natgillin/translations-raw huggingface dataset:
NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection. 
IME ZDRAVILA ADVATE 2000 i.e. prašek in vehikel za raztopino za injiciranje
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/008 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/008
NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa 
ADVATE 500 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa
EU/1/03/271/012 
EU/1/03/271/002 EU/1/03/271/012
Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa. 
Vsaka viala vsebuje nominalno 500 i.e. humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 3000 IU powder for solution for injection Octocog alfa 
IME ZDRAVILA IN POT(I) UPORABE ADVATE 3000 i.e. prašek za raztopino za injiciranje oktokog alfa za i.v.
NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection. 
IME ZDRAVILA ADVATE 1000 i.e. prašek in vehikel za raztopino za injiciranje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 500 IU powder for solution for injection Octocog alfa 
IME ZDRAVILA IN POT(I) UPORABE ADVATE 500 i.e. prašek za raztopino za injiciranje oktokog alfa za i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/018 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/018
NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection. 
IME ZDRAVILA ADVATE 250 i.e. prašek in vehikel za raztopino za injiciranje
EU/1/03/271/020 
EU/1/03/271/010 EU/1/03/271/020
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/012 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/012
ADVATE should be administered via the intravenous route. 
Zdravilo ADVATE dajemo intravensko.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1500 IU octocog alfa, approx. 300 IU/ml after reconstitution. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 1500 i.e. oktokoga alfa, približno 300 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/006 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/006
NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII) 
ADVATE 1000 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa (rekombinantni humani koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection. 
IME ZDRAVILA ADVATE 3000 i.e. prašek in vehikel za raztopino za injiciranje
EU/1/03/271/011 
EU/1/03/271/001 EU/1/03/271/011
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1000 IU powder for solution for injection Octocog alfa 
IME ZDRAVILA IN POT(I) UPORABE ADVATE 1000 i.e. prašek za raztopino za injiciranje oktokog alfa za i.v.
EU/1/03/271/017 
EU/1/03/271/007 EU/1/03/271/017
During the shelf life the blister with the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months. 
V času roka uporabnosti lahko pretisni omot z zdravilom shranjujete pri sobni temperaturi (do 25 °C), in sicer enkrat za največ šest mesecev.
NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection. 
IME ZDRAVILA ADVATE 500 i.e. prašek in vehikel za raztopino za injiciranje
You should be aware of the early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness. 
V redkih primerih lahko pride do anafilaktične reakcije (hude, nenadne alergijske reakcije) na zdravilo ADVATE, zato morate poznati zgodnje znake alergijske reakcije, kot so izpuščaj, koprivnica, urtike (majhne srbeče rdeče pike po koži), srbenje po vsem telesu, otekanje ustnic in jezika, težave z dihanjem, piskanje v pljučih, občutek tiščanja v prsih, splošno slabo počutje in omotica.
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa 
ADVATE 1500 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/015 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/015
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection. 
IME ZDRAVILA ADVATE 1500 i.e. prašek in vehikel za raztopino za injiciranje
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1500 IU powder for solution for injection Octocog alfa 
IME ZDRAVILA IN POT(I) UPORABE ADVATE 1500 i.e. prašek za raztopino za injiciranje oktokog alfa za i.v.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/017 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/017
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII) 
ADVATE 1500 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa (rekombinantni humani koagulacijski faktor VIII)
EU/1/03/271/013 
EU/1/03/271/003 EU/1/03/271/013
EU/1/03/271/015 
EU/1/03/271/005 EU/1/03/271/015
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 50 IU/ml after reconstitution. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 250 i.e. oktokoga alfa, približno 50 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/005 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/005
NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa 
ADVATE 3000 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa
Sodium chloride Histidine 
Bolezni prebavil bruhanje pruritus izpuščaj hiperhidroza urtikarija
ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
Zdravilo ADVATE po rekonstituciji vsebuje približno 400 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/014 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/014
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/020 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/020
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. 
