natgillin/translations-raw huggingface dataset:
Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Pomoćne tvari: natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev klorid, voda za
If you have previously received one or two doses of a similar H5N1 AS03-containing vaccine
Ako ste ranije primili jednu ili dvije doze sličnog H5N1 cjepiva s adjuvansom AS03 • Odrasli stariji od 18 godina: primit ćete jednu dozu cjepiva Pumarix.
In another clinical study (Q-Pan-H5N1-001), anti-HA responses against A/Vietnam/1194/2004 following administration of AS03-adjuvanted vaccine containing 3.75 µg derived from A/Indonesia/5/2005 were as follows:
U drugom kliničkom ispitivanju (Q-Pan-H5N1-001), zabilježeni su sljedeći anti-HA odgovori protiv soja A/Vietnam/1194/2004 nakon primjene cjepiva s adjuvansom AS03 koje sadrži 3,75 µg dobivenog
In a clinical study (D-Pan-H5N1-012), subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from either A/Vietnam/1194/2004 or Indonesia/5/2005 six months after they had received one or two priming doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 on day 0 or on days 0 and 21 respectively.
U kliničkom ispitivanju (D-Pan-H5N1-012) osobe od 18 do 60 godina primile su dozu cjepiva s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog ili od soja A/Vietnam/1194/2004 ili Indonesia/5/2005, šest mjeseci nakon što su primili jednu ili dvije inicijalne doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004, i to samo na 0. dan ili na 0. i 21. dan.
After the vaccine is mixed: After mixing, use the vaccine within 24 hours and do not store above 30°C.
Nakon miješanja, primijenite cjepivo unutar 24 sata, te nemojte čuvati iznad 30°C.
There are no data with Pumarix using the subcutaneous route.
Nema podataka o supkutanoj primjeni cjepiva Pumarix.
During the pandemic, the applicant will conduct a prospective cohort study as identified in the
Za vrijeme pandemije, plan vođenja registra bit će prijavljen kao dio
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre
3faktor serokonverzije: omjer geometrijske sredine titra (GMT) nakon i prije cijepljenja.
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/05/2005 manufactured using a different process administered after one or two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 manufactured using a different
Jedna doza cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Indonesia/05/2005, proizvedenog različitim postupkom proizvodnje, primijenjena nakon jedne ili dvije doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 proizvedenog različitim
Half dose N=44
Pola doze N=44
Full dose N=41
Puna doza N=41
One pack containing: - one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber).
- jedno pakovanje s 50 bočica (staklo tip I) od 2,5 ml suspenzije s čepom (butil guma).
There was no increase after the second dose whether the children received half of the adult or the adult dose, except for some side effects which were higher after the second dose, particularly for rates of fever in < 6 years old
Neovisno o tome jesu li djeca primila pola doze ili cijelu dozu za odrasle, nije zabilježeno povećanje učestalosti nakon druge doze, osim kod nekih nuspojava koje su se javljale češće nakon druge doze, što se osobito odnosi na učestalost vrućice u djece mlađe od
In another clinical study, 39 subjects aged 18-60 years received a dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Indonesia/5/2005 fourteen months after they had received two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Vietnam/1194/2004 administered on day 0 and day 21.
U drugom kliničkom ispitivanju, 39 ispitanika od 18 do 60 godina je primilo dozu cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Indonesia/5/2005 četrnaest mjeseci nakon što su primili dvije doze cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Vietnam/1194/2004 i to na 0. i 21. dan.
NAME OF THE MEDICINAL PRODUCT Pumarix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Uputa o lijeku: informacija za korisnika Pumarix suspenzija i emulzija za emulziju za injekciju cjepivo protiv pandemijske influence (H5N1) (fragmentirani virion, inaktivirano, adjuvantirano)
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde and sodium deoxycholate) of this vaccine.
Anamneza anafilaktičke (tj. životno ugrožavajuće) reakcije na bilo koji sastojak ovog cjepiva ili na tvari koje se u cjepivu nalaze u tragovima (jaja i pileći proteini, ovalbumin, formaldehid i natrijev deoksikolat).
In a clinical study (Q-Pan-H5N1-010), a booster dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 was given 15 months after primary vaccination.
U kliničkom ispitivanju (Q-Pan-H5N1-010) 15 mjeseci nakon primovakcinacije provedeno je docjepljivanje dozom cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Turkey/Turkey/1/2005.
A clinical study (D-H5N1-009), evaluated the reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two adult (i.e. 0.5 ml) doses or two half adult (i.e. 0.25 ml) doses (21 days apart) of another Pandemic influenza vaccine (H5N1 A/Vietnam/1194/2004 manufactured in Dresden, Germany).
U kliničkom ispitivanju (D-H5N1-009) procjenjivana je reaktogenost u djece od 3 do 5 godina, i od 6 do 9 godina, koja su u razmaku od 21 dan primila dvije doze za odrasle (tj. 0,5 ml) ili dvije polovice doze za odrasle (tj. 0,25 ml) drugog Cjepiva protiv pandemijske influence (H5N1
In a consistency study (Q-Pan-H5N1-002), the anti-haemagglutinin (anti-HA) antibody responses twenty-one days and six months after the second dose were as follows:
U ispitivanju konzistencije (Q-Pan-H5N1-002), odgovori anti-hemaglutinin (anti-HA) protutijela 21
Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Pomoćne tvari: tiomersal, natrijev klorid, natrijev hidrogenfosfat, kalijev dihidrogenfosfat, kalijev
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and
Adjuvans AS03 sadrži skvalen (10,69 miligrama), DL-α-tokoferol (11,86 miligrama) i polisorbat 80
Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) post
Stoga se u male djece (u dobi do približno 6 godina) nakon cijepljenja preporučuje kontrola tjelesne temperature i primjena mjera za snižavanje
One dose of AS03-adjuvanted vaccine containing 3.75 µg HA derived from A/Turkey/Turkey/1/2005 administered after two doses of AS03-adjuvanted vaccine containing 3.75 µg HA derived from Indonesia/5/2005
Jedna doza cjepiva s adjuvansom AS03 i 3,75 µg HA dobivenog iz soja A/Turkey/Turkey/1/2005 primijenjena nakon dvije doze cjepiva s adjuvansom AS03 koje sadrži 3,75 µg HA dobivenog iz soja
• one pack containing 50 vials of 2.5 ml suspension (antigen)
• jednog pakovanja koje sadrži 50 bočica s 2,5 ml suspenzije (antigen) • dva pakovanja koja sadrže po 25 bočica s 2,5 ml emulzije (adjuvans)
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.