natgillin/translations-raw huggingface dataset:
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 mikrograma otopina za injekciju u napunjenoj brizgalici Svaka napunjena brizgalica s 0,5 ml otopine sadrži 180 mikrograma peginterferona alfa-2a*.
The possibility to consider shortening treatment duration to 24 weeks in genotype 1 and 4 patients was examined based on a sustained rapid virological response observed in patients with rapid virological response at week 4 in studies NV15942 and ML17131 (see Table 15).
U ispitivanjima NV15942 i ML17131 (vidjeti tablicu 15) ispitivana je mogućnost skraćivanja trajanja terapije na 24 tjedna u bolesnika s genotipom 1 i 4 na temelju trajnog virološkog odgovora opaženog u bolesnika s brzim virološkim odgovorom u 4. tjednu.
Fertility
Lamivudin
Low viral load = ≤ 800,000 IU/ml; High viral load= > 800,000 IU/ml RVR = rapid viral response (HCV RNA undetectable) at week 4 and HCV RNA undetectable at week 24
Genotip 4 bez RVR-a mala količina virusa = ≤ 800 000 IU/ml; velika količina virusa = > 800 000 IU/ml RVR (eng. rapid viral response) = brzi virološki odgovor (nemjerljiv HCV RNK) u 4. tjednu i nemjerljiv HCV RNK u 24. tjednu
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 135 µg PRE-FILLED PEN
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 135 µg NAPUNJENA BRIZGALICA
HCV monoinfected patients and HBV monoinfected patients
Bolesnici inficirani samo HCV-om ili samo HBV-om
Blood disorders: Pure red cell aplasia (a severe form of anemia where red blood cell production is decreased or stopped); it can result in symptoms such as feeling very tired with no energy Immune system disorders: Vogt Koyanagi Harada disease - a rare disease characterised by loss of vision, hearing and skin pigmentation; liver and kidney transplant rejections Psychiatric and nervous system disorders: Mania (episodes of exaggerated elevation of mood) and bipolar disorders (episodes of exaggerated elevation of mood alternating with sadness and hopelessness); thoughts about threatening the life of others, stroke Eye disorders: Rare form of retinal detachment with fluid in the retina Heart and blood vessel disorders: Peripheral ischaemia (insufficient blood supply to the extremities) Digestive system disorders: Ischaemic colitis (insufficient blood supply to the bowels), changes in the colour of the tongue
Poremećaji imunološkog sustava: Vogt Koyanagi Harada bolest - rijetka bolest karakterizirana gubitkom vida, sluha i pigmentacije kože; odbacivanje jetrenog i bubrežnog presatka Psihijatrijski poremećaji i poremećaji živčanog sustava: manija (epizode pretjerano dobrog raspoloženja) i bipolarni poremećaji (epizode pretjerano dobrog raspoloženja izmjenjuju se s tugom i beznađem); razmišljanja o ugrožavanju života drugih ljudi, moždani udar.
Low viral load = ≤ 800,000 IU/ml; High viral load = > 800,000 IU/ml * Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 w vs. Pegasys 180 mcg & ribavirin 800 mg, 48 w: Odds Ratio (95% CI) = 1.52 (1.07 to 2.17) P-value (stratified Cochran-Mantel-Haenszel test) = 0.020 * Pegasys 180 mcg & ribavirin 1000/1200 mg, 48 w vs. Pegasys 180 mcg & ribavirin 1000/1200 mg, 24 w: Odds Ratio (95% CI) = 2.12 (1.30 to 3.46) P-value (stratified Cochran-Mantel-Haenszel test) = 0.002.
