natgillin/translations-raw huggingface dataset:
Patients should be started at 62.5 microgram (0.25 ml) subcutaneously every other day, and increased slowly to a dose of 250 microgram (1.0 ml) every other day (see Table A).
Bolesnici trebaju početi s dozom od 62,5 mikrograma (0,25 ml) supkutano svaki drugi dan, te polako povećavati dozu do 250 mikrograma (1,0 ml) svaki drugi dan (vidjeti Tablicu A).
Debridement and, less often, skin grafting are occasionally required and healing may take up to 6 months.
Povremeno je potreban debridman i, manje često, presađivanje kože, a zacjeljivanje može potrajati do 6 mjeseci.
The most frequently observed adverse reactions are a flu-like symptom complex (fever, chills, arthralgia, malaise, sweating, headache, or myalgia), which is mainly due to the pharmacological effects of the medicinal product, and injection site reactions.
Najčešće zabilježene nuspojave su kompleks simptoma nalik gripi (vrućica, zimica, artralgija, malaksalost, znojenje, glavobolja ili mialgija), koji su uglavnom uzrokovani farmakološkim učincima lijeka i reakcijama na mjestu injiciranja.
No benefit, attributable to Extavia, in quality of life (as measured by FAMS - Functional Assessment of MS: Treatment Outcomes Index) was seen.
Nije uočena nikakva korist koja bi se mogla pripisati Extaviji za kvalitetu života (mjerenu prema Funkcionalnoj procjenu multiple skleroze: Indeks ishoda liječenja).
Adults and adolescents from 12-17 years of age The recommended dose of Extavia is 250 microgram (8.0 million IU), contained in 1 ml of the reconstituted solution (see section 6.6), to be injected subcutaneously every other day.
Odrasle osobe i adolescenti u dobi od 12 do 17 godina Preporučena doza Extavije je 250 mikrograma (8,0 milijuna IU), sadržanih u 1 ml pripremljene otopine (vidjeti dio 6.6), koja se supkutano injicira svaki drugi dan.
No acute toxicity studies have been performed.
Nisu provedena ispitivanja akutne toksičnosti.
In MS, inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly.
Kod MS-a, upala uništava zaštitnu ovojnicu (koja se naziva mijelin) oko živaca u središnjem živčanom sustavu i sprečava pravilno funkcioniranje živaca.
The effect of alternate-day administration of 250 microgram (8.0 million IU) Extavia on drug metabolism in multiple sclerosis patients is unknown.
Učinak primjene 250 mikrograma (8,0 milijuna IU) Extavije svakog drugog dana na metabolizam lijeka u bolesnika s multiplom sklerozom nije poznat.
Maximum serum levels of about 40 IU/ml were found 1-8 hours after subcutaneous injection of 500 microgram (16.0 million IU) interferon beta-1b.
Maksimalne razine u serumu od oko 40 IU/ml pronađene su 1-8 sati nakon supkutane injekcije 500 mikrograma (16,0 milijuna IU) interferona beta-1b.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist or nurse.
Ako se bilo koja od nuspojava pogorša, ili ako primijetite bilo koju nuspojavu koja nije navedena u ovoj uputi, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
Cases of pancreatitis were observed with Extavia use, often associated with hypertriglyceridaemia.
Uz primjenu Extavije zabilježeni su slučajevi pankreatitisa, često povezanog s hipertrigliceridemijom.
Please refer to section 3 of the leaflet, “How to use Extavia”, for further details on how to use Extavia.
Pogledajte dio 3 Upute o lijeku, „Kako primjenjivati Extaviju“, za više pojedinosti o tome kako primjenjivati Extaviju.
► Tell your doctor immediately and stop using Extavia: if you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
Odmah se obratite liječniku i prestanite koristiti Extaviju: ako osjetite simptome kao što su svrbež po cijelom tijelu, oticanje lica i/ili jezika ili iznenadna nedostatak zraka.
To minimise the risk of injection site necrosis patients should be advised to: use an aseptic injection technique, rotate the injection sites with each dose.
