natgillin/translations-raw huggingface dataset:
How to store ABILIFY
Shranjevanje zdravila ABILIFY
6 mg aspartame (E 951) and 0.225 mg lactose per orodispersible tablet
6 mg aspartama (E 951) in 0,225 mg laktoze na orodisperzibilno tableto Za celoten seznam pomožnih snovi glejte poglavje 6.1.
ABILIFY 10 mg orodispersible tablets Red iron oxide (E 172)
ABILIFY 10 mg orodisperzibilne tablete rdeči železov oksid (E 172)
In intravenous reproductive toxicity studies, no new safety concerns were observed at maternal exposures up to 15 (rat) and 29 (rabbit) times human exposure at 30 mg.
Pri izpostavljenosti mater, ki je bila 15krat (podgane) in 29-krat (kunčice) večja od izpostavljenosti človeka pri 30 mg odmerku pri študijah vplivov na sposobnost razmnoževanja po intravenskem dajanju niso ugotovili dodatnih težav glede varnosti.
Musculoskeletal and connective tissue disorders
Bolezni mišično skeletnega sistema in vezivnega tkiva rabdomioliza mialgija togost
Manic episodes in Bipolar I Disorder in adolescents aged 13 years and older The frequency and type of adverse reactions in adolescents with Bipolar I Disorder were similar to those in adults except for the following reactions: very commonly (≥ 1/10) somnolence (23.0 %), extrapyramidal disorder (18.4 %), akathisia (16.0 %), and fatigue (11.8 %); and commonly (≥ 1/100, < 1/10) abdominal pain upper, heart rate increased, weight increased, increased appetite, muscle twitching, and dyskinesia.
Pri mladostnikih z bipolarno motnjo I so bili neželeni učinki po pogostnosti in vrsti podobni kot pri odraslih, z izjemo naslednjih: somnolence (23,0 %), ekstrapiramidnih motenj (18,4 %), akatizije
ABILIFY 30 mg tablets Red iron oxide (E 172)
ABILIFY 30 mg tablete rdeči železov oksid (E 172)
Potential for other medicinal products to affect ABILIFY solution for injection
Možnost vpliva drugih zdravil na ABILIFY raztopina za injiciranje Sočasna uporaba lorazepama v obliki raztopine za injiciranje ne vpliva na farmakokinetiko ABILIFY
The most commonly reported adverse reactions in placebo-controlled trials were nausea, dizziness and somnolence each occurring in more than 3 % of patients treated with aripiprazole solution for injection.
Vsak se je pojavil pri več kot 3 % bolnikov, ki so se zdravili z aripiprazolom v obliki raztopine za injiciranje.
ABILIFY 1 mg/mL oral solution is a clear, colourless to light yellow liquid supplied in bottles with polypropylene child-resistant closure containing 50 mL, 150 mL or 480 mL per bottle.
Na voljo je v plastenkah, ki imajo za otroke varno zaporko iz polipropilena in vsebujejo 50 ml, 150 ml ali 480 ml.
ABILIFY 15 mg orodispersible tablets Yellow iron oxide (E 172)
ABILIFY 15 mg orodisperzibilne tablete rumeni železov oksid (E 172)
ABILIFY 30 mg orodispersible tablets 30 mg: Round and pink, marked with "A" over "643" on one side and "30" on the other.
ABILIFY 30 mg orodisperzibilne tablete so okrogle oblike in roza barve, označene z '"A" nad "643"'
• tiredness,
• driska,
• low levels of blood platelets,
• nizke ravni trombocitov,
Excipient with known effect 186.54 mg lactose (as monohydrate) per tablet
186,54 mg laktoze (v obliki monohidrata) na tableto Za celoten seznam pomožnih snovi glejte poglavje 6.1.
ABILIFY contains the active substance aripiprazole and belong to a group of medicines called antipsychotics.
Raztopina za injiciranje ABILIFY vsebuje učinkovino aripiprazol in spada v skupino zdravil,
Water for injections
Raztopina za injiciranje.
Peripheral oedema
peroralna raztopina
In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain.
Zvečanje telesne mase Klinična preskušanja niso pokazala, da bi aripiprazol povzročil klinično pomembno zvečanje telesne mase.
ABILIFY 10 mg orodispersible tablets
ABILIFY 10 mg orodisperzibilne tablete
Magnesium stearate
OVOJNINAH NALEPKA VIALE
• high blood pressure,
• visok krvni tlak, • izguba zavesti,
Temperature regulation disorder (e.g. hypothermia, pyrexia) Chest pain
Splošne težave in spremembe na mestu aplikacije izčrpanost motnje uravnavanja telesne temperature (npr. hipotermija, pireksija)
When weak inhibitors of CYP3A4 (e.g. diltiazem) or CYP2D6 (e.g. escitalopram) are used concomitantly with aripiprazole, modest increases in plasma aripiprazole concentrations may be expected.