* Pegasys 180 mikrograma i ribavirin 1000/1200 mg, 48 tj. u odnosu na Pegasys 180 mikrograma i ribavirin 800 mg, 48 tj.: Omjer izgleda (95% CI) = 1,52 (1,07 do 2,17) P-vrijednost (stratificirani Cochran-Mantel-Haenszel test) = 0,020
HIV-HCV co-infected adult patients
Odrasli bolesnici s HIV-HCV koinfekcijom
Infections: Infection of the heart, infection of the external ear Blood disorders: Severe reduction in red blood cells, white blood cells and platelets Immune system disorders: Severe allergic reaction, systemic lupus erythematosus (an illness where the body attacks its own cells), rheumatoid arthritis (an autoimmune disease) Hormone system disorders: Diabetic ketoacidosis, a complication of uncontrolled diabetes Psychiatric and nervous system disorders: Suicide, psychotic disorders (severe problems with personality and deterioration in normal social functioning), coma (a deep prolonged unconsciousness), seizures, facial palsy (weakness of the facial muscle) Eye disorders: Inflammation and swelling of the optic nerve, inflammation of the retina, ulceration of the cornea
Hormonski poremećaji: dijabetička ketoacidoza, komplikacija nekontrolirane šećerne bolesti Psihijatrijski poremećaji i poremećaji živčanog sustava poremećaji: samoubojstvo, psihotični poremećaji (teški problemi s osobnošću i pogoršanje normalnog funkcioniranja u društvu), koma (duboka i dugotrajna nesvijest), konvulzije, paraliza lica (slabost mišića lica)
NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection
Pegasys 180 mikrograma otopina za injekciju
Each pre-filled syringe of 0.5 ml solution contains 90, 135 or 180 micrograms peginterferon alfa-2a.
Svaka napunjena brizgalica s 0,5 ml otopine sadrži 135 mikrograma peginterferona alfa-2a*.
● the medicine is cloudy
● je lijek mutan
Digestive system disorders: Stomach ulcer, inflammation of the pancreas Liver disorders: Liver failure, bile duct inflammation, fatty liver Muscle and bone disorders: Inflammation of the muscles Kidney disorders: Kidney failure
Poremećaji jetre: zatajenje jetre, upala žučnog kanala, masna jetra Poremećaji mišića i kostiju: upala mišića
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/016
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/016
● Select the injection site in the abdomen or thigh (except your navel or waistline).
Odaberite mjesto u predjelu bedra ili trbuha (bilo koje osim pupka i struka) u koje ćete ubrizgati dozu.
* Subgroup of patients with genotype D had a higher proportion with baseline ALT < 1.5x ULN (13/31) compared to other genotype groups ** Patients switched to Pegasys treatment post-principal observation period and before Week 24 follow-up were counted as non-responders.
D imala je veći udio bolesnika s početnom vrijednošću ALT-a < 1,5 x GGN (13/31) nego skupine bolesnika s drugim genotipovima (16/70).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 180 µg PRE-FILLED SYRINGE
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 180 µg NAPUNJENA ŠTRCALJKA
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 90 micrograms peginterferon alfa-2a.
NAVOĐENJE DJELATNE(IH) TVARI Jedna štrcaljka s 0,5 ml otopine sadrži 90 mikrograma peginterferona alfa-2a.
Flushing Hypertension Cerebral haemorrhage, vasculitis
ječmenac, infekcija mokraćnog sustava, nazofaringitis
HIV-HCV co-infected patients
Bolesnici koinficirani HIV-om i HCV-om
Pegasys 135 micrograms solution for injection in pre-filled syringe The syringe is labeled with graduations corresponding to doses of 135 mcg, 90 mcg and 45 mcg.
Na štrcaljki se nalaze oznake koje odgovaraju dozama od 135 mikrograma, 90 mikrograma i 45 mikrograma.
The occurrence of anaemia (haemoglobin <10 g/dl) has been observed in up to 15% of CHC patients in clinical trials on the combined treatment of Pegasys with ribavirin.
U kliničkim ispitivanjima kombiniranog liječenja lijekom Pegasys i ribavirinom, opaženo je da se anemija (hemoglobin <10 g/dl) javila u do 15% bolesnika koji boluju od kroničnog hepatitisa C.
