natgillin/translations-raw huggingface dataset:
Please consult your doctor immediately.
Takoj se posvetujte z zdravnikom.
Bio-Set System:
Sistem Bio-Set
These factors make control of such studies and interpretation of the results challenging.
Ti dejavniki predstavljajo izziv pri nadzorovanju in interpretaciji takšnih študij.
Interactions with other medicines are not known.
Medsebojno delovanje z drugimi zdravili ni znano.
Frequencies have been evaluated according to 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).
Pogostnosti so opredeljene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
However, in many cases little information was provided on the methods, patient populations and nature of the inhibitors to assess the information in the context of more recent published data.
Vendar pa je bilo v številnih primerih premalo podatkov o metodah, populaciji bolnikov in naravi zaviralcev, da bi ocenili informacije v okviru novejših objavljenih podatkov.
The PRAC adopted a recommendation on 01 September 2017 which was then considered by the CHMP, in accordance with Article 107k of Directive 2001/83/EC.
Odbor PRAC je 1. septembra 2017 sprejel priporočilo, ki ga je nato v skladu s členom 107k Direktive 2001/83/ES obravnaval odbor CHMP.
For products for which section 4.2 contains the following statement for PUPs: “<Previously untreated patients.
Za zdravila, pri katerih poglavje 4.2 vsebuje naslednjo izjavo za predhodno nezdravljene bolnike: „<Predhodno nezdravljeni bolniki.
Data have been obtained from clinical studies in 61 children under 6 years of age and non-interventional studies in children of all ages.
Podatki so bili pridobljeni v kliničnih preskušanjih pri 61 otrocih, mlajših od 6 let in neintervencijskih kliničnih preskušanjih pri otrocih vseh starosti.
The lead authors of the SIPPET study were also invited to respond to a list of questions regarding the study methods and findings and to present their conclusions at the February 2017 PRAC plenary meeting.
Vodilni avtorji študije SIPPET so bili pozvani, naj odgovorijo na seznam vprašanj v zvezi z metodami v študiji in ugotovitvami ter predstavijo svoje sklepe na plenarnem zasedanju odbora PRAC februarja 2017.
4.7 Effects on ability to drive or use machines
4.7 Vpliv na sposobnost vožnje in upravljanja strojev
Frequency of doses (hours)/ Duration of therapy (days)
Pogostost odmerjanja (ure)/ trajanje zdravljenja (dnevi)
VWF is not present in rFVIII, but there is significant heterogeneity within the rFVIII class for instance due to the different manufacturing processes used, with a wide range of products from different manufacturers produced over the past 20 years.
VWF ni prisoten pri rFVIII, vendar je v razredu rFVIII znatna heterogenost, na primer zaradi različnih proizvodnih postopkov, saj je bil v zadnjih 20 letih proizveden širok nabor zdravil različnih izdelovalcev.
A retrospective review has been done on 40 patients, and 39 patients were included in a prospective investigator-initiated clinical study.
Retrospektivni pregled je bil narejen pri 40 bolnikih, v prospektivno klinično študijo na pobudo raziskovalca, pa je bilo vključenih 39 bolnikov.
How much KOGENATE Bayer you should use and how often you should use it depends on many factors such as:
Koliko zdravila KOGENATE Bayer morate uporabiti in kako pogosto je odvisno od več dejavnikov, kot so:
Furthermore, over time there have been changes in manufacturing process of individual products and changes in treatment regimens between centres, hence “like for like” comparisons between products is not always possible.
Poleg tega je sčasoma prišlo do sprememb v proizvodnem postopku pri posameznih zdravilih in sprememb v shemah zdravljenja med centri, zato primerjave „med podobnimi“ niso vedno možne.
The material should not be warmer than body temperature (not exceed 37 °C).
Ne smeta biti toplejši kot je telesna temperatura (ne več kot 37 °C).
Therefore, if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
The PRAC considered the views expressed by experts during an ad-hoc meeting.
Odbor PRAC je obravnaval stališča, ki so jih izrazili strokovnjaki na ad hoc sestanku.
The PRAC consulted an ad-hoc expert meeting on some of the aspects that formed part of the detailed grounds submitted by LFB Biomedicaments.
Odbor PRAC se je posvetoval s strokovnjaki na ad hoc sestanku glede nekaterih vidikov, ki so del podrobno opisanih razlogov, predložnih s strani družbe LFB Biomedicaments.
In particular, only 13 patients (10% of the FVIII arm) received a third generation rFVIII product.
Pravzaprav je le 13 bolnikov (10 % veje FVIII) prejelo zdravilo z rFVIII tretje generacije.
