natgillin/translations-raw huggingface dataset:
Other ingredients: hydrochloric acid 3.7% and/ or sodium hydroxide (to adjust pH), water for injections.
Pomožne snovi: klorovodikova kislina 3, 7% ali/ in natrijev hidroksid (za prilagoditev pH), voda za injekcije.
See leaflet for further information.
Opozorila in dodatne informacije so navedene v navodilu za uporabo.
IV Intravenous use.
Intravenska uporaba.
18 Store below 30 °C.
POSEBNA NAVODILA ZA SHRANJEVANJE 19 Shranjujte pri temperaturi do 30 °C.
After first opening and dilution, store at 2-8 °C and use within 24 hours.
Po prvem odprtju in razredčitvi shranjujte pri temperaturi 2- 8 °C in uporabite v 24 urah.
Organon Kloosterstraat 6 5349 AB Oss The Netherlands
Organon Kloosterstraat 6 5349 AB Oss Nizozemska
19 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
20 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL LABEL, 10 x 5 ml vials
OZNAČEVANJE NA VIALI, 10 vial po 5 ml
Bridion 100 mg/ ml injection sugammadex IV
Bridion 100 mg/ ml injekcija sugamadeks i. v.
20 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
21 PODATKI NA ZUNANJI OVOJNINI
OUTER CARTON, 10 x 2 ml vials
ŠKATLA 10 vial po 2 ml
21 Store below 30 °C.
POSEBNA NAVODILA ZA SHRANJEVANJE 22 Shranjujte pri temperaturi do 30 °C.
22 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VIAL LABEL, 10 x 2 ml vials
OZNAČEVANJE NA VIALI, 10 vial po 2 ml
Read all of this leaflet carefully before you are given this medicine. • Keep this leaflet.
Predno vam bodo dali zdravilo natančno preberite navodilo! • Navodilo shranite.
You may need to read it again. • If you have further questions, ask your anaesthetist. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your anaesthetist or other doctor.
Morda ga boste želeli ponovno prebrati. • Če imate dodatna vprašanja, se posvetujte z anestezistom. • Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega anestezista ali katerega drugega zdravnika.
What Bridion is and what it is used for 2.
Kaj je zdravilo Bridion in za kaj ga uporabljamo 2.
Before Bridon is given 3.
Kaj morate vedeti, preden vam bo dano zdravilo Bridion 3.
How Bridion is given 4.
Kako dajati zdravilo Bridion 4.
How Bridion is stored 6.
Kako je shranjeno zdravilo Bridion 6.
WHAT BRIDION IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO BRIDION IN ZA KAJ GA UPORABLJAMO
Bridion is one of a group of medicines called Selective Relaxant Binding Agents.
Bridion sodi v skupino zdravil, ki jim pravimo selektivni vezalci relaksantov.
It is used to speed up the recovery of your muscles after an operation.
Uporabljamo ga za pospešeno odpravo ohlapnosti mišic po operaciji.
This makes it easier for the surgeon to do the operation.
Pri nekaterih vrstah operacij morajo biti bolnikove mišice popolnoma sproščene, da bi kirurg lažje operiral.
Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again.
Ker pa mišični relaksanti sprostijo tudi dihalne mišice, potrebuje bolnik med operacijo in po njej pomoč pri dihanju (umetno ventilacijo) tako dolgo, dokler ni spet zmožen dihati samostojno.
Bridion is used to stop muscle relaxants working.
Zdravilo Bridion uporabljamo za ustavitev delovanja mišičnih relaksantov.
Bridion is given to speed up your recovery from the muscle relaxant – for example, at the end of an operation to allow you to breathe normally earlier.
Bridion uporabljamo za pospešitev okrevanja od delovanja mišičnega relaksanta, na primer na koncu operacije, da bi bolnik lahko prej začel normalno dihati.
BEFORE BRIDION IS GIVEN
KAJ MORATE VEDETI, PREDEN VAM BO DANO ZDRAVILO BRIDION
You should not be given Bridion • if you are allergic (hypersensitve) to sugammadex or any of the other ingredients. → Tell your anaesthetist if this applies to you.
