natgillin/translations-raw huggingface dataset:
For more information about treatment with Crixivan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Crixivan preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Crixivan is an antiviral medicine for treating adults infected with human immunodeficiency virus type 1 (HIV 1), a virus that causes acquired immune deficiency syndrome (AIDS).
Zdravilo Crixivan je protivirusno zdravilo za zdravljenje odraslih, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
What benefits of Crixivan have been shown in studies?
Kakšne koristi je zdravilo Crixivan izkazalo v študijah?
Ritonavir, another protease inhibitor, is sometimes used with Crixivan as a ‘booster'.
Ritonavir, ki je prav tako zaviralec proteaze, se včasih uporablja skupaj z zdravilom Crixivan kot „ojačevalec“.
What is Crixivan and what is it used for?
Kaj je zdravilo Crixivan in za kaj se uporablja?
Crixivan does not cure HIV infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Crixivan ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
What are the risks associated with Crixivan?
Kakšna tveganja so povezana z zdravilom Crixivan?
By blocking this enzyme, indinavir stops the virus from reproducing normally and thereby slows down the spread of infection.
Indinavir z zaviranjem proteaze prepreči normalno razmnoževanje virusa in tako upočasni širitev okužbe.
Why is Crixivan been approved?
Zakaj je bilo zdravilo Crixivan odobreno?
For practical information about using Crixivan, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Crixivan naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The active substance in Crixivan, indinavir, is a protease inhibitor.
Zdravilna učinkovina zdravila Crixivan, indinavir, je zaviralec proteaze.
Crixivan should only be prescribed by doctors with experience in treating HIV and can only be obtained by prescription.
Zdravilo Crixivan lahko predpiše samo zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV, izdaja tega zdravila pa je le na recept.
It slows down the rate at which indinavir is broken down, helping to increase levels of indinavir in the blood.
Ker upočasni hitrost razgradnje indinavirja, s tem zviša njegove ravni v krvi.
Crixivan is used in combination with other antiviral medicines and contains the active substance indinavir.
Zdravilo Crixivan se uporablja v kombinaciji z drugimi protivirusnimi zdravili, vsebuje pa zdravilno učinkovino indinavir.
For the full list of side effects reported with Crixivan, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Crixivan, glejte navodilo za uporabo.
How is Crixivan used?
Kako se zdravilo Crixivan uporablja?
How does Crixivan work?
Kako zdravilo Crixivan deluje?
The frequency of injections is adjusted again after 6 and 9 months depending on how well the medicine is working.
Pogostost injiciranja se ponovno prilagodi po šestih in devetih mesecih, odvisno od tega, kako dobro zdravilo deluje.
At the start of treatment, Waylivra is given once a week.
Na začetku zdravljenja se zdravilo Waylivra daje enkrat na teden.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3141249.
Nadaljnje informacije glede določitve zdravila sirote lahko najdete tukaj: ema.europa.eu/medicines/human/orphan-designations/eu3141249.
What measures are being taken to ensure the safe and effective use of Waylivra?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Waylivra?
Patients must therefore be monitored closely and the frequency of injections adjusted if needed.
Zato je treba bolnike pozorno spremljati in po potrebi prilagoditi število injiciranj.
Further information on Waylivra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/waylivra.
Nadaljnje informacije o zdravilu Waylivra so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/waylivra.
An overview of Waylivra and why it is authorised in the EU
Pregled zdravila Waylivra in zakaj je odobreno v EU
Depending on the results, frequency of injections may be adjusted, or treatment paused or discontinued.
Glede na rezultate je mogoče pogostost injiciranja prilagoditi ali zdravljenje začasno prekiniti ali ukiniti.
As for all medicines, data on the use of Waylivra are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Waylivra stalno spremljajo.
Why is Waylivra authorised in the EU?
Zakaj je zdravilo Waylivra odobreno v EU?
After 3 months, patients who have had a sufficient reduction in the level of triglycerides can continue to receive the medicine once every 2 weeks.
Po treh mesecih lahko bolniki, pri katerih so se ravni trigliceridov zadostno znižale, zdravilo prejemajo vsaka dva tedna.
The main risk with this medicine is thrombocytopenia which, when severe, can lead to bleeding.
Glavno tveganje pri tem zdravilu je trombocitopenija, ki lahko, kadar je huda, povzroči krvavitve.
