natgillin/translations-raw huggingface dataset:
The administration of radiopharmaceutical creates risks for other persons from external radiation or contamination from spills of urine, vomiting etc. Local regulations for radioactive materials must be applied in the radiation protection precautions and waste disposal. 
Pri dajanju radiofarmakov obstaja za druge osebe tveganje pred zunanjim sevanjem ali onesnaženjem z razlitjem urina, bruhanjem itd.
Radioactivity in bottom piece of ITLC-SG MAM strip (Rf 0-0.40) A = 100 x ---------------------------------------------------------------------------------Total radioactivity in both pieces of ITLC-SG MAM strip 
radioaktivnost spodnjega kosa ITLC-SG MAM traku (Rf 0-0,40) A = 100 x ------------------------------------------------------------------------------Celotna radioaktivnost obeh kosov ITLC-SG MAM traku
Radioactivity in top piece of ITLC-SG SSCS strip (Rf 0.75-1.0) B = 100 x -----------------------------------------------------------------------------Total radioactivity in both pieces of ITLC-SG SSCS Strip 
radioaktivnost zgornjega kosa ITLC-SG SSCS traku (Rf 0,75 - 1,0) A = 100 x -----------------------------------------------------------------------------------Celotna radioaktivnost obeh kosov ITLC-SG SSCS traku
The data indicate that the 99mTc-depreotide displays high-affinity binding to somatostatin receptors. 
Podatki kažejo, da ima 99mTc depreotid visoko vezalno afiniteto za somatostatinske receptorje.
In vitro data and studies in laboratory animals indicate that 99mTc-depreotide binds with high affinity to somatostatin receptor (SSTR) subtypes 2, 3 
Podatki in vitro in študije na laboratorijskih živalih kažejo, da se 99mTc-depreotid veže z visoko afiniteto na podtipe 2,3 in 5 somatostatinskih receptorjevg
When injected, the radiolabelled compound binds to malignant cancer tissue. 
Po injiciranju, se radioaktivno označena spojina veže na maligno rakasto tkivo.
A. MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
Sodium pertechnetate (99mTc) solution for injection containing oxidants ought not to be used for the 
Raztopine natrijevega pertehnetata (99mTc) za injiciranje, ki vsebujejo oksidante, ne smemo uporabljati za
The contents of the NeoSpect vial are not radioactive; however, after the addition of sodium pertechnetate (99mTc) solution for injection, adequate shielding of the final preparation must be 
Vsebina NeoSpect viale ni radioaktivna; vendar je po dodatku raztopine natrijevega pertehnetata (99mTc) za injiciranje potrebno zagotavljati ustrezno zaščito pred sevanjem
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 47 micrograms depreotide as depreotide trifluoroacetate. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsaka viala vsebuje 47 mikrogramov depreotida v obliki depreotidnega trifluoroacetata.
The corresponding negative predictive value and positive predictive value for NeoSpect in association with chest X-ray were 96-98% and 6178% respectively. 
Ustrezna negativna in pozitivna napovedna vrednost za NeoSpect v povezavi z rentgensko sliko prsnega koša je bila 96-98% oziroma 61-78%.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 
• Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika.
1 vial containing 47 micrograms of depreotide. 
1 viala vsebuje 47 mikrogramov depreotida.
NeoSpect is not recommended for use in children under 18 years of age, as data are not available for this age group. 
NeoSpect se ne priporoča za uporabo pri otrocih mlajših od 18 let, ker za to starostno skupino ni podatkov.
Name and address of the manufacturer responsible for batch release CIS bio international 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM CIS bio international
History of hypersensitivity reaction to depreotide, any of the excipients of NeoSpect or sodium pertechnetate (99mTc) solution for injection. 
V anamnezi navedena preobčutljivost za depretoid, katerokoli pomožno snov NeoSpekta ali raztopino natrijevega pertehnetata (99mTc) za injiciranje.
NeoSpect is used for preparation of technetium (99mTc) depreotide solution for injection. 
NeoSpect se uporablja za pripravo raztopine tehnecijevega (99mTc) depreotida za injiciranje.
5 vials, each vial containing 47 micrograms of depreotide. 
