natgillin/translations-raw huggingface dataset:
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 2000 IU epoetin beta.
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 2000 IU epoetina beta.
· Do not handle the syringe by holding the plunger or needle cap.
Nemojte štrcaljku držati za klip ili zatvarač igle.
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 2000 IU pre-filled syringe
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 2000 IU napunjenu štrcaljku
1 pre-filled syringe (0.3 ml) and 1 needle (27G1/2)
1 napunjena štrcaljka (0,3 ml) i 1 igla (27G1/2)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 10,000 IU pre-filled syringe
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 10 000 IU napunjenu štrcaljku
INFORMATION IN BRAILLE neorecormon 4000 IU
neorecormon 4000 IU
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 30,000 IU pre-filled syringe
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 30 000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 5000 IU pre-filled syringe
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 5000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABELS 3000 IU pre-filled syringe
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA za 3000 IU napunjenu štrcaljku
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 10,000 IU pre-filled syringe
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 10 000 IU napunjenu štrcaljku
(5) Attach the device to the vial until the snap lock clicks home. (6) Put the green needle on the syringe contained in the package and remove the needle cover.
(6) Stavite zelenu iglu na štrcaljku iz pakiranja i uklonite pokrov igle.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 30,000 IU epoetin beta.
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 30 000 IU epoetina beta.
Form a skin fold by pinching the skin between thumb and forefinger.
Palcem i kažiprstom naberite kožu.
NeoRecormon 30,000 IU solution for injection in pre-filled syringe
NeoRecormon 20 000 IU otopina za injekciju u napunjenoj štrcaljki
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5000 IU/1 ml
5000 IU/1 ml
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 4000 IU pre-filled syringe
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 4000 IU napunjenu štrcaljku
4 pre-filled syringes (0.6 ml) and 4 needles (27G1/2)
4 napunjene štrcaljke (0,6 ml) i 4 igle (27G1/2)
15 Insert the needle into the injection port (follow the instruction of the injection port provider) ·Do not hold or push on the plunger while inserting needle.
15. Uvedite iglu u kateter (slijedite upute dobavljača katetera)
Keep the pre-filled syringe in the outer carton, in order to protect from light.
Napunjenu štrcaljku čuvajte u vanjskom pakiranju radi zaštite od svjetlosti.
Remove the needle and syringe from the injection port at the same angle as inserted.
Izvucite iglu i štrcaljku iz katetera pod istim kutom pod kojim ste ih uveli.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 500 IU epoetin beta.
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 500 IU epoetina beta.
NAME OF THE MEDICINAL PRODUCT NeoRecormon 20,000 IU solution for injection in pre-filled syringe Epoetin beta
NeoRecormon 20 000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
PHARMACEUTICAL FORM AND CONTENTS Lyophilisate and solvent for solution for injection 1 vial with lyophilisate (50,000 IU) for solution for injection, 1 ampoule with preserved solvent (10 ml), 1 reconstitution and withdrawal device, 1 disposable syringe (10 ml), 1 needle (21G2)
Liofilizat i otapalo za otopinu za injekciju 1 bočica s liofilizatom (50 000 IU) za otopinu za injekciju, 1 ampula s otapalom s konzervansom
Keep the pre-filled syringe in the outer carton, in order to protect from light
Napunjenu štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 10,000 IU epoetin beta.
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 10 000 IU epoetina beta.
1 pre-filled syringe (0.6 ml) and 1 needle (27G1/2)
1 napunjena štrcaljka (0,6 ml) i 1 igla (27G1/2)
NAME OF THE MEDICINAL PRODUCT NeoRecormon 5000 IU solution for injection in pre-filled syringe Epoetin beta
NeoRecormon 5000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/046
EU/1/97/031/046
NAME OF THE MEDICINAL PRODUCT NeoRecormon 500 IU solution for injection in pre-filled syringe Epoetin beta
NeoRecormon 500 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
These antibodies have been shown to cross-react with all erythropoietic proteins, and patients suspected or confirmed to have neutralising antibodies to erythropoietin should not be switched to NeoRecormon (see section 4.8).
Stoga se bolesnicima kod kojih postoji sumnja ili kod kojih je potvrđeno da imaju neutralizirajuća antitijela na eritropoetin, ne smije uvoditi terapija lijekom NeoRecormon
Only one vial of NeoRecormon Multidose must be in use (i.e. reconstituted) at any one time.
Istovremeno u primjeni (tj. pripremljena) treba biti samo jedna bočica lijeka NeoRecormon Multidose.
