natgillin/translations-raw huggingface dataset:
• purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis)
• škrlatno-rde i madeži, zvišana telesna temperatura, srbenje (znaki vnetja krvnih žil, imenovanega vaskulitis)
The initial dose is 40 mg once daily for children weighing below 35 kg and 80 mg once daily for those weighing 35 kg or more.
Za otroke s telesno maso pod 35 kg je za etni odmerek 40 mg enkrat na dan, za tiste s telesno maso 35 kg ali ve pa 80 mg enkrat na dan. Odmerek je treba prilagoditi glede na odziv krvnega tlaka.
Paediatric hypertension
Hipertenzija pri pediatri nih bolnikih
One film-coated tablet contains 80 mg of valsartan.
Ena filmsko obložena tableta vsebuje 80 mg valsartana.
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
V primeru izpostavljenosti antagonistom angiotenzina II od drugega trimese ja nose nosti dalje je priporo en ultrazvo ni pregled delovanja ledvic in lobanje.
Decrease in haemoglobin, Decrease in haematocrit, Neutropenia, Thrombocytopenia
Bolezni krvi in limfati nega sistema neznana znižana koncentracija hemoglobina, zmanjšanje hematokrita, nevtropenija, trombocitopenija
Dizziness, Postural dizziness
Sr no popuš anje
AIIRAs therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalemia); see also section 5.3 “Preclinical safety data”.
zapoznela zakostenitev lobanje) in toksi ne u inke pri novorojen ku (odpoved ledvic, hipotenzija, hiperkaliemija) (glejte tudi poglavje 5.3).
Renal function and serum potassium should be closely monitored.
Natan no je treba spremljati delovanje ledvic in vrednosti kalija v serumu.
Evaluation of patients with heart failure should always include assessment of renal function.
Pregled bolnikov s sr nim popuš anjem mora vedno vklju evati oceno ledvi ne funkcije.
Diovan can be given together with other treatment for heart attack, and your doctor will decide which treatment is suitable for you.
Zdravilo Diovan je mogo e jemati skupaj z drugimi zdravili za zdravljenje sr nega napada.
• allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain,
• lahko pride do alergijskih reakcij z izpuš ajem, s srbenjem in s koprivnico; simptomov zvišane telesne temperature, otekanja sklepov in bole in v sklepih, bole in v mišicah, otekanja bezgavk in/ali simptomov, podobnih gripi (znaki serumske bolezni)
• if you are suffering from a narrowing of the kidney artery.
• e imate zožanje ledvi ne arterije,
• spinning sensation (vertigo)
• obutek vrtenja (vrtoglavica)
Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily.
Zdravnik bo odmerek v obdobju ve tednov postopoma zviševal do najve 160 mg dvakrat na dan. Kon ni odmerek je odvisen od tega, kako prenašate zdravilo.
4.2 Posology and method of administration
4.2 Odmerjanje in na in uporabe
Renal failure and impairment, Elevation of serum creatinine General disorders and administration site conditions Uncommon
Bolezni se il neznana odpoved ali okvara ledvic, zvišana koncentracija kreatinina v serumu Splošne težave in spremembe na mestu aplikacije ob asni utrujenost
Available data are described in sections 4.8, 5.1 and 5.2.
Razpoložljivi podatki so navedeni v poglavjih 4.8, 5.1 in 5.2, vendar varnost in u inkovitost zdravila Diovan pri otrocih, ki so stari od 1 leta do 6 let, nista dokazani.
If you get any of these, see a doctor immediately.
• koprivnica, srbenje e opazite kateregakoli od teh simptomov, pojdite takoj k zdravniku.
Renal function and serum potassium should be closely monitored during treatment with valsartan.
Med zdravljenjem z valsartanom je treba natan no spremljati delovanje ledvic in vrednosti kalija v serumu.
• if you are being treated after a heart attack, a combination with ACE inhibitors (a medication to treat heart attack) is not recommended.
Poleg tega: e se zdravite po sr nem napadu, ni priporo ena uporaba kombinacije z zaviralci ACE (zdravili za zdravljenje srnega napada).
• if you have severe heart disease other than heart failure or heart attack.
• e imate hudo bolezen srca, razen sr nega popuš anja in sr nega napada,
Hypersensitivity including serum sickness
Bolezni imunskega sistema neznana preob utljivost, vklju no s serumsko boleznijo
There was no difference in all-cause mortality, cardiovascular mortality or morbidity when beta blockers were administered together with the combination of valsartan + captopril, valsartan alone, or captopril alone.
