natgillin/translations-raw huggingface dataset:
For each inhalation session with the I-Neb AAD, the content of one 1-ml ampoule of Ventavis 20 microgram/ml, showing two coloured rings (-yellow-red), will be transferred into the appropriate nebuliser medication chamber with golden coloured latch together with the golden colour disc immediately before use. 
Za svaku inhalaciju pomoću sustava I-Neb AAD sadržaj jedne ampule od 1 ml lijeka Ventavis 20 mikrograma/ml označene s dva prstena u boji (žuti-crveni) premješta se u odgovarajuću komoru za lijek s jezičkom zlatne boje zajedno s diskom zlatne boje neposredno prije primjene.
Moreover, the benefit of Ventavis has not been established in patients with concomitant Chronic Obstructive Pulmonary Disease (COPD) and severe asthma. 
Nadalje, u bolesnika s popratnom kroničnom opstruktivnom bolesti pluća (KOPB) i teškom astmom nije utvrđena korist lijeka Ventavis.
Multipack: 168 (4 x 42) ampoules with 1 ml co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber). 
Višestruko pakiranje: 168 (4 x 42) ampula s 1 ml pakiranih zajedno sa zamjenskim setom Breelib (sadrži 1 nastavak za usta i 1 komoru za lijek).
Polígono Industrial Santa Rosa s/n 28806 Alcalá de Henares Madrid 
Berlimed S.A. Polígono Industrial Santa Rosa s/n
300 ampoules with 2 ml. 
300 ampula s 2 ml.
No reliable conclusion could be drawn on efficacy of the association as the sample size was limited and the study was of short duration. 
Zbog ograničene veličine uzorka i kratkog trajanja ispitivanja ne može se donijeti pouzdan zaključak o djelotvornosti te kombinacije lijekova.
Each ampoule with 1 ml contains 10 microgram iloprost. 
Svaka ampula s 1 ml otopine sadrži 10 mikrograma iloprosta.
Ventavis 20 mcg/ml 1 ml ampoule yellow-red ring 
Ventavis 20 mikrograma/ml ampula od 1 ml žuti-crveni prsten
EU/1/03/255/013 [168 (4 x 42) x 1 ml] co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber). 
EU/1/03/255/013 [168 (4 x 42) x 1 ml] pakirano zajedno sa zamjenskim setom Breelib (sadrži 1
Ventavis 10 mcg/ml (1 ml ampoule with white and yellow rings) 
Ventavis 10 µg/ml (ampula od 1 ml s bijelim i žutim prstenom)
4.2 Posology and method of administration Drug product 
4.2 Doziranje i način primjene
Ventavis 20 mcg/ml (1 ml ampoule with yellow and red rings) 
Ventavis 20 µg/ml (ampula od 1 ml sa žutim i crvenim prstenom)
At initiation of Ventavis treatment the first inhaled dose should be 2.5 microgram iloprost as delivered at the mouthpiece of the nebuliser. 
Na početku liječenja lijekom Ventavis, prva doza koja se inhalira je 2,5 mikrograma iloprosta dostavljena putem nastavka nebulizatora za usta.
Ventavis 20 microgram/ml 
Ventavis 20 mikrograma/ml.
There is no need for dose adaptation in patients with a creatinine clearance >30 ml/min (as determined from serum creatinine using the Cockroft and Gault formula). 
U bolesnika čiji je klirens kreatinina veći od 30 ml/min (utvrđen iz serumskog kreatinina pomoću
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET • Periodička izvješća o neškodljivosti
• 1 ml ampoules, colourless, glass type I, containing 1 ml nebuliser solution, ring coded with two coloured rings (white - yellow). 
• ampule od 1 ml, od bezbojnog stakla tipa I, s 1 ml otopine za nebulizator, označene s dva prstena u različitim bojama (bijeli - žuti).
For the 5 microgram dose of Ventavis 20 microgram/ml the medication chamber with the gold coloured latch is used together with the gold control disc. 
Za dozu od 5 mikrograma lijeka Ventavis 20 mikrograma/ml koristi se komora za lijek sa zlatnim jezičkom u kombinaciji sa zlatnim kontrolnim diskom.
Trometamol 
trombocitopenija
- Multipack containing 168 (4x42) ampoules for use with the Breelib and I-Neb nebuliser. 
- Višestruko pakiranje s 168 (4 x 42) ampula za primjenu pomoću nebulizatora Breelib ili I-Neb.
