natgillin/translations-raw huggingface dataset:
Cases of skin papillomas, abnormal serum protein electrophoresis and one case each of lipofibroma, pulmonary mass and decreased T-cell V beta repertoire were reported.
Opisani so bili primeri kožnih papilomov, nenormalne elektroforeze beljakovin v serumu ter po en primer lipofibroma, pljučne mase in zmanjšanja repertoarja T-celic V beta.
The MAH will review the occurrence of angioedema, anaphylactic reactions, systemic allergic events and severe cutaneous adverse reactions during the FU period, particularly in those patients who had unsuccessful response and received ERT or SCT.
MAH bo pregledal pojavljanje angioedema, anafilaktičnih reakcij, sistemskih alergijskih dogodkov in hudih kožnih neželenih reakcij med obdobjem spremljanja, zlasti pri bolnikih, pri katerih odziv ni bil uspešen in so prejemali encimsko nadomestno zdravljenje ali so imeli presaditev matičnih celic.
Because it is given soon after it is made, the final results of some of these tests will not be ready before the medicine is given.
je mogoče, da dokončni rezultati nekaterih izmed teh preizkusov niso na voljo pred uporabo zdravila.
• if there was a problem at the time the cells were taken for making the medicine
• če so bile težave ob času odvzema celic za izdelavo zdravila,
Table 2 Rate of severe infections per person year of exposure (pivotal population)* Pre treatment
Delež hudih okužb na oseba-leto izpostavljenosti (ključna populacija)*
In those patients treated in the pivotal study, the rate of severe infections declined throughout the follow-up period (Table 2).
Pri bolnikih, ki so se zdravili v ključni študiji, je delež hudih okužb med obdobjem spremljanja upadal
Read all of this leaflet carefully before you (or your child) are given this medicine because it contains important information for you.
Pred začetkom prejemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
As Strimvelis will be administered following busulfan conditioning, patients of childbearing potential must use reliable barrier contraception during administration of Strimvelis and for at least 6 months afterwards.
Ženske v rodni dobi Ker se zdravilo Strimvelis uporablja po predpripravi z busulfanom, morajo bolnice v rodni dobi uporabljati zanesljivo pregradno kontracepcijsko zaščito med uporabo zdravila Strimvelis in vsaj še 6 mesecev potem.
Adverse events related to the use of central venous catheters (CVCs) have been reported (e.g., serious CVC infections and thrombosis in the device).
Poročali so o neželenih učinkih, povezanih z uporabo centralnih venskih katetrov (npr. resne okužbe centralnega venskega katetra in tromboza v njem).
Strimvelis is made specially for each patient, using the patient's own bone marrow cells.
Zdravilo Strimvelis je izdelano za vsakega bolnika posebej z uporabo njegovih lastnih celic kostnega mozga.
This medicinal product contains 0.15 mmol sodium per ml (see section 4.4).
To zdravilo vsebuje 0,15 mmol natrija na mililiter (glejte poglavje 4.4).
Strimvelis is an autologous cellular therapy.
Zdravilo Strimvelis je avtologno celično zdravljenje.
If it is possible that you could become pregnant, you must use a barrier contraceptive (such as condoms) during treatment and for at least 6 months afterwards.
Če je mogoče, da bi zanosili, morate med zdravljenjem in vsaj še 6 mesecev po zdravljenju porabljati pregradno kontracepcijsko zaščito
Strimvelis is not tested for transmissible infectious agents.
Zdravilo Strimvelis ni testirano za prenosljive infekcijske povzročitelje.
Year 3/ 3 Years Post-Treatmentb
3. leto/3 leta po zdravljenjub
Strimvelis should not be administered to women who are breast-feeding.
Zdravila Strimvelis se ne sme dajati ženskam, ki dojijo.
Strimvelis contains sodium
Zdravilo Strimvelis vsebuje natrij
The infusion bags are provided in a closed container.
Infuzijske vrečke so dobavljene v zaprtem vsebniku.
- Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on it. - Always show the Patient Alert Card to your doctor or nurse when you see them or if you go to hospital.
- Na obisku v ordinaciji ali če greste v bolnišnico, opozorilno kartico bolnika vedno pokažite zdravniku ali medicinski sestri.