MINIMUM PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 3000 IU pre-filled syringe
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA za 3000 IU napunjenu štrcaljku
Storage Instructions
Prijavljivanje nuspojava
In this case you should not be switched to NeoRecormon.
U tom slučaju ne biste smjeli biti prebačeni na liječenje lijekom
Always follow aseptic techniques.
Čuvati na 2°C-8°C Uvijek se pridržavajte aseptičkih postupaka
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/035
EU/1/97/031/035
The solution is administered subcutaneously at a dose of 3 x 250 IU/kg b.w.
Otopina se daje supkutano u dozi od 3 x 250 IU/kg tjel. mase tjedno.
Medicinal product contains phenylalanine and sodium, see leaflet for further information
Lijek sadrži fenilalanin i natrij.
6 pre-filled syringes (0.3 ml) and 6 needles (27G1/2)
6 napunjenih štrcaljki (0,3 ml) i 6 igala (27G1/2)
NAME OF THE MEDICINAL PRODUCT NeoRecormon 4000 IU solution for injection in pre-filled syringe Epoetin beta
NeoRecormon 4000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
INFORMATION IN BRAILLE neorecormon 3000 IU
neorecormon 3000 IU
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 3000 IU epoetin beta.
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 3000 IU epoetina beta.
NAME OF THE MEDICINAL PRODUCT NeoRecormon 30,000 IU solution for injection in pre-filled syringe Epoetin beta
NeoRecormon 30 000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
NeoRecormon 2000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 2000 international units (IU) corresponding to 16.6 micrograms epoetin beta* (recombinant human erythropoietin).
Jedna napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 2000 internacionalnih jedinica (IU) što odgovara 16,6 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
NAME OF THE MEDICINAL PRODUCT NeoRecormon 2000 IU solution for injection in pre-filled syringe Epoetin beta
NeoRecormon 2000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
If you do not respond adequately to NeoRecormon, your doctor will check your dose and will inform you if you need to change doses.
Ako ne budete odgovarali na lijek NeoRecormon na odgovarajući način, Vaš liječnik će provjeriti
STATEMENT OF ACTIVE SUBSTANCE(S) 1 pre-filled syringe contains 4000 IU epoetin beta.
NAVOĐENJE DJELATNE(IH) TVARI 1 napunjena štrcaljka sadrži 4000 IU epoetina beta.
6 pre-filled syringes (0.6 ml) and 6 needles (27G1/2)
6 napunjenih štrcaljki (0,6 ml) i 6 igala (27G1/2)
NAME OF THE MEDICINAL PRODUCT NeoRecormon 10,000 IU solution for injection in pre-filled syringe Epoetin beta
NeoRecormon 10 000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
· Do not hold the plunger while you remove the needle cap. · Do not touch the needle after removing the needle cap. · Do not re-cap the needle.
Nemojte dodirivati iglu nakon što skinete zatvarač igle.
NeoRecormon 20,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 20,000 international units (IU) corresponding to 166 micrograms epoetin beta* (recombinant human erythropoietin).
Jedna napunjena štrcaljka s 0,6 ml otopine za injekciju sadrži 20 000 internacionalnih jedinica (IU) što odgovara 166 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/034
EU/1/97/031/034
Treatment of symptomatic chemotherapy-induced anaemia in cancer patients NeoRecormon should be administered by the subcutaneous route to patients with anaemia (e.g.
Liječenje simptomatske anemije uzrokovane kemoterapijom u bolesnika s rakom
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/033
EU/1/97/031/033
Meta-analysis of overall survival data produced a hazard ratio point estimate of 1.06 in favour of controls (95% CI: 1.00, 1.12; 53 trials and 13,933 patients) and for cancer patients receiving chemotherapy, the overall survival hazard ratio was 1.04 (95% CI: 0.97, 1.11; 38 trials and
Meta-analiza podataka o ukupnom preživljenju dala je procjenu omjera rizika od 1,06 u korist kontrolnih skupina (95% CI: 1,00; 1,12; 53
· The other ingredients are: urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-Glutamic acid, and L-Phenylalanine and water for injections.
Drugi sastojci su: urea, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat, natrijev hidrogenfosfat, kalcijev klorid, glicin, L-leucin, L-izoleucin, L-treonin, L- glutamatna kiselina, L-fenilalanin i voda za injekcije.
