natgillin/translations-raw huggingface dataset:
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJ
Excessive administration rate (>10 ml/kg/h) may result in circulatory overload.
Preveliki odmerki ali prehitro dajanje (tj. >10 ml/kg/uro) lahko povzročijo takojšnje kardiopulmonarne učinke.
Sodium lactate N-acetyl-l cysteine
CaC12 2H2O NaOH natrijev laktat N-acetil-l cistein
Due to the plasma expanding properties of Oxyglobin, the possibility of circulatory overload should be considered especially when administering adjunctive intravenous fluids, particularly colloidal solutions.
Zaradi lastnosti Oxyglobina, ki razširja plazmo, je treba preučiti možnost pojava prevelike obremenitve krvnega obtoka, posebno pri dajanju dodatnih intravenskih tekočin, zlasti koloidnih raztopin.
Duration hours): Oxyglobin levels over 1 g/dL**
Trajanje(ure): koncentracije Oxyglobina nad 1 g/dl
Due to the plasma expanding properties of Oxyglobin, the possibility of circulatory overload and pulmonary oedema should be considered especially when administering adjunctive intravenous fluids, particularly colloidal solutions.
Zaradi lastnosti Oxyglobina, ki razširja plazmo, je treba preučiti možnost pojava prevelike obremenitve krvnega obtoka in pljučnega edema, posebno pri dajanju dodatnih intravenskih tekočin, zlasti koloidnih raztopin.
Optical methods are not reliable for coagulation assays in the presence of Oxyglobin.
Pri uporabi Oxyglobina optične metode niso zanesljive v preizkusih strjevanja krvi.
Haeme degrades according to common pathways leading to bilirubin and bile pigments.
Hem se razgradi na običajni način in tako nastanejo bilirubin in žolčna barvila.
PACKAGE LEAFLET: Oxyglobin 130 mg/ml solution for infusion for dogs
NAVODILO ZA UPORABO Oxyglobin 130 mg/ml, raztopina za infundiranje za pse
Oxyglobin is intended for single administration only.
Oxyglobin je namenjen zgolj za enkratno uporabo.
B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
Oxyglobin is intended for single administration.
Oxyglobin je namenjen za enkratno uporabo.
The safety and efficacy of Oxyglobin have not been evaluated in dogs with thrombocytopenia with active bleeding, oliguria or anuria, or advanced cardiac disease.
Varnosti in učinkovitosti uporabe Oxyglobina niso ocenjevali pri psih s trombocitopenijo in aktivno krvavitvijo, oligurijo ali anurijo ali z napredujočo srčno boleznijo.
A commonly observed undesirable effect was circulatory overload with associated clinical signs such as tachypnea, dyspnea, harsh lung sounds and pulmonary oedema.
Pogosto opaženi stranski učinek je bila preobremenitev krvnega obtoka z odgovarjajočimi kliničnimi znaki, kot so tahipneja, dispneja, rezki glasovi v pljučih in pljučni edem.
Side effects which were observed included mild to moderate discolouration of the mucous membranes, sclera, and urine due to metabolism and/or excretion of haemoglobin.
Med opaženimi neželenimi učinki so bili blago do zmerno obarvanje sluznic, beločnice in urina zaradi presnove in/ali izločanja hemoglobina.
Keep out of the reach and sight of children.
Shranjujte nedosegljivo otrokom.
Adverse effects commonly seen were vomiting, a loss of appetite, and fever.
Običajni neželeni učinki so bili bruhanje, izguba teka in zvišanje telesne temperature.
None.
Jih ni
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA
Solution for infusion
Raztopina za infundiranje
Name and address of the manufacturer of the biological active substance OPK Biotech LLC
OPK Biotech LLC
Effects commonly seen were vomiting, loss of appetite, fever, and circulatory overload with associated clinical signs such as tachypnea, dyspnea, harsh lung sounds, and pulmonary oedema; circulatory overload was controlled by slowing the rate of administration.
Pogosto opaženi stranski učinki so bili bruhanje, izguba teka, zvišanje telesne temperature in preobremenitev krvnega obtoka z odgovarjajočimi kliničnimi znaki, kot so tahipneja, dispneja, rezki glasovi v pljučih in pljučni edem.
