natgillin/translations-raw huggingface dataset:
Based on the review of the data and the company's response to the CHMP lists of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zemfirza could not have been approved for the treatment of ovarian cancer. 
Na podlagi pregleda podatkov in odgovorov družbe na sezname vprašanj, ki jih je zastavil CHMP, je Odbor v času umika izrazil določene zadržke in je začasno menil, da zdravila Zemfirza ni mogoče odobriti za zdravljenje raka jajčnikov.
By blocking VEGF receptors, this medicine is expected to reduce blood supply to the cancer cells, thus slowing down the growth and spread of the cancer. 
Z zaviranjem receptorjev VEGF naj bi to zdravilo zmanjšalo dotok krvi do rakavih celic ter tako upočasnilo rast in širjenje raka.
What was Zemfirza expected to be used for? 
Za kaj naj bi se zdravilo Zemfirza uporabljalo?
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of the questions still remaining at this late stage of the review. 
Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da se je za umik vloge odločila zaradi vprašanj, ki so v pozni fazi pregleda še vedno ostajala odprta.
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Zemfirza had not been shown to outweigh its risks and had requested further clarification from the company. 
Zato je CHMP v času umika menil, da koristi zdravila Zemfirza ne odtehtajo z njim povezanih tveganj in je od družbe zahteval dodatna pojasnila.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Zemfirza. 
Družba je CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Zemfirza.
Zemfirza was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 29 July 2014 for treatment of ovarian cancer. 
Zdravilo Zemfirza je bilo dne 29. julija 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih boleznih) za zdravljenje raka jajčnikov.
Zemfirza was expected to be used to treat women with cancer of the ovaries, including cancer of the fallopian tubes that connect the ovaries to the womb and cancer of the peritoneum (the membrane lining the abdomen). 
Zdravilo Zemfirza naj bi se uporabljalo za zdravljenje žensk z rakom jajčnikov, vključno z rakom jajcevodov, ki povezujejo jajčnike z maternico, in rakom peritoneja (sluznice, ki obdaja trebuh).
Withdrawal of the marketing authorisation application for Zemfirza (cediranib) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Zemfirza (cediranib)
The active substance in Zemfirza, cediranib, blocks the activity of ‘vascular endothelial growth factor' (VEGF) receptors. 
Zdravilna učinkovina v zdravilu Zemfirza, cediranib, zavira aktivnost receptorjev vaskularnega endotelijskega rastnega faktorja (VEGF).
Zemfirza is a cancer medicine that contains the active substance cediranib. 
Zemfirza je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino cediranib.
These receptors are found in high amounts on blood vessel cells and are involved in the development of new blood vessels that supply nutrients to cancer cells. 
Ti receptorji so v veliki meri prisotni na celicah krvnih žil in so vključeni v razvoj novih krvnih žil, ki rakavim celicam dovajajo hranila.
How does Zemfirza work? 
Kako zdravilo Zemfirza deluje?
What is Zemfirza? 
Kaj je zdravilo Zemfirza?
In the study, Zemfirza was compared with placebo (a dummy treatment) and was given together with platinum-based medicines during initial treatment and subsequently on its own during a maintenance period. 
V začetnem obdobju so ga dajali skupaj z zdravilom na osnovi platine, v vzdrževalnem obdobju pa samostojno.
Do not 
Komplet ne
Higher doses may be justified in some clinical circumstances. 
Višje doze so opravičljive v določenih kliničnih okoliščinah.
This material will then be injected into your vein. 
Ta pripravek bo potem injiciran v vašo veno.
Its receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organisations. 
Njegov prevzem, shranjevanje, uporaba, premeščanje in uničenje so predmet posebnih predpisov in/ali ustreznih pooblastil pristojnih lokalnih uradnih organov.
The doctor can also determine how much disease there is. 
Zdravnik lahko določi tudi, kako razširjena je bolezen.
The radiolabelled product should not contain more than 10% free technetium. 
Radioaktivno označen pripravek ne sme vsebovati več kot 10% prostega tehnecija.
This dose of radioactivity is safe and will be gone from the body in about 24 
Doza radioaktivnosti je varna in se bo izločila iz telesa v 24 urah.
For instructions for preparation see section 6.6. 
Za navodila za pripravo glejte poglavje 6.6.
No interactions with other medicines have been described to date. 
Medsebojno delovanje z drugimi zdravili do sedaj ni bilo opisano.
This helps your doctor make a diagnosis and evaluate the extent of your illness. 
To bo vašemu zdravniku pomagalo postaviti diagnozo in oceniti stopnjo vaše bolezni.
