natgillin/translations-raw huggingface dataset:
Zalasta 5 mg orodispersible tablets Zalasta 7.5 mg orodispersible tablets Zalasta 10 mg orodispersible tablets Zalasta 15 mg orodispersible tablets Zalasta 20 mg orodispersible tablets Olanzapine
Zalasta 5 mg orodisperzibilne tablete Zalasta 7,5 mg orodisperzibilne tablete Zalasta 10 mg orodisperzibilne tablete Zalasta 15 mg orodisperzibilne tablete Zalasta 20 mg orodisperzibilne tablete olanzapinum
CARTON FOR ZALASTA 5 mg ORODISPERSIBLE TABLETS
ZLOŽENKA ZA ZALASTA 5 MG ORODISPERZIBILNE TABLETE
Glucosuria Increased appetite
Zvišane ravni glukoze Zvišane ravni trigliceridov Glikozurija Povečan apetit
Further information on Jivi can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Jivi.
Nadaljnje informacije o zdravilu Jivi so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Jivi.
What measures are being taken to ensure the safe and effective use of Jivi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Jivi?
The European Medicines Agency decided that Jivi's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Jivi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Other information about Jivi
Druge informacije o zdravilu Jivi
Why is Jivi authorised in the EU?
Zakaj je zdravilo Jivi odobreno v EU?
What benefits of Jivi have been shown in studies?
Kakšne koristi je zdravilo Jivi izkazalo v študijah?
What is Jivi and what is it used for?
Kaj je zdravilo Jivi in za kaj se uporablja?
As for all medicines, data on the use of Jivi are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Jivi stalno spremljajo.
Patients or their carers may be able to inject Jivi themselves at home once they have been trained appropriately.
Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Jivi injicirajo sami doma.
The most common side effect with Jivi (which may affect more than 1 in 10 people) is headache.
Najpogostejši neželeni učinek zdravila Jivi (ki se lahko pojavi pri več kot 1 od 10 bolnikov) je glavobol.
Since this could potentially cause problems especially in children below 12 years of age, Jivi is only approved for use in adults and children from 12 years of age.
Ker lahko to povzroči težave, zlasti pri otrocih, mlajših od 12 let, je zdravilo Jivi odobreno le za uporabo pri odraslih in otrocih, starejših od 12 let.
Jivi is given by injection into a vein.
Zdravilo Jivi se daje z injekcijo v veno.
An overview of Jivi and why it is authorised in the EU
Pregled zdravila Jivi in zakaj je odobreno v EU
What are the risks associated with Jivi?
Kakšna tveganja so povezana z zdravilom Jivi?
Hypersensitivity (allergic) reactions are common with Jivi (affecting up to 1 in 10 people) and may include swelling, burning and stinging at the injection site, chills, flushing, tingling, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest and wheezing.
Občasne preobčutljivostne (alergijske) reakcije pri uporabi zdravila Jivi (ki se lahko pojavijo pri največ 1 bolniku od 10) lahko vključujejo oteklost, pekoč občutek in zbadanje na mestu injiciranja, mrzlico, vročinske oblive, mravljinčenje, srbeč izpuščaj, glavobol, koprivnico, nizek krvni tlak, letargijo, navzejo in bruhanje, nemir, hiter srčni utrip, tiščanje v prsnem košu in piskanje v pljučih.
Jivi can be used in adults and children from 12 years of age who have been treated previously.
Zdravilo Jivi se lahko uporablja pri odraslih in otrocih, starejših kot 12 let, ki so bili predhodno zdravljeni.
Jivi must not be used in patients with allergy to mouse or hamster proteins.
Zdravila Jivi ne smejo uporabljati bolniki z alergijo na beljakovine miši ali hrčkov.
Side effects reported with Jivi are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Jivi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Jivi have also been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Jivi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as on the severity of the haemophilia, the extent and location of the bleeding and the patient's condition and weight.