Med sočasno uporabo aripiprazola in šibkih zaviralcev CYP3A4 (npr. diltiazema) ali CYP2D6 (npr. escitaloprama)
ABILIFY 30 mg orodispersible tablets
ABILIFY 30 mg orodisperzibilne tablete
Tablet coat
• kolcanje.
• inflammation of the liver,
• vnetje trebušne slinavke,
Aripiprazole was superior to placebo in change from baseline at week 4 and at week 12 on the Y-MRS total score.
Aripiprazol se je v 4. tednu in v 12. tednu pri spremembi skupne ocene po lestvici YMRS od izhodišča izkazal za boljšega od placeba.
It is important that you carry on receiving ABILIFY solution for injection for as long as your doctor has told you to.
Odmerek ABILIFY raztopine za injiciranje in trajanje zdravljenja bo določil zdravnik.
Methyl parahydroxybenzoate (E 218) Propylene glycol
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi dinatrijev edetat fruktoza glicerol mlečna kislina metilparahidroksibenzoat (E 218) propilenglikol propilparahidroksibenzoat (E 216) natrijev hidroksid saharoza prečiščena voda aroma pomaranče
ABILIFY 15 mg orodispersible tablets
ABILIFY 15 mg orodisperzibilne tablete
Schizophrenia with oral aripiprazole
Uporaba peroralnega aripiprazola pri shizofreniji
Tics associated with Tourette's disorder in paediatric patients (see section 4.2) The efficacy of aripiprazole was studied in paediatric subjects with Tourette's disorder (aripiprazole: n = 99, placebo: n = 44) in a randomised, double-blind, placebo-controlled, 8 week study using a fixed dose weight-based treatment group design over the dose range of 5 mg/day to 20 mg/day and a starting dose of 2 mg.
Trzaji, povezani s Tourettovim sindromom, pri pediatričnih bolnikih (glejte poglavje 4.2) Učinkovitost aripiprazola je bila raziskana pri pediatrični populaciji s Tourettovo motnjo (aripiprazol:
• slower heartbeat,
• kolcanje, • suha usta.
ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"' on one side and ‘15' on the other.
Okrogle oblike in rumene barve, označene z "A" nad "641" na eni strani in 15 na drugi.
In clinical trials oral aripiprazole has not been shown to induce clinically relevant weight gain.
Zvečanje telesne mase Klinična preskušanja niso pokazale, da bi peroralni aripiprazol povzročil klinično pomembno zvečanje telesne mase.
Crospovidone
Distonija
ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"' on one side and ‘30' on the other.
Okrogle oblike in roza barve, označene z "A" nad "643" na eni strani in 30 na drugi.
ABILIFY 15 mg tablets Yellow iron oxide (E 172)
ABILIFY 15 mg tablete rumeni železov oksid (E 172)
Talk to your doctor before taking ABILIFY.
Pred začetkom uporabe zdravila ABILIFY se posvetujte z zdravnikom.
Sulfobutylether β-cyclodextrin (SBECD) Tartaric acid
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi sulfobutileter betaciklodekstrin (SBECD) vinska kislina natrijev hidroksid voda za injekcije
ABILIFY contains sodium
Zdravilo ABILIFY vsebuje natrij
Tell the doctor or nurse if you feel dizzy or faint after the injection.
Če ste po prejemu injekcije omotični ali omedlite, o tem obvestite zdravnika ali medicinsko sestro.
ABILIFY 30 mg tablets Each tablet contains 30 mg of aripiprazole.
57 mg laktoze (v obliki monohidrata) na tableto ABILIFY 30 mg tablete Ena tableta vsebuje 30 mg aripiprazola.
The occurrence of suicidal behaviour is inherent in psychotic illnesses and mood disorders and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with aripiprazole (see section 4.8).
V nekaterih primerih so o njegovem pojavu poročali zgodaj po uvedbi ali zamenjavi antipsihotičnega zdravljenja,
This can lead to symptoms such as:
To lahko privede do simptomov, kot so:
Overall Response Rate, %
Celokupni delež odgovora, %
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2018
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 12. december 2018
Children and adolescents Ogivri is not recommended for anyone under the age of 18 years.
Otroci in mladostniki Zdravilo Ogivri ni priporočljivo za mlajše od 18 let.