Zdravilo Bridion vam ne smejo dati • če ste alergični na (preobčutljivi za) sugamadeks ali katerokoli sestavino zdravila. → Če to velja za vas, morate obvestiti svojega anestezista.
This is important as Bridion is removed from your body by the kidneys. • if you have heart disease or have had it in the past. • if you have liver disease or have had it in the past. • if you have fluid retention (oedema). • if you are on a controlled salt diet. → Tell your anaesthetist if any of the above applies to you.
Bodite posebno pozorni pri prejemu zdravila Bridion Preden prejmete to zdravilo, mora vaš anestezist vedeti: • če imate ali ste imeli kdaj v preteklosti ledvično bolezen - to je pomembno, ker se zdravilo Bridion odstranjuje iz telesa z ledvicami, • če imate ali ste imeli kdaj v preteklosti bolezni srca, • če imate ali ste imeli kdaj v preteklosti bolezni jeter, • če imate zastajanje tekočine v telesu (edem), • če ste na dieti z omejeno količino natrija. → Če to velja za vas, morate obvestiti svojega anestezista.
Taking other medicines → Please tell your anaesthetist if you are taking or have recently taken other medicines, including medicines obtained without a prescription or herbal products.
To se nanaša tudi na zdravila ali zeliščne pripravke, ki ste jih dobili brez recepta.
Bridion may affect other medicines or be affected by them.
Zdravilo Bridion lahko namreč vpliva na druga zdravila in druga zdravila lahko vplivajo nanj.
25 Some medicines reduce the effect of Bridion → It is especially important that you tell your anaesthetist if you have recently taken: • toremifene (used to treat breast cancer). • flucloxacillin (an antibiotic). • fusidic acid (an antibiotic).
Nekatera zdravila zmanjšajo učinek zdravila Bridion → Izredno pomembno je, da anestezistu poveste, če ste pred kratkim jemali: • toremifen (ki ga uporabljamo za zdravljenje raka dojk), • flukloksacilin (antibiotik), • fusidinsko kislino (antibiotik).
Bridion can affect hormonal contraceptives • Bridion can make hormonal contraceptives - including the ‘ Pill’, vaginal ring, implants or a hormonal IntraUterine System (IUS) - less effective because it reduces how much you get of the progestogen hormone.
Zdravilo Bridion lahko vpliva na hormonske kontraceptive • Zdravilo Bridion lahko zmanjša učinkovitost hormonskih kontraceptivov - vključno "tabletke", vaginalnega obročka, implantatov (vsadkov) ali hormonskih znotrajmaterničnih sistemov (IUS),
The amount of progestogen lost by using Bridion is about the same as missing one oral contraceptive Pill. → If you are taking the Pill on the same day as Bridion is given to you, follow the instructions for a missed dose in the Pill’ s package leaflet. → If you are using other hormonal contraceptives (for example a vaginal ring, implant or IUS) you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the advice in the package leaflet.
pri uporabi zdravila Bridion, je približno enaka, kot če bolnica pozabi vzeti eno peroralno kontracepcijsko tabletko. → Če vzamete tabletko isti dan, ko prejmete zdravilo Bridion, upoštevajte navodila za ravnanje v primeru izpuščenega odmerka, ki so podana v priloženem navodilu za uporabo tabletk. → Če uporabljate druga hormonska kontracepcijska sredstva (na primer vaginalni obroček, vsadek ali znotrajmaternični sistem), morate v naslednjih 7 dneh dodatno uporabljati katero od nehormonskih kontracepcijskih metod (na primer kondom) in upoštevati nasvete iz priloženega navodila za uporabo.
However, it may affect the results of a blood test for a hormone called progesterone and some blood clotting tests.
Vpliv na krvne preiskave Zdravilo Bridion na splošno ne vpliva na laboratorijske preiskave, lahko pa vpliva na izvide krvnih preiskav za določanje hormona progesterona in na nekatere preiskave strjevanja krvi.