Studies evaluated the use of Strimvelis with a range of 0.9 million - 18.2 million CD34+ cells/kg.
Študije so ovrednotile uporabo zdravila Strimvelis v razponu od 0,9 milijona do 18,2 milijona celic CD34+/kg.
A medicine called busulfan is given four times a day for two days (total of 8 doses)
Dva dni boste štirikrat na dan (skupno 8 odmerkov) dobili zdravilo, imenovano busulfan
CD34+ cells derived from healthy human umbilical cord blood, transduced with the vector used for the production of Strimvelis, were administered intravenously to busulfan-conditioned mice.
Celice CD34+, pridobljene iz popkovnične krvi zdravih ljudi in transducirane z vektorjem, ki se uporablja za izdelavo zdravila Strimvelis, so intravensko dali mišim, ki so prehodno kot pripravo prejemale busulfan.
Treatment failure was observed in a patient treated in the clinical trials with <2 millions CD34+cell/kg.
V kliničnih preskušanjih so opažali neuspeh zdravljenja pri bolnikih, zdravljenih z < 2 milijonoma celic CD34+/kg.
If busulfan AUC exceeds 4000 nanograms/ml*h (974 µmol/L.minute), the dose should be appropriately reduced based on the AUC.
Če AUC busulfana preseže 4000 nanogramov/ml*h
Serious adverse reactions include autoimmunity (e.g. autoimmune haemolytic anaemia, autoimmune aplastic anaemia, autoimmune hepatitis, autoimmune thrombocytopenia and Guillain-Barré syndrome).
Med resnimi neželenimi učinki so avtoimunske motnje (npr. avtoimunska hemolitična anemija, avtoimunska aplastična anemija, avtoimunski hepatitis, avtoimunska trombocitopenija in Guillain-Barréjev sindrom).
Patients can develop autoimmunity.
Bolnikom se lahko pojavi avtoimunost.
Before and during Strimvelis treatment
Pred zdravljenjem z zdravilom Strimvelis in med zdravljenjem Kdaj
Some patients have had to resume long-term enzyme replacement therapy and/or receive a stem cell transplant (see section 5.1).
Nekateri bolniki so morali znova začeti uporabljati dolgoročno nadomestno zdravljenje z encimom in/ali opraviti presaditev matičnih celic
Treatment sample of stem cells collected to make Strimvelis (see above)
Za izdelavo zdravila Strimvelis (glejte zgoraj)
Post treatment
Po zdravljenju
Strimvelis can only be made if the doctor can collect enough of the right kind of cells from the patient's own bone marrow.
Zdravilo Strimvelis je mogoče izdelati le, če lahko zdravnik iz bolnikovega kostnega mozga pridobi pravo vrsto celic.
Strimvelis is for intravenous infusion.
Zdravilo Strimvelis je namenjeno za intravensko infundiranje.
• if the medicine got contaminated while it was being made
• če je med izdelavo zdravila prišlo do onesnaženja,
Gently agitate the infusion bag to re-disperse any cellular aggregates, administer using a transfusion administration set with filter to remove any remaining cellular aggregates.
Infuzijsko vrečko previdno obračajte, da boste dispergirali celične skupke, zdravilo pa uporabite po kompletu za dajanje transfuzij s filtrom, da boste odstranili morebitne preostale celične skupke.
restricted prescription details and controlled access/product consent form, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
(MAH) s pristojnim nacionalnim organom uskladiti vsebino in obliko izobraževalnih gradiv za starše/negovalce in zdravstvene delavce, podrobnosti o omejenem predpisovanju in obrazec soglasja o nadzorovanem dostopu/zdravilu, vključno s komunikacijskimi mediji, načinom distribucije in morebitnimi drugimi vidiki programa.
• inflamed itchy skin (atopic dermatitis, eczema)
• vneta, srbeča koža (atopijski dermatitis, ekcem)
This is because Strimvelis is a gene therapy product.
ker je zdravilo Strimvelis zdravilo za gensko zdravljenje.
Negative test results are required on at least 3 sequential occasions over a period of at least 4 weeks, after completion of treatment for hepatitis C, with the final test conducted no more than 3 days prior to cell harvest.
tednov po zaključku zdravljenja za okužbo z virusom hepatitisa C, pri čemer se končni test opravi največ tri dni pred odvzemom celic.
