natgillin/translations-raw huggingface dataset:
If the patient has , the 13C-urea contained in the Pylobactell tablet is broken down and the carbon dioxide in the breath also contains 13C.
Če je H. pylori prisotna v bolnikovem želodcu ali dvanajstniku, se bo 13C-sečnina, ki jo vsebuje tableta, razgradila in posledično bo ogljikov dioksid v izdihanem zraku prav tako vseboval 13C.
The full EPAR for Pylobactell is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pylobactell je na voljo tukaj.
Why has Pylobactell been approved?
Zakaj je bilo zdravilo Pylobactell odobreno?
The data to support the use of Pylobactell comes from two main studies of the use of antibiotics to treat H. pylori infection, where it was used as a test. A total of 366 patients underwent both a Pylobactell test and a standard biopsy test (where a sample from the stomach is analysed to see if it is infected).
Skupno 366 bolnikov je bilo testiranih tako s testom na podlagi zdravila Pylobactell kot s standardnim testom na podlagi biopsije (pri katerem se analizira vzorec iz želodca, da bi ugotovili, ali je okužen).
Pylobactell is a breath test: breath samples are collected in the tubes provided in the kit.
Zdravilo Pylobactell je dihalni test: v epruveto, ki je sestavni del kompleta, se odvzamejo vzorci izdihanega zraka.
The Committee for Medicinal Products for Human Use (CHMP) decided that Pylobactell's benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Pylobactell za in vivo diagnostiko okužb želodca in dvanajstnika s H. pylori večje od z njim povezanih tveganj.
It is available as a kit that includes a white soluble tablet containing 100 mg of the active substance 13C-urea.
Zdravilo Pylobactell je diagnostični test. Na voljo je v obliki kompleta, ki vsebuje belo tableto za peroralno raztopino, ki vsebuje 100 mg zdravilne učinkovine 13C-sečnina.
How has Pylobactell been studied?
Kako je bilo zdravilo Pylobactell raziskano?
What is Pylobactell?
Kaj je zdravilo Pylobactell?
What is Pylobactell used for?
Za kaj se zdravilo Pylobactell uporablja?
How does Pylobactell work?
Kako zdravilo Pylobactell deluje?
How is Pylobactell used?
Kako se zdravilo Pylobactell uporablja?
The full EPAR for Kogenate Bayer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Kogenate Bayer je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Skin- associated hypersensitivity reactions (itching, hives and rash) may occur commonly (in between 1 and 10 patients in 100) but a severe allergic reaction is rare (between 1 and 10 in 10,000 patients).
Preobčutljivostne reakcije, povezane s kožo (srbenje, koprivnica in izpuščaj) se pojavijo pogosto (pri med 1 in 10 bolnikih od 100), toda resne alergijske reakcije so redke (pri med 1 in 10 bolnikih od 10 000).
This is a summary of the European public assessment report (EPAR) for Kogenate Bayer.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kogenate Bayer.
The main measure of effectiveness in the studies was the number of treatments required to stop each new bleed.
Glavno merilo učinkovitosti je bilo število potrebnih zdravljenj za zaustavitev vsake nove krvavitve.
The dose and duration of treatment depend on whether it is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight.
Odmerek in trajanje zdravljenja sta odvisna od tega, ali se zdravilo uporablja za zdravljenje ali preprečevanje krvavitev ali med kirurškim posegom, ter od ravni faktorja VIII, resnosti hemofilije, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
The data provided on immune tolerance induction in patients with inhibitors showed that some patients benefit from the high dosage and the inhibitor could be eliminated, nevertheless the data were not considered sufficient to specifically approve the medicine for this use.
Podatki, dobljeni o indukciji imunske tolerance pri bolnikih z zaviralci, so pokazali, da nekaterim bolnikom koristijo visoki odmerki in se zaviralci odstranijo, vendar pa so bili podatki ocenjeni kot nezadostni, da bi lahko zdravilo odobrili za to specifično uporabo.