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/032
EU/1/97/031/032
If you are donating your own blood before surgery, your doctor will need to: · check that you are capable of giving blood, especially if you weigh less than 50 kg · check that you have a sufficient level of red blood cells (haemoglobin of at least 11 g/dL) · make sure that only 12 % of your blood will be donated at once.
● provjeriti jeste li u stanju dati krv, osobito ako Vam je tjelesna masa manja od 50 kg
(content of accompanying solvent ampoule).
(doza održavanja).
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/043
EU/1/97/031/043
A sustained haemoglobin level of greater than 12 g/dl (7.5 mmol/l) should be avoided; guidance for appropriate dose adjustment for when haemoglobin values exceeding 12 g/dl (7.5 mmol/l) are observed are described below.
Treba izbjegavati trajnu razinu hemoglobina iznad 12 g/dl (7,5 mmol/l).
NAME OF THE MEDICINAL PRODUCT NeoRecormon 6000 IU solution for injection in pre-filled syringe Epoetin beta
NeoRecormon 6000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/038
EU/1/97/031/038
NeoRecormon 6000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 6000 international units (IU) corresponding to 49.8 micrograms epoetin beta* (recombinant human erythropoietin).
Jedna napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 6000 internacionalnih jedinica (IU) što odgovara 49,8 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/036
EU/1/97/031/036
INFORMATION IN BRAILLE neorecormon 500 IU
NeoRecormon 500 IU
Vascular disorders
Organski sustav
NAME OF THE MEDICINAL PRODUCT NeoRecormon 3000 IU solution for injection in pre-filled syringe Epoetin beta
NeoRecormon 3000 IU otopina za injekciju u napunjenoj štrcaljki epoetin beta
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/042
EU/1/97/031/042
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/037
EU/1/97/031/037
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/045
EU/1/97/031/045
QUALITATIVE AND QUANTITATIVE COMPOSITION NeoRecormon 500 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 500 international units (IU) corresponding to 4.15 micrograms epoetin beta* (recombinant human erythropoietin).
Jedna napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 500 internacionalnih jedinica (IU) što odgovara 4,15 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/029
EU/1/97/031/029
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/025
EU/1/97/031/025
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/026
EU/1/97/031/026
1 syringe contains: Urea, sodium chloride, polysorbate 20, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, calcium chloride dihydrate, glycine, L-Leucine, L-Isoleucine, L-Threonine, L-glutamic acid, L-Phenylalanine, and water for injections.
POPIS POMOĆNIH TVARI 1 štrcaljka sadrži: ureju, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat, natrijev hidrogenfosfat, kalcijev klorid, glicin, L-leucin, L-izoleucin, L-treonin, L-glutamatnu kiselinu, Lfenilalanin i vodu za injekcije.
NeoRecormon 3000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 3000 international units (IU) corresponding to 24.9 micrograms epoetin beta* (recombinant human erythropoietin).
Jedna napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 3000 internacionalnih jedinica (IU) što odgovara 24,9 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
NeoRecormon 4000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.3 ml solution for injection contains 4000 international units (IU) corresponding to 33.2 micrograms epoetin beta* (recombinant human erythropoietin).
Jedna napunjena štrcaljka s 0,3 ml otopine za injekciju sadrži 4000 internacionalnih jedinica (IU) što odgovara 33,2 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
NeoRecormon 10,000 IU solution for injection in pre-filled syringe One pre-filled syringe with 0.6 ml solution for injection contains 10,000 international units (IU) corresponding to 83 micrograms epoetin beta* (recombinant human erythropoietin).
Jedna napunjena štrcaljka s 0,6 ml otopine za injekciju sadrži 10 000 internacionalnih jedinica (IU) što odgovara 83 mikrograma epoetina beta* (rekombinantnog ljudskog eritropoetina).
Roche d.o.o Tel: +385 1 4722 333
Tel: + 385 1 47 22 333
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/044
EU/1/97/031/044
Sodium dihydrogen phosphate dihydrate, Disodium phosphate dodecahyrate, Calcium chloride dihydrate, Glycine,
natrijev dihidrogenfosfat, natrijev hidrogenfosfat,
· Contact your healthcare professional if you have any questions.
Ako imate bilo kakvih pitanja, obratite se svom zdravstvenom radniku.
For storage conditions of the reconstituted medicinal product see section 6.3.