5 vial, vsaka viala vsebuje 47 mikrogramov depreotida.
NeoSpect 47 micrograms. 
NAVODILO ZA UPORABO NeoSpect 47 mikrogramov.
The radiation dose from 18FDG-PET (Fluorodeoxyglucose - Positron Emission Tomography) is lower than that from NeoSpect, whilst still achieving high sensitivity and specificity. 
Doza sevanja je pri 18FDG-PET (Fluorodeoksiglukoza - pozitron emisijska tomografija) nižji kot pri
An assay of the radiochemical purity of the prepared injection can be performed using the following 
Test radiokemijske čistosti pripravljene raztopine za injiciranje se lahko izvede s pomočjo naslednjih kromatografskih postopkov.
Two Gelman ITLC-SG strips (2 cm x 10 cm) Two developing tanks and covers 
Dva Gelman ITLC-GS trakova (2 cm x 10 cm) Dva generatorja za razvijanje s pokrovi Nasičena raztopina natrijevega klorida (SSCS)1 (1 Glejte točko 1.)
Assay the total radioactivity, complete the user radiation label and attach it to the lead shielded vial. 
Izmerite skupno radioaktivnost, izpišite signaturo s podatki o sevanju za uporabnika in jo pritrdite
When a solution of the radioactive substance sodium pertechnetate (99mTc) is added to the vial, 99mTc-depreotide is formed. 
Ko v vialo dodamo raztopino radioaktivne spojine natrijevega pertehnetata (99mTc), nastane 99mTc-depreotid.
Remove the strip from the tank and allow the strip to dry behind a lead shield. 
Odstranite trak iz generatorja in ga dajte sušiti za svinčeno zaščitno ploščo.
- The active substance is 47 micrograms depreotide as depreotide trifluoroacetate. 
- Zdravilna učinkovina je 47 mikrogramov depreotida v obliki depreotidnega trifluoroacetata.
* fatigue 
* utrujenosti
SPECT images (Single Photon Emission Computed Tomography) obtained between 2 and 4 hours following 99mTc-depreotide injection are required for optimal image interpretation. 
Za optimalno tolmačenje slik, je potrebno SPEC slike (računalniška tomografija emisije posameznih fotonov) posneti 2 do 4 ure po injekciji 99m Tc-depreotida.
99mTc-depreotide is administered intravenously in a single dose. 
99mTc-depreotid se daje intravensko v enkratnem odmerku.
Hydrochloric acid and/or sodium hydroxide (pH adjustment) 6.2 Incompatibilities 
klorovodikova kislina in/ali natrijev hidroksid (pH uravnavanje)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION NeoSpect 47 micrograms, kit for radiopharmaceutical preparation Depreotide 
IME ZDRAVILA IN POT(I) UPORABE NeoSpect 47 mikrogramov, komplet za pripravo radiofarmaka Depreotid
The volume of diluted sodium pertechnetate (99mTc) solution for injection, added to the vial 
Volumen razredčene raztopine natrijevega pertehnetata (99mTc) za injiciranje dodane v vialo
Label the solution with a one month expiration date. 
Označite raztopino z enomesečnim datumom zapadlosti.
99mTc-depreotide is not recommended for use in patients below the age of 18 as data are not available for this age group. 
Pri bolnikih mlajših od 18 let, uporabe 99mTc-depretoida ne priporočamo, ker za to starostno skupino ni podatkov.
Sodium chloride 0.9% w/v solution for injection must be used as the diluent. 
Za redčenje moramo uporabljati 0,9% (m/v) raztopino natrijevega klorida za injiciranje.
* nausea 
* bruhanju
Immediately transfer the reaction vial to a lead safe in the boiling water bath, maintaining the vial in the upright position. 
Takoj prenesite reakcijsko vialo v kopel z vrelo vodo v svinčev ščitnik.
2) 1:1 Methanol / 1M Ammonium Acetate (MAM) 1M Ammonium Acetate - Add 3.9 ± 0.1 grams of solid ammonium acetate to a 50 ml volumetric flask. 
1M amonijev acetat - dodajte 3,9 ± 0,1 grama trdnega amonijevega acetate v 50 ml graduirano bučko.