The European Commission granted a marketing authorisation valid throughout the EU for Kogenate Bayer on 4 August 2000.
Evropska komisija je dovoljenje za promet z zdravilom Kogenate Bayer, veljavno po vsej Evropski uniji, izdala 4. avgusta 2000.
Kogenate Bayer is similar to another medicine that was previously authorised in the EU called Kogenate, but it is prepared differently so that there are no human-derived proteins in the medicine.
Zdravilo Kogenate Bayer je podobno drugemu zdravilu, ki je že odobreno v EU, imenovanemu Kogenate, vendar je pripravljeno na drugačen način, tako da v zdravilu ni nobenih beljakovin humanega izvora.
What measures are being taken to ensure the safe and effective use of Kogenate Bayer?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kogenate Bayer?
The Agency decided that Kogenate Bayer's benefits are greater than its risks and recommended that it be given marketing authorisation.
Agencija je sklenila, da so koristi zdravila Kogenate Bayer večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
In the previously untreated patients, about 90% of bleeding episodes responded to treatment with one or two injections into a vein.
Pri predhodno nezdravljenih bolnikih se je 90 % krvavitev odzvalo na zdravljenje z enim ali dvema injiciranjema v veno.
Patients or their carers may be able to administer Kogenate Bayer themselves at home once they have been trained appropriately.
Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Kogenate Bayer dajejo sami doma.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kogenate Bayer have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Kogenate Bayer upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
Other information about Kogenate Bayer
Druge informacije o zdravilu Kogenate Bayer
Kogenate Bayer given as an injection into a vein has been studied in 66 patients who had previously been treated with recombinant human coagulation factor VIII and 61 children who had not.
Zdravilo Kogenate Bayer, dano z injiciranjem v veno, je bilo proučevano pri 66 bolnikih, ki so bili predhodno zdravljeni z rekombinantnim humanim koagulacijskim faktorjem VIII ter pri 61 predhodno nezdravljenih otrocih.
Because of this, Kogenate Bayer has been compared with Kogenate to show that the two medicines are equivalent.
Zato so zdravilo Kogenate Bayer primerjali z zdravilom Kogenate, da bi pokazali, da sta enakovredni.
The dose may need to be adjusted if Kogenate Bayer is to be given continuously as an infusion into a vein.
Odmerek bo morda treba prilagoditi, če se zdravilo Kogenate Bayer daje z neprekinjenim infundiranjem v veno.
For more information about treatment with Kogenate Bayer, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Kogenate Bayer preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Kogenate Bayer is intended for either short-term or long-term use.
Namenjeno je za kratkotrajno ali dolgotrajno uporabo.
Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles and internal organs.
Bolnikom s hemofilijo A primanjkuje faktorja VIII, kar povzroča težave s strjevanjem krvi, kot so krvavenje v sklepe, mišice ali notranje organe.
The Agency concluded that Kogenate Bayer has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Zaključila je, da se je zdravilo Kogenate Bayer izkazalo za učinkovito pri zdravljenju in preprečevanju krvavenja pri bolnikih s hemofilijo A in da ima sprejemljiv varnostni profil.
What is Kogenate Bayer and what is it used for?
Kaj je zdravilo Kogenate Bayer in za kaj se uporablja?
In the previously treated patients, overall, 95% of bleeds responded to one or two injections of Kogenate Bayer into a vein.
Pri predhodno zdravljenih bolnikih se je 95 % krvavitev odzvalo na eno ali dve injiciranji zdravila Kogenate Bayer v veno.
Kogenate Bayer is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Zdravilo Kogenate Bayer se uporablja za odpravo pomanjkanja faktorja VIII z nadomeščanjem manjkajočega faktorja VIII, kar zagotovi začasno obvladovanje motnje strjevanja krvi.
For the full list of all side effects reported with Kogenate Bayer, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Kogenate Bayer, glejte navodilo za uporabo.