The most common side effects with Waylivra are reduced platelet levels (which may affect 4 in 10 people) and reactions at the site of the injection such as pain, swelling, itching, or bruising (which may affect 8 in 10 people).
Najpogostejši neželeni učinki zdravila Waylivra so zmanjšane ravni trombocitov (ki se lahko pojavijo pri 4 od 10 bolnikov) in reakcije na mestu injiciranja, kot so bolečina, otekanje, srbenje ali podplutbe (ki se lahko pojavijo pri 8 od 10 bolnikov).
Other information about Waylivra
Druge informacije o zdravilu Waylivra
Side effects reported with Waylivra are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Waylivra, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
It is only given to patients in whom other medicines to reduce triglycerides have not worked and who are at high risk of developing pancreatitis.
Prejemajo ga lahko samo bolniki, pri katerih druga zdravila za zmanjšanje trigliceridov niso delovala in pri katerih obstaja veliko tveganje za razvoj pankreatitisa.
Waylivra has been given ‘conditional authorisation'.
Zdravilo Waylivra je pridobilo „pogojno dovoljenje za promet“.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Waylivra have also 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 Waylivra upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For more information about using Waylivra, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Waylivra glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Excess fat builds up in various parts of the body and leads to symptoms including abdominal pain (belly ache), deposits of fat under the skin and pancreatitis (inflammation of the pancreas).
Presežna maščoba se kopiči v različnih delih telesa in pri tem povzroča simptome, kot so bolečine v trebuhu, nalaganje maščobe pod kožo in pankreatitis (vnetje trebušne slinavke).
Waylivra is available as a solution for injection under the skin, which patients or their carers can inject themselves once they have been trained.
Zdravilo Waylivra je na voljo kot raztopina za injiciranje pod kožo, ki jo bolniki ali njihovi negovalci po ustreznem usposabljanju lahko injicirajo sami.
What is Waylivra and what is it used for?
Kaj je zdravilo Waylivra in za kaj se uporablja?
The European Medicines Agency decided that, for patients at high risk of pancreatitis and for whom other medicines and a low-fat diet have not worked well enough, Waylivra's benefits are greater than its risks and that it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Waylivra za bolnike, pri katerih obstaja veliko tveganje za pankreatitis in pri katerih druga zdravila in prehrana z nizko vrednostjo maščob niso dovolj učinkoviti, večje od z njim povezanih tveganj, in da se lahko odobri za uporabo v EU.
The active substance in Waylivra, volanesorsen, is an ‘antisense oligonucleotide,' a very short piece of synthetic RNA (a type of genetic material).
Učinkovina v zdravilu Waylivra, volanesorsen, je „protismerni oligonukleotid“, zelo kratek košček sintetične RNK (vrste genskega materiala).
After 3 months, patients given Waylivra had an average 77% reduction in the level of triglycerides compared with an average 18% reduction in patients given placebo (a dummy treatment).
Po treh mesecih so se pri bolnikih, ki so jemali zdravilo Waylivra, ravni trigliceridov v povprečju zmanjšale za 77 % v primerjavi s povprečnim zmanjšanjem za 18 % pri bolnikih, ki so prejemali placebo (zdravilo brez zdravilne učinkovine).
What are the risks associated with Waylivra?
Kakšna tveganja so povezana z zdravilom Waylivra?
What benefits of Waylivra have been shown in studies?
Kakšne koristi je zdravilo Waylivra izkazalo v študijah?
Waylivra must not be used in patients who have long-term or unexplained thrombocytopenia (low blood platelet levels).
Zdravilo Waylivra se ne sme uporabljati pri bolnikih, ki imajo dolgotrajno ali nepojasnjeno trombocitopenijo (nizke ravni trombocitov v krvi).
FCS is rare, and Waylivra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 19 February 2014.
FCS je redka bolezen, zato je bilo zdravilo Waylivra 19. februarja 2014 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
Waylivra contains the active substance volanesorsen.
Zdravilo Waylivra vsebuje učinkovino volanesorsen.
Waylivra can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in treating FCS.
Izdaja zdravila je le na recept, zdravljenje z njim pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem FCS.
Since Waylivra has been given conditional authorisation, the company that markets Waylivra will provide results of a study based on a registry of patients to investigate how blood checks and adjustments to frequency of injections are carried out in practice and how well they work to prevent thrombocytopenia and bleeding.