Odmerek in pogostnost injiciranja sta odvisna od tega, ali se zdravilo uporablja za zdravljenje ali preprečevanje krvavitev, ter od resnosti hemofilije, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
For more information about using Jivi, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Jivi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
The company that markets Jivi will conduct a study to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other organs.
Družba, ki trži zdravilo Jivi, bo izvedla študijo za proučitev potencialnega učinka kopičenja PEG v horoidnem pletežu možganov in v drugih organih.
In a second part of the study, 17 patients received Jivi to control bleeding during 20 major surgeries.
V drugem delu študije je 17 bolnikov prejelo zdravilo Jivi za obvladovanje krvavitev pri 20 velikih kirurških posegih.
The active substance in Jivi, damoctocog alfa pegol, works in the same way as the body's factor VIII.
Učinkovina v zdravilu Jivi, damoktokog alfa pegol, deluje na enak način kot faktor VIII.
Jivi can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Predpisovanje in izdaja zdravila Jivi je le na recept, zdravljenje z njim pa mora biti pod nadzorom zdravnika z izkušnjami pri zdravljenju hemofilije.
Following treatment with factor VIII products, including Jivi, some patients may develop inhibitors (antibodies) against factor VIII, preventing the medicine from working effectively and resulting in a loss of bleeding control.
Po zdravljenju z zdravili s faktorjem VIII, vključno z zdravilom Jivi, se lahko pri nekaterih bolnikih pojavijo zaviralci (protitelesa) faktorja VIII, ki izničijo delovanje zdravila in tako povzročijo izgubo nadzora nad krvavitvijo.
Jivi has been shown to be effective at reducing the number of bleeding episodes in patients with severe haemophilia and stopping bleeding when it occurs.
Zdravilo Jivi se je izkazalo za učinkovito pri zmanjšanju števila krvavitev pri bolnikih s hudo hemofilijo in pri ustavljanju krvavitev.
However, laboratory studies show that PEG, which is part of the active substance in Jivi, may accumulate in the body, including in a structure in the brain called the choroid plexus, following long-term treatment.
Vendar so laboratorijske študije pokazale, da se lahko PEG, ki je del učinkovine zdravila Jivi, po dolgotrajnem zdravljenju kopiči v telesu, tudi v strukturi v možganih, imenovani horoidni pletež.
Part of the active substance is a substance called polyethylene glycol, ‘PEG', which is included to help the medicine remain in the body for longer and thereby prolong its action.
Del učinkovine je snov z imenom polietilenglikol (PEG), ki pripomore k počasnejšemu izločanju zdravila iz telesa in s tem podaljša njegovo delovanje.
In a study of 134 patients from 12 years of age, 114 patients given Jivi as a preventive treatment had around 2 bleeding episodes per year.
V študiji, ki je vključevala 134 bolnikov, starih 12 let ali več, je 114 bolnikov, ki so prejemali zdravilo Jivi kot preventivno zdravljenje, imelo približno dve krvavitvi na leto.
In a second study in 61 children aged below 12 years, Jivi given as preventive treatment reduced the number of bleeding episodes to around 3 episodes a year.
V drugi študiji, ki je vključevala 61 otrok, mlajših od 12 let, je zdravilo Jivi, dajano kot preventivno zdravljenje, zmanjšalo število krvavitev na približno tri na leto.
How is Jivi used?
Kako se zdravilo Jivi uporablja?
Studies show that Jivi is effective at preventing and treating bleeding episodes in patients with haemophilia A and its safety is comparable to that of other factor VIII products.
Študije so pokazale, da zdravilo Jivi učinkovito preprečuje in zdravi krvavitve pri bolnikih s hemofilijo A ter da je varnost zdravila primerljiva z varnostjo drugih zdravil s faktorjem VIII.
How does Jivi work?
Kako zdravilo Jivi deluje?
