natgillin/translations-raw huggingface dataset:
Sodium dihydrogen phosphate dihydrate Silica, colloidal anhydrous Hydroxyethylcellulose Citric acid 
6.1 Seznam pomožnih snovi natrijev benzoat sorbitol, tekoči glicerol natrivej saharinat ksilitol natrijev dihidrogenfosfat dihidrat silicijev dioksid, koloidni, brezvodni hidroksietilceluloza citronska kislina aroma medu prečiščena voda
The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions during) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 
Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se med enim ciklom zdravljenja pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (več kot 1, toda manj kot 10 od 100 zdravljenih živali) - občasni (več kot 1, toda manj kot 10 od 1.000 zdravljenih živali) - redki (več kot 1, toda manj kot 10 od 10.000 zdravljenih živali) - zelo redki (manj kot 1 od 10.000 zdravljenih živali, vključno s posameznimi primeri).
One ml contains: Meloxicam 0.5 mg (equivalent to 0.02 mg per drop) 
Meloksikam 0,5 mg (kar ustreza 0,02 mg v 1 kapljici)
These side effects usually disappear within one to two days without treatment. 
Ti neželeni učinki običajno izzvenijo brez zdravljenja v enem do dveh dneh.
The vaccine's effectiveness was assessed in one main study involving 2,654 adults, around half of whom were elderly (over 60 years of age). 
Učinkovitost cepiva so proučevali v eni glavni študiji z 2 654 bolniki, od katerih jih je bila približno polovica starejših (starejših od 60 let).
The full EPAR for Optaflu 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 cepivo Optaflu je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Optaflu? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe
This is a summary of the European public assessment report (EPAR) for Optaflu. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Optaflu.
What benefit has Optaflu shown during the studies? 
Kakšne koristi je zdravilo Optaflu izkazalo med študijami?
The most common side effects with Optaflu (seen in more than 1 patient in 10) are headache, reddening of the skin, muscle pain, pain at the site of injection, malaise (feeling unwell) and fatigue (tiredness). 
Najpogostejši neželeni učinki cepiva Optaflu (opaženi pri več kot 1 bolniku od 10) so glavobol, pordelost kože, bolečine v mišicah, bolečina na mestu injiciranja, slabo počutje in utrujenost.
Other information about Optaflu 
Druge informacije o zdravilu Optaflu
A risk management plan has been developed to ensure that Optaflu is used as safely as possible. 
Za zagotovitev čim varnejše uporabe cepiva Optaflu je bil pripravljen načrt obvladovanja tveganj.
influenza vaccine (surface antigen, inactivated, prepared in cell cultures) 
cepivo proti gripi (površinski antigen, neaktiviran, pripravljen v celičnih
For more information about treatment with Optaflu, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju s cepivom Optaflu preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is the risk associated with Optaflu? 
Kakšna tveganja so povezana z zdravilom Optaflu?
A/California/7/2009 (H1N1)pdm09-like strain; A/Switzerland/9715293/2013 (H3N2)-like strain; and 
Vsebuje površinske antigene treh različnih sevov (vrst) virusa influence (gripe): sev, podoben sevu A/California/7/2009 (H1N1)pdm09; sev, podoben sevu A/Switzerland/9715293/2013 (H3N2) in sev,
Optaflu is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications from the disease. 
Zdravilo Optaflu se uporablja za cepljenje odraslih proti gripi, zlasti tistih, pri katerih obstaja povečano tveganje za nastanek zapletov pri bolezni.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Optaflu, 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.
Optaflu is a vaccine. 
Zdravilo Optaflu je cepivo.
Optaflu is a vaccine, which is available as a suspension for injection in a pre-filled syringe. 
Zdravilo Optaflu je cepivo, ki je na voljo kot suspenzija za injiciranje v napolnjeni injekcijski brizgi.
Optaflu is given as one injection of 0.5 ml into the muscle at the top of the arm. 
Cepivo Optaflu se daje v obliki ene 0,5-mililitrske injekcije v mišico nadlahti.
The two vaccines were similar in triggering the production of antibodies, both in adults 60 years of age and below, and in the elderly. 
Cepivi imata podoben učinek pri sprožanju nastanka protiteles pri odraslih, mlajših od 60 let, ter pri starejših.
Optaflu contains fragments from the surface of three different strains of flu virus. 
Cepivo Optaflu vsebuje delce s površine treh različnih sevov virusa gripe.
The ability of Optaflu to trigger the production of antibodies (immunogenicity) was first assessed using a formulation of the vaccine that included the virus strains expected to cause flu in the 2004/2005 season. 