Uvjete čuvanja otopine pripremljene za primjenu vidjeti u dijelu 6.3. 6.5 Vrsta i sadržaj spremnika
Sodium chloride, Polysorbate 20, Sodium dihydrogen phosphate, Disodium hydrogen phosphate, Calcium chloride, Glycine,
POPIS POMOĆNIH TVARI 1 bočica sadrži: ureju, natrijev klorid, polisorbat 20, natrijev dihidrogenfosfat, natrijev hidrogenfosfat,
MARKETING AUTHORISATION NUMBER(S) EU/1/97/031/031
EU/1/97/031/031
The powder is white.
Prašak je bijel.
Allow to stand for 5 minutes.
Pustite da odstoji 5 minuta.
Allow the area to dry.
Pustite da se to područje osuši.
Let it warm up on its own.
Pustite da se sama zagrije.
You should then continue with injections at the recommended intervals as before.
Nakon toga trebate nastaviti s injekcijama u preporučenim intervalima kao i ranije.
Your doctor may check your blood regularly if considered necessary.
Liječnik Vam može redovito kontrolirati krv ako to bude smatrao potrebnim.
Satisfactory clinical response after 7 days?
Zadovoljavajući klinički odgovor nakon 7 dana?
If you feel a spinning sensation or feel tired, do not drive or use any tools or machines until you are feeling normal again.
Ako osjećate da Vam se vrti ili se osjećate umorno, nemojte voziti ili koristiti bilo kakve alate ili strojeve dok se opet ne budete osjećali normalno.
Your doctor may decide to delay or interrupt your treatment, but only if necessary.
Liječnik može odlučiti odgoditi ili prekinuti Vaše liječenje, ali samo ako to bude nužno.
These can include:
One mogu uključivati:
- if you have, or suspect you have, an active and severe infection.
ako imate, ili sumnjate da imate, aktivnu i tešku infekciju.
Please note that the preparation of the injection takes about 30 minutes.
Napominjemo da za pripremu injekcije treba oko 30 minuta.
Fever lasting longer than 3 days or any other symptoms that might suggest a serious infection.
Vrućica koja traje dulje od 3 dana ili bilo koji drugi simptomi koji mogu ukazivati na ozbiljnu infekciju.
(There will be water remaining in the vial.)
(U bočici će ostati nešto vode.)
The majority of these events were mild in severity.
Većina tih događaja bila je blaga po težini.
Pain in the back or muscles.
Bol u leđima ili mišićima.
Steady state was reached after 110 days.
Stanje dinamičke ravnoteže bilo je dosegnuto nakon 110 dana.
Physician Global Assessment < 2
Liječnikova opća procjena <2
if you need to have any vaccinations.
ako trebate ikakva cjepiva.
Overall study population; N=454
Cjelokupna ispitivana populacija; N=454
The total treatment duration ranged from 6 months to 2 years.
Ukupno trajanje liječenja bilo je od 6 mjeseci do 2 godine.
Then talk to the doctor to discuss when you should inject the next dose.
Zatim razgovarajte s liječnikom kada biste trebali ubrizgati sljedeću dozu.
This additional dose could be provided as early as 7 days after the first treatment dose.
Ta dodatna doza mogla se dati već 7 dana nakon prve doze u liječenju.
If possible, avoid touching the rubber stopper with your fingers.
Ako je moguće, izbjegavajte dodirivanje gumenog čepa prstima.
However, clinical experience in such patients is limited.
Međutim, klinička iskustva u takvih bolesnika su ograničena.
Neutropenia and leukopenia
Neutropenija i leukopenija
Your healthcare provider will instruct you on the right amount for you.
Osoba koja Vam pruža zdravstvenu skrb uputit će Vas u to koja je odgovarajuća količina za Vas.
It is important to tell your doctor if you are pregnant, if you think you may be pregnant or are planning to have a baby.
Važno je da obavijestite svog liječnika ako ste trudni, ako mislite da biste mogli biti trudni ili ako planirate imati dijete.
Wash your hands with soap and water, then dry them on a clean towel.
Operite ruke sapunom i vodom, zatim ih osušite čistim ručnikom.
Of the patients who had achieved a complete response, 89.3% maintained response without relapsing.
Od bolesnika koji su postigli potpuni odgovor, 89,3% održalo je odgovor bez relapsa.
Long term data from observational study
Dugoročni podaci iz opservacijskog ispitivanja
If you use more Ilaris than you should
Ako primijenite više Ilarisa nego što ste trebali
Your doctor will discuss with you the need to start or adjust a urate lowering therapy to lower the uric acid level in your blood.
Vaš liječnik će razgovarati s Vama o potrebi započinjanja ili prilagođavanja terapije za snižavanje urata kako bi se smanjila razina mokraćne kiseline u Vašoj krvi.
