FrancophonIA/ELRC3.0 huggingface dataset:
English: ADVATE contains approximately 125 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Croatian: ADVATE sadrži približno 125 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: O tome treba voditi računa u bolesnika s ograničenjem unosa natrija.
English: 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.
Croatian: Unutar roka valjanosti, bočica s praškom se može čuvati na sobnoj temperaturi (do 25°C) u jednokratnom razdoblju ne duljem od 6 mjeseci.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/008
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/008
English: During the shelf life, the product may be kept at room temperature (up to 25 °C) for a single period not exceeding 6 months.
Croatian: Unutar roka valjanosti, lijek se može čuvati na sobnoj temperaturi (do 25 °C) u jednom razdoblju ne duljem od 6 mjeseci.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/018
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/018
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1500 IU powder for solution for injection Octocog alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 1500 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa (recombinant human coagulation factor VIII)
Croatian: ADVATE 1000 IU prašak i otapalo za otopinu za injekciju oktokog alfa (rekombinantni ljudski koagulacijski faktor VIII)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 3000 IU powder for solution for injection Octocog alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 3000 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 500 IU powder for solution for injection Octocog alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 500 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa
Croatian: ADVATE 500 IU prašak i otapalo za otopinu za injekciju oktokog alfa
English: Respiratory, thoracic and mediastinal disorders Dyspnoea
Croatian: Poremećaji probavnog sustava povraćanje svrbež osip hiperhidroza
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/012
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/012
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE SOLVENT (BAXJECT III SYSTEM)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S OTAPALOM (SUSTAV BAXJECT III)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/006
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/006
English: ADVATE contains approximately 400 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Croatian: ADVATE sadrži približno 400 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
English: ADVATE contains approximately 250 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Croatian: ADVATE sadrži približno 250 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
English: ADVATE contains approximately 500 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Croatian: ADVATE sadrži približno 500 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
English: 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.
Croatian: Sadržaj: 1 bočica s 1000 IU oktokoga alfa i 1 bočica s 2 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/010
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/010
English: 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.
Croatian: Sadržaj: 1 bočica s 3000 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
English: 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.
Croatian: Sadržaj: 1 bočica s 3000 IU oktokoga alfa i 1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
English: 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.
Croatian: Sadržaj: 1 bočica s 1000 IU oktokoga alfa, 1 bočica s 2 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/020
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/020
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1000 IU powder for solution for injection Octocog alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA ADVATE 1000 IU prašak za otopinu za injekciju oktokog alfa i.v. primjena
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/017
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/013
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/013
English: ADVATE contains approximately 300 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Croatian: ADVATE sadrži približno 300 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
English: ADVATE contains approximately 600 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Croatian: ADVATE sadrži približno 600 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/015
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/015
English: ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Croatian: ADVATE sadrži približno 200 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/009
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/009
English: ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Croatian: ADVATE sadrži približno 50 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
English: 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.
Croatian: Sadržaj: 1 bočica s 2000 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL FOR THE SOLVENT (BAXJECT II DEVICE)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S OTAPALOM (UREĐAJ BAXJECT II)
English: ADVATE contains approximately 100 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Croatian: ADVATE sadrži približno 100 IU po ml ljudskog koagulacijskog faktora VIII (rDNK), oktokoga alfa nakon rekonstitucije.
English: 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.
Croatian: Sadržaj: 1 bočica s 250 IU oktokoga alfa i 1 bočica s 2 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
English: 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.
Croatian: Sadržaj: 1 bočica s 250 IU oktokoga alfa i 1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/005
English: 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.
Croatian: Sadržaj: 1 bočica s 500 IU oktokoga alfa i 1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/014
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/014
English: 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.
Croatian: Sadržaj: 1 bočica s 500 IU oktokoga alfa i 1 bočica s 2 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
English: 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.
Croatian: Sadržaj: 1 bočica s 250 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
English: Tabulated summary of adverse reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene malaksalost nepoznato
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/011
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/011
English: 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.
Croatian: Sadržaj: 1 bočica s 2000 IU oktokoga alfa i1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
English: Recovery at Cmax (IU/dL per IU/kg)a
Croatian: Klirens (ml/kg*h)
English: 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.
Croatian: Sadržaj: 1 bočica s 250 IU oktokoga alfa, 1 bočica s 2 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/019
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/019
English: 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.
Croatian: Sadržaj: 1 bočica s 1500 IU oktokoga alfa i 1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
English: 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.
Croatian: Sadržaj: 1 bočica s 1000 IU oktokoga alfa i 1 bočica s 5 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/001
English: 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.