There have been cases where treatment with Strimvelis has been unsuccessful.
Opisani so bili primeri neuspešnega zdravljenja z zdravilom Strimvelis.
Strimvelis is a cloudy to clear, colourless to pink dispersion of cells for infusion, which is supplied in one or more infusion bags.
Izgled zdravila Strimvelis in vsebina pakiranja Zdravilo Strimvelis je motna do bistra, brezbarvna do rožnata disperzija celic za infundiranje, ki je na voljo v eni ali več infuzijskih vrečkah.
An antihistamine medicine may be given to make it less likely that you will react to the infusion
To je zdravilo, ki zmanjša verjetnost reakcij na infuzijo
This medicinal product contains 0.15 mmol sodium per ml.
To zdravilo vsebuje 0,15 mmol natrija na ml.
No immunogenicity testing has been conducted with Strimvelis.
Imunogenega testiranja z zdravilom Strimvelis niso izvedli.
A CD34+ stem cell back-up containing at least 1 million CD34+ cells per kg is required.
Potreben je rezervni vzorec matičnih celic CD34+ z vsaj 1 milijonom celic CD34+ na kilogram.
50 ml ethylene vinyl acetate (EVA) infusion bag, with a luer spike interconnector closed with a luer lock cap, packed in a re-usable outer container.
50-ml infuzijska vrečka iz etilenvinilacetata (EVA) z vmesnim nastavkom luer za iglo, zaprtim s pokrovčkom luer, pakirana v zunanji vsebnik za večkratno uporabo.
The effect on breast-fed infants of administration of Strimvelis to their mothers has not been studied.
Vpliva uporabe zdravila Strimvelis pri materah na dojene dojenčke niso raziskali.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS INFUSION BAG
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH INFUZIJSKA VREČKA
It is recommended that an intravenous antihistamine be administered 15-30 minutes before the infusion of Strimvelis.
Od 15 do 30 minut pred infuzijo zdravila Strimvelis je priporočljivo uporabiti intravenski antihistaminik.
Strimvelis will be administered at a specialist transplant centre, and by physicians with previous experience in the treatment and management of patients with ADA-SCID and the use of autologous CD34+ ex vivo gene therapy products.
Uporaba zdravila Strimvelis bo potekala v specialističnem transplantacijskem centru in ga bodo dajali zdravniki, ki že imajo izkušnje z zdravljenjem in vodenjem bolnikov z ADA-SCID ter z uporabo avtolognih CD34+ terapevtskih izdelkov ex vivo.
Posology The recommended dose range of Strimvelis is between 2 and 20 million CD34+ cells/kg.
Odmerjanje Priporočeni razpon odmerkov zdravila Strimvelis je od 2 do 20 milijonov celic CD34+/kg.
In some cases, it might not be possible to go ahead with the planned treatment with Strimvelis.
Če zdravljenja z zdravilom Strimvelis ni mogoče dokončati V nekaterih primerih načrtovanega zdravljenja z zdravilom Strimvelis ni mogoče nadaljevati.
It is unknown whether Strimvelis is excreted in human milk.
Ni znano, ali se zdravilo Strimvelis izloča v materinem mleku.
Backup sample of stem cells collected to be stored as a backup (see above)
Shranjen bo kot rezerva (glejte zgoraj)
METHOD OF ADMINISTRATION Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo!
NAME OF THE MEDICINAL PRODUCT Strimvelis 1-10 million cells/ml dispersion for infusion.
IME ZDRAVILA Strimvelis 1-10 milijonov celic/ml disperzija za infundiranje
Findings that TREC (T cell receptor excision circles) in peripheral blood lymphocytes were increased above baseline (median 141, range 56 to 1542 copies/100ng DNA) at Years 1 and maintained to 3 post-treatment and that all subjects had evidence of polyclonal V-beta chains at one or more time points following gene therapy provides further supportive evidence of functional T cell development.
