natgillin/translations-raw huggingface dataset:
Entry criteria included CF, FEV1 ≤ 75% predicted, stable pulmonary disease, a recent positive sputum culture for P. aeruginosa, and previous treatment with aerosolised antibiotics without demonstration of drug intolerance. 
Merila za sodelovanje so vključevala CF, napovedani odstotek FEV1 ≤ 75 %, stabilno pljučno bolezen,
whereas MIC90 increased intermittently to 4 times the initial MIC. 
Niso opazili povečanja MIK50 (± 2 spremembi v redčenju) za povzročitelja P. aeruginosa, pri čemer se je povečanje MIK90 pokazalo v prehodnem 4-kratnem povečanju začetne MIK.
Powder and solvent for nebuliser solution. 
prašek in vehikel za inhalacijsko raztopino za nebulator Bel do sivkasto bel prašek.
Pulmonary function and respiratory symptoms significantly improved from baseline to Day 28 in patients treated with one course of Cayston. 
Pri bolnikih, ki so prejeli en cikel zdravljenja z zdravilom Cayston, so se pljučna funkcija in respiratorni simptomi pomembno izboljšali od izhodiščne točke do 28. dneva.
A decrease in P. aeruginosa susceptibility to aztreonam and other beta-lactam antibiotics was observed in clinical studies of Cayston. 
V kliničnih študijah z zdravilom Cayston so opazili zmanjšanje občutljivosti povzročitelja P. aeruginosa na aztreonam in druge betalaktamske antibiotike.
Always take this medicine exactly as your doctor has told you. 
Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
Renal impairment 
- vnetje žrela
Open the ampoule of solvent by twisting off the tip. 
Zasukajte vrh in tako odprite ampulo z vehiklom.
A total of 137 paediatric patients aged 6 to 17 years with chronic P. aeruginosa infection and FEV1 ≤ 75% predicted have received Cayston in Phase 2 and Phase 3 clinical studies (6-12 years, n = 35; 13-17 years, n = 102). 
≤ 75% (6-12 let, n = 35; 13-17 let, n = 102).
administration. 
uporabi.
Package leaflet: Information for the user Cayston 75 mg powder and solvent for nebuliser solution 
Navodilo za uporabo Cayston 75 mg prašek in vehikel za inhalacijsko raztopino za nebulator aztreonam
This summary was last updated in 03-2013. 
Povzetek je bil nazadnje posodobljen 03-2013.
EMA/190324/2013 EMEA/H/C/001098 
EMA/238944/2013EMA/238944/2013 EMEA/H/C/001098
Because pantoprazole has been in use for many years, the applicant presented data from the scientific literature. 
Ker je pantoprazol v uporabi že več let, je predlagatelj predstavil podatke iz znanstvene literature.
It is available as gastroresistant tablets (20 mg). 
Na voljo je v obliki gastrorezistenčnih tablet (20 mg).
Pantoprazole-containing medicines have been available in the European Union (EU) since 1994. 
Zdravila, ki vsebujejo pantoprazol, so v Evropski uniji (EU) na voljo od leta 1994 naprej.
The patient may need to take the medicine for two to three days in a row for symptoms to improve. 
Bolnik bo morda moral zdravilo jemati dva do tri dni zapored, da se simptomi izboljšajo.
The full EPAR for Somac Control 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 Somac Control je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The main measure of effectiveness was the number of patients with symptoms of heartburn over the first two weeks of treatment. 
Glavno merilo učinkovitosti je bilo število bolnikov s simptomi zgage v prvih dveh tednih zdravljenja.
Patients should not take the medicine for longer than four weeks without consulting their doctor. 
Bolniki zdravila ne smejo jemati dlje kot štiri tedne brez posveta pri zdravniku.
The recommended dose of Somac Control is one tablet once a day until symptoms have stopped. 
Priporočeni odmerek zdravila Somac Control je ena tableta enkrat na dan, dokler simptomi ne izzvenijo.
