natgillin/translations-raw huggingface dataset:
If CVP increases to a clinically unacceptable level and/or if signs of circulatory overload are observed, the infusion of Oxyglobin should be temporarily discontinued and re-instituted at a slower rate when signs abate and/or CVP decreases. 
Če se CVP zveča na klinično nesprejemljivo vrednost in/ali če so opaženi znaki preobremenjenosti krvnega obtoka, je treba začasno prenehati dajati Oxyglobin in ga ponovno začeti dajati počasneje, ko se znaki ublažijo in/ali ko se vrednost CVP
Treatment of circulatory overload may be necessary. 
Lahko je potrebno zdravljenje prevelike obremenitve krvnega obtoka.
Remove overwrap prior to use. 
Pred uporabo odstranite zunanji ovoj.
Cleared from plasma (days)*** 
Izčistek iz plazme (dnevi)***
Modified Lactated Ringer's Solution containing the standard components: Water for injection, NaCl 
Modificirana raztopina Ringerjevega laktata, ki vsebuje običajne sestavine: vodo za injekcije,
Shelf-life after first opening the immediate packaging: 24 hours. 
Rok uporabnosti po prvem odpiranju stične ovojnine : 24 ur
Dipstick measurements (i.e., pH, glucose, ketones, protein) are inaccurate while gross discolouration of the urine is present. 
Meritve z merilnimi trakovi (pH, krvni sladkor, ketoni, beljakovine) niso točne, opazno pa je tudi močno obarvanje urina.
Hemoglobin glutamer-200 (bovine) - 130 mg/ml 
Hemoglobin glutamer-200 (goveji) - 130 mg/ml
To be supplied only on veterinary prescription. 
Izdaja zdravila je le na veterinarski recept.
Use of Oxyglobin does not require typing or cross-matching of the recipient's blood. 
Pri uporabi Oxyglobina ni treba določati krvne skupine ali navzkrižno preverjati krvi prejemnika infuzije.
125 ml infusion bag. 
125 ml infuzijska vrečka
Marketing authorisation holder: OPK Biotech Netherlands BV Teleportboulevard 140 
Imetnik dovoljenja za promet z zdravilom: OPK Biotech Netherlands BV Teleportboulevard 140
Chemistry: The presence of Oxyglobin in serum may interfere with colorometric readings and result in artifactual increases or decreases in the results of serum chemistry tests depending on the dosage administered, the time since infusion, the type of analyzer and the reagents used. 
Biokemija: Prisotnost Oxyglobina v serumu lahko vpliva na odčitke kolorimetričnih vrednosti in povzroči umetno zvečanje ali zmanjšanje vrednosti biokemičnih preiskav seruma, odvisno od danih odmerkov, časa, ki je pretekel od infuzije, vrste analizatorja in uporabljenih reagentov.
60 ml infusion bag. 
60 ml infuzijska vrečka
Oxyglobin Dose (ml/kg) 
Odmerek (ml/kg)
Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours independent of the underlying condition. 
Oxyglobin zagotavlja oksiforno podporo pri psih in izboljša klinične znake anemije za najmanj 24 ur,
During the clinical safety and efficacy study, adverse events were seen which may have been related to Oxyglobin and/or the underlying disease causing anaemia. 
V raziskavi o klinični varnosti in učinkovitosti zdravila so opazili neželene pojave, ki so bili morda povezani z Oxyglobinom in/ali osnovno boleznijo, ki povzroča anemijo.
Treatment with Oxyglobin results in a mild decrease in PCV (packed cell volume) immediately post infusion. 
Zdravljenje z Oxyglobinom povzroči manjše zmanjšanje PCV (hematokritov) takoj po infuziji.
Oxyglobin is a haemoglobin-based oxygen carrying fluid that increases plasma and total haemoglobin concentrations and thus increases arterial oxygen content. 