Sposobnost cepiva Optaflu pri sprožanju tvorjenja protiteles (imunogenost) so najprej ocenili z uporabo formulacij cepiva, ki so vsebovale virusne seve, ki naj bi povzročili gripo v sezoni 2004/2005.
The European Commission granted a marketing authorisation valid throughout the European Union for 
Evropska komisija je dovoljenje za promet s cepivom Optaflu, veljavno po vsej Evropski uniji, izdala 1. junija 2007.
The effects of Optaflu were compared to those of a similar flu vaccine that was made in eggs. 
Učinke cepiva Optaflu so primerjali z učinki podobnega cepiva proti gripi, ki je bilo izdelano v jajcih.
The CHMP decided that Optaflu's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi cepiva Optaflu večje od z njim povezanih tveganj, in priporočil, da se
The study compared the ability of the two vaccines to trigger the production of antibodies (immunogenicity), by comparing antibody levels before injection 
V študiji so primerjali učinkovitost obeh cepiv pri sprožanju tvorjenja protiteles (imunogenost), tako da so primerjali ravni protiteles pred injiciranjem in tri tedne
For the full list of all side effects reported with Optaflu, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Optaflu, glejte navodilo za uporabo.
In the original main study, both Optaflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains, as defined in criteria laid down by the CHMP for flu vaccines. 
V osnovni glavni študiji sta cepivo Optaflu in primerjalno cepivo spodbudila nastanek zadostnih ravni protiteles za zaščito pred vsemi tremi sevi gripe v skladu z merili Odbora za zdravila za uporabo v humani medicini (CHMP) za cepiva proti gripi.
Later seasonal formulations of Optaflu have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main study. 
Poznejše sezonske formulacije zdravila Optaflu so sprožile podobne odzive protiteles proti trem sevom gripe, vključenim v cepivo, kot so bili tisti, opaženi v glavni študiji.
Optaflu contains fragments (surface antigens) of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in Optaflu before the vaccine can be used. 
V cepivo Optaflu je treba pred njegovo uporabo vključiti delce (površinske antigene) virusnih sevov, za katere se glede na priporočila SZO za severno poloblo in priporočila Evropske unije (EU) predvideva, da bodo povzročali gripo v prihodnji sezoni.
The use of the vaccine should be based on official 
Uporabljati se mora v skladu z uradnimi priporočili.
The antibodies will then help to protect against the disease caused by these strains of the flu virus. 
Ta mu bodo pomagala pri obrambi pred boleznijo, ki jo ti sevi virusa gripe povzročajo.
The viruses used to obtain the surface antigen that are included in Optaflu are grown in mammalian cells, unlike those used for other flu vaccines, which are grown in hen's eggs. 
Viruse, ki se uporabijo za pridobitev površinskih antigenov, ki so nato vključeni v cepivo Optaflu, gojijo v celicah sesalcev, medtem ko viruse, uporabljene v drugih cepivih proti gripi, gojijo v kokošjih jajcih.
The studies lasted from four months to two 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.
This authorisation was based on the authorisation granted to Competat on 28 July 2006 (‘informed consent'). 
Izdaja tega dovoljenja je temeljila na dovoljenju za promet z zdravilom Competat, ki je bilo izdano 28. julija 2006 (uporaba dokumentacije s soglasjem).
What measures are being taken to ensure the safe and effective use of Glubrava? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Glubrava?
The full EPAR for Glubrava 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 Glubrava je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Pioglitazone / metformin hydrochloride 
Glubrava pioglitazonijev/metforminijev hidroklorid
Elderly patients should have their kidney function monitored regularly. 
Pri starejših bolnikih je treba redno spremljati delovanje ledvic.
The European Commission granted a marketing authorisation valid throughout the European Union, for Glubrava on 11 December 2007. 
Evropska komisija je dovoljenje za promet z zdravilom Glubrava, veljavno po vsej Evropski uniji, izdala 11. decembra 2007.
The usual dose of Glubrava is one tablet taken twice a day. 
Običajni odmerek zdravila Glubrava je ena tableta dvakrat dnevno.
Treatment with Glubrava should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit. 
Zdravljenje z zdravilom Glubrava 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 Glubrava. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Glubrava.
In all studies, adding pioglitazone 30 mg to metformin led to an improvement in the control of blood glucose, with levels of HbA1c which 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 od 0,64 do 0,89 % v primerjavi z ravnmi, doseženimi samo z metforminom.
For more information about treatment with Glubrava, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Glubrava preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What is the risk associated with Glubrava? 
Kakšna tveganja so povezana z zdravilom Glubrava?
The company that markets Glubrava will produce educational material 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. 
Družba, ki trži zdravilo Glubrava, bo pripravila 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.
