natgillin/translations-raw huggingface dataset:
Common: redness at the injection site, swelling at the injection site, fever, shivering Uncommon: injection site reactions (such as bruising, induration, pruritus, warmth), asthenia, chest 
Manje često: reakcije na mjestu injiciranja (poput stvaranja modrica, otvrdnuća, pruritusa, osjećaja
The mixed vaccine is a whitish emulsion. 
Pripremljeno cjepivo je bjelkasta emulzija.
• Shortness of breath 
• osjećaj omaglice
Full dose N=42 
Puna doza N=42
Skin and subcutaneous tissue disorders Common: sweating Uncommon: pruritus, rash 
Poremećaji kože i potkožnog tkiva Često: znojenje
The ability to induce protection against homologous and heterologous vaccine strains was assessed non-clinically with A/Indonesia/05/05 (H5N1) using ferret challenge models. 
U nekliničkom ispitivanju sa sojem A/Indonesia/05/05 (H5N1) procjenjivala se sposobnost poticanja zaštite protiv homolognih i heterolognih sojeva u cjepivu primjenom modela s izlaganjem tvorova.
Full dose N=43 
Puna doza N=43
In another clinical study (Q-Pan-H5N1-001), the anti-haemagglutinin (anti-HA) antibody responses in subjects aged 18-64 years were as follows: 
U drugom kliničkom ispitivanju (Q-Pan-H5N1-001), odgovori anti-hemaglutinin protutijela (anti-HA)
Split influenza virus, inactivated, containing antigen* equivalent to: *Antigen: A/Indonesia/5/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 
fragmentirani virus influence, inaktivirani, koji sadrži antigen* koji odgovara: *Antigen: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that were followed in a prospective clinical study. 
U prospektivnom kliničkom ispitivanju nije bilo dokaza o povećanom riziku od nuspojava u
In a clinical study (D-Pan-H5N1-009, -023), children aged 3 to 5 and 6 to 9 years old received two doses of either a full (0.5 ml) or a half dose (0.25 ml) of an AS03-adjuvanted vaccine containing 3.75 
U kliničkom ispitivanju (D-Pan-H5N1-009, -023) djeca od 3 do 5, te od 6 do 9 godina primila su u dva navrata punu dozu (0,5 ml) ili polovinu doze (0,25 ml) cjepiva s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 (H5N1) na 0. i 21. dan.
Saint-Foy, Quebec, 
IB Biomedical Corporation of Quebec koja djeluje kao
3.75 micrograms* AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 
Adjuvans AS03 sadrži skvalen, DL-α tokoferol i polisorbat 80
Split influenza virus, inactivated, containing antigen* equivalent to: A/H5N1/Indonesia/5/2005 like strain used (PR8-IBCDC-RG2)3.75 micrograms** per 0.5 ml 
fragmentirani virus influence,inaktiviran, koji sadrži antigen* koji odgovara soju: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2) 3,75 mikrograma**
Nervous system disorders Very common: headache Uncommon: dizziness, paraesthesia 
Manje često: vrtoglavica Poremećaji dišnog sustava, prsišta i sredoprsja: Manje često: dispneja
Immune response to A/Vietnam/1194/2004 3 to 5 years 
Imunološki odgovor na A/Vietnam/1194/2004 21 dan nakon 2. doze
Depending on and after implementation of vaccine strain, when first pandemic will take place. 
Ovisno o pojavi prve pandemije te soju primijenjenom u cjepivu.
Split influenza virus inactivated, containing antigen equivalent to: A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2) 
fragmentirani virus influence,inaktiviran, koji sadrži antigen koji odgovara soju: A/Indonesia/05/2005 (H5N1) poput kojeg je korišten soj (PR8-IBCDC-RG2)
A 4-fold increase in serum neutralising antibody against A/Vietnam/1194/2004 was achieved in 44.7% of subjects at day 21, 53.2% at day 42 and 38.3% at day 180. 
