natgillin/translations-raw huggingface dataset:
The recommended dose is 100 mg per day (given as one 50 mg tablet every 12 hours).
Priporočeni odmerek je 100 mg na dan (ki se daje kot ena 50-miligramska tableta vsakih 12 ur).
This is a summary of the European public assessment report (EPAR) for Rilutek.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Rilutek.
Other information about Rilutek
Druge informacije o zdravilu Rilutek
ALS is a form of motor neuron disease where the nerve cells responsible for sending instructions to the muscles gradually deteriorate, leading to weakness, muscle wasting and paralysis.
ALS je oblika bolezni motoričnega nevrona, pri kateri se živčne celice, odgovorne za pošiljanje navodil mišicam, postopoma kvarijo, kar povzroči šibkost, uničevanje mišic in paralizo.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rilutek.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Rilutek 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day.
Zdravilo Rilutek v odmerku 50 mg/dan ni bilo bolj učinkovito kot placebo, odmerek 200 mg/dan pa ni bil bolj učinkovit kot odmerek 100 mg/dan.
The CHMP decided that Rilutek's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Rilutek večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The most common side effects seen with Rilutek (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests.
Najpogostejši neželeni učinki zdravila Rilutek (pri več kot 1 bolniku od 10) so navzeja (slabost), šibkost in nenormalen test jetrnih funkcij.
What is the risk associated with Rilutek?
Kakšna tveganja so povezana z zdravilom Rilutek?
Rilutek is used in patients with amyotrophic lateral sclerosis (ALS).
Zdravilo Rilutek se uporablja pri bolnikih z amiotrofično lateralno sklerozo (ALS).
Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Zdravilo Riluzol zavira sproščanje glutamata, kar naj bi pomagalo preprečevati uničevanje živčnih celic.
It is thought that the destruction of nerve cells in motor neuron disease may be caused by too much of the neurotransmitter glutamate.
Domnevajo, da lahko uničenje živčnih celic pri bolezni motoričnega nevrona povzroči prevelika količina živčnega prenašalca glutamata.
Looking at the results of the three studies together, over 18 months, patients who received Rilutek 100 mg/day had an average survival time that was about 2 months longer than the survival time for patients who received placebo.
Glede na skupne rezultate treh študij, ki so trajale 18 mesecev, je bil pri bolnikih, ki so prejemali 100 mg zdravila Rilutek na dan, čas preživetja približno 2 meseca daljši kot pri tistih, ki so prejemali placebo.
Rilutek is used to extend the patient's life or to delay the need for mechanical ventilation.
Zdravilo Rilutek se uporablja za podaljševanje življenja bolnika ali časa, ki mu ostane do mehanične ventilacije.
Rilutek is a medicine containing the active substance riluzole.
Rilutek je zdravilo, ki vsebuje zdravilno učinkovino riluzol.
Treatment with Rilutek should only be started by a specialist doctor with experience in the management of motor neuron diseases.
Zdravljenje z zdravilom Rilutek sme uvesti le zdravnik specialist z izkušnjami z zdravljenjem bolezni motoričnega nevrona.
The medicine was not more effective than placebo in the late stages of ALS.
V poznih stadijih bolezni ALS zdravilo ni bilo bolj učinkovito kot placebo.
The average survival time was significantly longer for patients who received Rilutek compared with patients who received placebo.
Pri bolnikih, ki so prejemali Rilutek, je bil povprečni čas preživetja znatno daljši kot pri tistih, ki so prejemali placebo.
Why has Rilutek been approved?
Zakaj je bilo zdravilo Rilutek odobreno?
Rilutek must not be used in patients who have liver disease or who have abnormally high levels of liver enzymes.
Zdravila Rilutek ne smejo uporabljati bolniki z boleznimi jeter ali bolniki z nenormalno visokimi ravnmi jetrnih encimov.
Rilutek should not be used in patients with any other form of motor neuron disease.