Other side effects such as bone fracture, increased weight and oedema (swelling) may occur in less than 1 in 10 patients. 
Drugi neželeni učinki, kot so zlom kosti, povečana telesna masa in edemi (otekanje), se lahko pojavijo pri manj kot 1 bolniku od 10.
Other information about Glubrava 
Druge informacije o zdravilu Glubrava
What benefit has Glubrava shown during the studies? 
Kakšne koristi je zdravilo Glubrava izkazalo med študijami?
Glubrava is a medicine that is available as tablets containing two active substances, pioglitazone (15 mg) and metformin hydrochloride (850 mg). 
Glubrava je zdravilo, ki je na voljo v obliki tablet z dvema zdravilnima učinkovinama, pioglitazon (15 mg) in metforminijev hidroklorid (850 mg).
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 Glubrava. 
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.
Patients changing from metformin only to Glubrava may need to introduce pioglitazone slowly until a dose of 30 mg per day is reached. 
Pri bolnikih, ki prehajajo z metformina na jemanje zgolj zdravila Glubrava, je treba pioglitazon uvajati počasi, dokler se ne doseže odmerek 30 mg na dan.
As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes. 
Zaradi delovanja obeh zdravilnih učinkovin se raven glukoze v krvi zniža, kar prispeva k vzpostavitvi nadzora nad sladkorno boleznijo tipa 2.
They measured the level in the blood of a substance (HbA1c), which gives an indication of how well the blood glucose is controlled. 
V študijah so merili raven snovi v krvi (HbA1c), ki kaže, kako dobro je raven glukoze v krvi uravnana.
It is possible to change to Glubrava directly from metformin if appropriate. 
Možen je tudi neposreden prehod z metformina na zdravilo Glubrava, če je to ustrezno.
Taking Glubrava with or just after food may reduce any stomach problems caused by metformin. 
Sočasno jemanje zdravila Glubrava s hrano ali neposredno po obroku lahko ublaži želodčne težave, ki jih povzroča metformin.
Glubrava must not be used where there is alcohol intoxication, diabetic ketoacidosis (high levels of ketones), conditions that may affect the kidneys, and during breast-feeding. 
Zdravilo Glubrava se ne sme uporabljati v primeru alkoholiziranosti, diabetične ketoacidoze (visoke koncentracije ketonov), bolezni, ki utegnejo prizadeti ledvice, in med dojenjem.
Why has Glubrava been approved? 
Zakaj je bilo zdravilo Glubrava odobreno?
The Committee decided that Glubrava's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zaključil je, da so koristi zdravila Glubrava večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The CHMP concluded that the effectiveness of pioglitazone and metformin in type 2 diabetes had been shown, and that Glubrava 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 Glubrava poenostavlja zdravljenje ter izboljšuje zavezanost bolnikov k jemanju zdravila, kadar je potrebna kombinacija zdravilnih učinkovin.
Glubrava contains two active substances which each have a different mode of action. 
Zdravilo Glubrava vsebuje dve zdravilni učinkovini, ki imata različen način delovanja.
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, driska, izguba teka, slabost in bruhanje.
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 uravnavanja.
Glubrava 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.
At subsequent reviews, prescribers should confirm that benefits to patients are maintained. 
Pri nadaljnjih pregledih morajo zdravniki, ki zdravilo predpisujejo, preveriti, ali zdravilo še vedno zagotavlja enake koristi.
What is Glubrava? 
Kaj je zdravilo Glubrava?
Glubrava must not be used in patients who have heart failure, or problems with their liver or their kidneys. 
Zdravila Glubrava ne smejo jemati bolniki s srčnim popuščanjem ter bolniki, ki imajo težave z jetri ali ledvicami.
Glubrava 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 uravnavanja.
What is Glubrava used for? 
Za kaj se zdravilo Glubrava uporablja?
Three studies of Actos used with metformin as separate tablets were used to support the use of Glubrava in the same indication. 
V podporo uporabi zdravila Glubrava za enako indikacijo so bile predstavljene tri študije zdravila Actos, uporabljenega skupaj z metforminom v obliki ločenih tablet.
For the full list of all side effects reported with Glubrava, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Glubrava, glejte navodilo za uporabo.
Glubrava is used in adults (particularly those who are overweight) who have type 2 diabetes. 
Zdravilo Glubrava se uporablja pri odraslih, ki imajo sladkorno bolezen tipa 2, še zlasti pri bolnikih s čezmerno telesno maso.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Glubrava have also been included in the summary of product characteristics and the package leaflet. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili vključeni priporočila in previdnostni ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki za varno in učinkovito uporabo zdravila Glubrava.