Za smanjenje rizika od nekroze na mjestu injiciranja bolesnike treba savjetovati da: koriste aseptične načine injiciranja, mijenjaju mjesto injiciranja sa svakom dozom.
RR-MS, SP-MS and single clinical event suggestive of MS In all multiple sclerosis studies Extavia was effective in reducing disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
RR-MS, SP-MS i jednokratan klinički događaj koji upućuje na MS U svim ispitivanjima multiple skleroze, Extavia je bila djelotvorna u smanjivanju aktivnosti bolesti (akutne upale u središnjem živčanom sustavu i trajne promjene tkiva), mjerene snimanjem magnetskom rezonancijom (MR).
PART III: EXTAVIA Medication record
DIO III: Bilješke o injiciranju lijeka EXTAVIA
In multifocal patients, the risk for CDMS was independent from MRI findings at baseline, indicating a high risk for CDMS because of the dissemination of the disease based on clinical findings.
U multifokalnih bolesnika rizik od KDMS-a nije ovisio od nalazima na snimci MR-om napravljenoj na početku, što upućuje na visoki rizik od KDMS-a zbog diseminacije bolesti na temelju kliničkih nalaza.
Common (1/100 to
Često (1/100 i
Solvent for Extavia For subcutaneous use after reconstitution.
Otapalo za lijek Extavia Za supkutanu primjenu nakon pripreme otopine.
The reconstituted product is colourless to light yellow and slightly opalescent to opalescent.
Rekonstituirani lijek je bezbojan do svijetlo žut te blago opalescentan do opalescentan.
Secondary Progressive Multiple Sclerosis (North American Study)
Sekundarno progresivna multipla skleroza (Sjevernoameričko ispitivanje)
The 30-gauge needles provided with the application kit for the administration of this medicine can be used either for manual injection OR with an ExtaviPro 30G auto-injector.
Igle veličine 30 G priložene uz set za primjenu ovog lijeka mogu se koristiti za ručno ubrizgavanje ILI s autoinjektorom ExtaviPro 30G.
In two years, the risk was 85% in the placebo group and 69% in the Extavia group (Hazard Ratio = 0.57, 95% confidence interval (0.46, 0.71), p<0.00001).
U dvije godine rizik je bio 85% u placebo skupini i 69% u skupini koja je primala Extaviju (omjer hazarda = 0,57, interval pouzdanosti 95% (0,46, 0,71), p<0,00001).
Secondary Progressive Multiple Sclerosis (European Study)
Sekundarno progresivna multipla skleroza (Europsko ispitivanje)
Caution should be exercised when Extavia is administered in combination with medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e.g. anti-epileptics.
Treba biti oprezan prilikom primjene Extavije u kombinaciji s lijekovima koji imaju uski terapijski indeks te su uvelike ovisni o sustavu jetrenog citokroma P450 zbog klirensa, primjerice antiepileptici.
The administration of cytokines to patients with a pre-existing monoclonal gammopathy has been associated with the development of systemic capillary leak syndrome with shock-like symptoms and fatal outcome.
Primjena citokina u bolesnika s postojećom monoklonalnom gamapatijom povezuje se s razvojem sindroma povećane propustljivosti sistemskih kapilara uz simptome nalik šoku i sa smrtnim ishodom.
Class label for interferon beta products (see section 4.4).
Značajka skupine lijekova koji sadrže interferon beta (vidjeti dio 4.4).
However, it is known that the biological response-modifying properties of interferon beta-1b are mediated through its interactions with specific cell receptors found on the surface of human cells.
Ipak, poznato je da su biološka svojstva interferona beta-1b koja modificiraju reakciju rezultat njegovih interakcija sa specifičnim staničnim receptorima koji se nalaze na površini ljudskih stanica.
For details on storage conditions see section 5 of the leaflet, “How to store Extavia”.
Za pojedinosti o uvjetima čuvanja pogledajte dio 5 Upute o lijeku, „Kako čuvati Extaviju“.
