natgillin/translations-raw huggingface dataset:
Zoledronic acid Teva Generics 5 mg solution for infusion in bags zoledronic acid
Zoledronska kislina Teva Generics 5 mg raztopina za infundiranje v vrečah zoledronska kislina
Zoledronic acid Teva Generics may also cause other side effects Very common: (may affect more than 1 in 10 people) Fever
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): Vročina.
You may eat normally on the day you are treated with Zoledronic acid Teva Generics.
Na dan, ko dobite zdravilo Zoledronska kislina Teva Generics, lahko normalno jeste.
NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion zoledronic acid
Zoledronska kislina Teva Generics 5 mg raztopina za infundiranje zoledronic acid
Zoledronic acid Teva Generics 5 mg solution for infusion in bottles zoledronic acid
Zoledronska kislina Teva Generics 5 mg raztopina za infundiranje zoledronska kislina
Non-vertebral fracture (1) *p-value <0.05, **p-value <0.01 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
*vrednost p < 0,05, **vrednost p < 0,01
- Do not use Zoledronic acid Teva Generics after the expiry date which is stated on the bag.
- Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in
Skin and subcutaneous tissue disorders Uncommon Rash, hyperhydrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Bolezni živčevja pogosti glavobol, omotičnost občasni letargija, parestezija, somnolenca, tremor, sinkopa, motnje okušanja
Zoledronic acid Teva Generics may also cause other side effects Very common (may affect more than 1 in 10 people) Fever
Nekateri neželeni učinki so lahko resni Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov):
This is called a ‘response'.
To imenujemo ‘odziv'.
This may lead to very serious infection.
To lahko vodi v zelo resno okužbo.
• then at least every month after that.
• po tem najmanj enkrat mesečno.
• every week for the first 8 weeks of treatment
• vsak teden v prvih 8 tednih zdravljenja,
However, the signs and symptoms can be greatly reduced or disappear for a period of time.
Lahko pa se znaki in simptomi močno zmanjšajo ali za nekaj časa izginejo.
Date of first authorisation: 20th September 2018
Datum prve odobritve: 20. september 2018
However, on some days you do not take any of the medicines.
Na nekatere dni pa ne boste vzeli nobenega zdravila.
Do not use while pregnant or breastfeeding.
Ne uporabljajte med nosečnostjo ali dojenjem.
Time to event
Čas do dogodka
A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Nacionalno nadzorovan sistem distribucije je bil uveljavljen v sodelovanju z vsemi pristojnimi nacionalnimi organi.
Take your next capsule at the usual time the next day.
Naslednjo kapsulo vzemite naslednji dan ob običajnem času.
• An excess of iron in the body
• prevelika količina železa v telesu;
Key elements to be included
Ključni elementi, ki morajo biti vsebovani
• Depending on the day of the cycle, you will take one or more of the medicines.
• Odvisno od dneva cikla boste vzeli eno ali več zdravil.
Special populations Elderly
Posebne populacije Starejši
For all indications described below:
Za vse indikacije, opisane v nadaljevanju:
Pregnancy, breast-feeding and contraception - information for women and men
Nosečnost, dojenje in kontracepcija - informacije za ženske in moške
No overall difference in safety or efficacy was observed between these patients and younger patients, but greater pre-disposition of older individuals cannot be ruled out.
Splošnih razlik v varnosti in učinkovitosti med temi bolniki in mlajšimi bolniki niso opazili, vendar pa pri starejših bolnikih ni mogoče izključiti večje predispozicije.
Follow-up and end of treatment
Sledenje in konec zdravljenja
This can damage the bones and kidneys.
To lahko poškoduje kosti in ledvice.
Before you start treatment, your doctor will tell you:
Preden boste začeli z zdravljenjem, vam bo zdravnik povedal:
• After completing each 28-day cycle, you should start a new ‘cycle' over the next 28 days.
• Po dokončanju vsakega 28-dnevnega cikla boste začeli nov ‘cikel', ki bo trajal naslednjih 28 dni.
Overall response [n, %] Complete response [n, %]
Celokupni odgovor [n, %] Popolni odgovor [n, %]
Therefore you must tell your doctor immediately if you experience:
Zato morate zdravniku takoj povedati, če imate:
Enhanced clinical and laboratory monitoring is warranted notably during the first weeks of treatment.
Natančnejše klinično in laboratorijsko spremljanje je upravičeno še posebej v prvih tednih zdravljenja.
Grade ≥ 3 infections occurred within the context of neutropenia in less than one-third of the patients.
