natgillin/translations-raw huggingface dataset:
Experience in CHB patients with advanced fibrosis or cirrhosis In a placebo-controlled study in 651 patients with clinically compensated chronic hepatitis B and histologically confirmed fibrosis or cirrhosis, lamivudine treatment (median duration 32 months) significantly reduced the rate of overall disease progression (34/436, 7.8 % for lamivudine versus 38/215, 17.7 % for placebo, p=0.001), demonstrated by a significant reduction in the proportion of patients having increased Child-Pugh scores (15/436, 3.4 % versus 19/215, 8.8 %, p=0.023) or developing hepatocellular carcinoma (17/436, 3.9 % versus 16/215, 7.4 %, p=0.047).
7,8% za lamivudin u odnosu na 38/215, tj. 17,7% za placebo, p=0,001), što se očitovalo značajnim smanjenjem broja bolesnika s povećanim Child-Pugh indeksom (15/436, tj 3,4% prema 19/215, tj. 8,8%, p=0,023) ili onih koji su razvili hepatocelularni karcinom (17/436, tj.
Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Nakon prekida liječenja redovno treba pratiti razine ALT i HBV DNK u serumu radi mogućeg kasnijeg relapsa virusa.
Each ml of the oral solution contains 5 mg lamivudine
Jedan ml oralne otopine sadrži 5 mg lamivudina
Experience in patients with HBeAg negative CHB
Iskustvo u HBeAg negativnih bolesnika s kroničnim hepatitisom B
In a long-term follow-up study of patients who had previously seroconverted and discontinued lamivudine, late virological relapse occurred in 39 % of the subjects.
39% ispitanika došlo je do kasnog virološkog relapsa.
Contains amongst others: sugar (sucrose), preservatives: methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
šećer (saharozu), konzervanse: metilparahidroksibenzoat (E218) i propilparahidroksibenzoat (E216)
Elevations of CPK
Povišene razine CK
Each ml of oral solution contains 5 mg of lamivudine.
Jedan ml oralne otopine sadrži 5 mg lamivudina.
• cladribine, used to treat hairy cell leukaemia Tell your doctor if you're being treated with any of these.
• kladribin, koji se primjenjuje za liječenje leukemije vlasastih stanica
For patients who develop evidence of recurrent hepatitis post-treatment, there are insufficient data on the benefits of re-initiation of lamivudine treatment.
Nema dostatnih podataka o prednostima ponovnog uvođenja terapije lamivudinom u bolesnika kod kojih se nakon liječenja pojave dokazi o rekurentnom hepatitisu.
ALT elevations (see section 4.4)
(vidjeti dio 4.2).
Experience in patients with HBeAg positive CHB and compensated liver disease In controlled studies, 1 year of lamivudine therapy significantly suppressed HBV DNA replication (34-57 % of patients were below the assay detection limits (Abbott Genostics solution hybridization assay, LLOD < 1.6pg/ml)], normalised ALT level (40-72 % of patients), induced HBeAg seroconversion (HBeAg loss and HBeAb detection with HBV DNA loss [by conventional assay], 1618 % of patients), improved histology (38-52 % of patients had a  2 point decrease in the Knodell Histologic Activity Index [HAI]) and reduced progression of fibrosis (in 3-17 % of patients) and progression to cirrhosis.
HBV DNK [34-57 % bolesnika bilo je ispod granice detekcije laboratorijskog testa (Abbott Genostics hibridizacijski test u otopini, LLOD < 1,6 pg/ml)}, normalizirala razinu ALT (40-72% bolesnika), potakla serokonverziju HBeAg (nestanak HBeAg i pojavu HBeAb protutijela uz gubitak HBV DNK [uobičajenim testovima], 16-18 % bolesnika), poboljšala histološke nalaze (u 38-52 % bolesnika
The proportion of patients who had post-treatment ALT elevations in association with an increase in bilirubin levels was low and similar in patients receiving either lamivudine or placebo.
