FrancophonIA/ELRC3.0 huggingface dataset:
English: The company mainly presented the results of two studies on the prevention of RDS, involving over 1,500 premature neonates in total, where SURFAXIN was compared with other surfactant agents (one which has no protein component and two others which contain animal-derived protein).
Slovenian: Podjetje je v glavnem predstavilo rezultate dveh raziskav o preprečevanju sindroma dihalne stiske, ki sta skupno zajemali 1500 nedonošenčkov in v katerih so zdravilo SURFAXIN primerjali z drugimi površinsko aktivnimi sredstvi (eno je bilo brez beljakovinske sestavine, drugi dve pa sta vsebovali beljakovine živalskega porekla).
English: SURFAXIN was expected to be used for the prevention of RDS in premature neonates of less than 32 weeks of gestational age (babies born 8 weeks or more too early), and, the treatment of RDS in premature neonates of less than 37 weeks of gestational age (babies born 3 weeks or more too early).
Slovenian: Zdravilo SURFAXIN naj bi se uporabljalo za preprečevanje sindroma dihalne stiske pri nedonošenčkih gestacijske starosti manj kot 32 tednov (novorojenčki, rojeni 8 ali več tednov prezgodaj) in za zdravljenje sindroma dihalne stiske pri nedonošenčkih gestacijske starosti manj kot 37 tednov (novorojenčki, rojeni 3 ali več tednov prezgodaj).
English: Effectiveness was measured by looking at frequency of RDS, survival with or without related pulmonary disorder (“bronchopulmonary dysplasia”), at different points in time.
Slovenian: Učinkovitost so merili z opazovanjem pogostosti sindroma dihalne stiske in stopnje preživetja z ali brez povezane pljučne motnje (bronhopulmonarna displazija) v različnih časovnih točkah.
English: Following CHMP opinion, it usually takes around 2 months for the European Commission to grant an authorisation.
Slovenian: Ko CHMP izda mnenje, Evropska komisija v približno 2 mesecih izda dovoljenje.
English: What documentation was presented by the Company to support the application to the CHMP?
Slovenian: Katero dokumentacijo je podjetje predložilo CHMP v podporo svoji vlogi?
English: On 7 June 2006, Pharm Research Associates (UK) Limited has officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their marketing application for SURFAXIN, for the prevention and treatment of respiratory distress syndrome (RDS) in premature babies.
Slovenian: Podjetje Pharm Research Associates (UK) Limited je 7. junija 2006 uradno obvestilo Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet za zdravilo SURFAXIN, namenjeno preprečevanju in zdravljenju sindroma dihalne stiske (RDS) pri nedonošenčkih.
English: What is SURFAXIN?
Slovenian: Kaj je zdravilo SURFAXIN?
English: RDS is a lung disorder that causes increasing difficulty in breathing.
Slovenian: Sindrom dihalne stiske je pljučna motnja, ki povzroča vedno težje dihanje.
English: The company informed the EMEA that there were no ongoing clinical trials or compassionate use programmes with SURFAXIN at the time of the withdrawal.
Slovenian: EMEA je prejela obvestilo podjetja, da v času umika vloge niso tekla nobena klinična preizkušanja ali programi sočutne uporabe zdravila SURFAXIN.
English: SURFAXIN is an artificial surfactant expected to compensate for the lack of natural surfactant in babies with RDS.
Slovenian: Zdravilo SURFAXIN je umetni surfaktant, ki lahko domnevno nadomesti pomanjkanje naravnega surfaktanta pri dojenčkih s sindromom dihalne stiske.
English: Once the Company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining question(s) (at around day 180) to the Company.
Slovenian: Ko podjetje pripravi odgovore na vprašanja, jih CHMP pregleda in pred izdajo mnenja lahko zaprosi podjetje še za odgovore na dodatna vprašanja (180. dan).
English: Active substances: sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid.
Slovenian: Zdravilne učinkovine: sinapultid, dipalmitoil-fosfatidilholin, palmitoil-oleoil fosfatidilglicerol in palmitinska kislina.
English: Based on the review of the data and the company's response to the CHMP list of questions at the time of the withdrawal, the CHMP had concerns and was of the provisional opinion that SURFAXIN could not be approved for the prevention and treatment of respiratory distress syndrome in premature babies.
Slovenian: Na podlagi pregleda podatkov in odgovorov podjetja na seznam vprašanj, ki jih je zastavil CHMP, je imel Odbor v času umika vloge zadržke in bil začasnega mnenja, da za zdravilo SURFAXIN ni mogoče odobriti dovoljenja za zdravljenje nedonošenčkov s sindromom dihalne stiske.