These benefits were also accompanied by a substantial reduction (85.4%) in the number of patients who would require other diagnostic imaging 
Te prednosti so bile spremljane tudi z znatnim zmanjšanjem (85,4%) števila bolnikov, ki bi potrebovali druge diagnostične postopke slikanja.
• It does not contain all the information about your medicine that you may need to know, so please refer to the Summary of Product Characteristics or ask your doctor or nurse if you have any questions. 
• Navodilo ne vsebuje vseh informacij o zdravilu, ki jih boste morda potrebovali, zato poglejte Povzetek glavnih značilnosti zdravila ali se posvetujte z zdravnikom ali sestro, če imate vprašanja.
Reconstituted and radiolabelled material - 4 hours. 
Rekonstituiran in radioaktivno označen material - 4 ure.
% Free Technetium = Activity in top half of strip × 100 
% prostega tehnecija = aktivnost v zgornji polovici ploščice x 100
Any woman who has missed a period should be assumed to be pregnant until proven otherwise. 
Za vsako žensko z izostalo menstruacijo naj velja, da je noseča, dokler ni dokazano nasprotno.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines 
Prosimo, da obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če
It should be noted, however, that these studies did not assess genotoxicity, carcinogenic potential, or toxicity to reproduction. 
Potrebno pa je upoštevati, da te študije niso ovrednotile genotoksičnosti, karcinogenega potenciala ali vpliva na sposobnost razmnoževanja.
Patients have been given four times the amount you will receive with no adverse reactions. 
Bolniki so prejeli štirikrat večjo količino zdravila, kot ga boste prejeli vi, in niso imeli neželenih učinkov.
Post-marketing experience currently comprises greater than 70,000 vials sold, with two reports of self 
Postmarketinška izkušnja trenutno zajema preko 70.000 prodanih vial zdravila in 2 poročili o
In vitro, a positive binding to lymphocytes up to 2-6% has been shown. 
In vitro je bila pokazana pozitivna vezava na limfocite v obsegu 2-6%.
The resulting solution has a pH of 4.5-5.5 and is intended for intravenous use only. 
Tako pripravljena raztopina ima pH 4,5 - 5,5 in je namenjena samo za intravensko uporabo.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 1997 
DATUM PRIDOBITVE / PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 14. februar 1997
Immunoscintigraphy should be performed one to eight hours after injection. 
Imunoscintigrafija naj bo opravljena eno do osem ur po injiciranju.
There are, as yet, limited data on safety following repeated use. 
Do sedaj so na razpolago le omejeni podatki o varnosti ponovnega vnosa zdravila.
Administration of LeukoScan to young subjects should only be performed after consideration of the possible risks and benefits to the individual subject. 
Vnos zdravila LeukoScan mladim osebam naj se izvede samo po pretehtanju možnih tveganj in koristi za posameznika.
• It is possible to have a serious allergic reaction to LeukoScan. 
• Možno je, da na zdravilo LeukoScan odreagirate z resno alergijsko reakcijo.
• If you have any further questions, please ask your doctor. 
• Če imate dodatna vprašanja, se posvetujte z zdravnikom.
You produce many different kinds of antibodies. 
Telo tvori veliko različnih vrst protiteles.
An antibody is a natural substance made by the body which binds to foreign substances to help remove them from your body. 
Protitelo je naravna, v telesu proizvedena snov, ki se veže na tuje snovi z namenom, da bi jih pomagala odstraniti iz vašega telesa.
Appropriate aseptic precautions should be taken, complying with the requirements of Good Manufacturing Practices (GMP) for pharmaceuticals. 
Uporabljati je potrebno ustrezne aseptične previdnostne ukrepe, ki so v skladu z zahtevami dobre proizvodne prakse (GMP) za zdravila.
It is produced in mice and purified so that it can be used in humans. 
Nastaja v telesu miši in je prečiščeno, tako, da se lahko uporablja pri ljudeh.
The unreconstituted contents of the vial before radiolabelling are not to be directly administered to patients. 
Nerekonstituirana vsebina viale pred označevanjem z radionuklidom ne sme biti direktno aplicirana bolnikom.
If you have any further questions on the use of this product, ask your doctor. 
Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte z zdravnikom.
The magnitude of these increases were assessed by the investigators to be of no clinical consequence on an individual patient basis. 
Raziskovalci so ocenili, da ti porasti niso imeli kliničnih posledic za posameznega bolnika.
Do not store above 25°C. 
Shranjujte pri temperaturi do 25ºC.
Add the prepared eluate into the shielded vial, shake and allow the labelling reaction to proceed for ten minutes. 
