natgillin/translations-raw huggingface dataset:
Absorption:
Absorbcija:
Adefovir dipivoxil is a dipivaloyloxymethyl ester prodrug of the active substance adefovir.
Adefovirdipivoksil je predzdravilo, dipivaloiloksimetilni ester zdravilne učinkovine adefovir.
The oral bioavailability of adefovir from 10 mg adefovir dipivoxil is 59%.
Oralna biološka razpoložljivost adefovirja iz 10 mg adefovirdipivoksila je 59%.
Following oral administration of a single dose of 10 mg adefovir dipivoxil to chronic hepatitis B patients, the median (range) peak serum concentration (Cmax) was achieved after 1.75 h (0.58-4.0 h).
Po peroralno vzetem enkratnem odmerku 10 mg adefovirdipivoksila bolnikov s kroničnim hepatitisom B je bila mediana (območje) vrednost najvišje serumske koncentracije (Cmax) dosežena po 1, 75 h (0, 58- 4, 0 h).
Median Cmax and AUC0-∞ values were 16.70 (9.66-30.56) ng/ ml and 204.40 (109.75-356.05) ng·h/ ml, respectively.
Mediana Cmax je bila 16, 70 (9, 66- 30, 56) ng/ ml in mediana AUC0- ∞ 204, 40 (109, 75- 356, 05) ng· h/ ml.
Systemic exposure to adefovir was not affected when 10 mg adefovir dipivoxil was taken with a high fat meal.
Sistemska izpostavljenost adefovirju ni bila spremenjena, ko je bil 10 mg adefovirdipivoksila vzet ob z maščobami bogatem obroku.
11 Distribution:
Porazdelitev:
Preclinical studies show that after oral administration of adefovir dipivoxil, adefovir is distributed to most tissues with the highest concentrations occurring in kidney, liver and intestinal tissues.
Predklinične raziskave so pokazale, da se po peroralnem vnosu adefovirdipivoksila, adefovir porazdeli po večini tkiv z najvišjo koncentracijo doseženo v ledvicah, jetrih in tkivu prebavil.
In vitro binding of adefovir to human plasma or human serum proteins is ≤ 4%, over the adefovir concentration range of 0.1 to 25 μ g/ ml.
In vitro je bila vezava adefovirja v koncentracijskem območju od 0, 1 do 25 μg/ ml na človeške plazemske ali serumske proteine ≤ 4%.
The volume of distribution at steady-state following intravenous administration of 1.0 or 3.0 mg/ kg/ day is 392±75 and 352±9 ml/ kg, respectively.
Volumen porazdelitve v stanju dinamičnega ravnotežja (steady- state) po intravenskemu vnosu 1, 0 mg/ kg/ dan je 392 ± 75 ml/ kg oziroma po intravenskem vnosu 3, 0 mg/ kg/ dan je 352 ± 9 ml/ kg.
Following oral administration, adefovir dipivoxil is rapidly converted to adefovir.
Po peroralnem vnosu se adefovirdipivoksil hitro pretvori v adefovir.
At concentrations substantially higher (> 4,000-fold) than those observed in vivo, adefovir did not inhibit any of the following human CYP450 isoforms, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4.
CYP1A2, CYP2D6, CYP2C9, CYP2C19 in CYP3A4.
Adefovir is excreted renally by a combination of glomerular filtration and active tubular secretion.
Adefovir se izloča preko ledvic s kombinacijo glomerularne filtracije in aktivne tubularne sekrecije.
The median (min-max) renal clearance of adefovir in subjects with normal renal function (Clcr > 80 ml/ min) is 211 ml/ min (172-316 ml/ min), approximately twice calculated creatinine clearance (Cockroft-Gault method).
Mediani (min- max) ledvični očistek adefovirja pri osebah z normalno ledvično funkcijo (CLCR > 80 ml/ min) je 211 ml/ min (172- 316 ml/ min), kar je približno dvakratna vrednost očistka kreatinina (Cockroft- Gault metoda).
After repeated administration of 10 mg adefovir dipivoxil, 45% of the dose is recovered as adefovir in the urine over 24 hours.
Po večkratnem vnosu 10 mg adefovirdipivoksila se lahko 45% odmerka zazna v seču kot adefovir v obdobju 24 ur.
Plasma adefovir concentrations declined in a biexponential manner with a median terminal elimination half-life of 7.22 h (4.72-10.70 h).
Upadanje plazemske koncentracije adefovirja je bilo bieksponentno in mediani končni razpolovni čas izločanja 7, 22 h (4, 72- 10, 70 h).
