natgillin/translations-raw huggingface dataset:
Retrospective analyses in subgroups showed that a treatment effect on disability progression is most likely in patients with active disease before treatment commences (Hazard Ratio 0.72, 95% confidence interval (0.59, 0.88), p=0.0011, corresponding to a 28% risk reduction due to Extavia in patients with relapses or pronounced EDSS progression, 8 million IU Extavia versus all placebo patients).
Retrospektivne analize v podskupinah so pokazale, da je učinek zdravljenja na napredovanje invalidnosti najverjetnejši pri bolnikih, ki imajo aktivno bolezen, preden se začne zdravljenje (razmerje tveganja = 0, 72, 95% interval zaupanja (0, 59, 0, 88), p=0, 0011, kar ustreza 28% zmanjšanju tveganja zaradi zdravila Extavia pri bolnikih z recidivi ali izrazitim napredovanjem EDSS; 8 milijonov i. e. zdravila Extavia v primerjavi z vsemi bolniki na placebu).
From these retrospective subgroup analyses there was evidence to suggest that relapses as well as pronounced EDSS progression (EDSS > 1 point or > 0.5 point for EDSS > =6 in the previous two years) can help to identify patients with active disease.
Te retrospektivne analize podskupin so pokazale, da lahko recidivi in izrazito napredovanje EDSS (EDSS > 1 točko ali > 0, 5 točke pri EDSS > =6 v zadnjih dveh letih) pomagajo odkriti bolnike z aktivno boleznijo.
In both trials secondary progressive multiple sclerosis patients receiving Extavia showed a reduction in frequency (30%) of clinical relapses.
V obeh preskušanjih se je pri bolnikih s sekundarno progresivno multiplo sklerozo, ki so dobivali zdravilo Extavia, pogostnost kliničnih recidivov zmanjšala (30%).
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).
Enkratni demielinizacijski dogodek, ki nakazuje multiplo sklerozo Pri bolnikih z enim samim kliničnim dogodkom in izvidi magnetno resonančnega slikanja (MRI - Magnetic Resonance Imaging), ki kažejo na multiplo sklerozo (vsaj dve klinično tihi leziji na T2 - poudarjenem magnetnoresonančnem slikanju) so opravili kontrolirano klinično preskušanje.
After the placebo-controlled phase, patients entered a pre-planned follow-up phase with Extavia to evaluate the effects of immediate versus delayed start of Extavia treatment, comparing patients initially randomised to Extavia (“ immediate treatment group”) or to placebo (“ delayed treatment group”).
Po zaključku s placebom kontroliranega dela študije so bolnike vključili v vnaprej načrtovan kontrolni del študije z zdravilom Extavia, da bi ocenili učinke takojšnjega začetka zdravljenja z zdravilom Extavia v primerjavi z odloženim začetkom zdravljenja.
12 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).
Zmanjšanje tveganja je bilo 47- odstotno (razmerje tveganja = 0, 53, interval zaupanja = 95% (0, 39, 0, 73), p < 0, 0001).
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).
V dveletnem obdobju trajanja študije se je CMDS pojavil pri 45% bolnikov v skupini, ki je prejemala placebo, in pri 28% bolnikov, ki so prejmali zdravilo Extavia (metoda Kaplan- Meier).
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).
Ta učinek zdravljenja je bilo še vedno mogoče opaziti po dodatnem letu spremljanja, ko je je bilo zmanjšanje tveganja 41- odstotno (razmerje tveganja=0, 59, 95% interval zaupanja (0, 42, 0, 83), p=0, 0011).
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).
V triletnem trajanju študije je do CDMS prišlo pri 51% bolnikov v skupini z odloženim zdravljenjem v primerjavi s 37% v skupini s takojšnjim zdravljenjem (po metodi Kaplan- Meier).
In two years, the risk in the placebo group was 85% and 69% in the Extavia group (Hazard Ratio = 0.57, 95% confidence interval (0.46, 0.71), p < 0.00001).
V dveh letih je bilo zmanjšanje tveganja v skupini placebo 85- odstotno v skupini z zdravilom Extavia 69- odstotno (razmerje tveganja = 0, 57, interval zaupanja = 95% (0, 46, 0, 71), p < 0, 00001).
After 3 years, a pre-planned interim analysis showed EDSS progression (confirmed increase in EDSS of greater than or equal to 1.0 compared to baseline) occurred in 24% of the patients in the delayed treatment group compared to 16% in the immediate treatment group [Hazard Ratio = 0.6, 95% confidence interval (0.39, 0.92), p=0.022].
