natgillin/translations-raw huggingface dataset:
Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Plaza 254
Nositelj odobrenja za stavljanje lijeka u promet Bristol-Myers Squibb Pharma EEIG Plaza 254
Rifampicin/Efavirenz (600 mg once daily/600 mg once daily)
rifampicin/efavirenz (600 mg jedanput na dan/600 mg jedanput na dan)
Psychiatric adverse reactions have been reported in patients treated with efavirenz.
U bolesnika liječenih efavirenzom prijavljene su psihijatrijske nuspojave.
Refer to the prescribing information for velpatasvir/sofosbuvir/ voxilaprevir for more information.
Za više informacija pogledati podatke o propisivanju lijekova velpatasvir/sofosbuvir/voksilaprevir.
OUTER CARTON AND LABEL TEXT FOR BOTTLE PACK
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU TEKST NA KUTIJI I NALJEPNICI BOČICE
AUC: ↓ 37% (↓ 14 to ↓ 55)
AUC: ↓ 37% (↓ 14 do
ANTIANXIETY AGENTS Lorazepam/Efavirenz (2 mg single dose/600 mg once daily)
ANKSIOLITICI lorazepam/efavirenz (2 mg u jednokratnoj dozi/600 mg jedanput na dan)
Refer to the prescribing information for sofosbuvir/velpatasvir for more information.
Za više informacija pogledati podatke o propisivanju lijekova sofosbuvir/velpatasvir.
Bottle: 30 film-coated tablets
30 filmom obloženih tableta Blister:
Bristol-Myers Squibb GmbH & CO. KGaA Tel: +49 89 121 42-0
KGaA Tel: +49 89 121 42-0
AUC: ↑ 11% (↑ 5 to ↑ 18)
AUC: ↑ 34% (↑ 18 do
Coadministration of glecaprevir/pibrentasvir with efavirenz is not recommended (see section 4.5).
Istodobna primjena glekaprevira/pibrentasvira s efavirenzom se ne preporučuje (vidjeti dio 4.5).
Each hard capsule contains 200 mg of efavirenz.
Jedna tvrda kapsula sadrži 200 mg efavirenza.
SUSTIVA 100 mg hard capsules efavirenz
SUSTIVA 100 mg tvrde kapsule efavirenz
Nelfinavir/Efavirenz (750 mg q8h/600 mg once daily)
nelfinavir/efavirenz (750 mg svakih 8h/600 mg jedanput na dan)
Cmin: ↓ 35% (↓ 24 to ↓ 44) Efavirenz:
Cmax: ↓ 20% (↓ 15 do ↓ 24) Cmin: ↓ 35% (↓ 24 do ↓ 44) efavirenz:
Each hard capsule contains 100 mg of efavirenz.
Jedna tvrda kapsula sadrži 100 mg efavirenza.
Antimycobacterials Rifabutin/Efavirenz (300 mg once daily/600 mg once daily)
Antimikobakterijski lijekovi rifabutin/efavirenz (300 mg jedanput na dan/600 mg jedanput na dan)
Ritonavir/Efavirenz (500 mg twice daily/600 mg once daily)
ritonavir/efavirenz (500 mg dvaput na dan/600 mg jedanput na dan)
Cmin: ↓ 82% (↓ 79 to ↓ 85) Levonorgestrel (active metabolite): AUC: ↓ 83% (↓ 79 to ↓ 87)
Cmax: ↓ 46% (↓ 39 do ↓ 52) Cmin: ↓ 82% (↓ 79 do ↓ 85) levonorgestrel (aktivni metabolit):
NAME OF THE MEDICINAL PRODUCT SUSTIVA 600 mg film-coated tablets efavirenz
NAZIV LIJEKA SUSTIVA 600 mg filmom obložene tablete efavirenz
Ritonavir:
atovakvon:
Cmax: ↑ 38%
Cmax: ↑ 38% vorikonazol:
AUC: ↓ 60% (↓ 52 to ↓ 68)
AUC: ↓ 60% (↓ 52 do
Hepatic failure
Insuficijencija bubrega
Resistant virus emerges rapidly when efavirenz is administered as monotherapy.
Monoterapijska primjena efavirenza brzo dovodi do nastanka rezistentnog soja virusa.
The pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.4).
