natgillin/translations-raw huggingface dataset:
skadliga mängder av ämnen från cancercellerna tar sig in i blodbanan, har ibland setts när VEPESID tas med andra läkemedel för behandling av cancer.
Severe liver, kidney or heart damage from a condition called tumour lysis syndrome, caused by harmful amounts of substances from the cancer cells getting into the blood stream, has been seen sometimes when VEPESID is taken along with other drugs used to treat cancer.
vanliga akut leukemi
common acute leukaemia
6.4 Särskilda förvaringsanvisningar [Kompletteras nationellt]
SPECIAL STORAGE CONDITIONS [To be completed nationally]
Hos barn elimineras ungefär 55 % av dosen i urin som etoposid på 24 timmar. Medelvärdet på njurclearance av etoposid är 7 till 10 ml/min/m2 eller ungefär 35 % av total kroppsclearance över ett dosintervall på 80 till 600 mg/m2.
The mean renal clearance of etoposide is 7 to 10 mL/min/m2 or about 35% of the total body clearance over a dose range of 80 to 600 mg/m2.
Ett alternativt doseringsschema för VEPESID och associerade namn kapslar är 50 mg/m2/dag under 2
An alternative dosage schedule for VEPESID and associated names capsules is 50 mg/m2/day for 2 to 3 weeks, with courses repeated after a one week rest period or upon recovery from myelosuppression.
INFORMATION I PUNKTSKRIFT [Kompletteras nationellt]
INFORMATION IN BRAILLE [To be completed nationally]
VEPESID och associerade namn (se Bilaga I) 50 mg kapsel, mjuk VEPESID och associerade namn (se Bilaga I) 100 mg kapsel, mjuk
VEPESID and associated names (see Annex I) 50 mg capsule, soft VEPESID and associated names (see Annex I) 100 mg capsule, soft
UNIK IDENTITETSBETECKNING - I ETT FORMAT LÄSBART FÖR MÄNSKLIGT
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
sig fullständigt efter 20 dagar och ingen kumulativ toxicitet har rapporterats. De lägsta värdena med granulocyter och trombocyter tenderar att uppträda omkring 10 till 14 dagar efter administreringen av etoposid beroende på administreringsväg och behandlingsschema.
Granulocyte and platelet nadirs tend to occur about 10 to 14 days after administration of etoposide depending on the way of administration and treatment scheme.
feber
• fever
Varje mjuk kapsel innehåller 100 mg etoposid
Each soft capsule contains 100mg of etoposide
Graviditet
Pregnancy
VEPESID och associerade namn innehåller natriumetylparahydroxybensoat och natriumpropylparahydroxybensoat
VEPESID and associated names contains sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate.
svullnad i ansikte och tunga
• face and tongue swelling
Hjärtat vanliga arytmier, hjärtinfarkt
Cardiac disorders common arrythmia, myocardial infarction
6.1 Förteckning över hjälpämnen
6.1 List of excipients
Patienter med försämrad njurfunktion
Impaired hepatic function
som kan upplevas med VEPESID och associerade namn är;
Other side effects experienced with VEPESID and associated names that are;
sig vara teratogent hos möss och råttor (se avsnitt 5.3). På grund av etoposids mutagena potential krävs ett effektivt preventivmedel för både män och kvinnor under behandling och upp till 6 månader efter avslutad behandling (se avsnitt 4.4).
Given the mutagenic potential of etoposide, an effective contraceptive is required for both male and female patients during treatment and up to 6 months after ending treatment (see section 4.4).
VEPESIDS utseende och förpackningsstorlekar
What VEPESID looks like and contents of the pack
Vad VEPESID och associerade namn innehåller
What VEPESID and associated names contains
Överkänslighet mot den aktiva substansen eller mot något hjälpämne
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Hur du tar VEPESID och associerade namn
How to take VEPESID and associated names
- testikelcancer
Ovarian cancer
Det är viktigt att rapportera misstänkta biverkningar efter att läkemedlet godkänts. Det gör det möjligt att kontinuerligt övervaka läkemedlets nytta-riskförhållande.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Den visar sig som frossa, feber, takykardi, bronkospasm, dyspné och hypotoni och kan vara fatal.
Anaphylactic reactions manifested by chills, fever, tachycardia, bronchospasm, dyspnoea, and hypotension which can be fatal can occur with the initial dose of etoposide.
