FrancophonIA/ELRC3.0 huggingface dataset:
English: The use in such animals is not recommended.
Slovenian: Uporaba zdravila pri teh živalih ni priporočljiva.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Zdravilna učinkovina:
English: Do not combine the contents of more than one bag.
Slovenian: Ne združujte vsebine več vrečk.
English: The plasma half-life is 30-40 hours.
Slovenian: Njegova razpolovna doba v plazmi je 30-40 ur.
English: Do not add medications or other solutions to the bag.
Slovenian: V vrečko ne dodajajte zdravil ali drugih raztopin.
English: <Batch> <Lot> {number}
Slovenian: <Serija> <lot>{številka}
English: In certain clinical situations, a dosage of 15-30 ml/kg may be appropriate.
Slovenian: Pri nekaterih kliničnih stanjih je primeren odmerek 15-30 ml/kg.
English: MA 02141
Slovenian: Cambridge MA 02141
English: Concomitant treatment of the cause of the anaemia should be instituted.
Slovenian: Začeti je treba s sočasnim zdravljenjem vzroka anemije.
English: Coagulation: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) can be accurately determined using methods that are mechanical, magnetic, and light scattering.
Slovenian: Koagulacija: Protrombinski čas (PT) in aktivirani delni tromboplastinski čas (aPTT) je mogoče natančno določiti z uporabo mehanskih in magnetnih metod in z razprševanjem svetlobe.
English: The optimum dosage is based upon the degree and chronicity of the anaemia and the desired duration of the effect.
Slovenian: Optimalni odmerki so odvisni od stopnje in kroničnosti anemije ter od želenega trajanja učinka.
English: Clinical Pathology
Slovenian: Klinična patologija
English: A box with one (1) polyolefin infusion bag (containing either 60 ml or 125 ml), within an overwrap.
Slovenian: Škatla z eno (1) poliolefinsko infuzijsko vrečko (ki vsebuje bodisi 60 ml bodisi 125 ml) v zunanjem ovoju.
English: Do not use in animals previously treated with Oxyglobin.
Slovenian: Ne uporabite v živali, ki so jih predhodno zdravili z Oxyglobinom.
English: Pharmacotherapeutic group: Blood substitutes, ATCvet code: QB05AA10.
Slovenian: Farmakoterapevtska skupina: Nadomestki za kri, oznaka ATC vet : QB05AA10
English: Signs of circulatory overload should be carefully monitored or central venous pressure (CVP) measured (increase in CVP has been recorded in all treated dogs in which it was measured).
Slovenian: Znake preobremenjenosti krvnega obtoka je treba skrbno spremljati ali meriti centralni venski tlak (CVP) (zvečanje CVP so opazili pri vseh zdravljenih psih, pri katerih so ga merili).
English: Shelf-life of the veterinary medicinal product as packaged for sale: 60 ml - 3 years
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo : 60 ml - 3 leta
English: Use within 24 hours of removing overwrap.
Slovenian: Uporabite v 24 urah po odstranitvi zunanjega ovoja.
English: Dogs
Slovenian: Psi.
English: Confirm that haemoglobin is measured, not calculated from red blood cell number.
Slovenian: Dokaz, da se hemoglobin meri, ne pa izračuna iz števila rdečih krvnih telesc.
English: Do not use after the expiry date stated on the label.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
English: * range based on mean ± SD ** range based on estimated mean value with bounds of a 95 % prediction interval *** range based on 5 terminal half-lives
Slovenian: * razpon na osnovi srednje vrednosti ± SD ** razpon, zasnovan na ocenjeni srednji vrednosti, z mejami 95 % napovedanega intervala
English: Signs of circulatory overload should be carefully monitored or central venous pressure (CVP) measured.
Slovenian: Znake preobremenjenosti krvnega obtoka je treba skrbno spremljati ali meriti centralni venski tlak (CVP).
English: A small amount of unstabilised tetrameric haemoglobin (<5 %) may be excreted through the kidneys, resulting in transient haemoglobinuria for < 4 hours.
Slovenian: Majhna količina nestabiliziranega tetramernega hemoglobina (< 5 %) se lahko izloči skozi ledvice, kar povzroči prehodno hemoglobinurijo, ki traja manj kot 4 ure.
English: A. LABELLING
Slovenian: A OZNAČEVANJE
English: Urinalysis: Sediment examination is accurate.
Slovenian: Preiskava urina: Preiskava sedimenta je točna.
English: Do not administer with other fluids or medicinal products concurrently via the same infusion set.
Slovenian: Zdravila ne dajajte istočasno z drugimi tekočinami ali zdravili s pomočjo istega infuzijskega seta.