The 20 patients who were given Jivi for treating bleeding when it occurred had around 23 bleeding episodes a year.
Bolniki, ki so prejemali zdravilo Jivi za zdravljenje krvavitev po potrebi so imeli približno 23 krvavitev na leto.
Jivi was rated good or excellent at stopping bleeding in all surgeries.
Zdravilo Jivi je bilo pri vseh kirurških posegih ocenjeno kot odlično ali dobro pri preprečevanju krvavitev.
Jivi is a medicine used to treat and prevent bleeding in patients with haemophilia A, an inherited bleeding disorder caused by lack of a clotting protein called factor VIII.
Zdravilo Jivi se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A, tj. prirojeno motnjo strjevanja krvi zaradi pomanjkanja koagulacijske beljakovine, imenovane faktor VIII.
Patients with haemophilia A lack factor VIII, a protein needed for blood to clot and, as a result, they bleed readily.
Bolnikom s hemofilijo A primanjkuje faktorja VIII, tj. beljakovine, potrebne za normalno strjevanje krvi, zato hitro zakrvavijo.
Jivi contains the active substance damoctocog alfa pegol.
Zdravilo Jivi vsebuje učinkovino damoktokog alfa pegol.
Annex I List of the names, pharmaceutical form, strength of the medicinal product, route of administration, Marketing Authorisation Holders in the Member States
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
AstraZeneca Oy Itsehallintokuja 4 02600 Espoo Finland
AstraZeneca Oy, Itsehallintokuja 4, 02600 Espoo
Radnička cesta 80 10 000 Zagreb Croatia
AstraZeneca d.o.o., Radnička cesta 80, 10 000 Zagreb, Croatia
Belgium NV AstraZeneca SA Rue Egide van Ophemstraat 110, B-1180 Brussel Belgium
NV AstraZeneca SA, Rue Egide van Ophemstraat, 110, B1180 Brussel
Luxembourg NV AstraZeneca SA Rue Egide van Ophemstraat B-1180 Brussel
NV AstraZeneca SA, Rue Egide van Ophemstraat, B-1180 Brussel Belgium
28033 Madrid
2730-097 Barcarena Portugal
Rua Humberto Madeira, 7 Queluz de baixo 2730-097 Barcarena Portugal
Rua Humberto Madeira, 7, Queluz de baixo
Netherlands AstraZeneca BV Louis Pasteurlaan 5
AstraZeneca BV, Louis Pasteurlaan 5, 2719 EE Zoetermeer, The Netherlands
Plendil 10mg Prolongedrelease, Film-coated Tablets
Plendil 10mg Prolonged-release, Film-coated Tablets
Plendil 2.5mg Prolongedrelease, Film-coated Tablets
Plendil 2.5mg Prolonged-release, Film-coated Tablets
PLENDIL ER 5 mg
PLENDIL ER 5 mg 5 mg
PLENDIL ER 10 mg
PLENDIL ER 10 mg 10 mg
Plendil 5mg Prolongedrelease, Film-coated Tablets
Plendil 5mg Prolonged-release, Film-coated Tablets
Plendil retard 2,5 mgFilmtabletten
Plendil retard 2,5 mg - Filmtabletten
Plendil 5 mg Retard
Plendil 5 mg Retard 5 mg
It must never be given to anyone else.
Nikdar ga ne sme dobiti nihče drug.
This will take about 20 minutes
To bo trajalo približno 20 minut.
There are several reasons why this might happen, for example:
Razlogi za to so različni, na primer:
6 hours.
6 ur
What is done
Kaj bo narejeno
There are also links to other websites about rare diseases and treatments.
, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
Long-term follow-up
Dolgoročno spremljanje
Why
Zakaj
These may affect up to 1 in 10 people.
Pojavijo se lahko pri največ 1 od 10 oseb.
Survival n
Preživetje n
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 26 May 2016
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 26. maj 2016
Milan Italy
Milan Italija
Continued follow-up is recommended.