Lactic acidosis (a build-up of lactic acid in the body) is a side effect which may occur in less than 1 in 10,000 patients. 
Ti neželeni učinki so zelo pogosti, ampak v večini primerov izginejo sami od sebe. Laktacidoza (kopičenje mlečne kisline v telesu) je neželeni učinek, ki se lahko pojavi pri manj kot 1 bolniku od 10 000.
How does Glubrava work? 
Kako zdravilo Glubrava deluje?
How is Glubrava used? 
Kako se zdravilo Glubrava uporablja?
How has Glubrava been studied? 
Kako je bilo zdravilo Glubrava raziskano?
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented: 
Države članice morajo zagotoviti, da so implementirani vsi pogoji ali omejitve v zvezi z varno in učinkovito uporabo zdravila, ki so opisani spodaj.
• Patient Alert Card - to address the risk of getting infections which can become serious if not treated. 
• opozorilno kartico za bolnika, -da opozori na tveganje za okužbe, ki lahko postanejo resne, če niso zdravljene.
The Member States shall discuss and agree the content and format of the educational material, together with a communication plan, with the national competent authority prior to distribution of the educational material. 
Imetnik dovoljenja za promet se mora pred razdelitvijo izobraževalnega gradiva o njegovi vsebini in obliki, skupaj z načrtom obveščanja, dogovoriti z nacionalnim organom, pristojnim za zdravila.
• Prevention of medical errors and infusion reactions 
• preprečevanje medicinskih napak in reakcij, povezanih z infundiranjem,
• The product should not be given to patients with active or suspected infection 
• Zdravilo se ne sme dajati bolnikom z aktivno okužbo ali pri sumu na okužbo.
• Diagnosis of Macrophage Activation Syndrome in sJIA patients 
• diagnozo sindroma aktivacije makrofagov pri bolnikih s sJIA,
• Monitoring of the patient for infusion reactions 
• nadzorovanje bolnika zaradi reakcij, povezanih z infundiranjem,
• Dose calculation (RA and sJIA patients), preparation of infusion and infusion rate 
• izračun odmerka (bolniki z revmatoidnim artritisom in sJIA), priprava infuzije in hitrost infundiranja,
The Marketing Authorisation Holder (MAH) shall provide an educational pack covering the therapeutic indications RA and sJIA, targeting all physicians who are expected to prescribe/use RoActemra containing the following: 
Imetnik dovoljenja za promet mora zagotoviti, da bo vsem zdravnikom, ki bodo predpisovali/uporabljali zdravilo RoActemra, razdelil izobraževalno gradivo za indikaciji revmatoidni artritis in sJIA, ki vključuje:
• Preparation of infusion 
• priprava infuzije,
• Recommendations for dose interruptions in sJIA patients 
• priporočila za prekinitev odmerjanja pri bolnikih s sJIA.
• Serious hypersensitivity reactions and their management 
• resne preobčutljivostne reakcije in njihovo zdravljenje,
The Patient Information Pack should contain the following key elements: 
Paket informacij za bolnike mora vključevati naslednje glavne vsebine:
The Nurse Information Pack should contain the following key elements: 
Paket informacij za medicinske sestre mora vključevati naslednje glavne vsebine:
The Physician Information Pack should contain the following key elements: 
Paket informacij za zdravnike mora vključevati naslednje glavne vsebine:
• Patient Information Pack 
• paket informacij za bolnike.
• Serious infusion reaction and their management 
• resne reakcije, povezane z infundiranjem in njihovo zdravljenje,
• Nurse Information Pack 
• paket informacij za medicinske sestre,
- to address the risk that patients using RoActemra may develop complications of diverticulitis which can become serious if not treated. 
Dodatno se lahko nekatere predhodne okužbe ponovno pojavijo; -da opozori na tveganje, da se lahko pri bolnikih, ki uporabljajo zdravilo RoActemra, pojavijo zapleti divertikulitisa.
• Physician Information Pack 
• paket informacij za zdravnike,
The European Commission granted a marketing authorisation valid throughout the European Union for Kinzalkomb on 19 April 2002. 
Evropska komisija je dovoljenje za promet z zdravilom Kinzalkomb, veljavno po vsej Evropski uniji, izdala 19. aprila 2002.
What measures are being taken to ensure the safe and effective use of Kinzalkomb? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kinzalkomb?
Kinzalkomb must not be used in women who are more than three months pregnant. 
Zdravila Kinzalkomb ne smejo uporabljati ženske, ki so noseče več kot tri mesece.
This is a summary of the European public assessment report (EPAR) for Kinzalkomb. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Kinzalkomb.