natgillin/translations-raw huggingface dataset:
The CHMP reviewed the available safety data on fibrin sealants from clinical studies, post-marketing use and the published literature, focusing on reported cases of confirmed or suspected gas embolism.
CHMP je pregledal razpoložljive varnostne podatke o fibrinskih lepilih iz kliničnih študij, podatke o uporabi zdravila po izdaji dovoljenja za promet in podatke iz objavljene literature, pri čemer se je osredotočil na opisane primere potrjene ali domnevne plinske embolije.
• Surgeons should note the potential risk of gas embolism with incorrect spray application of Tisseel, Tissucol and Artiss and take the necessary precautions detailed in the updated prescribing advice for these medicines.
• Kirurgi naj upoštevajo morebitno tveganje za plinsko embolijo pri neustreznem pršenju zdravil Tisseel, Tissucol in Artiss ter izvajajo potrebne varnostne ukrepe, opredeljene v posodobljenih navodilih o predpisovanju teh zdravil.
On 13 December 2012, the European Medicines Agency completed a review of the safety and effectiveness of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names), following concerns over the risk of gas embolism when these medicines are given by spray application.
Evropska agencija za zdravila je 13. decembra 2012 zaključila pregled varnosti in učinkovitosti fibrinskih lepil Tisseel, Tissucol, Artiss in Beriplast P (in povezanih imen), ki je bil sprožen zaradi zadržkov glede tveganja za plinsko embolijo pri nanosu teh zdravil s pršenjem.
They are composed of two solutions, one containing fibrinogen and another containing thrombin, both of which are proteins involved in the blood clotting process.
Sestavljena so iz dveh raztopin, od katerih ena vsebuje fibrinogen, druga pa trombin.
Regarding Tisseel, Tissucol and Artiss (and associated names), the CHMP concluded that, although the risk of gas embolism was considered very low, risk minimisation measures should be implemented when these medicines are given by spray application to help ensure they are used safely.
Glede zdravil Tisseel, Tissucol in Artiss (in povezanih imen) je CHMP zaključil, da je treba kljub majhnemu tveganju za plinsko embolijo sprejeti ukrepe za zmanjšanje tveganj pri nanosu teh zdravil s pršenjem, da se zagotovi njihova varna uporaba.
The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, stopping the bleeding.
Fibrini se nato združijo (medsebojno zlepijo) in ustvarijo fibrinski strdek, ki pomaga zaceliti rano, saj ustavi krvavenje.
The CHMP noted that all of the cases of gas embolism seen with Evicel and Quixil were related to the use of the spray device at higher-than-recommended pressures or in closer proximity to the tissue surface than recommended.
CHMP je opozoril, da so bili vsi primeri plinske embolije, o katerih so poročali pri uporabi zdravil Evicel in Quixil, posledica uporabe večjega tlaka od priporočenega ali manjše razdalje od tkiva od priporočene.
As Beriplast P (and associated names) does not require a gas-assisted spray device, the CHMP concluded that there is no risk of gas embolism with this product when used in accordance with the prescribing advice and with the recommended device.
Ker zdravilo Beriplast P (in povezana imena) ne zahteva uporabe pripomočka za plinsko pršenje, je CHMP zaključil, da pri uporabi tega zdravila v skladu z navodili o predpisovanju skupaj s priporočeno napravo tveganje za plinsko embolijo ne obstaja.
Fibrin sealants can be applied by dripping or spraying the solution onto bleeding tissue.
Fibrinska lepila se lahko nanesejo s kapanjem ali pršenjem raztopine na krvaveče področje.
The Committee also considered the spray devices used together with these medicines, and the benefit of giving fibrin sealants by spray application.
Prav tako je preučil pršilnike, ki se uporabljajo z zadevnimi zdravili, ter koristi nanosa fibrinskih lepil s pršenjem.