Ker je zdravilo Waylivra pridobilo pogojno dovoljenje, bo podjetje, ki ga trži, zagotovilo rezultate študije na podlagi registra bolnikov, s katero bo preučeno, kako se krvni pregledi in prilagoditve pogostosti injiciranja izvajajo v praksi ter kako dobro delujejo pri preprečevanju trombocitopenije in krvavitev.
Waylivra is a medicine used to treat familial chylomicronaemia syndrome (FCS), a genetic condition that gives rise to high levels of fats called triglycerides in the blood.
Waylivra je zdravilo, ki se uporablja za zdravljenje sindroma družinske hilomikronemije (FCS), tj. genetskega stanja, ki povzroča visoko raven maščob, imenovanih trigliceridi, v krvi.
All patients in the study were on a low fat diet in addition to receiving Waylivra or placebo.
Vsi bolniki v študiji so poleg jemanja zdravila Waylivra ali placeba uživali tudi hrano z nizko vsebnostjo maščobe.
The company that markets Waylivra will provide educational materials for patients and healthcare professionals with information on the risk of thrombocytopenia and bleeding with treatment and the importance of regularly checking platelet levels in patients.
Podjetje, ki trži zdravilo Waylivra, bo priskrbelo izobraževalno gradivo za bolnike in zdravstvene delavce z informacijami o tveganju za trombocitopenijo in krvavitve pri zdravljenju ter pomenu rednega preverjanja ravni trombocitov pri bolnikih.
What information is still awaited for Waylivra?
Katere informacije o zdravilu Waylivra še pričakujemo?
Waylivra effectively reduces triglyceride levels and is expected to reduce the risk of pancreatitis in patients with FCS.
Zdravilo Waylivra učinkovito zniža ravni trigliceridov in pričakuje se, da bo pri bolnikih z FCS zmanjšalo tveganje za pankreatitis.
For the full list of side effects and restrictions with Waylivra, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Waylivra glejte navodilo za uporabo.
Waylivra, along with a low fat diet, is used to reduce triglyceride blood levels in patients with FCS that has been confirmed by genetic testing.
Zdravilo Waylivra, se skupaj s prehrano z nizko vsebnostjo maščob, uporablja za zmanjšanje ravni trigliceridov v krvi pri bolnikih s FCS, ki je bil potrjen z genetskim testiranjem.
Because Waylivra can reduce blood levels of platelets (components that help the blood to clot), patients' blood platelet levels should be checked regularly, in addition to regular checks of triglycerides to see how well the medicine is working.
Ker lahko zdravilo Waylivra zniža ravni trombocitov (komponent, ki pomagajo pri strjevanju krvi) v krvi, je treba poleg rednih pregledov trigliceridov, redno preverjati tudi bolnikove ravni trombocitov v krvi, da se ugotovi, kako dobro zdravilo deluje.
How does Waylivra work?
Kako zdravilo Waylivra deluje?
How is Waylivra used?
Kako se zdravilo Waylivra uporablja?
By blocking the production of this protein, the medicine reduces the level of triglycerides in the blood and, as a result, fat accumulation in the body, which is expected to reduce the risk of pancreatitis.
Zasnovan je bil tako, da zavira tvorjenje beljakovine, ki upočasnjuje razgradnjo maščob, imenovane apolipoprotein C-III. Z zaviranjem tvorjenja te beljakovine zdravilo zmanjša ravni trigliceridov v krvi in s tem kopičenje maščobe v telesu, kar naj bi zmanjšalo tveganje za pankreatitis.
Waylivra was effective in reducing triglycerides in the blood in a study of 67 patients with FCS.
Zdravilo Waylivra je bilo v študiji, v katero je bilo vključenih 67 bolnikov s FCS, uspešno pri zmanjšanju trigliceridov v krvi.
Close surveillance with regard to immunological reactions is especially important in such situations.
Natančno spremljanje glede imunoloških reakcij je v takšnih situacijah še posebno pomembno.
Antithrombin contains two functionally important domains.
Antitrombin vsebuje dve funkcionalno pomembni domeni.
The safety and efficacy of ATryn in children and adolescents (<18 years) have not been established.
Varnost in učinkovitost zdravila ATryn pri otrocih in mladostnikih (<18 let) nista bili dokazani.
The Physician educational material shall contain the following key elements:
Izobraževalno gradivo za zdravnike mora vsebovati naslednje ključne elemente:
The experience from repeated treatment with this medicine is very limited.