The product is a kit for radiopharmaceutical preparation. 
Zdravilo je komplet za pripravo radiofarmaka.
NAME OF THE MEDICINAL PRODUCT NeoSpect 47 micrograms, kit for radiopharmaceutical preparation. 
IME ZDRAVILA NeoSpect 47 mikrogramov, komplet za pripravo radiofarmaka
- if you are suffering from diabetes or other related conditions - if you have a renal disease - if you have a liver disease 
Bodite posebno pozorni pri uporabi zdravila NeoSpect Če imate sladkorno bolezen ali druga z njo povezana stanja Če imate ledvično bolezen
The solution may be diluted with sodium chloride 0.9% w/v solution for injection for more convenient injection. 
Za prikladnejšo injekcijo se raztopino lahko redči z 0,9% (m/v) raztopino natrijevega klorida za injiciranje.
* abdominal pain 
* trebušni bolečini
- The other ingredients are sodium glucoheptonate dihydrate, stannous chloride dihydrate, 
- Druge sestavine so natrijev α-D-glukoheptonat dihidrat, kositrov (II) klorid dihidrat, dinatrijev edetat, klorovodikova kislina in/ali natrijev hidroksid za uravnavanje pH.
To be reconstituted with sodium pertechnetate (99mTc) solution for injection (not included in this kit). 
Rekonstituira se z raztopino natrijevega pertehnetata (99mTc) za injiciranje (ni priložena v tem
Place the developing tanks behind a lead shield. 
Namestite generatorja za razvijanje za svinčeno zaščitno ploščo.
Most frequently reported were: 
Najpogosteje so poročali o: * glavobolu
Pharmacotherapeutic group: Diagnostic radiopharmaceutical for use in tumour detection 
Farmakoterapevtska skupina: Radiodiagnostiki za tumorje
Bone surface 
Površina kosti
Kidneys Spleen 
Ledvice Vranica Moda
Thyroid gland Bone marrow Liver 
Ščitnica Kostni mozeg Jetra
The amount of radioactivity is calculated according to the planned time of injection to the patient, to obtain a single patient dose of 555 - 740 MBq from the entire 
Količino radioaktivnosti se izračuna glede na načrtovani čas injiciranja bolniku tako, da se doseže odmerek za enega bolnika 555-740 MBq iz celotne rekonstituirane viale Varnost in učinkovitost 99mTc-depreotida so ugotovili v kliničnih študijah z uporabo raziskovalnega materiala, ki je imel pred dajanjem bolniku z ITLC določeno radiokemijsko
Sodium pertechnetate (99mTc) solution for injection (Ph.Eur) is used for reconstitution. 
Za rekonstitucijo se uporablja raztopino natrijevega pertehnetata (99mTc) za injiciranje (Ph.Eur).
information should always be sought about pregnancy. 
Kadar je treba uporabiti radioaktivna zdravila pri ženskah v rodnem obdobju, moramo vedno pridobiti podatke o nosečnosti.
No specific interaction studies with other medicinal products have been performed, and there are little available data on such interactions. 
O takšnem medsebojnem delovanju je razpoložljivih le malo podatkov.
The containers are closed with butyl rubber stoppers and sealed with aluminium caps. 
Zdravilo je polnjeno v 5 ml viale iz stekla tipa I. Viale so zaprte z butilnimi gumijastimi zamaški in zapečatene z aluminijastimi kapicami.
NAME OF THE MEDICINAL PRODUCT NeoSpect 47 micrograms, kit for radiopharmaceutical preparation Depreotide 
NeoSpect 47 mikrogramov, komplet za pripravo radiofarmaka Depreotid
The activity administered must be such that the resulting radiation dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result. 
Uporabljen mora biti postopek z najnižjo dozo sevanja, ki omogoča iskani diagnostični
99mTc-depreotide is therefore contraindicated in pregnancy. 
Zato je 99mTc-depretoid v nosečnosti kontraindiciran (Glejte 4.3).