Četverostruki porast neutralizirajućih protutijela protiv A/Indonesia/5/2005 u serumu, postignut je 21. dana u 76,6% ispitanika, 42. dana u 97,9%, te 180. dana u 91,5%, a 100% ispitanika imalo je titar od
Presentation of data will take into consideration the following recommendations: 
uzimajući u obzir službene preporuke.
In other clinical studies where children 6 months to 17 years received another pandemic influenza vaccine (H5N1 A/Indonesia/05/2005 manufactured in Dresden, Germany), increases in the frequency of some side effects (including injection site pain, redness and fever) were seen after the second dose 
U drugim kliničkim ispitivanjima, u kojima su djeca u dobi od 6 mjeseci do 17 godina primila drugo cjepivo protiv pandemijske influence (H5N1 A/Indonezija/05/2005, proizvedeno u Dresdenu,
Talk to your doctor or nurse before you are given Pumarix: 
Prije nego što primite Pumarix provjerite sa svojim liječnikom ili medicinskom sestrom:
This can cause skin rashes, joint pain and 
• upala krvnih žila (vaskulitis), što može uzrokovati osipe po koži, bol u zglobovima i probleme s bubrezima
Additional side effects in children 
I DOHVATA DJECE
4.5 Interaction with other medicinal products and other forms of interaction There are no data on co-administration of Pumarix with other vaccines. 
Nema podataka o istovremenoj primjeni cjepiva Pumarix s drugim cjepivima.
In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing four different doses of H5N1 antigen (3.75, 1.5, 0.6 and 0.24 µg of HA antigen) adjuvanted with half dose of AS03. 
- Model s heterolognim pandemijskim H5N1 sojem (A/Hong Kong/156/97) U tom ispitivanju zaštite, tvorovi (šest tvorova/skupina) su imunizirani intramuskularno predloženim cjepivom koje je sadržavalo četiri različite doze antigena H5N1 (3,75; 1,5; 0,6 i 0,24 µg HA antigena),
Fainting can occur following, or even before, any needle injection. 
Nakon bilo kojeg uboda iglom, a ponekad čak i prije uboda, može doći do gubitka svijesti.
2booster seroconversion rate: proportion of subjects who were either seronegative at pre-booster and have a protective post-vaccination titre of ≥1:40, or who were seropositive at pre-booster and have a 4 
1stopa seroprotekcije (tj. udio ispitanika koji su postigli titar inhibicije hemaglutinacije ≥1:40) 2stopa serokonverzije (tj. udio ispitanika koji su bili seronegativni prije cijepljenja i postigli zaštitni titar ≥1:40 nakon cijepljenja, ili koji su bili seropozitivni prije cijepljenja i imali četverostruki porast
Adverse reactions from clinical trials with the mock-up vaccine are listed here below (see section 5.1 for more information on mock-up vaccines). 
U tekstu koji slijedi navedene su nuspojave iz kliničkih ispitivanja sa 'mock-up' cjepivom (za više
The emulsion presents as a whitish appearance. 
Emulzija je bjelkaste boje.
2seroconversion rate (i.e. proportion of subjects who were either seronegative at pre-vaccination and have a protective post-vaccination titre of ≥ 1:40, or who were seropositive at pre-vaccination and 3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT) Twenty-one days after the second dose, a 4-fold increase in serum neutralising antibody against A/Indonesia/5/2005 was achieved in 94.4% of subjects aged 18-60 years and in 80.4% of subjects over 60 years of age. 
Dvadeset i jedan dan nakon druge doze, u osoba od 18 do 60 godina postignut je četverostruki porast neutralizirajućih protutijela protiv A/Indonesia/5/2005 u serumu 94,4% ispitanika, a u osoba starijih od 60 godina u 80,4% ispitanika.
Administration of an AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) manufactured using a different process Paediatric population 
Primjena cjepiva koja sadrže adjuvans AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004
From post-marketing experience with AS03-containing vaccines containing 3.75 µg HA derived from A/California/7/2009 (H1N1), the following adverse reactions have been reported: 
Iz postmarketinškog iskustva s AS03-cjepivima koja sadrže 3,75 µg hemaglutinina dobivenog iz soja
How Pumarix is given 
Cjepivo se treba davati
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 
Sažetka opisa svojstava lijeka obnavljati prema potrebi.