What are the risks associated with Kogenate Bayer?
Kakšna tveganja so povezana z zdravilom Kogenate Bayer?
The active substance in Kogenate Bayer, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Zdravilna učinkovina v zdravilu Kogenate Bayer, oktokog alfa (humani koagulacijski faktor VIII), je snov, ki pomaga pri strjevanju krvi.
For practical information about using Kogenate Bayer, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Kogenate Bayer naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
What benefits of Kogenate Bayer have been shown in studies?
Kakšne koristi je zdravilo Kogenate Bayer izkazalo v študijah?
Why is Kogenate Bayer approved?
Zakaj je bilo zdravilo Kogenate Bayer odobreno?
Kogenate Bayer given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Proučevali so, ali je zdravilo Kogenate Bayer, dano v velikih odmerkih, učinkovito pri odstranjevanju protiteles proti faktorju VIII iz krvi (postopek, znan kot indukcija imunske tolerance), tako da zdravljenje s faktorjem VIII ostane učinkovito.
Kogenate Bayer is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Kogenate Bayer je zdravilo, ki se uporablja za zdravljenje in preprečevanje krvavenja pri bolnikih s hemofilijo A (dedno motnjo strjevanja krvi, ki jo povzroča pomanjkanje faktorja VIII).
Kogenate Bayer as a continuous infusion has also been studied in 15 patients with haemophilia A undergoing major surgery.
Zdravilo Kogenate Bayer v obliki neprekinjene infuzije je bilo proučevano tudi pri 15 bolnikih s hemofilijo A, ki so prestali zahtevnejši kirurški poseg.
It is not intended to provide practical advice on how to use Kogenate Bayer.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Hypersensitivity (allergic) reactions have been reported with factor VIII medicines and may in some cases become severe.
Pri uporabi zdravil, ki vsebujejo faktor VIII, so poročali o preobčutljivostnih (alergijskih) reakcijah, ki lahko v nekaterih premerih postanejo hude.
Kogenate Bayer can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia.
Predpisovanje in izdaja zdravila Kogenate Bayer je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem hemofilije.
Kogenate Bayer is available as a powder and solvent that are mixed together to make a solution for injection or infusion (drip) into a vein.
Zdravilo Kogenate Bayerje na voljo v obliki praška in vehikla za pripravo raztopine za injiciranje ali infundiranje (kapalne infuzije) v veno.
It contains the active substance octocog alfa (human coagulation factor VIII).
Zdravilo Kogenate Bayer vsebuje zdravilno učinkovino oktokog alfa (humani koagulacijski faktor VIII).
How does Kogenate Bayer work?
Kako zdravilo Kogenate Bayer deluje?
How is Kogenate Bayer used?
Kako se zdravilo Kogenate Bayer uporablja?
Kogenate Bayer must not be used in people who are known to be hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.
(alergične na) humani koagulacijski faktor, mišje ali hrčkove beljakovine ali katero koli drugo sestavino zdravila.
2 patches + 1 cleansing gel
2 obliža + 1 čistilni gel
1 patch + 1 cleansing gel
1 obliž + 1 čistilni gel
The European Commission granted a marketing authorisation valid throughout the European Union for Competact on 28 July 2006.
Evropska komisija je dovoljenje za promet z zdravilom Competact, veljavno po vsej Evropski uniji, izdala 28. julija 2006.
The studies lasted from 4 months to 2 years and involved 1,305 patients who took the combination.
Študije so trajale od štiri mesece do dve leti in so vključevale 1 305 bolnikov, ki so prejemali omenjeno kombinacijo.
Other information about Competact
Druge informacije o zdravilu Competact
What measures are being taken to ensure the safe and effective use of Competact?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Competact?
The full EPAR for Competact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Competact je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The usual dose of Competact is one tablet taken twice a day.
Običajni odmerek zdravila Competact je ena tableta dvakrat dnevno.