Ventavis 10 microgram/ml nebuliser solution Ventavis 20 microgram/ml nebuliser solution 
Ventavis 10 mikrograma/ml otopina za nebulizator Ventavis 20 mikrograma/ml otopina za nebulizator
- Multipack containing 168 (4x42) ampoules with Breelib consumables set (containing 1 
- Višestruko pakiranje sadrži 168 (4x42) ampula sa zamjenskim setom za Breelib (sadrži
If this dose is well tolerated, dosing should be increased to 5 microgram iloprost and maintained at that dose. 
Ako se ta doza podnosi dobro, doziranje je potrebno povećati i zadržati na dozi s 5 mikrograma iloprosta.
If this dose is well tolerated, dosing should be increased to 5 microgram iloprost using 2 ml ampoule of Ventavis 10 microgram/ml and maintained at that dose. 
Ako se ta doza podnosi dobro, doziranje se treba povećati i zadržati na dozi s 5 mikrograma iloprosta korištenjem ampule od 2 ml lijeka Ventavis 10
Ventavis 20 microgram/ml is available in the following packs: - Pack containing 30 ampoules or 42 ampoules for use with the Breelib and I-Neb nebuliser. 
• ampule od 1 ml za primjenu pomoću nebulizatora Breelib ili I-Neb: − Pakiranje sadrži 30 ili 42 ampule za primjenu pomoću nebulizatora Breelib i I-Neb.
For each medication chamber there is a corresponding colour coded control disc: 
Svaka komora za lijek obilježena je odgovarajućom bojom i ima kontrolni disk označen tom istom odgovarajućom bojom.
Each ampoule with 1 ml contains 20 microgram iloprost. 
Svaka ampula s 1 ml otopine sadrži 20 mikrograma iloprosta.
For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis 20 microgram/ml with two coloured rings (yellow - red), is transferred into the medication chamber immediately before use. 
Za svaku inhalaciju pomoću I-Neb AAD sadržaj jedne ampule od 1 ml lijeka Ventavis 20 mikrograma/ml označene s dva prstena u boji (žuti - crveni), premješta se u komoru za lijek neposredno prije primjene.
Ventavis 10 mcg/ml 1 ml ampoule white - yellow ring 
Ventavis 10 µg/ml ampula od 1 ml bijeli - žuti prsten
For each inhalation session with the I-Neb AAD, the content of one 1 ml ampoule of Ventavis, with two coloured rings (white - yellow) is transferred into the medication chamber immediately before use. 
Za svaku inhalaciju pomoću I-Neb AAD sadržaj jedne ampule od 1 ml lijeka Ventavis označene s dva prstena u boji (bijeli - žuti), premješta se u komoru za lijek neposredno prije primjene.
EU/1/03/255/014 [168 (4 x 42) x 1 ml] co-packed with Breelib consumables set (containing 1 mouthpiece and 1 medication chamber). 
EU/1/03/255/014 [168 (4 x 42) x 1 ml] pakirano zajedno sa zamjenskim setom Breelib (sadrži
Ventavis 10 mcg/ml 1 ml ampoule white-yellow ring 
Ventavis 10 mikrograma/ml ampula od 1 ml bijeli-žuti prsten
No study has been performed with Ventavis in children with pulmonary hypertension. 
Na djeci s plućnom hipertenzijom nije provođeno ispitivanje s lijekom Ventavis.
The I-Neb AAD nebuliser has been shown to be suitable for the administration of Ventavis 10 microgram/ml (1 ml ampoule) and 20 microgram/ml nebuliser solution. 
AAD pokazao se prikladnim za primjenu Ventavis 10 mikrograma/ml (ampula od 1 ml) i
Different nebuliser devices can be used to administer Ventavis 20µg/ml. 
Za primjenu lijeka Ventavis 20µg/ml mogu se koristiti različiti nebulizatori.
Blood pressure should be checked while initiating Ventavis. 
Na početku liječenja lijekom Ventavis potrebno je kontrolirati krvni tlak.
• For the 5 microgram dose the medication chamber with the purple coloured latch is used together with the purple control disc. 
• Za dozu od 5 mikrograma koristi se komora za lijek s ljubičasto obojenim jezičkom zajedno s ljubičastim kontrolnim diskom.
Only patients who are maintained at the 5 microgram dose and who have repeatedly experienced extended inhalation times with Ventavis 10 microgram/ml, which could result in incomplete inhalation, may be considered suitable for switching to Ventavis 20 microgram/ml. 