Dodajte pripravljeni eluat v vialo, nameščeno v zaščitnem vsebniku, stresajte in pustite, da reakcija označevanja teče 10 minut.
SPECT acquisition parameters recommended are: 60 projections in a 360o step-and-shoot technique, 30 seconds per view in at least a 64 x 64 matrix. 
Priporočeni SPECT parametri so: 60 projekcij v 360° “step-and-shoot” tehniki, 30 sekund za posamezno smer, z matriko najmanj 64 x 64.
• If you know that you are allergic (hypersensitive) to sulesomab or any protein which comes from a mouse, tell your doctor. 
• Če veste, da ste alergični (preobčutljivi) na sulezomab ali katerokoli beljakovino, ki izhaja iz miši, o tem povejte svojemu zdravniku.
If your doctor decides to give it to you again after several weeks or several months, your blood should be tested first to see if you have developed an allergy to 
Če se bo vaš zdravnik po nekaj tednih ali nekaj mesecih odločil, da vam ga bo dal še enkrat, je potrebno najprej pregledati vašo kri in pogledati, če ste razvili alergijo na zdravilo LeukoScan.
For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. 
Pri vsakem bolniku mora biti izpostavljenost ionizirajočemu sevanju upravičljiva na osnovi možne koristi za bolnika.
Patients with known allergies or hypersensitivity to mouse proteins. 
Bolniki z znanimi alergijami ali preobčutljivostjo na mišje beljakovine.
Human Anti-mouse Antibody (HAMA) 
Človeška protitelesa proti mišjemu antigenu (HAMA)
B. CONDITIONS OF THE MARKETING AUTHORISATION • CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE 
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM • POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE; PREDPISANI IMETNIKU
Do not refrigerate or freeze. 
Po pripravi ne shranjujte v hladilniku.
• If the prepared solution of LeukoScan appears discoloured or contains particles, it should not be 
• Če je pripravljena raztopina zdravila LeukoScan videti razbarvana ali vsebuje delce, ne sme biti
When the solvent front is within 1 cm of the top of the strip, remove it, cut it in half and place each into a glass tube. 
Ko fronta topila doseže 1 cm do zgornjega roba ploščice, ploščico vzemite iz komore, prerežite na pol in vsako od polovic namestite v stekleno cevko.
These include a small increase in the number of certain white blood cells called eosinophils (but without any apparent symptoms) and rash. 
Poročila so vključevala majhen porast v številu določenih belih krvnih celic, imenovanih eozinofilci, (vendar brez vidnih simptomov) in izpuščaj.
4.5 Interactions with other medicinal products and other forms of interaction Formal drug interaction studies have not been performed, but no drug interactions have been described to date, including patients receiving antibiotics. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Uradne študije medsebojnega delovanja z drugimi zdravili niso bile izvedene, vendar do danes ni bila opisana nobena reakcija medsebojnega delovanja z drugimi zdravili, vključno z antibiotiki.
4.4 Special warnings and special precautions for use Safety and diagnostic accuracy in persons under 21 years of age have not been established. 
Varnost in diagnostična natančnost pri osebah, mlajših od 21 let, nista bili določeni.
Total volume in vial equals 1.5 ml. 
Celokupni volumen v viali znaša 1,5 ml.
Some side effects, although not common, have been reported. 
Poročali so o nekaterih neželenih učinkih, ki pa niso bili pogosti.
These revealed no remarkable findings. 
Te niso podale pomembnejših izsledkov.
None of these were considered serious, and all resolved without sequelae. 
Nobeden od teh dogodkov ni bil resen in vsi so minili brez
Name and address of the manufacturer(s) of the biological active substance(s) Immunomedics, Inc. 
Ime in naslov izdelovalca (izdelovalcev) biološke zdravilne učinkovine (učinkovin) Immunomedics, Inc.
For most diagnostic investigations using a nuclear medicine procedure, the radiation dose delivered (effective dose/EDE) is less than 20 mSv. 
Za večino diagnostičnih preiskav, kjer je uporabljen nuklearni medicinski postopek, je oddana doza sevanja (efektivna doza/EDE) manjša od 20 mSv.
After injection, any remaining portion of the reconstituted solution should be discarded. 
Po injiciranju je vsak preostanek rekonstituirane raztopine potrebno zavreči.
LeukoScan is contraindicated in pregnancy. 
Zdravilo LeukoScan je v nosečnosti kontraindicirano.
One to eight hours later after the injection you will be placed on a special table and pictures will be taken with standard nuclear cameras. 
Eno do osem ur po injekciji vas bodo položili na posebno mizo in naredili posnetke s standardnimi nuklearnimi kamerami.