5.1 Farmakodinamične lastnosti Oxyglobin je oksiforna tekočina na podlagi hemoglobina, ki povečuje koncentracije v plazmi ter celotne koncentracije hemoglobina, in s tem vsebnost kisika v arterijah.
Oxyglobin should be administered using aseptic technique via a standard intravenous infusion set and catheter. 
Oxyglobin se aplicira z uporabo aseptičnega postopka s pomočjo standardnega intravenskega infuzijskega seta in katetra.
Undesirable effects include mild to moderate yellow/orange discoloration of the skin, mucous membranes, sclera, dark faeces and discoloured or turbid urine due to metabolism and/or excretion of haemoglobin. 
Neželeni učinki vključujejo blago do zmerno rumeno/oranžno obarvanje kože, sluznic, beločnice, temno blato in obarvan ali moten urin zaradi presnove in/ali izločanja hemoglobina.
The recommended dosage of Oxyglobin is 30 ml/kg of body weight administered intravenously at a rate up to 10 ml/kg/h. 
Priporočeni odmerek Oxyglobina je 30 ml/kg telesne mase, dan intravensko s hitrostjo do 10
Plasma volume expanders, such as Oxyglobin, are contraindicated in dogs predisposed to circulatory overload with conditions such as oliguria or anuria or advanced cardiac disease (i.e., congestive heart failure) or otherwise severely impaired cardiac function. 
Raba ekspanderjev volumna plazme kot je Oxyglobin, je kontraindicirana pri psih, ki so nagnjeni k preveliki obremenitvi krvnega obtoka v stanjih, kot so oligurija ali anurija ali napredujoča bolezen srca (tj. kongestivna srčna odpoved), ali pri kaki drugi hudi okvari srčne funkcije.
Immediate postinfusion plasma concentration* (g/dl) 
Koncentracija v plazmi takoj po infuziji * (g/dl)
THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” 
BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM”
As with any intravenous fluid administration, Oxyglobin should be warmed to 37 °C prior to administration. 
Tako kot pred uporabo vsake intravenske tekočine, je treba Oxyglobin segreti na 37 ° C. Ne segrevajte v mikrovalovni pečici.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS 
NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN
Adverse events related to Oxyglobin and/or the underlying disease causing anaemia have been observed. 
Opazili so neželene pojave v zvezi z Oxyglobinom in/ali osnovno boleznijo, ki povzroča anemijo.
Table A: Pharmacokinetic Parameters at Multiple Dose Levels after a Single Infusion of Oxyglobin Dose (ml/kg) 
Preglednica A: Farmakokinetični parametri pri ponovljenih odmerkih po enkratni infuziji Oxyglobina
The safety of Oxyglobin for use in pregnant or lactating bitches has not been determined. 
Varnost uporabe Oxyglobina pri brejih ali doječih psicah ni bila ugotovljena.
Solution for infusion. 
Raztopina za infundiranje.
Duration (hours): Oxyglobin levels over 1 g/dl** 
Trajanje (ure): koncentracije Oxyglobina nad 1 g/dL
Occasionally noted effects were diarrhoea, discolouration of the skin, cardiac arrhythmias and very rarely nystagmus. 
Občasno opaženi neželeni učinki so bili diareja, obarvanje kože, srčne aritmije in zelo poredko nistagmus.
The animal should not be over-hydrated prior to administration. 
Pred uporabo zdravila žival ne sme preveč piti.
Oxyglobin 130 mg/ml solution for infusion for dogs 
Oxyglobin 130 mg/ml, raztopina za infundiranje za pse
Circulatory overload may be controlled by slowing the rate of administration. 
Preveliko obremenitev krvnega obtoka je mogoče nadzorovati z upočasnjenim dajanjem zdravila.
Occasionally noted adverse events were diarrhoea, cardiac arrhythmias and very rarely nystagmus. 
Občasno opaženi neželeni pojavi so bili diareja, srčne aritmije in zelo poredko nistagmus.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
9 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
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!