No s obzirom da se manje od 1% efavirenza izlučuje mokraćom u nepromijenjenom obliku, utjecaj oštećenja bubrega na eliminaciju efavirenza trebao bi biti minimalan (vidjeti dio 4.4).
Each hard capsule contains 50 mg of efavirenz.
Jedna tvrda kapsula sadrži 50 mg efavirenza.
Posaconazole/Efavirenz --/400 mg once daily
posakonazol/efavirenz --/400 mg jedanput na dan posakonazol:
Each hard capsule contains 114.0 mg of lactose (as monohydrate).
Pomoćna tvar s poznatim učinkom Jedna tvrda kapsula sadrži 114 mg laktoze (u obliku hidrata).
if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
ako je netko od članova Vaše obitelji (roditelji, bake i djedovi, braća ili sestre) iznenada umro zbog tegoba sa srcem ili su rođeni s bolešću srca. ako Vam je liječnik rekao da imate visoke ili niske razine elektrolita u krvi, kao što su kalij ili magnezij. ako trenutno uzimate neki od sljedećih lijekova: (također vidjeti dio „Drugi lijekovi i SUSTIVA“):
Capsule shell: Gelatine, Sodium laurilsulfate, Yellow iron oxide (E172), Titanium dioxide (E171), Silicon dioxide (E551)
Ovojnica kapsule: želatina, natrijev laurilsulfat, željezov oksid, žuti (E172), titanijev dioksid (E171), silicijev dioksid (E551)
Darunavir/ritonavir/Efavirenz (300 mg twice daily*/100 mg twice daily/600 mg once daily)
darunavir/ritonavir/efavirenz (300 mg dvaput na dan*/100 mg dvaput na dan/600 mg jedanput na dan)
SUSTIVA 200 mg hard capsules efavirenz
SUSTIVA 200 mg tvrde kapsule efavirenz
Bristol-Myers Squibb S.r.l.
Bristol-Myers Squibb Pharmaceuticals Ltd.
SUSTIVA is recommended to be taken on an empty stomach preferably at bedtime.
Preporučuje se uzimati lijek efavirenz na prazan želudac, po mogućnosti prije spavanja.
Fluconazole/Efavirenz (200 mg once daily/400 mg once daily)
flukonazol/efavirenz (200 mg jedanput na dan /400 mg jedanput na dan)
Cmax: ↑ 49% (↑ 32 to ↑ 69)
Cmax: ↑ 49% (↑ 32 do ↑ 69) efavirenz:
Paroxetine/Efavirenz (20 mg once daily/600 mg once daily)
paroksetin/efavirenz (20 mg jedanput na dan/600 mg jedanput na dan)
These drugs include: - antiarrhythmics of classes IA and III, - neuroleptics, antidepressive agents, - certain antibiotics including some agents of the following classes: macrolides, fluoroquinolones,
Navedeni lijekovi uključuju: - antiartimike skupina IA i III, - neuroleptike, antidepresive, - pojedine antibiotike koji uključuju neke tvari sljedećih klasa: makrolide, fluorokinolone te antimikotike koji sadrže imidazol i triazol, - pojedine antihistaminike koji nemaju sedativno djelovanje (terfenadin, astemizol), - cisaprid, - flekainid, - pojedine antimalarike, - metadon.
Cmin: ↓ 37% (↓ 17 to ↓ 52) Efavirenz:
Cmax: ↓ 28% (↓ 7 do ↓ 44) Cmin: ↓ 37% (↓ 17 do ↓ 52) efavirenz:
SUSTIVA is for oral use.
SUSTIVA se uzima kroz usta.
Simvastatin/Efavirenz (40 mg once daily/600 mg once daily)
simvastatin/efavirenz (40 mg jedanput na dan/600 mg jedanput na dan)
Valproic acid/Efavirenz (250 mg twice daily/600 mg once daily)
valproična kiselina/efavirenz (250 mg dvaput na dan/600 mg jedanput na dan)
Fosamprenavir/ritonavir/Efavirenz (700 mg twice daily/100 mg twice daily/600 mg once daily)
fosamprenavir/ritonavir/efavirenz (700 mg dvaput na dan/100 mg dvaput na dan/600 mg jedanput na dan)
Voriconazole/Efavirenz (400 mg twice daily/300 mg once daily)
vorikonazol/efavirenz (400 mg dvaput na dan/300 mg jedanput na dan)
a NC = F, noncompleter = failure.
