natgillin/translations-raw huggingface dataset:
80 Types of safety syringe There are two types of safety syringes used for Arixtra, designed to protect you from needle stick injuries following injection.
81 Vrste varnostnih brizg Za uporabo zdravila Arixtra sta na voljo dve vrsti varnostnih brizg, ki sta zasnovani tako, da preprečita vbodne poškodbe po injiciranju zdravila.
1 Needle guard 2 Plunger 3 Finger-grip 4 Security sleeve
Ščitnik igle 1 Bat 2 Držalo za prste 3 Varnostni tulec 4
STEP BY STEP GUIDE TO USING ARIXTRA
POSTOPNA NAVODILA ZA UPORABO ZDRAVILA ARIXTRA
Instructions for use These instructions are for both types of syringes (automatic and manual needle protection system).
Navodila za uporabo Ta navodila veljajo za obe vrsti injekcijskih brizg (s samodejnim in ročnim sistemom za zaščito igle).
Remove the syringe from the carton and check that: • the expiry date has not passed • the solution is clear and colourless and doesn’ t contain particles • the syringe has not been opened or damaged
Iz škatle vzemite injekcijsko brizgo in preverite: • da datum izteka roka uporabnosti še ni pretečen. • če je raztopina bistra in brezbarvna ter ne vsebuje delcev. • da injekcijska brizga še ni bila odprta ali poškodovana.
Remove the needle guard, by first twisting it (picture B1) and then pulling it in a straight line away from the body of the syringe (picture B2).
Odstranite ščitnik igle tako, da ga najprej zavrtite (slika B1), nato pa potegnite naravnost stran od telesa injekcijske brizge (slika B2).
Important note • Do not touch the needle or allow it to touch any surface before the injection. • It is normal to see a small air bubble in this syringe.
Pomembna opomba • Ne dotikajte se igle in pazite, da se igla pred injiciranjem ne dotakne nobene površine. • Prisotnost majhnega zračnega mehurčka v injekcijski Slika B1 brizgi je normalna.
Do Picture B1 not try to remove this air bubble before making the injection - you may lose some of the medicine if you do.
Pred injiciranjem zračnega mehurčka ne poskušajte odstraniti, ker lahko pri tem izgubite tudi nekaj zdravila.
Picture E Syringe automatic system
Slika E Injekcijska brizga s samodejnim sistemom
Picture F Syringe manual system
Slika F Injekcijska brizga z ročnim sistemom
After the injection hold the syringe in one hand by gripping the security sleeve, use the other hand to hold the finger grip and pull firmly back.
Po injiciranju injekcijsko brizgo z eno roko primite za varnostni tulec z drugo roko pa primite za držalo za prste in močno povlecite nazaj.
Arixtra 2.5 mg/ 0.5 ml solution for injection fondaparinux sodium
Arixtra 2, 5 mg/ 0, 5 ml raztopina za injiciranje natrijev fondaparinuks
Arixtra is used to: • prevent the formation of blood clots in the blood vessels of the legs or lungs after orthopaedic surgery (such as hip or knee surgery) or abdominal surgery • prevent the formation of blood clots during and shortly after a period of restricted mobility due to acute illness • treat some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart).
Arixtra se uporablja za: • preprečevanje tvorbe krvnih strdkov v žilah nog ali pljuč po ortopedskih operacijah (kot so operacije kolka ali kolen) ali po operacijah v trebušni votlini. • preprečevanje nastajanja krvnih strdkov med obdobjem in po obdobju omejene gibljivosti (imobilizacije) zaradi akutne bolezni. • zdravljenje nekaterih oblik srčnega infarkta in hude oblike angine pektoris (bolečine, ki je posledica zoženja arterij v srcu).
84 Take special care with Arixtra:
Bodite posebno pozorni pri uporabi zdravila Arixtra:
To treat some types of heart attack, a health professional may give the first dose into a vein (intravenously). • Do not inject Arixtra into muscle.
Pri zdravljenju nekaterih oblik srčnega infarkta vam lahko zdravstveno osebje prvi odmerek zdravila aplicira v žilo (intravensko). • Ne injicirajte zdravila Arixtra v mišico.