Zdravila Rilutek ne bi smeli uporabljati pri bolnikih, ki imajo druge oblike bolezni motoričnega nevrona.
Across the studies, Rilutek was given as 50, 100 or 200 mg per day, and for up to 18 months.
V študijah so bolniki največ 18 mesecev prejemali 50, 100 ali 200 mg zdravila Rilutek na dan.
For the full list of all side effects reported with Rilutek, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Rilutek, glejte navodilo za uporabo.
How has Rilutek been studied?
Kako je bilo zdravilo Rilutek raziskano?
The active substance in Rilutek, riluzole, acts on the nervous system.
Zdravilna učinkovina zdravila Rilutek je riluzol, ki učinkuje na živčni sistem.
What is Rilutek used for?
Za kaj se zdravilo Rilutek uporablja?
What is Rilutek?
Kaj je zdravilo Rilutek?
How is Rilutek used?
Kako se zdravilo Rilutek uporablja?
How does Rilutek work?
Kako zdravilo Rilutek deluje?
Rilutek has been compared with placebo (a dummy treatment) in three studies involving a total of 1,282 patients.
V treh študijah, ki so vključevale 1 282 bolnikov, so učinek zdravila Rilutek primerjali z učinkom placeba (zdravila brez zdravilne učinkovine).
This authorisation was based on the authorisation granted to Stalevo in 2003 (‘informed consent').
Ta odobritev je temeljila na dovoljenju za promet, odobrenem za zdravilo Stalevo leta 2003 (uporaba dokumentacije s soglasjem).
The use of combinations of levodopa and carbidopa is well established, having been in use since the mid-1970s.
Uporaba kombinacij levodope in karbidope je dobro uveljavljena, in sicer od sredine sedemdesetih let prejšnjega stoletja.
All of the tablets contain 200 mg entacapone.
Vse tablete vsebujejo 200 mg entakapona.
They should not be used in patients with severe liver problems.
Zdravilo se ne sme uporabljati pri bolnikih s hudo okvaro jeter.
They are linked with a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Povezani so z zmanjšanjem učinka levodope, ko bolnik občuti nenadne prehode med stanjem „on“, ko se lahko premika, in stanjem „off“, ko ima težave z gibanjem.
• a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
• anamnezo nevroleptičnega malignega sindroma (nevarne bolezni živčnega sistema, ki jo običajno povzročijo antipsihotična zdravila) ali rabdomiolizo (razgradnjo mišičnega tkiva).
• severely reduced liver function;
• hudo okvaro delovanja jeter;
Having all three substances in the same tablet can lower the number of tablets the patients have to take and help them stick to treatment.
Ker ena tableta vsebuje vse tri učinkovine, je število tablet, ki jih mora bolnik zaužiti, manjše, kar jim pomaga držati se režima zdravljenja.
The full EPAR for Levodopa/Carbidopa/Entacapone Orion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko poročilo o oceni zdravila (EPAR) za zdravilo Levodopa/Carbidopa/Entacapone Orion je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The maximum daily dose of Levodopa/Carbidopa/Entacapone Orion is 10 tablets, except for the tablets containing 175 mg levodopa and 43.75 mg carbidopa, for which the maximum daily dose is eight tablets, and those containing 200 mg levodopa and 50 mg carbidopa, for which it is seven tablets.
Največji dnevni odmerek zdravila Levodopa/Carbidopa/Entacapone Orion je 10 tablet, razen pri tabletah, ki vsebujejo 175 mg levodope in 43,75 mg karbidope, pri katerih je največji dnevni odmerek osem tablet, ter pri tistih, ki vsebujejo 200 mg levodope in 50 mg karbidope, ko je največji dnevni odmerek sedem tablet.
Serious side effects which have been reported much less often include gastrointestinal haemorrhage (bleeding in the gut) and angioedema (swelling under the skin of face or limbs).
Resni neželeni učinki, o katerih so poročali zelo redko, vključujejo gastrointestinalno hemoragijo (krvavitve v črevesju) ter angiodem (podkožne otekline na obrazu in okončinah).
