natgillin/translations-raw huggingface dataset:
In ARIES-2, ambrisentan (combined dose group) significantly delayed the time to clinical worsening of PAH compared to placebo (p<0.001), the hazard ratio demonstrated an 80% reduction (95% CI:
V študiji ARIES-2 je ambrisentan (skupina s kombiniranim odmerkom) v primerjavi s placebom pomembno podaljšal čas do kliničnega poslabšanja PAH (p < 0,001), razmerje tveganja kaže 80 % zmanjšanje (95-% interval zaupanja: od 47 % do 92 %).
Decrease in systolic and diastolic blood pressures has been reported with ambrisentan therapy.
Med zdravljenjem z ambrisentanom je bilo opisano znižanje sistoličnega in diastoličnega krvnega tlaka.
Chronic administration of ambrisentan was not associated with a change in plasma testosterone in clinical studies.
V kliničnih študijah se pri dolgotrajni uporabi ambrisentana vrednost testosterona v plazmi ni spremenila.
Ambrisentan Mylan 10 mg film-coated tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'
Ambrisentan Mylan 10 mg filmsko obložene tablete vsebujejo manj kot 1 mmol (23 mg) natrija na tableto, kar v bistvu pomeni ‘brez natrija'.
The effect of 7-day dosing of sildenafil (20 mg three times daily) on the pharmacokinetics of a single dose of ambrisentan, and the effects of 7-day dosing of ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of sildenafil were investigated in 19 healthy volunteers.
Učinek 7-dnevne uporabe sildenafila (20 mg trikrat na dan) na farmakokinetiko enkratnega odmerka ambrisentana in učinek 7-dnevne uporabe ambrisentana (10 mg enkrat na dan) na farmakokinetiko enkratnega odmerka sildenafila so raziskovali pri 19 zdravih prostovoljcih.
What Ambrisentan Mylan looks like and contents of the pack
Izgled zdravila Ambrisentan Mylan in vsebina pakiranja
The effects of steady-state ambrisentan (10 mg once daily) on the pharmacokinetics and pharmacodynamics of a single dose of warfarin (25 mg), as measured by PT and INR, were investigated in 20 healthy volunteers.
Učinek ambrisentana v stanju dinamičnega ravnovesja (10 mg enkrat na dan) na farmakokinetiko in farmakodinamiko enkratnega odmerka varfarina (25 mg), vrednoteno s PT in INR, so raziskovali pri 20 zdravih prostovoljcih.
Fluid retention
Zastajanje tekočin
In an open label study (AMB222), ambrisentan was studied in 36 patients to evaluate the incidence of increased serum aminotransferase concentrations in patients who had previously discontinued other ERA therapy due to aminotransferase abnormalities.
Namen študije je bil ovrednotiti pojavnost zvišane koncentracije serumske aminotransferaze pri bolnikih, pri katerih je bilo prekinjeno predhodno zdravljenje z drugim ERA zaradi nenormalnih vrednosti aminotransferaze.
Across the 12 week placebo-controlled Phase 3 clinical studies, mean haemoglobin concentrations decreased for patients in the ambrisentan groups and were detected as early as week 4 (decrease by 0.83 g/dL); mean changes from baseline appeared to stabilise over the subsequent 8 weeks.
Pri bolnikih, ki so prejemali ambrisentan, se je med 12-tedenskimi s placebom nadzorovanimi kliničnimi študijami 3. faze srednja vrednost koncentracije hemoglobina znižala, kar so ugotovili že 4. teden (znižanje za 0,83 g/dl).
How to take Ambrisentan Mylan
Kako jemati zdravilo Ambrisentan Mylan
The testicular changes were not fully recoverable during the off-dose periods evaluated.
V času vrednotenja brez dajanja zdravila te spremembe na modih niso povsem izginile.
Furthermore, ambrisentan did not induce MRP2, Pgp or BSEP protein expression in rat hepatocytes.
Poleg tega ambrisentan v podganjih jetrnih parenhimskih celicah ni induciral ekspresije beljakovin MRP2, Pgp ali BSEP.
Talk to your doctor if you have any questions or concerns about this.
Če imate o tem kakršno koli vprašanje ali ste zaskrbljeni, se posvetujte s svojim zdravnikom.
In addition to the above, except abnormal blood test results for liver function:
Poleg zgoraj naštetega, razen nenormalnih izvidov preiskave krvi za delovanje jeter: • zvonjenje v ušesih (tinitus) le med kombiniranim zdravljenjem.