Dodatna potrditev razvoja funkcionalnih celic T sta ugotovitvi, da se je TREC (T cell receptor excision circles - izrezni krožci receptorjev celic T) v limfocitih periferne krvi po 1 letu povečal nad izhodiščno vrednost (mediana 141, razpon od 56 do 1542 kopij/100 ng DNA) in se je ohranil do 3. leta po zdravljenju ter da so imeli vsi bolniki ugotovljene poliklonske verige V-beta na eni ali več časovnih točkah po genskem zdravljenju.
Hepatic enzyme increaseda, antinuclear antibody (ANA) positive
Preiskave zvišanje jetrnih encimova, pozitivna protijedrna protitelesa (antinuclear antibodyANA)
Effects on male and female fertility have not been evaluated in animal studies.
V študijah na živalih niso ocenili učinkov na plodnost samcev in samic.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Strimvelis 1-10 million cells/ml dispersion for infusion.
IME ZDRAVILA IN POT(I) UPORABE Strimvelis 1-10 milijonov celic/ml disperzija za infundiranje za intravensko uporabo
However, vector insertions into chromosomal regions previously associated with leukaemia in comparable trials of gene therapy in Wiskott Aldrich Syndrome, X-SCID and Chronic Granulomatous Disease have been documented.
Vendar pa so bili v primerljivih preskušanjih genskega zdravljenja pri Wiskott-Aldrichevem sindromu, X-SCID in kronični granulomatozni bolezni dokumentirani primeri vstavitve vektorja v kromosomske regije, predhodno povezane z levkemijo.
The infusion bag is placed inside a closed outer container.
Infuzijska vrečka je položena v zaprt zunanji vsebnik.
This should be taken into consideration by patients on a controlled sodium diet.
To je treba upoštevati pri bolnikih na dieti z omejitvijo natrija.
Bag No.:
Št. vrečke:
How to store Strimvelis
Kako se daje zdravilo Strimvelis
Antineutrophil cytoplasmic antibody positive, smooth muscle antibody positive aAdverse reactions considered potentially related to busulfan conditioning
pozitivna protinevtrofilna citoplazemska protitelesa, pozitivna protitelesa proti gladkim mišicam aNeželeni učinki, za katere velja, da so morda povezani s predpripravo z busulfanom.
The MAH shall complete, within the stated timeframe, the below measure:
Imetnik dovoljenja za promet mora v določenem časovnem okviru izvesti naslednje ukrepe:
After infusion, CD34+ cells engraft in the bone marrow where they repopulate the haematopoetic system with a proportion of cells that express pharmacologically active levels of the ADA enzyme.
Po infundiranju se celice CD34+ vrastejo v kostnem mozgu in v hematopoetskem sistemu ustvarijo delež celic z izraženo farmakološko aktivno ravnjo encima ADA.
Current or previous history of leukaemia or myelodysplasia.
Levkemija ali mielodisplazija trenutno ali kdaj v preteklosti.
Interventionfree survival in this pivotal population (defined as survival without the requirement for long-term (≥3 month) re-introduction of PEG-ADA, or stem cell transplant) was 92% (11/12 subjects) (82% (14/17 subjects) for integrated population).
ponovni uvedbi PEG-ADA in brez potrebe po presaditvi matičnih celic) 92 % (11/12 bolnikov) (82 %
Pharmacotherapeutic group: Immunostimulants, other immunostimulants , ATC code: not yet assigned
Farmakoterapevtska skupina: zdravila za spodbujanje imunske odzivnosti, druga zdravila za spodbujanje imunske odzivnosti.
Following administration, a saline filled 50 ml syringe should be used to flush the bag through.
Po uporabi je treba vrečko izprati s 50-ml brizgo s fiziološko raztopino.
The identity of the patient must be matched with the essential unique patient information on the primary and/or outer container prior to infusion.
Identiteto bolnika je treba pred infundiranjem preveriti s primerjavo ključnih edinstvenih bolnikovih informacij na primarni in/ali zunanji ovojnini.
Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Seznam neželenih učinkov v preglednici Neželeni učinki so navedeni spodaj po organskih sistemih MedDRA in pogostnosti.