0,93 mg av natriumetylparahydroxybensoat (E215) och
• 0.93 mg of sodium ethyl parahydroxybenzoate (E215) and
Den vanliga dosen är 100 till 200 mg/m2 kroppsyta, dagligen under 5 dagar
The usual dose is 100 to 200 mg/m2 body surface area, daily for 5 days in a row or 200 mg/m2 body surface area on days 1, 3
VEPESID och associerade namn innehåller
VEPESID and associated names contains
diarré
• diarrhoea
Öppna inte någon <burk> <blisterkarta> där det finns tecken på kapselläckage.
Do not open any <bottle> <blister> in which there is evidence of capsule leakage.
i kombination med andra godkända kemoterapeutiska medel för andra linjens behandling av Hodgkins lymfom hos vuxna.
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the second line treatment of Hodgkin's lymphoma in adults.
Etoposid är mutagent
Etoposide is mutagenic in mammalian cells.
En alternativ dosering på 50 mg/m2 kroppsyta som tas dagligen under 2
An alternative dosing of 50 mg/m body surface area taken each day for 2 to 3 weeks is sometimes used.
akut leukemi
• acute leukaemia
som liknar dina.
even if their signs of illness are the same as yours.
skadliga mängder av ämnen från dessa cancerceller släpps ut i blodet. Om detta inträffar kan det orsaka problem med lever, njurar, hjärta eller blod och leda till dödsfall om det
If this happens it can cause problems with the liver, kidney, heart or blood, which may result in death if not treated.
Monoterapi
Monotherapy
Beskrivning av utvalda biverkningar
Description of selected adverse reactions
Etoposid är höggradigt bundet (97 %)
In vitro, etoposide is highly protein bound (97%) to human plasma proteins.
ske förrän efter minst 21 dagar efter den första behandlingskuren.
This course of treatment may then be repeated, depending on the results of blood tests, but this will not be for at least 21 days after the first course of treatment.
Reproduktionstoxicitet
Reproductive toxicity
En 100 mg peroral dos är jämförbar med en 75 mg intravenös dos; en 400 mg peroral dos är jämförbar med en 200 mg intravenös dos. Variabilitet av exponering hos en och samma patient (d.v.s. mellan cykler) är större vid peroral administrering än efter intravenös administrering (se avsnitt 4.4 och 5.2).
A 100 mg oral dose would be comparable to a 75 mg intravenous dose; a 400 mg oral dose would be comparable to a 200 mg intravenous dose.
som anges i kapitel 4 i avdelning III
See section 4.
0,47 mg av natriumpropylparahydroxybensoat (E217).
• 0.47 mg of sodium propyl parahydroxybenzoate (E217).
som exempelvis utmattning, sömnighet, illamående, kräkningar, kortikal blindhet samt överkänslighetsreaktioner med blodtrycksfall.
nausea, vomiting, cortical blindness, hypersensitivity reactions with hypotension.
symtom vid administreringsstället mycket vanliga asteni, sjukdomskänsla sällsynta feber
General disorders and administration site conditions very common asthenia, malaise rare pyrexia
0,61 mg av natriumpropylparahydroxybensoat (E217).
• 0.61 mg of sodium propyl parahydroxybenzoate (E217).
Uppmätt kreatininclearance
Measured Creatinine Clearance
så måste försiktighet iakttas när man hanterar VEPESID och associerade namn kapslar.
As with all medicines used to treat cancer, care must be taken when handling VEPESID and associated names capsules.
Kombinationsbehandling
Combination therapy
Dosmultipeln (baserad på mg/m2-doser) för dessa fynd vid nivån för icke observerad biverkning i prekliniska studier var ≥ ungefär 0,05 gånger jämfört med högsta kliniska dos. Historiskt sett har prekliniska arter varit mer känsliga jämfört med människor mot cytotoxiska ämnen.
The dose multiple (based on mg/m2 doses) for these findings at the no-observed adverse-effect-level in the preclinical studies were ≥ approximately
Biverkning (MedDRA-terminologi)
Frequency Adverse Reaction (MedDRA Terms)
Dessutom
APPROPRIATE
1,22 mg av natriumetylparahydroxybensoat (E215) och
• 1.22 mg of sodium ethyl parahydroxybenzoate (E215) and
i kombination med andra godkända kemoterapeutiska medel för behandling av recidiverande eller refraktär non-Hodgkins lymfom hos vuxna.
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory non-Hodgkin's lymphoma in adults.
i kombination med andra godkända kemoterapeutiska medel för behandling av recidiverande eller refraktär testikelcancer hos vuxna.
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of recurrent or refractory testicular cancer in adults.
sen S- och tidig G2-del av cellcykeln i mammaliska celler. Två dosberoende responser ses:
The main effect of etoposide appears to be at the late S and early G2 portion of the cell cycle in mammalian cells.