• if you are allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6 and end of section 2).
• če ste alergični na oktokog alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6 in v zadnjem odstavku poglavja 2),
Do not touch the syringe tip with your hand or any surface.
Ne dotikajte se konice injekcijske brizge z roko ali katero koli površino.
For infusion, the product must be prepared under aseptic conditions.
Za infundiranje je treba zdravilo pripraviti v aseptičnih pogojih.
These different manufacturing processes (including the different cell lines used to engineer the rFVIII products) can in theory lead to differential immunogenicity.
Različni proizvodni postopki (vključno z različnimi celičnimi linijami, ki se uporabljajo za pripravo zdravil rFVIII) lahko teoretično vodijo do različne imunogenosti.
The available data showed that in many studies including the EUHASS registry (Iorio A, 20174; Fischer K, 20155) the frequency could be classified as “uncommon”.
Iz razpoložljivih podatkov je razvidno, da se v številnih študijah, vključno z registrom EUHASS (Iorio A, 20174; Fischer K, 20155) pogostnost lahko razvrsti kot „občasno“.
• The SIPPET study has methodological limitations, with particular uncertainty around whether the randomisation process (block size of 2) may have introduced a selection bias in the study.
• študija SIPPET ima metodološke omejitve, zlasti negotovost, ali je postopek randomizacije (velikost bloka 2) v študiji lahko povzročil pristranskost izbire;
Although this became non-significant when UK patients (also included in the RODIN/Pednet study were excluded.
Vendar je to postalo statistično nepomembno, ko so iz študije izključili bolnike iz Združenega kraljestva (vključeni tudi v študijo RODIN/Pednet).
PRAC also considered grounds submitted by LFB Biomedicaments as basis for their request for reexamination of the PRAC recommendation and the views of two experts meetings held on 22 February and 3 August 2017.
Odbor PRAC je upošteval tudi razloge, ki jih je predložila družba LFB Biomedicaments kot podlago za zahtevo za ponovno preučitev priporočila odbora PRAC, ter mnenji z dveh strokovnih sestankov, ki sta potekala 22. februarja in 3. avgusta 2017;
In case of shock, standard medical treatment for shock should be implemented.
V primeru šoka je treba začeti s standardnimi ukrepi za zdravljenje šoka.
The safety and efficacy of {(Invented) name} in previously untreated patients have not yet been established.
Varnost in učinkovitost zdravila {(izmišljeno) ime} pri predhodno nezdravljenih bolnikih še nista bili dokazani.
Wash your hands thoroughly using soap and warm water.
Roke si temeljito umijte z milom in toplo vodo.
Prevention of bleeding
Preprečevanje krvavitve
The PRAC recommended changes to the product information accordingly.
Odbor PRAC je v skladu s tem priporočil spremembe informacij o zdravilu.
Bayer Corporation (license holder) Bayer HealthCare LLC 800 Dwight Way
Bayer Corporation (imetnik licence) Bayer HealthCare LLC 800 Dwight Way
KOGENATE Bayer should be injected intravenously over 2 to 5 minutes.
Zdravilo KOGENATE Bayer je treba injicirati intravensko 2 do 5 minut.
Every 24 hours, at least 1 day, until healing is achieved.
Vsakih 24 ur, vsaj 1 dan, dokler se rana ne zaceli.
The additional points of clarification provided by the SIPPET authors do not fully resolve this uncertainty.
Dodatna pojasnila, ki so jih predložili avtorji študije SIPPET, teh negotovosti ne odpravijo v celoti.
• if you are allergic to mouse or hamster protein.
• če ste alergični na beljakovine miši ali hrčkov.
Now remove and discard the adapter housing (E).
Zdaj odstranite in zavrzite ohišje adapterja (E).
However, the general estimates of inhibitor rates from these studies for individual products are broadly in line with the findings from large observational studies.
Vendar so splošne ocene stopenj pojava zaviralcev iz teh študij za posamezna zdravila na splošno v skladu z ugotovitvami velikih opazovalnih študij.
Not known (frequency cannot be estimated from the available data): • dysgeusia (strange taste)
Neznana (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) • disgevzija (neobičajen okus)
The solution must be prepared on a clean and dry surface.
Raztopino morate pripraviti na čisti in suhi površini.
Do not use this medicine after the expiry date which is stated on labels and cartons.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepkah in škatlah.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor.
Če menite, da je učinek tega zdravila premočan ali prešibak, se posvetujte z zdravnikom.
Following the adoption of the PRAC recommendation during the May 2017 PRAC meeting, the MAH LFB Biomedicaments expressed their disagreement with the initial PRAC recommendation.