• reduced numbers of blood cells (autoimmune haemolytic anaemia, autoimmune aplastic anaemia)
• zmanjšano število rdečih krvnih celic (avtoimunska hemolitična anemija, avtoimunska aplastična anemija)
• blood test results positive for antineutrophil cytoplasmic antibody and smooth muscle antibody
• rezultati preiskav krvi (pozitivni za protinevtrofilna citoplazemska protitelesa, protitelesa proti gladkim mišicam)
Treatment with Strimvelis resulted in a 100% survival rate at 3 years post therapy, a decrease in the severe infection rate, an increase in T-lymphocytes (CD3+) and all subjects having post-baseline venous red blood cell deoxyadenosine nucleotide (RBC dAXP) levels below pathological levels (>100 nmol/ml).
Delež hudih okužb se je zmanjšal, število limfocitov T (CD3+) se je povečalo in vsi bolniki so imeli poizhodiščno koncentracijo deoksiadenozinnukleotida v venskih eritrocitih (RBC dAXP) pod patološko vrednostjo (> 100 nmol/ml).
Reproductive and developmental toxicity studies were not performed.
Študij škodljivega učinka na sposobnost razmnoževanja in razvojne toksičnosti niso izvedli.
Before Strimvelis is made, the doctor will do tests to make sure that you (or your child) are not carrying certain infections (see section 2).
Pred izdelavo zdravila Strimvelis bo zdravnik opravil preizkuse, s katerimi bo preveril, da niste nosilec (oz.
CD34+ cells/kg:
Celotno število celic: x 106 celic CD34+/kg:
Strimvelis has not been studied in patients with renal impairment.
Zdravilo Strimvelis ni raziskano pri bolnikih z okvaro ledvic.
No evidence of causality to the product has been established.
Vzročna povezanost z zdravilom ni bila ugotovljena.
The safety and efficacy of Strimvelis in children less than six months of age or over 6 years 1 month has not been established (see section 4.4).
Pediatrična populacija Varnost in učinkovitost zdravila Strimvelis pri otrocih, mlajših od 6 mesecev ali starejših od 6 let in 1
Hypothyroidism Autoimmune thyroiditis
Bolezni endokrinega sistema hipotiroidizem avtoimunski tiroiditis
Another subject needed transient PEG-ADA administration due to an autoimmune event (see section 4.4).
PEG-ADA. Drug bolnik je prehodno potreboval PEG-ADA zaradi avtoimunskega dogodka (glejte poglavje
Following successful engraftment in the patient, the effects of the product are expected to be life-long.
Pričakovano je, da učinki zdravila po uspešni vrasti ("engraftment") trajajo vse življenje.
An autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence with a concentration of 1-10 million CD34+ cells/ml.
Avtologna, s CD34+ obogatena celična frakcija s celicami CD34+, transduciranimi z retrovirusnim vektorjem, ki kodira zaporedje človeške ADA cDNA, s koncentracijo 1-10 milijonov celic CD34+/ml.
Pre-treatment conditioning
Predpriprava pred zdravljenjem
All these patients had previously taken PEG-ADA.
Vsi ti bolniki so predhodno uporabljali
Strimvelis goes through a range of tests before it is used.
Morda boste potrebovali drugo zdravljenje Zdravilo Strimvelis je pred uporabo podvrženo številnim preizkusom.
The educational materials should address the following safety concerns/key elements: Autoimmunity, Unsuccessful response to gene therapy, and Malignancy due to insertional oncogenesis (e.g. leukaemia, myelodysplasia).
neuspešen odziv na gensko zdravljenje in malignost zaradi insercijske onkogeneze (npr. levkemija, mielodisplazija).
• inflamed liver (autoimmune hepatitis)
• vnetje jeter (avtoimunski hepatitis)
One year post treatment, median ADA activity (mononuclear cells adenosine deaminase) in peripheral blood lymphocytes was 181.2 (range 42.11678.2) nmol/h/mg protein, compared to a baseline median (range) of 80.6 (30.5-92.3) nmol/h/mg protein.
1678,2) nmol/h/mg beljakovin; izhodiščno je bila ta aktivnost (razpon) 80,6 (30,5-92,3) nmol/h/mg beljakovin.
Strimvelis is transported directly to the medical facility where the infusion will be administered.
Naslednje informacije so namenjene samo zdravstvenemu osebju: Zdravilo Strimvelis se transportira neposredno v zdravstveno ustanovo, v kateri bo infundirano.