Tabell över sammanfattning av biverkningar
SUMMARY OF PRODUCT CHARACTERISTICS
som administreras peroralt är 100 till 200 mg/m2/dag på dag 1
The usual dose of VEPESID and associated names administered orally is 100 to 200 mg/m2/day on days 1 to 5 or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks.
Överkänslighet
Hypersensitivity
infektion, om trombocytantalet är lägre än 25 000 celler/mm3, om någon annan grad 3- eller 4-toxicitet utvecklas eller om njurclearance är lägre än 50 ml/min.
Doses subsequent to initial dose should be adjusted if neutrophil count less than 500 cells/mm occurs for more than 5 days or is associated with fever or infection, if platelet count less than 25,000 cells/mm occurs, if any grade 3 or 4 toxicity develops or if renal clearance is less than 50 ml/min.
Läkemedelsinteraktioner
Drug interactions
i kombination med andra godkända kemoterapeutiska medel för behandling av småcellig lungcancer hos vuxna.
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of small-cell lung cancer in adults.
aptitlöshet
• dizziness
Ytterligare information om detta läkemedel finns på Europeiska läkemedelsmyndighetens webbplats http://www.ema.europa.eu, och på Läkemedelsverkets webbplats http://www.lakemedelsverket.se.
Detailed information on this medicinal product is available on the website of [name of MS Agency link].
i kombination med andra godkända kemoterapeutiska medel för behandling av icke-epitelial ovarialcancer hos vuxna.
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of non-epithelial ovarian cancer in adults.
Nedsatt njurfunktion
Impaired renal function
svårighet att svälja
• difficulty swallowing
Överdosering
4.9 Overdose
som släpps ut från cancercellerna tar sig in i blodbanan)
• tumour lysis syndrome (complications of substances released from treated cancer cells entering the blood)
Påverkan på förmågan att framföra fordon eller använda maskiner har inte studerats. Etoposid kan orsaka biverkningar
No studies on the effects on the ability to drive and use machines have been performed.
tillfälligt håravfall
• temporary hair loss
ingen känd frekvens infertilitet
Reproductive system and breast disorders not known infertility
som en bifasisk process med en distribueringshalveringstid på ungefär 1,5 timmar och terminal eliminationshalveringstid varierande mellan 4 till 11 timmar. Totala kroppsclearancevärden varierar mellan 33 till 48 ml/min eller 16 till 36 ml/min/m2 och, liksom den
Total body clearance values range from 33 to 48 mL/min or 16 to 36 mL/min/m2 and, like the terminal elimination half-life, are independent of dose over a range 100 to 600 mg/m2.
i kombination med andra godkända kemoterapeutiska medel för behandling av recidiverande eller refraktär akut myeloisk leukemi hos vuxna.
VEPESID and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of relapsed or refractory acute myeloid leukaemia in adults.
signifikanta toxiciteten vid behandling med VEPESID och associerade namn.
Bacterial infections should be brought under control before treatment with VEPESID and associated names.
Magtarmkanalen mycket vanliga buksmärta, anorexi, förstoppning, illamående och kräkningar vanliga diarré, mukosit (innefattande stomatit och esofagit)
nausea and vomiting common diarrhoea, mucositis (including stomatitis and esophagitis)
SÄRSKILDA FÖRVARINGSANVISNINGAR
6.4 Special precautions for storage
i rad eller 200 mg/m2 kroppsyta på dag 1, 3 och 5. Den dagliga dosen kan ibland delas upp för att tas morgon och kväll.
The daily dose may sometimes be split to be taken morning and evening.
VEPESID och associerade namn 100 mg mjuka kapslar [Se bilaga I - Kompletteras nationellt]
VEPESID and associated names 50mg Soft Capsules VEPESID and associated names 100mg Soft Capsules [See Annex I - To be completed nationally]
Öppna inte någon burk om det finns tecken på kapselläckage.
Do not open any blister in which there is evidence of capsule leakage.
VEPESID och associerade namn (se Bilaga 1) 100 mg mjuka kapslar [Se bilaga I - Kompletteras nationellt]
VEPESID and associated names (see Annex 1) 50 mg capsule, soft VEPESID and associated names (see Annex 1) 100 mg capsule, soft [See Annex I - To be completed nationally]
som behandling.
For oral use.
ÖGA
Date
BRUKSANVISNING [Kompletteras nationellt]
INSTRUCTIONS ON USE [To be completed nationally]
LÄKEMEDEL OCH AVFALL I FÖREKOMMANDE FALL Ej använt läkemedel och avfall
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
ska etoposid administreras i minskad dos (se avsnitt 4.2).
