natgillin/translations-raw huggingface dataset:
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.
SYLVANT does not contain preservatives; therefore do not store any unused portion of the infusion solution for re-use.
Zdravilo SYLVANT ne vsebuje konservansov, zato neporabljene infuzijske raztopine ne shranjujte za ponovno uporabo.
If not used immediately, in-use storage times and conditions are the responsibility of the user.
Če zdravilo ne bo porabljeno takoj po pripravi in redčenju, je za čas in pogoje shranjevanja odgovoren uporabnik.
This leaflet was last revised in MM/YYYY Other sources of information
Navodilo je bilo nazadnje revidirano dne MM/LLLL Drugi viri informacij
In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Za zagotavljanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije danega zdravila.
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.
Po obdobju spremljanja, ki je trajalo mediano 6 let, je preživelo vseh 60 bolnikov, pri 58 od 60 bolnikov pa je bila bolezen pod nadzorom.
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.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden prejmete to zdravilo.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
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.
Zdravljenje so nadaljevali, dokler ni prišlo do neuspeha zdravljenja (ki je bil opredeljen kot napredovanje bolezni s poslabšanjem simptomov, radiološko potrjenim napredovanjem bolezni ali poslabšanjem telesne zmogljivosti bolnika) ali do nesprejemljivega toksičnega učinka zdravila.
• drop in the number of white blood cells (neutropenia)
• zmanjšanje števila belih krvnih celic (nevtropenija)
SYLVANT is not likely to affect your ability to drive, cycle, or use any tools or machines.
Ni verjetno, da bi zdravilo SYLVANT vplivalo na vašo sposobnost vožnje motornih vozil ali kolesa in uporabe naprav ali strojev.
The safety and efficacy of siltuximab in children aged 17 years and younger have not been established.
Varnost in učinkovitost siltuksimaba pri otrocih, starih 17 let ali manj, nista bili dokazani.
You should not stop using SYLVANT without discussing with your doctor first.
Z uporabo zdravila SYLVANT ne smete prenehati, ne da bi se o tem prej pogovorili z zdravnikom.
Chemical and physical in-use stability has been demonstrated for up to 8 hours at room temperature (see section 6.6).
Po pripravi in redčenju Dokazano je, da je raztopina pri sobni temperaturi kemijsko in fizikalno stabilna do 8 ur (glejte poglavje 6.6).
< 1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000).
(≥1/10.000 in <1/1.000); zelo redki (<1/10.000).
• SYLVANT will be given as an “intravenous infusion” (a drip into a vein, usually in your arm).
• Zdravilo SYLVANT boste prejemali v obliki intravenske infuzije (skozi cevko v veno, običajno na roki).
Siltuximab should be given to a pregnant woman only if the benefit clearly outweighs the risk.
Nosečnice smejo prejemati siltuksimab samo kadar koristi zdravljenja nedvomno presegajo tveganja.
Other medicines and SYLVANT
Druga zdravila in zdravilo SYLVANT
Treatment criteria
Kriteriji za zdravljenje
All tumour responses were durable for > 18 weeks.
Vsi tumorski odzivi so trajali več kot 18 tednov.
Clinical efficacy and safety
Klinična učinkovitost in varnost Študija 1
Infusion related reactions and hypersensitivity
Infuzijske reakcije in preobčutljivost
• oral contraceptives, used to prevent pregnancy.
• peroralni kontraceptivi za preprečevanje zanositve.
The European Medicines Agency has waived the obligation to submit the results of studies with siltuximab in all subsets of the paediatric population in CD (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s siltuksimabom za vse podskupine pediatrične populacije s Castlemanovo boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
If you think you have been given too much SYLVANT, tell your doctor or nurse straight away.
Če menite, da ste prejeli preveč zdravila SYLVANT, takoj opozorite zdravnika ali medicinsko sestro.
• you are due to have a vaccination or may need to have one in the near future - this is because some vaccines should not be given with SYLVANT.
• če se ravno nameravate cepiti ali če boste cepivo morda potrebovali v bližnji prihodnosti - med zdravljenjem z zdravilom SYLVANT namreč ne smete prejeti nekaterih cepiv.
Durable complete symptomatic responsed Duration of durable complete symptomatic response (days) median (min, max)
trajni popolni simptomatski odzivd trajanje trajnega popolnega simptomatskega odziva (dnevi), mediana vrednost (najmanjša ,
Live, attentuated vaccines should not be given concurrently or within 4 weeks before initiating SYLVANT as clinical safety has not been established.
Bolniki ne smejo prejeti živih atenuiranih cepiv sočasno ali v roku 4 tednov pred začetkom uporabe zdravila SYLVANT, saj klinična varnost ni bila dokazana.
Further immunogenicity analyses were conducted for all positive samples from the 4 patients with detectable anti-siltuximab antibodies.
Nadaljnje analize imunogenosti so izvedli pri vseh pozitivnih vzorcih 4 bolnikov z merljivimi protitelesi proti siltuksimabu.