Priporočljivo je stalno spremljanje.
The presence of the transgene leads to increased expression of ADA.
Prisotnost transgena poveča izražanje ADA.
Patients should be closely monitored for potential catheter-related events.
Bolnike je treba natančno nadzorovati glede možnih dogodkov, povezanih s katetrom.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Ker študij o kompatibilnosti ni, se tega zdravila ne sme mešati z drugimi zdravili.
Patient ID:
ID bolnika:
MARKETING AUTHORISATION NUMBER(S) EU/1/16/1097/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/16/1097/001
If the tests show anything that might affect you (or your child), the doctor will treat you as appropriate.
Če preizkusi pokažejo kar koli, kar bi lahko vplivalo na vas (oz. na vašega otroka), vas bo zdravnik zdravil, kot je potrebno.
Patients are expected to enrol in a post-treatment registry and will be followed-up long term.
Pričakovano je, da se bolniki vključijo v register po zdravljenju in bodo dolgoročno spremljani.
The period of administration is approximately 20 minutes (see section 6.6).
Čas dajanja je približno 20 minut (glejte poglavje 6.6).
This information is provided in the Patient Alert Card.
Ta informacija je navedena na opozorilni kartici bolnika.
The bags must be kept in the outer container until ready to use.
Vrečke je treba hraniti v zunanjem vsebniku, dokler niso pripravljene za uporabo.
The majority of mice showed reconstitution of the haematopoietic system by the end of the study.
Pri večini miši so do konca študije ugotovili obnovo hematopoetskega sistema.
If you have any questions about symptoms or side effects, or if any symptoms concern you
Če imate vprašanja o simptomih ali neželenih učinkih, ali če vas kakšen simptom skrbi
If you are pregnant or breast-feeding, if you think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, o tem obvestite zdravnika, preden dobite to zdravilo.
c Severe infections are those requiring or prolonging hospitalisation.
c Hude okužbe so okužbe, ki zahtevajo sprejem v bolnišnico ali podaljšajo bivanje v bolnišnici.
The physician should monitor and/or treat the patient as appropriate.
Zdravnik mora bolnika nadzorovati in/ali zdraviti, kot je potrebno.
• the backup sample, at least 3 weeks before.
• rezervni vzorec vsaj 3 tedne prej.
ADA activity remained increased throughout the duration of the 3 year follow up.
Aktivnost ADA je ostala večja med celotnim 3-letnim spremljanjem.
They are all caused by the immune system becoming over-active and attacking the body's own tissues.
Vsi so posledica tega, da postane imunski sistem preveč dejaven in napade tkiva lastnega telesa:
Given the small patient population and size of the cohorts, adverse reactions in the table 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 tej preglednici ne dajejo popolnega vpogleda v naravo in pogostnost teh dogodkov.
The infusion rate should not exceed 5 ml/kg/h.
Hitrost infundiranja ne sme preseči 5 ml/kg/uro.
The MAH will also evaluate intervention-free survival.
MAH bo ocenil tudi preživetje brez ukrepanja.
Use of Strimvelis in patients older than those previously studied should be carefully considered and reserved only for occasions where all other reasonable treatment options have been exhausted.
O uporabi zdravila Strimvelis pri bolnikih, ki so starejši, kot so bili raziskani, je treba pazljivo razmisliti in jo pridržati le za primere, ko so izčrpane vse druge smiselne možnosti zdravljenja.
No clinical data on exposed pregnancies are available.
Kliničnih podatkov o izpostavljenih nosečnostih ni.
• if there were not enough of the right type of cells to make the medicine
• če ni bilo dovolj prave vrste celic za izdelavo zdravila,
• the treatment sample, 4 to 5 days before.
• terapevtski vzorec 4 do 5 dni prej.
Patients who previously received PEG-ADA had this treatment withdrawn 10 to 22 days prior to Strimvelis therapy.