These include Quixil, Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Mednje spadajo zdravila Quixil, Tisseel, Tissucol, Artiss in Beriplast P (in povezana imena).
The current conclusions concern Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Trenutni zaključki veljajo za zdravila Tisseel, Tissucol, Artiss in Beriplast P (in povezana imena).
Questions and answers on the review of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names) given by spray application
Vprašanja in odgovori v zvezi s pregledom fibrinskih lepil Tisseel, Tissucol, Artiss in Beriplast P (in povezanih imen) za pršenje
Evicel is the only centrally authorised fibrin sealant for use by spray application.
Edino fibrinsko lepilo za uporabo s pršenjem, odobreno po centraliziranem postopku, je zdravilo Evicel.
• There is no risk of gas embolism with Beriplast P when used in accordance with the prescribing advice and with the recommended device.
• Pri uporabi zdravila Beriplast P v skladu z navodili o predpisovanju skupaj s priporočeno napravo tveganje za plinsko embolijo ne obstaja.
30 x 1 tablets (unit dose)
30 × 1 tableta (posamezni odmerek)
Tell your doctor:
Povejte zdravniku:
Some patients have actually committed suicide.
Nekaj bolnikov je naredilo samomor.
Date of latest renewal: 23 April 2014
Datum zadnjega podaljšanja: 23. april 2014
Risk to the infant can not be excluded.
Tveganja za dojenčka ne moremo izključiti.
Do not add more food.
Hrane ne dodajte več.
---, not performed.
--, ni izvedeno.
Control regimen (n=635)
kontrolna skupina (n = 635)
any signs of inflammation or infection.
katere koli znake vnetja ali okužbe.
Long-term use of efavirenz in this study was not associated with any new safety concerns.
Dolgotrajna uporaba efavirenza v tej študiji ni bila povezana s kakršnimi koli novimi pomisleki glede varnosti.
These metabolites are essentially inactive against HIV-1.
Ti metaboliti so v glavnem neaktivni proti HIV-1.
Effect of food
Vpliv hrane
if any member of your family (parents, grandparents, brothers or sisters) has died suddenly due to a heart problem or was born with heart problems.
če je kateri koli član vaše družine (starši, stari starši, bratje ali sestre) nenadoma umrl zaradi težav s srcem ali je bil rojen z okvaro na srcu.
Undesirable effects in children were generally similar to those of adult patients.
Neželeni učinki pri otrocih so bili na splošno podobni kakor pri odraslih bolnikih.
Your doctor will test for these changes.
Zdravnik bo opravil preiskave glede teh sprememb
Interaction studies have only been performed in adults.
Študije medsebojnega delovanja so bile izvedene samo pri odraslih.
Children and adolescents (3 months to 17 years)
Otroci in mladostniki (stari od 3 mesecev do 17 let)
Studies were conducted in healthy subjects unless otherwise noted.
Študije so izvajali na zdravih osebah, razen če ni drugače navedeno.
Tell your doctor immediately if you are pregnant or intend to become pregnant.
Zdravniku takoj povejte, če ste noseči ali če nameravate zanositi.
Gender, race, elderly
Spol, rasa, starejši bolniki
Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Take reakcije so značilno opazili v prvih nekaj tednih ali mesecih po uvedbi CART.
SUSTIVA must be taken every day.
Zdravilo SUSTIVA je treba jemati vsak dan.
If you are affected, do not drive and do not use any tools or machines.
Če se to pojavi pri vas, ne vozite in ne upravljajte z orodji ali s stroji.
Some patients have more serious symptoms that may affect mood or the ability to think clearly.
Nekateri bolniki imajo hujše simptome, ki lahko vplivajo na njihovo razpoloženje ali zmožnost jasnega mišljenja.
Study ACTG 364 48 weeks
Študija ACTG 364 48 tednov
Dose reduction or splitting the daily dose has not been shown to provide benefit.