The tablets should be swallowed whole with liquid before a meal and should not be chewed or crushed. 
Tablete se pogoltnejo cele s tekočino pred obrokom in se ne smejo žvečiti ali zdrobiti.
The European Commission granted a marketing authorisation valid throughout the EU for Somac Control on 12 June 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Somac Control, veljavno po vsej Evropski uniji, odobrila dne 12. junija 2009.
Somac Control is similar to a ‘reference medicine' already authorised in the European Union (EU) called Somac. 
Zdravilo Somac Control je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Somac.
The most common side effects with Somac Control (seen in around 1 patient in 100) are diarrhoea and headache. 
Najpogostejša neželena učinka zdravila Somac Control (opažena pri približno 1 bolniku od 100) sta driska in glavobol.
If there is no improvement in symptoms within two weeks of continuous treatment, patients should consult their doctor. 
Če v dveh tednih neprekinjenega zdravljenja ne pride do izboljšanja simptomov, naj se bolnik posvetuje z zdravnikom.
‘Gastroresistant' means that the tablet's contents pass through the stomach without being broken down until they reach the intestine. 
Izraz „gastrorezistenten“ pomeni, da vsebina tablet preide skozi želodec in se ne razgradi, dokler ne doseže črevesa.
This is a summary of the European public assessment report (EPAR) for Somac Control. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Somac Control.
For more information about treatment with Somac Control, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Somac Control preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Somac Control must not be used in people who are hypersensitive (allergic) to pantoprazole, soya or any of the other ingredients. 
Zdravila Somac Control ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) pantoprazol, sojo ali katero koli drugo sestavino zdravila.
The medicine can be obtained without a prescription. 
Izdaja zdravila je brez recepta.
The applicant also presented information from two main studies looking at the effects of pantoprazole 20 mg in a total of 563 adults who had symptoms of acid reflux, including at least one episode of heartburn in the three days before the studies began. 
Prav tako je predstavil podatke iz dveh glavnih študij, v katerih so učinke pantoprazola v odmerku 20 mg proučevali pri skupno 563 odraslih, ki so imeli simptome kislega refluksa in vsaj eno epizodo zgage v treh dneh pred začetkom študije.
What benefit has Somac Control shown during the studies? 
Kakšne koristi je zdravilo Somac Control izkazalo med študijami?
In the first study, 74% of the patients taking pantoprazole (80 out of 108) and 43% of those taking placebo (48 out of 111) had no heartburn after two weeks. 
V prvi študiji 74 % (80 od 108) bolnikov, ki so jemali pantoprazol, in 43 % (48 od 111) tistih, ki so jemali placebo, po dveh tednih ni imelo simptomov zgage.
The CHMP therefore decided that Somac Control's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zato je zaključil, da so koristi zdravila Somac Control večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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 Somac Control. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Somac Control, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In the second study, 70% of the patients taking pantoprazole (121 out of 172) and 59% of those talking ranitidine (102 out of 172) had no heartburn after two weeks of treatment. 
V drugi študiji 70 % (121 od 172) bolnikov, ki so jemali pantoprazol, in 59 % (102 od 172) tistih, ki so jemali ranitidin, po dveh tednih zdravljenja ni imelo simptomov zgage.
It is used for long-term treatments and is also used to treat a wider range of gastrointestinal diseases (conditions affecting the gut) than Somac Control. 
Uporablja se za dolgotrajno zdravljenje in za zdravljenje širšega spektra bolezni prebavil (stanj, ki prizadenejo črevesje) kot zdravilo Somac Control.
It works by blocking ‘proton pumps', proteins found in specialised cells in the stomach lining that pump acid into the stomach. 
Deluje tako, da zavira „protonske črpalke“, tj. beljakovine v posebnih celicah v želodčni sluznici, ki črpajo kislino v želodec.