Psychiatric disorders Depression
Psihijatrijski poremećaji Depresija
Before preparing your injection, decide where you are going to inject.
Prije pripreme injekcije odlučite se za mjesto injiciranja.
3 - Remove the cap from the needle by pulling and not twisting it.
3 - Uklonite zatvarač s igle povlačenjem, a ne okretanjem.
Single clinical event indicating a high risk of developing multiple sclerosis: Extavia has been shown to delay progression to definite multiple sclerosis.
Pojedinačni klinički događaj koji ukazuje na visoki rizik od razvoja multiple skleroze: Pokazalo se da Extavija odgađa napredak pojave klinički jasne multiple skleroze.
In patients with a single clinical event suggestive of multiple sclerosis, efficacy has been demonstrated over a period of three years.
U bolesnika s jednokratnim kliničkim događajem koji upućuje na multiplu sklerozu dokazana je djelotvornost tijekom razdoblja od tri godine.
An example of a medication record is also included (see Annex Part III).
Također je uključen i primjer bilježenja podataka o injiciranju (pogledajte dodatak Dio III).
Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon beta products.
Slučajevi nefrotskog sindroma s različitim podležećim nefropatijama uključujući kolabirajuću fokalnu segmentalnu glomerulosklerozu (FSGS), bolest minimalnih promjena (engl. minimal change disease, MCD), membranoproliferativni glomerulonefritis (MPGN) i membransku glomerulopatiju (MGN) zabilježeni su za vrijeme terapije lijekovima koji sadrže interferon beta.
Table A Schedule for dose titration*
A Raspored titriranja doze*
If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of Extavia is recommended.
Ako se dijagnosticira TMA, potrebno je bez odlaganja započeti liječenje (razmotriti plazmaferezu) i preporučuje se odmah prekinuti liječenje Extavijom.
Therapy with Extavia was well accepted in the study of patients with a single clinical event as indicated by a high rate of trial completion (92.8% in the Extavia group).
Liječenje Extavijom bilo je dobro prihvaćeno u ispitivanju s bolesnicima s jednokratnim kliničkim događajem, na što je upućivao visoki postotak bolesnika koji su dovršili ispitivanje (92,8% u skupini koja je primala Extaviju).
The treatment with Extavia should be initiated under the supervision of a physician experienced in the treatment of the disease.
Liječenje s Extavijom treba započeti pod nadzorom liječnika koji ima iskustva u liječenju bolesti.
Rare (1/10,000 to
Rijetko (1/10 000 i <1/1000)
Limited information available on the transfer of interferon beta-1b into breast milk, together with the chemical / physiological characteristics of interferon beta, suggests that levels of interferon beta-1b excreted in human milk are negligible.
Dostupni ograničeni podaci o prijelazu interferona beta-1b u majčino mlijeko, skupa s kemijskim/fiziološkim osobinama interferona beta, upućuju da su razine interferona beta-1b izlučene u majčino mlijeko zanemarive.
Select an injection site.
Odaberite mjesto injiciranja.
• 1 Extavia vial (with powder for solution for injection)
• 1 bočica Extavije (s praškom za otopinu za injekciju)
• Patients with secondary progressive multiple sclerosis with active disease, evidenced by relapses.
• Bolesnika sa sekundarno progresivnom multiplom sklerozom s aktivnom bolešću što se dokazuje relapsima.
General disorders and administration site conditions Injection site reaction (various kinds)
Opći poremećaji i reakcije na mjestu primjene Reakcije na mjestu primjene (različite vrste)
Within the study period of two years, CDMS occurred in 45% of the placebo group compared to 28% of the Extavia group (Kaplan-Meier estimates).
U dvogodišnjem razdoblju ispitivanja, KDMS se javio u 45% placebo skupine u usporedbi s 28% skupine koja je primala Extaviju (Kaplan-Meierove procjene).
After your injection, fill in the used injection site and date in the table in your injection record (see the example: Keeping track of your injection sites and dates).