Table A:
DODATEK I
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEVTSKI PODATKI 6.1.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
60 ml infusion bag 125 ml infusion bag
Infuzijske vrečke s 60 ml. Infuzijske vrečke s 125 ml.
ADVERSE REACTIONS
Posebna opozorila
4.4 Special warnings
6.4 Posebna navodila za shranjevanje
D. STATEMENT OF THE MRLs
D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
Oxyglobin is intended for single intravenous administration by infusion.
Oxyglobin se aplicira aseptično s pomočjo standardnega intravenskega infuzijskega seta in katetra.
C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
The capsules should be given with food at around the same time each day.
Kapsule je treba dajati s hrano vsak dan ob približno isti uri.
Ibrance is available as capsules (75 mg, 100 mg and 125 mg).
Zdravilo Ibrance je na voljo v obliki kapsul (75 mg, 100 mg in 125 mg).
Ibrance is used in the following ways:
Zdravilo Ibrance se uporablja na naslednje načine:
What measures are being taken to ensure the safe and effective use of Ibrance?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ibrance?
If the patient experiences certain side effects, treatment may need to be interrupted or stopped, or the dose reduced.
Če bolnik občuti določene neželene učinke, bo zdravljenje morda treba prekiniti ali ukiniti ali zmanjšati odmerek.
The full EPAR for Ibrance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ibrance je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Regarding safety, the main risk is neutropenia, which is a well-known risk of many cancer medicines and is considered manageable.
Kar zadeva varnost, je glavno tveganje nevtropenija, ki je dobro znano tveganje številnih zdravil za zdravljenje raka in velja za obvladljivo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Ibrance's benefits are greater than its risks and recommended that it be approved for use in the EU.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zato zaključil, da so koristi zdravila Ibrance večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
The recommended dose is 125 mg once a day for 21 consecutive days, followed by a 7-day break to complete a 28-day treatment cycle.
Priporočeni odmerek je 125 mg enkrat na dan 21 zaporednih dni, čemur sledi 7 dni brez zdravljenje, tako da celotni cikel traja 28 dni.
In both studies, the main measure of effectiveness was how long patients lived without their disease getting worse (progression-free survival).
V obeh študijah je bilo glavno merilo učinkovitosti preživetje bolnic brez poslabšanja bolezni (preživetje brez napredovanja).
This is a summary of the European public assessment report (EPAR) for Ibrance.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ibrance.
Treatment should continue for as long as the patient is benefitting from it and side effects are tolerable.
Zdravljenje je treba nadaljevati, dokler ima bolnik od njega korist, neželeni učinki pa so znosni.
Ibrance is a cancer medicine used to treat locally advanced or metastatic breast cancer (cancer that has begun to spread to other parts of the body).
Ibrance je zdravilo proti raku, ki se uporablja za zdravljenje lokalno napredovalega ali metastatskega raka dojk (raka, ki se je začel širiti v druge dele telesa).
Other information about Ibrance
Druge informacije o zdravilu Ibrance
The first study involved 521 women with metastatic breast cancer that had got worse after treatment with a hormonal medicine.
Prva študija je vključevala 521 žensk z metastatskim rakom dojk, ki se je poslabšal po zdravljenjem s hormonskim zdravilom.
Ibrance can only be used when the cancer cells have receptors for certain hormones on their surface (HR-positive) and do not produce abnormally large quantities of a receptor called HER2 (HER [human epidermal growth factor] negative).
Zdravilo Ibrance se sme uporabljati le, če imajo rakave celice na površini receptorje za določene hormone (so HR-pozitivne) in ne proizvajajo nenormalno velikih količin receptorja, imenovanega HER2 (so HER-negativne [HER, humani epidermalni rastni faktor]).
Ibrance has been studied in two main studies of women with HR-positive, HER2-negative breast cancer.
Zdravilo Ibrance so preučevali v dveh glavnih študijah pri ženskah s HR-pozitivnim, HER2-negativnim rakom dojk.
The second study involved 666 women who had been through the menopause and whose breast cancer had started to spread and who had not yet received cancer treatment.
Druga študija je vključevala 666 žensk po menopavzi, pri katerih se je rak dojk začel širiti in ki se še niso zdravile zaradi raka.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ibrance have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ibrance upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Ibrance can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in the use of cancer medicines.