LeukoScan [99mTc] can be used after ten minutes and should be used within four hours after preparation. 
Zdravilo LeukoScan [99mTc] se lahko uporabi po desetih minutah in mora biti uporabljeno v štirih urah po pripravi.
Prior to administration, the solution should be inspected visually for particulate matter and discoloration, and quality control should be performed (see section 12). 
Pred uporabo je potrebno preveriti, če raztopina ne vsebuje vidnih delcev ali razbarvanja in izvesti kontrolo kakovosti (glejte poglavje 12).
If you take more LeukoScan than you should 
Če ste uporabili večji odmerek zdravila LeukoScan, kot bi smeli
The distribution half-life was approximately 1.5 hours; the route of excretion is essentially renal with 41% of the radiolabel excreted in urine over the first 24 hours after administration. 
Razpolovni čas porazdelitve je znašal približno 1,5 ure, pot izločanja je pretežno renalna, 41% radioaktivnega označevalca se izloči z urinom v prvih 24 urah po vnosu.
This difference is perhaps explained by the anatomically and pathophysiology more complicated clinical setting of osteomyelitis in the diabetic foot, making differentiation of soft tissue and bone infection more difficult than in other presentations of long bone osteomyelitis. 
To razliko je morda mogoče razložiti z anatomsko in patofiziološko bolj zapleteno klinično sliko osteomielitisa pri diabetičnem stopalu, kjer je razlikovanje med infekcijo mehkih tkiv in kosti težje kakor pri drugih vrstah osteomielitisa dolgih kosti.
This will help the doctor determine whether there is infection in the bone and what kind of treatment to use. 
Postopek bo zdravniku pomagal ugotoviti, če je vnetje kosti prisotno, in se odločiti za način zdravljenja.
Therefore, you doctor should keep you under close observation for a short time after he has given you this medicine. 
Zaradi tega vas mora vaš zdravnik nekaj časa po injiciranju tega zdravila skrbno opazovati.
The overall radiation dose received by the patient over time should also be taken into 
Upoštevati je potrebno tudi celokupno dozo sevanja, ki jo pacient prejme v določenem obdobju.
The eosinophil count increased from 2.7% preinjection to 2.9% at 24 hours post-injection, and to 3.9% at 10 days, with the magnitude of both increases being statistically significant. 
Delež eozinofilcev je od 2,7% pred injiciranjem porasel na 2,9% v 24 urah po injiciranju in na 3,9% v 10 dneh po injiciranju, pri čemer sta bila oba porasta statistično značilna.
It will contain the radioactive technetium isotope in an amount called 740-1110 MBq. 
Vseboval bo radioaktivni tehnecijev izotop v količini, ki se imenuje 740 - 1110 MBq.
Date of approval of latest variation or transfer: MM/YYYY 
Datum odobritve zadnje spremembe ali prenosa: DD/MM/LLLL
No studies effects of food/drink have been performed. 
Uporaba zdravila LeukoScan s hrano in pijačo Raziskave vpliva hrane/pijače niso bile izvedene.
Exposure to ionising radiation is linked with cancer induction and a potential for development of hereditary defects. 
Izpostavitev ionizirajočemu sevanju je povezana z indukcijo raka in možnostjo za nastanek dednih napak.
When it is necessary to administer radioactive medicinal products to women of childbearing potential, information should always be sought about pregnancy. 
Če je potrebno aplicirati radioaktivna zdravila ženski v rodni dobi, je vedno potrebno pridobiti informacijo o nosečnosti.
When it is combined to the radioactive technetium isotope and injected into your vein, it finds an abnormal accumulation of white blood cells and attaches to them. 
Ko je kombinirano z radioaktivnim tehnecijevim izotopom in injicirano v vašo veno, najde nenormalno nakopičenje belih krvnih celic in se veže nanje.
Count each tube in a gamma scintillation counter, dose calibrator or radiochromatogram analyzer. 
Opravite meritev vsake cevke v gama scintilacijskem števcu, doznem kalibratorju ali radiokromatogramskem analizatorju.
LeukoScan (sulesomab) is a special kind of antibody which binds to the surface of certain kinds of blood cells called leukocytes. 
LeukoScan (sulezomab) je posebne vrste protitelo, ki se veže na površino določene vrste krvnih celic, imenovanih levkociti.
Shortly after mixing the LeukoScan with the radioactive technetium isotope, the doctor will inject it into your vein. 
Kmalu po mešanju zdravila LeukoScan z radioaktivnim tehnecijevim izotopom bo zdravnik zdravilo vbrizgal v vašo veno.
Pharmacokinetic studies were performed after the intravenous administration of the product. 