Each pre-filled pen of 0.5 ml solution contains
Jedna napunjena brizgalica s 0,5 ml otopine sadrži 135 ili
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 90 µg PRE-FILLED SYRINGE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 1 x 90 µg NAPUNJENA ŠTRCALJKA
Heart and blood vessel disorders: Heart attack, heart failure, heart pain, rapid heart rhythm, rhythm disorders or inflammation of the lining of the heart and cardiac muscle, bleeding in the brain and inflammation in the vessels
Poremećaji oka: upala i natečenost optičkog živca, upala mrežnice, vrijed rožnice Poremećaji srca i krvnih žila: srčani udar, zatajenje srca, bol u srcu, brzi srčani ritam, poremećaji ritma ili upala srčane ovojnice i srčanog mišića, krvarenje u mozgu i upala krvnih žila Poremećaji dišnog sustava: intersticijska upala pluća (upala pluća uključujući smrtni ishod), krvni ugrušci u plućima
Retinal haemorrhage
Tablični prikaz nuspojava
Exposure to Pegasys was decreased in studies following administration of Pegasys in the arm compared to administration in the abdomen and thigh.
Ispitivanja koja su pratila izloženost lijeku Pegasys nakon njegove primjene u nadlakticu pokazuju da je ona bila niža nego u njegovoj primjeni u predjel trbuha i bedra.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 180 µg VIAL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 180 µg BOČICA
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.
Farmakokinetika lijeka Pegasys bila je podjednaka u zdravih ispitanika i bolesnika s hepatitisom B ili C.
HCV RNA levels decline in a biphasic manner in responding patients with hepatitis C who have received treatment with 180 micrograms Pegasys.
U bolesnika s hepatitisom C koji su nakon primjene lijeka Pegasys u dozi od 180 mikrograma postigli virološki odgovor, razine HCV RNK opadaju u dvije faze.
Hyperglycaemia, type 1 diabetes mellitus
Poremećaji metabolizma i prehrane smanjen tek hiperglikemija, šećerna bolest tipa 1
Pegasys 180 mcg Ribavirin 800 mg
* Pegasys 180 mikrograma i ribavirin 800 mg u odnosu na Pegasys 180 mikrograma:
Ascites
Trombociti
1 x 200 mg tablets A.M. 1 x 200 mg tablets P.M.
1 x 200 mg tableta prije podne 1 x 200 mg tableta poslije podne
Rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 1000 people) are:
Rijetke nuspojave pri primjeni kombiniranog liječenja lijekom Pegasys i ribavirinom koje se (mogu se javiti u do 1 na 1000 osoba):
Pegasys 180 micrograms solution for injection in pre-filled syringe The syringe is labeled with graduations corresponding to doses of 180 mcg, 135 mcg and 90 mcg.
Na štrcaljki se nalaze oznake koje odgovaraju dozama od 180 mikrograma, 135 mikrograma i 90 mikrograma.
● use if medicine is cloudy, hazy, discoloured or has particles in it.
● ne primjenjujte ako je lijek mutan, magličast, ako je promijenio boju ili sadrži vidljive čestice.
Very rare side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 10,000 people) are:
Vrlo rijetke nuspojave pri primjeni kombiniranog liječenja lijekom Pegasys i ribavirinom (mogu se javiti u do 1 na 10 000 osoba):
(all other genotypes).
(genotip 2 i 3) odnosno 48 tjedana (svi drugi genotipovi).
HBV-DNA was measured by the COBAS AMPLICOR HBV
Virološki odgovor definiran je kao nemjerljiva količina HCV RNK mjerena testom COBAS AMPLICOR
NAME OF THE MEDICINAL PRODUCT Pegasys 135 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Pegasys 135 mikrograma otopina za injekciju u napunjenoj štrcaljki peginterferon alfa-2a
NAME OF THE MEDICINAL PRODUCT Pegasys 90 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Pegasys 90 mikrograma otopina za injekciju u napunjenoj štrcaljki peginterferon alfa-2a
NAME OF THE MEDICINAL PRODUCT Pegasys 135 micrograms solution for injection in pre-filled pen Peginterferon alfa-2a
Pegasys 135 mikrograma otopina za injekciju u napunjenoj brizgalici peginterferon alfa-2a
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a.