Okužbe stopnje ≥ 3 so se pojavile v povezavi z nevtropenijo pri manj kot eni tretjini bolnikov.
It is recommended that your partner seeks medical advice.
Priporočljivo je, da vaša partnerica poišče zdravniško pomoč.
This medicine belongs to a group of medicines which affect how your immune system works.
To zdravilo spada v skupino zdravil, ki vplivajo na delovanje vašega imunskega sistema.
• The patient has acknowledged the aforementioned conditions.
• bolnica potrdi navedene pogoje.
• more than 12 hours have passed - do not take your capsule.
• je minilo več kot 12 ur - ne vzemite kapsule.
• Infections of all types
• okužbe vseh vrst;
An extended follow-up efficacy analysis was conducted with a median follow-up of 130.7 weeks.
Opravili so podaljšano sledilno analizo učinkovitosti z mediano sledenja 130,7 tedna.
• some medicines used to prevent pregnancy such as oral contraceptives, as they may stop working
• nekatera zdravila, ki se uporabljajo za preprečevanje nosečnosti, kot so peroralni kontraceptivi, saj lahko prenehajo delovati
Currently available pharmacokinetic data are described in section 5.2.
Farmakokinetični podatki, ki so trenutno na voljo, so opisani v poglavju 5.2.
Your doctor should check whether you have ever had hepatitis B infection
Vaš zdravnik mora preveriti, ali ste kdaj imeli okužbo z virusom hepatitisa B;
If you are newly diagnosed, your doctor may also assess your treatment based on your age and other conditions you already have.
Če so vam diagnozo postavili na novo, lahko zdravnik tudi oceni vaše zdravljenje na podlagi vaše starosti in drugih bolezni, ki jih mogoče že imate.
Children and adolescents Lenalidomide is not recommended for use in children and adolescents under 18 years.
Otroci in mladostniki Zdravilo Lenalidomide ni priporočeno za uporabo pri otrocih in mladostnikih, mlajših od 18 let.
• Changes to the colour of your skin, sensitivity to sunlight
• spremembe barve vaše kože, občutljivost na sončno svetlobo;
The following information should also be provided in the appropriate brochure:
V ustrezni brošuri je treba navesti tudi naslednje informacije:
• Periodic safety update reports The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
• Each 28 - day cycle is called a ‘treatment cycle'.
• Vsak 28-dnevni cikel se imenuje ‘cikel zdravljenja'.
• That the patient should not donate blood
• opozorilo, da bolnik ne sme darovati krvi;
Lenalidomide has an asymmetric carbon atom and can therefore exist as the optically active forms S(-) and R(+).
Lenalidomid ima asimetrični ogljikov atom, zato obstaja v dveh optično aktivnih oblikah, S(-) in R(+).
g Best assessment of adjudicated response during the treatment phase of the study (for definitions of each response category, Data cut-off date = 24 May 2013).
g Najboljša ocena odziva po strokovni presoji med fazo zdravljenja tekom študije (za definicije vsake kategorije odzivov, Datum zaključka zbiranja podatkov 24. maja 2013).
In both studies, dose adjustments were allowed based on clinical and laboratory finding.
V obeh študijah so bile dovoljene prilagoditve odmerka glede na klinične in laboratorijske ugotovitve.
Approximately 30% of the medicinal product in the body was removed during a single 4hour dialysis session.
Približno 30 % zdravila v telesu je bilo odstranjenega v enem 4-urnem ciklu dialize.
Frequencies are defined as: 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).
Njihova pogostnost je določena kot: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
You should continue the cycles of treatment until your doctor tells you to stop.
S cikli zdravljenja morate nadaljevati, dokler vam zdravnik ne naroči, da prekinete.
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
Bolnikom je treba priporočiti, da svojega partnerja ali skrbnika obvestijo o svojem zdravljenju, saj bi ti lahko opazili simptome, ki se jih bolnik ne zaveda.
Patients with known risk factors for infections should be closely monitored.
Bolnike z znanimi dejavniki tveganja za okužbe je treba skrbno spremljati.
• Ringing in the ears (tinnitus)
• zvonjenje v ušesih (tinitus);
If any of the above applies to you, tell your doctor before starting treatment.
Če karkoli od zgoraj navedenega velja za vas, to povejte zdravniku, preden začnete z zdravljenjem.
In IFM 2005-02, the adverse reactions were from the maintenance treatment period only.
V študiji IFM 2005-02 so bili neželeni učinki samo iz obdobja vzdrževalnega zdravljenja.
A second analysis identified events that occurred after the start of maintenance treatment.