Pioglitazone / metformin hydrochloride
Competact pioglitazonijev/metforminijev hidroklorid
Treatment with Competact should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Zdravljenje z zdravilom Competact je treba ponovno oceniti po treh do šest mesecih in ga pri bolnikih, ki od njega nimajo zadostne koristi, prekiniti.
This is a summary of the European public assessment report (EPAR) for Competact.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Competact.
A risk management plan has been developed to ensure that Competact is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Competact je bil pripravljen načrt obvladovanja tveganj.
In all studies, adding pioglitazone 30 mg to metformin led to an improvement in the control of blood glucose, with levels of HbA1c further decreasing by 0.64 to 0.89% compared with the levels on metformin alone.
V vseh študijah je dodajanje 30 mg pioglitazona k metforminu prispevalo k boljšemu uravnavanju glukoze v krvi, pri čemer so se ravni HbA1c nadalje znižale za 0,64 do 0,89 % v primerjavi z ravnmi, doseženimi samo z metforminom.
What benefit has Competact shown during the studies?
Kakšne koristi je zdravilo Competact izkazalo med študijami?
For more information about treatment with Competact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Competact preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Competact is a medicine that is available as tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg).
Competact je zdravilo, ki je na voljo v obliki tablet, ki vsebujejo dve zdravilni učinkovini, pioglitazonijev (15 mg) in metforminijev hidroklorid (850 mg).
In addition, the company that markets Competact will produce educational materials for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Poleg tega bo družba, ki trži zdravilo Competact, zagotovila izobraževalno gradivo za zdravnike, ki bodo predpisovali zdravilo, in bo vključevalo možno tveganje za srčno popuščanje in rak sečnega mehurja pri zdravljenju s pioglitazonom, merila za izbiro bolnikov in potrebo po redni oceni zdravljenja ter prekinitvi zdravljenja, če bolnikom ne koristi več.
The Committee decided that Competact's benefits are greater than its risks and recommended that it be given marketing authorisation.
Sklenil je, da so koristi zdravila Competact večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Competact is used in adults (particularly those who are overweight) who have type 2 diabetes.
Zdravilo Competact se uporablja pri odraslih (zlasti pri tistih s čezmerno telesno maso), ki imajo sladkorno bolezen tipa 2.
It is possible to change to Competact directly from metformin if appropriate.
Možen je tudi neposreden prehod z metformina na zdravilo Competact, če je to ustrezno.
Patients changing from metformin only to Competact may need to slowly introduce pioglitazone until a dose of 30 mg per day is reached.
Pri bolnikih, ki prehajajo z metformina na jemanje zgolj zdravila Competact, je treba pioglitazon uvajati počasi, dokler ni dosežen odmerek 30 mg na dan.
Taking Competact with or just after food may reduce any stomach problems caused by metformin.
Jemanje zdravila Competact sočasno s hrano ali neposredno po obroku lahko ublaži želodčne težave, ki jih povzroča metformin.
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 Competact.
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.
Competact contains two active substances which each have a different mode of action.
Zdravilo Competact vsebuje dve zdravilni učinkovini, ki imata različen način delovanja.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Competact, 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.
The CHMP concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Competact simplifies treatment and improves compliance when a combination of the active substances is required.
Odbor CHMP je zaključil, da je bila učinkovitost pioglitazona in metformina pri zdravljenju sladkorne bolezni tipa 2 dokazana in da zdravilo Competact poenostavlja zdravljenje ter izboljšuje zavezanost bolnikov k jemanju zdravila, kadar je potrebna kombinacija zdravilnih učinkovin.
At the start of treatment, abdominal pain (stomach ache), diarrhoea, loss of appetite, nausea (feeling sick) and vomiting may occur.
Na začetku zdravljenja se lahko pojavijo bolečine v trebuhu (bolečine v želodcu), driska, izguba teka, slabost in bruhanje.