Zmanjšanje odmerka ali razdelitev dnevnega odmerka nista pokazala nobene koristi.
Discuss with your doctor the precautions needed to avoid infecting other people.
Posvetujte se s svojim zdravnikom o potrebnih previdnostnih ukrepih, da se izognete okužbi drugih ljudi.
This will strengthen your immune system and reduce the risk of developing illnesses linked to HIV infection.
To bo okrepilo vaš imunski sistem in zmanjšalo tveganje za razvoj bolezni, povezanih z okužbo z virusom HIV.
You must check with your doctor first.
Najprej se morate posvetovati z zdravnikom.
48 weeks
48 tednov
The dose for children and adolescents is calculated by body weight and is taken once daily as shown below:
Odmerek za otroke in mladostnike je izračunan glede na telesno težo ter se vzame enkrat na dan, kakor je prikazano v naslednji tabeli:
Insufficient numbers of elderly patients have been evaluated in clinical studies to determine whether they respond differently than younger patients.
V kliničnih študijah niso preučili zadostnega števila starejših bolnikov, da bi lahko ugotovili, ali se ti odzivajo drugače od mlajših bolnikov.
Tell your doctor immediately if you feel depressed, have suicidal thoughts or have strange thoughts (see section 4, Possible side effects).
Takoj povejte zdravniku, če se počutite depresivno, mislite na samomor ali imate čudne misli (glejte poglavje 4, Možni neželeni učinki).
Efavirenz has been studied in over 9,000 patients.
Efavirenz so preučevali pri več kot 9.000 bolnikih.
Keep the medicine container with you so that you can easily describe what you have taken.
S seboj imejte embalažo zdravila, da boste lahko opisali, kaj ste zaužili.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Priporočamo, da z virusom HIV okužene matere svojih otrok ne dojijo v nobenem primeru, da bi se izognile prenosu virusa HIV.
Therefore, efavirenz should not be given to children less than 3 months of age.
Zato se efavirenza ne sme dati otrokom, mlajšim od 3 mesecev.
Use a small container for mixing.
Za mešanje uporabite majhno posodo.
Make sure the child eats the full amount of the mixture of food and capsule contents.
Zagotovite, da je otrok pojedel vso mešanico hrane in vsebine kapsule.
Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Kakršnekoli vnetne simptome je potrebno obravnavati in uvesti zdravljenje, kadar je potrebno.
The clinical significance of these effects is not known.
Klinični pomen teh učinkov ni znan.
One patient experienced involuntary muscle contractions.
Pri enem bolniku so se pojavile nehotene mišične kontrakcije.
Efavirenz is highly bound (approximately 99.5 - 99.75%) to human plasma proteins, predominantly albumin.
Efavirenz se močno veže (približno 99,5 - 99,75 %) na človeške plazemske beljakovine, predvsem na albumin.
Tell your doctor if you notice any of the following side effects:
Zdravniku povejte, če opazite katerega koli od naslednjih neželenih učinkov:
Treatment of overdose with efavirenz should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status.
Zdravljenje prevelikega odmerjanja z efavirenzem naj vključuje splošne podporne ukrepe, vključno s spremljanjem življenjskih znakov in opazovanjem bolnikovega kliničnega stanja.
Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms.
Nekaj bolnikov, ki so pomotoma jemali 600 mg dvakrat na dan, je poročalo o večjem pojavljanju simptomov živčnega sistema.
Other interactions: efavirenz does not bind to cannabinoid receptors.
Druge interakcije: efavirenz se ne veže na kanabinoidne receptorje.
Increases in bupropion dosage should be guided by clinical response, but the maximum recommended dose of bupropion should not be exceeded.
Odmerek bupropiona je treba povečati glede na klinični odziv, vendar največji priporočeni odmerek bupropiona ne sme biti presežen.
if your doctor has told you that you have high or low levels of electrolytes such as potassium or magnesium in your blood.