Ventavis 20 mikrograma/ml otopina za nebulizator Prelazak na Ventavis 20 mikrograma/ml može se razmotriti samo u bolesnika koji su na održavanju dozom od 5 mikrograma i koji su opetovano imali produljeno vrijeme inhalacije s lijekom Ventavis 10 mikrograma/ml, što može rezultirati nepotpunom inhalacijom.
Ventavis 20 microgram/ml nebuliser solution 
Ventavis 20 mikrograma/ml otopina za nebulizator
For each inhalation session, the content of one ampoule containing 2 ml of Ventavis 10 microgram/ml nebuliser solution and marked with two coloured rings (white - pink) is transferred into the nebuliser medication chamber immediately before use. 
Neposredno prije svake pojedinačne inhalacije sadržaj jedne ampule od 2 ml Ventavis 10 mikrograma/ml otopine za nebulizator označene s dva prstena u boji (bijeli - ružičasti) premješta se u komoru za lijek u nebulizatoru.
• 1 ml ampoules for use with Breelib or I-Neb nebulisers: 
• ampule od 2 ml za primjenu pomoću nebulizatora Venta-Neb:
What Ventavis looks like and content of the pack: 
Moguće nuspojave Kako čuvati Ventavis Sadržaj pakiranja i druge informacije
168 (4 x 42) AMPOULES WITH 1 ML CO-PACKED WITH BREELIB CONSUMABLES SET 
168 (4 x 42) AMPULA S 1 ML PAKIRANO ZAJEDNO SA ZAMJENSKIM
Symptoms can include chest pain, - a heart attack within the last six months, - a weak heart (decompensated cardiac failure) which is not under close medical observation, - severe unstable heartbeat, - a defect of the heart valves (inborn or acquired) that causes the heart to work poorly (not related to pulmonary hypertension), 
− oštećenje srčanih zalistaka (urođeno ili stečeno) koje uzrokuje oslabljeni rad srca (koje nije povezano s plućnom hipertenzijom),
For patients being switched from an alternative device to the Breelib nebuliser the first inhalation should be made with Ventavis 10 microgram/ml (1ml ampoule) delivering 2.5 microgram iloprost at the mouthpiece and under close medical supervision to ensure that the faster inhalation provided by Breelib is well tolerated. 
Bolesnici koji prelaze s drugog uređaja na Breelib nebulizator u prvoj inhalaciji trebaju primijeniti lijek Ventavis 10 mikrograma/ml (ampula od 1 ml) kojom se dostavlja 2,5 mikrograma iloprosta putem nastavka za usta nebulizatora,
Ventavis 10 microgram/ml, Nebuliser solution Iloprost 
Ventavis 10 mikrograma/ml otopina za nebulizator iloprost
2 ml ampoule white - pink ring 
Ventavis 10 µg/ml ampula od 2 ml bijeli - ružičasti prsten
30 ampoules with 1 ml. 
Otopina za nebulizator. 30 ampula s 1 ml.
Ampoule coloured ring Dosage 
Ampula/ boje prstenova
Different nebuliser devices can be used to administer Ventavis. 
Za primjenu lijeka Ventavis mogu se koristiti različiti nebulizatori.
Musculoskeletal and connective tissue disorders 
Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u čeljusti /
Medication chamber latch 
France Bayer HealthCare
You should use the green baffle plate to obtain the optimal droplet size for the administration of Ventavis. 
Radi postizanja optimalne veličine kapljica, za primjenu lijeka Ventavis potrebno je koristiti zelenu ploču.
Ventavis 20 microgram/ml nebuliser solution Iloprost 
Ventavis 20 mikrograma/ml otopina za nebulizator iloprost
For the 5 microgram dose of Ventavis 10 microgram/ml the medication chamber with the purple coloured latch is used together with the purple control disc. 
Za dozu od 5 mikrograma lijeka Ventavis 10 mikrograma/ml koristi se komora za lijek s ljubičastim jezičkom u kombinaciji s ljubičastim kontrolnim diskom.
Hepatic impairment 
Doza iloprosta
Berlimed S.A. 
Bayer S.p.A.
2.5 mcg 
2,5 µg
EU/1/03/255/007 [90 (3 x 30) x 2 ml] EU/1/03/255/008 [300 (10 x 30) x 2 ml] 
EU/1/03/255/008 [300 (10 x 30) x 2 ml]
30 AMPOULES WITH 1 ML 
Otopina za nebulizator. 30 ampula s 1 ml
P1 Programme 1: 5 microgram active substance on the mouth piece 25 inhalation cycles. 
