natgillin/translations-raw huggingface dataset:
Recommendations and precautions to be followed by healthcare professionals for the safe and effective use of Ondexxya have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ondexxya upoštevati zdravstveni delavci, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
As for all medicines, data on the use of Ondexxya are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Ondexxya stalno spremljajo.
Side effects reported with Ondexxya are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Ondexxya, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The European Medicines Agency noted that it has not been established that antifactor Xa activity can be used as a reliable measure for reduced bleeding and that there was not enough evidence on the use of Ondexxya to reverse the effects of edoxaban, another factor Xa inhibitor.
Evropska agencija za zdravila je opozorila, da ni bilo dokazano, da bi lahko bilo delovanje antifaktorja Xa zanesljivo sredstvo za zmanjšanje krvavitev in da ni dovolj dokazov o uporabi zdravila Ondexxya za odpravo učinkov edoksabana, drugega zaviralca faktorja Xa.
For more information about using Ondexxya, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Ondexxya glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
An overview of Ondexxya and why it is authorised in the EU
Pregled zdravila Ondexxya in zakaj je odobreno v EU
Ondexxya is a medicine used for stopping life-threatening or uncontrolled bleeding in adults taking the anticoagulant medicines apixaban or rivaroxaban.
Ondexxya je zdravilo, ki se uporablja za zaustavitev življenjsko nevarne ali neobvladane krvavitve pri odraslih, ki jemljejo antikoagulacijsko zdravilo apiksaban ali rivaroksaban.
Why is Ondexxya authorised in the EU?
Zakaj je bilo zdravilo Ondexxya odobreno v EU?
Based on studies in healthy volunteers, the most common side effects with Ondexxya (which may affect more than 1 in 10 people) are flushing, feeling hot, both of which are related to infusing the medicine, and a short-lived increase in levels of certain proteins indicating blood clotting.
Na podlagi študij pri zdravih prostovoljcih so najpogostejši neželeni učinki zdravila Ondexxya (ki se lahko pojavijo pri več kot 1 bolniku od 10 ) rdečica, občutek vročine (oba povezana z infundiranjem zdravila) in kratkotrajno povečanje ravni določenih beljakovin, ki kažejo na strjevanje krvi.
Since Ondexxya has been given conditional authorisation, the company that markets Ondexxya will provide evidence from studies in patients with major bleeding to reliably link antifactor X activity with the ability to stop bleeding and to clarify the risk of thromboembolism.
Ker je zdravilo Ondexxya pridobilo pogojno dovoljenje za promet, bo podjetje, ki ga trži, zagotovilo dokaze iz študij pri bolnikih z večjo krvavitvijo, da bi zanesljivo povezalo delovanje antifaktorja X z zmožnostjo za zaustavitev krvavitve in pojasnilo tveganje za trombembolijo.
What benefits of Ondexxya have been shown in studies?
Kakšne koristi zdravila Ondexxya so se pokazale v študijah?
After treatment with Ondexxya, antifactor Xa activity was reduced on average by 90% in 83 patients taking apixaban and by 78% in 70 patients taking rivaroxaban.
Po zdravljenju z zdravilom Ondexxya se je delovanje antifaktorja Xa v povprečju zmanjšalo za 90 % pri 83 bolnikih, ki so jemali apiksaban, in za 78 % pri 70 bolnikih, ki so jemali rivaroksaban.
Ondexxya has been given ‘conditional authorisation'.
Zdravilo Ondexxya je pridobilo „pogojno dovoljenje za promet“.
Other information about Ondexxya
Druge informacije o zdravilu Ondexxya
Ondexxya must not be used in patients who are allergic to hamster proteins.
Zdravilo Ondexxya se ne sme uporabljati pri bolnikih z alergijo na beljakovine hrčka.
Ondexxya is given by infusion (drip) into a vein over about 2.5 hours.
Zdravilo Ondexxya se daje kot približno 2,5-urna (kapalna) infuzija v veno.
What is Ondexxya and what is it used for?
Kaj je zdravilo Ondexxya in za kaj se uporablja?