English: In infants, RDS is caused by a lack of lung surfactant; a complex of protein and fat that is normally present in lungs and helps the air sacs of the lung to inflate with air easily.
Slovenian: Sindrom dihalne stiske pri novorojenčkih je posledica pomanjkanja pljučnega surfaktanta, kompleksa beljakovine in maščobe, ki je običajno prisoten v pljučih in lajša polnjenje pljučnih mešičkov z zrakom.
English: RDS is a life-threatening disease.
Slovenian: Sindrom dihalne stiske je življenjsko nevarna bolezen.
English: What was SURFAXIN expected to be used for?
Slovenian: Za kaj naj bi se zdravilo SURFAXIN uporabljalo?
English: The active substances of SURFAXIN are sinapultide, dipalmitoylphosphatidylcholine, palmitoyl-oleoyl phosphatidylglycerol and palmitic acid.
Slovenian: Zdravilne učinkovine zdravila SURFAXIN so sinapultid, dipalmitoil-fosfatidilholin, palmitoil-oleoil, fosfatidilglicerol in palmitinska kislina.
English: How is SURFAXIN expected to work?
Slovenian: Kako naj bi zdravilo SURFAXIN delovalo?
English: The likelihood of lack of surfactant is higher in premature neonates.
Slovenian: Pri nedonošenčkih je verjetnost pomanjkanja surfaktanta večja.
English: SURFAXIN is a white suspension (i.e. a solution in which active substance is dissolved) to be administered into the lungs via a tube.
Slovenian: raztopina v kateri je raztopljena zdravilna učinkovina) za dovajanje v pljuča s pomočjo tubusa.
English: The application was at the stage of review of answers to remaining questions, adopted at around day 180, when the Company withdrew it. After the CHMP had assessed the responses from the Company to a list of questions, there were still unresolved outstanding issues.
Slovenian: Ko je podjetje vlogo umaknilo, je bila ta na stopnji pregledovanja odgovorov na preostala vprašanja, ki so bili prejeti okoli 180. dne.
English: Subcutaneous use pre-filled syringe (glass)
Slovenian: 6 mg raztopina za injiciranje subkutana uporaba napolnjena brizga (steklena)
English: • you are under 18 years.
Slovenian: • če ste mlajši od 18 let.
English: The test will take about 45 minutes.
Slovenian: Test bo trajal približno 45 minut.
English: A supply of drinking water will be needed.
Slovenian: Potrebna bo oskrba s pitno vodo.
English: Your doctor now wants to find out if the treatment has worked.
Slovenian: Vaš zdravnik sedaj hoče ugotoviti, če je to zdravljenje učinkovalo.
English: Wait 5 minutes
Slovenian: Počakajte 5 minut
English: This is especially important after eradication therapy.
Slovenian: To je še posebej pomembno po eradikacijskem zdravljenju.
English: This should be checked routinely.
Slovenian: To se preverja rutinsko.
English: Test is now complete
Slovenian: Test je sedaj končan
English: How does the test work?
Slovenian: Kako deluje test?
English: Do not smoke, eat or drink during this time.
Slovenian: Med tem ne smete kaditi, jesti ali piti.
English: This is not supplied within the box.
Slovenian: To ni priložen v škatli.
English: There are no concerns in relation to the clinical use of the product.
Slovenian: Ni pomislekov glede na klinično uporabo izdelka.
English: If there is a significant increase in the amount of
Slovenian: Če je ta količina znatno povečana.
English: (v) patient fasted for hours Please note that (i) - (iii) will affect result of test.
Slovenian: (v) Bolniki se je postil zadnjih ur Prosimo upoštevajte, da imajo točke (i) - (iii) vpliv na rezultat testa.
English: IRMS source parameters and tuning must be optimised daily.
Slovenian: Izvorne parametre IRMS in nastavitve je treba optimirati dnevno.
English: The specificity estimates were all above 90 % with corresponding lower confidence limits ranging from 85 % to 90 %.
Slovenian: Ocene specifičnosti so vse bile nad 90 % z ustreznimi spodnjimi mejami zaupanja od 85 % do 90 %.
English: Your doctor will tell you when the results of your test will be available and who to contact for these results.
Slovenian: Zdravnik vas bo obvestil, kdaj bodo rezultati testa na razpolago in na koga se boste morali obrniti za rezultate.
English: You must not smoke before or during the test.
Slovenian: Neposredno pred ali med testom ne smete kaditi.