If you inject too much Arixtra Contact your doctor or pharmacist for advice as soon as possible, because of the increased risk of bleeding.
Če ste injicirali prevelik odmerek zdravila Arixtra Zaradi večje možnosti za pojav krvavitev se čim prej posvetujte s svojim zdravnikom ali farmacevtom.
85 If you forget to take Arixtra • Take the dose as soon as you remember.
Če ste pozabili uporabiti zdravilo Arixtra • Odmerek injicirajte takoj, ko se spomnite.
Don’ t stop using Arixtra without advice If you stop the treatment before your doctor told you to, you are at risk of developing a blood clot in a vein of your leg or lung.
86 Zdravila Arixtra ne prenehajte uporabljati brez zdravnikovega nasveta Če prenehate uporabljati zdravilo prej, kot vam je predpisal zdravnik, ste v nevarnosti, da se vam v venah nog ali pljuč razvije krvni strdek.
Common side effects These may affect more than 1 in 100 people treated with Arixtra. • bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, gums) • anaemia (a reduction in the number of red blood cells)
Pogosti neželeni učinki Pojavijo se lahko pri več kot 1 od 100 bolnikov, ki se zdravijo z zdravilom Arixtra. • krvavitev (npr. iz rane na mestu operacije, razjede želodca, nosu, dlesni); • anemija (zmanjšanje števila rdečih krvnih celic).
Rare side effects These may affect up to 1 in every 1000 people treated with Arixtra. • allergic reaction • internal bleeding in the brain or abdomen • anxiety or confusion • headache • fainting or dizziness, low blood pressure • drowsiness or tiredness • flushing • coughing • leg pain or stomach pain • diarrhoea or constipation • indigestion • wound infection • increase in bilirubin (a substance produced by the liver) in the blood • reduction in potassium in your blood
Redki neželeni učinki Pojavijo se lahko pri do 1 od 1. 000 bolnikov, ki se zdravijo z zdravilom Arixtra. • alergijska reakcija; • notranja krvavitev v možganih ali trebuhu; • anksioznost ali zmedenost; • glavobol; • omedlevica ali omotica, nizek krvni tlak; • zaspanost ali utrujenost; • zardevanje; • kašljanje; • bolečine v nogah ali trebuhu; • driska ali zaprtost; • prebavne težave; • okužba rane; • povečane vrednosti bilirubina (substanca, ki nastaja v jetrih) v krvi; • zmanjšanje vrednosti kalija v krvi.
• Keep out of the reach and sight of children • Do not freeze • Arixtra does not need to be kept in the fridge.
87 • Ne zamrzujte. • Zdravila Arixtra ni treba shranjevati v hladilniku.
Do not use Arixtra: • after the expiry date stated on the label and carton • if you notice any particles in the solution, or if the solution is discoloured • if you notice that the syringe is damaged • if you have opened a syringe and you do not use it straightaway.
Ne uporabljajte zdravila Arixtra: • po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli; • če ste v raztopini opazili kakršnekoli delce ali spremembo barve; • če je injekcijska brizga poškodovana; • če ste odprli injekcijsko brizgo in jo niste takoj uporabili.
What Arixtra contains • The active substance is 2.5 mg fondaparinux sodium in 0.5 ml solution for injection
Kaj vsebuje zdravilo Arixtra • Zdravilna učinkovina je 2, 5 mg natrijevega fondaparinuksa v 0, 5 ml raztopine za injiciranje.
87 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
88 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Tel: + 39 (0)45 9218 111
89 Suomi/ Finland Italia GlaxoSmithKline Oy GlaxoSmithKline S. p. A.
89 Types of safety syringe There are two types of safety syringes used for Arixtra, designed to protect you from needle stick injuries following injection.
90 Vrste varnostnih brizg Za uporabo zdravila Arixtra sta na voljo dve vrsti varnostnih brizg, ki sta zasnovani tako, da preprečita vbodne poškodbe po injiciranju zdravila.
Picture D
Slika D 92 8.
Inject ALL of the contents of the syringe by pressing down on the plunger as far as it goes (picture E).