Ondexxya can only be obtained with a prescription and it must be used in hospital only.
Predpisovanje in izdaja zdravila Ondexxya je le na recept, uporabljati pa se sme samo v bolnišnicah.
What are the risks associated with Ondexxya?
Kakšna tveganja so povezana z zdravilom Ondexxya?
On the basis of studies in healthy volunteers and preliminary data from studies in patients, Ondexxya was found effective for reducing antifactor Xa activity in those taking anticoagulants that block factor Xa (factor Xa inhibitors).
Na podlagi študij pri zdravih prostovoljcih in predhodnih podatkov iz študij pri bolnikih je bilo ugotovljeno, da zdravilo Ondexxya učinkovito zmanjšuje delovanje antifaktorja Xa pri tistih, ki jemljejo antikoagulante, ki zavirajo faktor Xa (zaviralce faktorja Xa).
Two main studies have found Ondexxya effective in healthy volunteers who took either apixaban or rivaroxaban, two anticoagulants that block the effect of factor Xa.
V dveh glavnih študijah je bilo mogoče opaziti učinkovitost zdravila Ondexxya pri zdravih prostovoljcih, ki so jemali apiksaban ali rivaroksaban, torej enega od antikoagulantov, ki zavirata učinek faktorja Xa.
involving people who had taken rivaroxaban, the full dose of Ondexxya reduced antifactor Xa activity by 97% on average in 26 people, compared with 45% in 13 people receiving placebo.
V drugi študiji, v kateri so udeleženci vzeli rivaroksaban, je celotni odmerek zdravila Ondexxya zmanjšal delovanje antifaktorja Xa v povprečju za 97 % pri 26 ljudeh v primerjavi s 45 % pri 13 ljudeh, ki so prejeli placebo.
Andexanet alfa, the active substance in Ondexxya, acts as a decoy target for anticoagulants called factor Xa inhibitors such as apixaban and rivaroxaban.
Učinkovina v zdravilu Ondexxya, andeksanet alfa, deluje kot vaba za antikoagulante, imenovane zaviralci faktorja Xa, kot sta apiksaban in rivaroksaban.
When Ondexxya is given, the anticoagulants attach to andexanet alfa instead, and they are no longer available to block factor Xa.
Ob uporabi zdravila Ondexxya se antikoagulanti vežejo na učinkovino andeksanet alfa in tako niso več na voljo za zaviranje faktorja Xa.
In the first study, involving people who had taken apixaban, the full dose of Ondexxya reduced antifactor Xa activity by 92% on average in 23 people compared with 33% in 8 people receiving placebo (a dummy treatment).
V prvi študiji, v kateri so udeleženci vzeli apiksaban, je celotni odmerek zdravila Ondexxya zmanjšal delovanje antifaktorja Xa v povprečju za 92 % pri 23 ljudeh v primerjavi s 33 % pri osmih ljudeh, ki so prejeli placebo (zdravilo brez učinkovine).
For the full list of side effects and restrictions of Ondexxya, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Ondexxya glejte navodilo za uporabo.
Ondexxya contains the active substance andexanet alfa.
Zdravilo Ondexxya vsebuje učinkovino andeksanet alfa.
What information is still awaited for Ondexxya?
Katere informacije o zdravilu Ondexxya še pričakujemo?
A further ongoing study involved patients taking a factor Xa inhibitor anticoagulant who had major bleeding.
V nadaljnji potekajoči študiji so sodelovali bolniki z večjo krvavitvijo, ki jemljejo antikoagulant, ki je zaviralec faktorja Xa.
How is Ondexxya used?
Kako se zdravilo Ondexxya uporablja?
How does Ondexxya work?
Kako zdravilo Ondexxya deluje?
The MAH should provide adequate and satisfactory data confirming the bioequivalence of their product with the reference product within one year of the European Commission decision.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti zadostne in zadovoljive podatke, ki potrjujejo biološki enakovrednost njegovega zdravila in referenčnega zdravila v enem letu od sklepa Evropske komisije.
