natgillin/translations-raw huggingface dataset:
For more information about treatment with TachoSil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom TachoSil preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
A risk management plan has been developed to ensure that TachoSil is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila TachoSil je bil pripravljen načrt obvladovanja tveganj.
TachoSil should only be used by an experienced surgeon.
Zdravilo TachoSil lahko uporablja le izkušen kirurg.
The main measure of effectiveness was the number of patients whose bleeding had stopped after three minutes.
Glavno merilo učinkovitosti je bilo število bolnikov, ki so prenehali krvaveti po treh minutah.
What benefit has TachoSil shown during the studies?
Kakšne koristi je zdravilo TachoSil izkazalo med študijami?
Thrombin works by converting fibrinogen into smaller units called fibrin, which then stick together to form a local clot.
Trombin deluje tako, da pretvarja fibrinogen v manjše enote, imenovane fibrin, ki se nato zlepljajo in tvorijo lokalni strdek.
The CHMP decided that TachoSil's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila TachoSil večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The first study looking at lung surgery patients was not sufficient to support the use of TachoSil in sealing tissue since very few patients in the study had any air leakage.
Prva študija na bolnikih, operiranih na pljučih, ni zadoščala za podporo uporabe zdravila TachoSil za zapiranje tkiva, saj so pri zelo malo bolnikih iz študije zaznali kakršno koli uhajanje zraka.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for TachoSil.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with TachoSil?
Kakšna tveganja so povezana z zdravilom TachoSil?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for TachoSil, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
TachoSil should only be applied directly onto the treatment site so that it covers 1 to 2 cm beyond the edge of the wound.
Zdravilo TachoSil se uporablja le neposredno na mestu zdravljenja, in sicer tako, da sega 1-2 cm preko robov rane.
In the first study, the average time until bleeding stopped was 3.9 minutes with TachoSil compared with 6.3 minutes with the argon beamer, and in the second study, these values were 3.6 and 5.0 minutes, respectively.
V prvi študiji je bil povprečen čas, potreben za zaustavitev krvavitve, pri uporabi zdravila TachoSil 3,9 minut, ob uporabi argonskega plazemskega koagulatorja pa 6,3 minute, medtem ko so bile v drugi študiji te vrednosti 3,6 in 5,0 minut.
This way it prevents the cerebrospinal fluid from leaking.
S tem prepreči prepuščanje cerebrospinalne tekočine.
The active substances in TachoSil, fibrinogen and thrombin, are proteins extracted from blood, which are involved in the natural clotting process.
Zdravilni učinkovini v zdravilu TachoSil, fibrinogen in trombin, sta beljakovini, ki ju pridobivajo iz krvi, in ki sodelujeta pri naravnem procesu strjevanja krvi.
• during an operation, to stop bleeding and to seal the surfaces of internal organs;
• pri kirurških posegih za zaustavitev krvavitve in za zapiranje površin notranjih organov;
• Two studies were carried out to see if TachoSil could be used as a tissue sealant.
• Izvedeni sta bili dve študiji, da bi preverili, ali bi bilo mogoče zdravilo TachoSil uporabiti za zapiranje tkiva.
TachoSil must not be applied inside a blood vessel.
Zdravilo TachoSil se ne sme uporabiti znotraj krvnih žil.
However, in the second study, which involved 301 patients, it took an average of 15.3 hours for leakage to stop with TachoSil compared with 20.5 hours with current techniques.
Vendar pa je bil v drugi študiji, v kateri je sodeloval 301 bolnik, čas, potreben za zaustavitev puščanja, v povprečju 15,3 ure z zdravilom TachoSil v primerjavi z 20,5 ure pri standardnih tehnikah.
• Another study in 726 patients compared TachoSil with current techniques used in daily practice in preventing CSF leakage during neurological surgery.
• V drugi študiji pri 726 bolnikih so zdravilo TachoSil primerjali s tehnikami, ki se trenutno uporabljajo v dnevni praksi preprečevanja prepuščanja cerebrospinalne tekočine pri nevrokirurških posegih.
The main measure of effectiveness was the time until the bleeding stopped.
Glavno merilo učinkovitosti je bil čas, potreben za zaustavitev krvavitve.
• Two of the studies looked at the effects of TachoSil in stopping bleeding.
• v dveh študijah so raziskovali vpliv zdravila TachoSil na zaustavitev krvavitve.
Like other sealants, TachoSil may cause an allergic reaction.