če vam je zdravnik povedal, da imate visok ali nizek nivo elektrolitov, kot sta kalij ali magnezij, v krvi.
This decrease in atazanavir Cmin might negatively impact the efficacy of atazanavir.
To zmanjšanje Cmin atazanavirja lahko negativno vpliva na učinkovitost atazanavirja.
24 weeks
24 tednov
In controlled trials, the frequency of specific serious psychiatric events were:
V nadzorovanih preskušanjih je bila pogostnost določenih resnih psihiatričnih neželenih učinkov sledeča:
Caution is warranted since this dose adjustment might be insufficient in some patients.
Previdnost je utemeljena, saj je lahko tako prilagajanje odmerkov pri nekaterih bolnikih nezadostno.
Skin and subcutaneous tissue disorders very common rash (11.6%)*
Bolezni kože in podkožja zelo pogosti izpuščaj (11,6 %)*
5 SUSTIVA capsules must be opened carefully over the food container, as described in steps 6-7, so that the contents do not spill.
5 Previdno odprite kapsule SUSTIVA nad posodo s hrano, kakor je opisano v korakih 6-7, da ne raztresete vsebine.
What SUSTIVA is and what it is used for 2.
Kaj je zdravilo SUSTIVA in za kaj ga uporabljamo 2.
Patients should be informed that if they do occur, these common symptoms are likely to improve with continued therapy and are not predictive of subsequent onset of any of the less frequent psychiatric symptoms.
Bolnikom je treba povedati, da se bodo ti običajni simptomi, če se pojavijo, najverjetneje z nadaljevanjem terapije izboljšali, in da ne napovedujejo kasnejšega pojava katerega od manj pogostih psihiatričnih simptomov.
For a summary of clinical and pharmacodynamic information, see section 5.1.
Za povzetek kliničnih in farmakodinamičnih informacij glejte poglavje 5.1.
This may make some side effects (for example, dizziness, drowsiness) less troublesome.
Tako so lahko nekateri neželeni učinki (na primer omotica, zaspanost) manj moteči.
Responder rates were highest in patients who switched NRTIs.
Deleži odziva so bili najvišji pri bolnikih, ki so zamenjali NRTI.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Once you start taking SUSTIVA, look out for:
Ko začnete jemati zdravilo SUSTIVA, bodite pozorni na:
- severe disturbances of electrolyte balance e.g. hypokalemia or hypomagnesemia.
- hudo motnjo elektrolitskega ravnotežja, npr. hipokaliemijo ali hipomagnezemijo.
9 If the daily dose consists of more than one capsule, follow steps 5-8 for each capsule.
9 Če za dnevni odmerek potrebujete več kapsul, ponovite korake 5-8 za vsako kapsulo.
Patients should be monitored for seizure control.
Bolnike je treba nadzorovati glede krčev.
unexplained feelings of distress not associated with hallucinations, but it may be difficult to think clearly or sensibly suicide
nepojasnjeni občutki stiske, ki niso povezani s halucinacijami, lahko pa povzročajo težave pri jasnem ali razumnem razmišljanju samomor.
if you have a history of liver disease, including active chronic hepatitis.
če ste v preteklosti imeli bolezen jeter, vključno z aktivnim kroničnim hepatitisom.
QTc Prolongation
Podaljšanje intervala QTc
The mechanism of tumour formation and the potential relevance for humans are not known.
Mehanizem nastanka tumorjev in možen pomen za ljudi nista znana.
Patients who cannot swallow
Bolniki, ki zdravila ne morejo pogoltniti
rare photoallergic dermatitis
redki fotoalergijski dermatitis‡
It is important to tell your doctor or pharmacist if you are taking any of the following:
Pomembno je, da zdravniku ali farmacevtu poveste, če jemljete kar koli od naštetega:
if you have a heart disorder, such as abnormal electrical signal called prolongation of the QT interval.