The following procedure shows how you do this.
Naslednji postopek prikazuje, kako to naredite.
Never use more than one injection in the same day.
Nikoli ne uporabite več kot ene injekcije v istem dnevu.
Date of first authorisation: 30 August 2012 Date of latest renewal: 23 June 2017
Datum prve odobritve: 30. avgust 2012 Datum zadnjega podaljšanja: 23. junij 2017
In other cases, seek help as soon as possible
V drugih primerih čimprej poiščite pomoč.
The majority of these reactions were mild or moderate.
Večina teh reakcij je bila blage ali zmerne stopnje.
Interim data for the NIS should be provided every second year.
Vmesne podatke za NIS je treba zagotoviti vsako drugo leto.
Long-term safety data are not yet available for this paediatric population.
Dolgoročni podatki o varnosti za to pediatrično populacijo še niso na voljo.
This assessment should be conducted more frequently within the first months of treatment.
Takšne ocene je treba pogosteje opravljati v prvih mesecih zdravljenja.
A risk to the breast-fed newborn/infant cannot be excluded.
Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
The clinical studies conducted could neither exclude nor confirm such an increased risk.
Opravljene klinične študije niso mogle niti ovreči niti potrditi takšnega povečanega tveganja.
See Table 1 under “Adults” section.
Glejte preglednico 1 v poglavju “Odrasli”.
These changes were neither associated with any changes in other laboratory parameters nor with any reported clinical symptoms.
Te spremembe niso bile povezane s spremembami drugih laboratorijskih parametrov in tudi ne s kakršnimi koli zabeleženimi kliničnimi simptomi.
Specifically, clearance decreases with increasing age from 1 year old to adults.
Natančneje povedano se očistek zmanjšuje z naraščajočo starostjo od starosti 1 leta do odraslih.
If any powder remains, repeat steps 2.5 and 2.6.
Če ostane v viali neraztopljen prašek, ponovite koraka 2.5 in 2.6.
Paediatric population (≥1 year)
Pediatrična populacija (≥1 leto)
A-1121 Vienna
A-1121 Dunaj
No subject discontinued the studies due to an adverse event.
Noben preiskovanec ni prekinil študije zaradi kakega neželenega dogodka.
You will find detailed instructions for injections at the end of this leaflet.
Podrobna navodila za injiciranje boste našli na koncu tega navodila.
It is recommended that your doctor performs these examinations once a year during the first 2 years after starting treatment, and then at a minimum of five-year intervals.
Priporočljivo je, da vaš zdravnik opravi to preiskavo enkrat letno v prvih dveh letih po začetku zdravljenja in nato najmanj v petletnih razmikih.
In general, fluid overload can be prevented by appropriate and timely assessment of parenteral nutrition needs.
Preobremenitev s tekočinami lahko preprečimo z ustreznim in pravočasnim ocenjevanjem potrebe po parenteralni prehrani.
The absolute bioavailability of subcutaneous teduglutide is high (88%).
Absolutna biološka razpoložljivost podkožnega teduglutida je visoka (88 %).
NOTE: Before you start, make sure you have a clean work surface and that you have washed your hands before proceeding.
OPOZORILO: Pred začetkom postopka zagotovite čisto delovno površino in si umijte roke, preden nadaljujete.
Seek immediate medical attention if any of the following side effects occur:
Takoj poiščite medicinsko pomoč, če se pojavi kateri koli od naslednjih neželenih učinkov:
Reproductive and developmental toxicity
Reproduktivna in razvojna toksičnost
- if you have other severe diseases that are not well controlled.
- če imate druge težke bolezni, ki niso dobro nadzorovane.
Subsequent colonoscopies are recommended at a minimum of five year intervals.
Nadaljnje kolonoskopije so priporočljive v razmikih po najmanj pet let.
Frequencies are defined as 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 available data).
Pogostnosti so opredeljene kot 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).
You can still use the medicine that is already in the syringe.
Še vedno lahko uporabite zdravilo, ki je že v injekcijski brizgi.
In children below the age of two years, treatment should be evaluated after 12 weeks.