Somac Control is used for the short-term treatment of the symptoms of acid reflux in adults. 
Zdravilo Somac Control se uporablja za kratkotrajno zdravljenje simptomov kislega refluksa pri odraslih.
The CHMP noted that pantoprazole 20 mg was effective in the short-term treatment of reflux symptoms and that there is a long safety experience with the medicine as a prescription medicine. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je pantoprazol v odmerku 20 mg učinkovit pri kratkotrajnem zdravljenju simptomov refluksa in da obstajajo dolgotrajne izkušnje glede varne uporabe tega zdravila, ki se izdaja na recept.
Somac Control is a medicine that contains the active substance pantoprazole. 
Zdravilo Somac Control je zdravilo, ki vsebuje zdravilno učinkovino pantoprazol.
Other information about Somac Control 
Druge informacije o zdravilu Somac Control:
It must not be used with atazanavir (a medicine used to treat human immunodeficiency virus [HIV] infection). 
Zdravilo Somac Control se ne uporabljati z atazanavirjem (zdravilom za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti [HIV]).
The first study compared pantoprazole with placebo (a dummy treatment) in 219 adults, and the second compared it with ranitidine (another medicine used to treat acid reflux symptoms) in 344 adults. 
V prvi študiji so pri 219 odraslih primerjali pantoprazol s placebom (zdravilom brez zdravilne učinkovine), v drugi pa pri 344 odraslih učinke pantoprazola z ranitidinom (drugim zdravilom za zdravljenje simptomov kislega refluksa).
Acid reflux is when acid produced in the stomach escapes into the gullet, causing heartburn and acid regurgitation (acid flowing up into the mouth). 
Kisli refluks je vračanje kisline, ki se tvori v želodcu, v požiralnik, kar povzroča zgago ter regurgitacijo kisline (dviganje kisline proti ustom).
Pantoprazole was also more effective than placebo at reducing symptoms of acid regurgitation. 
Pantoprazol je bil učinkovitejši od placeba tudi pri lajšanju simptomov regurgitacije kisline.
For the full list of all side effects reported with Somac Control, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi pantoprazola, glejte navodilo za uporabo.
What is the risk associated with Somac Control? 
Kakšna tveganja so povezana z zdravilom Somac Control?
This prevents the active substance from being destroyed by the acid in the stomach. 
S tem se prepreči, da bi kislina v želodcu razgradila zdravilno učinkovino.
The reference medicine, Somac, is only available with a prescription. 
Referenčno zdravilo Somac se izdaja le na recept.
The active substance in Somac Control, pantoprazole, is a proton pump inhibitor. 
Zdravilna učinkovina zdravila Somac Control, pantoprazol, je zaviralec protonske črpalke.
By blocking the pumps, pantoprazole reduces acid production, relieving the symptoms of acid reflux. 
Pantoprazol z zaviranjem črpalk zmanjša nastajanje kisline in s tem lajša simptome kislega refluksa.
Why has Somac Control been approved? 
Zakaj je bilo zdravilo Somac Control odobreno?
Pantoprazole was more effective than placebo and ranitidine at improving the symptoms of acid reflux. 
Pantoprazol je bil pri izboljšanju simptomov kislega refluksa učinkovitejši od placeba in ranitidina.
It was also of the opinion that, based on the experience of the use of pantoprazole, the availability of 
Menil je tudi, da je glede na izkušnje z uporabo pantoprazola dostopnost zdravila Somac Control brez medicinskega nadzora ustrezna.
What is Somac Control? 
Kaj je zdravilo Somac Control?
How has Somac Control been studied? 
Kako je bilo zdravilo Somac Control raziskano?
What is Somac Control used for? 
Za kaj se zdravilo Somac Control uporablja?
How is Somac Control used? 
Kako se zdravilo Somac Control uporablja?
How does Somac Control work? 
Kako zdravilo Somac Control deluje?