Izkušnje z večkratnim zdravljenjem s tem zdravilom so zelo omejene.
It is one of the most important natural inhibitors of blood coagulation.
Je eden najpomembnejših naravnih zaviralcev koagulacije krvi.
• bleeding (at site of infusion or after surgery)
• krvavitev (na mestu infundiranja ali po operaciji),
This post-marketing surveillance will run up until such time as 40 patients are enrolled.
Pomarketinško spremljanje bo trajalo dokler ne bo vključenih 40 bolnikov.
Response may vary in individual patients, achieving different levels of in vivo recovery and different half-lives.
Odziv se lahko pri posameznih bolnikih razlikuje, dosežene so različne ravni in vivo okrevanja in različne razpolovne dobe.
Patients treated with this medicine should be monitored for possible clinical immunological reactions.
Bolnike, zdravljene s tem zdravilom, je treba nadzorovati glede morebitnih kliničnih imunoloških reakcij.
• Information about the currently registered indications and population, including that the product is not indicated in the paediatric population.
• Informacije o trenutno odobrenih indikacijah in populaciji, vključno s podatkom, da zdravilo ni indicirano za uporabo pri pediatrični populaciji.
Paediatric antithrombin levels may be different from adult levels, particularly in neonates.
Pediatrične ravni antitrombina se lahko razlikujejo od ravni pri odraslih, zlasti pri novorojencih.
Frequency category
Kategorija pogostosti
After reconstitution, from a microbiological pointy of view, this medicinal product should be used immediately.
Po rekonstituciji je treba iz mikrobiološkega vidika to zdravilo takoj porabiti.
Date of first authorisation: 28 July 2006 Date of latest renewal: 15 July 2016
Datum zadnjega podaljšanja: 15. julij 2016
Antibody status should be monitored and reported.
Stanje protiteles je treba nadzorovati in zabeležiti.
• Clearance: 0.665 ± 0.0493 l/h (Mean ± SE)
• Očistek: 0,665 ± 0,0493 l/h (povprečje ± SE)
Do not use solutions that are cloudy or have deposits.
Ne uporabljajte raztopin, ki so motne ali imajo usedline.
The factors most strongly inhibited are thrombin and Factor Xa, but also factors of contact activation, intrinsic system and the Factor VIIa/tissue factor complex.
Faktorja, ki sta najmočneje inhibirana, sta trombin in faktor Xa, a tudi faktorji kontaktne aktivacije, intrinzičnega sistema in faktor VIIa/kompleks tkivnega faktorja.
Population pharmacokinetic parameters for ATryn derived from the same study revealed (mean ± SD):
Populacijski farmakokinetični parametri za ATryn, pridobljeni iz iste študije, so pokazali (povprečje ± SD):
A risk to the suckling child cannot be excluded.
Tveganja za dojenega novorojenca/otroka ne moremo izključiti.
This medicine is intended for single use only.
To zdravilo je namenjeno le za enkratno uporabo.
However, chemical and physical stability has been demonstrated for 3 hours after reconstitution and 8 hours after dilution at a temperature not above 25°C.
Vendar pa sta bili kemična in fizikalna stabilnost zdravila med uporabo dokazani za 3 ure po rekonstituciji in 8 ur po redčenju pri temperaturi do 25 °C.
Frequencies are defined as: common (≥ 1/100 to < 1/10) and uncommon (≥1/1,000 to <1/100).
Po pogostosti so neželeni učinki opredeljeni kot: pogosti (≥1/100 do <1/10) in občasni (≥1/1000 do
Compatibility with PVC infusion lines with in-line filters has been established.
Dokazana je bila združljivost s PVC-infuzijskimi kanali s filtri.
As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Kot pri vsakem intravenskem beljakovinskem zdravilu so možne alergijske reakcije zaradi preobčutljivosti.
In case of shock, standard medical treatment should be administered.
Če nastopi šok, je potrebna običajna zdravniška oskrba.
This may result in a higher tendency to form clots in your blood vessels.
To lahko povzroči večjo nagnjenost k nastajanju strdkov v vaših žilah.
The results of completed study GTC AT HD 012-04 and in particular the results of investigations in pregnant women treated during the peri-partum period have been submitted.
Predloženi so bili rezultati dokončane študije GTC AT HD 012-04 in še zlasti rezultati raziskav pri nosečnicah, zdravljenih v obdobju pred porodom, med porodom in po njem.