After labelling with the radioactive sodium pertechnetate (99mTc) solution for injection, radiolabelled NeoSpect will be injected 
Po označevanju z raztopino radioaktivnega natrijevega pertehnetata (99mTc) za injiciranje, vam bodo injicirali radioaktivno Slikanje (skeniranje) je lahko 2-4 ure po injekciji NeoSpecta.
Store the reconstituted solution for injection upright at 15 °C - 25 °C and use within 5 hours of 
Rekonstituirano raztopino shranjujte v pokončnem položaju pri 15˚C-25˚C in jo uporabite
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
Ime in naslov izdelovalca, odgovornega za sproščanje serij
WHAT NeoSpect IS AND WHAT IT IS USED FOR 
Kaj je zdravilo NeoSpect in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo NeoSpect
After reconstitution with sodium pertechnetate (99mTc) solution for injection, 99mTc-depreotide is 
Po rekonstituciji z raztopino natrijevega pertehnetata(99mTc) za injiciranje, nastane
The area where the radioactive compound is collected, will light up on the picture and give information on the location of the tumour. 
Vaš zdravnik bo posnel sliko (sken) vaših pljuč z uporabo Predel v katerem se zbere radioaktivna spojina bo na sliki osvetljen in bo dal informacijo o mestu Ocena prav tako vključuje pregled s CT (slikanje z računalniško tomografijo) ali rentgensko slikanje
Each vial contains: 47 micrograms depreotide as depreotide trifluoroacetate 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka viala vsebuje: 47 mikrogramov depreotida v obliki depreotidnega trifluoroacetata
This can give the doctor valuable information such as the location of a tumour. 
To daje lahko zdravniku dragocene
* flushing 
* omotici
Instructions for the preparation of 99mTc-depreotide: 
99mTc
4.2 Posology and method of administration 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji
Reconstitute with sodium pertechnetate (99mTc) injection. 
Rekonstituirajte z raztopino natrijevega pertehnetata (99mTc) za injiciranje.
The recommended dosage is one vial (approximately 47 micrograms of depreotide) labelled with 
Priporočeno odmerjanje je ena viala (približno 47 mikrogramov depreotida) označena s 555-740 MBq
Date of first authorisation:19 January 2015 
Datum prve odobritve: 19. januar 2015
You should not do both. 
Obojega ne smete hkrati.
• are over 75 years of age 
• če ste starejši od 75 let.
It is especially important to tell your doctor if you take: 
Posebej pomembno je, da zdravniku poveste, če jemljete:
The clinical significance of this finding is currently unknown. 
Klinični pomen te ugotovitve trenutno ni znan.
DATE OF THE REVISION OF THE TEXT 
DATUM ZADNJE REVIZIJE BESEDILA
• sudden confusion, difficulty speaking,or understanding others 
• nenadno zmedenost, težave z govorjenjem ali razumevanjem drugih
Your doctor will decide if this medicine is appropriate for you. 
Zdravnik bo presodil, ali je to zdravilo primerno za vas.
• If you forget a dose, take it as soon as you remember. 
• Če pozabite vzeti odmerek, ga vzemite takoj, ko se spomnite.
• sudden numbness or weakness of your arm, leg or face, especially if only on one side of the body 
• nenadno omrtvelost ali šibkost roke, noge ali obraza, zlasti, če se pojavi le na eni strani telesa
• double vision 
• dvojni vid
The mean volume of distribution of vorapaxar is approximately 424 litres. 
Povprečni volumen porazdelitve vorapaksarja je približno 424 litrov.
Treatment of presumed overdose should address signs and symptoms. 
Zdravljenje domnevnega prevelikega odmerjanja mora biti usmerjeno na znake in simptome.
Patients receiving digoxin should be monitored as clinically indicated. 
Bolnike, ki prejemajo digoksin, je treba spremljati, kot je klinično indicirano.
Know the medicines you take. 
Bodite seznanjeni z zdravili, ki jih jemljete.
Patients with low body weight (<60 kg) 
Bolniki z majhno telesno maso (< 60 kg)
• Do not take a double-dose (two doses at the same time) to make up for a forgotten dose. 
• Ne vzemite dvojnega odmerka (dveh odmerkov hkrati), če ste pozabili vzeti prejšnji odmerek.