Competact must not be used in patients who have a disease that causes lack of oxygen to the tissues such as a recent heart attack or shock.
Prav tako ga ne smejo uporabljati bolniki z obolenjem, ki povzroča pomanjkanje kisika v tkivih, kot je denimo nedavni srčni napad ali šok.
Competact must not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may effects the kidneys, and during breast-feeding.
Ne sme se uporabljati v primeru alkoholiziranosti, diabetične ketoacidoze (visoke koncentracije ketonov), bolezni, ki utegnejo prizadeti ledvice, in med dojenjem.
What is the risk associated with Competact?
Kakšna tveganja so povezana z zdravilom Competact?
Pioglitazone on its own has been approved in the EU under the name Actos and can be used with metformin in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Pioglitazon kot samostojno zdravilo, ki ga je EU odobrila pod imenom Actos, se lahko uporablja skupaj z metforminom pri bolnikih s sladkorno boleznijo tipa 2, pri katerih zgolj z metforminom ni mogoče doseči zadovoljivega nadzora.
Competact must not be used in patients who have heart failure, or problems with their liver or their kidneys.
Zdravila Competact ne smejo jemati bolniki s srčnim popuščanjem ter bolniki, ki imajo težave z jetri ali ledvicami.
Why has Competact been approved?
Zakaj je bilo zdravilo Competact odobreno?
Competact is used in patients who are not satisfactorily controlled on metformin (a diabetes medicine) used on its own and at the maximum possible dose.
Uporablja se pri bolnikih, pri katerih zgolj z metforminom (zdravilom za zdravljenje sladkorne bolezni), tudi v največjem možnem odmerku, ni mogoče doseči zadovoljivega nadzora.
For the full list of side effects reported with Competact, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Competact, glejte navodilo za uporabo.
Three studies of Actos used with metformin as separate tablets were used to support the use of Competact in the same indication.
V podporo uporabi zdravila Competact za enako indikacijo so bile uporabljene tri študije zdravila Actos, uporabljenega skupaj z metforminom v obliki ločenih tablet.
How has Competact been studied?
Kako je bilo zdravilo Competact raziskano?
What is Competact used for?
Za kaj se zdravilo Competact uporablja?
How does Competact work?
Kako zdravilo Competact deluje?
How is Competact used?
Kako se zdravilo Competact uporablja?
What is Competact?
Kaj je zdravilo Competact?
August 2015
avgust 2015
Adults, including the elderly
Odrasli, vključno s starejšimi osebami
Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.
Natančno preberite navodilo, preden dobite to cepivo, ker vsebuje za vas pomembne podatke!
The MAH submitted the data requested above on 5 August 2015 and an opinion was adopted by the CHMP on 28 April 2016.
Imetnik dovoljenja za promet je 5. avgusta 2015 predložil zgoraj zahtevane podatke, mnenje CHMP je bilo sprejeto 28. aprila 2016.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 May 2008
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 20. maj2008
These side effects usually disappear within 1-2 days without treatment.
Ti neželeni učinki običajno minejo brez zdravljenja v 1 do 2 dneh.
In the first few weeks after vaccination with Pandemrix the results of these tests may not be correct.
V prvih nekaj tednih po cepljenju s cepivom Pandemrix so lahko rezultati teh preiskav napačni.
These data suggest that the excessive risk tends to decline with increasing age at vaccination.
Ti podatki kažejo, da se dodatno tveganje zmanjšuje z naraščajočo starostjo ob cepljenju.
See sections 4.4, 4.8 and 5.1 for details.
Za podrobnosti glejte poglavja 4.4, 4.8 in 5.1.
• Short-term sleepiness following vaccination
• kratkotrajna nespečnost po cepljenju;
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or use machines.
Nekateri učinki, navedeni v poglavju 4.8, "Neželeni učinki", lahko vplivajo na sposobnost vožnje ali upravljanja s stroji.