natgillin/translations-raw huggingface dataset:
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER (BAXJECT III SYSTEM)
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PRAŠKOM (SUSTAV BAXJECT III)
NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection.
NAZIV LIJEKA ADVATE 500 IU prašak i otapalo za otopinu za injekciju
NAME OF THE MEDICINAL PRODUCT ADVATE 250 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 250 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 250 IU powder for solution for injection Octocog alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 250 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa.
Jedna bočica nominalno sadrži 250 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 2000 IU powder for solution for injection Octocog alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 2000 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 500 IU/ml after reconstitution.
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 1000 IU oktokoga alfa, približno 500 IU/ml nakon pripreme otopine.
Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), octocog alfa.
Jedna bočica nominalno sadrži 3000 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/016
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/016
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 1000 IU octocog alfa, approx. 200 IU/ml after reconstitution.
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 1000 IU oktokoga alfa, približno 200 IU/ml nakon pripreme otopine.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE POWDER (BAXJECT II DEVICE)
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PRAŠKOM (UREĐAJ BAXJECT II)
NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 3000 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa
ADVATE 2000 IU prašak i otapalo za otopinu za injekciju oktokog alfa
STATEMENT OF ACTIVE SUBSTANCE(S) 1 vial: 250 IU octocog alfa, approx. 50 IU/ml after reconstitution.
NAVOĐENJE DJELATNE(IH) TVARI 1 bočica: 250 IU oktokoga alfa, približno 50 IU/ml nakon pripreme otopine.
NAME OF THE MEDICINAL PRODUCT ADVATE 2000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 2000 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection.
NAZIV LIJEKA ADVATE 1500 IU prašak i otapalo za otopinu za injekciju
ADVATE contains approximately 750 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
ADVATE sadrži približno 750 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), octocog alfa.
Jedna bočica nominalno sadrži 2000 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
Development of inhibitors is a known complication in the treatment of haemophilia A. If your bleeding is not controlled with ADVATE, tell your doctor immediately.
Stvaranje inhibitora poznata je komplikacija u liječenju hemofilije A.
NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
ADVATE 1500 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa.
Jedna bočica nominalno sadrži 500 IU ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa.
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