Pregnancy and breast-feeding → Tell your anaesthetist if you are pregnant or might be pregnant.
Nosečnost in dojenje → Povejte anestezistu, če ste noseči ali bi lahko bili noseči.
Sugammadex can be used during breast-feeding.
Sugamadeks se lahko uporablja med dojenjem.
Driving and using machines Your doctor will tell you when it is safe to drive or operate machinery after you have been given Bridion.
Vpliv na sposobnost upravljanja vozil in strojev Zdravnik vam bo povedal, kdaj lahko spet varno vozite in upravljate s stroji po prejemu zdravila Bridion.
Bridion is not known to have an effect on alertness or concentration.
Kolikor je znano, zdravilo Bridion ne vpliva na budnost ali na koncentracijo.
HOW BRIDION IS GIVEN
KAKO DAJATI ZDRAVILO BRIDION
The dose Your anaesthetist will work out the dose of Bridion you need based on: • your weight • how much the muscle relaxant medicine is still affecting you.
Odmerek Odmerek zdravila Bridion, ki ga potrebujete, bo določil anestezist na podlagi: • vaše telesne mase, • tega koliko ste še pod vplivom mišičnega relaksanta.
A higher dose may be given if the anaesthetist wants you to recover faster.
Če bo anestezist želel, da se prej zbudite iz anestezije, bo uporabil večji odmerek zdravila.
The dose of Bridion for children is 2 mg/ kg (children and adolescents between 2-17 years old).
Odmerek zdravila Bridion za otroke je 2 mg/ kg (otroci in mladostniki stari 2 – 17 let).
How Bridion is given Bridion will be given to you by your anaesthetist.
Kako uporabljati zdravilo Bridion Zdravilo Bridion vam bo dal anestezist.
It is given into a vein (intravenously) as a single injection.
Zdravilo dajemo v veno (intravensko) z enkratno injekcijo.
But even if this happens, it is unlikely to cause any problems.
Če ste prejeli večji odmerek zdravila Bridion, kot je priporočljivo Ker bo anestezist natančno spremljal vaše stanje, je malo verjetno, da boste prejeli preveč zdravila Bridion, in tudi če se to zgodi, verjetno ne bo povzročilo nikakršnih težav.
If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.
27 Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom ali s farmacevtom.
Like all medicines, Bridion can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Bridion neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
26 If these side effects occur while you are under anaesthesic, they will be seen and treated by your anaesthetist.
Če se v času anestezije pri vas pojavijo naslednji neželeni učinki, jih bo ugotovil in zdravil anestezist.
Very common side effects (in more than 1 user in 10) • A temporary unpleasant taste in your mouth.
Zelo pogosti neželeni učinki (pojavljajo se pri več kot 1 uporabniku na 10 uporabnikov) • začasen pojav neprijetnega okusa v ustih
Common side effects (in 1 to 10 users in 100) • Light anaesthesia - you may start to come out of deep sleep, so need more anaesthetic.
Pogosti neželeni učinki (pojavljajp se pri 1 do 10 uporabnikov na 100 uporabnikov) • Blaga anestezija - lahko se boste začeli zbujati iz globokega spanca in boste potrebovali več anestetika.
This might cause you to move or cough at the end of the operation. • Your muscles may turn weak again after the operation (if a too low dose is administered).
Zaradi tega se boste morda tudi premaknili ali zakašljali ob koncu operacije. • Po operaciji bodo lahko vaše mišice spet postale šibke (če ste prejeli premajhen odmerek).
Uncommon side effects (in 1 to 10 users in 1,000) • Being awake during the operation (anaesthesia awareness) • Shortness of breath due to muscle cramps of the airways (bronchospasm) occurred in patients with a history of asthma • Allergic (hypersensitivity) reactions - such as a rash or red skin.