Essential preparation
Osnovna priprema
This may affect your ability to drive or use tools or machines.
To može utjecati na Vašu sposobnost upravljanja vozilima ili korištenja alata ili strojeva.
Two open-label, uncontrolled, long-term phase III studies were performed.
Provedena su dva otvorena, nekontrolirana, dugoročna ispitivanja faze III.
These are used mainly in rheumatic and autoimmune diseases.
Oni se primjenjuju uglavnom kod reumatskih i autoimunih bolesti.
(2°C to 8°C) and used within 24 hours.
(2°C do 8°C) i upotrijebiti u roku od 24 sata.
The clinical significance of this observation is unknown.
Klinički značaj tog opažanja nije poznat.
More information on each of these diseases is given below.
Više informacija o svakoj od ovih bolesti navedeno je u nastavku.
Canakinumab also reduced the risk of subsequent attacks (see Table 5).
Kanakinumab je također smanjio rizik od naknadnih napada (vidjeti Tablicu 5).
Results for the components of the adapted paediatric ACR which included systemic and arthritic components, were consistent with the overall ACR response results.
Rezultati za komponente prilagođenog pedijatrijskog ACR odgovora koje su uključivale sistemske i artritične komponente bili su u skladu s ukupnim rezultatima ACR odgovora.
No neutralising antibodies were detected.
Nisu bila uočena neutralizirajuća protutijela.
Do not stop taking Ilaris unless your doctor tells you to.
Nemojte prestati primjenjivati Ilaris osim ako Vam to ne savjetuje Vaš liječnik.
Do not try to administer an injection yourself if you have not been properly trained or if you are not sure how to do it.
Ne pokušavajte sami primijeniti injekciju ako niste pravilno obučeni ili ako niste sigurni kako to učiniti.
The risk for the foetus/mother is unknown.
Rizik za fetus/majku nije poznat.
Tell your doctor or your child's doctor immediately if you notice any of these symptoms.
Odmah se obratite svom liječniku ili liječniku vašeg djeteta ako primijetite bilo koji od tih simptoma.
Date of first authorisation: 23 October 2009 Date of latest renewal: 19 June 2014
Datum posljednje obnove odobrenja: 19. lipnja 2014.
The studies were 12 weeks followed by 12-week double-blind extension.
Ispitivanja su trajala 12 tjedana, nakon čega je uslijedio dvostruko slijepi produžetak od 12 tjedana.
Women who are pregnant or who desire to become pregnant should therefore only be treated after a thorough benefit-risk evaluation.
Žene koje su trudne ili koje žele zatrudnjeti smiju se stoga liječiti samo nakon temeljite procjene koristi i rizika.
Always use new, unopened needles and syringes.
Uvijek upotrebljavajte nove, neotvorene igle i štrcaljke.
Gouty arthritis: Ilaris is not recommended for children or adolescents under 18 years of age.
Urični artritis: Ilaris se ne preporučuje za djecu ili adolescente mlađe od 18 godina.
Do not inject air into the liquid.
Ne ubrizgavajte zrak u tekućinu.
If bleeding occurs, apply a clean, dry cotton swab over the area, and press gently for 1 to 2 minutes, or until bleeding stops.
Ako dođe do krvarenja, stavite čisti, suhi pamučni jastučić na to područje i lagano pritišćite 1 do 2 minute ili dok se krvarenje ne zaustavi.
Frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Kategorije učestalosti definirane su prema sljedećem načelu: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
This means that it is injected through a short needle into the fatty tissue just under the skin.
To znači da se ubrizgava kroz kratku iglu u masno tkivo ispod kože.
The mean number of gouty arthritis attacks in the previous 12 months was 6.5.
Srednja vrijednost broja napada uričnog artritisa u prethodnih 12 mjeseci bio je 6,5.
Do not use Ilaris - if you are allergic to canakinumab or any of the other ingredients of this medicine (listed in section 6).
Nemojte primjenjivati Ilaris - ako ste alergični na kanakinumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
If you accidentally inject more Ilaris than the recommended dose, it is unlikely to be serious, but you should inform your doctor, pharmacist or nurse as soon as possible.
Ako slučajno ubrizgate više Ilarisa od preporučene doze, mala je vjerojatnost da će to biti ozbiljno, ali trebate čim prije obavijestiti svoga liječnika, ljekarnika ili medicinsku sestru.
9/l were reported in 2% of patients in the comparative trials.
9/l zabilježeno je u 2% bolesnika u komparativnim ispitivanjima.