Slika E Injekcijska brizga s samodejnim sistemom
92 PACKAGE LEAFLET
93 NAVODILO ZA UPORABO
Arixtra 7.5 mg/ 0.6 ml solution for injection Arixtra 10 mg/ 0.8 ml solution for injection Fondaparinux sodium
Arixtra 5 mg/ 0, 4 ml raztopina za injiciranje Arixtra 7, 5 mg/ 0, 6 ml raztopina za injiciranje Arixtra 10 mg/ 0, 8 ml raztopina za injiciranje natrijev fondaparinuks
Arixtra is used to treat patients with a blood clot in the blood vessels of their legs (deep vein thrombosis) and/ or lungs (pulmonary embolism).
Zdravilo Arixtra se uporablja za zdravljenje bolnikov s krvnimi strdki v žilah nog (globoka venska tromboza) in/ ali pljuč (pljučna embolija).
Do not use Arixtra: • if you are allergic (hypersensitive) to fondaparinux sodium or to any of the other ingredients of Arixtra • if you are bleeding excessively • if you have a bacterial heart infection • if you have severe kidney disease. → Tell your doctor if you think any of these applies to you.
Če menite, da se karkoli od navedenega nanaša na vas, o tem obvestite svojega zdravnika.
Your doctor needs to know before you take Arixtra: • if you have a risk uncontrolled bleeding (haemorrhage) including:
Pred začetkom zdravljenja z zdravilom Arixtra morate svojemu zdravniku povedati: • če imate tveganje za pojav nenadzorovane krvavitve, vključno z:
• if you have severe liver disease • if you have kidney disease
94 • Če imate ledvično bolezen. • Če ste stari 75 let ali več.
93 • if you are 75 years old or older. → Tell your doctor if any of these applies to you.
Če se karkoli od navedenega nanaša na vas, o tem obvestite svojega zdravnika.
Children Arixtra has not been tested in children and adolescents under the age of 17 years.
Otroci Pri otrocih in mladostnikih, mlajših od 17 let, uporaba zdravila Arixtra niso raziskovali.
Your weight Below 50 kg Between 50 kg and 100 kg Over 100 kg
Telesna masa manjša od 50 kg od 50 kg do 100 kg večja od 100 kg
Usual dose 5 mg once a day 7.5 mg once a day 10 mg once a day.
Običajni odmerek 5 mg enkrat na dan 7, 5 mg enkrat na dan 10 mg enkrat na dan.
This dose may be reduced to 7.5 mg once a day if you have moderate kidney disease.
Če imate zmerno okvaro ledvic, se lahko ta odmerek zmanjša na 7, 5 mg enkrat na dan.
There are different syringes for the 5 mg, 7.5 mg and 10 mg doses.
Za odmerke 5 mg, 7, 5 mg in 10 mg so na voljo različne injekcijske brizge.
For step-by-step instructions please see over the page. • Do not inject Arixtra into muscle.
Postopna navodila za uporabo se nahajajo na drugi strani tega navodila. • Ne injicirajte zdravila Arixtra v mišico.
94 Don’ t stop using Arixtra without advice If you stop the treatment before your doctor told you to, the blood clot may not be treated properly and you may also be at risk of developing a new blood clot in a vein of your leg or in the lung.
V tem primeru tudi obstaja možnost, da se vam v venah nog ali pljuč ponovno razvije krvni strdek.
Common side effects These may affect more than 1 in 100 people treated with Arixtra. • bleeding (for example from an operation site, an existing stomach ulcer, nosebleed, bruising)
Pogosti neželeni učinki Pojavijo se lahko pri več kot 1 od 100 bolnikov, ki se zdravijo z zdravilom Arixtra. • krvavitev (na primer iz rane na mestu operacije, razjede želodca, nosu ali pojav modrice).