At day 42, the neutralising antibody responses were as follows: Immune response to A/Vietnam/1194/2004 21 days after 2 
Četverostruki porast neutralizirajućih protutijela protiv A/Vietnam/1194/2004 u serumu postignut je
You may need to read it again. 
I u tim slučajevima možete primiti
• They will give Pumarix as an injection into a muscle 
Za primjenu u mišić
There are very limited safety and immunogenicity data available on the administration of an AS03adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 (H5N1) manufactured using a different process and on administration of half a dose of the same vaccine (i.e. 1.875 µg HA and half the amount of AS03 adjuvant) at 0 and 21 days in children aged 3 to 9 years. 
Za djecu od 3 do 9 godina postoje vrlo ograničeni podaci o sigurnosti i imunogenosti cjepiva s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 (H5N1)
6.6 Special precautions for disposal and other handling 
POSEBNE MJERE ČUVANJA
Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Tablet container (HDPE) 
Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Blister (PVC/PVdC/alu) Spremnik za tablete (HDPE)
28 tablets 30 tablets 84 tablets 100 tablets 60 tablets 
28 tableta 30 tableta 84 tableta 100 tableta 60 tableta
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet 
Filmom obložene tablete Filmom obložene tablete Filmom obložene tablete Filmom obložene tablete Filmom obložene tablete
Lamivudine Teva Lamivudine Teva Lamivudine Teva Lamivudine Teva Lamivudine Teva 
Lamivudin Teva Lamivudin Teva Lamivudin Teva Lamivudin Teva Lamivudin Teva
Strength Pharmaceutical Form Route of Administration 
Farmaceutski oblik Put primjene Unutarnje pakovanje Veličina pakovanja
This could be serious. 
To bi moglo biti ozbiljno.
• wearing appropriate protective clothing. 
• nosite prikladnu zaštitnu odjeću.
The patients recovered spontaneously. 
Bolesnici su se spontano oporavili.
Any infection that you already have may get worse. 
Bilo koja infekcija koju već imate mogla bi se pogoršati.
Talk to your doctor about reliable methods of contraception. 
Porazgovarajte sa svojim liječnikom o pouzdanim metodama kontracepcije.
Take Gilenya once a day with a glass of water. 
Uzimajte Gilenyu jedanput na dan uz čašu vode.
The following should be considered: 
Treba razmotriti sljedeće:
The dose depends on body weight: 
Doza ovisi o tjelesnoj težini:
Early on, there may not be any symptoms. 
U početku možda neće biti nikakvih simptoma.
Final Study report by 15 December 
Završno izvješće o ispitivanju do 15. prosinca
Children and adolescents (10 years of age and above): 
Djeca i adolescenti (10 i više godina):
You may need to be monitored more closely. 
Možda će vas trebati pažljivo pratiti.
Do not exceed the recommended dose. 
Nemojte premašiti preporučenu dozu.
• With third degree AV block occurring at any time; 
• S AV blokom trećeg stupnja koji se pojavi u bilo kojem trenutku;
• GILENYA is teratogenic. 
• GILENYA je teratogena.
Teriflunomide is also eliminated slowly from the plasma. 
Teriflunomid se također sporo eliminira iz plazme.
Week Monday Tuesday Wednesday Thursday Friday Saturday Sunday 
Tjedan Ponedjeljak Utorak Srijeda Četvrtak Petak
White blood cells fight infection. 
Bijele krvne stanice bore se protiv infekcije.
Your doctor will tell you whether your illness allows you to drive vehicles, including a bicycle, and use machines safely. 
Liječnik će Vam reći da li Vam bolest dozvoljava da sigurno upravljate vozilima, uključujući bicikl, i strojevima.
During the first twelve months of treatment your doctor will request blood tests to monitor your liver function. 
Tijekom prvih dvanaest mjeseci liječenja, liječnik će zatražiti krvne pretrage da bi pratio funkciju Vaše jetre.