Moguća su dva programa primjene: P1 program 1: 5 mikrograma djelatne tvari u nastavku za usta uz 25 ciklusa inhalacije.
Dose per inhalation session 
Doza po pojedinačnoj inhalaciji
Symptoms 
Lijek
I-Neb AAD nebuliser: 
I Neb AAD
Ventavis 10 microgram/ml 
Ventavis 10 mikrograma/ml Breelib
I-Neb AAD Estimated inhalation time 
I-Neb AAD Jezičak u komori za lijek
30 ampoules with 1 ml 42 ampoules with 1 ml Multipack: 168 (4 x 42) ampoules with 1 ml 
PAKIRANJE S 42 AMPULE U KARTONSKOJ KUTIJI SA 168 (4 x 42) AMPULA S 1 ML PAKIRANJE S 42 AMPULE U KARTONSKOJ KUTIJI SA 168 (4 x 42) AMPULA S 1 ML
1 ml ampoule yellow - red ring 5 mcg golden golden 
Ventavis 20 mikrograma/ml ampula od 1 ml žuti-crveni prsten 5 µg zlatni zlatni
Following intravenous infusion, the apparent steady-state volume of distribution was 0.6 to 0.8 l/kg in healthy subjects. 
0,6 do 0,8 l/kg u zdravih ispitanika.
Thrombocytopenia 
o tirofiban,
Bayer, spol. 
Bayer OÜ
• 2 ml ampoules for the use with Venta-Neb: Pack containing 30, 90, 100 or 300 ampoules. 
Pakiranje sadrži 30, 90, 100 ili 300 ampula.
Start therapy by inhaling 2.5 microgram iloprost using 1 ml ampoule of Ventavis 10 microgram/ml (with white and yellow rings). 
Liječenje započnite inhalacijom 2,5 mikrograma iloprosta korištenjem ampule od 1 ml lijeka Ventavis
Change in BOD week 108(1) 
Promjena BOD 108. tjedan(1)
Take your next dose at the scheduled time. 
Uzmite sljedeću dozu u uobičajeno vrijeme.
Use of alternative contraceptive methods is recommended. 
Preporučuje se primjena alternativnih kontracepcijskih metoda.
Nevertheless, their impact remains limited (31%). 
Međutim, njihov je utjecaj ograničen (≤31%).
The study results are shown in Table 1. 
Rezultati ispitivanja prikazani su u Tablici 1.
AUBAGIO is taken every day as a single daily dose at any time of the day. 
AUBAGIO se uzima svaki dan kao pojedinačna dnevna doza u bilo koje doba dana.
The tablets should be swallowed whole with some water. 
Tablete se moraju progutati cijele, s malo vode.
Tell your your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
This includes medicines obtained without a prescription. 
To uključuje i lijekove koji ste nabavili bez recepta.
Accelerated elimination procedure 
Postupak ubrzane eliminacije
Do not take AUBAGIO if you are, or think you may be pregnant. 
Nemojte uzeti AUBAGIO ako ste trudni ili mislite da biste mogli biti trudni.
The recovery time varied between months and years. 
Vrijeme oporavka kretalo se u rasponu od nekoliko mjeseci do nekoliko godina.
You may experience side effects similar to those described in section 4 below. 
Možda će Vam se pojaviti nuspojave slične onima opisanima u dijelu 4.
• Talk with your doctor about the best method of contraception for you and any potential need for contraception change. 
• Razgovarajte sa svojim liječnikom o najboljoj metodi kontracepcije za Vas te o mogućoj potrebi za promjenom metode kontracepcije.
Characteristics in specific groups of patients 
Značajke u određenim skupinama bolesnika
Date of first authorisation: 26 August 2013 Date of latest renewal: 28 May 2018 
Datum posljednje obnove odobrenja: 28. svibnja 2018.
• balance problems. 
• poteškoće s ravnotežom.
Serious opportunistic infections occurred in 0.2% of each group. 
Ozbiljne oportunističke infekcije javile su se u 0,2% bolesnika u svakoj skupini.
Although human data are lacking, no effect on male and female fertility is anticipated. 
Premda nedostaju podaci u ljudi, ne očekuje se učinak na plodnost u muškaraca i žena.
- you have weakness, numbness and pain in the hands and feet. 
- ako osjećate slabost, utrnulost i bol u rukama i stopalima.
- you have high blood pressure (hypertension) whether it is controlled with medicines or not. 