Občasni neželeni učinki (pojavljajo se pri 1 do 10 uporabnikov na 1. 000 uporabnikov) • Budnost bolnika med operacijo (zavedanje v času anestezije). • Težko dihanje zaradi krča mišic v dihalnih poteh (bronhospazem), ki se pojavlja pri bolnikih z astmo v preteklosti, • Alergične (preobčutljivostne) reakcije, na primer izpuščaj ali pordela koža.
HOW BRIDION IS STORED
KAKO JE SHRANJENO ZDRAVILO BRIDION
Do not use Bridion after the expiry date which is stated on the vial and the carton.
Zdravila Bridion ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in na škatli.
After first opening and dilution, store at 2 to 8 °C and use within 24 hours.
Po prvem odprtju in razredčitvi shranjujte pri temperaturi 2- 8 °C in uporabite v 24 urah.
What Bridion contains
Kaj vsebuje zdravilo Bridion
- The active substance is sugammadex.
- Zdravilna učinkovina je sugamadeks.
1 ml solution for injection contains 100 mg sugammadex (as sodium salt)
1 ml raztopine za injiciranje vsebuje 100 mg sugamadeksa (v obliki natrijeve soli).
- The other ingredients are water for injections, hydrochloric acid 3.7% and/ or sodium hydroxide
- Pomožne snovi so voda za injekcije, klorovodikova kislina 3, 7% ali/ in natrijev hidroksid (za
(to adjust pH).
prilagoditev pH).
It comes in two different pack sizes, containing either 10 vials with 2 ml or 10 vials with 5 ml solution for injection.
Na voljo je v dveh velikostih pakiranja, ki vsebujeta bodisi 10 vial po 2 ml ali 10 vial po 5 ml raztopine za injiciranje.
Marketing Authorisation Holder and Manufacturer N. V.
28 Imetnik dovoljenja za promet z zdravilom in izdelovalec N. V.
Manufacturers • N. V.
Izdelovalci • N. V.
Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands • Organon (Ireland) Ltd., Drynam Road, Swords, Co.
Organon, Kloosterstraat 6, 5349 AB Oss, Nizozemska • Organon (Ireland) Ltd., Drynam Road, Swords, Co.
27 Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu
--------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
--------------------------------------------------------------------------------------------------------------------------- Naslednje informacije so namenjene samo zdravstvenemu osebju:
Busilvex is a concentrate to be made up into a solution for infusion (drip into a vein).
Zdravilo Busilvex je koncentrat za pripravo raztopine za infundiranje (dajanje v veno).
What is Busilvex used for?
Za kaj se uporablja zdravilo Busilvex?
Busilvex is used in adults and children as a ‘ conditioning’ (preparative) treatment before transplantation of haematopoietic progenitor cells (the cells that make blood cells).
Zdravilo Busilvex se uporablja pri odraslih in otrocih kot pripravljalna terapija pred presaditvijo hematopoetskih progenskih celic (krvotvornih celice).
This type of transplant is used in patients who need to replace their blood-making cells, because they have a blood disorder (such as a rare type of anaemia) or a cancer of the blood.
Ta vrsta presaditve se uporablja pri bolnikih, ki potrebujejo zamenjavo krvotvornih celic, ker imajo krvno motnjo (kot npr. redko vrsto anemije) ali krvnega raka.
Busilvex treatment is followed by treatment with another medicine (cyclophosphamide in adults, and cyclophosphamide or melphalan in children).
Terapiji z zdravilom Busilvex sledi zdravljenje z drugim zdravilom (ciklofosfamidom pri odraslih ter ciklofosfamidom ali melfalanom pri otrocih).
Because of the number of patients in the European Union (EU) that undergo this type of conditioning and transplant is low, busulfan was designated as an ‘ orphan medicine’ (a medicine used in rare diseases) on 29 December 2000.
Ker je število bolnikov v Evropski uniji (EU), ki prejemajo tovrstno terapijo in presaditev, majhno, je bil busulfan dne 29. decembra 2000 določen kot zdravilo sirota (zdravilo, ki se uporablja pri redkih boleznih).