če imate motnjo v delovanju srca, kot je nenormalen električni signal, ki se imenuje podaljšanje intervala QT.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Dosing at bedtime seems to improve the tolerability of these symptoms and can be recommended during the first weeks of therapy and in patients who continue to experience these symptoms (see section 4.2).
Kaže, da odmerjanje pred spanjem izboljša prenašanje teh simptomov in ga lahko priporočamo v prvih tednih zdravljenja ter pri bolnikih, pri katerih se ti simptomi nadaljujejo (glejte poglavje 4.2).
Confirmatory testing by a more specific method such as gas chromatography/mass spectrometry is recommended in such cases.
V teh primerih je priporočljiva uporaba bolj specifičnih potrditvenih metod, kot sta plinska kromatografija/masna spektrometrija.
If available, 90% or 95% confidence intervals are shown in parentheses.
90-odstotni ali 95-odstotni intervali zaupanja so prikazani v oklepajih, če so na voljo.
If you are pregnant, you should take SUSTIVA only if you and your doctor decide it is clearly needed.
Če ste noseči, lahko zdravilo SUSTIVA jemljete le, če se z zdravnikom skupaj odločita, da je to nujno potrebno.
Use in the paediatric population
Uporaba pri pediatrični populaciji
Your doctor has prescribed SUSTIVA for you because you have HIV infection.
Zdravnik vam je predpisal zdravilo SUSTIVA, ker ste okuženi z virusom HIV.
Patients with severe hepatic impairment (Child Pugh Class C) (see section 5.2).
Bolniki s hudo okvaro jeter (razred C po Child Pugh-u) (glejte poglavje 5.2).
14 Have the child eat the full amount again (illustration f).
14 Znova dajte otroku vso količino hrane (slika f).
Try not to miss a dose.
Trudite se, da ne bi izpustili nobenega odmerka.
Not recommended as the exposure to both PIs is expected to be significantly decreased.
Ne priporočamo, ker lahko pričakujemo, da bi s tem pomembno zmanjšali izpostavitev obema ZP.
Frequency is defined using 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); or very rare (< 1/10,000).
Pogostnost je definirana z uporabo sledečega dogovora: zelo pogosti (≥ 1/10); pogosti (≥ 1/100, < 1/10); občasni (≥ 1/1.000, < 1/100); redki (≥ 1/10.000, < 1/1.000) ali zelo redki (< 1/10.000).
Instructions for capsule sprinkle method:
Navodila za uporabo metode posutja kapsule:
astemizole or terfenadine (used to treat allergy symptoms)
astemizol ali terfenadin (za zdravljenje alergijskih simptomov)
The incidence of erythema multiforme or Stevens-Johnson syndrome was approximately 0.1%.
Pojavnost multiformnega eritema ali Stevens-Johnsonovega sindroma je bila približno 0,1 %.
†These adverse reactions were identified through post-marketing surveillance; however, the frequencies were determined using data from 16 clinical trials (n=3,969).
†Te neželene učinke so odkrili med spremljanjem zdravila na trgu; vendar pa so bile pogostnosti določene z uporabo podatkov iz 16 kliničnih preskušanj (n = 3.969).
What you need to know before you take SUSTIVA 3.
Kaj morate vedeti, preden boste vzeli zdravilo SUSTIVA 3.
When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by SUSTIVA or by other medicines that you are taking at the same time, or by the HIV disease itself.
Pri zdravljenju okužbe s HIV je včasih težko reči, ali se nekateri neželeni učinki pojavijo zaradi zdravila SUSTIVA, drugih zdravil, ki jih jemljete sočasno, ali zaradi bolezni HIV same.
Despite the decrease in buprenorphine exposure, no patients exhibited withdrawal symptoms.
Kljub zmanjšanju izpostavljenosti buprenorfinu se pri bolnikih niso pokazali odtegnitveni simptomi.