Udio bolesnika u kojih je zabilježen porast razina ALT nakon liječenja uz istodobni porast razina bilirubina, bio je malen i sličan u obje skupine bolesnika
Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see section decompensated liver disease in combination with a second agent, without cross-resistance to lamivudine (see section 4.2).
Početak liječenja lamivudinom treba razmotriti samo kad primjena alternativnog antivirusnog lijeka s višom genetskom barijerom nije dostupna ili prikladna (vidjeti dio 5.1).
Thrombocytopenia Metabolism and nutrition disorders Very rare
Poremećaji metabolizma i prehrane
of patients with pre-treatment ALT > 2 x ULN seroconverted.
(20/26) bolesnika koji su prije liječenja imali razine ALT >2 x veće od gornje granice normale.
NAME OF THE MEDICINAL PRODUCT Zeffix 5 mg/ml oral solution Lamivudine
Uputa o lijeku: Informacije za bolesnika Zeffix 5 mg/ml oralna otopina lamivudin
Talk to your doctor before you take Zeffix.
Ako dojite ili planirate dojiti: razgovarajte sa svojim liječnikom prije nego počnete uzimati Zeffix.
Adverse reactions are listed below by system organ class and frequency.
Nuspojave su navedene po organskim sustavima i učestalosti pojavljivanja.
: + 33 (0)1 39 17 84 44 diam@gsk.com
Laboratoire GlaxoSmithKline Tél. : + 33 (0)1 39 17 84 44 diam@gsk.com
A side effect which may show up in blood tests is: • a decrease in the number of cells involved in blood clotting (thrombocytopenia).
Česte nuspojave koje se mogu pojaviti u Vašim krvnim testovima su: • povišene vrijednosti enzima koji se stvara u mišićima (kreatin fosfokinaza) što može upućivati na oštećenje tjelesnog tkiva.
Spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline.
Nakon započinjanja antivirusne terapije serumske razine ALT mogu se povećavati u nekih bolesnika istodobno sa smanjenjem serumskih razina HBV DNK.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 100 mg lamivudine
Jedna filmom obložena tableta sadrži 100 mg lamivudina
The pharmacokinetics of lamivudine are unaffected by hepatic impairment.
Oštećenje funkcije jetre ne utječe na farmakokinetiku lamivudina.
Five percent (3/56) of patients without the YMDD mutant and 13 % (11/82) of patients with YMDD mutant showed worsening in liver inflammation compared to pre-treatment.
U 5% (3/56) bolesnika bez YMDD tipa virusa i 13% (11/82)
Sucrose (20 % w/v) Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Citric acid (anhydrous) Propylene glycol
6.1 Popis pomoćnih tvari saharoza (20 % m/V) metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) citratna kiselina (bezvodna) propilenglikol natrijev citrat umjetna aroma jagode umjetna aroma banane voda, pročišćena
Forty patients (HBeAg negative or HBeAg positive) with either decompensated liver disease or recurrent HBV following liver transplantation and YMDD mutant were enrolled into an open label arm of study NUC20904.
U otvoreni dio ispitivanja NUC20904 uključeno je 40 bolesnika (HbeAg negativnih ili HbeAg pozitivnih) koji su imali dekompenziranu bolest jetre ili rekurentni HBV nakon transplantacije jetre i YMDD-mutirani HBV.
Accidentally taking too much Zeffix is unlikely to cause any serious problems.
Mala je vjerojatnost ozbiljnijih problema u bolesnika koji su slučajno uzeli preveliku dozu lijeka Zeffix.
GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 produkt.info@gsk.com
KG Tel.: + 49 (0)89 36044 8701 product.info@gsk.com
SPECIAL STORAGE CONDITIONS Do not store above 30C
6.4 Posebne mjere pri čuvanju lijeka Ne čuvati na temperaturi iznad 30°C.
How to store Zeffix Keep this medicine out of the sight and reach of children.
Kako uzimati Zeffix Uvijek uzimite ovaj lijek točno onako kako Vam je rekao liječnik.
Lactic acidosis Immune system disorders: Rare
Poremećaji imunološkog sustava
Reduction of erythrocytes and neutrophil counts were identified as the effects most likely to be of clinical relevance.
Zabilježeni klinički značajni učinci bili su smanjenje broja eritrocita i neutrofila.
ALT  2 x baseline value and absolute ALT > 500 IU/l
ALT ≥ 2 x početne vrijednosti ALT ≥ 3 x početne vrijednosti † ALT ≥ 2 x početne vrijednosti i apsolutni ALT >
Česká republika GlaxoSmithKline s.r.o.
GlaxoSmithKline Slovakia s. r. o.
NAME OF THE MEDICINAL PRODUCT Zeffix 100 mg film-coated tablets Lamivudine
Uputa o lijeku: Informacije za bolesnika Zeffix 100 mg filmom obložene tablete lamivudin
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMAKOLOŠKA SVOJSTVA 5.1 Farmakodinamička svojstva
Marketing Authorisation Holder
Nositelj odobrenja za stavljanje u lijeka promet
NAME OF THE MEDICINAL PRODUCT Zeffix 100 mg film-coated tablets
Zeffix 100 mg filmom obložene tablete
GlaxoSmithKline S.p.A. Tel: + 39 (0)45 9218 111
GlaxoSmithKline Pharmaceuticals s.a./n.v Tél/Tel : + 32 (0) 10 85 52 00
Hypromellose
Angioedem
ALT  2 x baseline value
- početni ALT > 2 x GGN
Clinical resistance
Alergijske reakcije
Laboratoire GlaxoSmithKline Tél.
GlaxoSmithKline Kft.
50 x 1 tablet(unit dose) 105 tablets
50 x 1 tableta (jedinična doza)
Oral use Oral use blister (OPA/alu/PVC) blister (OPA/alu/PVC)
blister (OPA/alu/PVC 105 tableta
Route of Administration
Put primjene Pakovanje
It is available as tablets (200 mg).
Dostupan je u obliku tableta (200 mg).
This finding was based on the results from 769 patients.
Ovaj se nalaz temeljio na rezultatima prikupljenima u 769 bolesnika.
Nexavar is given as two tablets twice a day, without food or with a meal that is low in fat.
Nexavar se primjenjuje kao dvije tablete dva puta dnevno, bez hrane ili uz obrok koji je siromašan mastima.
EPAR summary for the public sorafenib
EPAR, sažetak za javnost sorafenib
To manage side effects, treatment may have to be temporarily interrupted or the dose may be reduced.
Kako bi se upravljalo nuspojavama, liječenje se mora privremeno prekinuti ili se doza mora smanjiti.
Nexavar is used to treat patients who have the following diseases:
Nexavar se koristi za liječenje bolesnika koji imaju sljedeće bolesti:
This means that it blocks some specific enzymes known as protein kinases.
To znači da inhibira određene enzime poznate pod nazivom proteinske kinaze.
The European Commission granted a marketing authorisation valid throughout the European Union for Nexavar on 19 July 2006.
Europska komisija izdala je odobrenje za stavljanje u promet koje za lijek Nexavar vrijedi na prostoru Europske unije od 19. srpnja 2006.
Other information about Nexavar
Ostale informacije o lijeku Nexavar
This finding was based on the results from all 903 patients, including about 200 who had switched from placebo to Nexavar before the end of the study.
Ovaj nalaz temeljio se na rezultatima prikupljenima kod svih 903 bolesnika, uključujući otprilike 200 bolesnika koji su prešli s placeba na Nexavar prije završetka ispitivanja.
The main measures of effectiveness were how long the patients survived or how long the patients lived without their disease getting worse.
Glavna mjera djelotvornosti bilo je razdoblje preživljenja bolesnika ili koliko su dugo bolesnici živjeli bez pogoršanja bolesti.
This is a summary of the European public assessment report (EPAR) for Nexavar.
Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Nexavar.
The treatment is continued as long as the patient continues to benefit from it without too many side effects.
Liječenje se nastavlja tako dugo dok bolesnik ima koristi od liječenja bez mnogo nuspojava.
Because the numbers of patients with these diseases are low, the diseases are considered ‘rare', and Nexavar was designated an ‘orphan medicine' (a medicine used in rare diseases).
Budući da je broj bolesnika s ovim bolestima nizak, dotična se bolest smatra „rijetkom” te se Nexavar označava kao lijek za liječenje rijetkih bolesti.
Nexavar has been compared with placebo (a dummy treatment) in three main studies.
Nexavar je uspoređen s placebom (liječenjem bez djelatne tvari) u tri glavna ispitivanja.
Treatment with Nexavar should be supervised by doctors who have experience of anticancer treatments.
Liječenje lijekom Nexavar trebaju nadzirati liječnici koji su iskusni u liječenju raka.
The summaries of the opinions of the Committee for Orphan Medicinal Products for Nexavar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Sažetak mišljenja Povjerenstva za lijekove za rijetke bolesti o lijeku Nexavar možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation:
The first study involved 602 patients with hepatocellular carcinoma; the second involved 903 patients with advanced renal cell carcinoma in whom one previous anticancer treatment had stopped working; and the third study involved 417 patients with differentiated thyroid carcinoma that had progressed or spread locally or to other parts of the body and did not respond to treatment with radioactive iodine.
Prvo je ispitivanje obuhvatilo 602 bolesnika s hepatocelularnim karcinomom; drugo je ispitivanje obuhvatilo 903 bolesnika s uznapredovanim karcinomom bubrežnih stanica u kojih je prethodno liječenje karcinoma prestalo djelovati; a treće je ispitivanje obuhvatilo 417 bolesnika s diferenciranim karcinomom štitnjače koji je napredovao ili se raširio lokalno ili u druge dijelove tijela i koji nisu odgovorili na liječenje radioaktivnim jodom.
The active substance in Nexavar, sorafenib, is a protein kinase inhibitor.
Djelatna tvar lijeka Nexavar, sorafenib, je inhibitor proteinske kinaze.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nexavar.
Objašnjava kako je Povjerenstvo za lijekove za uporabu u ljudi (CHMP) ocijenilo lijek da bi donijelo odluku o izdavanju odobrenja za stavljanje lijeka u promet i preporučilo uvjete za njegovu uporabu.
• hepatocellular carcinoma (11 April 2006)
• hepatocelularni karcinom (11. travnja 2006.)
The most common side effects with Nexavar are diarrhoea, rash, alopecia (hair loss), infection, hand foot skin reaction (rash and pain on the palms of the hands and soles of the feet) and fatigue (tiredness).
Najčešće nuspojave lijeka Nexavar su proljev, osip, alopecija (gubitak kose), infekcija, reakcija kože ruku i nogu (osip i bol u dlanovima ruku i potplata na stopalima) i iscrpljenost (umor).
• hepatocellular carcinoma (a type of liver cancer);
• hepatocelularni karcinom (tip raka jetre);
The most important serious side effects are myocardial infarction (heart attack) or ischaemia (reduced oxygen supply to the heart), gastrointestinal perforation (a hole that develops in the wall of the gut), drug-induced hepatitis (a disease of the liver), haemorrhage (bleeding) and hypertension or hypertensive crisis (high blood pressure).
Najvažnije ozbiljne nuspojave su infarkt miokarda (srčani udar) ili ishemija (smanjena opskrba kisikom u srce), gastrointestinalna perforacija (rupa koja se razvija u stjenci crijeva), hepatitis izazvan lijekovima (bolest jetre), hemoragija (krvarenje) i preosjetljivost ili hipertenzivna kriza (visoki krvni tlak).
These enzymes can be found in some receptors on the surface of cancer cells, where they are involved in the growth and spread of cancer cells, and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels.
Ovi se enzimi nalaze u određenim receptorima na površini stanica karcinoma, gdje su uključeni u rast i širenje stanica raka, te u krvnim žilama koje opskrbljuju tumore, gdje su uključeni u razvoj novih krvnih žila.
By blocking these enzymes, Nexavar can reduce the growth of cancer cells and cut off the blood supply that keeps cancer cells growing.
Inhibirajući ove enzime, Nexavar može smanjiti rast stanica karcinoma i prekinuti opskrbu krvlju čime se održava rast stanica.
The patients taking Nexavar lived for longer without their disease getting worse (167 days, around five and a half months) than those who took placebo (84 days, around three months).
Nexavar živjeli su duže bez pogoršanja bolesti (167 dana, otprilike pet i pol mjeseci) od onih koji su uzimali placebo (84 dana, otprilike tri mjeseca).
Nexavar was more effective than placebo in increasing how long the patients survived or how long the patients lived without their disease getting worse.
Nexavar je bio djelotvorniji od placeba u produljivanju razdoblja preživljenja bolesnika ili razdoblja tijekom kojeg su bolesnici živjeli bez pogoršanja bolesti.
What is Nexavar?
Što je Nexavar?
Why has Nexavar been approved?
Zašto je Nexavar odobren?
What is the risk associated with Nexavar?
Koji su rizici povezani s lijekom Nexavar?
The CHMP decided that Nexavar's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je odlučio da koristi od lijeka Nexavar nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
• advanced renal cell carcinoma (a type of kidney cancer) when anticancer treatment with interferon alfa or interleukin 2 has failed or cannot be used;
• uznapredovali karcinom bubrežnih stanica (tip raka bubrega) u slučaju kada protutumorska terapija interferonom alfa ili interleukinom 2 nije bila uspješna ili se nije mogla primijeniti;
• renal cell carcinoma (29 July 2004)
• karcinom bubrežnih stanica (29. srpnja 2004.)
• differentiated thyroid carcinoma (a type of cancer originating from the follicular cells of the thyroid gland) when the cancer has progressed or spread locally or to other parts of the body and does not respond to treatment with radioactive iodine.
• diferencirani karcinom štitnjače (tip raka koji potječe iz folikularnih stanica štitnjače) u slučaju kada je karcinom uznapredovao ili se lokalno proširio u druge dijelove tijela i ne odgovara na liječenje radioaktivnim jodom.
• papillary thyroid cancer and follicular thyroid cancer (13 November 2013) The full EPAR for Nexavar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku (EPAR) za lijek Nexavar nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
For more information about treatment with Nexavar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Nexavar pročitajte u uputi o lijeku (također dio EPAR-a) odnosno obratite se svom liječniku ili ljekarniku Sažetak je posljednji put ažuriran: 05.2014.
In the study of hepatocellular carcinoma, the patients taking Nexavar survived for an average of 10.7 months, compared with 7.9 months in those taking placebo.
U ispitivanju hepatocelularnog karcinoma, bolesnici koji su uzimali Nexavar preživjeli su prosječno 10,7 mjeseci u usporedbi sa 7,9 mjeseci u osoba koje su uzimale placebo.
For the full list of all side effects and restrictions with Nexavar, see the package leaflet.
Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Nexavar potražite u uputi o lijeku.
What benefit has Nexavar shown during the studies?
Koje su koristi lijeka Nexavar dokazane u ispitivanjima?
In the study in differentiated thyroid carcinoma, the patients taking Nexavar lived for an average of 10.8 months without their disease getting worse, compared with 5.8 months in those taking placebo.
U ispitivanju diferenciranog karcinoma štitnjače, bolesnici koji su uzimali Nexavar živjeli su prosječno 10,8 mjeseci bez pogoršanja bolesti u usporedbi s 5,8 mjeseci u onih koji su uzimali placebo.
Nexavar is a cancer medicine that contains the active substance sorafenib.
Nexavar je citostatik koji sadrži djelatnu tvar sorafenib.
What is Nexavar used for?
Za što se Nexavar koristi?
In the study of renal cell carcinoma, the patients taking Nexavar survived for an average of 19.3 months, compared with 15.9 months in those taking placebo.
U ispitivanju karcinoma bubrežnih stanica, bolesnici koju su uzimali Nexavar preživjeli su prosječno 19,3 mjeseca u usporedbi s 15,9 mjeseci u osoba koje su uzimale placebo.