Croatian: Sadržaj: 1 bočica s 1500 IU oktokoga alfa i 1 bočica s 2 ml sterilizirane vode za injekcije već pričvršćene na sustav BAXJECT III.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa
Croatian: ADVATE 1000 IU prašak i otapalo za otopinu za injekciju oktokog alfa
English: 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.
Croatian: Sadržaj: 1 bočica s 500 IU oktokoga alfa, 1 bočica s 2 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
English: 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.
Croatian: Sadržaj: 1 bočica s 500 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
English: 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.
Croatian: Sadržaj: 1 bočica s 1000 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
English: 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.
Croatian: Sadržaj: 1 bočica s 1500 IU oktokoga alfa, 1 bočica s 5 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
English: 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.
Croatian: Sadržaj: 1 bočica s 1500 IU oktokoga alfa, 1 bočica s 2 ml sterilizirane vode za injekcije, 1 uređaj BAXJECT II.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/002
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/004
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/007
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/03/271/007
English: - If you get any side effects talk to your doctor.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: 23 September 2014
Croatian: 23. rujna 2014.
English: 23 August 2014
Croatian: 23. kolovoza 2014.
English: Within 3 months after adoption of CMDh agreement
Croatian: Unutar 3 mjeseca nakon usvajanja sporazuma CMDh-a
English: - submission of the variation by the Marketing Authorisation Holders of methadone tablets containing povidone of low molecular weight (K25 or K30)
Croatian: - dostavljanje izmjene od strane nositelja odobrenja za stavljanje lijeka u promet za tablete metadona koje sadrže povidon niske molekulske mase (K25 ili K30)
English: Implementation of the agreement by the Member States: - suspension of the marketing authorisations of methadone oral solutions containing povidone of high molecular weight (K90)
Croatian: Provedba sporazuma od strane država članica: - suspenzija odobrenja za stavljanje u promet peroralnih otopina metadona koje sadrže povidon visoke molekulske mase (K90)
English: Adoption of CMDh agreement:
Croatian: Donošenje sporazuma CMDh-a:
English: July 2014 CMDh meeting
Croatian: Sastanak CMDh-a u srpnju 2014.
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Croatian: Prosljeđivanje prijevoda dodatka sporazumu nadležnim nacionalnim tijelima:
English: Dose reduction is not recommended.
Croatian: Redukcija doze se ne preporučuje.
English: You should use effective methods of contraception during this time.
Croatian: Morate koristiti učinkovite metode kontracepcije tijekom tog vremena.
English: Your doctor will monitor you and your liver function.
Croatian: Vaš liječnik će nadzirati Vas i funkciju Vaše jetre.
English: The powder should dissolve in less than 60 minutes.
Croatian: Prašak bi se morao otopiti za manje od 60 minuta.
English: 30/11/2015 (aligned with expected PSUR cycle)
Croatian: 30.11.2015. (ujednačeno s očekivanim ciklusom
English: • cyclosporin, used during and after organ transplants
Croatian: • ciklosporin, koristi se tijekom i nakon presađivanja organa
English: Do not remove contents until all of the powder has been completely dissolved.
Croatian: Nemojte uklanjati sadržaj dok se prašak u potpunosti ne otopi.
English: Therefore, an increased susceptibility to specific tumours cannot be entirely ruled out.
Croatian: Stoga ne može biti potpuno isključena povišena osjetljivost na specifične tumore.
English: • It will be given slowly over a period of 1 hour.
Croatian: • Lijek će Vam biti primijenjen polagano, tijekom razdoblja od 1 sat.
English: 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.
Croatian: 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.
English: Your doctor may prescribe medicines to correct this.
Croatian: Liječnik Vam može propisati lijekove za popravljanje tog stanja.
English: 200 Great Valley Parkway Malvern
Croatian: 200 Great Valley Parkway
English: • You will receive treatment until you and your doctor agree that you will no longer benefit from the treatment.
Croatian: • Liječenje će trajati dok se sa svojim liječnikom ne složite da od nastavka liječenja više nećete imati koristi.
English: 206 days
Croatian: 206 dana
English: Protocol:
Croatian: Protokol:
English: 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.
Croatian: To pomaže smanjenju veličine zahvaćenih limfnih čvorova, što umanjuje simptome bolesti i moralo bi Vam pomoći u obavljanju normalnih dnevnih zadataka.
English: • oral contraceptives, used to prevent pregnancy.
Croatian: • oralne kontraceptive, koriste se u svrhu sprječavanja trudnoće.
English: SYLVANT should remain at room temperature for the duration of the preparation.
Croatian: SYLVANT mora ostati na sobnoj temperaturi tijekom trajanja pripreme.
English: The registry should be continued for the either 100 patients, or 5 years, whichever is greater.
Croatian: Registar je potrebno nastaviti voditi bilo za 100 bolesnika ili tijekom 5 godina, ovisno o tome što je veće.