Pri otrocih, mlajših od dveh let, je treba zdravljenje oceniti po 12 tednih.
3.7 Your dose in ml has been calculated by your doctor.
3.7 Vaš odmerek v ml je izračunal vaš zdravnik.
This container must be puncture proof (top and sides).
Ta vsebnik mora biti odporen na vbode (na vrhu in ob straneh).
In general, the side effects in children and adolescents are similar to those seen in adults.
Na splošno so neželeni učinki pri otrocih in mladostnikih podobni kot pri odraslih.
Children below 1 year of age
Otroci, mlajši od 1 leta
Let the vial rest for approximately 30 seconds.
Vialo pustite mirovati približno 30 sekund.
Pharmacokinetics in subpopulations
Farmakokinetika v subpopulacijah
Despite the limited sample size, which did not allow meaningful statistical comparisons, clinically meaningful, numerical reductions in the requirement for parenteral support were observed across all age groups.
Kljub omejeni velikosti vzorca, ki ni omogočala pomembnih statističnih primerjav, so v vseh starostnih skupinah opazili klinično pomembna številčna zmanjšanja v potrebi po parenteralni podpori.
Paediatric population See also general precautions for adults under this section.
Pediatrična populacija Glejte tudi splošne previdnostne ukrepe za odrasle v tem poglavju.
Limited data from clinical studies have shown that some patients may take longer to respond to treatment (i.e., those who still have presence of colon-in-continuity or distal/terminal ileum); if no overall improvement is achieved after 12 months, the need for continued treatment should be reconsidered.
Omejeni podatki iz kliničnih študij so pokazali, da nekateri bolniki potrebujejo dalj časa, da se odzovejo na zdravljenje (tj. tisti, ki imajo še ohranjen kolon ali distalni/terminalni ileum); če se po 12 mesecih v celoti gledano ne pokaže nikakršen napredek, je treba pretehtati, ali je potrebno nadaljevanje zdravljenja.
Structural adaptations were transient in nature and returned to baseline levels within three weeks of discontinuing the treatment.
Strukturne prilagoditve so bile prehodne narave in so se vrnile na izhodiščno raven v treh tednih po ukinitvi zdravljenja.
In the event of an overdose, the patient should be carefully monitored by the medical professional.
V primeru prevelikega odmerjanja mora bolnika skrbno nadzorovati zdravstveni delavec.
The safety and efficacy of Revestive in children below 1 year of age have not been established.
Varnost in učinkovitost zdravila Revestive pri otrocih, mlajših od 1 leta, nista bili dokazani.
The efficacy data presented are derived from 2 controlled studies in paediatric patients up to 24 weeks duration.
Predstavljeni podatki o učinkovitosti so pridobljeni iz dveh nadzorovanih študij pri pediatričnih bolnikih, v trajanju do 24 tednov.
Try to inject in another place in the cleaned skin area.
Poskusite injicirati v drugo mesto injiciranja na očiščenem področju kože.
These studies included 101 patients in the following age groups: 5 patients 1-2 years, 56 patients 2 to <6 years, 32 patients 6 to <12 years, 7 patients 12 to <17 years, and 1 patient 17 to <18 years.
V teh študijah je bil vključen 101 bolnik v naslednjih starostnih skupinah: 5 bolnikov od 1 do 2 leti, 56 bolnikov od 2 do <6 let, 32 bolnikov od 6 do <12 let, 7 bolnikov od 12 do <17 let in 1 bolnik od 17 do <18 let.
- if your child has other severe diseases that are not well controlled.
- če ima vaš otrok druge težke bolezni, ki niso dobro nadzorovane.
Efficacy and safety in all patients should be closely monitored on an ongoing basis according to clinical treatment guidelines.
Pri vseh bolnikih je treba učinkovitost in varnost redno skrbno spremljati skladno s smernicami kliničnega zdravljenja.
Reduction in infusion time
Skrajšanje infuzijskega časa
Clinical assessment by the physician should consider individual treatment objectives and patient preferences.