Po treh letih je vnaprej načrtovana vmesna analiza pokazala napredovanje na lestvici EDSS (potrjeno večja ocena na lestvici EDSS za 1, 0 ali več, v primerjavi z izhodiščno) pri 24% bolnikov v skupini z
There is no evidence for benefit in terms of confirmed disability progression in the majority of patients receiving “ immediate” treatment.
13 odloženim zdravljenjem v primerjavi s 16% bolnikov v skupini s takojšnjim zdravljenjem [razmerje tveganja 0, 6, 95% interval zaupanja (0, 39, 0, 92), p = 0, 022].
Treatment Outcomes Index) was seen.
Po merilih ocene sposobnosti pri multipli sklerozi (FAMS - Functional Assessment of MS) niso opažali izboljšanja kakovosti življenja, ki bi ga lahko pripisali zdravilu Extavia.
Significant effects were also obtained in patients with less disseminated and less active disease at the time of the first event, the risk in two years for progression to CDMS in patients with monofocal onset was 47% for placebo and 24% for Extavia, without gadolinium (Gd-) enhancement 41% and 20%, with less than 9 T2 lesions 39% and 18%.
Pomembne učinke so dosegli tudi pri bolnikih z manj diseminirano in manj aktivno boleznijo v času prvega dogodka, tveganje do napredovanja do CDMS v dveh letih pri bolnikih z monofokalnim začetkom je bilo pri placebu 47% in 24% pri zdravilu Extavia, brez ojačitve z gadolinijem (Gd) 41% in 20%, z manj kot 9 lezij T2 39% in 18%.
Further subgroup analyses indicated a high risk for progression to CDMS within 2 years in monofocal patients with at least 9 T2-lesions (55% risk for placebo, 26% for Extavia) or Gd-enhancement (63% versus 33%).
Nadaljnja analiza podskupin kaže na veliko tveganje za napredovanje do CDMS v 2 letih pri monofokalnih bolnikih z vsaj 9 lezijami T2 (55- odstotno tveganje pri placebu, 26% z zdravilom Extavia) ali ojačanjem z Gd (63% proti 33%).
However, the long-term impact of early treatment with Extavia is unknown even in these high risk subgroups as this study was mainly designed to assess the time to CDMS rather than the long term evolution of the disease.
Vendar je dolgotrajen učinek zgodnjega zdravljenja z zdravilom Extavia neznan tudi pri teh podskupinah z velikim tveganjem, kajti študija je bila namenjena ocenjevanju časa do CDMS, ne pa dolgotrajnega razvoja bolezni.
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).
Pri bolnikih z enim samim kliničnim dogodkom je bilo zdravljenje z zdravilom Extavia dobro sprejeto, na kar kaže veliko število bolnikov, ki so zaključili preskušanje (92, 8% v skupini, ki je prejemala zdravilo Extavia).
RR-MS, SP-MS and single clinical event suggestive of MS Extavia was effective in all multiple sclerosis studies to reduce disease activity (acute inflammation in the central nervous system and permanent tissue alterations) as measured by magnetic resonance imaging (MRI).
RRMS, SPMS in enkratni demielinizacijski dogodek, ki nakazuje multiplo sklerozo Zdravilo Extavia je v vseh študijah multiple skleroze učinkovito zmanjšalo aktivnost bolezni (akutno vnetje v osrednjem živčevju in trajne spremembe tkiva), merjeno z magnetnoresonančnim slikanjem (MRS).
Extavia serum levels were followed in patients and volunteers by means of a not completely specific bioassay.
Koncentracijo zdravila Extavia v serumu so pri bolnikih in prostovoljcih spremljali z ne povsem specifičnim biološkim preizkusom.
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.
Največjo koncentracijo v serumu okrog 40 i. e. / ml so izmerili od 1 do 8 ur po subkutani injekciji 500 mikrogramov (16, 0 milijonov i. e.) interferona beta- 1b.
From various studies mean clearance rates and half-lives of disposition phases from serum were estimated to be at most 30 ml·min-1·kg-1 and 5 hours, respectively.
Na temelju različnih raziskav je bil ocenjeni povprečni očistek največ 30 ml· min- 1· kg- 1, razpolovni čas dispozicijske faze iz seruma pa 5 ur.
Extavia injections given every other day do not lead to serum level increases, and the pharmacokinetics does not seem to change during therapy.
Injiciranje zdravila Extavia vsak drugi dan ne povzroči povečanja koncentracije v serumu in kot kaže, se farmakokinetika med zdravljenjem ne spremeni.