Uncommon side effects These may affect up to 1 in 100 people treated with Arixtra. • swelling (oedema) • headache • pain • feeling sick or being sick (nausea or vomiting) • low number of red blood cells (anaemia) • low number of platelets (blood cells necessary for blood clotting) • increase in some chemical (enzymes) produced by the liver
Občasni neželeni učinki Pojavijo se lahko pri do 1 od 100 bolnikov, ki se zdravijo z zdravilom Arixtra. • oteklina (edem); • glavobol; • bolečina; • siljenje na bruhanje (navzea) ali bruhanje; • zmanjšanje števila rdečih krvnih celic (anemija); • zmanjšanje števila trombocitov (krvnih celic, pomembnih za strjevanje krvi); • povečana aktivnost jetrnih encimov.
Rare side effects These may affect up to 1 in every 1000 people treated with Arixtra. • allergic reaction • internal bleeding in the brain, liver or abdomen • rash • dizziness • pain and swelling at injection site • high number of platelets (blood cells necessary for blood clotting) • increase in the amount of non-protein nitrogen in the blood
Redki neželeni učinki Pojavijo se lahko pri do 1 od 1. 000 bolnikov, ki se zdravijo z zdravilom Arixtra. • alergijska reakcija; • notranja krvavitev v možganih, jetrih ali trebuhu; • izpuščaj; • omotica; • bolečina in oteklina na mestu injiciranja; • zvišanje števila trombocitov (krvnih celic, potrebnih za strjevanje krvi); • povečanje vrednosti neproteinskega dušika v krvi.
HOW TO STORE ARIXTRA • Keep out of the reach and sight of children • Do not freeze • Arixtra does not have to be kept in the fridge.
• Zdravilo shranjujte nedosegljivo otrokom! • Ne zamrzujte. • Zdravila Arixtra ni treba shranjevati v hladilniku.
Do not use Arixtra: • after the expiry date stated on the label and carton • if you notice any particles in the solution, or if the solution is discoloured • if you notice that the syringe is damaged • if you have opened a syringe and you do not use it straightaway.
Ne uporabljajte zdravila Arixtra: • po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli; • če ste v raztopini opazili kakršnekoli delce ali spremembo barve; • če je injekcijska brizga poškodovana; • če ste odprli injekcijsko brizgo in je niste takoj uporabili.
Medicines and syringes should not be disposed of via wastewater or household waste.
96 Zdravila in injekcijskih brizg ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What Arixtra contains The active substance is: • 5 mg fondaparinux sodium in 0.4 ml solution for injection • 7.5 mg fondaparinux sodium in 0.6 ml solution for injection • 10 mg fondaparinux sodium in 0.8 ml solution for injection
Kaj vsebuje zdravilo Arixtra Zdravilna učinkovina je: • 5 mg natrijevega fondaparinuksa v 0, 4 ml raztopine za injiciranje. • 7, 5 mg natrijevega fondaparinuksa v 0, 6 ml raztopine za injiciranje. • 10 mg natrijevega fondaparinuksa v 0, 8 ml raztopine za injiciranje.
The other ingredient(s) are sodium chloride, water for injections, and hydrochloric acid and/ or sodium hydroxide to adjust the pH.
Pomožne snovi so natrijev klorid, voda za injekcije in klorovodikova kislina in/ ali natrijev hidroksid za uravnavanje pH.
What Arixtra looks like and contents of the pack Arixtra is a clear and colourless to slightly yellow solution for injection.
Izgled zdravila Arixtra in vsebina pakiranja Arixtra je bistra in brezbarvna do rahlo rumena raztopina za injiciranje.
96 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
97 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
Tel: + 39 (0)45 9218 111
98 Suomi/ Finland Italia GlaxoSmithKline Oy GlaxoSmithKline S. p. A.
98 Types of safety syringe There are two types of safety syringes used for Arixtra, designed to protect you from needle stick injuries following injection.
99 Vrste varnostnih brizg Za uporabo zdravila Arixtra sta na voljo dve vrsti varnostnih brizg, ki sta zasnovani tako, da preprečita vbodne poškodbe po injiciranju zdravila.
Remove the syringe from the carton and check that: • the expiry date has not passed • the solution is clear and colourless to slightly yellow and doesn’ t contain particles
Iz škatle vzemite injekcijsko brizgo in preverite: • da datum izteka roka uporabnosti še ni pretečen. • če je raztopina bistra in brezbarvna ter ne vsebuje delcev. • da injekcijska brizga še ni bila odprta ali poškodovana.