Specifically for Pediatric patients: 
Posebno za pedijatrijske bolesnike:
The warnings and precautions listed above also apply to children and adolescents. 
Upozorenja i mjere opreza navedena iznad također vrijede i za djecu i adolescente.
Taking Gilenya at the same time each day will help you remember when to take your medicine. 
Uzimanje Gilenye u isto vrijeme svakoga dana pomoći će Vam da se sjetite kada trebate uzeti lijek.
Other dosing regimens have not been approved. 
Drugi režimi doziranja nisu odobreni.
This increases your risk of developing cancers, in particular skin cancers. 
To povećava rizik od nastajanja raka, naročito raka kože.
• Signs and symptoms of infection; 
• Znakovi i simptomi infekcije
Symptoms of a relapse may disappear completely when the relapse is over, but some problems may remain. 
Simptomi relapsa mogu potpuno nestati kada relaps završi, ali neke poteškoće mogu i ostati.
Specific measures are also included in the Physician Information Pack. 
Specifične mjere su također uključene i u informativni paket za liječnike.
Infections could be serious and life-threatening. 
Infekcije bi mogle biti ozbiljne i opasne po život.
Your doctor may monitor your electrocardiogram continuously during that time. 
Liječnik će Vam možda kontinuirano pratiti elektrokardiogram u tom razdoblju.
Do not store above 25°C. 
Ne čuvati na temperaturi iznad 25˚C.
Never take a double dose to make up for a forgotten dose. 
Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
Characteristics in specific groups of patients 
Karakteristike u specifičnim skupinama bolesnika
• regularly applying sunscreen with a high degree of UV protection. 
• redovito nanosite kremu za sunčanje s visokim stupnjem UV zaštite.
If you are a woman, your doctor will also recommend HPV screening. 
Ako ste žena, Vaš liječnik će preporučiti i probir na HPV.
Patients may be monitored with continuous ECG during the first 6 hours. 
Bolesnike se može pratiti kontinuiranim EKG-om tijekom prvih 6 sati.
The safety and efficacy of Gilenya in children aged below 10 years have not yet been established. 
Sigurnost i djelotvornost Gilenye u djece u mlađe od 10 godina nije još ustanovljena.
The possibility of recurrence of exceptionally high disease activity should be considered. 
Potrebno je uzeti u obzir mogućnost ponovnog javljanja iznimno visoke aktivnosti bolesti.
Detailed information of adverse reactions with no recommendation should not be included in this section. 
Detaljne informacije o nuspojavama bez preporuke ne bi trebale biti uključene u ovom dijelu.
Your ability to drive and use machines may be impaired during and potentially after this time period. 
Vaša sposobnost upravljanja vozilima i strojevima mogla bi za to vrijeme biti narušena, a potencijalno i nakon tog vremenskog razdoblja.
Gilenya will stay in your body for up to 2 months after you stop taking it. 
Gilenya će ostati u Vašem tijelu do 2 mjeseca nakon što je prestanete uzimati.
S1P4 could partially contribute to the effect but was not the main receptor responsible for the lymphoid depletion. 
S1P4 bi mogao djelomično doprinositi učinku, ali nije glavni receptor odgovoran za limfoidnu depleciju.
In this case, it is recommended to repeat the first-dose observation period. 
U ovom slučaju preporučuje se ponoviti razdoblje motrenja prve doze.
This is called demyelination. 
To se zove demijelinizacija.
To switch from teriflunomide, your doctor may advise you to wait for a certain time or to go through an accelerated elimination procedure. 
Da biste se prebacili s teriflunomida, liječnik Vam može savjetovati da pričekate određeno vrijeme ili da prođete kroz postupak ubrzane eliminacije.
• Corticosteroids, due to a possible added effect on the immune system. 
• Kortikosteroide, zbog mogućeg dodatnog učinka na imunološki sustav.
It must be repeated at suitable intervals. 
Test se mora ponavljati u odgovarajućim intervalima.
Otherwise, it may not be possible for the doctor to understand the results of the test, and for certain types of blood test your doctor may need to take more blood than usual. 