- Nakon injiciranja unesite mjesto i datum injiciranja u tablicu praćenja injiciranja (pogledajte primjer: „Bilježenje mjesta i datuma primjene injekcije“).
The most serious events often occurred in patients exposed to other medicinal products or substances known to be associated with hepatotoxicity or in the presence of co-morbid medical conditions (e.g. metastasising malignant disease, severe infection and sepsis, alcohol abuse).
Najozbiljniji događaji često su se javljali u bolesnika izloženih drugim lijekovima ili tvarima za koje se zna da su povezane s hepatotoksičnošću ili u slučaju istodobnog postojanja drugih bolesti (npr. metastazirajuće zloćudne bolesti, teške infekcije i sepse, alkoholizma).
Do not use this medicine if you notice it contains particles or is discoloured.
Ovaj lijek se ne smije upotrijebiti ako primijetite da sadrži čestice ili je promijenjene boje.
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, i.e. essentially ‘sodiumfree'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po ml, tj. zanemarive količine natrija.
Generally, dose titration is recommended at the start of treatment.
Na početku liječenja se općenito preporučuje titriranje doze.
if you notice pain in your belly which is radiating to your back , and/or you feel sick or have a fever.
Ako primijetite bol u trbuhu koja se širi prema leđima i/ili osjećate mučninu ili imate vrućicu.
Storage after reconstitution
Čuvanje nakon pripreme
Patients and investigators remained blinded to the initial treatment allocation.
Bolesnici i ispitivači nisu bili upoznati s terapijom koja je bolesnicima u početku bila dodijeljena.
Further subgroup analyses indicated a high risk for progression to CDMS within 2 years in monofocal patients with at least 9 T2lesions (55% risk for placebo, 26% for Extavia) or Gd-enhancement (63% versus 33%).
Daljnje analize podskupina ukazale su na visoki rizik od progresije u KDMS unutar 2 godine u monofokalnih bolesnika s najmanje 9 T2-lezija (55% rizik za placebo, 26% za Extaviju) ili pojačanjem signala gadolinijem (63% u odnosu na 33%).
Throw the swab away.
Bacite tupfer.
At present it is not known how long treatment with Extavia should last.
Zasada nije poznato koliko dugo treba trajati liječenje Extavijom.
It can be extensive and may involve muscle fascia as well as fat and therefore can result in scar formation.
Ona može biti opsežna i uključivati fasciju mišića kao i masno tkivo te stoga rezultirati nastajanjem ožiljka.
5 - Remove the swab from the top of the vial.
5 - Maknite tupfer s vrha bočice.
6 - Holding the edges securely, remove and discard the packaging ensuring the vial adapter remains on the vial.
6 - Čvrsto držeći rubove, maknite i odložite pakovanje pazeći da nastavak ostane na bočici.
► Rare (may affect up to 1 in 1,000 people):
► Rijetke (mogu se javiti u do 1 na 1000 osoba):
Leave the swab on top of the vial.
Ostavite tupfer na vrhu bočice.
• 30-gauge needles for injecting your medicine
• Igle veličine 30 G za injiciranje Vašeg lijeka
14 - Remove any excess air bubbles by gently tapping the syringe.
14 -Uklonite sve suvišne mjehuriće zraka laganim tapkanjem štrcaljke.
C) Reconstituting and drawing up the solution for injection, step by step D) Making the injection manually (to make an injection with the ExtaviPro 30G auto injector, refer to the instructions for use provided with the auto-injector)
C) Priprema i izvlačenje otopine za injekciju, korak po korak D) Ručno davanje injekcije (za davanje injekcije s ExtaviPro 30G autoinjektorom pogledajte upute za uporabu priložene uz autoinjektor)
In the pivotal study of patients with a single clinical event suggestive of multiple sclerosis an auto-injector was used in the majority of patients.
U pivotalnom ispitivanju bolesnika s pojedinačnim kliničkim događajem koji ukazuje na multiplu sklerozu autoinjektor je korišten u većine bolesnika.
Blood triglycerides increased
Povišenje triglicerida u krvi
250 microgram (8.0 million IU) per ml after reconstitution.