NAVOĐENJE DJELATNE(IH) TVARI Jedna štrcaljka s 0,5 ml otopine sadrži 135 mikrograma peginterferona alfa-2a.
Abdominal pain upper, stomatitis, nausea, aphthous stomatitis, oral disorder
Poremećaji probavnog sustava probavni poremećaj bol u gornjem dijelu abdomena, stomatitis, mučnina, aftozni stomatitis, poremećaj usta
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 180 µg PRE-FILLED PEN
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE 180 µg NAPUNJENA BRIZGALICA
Pegasys 180 mcg Ribavirin 800 mg 24 weeks
180 mikrograma i ribavirin 800 mg 48 tjedana
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/006
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/006
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 135 µg PRE-FILLED PENS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 4 x 135 µg NAPUNJENE BRIZGALICE
respectively.
om.
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen of 0.5 ml solution contains 135 micrograms peginterferon alfa-2a.
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena brizgalica s 0,5 ml otopine sadrži 135 mikrograma peginterferona alfa-2a.
STATEMENT OF ACTIVE SUBSTANCE(S) Each syringe of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a.
NAVOĐENJE DJELATNE(IH) TVARI Jedna štrcaljka s 0,5 ml otopine sadrži 180 mikrograma peginterferona alfa-2a.
Detailed instructions are provided at the end of this leaflet (see “How to inject Pegasys”).
Detaljne upute nalaze se na kraju upute o lijeku (pogledajte dio
Pegasys 135 micrograms solution for injection in pre-filled syringe The syringe contains graduation marks corresponding to 135 micrograms (mcg), 90 mcg and 45 mcg.
Na štrcaljki se nalaze oznake koje odgovaraju 135 mikrograma (µg), 90 µg i 45 µg.
You remember on
Pogledajte dio
Pegasys 180 micrograms solution for injection in pre-filled syringe The syringe contains graduation marks corresponding to 180 micrograms (mcg), 135 mcg and 90 mcg.
Na štrcaljki se nalaze oznake koje odgovaraju 180 mikrograma (µg), 135 µg i 90 µg.
Hepatic dysfunction
Oštećenje jetrene funkcije
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg PRE-FILLED SYRINGE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 1 x 180 µg NAPUNJENA ŠTRCALJKA
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 1 ml solution contains 180 micrograms peginterferon alfa-2a.
NAVOĐENJE DJELATNE(IH) TVARI Jedna bočica s 1 ml otopine sadrži 180 mikrograma peginterferona alfa-2a.
● a pre-filled syringe of Pegasys
• Pegasys napunjena štrcaljka
Common side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 10 people) are:
Česte nuspojave pri primjeni kombiniranog liječenja lijekom Pegasys i ribavirinom (mogu se javiti u do 1 na 10 osoba):
Hypothyroidis m, hyperthyroidi sm
Endokrini poremećaji hipotireoidizam, hipertireoidizam dijabetes dijabetička ketoacidoza
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 135 µg PRE-FILLED SYRINGES
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 4 x 135 µg NAPUNJENE ŠTRCALJKE
Withhold ribavirin
Ribavirin
In patients who develop evidence of hepatic decompensation during treatment, Pegasys should be discontinued.
Liječenje lijekom Pegasys treba prekinuti u bolesnika koji za vrijeme liječenja razviju znakove dekompenzacije jetre.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 135 µg PRE-FILLED PEN
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 1 x 135 µg NAPUNJENA BRIZGALICA
3 x 200 mg tablets A.M. 3 x 200 mg tablets P.M.
3 x 200 mg tableta prije podne 3 x 200 mg tableta poslije podne
Peptic ulcer, pancreatitis
suha usta gastrointestinalno krvarenje peptični ulkus,
Roche a/s c/o Icepharma hf Simi: +354 540 8000
Ísland Roche a/s c/o Icepharma hf
Nervous system disorders
Stupanj poremećaja Indeks
Response rates in groups A and B at the end of 24 weeks follow-up are presented in Table 22.