Etoposide has been shown to be teratogenic in mice and rats (see section 5.3).
trombocytantal, hemoglobinvärde, antal vita blodkroppar och differentialräkning.
The following haematological parameters should be measured at the start of therapy and prior to each subsequent dose of VEPESID and associated names: platelet count, haemoglobin, white blood cell count and differential.
• krampanfall
• convulsions (seizure)
• rodnad
• bleeding
illamående och kräkningar
• nausea and vomiting
ska läkaren väga behovet och nyttan av läkemedlet mot risken för biverkningar.
In all instances where the use of VEPESID and associated names is considered for chemotherapy, the physician must evaluate the need and usefulness of the drug against the risk of adverse reactions.
svalget
Posology
Denna bipacksedel ändrades senast <{MM/ÅÅÅÅ}><{månad ÅÅÅÅ}>. [Kompletteras nationellt]
[See Annex I - To be completed nationally] This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
TILLVERKNINGSSATSNUMMER Batch nr. ÖVRIGT Cytostatikum.
OTHER Cytotoxic.
blödning
Hypertension
Natriumpropylparahydroxybensoat (E217)
Sodium ethyl parahydroxybenzoate (E215) Sodium propyl parahydroxybenzoate (E217) Titanium dioxide (E171) Red iron oxide (E172)
i kombinationen eller utifrån effekterna av tidigare strål- eller cytostatikabehandling (se avsnitt 4.4)
Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiotherapy or chemotherapy (see section 4.4), which may have compromised bone marrow reserve.
Påverkan på förmågan att framföra fordon eller använda maskiner har inte studerats. Om du känner dig trött, mår illa, känner dig yr eller
Etoposide may cause adverse reactions that affect the ability to drive and use machines such as fatigue, somnolence,
Amning
Breastfeeding
ska avbrytas eller om behandlingen med VEPESID och associerade namn
Talk to your doctor or pharmacist before taking VEPESID and associated names
serumalbumin
Low serum albumin
Събитията са смъртни случаи поради всякаква причина.
Events are death due to any cause.
MTD не е постигната.
The MTD was not reached.
Не използвайте Adcetris, ако:
Do NOT use Adcetris if you:
Представлява обединяване на предпочитани термини.
Represents pooling of preferred terms.
Дозата на това лекарство зависи от телесното Ви тегло.
The dose of this medicine depends on your body weight.
Смъртен случай или без предшестваща прогресия или повече от едно пропуснато посещение за оценка.
Death without either prior progression or more than one missed assessment visit.
Безопасността и ефикасността на ADCETRIS при деца на възраст под 18 години все още не са установени.
The safety and efficacy of ADCETRIS in children less than 18 years have not yet been established.
Представителните рискови фактори за тези анализи са:
Representative risk factors for these analyses were:
Не може да се изключи риск за новородените/кърмачетата.
A risk to the newborn/infant cannot be excluded.
4 години.
4 years.
От подходящите пациенти се изисква да имат най-малко един от следните рискови фактори:
Eligible patients were required to have at least one of the following risk factors:
В това проучване при 36 пациенти не се съобщават нови съображения за безопасност.
In this study in 36 patients, no new safety concerns were reported.
Като цяло този вид реакции възникват в рамките на минути до няколко часа след приключване на вливането.
In general, these types of reactions occur within minutes to several hours following completion of the infusion.
Той не е предназначен за употреба при деца.
It is not for use in children.
То се прилага от Вашия лекар или медицинска сестра в продължение на 30 минути.
It is given by your doctor or nurse over 30 minutes.
Посочва резултати от нестратифициран анализ.
Indicates results from non-stratified analysis.
Все пак, химическа и физическа стабилност е доказана за 24 часа при температура 2 °C-8 °C.
However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C-8 °C.
Въпреки това, те могат да възникнат след повече от няколко часа след приключване на вливането, но това не е често.
However, they may develop more than several hours after completion of the infusion but this is uncommon.
Следователно е малко вероятно да има някакъв съществен принос към системните ефекти на ММАЕ.
Thus, it is not likely to have any substantial contribution to the systemic effects of MMAE.
Таблица 14 включва резултатите за ORR4 и други ключови вторични крайни точки.
Table 14 includes the results for ORR4 and other key secondary endpoints.
Вашият лекар редовно ще прави кръвни изследвания, за да се увери, че за Вас е безопасно да получавате това лекарство.
Your doctor will perform regular blood tests to make sure that it is safe for you to receive this medicine.
Вижте листовките на тези лекарства за допълнителна информация за тяхната употреба и ефекти.
See the package leaflets for these medicines for additional information on their use and effects.
Не е изключен принос към механизма на действие от други функции, свързани с антитялото.