Po sprejetju priporočila odbora PRAC maja 2017 na seji odbora PRAC je imetnik dovoljenja za promet z zdravilom LFB Biomedicaments izrazil nestrinjanje s prvotnim priporočilom odbora PRAC.
Do not increase your dose of medicine you use to control your bleeding without consulting your doctor.
Ne povečajte odmerka zdravila, ki ga uporabljate za nadzor krvavitev, ne da bi se posvetovali z zdravnikom.
Differences between products in each FVIII class and consequently differential risks between individual products, are biologically plausible.
Razlike med zdravili v vsakem razredu FVIII in posledično različna tveganja med posameznimi zdravili so biološko verjetne.
Overall, the expert group supported the PRAC initial conclusions and agreed that the proposed product information provides an adequate level of information to appropriately communicate to prescribers and patients about the risk of inhibitor development.
Na splošno je strokovna skupina podprla prvotne zaključke odbora PRAC in se strinjala, da predlagane informacije o zdravilu zagotavljajo ustrezno raven podatkov, s katero primerno obvestijo zdravnika in bolnike o tveganju za pojav zaviralcev.
Warnings and precautions Take special care with KOGENATE Bayer and talk to your doctor or pharmacist if:
Opozorila in previdnostni ukrepi Bodite posebno pozorni pri uporabi zdravila KOGENATE Bayer in se posvetujte z zdravnikom ali farmacevtom, če:
The data came from a very wide range of heterogenous studies across products and over time.
Podatki so izhajali iz zelo širokega nabora heterogenih študij z različnimi zdravili in v različnih obdobjih.
If any component of the package is opened or damaged, do not use it.
Če je kateri koli sestavni del pakiranja odprt ali poškodovan, ga ne uporabite.
The experts also suggested studies which could further characterise the immunogenic properties of the factor VIII medicinal products (e.g. mechanistic, observational studies).
Strokovnjaki so predlagali tudi študije, s katerimi bi lahko dodatno pojasnili imunogene lastnosti zdravil s faktorjem VIII (npr. mehanistične, opazovalne študije).
Although the clinical studies for some individual products have identified limited numbers of cases of inhibitor development, these tend to be small studies with methodological limitations, or studies not adequately designed to evaluate this risk.
Čeprav so klinične študije za nekatera posamezna zdravila ugotovile omejeno število primerov pojava zaviralcev, gre za majhne študije z metodološkimi omejitvami ali študije, ki niso ustrezno zasnovane za ovrednotenje tega tveganja;
Place the vial on a rigid, non-slip surface and hold it firmly with one hand.
Vialo postavite na trdno nedrsečo površino in jo z eno roko močno držite.
Results of clinical studies not sufficiently robust (e.g. suffering from methodolical limitations) should not be reflected in the product information on FVIIII products.
Rezultati kliničnih študij, ki niso dovolj robustni (npr. imajo metodološke omejitve), se ne smejo odražati v informacijah o zdravilih s FVIIII.
The pre-filled syringe contains water for injections to be used to reconstitute the contents of the vial.
Napolnjene injekcijske brizge vsebujejo vodo za injekcije, ki se uporablja za rekonstitucijo vsebine viale.
The infusion rate should be calculated based on the clearance and the desired FVIII level.
Hitrost infundiranja je treba izračunati glede na očistek in želeno raven FVIII.
If symptoms of hypersensitivity occur, patients should be advised to discontinue the use of the medicinal product immediately and contact their physician.
Če se pojavijo simptomi preobčutljivosti, je treba bolnikom svetovati, da naj takoj prenehajo uporabljati zdravilo in se posvetujejo z zdravnikom.
• nausea this can constitute an early warning for hypersensitivity and anaphylactic reactions.
• občutek siljenja na bruhanje to lahko pomeni zgodnje opozorilo za pojav preobčutljivosti in anafilaktičnih reakcij.
On 6 July 2016 Paul-Ehrlich-Institut Germany initiated a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the potential impact of the results of the SIPPET study on the marketing authorisations of relevant FVIII products and to issue a recommendation on whether these should be maintained, varied, suspended or revoked and whether any risk minimisation measures should be implemented.
Družba Paul-Ehrlich-Institut iz Nemčije je 6. julija 2016 sprožila napotitev na podlagi člena 31 Direktive 2001/83/ES in podatkov o farmakovigilanci in zaprosila odbor PRAC, da oceni možen učinek rezultatov študije SIPPET na dovoljenja za promet z ustreznimi zdravili s FVIII in izda priporočilo, ali je treba ta dovoljenja ohraniti, spremeniti, začasno prekiniti ali preklicati ali pa je treba izvajati ukrepe za zmanjšanje tveganja.