What is the outcome of the review? 
Kakšen je izid pregleda?
The review of Diotop was initiated at the request of the United Kingdom, under Article 29(4) of Directive 2001/83/EC. 
Pregled zdravila Diotop se je začel na zahtevo Združenega kraljestva v skladu s členom 29(4) Direktive 2001/83/ES.
Why was Diotop reviewed? 
Zakaj je bilo zdravilo Diotop pregledano?
What is Diotop? 
Kaj je zdravilo Diotop?
The grounds for the referral were concerns raised by Germany that the data provided by the company were not enough to demonstrate the safety and effectiveness of Diotop. 
Razlog za napotitev so bili pomisleki Nemčije, da podatki, ki jih je zagotovila družba, niso bili dovolj za potrditev varnosti in učinkovitosti zdravila Diotop.
The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use. 
Opravil ga je Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji EMA, pristojen za vprašanja v zvezi z zdravili za uporabo v humani medicini.
The two active substances in Diotop have different effects. 
Učinkovini zdravila Diotop imata različne učinke.
Temmler Pharma GmbH requested that the marketing authorisation for Diotop granted by the UK and Austria in 2016 be recognised in Germany (the ‘concerned Member State'). 
Družba Temmler Pharma GmbH je zahtevala, da se dovoljenje za promet z zdravilom Diotop, izdano leta 2016 v Združenem kraljestvu in Avstriji, prizna tudi v Nemčiji („zadevni državi članici“).
Both diclofenac and omeprazole have been authorised in the EU for many years. 
Diklofenak in omeprazol sta v EU odobrena že več let.
EMA completes review following disagreement among EU Member States 
Evropska agencija za zdravila zaključila pregled po nesoglasju med državami članicami EU
However, the Member States were not able to reach an agreement and the UK medicines regulatory agency referred the matter to EMA for arbitration on 28 September 2018. 
Ker pa države članice niso dosegle soglasja, je britanska regulativna agencija za zdravila dne 28. septembra 2018 zadevo napotila na Evropsko agencijo za zdravila v arbitražo.
The European Commission issued an EU-wide legally binding decision on the marketing authorisation of Diotop on 31/01/2019. 
Evropska komisija je na ravni EU 31/01/2019 izdala končno pravno zavezujočo odločbo o izdaji dovoljenja za promet z zdravilom Diotop.
The Agency considered that, although the particular combination in Diotop (diclofenac 75 mg / omeprazole 20 mg) has never been tested in any published study, the data from studies of higher doses of diclofenac or other NSAIDs taken with omeprazole are enough to support the use of the specific combination in Diotop. 
Agencija je menila, da čeprav posebna kombinacija v zdravilu Diotop (diklofenak 75 mg/omeprazol 20 mg) ni bila nikoli preskušena v nobeni objavljeni študiji, podatki iz študij višjih odmerkov diklofenaka ali drugih nesteroidnih protivnetnih zdravil, ki se uporabljajo z omeprazolom, zadostujejo za podporo uporabi posebne kombinacije v zdravilu Diotop.
On 15 November 2018, the European Medicines Agency completed a review of Diotop following a disagreement among EU Member States regarding its authorisation. 
Evropska agencija za zdravila je 15. novembra 2018 zaključila pregled v zvezi z izdajo dovoljenja za promet z zdravilom Diotop po nesoglasju med državami članicami EU.
The company submitted data from the published literature on the use of several NSAIDs (including diclofenac at the dose of 50 to 150 mg a day) and omeprazole in combination. 
Družba je predložila podatke iz objavljene literature o uporabi več nesteroidnih protivnetnih zdravil (vključno z diklofenakom v odmerku 50-150 mg na dan) v kombinaciji z omeprazolom.
Diotop is a medicine used to relieve symptoms such as swelling and pain caused by the joint disorders rheumatoid arthritis, osteoarthritis or ankylosing spondylitis. 