Farmakokinetične študije so bile izpeljane po intravenskem vnosu zdravila.
The clinical results indicate that among different presentations of osteomyelitis, LeukoScan can show different results. 
Klinični rezultati nakazujejo, da lahko pri različnih vrstah osteomielitisa zdravilo LeukoScan daje različne rezultate.
Important information about some ingredients of LeukoScan If you have been told that you have an intolerance to some sugars, inform your doctor before you are 
Pomembne informacije o nekaterih sestavinah zdravila LeukoScan Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila
For this medicinal product, the effective dose equivalent resulting from an administered activity of 750 MBq is typically 7.7 mSv for a 70 kg individual. 
Za to zdravilo tipični učinkoviti ekvivalent doze, ki izhaja iz aplicirane aktivnosti 750 MBq, za 70 kg težko osebo znaša 7,7 mSv.
Based on the activity measured in the activity calibrator, withdraw a sufficient amount of the product to provide the desired activity (750-1100 MBq of 99mTc, see Dosage and Administration). 
Na osnovi merjenja aktivnosti v kalibratorju aktivnosti odvzemite zadostno količino pripravka za zagotovitev željene aktivnosti (750-1100 MBq 99mTc, glejte Odmerjanje in način uporabe).
Reconstituted radiopharmaceuticals should be handled using waterproof gloves, adequate shielding of radioactivity, and aseptic technique. 
Pri ravnanju z rekonstituiranimi radiofarmaki je potrebno uporabljati vodotesne rokavice, ustrezno zaščito pred radioaktivnostjo in aseptično tehniko.
In a single-group, open-label, uncontrolled study of 53 patients with acute or chronic infections of unknown origin or extent, doses of LeukoScan from 0.1 mg to 1.0 mg were studied. 
V odprti, nekontrolirani študiji ene skupine 53 bolnikov z akutnimi ali kroničnimi infekcijami neznanega izvora ali stopnje so znašali preiskovani odmerki zdravila LeukoScan od 0,1mg do 1,0 mg.
Radiolabelling must take place immediately after reconstitution of product. 
Označevanje z radioaktivnim označevalcem mora biti opravljeno takoj po rekonstituciji.
Before administering a radioactive medicinal product to a mother who is breast feeding, consideration should be given as to whether the investigation could be reasonably delayed until the mother has ceased breast feeding and as to whether the most appropriate choice of radiopharmaceutical has been made, bearing in mind the secretion of activity in breast milk. 
Pred vnosom radioaktivnega zdravila materi, ki doji, je potrebno pretehtati, če je mogoče preiskavo preložiti na čas, ko mati ne bo več dojila, oziroma če je bil z ozirom na njegovo izločanje v mleku izbran najustreznejši radiofarmak.
In 49.7% of the patients, LeukoScan was presumed to provide clinical benefit not achievable by other available diagnostic imaging methods, with the potential that the diagnosis could have been made by LeukoScan alone in 70.3% of the patients. 
Za 49,7% bolnikov so predpostavljali, da bi zdravilo LeukoScan lahko doprineslo klinično korist, ki z drugimi razpoložljivimi diagnostičnimi metodami slikanja ni dosegljiva, z možnostjo, da bi bila diagnoza pri 70,3% bolnikov lahko postavljena zgolj z uporabo zdravila LeukoScan.
Like all medicines, LeukoScan can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo LeukoScan neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
This medicine 
Zdravilo je
LeukoScan is used to determine the presence of infections in long bones. 
Zdravilo LeukoScan se uporablja za določanje prisotnosti vnetij v dolgih kosteh.
B. CONDITIONS OF THE MARKETING AUTHORISATION C. SPECIFIC OBLIGATIONS TO BE FULFILLED BY THE MARKETING 
B. POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM C. POSEBNE ZAHTEVE, KI JIH MORA IZPOLNITI IMETNIK DOVOLJENJA
Reconstituted and radiolabelled material - Do not store above 25ºC. 
Rekonstituiran in radioaktivno označen material - Shranjujte pri temperaturi do 25 °C.
It is usual to advise that breast feeding can be restarted when the level in the milk will not result in a radiation dose to the child greater than 1 mSv. 
Običajno doječa mati prejme nasvet, da lahko ponovno prične z dojenjem, ko raven radioaktivnosti v mleku za otroka ne bo presegla obsevalne doze 1 mSv.
Pack size: one vial per carton container. 
Velikost pakiranja: 1 viala v kartonski škatli
Only very limited nonclinical studies have been performed with either the labeled or unlabeled agent. 
Tako z označenim kot z neoznačenim zdravilom so bile opravljene samo zelo omejene neklinične študije.