English: 4.5 Special precautions for use Special precautions for use in animals
Slovenian: 4.5 Posebni previdnostni ukrepi Posebni previdnostni ukrepi za uporabo pri živalih
English: Metabolism and excretion: Haemoglobin dissociates in plasma and is progressively incorporated in the protein pool of the organism.
Slovenian: Presnova in izločanje: Hemoglobin se razkroji v plazmi in se postopoma vgrajuje v beljakovinske zaloge v organizmu.
English: Do not freeze.
Slovenian: Ne shranjujte zamrzovalniku.
English: For animal treatment only - to be supplied only on veterinary prescription.
Slovenian: Samo za živali - oskrba le na podlagi veterinarskega recepta.
English: 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.
Slovenian: 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
English: Treatment of circulatory overload may be necessary.
Slovenian: Lahko je potrebno zdravljenje prevelike obremenitve krvnega obtoka.
English: Remove overwrap prior to use.
Slovenian: Pred uporabo odstranite zunanji ovoj.
English: Cleared from plasma (days)***
Slovenian: Izčistek iz plazme (dnevi)***
English: Modified Lactated Ringer's Solution containing the standard components: Water for injection, NaCl
Slovenian: Modificirana raztopina Ringerjevega laktata, ki vsebuje običajne sestavine: vodo za injekcije,
English: Shelf-life after first opening the immediate packaging: 24 hours.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine : 24 ur
English: Dipstick measurements (i.e., pH, glucose, ketones, protein) are inaccurate while gross discolouration of the urine is present.
Slovenian: Meritve z merilnimi trakovi (pH, krvni sladkor, ketoni, beljakovine) niso točne, opazno pa je tudi močno obarvanje urina.
English: North Yorkshire BD23 2RW
Slovenian: North Yorkshire BD23 2RW United Kingdom
English: Hemoglobin glutamer-200 (bovine) - 130 mg/ml
Slovenian: Hemoglobin glutamer-200 (goveji) - 130 mg/ml
English: To be supplied only on veterinary prescription.
Slovenian: Izdaja zdravila je le na veterinarski recept.
English: Use of Oxyglobin does not require typing or cross-matching of the recipient's blood.
Slovenian: Pri uporabi Oxyglobina ni treba določati krvne skupine ali navzkrižno preverjati krvi prejemnika infuzije.
English: 125 ml infusion bag.
Slovenian: 125 ml infuzijska vrečka
English: Marketing authorisation holder: OPK Biotech Netherlands BV Teleportboulevard 140
Slovenian: Imetnik dovoljenja za promet z zdravilom: OPK Biotech Netherlands BV Teleportboulevard 140
English: 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.
Slovenian: 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.
English: 60 ml infusion bag.
Slovenian: 60 ml infuzijska vrečka
English: Oxyglobin Dose (ml/kg)
Slovenian: Odmerek (ml/kg)
English: Oxyglobin provides oxygen carrying support to dogs improving the clinical signs of anaemia for at least 24 hours independent of the underlying condition.
Slovenian: Oxyglobin zagotavlja oksiforno podporo pri psih in izboljša klinične znake anemije za najmanj 24 ur,
English: 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.
Slovenian: 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.
English: Treatment with Oxyglobin results in a mild decrease in PCV (packed cell volume) immediately post infusion.
Slovenian: Zdravljenje z Oxyglobinom povzroči manjše zmanjšanje PCV (hematokritov) takoj po infuziji.
English: Oxyglobin is a haemoglobin-based oxygen carrying fluid that increases plasma and total haemoglobin concentrations and thus increases arterial oxygen content.
Slovenian: 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.
English: Oxyglobin should be administered using aseptic technique via a standard intravenous infusion set and catheter.
Slovenian: Oxyglobin se aplicira z uporabo aseptičnega postopka s pomočjo standardnega intravenskega infuzijskega seta in katetra.
English: 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.
Slovenian: 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.
English: The recommended dosage of Oxyglobin is 30 ml/kg of body weight administered intravenously at a rate up to 10 ml/kg/h.
Slovenian: Priporočeni odmerek Oxyglobina je 30 ml/kg telesne mase, dan intravensko s hitrostjo do 10
English: 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.
Slovenian: 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.
English: Immediate postinfusion plasma concentration* (g/dl)
Slovenian: Koncentracija v plazmi takoj po infuziji * (g/dl)
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
Slovenian: BESEDILO “ZDRAVILO SHRANJUJTE NEDOSEGLJIVO OTROKOM”
English: As with any intravenous fluid administration, Oxyglobin should be warmed to 37 °C prior to administration.
Slovenian: Tako kot pred uporabo vsake intravenske tekočine, je treba Oxyglobin segreti na 37 ° C. Ne segrevajte v mikrovalovni pečici.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGEIH SESTAVIN
English: Adverse events related to Oxyglobin and/or the underlying disease causing anaemia have been observed.