Zdravnikova klinična ocena mora upoštevati posamezne cilje zdravljenja in želje bolnika.
The antibody formation has not been associated with clinically relevant safety findings, reduced efficacy or changed pharmacokinetics of Revestive.
Tvorba protiteles ni bila povezana s klinično pomembnimi varnostnimi ugotovitvami, zmanjšano učinkovitostjo ali spremenjeno farmakokinetiko zdravila Revestive.
2.6 Let the vial rest for about two minutes.
2.6 Pustite vialo mirovati približno dve minuti.
Withdraw the solution from the second vial into the same injection syringe by repeating step 3.
Prenesite raztopino iz druge viale v isto injekcijsko brizgo s ponovitvijo koraka 3.
Bend your wrist back and quickly insert the needle at a 45° angle.
Upognite zapestje nazaj in hitro vbodite iglo pod kotom 45°.
What Revestive is and what it is used for
Kaj je zdravilo Revestive in za kaj ga uporabljamo
Gently grasp the cleaned skin at the injection site with one hand.
Nežno primite očiščeno kožo na mestu injiciranja z eno roko.
Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after one year of treatment, every 5 years thereafter while on continuous treatment with Revestive, and if they have new or unexplained gastrointestinal bleeding.
Kolonoskopijo/sigmoidoskopijo priporočajo za vse otroke in mladostnike po enem letu zdravljenja, nato enkrat na 5 let neprekinjenega zdravljenja z zdravilom Revestive in če imajo novo ali nepojasnjeno krvavitev v prebavila.
• Obligations to conduct post-authorisation measures
• Obveznost izvedbe ukrepov po pridobitvi dovoljenja za promet
The majority of reactions were moderate in severity and no occurrences led to drug discontinuation.
Večina reakcij je bila po izraženosti zmerna in v nobenem primeru ni povzročila prekinitve dajanja zdravila.
After a 4-week washout period, two of these patients had reinitiated parenteral nutrition support.
Po štiritedenskem obdobju spiranja sta dva od teh bolnikov spet začela s parenteralno prehransko podporo.
If this happens to you, do not drive or use machines until you feel better.
Če se vam to zgodi, ne smete upravljati vozil ali strojev, dokler se vaše počutje ne izboljša.
No unexpected systemic adverse reactions were seen (see section 4.8).
Pri tem niso opazili nobenih nepričakovanih sistemskih neželenih učinkov (glejte poglavje 4.8).
There was no reduction in PN/IV infusion days per week in the SOC arm.
V skupini s SOC se število dni z infuzijami PN/IV na teden ni zmanjšalo.
Treatment should not be initiated until it is reasonable to assume that a patient is stable following a period of intestinal adaptation.
Zdravljenja se ne sme začeti, dokler ni mogoče sklepati, da je bolnik stabilen po obdobju prilagajanja črevesa.
The objective was to evaluate safety/tolerability, pharmacokinetics and efficacy of teduglutide.
Cilj je bil ovrednotiti varnost/prenašanje, farmakokinetiko in učinkovitost teduglutida.
- if you have or are suspected to have cancer.
- če imate raka ali če obstaja sum, da imate raka.
Teduglutide was not associated with effects on reproductive performance, in utero or developmental parameters measured in studies to investigate fertility, embryo-foetal development and pre- and post-natal development.
Teduglutid ni bil povezan z učinki na reproduktivno sposobnost, z učinki na parametre in utero ali na razvojne parametre, izmerjene v študijah zaradi preučevanja plodnosti, embrionalnega-fetalnega razvoja ter razvoja pred in po rojstvu.
If necessary, press gently on the injection site with an alcohol swab or 2x2 gauze until any bleeding has stopped.
Po potrebi nežno pritisnite na mesto injiciranja z alkoholno blazinico ali zložencem gaze 2 x 2, dokler se krvavitev ne ustavi.
There are no data from the use of Revestive in pregnant women.
Podatkov o uporabi zdravila Revestive pri nosečnicah ni.
The maximum dose of teduglutide studied during clinical development was 86 mg/day for 8 days.