In patients with Parkinson's disease, the cells in the brain that produce dopamine (a substance used to transmit signals between nerve cells that help to control muscle movement) begin to die and the amount of dopamine in the brain decreases.
Pri bolnikih s Parkinsonovo boleznijo pričnejo celice, ki proizvajajo dopamin (snov, ki prenaša signale med živčnimi celicami, ki pomagajo pri nadzoru mišičnih gibov), odmirati, zato se količina dopamina v možganih zmanjša.
• phaeochromocytoma (a tumour of the adrenal gland);
• feokromocitom (tumor nadledvične žleze);
The CHMP decided that Levodopa/Carbidopa/Entacapone Orion's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Levodopa/Carbidopa/Entacapone Orion večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
The European Commission granted a marketing authorisation valid throughout the European Union for Levodopa/Carbidopa/Entacapone Orion on 24 August 2011.
Evropska komisija je dovoljenje za promet z zdravilom Levodopa/Carbidopa/Entacapone Orion, veljavno po vsej Evropski uniji, odobrila 24. avgusta 2011.
For more information about treatment with Levodopa/Carbidopa/Entacapone Orion, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Levodopa/Carbidopa/Entacapone Orion preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
Levodopa/Carbidopa/Entacapone Orion is used when these fluctuations cannot be treated with the standard combination alone.
Zdravilo Levodopa/Carbidopa/Entacapone Orion se uporablja, kadar teh fluktuacij ni mogoče zdraviti samo s standardno kombinacijo.
The strength of Levodopa/Carbidopa/Entacapone Orion that the patient should use is based on the amount of levodopa they need to control their symptoms.
Jakost zdravila Levodopa/Carbidopa/Entacapone Orion, ki naj jo bolnik jemlje, temelji na količini levodope, ki jo potrebuje za nadzor nad simptomi.
All of the active substances in Levodopa/Carbidopa/Entacapone Orion work to restore the levels of dopamine in the parts of the brain that control movement and co-ordination.
Vse zdravilne učinkovine v zdravilu Levodopa/Carbidopa/Entacapone Orion delujejo tako, da ponovno vzpostavijo ravni dopamina v tistih delih možganov, ki nadzirajo gibe in koordinacijo.
The most common side effects with Levodopa/Carbidopa/Entacapone Orion (seen in more than 1 patient in 10) are dyskinesia (uncontrollable movements), muscle pain, diarrhoea and nausea (feeling sick) and harmless urine discoloration.
Najpogostejši neželeni učinki zdravila Levodopa/Carbidopa/Entacapone Orion (opaženi pri več kot 1 bolniku od 10) so diskinezija (nekontrolirani gibi), bolečine v mišicah, diareja in slabost ter neškodljivo razbarvanje urina.
The studies showed that Levodopa/Carbidopa/Entacapone Orion is bioequivalent to the separate tablets.
Študije so pokazale, da je zdravilo Levodopa/Carbidopa/Entacapone Orion biološko enakovredno ločenim tabletam.
Levodopa/Carbidopa/Entacapone Orion is used in patients who are being treated with a combination of levodopa and an inhibitor of dopa decarboxylase (two standard treatments for Parkinson's disease) but are having ‘fluctuations' towards the end of the period between two doses of their medication.
Zdravilo Levodopa/Carbidopa/Entacapone Orion se uporablja pri bolnikih, ki se zdravijo s kombinacijo levodope in zaviralca dopa dekarboksilaze (dveh običajnih zdravil za Parkinsonovo bolezen), pri katerih pa se proti koncu obdobja med dvema odmerkoma zdravila pojavijo fluktuacije.
This is a summary of the European public assessment report (EPAR) for Levodopa/Carbidopa/Entacapone Orion.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Levodopa/Carbidopa/Entacapone Orion.
Levodopa/Carbidopa/Entacapone Orion is used to treat adults with Parkinson's disease.