Pri so asni uporabi antagonistov adrenergi nih receptorjev beta v kombinaciji z valsartanom in kaptoprilom, skupaj samo z valsartanom ali skupaj samo s kaptoprilom ni bilo razlik v umrljivosti iz vseh vzrokov ter v kardiovaskularni umrljivosti in obolevnosti.
The dose should be adjusted based on blood pressure response.
V primeru na rtovanja nose nosti je treba praviloma preiti na drugo vrsto zdravljenja proti zvišanemu krvnemu tlaku.
Rash, Pruritis
Okvara ledvic
No dose adjustment is required for adult patients with a creatinine clearance >10 ml/min (see sections 4.4 and 5.2).
Pri odraslih bolnikih z o istkom kreatinina > 10 ml/min (glejte poglavji 4.4 in 5.2) ni treba prilagajati odmerka.
Ejection fraction in valsartan treated patients was significantly increased and LVIDD significantly reduced from baseline at endpoint compared to placebo.
Iztisni delež se je ob zaklju ku študije pri bolnikih, zdravljenih z valsartanom, zve al, LVIDD pa zmanjšal glede na izhodiš e, oba statisti no zna ilno v primerjavi s placebom.
Ask your pharmacist how to dispose of medicines no longer required.
O na inu odstranjevanja zdravila, ki ga ne potrebujete ve , se posvetujte s farmacevtom.
Heart failure
Jetrna okvara
• You must tell your doctor if you think that you are (or might become) pregnant.
• zdravniku morate povedati e mislite, da ste nose i ali e na rtujete nose nost.
In heart failure patients:
Pri bolnikih s sr nim popuš anjem:
Diovan 320 mg film-coated tablets can be used
Diovan 320 mg filmsko obložene tablete je mogo e uporabljati:
Cough
eška
Diovan can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.
O tem, katero zdravljenje je primerno za vas, se bo odlo il vaš zdravnik.
Age does not affect the apparent clearance in heart failure patients.
Pri bolnikih s sr nim popuš anjem starost ne vpliva na navidezni o istek.
Respiratory, thoracic and mediastinal disorders Uncommon
Bolezni dihal, prsnega koša in mediastinalnega prostora ob asni kašelj
Skin and subcutaneous tissue disorders Not known
Bolezni kože in podkožja ob asni angioedem neznana izpuš aj, pruritus
You should check with your doctor or pharmacist if you are not sure.
e ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki na rtujejo nose nost, je treba im prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nose nosti; razen, e se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
Unless continued AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki na rtujejo nose nost je treba im prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nose nosti; razen, e se oceni, da je nadaljnje zdravljenje z antagonisti angiotenzina II nujno.
SUMMARY OF PRODUCT CHARACTERISTICS
POVZETEK GLAVNIH ZNA ILNOSTI ZDRAVILA
Valsartan may be administered with other heart failure therapies.
Valsartan je mogo e uporabljati skupaj z drugimi zdravili za sr no popuš anje.
Caution should be observed when initiating therapy in patients with heart failure.
Pri uvajanju zdravljenja bolnikom s sr nim popuš anjem je potrebna previdnost.
Immune system disorders Not known
Bolezni miši no-skeletnega sistema neznana mialgija
PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container [To be completed nationally] 6.6 Special precautions for disposal No special requirements.
6.4 Posebna navodila za shranjevanje [Izpolni država lanica]
Excretion:
Izlo anje:
An assessment of renal function should be included in the evaluation of patients post-myocardial infarction.
Pregled bolnikov po miokardnem infarktu mora vklju evati oceno ledvi ne funkcije.
Elderly
Ciper
Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
Pri so asni uporabi z zaviralci ACE so poro ali o reverzibilnem zvišanju koncentracije litija v serumu in o toksi nosti.
A study primarily aimed at establishing the long-term safety in CKD and non-CKD paediatric patients.
Poudarek rednih posodobljenih poro il o varnosti zdravila mora biti na uporabi pri pediatri ni populaciji.
• abdominal pain
• bole ine v trebuhu
• you must tell your doctor if you think you are (or might become) pregnant.
Svojemu zdravniku morate povedati, e mislite da ste nose i ali e na rtujete nose nost.
The MARVAL (Micro Albuminuria Reduction with Valsartan) study assessed the reduction in urinary albumin excretion (UAE) with valsartan (80-160 mg/od) versus amlodipine
Hrana zmanjša izpostavljenost valsartanu (merjeno z
Asthenia, Fatigue
• utrujenost
Annex A
PRILOGA A
EU/1/18/1299/001 YESCARTA
EU/1/18/1299/001 YESCARTA 0,4 x 1082 x 108 celic disperzija za infundiranje intravenska uporaba vreča (etilen vinil acetat)
The arbitration procedure started on 18 October 2007 with the adoption of a list of questions.
Arbitražni postopek se je začel 18. oktobra 2007 s sprejetjem seznama vprašanj.
The Decentralised Procedure, SE/H/575/07/DC, started on 1 September 2006.
Decentralizirani postopek SE/H/575/07/DC se je začel 1. septembra 2006.
Rapinyl and associated names
Rapinyl in povezana imena
The Rapporteur was Dr Tomas Salmonson (SE) and Dr Pierre Demolis (FR) was Co-Rapporteur.
Poročevalec je bil dr. Thomas Salmonson (SE), soporočevalec pa dr. Pierre Demolis (FR).
The Applicant provided written explanations on 7 April 2008.
Predlagatelj je predložil pisna pojasnila dne 7. aprila 2008.
These Member States were not able to reach an agreement and Sweden referred the reasons for disagreement to the EMEA on 27 September 2007.
Te države članice niso uspele doseči soglasja, zato je Švedska dne 27. septembra 2007 njihove razloge za nestrinjanje predložila agenciji EMEA.
International Non-Proprietary Name (INN): fentanyl citrate
Mednarodno nelastniško ime (INN): fentanil citrat
The Reference Member State was Sweden and the Concerned Member States were Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Portugal, Slovak Republic, Slovenia, Spain and United Kingdom.
Referenčna država članica je bila Švedska, zadevne države članice pa so bile Avstralija, Belgija, Ciper, Češka republika, Danska, Estonija, Finska, Francija, Nemčija, Grčija, Madžarska, Islandija, Irska, Italija, Latvija, Litva, Luksemburg, Norveška, Poljska, Portugalska, Slovaška republika, Slovenija, Španija in Združeno kraljestvo.
This refers to the bridging strategy of the Applicant and was considered to be a serious public health concern.
To se nanaša na predlagateljevo strategijo za premostitev in se upošteva kot resen zadržek v zvezi z javnim zdravjem.
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29(4)1 ZA ZDRAVILO
A positive opinion was adopted by consensus on 26 June 2008
Odbor je dne 26. junija 2008 soglasno sprejel pozitivno mnenje.
Significant difference has been identified with regard to the need for further clinical efficacy and safety data for the evaluation of the benefit/risk and the lack of PK data under normal conditions of use of the product.
Pomembne razlike so bile ugotovljene v zvezi s potrebo po nadaljnjih podatkih o klinični učinkovitosti in varnosti za oceno koristi/tveganj ter s pomanjkanjem podatkov o farmakokinetiki v normalnih okoliščinah uporabe zdravila.
During their June 2008 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Rapinyl and associated names, that the objections raised by Germany, France, Norway and United Kingdom should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, Labelling and Package Leaflet of the Reference Member State should be amended.
Med srečanjem junija 2008 je CHMP na podlagi vseh predloženih podatkov in znanstvene razprave v okviru Odbora predstavil svoje mnenje, da je razmerje med koristmi ter tveganji za zdravilo Rapinyl in povezana imena ugodno ter da ugovori, ki so jih podali Nemčija, Francija, Norveška in Združeno kraljestvo, ne smejo preprečiti odobritve dovoljenja za promet z zdravilom, pa tudi da je treba povzetek glavnih značilnosti zdravila, označevanje in navodila za uporabo referenčne države članice spremeniti.
Rapinyl and associated names, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, sublingual tablets is indicated for the management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Zdravilo Rapinyl in povezana imena, 50 µg, 100 µg, 200 µg, 300 µg, 400 µg, 600 µg in 800 µg, v obliki podjezičnih tablet je namenjeno za zdravljenje prebijajoče bolečine pri odraslih bolnikih, katerih kronične bolečine zaradi raka se zdravi z opioidi.
ProStrakan Ltd submitted applications for Rapinyl and associated names, 50µg, 100µg, 200µg, 300µg, 400µg, 600µg, 800µg, sublingual tablets.
Družba ProStrakan Ltd. je predložila vloge za zdravilo Rapinyl in povezana imena, 50 µg, 100 µg, 200 µg, 300 µg, 400 µg, 600 µg, 800 µg, v obliki podjezičnih tablet.
Appropriate aseptic technique should be used.
Uporabiti je potrebno ustrezno aseptično tehniko.
 Risk Management Plan (RMP)
• Načrt za obvladovanje tveganj (RMP)
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če se zdravilo ne uporabi takoj, so časi in pogoji shranjevanja odgovornost uporabnika.
WestEnd Office Building B torony Hungary
WestEnd Office Building B torony Madžarska
• Your doctor will advise you of the risks and benefits of taking Herzuma during pregnancy.
• Zdravnik vam bo svetoval glede tveganja in koristi uporabe zdravila Herzuma v času nosečnosti.
Herzuma is not recommended for anyone under the age of 18 years.
Zdravilo Herzuma ni priporočljivo za mlajše od 18 let.
The patient who missed the dose should not wait until the next planned cycle.
Bolnik, ki izpusti odmerek, naj ne čaka do naslednjega planiranega cikla.
Trastuzumab can cause breathing difficulties, especially when it is first given.
Trastuzumab lahko povzroči težave z dihanjem, še zlasti, ko ga prejmete prvič.
which was followed by
temu je sledil
For intravenous use only
Le za intravensko uporabo
The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Zdravilo ni namenjeno shranjevanju po rekonstituciji in razredčitvi, razen če je to potekalo v kontroliranih in validiranih aseptičnih pogojih.
Other side effects that have been reported with Herzuma use (frequency cannot be estimated from the available data):
Drugi neželeni učinki, o katerih so poročali v zvezi z uporabo zdravila Herzuma (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov):
Units 2100, 2110, 2120 and 2130 Phase 18, Central Park Bridgend Industrial Estate, Bridgend, CF31 3TY, UNITED KINGDOM
Units 2100, 2110, 2120 and 2130 Phase 18, Central Park Bridgend Industrial Estate Bridgend, CF31 3TY Velika Britanija
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), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
For storage conditions after reconstitution of the medicinal product, see section 6.3 and 6.6.
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavji 6.3 in 6.6.
Herzuma should only be given by a doctor or nurse.
Zdravilo Herzuma lahko daje le zdravnik ali medicinska sestra.
If diluted aseptically, it may be stored for 24 hours (do not store above 30ºC).
Če je raztopljena v aseptičnih pogojih, jo lahko shranjujemo do 24 ur (ne shranjujte pri temperaturi nad 30 °C).
(32 - ne)
(32 - no)
This medicinal product must not be diluted with glucose solutions since these cause aggregation of the protein.
Tega zdravila se ne sme redčiti z raztopinami glukoze, ker le-te povzročajo agregacijo beljakovin.
Overexpression of HER2 is observed in 20% - 30% of primary breast cancers.
Čezmerno izražanje HER2 so opazili pri 20 % do 30 % primarnega raka dojk.
Only patients with a large amount of HER2 will be treated with Herzuma.
Le bolniki z velikim številom HER2 bodo zdravljeni z zdravilom Herzuma.
No formal medicinal product interaction studies have been performed.
Formalnih študij medsebojnega delovanja z zdravili niso izvedli.
When Herzuma binds to HER2 it stops the growth of such cells and causes them to die.
Ko se zdravilo Herzuma veže na HER2, zaustavi rast teh celic in povzroči njihovo smrt.
These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with trastuzumab.
Ta zdravila (ali kateri koli antraciklin) lahko poškodujejo srčno mišico in zvečajo tveganje za nastanek težav s srcem ob uporabi trastuzumaba;
Herzuma is not genotoxic.
Zdravilo Herzuma ni genotoksično.
Herzuma is given as an intravenous infusion (“drip”) directly into your veins.
Zdravilo Herzuma se daje kot intravenska infuzija (»s kapljanjem«) neposredno v vaše žile.
Therefore, these patients should not be treated with Herzuma (see section 4.3).
Zato takih bolnikov ne smemo zdraviti z zdravilom Herzuma (glejte poglavje 4.3).
 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.
FP + H: Fluoropyrimidine/cisplatin + trastuzumab FP: Fluoropyrimidine/cisplatin a: Odds ratio
FP+H: fluoropirimidin/cisplatin + trastuzumab FP: fluoropirimidin/cisplatin a: razmerje obetov
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 Herzuma 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 Herzuma.
However, trastuzumab may elevate the overall exposure of one doxorubicin metabolite, (7-deoxy-13 dihydro-doxorubicinone, D7D).
Trastuzumab pa lahko zviša celokupno izpostavljenost enemu metabolitu doksorubicina (7-deoksi-13-dihidro-doksorubicinonu, D7D).
The European Medicines Agency has waived the obligation to submit the results of studies with 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 s trastuzumabom za vse podskupine pediatrične populacije pri raku dojk in raku želodca (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In the pivotal trial (BO16216), trastuzumab and anastrozole were administered from day 1.
V ključni študiji (BO16216) so trastuzumab in anastrozol dajali od 1. dne dalje.
Herzuma may affect your ability to drive a car or operate machines.
Zdravilo Herzuma lahko vpliva na vašo sposobnost za vožnjo ali upravljanje strojev.
Other side effects can occur at any time during treatment with Herzuma, not just related to an infusion.
Drugi neželeni učinki se lahko pojavijo kadar koli med zdravljenjem z zdravilom Herzuma in niso povezani le z infuzijo.
 Periodic safety update reports
• Redno posodobljena poročila o varnosti zdravila
Do not stop using this medicine without talking to your doctor first.
Ne prenehajte uporabljati tega zdravila brez posvetovanja s svojim zdravnikom.
Use of other reconstitution solvents should be avoided.
Uporaba drugih vehiklov za rekonstitucijo ni dovoljena.
 you suffer from breathlessness, especially if you are currently using a taxane.
• težko dihate, še posebno, če se trenutno zdravite s taksani.
1 Year N = 1702***
trastuzumab 1 leto n = 1702***
Patients experiencing infusion-related symptoms (see section 4.4) should be advised not to drive and use machines until symptoms abate.
Bolnikom, pri katerih se pojavijo simptomi, povezani z infundiranjem (glejte poglavje 4.4), je treba svetovati, naj ne upravljajo vozil in strojev, dokler ti ne izzvenijo.
Placental transfer of trastuzumab during the early (days 20 - 50 of gestation) and late (days 120 - 150 of gestation) foetal development period was observed.
Opazili so prehod trastuzumaba prek placente v zgodnjem obdobju (20. do 50. dan gestacije) in v poznem obdobju (120. do 150. dan gestacije) razvoja ploda.
• dry mouth and skin
• suha usta in koža
Although the number of cases identified by a search of the safety database and meeting the CairoBishop criteria for diagnosis was low, it is endorsed that a contributing factor of trastuzumab to tumour lysis syndrome (TLS) could not be excluded.
Čeprav je bilo število primerov, ki so jih ugotovili z iskanjem po podatkovni zbirki o varnosti in ki izpolnjujejo Cairo-Bishopova merila za diagnozo, majhno, je potrjeno, da dejavnika, ki ga k sindromu razpada tumorja prispeva trastuzumab, ni mogoče izključiti.
(12.3 - ne)
(12,3 - no)
Other medicines and Herzuma
Druga zdravila in zdravilo Herzuma
Therefore, from the mechanism of action there is evidence that trastuzumab can cause tumour lysis syndrome.
Iz mehanizma delovanja namreč obstajajo dokazi, da trastuzumab lahko povzroči sindrom razpada tumorja.
The presence of anti-trastuzumab antibodies had no impact on pharmacokinetics, efficacy (determined by pathological Complete Response [pCR] and event free survival [EFS]) and safety determined by occurrence of administration related reactions (ARRs) of trastuzumab intravenous.
Prisotnost protiteles proti trastuzumabu ni vplivala na farmakokinetiko, učinkovitost (določeno s patološkim popolnim odgovorom [pCR] in preživetjem brez dogodka (Event Free Survival [EFS])) in varnost, določeno s pojavom reakcij, povezanih z aplikacijo trastuzumaba v intravenski obliki.
(6.2 - ne)
(6,2 - no)
Trastuzumab 1 Year N = 1693
trastuzumab 1 leto n = 1693
The dose of Herzuma depends on your body weight.
Odmerek zdravila Herzuma je odvisen od vaše telesne mase.
Herzuma loading dose should be administered as a 90-minute intravenous infusion.
Uvajalni odmerek zdravila Herzuma se daje kot 90-minutna intravenska infuzija.
The median duration of follow-up in the trastuzumab arm was 3.8 years.
Mediana spremljanja v skupini, ki je prejemala trastuzumab, je bila 3,8 let.
For instructions on reconstitution of Herzuma intravenous formulation before administration, see section 6.6.
Za navodila glede rekonstitucije zdravila Herzuma v intravenski obliki pred dajanjem glejte poglavje 6.6.