Remove the needle guard, by first twisting it (picture B1), and then pulling it in a straight line away from the body of the syringe (picture B2).
Odstranite ščitnik igle tako, da ga najprej zavrtite (slika B1), nato pa potegnite naravnost stran od telesa injekcijske brizge (slika B2).
Important note • Do not touch the needle or allow it to touch any surface before the injection. • It is normal to see a small air bubble in this syringe.
Pomembna opomba • Ne dotikajte se igle in pazite, da se igla pred injiciranjem ne dotakne nobene površine. • Prisotnost majhnega zračnega mehurčka v injekcijski brizgi je normalna.
Picture B1
Pred injiciranjem zračnega Slika B1 mehurčka ne poskušajte odstraniti, ker lahko pri tem izgubite tudi nekaj zdravila.
Atriance is a solution for infusion.
Zdravilo Atriance je raztopina za infundiranje.
It contains the active substance nelarabine.
Vsebuje zdravilno učinkovino nelarabin.
Atriance is used to treat patients with T-cell acute lymphoblastic leukaemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
Zdravilo Atriance je namenjeno za zdravljenje bolnikov z akutno limfoblastno levkemijo celic T (T- ALL) in limfoblastnim limfomom celic T (T- LBL).
These are types of cancer where T-lymphoblasts (a type of immature white blood cell) multiply too quickly.
To sta vrsti raka, pri kateri se limfoblasti T (vrsta nezrelih belih krvničk) množijo prehitro.
In T-ALL the abnormal cells are mainly in the blood and bone marrow, and in T-LBL they are mainly in the lymphatic system (lymph nodes or thymus gland).
Pri T- ALL se nenormalne celice nahajajo predvsem v krvi in kostnem mozgu, pri T- LBL pa v limfatičnem sistemu (bezgavkah ali timusu).
Atriance is used when patients have failed to respond to, or have stopped responding to at least two types of chemotherapy.
Zdravilo Atriance se uporablja pri bolnikih, ki se niso odzvali ali pa so se prenehali odzivati na najmanj dve vrsti kemoterapije.
Because the number of patients with these diseases is low, the diseases are considered ‘ rare’, and Atriance was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 16 June 2005.
Ker je število bolnikov s tema boleznima majhno, velja ta bolezen za redko, zato je bilo zdravilo Atriance 16. junija 2005 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Atriance is given by intravenous infusion (a drip into a vein) under the supervision of a doctor who has experience in the use of these types of medicine.
Zdravilo Atriance se daje z intravensko infuzijo (dajanje v veno) pod nadzorom zdravnika z izkušnjami z uporabo tovrstnih zdravil.
The dose and frequency of infusion depend on the patient ’ s age and body surface area.
Odmerek in pogostost infuzije sta odvisna od starosti in površine telesa bolnika.
In adults and adolescents aged over 16 years, the recommended starting dose is 1,500 mg per square metre, given over two hours on days 1, 3 and 5, repeated every 21 days.
Pri odraslih in mladostnikih, starejših od 16 let, znaša priporočen začetni odmerek 1500 mg na kvadratni meter, ki ga bolnik prejme v času dveh ur na 1., 3. in 5. dan, pri čemer se to zdravljenje ponovi vsakih 21 dni.
Younger patients receive a lower dose (650 mg per square metre) given over one hour on five consecutive days, repeated every 21 days.
Mlajši bolniki prejmejo manjši odmerek (650 mg na kvadratni meter) v času ene ure pet zaporednih dni, pri čemer se zdravljenje ponovi vsakih 21 dni.
Treatment should be stopped if the patient develops serious side effects affecting the brain or nervous system.
Zdravljenje je treba prekiniti, če se pri bolniku razvijejo resni neželeni učinki, ki prizadenejo možgane ali živčni sistem.
Patients receiving Atriance should be monitored regularly for changes in blood counts and should receive adequate hydration if they are at risk of tumour lysis syndrome (a complication due to the breakdown of cancer cells).