Slovenian: Opazili so neželene pojave v zvezi z Oxyglobinom in/ali osnovno boleznijo, ki povzroča anemijo.
English: Table A: Pharmacokinetic Parameters at Multiple Dose Levels after a Single Infusion of Oxyglobin Dose (ml/kg)
Slovenian: Preglednica A: Farmakokinetični parametri pri ponovljenih odmerkih po enkratni infuziji Oxyglobina
English: The safety of Oxyglobin for use in pregnant or lactating bitches has not been determined.
Slovenian: Varnost uporabe Oxyglobina pri brejih ali doječih psicah ni bila ugotovljena.
English: Solution for infusion.
Slovenian: Raztopina za infundiranje.
English: Duration (hours): Oxyglobin levels over 1 g/dl**
Slovenian: Trajanje (ure): koncentracije Oxyglobina nad 1 g/dL
English: Occasionally noted effects were diarrhoea, discolouration of the skin, cardiac arrhythmias and very rarely nystagmus.
Slovenian: Občasno opaženi neželeni učinki so bili diareja, obarvanje kože, srčne aritmije in zelo poredko nistagmus.
English: The animal should not be over-hydrated prior to administration.
Slovenian: Pred uporabo zdravila žival ne sme preveč piti.
English: Oxyglobin 130 mg/ml solution for infusion for dogs
Slovenian: Oxyglobin 130 mg/ml, raztopina za infundiranje za pse
English: Manufacturer for the batch release: Dales Pharmaceutical Ltd. Snaygill Industrial Estate Keighley Road
Slovenian: Snaygill Industrial Estate Keighley Road
English: Circulatory overload may be controlled by slowing the rate of administration.
Slovenian: Preveliko obremenitev krvnega obtoka je mogoče nadzorovati z upočasnjenim dajanjem zdravila.
English: Occasionally noted adverse events were diarrhoea, cardiac arrhythmias and very rarely nystagmus.
Slovenian: Občasno opaženi neželeni pojavi so bili diareja, srčne aritmije in zelo poredko nistagmus.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: 9 DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJ
English: Excessive administration rate (>10 ml/kg/h) may result in circulatory overload.
Slovenian: Preveliki odmerki ali prehitro dajanje (tj. >10 ml/kg/uro) lahko povzročijo takojšnje kardiopulmonarne učinke.
English: Sodium lactate N-acetyl-l cysteine
Slovenian: CaC12 2H2O NaOH natrijev laktat N-acetil-l cistein
English: 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.
Slovenian: Zaradi lastnosti Oxyglobina, ki razširja plazmo, je treba preučiti možnost pojava prevelike obremenitve krvnega obtoka, posebno pri dajanju dodatnih intravenskih tekočin, zlasti koloidnih raztopin.
English: Duration hours): Oxyglobin levels over 1 g/dL**
Slovenian: Trajanje(ure): koncentracije Oxyglobina nad 1 g/dl
English: 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.
Slovenian: 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.
English: Optical methods are not reliable for coagulation assays in the presence of Oxyglobin.
Slovenian: Pri uporabi Oxyglobina optične metode niso zanesljive v preizkusih strjevanja krvi.
English: Haeme degrades according to common pathways leading to bilirubin and bile pigments.
Slovenian: Hem se razgradi na običajni način in tako nastanejo bilirubin in žolčna barvila.
English: PACKAGE LEAFLET: Oxyglobin 130 mg/ml solution for infusion for dogs
Slovenian: NAVODILO ZA UPORABO Oxyglobin 130 mg/ml, raztopina za infundiranje za pse
English: Oxyglobin is intended for single administration only.
Slovenian: Oxyglobin je namenjen zgolj za enkratno uporabo.
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Slovenian: B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
English: Oxyglobin is intended for single administration.
Slovenian: Oxyglobin je namenjen za enkratno uporabo.
English: The safety and efficacy of Oxyglobin have not been evaluated in dogs with thrombocytopenia with active bleeding, oliguria or anuria, or advanced cardiac disease.
Slovenian: Varnosti in učinkovitosti uporabe Oxyglobina niso ocenjevali pri psih s trombocitopenijo in aktivno krvavitvijo, oligurijo ali anurijo ali z napredujočo srčno boleznijo.
English: A commonly observed undesirable effect was circulatory overload with associated clinical signs such as tachypnea, dyspnea, harsh lung sounds and pulmonary oedema.
Slovenian: Pogosto opaženi stranski učinek je bila preobremenitev krvnega obtoka z odgovarjajočimi kliničnimi znaki, kot so tahipneja, dispneja, rezki glasovi v pljučih in pljučni edem.