V drugi analizi so ugotovili dogodke po začetku vzdrževalnega zdravljenja.
Lenalidomide has minor or moderate influence on the ability to drive and use machines.
Lenalidomid ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
In particular, tell your doctor or nurse if you are taking any of the following medicines:
Zdravniku ali medicinski sestri še zlasti povejte, če jemljete katero od naslednjih zdravil:
Table 4: Summary of overall efficacy data
Preglednica 4: Povzetek celokupnih podatkov o učinkovitosti
Lenalidomide is taken on certain days over 4 weeks (28 days).
Zdravilo Lenalidomide se jemlje na določene dneve znotraj 4 tednov (28 dni).
• Description of risk of SPM
• opis tveganja SPM;
• on what days of your treatment cycle to take each medicine.
• na katere dni cikla zdravljenja jemljete vsako zdravilo.
Common Sepsis◊, Sinusitis◊
pogosti sepsa◊, sinusitis◊
If more than 12 hours has elapsed since missing a dose at the normal time, the patient should not take the dose, but take the next dose at the normal time on the following day.
Če je minilo več kot 12 ur, odkar je bolnik pozabil vzeti odmerek ob običajnem času, bolnik tega odmerka ne sme vzeti, ampak mora vzeti naslednji odmerek naslednji dan ob običajnem času.
• do not put pressure on the center of the capsule, as this can cause it to break.
• ne pritiskajte na osrednji del kapsule, ker bi jo s tem lahko prelomili.
Otherwise, decrease by one dose level at start of next cycle.
Sicer v začetku naslednjega cikla odmerek zmanjšajte za eno raven.
OTHER SPECIAL WARNING(S), IF NECESSARY WARNING: Risk of severe birth defects.
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA OPOZORILO: Tveganje hudih prirojenih okvar.
Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment for safe disposal.
Bolnikom je treba naročiti, da nikoli ne dajo svojega zdravila drugim in da po koncu zdravljenja vrnejo neporabljene kapsule farmacevtu za varno odstranitev.
It is recommended to press only on one end of the capsule to remove it from the blister thereby reducing the risk of capsule deformation or breakage.
Priporočljivo je pritisniti samo na en konec kapsule, da jo odstranite iz pretisnega omota, s čimer boste zmanjšali nevarnost, da bi se kapsula deformirala ali prelomila.
These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Vse to so lahko znaki resne in potencialno smrtno nevarne bolezni možganov, ki se imenuje progresivna multifokalna levkoencefalopatija (PML).
• less than 12 hours have passed - take your capsule immediately.
• je minilo manj kot 12 ur - kapsulo vzemite takoj;
f Median follow-up post-ASCT for all surviving subjects.
f Mediana spremljanja po ASCT za vse preživele bolnike.
These patients should be monitored closely, especially during the first cycle or dose-escalation, and appropriate precautions taken.
Te bolnike je treba skrbno spremljati, posebno med prvim ciklom ali ob zvečanju odmerka, in pri njih uvesti ustrezne previdnostne ukrepe.
Other intrinsic factors
Drugi intrinzični dejavniki
Tests and checks
Preiskave in kontrolni pregledi
• Guidance on handling lenalidomide for patients, caregivers and family members
• smernice za ravnanje z lenalidomidom za bolnike, skrbnike in družinske člane;
This requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Ta zahteva vključuje ženske v rodni dobi, ki upoštevajo popolno in neprekinjeno abstinenco.
• you should take lenalidomide at about the same time on the scheduled days.
• Lenalidomid morate jemati na načrtovane dni približno ob istem času.
The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception.
Tveganje za vensko trombembolijo se nadaljuje 4−6 tednov po prekinitvi jemanja kombinirane peroralne kontracepcije.
Developmental toxicity studies were previously conducted in rabbits.
Študije razvojne toksičnosti so predhodno opravili na kuncih.
Although it was observed at maternotoxic levels they may be attributable to a direct effect.
Čeprav so te učinke opazili pri odmerkih, ki so bili maternalno toksični, so lahko tudi posledica neposrednega učinka.
• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
• spolni odnosi samo z moškim partnerjem, ki so mu opravili vazektomijo; vazektomijo je treba potrditi z dvema negativnima preiskavama sperme;
Summary of results of efficacy analyses as of cut-off date for extended follow-uppooled studies MM-009 and MM-010 (cut-offs 23 July 2008 and 2 March 2008, respectively)
Povzetek rezultatov analiz učinkovitosti na datum zaključka podaljšanega sledenja - zbrani študiji MM-009 in MM-010 (zaključek 23. julija 2008 oziroma 2. marca 2008)
You will take these other medicines at the start of treatment and then continue to take lenalidomide on its own.