However, despite the lack of robust evidence to support differential risks between rFVIII products, differential risks cannot be excluded, as this is a heterogeneous product class with differences in composition and formulations.
Vendar kljub pomanjkanju robustnih dokazov v podporo različnega tveganja med zdravili z rFVIII slednjega ni mogoče izključiti, saj gre za heterogen razred zdravil z razlikami v sestavi in formulacijah.
This should be considered for a continuous infusion administration.
To je treba upoštevati pri uporabi kontinuirane infuzije.
These studies have yielded different results and suffer from the limitations of observational studies, and in particular from possible selection bias.
Te študije so prinesle različne rezultate in imajo omejitve opazovalnih študij, zlasti zaradi morebitne napake pri izbiri.
Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.
V določenih primerih so lahko potrebni večji odmerki od izračunanih, še posebej na začetku zdravljenja.
The specific activity of KOGENATE Bayer is approximately 4000 IU/mg protein.
Specifična aktivnost zdravila KOGENATE Bayer je približno 4000 i.e./mg beljakovine.
Factor VIII level required (%) (IU/dl)
Potrebna raven faktorja VIII (%) (i.e./dl)
Consequently, patients should be evaluated and monitored for cardiac risk factors.
Pri bolnikih je treba oceniti in spremljati dejavnike tveganja za srčnožilne bolezni.
Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Aktivirani faktor VIII deluje kot kofaktor za aktivirani faktor IX in pospešuje pretvorbo faktorja X v aktivirani faktor X. Aktivirani faktor X pretvori protrombin v trombin.
The known risk factors for inhibitor development can be grouped into patient and treatment-related factors:
Znane dejavnike tveganja za pojav zaviralcev lahko združimo v dejavnike, povezane z bolniki in zdravljenjem:
Remove the protective cap from the vial (A) and wipe the rubber stopper on the vial with a alcohol swab and allow it to air dry before use.
Odstranite zaščitno zaporko z viale (A) in očistite gumijasti zamašek na viali z alkoholnim tamponom ter pustite, da se pred uporabo osuši na zraku.
This medicine must not be mixed with other infusion solutions.
Tega zdravila ne smete mešati z drugimi raztopinami za infundiranje.
Re-examination procedure
Postopek ponovne proučitve
Of the larger and more relevant studies for pdFVIII products, inhibitor rates observed (often not stated if high or low titre) ranged from 3.5 to 33%, with most around 10-25%.
Pri večjih in bolj relevantnih študij za zdravila s pdFVIII so bile opažene stopnje pojava zaviralcev (pogosto ni bila navedena raven titrov) v razponu od 3,5 do 33 %, pri večini približno 10-25 %.
• mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing)
• blaga hipotenzija (blago znižanje krvnega tlaka, zaradi česar se vam lahko vrti, ko vstanete)
In situations where the venipuncture set provided cannot be used (e.g. when infusing into a peripheral or central line), a separate filter compatible with KOGENATE Bayer should be used.
V primerih, ko priloženega pribora za vensko punkcijo ni mogoče uporabiti (npr. pri infundiranju v periferni ali centralni kanal) je treba uporabiti ločen filter, ki je združljiv z zdravilom KOGENATE Bayer.
>), the above frequency for PUPs should not be implemented.
>), zgoraj navedene pogostnosti za predhodno nezdravljene bolnike ne bi smeli uveljaviti.
If you cannot use the venipuncture set provided, use a separate filter as your nurse or doctor has instructed.
Če priloženega pribora za vensko punkcijo ne morete uporabiti, uporabite ločen filter, kot vam je svetovala medicinska sestra ali zdravnik.
Inhibitor rates in these studies range from 15 to 38% for all inhibitors and 9 to 22.6% for high titre inhibitors; i.e. within the range of ‘very common'.
Stopnje pojava zaviralcev v teh študijah se gibljejo od 15 do 38 % za vse titre zaviralcev in od 9 do 22,6 % za visoke titre zaviralcev; tj. v območju „zelo pogosti“.
60 % (0.6 IU/mL) 1.8 40 % (0.4 IU/mL) 1.2
100 % (1 i.e./ml) 3,0 60 % (0,6 i.e./ml) 1,8 40 % (0,4 i.e./ml) 1,2
As the evidence suggests that all human FVIII products carry a risk of inhibitor development such statements should be removed.
Ker dokazi kažejo, da imajo vsa zdravila s FVIII v humani medicini tveganje za pojav zaviralcev, je treba take izjave odstraniti.