Vsebina: 1 viala z 2000 i.e. oktokoga alfa in 1 viala s 5 ml sterilne vode za injekcije, sestavljeni v sistemu BAXJECT III.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 250 IU/ml after reconstitution. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 500 i.e. oktokoga alfa, približno 250 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
EU/1/03/271/018 
EU/1/03/271/008 EU/1/03/271/018
ADVATE contains approximately 500 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
Zdravilo ADVATE po rekonstituciji vsebuje približno 500 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 500 IU octocog alfa, approx. 100 IU/ml after reconstitution. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 500 i.e. oktokoga alfa, približno 100 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa 
ADVATE 1000 i.e. prašek in vehikel za raztopino za injiciranje oktokog alfa
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/011 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/011
ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
Zdravilo ADVATE po rekonstituciji vsebuje približno 300 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/019 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/019
EU/1/03/271/014 
EU/1/03/271/004 EU/1/03/271/014
ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
Zdravilo ADVATE po rekonstituciji vsebuje približno 600 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
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. 
Vsebina: 1 viala z 2000 i.e. oktokoga alfa, 1 viala s 5 ml sterilne vode za injekcije, 1 pripomoček BAXJECT II.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 500 IU/ml after reconstitution. 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala: 1000 i.e. oktokoga alfa, približno 500 i.e./ml po rekonstituciji Specifična aktivnost: približno 4.000 - 10.000 i.e./mg beljakovin
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. 
Vsebina: 1 viala z 1000 i.e. oktokoga alfa in 1 viala z 2 ml sterilne vode za injekcije, sestavljeni v sistemu BAXJECT III.
ADVATE contains approximately 250 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
Zdravilo ADVATE po rekonstituciji vsebuje približno 250 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
Hypersensitivity c 
slika a slika b slika c
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/013 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/013
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/010 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/010
ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
Zdravilo ADVATE po rekonstituciji vsebuje približno 100 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
Zdravilo ADVATE po rekonstituciji vsebuje približno 50 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
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. 
Vsebina: 1 viala z 250 i.e. oktokoga alfa in 1 viala s 5 ml sterilne vode za injekcije, sestavljeni v sistemu 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. 
Vsebina: 1 viala z 1000 i.e. oktokoga alfa, 1 viala s 2 ml sterilne vode za injekcije, 1 pripomoček BAXJECT II.
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. 
Vsebina: 1 viala z 3000 i.e. oktokoga alfa, 1 viala s 5 ml sterilne vode za injekcije, 1 pripomoček BAXJECT II.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/009 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/009
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. 
Vsebina: 1 viala z 3000 i.e. oktokoga alfa in 1 viala s 5 ml sterilne vode za injekcije, sestavljeni v sistemu BAXJECT III.
ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution. 
Zdravilo ADVATE po rekonstituciji vsebuje približno 200 i.e. na mililiter humanega koagulacijskega faktorja VIII (rDNA), oktokoga alfa.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/004 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/004
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. 
Vsebina: 1 viala z 500 i.e. oktokoga alfa in 1 viala s 5 ml sterilne vode za injekcije, sestavljeni v sistemu BAXJECT III.
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. 
Vsebina: 1 viala z 1500 i.e. oktokoga alfa in 1 viala s 5 ml sterilne vode za injekcije, sestavljeni v sistemu BAXJECT III.
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. 
Vsebina: 1 viala z 250 i.e. oktokoga alfa, 1 viala s 2 ml sterilne vode za injekcije, 1 pripomoček BAXJECT II.
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. 
Vsebina: 1 viala z 250 i.e. oktokoga alfa, 1 viala s 5 ml sterilne vode za injekcije, 1 pripomoček BAXJECT II.
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. 
Vsebina: 1 viala z 250 i.e. oktokoga alfa in 1 viala z 2 ml sterilne vode za injekcije, sestavljeni v sistemu BAXJECT III.
During the shelf life, the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months. 
V času roka uporabnosti lahko zdravilo shranjujete pri sobni temperaturi (do 25 °C), in sicer enkrat za največ šest mesecev.
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. 
Vsebina: 1 viala z 500 i.e. oktokoga alfa in 1 viala z 2 ml sterilne vode za injekcije, sestavljeni v sistemu BAXJECT III.
EU/1/03/271/019 
EU/1/03/271/009 EU/1/03/271/019
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/002 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/002
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. 