- ako imate visok krvni tlak (hipertenziju), neovisno o tome kontrolirate li ga lijekovima ili ne.
Symptoms may disappear completely after the relapse is over, but over time, some problems may remain between relapses. 
Simptomi mogu u potpunosti nestati nakon završetka relapsa, no s vremenom se neke tegobe mogu zadržati i između relapsa.
• Requires a pregnancy status check before treatment 
• zahtijeva provjeru statusa trudnoće prije liječenja
AUBAGIO can cause an increase in blood pressure. 
AUBAGIO može uzrokovati povišenje krvnoga tlaka.
This can cause physical disabilities that may interfere with your daily activities. 
To može uzrokovati tjelesnu onesposobljenost koja može ometati izvršavanje svakodnevnih aktivnosti.
Each wallet is placed in a protective sleeve. 
Svaki je kartonski ovitak umetnut u zaštitnu košuljicu.
• Educational material for Healthcare professionals 
• Edukacijske materijale za zdravstvene radnike
No similar subgroup analysis was performed in TOWER as no MRI data were obtained. 
U ispitivanju TOWER nije provedena slična analiza podskupine jer nisu prikupljeni MRI podaci.
The mean age of the study population was 37.9 years. 
Prosječna dob ispitivane populacije bila je 37,9 godina.
In such cases, patients should refrain from driving and using machines. 
U takvim slučajevima bolesnici se moraju suzdržati od upravljanja vozilima i rada sa strojevima.
What multiple sclerosis is 
Što je multipla skleroza
Efficacy in patients with high disease activity: 
Djelotvornost u bolesnika s bolešću visokoga stupnja aktivnosti:
These elevations occurred mostly within the first 6 months of treatment. 
Ta su povećanja uglavnom nastupila unutar prvih 6 mjeseci liječenja.
Other medicines and AUBAGIO 
Drugi lijekovi i AUBAGIO
AUBAGIO may be taken with or without food. 
AUBAGIO se može uzimati s hranom ili bez nje.
These symptoms vary from patient to patient but usually involve: 
Ti se simptomi razlikuju od bolesnika do bolesnika, ali obično obuhvaćaju sljedeće:
The choice between the 3 elimination procedures should depend on the patient's tolerability. 
Izbor jednoga od triju postupaka eliminacije ovisi o podnošljivosti bolesnika.
• difficulty walking 
• poteškoće s hodanjem
Potential to prolong the QT interval 
Potencijal za produljenje QT-intervala
Contents of the pack and other information What AUBAGIO contains 
Sadržaj pakiranja i druge informacije Što AUBAGIO sadrži
AUBAGIO should be used with caution in patients aged 65 years and over due to insufficient data on safety and efficacy. 
AUBAGIO se mora primjenjivati uz oprez u bolesnika u dobi od 65 godina i starijih zbog nedostatnih podataka o sigurnosti i djelotvornosti.
The safety and efficacy of teriflunomide in children aged from 10 to less than 18 years has not yet been established. 
Sigurnost i djelotvornost teriflunomida u djece i adolescenata u dobi od 10 do manje od 18 godina nisu još ustanovljene.
The time can be reduced to a few weeks by taking certain medicines which speed up removal of AUBAGIO from your body. 
To se vrijeme može skratiti na nekoliko tjedana uzimanjem određenih lijekova koji ubrzavaju uklanjanje lijeka AUBAGIO iz tijela.
The majority of effects reflect the basic mode of action of the compound (inhibition of dividing cells). 
Većina učinaka odražava osnovni način djelovanja spoja (inhibicija stanica koje se dijele).
Talk to your doctor or pharmacist before taking AUBAGIO if: - you have liver problems and/or if you drink large amounts of alcohol. 
Obratite se svom liječniku ili ljekarniku prije nego uzmete AUBAGIO: - ako imate tegobe s jetrom i/ili pijete alkohol u većim količinama.
Please read section 4. 
Pročitajte dio 4.
Hazard ratio (CI95%) 
Omjer hazarda (CI95%)
• Requires concomitant use of effective contraception in women of child-bearing potential 
• zahtijeva istodobnu primjenu djelotvorne kontracepcije u žena reproduktivne dobi
Teriflunomide 14 mg (N=1002) 
teriflunomid 14 mg (N=1002)
If you are affected, do not drive or use machines. 
Ako primijetite omaglicu, nemojte upravljati vozilima niti rukovati strojevima.