• needing an urgent operation to open blocked arteries in the heart. 
• potrebo po nujni operaciji za odprtje zamašenih arterij v srcu.
In general, a body weight <60 kg is a risk factor for bleeding. 
Na splošno je telesna masa < 60 kg dejavnik tveganja za krvavitve.
The most common adverse reaction reported during treatment is bleeding. 
Najpogostejši neželeni učinek, o katerem so poročali med zdravljenjem, je krvavitev.
• sudden difficulty in walking or loss of balance or co-ordination 
• nenadne težave s hojo ali izgubo ravnotežja ali koordinacije gibov
• pink, red, or brown urine 
• rožnat, rdeč ali rjav urin
• bleeding that is severe or that you cannot control 
• krvavitev, ki je huda ali je ne morete obvladati
The median Body Mass Index was 28. 
Mediani indeks telesne mase je bil 28.
The median Body Mass Index was 27. 
Mediani indeks telesne mase je bil 27.
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). 
Pogostnosti so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni je mogoče oceniti iz razpoložljivih podatkov).
• suddenly feeling dizzy or sudden severe headache with no known cause 
• nenaden občutek omotice ali nenaden hud glavobol brez znanega vzroka
Zontivity may affect the way other medicines work, and other medicines may affect how Zontivity works. 
Zdravilo Zontivity lahko vpliva na delovanje drugih zdravil in druga zdravila lahko vplivajo na delovanje zdravila Zontivity.
The safety and efficacy of Zontivity in children aged less than 18 years have not yet been established. 
Varnost in učinkovitost zdravila Zontivity pri otrocih, mlajših od 18 let, še nista bili dokazani.
You may be at increased risk of bleeding. 
Obstaja lahko večje tveganje za krvavitev.
There are no reliable data on the use of vorapaxar in pregnant women. 
Zanesljivih podatkov o uporabi vorapaksarja pri nosečnicah ni.
Zontivity should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus. 
Zdravilo Zontivity se sme med nosečnostjo uporabljati le, če možna korist za mater upravičuje možno tveganje za plod.
• Do not stop taking Zontivity without first talking to the doctor who prescribed it for you. 
• Ne prenehajte jemati zdravila Zontivity, ne da bi se prej posvetovali z zdravnikom, ki vam ga je predpisal.
Zontivity is used to lower your chance of: 
Zdravilo Zontivity se uporablja za zmanjšanje možnosti za:
If Zontivity must be temporarily discontinued, restart it as soon as possible. 
Če je treba uporabo zdravila Zontivity začasno prekiniti, zdravilo čim prej znova uvedite.
Any unused medicinal product or material should be disposed of in accordance with local requirements. 
Neuporabljeno zdravilo ali material zavrzite v skladu z lokalnimi predpisi.
These differences are not considered to be clinically relevant and no dose adjustment is necessary. 
Te razlike ne veljajo za klinično pomembne in prilagoditev odmerka ni potrebna.
There is less information about other types of surgery but the overall evidence does not suggest an excessive risk of major bleeding. 
O drugih vrstah operacij je manj informacij, toda v celoti izsledki ne kažejo povečanega tveganja za večje krvavitve.
Phospholipidosis occurs at acceptable human to animal safety margins and was reversible. 
Fosfolipidoza se je pojavila ob sprejemljivi varnostni meji med človekom in živalmi in je bila reverzibilna.
Your doctor will determine if you should take Zontivity for more than 24 months. 
Zdravnik bo odločil, če morate zdravilo Zontivity jemati več kot 24 mesecev.
The effect of vorapaxar on the QTc interval was evaluated in a thorough QT study and in other studies. 
Vpliv vorapaksarja na interval QTc so ocenili v podrobni študiji QT in drugih študijah.
• Patients with any active pathological bleeding (see sections 4.4 and 4.8). 
• bolniki s kakršno koli aktivno patološko krvavitvijo (glejte poglavji 4.4 in 4.8),
• red or black stools (looks like tar) 
• rdeče ali črno blato (na pogled kot katran)
Keep a list of them to show your doctor and pharmacist when you get a new medicine. 