Predpisovanje in izdaja zdravila Ibrance je le na recept, zdravljenje pa mora začeti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
What is Ibrance and what is it used for?
Kaj je zdravilo Ibrance in za kaj se uporablja?
What benefits of Ibrance have been shown in studies?
Kakšne koristi je zdravilo Ibrance izkazalo v študijah?
• together with fulvestrant (another hormonal medicine for cancer) in patients who have previously been treated with a hormonal medicine.
• skupaj s fulvestrantom (drugim hormonskim zdravilom za zdravljenje raka) pri bolnikih, ki so se predhodno zdravili s hormonskim zdravilom.
• together with an aromatase inhibitor (a hormonal medicine for cancer);
• skupaj z zaviralcem aromataze (hormonskim zdravilom proti raku);
Why is Ibrance approved?
Zakaj je bilo zdravilo Ibrance odobreno?
It is not intended to provide practical advice on how to use Ibrance.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What are the risks associated with Ibrance?
Kakšna tveganja so povezana z zdravilom Ibrance?
They received either Ibrance and letrozole (an aromatase inhibitor) or placebo and letrozole.
Prejemale so zdravilo Ibrance in letrozol (zaviralec aromataze) ali placebo in letrozol.
For more information about treatment with Ibrance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Ibrance preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Ibrance (which may affect more than 1 in 5 people) are neutropenia (low blood levels of neutrophils, a type of white blood cell that fights infection), infections, leucopenia (low white blood cell counts), tiredness, nausea (feeling sick), stomatitis (inflammation of the lining of the mouth), anaemia (low red blood cell counts), alopecia (hair loss) and diarrhoea.
Najpogostejši neželeni učinki zdravila Ibrance (ki se lahko pojavijo pri več kot 1 bolniku od 5) so nevtropenija (nizke vrednosti nevtrofilcev v krvi, vrste belih krvnih celic, ki se borijo proti okužbam), okužbe, levkopenija (nizke vrednosti belih krvnih celic), utrujenost, navzeja (slabost), stomatitis (vnetje ustne sluznice), anemija (nizke vrednosti rdečih krvnih celic), alopecija (izguba dlak) in driska.
In women who have not yet reached menopause, a medicine called a luteinising hormone-releasing hormone agonist should also be given.
Pri ženskah, ki še niso prišle v menopavzo, je treba dajati tudi zdravilo, imenovano agonist gonadoliberina.
The most common severe side effects with Ibrance (which may affect up to 1 in 50 people) are neutropenia, leucopenia, anaemia, tiredness and infections.
Najpogostejši resni neželeni učinki zdravila Ibrance (ki se lahko pojavijo pri največ 1 bolniku od 50) so nevtropenija, levkopenija, anemija, utrujenost in okužbe.
Ibrance has been shown to prolong the time patients live without their disease getting worse by an average of 6 to 10 months, which is considered of clear clinical value.
Zdravilo Ibrance dokazano podaljšuje čas brez poslabšanja bolezni na povprečno 6 do 10 mesecev, kar ima jasno klinično vrednost.
Ibrance must not be used by patients who are taking St John's wort (a herbal preparation used to treat depression).
Zdravila Ibrance ne smejo uporabljati bolniki, ki jemljejo šentjanževko (zeliščni pripravek, namenjen za zdravljenje depresije).
For practical information about using Ibrance, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Ibrance naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Women taking Ibrance and fulvestrant lived on average 11.2 months without their disease getting worse compared with 4.6 months for women taking placebo and fulvestrant.
Ženske, ki so jemale zdravilo Ibrance in fulvestrant, so živele povprečno 11,2 meseca dlje, ne da bi se jim bolezen poslabšala, v primerjavi s 4,6 meseca pri ženskah, ki so jemale placebo in fulvestrant.
By blocking CDK4 and CDK6, Ibrance slows the growth of HRpositive breast cancer cells.
Z zaviranjem encimov CDK4 in CDK6 zdravilo Ibrance upočasni rast HR-pozitivnih celic raka dojk.
Women taking Ibrance and letrozole lived on average 24.8 months without their disease getting worse compared with 14.5 months for women taking placebo and letrozole.
Ženske, ki so jemale zdravilo Ibrance in letrozol, so živele povprečno 24,8 meseca dlje, ne da bi se jim bolezen poslabšala, v primerjavi s 14,5 meseca pri ženskah, ki so jemale placebo in letrozol.