Pri bolnikih, ki prejemajo zdravilo Atriance, je treba redno nadzirati spremembe krvne slike, poleg tega morajo zaužiti dovolj tekočine, če pri njih obstaja tveganje za pojav sindroma tumorske lize (zapleta, ki nastane zaradi razgradnje rakavih celic).
Patients who have problems with their kidneys should be closely monitored for side effects during Atriance treatment.
Pri bolnikih, ki imajo težave z ledvicami, je treba med zdravljenjem z zdravilom Atriance skrbno spremljati morebitno pojavljanje neželenih učinkov.
Atriance should be used with caution in patients with liver problems.
Pri bolnikih s težavami z jetri je treba zdravilo Atriance uporabljati previdno.
The active substance in Atriance, nelabarine, is a cytotoxic, a medicine that kills cells that are dividing, such as cancer cells.
Zdravilna učinkovina zdravila Atriance, nelarabin, je citotoksik, tj. zdravilo, ki ubija celice, ki se množijo, kot na primer rakave celice.
It belongs to the group of anti-cancer medicines called ‘ antimetabolites’.
Spada v skupino zdravil proti raku, imenovanih „ antimetaboliti “.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Nelarabine is converted within cells to an analogue of guanine, one of the fundamental chemicals that make up DNA.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Nelarabin se v celicah pretvori v analog gvanina, eno od osnovnih spojin, ki tvorijo DNA.
In the body, this active analogue takes the place of guanine and interferes with the enzymes involved in making new DNA, DNA polymerases.
DNA polimeraze.
This stops the production of DNA and thus slows down the growth and multiplication of tumour cells.
To zaustavi tvorbo DNA in posledično upočasni rast in množenje tumorskih celic.
As the active guanine analogue accumulates in T-cells and lasts longer in these cells, Atriance slows down the growth and multiplication of the cells involved in T-ALL and T-LBL.
Ker se aktivni analog gvanina nabira v celicah T ter je v njih trajnejši, zdravilo Atriance upočasni rast in množenje celic, sodelujočih pri T- ALL in T- LBL.
The effects of Atriance were first tested in experimental models before being studied in humans.
Učinki zdravila Atriance so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali na ljudeh.
Atriance has been studied in two main studies of patients with T-ALL and T-LBL who had stopped responding to one or more previous anticancer treatments.
Zdravilo Atriance so preučevali v okviru dveh glavnih študij z bolniki s T- ALL in T- LBL, ki so se prenehali odzivati na eno ali več predhodnih zdravil proti raku.
The first study involved a total of 70 children and young adults aged below 21 years, and the second involved a total of 40 adults and adolescents aged over 16 years.
V prvo študijo je bilo vključenih 70 otrok in mlajših odraslih, starih do 21 let, v drugo pa skupno 40 odraslih in mladostnikov, starejših od 16 let.
Around half of the patients had failed two or more previous treatments.
Pri približno polovici bolnikov sta bili dve ali več predhodnih zdravljenj neuspešnih.
In both studies, the patients were treated with Atriance, but its effects were not compared with those of any other medicine.
V obeh študijah so bolniki prejemali zdravilo Atriance, pri čemer pa njegovih učinkov niso primerjali z nobenim drugim zdravilom.
The main measure of effectiveness was the proportion of patients who responded to treatment, defined as no evidence of disease and recovery of blood cell counts, within a month of starting Atriance treatment.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so se v času enega meseca od pričetka zdravljenja z zdravilom Atriance odzvali na zdravljenje, pri čemer je bil odziv definiran kot odsotnost znakov bolezni in izboljšanje krvne slike.
What benefit has Atriance shown during the studies?
Kakšne koristi je zdravilo Atriance izkazalo med raziskavami?
In the first study, among the 39 children and young adults who had failed two or more previous treatments, five (13%) had a complete response to treatment after a month, with no evidence of disease and normal blood counts.
V prvi študiji je izmed 39 otrok in mlajših odraslih, pri katerih sta bili dve ali več predhodnih zdravljenj neuspešnih, doseglo po enem mesecu popoln odziv na zdravljenje pet (13%) bolnikov, ki niso imeli znakov bolezni in so imeli normalno krvno sliko.