Pink, round, biconvex film-coated tablet with ‘M' debossed on one side and ‘AN' on the other, approximately 5.7 mm in diameter.
Rožnata, okrogla, bikonveksna filmsko obložena tableta premera približno 5,7 mm, z vtisnjeno oznako „M“ na eni strani in „AN“ na drugi strani.
The placebo-adjusted improvement in mean 6MWD at week 12 compared to baseline was 30.6 m (95% CI: 2.9 to 58.3; p=0.008) and 59.4 m (95% CI: 29.6 to 89.3; p<0.001) for the 5 mg group, in ARIES-1 and 2 respectively.
V skupini, ki je prejemala 5 mg odmerek, je v študiji ARIES-1 na placebo prilagojeno izboljšanje povprečnega rezultata 6MWD v 12. tednu v primerjavi z izhodiščem znašalo 30,6 m (95-% interval zaupanja: 2,9 do 58,3; p = 0,008), v študiji ARIES-2 pa 59,4 m (95-% interval zaupanja: 29,6 do 89,3; p < 0,001).
The effects of repeat dosing of cyclosporine A (100 - 150 mg twice daily) on the steady-state pharmacokinetics of ambrisentan (5 mg once daily), and the effects of repeat dosing of ambrisentan (5 mg once daily) on the steady-state pharmacokinetics of cyclosporine A (100 - 150 mg twice daily) were studied in healthy volunteers.
Učinke ponavljajočih se odmerkov ciklosporina A (100 - 150 mg dvakrat na dan) na farmakokinetiko ambrisentana (5 mg enkrat na dan) v stanju dinamičnega ravnovesja in učinke ponavljajočih se odmerkov ambrisentana (5 mg enkrat na dan) na farmakokinetiko ciklosporina A (100-150 mg dvakrat na dan) v stanju dinamičnega ravnovesja so raziskali pri zdravih prostovoljcih.
It is recommended that the tablet is swallowed whole and it can be taken with or without food.
Lahko jo jemlje skupaj s hrano ali brez nje.
Each film-coated tablet contains 5 mg or 10 mg.
Ena filmsko obložena tableta vsebuje 5 ali 10 mg ambrisentana.
Nasal bone hyperplasia of the ethmoid turbinates has been observed in the nasal cavity of rats treated with ambrisentan, at exposure levels 3-fold the clinical AUC.
Pri podganah, ki so prejemale ambrisentan, so pri izpostavljenosti, ki je ustrezala 3-kratni vrednosti AUC pri klinični uporabi, poročali o hiperplaziji nosne kosti etmoidnega labirinta.
Initiation of ambrisentan is not recommended for patients with clinically significant anaemia.
Pri bolnikih s klinično pomembno anemijo uvedba zdravljenja z ambrisentanom ni priporočljiva.
The active substance is ambrisentan.
Učinkovina je ambrisentan.
Ambrisentan Mylan 10 mg film-coated tablets contain lactose.
Ambrisentan Mylan 10 mg filmsko obložene tablete vsebujejo laktozo.
Ambrisentan Mylan 5 mg film-coated tablets contain the azo-colouring agent Allura red AC Aluminium Lake (E129), which may cause allergic reactions.
Ambrisentan Mylan 5 mg filmsko obložene tablete vsebujejo azo barvilo alurno rdeče AC (E129), ki lahko povzroči alergijske reakcije.
Each tablet contains approximately 52 mg of lactose and 20 micrograms of Allura red AC Aluminium lake
Ena tableta vsebuje približno 52 mg laktoze in 20 mikrogramov alurno rdečega barvila AC. Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Each tablet contains approximately 26 mg of lactose and 10 micrograms of Allura red AC Aluminium lake
Ena tableta vsebuje približno 26 mg laktoze in 10 mikrogramov alurno rdečega barvila AC. Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Cases of autoimmune hepatitis, including cases of exacerbation of autoimmune hepatitis, and hepatic injury have been reported during ambrisentan therapy.
Med zdravljenjem z ambrisentanom so bili opisani primeri avtoimunskega hepatitisa, vključno s primeri poslabšanja avtoimunskega hepatitisa, in okvara jeter.
The effects of acute and repeat dosing of rifampicin (600 mg once daily) on the steady-state pharmacokinetics of ambrisentan (10 mg once daily) were studied in healthy volunteers.