The identity of the patient must be matched with the essential unique patient information on the infusion bag(s) and/or outer container prior to infusion.
Identiteto bolnika je treba pred infundiranjem preveriti s primerjavo ključnih edinstvenih bolnikovih informacij na infuzijski vrečki/infuzijskih vrečkah in/ali zunanjem vsebniku.
No. of severe infections
Št. hudih okužb 29
Patients who have previously tested positive for hepatitis C can be treated with Strimvelis, provided they demonstrate absence of ongoing infection using a nucleic acid test with a limit of quantification of ≤15 international units/ml.
Strimvelis, če je z uporabo testa za nukleinske kisline z mejo določljivosti ≤15 IE/ml, dokazana odsotnost potekajoče okužbe.
Name and address of the manufacturer responsible for batch release MolMed SpA
Ime in naslov izdelovalca, odgovornega za sproščanje serij
Non-interventional PASS: In order to investigate the long term safety and efficacy of Strimvelis gene therapy, the MAH should conduct and submit the results of a long term prospective, non-interventional follow up study using data from a registry of patients with adenosine deaminase severe combined immunodeficiency (ADA-SCID) treated with Strimvelis.
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet: Za proučitev dolgoročne varnosti in učinkovitosti genskega zdravljenja z zdravilom Strimvelis mora MAH izvesti in predložiti rezultate dolgoročne prospektivne,
Strimvelis has not been studied in patients with hepatic impairment.
Zdravilo Strimvelis ni raziskano pri bolnikih z okvaro jeter.
The 3 month hospitalisation period immediately post gene therapy was excluded from the calculation d dAXP=dAMP+dADP+dATP.
d dAXP = dAMP + dADP + dATP.
The infusion bag(s) is/are placed inside a closed outer container.
Infuzijska vrečka/infuzijske vrečke je/so položena/položene v zaprt zunanji vsebnik.
Strimvelis is used to treat a serious condition called ADA-SCID (Adenosine Deaminase-Severe Combined Immune Deficiency).
Zdravilo Strimvelis se uporablja za zdravljenje resne motnje, hude kombinirane imunske pomanjkljivosti s pomanjkanjem adenozin deaminaze, ki jo pogosto označujejo z angleško kratico ADA-SCID (Adenosine
• inflamed thyroid gland (autoimmune thyroiditis)
• vnetje žleze ščitnice (avtoimunski tiroiditis)
No cases of leukaemia or myelodysplasia have been reported following treatment with Strimvelis.
Po zdravljenju z zdravilom Strimvelis ni bilo zabeleženih primerov levkemije ali mielodisplazije.
- The active substance is autologous (the patient's own) CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence.
- Zdravilna učinkovina je avtologna (bolniku lastna), s CD34+ obogatena celična frakcija s celicami CD34+, transduciranimi z retrovirusnim vektorjem, ki kodira zaporedje človeške ADA cDNA.
Asthma, rhinitis allergic
Bolezni dihal, prsnega koša in mediastinalnega prostora astma, alergijski rinitis
Time period (Years)
Obdobje (leta) n/a
Strimvelis is a type of medicine called a gene therapy.
Kaj je zdravilo Strimvelis in za kaj ga uporabljamo Zdravilo Strimvelis spada med zdravila, ki se uporabljajo za t. i. gensko zdravljenje.
Vascular disorders
avtoimunska trombocitopenija
Autoimmune hepatitis
Žilne bolezni hipertenzijaa
Also contains sodium chloride.
SEZNAM POMOŽNIH SNOVI Vsebuje tudi natrijev klorid.
x 106
četrtletje 2037.
Dispersion for infusion.
z infuzijo v veno.
Exp.: {DD MMM YY} {hh:mm} SPECIAL STORAGE CONDITIONS
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA Exp.: {DD MMM LL} {hh:mm}
An autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells.
2.1 Splošen opis Avtologna, s CD34+ obogatena celična frakcija s celicami CD34+, transduciranimi z retrovirusnim vektorjem, ki kodira zaporedje človeške adenozin deaminaze (ADA) cDNA iz človeških hematopoetskih matičnih/predhodniških celic (CD34+).
• underactive thyroid gland (hypothyroidism)
• premalo dejavna žleza ščitnica (hipotiroidizem)