Contributions to the mechanism of action by other antibody associated functions have not been excluded.
Вие и Вашият партньор трябва да използвате два метода на ефективна контрацепция по време на лечението Ви с това лекарство.
You and your partner must use two methods of effective contraception during your treatment with this medicine.
Две или повече предходни спасителни терапии.
• Two or more prior salvage therapies.
Вашият лекар или медицинска сестра също така ще Ви наблюдават по време на и след вливането.
Your doctor or nurse will also monitor you during and after the infusion.
Други лекарства и Adcetris
Other medicines and Adcetris
Изчислена от претеглена процедура на Holm
Calculated from a weighted Holm's procedure
След разтваряне/разреждане от микробиологична гледна точка, продуктът трябва да се използва незабавно.
After reconstitution/dilution, from a microbiological point of view, the product should be used immediately.
Лекарят или медицинската сестра ще изхвърлят това лекарство.
The doctor or nurse will dispose of this medicine.
Резултатите за безопасност и ефикасност в тези проучвания са в съответствие с резултатите от проучване C25001.
The safety and efficacy results in these studies were consistent with results in Study C25001.
Липсват данни от употребата на ADCETRIS при бременни жени.
There are no data from the use of ADCETRIS in pregnant women.
Продължаване със същата доза и схема
Continue with the same dose and schedule
Изследователските оценки са като цяло съответстващи на независимия преглед на резултатите от сканирането.
The investigator assessments were generally consistent with the independent review of the scans.
Както всички лекарства, това лекарство може да предизвика нежелани реакции, въпреки че не всеки ги получава.
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Доза и честота
Dose and frequency
Експозициите са приблизително пропорционални на дозата.
Exposures were approximately dose proportional.
Честотата на нежеланите реакции, описани по-долу и в Таблица 3, е определена въз основа на данните, получени от клинични изпитвания.
Frequencies of adverse reactions described below and in Table 3 have been determined based on data generated from clinical studies.
Реакции, свързани с вливането на това лекарство могат да засегнат повече от 1 на 10 души.
Infusion reactions to this medicine may affect more than 1 in 10 people.
При липса на проучвания за несъвместимости този лекарствен продукт не трябва да се смесва с други лекарствени продукти, освен тези посочени в точка 6.6.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
По системата на Ann Arbor IPFP = International Prognostic Factor Project
Per Ann Arbor Staging IPFP = International Prognostic Factor Project
Трябва да се имат предвид процедурите за правилна работа и изхвърляне на противоракови лекарства.
Procedures for proper handling and disposal of anticancer medicines should be considered.
В проучването пациентите са получили първата си доза след възстановяване от ASCT (между дни 30-45 след ASCT).
In the study, patients were to receive their first dose after recovery from ASCT (between days 30-45 following ASCT).
Резултатите от тези post-hoc анализи показват повишена клинична полза за пациенти с два или повече рискови фактори, но няма разлика, дължаща се на някой от индивидуалните рискови фактори.
The results of these post-hoc analyses suggest increased clinical benefit for patients with two or more risk factors but no difference based on any of the individual risk factors.
ECOG статус
ECOG status
Вашето лечение може да повлияе способността Ви да шофирате или да работите с машини.
Your treatment may influence your ability to drive or operate machines.
Post-hoc анализите са извършени, за да се оцени въздействието на повишен риск (брой рискови фактори) върху клиничната полза (Таблица 8).
Post-hoc analyses were performed to evaluate the impact of increased risk (number of risk factors) on clinical benefit (Table 8).
Прекратяване на лечението a.
Discontinue treatment a.
Препоръките за дозиране при пациенти на възраст 65 и повече години са същите като при възрастни.
The dosing recommendations for patients aged 65 and older are the same as for adults.
Освен това трябва да уведомите партньора или болногледачите си за лечението, тъй като те може да забележат симптоми, които
You should also inform your partner or caregivers about your treatment, since they may notice symptoms that you are not aware of.
Степен 1 (парестезия и/или загуба на рефлекси, без загуба на функция)
Grade 1 (paraesthesia and/or loss of reflexes, with no loss of function)
За да се подобри възможността за проследяване на биологичните лекарствени продукти, името и партидният номер на прилагания продукт трябва да бъдат ясно отбелязани.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Наличните в момента данни са описани в точки 4.8, 5.1 и 5.2.
Currently available data are described in sections 4.8, 5.1 and 5.2.
Брой пациенти с прогресия на заболяване то или смъртни случаи a
Number of patients with disease progression or death a
Резултатите за ефикасност са представени в Таблица 7.
The efficacy results are shown in Table 7.