No acute toxicity studies have been carried out.
Študij akutne toksičnosti ni bilo.
No long-term studies have been conducted.
14 Dolgoročnih študij niso izvajali.
Powder Human albumin Mannitol (E421)
Prašek humani albumin manitol (E421)
Solvent Sodium chloride Water for injections
Vehikel natrijev klorid voda za injekcije
This medicinal product must not be mixed with other medicinal products except for the supplied solvent mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6. 6.
However, in-use stability has been demonstrated for 3 hours at 2-8 °C.
Stabilnost po pripravi je dokazana za 3 ure pri temperaturi od 2 do 8 °C.
14 6.4 Special precautions for storage
6. 4 Posebna navodila za shranjevanje
For storage conditions of the reconstituted product, see section 6.3.
Za pogoje shranjevanja rekonstituiranega zdravila glejte poglavje 6. 3.
Powder 3 ml vial (clear type I glass) with a butyl rubber stopper (type I) and aluminium overseal.
Prašek 3 ml viala (prozorno steklo tipa I) z zamaškom iz butilne gume (tip I) in zaporko iz aluminija.
Solvent 1.2 ml pre-filled syringe (type I glass) with 1.2 ml solvent.
Vehikel 1, 2 ml napolnjena injekcijska brizga (steklo tipa I) z 1, 2 ml vehikla.
- Unit pack containing 5 vials with powder and 5 pre-filled syringes with solvent
- posamično pakiranje, ki vsebuje 5 vial s praškom in 5 napolnjenih injekcijskih brizg z vehiklom
- Unit pack containing 15 vials with powder and 15 pre-filled syringes with solvent
- posamično pakiranje, ki vsebuje 15 vial s praškom in 15 napolnjenih injekcijskih brizg z
- 3-month multipack containing 45 (3x15) vials with powder and 45 (3x15) pre-filled syringes
- 3- mesečno skupno pakiranje, ki vsebuje 45 (3x15) vial s praškom in 45 (3x15) napolnjenih
with solvent
injekcijskih brizg z vehiklom
6.6 Special precautions for disposal and other handling
15 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Reconstitution To reconstitute lyophilised interferon beta-1b for injection, the pre-filled syringe with solvent should be used with a needle or a vial adapter to inject the 1.2 ml of the solvent (sodium chloride 5.4 mg/ ml (0.54%) solution for injection) into the Extavia vial.
Rekonstitucija Za pripravo liofiliziranega interferona beta- 1b za injiciranje je treba uporabiti napolnjeno injekcijsko brizgo z vehiklom in iglo ali adapter z iglo za vialo ter vbrizgati 1, 2 ml vehikla (raztopina natrijevega klorida, 5, 4 mg/ ml (0, 54%) raztopina za injekcije) v vialo z zdravilom Extavia.
After reconstitution, 1.0 ml of the solution should be drawn from the vial into the syringe for the administration of 250 micrograms Extavia.
Za odmerjanje 250 mikrogramov zdravila Extavia, je treba po rekonstituciji potegniti 1, 0 mililiter raztopine iz viale v brizgo.
Inspection prior to use The reconstituted product should be inspected visually before use.
Pregled pred uporabo Pripravljeno zdravilo je treba pred uporabo pregledati.
The product should be discarded before use if it contains particulate matter or is discoloured.
Če vsebuje delce ali je obarvano, se ga ne sme uporabiti, temveč ga je treba zavreči.
16 ANNEX II
16 DODATEK II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Boehringer Ingelheim Austria Dr. -Boehringer-Gasse 5-11 A-1121 Vienna Austria
Boehringer Ingelheim Austria Dr. - Boehringer- Gasse 5- 11 A- 1121 Dunaj Avstrija
5650 Hollis Street Emeryville, CA 94608 USA
5650 Hollis Street Emeryville, CA 94608 ZDA
PSURs:
Redna posodobljena poročila o varnosti zdravila (PSUR):
The Marketing Authorisation Holder ensures that the system of pharmacovigilance, as described in version 3 dated 01 December 2008 presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je opisan v različici 3 z dne 1. decembra 2008, predstavljeni v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in da deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
The Marketing Authorisation Holder commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu famakovigilance, ki je bil sprejet v različici 1. 0 načrta za obvladovanje tveganja (Risk Management Plan - RMP), predstavljenem v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP, s katerimi soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR).
18 V skladu s smernicami CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljen načrt za obvladovanje tveganja (RMP) predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
18 In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljen načrt za obvladovanje tveganja predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjševanje tveganja, • v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja), • na zahtevo Evropske agencije za zdravila (EMEA).