English: This is important for the proper functioning of the test.
Slovenian: To je zelo pomembno za pravilno opravljanje testa.
English: The endogenous production of urea amounts to 25 - 35 g/day.
Slovenian: Endogena proizvodnja sečnine znaša 25 - 35 g/dan.
English: This is not included in this kit but may have been supplied separately.
Slovenian: Ta ni vključen v tem setu, lahko pa je dostavljen ločeno.
English: • fasting (not taking food) may have medical implications for you
Slovenian: • če ima lahko post (neuživanje hrane) za vas medicinske posledice.
English: Explanation of results:
Slovenian: Pojasnilo rezultatov:
English: It is important to follow the instructions for use described in Section 6.6 adequately, otherwise the validity of the test result will be questionable.
Slovenian: Pomembno je, da natančno upoštevate vsa navodila za uporabo opisana v poglavju 6.6, saj so v nasprotnem primeru lahko testni rezultati vprašljivi.
English: Overdose is unlikely to occur in the intended clinical circumstances.
Slovenian: Preveliko odmerjanje je v predvidenih kliničnih okoliščinah malo verjetno.
English: If a repeat test is required, it should not be carried out until the following day.
Slovenian: Če je potreben ponovni test, se ga ne sme opravljati do naslednjega dne.
English: The test procedure involves the following steps: (A brief form of these instructions is included on the back of the Analysis Request Form)
Slovenian: Testni postopek obsega sledeče korake: (skrajšana verzija teh navodil se nahaja na zadnji strani obrazca za naročilo analize)
English: Instruments must be linear over a wide range of CO2 concentrations, typically 1.0 - 6.0%.
Slovenian: Instrumenti morajo meriti linearno na širokem območju koncentracij CO2 (običajno 1,0 - 6,0 %).
English: Do not take the test if:
Slovenian: Ne jemljite test:
English: Idifarma Desarrollo Farmaceutico S.L., Polígono Mocholí, C/ Noáin, No.1, 31110 Noáin, Navarra, , Spain.
Slovenian: Idifarma Desarrollo Farmaceutico S.L., Polígono Mocholí, C/ Noáin, No.1, 31110 Noáin, Navarra, , Španija.
English: The expiry date refers to the last day of that month.
Slovenian: Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca..
English: Suppression of H. pylori might give false negative results.
Slovenian: Supresija H. pylori lahko daje lažne negativne rezultate.
English: A security label for re-sealing the kit is also provided.
Slovenian: Prav tako je priložena varnostna etiketa za ponovno zapečatenje seta.
English: The dissolved tablet must be taken immediately.
Slovenian: Raztopljeno tableto morate zaužiti takoj.
English: Adults: The tablet is to be dissolved in water and taken 10 minutes after the start of the breath test procedure.
Slovenian: Odrasli bolniki: tableto je treba raztopiti v vodi ter raztopino zaužiti 10 minut po začetku postopka dihalnega testa.
English: You will be asked to drink a "test meal".
Slovenian: Prosili vas bodo, da popijete t.i. "testni obrok".
English: Driving and using machines This test should not affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ta test ne bo vplival na vašo sposobnost upravljanja vozil in strojev.
English: Please tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika,farmacevta ali medicinske sestre, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, tudi če ste ga dobili brez recepta.
English: Transfer of the breath sample through the analytical system must be accomplished without isotope fractionation.
Slovenian: Prenos vzorcev izdihanega zraka skozi analizni sistem mora biti dosežen brez frakcioniranja izotopov.
English: Dispose of the empty sachet, mixing vial and straws as normal waste, but keep this leaflet for reference.
Slovenian: Prazno vrečko, vialo za mešanje in slamice odstranite kot običajne odpadke, vendar pa to navodilo shranite za referenco.
English: C in the breath will depend on the type of food that you have eaten.
Slovenian: Dejanska količina 13C je odvisna od vrste hrane, ki ste jo zaužili.
English: Therefore, the test must not be used until four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents.
Slovenian: Iz tega razloga se testa ne sme uporabljati pred potekom štirih tednov po sistemskem antibakterijskem zdravljenju in dveh tednov po zadnjem odmerku zdravil, ki zavirajo sekrecijo kisline.
English: In comparison with biopsy based techniques for diagnosing H.pylori infection, using data from two therapeutic trials, Pylobactell achieved during different conditions (prestudy and follow-up visits) sensitivity estimates above 95 % with lower one-sided 95 % confidence limit ranging from 93 % to 98 %.