V začetku zdravljenja boste jemali tudi ta druga zdravila, nato pa boste jemali samo lenalidomid.
• the capsules can be taken either with or without food.
• Kapsule se lahko jemljejo s hrano ali brez nje.
Response rate
Stopnja odgovora
• She acknowledges that she understands the hazards and necessary precautions associated with the use of lenalidomide.
• mora potrditi, da razume tveganja in nujne previdnostne ukrepe, povezane z uporabo lenalidomida.
If any of these apply to you, do not take lenalidomide .
Če se karkoli od navedenega nanaša na vas, ne vzemite lenalidomida.
Rd vs Rd18
Rd proti Rd18
Table 7 summarises the results of the follow-up efficacy analyses - pooled studies MM-009 and MM-010.
V preglednici 7 je povzetek rezultatov sledilnih analiz učinkovitosti - združenih študij MM-009 in MM-010.
Effective measures to avoid pregnancy must be taken (see sections 4.4 and 4.6).
Uporabiti je treba zanesljive ukrepe za preprečevanje nosečnosti (glejte poglavji 4.4 in 4.6).
In both studies, treatment was to continue until disease progression.
V obeh študijah je zdravljenje trajalo do napredovanja bolezni.
The Educational brochures for patients should be of 3 types:
Izobraževalne brošure za bolnike morajo biti treh vrst:
If you had these symptoms prior to treatment with lenalidomide, tell your doctor about any change in these symptoms.
Če ste te simptome imeli že pred zdravljenjem z lenalidomidom, zdravnika obvestite o kakršni koli spremembi teh simptomov.
• if you have had blood clots in the past - you have an increased risk of developing blood clots in the veins and arteries during treatment
• če ste v preteklosti imeli krvne strdke - imate zvečano tveganje za nastanek krvnih strdkov v venah in arterijah med zdravljenjem;
Lenalidomide is poorly metabolized as 82% of the dose is excreted unchanged in urine.
Lenalidomid se slabo presnavlja, saj se 82 % odmerka izloči nespremenjenega z urinom.
The renal clearance of lenalidomide exceeds the glomerular filtration rate and therefore is at least actively secreted to some extent.
Ledvični očistek lenalidomida presega stopnjo glomerulne filtracije, zato se vsaj do neke mere aktivno izloča.
The median age was 73 in the 3 arms.
Mediana starosti v vseh 3 skupinah je bila 73 let.
Lenalidomide works by affecting the body's immune system and directly attacking the cancer.
Zdravilo Lenalidomide deluje tako, da vpliva na imunski sistem telesa in neposredno napada raka.
Your doctor may adjust your dose of lenalidomide or stop your treatment based on the results of your blood tests and on your general condition.
Zdravnik lahko prilagodi odmerek lenalidomida ali prekine zdravljenje na podlagi rezultatov krvnih preiskav ali vašega splošnega stanja.
Any unused product or waste material should be returned to the pharmacist for safe disposal in accordance with local requirements.
Neuporabljeno zdravilo ali odpadni material vrnite farmacevtu za varno odstranjevanje v skladu z lokalnimi predpisi.
If you are taking lenalidomide in combination with other medicines, you should refer to the package leaflets for these medicines for further information on their use and effects.
Če jemljete lenalidomid v kombinaciji z drugimi zdravili, glejte navodila za uporabo teh zdravil za nadaljnje informacije o njihovi uporabi in učinkih.
• Dose is modified based upon clinical and laboratory findings (see section 4.4).
• Odmerek spreminjajte na podlagi kliničnih in laboratorijskih izvidov (glejte poglavje 4.4).
Patients should be advised to promptly report febrile episodes.
Bolnikom je treba svetovati, da o febrilnih epizodah nemudoma obvestijo zdravnika.
• Infection of the sinuses that surround the nose
• okužba sinusov, ki obdajajo nos;
A female patient or a female partner of a male patient is considered to have childbearing potential unless she meets at least one of the following criteria:
Za bolnico ali partnerico moškega bolnika velja, da lahko zanosi, razen če izpolnjuje vsaj eno od naslednjih meril:
• Pneumonias (10.6%; combined term) from IFM 2005-02
• pljučnice (10,6 %; kombiniran izraz) v študiji IFM 2005-02,
• Women of childbearing potential unless all of the conditions of the Pregnancy Prevention
• ženske v rodni dobi, razen če izpolnjujejo vse pogoje programa za preprečevanje nosečnosti
Infection with or without neutropenia
Okužba z nevtropenijo ali brez nje
• Difficulty getting an erection
• težave pri doseganju erekcije;
In addition to the above adverse reactions identified from the pivotal clinical trials, the following table is derived from data gathered from post-marketing data.