IDV + NRTI a NC = F, liječenje nije završeno = neuspješno.
INFORMATION IN BRAILLE SUSTIVA 100 mg
16. PODACI NA BRAILLEOVOM PISMU SUSTIVA 100 mg
SUSTIVA may reduce the amount of posaconazole in your blood.
SUSTIVA može smanjiti koncentraciju itrakonazola u krvi. posakonazol.
How to take SUSTIVA 4.
3. Kako uzimati lijek SUSTIVA 4. Moguće nuspojave
Each SUSTIVA hard capsule contains 200 mg of the active substance efavirenz.
Jedna SUSTIVA tvrda kapsula sadrži 200 mg djelatne tvari efavirenz.
Each SUSTIVA hard capsule contains 50 mg of the active substance efavirenz.
Jedna SUSTIVA tvrda kapsula sadrži 50 mg djelatne tvari efavirenz.
The capsule shell contains: gelatine, sodium laurilsulfate, yellow iron oxide (E172), titanium dioxide (E171) and silicon dioxide.
Ovojnica kapsule sadrži: želatinu, natrijev laurilsulfat, žuti željezov oksid (E172), titanijev dioksid (E171) i silicijev dioksid.
Injection:
simvastatin:
Efavirenz levels may increase on stopping St. John's wort and the dose of efavirenz may need adjusting.
Nakon prestanka uzimanja gospine trave koncentracija efavirenza može se povećati, pa će biti potrebno prilagoditi njegovu dozu.
two 200 mg capsules one 600 mg tablet OR three 200 mg capsules *For information on the bioavailability of the capsule contents mixed with food vehicles, see section 5.2.
*Za informacije o bioraspoloživosti sadržaja kapsule pomiješanog s hranom, vidjeti dio 5.2.
NAME OF THE MEDICINAL PRODUCT SUSTIVA 200 mg hard capsules efavirenz
NAZIV LIJEKA SUSTIVA 200 mg tvrde kapsule efavirenz
Cmax: ↑ 50% (↑ 20 to ↑ 80)
Cmax: ↑ 50% (↑ 20 do ↑ 80) (indukcija CYP2B6)
Serious psychiatric adverse reactions have been reported in patients treated with efavirenz.
U bolesnika liječenih efavirenzom zabilježene su ozbiljne psihijatrijske nuspojave.
Indinavir/ritonavir/Efavirenz (800 mg twice daily/100 mg twice daily/600 mg once daily)
indinavir/ritonavir/efavirenz (800 mg dvaput na dan/100 mg dvaput na dan/600 mg jedanput na dan)
METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
5. NAČIN I PUT(EVI) PRIMJENE LIJEKA Kroz usta.
NAME OF THE MEDICINAL PRODUCT SUSTIVA 50 mg hard capsules efavirenz
NAZIV LIJEKA SUSTIVA 50 mg tvrde kapsule efavirenz
Telaprevir/Efavirenz (1,125 mg q8h/600 mg once daily)
telaprevir/efavirenz (1125 mg svakih 8h/600 mg jedanput na dan)
Cmin: ↓ 62% (↓ 44 to ↓ 75) N-monodesmethyl diltiazem: AUC: ↓ 37% (↓ 17 to ↓ 52)
AUC: ↓ 75% (↓ 59 do ↓ 84) Cmax: ↓ 64% (↓ 57 do ↓ 69) Cmin: ↓ 62% (↓ 44 do ↓ 75) N-monodezmetil diltiazem: AUC: ↓ 37% (↓ 17 do ↓ 52) Cmax: ↓ 28% (↓ 7 do ↓ 44) Cmin: ↓ 37% (↓ 17 do ↓ 52) efavirenz:
Each SUSTIVA hard capsule contains 100 mg of the active substance efavirenz.
Jedna SUSTIVA tvrda kapsula sadrži 100 mg djelatne tvari efavirenz
Dose adjustment of pravastatin may be required (refer to the Summary of Product Characteristics for pravastatin).
Može biti potrebno prilagođavati dozu pravastatina (vidjeti Sažetak opisa svojstava lijeka za pravastatin).
Efavirenz has not been studied in controlled studies in patients with advanced HIV disease, namely with CD4 counts < 50 cells/mm3, or in PI or NNRTI experienced patients.
Nisu provedena kontrolirana ispitivanja efavirenza u bolesnika s uznapredovalom HIV bolešću, kao što su osobe s < 50 CD4 stanica/mm3, niti u bolesnika koji su već primali inhibitore proteaze ili NNRTI-je.
NAME OF THE MEDICINAL PRODUCT SUSTIVA 100 mg hard capsules efavirenz
NAZIV LIJEKA SUSTIVA 100 mg tvrde kapsule efavirenz
Printing ink: Cochineal carminic acid (E120), Indigo carmine (E132), Titanium dioxide (E171)
Tinta za označavanje: boja karmin crvena (E120), indigo karmin (E132), titanijev dioksid (E171) SUSTIVA 100 mg tvrde kapsule
Azithromycin/Efavirenz (600 mg single dose/400 mg once daily)
Antibiotici azitromicin/efavirenz (600 mg jednokratna doza/400 mg jedanput na dan)
3, or after failure of protease inhibitor (PI) containing regimens.
3, niti u bolesnika koji su već primali inhibitore proteaze ili NNRTI-je.
EFV + IDV + NRTIs 157 60 (52, 68) IDV + NRTIs a NC = F, noncompleter = failure.
IDV + ZDV + 3TC a NC = F, liječenje nije završeno = terapijski neuspjeh. b C.I., interval pouzdanosti.
Cmax: ↓ 18% (↓ 59 to ↑ 12)
AUC: ↓ 40% (↓ 26 do Cmax: ↓ 18% (↓ 59 do ↑ 12)
The dose of lopinavir/ritonavir tablets should be increased to 500/125 mg twice daily when co-administered with efavirenz 600 mg once daily.
Koncentracije lopinavira: slično kao kod primjene lopinavira/ritonavira u dozi od 400/100 mg dvaput na dan bez efavirenza lopinavir/ritonavir tableta mora se povisiti na 500/125 mg dvaput na dan kada se primjenjuju istodobno s efavirenzom u dozi od 600 mg jedanput na dan.
Liver enzyme monitoring should be considered for patients without pre-existing hepatic dysfunction or other risk factors.
U bolesnika koji nemaju postojeće poremećaje funkcije jetre ili druge čimbenike rizika mora se razmotriti praćenje jetrenih enzima.
Cmin: ↓ 43% (↓ 18 to ↓ 60) Efavirenz:
Cmax: ↓ 35% (↓ 12 do ↓ 52) Cmin: ↓ 43% (↓ 18 do ↓ 60) efavirenz:
Cmin: ↓ 45% (↓ 31 to ↓ 56) Efavirenz:
Cmax: ↓ 32% (↓ 15 do ↓ 46) Cmin: ↓ 45% (↓ 31 do ↓ 56) efavirenz:
Cmin: ↓ 46% (↓ 31 to ↓ 58) Efavirenz:
Cmax: ↓ 29% (↓ 15 do ↓ 40) Cmin: ↓ 46% (↓ 31 do ↓ 58) efavirenz:
Pravastatin/Efavirenz (40 mg once daily/600 mg once daily)
pravastatin/efavirenz (40 mg jedanput na dan/600 mg jedanput na dan)
Voriconazole/Efavirenz (200 mg twice daily/400 mg once daily)
vorikonazol/efavirenz (200 mg dvaput na dan/400 mg jedanput na dan)
Slovenská republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 58282010 dpoc_czechslovak @merck.com
Česká republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 msd_cr@merck.com
Medicines that impact heart rhythm: - Medicines used to treat heart rhythm problems such as flecainide or metoprolol.
lijekovi koji utječu na srčani ritam: - lijekovi koji se koriste za liječenje problema srčanog ritma: kao što su flekainid ili metoprolol. - lijekovi koji se koriste za liječenje depresije kao što su imipramin, amitriptilin ili klomipramin. - antibiotici, uključujući sljedeće tipove: makrolidi, fluorokinoloni ili imidazol
Cmax: ↓ 76% (↓ 63 to ↓ 79)
Cmax: ↓ 76% (↓ 63 do ↓ 79) simvastatinska kiselina:
Proguanil: AUC: ↓ 43% (↓ 7 to ↓ 65)
simeprevir: AUC: ↓ 71% (↓ 67 do ↓
Cmax: ↑ 23% (↓ 1 to ↑ 53) *
Cmax: ↑ 23% (↓ 1 do ↑ 53)* efavirenz:
See package leaflet for further information.
Vidjeti dio Opis odabranih nuspojava za detaljnije informacije.
AUC: ↓ 21% Cmax: ↔
AUC: ↓ 21% Cmax: ↔ efavirenz:
Cmax: ↓ 20% (↓ 15 to ↓ 24)
Cmax: ↓ 24 % (↓ 15 do
Efavirenz: AUC: ↑ 17% (↑ 6 to ↑ 29) **
AUC: ↔* (↓ 9 do ↑ 10) Cmax: ↑ 17%* (↑ 8 do ↑ 27) Cmin: ↓ 42%* (↓ 31 do
The median increase from baseline in CD4+ count at 48 weeks of therapy was 238 cells/mm3 and the median increase in
Medijan porasta broja CD4+ stanica od početne vrijednosti do 48. tjedna liječenja iznosio je 238 stanica/mm3, a medijan porasta postotka CD4+ stanica iznosio je 13%.
AUC: ↓ 36% C12: ↓ 21%
AUC: ↓ 36% C12: ↓ 21% Cmax: ↓ 36% (indukcija UGT1A1)
OPIOIDS
LIJEKA
EFV + IDV + NRTIs 157 60 (52, 68) IDV + NRTIs a
EFV + IDV + NRTI IDV + NRTI
Cmin: ↓ 63% (↓ 44 to ↓ 75) Desacetyl diltiazem:
Cmax: ↓ 60% (↓ 50 do ↓ 68) Cmin: ↓ 63% (↓ 44 do ↓ 75) dezacetil-diltiazem:
The capsule shell contains: gelatine, sodium laurilsulfate, yellow iron oxide (E172) and silicon dioxide.
Ovojnica kapsule sadrži: želatinu, natrijev laurilsulfat, žuti željezov oksid (E172) i silicijev dioksid (E551).
Cmin: ↑ 12%*/** (↓16 to ↑49) (CYP3A4 induction).
Cmax: ↑ 11% (↑ 6 do ↑ 16) Cmin: ↔ (indukcija CYP3A4)
The capsule shell contains: gelatine, sodium laurilsulfate, titanium dioxide (E171) and silicon dioxide.
Ovojnica kapsule sadrži: želatinu, natrijev laurilsulfat, titanijev dioksid (E171) i silicijev dioksid (E551).
Norbuprenorphine:
vorikonazol:
Efficacy results for studies ACTG 364 and 020 are found in Table 4.
U Tablici 4 prikazani su rezultati djelotvornosti u ispitivanjima ACTG 364 i 020.
Ethinyloestradiol: AUC: ↔
etinilestradiol:
Darunavir:
rifabutin:
EU/1/99/110/003: bottle EU/1/99/110/004: blister
EU/1/99/110/004 - blister
(CYP3A4 induction) In a study of HIV infected intravenous drug users, co-administration of efavirenz with methadone resulted in decreased plasma levels of methadone and signs of opiate withdrawal.
Cmax: ↓ 45% (↓ 25 do ↓ 59) (indukcija CYP3A4) U ispitivanju intravenskih ovisnika zaraženih HIVom istodobna primjena efavirenza i metadona dovela je do sniženja koncentracije metadona u plazmi i znakova ustezanja od opijata.
(CYP3A induction by efavirenz)
↑ 50)b efavirenz:
Artemether:
lorazepam:
Simvastatin acid: AUC: ↓ 58% (↓ 39 to ↓ 68)
AUC: ↓ 58% (↓ 39 do
How to store SUSTIVA
Kako čuvati lijek SUSTIVA
Efficacy results for studies ACTG 364 and 020 are found in Table 3.
U Tablici 3 prikazani su rezultati djelotvornosti u ispitivanjima ACTG 364 i 020.
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy.
Tijekom antivirusne terapije mogu se povećati tjelesna težina i povisiti razine lipida i glukoze u krvi.
Cmax: ↑ 11% (↑ 6 to ↑ 16)
AUC: ↑ 17% (↑ 6 do
Cmax: ↓ 13% (↓ 0 to ↓ 23)
Cmax: ↓ 13% (↓ 0 do ↓ 23) 4-hidroksi atorvastatin:
Cmax: ↓ 34% (↓ 21 to ↓ 47)
Cmax: ↓ 34% (↓ 21 do ↓ 47) hidroksibupropion:
Clarithromycin/Efavirenz (500 mg q12h/400 mg once daily)
Preporuke za istodobnu primjenu s efavirenzom klaritromicin/efavirenz (500 mg svakih 12h/400 mg jedanput na dan)
Morning Cmax: ↑ 24% (↑ 12 to ↑ 38) Evening Cmax: ↔
ritonavir: jutarnji AUC: ↑ 18% (↑ 6 do ↑ 33) večernji AUC: ↔ jutarnji Cmax: ↑ 24% (↑ 12 do ↑ 38) večernji Cmax: ↔ jutarnji Cmin: ↑ 42% (↑ 9 do
Tablet core
Zatajenje jetre
STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains: efavirenz 100 mg.
2. KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Jedna tvrda kapsula sadrži 100 mg efavirenza.
Cmax: ↓ 12% (↓ 1 to ↓ 26)
Cmax: ↓ 12% (↓ 1 do ↓ 26) 2-hidroksi atorvastatin:
Bottle: EU/1/99/110/008
EU/1/99/110/008
Itraconazole/Efavirenz (200 mg q12h/600 mg once daily)
Antifungalni lijekovi itrakonazol/efavirenz (200 mg svakih 12h/600 mg jedanput na dan)
Tell your doctor immediately.
Odmah obavijestite svog liječnika.
Use in children of more than 2 years old
Primjena u djece starije od 2 godine
There are two alternative treatment schedules:
Postoje dva alternativna rasporeda terapije:
There are two groups:
Postoje dvije skupine:
In particular, tell your doctor if you have:
Obavezno obavijestite svog liječnika ako imate:
The following information is intended for healthcare professionals only (see section 3 for further information):
Sljedeće informacije namijenjene su samo zdravstvenim radnicima (vidjeti dio 3 za dodatne informacije):
● Coombs test positive
• pozitivan Coombsov test
The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued.
Terapijski učinak treba procijeniti nakon svakog ciklusa; ako se terapijski učinak ne opazi nakon 6 mjeseci, liječenje treba prekinuti.
Allergic reactions are rare.
Alergijske reakcije su rijetke.
Kawasaki disease
Kawasakijeva bolest
Date of latest renewal: 24 April 2017
Datum posljednje obnove odobrenja: 24. travnja 2017.
● feeling cold
● osjećaj hladnoće
It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3 - 5 days equilibrium is reached between the intra- and extravascular compartments.
Raspodjeljuje se relativno brzo između plazme i ekstravaskularne tekućine, nakon približno 3 - 5 dana postiže se ravnoteža između intra- i ekstravaskularnih odjeljaka.
It is worth considering that these 2 subjects contributed to the higher frequency of infusions with reactions in this group.
Valja uzeti u obzir da su ta 2 ispitanika pridonijela većoj učestalosti infuzija s reakcijama u toj skupini.
Symptoms of TRALI typically develop during or within 6 hours of a transfusion, often within 1 - 2 hours.
Simptomi TRALI-ja obično se razviju tijekom ili unutar 6 sati od transfuzije, često unutar 1 - 2 sata.
This half-life may vary from patient to patient, in particular in primary immunodeficiency.
Taj poluvijek može se razlikovati od bolesnika do bolesnika, a naročito u primarnoj imunodeficijenciji.
Assessment of vital signs in clinical trials of the paediatric population did not indicate any pattern of clinically relevant changes.
Procjena vitalnih znakova u kliničkim ispitivanjima pedijatrijske populacije nije pokazala nikakav obrazac klinički značajnih promjena.
You must not be given a double dose to make up for a forgotten dose.
Ne smijete primiti dvostruku dozu kako bi se nadoknadila zaboravljena doza.
• Guillain Barré syndrome, where the immune system damages the nerves and hinders them from working properly.
• Guillain-Barréov sindrom, pri kojem imunološki sustav oštećuje živce ometajući tako njihov ispravan rad.