250 mikrograma (8,0 milijuna IU) po ml nakon pripreme otopine za primjenu.
Within the study period of three years, CDMS occurred in 51% of the delayed treatment group compared to 37% of the immediate treatment group (Kaplan-Meier estimates).
U trogodišnjem razdoblju ispitivanja KDMS se javio u 51% skupine s odgođenim početkom liječenja, u usporedbi s 37% skupine s neposredno započetim liječenjem (Kaplan-Meierove procjene).
3 ml vial (clear type I glass) with a butyl rubber stopper (type I) and aluminium overseal containing 300 microgram (9.6 million IU) of (recombinant interferon beta-1b) powder.
Bočica od 3 ml (prozirno staklo tipa I) s butilnim gumenim čepom (tip I) i aluminijskom zaštitnom kapicom, koja sadrži 300 mikrograma (9,6 milijuna IU) praška (rekombinantnog interferona beta-1b).
This treatment effect was still evident after the additional year of follow-up at which stage the risk reduction was 41% (Hazard Ratio = 0.59, 95% confidence interval (0.42, 0.83), p=0.0011).
Taj terapijski učinak bio je još uvijek vidljiv nakon dodatne godine naknadnog praćenja u kojoj fazi je smanjenje rizika iznosilo 41% (omjer hazarda = 0,59, interval pouzdanosti 95% (0,42, 0,83), p=0,0011).
Thrombocytopenia Thrombotic microangiopathy including thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome#
Trombotička mikroangiopatija uključujući trombotičku trombocitopeničku purpuru/hemolitički uremički sindrom#
What Extavia contains The active substance is interferon beta-1b.
Što Extavia sadrži Djelatna tvar je interferon beta-1b.
- Pack containing 5 vials with powder and 5 pre-filled syringes with solvent - Pack containing 14 vials with powder and 14 pre-filled syringes with solvent - Pack containing 15 vials with powder and 15 pre-filled syringes with solvent - Pack containing 14 vials with powder and 15 pre-filled syringes with solvent
- Pakiranje koje sadrži 5 bočica s praškom i 5 napunjenih štrcaljki s otapalom - Pakiranje koje sadrži 14 bočica s praškom i 14 napunjenih štrcaljki s otapalom - Pakiranje koje sadrži 15 bočica s praškom i 15 napunjenih štrcaljki s otapalom - Pakiranje koje sadrži 14 bočica s praškom i 15 napunjenih štrcaljki s otapalom
In the placebo-controlled phase, Extavia delayed the progression from the first clinical event to clinically definite multiple sclerosis (CDMS) in a statistically significant and clinically meaningful manner, corresponding to a risk reduction of 47% (Hazard Ratio = 0.53, 95% confidence interval (0.39, 0.73), p<0.0001).
U placebom kontroliranoj fazi, Extavija je odgodila progresiju od prvog kliničkog događaja do klinički definitivne multiple skleroze (KDMS) na statistički i klinički značajan način, što odgovara smanjenju rizika za 47% (omjer hazarda = 0,53, interval pouzdanosti 95% (0,39, 0,73), p<0,0001).
Periodic monitoring of early signs or symptoms, e.g. oedema, proteinuria and impaired renal function, is recommended, especially in patients at higher risk of renal disease.
Preporučuje se periodičko praćenje ranih znakova ili simptoma, npr. edema, proteinurije i oštećenja bubrežne funkcije, pogotovo u bolesnika s visokim rizikom od razvoja bolesti bubrega.
At the beginning of treatment side effects are common but in general they decrease with further treatment.
Na početku liječenja nuspojave su česte, ali općenito se smanjuju uz nastavak liječenja.
If your depression and/or suicidal thoughts are severe, you will not be prescribed Extavia (see also “Do not use Extavia”).
Ako su Vaša depresija i/ili misli o samoubojstvu jako izraženi, nećete se liječiti Extavijom (pogledajte također „Nemojte primjenjivati Extaviju“).