Vsebina: 1 viala z 500 i.e. oktokoga alfa, 1 viala s 2 ml sterilne vode za injekcije, 1 pripomoček BAXJECT II.
Including tooth extraction. 
Kirurški poseg Manjši, vključno z izdrtjem zoba
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. 
Vsebina: 1 viala z 500 i.e. oktokoga alfa, 1 viala s 5 ml sterilne vode za injekcije, 1 pripomoček 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. 
Vsebina: 1 viala z 1500 i.e. oktokoga alfa, 1 viala s 5 ml sterilne vode za injekcije, 1 pripomoček BAXJECT II.
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. 
Vsebina: 1 viala z 1000 i.e. oktokoga alfa in 1 viala s 5 ml sterilne vode za injekcije, sestavljeni v sistemu BAXJECT III.
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. 
Vsebina: 1 viala z 1500 i.e. oktokoga alfa, 1 viala s 2 ml sterilne vode za injekcije, 1 pripomoček 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. 
Vsebina: 1 viala z 1000 i.e. oktokoga alfa, 1 viala s 5 ml sterilne vode za injekcije, 1 pripomoček BAXJECT II.
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. 
Vsebina: 1 viala z 1500 i.e. oktokoga alfa in 1 viala z 2 ml sterilne vode za injekcije, sestavljeni v sistemu BAXJECT III.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/007 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/007
Post procedural haemorrhage 
SEZNAM POMOŽNIH SNOVI
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/001 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/001
Laboratory test abnormal 
MedDRA Standardna klasifikacija po organskih sistemih
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE) 
NALEPKA NA VIALI S PRAŠKOM (PRIPOMOČEK BAXJECT II)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE) 
NALEPKA NA VIALI Z VEHIKLOM (PRIPOMOČEK BAXJECT II)
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/003 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/03/271/003
23 August 2014 
23. avgusta 2014
- submission of the variation by the Marketing Authorisation Holders of methadone tablets containing povidone of low molecular weight (K25 or K30) 
- predložitev sprememb s strani imetnikov dovoljenja za promet s tabletami metadona, ki vsebujejo povidon z majhno relativno molekulsko maso (K25 ali K30)
Transmission to National Competent Authorities of the translations of the annexes to the agreement: 
Posredovanje prevodov prilog k sporazumu pristojnim nacionalnim organom:
Within 3 months after adoption of CMDh agreement 
v 3 mesecih po sprejetju sporazuma skupine CMDh
Implementation of the agreement by the Member States: - suspension of the marketing authorisations of methadone oral solutions containing povidone of high molecular weight (K90) 
Izvajanje sporazuma v državah članicah: - začasen umik dovoljenj za promet s peroralnimi raztopinami, ki vsebujejo metadon in povidon z veliko relativno molekulsko maso (K90)
July 2014 CMDh meeting 
Sprejetje sporazuma skupine CMDh: zasedanje skupine CMDh julija 2014
The powder should dissolve in less than 60 minutes. 
Prašek se mora raztopiti v manj kot 60 minutah.
A risk to the newborns/infants cannot be excluded. 
Tveganja za novorojenca/otroka ne moremo izključiti.
You should use effective methods of contraception during this time. 
V tem času morate uporabljati zanesljivo kontracepcijsko metodo.
Dose reduction is not recommended. 
Zmanjševanje odmerka ni priporočljivo.
The following information is intended for healthcare professionals only: 
Navodilo je namenjeno samo zdravstvenim delavcem:
Date of first authorisation: 22 May 2014 Date of latest renewal: 2 April 2019 
Datum prve pridobitve dovoljenja za promet: 22. 05. 2014 Datum zadnjega podaljšanja: 2. aprila 2019
Therefore, an increased susceptibility to specific tumours cannot be entirely ruled out. 
Zato povečane občutljivosti za nekatere tumorje ne moremo popolnoma izključiti.
• high blood pressure 
• zvišan krvni tlak
negative. 
negativni).
• cyclosporin, used during and after organ transplants 
• ciklosporin, ki ga uporabljamo med presaditvijo organa in po njej
• It will be given slowly over a period of 1 hour. 
• Infuzijo boste prejemali počasi, trajala bo 1 uro.
Your doctor may prescribe medicines to correct this. 