19 ANNEX III
19 DODATEK III
Extavia 250 microgram/ ml powder and solvent for solution for injection Interferon beta-1b
Extavia 250 mikrogramov/ ml prašek in vehikel za raztopino za injiciranje interferon beta- 1b
1 ml contains 250 microgram (8 million IU) interferon beta-1b when reconstituted.
1 ml vsebuje 250 mikrogramov (8 milijonov i. e.) interferona beta- 1b po rekonstituciji.
1 vial contains 300 microgram (9.6 million IU) interferon beta-1b.
1 viala vsebuje 300 mikrogramov (9, 6 milijonov i. e.) interferona beta- 1b.
Sodium chloride, water for injections.
Prašek: humani albumin, manitol Vehikel: natrijev klorid, voda za injekcije
15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
5 vial s praškom in 5 napolnjenih injekcijskih brizg z 1, 2 ml vehikla 15 vial s praškom in 15 napolnjenih injekcijskih brizg z 1, 2 ml vehikla
For subcutaneous use after reconstitution with 1.2 ml of solvent.
Za subkutano uporabo po rekonstituciji z 1, 2 ml vehikla Za enkratno uporabo.
In-use stability demonstrated for 3 hours at 2-8°C.
Stabilnost po pripravi je dokazana za 3 ure pri temperaturi od 2 do 8 °C.
5 vials with powder and 5 pre-filled syringes with solvent 15 vials with powder and 15 pre-filled syringes with solvent
5 vial s praškom in 5 napolnjenih injekcijskih brizg z vehiklom 15 vial s praškom in 15 napolnjenih injekcijskih brizg z vehiklom
3-month multipack comprising 3 cartons, each containing 15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
45 vial s praškom in 45 napolnjenih injekcijskih brizg z 1, 2 ml vehikla 3- mesečno skupno pakiranje s tremi škatlami, od katerih vsaka vsebuje 15 vial s praškom in 15 napolnjenih injekcijskih brizg z 1, 2 ml vehikla
3-month multipack comprising 45 vials with powder and 45 pre-filled syringes with solvent
3- mesečno skupno pakiranje, ki vsebuje 45 vial s praškom in 45 napolnjenih injekcijskih brizg z vehiklom
Component of a 3-month multipack comprising 3 cartons, each containing 15 vials with powder and 15 pre-filled syringes with 1.2 ml solvent.
15 vial s praškom in 15 napolnjenih injekcijskih brizg z 1, 2 ml vehikla del 3- mesečnega skupnega pakiranja s 3 škatlami, od katerih vsaka vsebuje 15 vial s praškom in 15 napolnjenih injekcijskih brizg z 1, 2 ml vehikla
Solvent for reconstitution of Extavia 1.2 ml sodium chloride solution 5.4 mg/ ml
Vehikel za rekonstitucijo zdravila Extavia 1, 2 ml raztopine natrijevega klorida 5, 4 mg/ ml
28 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
28 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Extavia 250 microgram/ ml powder for solution for injection Interferon beta-1b Subcutaneous use
Extavia 250 mikrogramov/ ml prašek in vehikel za raztopino za injiciranje interferon beta- 1b Subkutana uporaba
250 mcg (8 million IU) per ml after reconstitution.
250 mcg (8 milijonov i. e.) / ml po rekonstituciji
31 PACKAGE LEAFLET:
31 NAVODILO ZA UPORABO
Extavia 250 microgram/ ml powder and solvent for solution for injection Interferon beta-1b Read all of this leaflet carefully before you start using this medicine.
Extavia 250 mikrogramov/ ml prašek in vehikel za raztopino za injiciranje interferon beta- 1b
What Extavia is and what it is used for 2.
Kaj je zdravilo Extavia in za kaj ga uporabljamo 2.
Before you use Extavia 3.
Kaj morate vedeti, preden boste uporabili zdravilo Extavia 3.
How to use Extavia 4.
Kako uporabljati zdravilo Extavia 4.
How to store Extavia 6.
Shranjevanje zdravila Extavia 6.
Further information Annex – self-injection procedure
Dodatne informacije Dodatek – postopek samoinjiciranja
WHAT EXTAVIA IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO EXTAVIA IN ZA KAJ GA UPORABLJAMO
What Extavia is Extavia is a type of medicine known as interferon used to treat multiple sclerosis.
Kaj je zdravilo Extavia Extavia je vrsta zdravila, znanega kot interferon, za zdravljenje multiple skleroze.
How Extavia works Multiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord.