How is Nexavar used?
Kako se Nexavar koristi?
How does Nexavar work?
Kako djeluje Nexavar?
How has Nexavar been studied?
Kako se Nexavar ispitivao?
Throw it away and start again from step 1.
Odbacite je i započnite ponovno od koraka 1.
Date of first authorisation: 30 July 2018
Datum prvog odobrenja: 30. srpnja 2018.
You will also need 2 syringes:
Bit će Vam potrebne i 2 štrcaljke:
3) Wash your hands before preparing the medicine.
3) Operite ruke prije pripreme lijeka.
A minimum clinical response is defined as at least:
Minimalni klinički odgovor definira se najmanje kao:
Not known (frequency cannot be estimated from the available data):
Nepoznato (učestalost nije moguće procijeniti iz dostupnih podataka):
SD = standard deviation
SD = standardna devijacija
• you are pregnant
• ste trudni
Generalised LD
Generalizirani LD
This can help make the injections more comfortable.
To može pomoći da primjena injekcija bude ugodnija.
• Then have your normal dose the next day.
• Zatim primijenite svoju redovnu dozu sljedećeg dana.
Dose increases should not be made more frequently than every 4 weeks.
Doza se ne smije povećavati češće od svaka 4 tjedna.
• loss of interest in food
• gubitak interesa za hranu
Contact them if you are unclear about anything or if you need more information or help.
Obratite im se ako Vam je bilo što nejasno ili ako trebate više informacija ili pomoć.
This improves the ability of the body to control energy levels.
Time se poboljšava sposobnost tijela da kontrolira razine energije.
Contents of the pack and other information 7.
Sadržaj pakiranja i druge informacije 7.
• unusually heavy or long menstrual bleeding
• neuobičajeno obilno ili dugo menstrualno krvarenje
Annual reports to be submitted as part of the annual re-assessment.
Godišnja izvješća potrebno je dostaviti u okviru godišnje revizije procjene.
Your doctor might need to change your treatment.
On će Vam možda morati promijeniti liječenje.
Most events occurred during the initial 1-2 months of initiation of treatment.
Većina događaja zabilježena je tijekom početnih 1-2 mjeseca od uvođenja liječenja.
• ‘U' means ‘Units'.
• "U" označava "jedinice" (od engl.
It is anticipated that most children will require increasing per kg dose, especially as they reach puberty.
Očekuje se da će većini djece biti potrebno povećati dozu po kg, posebno kad uđu u pubertet.
• swelling of your face, lips, tongue or throat
• oticanje lica, usnica, jezika ili grla
1) Get together all the materials you will need for your injection.
1) Pripremite sve materijale koji su Vam potrebni za injekciju.
The injection should be administered at the same time every day.
Injekciju treba davati svakog dana u isto vrijeme.
It is also aimed to guide prescribers about the appropriate management of these risks.
Cilj je također uputiti propisivače u pravilno upravljanje tim rizicima.
• 0.5% HbA1c reduction and/or 25% reduction in insulin requirements and / or
• 0,5% smanjenje HbA1c i/ili 25% smanjenje potrebe za inzulinom i/ili
Overall, the safety and tolerability of metreleptin are similar in children and adults.
Sveukupno, sigurnost i podnošljivost metreleptina slične su u odraslih i u djece.
Details on how to access these are available from your doctor.
Pojedinosti o pristupu tim materijalima dostupni su kod vašeg liječnika.
The co-primary efficacy endpoints in this study were defined as:
Ko-primarne mjere ishoda djelotvornosti u tom ispitivanju bile su definirane kao:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima, osim onim navedenim u dijelu 6.6.
A higher accumulation is observed with higher ADA levels.
Viša akumulacija opažena je kod viših razina ADA.
1077 ZX Amsterdam The Netherlands
1077 ZX Amsterdam Nizozemska
Serious and severe infections
Ozbiljne i teške infekcije
Dose decreases based on weight loss may be made weekly.
Smanjenja doze na temelju gubitka težine mogu se uvoditi tjedno.