natgillin/translations-raw huggingface dataset:
NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII) 
ADVATE 500 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
Each vial contains nominally 1500 IU human coagulation factor VIII (rDNA), octocog alfa. 
Jedna bočica nominalno sadrži 1500 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa 
ADVATE 250 IU prašak i otapalo za otopinu za injekciju oktokog alfa
NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa 
ADVATE 3000 IU prašak i otapalo za otopinu za injekciju oktokog alfa
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa 
ADVATE 1500 IU prašak i otapalo za otopinu za injekciju oktokog alfa
- Do not refrigerate the preparation after reconstitution. 
• Nakon pripreme otopine, lijek se ne smije vratiti u hladnjak.
Each vial contains nominally 1000 IU human coagulation factor VIII (rDNA), octocog alfa. 
Jedna bočica nominalno sadrži 1000 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
The product may not be returned to refrigerated storage again. 
- Nakon rekonstitucije, lijek se ne smije vratiti u hladnjak.
ADVATE contains approximately 125 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
ADVATE sadrži približno 125 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
To be taken into consideration by patients on a controlled sodium diet. 
O tome treba voditi računa u bolesnika s ograničenjem unosa natrija.
During the shelf life the powder vial may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months. 
Unutar roka valjanosti, bočica s praškom se može čuvati na sobnoj temperaturi (do 25°C) u jednokratnom razdoblju ne duljem od 6 mjeseci.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/008 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/008
During the shelf life, the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months. 
Unutar roka valjanosti, lijek se može čuvati na sobnoj temperaturi (do 25 °C) u jednom razdoblju ne duljem od 6 mjeseci.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/018 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/018
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1500 IU powder for solution for injection Octocog alfa 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 1500 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII) 
ADVATE 1000 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 3000 IU powder for solution for injection Octocog alfa 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 3000 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 500 IU powder for solution for injection Octocog alfa 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 500 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa 
ADVATE 500 IU prašak i otapalo za otopinu za injekciju oktokog alfa
Respiratory, thoracic and mediastinal disorders Dyspnoea 
Poremećaji probavnog sustava povraćanje svrbež osip hiperhidroza
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/012 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/012
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S OTAPALOM (SUSTAV BAXJECT III)
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/006 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/006
ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
ADVATE sadrži približno 400 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
ADVATE contains approximately 250 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
ADVATE sadrži približno 250 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
ADVATE contains approximately 500 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
ADVATE sadrži približno 500 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system. 
Sadržaj: 1 bočica s 1000 IU oktokoga alfa i 1 bočica s 2 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/010 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/010
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 3000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device. 
Sadržaj: 1 bočica s 3000 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 3000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system. 
Sadržaj: 1 bočica s 3000 IU oktokoga alfa i 1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device. 
Sadržaj: 1 bočica s 1000 IU oktokoga alfa, 1 bočica s 2 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/020 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/020
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1000 IU powder for solution for injection Octocog alfa 
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 1000 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/017 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/017
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/013 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/013
ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
ADVATE sadrži približno 300 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
ADVATE sadrži približno 600 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/015 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/015
ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
ADVATE sadrži približno 200 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/009 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/009
ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
ADVATE sadrži približno 50 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 2000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device. 
Sadržaj: 1 bočica s 2000 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE) 
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S OTAPALOM (UREĐAJ BAXJECT II)
ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
ADVATE sadrži približno 100 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system. 
Sadržaj: 1 bočica s 250 IU oktokoga alfa i 1 bočica s 2 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system. 
Sadržaj: 1 bočica s 250 IU oktokoga alfa i 1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/005 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/005
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system. 
Sadržaj: 1 bočica s 500 IU oktokoga alfa i 1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/014 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/014
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system. 
Sadržaj: 1 bočica s 500 IU oktokoga alfa i 1 bočica s 2 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device. 
Sadržaj: 1 bočica s 250 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
Tabulated summary of adverse reactions 
Opći poremećaji i reakcije na mjestu primjene malaksalost nepoznato
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/011 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/011
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 2000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system. 
Sadržaj: 1 bočica s 2000 IU oktokoga alfa i1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
Recovery at Cmax (IU/dL per IU/kg)a 
Klirens (ml/kg*h)
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device. 
Sadržaj: 1 bočica s 250 IU oktokoga alfa, 1 bočica s 2 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/019 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/019
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system. 
Sadržaj: 1 bočica s 1500 IU oktokoga alfa i 1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system. 
Sadržaj: 1 bočica s 1000 IU oktokoga alfa i 1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/001 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/001
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system. 
Sadržaj: 1 bočica s 1500 IU oktokoga alfa i 1 bočica s 2 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa 
ADVATE 1000 IU prašak i otapalo za otopinu za injekciju oktokog alfa
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device. 