Maintenance dose:
Doza održavanja:
● general physical health deterioration
● pogoršanje općeg tjelesnog zdravlja
It is usually prepared from pooled plasma from not fewer than 1000 donors.
Normalno je pripremljen iz pûla plazme od najmanje 1000 davatelja.
Tell your doctor or pharmacist immediately and follow his/her instructions.
Odmah obavijestite svog liječnika ili ljekarnika i pridržavajte se njegovih/njenih uputa.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primite ovaj lijek.
Patients with pre-existing risk factors
Bolesnici s postojećim čimbenicima rizika
Seek medical care with no delay if any of the following side effects happen during or after the infusion:
Zatražite medicinsku skrb bez odlaganja ako se tijekom ili nakon infuzije pojavi bilo koja od sljedećih nuspojava:
In case of shock, standard medical treatment for shock should be implemented.
U slučaju šoka potrebno je uvesti standardno medicinsko liječenje za šok.
The mechanism of action in indications other than replacement therapy is not fully elucidated, but includes immunomodulatory effects.
Mehanizam djelovanja u indikacijama osim onih za nadomjesnu terapiju još nije u potpunosti razjašnjen, ali uključuje imunomodulatorni učinak.
Neutropenia/Leukopenia
Neutropenija/leukopenija
For safety information with respect to transmissible agents, see section 4.4.
Za informacije o sigurnosti u pogledu prenosivih agensa, vidjeti dio 4.4.
2 g/kg in one dose in association with acetylsalicylic acid
2 g/kg u jednoj dozi, zajedno s acetilsalicilatnom kiselinom
Single dose toxicity studies were carried out in rats and mice.
Ispitivanja toksičnosti jednostruke doze su rađena na štakorima i miševima.
In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations.
U rijetkim i izoliranim slučajevima, sljedeće nuspojave su zabilježene za pripravke imunoglobulina.
You will be watched carefully until an hour after the infusion to detect potential side effects.
Pomno će Vas nadzirati jedan sat nakon završetka infuzije kako bi se uočile potencijalne nuspojave.
No evidence is available to require a dose adjustment.
Nema dokaza da je potrebna prilagodba doze.
● photophobia (excessive sensitivity to light)
● fotofobija (prekomjerna osjetljivost na svjetlo)
All other patients should be observed for at least 20 minutes after administration
Sve druge bolesnike treba promatrati barem 20 minuta nakon primjene lijeka.
Guillain Barré syndrome
Guillain-Barréov sindrom
6.6 Special precautions for disposal and other handling The product should be brought to room or body temperature before use.
6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Lijek mora dostići sobnu temperaturu ili temperaturu tijela prije uporabe.
- The other ingredients are sorbitol and water for injections (see section 2 for further information about ingredients).
Drugi sastojci su sorbitol i voda za injekcije (za dodatne informacije o sastojcima, vidjeti dio 2).
Patients with rare hereditary problems of fructose intolerance must not take this medicine.
Bolesnici s rijetkim nasljednim nepodnošenjem fruktoze ne smiju primiti ovaj lijek.
Distribution of the IgG subclasses (approx. values): IgG1 66.6%
Raspodjela podvrsta IgG (približne vrijednosti): IgG1 66,6%
MedDRA System Organ Class (SOC)
MedDRA klasifikacija organskih sustava (SOC)
Your doctor will consider your risk factors and take measures such as to decrease the rate of infusion or to stop the treatment.
Liječnik će razmotriti čimbenike rizika koje imate i poduzeti mjere opreza kao što su smanjenje brzine infuzije ili prekid liječenja.
Cyanosis (lack of oxygen in the blood) was reported in one child but not in adults.
Cijanoza (nedostatak kisika u krvi) zabilježena je u slučaju jednog djeteta, ali ne i u odraslih.
This could particularly happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your heart or your kidneys.
To se naročito može dogoditi ako ste rizični bolesnik, primjerice stariji bolesnik ili bolesnik sa srčanim ili bubrežnim problemima.
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Sigurnost primjene ovog lijeka u trudnoći nije utvrđena kontroliranim kliničkim ispitivanjima i prema tome može se samo uz oprez primijeniti u trudnica i dojilja.
There were no other subjects with more than 1 infusion with adverse reactions in both groups.
Od ostalih ispitanika, ni jedan nije imao više od 1 infuzije s nuspojavama u obje skupine.