Busilvex should be used by a doctor who has experience in treatments given before transplantation.
Zdravilo Busilvex mora uporabljati zdravnik z izkušnjami pri pripravljalnih terapijah, ki jim sledi presaditev.
The recommended dose of Busilvex in adults is 0.8 mg per kilogram body weight.
Priporočeni odmerek zdravila Busilvex pri odraslih je 0, 8 mg na kilogram telesne mase.
In children up to 17 years of age, the recommended dose of Busilvex is based on the weight of the child and varies between 0.8 and 1.2 mg/ kg.
Pri otrocih, starih do 17 let, je priporočeni odmerek zdravila Busilvex odvisen od telesne mase otroka in se giblje med 0, 8 in 1, 2 mg/ kg.
Busilvex is given as a central intravenous infusion (drip into a central vein in the chest).
Zdravilo Busilvex se daje kot intravenska infuzija skozi centralni venski kateter (dajanje v centralno veno prsnega koša).
Each infusion lasts for two hours and it is given to the patient every six hours on four consecutive days before treatment with cyclophosphamide or melphalan and the transplant.
Vsaka infuzija traja dve uri, bolnik pa jo prejme vsakih šest ur v obdobju štirih zaporednih dni pred terapijo s ciklofosfamidom ali melfalanom in presaditvijo.
Before receiving Busilvex, patients are given anticonvulsive medicines (to prevent seizures) and anti-emetic medicines (to prevent vomiting).
Pred prejetjem zdravila Busilvex prejmejo bolniki zdravila proti konvulzijam (za preprečitev epileptičnih napadov) in antiemetike (za preprečitev bruhanja).
The active substance in Busilvex, busulfan, belongs to a group of medicines called ‘ alkylating agents’.
Zdravilna učinkovina busulfan v zdravilu Busilvex spada v skupino zdravil, imenovanih „ alkilirajoče učinkovine “.
These substances are ‘ cytotoxic’.
Te učinkovine so „ citotoksične “.
This means that they kill cells, especially cells that develop rapidly, such as cancer or progenitor (or ‘ stem ’) cells (cells that make other types of cell).
To pomeni, da uničujejo celice, še posebej hitro razvijajoče se celice, kot so npr. rakave ali progenske (ali „ matične “) celice (celice, ki tvorijo druge vrste celic).
Busulfan is used before transplantation to destroy abnormal cells and the patient ’ s existing haematopoietic progenitor cells.
Busulfan se uporablja pred presaditvijo z namenom uničiti nenormalne celice in obstoječe bolnikove hematopoetske progenske celice.
This is called ‘ myeloablation’.
To se imenuje „ mieloablacija “.
Cyclophosphamide or melphalan is then used to suppress the 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Zatem se z namenom zaviranja delovanja imunskega sistema uporabi ciklofosfamid ali melfalan, s čimer se zmanjša naravna 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. immune system, so that the body ’ s natural defences are decreased.
Reproduction is authorised provided the source is acknowledged. obramba telesa.
This helps the transplanted cells to ‘ engraft ’ (when they start to grow and produce normal blood cells).
To pomaga presajenim celicam, da se „ primejo “ (celice začnejo rasti in proizvajati normalne krvne celice).
The effects of Busilvex were first tested in experimental models before being studied in humans.
Učinki zdravila Busilvex so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The applicant also presented data from the scientific literature.
Predlagatelj je predstavil tudi podatke iz znanstvene literature.
Busilvex has been studied in patients, mainly with blood cancer, who needed transplantation of haematopoietic progenitor cells.
Zdravilo Busilvex je bilo raziskano večinoma pri bolnikih s krvnim rakom, ki so potrebovali presaditev hematopoetskih progenskih celic.
The main measures of effectiveness were the number of patients with myeloablation (with reduced counts of white blood cells and platelets) and ‘ engraftment’ (the time for the white blood cells to return to higher levels).