Učinke enkratnega in ponavljajočega se odmerjanja rifampicina (600 mg enkrat na dan) na farmakokinetiko ambrisentana (10 mg enkrat na dan) v stanju dinamičnega ravnovesja so raziskali pri zdravih prostovoljcih.
Ambrisentan Mylan 5 mg film-coated tablets contain lactose.
Ambrisentan Mylan 5 mg filmsko obložene tablete vsebujejo laktozo.
Ambrisentan did not have any clinically relevant effects on the pharmacokinetics of tadalafil.
Ugotovili so, da ambrisentan ne vpliva klinično pomembno na farmakokinetiko tadalafila.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum pridobitve dovoljenja za promet:
Ambrisentan Mylan 10 mg film-coated tablets contain the azo-colouring agent Allura red AC Aluminium Lake (E129), which may cause allergic reactions.
Ambrisentan Mylan 10 mg filmsko obložene tablete vsebujejo azo barvilo alurno rdeče AC (E129), ki lahko povzroči alergijske reakcije.
Pack sizes of 30 film-coated tablets and unit dose blisters of 30x1 film-coated tablets Not all pack sizes may be marketed.
Velikosti pakiranja po 30 filmsko obloženih tablet in enoodmerni pretisni omoti s 30 × 1 filmsko obloženo tableto.
Women receiving ambrisentan must be advised of the risk of foetal harm and alternative therapy initiated if pregnancy occurs (see sections 4.3, 4.4 and 5.3).
Če ženska zanosi, je treba uvesti alternativno obliko zdravljenja (glejte poglavja 4.3, 4.4 in 5.3).
6.5 Nature and contents of container
6.5 Vrsta ovojnine in vsebina pretisni omoti PVC/PVdC
However, multiple doses of ambrisentan had no clinically relevant effect on cyclosporine A exposure, and no dose adjustment of cyclosporine A is warranted.
Večkratni odmerki ambrisentana pa na izpostavljenost ciklosporinu A ne vplivajo klinično pomembno in odmerka ciklosporina A ni treba prilagoditi.
Do not take Ambrisentan Mylan: - if you are allergic to ambrisentan or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Ambrisentan Mylan: - če ste alergični na ambrisentan ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če ste noseči, nameravate zanositi ali bi lahko zanosili, ker ne uporabljate zanesljive metode kontracepcije; glejte poglavje ‘Nosečnost'; - če dojite; glejte poglavje ‘Dojenje'; - če imate bolezen jeter.
Peripheral oedema, fluid retention and headache (including sinus headache, migraine) were the most common adverse reactions observed with ambrisentan.
Najpogostejši neželeni učinki, opaženi z ambrisentanom, so bili periferni edemi, zastajanje tekočine in glavoboli (vključno s sinusnim glavobolom, migreno).
Ear and labyrinth disorders Tinnitus
Ušesne bolezni, vključno z motnjami labirinta tinitus
Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.5 and 5.2).
Bolnike, ki prejemajo ambrisentan, je treba ob uvedbi zdravljenja z rifampicinom natančno nadzorovati (glejte poglavji 4.5 in 5.2).
The efficacy of ambrisentan as monotherapy has not been established in patients with WHO functional class IV PAH.
Pri bolnikih s PAH funkcijskega razreda IV po SZO učinkovitost ambrisentana kot samostojnega zdravila ni bila dokazana.
In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them.
Pri bolnikih s PAH se te žile zožijo in tako srce težje potiska kri skozi njih, kar povzroči utrujenost, omotico in težko dihanje.
→ Don't breast-feed while you're taking Ambrisentan Mylan.
→ Med jemanjem zdravila Ambrisentan Mylan ne smete dojiti.
Ambrisentan Mylan 5 mg film-coated tablets Ambrisentan Mylan 10 mg film-coated tablets ambrisentan
Ambrisentan Mylan 5 mg filmsko obložene tablete Ambrisentan Mylan 10 mg filmsko obložene tablete ambrisentan
Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 5.2).
Bolnike, ki prejemajo ambrisentan, je treba ob uvedbi zdravljenja z rifampicinom natančno nadzorovati (glejte poglavji 4.4 in 5.2).
Patients on ambrisentan therapy should be closely monitored when starting treatment with rifampicin (see sections 4.4 and 4.5).
Bolnike, ki prejemajo ambrisentan, je treba ob uvedbi zdravljenja z rifampicinom natančno nadzorovati (glejte poglavji 4.4 in 4.5).
The effects of 12 days dosing with ambrisentan (10 mg once daily) on the pharmacokinetics of a single dose of oral contraceptive containing ethinyl estradiol (35 μg) and norethindrone (1 mg) were studied in healthy female volunteers.
Pri zdravih prostovoljkah so raziskali učinke 12-dnevne uporabe ambrisentana (10 mg enkrat na dan) na farmakokinetiko enkratnega odmerka peroralnega kontraceptiva z etinilestradiolom (35 µg) in noretindronom (1 mg).
→ Don't take two doses at the same time to make up for a forgotten dose Don't stop taking Ambrisentan Mylan without your doctor's advice Ambrisentan Mylan is a treatment that you will need to keep on taking to control your PAH.
→ Ne prenehajte z jemanjem zdravila Ambrisentan Mylan brez nasveta zdravnika.
→ Tell your doctor straight away if you get these effects or if they happen suddenly after taking Ambrisentan Mylan.
→ Če se vam pojavijo ti učinki ali nastanejo nenadoma po jemanju zdravila Ambrisentan, to takoj povejte svojemu zdravniku.
No previously unknown adverse reactions were identified with long-term treatment or for ambrisentan in combination with tadalafil.
Med dolgoročnim zdravljenjem in med uporabo ambrisentana v kombinaciji s tadalafilom niso ugotovili kakšnih prej še neznanih neželenih učinkov.
Ambrisentan Mylan tablets contain a colouring agent called Allura red AC Aluminium Lake (E129) which may cause allergic reactions.
Tablete Ambrisentan Mylan vsebujejo alurno rdeče barvilo AC (E129), ki lahko povzroči alergijske reakcije.
Ambrisentan had no effects on the steady-state pharmacokinetics and anti-coagulant activity of warfarin in a healthy volunteer study (see section 5.2).
V študiji pri zdravih prostovoljcih ambrisentan ni vplival na farmakokinetiko v stanju dinamičnega ravnovesja in antikoagulantno delovanje varfarina (glejte poglavje 5.2).
Each tablet contains 10 mg of ambrisentan.
Ena tableta vsebuje 10 mg ambrisentana.
Reductions in haemoglobin concentrations and haematocrit have been associated with endothelin receptor antagonists (ERAs) including ambrisentan.
V povezavi z antagonisti endotelinskih receptorjev (ERA - endothelin receptor antagonists), vključno z ambrisentanom, so poročali o znižanju koncentracije hemoglobina in hematokrita.
Tadalafil monotherapy
Monoterapija s tadalafilom
Each tablet contains 5 mg of ambrisentan.
Ena tableta vsebuje 5 mg ambrisentana.
% difference
Razmerje obetov
Therefore the dose of ambrisentan should be limited to 5 mg once daily when co-administered with cyclosporine A
Na podlagi teh sprememb je treba odmerek ambrisentana omejiti na 5 mg enkrat na dan, kadar se jemlje v kombinaciji s ciklosporinom A (glejte poglavje 4.2).
Ambrisentan monotherapy
Monoterapija z ambrisentanom
Poly(vinyl alcohol)(partly hydrolysed) Titanium dioxide (E171) Macrogol
Filmska obloga polivinilalkohol (delno hidroliziran) titanov dioksid (E171) makrogol smukec (E553b) alurno rdeče AC (E129) indigotin (E132)
What Ambrisentan Mylan contains
Kaj vsebuje zdravilo Ambrisentan Mylan
Adverse reactions identified from 12-week placebo-controlled clinical trial data are included below by system organ class and frequency.
V nadaljevanju so po organskih sistemih in pogostnosti navedeni neželeni učinki zdravila, ugotovljeni v 12-tedenskem s placebom nadzorovanem kliničnem preskušanju.
If you have been told by your doctor that you have an intolerance to some sugars:
Če vam je vaš zdravnik povedal, da ne prenašate nekaterih sladkorjev: → Posvetujte se s svojim zdravnikom, preden začnete jemati to zdravilo.
However, there was no clinically relevant effect on ambrisentan exposure by day 8, following administration of multiple doses of rifampicin.
Toda do 8. dne niso po uporabi več odmerkov rifampicina ugotovili nobenega klinično pomembnega vpliva na izpostavljenost ambrisentanu.
Decreased haemoglobin
Znižana koncentracija hemoglobina.
• fainting
• omedlevica,
A food-effect study involving administration of ambrisentan to healthy volunteers under fasting conditions and with a high-fat meal indicated that the Cmax was decreased 12% while the AUC remained unchanged.
Študija kaže, da se je vrednost Cmax zmanjšala za 12 %, vrednost AUC pa se ni spremenila.
Cardiac disorders Cardiac failure
Srčne bolezni srčno popuščanje palpitacije zelo pogosti zelo pogosti
Peripheral oedema has been observed with ERAs including ambrisentan.
Pri uporabi ERA, vključno z ambrisentanom, so poročali o perifernem edemu.
Abnormalities of the lower jaw, tongue, and/or palate were seen at all doses tested.
Pri vseh raziskovanih odmerkih so poročali o nepravilnostih mandibule, jezika in/ali neba.
Time to First Clinical Failure Event (Adjudicated) Clinical failure, no.
Čas do kliničnega neuspeha
Ambrisentan has not been studied in individuals with hepatic impairment (with or without cirrhosis).
Pri osebah z okvaro jeter (s cirozo ali brez nje) uporabe ambrisentana niso raziskovali.
CI: -44.8, -20.7
% razlike −33,8; 95-% IZ: -44,8,
Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment (see section 5.1).
Zdravilo Ambrisentan Mylan je indicirano za zdravljenje pljučne arterijske hipertenzije (PAHpulmonary arterial hypertension) pri odraslih bolnikih v II.
Hepatobiliary disorders Hepatic injury (see section 4.4)
Bolezni jeter, žolčnika in žolčevodov okvara jeter (glejte poglavje 4.4)
There is limited experience with ambrisentan in individuals with severe renal impairment (creatinine clearance <30 ml/min); therapy should be initiated cautiously in this subgroup and particular care taken if the dose is increased to 10 mg ambrisentan.
Pri bolnikih s hudo okvaro ledvic (kreatininski očistek < 30 ml/min) so izkušnje z uporabo ambrisentana omejene.
Patients with WHO FC II and III had a mean baseline 6MWD of 353 metres.
in III. funkcijskem razredu po SZO so imeli izhodiščno 6-minutno prehojeno razdaljo (6MWD) 353 metrov.
Ambrisentan Mylan 10 mg film-coated tablets
Ambrisentan Mylan 10 mg filmsko obložene tablete
Ambrisentan Mylan 5 mg film-coated tablets
Ambrisentan Mylan 5 mg filmsko obložene tablete
Nasal congestion
peroralna uporaba
• diarrhoea
• bruhanje,
Swallow the tablet whole, with a glass of water, do not split, crush or chew the tablet.
Tableto pogoltnite celo skupaj s kozarcem vode.
Ambrisentan Mylan 5 mg film-coated tablets ambrisentan
Ambrisentan Mylan 5 mg filmsko obložene tablete ambrisentan
Ambrisentan Mylan 10 mg film-coated tablets ambrisentan
Ambrisentan Mylan 10 mg filmsko obložene tablete ambrisentan
Post-marketing reports of fluid retention occurring within weeks after starting ambrisentan have been received and, in some cases, have required intervention with a diuretic or hospitalisation for fluid management or decompensated heart failure.
V posameznih primerih je bilo treba zastajanje tekočin ali dekompenzirano srčno popuščanje zdraviti z diuretiki ali celo uvesti bolnišnično zdravljenje.
Outcome endpoints
Opazovani dogodki izida
Therefore, hepatic aminotransferases (ALT and AST) should be evaluated prior to initiation of ambrisentan and treatment should not be initiated in patients with baseline values of ALT and/or AST >3xULN (see section 4.3).
Pri bolnikih z izhodiščnimi vrednostmi ALT ali AST ali obeh > 3 × ZMN se zdravljenje z ambrisentanom ne sme uvesti (glejte poglavje 4.3).
Nasal bone hyperplasia has not been observed with ambrisentan in mice or dogs.
Pri uporabi ambrisentana pri miših ali psih o hiperplaziji nosne kosti niso poročali.
Hepatic impairment
Bolniki z okvaro ledvic
No clinically meaningful effects on the pharmacokinetics of ambrisentan or sildenafil were seen during a drug-drug interaction study in healthy volunteers, and the combination was well tolerated.
Pri zdravih prostovoljcih pri študiji medsebojnega delovanja z drugimi zdravili niso ugotovili klinično pomembnih učinkov na farmakokinetiko ambrisentana ali sildenafila.