The pharmacokinetics of adefovir are proportional to dose when given as adefovir dipivoxil over the dose range of 10 to 60 mg.
Farmakokinetične lastnosti adefovirja so sorazmerne odmerku vzetemu kot adefovirdipivoksil v razponu odmerka od 10 mg do 60 mg.
Repeated dosing of adefovir dipivoxil 10 mg daily did not influence the pharmacokinetics of adefovir.
Večkraten odmerek 10 mg adefovirdipivoksila na dan ni vplival na farmakokinetične lastnosti adefovirja.
Gender, age and ethnicity:
Spol, starost in pripadnost etnični skupini:
The pharmacokinetics of adefovir were similar in male and female patients.
Farmakokinetične lastnosti adefovirja so bile podobne pri moških in ženskih bolnikih.
Pharmacokinetic studies have not been conducted in children or in the elderly.
Farmakokinetične raziskave niso bile izvedene pri otrocih ali starejših.
The pharmacokinetics of adefovir dipivoxil were studied in an efficacy and safety study of a daily dose of 0.25 mg/ kg to 10 mg adefovir dipivoxil in children (aged 2 to < 18 years).
Farmakokinetične lastnosti adefovirdipivoksila so proučevali v študiji učinkovitosti in varnosti z dnevnim odmerkom 0, 25 mg/ kg do 10 mg adefovirdipivoksila pri otrocih (starih od 2 do < 18 let).
Pharmacokinetic analysis revealed that adefovir exposure was comparable among 3 age groups, 2 to 6 years (0.3 mg/ kg), 7 to 11 years (0.25 mg/ kg) and 12 to 17 years (10 mg) and all age groups achieved adefovir exposure in the target range (for efficacy results see section 5.1), which was based on adefovir plasma concentrations in adult patients with chronic hepatitis B with established safety and efficacy profiles.
Farmakokinetična analiza je pokazala, da je bila koncentracija adefovirja primerljiva med tremi starostnimi skupinami, in sicer 2 do 6 let (0, 3 mg/ kg), 7 do 11 let (0, 25 mg/ kg) in 12 do 17 let (10 mg), ter da so vse starostne skupine dosegle koncentracijo adefovirja v ciljnem obsegu (za rezultate učinkovitosti glejte poglavje 5. 1), ki je temeljil na plazemskih koncentracijah adefovirja pri odraslih bolnikih s kroničnim hepatitisom B z znanim profilom varnosti in učinkovitosti.
The mean (± SD) pharmacokinetic parameters of adefovir following administration of a single dose of 10 mg adefovir dipivoxil to patients with varying degrees of renal impairment are described in the table below:
Povprečni (± SD) farmakokinetični parametri za adefovir, po vzetju enkratnega odmerka 10 mg adefovirdipivoksila pri bolnikih z različnimi stopnjami motenj v delovanju ledvic, so opisani v spodnji tabeli:
Baseline Creatinine
Začetna vrednost
Clearance (ml/ min)
očistka kreatinina (ml/ min)
17.8±3.2
17, 8 ± 3, 2
22.4±4.0
22, 4 ± 4, 0
28.5±8.6
28, 5 ± 8, 6
51.6±10.3
51, 6 ± 10, 3
AUC0-∞ (ng·h/ ml) CL/ F (ml/ min) CLrenal (ml/ min)
AUC0- ∞ (ng· h/ ml) CL/ F (ml/ min)
201±40.8 469±99.0 231±48.9
201 ± 40, 8 469 ± 99, 0
266±55.7 356±85.6 148±39.3
266 ± 55, 7 356 ± 85, 6
455±176 237±118 83.9±27.5
455 ± 176 237 ± 118
1240±629 91.7±51.3 37.0±18.4
1. 240 ± 629 91, 7 ± 51, 3
A four-hour period of haemodialysis removed approximately 35% of the adefovir dose.
S štiri ure trajajočo hemodializo se je izločilo približno 35% odmerka adefovirja.
12 It is recommended that the dosing interval of 10 mg adefovir dipivoxil is modified in patients with creatinine clearance between 30 and 49 ml/ min.
Priporoča se prilagoditi interval med odmerki 10 mg adefovirdipivoksila pri bolnikih z očistkom kreatinina od 30 do 49 ml/ min.
Adefovir dipivoxil is not recommended in patients with creatinine clearance of < 30 ml/ min or in patients on dialysis (see section 4.2 and 4.4).
Pri bolnikih z očistkom kreatinina < 30 ml/ min ali pri bolnikih na dializi uporaba adefovirdipivoksila ni priporočena (glejte poglavji 4. 2 in 4. 4).
Pharmacokinetic properties were similar in patients with moderate and severe hepatic impairment compared to healthy volunteers (see section 4.2).
Farmakokinetične lastnosti so bile podobne pri bolnikih z zmernimi do resnimi motnjami v delovanju jeter in pri zdravih prostovoljcih (glejte poglavje 4. 2).
The primary dose-limiting toxic effect associated with administration of adefovir dipivoxil in animals (mice, rats and monkeys) was renal tubular nephropathy characterised by histological alterations and/ or increases in blood urea nitrogen and serum creatinine.
Najpomembnejši dozo omejujoč toksičen vpliv, povezan z vnosom adefovirdipivoksila pri živalih (miših, podganah in opicah), je ledvična tubularna nefropatija, ki jo označujejo histološke spremembe in/ ali zvišanje dušika v sečnini v krvi in zvišanje serumskega kreatinina.
Nephrotoxicity was observed in animals at systemic exposures at least 3-10 times higher than those achieved in humans at the recommended therapeutic dose of 10 mg/ day.
Nefrotoksičnost je bila opažena pri živalih pri sistemski izpostavljenosti, ki je bila najmanj 3 do 10 krat višja od dosežene izpostavljenosti pri človeku ob priporočenem terapevtskem odmerku 10 mg na dan.
No effects on male or female fertility, or reproductive performance, occurred in rats and there was no embryotoxicity or teratogenicity in rats or rabbits administered adefovir dipivoxil orally.
Pri podganah ni bilo opaženega vpliva na plodnost moških in žensk oziroma na reprodukcijsko sposobnost in prav tako ni prišlo do embriotoksičnosti oziroma teratogenosti pri podganah oziroma zajcih, ki so dobivali adefovirdipivoksil oralno.
Adefovir dipivoxil was mutagenic in the in vitro mouse lymphoma cell assay (with or without metabolic activation), but was not clastogenic in the in vivo mouse micronucleus assay.
Adefovirdipivoksil je bil mutagen v in vitro poskusu na celicah mišjega limfoma (z ali brez presnovne aktivacije), vendar ni bil klastogen v in vivo poskusu na mišjem mikronukleusu.
In long-term carcinogenicity studies in rats and mice with adefovir dipivoxil, no treatment-related increase in tumour incidence was found in mice or rats (systemic exposures approximately 10 and 4 times those achieved in humans at the therapeutic dose of 10 mg/ day, respectively).
V dolgoročnih karcinogenetskih raziskavah adefovirdipivoksila na podganah in miših niso odkrili z zdravljenjem povezanega povečanja incidence tumorjev (sistemska izpostavljenost je bila pri miših približno 10 krat oziroma pri podganah 4 krat večja od dosežene izpostavljenosti pri človeku s terapevtskimi odmerki 10 mg na dan).
Pregelatinised starch Croscarmellose sodium Lactose monohydrate Talc Magnesium stearate
Predgelirani škrob Premreženi natrijev karmelozat Laktoza monohidrat Smukec Magnezijev stearat
Hepsera is supplied in high-density polyethylene (HDPE) bottles with a child-resistant closure.
Hepsera se nahaja v plastenki iz zgoščenega polietilena (HDPE, High Density Polyethylene) z za otroke varno zaporko.
The following pack sizes are available: outer cartons containing 1 x 30 tablet and 3 x 30 tablet bottles.
Na voljo so naslednje velikosti pakiranj: škatle z 1 plastenko ali s 3 plastenkami po 30 tablet.
06 March 2003 Date of last renewal:
6. marec 2003 Datum zadnjega podaljšanja dovoljenja za promet:
Gilead Sciences Limited 13 Stillorgan Industrial Park Blackrock Co.
Gilead Sciences Ltd 13 Stillorgan Industrial Park Blackrock Co.
The Marketing Authorisation Holder will submit the PSURs on a yearly basis.
Imetnik dovoljenja za promet bo vsako leto predložil redno posodobljeno poročilo o varnosti zdravila (PSUR – “ Periodic Safety Update Report ”).
18 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
OZNAČEVANJE
3 x 30 tablets.
3 x 30 tablet.
EU/ 1/ 03/ 251/ 001 30 tablets EU/ 1/ 03/ 251/ 002 3 x 30 tablets
EU/ 1/ 03/ 251/ 001 30 tablet EU/ 1/ 03/ 251/ 002 3 x 30 tablet
Hepsera [outer packaging only]
Hepsera [samo na zunanji ovojnini]
21 PACKAGE LEAFLET
NAVODILO ZA UPORABO
Never pass it on to others.
- Zdravilo je bilo predpisano vam osebno in ga ne smete nikoli dati drugim.
if their symptoms seem the same as yours.
škodovalo, čeprav imajo znake bolezni, ki so videti podobni vašim.
- If you notice any side effects that you are worried about, whether they are listed in this leaflet or
- Če opazite katerikoli neželeni učinek, ki vas skrbi, ne glede na to, ali je omenjen v tem navodilu
not, talk to your doctor or pharmacist.
ali ne, obvestite svojega zdravnika ali farmacevta.
What Hepsera is and what it is used for 2.
Kaj je zdravilo Hepsera in za kaj ga uporabljamo 2.
Before you take Hepsera 3.
Kaj morate vedeti, preden boste vzeli zdravilo Hepsera 3.
How to take Hepsera 4.
Kako jemati zdravilo Hepsera 4.
How to store Hepsera 6.
Shranjevanje zdravila Hepsera 6.
WHAT HEPSERA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO HEPSERA IN ZA KAJ GA UPORABLJAMO
What Hepsera is Hepsera belongs to a group of medicines called antiviral medicines.
Kaj je zdravilo Hepsera Zdravilo Hepsera spada v skupino zdravil, imenovanih protivirusna zdravila.
What it is used for Hepsera is used to treat chronic hepatitis B, an infection with hepatitis B virus (HBV), in adults.
Za kaj ga uporabljamo Zdravilo Hepsera se uporablja za zdravljenje kronične okužbe z virusom hepatitisa B (HBV) pri odraslih.
BEFORE YOU TAKE HEPSERA
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO HEPSERA
Do not take Hepsera
Ne jemljite zdravila Hepsera
• If you are allergic (hypersensitive) to adefovir, adefovir dipivoxil or any of the other ingredients of Hepsera.
• Če ste alergični na (preobčutljivi za) adefovir, adefovirdipivoksil ali katerokoli sestavino zdravila Hepsera.
Tell your doctor at once if you could be allergic (hypersensitive) to adefovir, adefovir dipivoxil or any of the other ingredients of Hepsera.
Takoj obvestite svojega zdravnika, če obstaja možnost, da ste alergični na (preobčutljivi za) adefovir, adefovirdipivoksil ali katerokoli sestavino zdravila Hepsera.
Take special care with Hepsera
Bodite posebno pozorni pri uporabi zdravila Hepsera
• Don’ t stop taking Hepsera without your doctor’ s advice.
• Zdravila Hepsera ne prenehajte jemati brez posveta z zdravnikom.
22 • After stopping Hepsera tell your doctor immediately about any new, unusual or worsening symptoms that you notice after stopping treatment.
23 • Po prekinitvi jemanja zdravila Hepsera nemudoma povejte zdravniku, če po prenehanju zdravljenja opazite nove ali nenavadne simptome ali poslabšanje simptomov.
It’ s best for your doctor to monitor your health after stopping treatment with Hepsera.
Zato je najbolje, da zdravnik nadzoruje vaše zdravje po prekinitvi zdravljenja z zdravilom Hepsera.
look out for possible signs of lactic acidosis – see section 4, Possible side effects. your doctor should order blood tests every three months to check your medicine is keeping your chronic hepatitis B infection under control.
mora zdravnik vsake tri mesece naročiti analizo krvi, da preveri, ali je z zdravilom nadzorovana kronična okužba z virusom hepatitisa B.
• Tell your doctor or pharmacist if you are taking any other medicines or have recently taken any, including medicines and herbal products obtained without a prescription.
• Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, vključno z zdravili in izdelki rastlinskega izvora, ki ste jih dobili brez recepta.
• It is especially important to tell your doctor if you are taking or have recently taken any of the following medicines which may damage your kidneys, or interact with Hepsera:
• Še zlasti pomembno je, da obvestite zdravnika, če jemljete ali ste pred kratkim jemali katerokoli od naštetih zdravil, ki lahko poškodujejo ledvice ali medsebojno vplivajo z zdravilom Hepsera:
vancomycin and aminoglycosides, used for bacterial infections amphotericin B, for fungal infections foscarnet, cidofovir or tenofovir disoproxil fumarate, for viral infections pentamidine, for other types of infection.
vankomicin in aminoglikozidi, ki se uporabljajo proti bakterijskim okužbam; amfotericin B proti glivičnim okužbam; foskarnet, cidofovir ali tenofovirdizoproksil fumarat proti virusnim okužbam; pentamidin proti drugim vrstam okužb.
Taking Hepsera with food and drink
Jemanje zdravila Hepsera skupaj s hrano in pijačo
Hepsera contains lactose If you are lactose-intolerant, or if you have been told that you have an intolerance to some sugars, talk to your doctor before taking Hepsera.
Zdravilo Hepsera vsebuje laktozo Če ne prenašate laktoze ali če so vam povedali, da ne prenašate nekaterih sladkorjev, se pred jemanjem zdravila Hepsera posvetujte z zdravnikom.
It is important to take Hepsera exactly as your doctor has told you to make sure that your medicine is fully effective and to reduce the development of resistance to the treatment.
Pri jemanju zdravila Hepsera natančno upoštevajte zdravnikova navodila, da zagotovite popolno učinkovitost zdravila in zmanjšate možnost razvoja odpornosti na zdravljenje.
Check with your doctor or pharmacist if you are not sure how to take Hepsera.
Če niste prepričani, kako jemati zdravilo Hepsera, se posvetujte z zdravnikom ali s farmacevtom.
• The usual dose is one 10 mg tablet each day, taken with or without food.
• Običajni odmerek je ena 10- miligramska tableta na dan, s hrano ali brez nje.
• A different dose may be given to patients with kidney problems.
• Bolnikom z ledvičnimi težavami zdravnik lahko predpiše drugačen odmerek.
If you miss a dose or you vomit
Če ste pozabili vzeti odmerek ali ste bruhali
Do not take a double dose (two doses close together).
Ne vzemite dvojnega odmerka (dveh odmerkov drugega za drugim).
Effects when Hepsera is stopped
Učinki ob prenehanju jemanja zdravila Hepsera
If you have any questions on how to use Hepsera, ask your pharmacist or doctor.
Če imate vprašanja o uporabi zdravila Hepsera, se posvetujte s farmacevtom ali z zdravnikom.
Like all medicines, Hepsera can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Hepsera neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Very rare side effects (These can affect less than 1 in 10,000 people taking Hepsera)
Zelo redki neželeni učinki (lahko se pojavijo pri manj kot 1 od 10. 000 oseb, ki jemljejo zdravilo Hepsera)
• Lactic acidosis is a serious but very rare side effect of taking Hepsera.
• Laktoacidoza je resen, vendar zelo redek neželeni učinek pri jemanju zdravila Hepsera.
• Stomach pain
25 • bolečina v trebuhu
24 Contact your doctor at once if you get any of these symptoms.
Če imate kateregakoli od teh simptomov, nemudoma obvestite zdravnika.
Common side effects (These can affect 1 to 10 in every 100 people taking Hepsera)
Pogosti neželeni učinki (lahko se pojavijo pri 1 do 10 od 100 oseb, ki jemljejo zdravilo Hepsera)
Very common side effects (These can affect more than 10 in every 100 people taking Hepsera)
Zelo pogosti neželeni učinki (lahko se pojavijo pri več kot 10 od 100 oseb, ki jemljejo zdravilo Hepsera)
Some patients have experienced: • Rash and itching – common
Pri nekaterih bolnikih so se pojavili: • izpuščaj in srbenje – pogosto
• Feeling sick (nausea) or being sick (vomiting) – common
• slabost (navzea) ali bruhanje – pogosto
• Kidney failure – common
• ledvična odpoved – pogosto
• Kidney problems – very common
• težave z ledvicami – zelo pogosto
• Also tests may show decreases in phosphate (common) or increases in creatinine (very common) in the blood.
• Preiskave lahko pokažejo tudi znižanje fosfatov (pogosto) ali zvišanje kreatinina (zelo pogosto) v krvi.
Some patients may also experience: • Kidney failure
Pri nekaterih bolnikih se pojavi tudi: • ledvična odpoved;
• Damage to kidney tubule cells
• okvara celic ledvičnih tubulov;
• Muscle pain or weakness and softening of the bones (both associated with kidney problems)
• bolečine v mišicah ali mišična oslabelost in mehčanje kosti (oboje povezano z ledvičnimi težavami);
• Inflammation of the pancreas (pancreatitis)
26 • vnetje trebušne slinavke (pankreatitis)
If you notice any other effects, even ones not listed in this leaflet tell your doctor or pharmacist.