U suprotnom, Vaš liječnik možda neće moći razumjeti rezultate pretraga, a za određene vrste krvnih pretraga liječnik će možda morati uzeti više od uobičajene količine krvi.
Fingolimod is extensively distributed to body tissues with a volume of distribution of about 1,200260 litres. 
Fingolimod se ekstenzivno distribuira u tjelesna tkiva, s volumenom distribucije od približno 1200260 litara.
During routine MRI (in accordance with national and local recommendations), physicians should pay attention to PML suggestive lesions. 
Tijekom rutinskog MR-a (u skladu s nacionalnim i lokalnim preporukama) liječnici trebaju obratiti pozornost na lezije koje upućuju na PML.
Other medicines and Gilenya Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Drugi lijekovi i Gilenya Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
* p<0.05, ** p<0.001, compared to interferon beta-1a. 
* p<0,05, ** p<0,001, u usporedbi s interferonom beta-1a.
Specialised pre-natal monitoring will be performed. 
Provest će se specijalizirano prenatalno praćenje.
Posterior reversible encephalopathy syndrome (PRES)* 
Sindrom posteriorne reverzibilne encefalopatije (PRES)*
• Cases of seizure, including status epilepticus, have been reported. 
• Zabilježeni su slučajevi napadaja, uključujući status epilepticus.
The apparent absolute oral bioavailability is 93% (95% confidence interval: 79-111%). 
Apsolutna peroralna bioraspoloživost iznosi 93% (95%-tni interval pouzdanosti: 79-111%).
Expanded Disability Status Score (EDSS) was between 0 and 5.5. 
Expanded Disability Status Score) iznosio je između 0 i 5,5.
Frequencies were defined using the following convention: 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). 
Učestalosti su definirane prema sljedećoj podjeli: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
MRI findings may be apparent before clinical signs or symptoms. 
Nalazi MR-a mogu biti očigledni prije kliničkih znakova ili simptoma.
Gilenya can be taken with or without food. 
Gilenya se može uzimati s hranom ili bez nje.
Suspension of treatment during serious infections should be considered. 
Potrebno je razmotriti obustavljanje liječenja tijekom ozbiljnih infekcija.
The majority of patients were Tanner stage 2 or higher (94.4%) and were >40 kg (95.3%). 
Većina bolesnika je bila s Tanner stupnjem 2 ili višim i imali su >40 kg (95,3%).
Your white blood cell count (lymphocyte count) may also remain low during this time and the side effects described in this leaflet may still occur. 
Broj Vaših bijelih krvnih stanica (broj limfocita) također bi mogao ostati nizak za to vrijeme, a nuspojave opisane u ovoj uputi još uvijek bi se mogle pojaviti.
Clinical experience and pharmacokinetic information in patients aged above 65 years are limited. 
Kliničko iskustvo i farmakokinetičke informacije u bolesnika starijih od 65 su ograničeni.
The relationship of such events to Gilenya is uncertain. 
Povezanost tih događaja s Gilenyom nije sigurna.
Swallow each capsule whole 
Progutati svaku kapsulu cijelu
There are no data available for paediatric patients below 10 years old. 
Nema dostupnih podataka u pedijatrijskih bolesnika mlađih od 10 godina.
An ECG at 6 hours should also be performed and, in some circumstances, monitoring may involve an overnight stay; 
Također treba obaviti EKG nakon 6 sati, a u nekim okolnostima praćenje može uključivati i boravak preko noći;
Fingolimod absorption is slow (tmax of 12-16 hours) and extensive (≥85%). 
Apsorpcija fingolimoda je spora (tmax 12-16 sati) i opsežna (≥85%).
84 capsules (3 packs of 28) 
84 kapsula (3 pakiranja od 28)
Your doctor may decide to keep you under observation at the time you take the next dose. 
Liječnik će možda odlučiti staviti Vas na promatranje u vrijeme kada uzmete sljedeću dozu.
- Severe active infections, active chronic infections (hepatitis, tuberculosis). 
- Teške aktivne infekcije, aktivne kronične infekcije (hepatitis, tuberkuloza).
If these effects are pronounced, tell your doctor, because you may need treatment right away. 