• dizziness
Kombinirano:
Ambrisentan Mylan may harm unborn babies conceived before, during or soon after treatment.
Če zanosite pred, med ali kmalu po koncu zdravljenja, lahko zdravilo Ambrisentan Mylan škoduje nerojenemu otroku.
Ambrisentan has been shown to be teratogenic in rats and rabbits.
Pri podganah in kuncih je bilo dokazano, da je ambrisentan teratogen.
OTHER
občasni
Upper respiratory (e.g. nasal, sinus) congestion, sinusitis, nasopharyngitis, rhinitis
Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa dispneja zelo pogosti zelo pogosti kongestija zgornjih dihal (to je nosne votline, sinusov), sinuzitis, nazofaringitis, rinitis nazofaringitis zelo pogosti zelo pogosti sinuzitis, rinitis zamašenost nosu zelo pogosti zelo pogosti
Monotherapy pooled
Kumulativna monoterapija:
Date of first authorisation: 19 April 2010 Date of latest renewal: 17 February 2015
Datum prve odobritve: 19. april 2010 Datum zadnjega podaljšanja: 17. februar 2015
They are more likely during the first treatment.
Verjetnejše so med prvim zdravljenjem.
In rare cases, these reactions may lead to death.
V redkih primerih te reakcije lahko vodijo v smrt.
The disease can also affect other organs in your body.
Bolezen lahko prizadene tudi druge organe v telesu.
• producing less urine than normal
• manjše nastajanje urina, kot je normalno,
Each cycle lasts 28 days and is counted from day 1 of the cycle.
Vsak ciklus traja 28 dni in se šteje od 1. dne ciklusa.
• if you have had heart problems,
• če ste kdaj imeli težave s srcem,
Best response is a clinical response that did not improve with 3 additional cycles of treatment.
Najboljši odziv je klinični odziv, ki se ne izboljša po 3 dodatnih ciklusih zdravljenja.
Elderly (≥65 years of age)
Starejši (stari ≥ 65 let)
This is followed by a four- to five-week gap.
Temu bo sledil štiri- do pettedenski presledek.
See also section 4, ‘Possible side effects'.
Glejte tudi poglavje 4, "Možni neželeni učinki".
Median, all patients 95% CI
Mediana, vsi bolniki 95 % IZ
See section 5.1 for further information.
Za dodatne informacije glejte poglavje 5.1.
101 International Drive Portsmouth, NH 03801-2815 United States
101 International Drive Portsmouth, NH 03801-2815 Združene države Amerike
Your response to the vaccine may be weakened and you may not be fully protected.
Vaš odziv na cepivo je lahko oslabljen in lahko se zgodi, da po cepljenju niste povsem zaščiteni.
Electrolyte abnormalities should be corrected.
Nepravilnosti elektrolitov je treba korigirati.
Chemical and physical in-use stability has been demonstrated for 48 hours at ambient conditions (less than 25°C).
Kemična in fizikalna stabilnost med uporabo sta dokazani za 48 ur v okoljskih pogojih (temperatura do 25 °C).
The safety and efficacy of Arzerra in children aged below 18 years have not been established.
Varnost in učinkovitost zdravila Arzerra pri otrocih, mlajših od 18 let, nista bili dokazani.
Classical biotransformation studies have not been performed.
Klasične študije glede biotransformacije niso bile izvedene.
This includes herbal medicines and other medicines you can obtain without a prescription.
To velja tudi za zdravila rastlinskega izvora in druga zdravila, ki jih lahko dobite brez recepta.
Preclinical data reveal no special hazards for humans.
Predklinični podatki ne kažejo posebnih tveganj za človeka.
The lymphocytes multiply too quickly and live too long, so there are too many of them circulating in your blood.
Limfociti se pri tej bolezni razmnožujejo prehitro in živijo predolgo, zato jih je v krvi preveč.
Laboratory monitoring
Laboratorijsko spremljanje
Time of Progression-free Survival (Months)
Čas preživetja brez napredovanja (meseci)
• Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.
• Zdravniku povejte, če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev.
You will be checked closely and if you do have any reactions these will be treated.
Zdravstveno osebje vas bo natančno nadziralo in če se vam pojavijo kakšne reakcije, jih bodo zdravili.
Thus, the benefit of such a new combination over a rituximab based regimen is unknown.
Zato korist te nove kombinacije proti na rituksimabu temelječem režimu ni poznana.
90429 Nuremberg Germany
D-90429 Nuremberg Nemčija