle 135 mikrogramov/0,5 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 135 µg PRE-FILLED PENS
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 12 x 135 µg NAPOLNJENI INJEKCIJSKI PERESNIKI
Dental and periodontal disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Pri bolnikih, ki prejemajo zdravilo Pegasys v kombinaciji z ribavirinom, so poročali o zobnih in periodontalnih boleznih, ki lahko vodijo do izgube zob.
Roche Pharma AG Emil-Barell-Str. 1
Emil-Barell-Str. 1
NAME OF THE MEDICINAL PRODUCT Pegasys 90 micrograms solution for injection in pre-filled syringe Pegasys 135 micrograms solution for injection in pre-filled syringe Pegasys 180 micrograms solution for injection in pre-filled syringe
Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 12 x 180 µg PRE-FILLED PENS
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 12 x 180 µg NAPOLNJENI INJEKCIJSKI PERESNIKI
Pegasys dose
Odmerek zdravila Pegasys
1 pre-filled syringe + 1 injection needle 180 micrograms/0.5 ml
1 napolnjena injekcijska brizga + 1 injekcijska igla 180 mikrogramov/0,5 ml
1 x 200 mg tablets A.M.
1 x 200-mg tableta zvečer
Fertility
lamivudin
* Similar to end point of HBV DNA < 10
* za HBeAg-pozitivne bolnike: HBV DNA < 10
4 pre-filled syringes + 4 injection needles 180 micrograms/0.5 ml
4 napolnjene injekcijske brizge + 4 injekcijske igle 180 mikrogramov/0,5 ml
8) Dispose of pre-filled pen
8) Odvrzite napolnjeni injekcijski peresnik
Your doctor has determined the exact dose of Pegasys, and will tell you how often to use it.
Vaš zdravnik je določil natančen odmerek zdravila Pegasys.
Back pain, arthritis, muscle weakness, bone pain, neck pain, musculoskelet al pain, muscle cramps
bolečina v kosteh, bolečina v vratu, mišičnoskeletna bolečina, mišični krči miozitis rabdomioliza
1 pre-filled syringe + 1 injection needle 135 micrograms/0.5 ml
1 napolnjena injekcijska brizga + 1 injekcijska igla 135 mikrogramov/0,5 ml
1 ml of solution for injection in vial (Type I glass) with stopper (rubber butyl).
Viala (steklo tipa I) z zamaškom (butil guma) z 1 ml raztopine za injiciranje.
Pegasys 135 micrograms solution for injection in pre-filled pen Each pre-filled pen of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a*.
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Vsak injekcijski peresnik z 0,5 ml raztopine vsebuje 135 mikrogramov peginterferona alfa-2a*.
Measuring the dose of Pegasys
Odmerjanje zdravila Pegasys
The pharmacokinetics of Pegasys were similar between healthy subjects and patients with hepatitis B or C. Comparable exposure and pharmacokinetic profiles were seen in cirrhotic (Child-Pugh Grade A) and non-cirrhotic patients.
Pri zdravih prostovoljcih in bolnikih s hepatitisom B ali C je bila farmakokinetika zdravila Pegasys podobna.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 6 x 180 µg PRE-FILLED SYRINGES (WITHOUT BLUE BOX)Multipack
ZUNANJA OVOJNINA- 6 x 180 µg NAPOLNJENE INJEKCIJSKE BRIZGE (BREZ MODREGA OKENCA) - skupno pakiranje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 6 x 135 µg PRE-FILLED SYRINGES (WITHOUT BLUE BOX)Multipack
ZUNANJA OVOJNINA - 6 x 135 µg NAPOLNJENE INJEKCIJSKE BRIZGE (BREZ MODREGA OKENCA) - skupno pakiranje
Pegasys 180 micrograms solution for injection in pre-filled syringe EU/1/02/221/007
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/02/221/007
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja, epistaksa
Renal insufficiency
Bolezni sečil ledvična insuficienca
Vertigo, earache
vročinski valovi, žeja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 90 µg PRE-FILLED SYRINGE
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA- 1 x 90 µg NAPOLNJENA INJEKCIJSKA BRIZGA
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
Pri bolnikih, ki so prejemali zdravilo Pegasys skupaj z ribavirinom, so poročali o boleznih zob in dlesni, ki lahko vodijo do izgube zob.
Dysuria, incontinence, urinary tract disorder
Bolezni sečil disurija, inkontinenca, bolezen sečil
With respect to the decision to initiate treatment in paediatric patients see sections 4.2, 4.4 and 5.1.