Stope odgovora u skupinama A i B na kraju 24-tjednog razdoblja praćenja navedene su u tablici 22. Odgovor na liječenje lijekom Pegasys u skupini C bilo je u skladu s onim primijećenim u skupini A.
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/005
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/005
1 x 200 mg tablets A.M. 2 x 200 mg tablets P.M.
1 x 200 mg tableta prije podne 2 x 200 mg tableta poslije podne
Table 21: Sustained virological response based on genotype and pre-treatment viral load after Pegasys combination therapy with ribavirin in HIV-HCV co-infected patients Study NR15961 Interferon alfa-2a 3 MIU
Tablica 21: Trajni virološki odgovor nakon primjene lijeka Pegasys u kombinaciji s ribavirinom u bolesnika koinficiranih HIV-om i HCV-om, temeljen na genotipu i količini virusa prije početka liječenja
Keep the pre-filled syringe in the outer carton in order to protect from light
Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg PRE-FILLED PENS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 4 x 180 µg NAPUNJENE BRIZGALICE
Tooth extraction, cholecystectomy
Operativni i medicinski postupci vađenje zuba, kolecistektomija
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/013
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/013
● a cleansing swab
● vata za čišćenje
STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen of 0.5 ml solution contains 180 micrograms peginterferon alfa-2a.
NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena brizgalica s 0,5 ml otopine sadrži 180 mikrograma peginterferona alfa-2a.
Dose limiting toxicities were fatigue, elevated liver enzymes, neutropenia and thrombocytopenia, consistent with interferon therapy.
Kao i kod uobičajene interferonske terapije, simptomi toksičnosti kod kojih se doza morala prilagoditi, bili su zamor, povišeni jetreni enzimi, neutropenija i trombocitopenija.
HBeAg seroconversion rates
Stope HBeAg serokonverzije
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg VIALS
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 4 x 180 µg BOČICE
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/015
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/015
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/014
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/014
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 4 x 180 µg PRE-FILLED SYRINGES
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 4 x 180 µg NAPUNJENE ŠTRCALJKE
2 x 200 mg tablets A.M. 2 x 200 mg tablets P.M.
2 x 200 mg tableta prije podne 2 x 200 mg tableta poslije podne
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/004
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/004
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 135 µg PRE-FILLED SYRINGE
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 1 x 135 µg NAPUNJENA ŠTRCALJKA
Increases in ALT levels above baseline (BL) have been observed in patients treated with Pegasys, including patients with a virological response.
Kao i u liječenju drugim alfa interferonima, i u bolesnika liječenih lijekom Pegasys zamijećen je rast razina alanin aminotransferaza (ALT) iznad početnih vrijednosti, uključujući i bolesnike s virološkim odgovorom.
2 x 200 mg tablets A.M. 3 x 200 mg tablets P.M.
2 x 200 mg tableta prije podne 3 x 200 mg tableta poslije podne
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.
Prije početka liječenja kroničnog hepatitisa B trebaju biti zabilježene trajno povišene razine ALT-a u serumu.
Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja dispneja, epistaksa
Uncommon side effects with the combination of Pegasys and ribavirin (may affect up to 1 in 100 people) are:
Manje česte nuspojave pri primjeni kombiniranog liječenja lijekom Pegasys i ribavirinom (mogu se javiti u do 1 na 100 osoba):
Please refer to the ribavirin SmPC.
Pogledati sažetak opisa svojstava za ribavirin.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg VIAL
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 1 x 180 µg BOČICA
Optic neuropathy, papilloedema, retinal vascular disorder, retinopathy, corneal ulcer
Poremećaji bubrega i mokraćnog sustava dizurija, inkontinencija, poremećaj mokraćnog sustava
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - 1 x 180 µg PRE-FILLED PEN
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - 1 x 180 µg NAPUNJENA BRIZGALICA
COBAS AMPLICOR HBV MONITOR: HBV-DNA (IU/mL) = HBV-DNA
COBAS AMPLICOR HBV MONITOR: HBV DNK (IU/ml) = HBV DNK (kopija/ml) / ** Bolesnici koji su prešli na liječenje lijekom Pegasys nakon glavnog razdoblja promatranja i prije 24. tjedna praćenja smatrali su se bolesnicima bez odgovora.