Diotop je zdravilo, ki se uporablja za lajšanje simptomov, kot so otekanje in bolečina zaradi skupnih motenj revmatoidnega artritisa, osteoartritisa ali ankilozirajočega spondilitisa.
The Agency concluded that the benefits of Diotop outweigh its risks, and the marketing authorisation granted in the United Kingdom can be recognised in other Member States of the EU where the company has applied for a marketing authorisation. 
Agencija je zaključila, da koristi zdravila Diotop odtehtajo z njim povezana tveganja in da se dovoljenje za promet z njim, izdano v Združenem kraljestvu, lahko prizna tudi v drugih državah članicah EU, v katerih je družba zanj zaprosila.
EMA recommends authorisation of Diotop (diclofenac / omeprazole capsules) in the EU 
Evropska agencija za zdravila priporoča izdajo dovoljenja za promet z zdravilom Diotop (diklofenak/omeprazol kapsule) v EU
Diclofenac is a nonsteroidal antiinflammatory drug (NSAID) used for the relief of pain and inflammation in a wide range of conditions. 
Diklofenak je nesteroidno protivnetno zdravilo (NSAID), ki se uporablja za lajšanje bolečine in vnetja pri različnih obolenjih.
The Agency therefore concluded that the benefits of Diotop outweigh its risks, and therefore the marketing authorisation for Diotop should be granted in Germany. 
Agencija je zato zaključila, da koristi zdravila Diotop odtehtajo z njim povezana tveganja, zato se dovoljenje za promet z njim lahko izda tudi v Nemčiji.
Omeprazole is a widely-used treatment for indigestion and acid reflux that acts by reducing the amount of acid the stomach makes. 
Omeprazol se pogosto uporablja za zdravljenje prebavnih motenj in kislinskega refluksa in deluje tako, da zmanjšuje količino kisline v želodcu.
Diotop is used in adult patients who are at risk of developing stomach ulcers and whose disease is already controlled by diclofenac and omeprazole, the two active substances in Diotop, taken separately. 
Zdravilo Diotop se uporablja pri odraslih bolnikih, pri katerih obstaja tveganje za nastanek želodčnih razjed in pri katerih je bolezen že nadzorovana z ločenim jemanjem diklofenaka in omeprazola, ki sta učinkovini zdravila Diotop.
This summary was last updated in April 2013. 
Povzetek je bil nazadnje posodobljen 04-2013.
This will help them to protect against the disease. 
Ta mu bodo pomagala pri obrambi pred boleznijo.
It is available as a suspension for injection. 
Na voljo je v obliki suspenzije za injiciranje.
Protection starts 25 days after the last injection and lasts for at least a year. 
Zaščita je učinkovita od 25. dne po zadnji injekciji in traja vsaj eno leto.
The vaccine also contains ‘adjuvants' (aluminium hydroxide and saponin) to enhance the immune response. 
Cepivo vsebuje tudi „adjuvansa“ (aluminijev hidroksid in saponin) za povečanje imunskega odziva.
The first injection is given from one and a half months of age and the second injection is given three weeks later. 
Prva injekcija se daje od starosti enega meseca in pol, druga pa tri tedne pozneje.
The withdrawal period is the time allowed after administration of the medicine before the animal can be slaughtered and the meat or milk used for human consumption. 
Obdobje karence je čas, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso ali mleko uporabi za prehrano ljudi.
Results from a series of laboratory safety trials performed with vaccines of similar composition but containing different serotypes of the virus were also presented. 
Predstavljeni so bili tudi rezultati niza laboratorijskih študij varnosti, opravljenih s cepivi s podobno sestavo, ki pa so vsebovali drugačne serotipe virusa.
The studies also showed that the vaccine can be used in pregnant sheep. 
Študije so pokazale tudi, da se cepivo lahko uporablja pri brejih ovcah.
The vaccine is given to animals as an injection under the skin. 