Imejte seznam teh zdravil in ga pokažite zdravniku in farmacevtu, kadar dobite kakšno novo zdravilo.
Interruption of Zontivity treatment should be avoided. 
Prekinitvi zdravljenja z zdravilom Zontivity se je treba izogibati.
Do not take Zontivity: 
Ne jemljite zdravila Zontivity:
CYP2C8 substrates 
Substrati CYP2C8
Platelet inhibition with vorapaxar is gradual and reversible. 
Inhibicija trombocitov z vorapaksarjem je postopna in reverzibilna.
Table 3: CABG-Related Bleeds 
Preglednica 3: Krvavitve, povezane s CABG
• have had any recent serious injury or surgery 
• če ste pred nedavnim imeli kakšno resno poškodbo ali operacijo,
• if you are allergic to vorapaxar sulfate or any of the other ingredients of this medicine (listed in section 6) 
• če ste alergični na vorapaksarjev sulfat ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
• Take Zontivity on a regular basis and for as long as your doctor keeps prescribing it. 
• Zdravilo Zontivity jemljite redno in tako dolgo, dokler vam ga predpisuje zdravnik.
• low red blood cell count (anaemia) 
• majhno število rdečih krvnih celic (anemija)
Continued therapy after this time must be based on a re-evaluation of the benefits and risks for the individual of further therapy. 
Nadaljevanje zdravljenja po tem času mora temeljiti na ponovni oceni koristi in tveganj nadaljnega zdravljenja pri posamezniku.
Zontivity is used in adults who have had a heart attack or have a condition known as "peripheral arterial disease" (also known as poor circulation in the legs). 
Zdravilo Zontivity uporabljamo pri odraslih, ki so imeli srčni infarkt ali imajo bolezen, ki jo imenujemo "periferna arterijska bolezen" (prav tako znana kot slaba prekrvavitev v nogah).
In these subgroups, Zontivity should only be prescribed after careful assessment of individual potential risks and benefits and the need for co-medication that may further increase the risk of bleeding. 
Pri teh podskupinah se lahko zdravilo Zontivity predpiše le ko se pri posamezniku skrbno oceni morebitna tveganja in koristi ter potrebo po sočasnem zdravljenju, ki bi lahko dodatno povečalo tveganje za krvavitve.
Within that period the effect was similar regardless of the time from qualifying MI to the start of therapy with Zontivity. 
V tem času je bil učinek podoben ne glede na čas od MI, ki je dovoljeval vključitev v študijo, do začetka zdravljenja z zdravilom Zontivity.
Bleeding category definitions: 
Opredelitve kategorij krvavitev:
This reduces the chance of a blood clot forming and blocking the arteries, such as the arteries in the heart. 
Tako zmanjša možnost za nastanek krvnega strdka in posledično zamašitev arterij, na primer arterij v srcu.
HR 95% CI p-value (Z) vs (P) 0.83 (0.76, 0.90) <.001 
HR 95 % IZ p-vrednost (Z) vs (P) 0,83 (0,76, 0,90) < 0,001
• rifampin (used to treat tuberculosis and some other infections) 
• rifampin (uporablja se za zdravljenje tuberkuloze in nekaterih drugih okužb),
The European Medicines Agency has deferred the obligation to submit the results of studies with Zontivity in one or more subsets of the paediatric population in prevention of arterial thromboembolism (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Zontivity za eno ali več podskupin pediatrične populacije za preprečevanje arterijskih trombembolizmov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Patients with events (%) 
Bolniki z dogodki (%)
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake "EXP".
Platelets are blood cells that help with normal blood clotting. 
Trombociti (krvne ploščice) so celice, ki pomagajo pri normalnem strjevanju krvi.
This medicinal product does not require any special temperature storage conditions. 
Za shranjevanje zdravila niso potrebna posebna navodila glede temperature.
Studies in rats have shown vorapaxar and/or its metabolites are excreted in milk. 
Študije na podganah so pokazale, da se vorapaksar in/ali njegovi presnovki izločajo v mleko.
• have a bodyweight of less than 60 kg 
• če imate telesno maso manjšo od 60 kg,