The active substance in Ibrance, palbociclib, blocks the activity of enzymes known as cyclin-dependent kinases (CDK) 4 and 6, which play a key role in regulating the way cells grow and divide.
Zdravilna učinkovina v zdravilu Ibrance, palbociklib, zavira dejavnost encimov, imenovanih od ciklina odvisne kinaze (CDK) 4 in 6, ki imata ključno vlogo pri uravnavanju rasti in delitve celic.
In some cancers, including HR-positive breast cancer, the activity of CDK 4 and 6 is increased, which helps the cancer cells to multiply uncontrollably.
Pri nekaterih vrstah raka, vključno s HR-pozitivnim rakom dojk, se dejavnost encimov CDK 4 in 6 poveča, zato se rakave celice lažje nenadzorovano razmnožujejo.
For the full list of all side effects reported with Ibrance, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ibrance, glejte navodilo za uporabo.
How does Ibrance work?
Kako zdravilo Ibrance deluje?
How is Ibrance used?
Kako se zdravilo Ibrance uporablja?
Ibrance contains the active substance palbociclib.
Zdravilo Ibrance vsebuje zdravilno učinkovino palbociklib.
This means that it affects the activity of the immune system (the body's natural defences).
To pomeni, da učinkuje na aktivnost imunskega sistema (naravne obrambe telesa).
The company withdrew its application before the European Commission had adopted a formal decision.
Družba je umaknila svojo vlogo, še preden je Evropska komisija sprejela formalno odločitev.
Its effectiveness was studied in one main study, carried out in a number of hospitals and clinics (‘sites') in the United States of America and Germany.
Njegovo učinkovitost so preučevali v eni glavni študiji, izvedeni v številnih bolnišnicah in klinikah („lokacijah“) v Združenih državah Amerike in Nemčiji.
International non-proprietary name (INN): lenalidomide
Mednarodno nelastniško ime (INN): lenalidomid
The balance of benefits and risks for Revlimid remains unchanged.
Razmerje med koristmi in tveganji zdravila Revlimid ostaja nespremenjeno.
Ref. EMEA/294089/2008
EMEA/391210/2008 Error!
In addition, an inspection of one of the sites where the main study was carried out raised some concerns over the way the results were recorded, which could have further affected the reliability of the main study.
Poleg tega je inšpekcijski pregled ene izmed lokacij, kjer je bila izvedena glavna študija, vzbudil nekaj dvomov glede beleženja rezultatov, kar lahko še nadalje okrni zanesljivost glavne študije.
The evaluation had finished and the CHMP had given a negative opinion, which had been confirmed following a re-examination procedure.
Postopek ocenjevanja je bil zaključen in CHMP je izrazil negativno mnenje, ki ga je potrdil tudi postopek ponovne presoje.
Lenalidomide has been authorised in the European Union since June 2007 under the name Revlimid, for the treatment of multiple myeloma.
Lenalidomid je v Evropski uniji odobren od junija 2007 pod imenom Revlimid za zdravljenje multiplega mieloma.
The main measure of effectiveness was the proportion of patients who became ‘transfusion independent', meaning that their anaemia was controlled without the need for a blood transfusion over an eight-week period.
Glavno merilo učinkovitosti je bil delež bolnikov, ki so postali „neodvisni od transfuzije“, kar pomeni, da je bila njihova anemija v obdobju osmih tednov uravnana brez transfuzije krvi.
The effects of Lenalidomide Celgene Europe were first tested in experimental models before being studied in humans.
Učinki zdravila Lenalidomide Celgene Europe so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The study looked at the effects of treatment with a daily dose of 10 mg Lenalidomide Celgene Europe either given continuously or as a repeated cycle of three weeks on treatment followed by one week off.
Študija je preučevala učinke zdravljenja z dnevnim odmerkom 10 mg zdravila Lenalidomide Celgene Europe, ki so ga dajali bodisi neprekinjeno ali pa v ponavljajočem se ciklusu, ki je obsegal tri tedne prejemanja zdravila, ki jim je sledil en teden brez zdravila.
There are no consequences of this withdrawal on the use of Revlimid, which also contains lenalidomide, in its authorised indication.
Umik nima nobenih posledic za uporabo zdravila Revlimid, ki prav tako vsebuje lenalidomid, za odobreno indikacijo.