Zdravilo Levodopa/Carbidopa/Entacapone Orion se uporablja za zdravljenje odraslih bolnikov s Parkinsonovo boleznijo.
Levodopa/Carbidopa/Entacapone Orion must not be used together with other medicines that belong to the group ‘monoamine oxidase inhibitors' (a type of antidepressant).
Zdravilo Levodopa/Carbidopa/Entacapone Orion se ne sme uporabljati skupaj z drugimi zdravili, ki spadajo v skupino zaviralcev monoaminooksidaze (vrsta antidepresivov).
Levodopa/Carbidopa/Entacapone Orion must not be used in people who are hypersensitive (allergic) to levodopa, carbidopa, entacapone or any of the other ingredients.
Zdravila Levodopa/Carbidopa/Entacapone Orion ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) levodopo, karbidopo, entakapon ali katero koli drugo sestavino zdravila.
The company used some of the data from Comtess/Comtan to support the use of Levodopa/Carbidopa/Entacapone Orion and presented data from the published literature for levodopa and carbidopa.
Družba je v podporo uporabi zdravila Levodopa/Carbidopa/Entacapone Orion uporabila nekatere podatke o zdravilu Comtess/Comtan in predstavila podatke iz objavljene literature o levodopi in karbidopi.
Levodopa/Carbidopa/Entacapone Orion tablets should be taken whole, with or without food.
Tablete zdravila Levodopa/Carbidopa/Entacapone Orion je treba vzeti cele,s hrano ali brez nje.
Each Levodopa/Carbidopa/Entacapone Orion tablet contains one complete dose of levodopa, in seven strengths, with corresponding amounts of carbidopa and entacapone to improve its effectiveness.
Vsaka tableta zdravila Levodopa/Carbidopa/Entacapone Orion vsebuje en poln odmerek levodope v sedmih jakostih, za izboljšanje njene učinkovitosti pa še ustrezne količine karbidope in entakapona.
Levodopa/Carbidopa/Entacapone Orion is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Levodopa/Carbidopa/Entacapone Orion je zdravilo, ki vsebuje tri zdravilne učinkovine: levodopo, karbidopo in entakapon.
• narrow-angle glaucoma (increased pressure within the eye);
• glavkom z zaprtim zakotjem (povečan pritisk v očesu);
Levodopa/Carbidopa/Entacapone Orion must not be used in patients with:
Zdravilo Levodopa/Carbidopa/Entacapone Orion se ne sme uporabljati pri bolnikih, ki imajo:
The company carried out ‘bioequivalence' studies to show that taking Levodopa/Carbidopa/Entacapone Orion produces the same levels of levodopa, carbidopa and entecapone in the blood as taking separate tablets containing entacapone and the combination of levodopa and carbidopa.
Izvedla je tudi študije biološke enakovrednosti, da bi dokazala, da so ravni levodope, karbidope in entekapona v krvi pri jemanju zdravila Levodopa/Carbidopa/Entacapone Orion enake kot pri jemanju zdravilnih učinkovin v ločenih tabletah, od katerih ene vsebujejo entakapon, druge pa so kombinirane in vsebujejo levodopo in karbidopo.
For the full list of all side effects reported with Levodopa/Carbidopa/Entacapone Orion, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Levodopa/Carbidopa/Entacapone Orion, glejte navodilo za uporabo.
Other information about Levodopa/Carbidopa/Entacapone Orion
Druge informacije o zdravilu Levodopa/Carbidopa/Entacapone Orion
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levodopa/Carbidopa/Entacapone Orion.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Levodopa/Carbidopa/Entacapone Orion, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
They should be used with caution in patients with mild to moderately reduced liver function or severely reduced kidney function.
Bolniki z blago do zmerno resno okvaro delovanja jeter ali hudo okvaro ledvic morajo tablete jemati previdno.