Za specifično aktivnost glede genotipa virusa hepatitisa C glejte poglavji 4.2 in 5.1.
Diabetes
hemoglobin
Syncope, migraine, memory impairment, weakness, hypoaesthesia hyperaesthesi a, paraesthesia, tremor, taste disturbance, nightmares, somnolence
Bolezni živčevja glavobol, omotica*, motnje koncentracije sinkopa, migrena, motnje spomina, oslabelost, hipestezija, hiperestezija, parestezija, tremor, motnje okusa,
Genotype 2 and 3 (N=96)
Genotip B (n = 21)
Metabolism and nutrition disorders Decreased appetite
Presnovne in prehranske motnje anoreksija dehidracija
Do not use Pegasys
Zdravila Pegasys ne dajemo
Upper respiratory infection, bronchitis, fungal infection of the mouth and herpes (a common recurring viral infection affecting the lips, mouth) Blood disorders: Low platelet count (affecting the clotting ability), anaemia (low red cell count) and enlarged lymph glands
Okužbe: glivične, virusne in bakterijske okužbe, okužba zgornjih dihal, bronhitis, glivična okužba v ustih in herpes (pogosta ponavljajoča se virusna okužba, ki prizadane ustnice in usta).
Gastrointestinal disorder
Injiciranje raztopine
MARKETING AUTHORISATION NUMBERS Pegasys 180 micrograms solution for injection EU/1/02/221/003
Pegasys 180 mikrogramov raztopina za injiciranje EU/1/02/221/003
Pegasys 180 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a*.
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku Vsak injekcijski peresnik z 0,5 ml raztopine vsebuje 180 mikrogramov peginterferona alfa-2a*.
HIV-HCV co-infected adult patients
Odrasli bolniki, sočasno okuženi s HIV in HCV
The possibility of shortening treatment duration to 16 weeks in genotype 2 or 3 patients was examined based on a sustained virological response observed in patients with rapid virological response by week 4 in study NV17317 (see Table 17).
V študiji NV17317 so proučevali možnost skrajšanja zdravljenja bolnikov, okuženih z genotipom 2 ali 3 na 16 tednov, glede na trajni virološki odziv, opažen pri bolnikih, ki so imeli hiter virološki odziv v
In the NV17424 (PEDS-C) study, previously untreated paediatric patients 5 to 17 years of age (55% <12 years old) with compensated CHC and detectable HCV RNA were treated with Pegasys 180 mcg x BSA/1.73 m2 once weekly for 48 weeks with or without ribavirin 15 mg/kg/day.
(55 % < 12 let) s kompenziranim CHC in merljivo koncentracijo HCV RNA, bili zdravljeni z zdravilom Pegasys 180 µg/1,73 m2 telesne površine (TP) enkrat tedensko, 48 tednov in ribavirinom
Suicidal ideation, hallucinations
nervoznost, zmanjšan libido misli o samomoru, halucinacije samomor,
Dose limiting toxicities were fatigue, elevated liver enzymes, neutropenia and thrombocytopenia, consistent with interferon therapy.
Neželeni posledični učinki zdravljenja z interferoni, ki so omejevali odmerke, so bili utrujenost, zvišane vrednosti jetrnih encimov, nevtropenija in trombocitopenija.
In subjects older than 62 years, the absorption of Pegasys after a single subcutaneous injection of 180 micrograms was delayed but still sustained compared to young healthy subjects (tmax of 115 hours vs. 82 hours, older than 62 years vs. younger, respectively).
Pri bolnikih, starejših od 62 let, je bil tmax 115 ur, pri mlajših pa 82 ur.
Pure red cell aplasia
okvara žil mrežnice,
In patients who develop evidence of hepatic decompensation during treatment, Pegasys should be discontinued.
Pri bolnikih, pri katerih se razvijejo ali poslabšajo oftalmološke motnje, je treba zdravljenje z zdravilom Pegasys prekiniti.
Consideration should be given to replacing zidovudine in a combination anti-retroviral therapy regimen if this is already established.
Če je bila ugotovljena anemija, je smiselno razmisliti o zamenjavi zidovudina v kombinaciji protivirusnih zdravil.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 135 µg PRE-FILLED SYRINGES
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 4 x 135 µg NAPOLNJENE INJEKCIJSKE BRIZGE
Reproductive system disorders: Impotence (inability to maintain an erection) General disorders: Chest pain, flu-like illness, malaise (not feeling well), lethargy, hot flushes, thirst
Splošne težave: bolečina v prsih, bolezen, podobna gripi, občutek slabosti (neugodno počutje), zaspanost, vročinski valovi, žeja.