For the drug-drug interaction with etonogestrel implant, the PRAC noted the available data from 16 case reports and the published literature articles by Vieira et al., 2014 and Chappel et al., 2017.
Odbor PRAC je za medsebojno delovanje zdravil z vsadkom etonogestrela upošteval razpoložljive podatke iz 16 poročil o primerih in iz člankov, objavljenih v literaturi, avtorjev Vieira et al., 2014, in Chappel et al., 2017.
Annex IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Priloga IV ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM
Opening the capsule and taking the contents with a small amount of food may be considered for children who cannot swallow the hard capsule.
Odpiranje kapsule in jemanje vsebine z majhno količino hrane je lahko rešitev za otroke, ki ne morejo pogoltniti trdih kapsul.
In such patients, interruption or discontinuation of treatment must be considered (see section 4.8).
Pri teh bolnikih je potrebno razmisliti o prekinitvi oziroma prenehanju zdravljenja (glejte poglavje 4.8).
any signs of skin rash.
kateri koli znak kožnega izpuščaja.
The incidence of neural tube defects in the general population ranges from 0.5-1 case per 1,000 live births.
Pojavnost okvar nevralne cevi v splošni populaciji se giblje v razponu od 0,5 do 1 primer na 1.000 živorojenih otrok.
If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose.
Če kljub temu izpustite odmerek, vzemite naslednji odmerek takoj, ko je mogoče, vendar ne vzemite dvojnega odmerka, da bi nadomestili izpuščenega.
If you have severe liver disease, do not take SUSTIVA (see section 2, Do not take SUSTIVA).
Če imate hudo bolezen jeter, ne jemljite zdravila SUSTIVA (glejte poglavje 2, Ne jemljite zdravila SUSTIVA).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 May 1999
Datum prve odobritve: 28. maj 1999
Similar elevations were seen in patients treated with control regimens (5% after long-term treatment).
Podobna povišanja so opazili tudi pri bolnikih na kontrolnem režimu (5 % po dolgotrajnem zdravljenju).
The standard doses of NRTIs given every 12 hours were used in each of these studies.
V vsaki od teh študij so uporabili standardne odmerke NRTI-jev na vsakih 12 ur.
Contraindications of concomitant use
Kontraindikacije za sočasno uporabo
If any antiretroviral medicinal product in a combination regimen is interrupted because of suspected intolerance, serious consideration should be given to simultaneous discontinuation of all antiretroviral medicinal products.
Če bolnik katero od protiretrovirusnih zdravil v kombiniranem režimu preneha jemati zaradi suma intolerance, je treba resno premisliti o istočasnem prenehanju jemanja vseh protiretrovirusnih zdravil.
This medicine is not a cure for HIV infection and you may continue to develop infections or other illnesses associated with HIV disease.
To zdravilo ne pozdravi okužbe s HIV in pri vas se bodo lahko še naprej pojavljale okužbe ali druge bolezni, povezane z boleznijo HIV.
Clinical experience in controlled studies with combinations including didanosine or zalcitabine is limited.
Klinične izkušnje iz nadzorovanih študij s kombinacijami zdravil, ki so vključevale didanozin ali zalcitabin, so omejene.
What SUSTIVA is and what it is used for
Kaj je zdravilo SUSTIVA in za kaj ga uporabljamo
The doctor may also recommend this method of taking SUSTIVA for adults who cannot swallow capsules.
Zdravnik lahko takšen način uporabe zdravila SUSTIVA priporoči tudi odraslim osebam, ki ne morejo pogoltniti kapsul.
Verapamil, Felodipine, Nifedipine and Nicardipine
verapamil, felodipin, nifedipin in nikardipin
if you have a heart condition, such as changes in the rhythm or rate of the heart beat, a slow heart beat, or severe heart disease.
če imate bolezen srca, kot so sprememba ritma ali hitrosti bitja srca, počasen srčni utrip ali hudo bolezen srca.