The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions.
Kompleks faktorja VIII in von Willebrandovega faktorja (vWF) je sestavljen iz dveh molekul (faktor VIII in vWF) z različnim fiziološkim delovanjem.
Any unused solution must be discarded.
Neuporabljeno raztopino je treba zavreči.
If you have any questions about this medicine and compatible separate filters, contact your doctor.
Če imate kakršna koli vprašanja o tem zdravilu in z njim združljivih ločenih filtrih, se posvetujte z zdravnikom.
Do not shake the vial!
Ne stresajte viale!
This will usually be in the range of 20 to 40 IU of octocog alfa per kg of body weight, given every 2 to 3 days.
Velikost odmerka bo običajno od 20 do 40 i.e. oktokoga alfa na kilogram telesne mase, danega vsakih 2 do 3 dni.
a) By bolus infusions Repeat infusion every 8 - 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
a) z bolusnimi infuzijami Ponavljajte infuzijo vsakih 8 do 24 ur, dokler se rana ustrezno ne zaceli; nato nadaljujte zdravljenje vsaj še naslednjih 7 dni za vzdrževanje aktivnosti faktorja VIII na 30 do 60 % (i.e./dl).
If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately.
Če se pojavijo alergijske ali anafilaktične reakcije je treba takoj prenehati z injiciranjem/infundiranjem.
This included published literature (SIPPET study6), data generated in individual clinical trials and a range of observational studies submitted by the marketing authorisation holders, including the data generated in large multicentre cohort studies, data submitted by the national competent authorities of the EU Member States as well as responses provided by the Authors of the SIPPET study.
To je obsegalo objavljeno literaturo (študija SIPPET6), podatke, pridobljene v posameznih kliničnih preskušanjih, in vrsto opazovalnih študij, ki so jih predložili imetniki dovoljenja za promet, vključno s podatki, pridobljenimi v velikih multicentričnih kohortnih študijah, podatke, ki so jih predložili pristojni nacionalni organi držav članic EU, ter odzive avtorjev študije SIPPET.
In patients where immune tolerance was achieved the bleedings could be prevented or controlled with KOGENATE Bayer again, and the patients could continue with prophylactic treatment as maintenance therapy.
Pri bolnikih, pri katerih je bila imunska toleranca dosežena, je bilo mogoče krvavitev znova preprečiti ali nadzorovati z zdravilom KOGENATE Bayer, bolniki pa so lahko nadaljevali s profilaktičnim zdravljenjem kot vzdrževalnim zdravljenjem.
Frequency, type and severity of adverse reactions in children are expected to be the same as in all population groups except for the inhibitor formation.
Pričakuje se, da so pogostnost, vrsta in resnost neželenega učinka pri otrocih enaki kot pri ostalih populacijah bolnikov, razen glede nastanka zaviralcev.
patients (<6 years, male, severe haemophilia A, no previous treatment with any FVIII concentrate or only minimal treatment with blood components) were included from 42 sites.
Vključeni so bili primerni bolniki (< 6 let, moški, huda hemofilija A, brez predhodnega zdravljenja s katerim koli koncentratom FVIII ali le minimalno zdravljeni s krvnimi komponentami) iz 42 ustanov.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če se zdravila ne uporabi takoj po rekonstituciji, je za trajanje in pogoje shranjevanja pred uporabo odgovoren uporabnik.
There are no fertility data available.
Podatkov o vplivu na plodnost ni.
Your doctor will tell you, how often and at what intervals this medicine is to be administered.
Zdravnik vam bo svetoval, kako pogosto in v kakšnih presledkih morate uporabljati to zdravilo.
Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.
Ponavljajte vsakih 12 do 24 ur, 3 do 4 dni ali več, dokler ne mineta bolečina in onesposobljenost.
Do not remove the adapter from the plastic housing.
Ne odstranite adapterja s plastičnega ohišja.
KOGENATE Bayer has no influence on the ability to drive or to use machines.
Zdravilo KOGENATE Bayer nima vpliva na sposobnost vožnje in upravljanja strojev.
FVIII replacement therapy can be generally categorised into two broad classes of products; plasma derived (pdFVIII) and recombinant (rFVIII) FVIII.
Nadomestno zdravljenje s FVIII je na splošno mogoče razvrstiti v dve široki skupini izdelkov; plazemski (pdFVIII) in rekombinantni (rFVIII) FVIII.
The reconstituted medicinal product is a clear and colourless solution.
Rekonstituirano zdravilo je bistra in brezbarvna raztopina.