English: 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.
Slovenian: Med opaženimi neželenimi učinki so bili blago do zmerno obarvanje sluznic, beločnice in urina zaradi presnove in/ali izločanja hemoglobina.
English: Keep out of the reach and sight of children.
Slovenian: Shranjujte nedosegljivo otrokom.
English: Adverse effects commonly seen were vomiting, a loss of appetite, and fever.
Slovenian: Običajni neželeni učinki so bili bruhanje, izguba teka in zvišanje telesne temperature.
English: 1043EJ, Amsterdam The Netherlands
Slovenian: 1043EJ
English: None.
Slovenian: Jih ni
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA
English: Solution for infusion
Slovenian: Raztopina za infundiranje
English: Name and address of the manufacturer of the biological active substance OPK Biotech LLC
Slovenian: OPK Biotech LLC
English: 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.
Slovenian: 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.
English: Table A:
Slovenian: DODATEK I
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Slovenian: ZDRAVILA ALI ODPADNIH SNOVI, ČE OBSTAJAJO
English: 60 ml infusion bag 125 ml infusion bag
Slovenian: Infuzijske vrečke s 60 ml. Infuzijske vrečke s 125 ml.
English: NaOH
Slovenian: NaCl
English: ADVERSE REACTIONS
Slovenian: Posebna opozorila
English: 4.4 Special warnings
Slovenian: 6.4 Posebna navodila za shranjevanje
English: D. STATEMENT OF THE MRLs
Slovenian: D. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN ZAOSTANKOV ZDRAVILA (MRL)
English: Oxyglobin is intended for single intravenous administration by infusion.
Slovenian: Oxyglobin se aplicira aseptično s pomočjo standardnega intravenskega infuzijskega seta in katetra.
English: C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
Slovenian: C. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE
English: The capsules should be given with food at around the same time each day.
Slovenian: Kapsule je treba dajati s hrano vsak dan ob približno isti uri.
English: Ibrance is available as capsules (75 mg, 100 mg and 125 mg).
Slovenian: Zdravilo Ibrance je na voljo v obliki kapsul (75 mg, 100 mg in 125 mg).
English: Ibrance is used in the following ways:
Slovenian: Zdravilo Ibrance se uporablja na naslednje načine:
English: What measures are being taken to ensure the safe and effective use of Ibrance?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ibrance?
English: If the patient experiences certain side effects, treatment may need to be interrupted or stopped, or the dose reduced.
Slovenian: Če bolnik občuti določene neželene učinke, bo zdravljenje morda treba prekiniti ali ukiniti ali zmanjšati odmerek.
English: The full EPAR for Ibrance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: 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.
English: Regarding safety, the main risk is neutropenia, which is a well-known risk of many cancer medicines and is considered manageable.
Slovenian: Kar zadeva varnost, je glavno tveganje nevtropenija, ki je dobro znano tveganje številnih zdravil za zdravljenje raka in velja za obvladljivo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Priporočeni odmerek je 125 mg enkrat na dan 21 zaporednih dni, čemur sledi 7 dni brez zdravljenje, tako da celotni cikel traja 28 dni.
English: In both studies, the main measure of effectiveness was how long patients lived without their disease getting worse (progression-free survival).
Slovenian: V obeh študijah je bilo glavno merilo učinkovitosti preživetje bolnic brez poslabšanja bolezni (preživetje brez napredovanja).
English: This is a summary of the European public assessment report (EPAR) for Ibrance.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ibrance.
English: Treatment should continue for as long as the patient is benefitting from it and side effects are tolerable.
Slovenian: Zdravljenje je treba nadaljevati, dokler ima bolnik od njega korist, neželeni učinki pa so znosni.
English: 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).
Slovenian: 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).
English: Ibrance palbociclib
Slovenian: Ibrance palbociklib
English: Other information about Ibrance
Slovenian: Druge informacije o zdravilu Ibrance
English: The first study involved 521 women with metastatic breast cancer that had got worse after treatment with a hormonal medicine.
Slovenian: Prva študija je vključevala 521 žensk z metastatskim rakom dojk, ki se je poslabšal po zdravljenjem s hormonskim zdravilom.
English: 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).
Slovenian: 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]).
English: Ibrance has been studied in two main studies of women with HR-positive, HER2-negative breast cancer.
Slovenian: Zdravilo Ibrance so preučevali v dveh glavnih študijah pri ženskah s HR-pozitivnim, HER2-negativnim rakom dojk.
English: 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.
Slovenian: Druga študija je vključevala 666 žensk po menopavzi, pri katerih se je rak dojk začel širiti in ki se še niso zdravile zaradi raka.