• Blood pressure o Check periodically 
• krvni tlak o periodično provjeriti
If they become pregnant: 
Ako bolesnica zatrudni:
The long term safety of these combinations in the treatment of multiple sclerosis has not been established. 
Dugoročna sigurnost tih kombinacija u liječenju multiple skleroze nije utvrđena.
People with relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by their nerves not working properly. 
Osobe s relapsnim oblikom multiple skleroze imat će ponovljene napadaje (relapse) tjelesnih simptoma uzrokovane nepravilnim radom živaca.
Long term follow-up results from TEMSO long term extension safety study (overall median treatment duration approximately 5 years, maximum treatment duration approximately 8.5 years) did not present any new or unexpected safety findings. 
Rezultati dugoročnog praćenja dobiveni u dugoročnom nastavku ispitivanja sigurnosti TEMSO (ukupni medijan trajanja liječenja približno 5 godina, maksimalno trajanje liječenja približno 8,5 godina) nisu ukazali na nove ili neočekivane zaključke vezane uz sigurnost.
This may lead to an additive effect on the immune system and caution is, therefore, indicated. 
To može uzrokovati aditivni učinak na imunološki sustav pa je stoga potreban oprez.
• Educational card for patients 
• Edukacijsku karticu za bolesnike
This limits the inflammation that leads to nerve damage in MS. 
To ograničava upalu koja dovodi do oštećenja živaca u MS-u.
Do not stop taking AUBAGIO or change your dose without talking to your doctor first. 
Nemojte prestati uzimati AUBAGIO niti mijenjati dozu lijeka bez prethodnog razgovora sa svojim liječnikom.
Information to educate the patient: 
Informacije za edukaciju bolesnika:
For further information on the sample testing please contact the Marketing Authorisation Holder or its local representative (see section 7). 
Za dodatne informacije o ispitivanju uzoraka obratite se nositelju odobrenja za stavljanje gotovog lijeka u promet ili njegovom lokalnom predstavniku (vidjeti dio 7).
The primary endpoint was time to a second clinical episode (relapse). 
Primarni ishod bilo je vrijeme do druge kliničke epizode (relaps).
• Do this until the levels of AUBAGIO in your blood are low enough - your doctor will check this. 
• Koristite je sve dok razine lijeka AUBAGIO u Vašoj krvi ne budu dovoljno niske - to će provjeriti
In addition, if required for tolerability reasons, administration of cholestyramine or activated charcoal does not need to occur on consecutive days (see section 5.2). 
Osim toga, ako je to potrebno zbog podnošljivosti, kolestiramin ili aktivni ugljen ne moraju se primjenjivati tijekom uzastopnih dana (vidjeti dio 5.2).
The use of live attenuated vaccines may carry a risk of infections and should therefore be avoided. 
Primjena živih atenuiranih cjepiva može nositi rizik od infekcija pa je stoga treba izbjegavati.
• To remind both patients and HCP about the Pregnancy Registry (in countries where pregnancy registry is on-going) 
• podsjetnik i za bolesnicu i za zdravstvenog radnika o registru trudnoća (u onim zemljama u kojima se vodi registar trudnoće)
Before you take AUBAGIO, your doctor will make sure you have enough white blood cells and platelets in your blood. 
Prije nego uzmete AUBAGIO, liječnik će provjeriti imate li u krvi dovoljno bijelih krvnih stanica i krvnih pločica.
Effect of teriflunomide on BCRP and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates 
Učinak teriflunomida na BCRP i/ili supstrate organskog anionskog transportnog polipeptida B1 i B3 (OATP1B1/B3)
If you have taken too much AUBAGIO, call your doctor straight away. 
Ako ste uzeli previše lijeka AUBAGIO, odmah se obratite svome liječniku.
The mean number of relapses within the year before study inclusion was 1.4. 
Srednji broj relapsa unutar jedne godine prije uključivanja u ispitivanje iznosio je 1,4.
These effects are considered to be related to increase in renal tubular excretion and not related to changes in glomerular functions. 
Ti se učinci smatraju povezanima s povećanjem izlučivanja bubrežnim tubulima i nisu povezani s promjenama glomerularnih funkcija.
For further information on the laboratory testing please contact your doctor. 
Za daljnje informacije o laboratorijskim pretragama obratite se svome liječniku.
Table 1 - Main Results ( for the approved dose, ITT population) TEMSO-study 
Tablica1- Glavni rezultati (za odobrenu dozu, ITT populacija) Ispitivanje TEMSO