Največji odmerek tedulgutida, raziskan v okviru kliničnega razvoja, je znašal 86 mg/dan za 8 dni.
The patient's fluid status should be evaluated following parenteral support reduction and corresponding adjustment performed, as needed.
Tekočinsko stanje bolnika je treba oceniti po zmanjšanju parenteralne podpore in po potrebi opraviti ustrezno prilagoditev.
Several cases of benign colorectal polyps occurred during the course of the trials, however, the frequency was not increased compared to placebo-treated patients.
V preskušanjih so zabeležili več primerov benignih kolorektalnih polipov, vendar njihova pogostnost ni bila povečana v primerjavi z bolniki na placebu.
Carcinogenicity / mutagenicity Teduglutide was negative when tested in the standard battery of tests for genotoxicity.
Kancerogenost/ mutagenost Teduglutid je bil negativen pri testiranju s standardnim naborom testov za genotoksičnost.
4.4 Pull back the plunger slightly.
4.4 Bat povlecite nekoliko nazaj.
The physician should at each visit weigh the patient, determine the daily dose to be administered until next visit and inform the patient accordingly.
Zdravnik mora ob vsakem obisku stehtati bolnika, določiti dnevni odmerek, ki ga bo uporabljal do naslednjega obiska, in o tem seznaniti bolnika.
Unopened vials 4 years.
Neodprte viale 4 leta.
The data from use in subjects with moderate hepatic impairment do not suggest a need for restricted use.
Podatki o uporabi pri preiskovancih z zmerno okvaro jeter ne kažejo potrebe po omejevanju uporabe.
Short Bowel Syndrome is a disorder arising from an inability to absorb food nutrients and fluid across the gut.
Sindrom kratkega črevesa je bolezen, ki nastane zaradi nezmožnosti za absorpcijo hranilnih snovi in tekočine iz hrane preko črevesa.
Since teduglutide is a peptide it is likely that it follows the principal mechanism for peptide metabolism.
Ker je teduglutid peptid, verjetno sledi osnovnim mehanizmom presnove peptidov.
Important information about some of the ingredients in Revestive
Pomembne informacije o nekaterih sestavinah zdravila Revestive
The pharmacokinetic profile of Revestive in this paediatric population, as evaluated by clearance and volume of distribution, was different from that observed in adults after correcting for body weights.
Farmakokinetični profil teduglutida v tej pediatrični populaciji, ocenjen z očistkom in volumnom porazdelitve, se je razlikoval od tistega, ki so ga ugotovili pri odraslih po popravku za telesne mase.
International Short Bowel Syndrome Registry Non-interventional study (NIS) to gather further safety data, in order to further elucidate the potential and identified risk as outlined in the RMP, based on a CHMP approved protocol.
Neintervencijska študija (NIS) za pridobitev nadaljnjih podatkov o varnosti, s katerimi se še dodatno pojasni možno in ugotovljeno tveganje, kot je opisano v RMP, ki temelji na CHMP odobrenem protokolu.
Due to increased fluid absorption, patients with cardiovascular disease, such as cardiac insufficiency and hypertension, should be monitored with regard to fluid overload, especially during initiation of therapy.
Zaradi povečane absorpcije tekočin je treba bolnike z boleznimi srca in ožilja, na primer s srčnim popuščanjem ali hipertenzijo, nadzorovati glede preobremenitve s tekočinami, zlasti ob začetku zdravljenja.
The doctor will tell you which dose to inject.
Povedal vam bo, kateri odmerek injicirati.
*A glucagon-like peptide-2 (GLP-2) analogue produced in Escherichia coli cells by recombinant DNA technology.
*Analog glukagonu podobnega peptida-2 (GLP-2), ki ga proizvajajo celice Escherichia coli s tehnologijo rekombinantne DNK.
Fluid overload adverse events occurred most frequently during the first 4 weeks of therapy and decreased over time.
Neželeni dogodki preobremenitve s tekočino so se najpogosteje pojavljali prve 4 tedne zdravljenja, nato so sčasoma postajali redkejši.