Ako su ti učinci izraženi obratite se svom liječniku jer će Vam možda odmah biti potrebno liječenje.
- if you are allergic to fingolimod or any of the other ingredients of this medicine (listed in section 6). 
- ako ste alergični na fingolimod li neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
PML is a serious condition that may lead to severe disability or death. 
PML je ozbiljna bolest koja može dovesti do teške onesposobljenosti ili smrti.
After 12 months (month 36), 856 patients (93%) were still enrolled. 
Nakon 12 mjeseci (36. mjesec), 856 bolesnika (93%) bilo je još uvijek uključeno.
Inhaled salmeterol has also been shown to have a modest positive chronotropic effect. 
Pokazalo se i da inhalirani salmeterol ima skromni pozitivni kronotropni učinak.
Fingolimod has been studied in combination with atenolol and diltiazem. 
Fingolimod je bio ispitivan u kombinaciji s atenololom i diltiazemom.
Neutrophil count decreased * Not reported in Studies FREEDOMS, FREEDOMS II and TRANSFORMS. 
Smanjeni broj neutrofila * Nije zabilježeno u ispitivanjima FREEDOMS, FREEDOMS II i TRANSFORMS.
They usually did not require treatment and resolved within the first 24 hours on treatment. 
Obično nisu zahtijevali terapiju i povukli su se unutar prva 24 sata liječenja.
If myocardial ischaemia is suspected, it is recommended to seek advice from a cardiologist. 
Ako se sumnja na ishemiju miokarda, preporučuje se potražiti savjet kardiologa.
PML can only occur in the presence of a JCV infection. 
PML se može javiti samo u prisutnosti infekcije JCV-om.
The moles may itch, bleed or ulcerate - Convulsion, fits (more frequent in children and adolescents than in adults) 
Madeži mogu svrbjeti, krvariti ili ulcerirati - konvulzije, napadaji (češće u djece i adolescenata nego u odraslih)
Both studies included adult patients who had experienced ≥2 relapses in the prior 2 years or ≥1 relapse during the prior year. 
Oba su ispitivanja uključivala odrasle bolesnike koji su doživjeli ≥2 relapsa u prethodne 2 godine ili ≥1 relapsa tijekom prethodne godine.
Herpes viral infections Bronchitis 
Infekcije virusom herpesa Bronhitis
There are very limited data available in children between 10-12 years old (see sections 4.4, 4.8 and 
Dostupni su vrlo ograničeni podaci u djece između 10-12 godina starosti (vidjeti dijelove 4.4, 4.8 i
The following information is particularly important for children and adolescents and their caregivers: - Before you start Gilenya, your doctor will check your vaccination status. 
Sljedeće informacije posebno su važne za djecu i adolescente i njihove skrbnike: - Prije nego počnete uzimati Gilenyu, Vaš liječnik će provjeriti Vaš status cijepljenja.
• Patients must use effective contraception while taking GILENYA. 
• Bolesnice moraju koristiti učinkovitu kontracepciju dok uzimaju GILENYU.
Fingolimod blood clearance is 6.32.3 l/h, and the average apparent terminal half-life (t1/2) is 6-9 days. 
Klirens fingolimoda iz krvi iznosi 6,32,3 l/h, a prosječni prividni terminalni poluvijek (t1/2) je 6-9 dana.
As a result, you may feel dizzy or tired, or be consciously aware of your heartbeat, or your blood pressure may drop. 
Kao rezultat toga mogli biste osjećati omaglicu ili umor, ili svjesno osjećati otkucaje srca, ili Vam krvni tlak može pasti.
A third study targeting the same adult patient population was completed after registration of Gilenya. 
Treće ispitivanje koje je bilo usmjereno na istu odraslu bolesničku populaciju dovršeno je nakon registracije Gilenye.
Date of first authorisation: 17 March 2011 Date of latest renewal: 23 November 2015 
Datum posljednje obnove odobrenja: 23. studeni 2015.
Women of childbearing potential / Contraception in females 
Žene reproduktivne dobi / Kontracepcija u žena