Kot druga sredstva za zapiranje tkiva lahko tudi zdravilo TachoSil povzroči alergijske reakcije.
• during neurological surgery to prevent leakage of the fluid surrounding the brain (called cerebrospinal fluid or CSF).
• pri nevrokirurških posegih za preprečevanje puščanja tekočine, ki obdaja možgane (imenovane cerebrospinalna tekočina).
Why has TachoSil been approved?
Zakaj je bilo zdravilo TachoSil odobreno?
When TachoSil is applied to a bleeding area during surgery, the moisture causes the active substances to react together, leading to the rapid formation of a clot.
Ko se zdravilo TachoSil med kirurškim posegom uporabi na območju krvavitve, vlaga povzroči, da zdravilni učinkovini reagirata skupaj, kar spodbudi hitrejše tvorjenje strdka.
For the full list of all side effects and restrictions with TachoSil, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila TachoSil glejte navodilo za uporabo.
TachoSil was also more effective than standard materials at stopping bleeding during surgery on the heart or blood vessels.
Zdravilo TachoSil je bilo učinkovitejše od standardnih materialov pri zaustavljanju krvavitve med kirurškimi posegi na srcu ali krvnih žilah.
The clot enables the patch to stick more firmly to the tissue, helping to stop the bleeding and sealing the wound.
Zaradi strdka se obliž lahko tesneje prilega tkivu, kar pomaga zaustaviti krvavitev in zapreti rano.
• A sixth study looked at the effectiveness of TachoSil in surgery on the heart or major blood vessels.
• V šesti študiji so merili učinkovitost zdravila TachoSil pri kirurških posegih na srcu in glavnih krvnih žilah.
In the study in neurological surgery, TachoSil was comparable to current techniques: around 7% (25 out of 361) of patients treated with TachoSil had a leak of CSF, compared with around 8% (30 out of 365) of patients on current techniques.
V študiji nevrokirurških posegov je bilo zdravilo TachoSil primerljiv s sedanjimi tehnikami: pri približno 7 % (25 od 361) bolnikov, zdravljenih z zdravilom TachoSil, je prišlo do prepuščanja cerebrospinalne tekočine, v primerjavi s približno 8 % (30 od 365) tistimi, ki so bili zdravljeni s sedanjimi tehnikami.
TachoSil is a sealant patch coated with the active substances human fibrinogen and human thrombin.
Zdravilo TachoSil je obliž za zapiranje tkiva z zdravilnima učinkovinama humanim fibrinogenom in humanim trombinom.
The amount of TachoSil to be used depends on the size of the wound and the material can be cut to size if needed.
Količina zdravila TachoSil je odvisna od velikosti rane.
The study compared TachoSil with standard materials in 120 patients, of whom around three-quarters also had surgery on vessels with stitches and one-quarter had surgery on the heart.
V študiji so zdravilo TachoSil primerjali s standardnimi materiali pri 120 bolnikih, od katerih jih je približno 75 % imelo tudi kirurški poseg na ožilju s šivi, 25 % pa poseg na srcu.
After three minutes, bleeding had stopped in 75% of the patients treated with TachoSil (44 out of 59), compared with 33% of those treated with standard techniques (20 out of 60).
(44 od 59), zdravljenih z zdravilom TachoSil, v primerjavi s 33 % (20 od 60) tistih, zdravljenih s standardnimi tehnikami.
• as support to stitching during surgery on the blood vessels;
• kot pomoč pri šivanju pri kirurških posegih na ožilju;
Patients may also develop antibodies to the proteins in TachoSil, which could interfere with blood clotting.
Za beljakovine zdravila TachoSil se lahko pri bolniku pojavijo protitelesa, ki lahko ovirajo strjevanje krvi.
Effectiveness was measured by looking at whether air leaked from the lungs after surgery.
Merilo učinkovitosti je bilo, ali po kirurškem posegu iz pljuč uhaja zrak.
In neurological surgery, it works by sealing together the cut areas of the outermost layer (dura mater) of the membranes around the brain.
Pri nevrokirurških posegih deluje tako, da zapre razrezana tkiva zunanje možganske ovojnice (dura mater).
What is TachoSil used for?
Za kaj se zdravilo TachoSil uporablja?
How has TachoSil been studied?
Kako je bilo zdravilo TachoSil raziskano?
What is TachoSil?
Kaj je zdravilo TachoSil?
The studies compared the effects of TachoSil and an argon beamer (a device that sears the cut surface and reduces bleeding) in a total of 240 adults having liver surgery.