The CHMP had concerns over the way the main study was carried out, which meant that the safety of Lenalidomide Celgene Europe was difficult to assess.
CHMP je imel zadržke glede načina izvedbe glavne študije, zaradi česar je bilo težko oceniti varnost zdravila Lenalidomide Celgene Europe.
The exact way that lenalidomide works in myelodysplastic syndromes is not known, but it is thought that it blocks the growth of tumour cells in the bone marrow, while allowing the growth of normal bone marrow cells, including the cells that produce red blood cells.
Natančen način delovanja lenalidomida pri mielodisplastičnih sindromih ni znan, vendar se domneva, da blokira rast tumorskih celic v kostnem mozgu, medtem ko dopušča rast normalnih celic kostnega mozga, vključno s celicami, ki tvorijo rdeče krvne celice.
QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for LENALIDOMIDE CELGENE EUROPE
VPRAŠANJA IN ODGOVORI V ZVEZI Z UMIKOM VLOGE ZA DOVOLJENJE ZA PROMET z zdravilom LENALIDOMIDE CELGENE EUROPE
What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Lenalidomide Celgene Europe?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Lenalidomide Celgene Europe?
Lenalidomide Celgene Europe was designated as an orphan medicinal product on 8 March 2004.
Zdravilo Lenalidomide Celgene Europe je bilo dne 8. marca 2004 določeno kot zdravilo sirota.
In some cases, myelodysplastic syndromes can lead to the development of acute myeloid leukaemia (a type of cancer affecting the white blood cells).
V nekaterih primerih lahko mielodisplastični sindromi privedejo do razvoja akutne mieloidne levkemije (vrste raka, ki prizadene bele krvne celice).
What is happening with Revlimid used for the treatment of multiple myeloma?
Kaj to pomeni za nadaljnjo uporabo zdravila Revlimid, ki se uporablja za zdravljenje multiplega mieloma?
On 30 May 2008, Celgene Europe Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Lenalidomide Celgene Europe, for the treatment of anaemia due to myelodysplastic syndromes.
Družba Celgene Europe Limited je dne 30. maja 2008 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Lenalidomide Celgene Europe, namenjenim zdravljenju anemije, ki je posledica mielodisplastičnih sindromov.
The study involved 148 patients with transfusion-dependent anaemia, low or intermediate (level 1) risk myelodysplastic syndromes and a deletion of part of chromosome 5 (‘5q deletion').
Študija je vključevala 148 bolnikov z anemijo, ki zahteva transfuzije krvi, majhnim ali srednjim tveganjem (stopnja 1) za prisotnost mielodisplastičnih sindromov in izgubo dela kromosoma št. 5 („delecija 5q“).
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Lenalidomide Celgene Europe for the for the treatment of anaemia due to myelodysplastic syndromes.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil negativno mnenje in ni priporočil odobritve dovoljenja za promet z zdravilom Lenalidomide Celgene Europe, namenjenim zdravljenju anemije, ki je posledica mielodisplastičnih sindromov.
Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Lenalidomide Celgene Europe had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Zato je CHMP v času umika menil, da koristi zdravila Lenalidomide Celgene Europe niso bile zadostno dokazane in da ne odtehtajo znanih tveganj.
Multiple myeloma is a cancer of the plasma cells in the bone marrow.
Multipli mielom je rak plazemskih celic v kostnem mozgu.
The company informed the CHMP that it will continue to make lenalidomide available for patients included in clinical trials or compassionate use programmes.
Družba je obvestila CHMP, da bo bolnikom, vključenim v klinična preskušanja ali programe sočutne uporabe, še dalje omogočala dostop do lenalidomida.
Lenalidomide Celgene Europe was expected to be used to treat anaemia (low red blood cell counts) caused by myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Zdravilo Lenalidomide Celgene Europe naj bi se uporabljalo za zdravljenje anemije (nizkega števila rdečih krvnih celic), ki jo povzročajo mielodisplastični sindromi, skupina bolezni, pri katerih kostni mozeg tvori premalo krvnih celic.
Lenalidomide Celgene Europe is a medicine containing the active substance lenalidomide.
Lenalidomide Celgene Europe je zdravilo, ki vsebuje zdravilno učinkovino lenalidomid.