This medicinal product must not be mixed or diluted with other medicinal products except those mentioned in section 6.6.
Zdravila ne smemo mešati ali redčiti z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
• Your doctor will advise you of the risks and benefits of taking Ogivri during pregnancy.
• Zdravnik vam bo svetoval glede tveganja in koristi uporabe zdravila Ogivri v času nosečnosti.
The bioactivity of D7D and the clinical impact of the elevation of this metabolite were unclear.
Biološka aktivnost D7D in klinični vpliv zaradi dviga ravni tega metabolita nista bila jasna.
Therefore, your doctor may decide to continue to check your heart functions, even after you finish treatment.
Zato se bo vaš zdravnik morda odločil za nadaljevanje spremljanja delovanja vašega srca tudi po končanem zdravljenju.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Za izboljšanje sledljivosti bioloških zdravil je treba ime in številko serije uporabljenega zdravila jasno zabeležiti.
Side effects of not known frequency: frequency cannot be estimated from the available data
Neželeni učinki z neznano pogostnostjo - pogostnosti ni mogoče oceniti iz podatkov, ki so na voljo:
• increased muscle tone or tension (hypertonia)
• povečan mišični tonus ali napetost (hipertonija)
Ogivri should only be given by a doctor or nurse.
Zdravilo Ogivri lahko daje le zdravnik ali medicinska sestra.
In this section, the following categories of frequency have been used: 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 (cannot be estimated from the available data).
V tem poglavju so neželeni učinki navedeni po pogostnosti na naslednji način: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznano (ni mogoče oceniti iz razpoložljivih podatkov).
• breathlessness (including breathlessness at night),
• težave z dihanjem (vključno s težavami z dihanjem ponoči),
Ogivri can cause breathing difficulties, especially when it is first given.
Zdravilo Ogivri lahko povzroči težave z dihanjem, še zlasti, ko ga prejmete prvič.
Patients with HFI cannot break down fructose, which may cause serious side effects.
Bolniki s HFI ne morejo razgraditi fruktoze, kar lahko privede do resnih neželenih učinkov.
Therefore, these patients should not be treated with trastuzumab (see section 4.3).
Zato takih bolnikov ne smemo zdraviti s trastuzumabom (glejte poglavje 4.3).
Infusion reactions, allergic-like reactions and hypersensitivity It is estimated that approximately 40 % of patients who are treated with trastuzumab will experience some form of infusion-related reaction.
Infuzijske reakcije, alergiji podobne reakcije in preobčutljivost Ocenjujejo, da se pri približno 40 % bolnikov, ki prejemajo trastuzumab, pojavi neka oblika reakcij, povezanih z infuzijo.
If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine.
Če imate dedno intoleranco za fruktozo (HFI), kar je redka genetska bolezen, tega zdravila ne smete jemati.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če se zdravilo ne uporabi takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik.
* defined as absence of any invasive cancer both in the breast and axillary nodes
* Definiran kot odsotnost kakršnega koli invazivnega raka v dojkah in aksilarnih bezgavkah
The reconstituted solution should not be frozen.
Pripravljene raztopine se ne sme zamrzniti.
Approximately 17 % of cardiac dysfunction related events occurred after completion of trastuzumab.
Približno 17 % dogodkov, povezanih z motnjo delovanja srca, je nastopilo po zaključku zdravljenja s trastuzumabom.
Serious reactions have been treated successfully with supportive therapy such as oxygen, beta agonists, and corticosteroids.
Resne reakcije so uspešno zdravili s podpornim zdravljenjem, kot so kisik, beta agonisti in kortikosteroidi.
47.3 (32-ne)
47,3 (32-no)
See section 4.8 for how to report adverse reactions
Glejte poglavje 4.8 o tem, kako poročati o neželenih učinkih.
Duration of Response, Median months
Trajanje odgovora, mediana mesecev
Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Nekateri od teh simptomov so lahko resni in opisani so primeri smrti (glejte poglavje 2, “Opozorila in previdnostni ukrepi”).
The dose of Ogivri depends on your body weight.
Odmerek zdravila Ogivri je odvisen od vaše telesne mase.
These effects mainly occur with the first intravenous infusion (“drip” into your vein) and during the first few hours after the start of the infusion.
Ti učinki se pojavijo predvsem med prvo intravensko infuzijo (“kapljanjem” zdravila v žilo) in prvih nekaj ur po pričetku infuzije.
The results of these simulations indicate that at least 95 % of patients will reach concentrations that are < 1 mcg/mL (approximately 3 % of the population predicted Cmin,ss, or about 97 % washout) by 7 months.
Rezultati teh simulacij kažejo, da bo najmanj 95 % bolnikov do 7. meseca doseglo koncentracije < 1 μg/ml (približno 3 % Cmin, ss predvidene za populacijo ali približno 97-% izpiranje).
12 weeks.
24 mesecih.
As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during trastuzumab therapy and for 7 months after the last dose.
Ker se humani IgG1 izloča v materino mleko, potencialni škodljivi vpliv na otroka pa ni znan, naj ženske ne dojijo med zdravljenjem s trastuzumabom in še 7 mesecev po zadnjem odmerku.
4.7 Effects on ability to drive and use machines Ogivri may have a minor influence on the ability to drive and use machines (see section 4.8).
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Ogivri ima lahko blag vpliv na sposobnost vožnje in upravljanje strojev (glejte poglavje 4.8).
Trastuzumab loading dose should be administered as a 90-minute intravenous infusion.
Uvajalni odmerek trastuzumaba se daje kot 90-minutna intravenska infuzija.
These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Ogivri.
Ta zdravila (ali kateri koli antraciklin) lahko poškodujejo srčno mišico in zvečajo tveganje za nastanek težav s srcem ob uporabi zdravila Ogivri;
FP + H: Fluoropyrimidine/cisplatin + Trastuzumab FP: Fluoropyrimidine/cisplatin a Odds ratio
FP + H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin a Razmerje obetov
Trastuzumab 1 Year N = 1702***
Trastuzumab 1 leto n = 1702***
If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Ogivri treatment.
Če bodo pri vas nastopili kakršni koli znaki srčnega popuščanja (to je, da vaše srce ne črpa krvi v zadostni meri), bo zdravnik delovanje vašega srca preveril pogosteje (vsakih šest do osem tednov); lahko prejmete zdravila proti srčnemu popuščanju ali pa boste morda morali prenehati z zdravljenjem z zdravilom Ogivri.
What Ogivri is and what it is used for
Kaj je zdravilo Ogivri in za kaj ga uporabljamo
Time to Disease Progression, Median months
Čas do napredovanja bolezni, mediana mesecev
If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”).
Če boste začetni odmerek dobro prenašali, boste nadaljnje odmerke prejeli v 30 minutah (glejte poglavje 2, “Opozorila in previdnostni ukrepi”).
• if you have severe breathing problems at rest due to your cancer or if you need oxygen treatment.
• imate hude težave z dihanjem v mirovanju zaradi raka ali če potrebujete zdravljenje s kisikom.
When Ogivri binds to HER2 it stops the growth of such cells and causes them to die.
Ko se zdravilo Ogivri veže na HER2, zaustavi rast teh celic in povzroči njihovo smrt.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro, preden boste prejeli to zdravilo.
Women of childbearing potential should be advised to use effective contraception during treatment with trastuzumab and for 7 months after treatment has concluded (see section 5.2).
Ženskam v rodni dobi je treba svetovati, naj med zdravljenjem s trastuzumabom ter še 7 mesecev po zaključku zdravljenja uporabljajo učinkovito kontracepcijo (glejte poglavje 5.2).
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
• Hypersensitivity to the active substance, murine proteins, or to any of the excipients listed in section 6.1.
• Preobčutljivost na učinkovino, murine beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing trastuzumab in all subsets of the paediatric population for breast and gastric cancer (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje trastuzumab, za vse skupine pediatrične populacije pri raku dojk in raku želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Table 6 Efficacy results from study BO16348
Preglednica 6 Rezultati učinkovitosti študije BO16348
If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).
Če je redčenje potekalo aseptično, se lahko raztopino hrani do 24 ur (ne shranjujte pri temperaturi nad 30 °C).
Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Včasih se lahko med zdravljenjem ali občasno tudi po končanem zdravljenju pojavijo težave s srcem, ki so lahko resne.
If an alternate route of administration is required, other trastuzumab products offering such an option should be used
Če je potrebna drugačna pot uporabe, je treba uporabiti druga zdravila, ki vsebujejo trastuzumab in omogočajo to možnost.
Observation N = 1697***
Opazovanje n = 1697***
Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC03
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, monoklonska protitelesa, oznaka ATC: L01XC03
Only patients with a large amount of HER2 will be treated with Ogivri.
Le bolniki z velikim številom HER2 bodo zdravljeni z zdravilom Ogivri.
In this trial, 87 % of patients entered had disease that was IHC3+, and 95 % of patients entered had disease that was IHC3+ and/or FISH-positive.