10 - 15 cm from groin
10-15 cm od koljena knee
Single clinical event suggestive of multiple sclerosis One controlled clinical trial with Extavia was performed in patients with a single clinical event and Magnetic Resonance Imaging (MRI) features suggestive of multiple sclerosis (at least two clinically silent lesions on the T2-weighted MRI).
Jednokratan klinički događaj koji upućuje na multiplu sklerozu Jedno je kontrolirano kliničko ispitivanje s Extavijom provedeno u bolesnika s jednim kliničkim događajem i karakteristikama na snimci napravljenoj magnetskom rezonancijom (MR) koje upućuju na multiplu sklerozu (najmanje dvije klinički tihe lezije na T2 mjerenoj snimci MR-om).
Treatment with Extavia should be started under the supervision of a doctor who is experienced in the treatment of multiple sclerosis.
Liječenje Extavijom treba započeti pod nadzorom liječnika koji ima iskustva u liječenju multiple skleroze.
The absolute bioavailability of subcutaneously administered interferon beta-1b was approximately
Apsolutna bioraspoloživost supkutano primijenjenog interferona beta-1b bila je otprilike 50%.
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests (e.g. aspartate aminotransferase serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase serum glutamate pyruvate transaminase (SGPT) and gamma glutamyltransferase), are recommended prior to initiation and at regular intervals following introduction of Extavia therapy, and then periodically thereafter in the absence of clinical symptoms.
Uz laboratorijske pretrage koje su uobičajeno potrebne za praćenje bolesnika s multiplom sklerozom, preporučuje se izrada kompletne krvne slike i diferencijalne krvne slike, određivanje broja trombocita i biokemijskih parametara u krvi, što uključuje testove jetrene funkcije (npr. aspartat aminotransferaze, serumske glutamat-oksaloacetat transaminaze (SGOT), alanin aminotransferaze serumske glutamat piruvat transaminaze (SGPT) i gama glutamiltransferaze), prije započinjanja te u redovnim intervalima nakon uvođenja terapije Extavijom, a nakon toga periodički ako nema kliničkih simptoma.
The following side effects listing is based on reports from clinical trials with Extavia (List 1) and from side effects reported on the marketed product (List 2).
Popis nuspojava u nastavku temelji se na izvješćima iz kliničkih ispitivanja s Extavijom (Popis 1) te iz nuspojava prijavljenih za lijek nakon stavljanja u promet (Popis 2).
2.25 ml graduated (with dose marks of: 0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml) pre-filled syringe (type I glass) with 1.2 ml solvent.
Graduirana (s odmjernim oznakama za: 0,25 ml, 0,5 ml, 0,75 ml, 1,0 ml) napunjena štrcaljka od 2,25 ml (staklo tipa I) s 1,2 ml otapala.
Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated.
Redoviti testovi funkcije štitnjače preporučuju se u bolesnika s disfunkcijom štitnjače u anamnezi ili kako je klinički indicirano.
PART II: ROTATING INJECTION SITES
DIO II: PROMJENA MJESTA INJICIRANJA
Caution should be used and close monitoring considered when administering interferon beta to patients with severe renal failure.
Potreban je oprez i pomno praćenje prilikom primjene interferona beta u bolesnika s teškim zatajenjem bubrega.
Before injection, the Extavia solution has to be prepared from a vial of Extavia powder and 1.2 ml of liquid from the pre-filled solvent syringe.
Prije injiciranja otopinu Extavije treba pripremiti iz bočice praška Extavia i 1,2 ml tekućine iz otapalom napunjene štrcaljke.
► Tell your doctor immediately: - if you get some or all of these symptoms: foamy urine, fatigue, swelling, particularly and the ankles and eyelids, and weight gain, as they may be signs of a possible kidney problem.
Odmah se obratite svom liječniku: - ako dobijete neke ili sve od navedenih simptoma: pjenasta mokraća, umor, oticanje, posebice gležnjeva i kapaka te porast tjelesne težine, budući da to mogu biti znakovi problema s bubrezima.