To protect you from developing blood clots the medicine will continue to be administered to you until your doctor determines it safe to stop treatment.
Za zaščito pred nastajanjem krvnih strdkov boste zdravilo prejemali še naprej, dokler zdravnik ne ugotovi, da je varno prenehati z uporabo zdravila.
Adverse reactions are presented below by system organ class and absolute frequency.
Neželeni učinki so spodaj predstavljeni po organskih sistemih in absolutni pogostosti.
SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR
UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA
Around major surgical procedures this tendency to clot is even more increased.
Med večjimi operacijami je ta nagnjenost k nastajanju strdkov še večja.
The specific activity of ATryn is approximately 7 IU/mg protein.
Specifična aktivnost zdravila ATryn je približno 7 i.e./mg beljakovin.
Therapeutic Monitoring and Dose Adjustment
Terapevtsko spremljanje in prilagajanje odmerka
• Area under the curve: 587.88 ± 1.63 (% x h)
• Površina pod krivuljo: 587,88 ± 1,63 (% x h)
Available data do not suggest harmful effects to the mother or infant.
Po podatkih, ki so na voljo, ne kaže, da bi škodoval materi ali dojenčku.
This medicine is used in patients who have ‘congenital antithrombin deficiency' (inherited low levels of the protein antithrombin).
To zdravilo se uporablja pri bolnikih, ki imajo »prirojeno pomanjkanje antitrombina« (podedovane nizke ravni beljakovine antitrombin).
Vials should be brought at temperature not above 25°C prior to reconstitution.
Pred rekonstituiranjem morajo imeti viale temperaturo, ki ne presega 25 °C.
This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti popolnih informacij o tem zdravilu.
Pharmacotherapeutic Group: Antithrombotic agents: heparin group; ATC code: B01AB02.
Farmakoterapevtska skupina: Antitrombotiki: heparinska skupina heparinov, oznaka ATC: B01AB02.
The powder should be reconstituted with 10 ml of water for injections (WFI) injected along the side wall of the vial and gently swirled (not shaken) to prevent foaming.
Prašek je treba rekonstituirati z 10 ml vode za injekcije, ki jo vbrizgamo vzdolž stene viale in rahlo zavrtimo (ne stresamo), da preprečimo penjenje.
If you have an inborn deficiency of antithrombin, your blood level of antithrombin is lower than normal.
Če imate prirojeno pomanjkanje antitrombina, je raven antitrombina v krvi nižja od običajne.
The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo pregledala vse nove informacije, ki bodo morda na voljo vsako leto, SPC pa bo po potrebi posodobljen.
Please discuss possibility of stopping the treatment with your doctor.
Z zdravnikom se pogovorite o možnosti prenehanja zdravljenja.
Other medicines and ATryn
Druga zdravila in zdravilo ATryn
What ATryn is and what it is used for
KAJ JE ZDRAVILO ATryn IN ZA KAJ GA UPORABLJAMO
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
This medicine has been authorised under ‘exceptional circumstances'.
Zdravilo je pridobilo dovoljenje za promet v »izjemnih okoliščinah«.
This medicine contains 38 mg (1.65 mmol) sodium per 10 ml vial.
To zdravilo vsebuje 38 mg (1,65 mmol) natrija na 10 ml vialo.
The antithrombin activity level should be maintained above 80% for the duration of the treatment, unless clinical particulars would indicate a different effective level.
Raven aktivnosti antitrombina morate v času zdravljenja vzdrževati nad 80 %, razen če klinični podatki ne narekujejo drugačne učinkovite ravni.
Antithrombin, a 58 kD, 432 amino-acid glycoprotein, belongs to the serpin (serine protease inhibitor) superfamily.
Antitrombin, 58 kD, 432 aminokislinski glikoprotein, ki pripada naddružini serpinov (zaviralcev serinske proteaze).
In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting.
V telesu antitrombin blokira trombin, snov, ki ima osrednjo vlogo v procesu strjevanja krvi.
During consumptive states (e.g. major surgery, concomitant use of heparin) the actual dose may be higher.
Med večjo porabo (npr. večje operacije, hkratna uporaba heparina) je lahko dejanski odmerek višji.
The solution should be slightly yellow, clear to slightly opalescent.
Raztopina mora biti rumenkasta, bistra do rahlo opalescentna.