Uncommon side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 100 people) are:
Občasni neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 100 bolnikov) so:
Moderate (ANC: 0.749 - 0.5 x 109/l) and severe (ANC: < 0.5 x 109/l) neutropenia was observed respectively in 24% (216/887) and 5% (41/887) of patients receiving Pegasys 180 micrograms and ribavirin 1000/1200 milligrams for 48 weeks.
9/l) pa pri 5 % (41/887) bolnikov, ki so prejemali zdravilo Pegasys v odmerku 180 mikrogramov in ribavirin v odmerku 1000/1200 miligramov 48 tednov.
Collect the necessary items before beginning: Included in the pack:
Naslednje vrednosti lahko štejemo kot izhodiščne vrednosti ob začetku zdravljenja:
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg VIAL
ZUNANJA OVOJNINA - 1 x 180 µg VIALA
Weekly dose (mcg)
Tedenski odmerek (mikrogrami)
Pegasys 180 micrograms solution for injection in pre-filled pen Each pre-filled pen of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a*.
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Vsaka napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 180 mikrogramov peginterferona alfa2a*.
Hypertension, supraventricular arrhythmias, congestive heart failure, chest pain and myocardial infarction have been associated with alfa interferon therapies, including Pegasys.
Zdravljenje z interferoni, vključno z zdravilom Pegasys, povezujejo z neželenimi učinki, kot so hipertenzija, supraventrikularne aritmije, kongestivno srčno popuščanje, bolečina v prsih in miokardni infarkt.
Pegasys 135 micrograms solution for injection in pre-filled pen EU/1/02/221/011
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/02/221/011
Pegasys 180 micrograms solution for injection in pre-filled pen EU/1/02/221/014
Pegasys 180 mikrogramov raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/02/221/014
COBAS AMPLICOR HBV MONITOR: HBV-DNA (IU/mL) = HBV-DNA
COBAS AMPLICOR HBV MONITOR: HBV-DNA (i.e./ml) = HBV-DNA (kopije/ml)/5,26 ** Bolnike, ki so prešli na zdravljenje z zdravilom Pegasys po glavnem obdobju opazovanja in pred 24. tedenom obdobja spremljanja,
Chronic hepatitis B in adult patients
Povzetek varnostnega profila Kronični hepatitis B pri odraslih bolnikih
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a.
Ena napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 90 mikrogramov peginterferona alfa-2a.
Digestive system disorders: Stomach ulcer, inflammation of the pancreas
Bolezni prebavil: razjeda na želodcu, vnetje trebušne slinavke.
NAME OF THE MEDICINAL PRODUCT Pegasys 90 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
NAME OF THE MEDICINAL PRODUCT Pegasys 135 micrograms solution for injection in pre-filled pen Peginterferon alfa-2a
Pegasys 135 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi peginterferon alfa-2a
May cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old.
Pri novorojenčkih in otrocih do 3. leta starosti lahko povzroči toksične in anafilaktične reakcije.
Very rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 10,000 people) are:
Zelo redki neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 10.000 bolnikov) so:
Group B** Untreated (N=50)
Genotip C (n = 34)
Rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 1000 people) are:
Redki neželeni učinki pri kombiniranem zdravljenju zdravila Pegasys in ribavirina (pojavijo se lahko pri največ 1 od 1000 bolnikov) so:
Flushing Hypertension Cerebral haemorrhage, vasculitis
mišičnoskeletna bolečina, mišični krči miozitis rabdomioliza
Female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.
Med zdravljenjem in 4 mesece po končanem zdravljenju morajo bolnice v rodni dobi uporabljati učinkovito kontracepcijsko zaščito.
Nervous system disorders
Motnje jetrnega delovanja
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg PRE-FILLED SYRINGES
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 4 x 180 µg NAPOLNJENI INJEKCIJSKI PERESNIKI
Thyroid function
Status ciroze
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg PRE-FILLED SYRINGE
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA - 1 x 180 µg NAPOLNJENA INJEKCIJSKA BRIZGA
QUALITATIVE AND QUANTITATIVE COMPOSITION Pegasys 90 micrograms solution for injection in pre-filled syringe Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a*.
Pegasys 90 mikrogramov raztopina za injiciranje v napolnjeni injekcijski brizgi Vsaka napolnjena injekcijska brizga z 0,5 ml raztopine vsebuje 90 mikrogramov peginterferona alfa2a*.
Myositis
Okence
Musculoskeletal pain
Bolezni mišično-skeletnega sistema: vnetje mišic.