V študijah pri 240 odraslih bolnikih, ki so imeli kirurški poseg na jetrih, so primerjali vpliv zdravila TachoSil in argonskega plazemskega koagulatorja (naprave, s katero termično koaguliramo porezano površino in zmanjšamo krvavenje).
How does TachoSil work?
Kako zdravilo TachoSil deluje?
The studies compared TachoSil and standard surgical techniques, such as stitching and stapling, in a total of 490 patients having lung surgery.
V študijah so pri 490 bolnikih, ki so imeli kirurški poseg na pljučih, primerjali zdravilo TachoSil in standardne kirurške tehnike, kot so šivanje in spenjanje.
A third study compared TachoSil with standard stitching in 185 patients having kidney surgery.
V tretji študiji so pri 185 bolnikih, ki so imeli kirurški poseg na ledvicah, zdravilo TachoSil primerjali z običajnim šivanjem.
TachoSil was more effective than the argon beamer at stopping bleeding during liver surgery.
Pri kirurškem posegu na jetrih je bilo v primerjavi z argonskim plazemskim koagulatorjem zdravilo TachoSil učinkovitejše pri zaustavljanju krvavitve.
How is TachoSil used?
Kako se zdravilo TachoSil uporablja?
Thromboembolic complications (blood clots in vessels) may occur if TachoSil is applied inside a blood vessel.
Če se zdravilo TachoSil nenamerno uporabi v krvni žili, lahko nastanejo tromboembolični zapleti (krvni strdki v žilah).
TachoSil was more effective than stitching in the kidney surgery patients.
Pri bolnikih, ki so imeli kirurški poseg na ledvicah, je bilo zdravilo TachoSil bolj učinkovito kot šivanje.
This summary was last updated in 04-2008.
Povzetek je bil nazadnje posodobljen 04-2008.
This helps to protect against the diseases that these bacteria and viruses cause.
To pripomore k zaščiti pred boleznimi, ki jih povzročajo te bakterije in virusi.
The vaccine is ‘adsorbed'.
Cepivo je „adsorbirano“.
The Hib component has also been available in other vaccines.
Tudi sestavina proti Hib je bila na voljo v drugih cepivih.
This means that the active substances are fixed on aluminium compounds, to stimulate a better immune response.
To pomeni, da so zdravilne učinkovine fiksirane na aluminijeve spojine za boljšo stimulacijo imunskega odziva.
Their breathing should be monitored for up to three days after vaccination.
Pri teh otrocih je treba dihanje spremljati do tri dni po cepljenju.
In all of the studies, the main measure of effectiveness was the production of protective levels of antibodies after the final vaccination.
V vseh študijah je bilo glavno merilo učinkovitosti nastanek zaščitnih ravni protiteles po opravljenem končnem cepljenju.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) QUINTANRIX EPAR summary for the public
EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) QUINTANRIX Povzetek EPAR za javnost
It should be used according to official recommendations.
S cepivom cepimo v skladu z uradnimi priporočili.
The medicine can only be obtained with a prescription.
Cepivo se dobi samo na recept.
The European Commission granted a marketing authorisation valid throughout the EU for Quintanrix to GlaxoSmithKline Biologicals s.a. on 21 October 2004.
Evropska komisija je dovoljenje za promet s cepivom Quintanrix, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 21. oktobra 2004.
The effects of Quintanrix have been studied in five main studies involving over 2,000 infants.
Učinke cepiva Quintanrix so preučevali v petih glavnih študijah, v katere je bilo vključenih več kot 2000 dojenčkov.
It should not be given if the child has had encephalopathy (a brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis.
Cepiva ne smejo prejeti otroci, ki so imeli encefalopatijo (bolezen možganov) neznanega vzroka v sedmih dneh po prejšnjem cepljenju s cepivom proti oslovskemu kašlju.
• killed whole B. pertussis;
• uničene cele bakterije B. pertussis,
• ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
• „površinski antigen“ (beljakovino površine) virusa hepatitisa B.
These active substances were also available in other vaccines before that date.
Te zdravilne učinkovine so bile še pred tem na voljo tudi v drugih cepivih.
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
Ko otroka cepimo, imunski sistem prepozna dele bakterij in virusa kot „tuje“ in izdela protitelesa, usmerjena proti njim.
There was no impact of prior hepatitis B vaccination on the effectiveness of Quintanrix.
Predhodno cepljenje proti hepatitisu B ni vplivalo na učinkovitost cepiva Quintanrix.
Quintanrix is a vaccine, which is available as a powder and suspension to be made up into a suspension for injection.
Zdravilo Quintanrix je cepivo, ki je na voljo kot prašek in suspenzija, iz katerih se pripravi suspenzija za injiciranje.
The vaccine is given by deep injection into a muscle, preferably the thigh.
Cepivo se daje z globokim injiciranjem v mišico, najboljše v stegno.
Quintanrix is a vaccine.
Zdravilo Quintanrix je cepivo.
It is also used as a booster immunisation of young children during the second year of life.
Uporablja se tudi za obnovitveno cepljenje otrok med drugim letom življenja.
• toxoids from the bacteria that cause diphtheria and tetanus;
• toksoidov iz bakterij, ki povzročata davico in tetanus,
Other information about Quintanrix:
Druge informacije o zdravilu Quintanrix:
The Committee recommended that Quintanrix be given marketing authorisation.
Odbor je priporočil, da se za cepivo Quintanrix odobri dovoljenje za promet.
The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Površinske antigene virusa hepatitisa B proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri kvasovka prejme gen (DNK), s katerim lahko tvori beljakovine.
After the first vaccination course, a booster should be given, preferably before the end of the second year of life.
Po končanem osnovnem cepljenju je potrebno opraviti obnovitveno cepljenje, po možnosti pred dopolnjenim drugim letom starosti.
Quintanrix should not be used in people who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Cepiva Quintanrix ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilne učinkovine ali katerokoli drugo sestavino cepiva.
The recommended vaccination schedule for Quintanrix is three doses, given at intervals of at least four weeks within the first six months of life.
Priporočena shema cepljenja za cepivo Quintanrix je sestavljena iz treh odmerkov, ki se jih daje v prvih šestih mesecih življenja s časovnimi presledki najmanj 4 tedne.
Quintanrix can be given to children who received a hepatitis B vaccine at birth.
Cepivo Quintanrix se lahko daje otrokom, ki so prejeli cepivo proti hepatitisu B ob rojstvu.
Quintanrix contains small amounts of:
Cepivo Quintanrix vsebuje majhne količine:
What benefit has Quintanrix shown during the studies?
Kakšne koristi je zdravilo Quintanrix izkazalo med študijami?
The most common side effects with Quintanrix (seen in more than 1 in 10 doses of the vaccine) are irritability, drowsiness, loss of appetite, pain, redness and swelling, and fever.
Najpogostejši neželeni učinki cepiva Quintanrix (opaženi pri več kot 1 od 10 odmerkov cepiva) so razdražljivost, zaspanost, izguba apetita, bolečine, pordelost, otekanje in zvišana telesna temperatura.
• polysaccharides extracted from the ‘capsules' that surround the bacterium Hib - the polysaccharides are chemically attached (conjugated) to tetanus toxoid as a carrier protein because this improves the response to the vaccine;
• polisaharide iz kapsule, ki obdaja bakterijo Hib - polisaharidi so kemijsko vezani (konjugirani) na tetanusni toksoid, ki deluje kot nosilna beljakovina, saj to izboljša odziv na cepivo,
Quintanrix should be postponed in people with a severe sudden fever.
Cepljenje s cepivom Quintanrix je treba odložiti pri osebah s hudo, nenadno zvišano telesno temperaturo.
The fourth study compared the effects of Quintarix given at six, 10 and 14 weeks of age in 318 infants who either had or had not received a hepatitis B vaccine at birth.
V četrti študiji so primerjali učinke cepiva Quintanrix, uporabljenega pri šestih, 10 in 14 tednih starosti pri 318 dojenčkih, ki so prejeli cepivo proti hepatitisu B ob rojstvu ali pa ne.
The study of booster vaccination also showed Quintanrix was as effective as the two separate vaccines, with between 92 and 100% of the infants having protective levels of antibodies 42 days after the booster vaccination.
Študija obnovitvenega cepljenja je pokazala, da je cepivo Quintanrix enako učinkovito kot dve ločeni cepivi, saj je imelo 42 dni po obnovitvenem cepljenju od 92 do 100 % otrok zaščitne ravni protiteles.
The first dose can be administered at six weeks of age.
Otrok lahko prejme prvi odmerek cepiva pri 6 tednih starosti.
It contains the following active substances: toxoids (chemically weakened toxins) from diphtheria and tetanus, inactivated (killed) Bordetella pertussis (a bacterium that causes whooping cough), parts of the hepatitis B virus and polysaccharides (sugars) from the bacterium Haemophilus influenzae type b (‘Hib', a bacterium that causes meningitis).
Cepivo vsebuje naslednje zdravilne učinkovine: toksoida (kemijsko oslabljena toksina) iz bakterij, ki povzročata davico in tetanus, inaktivirano (uničeno) bakterijo Bordetella pertussis (bakterijo, ki povzroča oslovski kašelj), dele virusa hepatitisa B in polisaharide (sladkorje) iz bakterije Haemophilus influenzae tipa b („Hib“, bakterije, ki povzroča meningitis).
The active substances in Quintanrix have been available in the European Union (EU) for a number of years in other vaccines: diphtheria, tetanus, pertussis and hepatitis B, has been available in Tritanrix HepB since 1996.
Zdravilne učinkovine v cepivu Quintanrix so bile na voljo v Evropski uniji (EU) že več let v drugih cepivih: učinkovine proti davici, tetanusu, oslovskemu kašlju in hepatitisu B so bile na voljo v cepivu Tritanrix HepB od leta 1996.
For the full list of side effects reported with Quintanrix, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Quintanrix, glejte navodilo za uporabo.
As for all vaccines, if Quintanrix is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Če cepivo Quintanrix kot tudi vsa cepiva uporabimo pri veliko prezgodaj rojenih nedonošenčkih, obstaja tveganje pojava apneje (kratkih prekinitev dihanja).
What is the risk associated with Quintanrix?
Kakšna tveganja so povezana z zdravilom Quintanrix?
Why has Quintanrix been approved?
Zakaj je bilo zdravilo Quintanrix odobreno?
The Committee for Medicinal Products for Human Use (CHMP) decided that Quintanrix's benefits are greater than its risks for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Hib and for booster immunisation of young children during the second year of life.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi cepiva Quintanrix večje od z njim povezanih tveganj primarnega cepljenja dojenčkov (med prvim letom starosti) proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in invazivni bolezni, ki jo povzroči Hib, in tveganj obnovitvenega cepljenja majhnih otrok med drugim letom starosti.
Quintarix was as effective as the two separate vaccines at producing protective levels of antibodies.
Cepivo Quintanrix je enako učinkovito spodbudilo nastanek zaščitnih ravni protiteles kot ločeni cepivi.
Quintanrix is used to vaccinate infants under one year of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and ‘invasive' diseases caused by Hib (such as bacterial meningitis).
Cepivo Quintanrix se uporablja za cepljenje otrok, mlajših od enega leta, proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in „invazivnim“ boleznim, ki jih povzroča Hib (kot je bakterijski meningitis).
The fifth study looked at the effects of a fourth, booster dose of Quintanrix in the second year of life in 357 infants.
V peti študiji so pri 357 dojenčkih preučevali učinke četrtega, obnovitvenega odmerka cepiva Quintanrix v drugem letu starosti.
The full EPAR for Quintanrix can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za cepivo Quintanrix je na voljo tukaj.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Ob naravni izpostavitvi bakterijam ali virusu bo imunski sistem izdelal protitelesa hitreje.
Overall, between 95 and 100% of the infants had protective levels of antibodies to diphtheria, tetanus, pertussis, hepatitis B and Hib, one month after the first vaccination course.
V prvem mesecu po osnovnem cepljenju je imelo skupno 95 do 100 % dojenčkov zaščitne ravni protiteles proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in Hib.
How has Quintanrix been studied?
Kako je bilo zdravilo Quintanrix raziskano?
What is Quintanrix?
Kaj je zdravilo Quintanrix?
What is Quintanrix used for?
Za kaj se zdravilo Quintanrix uporablja?
How does Quintanrix work?
Kako zdravilo Quintanrix deluje?
In three studies, the effects of Quintarix were compared with those of the combination of Tritanrix HepB and a vaccine containing Hib: two of these studies involved a total of 1,208 infants who were vaccinated at two, four and six months of age and one involved 294 infants vaccinated at three, four and five months of age.
V dve študiji je bilo vključenih skupno 1208 dojenčkov, ki so bili cepljeni pri starostih dva, štiri in šest mesecev.
How is Quintanrix used?
Kako se zdravilo Quintanrix uporablja?
Quintanrix can also be used to boost previous vaccinations against diphtheria, tetanus and pertussis, against hepatitis B or against Hib, when it should be given at least six months after the last dose of the first vaccination course.
Cepivo Quintanrix se lahko uporablja za obnovitev odziva na prejšnja cepljenja proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in Hib.