English: Subgroup analyses
Croatian: Analiza podskupina
English: All tumour responses were durable for > 18 weeks.
Croatian: Svi tumorski odgovori trajali su tijekom > 18 tjedana.
English: Highest total dose in clinical trials
Croatian: Najviša ukupna doza u kliničkim ispitivanjima
English: Common (may affect up to 1 in 10 people): • high level of cholesterol in the blood
Croatian: Često (mogu se javiti u do 1 na 10 osoba): • visoka razina kolesterola u krvi
English: Other medicines and SYLVANT
Croatian: Drugi lijekovi i SYLVANT
English: The recommended needle for preparation is 21-gauge 1½ inch (38 mm).
Croatian: Preporučena igla za pripremu je 21-gauge 1½ inča (38 mm).
English: 3 weeks.
Croatian: 3 tjedna.
English: As with all therapeutic proteins, there is potential for the generation of anti-medicine antibodies (immunogenicity).
Croatian: Kao i sa svim terapijskim proteinima, postoji potencijal stvaranja protutijela na lijek (imunogenost).
English: None of these patients had neutralising antibodies.
Croatian: Niti jedan od ovih bolesnika nije imao neutralizirajuća protutijela.
English: Table 1: Treatment criteria Laboratory parameter
Croatian: Tablica 1: Kriteriji za liječenje Laboratorijski parametar
English: These infections may be serious, such as pneumonia or blood poisoning (also called “sepsis”).
Croatian: Te infekcije mogu biti ozbiljne, poput upale pluća ili trovanja krvi (također se naziva “sepsa”).
English: < 1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10000 and <1/1000); very rare (<1/10000).
Croatian: (≥ 1/100 i < 1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000).
English: Tell your doctor straight away if you have a severe allergic reaction during or after the infusion.
Croatian: Odmah obavijestite liječnika ako imate tešku alergijsku reakciju tijekom ili nakon infuzije.
English: No dose adjustment is required (see section 5.2).
Croatian: Nije potrebna prilagodba doze (vidjetio dio 5.2).
English: Before administering the infusion, the prescriber should consider delaying treatment, if the treatment criteria outlined in Table 1 are not met.
Croatian: Prije primjenjivanja infuzije, liječnik koji propisuje lijek mora uzeti u obzir odgodu liječenja, ukoliko se ne dostignu kriteriji za liječenje navedeni u Tablici 1.
English: Date of first authorisation: 22 May 2014 Date of latest renewal: 2 April 2019
Croatian: Datum posljednje obnove odobrenja: 2 travnja 2019
English: • SYLVANT is not recommended for use during pregnancy.
Croatian: • SYLVANT se ne preporučuje primjenjivati tijekom trudnoće.
English: (N/A; N/A)b
Croatian: (N/P; N/P)
English: • 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.
Croatian: • ako trenutno imate infekciju - jer SYLVANT može smanjiti Vašu sposobnost osjećanja ili borbe protiv infekcije pa se infekcije mogu pogoršati.
English: The safety and efficacy of siltuximab in children aged 17 years and younger have not been established.
Croatian: Sigurnost i djelotvornost siltuksimaba u djece u dobi od 17 godina i mlađih nisu ustanovljene.
English: NL-2333 CB Leiden The Netherlands
Croatian: NL-2333 CB Leiden Nizozemska
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, uvjeti i vrijeme čuvanja tijekom primjene odgovornost su korisnika.
English: Concurrent active serious infections
Croatian: Istovremene aktivne ozbiljne infekcije
English: • high level of 'uric acid' in the blood, which may cause gout
Croatian: • visoka razina 'mokraćne kiseline' u krvi, koja može izazvati giht
English: SYLVANT will be given to you by your doctor or nurse, in a hospital or clinic only.
Croatian: SYLVANT će Vam primijeniti liječnik ili medicinska sestra, isključivo u bolnici ili na klinici.
English: 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.
Croatian: S mikrobiološkog stajališta, osim ako metoda otvaranja/rekonstitucije/razrjeđivanja isključuje rizik za kontaminaciju mikroorganizmima, lijek se mora primijeniti odmah.
English: 2333 CB Leiden The Netherlands
Croatian: 2333 CB Leiden Nizozemska
English: 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.
Croatian: 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.
English: 70 days
Croatian: 70 dana
English: SYLVANT is not likely to affect your ability to drive, cycle, or use any tools or machines.
Croatian: Nije vjerojatno da će SYLVANT utjecati na Vašu sposobnost upravljanja vozilima, biciklom ili na upotrebu bilo kakvih alata ili strojeva.
English: • SYLVANT is available in packs containing 1 vial.
Croatian: • SYLVANT je dostupan u pakiranjima koja sadrže 1 bočicu.