Če opazite katerikoli druge neželene učinke, tudi tiste, ki niso omenjeni v tem navodilu, obvestite zdravnika ali farmacevta.
Do not use after the expiry date stated on the bottle and carton after {EXP}.
Ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na plastenki in škatli poleg oznake {EXP}.
Medicines should not be disposed of via wastewater or household waste – this helps protect the environment.
Zdravil ne smete odvreči v odpadne vode ali med gospodinjske odpadke – takšni ukrepi pomagajo varovati okolje.
What Hepsera contains
Kaj vsebuje zdravilo Hepsera
• The active substance in Hepsera is adefovir dipivoxil.
• Zdravilna učinkovina v zdravilu Hepsera je adefovirdipivoksil.
Each tablet contains 10 mg adefovir dipivoxil.
Vsaka tableta vsebuje 10 mg adefovirdipivoksila.
• The other ingredients are: pregelatinised starch, croscarmellose sodium, lactose monohydrate, talc and magnesium stearate.
• Pomožne snovi so: predgelirani škrob, natrijev karmelozat, laktoza monohidrat, smukec in magnezijev stearat.
The tablets are marked with “GILEAD” and “10” on one side and a stylised shape of a liver on the other side.
Na tabletah sta napisa “ GILEAD ” in “ 10 ” na eni strani ter stiliziran obris jeter na drugi.
Gilead Sciences Limited 13 Stillorgan Industrial Park Blackrock County Dublin Ireland
Gilead Sciences Limited 13 Stillorgan Industrial Park Blackrock County Dublin Irska
or
27 ali
26 Gilead Sciences Limited IDA Business & Technology Park Carrigtohill County Cork Ireland
Gilead Sciences Limited IDA Business & Technology Park Carrigtohill County Cork Irska
27 Italia Gilead Sciences S.r.l.
28 Suomi/ Finland Italia Gilead Sciences Sweden AB Gilead Sciences S. r. l.
Tel: + 39 02 439201
Puh/ Tel: + 46 (0) 8 5057 1849 Tel: + 39 02 439201
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
Content (Concentration)
Vsebina (koncentracija)
Herceptin is a powder that is made up into a solution for infusion (drip into a vein).
Zdravilo Herceptin je prašek, iz katerega se pripravi raztopina za infundiranje (kapalna infuzija v veno).
It contains the active substance trastuzumab.
Zdravilo vsebuje zdravilno učinkovino trastuzumab.
Herceptin is used to treat breast cancer.
Zdravilo Herceptin se uporablja za zdravljenje raka na dojkah.
It can only be used when the cancer has been shown to ‘ express ’ HER2: this means that the cancer produces a specific protein called HER2 in large quantities on the surface of the tumour cells.
Uporablja se le pri tistih oblikah raka, ki izražajo HER2: to pomeni, da rak na površini tumorskih celic izloča velike količine določene beljakovine, imenovane HER2.
Herceptin is used in metastatic breast cancer (when the cancer has spread to other parts of the body) and in early breast cancer (which has spread within the breast or to the glands under the arm but not to other parts of the body).
Zdravilo Herceptin se lahko uporablja za zdravljenje metastatskega raka dojk (ki se je razširil na druge dele telesa) in zgodnjega raka dojk (ki se je razširil v dojkah ali na žleze pod pazduho, vendar ne na druge dele telesa).
In metastatic breast cancer, Herceptin can be used in the following ways: • on its own in patients who have failed on at least two previous treatments; • in combination with paclitaxel or docetaxel (other anticancer medicines); • in combination with an aromatase inhibitor (another type of anticancer medicine), in women who have been through the menopause and whose cancer also expresses receptors for hormones such as oestrogen or progesterone on its surface.
Za zdravljenje metastatskega raka dojk se zdravilo Herceptin lahko uporablja na naslednje načine: • samostojno pri bolnicah, pri katerih sta bila vsaj dva poskusa predhodnega zdravljenja neuspešna, • v kombinaciji z zdraviloma paklitaksel ali docetaksel (drugi zdravili proti raku), • v kombinaciji z inhibitorji aromataze (drugo zdravilo proti raku) pri pomenopavznih ženskah, katerih rak na svoji površini izraža tudi receptorje za hormone, kot sta estrogen in progesteron.
In early breast cancer, Herceptin is used after surgery, chemotherapy and radiotherapy (if applicable).
Pri zgodnjem raku dojk se zdravilo Herceptin uporablja po operacijah, kemoterapiji in radioterapiji, če je primerno.