Kako deluje zdravilo Extavia Mutipla skleroza (MS) je dolgotrajna bolezen, ki vpliva na osrednje živčevje (OŽ), še zlasti na delovanje možganov in hrbtenjače.
In MS inflammation destroys the protective sheath (called myelin) around the nerves of the CNS and stops the nerves from working properly.
Pri MS vnetje uniči zaščitno ovojnico (imenovano mielinska ovojnica), ki obdaja živce v OŽ in prepreči njihovo pravilno delovanje.
An abnormal response by the body’ s immune system is thought to play an important part in the process which damages the CNS.
Predvidevajo, da ima nenormalen odziv imunskega sistema telesa pomembno vlogo v procesu, ki uničuje OŽ.
It can cause disability temporarily, such as difficulty walking.
Pri napadu MS (relapsu) se lahko pojavijo spremembe v OŽ, ki lahko povzročijo začasno prizadetost, na primer težave pri hoji.
Extavia has been shown to delay progression to definite multiple sclerosis.
Kako zdravilo Extavia pomaga v boju proti bolezni Enkraten klinični dogodek, ki kaže na veliko tveganje za razvoj multiple skleroze: pokazali so, da zdravilo Extavia upočasni napredovanje do dokončne multiple skleroze.
People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse.
Recidivno- remitentna multipla skleroza: bolniki z recidivno- remitentno MS imajo občasne napade ali relapse, med katerimi se simptomi znatno poslabšajo.
32 Secondary progressive multiple sclerosis:
32 Sekundarna progresivna multipla skleroza:
In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS.
V nekaterih primerih pri bolnikih z recidivno- remitentno MS ugotovijo večjo izraženost njihovih simptomov in napredovanje v drugo obliko MS, imenovano sekundarna progresivna MS.
What Extavia is used for Extavia is for use in patients ► who have experienced for the first time symptoms which indicate a high risk of developing multiple sclerosis.
Za kaj se uporablja zdravilo Extavia Zdravilo Extavia je namenjeno za uporabo pri bolnikih ► ki so prvič imeli simptome, ki predstavljajo veliko tveganje za razvoj multiple skleroze.
Your doctor will rule out any other reasons which could explain these symptoms before you are treated. ► who suffer from relapsing-remitting multiple sclerosis, with at least two relapses within the last two years. ► who suffer from secondary progressive multiple sclerosis with active disease shown by relapses.
Zdravnik bo pred zdravljenjem izključil možnost kakršnega koli drugega vzroka za te simptome; ► z recidivno- remitentno multiplo sklerozo z vsaj dvema relapsoma v zadnjih dveh letih; ► s sekundarno progresivno multiplo sklerozo, ki imajo aktivno bolezen, kar se kaže z relapsi.
BEFORE YOU USE EXTAVIA
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO EXTAVIA
Do not use Extavia
Ne uporabljajte zdravila Extavia
You should not start treatment with Extavia (see “ Pregnancy”).
Ne začnite zdravljenja z zdravilom Extavia (glejte Nosečnost);
any of the other ingredients of Extavia.
ali katerokoli sestavino zdravila Extavia;
- if you currently suffer from severe depression and/ or suicidal thoughts (see “ Take special
- če imate trenutno hudo depresijo, samomorilne misli ali oboje (glejte Bodite posebno
care” and section 4, “ Possible side effects”).
Možni neželeni učinki);
- if you have a severe liver disease (see “ Take special care”, “ Using other medicines” and
- če imate hudo bolezen jeter (glejte Bodite posebno pozorni, Uporaba drugih zdravil in
section 4, “ Possible side effects”).
Možni neželeni učinki).
Tell your doctor, if any of the above applies to you.
Obvestite svojega zdravnika, če karkoli od zgoraj navedenega velja za vas.
Take special care with Extavia
Bodite posebno pozorni pri uporabi zdravila Extavia
Your doctor also needs to know the following before you are given Extavia:
Predno vam zdravnik predpiše zdravilo Extavia, ga obvestite:
This is a disorder of the immune system where an
To je motnja imunskega sistema, pri kateri so v krvi
abnormal protein is found in the blood.
prisotne nenormalne beljakovine.
Problems with your small blood vessels (capillaries) may develop when using medicines like Extavia (systemic capillary leak syndrome).
Pri uporabi zdravil kot je Extavia se lahko pojavijo težave z majhnimi žilami (kapilarami) (sindrom sistemske kapilarne krvavitve).
Your
Med
doctor will closely monitor you during treatment.
zdravljenjem vas bo zdravnik pozorno nadziral.