Zdravnik vam za to lahko predpiše zdravila.
Time to treatment failure 
čas do neuspeha zdravljenja
The registry should be continued for the either 100 patients, or 5 years, whichever is greater. 
Register mora trajati dokler ni vključenih 100 bolnikov ali 5 let - kar je dlje.
Pennsylvania 
Pennsylvanija
Pack size of 1 vial. 
Velikost pakiranja z 1 vialo.
None of these patients had neutralising antibodies. 
Noben od teh bolnikov ni imel nevtralizirajočih protiteles.
• SYLVANT is available in packs containing 1 vial. 
• Zdravilo SYLVANT je na voljo v pakiranjih, ki vsebujejo 1 vialo.
The management of severe infusion reactions should be dictated by the signs and symptoms of the reaction. 
Zdravljenje hude infuzijske reakcije je treba voditi glede na znake in simptome reakcije.
Your doctor will monitor you and your liver function. 
Zdravnik bo spremljal vaše stanje in jetrno funkcijo.
These infections may be serious, such as pneumonia or blood poisoning (also called “sepsis”). 
Okužbe so lahko resne, kot na primer pljučnica ali zastrupitev krvi (kar imenujemo tudi sepsa).
The dose of the concomitant medicinal products should be adjusted as needed. 
Po potrebi je treba prilagoditi odmerek sočasno uporabljenega zdravila.
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 pomaga zmanjšati velikost prizadetih bezgavk in vam pomaga pri opravljanju vsakodnevnih opravil.
• You will receive treatment until you and your doctor agree that you will no longer benefit from the treatment. 
• Zdravljenje bo trajalo dokler se bosta z zdravnikom strinjala, da vam koristi.
Janssen Sciences Ireland UC 
Združene države Amerike Janssen Sciences Ireland UC
As this medicine will be given to you by your doctor or nurse, it is unlikely that you will be given too much. 
Zdravilo vam bosta dajala zdravnik ali medicinska sestra, zato ni veliko verjetnosti, da bi ga prejeli preveč.
Concurrent active serious infections 
Sočasne aktivne hude okužbe
Gastrointestinal perforation 
Perforacija gastrointestinalnega trakta
Immunomodulatory medicinal products may increase the risk of malignancy. 
Zdravila z imunomodulatornim učinkom lahko povečajo tveganje za pojav malignomov.
In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment should be instituted immediately. 
V primeru prevelikega odmerjanja je treba bolnika opazovati glede znakov ali simptomov neželenih učinkov in takoj uvesti ustrezno simptomatsko zdravljenje.
Do not remove contents until all of the powder has been completely dissolved. 
Vsebine ne odstranjujte iz viale, dokler se vsi trdni delci povsem ne raztopijo.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
V vsaki razvrstitvi pogostnosti so neželeni učinki navedeni po padajoči resnosti.
It is not known if SYLVANT is safe and effective in this population, therefore SYLVANT should not be given to children and adolescents. 
Ni znano ali je uporaba zdravila SYLVANT v tej populaciji varna in učinkovita, zato se zdravilo SYLVANT pri otrocih in mladostnikih ne sme uporabljati.
Common (may affect up to 1 in 10 people): • high level of cholesterol in the blood 
Pogosti (lahko se pojavijo pri največ 1 od 10 bolnikov): • zvečana koncentracija holesterola v krvi
Women of childbearing potential must use effective contraception during and up to 3 months after treatment (see section 4.5). 
Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijsko metodo med zdravljenjem in še do 3 mesece po njegovem zaključku (glejte poglavje 4.5).
Patients should be managed according to current clinical guidelines for management of hyperlipidaemia. 
Bolnike je treba zdraviti skladno z zadnjimi kliničnimi smernicami za zdravljenje hiperlipidemije.
Barnahely Ringaskiddy Co. Cork 
Ringaskiddy Co. Cork Irska
Median duration of siltuximab treatment was 5.52 years (range: 0.8 to 10.8 years); more than 50% of patients received siltuximab treatment for ≥5 years. 
Mediana trajanja zdravljenja s siltuksimabom je bila 5,52 let (razpon: 0,8 do 10,8 let); več kot 50% bolnikov je prejemalo siltuksimab ≥5 let.