Sadržaj: 1 bočica s 500 IU oktokoga alfa, 1 bočica s 2 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device. 
Sadržaj: 1 bočica s 500 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device. 
Sadržaj: 1 bočica s 1000 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device. 
Sadržaj: 1 bočica s 1500 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device. 
Sadržaj: 1 bočica s 1500 IU oktokoga alfa, 1 bočica s 2 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/002 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/002
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/004 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/004
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/007 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/007
- If you get any side effects talk to your doctor. 
- Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
23 September 2014 
23. rujna 2014.
23 August 2014 
23. kolovoza 2014.
Within 3 months after adoption of CMDh agreement 
Unutar 3 mjeseca nakon usvajanja sporazuma CMDh-a
- submission of the variation by the Marketing Authorisation Holders of methadone tablets containing povidone of low molecular weight (K25 or K30) 
- dostavljanje izmjene od strane nositelja odobrenja za stavljanje lijeka u promet za tablete metadona koje sadrže povidon niske molekulske mase (K25 ili K30)
Implementation of the agreement by the Member States: - suspension of the marketing authorisations of methadone oral solutions containing povidone of high molecular weight (K90) 
Provedba sporazuma od strane država članica: - suspenzija odobrenja za stavljanje u promet peroralnih otopina metadona koje sadrže povidon visoke molekulske mase (K90)
Adoption of CMDh agreement: 
Donošenje sporazuma CMDh-a:
July 2014 CMDh meeting 
Sastanak CMDh-a u srpnju 2014.
Transmission to National Competent Authorities of the translations of the annexes to the agreement: 
Prosljeđivanje prijevoda dodatka sporazumu nadležnim nacionalnim tijelima:
Dose reduction is not recommended. 
Redukcija doze se ne preporučuje.
You should use effective methods of contraception during this time. 
Morate koristiti učinkovite metode kontracepcije tijekom tog vremena.
Your doctor will monitor you and your liver function. 
Vaš liječnik će nadzirati Vas i funkciju Vaše jetre.
The powder should dissolve in less than 60 minutes. 
Prašak bi se morao otopiti za manje od 60 minuta.
30/11/2015 (aligned with expected PSUR cycle) 
30.11.2015. (ujednačeno s očekivanim ciklusom
• cyclosporin, used during and after organ transplants 
• ciklosporin, koristi se tijekom i nakon presađivanja organa
Do not remove contents until all of the powder has been completely dissolved. 
Nemojte uklanjati sadržaj dok se prašak u potpunosti ne otopi.
Therefore, an increased susceptibility to specific tumours cannot be entirely ruled out. 
Stoga ne može biti potpuno isključena povišena osjetljivost na specifične tumore.
• It will be given slowly over a period of 1 hour. 
• Lijek će Vam biti primijenjen polagano, tijekom razdoblja od 1 sat.
After a median of 6 years of follow-up, none of the 60 patients had died and maintenance of disease control was demonstrated in 58 of 60 patients. 
Nakon medijana od 6 godina praćenja, niti jedan od 60 bolesnika nije umro i održavanje kontrole bolesti bilo je pokazano u 58 od 60 bolesnika.
Your doctor may prescribe medicines to correct this. 
Liječnik Vam može propisati lijekove za popravljanje tog stanja.
200 Great Valley Parkway Malvern 
200 Great Valley Parkway
• You will receive treatment until you and your doctor agree that you will no longer benefit from the treatment. 
• Liječenje će trajati dok se sa svojim liječnikom ne složite da od nastavka liječenja više nećete imati koristi.
206 days 
206 dana
Protocol: 
Protokol:
This helps reduce the size of the affected lymph nodes, which reduces the symptoms of the illness and should help you carry out your normal daily tasks. 
To pomaže smanjenju veličine zahvaćenih limfnih čvorova, što umanjuje simptome bolesti i moralo bi Vam pomoći u obavljanju normalnih dnevnih zadataka.
• oral contraceptives, used to prevent pregnancy. 
• oralne kontraceptive, koriste se u svrhu sprječavanja trudnoće.
SYLVANT should remain at room temperature for the duration of the preparation. 
SYLVANT mora ostati na sobnoj temperaturi tijekom trajanja pripreme.
The registry should be continued for the either 100 patients, or 5 years, whichever is greater. 
Registar je potrebno nastaviti voditi bilo za 100 bolesnika ili tijekom 5 godina, ovisno o tome što je veće.
Subgroup analyses 
Analiza podskupina
All tumour responses were durable for > 18 weeks. 
Svi tumorski odgovori trajali su tijekom > 18 tjedana.
Highest total dose in clinical trials 
Najviša ukupna doza u kliničkim ispitivanjima
Common (may affect up to 1 in 10 people): • high level of cholesterol in the blood 
Često (mogu se javiti u do 1 na 10 osoba): • visoka razina kolesterola u krvi
Other medicines and SYLVANT 
Drugi lijekovi i SYLVANT
The recommended needle for preparation is 21-gauge 1½ inch (38 mm). 