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/009
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/009
Pegasys 180 mcg Ribavirin 1000/1200 mg 24 weeks
* Pegasys 180 mikrograma i ribavirin 1000/1200 mg, 48 tj. u odnosu na Pegasys 180 mikrograma i ribavirin 1000/1200 mg, 24 tj.:
Haemoglobin - stable cardiac disease decrease ≥ 2 g/dl during any 4 weeks
Hemoglobin - stabilna bolest srca smanjenje
Weekly doses of up to 540 and 630 micrograms have been administered in renal cell carcinoma and chronic myelogenous leukaemia clinical trials, respectively.
U kliničkim ispitivanjima tumora bubrežnih stanica odnosno kronične mijeloične leukemije, bolesnici su primali tjedne doze od 540 odnosno 630 mikrograma lijeka Pegasys.
Thyroid function abnormalities or worsening of pre-existing thyroid disorders have been reported with the use of alfa interferons, including Pegasys.
Prilikom primjene alfa interferona, uključujući i Pegasys, zabilježeni su poremećaji u funkciji štitnjače odnosno pogoršanja već postojećih poremećaja štitnjače.
Pegasys is intended for subcutaneous use (under the skin).
Pegasys je namijenjen za potkožnu primjenu.
Skin disorders: Rash, increased sweating, psoriasis, hives, eczema, sensitivity to sunlight, night sweats Muscle and bone disorders: Back pain, joint inflammation, muscle weakness, bone pain, neck pain, muscle pain, muscle cramps
Poremećaji mišićnokoštanog sustava i vezivnog tkiva mialgija, artralgija bol u leđima, artritis, slabost mišića, bolovi u kostima, bol u vratu, bol u mišićima i kostima, grčevi u mišićima miozitis rabdomioliza
Rash, pruritus, alopecia
povraćanje, dispepsija, disfagija,
● If you get any side effects, talk to your doctor, pharmacist or nurse.
• Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
MARKETING AUTHORISATION NUMBER(S) EU/1/02/221/003
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/02/221/003
Dyspnoea exertional, epistaxis, nasopharyngit is, sinus congestion, nasal congestion, rhinitis, sore throat
Poremećaji dišnog sustava, prsišta i sredoprsja dispneja, kašalj dispneja u naporu, epistaksa, nazofaringitis, kongestija sinusa, kongestija nosa,
Breathing disorders: Interstitial pneumonia (inflammation of the lungs including fatal outcome), blood clots in the lung
rinitis, grlobolja piskanje intersticijski pneumonitis uključujući smrtni ishod, plućna embolija plućna arterijska hipertenzija§
Ear and labyrinth disorders
Poremećaji uha i labirinta bol u uhu
Keep the pre-filled pen in the outer carton in order to protect from light
Napunjenu brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti
NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection in pre-filled syringe Peginterferon alfa-2a
Pegasys 180 mikrograma otopina za injekciju u napunjenoj štrcaljki peginterferon alfa-2a
NAME OF THE MEDICINAL PRODUCT Pegasys 180 micrograms solution for injection in pre-filled pen Peginterferon alfa-2a
Pegasys 180 mikrograma otopina za injekciju u napunjenoj brizgalici peginterferon alfa-2a
Pegasys dosing
Pegasys.
cells/mm3
≥ 1000 stanica/mm
acetic acid and water for injections.
bočica s Pegasys otopinom za injekciju
Substance overdose
Velika količina virusa
Dyspnoea, cough
disfagija,
Hepatic failure, cholangitis, fatty liver
streptokokni faringitis, gripa,
Hold the pre-filled pen comfortably in your hand.
6) Postavite napunjenu brizgalicu na mjesto injekcije Napunjenu brizgalicu držite opušteno u ruci.
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Pegasys and ribavirin combination therapy.
U bolesnika liječenih kombinacijom lijeka Pegasys i ribavirina, prijavljeni su poremećaji zubi i desni koji mogu izazvati gubitak zuba.