Cepivo se živalim injicira pod kožo.
There may also be a local reaction at the injection site, such as swelling (generally lasting less than a week) or ‘nodules' (hardening under the skin) that may last for more than 6 or 7 weeks. 
Po cepljenju se lahko pri živalih pojavi lokalna reakcija na mestu injiciranja, kot je oteklina (ki ne traja več kot en teden), ali otipljivi „noduli“ (zatrdline pod kožo), ki lahko trajajo več kot 6 ali 7 tednov.
In 2013 the CVMP considered that the submitted data were adequate for the authorisation of ZULVAC 8 Ovis to convert to a normal status. 
Leta 2013 je CVMP menil, da predloženi podatki zadostujejo, da dovoljenje za promet s cepivom ZULVAC 8 Ovis dobi običajen status.
ZULVAC 8 Ovis was initially authorised under ‘exceptional circumstances'. 
Cepivo ZULVAC 8 Ovis je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
Sheep may show a temporary increase in body temperature, no more than 1.2°C, in the 24 hours after vaccination. 
Do 24 ur po cepljenju se lahko pri ovcah pojavi prehodno povišanje telesne temperature, ki ne presega 1,2 °C.
The company also presented results from a series of studies with other vaccines that contain other serotypes of the bluetongue virus, as well as preliminary results from a study in sheep investigating how long the immunity produced by the vaccine lasted after vaccination. 
Družba je predstavila tudi rezultate iz niza študij z drugimi cepivi, ki vsebujejo druge serotipe bolezni modrikastega jezika, ter predhodne rezultate študije, opravljene na ovcah, v kateri so raziskovali, kako dolgo po cepljenju traja odpornost, ki nastane s cepivom.
The European Commission granted a marketing authorisation valid throughout the EU for ZULVAC 8 Ovis on 15 January 2010. 
Evropska komisija je dovoljenje za promet s cepivom ZULVAC 8 Ovis, veljavno po vsej Evropski uniji, odobrila dne 15. januarja 2010.
The European Medicines Agency (EMA) reviewed additional information submitted according to an agreed timetable on the quality, safety and efficacy of the vaccine. 
Evropska agencija za zdravila (EMA) je pregledala vse nove podatke o kakovosti, varnosti in učinkovitosti cepiva, ki so bili predloženi po dogovorjenem časovnem razporedu.
Information on the prescription status of this product may be found on the label/outer package. 
Podatki o predpisovanju tega cepiva so navedeni na nalepki/zunanji ovojnini.
In the future, if the animals are exposed to the bluetongue virus, the immune system will be able to produce antibodies more quickly. 
Ob ponovni izpostavitvi virusu bolezni modrikastega jezika v prihodnosti bo imunski sistem tako hitreje tvoril protitelesa.
When it is given to sheep, the immune system recognises the viruses as ‘foreign' and makes antibodies against them. 
Ko ovca prejme cepivo, imunski sistem viruse prepozna kot „tujke“ in proti njim razvije protitelesa.
The benefit-risk balance may be found in the scientific discussion module of this EPAR. 
Za razmerje med koristmi in tveganji glejte modul o znanstveni razpravi tega evropskega javnega poročila o oceni zdravila (EPAR).
What is the withdrawal period? 
Kaj je obdobje karence?
The studies showed that the vaccine is safe for sheep and that it prevents viraemia in animals from one and a half months of age that are infected with bluetongue virus serotype 8. 
Študije so pokazale, da je cepivo varno za uporabo pri ovcah in preprečuje viremijo pri živalih, starejših od enega meseca in pol, ki so okužene z virusom bolezni modrikastega jezika, serotip 8.
The vaccine is used to prevent viraemia (the presence of the virus in the blood) in sheep from one and a half months of age. 
Cepivo se uporablja za preprečevanje viremije (prisotnosti virusa v krvi) pri ovcah, starejših od enega meseca in pol.