EPAR summary for the public levodopa/carbidopa/entacapone
Povzetek EPAR za javnost levodopa/karbidopa/entakapon
What benefit has Levodopa/Carbidopa/Entacapone Orion shown during the studies?
Kakšne koristi je zdravilo Levodopa/Carbidopa/Entacapone Orion izkazalo med študijami?
What is the risk associated with Levodopa/Carbidopa/Entacapone Orion?
Kakšna tveganja so povezana z zdravilom Levodopa/Carbidopa/Entacapone Orion?
Why has Levodopa/Carbidopa/Entacapone Orion been approved?
Zakaj je bilo zdravilo Levodopa/Carbidopa/Entacapone Orion odobreno?
What is Levodopa/Carbidopa/Entacapone Orion?
Kaj je zdravilo Levodopa/Carbidopa/Entacapone Orion?
See the summary of product characteristics (also part of the EPAR) for full instructions on how patients should be switched to Levodopa/Carbidopa/Entacapone Orion, and on how the dose is adjusted during treatment.
Za vsa navodila o tem, kako naj bolniki preidejo na jemanje zdravila Levodopa/Carbidopa/Entacapone Orion in kako je treba odmerek med zdravljenjem prilagajati, glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
How does Levodopa/Carbidopa/Entacapone Orion work?
Kako zdravilo Levodopa/Carbidopa/Entacapone Orion deluje?
How has Levodopa/Carbidopa/Entacapone Orion been studied?
Kako je bilo zdravilo Levodopa/Carbidopa/Entacapone Orion raziskano?
What is Levodopa/Carbidopa/Entacapone Orion used for?
Za kaj se zdravilo Levodopa/Carbidopa/Entacapone Orion uporablja?
How is Levodopa/Carbidopa/Entacapone Orion used?
Kako se zdravilo Levodopa/Carbidopa/Entacapone Orion uporablja?
Invented name Strength Pharmaceutical Form Route of administration
Številka EU zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebnost velikost pakiranja
What happens
Kaj se bo dogajalo
All other bleeding events were nonserious.
Vsi drugi dogodki krvavitve niso bili resni.
*Patients who have not received transfusions in the prior 60 days.
*Bolniki, ki v predhodnih 60 dneh niso dobili transfuzije.
o The importance of annual check-ups.
o Pomen letnih kontrolnih pregledov.
The selection of the treatment centres will be conducted in collaboration with national health authorities as appropriate.
Centri za zdravljenje bodo izbrani v sodelovanju z nacionalnimi zdravstvenimi organi, kot je primerno.
***No patients are currently evaluable for these endpoints.
***Za te izide trenutno ni bolnikov, ki bi jih bilo mogoče oceniti.
NR = Not reached.
NR = ni dosežena (not reached).
This reduces or eliminates the need for blood transfusions.
To zmanjša ali odpravi potrebo po transfuzijah krvi.
Do not thaw the product until it is ready to be used.
Ne odtajajte izdelka, dokler ni pripravljen za uporabo.
This information is intended for doctors only.
Te informacije so le za zdravnike.
All reactions resolved.
Vse reakcije so izzvenele.
All patients remain alive at last follow-up.
Vsi bolniki so bili pri zadnjem spremljanju še živi.
When 20 patients have been treated with 6 months follow-up
Ko je bilo zdravljenih 20 bolnikov in po 6-mesečnem spremljanju
As this medicine will be given by a qualified doctor, they are responsible for the correct storage of the medicine before and during its use, as well as for its correct disposal.
Ker bo zdravilo dal usposobljen zdravnik, je odgovoren za pravilno shranjevanje zdravila pred in med uporabo ter za njegovo pravilno odstranitev.
A chemotherapy medicine is given for 4 days in a hospital
Zdravilo za kemoterapijo se daje 4 dni v bolnišnici
The minimum recommended dose is the same for adults and adolescents 12 years of age and older.
Najmanjši priporočeni odmerek zdravila je enak za odrasle in mladostnike, stare 12 let in več.