Preporučena igla za pripremu je 21-gauge 1½ inča (38 mm).
3 weeks. 
3 tjedna.
As with all therapeutic proteins, there is potential for the generation of anti-medicine antibodies (immunogenicity). 
Kao i sa svim terapijskim proteinima, postoji potencijal stvaranja protutijela na lijek (imunogenost).
None of these patients had neutralising antibodies. 
Niti jedan od ovih bolesnika nije imao neutralizirajuća protutijela.
Table 1: Treatment criteria Laboratory parameter 
Tablica 1: Kriteriji za liječenje Laboratorijski parametar
These infections may be serious, such as pneumonia or blood poisoning (also called “sepsis”). 
Te infekcije mogu biti ozbiljne, poput upale pluća ili trovanja krvi (također se naziva “sepsa”).
< 1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000). 
(≥ 1/100 i < 1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000).
Tell your doctor straight away if you have a severe allergic reaction during or after the infusion. 
Odmah obavijestite liječnika ako imate tešku alergijsku reakciju tijekom ili nakon infuzije.
No dose adjustment is required (see section 5.2). 
Nije potrebna prilagodba doze (vidjetio dio 5.2).
Before administering the infusion, the prescriber should consider delaying treatment, if the treatment criteria outlined in Table 1 are not met. 
Prije primjenjivanja infuzije, liječnik koji propisuje lijek mora uzeti u obzir odgodu liječenja, ukoliko se ne dostignu kriteriji za liječenje navedeni u Tablici 1.
Date of first authorisation: 22 May 2014 Date of latest renewal: 2 April 2019 
Datum posljednje obnove odobrenja: 2 travnja 2019
• SYLVANT is not recommended for use during pregnancy. 
• SYLVANT se ne preporučuje primjenjivati tijekom trudnoće.
(N/A; N/A)b 
(N/P; N/P)
• you have an infection at the moment - this is because SYLVANT may lower your ability to feel or fight infections, and infections may get worse. 
• ako trenutno imate infekciju - jer SYLVANT može smanjiti Vašu sposobnost osjećanja ili borbe protiv infekcije pa se infekcije mogu pogoršati.
The safety and efficacy of siltuximab in children aged 17 years and younger have not been established. 
Sigurnost i djelotvornost siltuksimaba u djece u dobi od 17 godina i mlađih nisu ustanovljene.
NL-2333 CB Leiden The Netherlands 
NL-2333 CB Leiden Nizozemska
If not used immediately, in-use storage times and conditions are the responsibility of the user. 
Ako se ne primijeni odmah, uvjeti i vrijeme čuvanja tijekom primjene odgovornost su korisnika.
Concurrent active serious infections 
Istovremene aktivne ozbiljne infekcije
• high level of 'uric acid' in the blood, which may cause gout 
• visoka razina 'mokraćne kiseline' u krvi, koja može izazvati giht
SYLVANT will be given to you by your doctor or nurse, in a hospital or clinic only. 
SYLVANT će Vam primijeniti liječnik ili medicinska sestra, isključivo u bolnici ili na klinici.
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. 
S mikrobiološkog stajališta, osim ako metoda otvaranja/rekonstitucije/razrjeđivanja isključuje rizik za kontaminaciju mikroorganizmima, lijek se mora primijeniti odmah.
2333 CB Leiden The Netherlands 
2333 CB Leiden Nizozemska
If you are pregnant or breast-feeding, think that you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given 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 uzmete ovaj lijek.
70 days 
70 dana
SYLVANT is not likely to affect your ability to drive, cycle, or use any tools or machines. 
Nije vjerojatno da će SYLVANT utjecati na Vašu sposobnost upravljanja vozilima, biciklom ili na upotrebu bilo kakvih alata ili strojeva.
• SYLVANT is available in packs containing 1 vial. 
• SYLVANT je dostupan u pakiranjima koja sadrže 1 bočicu.
Treatment was continued until treatment failure (defined as disease progression based on increase in symptoms, radiologic progression or deterioration in performance status) or unacceptable toxicity. 
Liječenje je nastavljeno do zatajenja liječenja (definirano kao progresija bolesti temeljena na povećanju simptoma, radiološkoj progresiji ili pogoršanju funkcionalnog stanja) ili neprihvatljive toksičnosti.
• The recommended dose is 11 milligrams per kilogram of body weight, given once every 
• Preporučena doza je 11 miligrama po kilogramu tjelesne težine, primijenjeno jedanput svaka
What SYLVANT looks like and contents of the pack 
Kako SYLVANT izgleda i sadržaj pakiranja