V tem preskušanju je 87 % vključenih bolnikov imelo bolezen, ki je bila IHC 3+, 95 % vključenih bolnikov pa je imelo bolezen, ki je bila IHC 3+ in/ali FISH-pozitivna.
In all patients cardiac function should be monitored during treatment (e.g. every 12 weeks).
Med zdravljenjem je treba nadzorovati delovanje srca pri vseh bolnikih (npr. vsakih 12 tednov).
21 (mg/mL, concentration of reconstituted solution)
21 (mg/ml, koncentracija pripravljene raztopine)
Your doctor may prescribe Ogivri for the treatment of breast and gastric cancer when:
Vaš zdravnik vam lahko zdravilo Ogivri predpiše za zdravljenje raka dojk in raka želodca, če:
• You should use effective contraception during treatment with Ogivri and for at least 7 months after treatment has ended.
• Med zdravljenjem z zdravilom Ogivri in vsaj še 7 mesecev po zaključku zdravljenja morate uporabljati učinkovito kontracepcijo.
The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Zdravila po rekonstituciji ali redčenju ni dovoljeno shranjevati, razen če sta rekonstitucija in redčenje potekala v kontroliranih in validiranih aseptičnih pogojih.
The rate was highest in patients who were administered trastuzumab concurrently with a taxane (2.0 %).
Delež je bil najvišji pri bolnikih, ki so trastuzumab prejeli sočasno s taksanom (2,0 %).
Very rarely, patients with severe breathing difficulties before treatment have died when they were given Ogivri.
Zelo redko je pri bolnikih, ki so imeli hude težave z dihanjem pred začetkom zdravljenja, pri uporabi zdravila Ogivri prišlo do smrtnih primerov;
An absolute benefit of 13 percentage points in favour of the trastuzumab arm was estimated in terms of 3-year event-free survival rate (65 % versus 52 %).
Absolutna korist 13 odstotnih točk v prid skupini, ki je prejemala trastuzumab, je bila ocenjena v smislu 3-letnega preživetja brez bolezni (65 % proti 52 %).
The efficacy results from the BO16348 trial following 12 months* and 8 years** median follow-up are summarized in Table 6:
Rezultati učinkovitosti študije BO16348 po medianem času spremljanja 12 mesecev* in 8 let** so povzeti v preglednici 6:
150 mg vial
150-mg viala
Study M77001: Full analysis set (intent-to-treat), 24 months results
3 Študija M77001: celotna skupina bolnikov (bolniki, ki so jih nameravali zdraviti, intent-to-treat), rezultati po
Trastuzumab 1 Year N = 1693
Trastuzumab 1 leto n = 1693
For intravenous use only after reconstitution and dilution
Za intravensko uporabo le po rekonstituciji in razredčitvi.
AC→PH (vs. AC→P) (NSABP B-31 and NCCTG N9831)*
AC→PH (v primerjavi z AC→P) (NSABP B-31 in NCCTG N9831)*
Treatment with Ogivri alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Samostojno zdravljenje z zdravilom Ogivri ali v kombinaciji s taksanom lahko vpliva na srce, še posebno, če ste se kdaj zdravili z antraciklinom (taksani in antraciklini sta dve drugi vrsti zdravil, ki se uporabljata za zdravljenje raka).
Switching treatment between trastuzumab intravenous and trastuzumab subcutaneous formulation and vice versa.
Prehod z zdravljenja s trastuzumabom v intravenski obliki na subkutano obliko in obratno
*Cmin,ss - Cmin at steady state **Cmax,ss = Cmax at steady state *** time to 90% of steady-state
* Cmin, ss - Cmin v stanju dinamičnega ravnovesja ** Cmax, ss = Cmax v stanju dinamičnega ravnovesja *** čas do 90 % stanja dinamičnega ravnovesja
Patients were either naïve to trastuzumab intravenous treatment (20.3 %) or pre-exposed to trastuzumab intravenous (79.7 %).
Bolniki še niso prejemali trastuzumaba v intravenski obliki (20,3 %) ali pa so bili predhodno izpostavljeni trastuzumabu v intravenski obliki (79,7 %).
In the neoadjuvant-adjuvant EBC study (BO22227), at a median follow-up exceeding 70 months, 10.1 % (30/296) of patients treated with trastuzumab intravenous developed antibodies against trastuzumab.
V študiji neoadjuvantnega-adjuvantnega zgodnjega raka dojk (BO22227) z mediano spremljanja, ki je presegla 70 mesecev, so se pri 10,1 % bolnikov (30/296), zdravljenih z intravensko obliko trastuzumaba, razvila protitelesa proti trastuzumabu.