Hb = Total Hb. WA Hb = Weighted average Hb.
Hb = skupni Hb. WA Hb = tehtano povprečje Hb.
(See section 4.4 for guidance on platelet monitoring and management.)
(Glejte poglavje 4.4. za smernice o spremljanju in obravnavi trombocitov.)
Frequencies are defined as: very common (≥1/10), and common (≥1/100 and <1/10).
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), in pogosti (≥ 1/100 do < 1/10).
o Contact details where a health care professional can receive further information.
o Kontaktni podatki, kjer lahko zdravstveni delavci dobijo dodatne informacije.
This will take place in a hospital and will take less than 30 minutes for each infusion bag.
To bo potekalo v bolnišnici in bo trajalo manj kot 30 minut za vsako infuzijsko vrečko.
Options may include providing reproductive material for storage in a tissue bank to use at a later time.
Možnosti lahko vključujejo shranitev reprodukcijskega materiala v banko tkiv za kasnejšo uporabo.
Risk of insertional oncogenesis
Tveganje za insercijsko onkogenezo
^N represents the total number of patients evaluable for TI, defined as patients who have completed their parent study (i.e., 24 months of follow-up), or achieved TI, or will not achieve TI in their parent study.
^N predstavlja skupno število bolnikov, ki so jih ovrednotili za TI, definirane kot bolnike, ki so zaključili svoje matične študije (tj. 24 mesecev spremljanja) ali so dosegli TI ali pa ne bodo dosegli TI v svoji matični študiji.
Date of first authorisation: 29 May 2019
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 29. maj 2019
NA = Not applicable.
NA = ni smiselno (not applicable).
• bump your head or have a head injury
• se udarite v glavo ali si poškodujete glavo;
Given the small patient population and size of cohorts, adverse reactions in the table below do not provide a complete perspective on the nature and frequency of these events.
Glede na majhno populacijo bolnikov in velikost kohort neželeni učinki v spodnji preglednici ne zagotavljajo celotnega pogleda na naravo in pogostnost teh dogodkov.
Tell your doctor immediately if side effects become severe or serious.
Takoj obvestite zdravnika, če neželeni učinki postanejo hudi ali resni.
• other pain
• druge bolečine
Because of this defect, people with TDT are anaemic and need frequent blood transfusions to survive.
Zaradi te okvare so ljudje s TDT anemični in za preživetje potrebujejo pogoste transfuzije krvi.
Study Total number (adolescents)
Skupno število (mladostniki)
Common (≥1% - <10%)
Pogosti (≥ 1% - < 10 %)
Patients should be made aware of the risk of bleeding events that are not easily identifiable, such as internal bleeding.
Bolnike je treba opozoriti na tveganje dogodkov krvavitev, ki jih ni enostavno prepoznati, na primer notranje krvavitve.
Name (Last, First):
Ime (priimek, ime):
This leaflet was last revised in <{MM/YYYY}>
Navodilo je bilo nazadnje revidirano dne{MM/LLLL}.
Effects on male and female fertility have not been evaluated in animal studies.
Vplivi na plodnost pri moških in ženskah niso bili ocenjeni v študijah na živalih.
Busulfan dose adjustments were made as needed based on pharmacokinetic monitoring.
Odmerek busulfana so prilagodili, kot je bilo potrebno na podlagi farmakokinetičnega spremljanja.
You must get medical attention if you:
Poiščite zdravniško pomoč, če:
o The potential risk of loss of response to gene therapy may lead to loss of transfusion independence or increase transfusion needs for patients who did not reach transfusionindependence.
o Možno tveganje izgube odgovora na gensko zdravljenje lahko vodi v izgubo neodvisnosti od transfuzij ali povečano potrebo po transfuziji pri bolnikih, ki niso dosegli neodvisnosti od transfuzije.
- Read the Patient Alert Card carefully and follow the instructions on it.
- Natančno preberite opozorilno kartico bolnika in upoštevajte navodila, ki so na njej.