Glavni merili učinkovitosti sta bili število bolnikov z mieloablacijo (zmanjšanim številom belih krvnih celic in krvnih ploščic) in „ prijetje presadka “ (čas, potreben za vrnitev števila belih krvnih celic na višjo raven).
All adults and children achieved myeloablation.
Pri vseh odraslih in otrocih je prišlo do mieloablacije.
On average, engraftment was reached in 10 days in adults and 11 days in children with ‘ autotransplantation’ (when the patient receives their own cells, harvested and stored before the transplant).
V primeru „ avtotransplantacije “ (ko bolnik prejme svoje lastne celice, ki so bile odvzete in shranjene pred presaditvijo) je bilo prijetje v povprečju doseženo v 10 dneh pri odraslih oz. v 11 dneh pri otrocih.
Engraftment was obtained in 13 days in adults and 21 days in children with ‘ allotransplantation’ (when the patient receives cells from a donor).
V primeru „ alotransplantacije “ (ko bolnik prejme celice donatorja) je bilo prijetje doseženo v 13 dneh pri odraslih oz. v 21 dneh pri otrocih.
Apart from the decrease in blood cell counts, which this is the intended effect of the medicine, the most serious side effects of Busilvex are infection, liver disorders including blocking of a liver vein, graft versus host disease (when the transplanted cells attack the body) and respiratory (lung) disorders.
Razen zmanjšanja števila krvnih celic v obtoku, kar je tudi nameravani učinek zdravila, so najresnejši neželeni učinki zdravila Busilvex okužbe, motnje delovanja jeter, vključno z blokado jetrne vene, bolezni presadka proti gostitelju (ko presajene celice napadejo telo) in pljučni zapleti.
For the full list of all side effects reported with Busilvex, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Busilvex, glejte navodilo za uporabo.
Busilvex should not be used in people who may be hypersensitive (allergic) to busulfan or any of the other ingredients.
Zdravila Busilvex ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) busulfan ali katero koli drugo sestavino zdravila.
It must not be used in women who are pregnant.
Ne smejo ga uporabljati nosečnice.
Breast-feeding should be stopped when treatment with Busilvex is started.
Ženske, ki dojijo, morajo ob uvedbi zdravila Busilvex, prenehati z dojenjem.
Because of this, female patients should not become pregnant during treatment and for up to six months afterwards, and male patients are advised not to father a child during and for up to six months after treatment with Busilvex.
Zaradi tega bolnice ne smejo zanositi med zdravljenjem in do šest mesecev po njem, moškim pa se svetuje, da ne spočnejo otroka med zdravljenjem z zdravilom Busilvex in do šest mesecev po njem.
Caution is needed when Busilvex is used at the same time as other medicines, such as itraconazole (used to treat some infections), ketobemidone (used to treat pain) and paracetamol.
Previdnost je potrebna pri sočasni uporabi zdravila Busilvex in drugih zdravil, kot npr. itrakonazola (ki se uporablja za zdravljenje okužb), ketobemidona (ki se uporablja za lajšanje bolečin) in paracetamola.
See the Package Leaflet for full details.
Za podrobnosti glejte navodilo za uporabo.
The Committee for Medicinal Products for Human Use (CHMP) concluded that the effectiveness of Busilvex had been shown, and that it provides an alternative to busulfan tablets, which have disadvantages such as the large number of tablets that need to be taken.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bila učinkovitost zdravila Busilvex dokazana in da zdravilo predstavlja alternativo busulfanu v tabletah, katerih slabost je veliko število tablet, ki jih je treba zaužiti.
The Committee decided that Busilvex’ s benefits are greater than its risks as conditioning treatment prior to haematopoietic progenitor cell transplantation.
Odbor je zaključil, da so koristi zdravila Busilvex kot pripravljalne terapije pred presaditvijo hematopoetskih progenskih celic večje od z njim povezanih tveganj.
The Committee recommended that Busilvex be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Busilvex odobri dovoljenje za promet.
Other information about Busilvex:
Druge informacije o zdravilu Busilvex: