natgillin/translations-raw huggingface dataset:
For more information about treatment with Rotarix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Rotarix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The vaccine can only be obtained with a prescription.
Izdaja cepiva je le na recept.
Rotarix contains a live attenuated (weakened) form of the human rotavirus (RIX4414 strain).
Cepivo Rotarix vsebuje živo atenuirano (oslabljeno) obliko humanega rotavirusa (sev RIX4414).
Overall, the clinical studies of Rotarix involved over 75,000 babies and took place in various countries worldwide.
Klinične študije cepiva Rotarix so skupaj zajele prek 75 000 dojenčkov in so potekale v različnih državah po vsem svetu.
A risk management plan has been developed to ensure that Rotarix is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Rotarix je bil pripravljen načrt obvladovanja tveganj.
The same vaccination course can be used in babies born up to 13 weeks prematurely (from 27 weeks gestational age).
Enaka shema se lahko uporabi pri dojenčkih, ki so se rodili največ 13 tednov prezgodaj (po 27. tednu gestacijske starosti).
The most common side effects with Rotarix (seen in between 1 and 10 patients in 100) are diarrhoea and irritability.
Najpogostejša neželena učinka cepiva Rotarix (opažena pri 1 do 10 bolnikih od 100) sta driska in razdražljivost.
Rotarix rotavirus vaccine, live
Rotarix cepivo proti rotavirusu, živo
It must also not be given to patients who have disorders that cause severe abnormalities of the immune system called ‘severe combined immunodeficiency', who have had intussusception in the past, or who have problems with their bowel that could put them at risk of intussusception.
Ne sme se uporabljati pri bolnikih z obolenji, ki povzročajo resne nepravilnosti imunskega sistema, imenovane „huda kombinirana imunodeficienca“, ki so v preteklosti imeli invaginacijo ali ki imajo težave s črevesjem, zaradi česar obstaja nevarnost za invaginacijo.
The first dose is given when the baby is older than six weeks.
Prvi odmerek dojenček prejme po šestem tednu starosti.
This helps to protect against gastroenteritis caused by rotavirus.
To pomaga pri zaščiti pred gastroenteritisom, ki ga povzroča rotavirus.
What benefit has Rotarix shown during the studies?
Kakšne koristi je zdravilo Rotarix izkazalo med študijami?
These results were compared with the findings of a study in babies born at full term who were vaccinated with Rotarix.
Te rezultate so primerjali z ugotovitvami študije pri polno donošenih dojenčkih, ki so bili cepljeni s cepivom Rotarix.
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 Rotarix.
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.
Rotarix is used in babies aged from 6 to 24 weeks to protect against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infections.
Cepivo Rotarix se uporablja pri dojenčkih, starih od 6 do 24 tednov, za zaščito pred gastroenteritisom (drisko in bruhanjem), ki ga povzroča okužba z rotavirusi.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rotarix, 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.
Rotarix must not be used in babies who are hypersensitive (allergic) to any of the ingredients of the vaccine or those who showed signs of allergy after receiving a dose of rotavirus vaccine in the past.
Cepivo Rotarix se ne sme uporabiti pri dojenčkih, ki so preobčutljivi za (alergični na) katero koli sestavino zdravila, ali dojenčkih, ki so v preteklosti kazali znake alergije po prejemu odmerka cepiva proti rotavirusom.
In the main study, the number of cases of severe rotavirus gastroenteritis was lower following vaccination with Rotarix: 0.1% of the babies vaccinated with Rotarix in whom effectiveness was assessed developed severe rotavirus gastroenteritis (12 out of over 9,000) compared with 0.9% of the babies who received placebo (77 out of almost 9,000).
V glavni študiji je bilo število primerov hudega rotavirusnega gastroenteritisa po cepljenju s cepivom Rotarix manjše: hud rotavirusni gastroenteritis se je razvil pri 0,1 % (12 od več kot 9 000) dojenčkov, cepljenih s cepivom Rotarix, pri katerih so ugotavljali učinkovitost cepiva, v primerjavi z 0,9 % (77 od skupno 9 000)dojenčkov, ki so prejeli placebo.
If the ready-made oral suspension is used, the contents of the prefilled oral applicator or tube should be given into the mouth of the baby.
Če se za cepljenje uporablja že pripravljena peroralna suspenzija, je treba vsebino predhodno napolnjenega peroralnega aplikatorja ali tube dati v dojenčkova usta.
If the powder and solvent are used, they should be mixed together just before the vaccine is given, and the resulting suspension given directly into the mouth of the baby using the oral applicator provided.
Če se za cepljenje uporabljata prašek in vehikel, ju je treba zmešati tik pred cepljenjem, tako dobljeno suspenzijo pa je treba dojenčku dati neposredno v usta s pomočjo priloženega peroralnega aplikatorja.
A further study looked at the safety of Rotarix and its ability to stimulate the production of antibodies in 1,009 babies born up to 13 weeks prematurely.
V dodatni študiji so proučevali varnost cepiva Rotarix ter njegovo sposobnost spodbujanja tvorbe protiteles pri 1 009 dojenčkih, rojenih največ 13 tednov prezgodaj.
Rotarix contains small amounts of rotavirus, a virus that causes gastroenteritis.
Cepivo Rotarix vsebuje majhno količino rotavirusa, tj. virusa, ki povzroča gastroenteritis.
The CHMP decided that Rotarix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Rotarix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Four additional studies were carried out in over 3,000 infants, to confirm that the ready-for-use forms of the vaccine were as safe and as effective as the powder and solvent formulation in stimulating the production of antibodies against rotavirus.
V štirih dodatnih študijah, v katerih je sodelovalo več kot 3 000 dojenčkov, so ugotavljali, ali so formulacije cepiva, ki so že pripravljene za uporabo, enako varne in učinkovite pri stimulaciji tvorbe protiteles proti rotavirusom kot formulacija, ki zajema prašek in vehikel.
Vaccination with Rotarix should be postponed in babies who have a sudden high fever, diarrhoea or vomiting.
Cepljenje s cepivom Rotarix je treba preložiti pri dojenčkih, ki imajo nenadno povišano telesno temperaturo, drisko ali bruhajo.
Rotarix is given as two doses, at least four weeks apart.
Cepivo Rotarix se daje v dveh odmerkih, med katerima mora biti najmanj štiritedenski premor.
The main study compared Rotarix with placebo (a dummy vaccine) in over 63,000 babies who were born at full term (after a pregnancy of at least 36 weeks).
V glavni študiji so cepivo Rotarix primerjali s placebom (cepivom brez zdravilne učinkovine) pri več kot 63 000 polno donošenih dojenčkih (rojenih po 36. tednu nosečnosti).
• an oral suspension in a prefilled oral applicator;
• kot peroralna suspenzija v predhodno napolnjenem peroralnem aplikatorju;
The benefit of the vaccine was measured by looking at how many babies developed severe rotavirus gastroenteritis in the months after they had been vaccinated and before they had reached one year of age.
Koristnost cepiva so merili na podlagi števila dojenčkov, pri katerih se je v obdobju po cepljenju in pred dopolnjenim enim letom starosti razvil hud rotavirusni gastroenteritis.
What is the risk associated with Rotarix?
Kakšna tveganja so povezana z zdravilom Rotarix?
When an infant is given the vaccine, the immune system (the system that fights diseases) recognises the weakened virus as ‘foreign' and makes defences against it. After vaccination, the immune system is able to respond more quickly when it is exposed to the virus again.
Ko dojenček prejme cepivo, imunski sistem (sistem, ki se bori proti boleznim) prepozna oslabljeni virus kot „tujek“ in proti njemu začne tvoriti protitelesa.
For the full list of all side effects reported with Rotarix, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Rotarix, glejte navodilo za uporabo.
Very rarely (seen in less than 1 patient in 10,000), a serious condition called intussusception (in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage) has been reported after the use of rotavirus vaccines.
Zelo redko (pri manj kot 1 bolniku od 10 000) so po uporabi cepiv proti rotavirusom poročali o resnem neželenem učinku, imenovanem invaginacija (pri katerem se del črevesja uviha v drug del črevesja, kar povzroči zaporo).
Ideally, both doses should be given before the baby is aged 16 weeks and they must be given by the time the baby is 24 weeks old.
Najbolje je, da se cepljenje z obema odmerkoma opravi pred dopolnjenim 16. tednom starosti, vsekakor pa mora biti zaključeno pred dopolnjenim 24. tednom starosti.
• a powder and solvent that are made up into an oral suspension in an oral applicator;
• kot prašek in vehikel, ki se v peroralnem aplikatorju zmešata v peroralno suspenzijo;
Rotarix was more effective than placebo in preventing severe gastroenteritis due to rotavirus.
Cepivo Rotarix je bilo pri preprečevanju hudega gastroenteritisa, ki ga povzroča rotavirus, učinkovitejše od placeba.
Why has Rotarix been approved?
Zakaj je bilo zdravilo Rotarix odobreno?
The study in premature babies showed that Rotarix was well tolerated and produced similar levels of antibodies as in infants born at full term.
Študija pri nedonošenčkih je pokazala, da cepivo Rotarix dobro prenašajo in da je cepivo spodbudilo tvorbo podobnih ravni protiteles kot pri polno donošenih novorojenčkih.
Rotarix is given according to official recommendations.
Daje se le v skladu z uradnimi priporočili.
Rotarix is a vaccine that is given by mouth.
Zdravilo Rotarix je cepivo, ki se jemlje peroralno.
How has Rotarix been studied?
Kako je bilo zdravilo Rotarix raziskano?
What is Rotarix?
Kaj je zdravilo Rotarix?
What is Rotarix used for?
Za kaj se zdravilo Rotarix uporablja?
How does Rotarix work?
Kako zdravilo Rotarix deluje?
How is Rotarix used?
Kako se zdravilo Rotarix uporablja?
The European Commission issued a decision on this opinion on 30 May 2011.
Evropska komisija je odločbo v zvezi s tem mnenjem izdala dne 30. maja 2011.
The questions and answers document published in September 2010 can be found here.
Dokument z vprašanji in odgovori, ki je bil objavljen septembra 2010, najdete tukaj.
The current review was initiated in October 2010 at the request of Germany.
Trenutni pregled je bil sprožen oktobra 2010 na zahtevo Nemčije.
• Patients who have any questions should speak to their doctor or pharmacist.
• Bolniki, ki imajo kakršnakoli vprašanja, naj se posvetujejo z zdravnikom ali s farmacevtom.
The CHMP noted at the time that the exact cause of the problems could not be identified with certainty.
CHMP je takrat ugotovil, da natančnega vzroka težav ni bilo mogoče z gotovostjo določiti.
• Post-marketing safety studies will be performed.
• Izvedene bodo varnostne študije v obdobju trženja.
The Committee noted that appropriate corrective measures are now in place at the manufacturing sites.
Odbor je ugotovil, da se v proizvodnih obratih zdaj izvajajo ustrezni korektivni ukrepi.
As with all medicines, doctors are reminded to continue reporting any suspected adverse effects.
Kot pri vseh zdravilih zdravnike opozarjamo, naj še naprej poročajo o morebitnih neželenih učinkih.
What are the recommendations for prescribers and patients?
Kakšna so priporočila za bolnike in zdravnike, ki zdravila predpisujejo?
What data has the CHMP reviewed?
Katere podatke je pregledal CHMP?
• With the new safeguards and improvements to the manufacturing process, doctors are advised that the benefits of the Octagam outweigh its risks and that they can start using the medicine again when it becomes available.
• Na podlagi novih zaščitnih ukrepov in izboljšav proizvodnega postopka se zdravnikom sporoči, da koristi zdravila Octagam odtehtajo z njim povezana tveganja ter da lahko ponovno uporabljajo zdravilo, ko bo na voljo.
What is Octagam?
Kaj je zdravilo Octagam?
The CHMP reviewed investigations that were carried out into the root cause of the problem and proposed corrective measures, including changes to the manufacturing process and tests to be performed during the manufacturing process and on the final products.
CHMP je pregledal preiskave, ki so bile izvedene, da bi se odkrili glavni vzroki težav, in predlagal primerne korektivne ukrepe, vključno s spremembo proizvodnega postopka in preverjanji, ki se morajo izvajati med proizvodnim postopkom in na končnih izdelkih.
The Committee also looked at results of batch analyses and independent testing of batches by Member States, as well as information from inspections of two of the manufacturing sites.
Odbor je tudi preučil rezultate analiz serij in neodvisnih preverjanj serij, ki so jih izvedle države članice, ter informacije inšpekcijskih pregledov v dveh proizvodnih obratih.
Immunoglobulins are antibodies (types of protein) normally found in the blood that help the body to fight infections and other diseases.
Imunoglobulini so protitelesa (vrsta beljakovin), ki jih običajno najdemo v krvi ter pomagajo telesu pri premagovanju okužb in drugih bolezni.
In addition, critical steps were identified in the manufacturing process that could explain the presence of substances that triggered the thromboembolic events.
Določene so bile tudi kritične točke proizvodnega postopka, s katerimi bi bilo mogoče razložiti prisotnost snovi, ki so sprožile tromboembolične dogodke.
The aim of the review was to assess all available data on the safety and quality issues related to the thromboembolic events seen with Octagam.
Cilj pregleda je bil oceniti vse razpoložljive podatke o varnosti in kakovosti, povezane s tromboemboličnimi dogodki, opaženimi pri jemanju zdravila Octagam.
It is also used in people with certain immune disorders such as idiopathic thrombocytopenic purpura and in patients who have had a bone marrow transplant.
Uporablja se tudi pri osebah z nekaterimi imunskimi motnjami, kot je na primer idiopatska trombocitopenična purpura, in pri bolnikih s presajenim kostnim mozgom.
Octagam is used in patients who are at risk of infection because they do not have sufficient antibodies including people with primary immunodeficiency syndrome, or children born with acquired immune deficiency syndrome (AIDS).
Zdravilo Octagam se uporablja pri bolnikih, pri katerih obstaja tveganje okužb zaradi nezadostnega števila protiteles, vključno z bolniki s sindromom primarne imunske pomanjkljivosti ali otroki, rojenimi s sindromom pridobljene imunske pomanjkljivosti (AIDS).
Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%)
Vprašanja in odgovori v zvezi s priporočilom za preklic začasnega umika dovoljenj za promet z zdravilom Octagam (humani normalni imunoglobulin 5 % in 10 %)
Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%) EMA/293780/2011 rev.
Vprašanja in odgovori v zvezi s priporočilom za preklic začasnega umika dovoljenj za promet z zdravilom Octagam (humani normalni imunoglobulin 5 % in 10 %) EMA/567271/2011 rev.
The European Medicines Agency has completed a review of Octagam and associated names that was triggered by reports of serious thromboembolic events in patients using the medicine.
Evropska agencija za zdravila je zaključila pregled zdravila Octagam in povezanih imen, ki so ga sprožila poročila o hudih tromboemboličnih dogodkih pri bolnikih, ki so jemali zdravilo.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the EU-wide suspension of the marketing authorisation for Octagam be lifted subject to certain conditions, including a change to the medicine's manufacturing process.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je priporočil, da se začasni umik dovoljenj za promet z zdravilom Octagam po vsej EU prekliče pod določenimi pogoji, vključno s spremembo postopka proizvodnje zdravila.
The CHMP also agreed on a test to detect factor XIa or other substances that can cause thromboembolic events before batches are released onto the market.
CHMP se je strinjal tudi s preverjanjem prisotnosti faktorja XIa ali drugih snovi, ki bi lahko povzročile tromboembolične dogodke, pred sproščanjem serij na tržišče.
In September 2010, the CHMP, following the suspension of the marketing authorisations of Octagam in Germany and Sweden, recommended that all authorisations for the medicine be suspended across the EU.
CHMP je septembra 2010 po začasnem umiku dovoljenj za promet z zdravilom Octagam v Nemčiji in na Švedskem priporočil, da se začasno umaknejo vsa dovoljenja za promet z zdravilom Octagam v EU.
The marketing authorisation holders will also be required to carry out post-marketing safety studies as soon as the medicine is reintroduced into the market in order to confirm the safety of the improved manufacturing process.
Ko bo zdravilo znova na tržišču, bodo imetniki dovoljenj za promet z zdravilom morali izvesti tudi varnostne študije v obdobju trženja in tako potrditi varnost izboljšanega proizvodnega postopka.
These events were thought to be related to problems with the medicine's manufacture, and included stroke, myocardial infarction (heart attack) and pulmonary embolism (clot in a blood vessel supplying the lungs).
Med dogodki, ki naj bi bili povezani s težavami pri proizvodnji zdravila, so bili kap, miokardni infarkt (srčni napad) in pljučna embolija (strdek v žili, ki dovaja kri v pljuča).
Why was Octagam reviewed?
Zakaj je bilo zdravilo Octagam pregledano?
Another enzyme, kallikrein, is considered to play a minor role.
Manjši vpliv naj bi imel tudi drug encim, imenovan kalikrein.
The marketing authorisations for Octagam in the EU were suspended by the European Commission, following a review by the CHMP in the September 2010.
Evropska komisija je dovoljenja za promet z zdravilom Octagam po vsej EU začasno umaknila po pregledu CHMP septembra 2010.1
Octagam is a solution for infusion (drip into a vein) that contains human normal immunoglobulin extracted from blood as the active substance.
Zdravilo Octagam je raztopina za infundiranje (kapalna infuzija v veno), ki vsebuje zdravilno učinkovino humani normalni imunoglobulin, pridobljen iz krvi.
The CHMP concluded the review with a recommendation that the suspension of the marketing authorisation for Octagam be lifted in the EU on the basis of the safeguards and the change to the medicine's manufacturing process.
CHMP je pregled sklenil s priporočilom, da se na podlagi ustreznih zaščitnih ukrepov in sprememb v postopku proizvodnje zdravila začasni umik dovoljenj za promet z zdravilom Octagam v EU prekliče.
The background to the suspension was an unexpectedly high number of reports of serious thromboembolic events (problems due to the formation of blood clots in the blood vessels) in patients
Dovoljenja za promet z zdravilom so začasno umaknili po nepričakovano visokem številu poročil o hudih tromboemboličnih dogodkih (težave zaradi nastajanja krvnih strdkov v žilah) pri bolnikih, ki so jemali zdravilo.
The CHMP concluded that the unexpected presence of factor XIa (an enzyme involved in blood clotting) in Octagam was the main cause of the thromboembolic events.
CHMP je sklenil, da je glavni vzrok tromboemboličnih dogodkov nepričakovana prisotnost faktorja XIa (encima, ki sodeluje pri strjevanju krvi) v zdravilu Octagam.
Contains aspartame.
Vsebuje aspartam.
Tell your doctor.
Povejte svojemu zdravniku.
Interaction studies have only been performed in adults.
Študije interakcij so izvajali samo pri odraslih.
This will usually pass on its own but if it does not, tell your doctor.
To običajno mine samo od sebe, če pa ne, povejte svojemu zdravniku.
Gröbenzell, Germany
Gröbenzell, Nemčija
City Tower, Hvězdova 1716/2b, 140 78 Praha 4 Czech Republic
City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Češka
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
In particular, tell your doctor if you are taking:
Še zlasti pa povejte svojemu zdravniku, če jemljete:
If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom, preden vzamete to zdravilo.
This leaflet was last revised in {MM/YYYY}.
Navodilo je bilo nazadnje revidirano v {mesec LLLL}
Your doctor will tell you how many Olanzapine Glenmark tablets to take and how long you should continue to take them.
Zdravnik vam bo povedal, koliko Olanzapine Glenmark tablet morate vzeti in kako dolgo naj bi jih jemali.
- if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
- če so vam v preteklosti ugotovili težave z očmi kot je določena vrsta glavkoma (povišan tlak v očesu).
- Medicines of this type may cause unusual movements mainly of the face or tongue.
• Tovrstna zdravila lahko povzročijo nenavadne zgibke predvsem v mišicah obraza ali jezika.
However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n = 467) as in male patients (n = 869).
Vendar pa je olanzapin (520 mg) pokazal primerljiv profil varnosti tako pri bolnikih ženskega (n = 467) kot moškega spola (n = 869).
In adult patients who completed 9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately 6 months.
Pri odraslih bolnikih, ki so zaključili 9-12 mesecev terapije, se je razmerje zvišanja povprečne glukoze v krvi upočasnilo po približno 6 mesecih.
If this has happened to you, tell your doctor.
Če se vam je zgodilo kaj takega, povejte svojemu zdravniku.
As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Kot običajen previdnostni ukrep vam lahko vaš zdravnik nadzoruje krvni tlak, če ste stari več kot 65 let.
If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.
Če ste bolnik z demenco, morate vi ali vaš skrbnik/sorodnik povedati vašemu zdravniku, če ste kdaj doživeli možgansko kap ali »majhno« možgansko kap.
31, D - 82194 Gröbenzell, Germany
31, D - 82194 Gröbenzell, Nemčija
Do not take Olanzapine Glenmark - if you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Olanzapine Glenmark: - če ste alergični na (preobčutljivi za) olanzapin ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
• In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Nekateri ljudje imajo lahko v začetnih obdobjih zdravljenja občutek omotice ali oslabelosti (z upočasnjenim srčnim utripom), zlasti pri vstajanju iz ležečega ali sedečega položaja.
Children and adolescents Olanzapine Glenmark is not for patients who are under 18 years.
Otroci in mladostniki Zdravilo Olanzapine Glenmark ni namenjeno bolnikom, mlajšim od 18 let.