Poleg zgoraj navedenih neželenih učinkov, ugotovljenih v ključnih kliničnih preskušanjih, je bila naslednja preglednica sestavljena iz podatkov, zbranih v obdobju trženja.
• The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding
• bolnica upošteva vse pogoje programa za preprečevanje nosečnosti, vključno s potrditvijo, da jih ustrezno razume;
Regular monitoring of visual ability is recommended.
Priporočljivo je redno spremljanje vida.
Prior to prescribing (and where appropriate, and in agreement with the National Competent Authority, prior to dispensing) all healthcare professionals who intend to prescribe (and dispense) Lenalidomide Accord are provided with a physician information pack containing the following:
Pred predpisovanjem (in kjer je ustrezno, in v dogovoru s pristojnimi nacionalnimi organi, pred izdajanjem) bodo vsi zdravstveni delavci, za katere se pričakuje, da bodo predpisovali (in izdajali) zdravilo Lenalidomide Accord, prejeli paket s podatki za zdravnike, ki vsebuje naslednje:
The MAH shall implement a pregnancy prevention programme (PPP) in each Member State.
Imetnik dovoljenja za promet z zdravilom mora izvajati program za preprečevanje nosečnosti (PPN) v vsaki državi članici.
Though this risk is not yet fully characterized, it should be kept in mind when considering and using lenalidomide in this setting.
Čeprav to tveganje še ni povsem pojasnjeno, ga je potrebno upoštevati pri odločanju in zdravljenju z lenalidomidom v teh okoliščinah.
• Certain types of skin tumour
• nekatere vrste tumorjev kože;
Most of the invasive SPMs were solid tumour malignancies.
Večina invazivnih SPM so bile malignosti s čvrstimi tumorji.
PML was reported several months to several years after starting the treatment with lenalidomide.
O PML so poročali nekaj mesecev do nekaj let po začetku zdravljenja z lenalidomidom.
Thus, lenalidomide can be administered with or without food.
Zato se lahko lenalidomid daje s hrano ali brez nje.
Details of the PPP including the set-up of national measures to assess the effectiveness of and compliance with the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Podrobnosti PPN, vključno z uvedbo nacionalnih ukrepov za ocenjevanje učinkovitosti in skladnosti s PPN, morajo biti dogovorjene s pristojnimi nacionalnimi organi in pripravljene pred prihodom zdravila na trg.
• Changes to blood thyroid hormone, low levels of calcium, phosphate or magnesium in the blood
• spremembe ravni tiroidnega hormona v krvi, nizke ravni kalcija, fosfata ali magnezija v krvi;
In this study, two methods were used to classify renal function: the urinary creatinine clearance measured over 24 hours and the creatinine clearance estimated by CockcroftGault formula.
V tej študiji so uporabljali dve metodi za razvrščanje delovanja ledvic: očistek kreatinina v urinu, merjen v obdobju, daljšem od 24 ur, in očistek kreatinina, ocenjen s Cockcroft-Gaultovo formulo.
Your doctor may check if you have a high total amount of tumour throughout the body, including your bone marrow.
Zdravnik lahko preveri, ali imate po vsem telesu, vključno s kostnim mozgom, veliko skupno tumorsko maso.
• If less than 12 hours has elapsed since missing a dose, the patient can take the dose.
• Če je od pozabljenega odmerka minilo manj kot 12 ur, lahko bolnik vzame odmerek.
• You must not take lenalidomide if you are pregnant, as it is expected to be harmful to an unborn baby.
• Lenalidomida ne smete jemati, če ste noseči, ker se pričakuje, da škoduje nerojenemu otroku.
• Serious allergic reaction that may begin as rash in one area but spread with extensive loss of skin over the whole body (Stevens-Johnson syndrome and/or toxic epidermal necrolysis).
• resna alergijska reakcija, ki se lahko začne kot izpuščaj v enem predelu, a se razširi z obsežnim odstopanjem kože po vsem telesu (Stevens-Johnsonov sindrom in/ali toksična epidermalna nekroliza);
Adverse reactions have been included under the appropriate category in the table below according to the highest frequency observed in any of the main clinical trials.
Neželeni učinki so bili vključeni v ustrezno kategorijo v spodnji preglednici glede na največjo pogostnost, ki so jo opazili v kateremkoli od glavnih kliničnih preskušanj.