Bolnikom, ki so predhodno prejemali PEG-ADA, so to zdravljenje prekinili od 10 do 22 dni pred uporabo zdravila Strimvelis.
Orchard Therapeutics (Netherlands) BV Prins Bernhardplein 200, 1097 JB Amsterdam, the Netherlands
Orchard Therapeutics (Netherlands) BV Prins Bernhardplein 200, 1097 JB Amsterdam, Nizozemska
Rate of severe infections per person-year of observation (95% confidence
Delež hudih okužb na bolnik-leto opazovanja (95-odstotni interval zaupanja)
Immune reconstitution
Imunska obnova
In some cases the patient may be unable to receive Strimvelis because of manufacturing issues.
V nekaterih primerih bolnik ne more dobiti zdravila Strimvelis zaradi težav pri izdelavi.
Strimvelis should only be administered after consultation with the patient and/or family.
Zdravilo Strimvelis se sme uporabiti le po posvetu z bolnikom in/ali njegovo družino.
For more information on what happens before and during treatment, see section 3, How Strimvelis is given.
Za več informacij o dogajanju pred zdravljenjem in med njim glejte 3. poglavje, Kako se daje zdravilo Strimvelis.
• weakness and pain in the feet and hands (Guillain-Barré syndrome)
• šibkost in bolečine v stopalih in dlaneh (Guillain-Barréjev sindrom)
Results at 3 years for the ITT population in the pivotal study*
Rezultati po 3 letih populacije ZNZ v ključni študiji*
Interim registry reports shall be submitted every 2 years.
Vmesna poročila o registrski študiji bodo predložena na 2 leti.
Do not use this medicine after the expiry date and time (EXP) which is stated on the container label and infusion bag label.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti (EXP), ki je naveden na nalepki vsebnika in nalepki infuzijske vrečke.
- The other ingredient is sodium chloride (see section 2, Strimvelis contains sodium).
- Druga sestavina je natrijev klorid (glejte poglavje 2, Zdravilo Strimvelis vsebuje natrij).
The median age across the program was 1.7 years (range 0.5 to 6.1) and 61% were males.
Mediana starost v programu je bila 1,7 let (razpon: od 0,5 do 6,1) in 61 % je bilo moškega spola.
Strimvelis has no or negligible long term influence on the ability to drive and use machines.
Zdravilo Strimvelis nima ali ima zanemarljiv dolgoročen vpliv na sposobnost vožnje in upravljanja s stroji.
No dose adjustment is expected to be required.
Predvidoma odmerka ni treba prilagoditi.
Results at 3 years for patients treated within the pivotal study are presented in Table 1.
Rezultati po 3 letih pri bolnikih, zdravljenih v ključni študiji, so prikazani v preglednici 1.
Positive test for human immunodeficiency virus (HIV) or presence of any other transmissible infectious agent listed in the current EU Cell and Tissue Directive prior to bone marrow harvest.
Pozitiven test za virus humane imunske pomanjkljivosti (HIV) ali prisotnost katerega koli drugega prenosljivega infekcijskega povzročitelja, navedenega v veljavni Direktivi EU o tkivih in celicah pred odvzemom kostnega mozga.
• if there was a delay in the medicine reaching the clinic where treatment is being carried out.
• če je prišlo do zamude med dostavo zdravila v bolnišnico, kjer poteka zdravljenje.
Carcinogenicity studies have not been conducted as no adequate animal model was available to evaluate the tumourigenic potential of Strimvelis due to the inability to achieve long-term engraftment of transduced cells in mice.
Študij kancerogenosti niso izvedli, ker ni ustreznega živalskega modela za oceno tumorigenega potenciala zdravila Strimvelis zaradi nezmožnosti za doseganje dolgoročne vrasti transduciranih celic pri miših.
Work surfaces and material which have potentially been in contact with Strimvelis must be decontaminated with appropriate disinfectant.
Delovne površine in material, ki so lahko bili v stiku z zdravilom Strimvelis, je treba dekontaminirati z ustreznim dezinfekcijskim sredstvom.
Reproductive and developmental studies have not been conducted.
Reproduktivnih in razvojnih študij niso izvedli.
The nature of Strimvelis is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Narava zdravila Strimvelis je takšna, da običajne študije farmakokinetike, absorpcije, porazdelitve, presnove in izločanja ne pridejo v poštev.
Inserting a new gene into the DNA could cause leukaemia.
Vstavitev novega gena v DNA lahko povzročil levkemijo.
Strimvelis should be used with caution in patients older than 6 years and 1 month and younger than 6 months as there are no data from clinical trials in these age ranges.
Zdravilo Strimvelis je treba previdno uporabljati pri bolnikih, starejših od 6 let in 1 meseca, ali mlajših od 6 mesecev, ker iz kliničnih preskušanj ni podatkov o bolnikih zunaj tega starostnega obdobja.
As this medicine will be given by a qualified doctor, they are responsible for correct disposal of the product.
To zdravilo vam bo dal usposobljen zdravnik, je tudi odgovoren za to, da bo zdravilo pravilno zavrženo.
What Strimvelis is and what it is used for 2.
Kaj je zdravilo Strimvelis in za kaj ga uporabljamo 2.
Severe infections n
Hude okužbe n
Eighty three percent were white (56% Caucasian/European heritage and 28% Arabic/North African heritage), 11% African American/African, and 6% Asian.
83 % je bilo belcev (56 % kavkaškega/evropskega porekla in 28 % arabskega/severnoafriškega porekla), 11 % je bilo
Older patients are typically less able to donate high numbers of CD34+ cells which may mean that older patients cannot be treated.
Starejši bolniki imajo praviloma manjšo zmožnost odvzema velikega števila celic CD34+; to lahko pomeni, da starejših bolnikov ni mogoče zdraviti.
UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
EDINSTVENI IDENTIFIKATOR - ČRTNA KODA 2D Navedba smiselno ni potrebna.
The long term effects and durability of response to Strimvelis on ADA-SCID are unknown (see section 5.1).
Dolgoročni vplivi zdravljenja z zdravilom Strimvelis na ADA-SCID in trajnost odziva niso znani (glejte poglavje 5.1).
Stage two quality control results will only be available after the product has been infused.
Rezultati kontrole kakovosti druge faze so na voljo šele po infundiranju zdravila.
Store at 15-30°C.
Shranjujte pri temperaturi od 15 do 30 °C.
About 15 to 30 minutes before treatment
Približno 15 do 30 minut pred zdravljenjem
Patients treated with Strimvelis should not donate blood, organs, tissues and cells for transplantation, at any time in the future.
Bolniki, zdravljeni z zdravilom Strimvelis, ne smejo darovati krvi, organov, tkiv ali celic za presaditev kadarkoli v prihodnosti.
Do not throw away any medicines via wastewater.
Zdravil ne smete odvreči v odpadne vode.
to make the bone marrow ready for Strimvelis
Da bo kostni mozeg pripravljen na zdravilo Strimvelis
Contents of the pack and other information What Strimvelis contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Strimvelis
The final clinical study report should be submitted after the 50th patient has 15 year follow-up visit; Q4 2037.
Končno poročilo o klinični študiji mora biti predloženo potem, ko 50. bolnik opravi obisk po 15 letih spremljanja; 4.
After notification, the treating physician may need to modify the treatment program of the patient accordingly (i.e. terminating the busulfan conditioning and/or administration of the stem cell back up treatment if appropriate).
Po obvestilu o tem bo lečeči zdravnik morda moral ustrezno prilagoditi bolnikov program zdravljenja (tj. končati predpripravo z busulfanom in/ali uporabiti zdravljenje z rezervnimi matičnimi celicami, če je to primerno).