Slovenian: V primerjavi z metodami za ugotavljanje infekcije s H. pylori, ki temeljijo na biopsiji, ob upoštevanju podatkov dveh terapevtskih preskušanj, je Pylobactell pod različnimi pogoji (pred študijo in ob kontrolnih pregledih bolnikov po zdravljenju) dosegel ocene občutljivosti nad 95 % s spodnjo enostransko 95 % mejo zaupanja z ustreznimi spodnjimi mejami zaupanja od 93 % do 98 %.
English: Breath samples collected during a test must remain in the original containers before analysis by IRMS.
Slovenian: Vzorci izdihanega zraka, ki se zbirajo med testom, morajo pred analizo z IRMS ostati v originalnih vsebnikih.
English: CO)NH2 + H2O → 2NH3 +
Slovenian: H2N(13CO)NH2 + H2O ® 2NH3 + 13CO2
English: Patient Name:
Slovenian: Ime bolnika:
English: It is excreted unchanged in the urine.
Slovenian: Izloča se nespremenjena s sečem.
English: • part of your stomach has been removed (partial gastrectomy) as the reliability of the test has not been proven in these patients
Slovenian: • če so vam odstranili del želodca (delna gastrektomija), ker pri teh bolnikih zanesljivost testa še ni bila dokazana.
English: You should fast for 4 hours before taking the test (See Section 2 Taking Pylobactell with food and drink)
Slovenian: Post: morate se postiti 4 ure pred opravljanjem testa (glejte poglavje 2, Uporaba zdravila Pylobactell skupaj s hrano in pijačo).
English: A positive urea breath test alone does not clinically confirm that eradication therapy is indicated.
Slovenian: Sam pozitiven rezultat dihalnega testa s sečnino še ni klinična potrditev, da je indicirano eradikacijsko zdravljenje.
English: Centre:
Slovenian: Center:
English: (iii) eradication therapy in the last 28 days?
Slovenian: (iii) bil na eradikacijskem zdravljenju v zadnjih 28 dnevih?
English: (i) antibiotics in the last 28 days?
Slovenian: (i) v zadnjih 28 dnevih jemal antibiotike?
English: It is therefore unlikely that the dose of 100 mg urea should cause any adverse effect on pregnancy and lactation.
Slovenian: Zatorej je le malo verjetno, da bi odmerek 100 mg sečnine lahko povzročal kakršnekoli neželene učinke med nosečnostjo in dojenjem.
English: Analytical file reference: Laboratory code:
Slovenian: Sklic na datoteko analize: Laboratorijska koda:
English: Ireland enquiries@torbetlaboratories.co.uk
Slovenian: Irska enquiries@torbetlaboratories.co.uk
English: ADDITIONAL KIT ITEM: SECURITY LABEL
Slovenian: DODATNI PREDMET SETA: VARNOSTNA ETIKETA {OZNAKA}
English: Reference gases must be standardised against an appropriate international standard to allow interlaboratory comparison of results.
Slovenian: Referenčni plin mora biti standardiziran po ustrezni mednarodni normi, tako da je možna primerjava rezultatov med laboratoriji.
English: Fill out the analysis request form with patient details on the left hand side of the form and the doctor's name and address on the right hand side.
Slovenian: Izpolnite obrazec za naročilo analize z bolnikovimi podatki na levi strani obrazca ter z imenom in naslovom zdravnika na desni strani.
English: For patients who do not tolerate the recommended test meal, an alternative test meal should be given.
Slovenian: Bolniki, ki ne prenašajo priporočenega testnega obroka, naj prejmejo alternativni testni obrok.
English: Alternatively, any other suitably-validated method may be used, carried out by any objectively qualified laboratory.
Slovenian: Alternativno je možno uporabiti katerokoli drugo ustrezno validirano metodo, ki jo mora opraviti ustrezno kvalificiran laboratorij.
English: Care should be taken in patients where fasting may have medical implications.
Slovenian: Posebna previdnost je potrebna pri bolnikih, pri katerih bi post lahko imel zdravstvene posledice.
English: It is not necessary to blow hard into the tubes, just breathe normally and cap them quickly.
Slovenian: Ni potrebno, da močno izdihnete v epruvete, temveč dihajte kot običajno ter nemudoma namestite zaporko.
English: • You have taken antibiotics or medication to treat Helicobacter pylori within the last 28 days
Slovenian: • če ste v zadnjih 28 dneh jemali antibiotike ali zdravila za zdravljenje okužbe z bakterijo Helicobacter pylori.
English: The validity of the test result may be affected if the patient is currently being treated with antibiotics or a proton-pump inhibitor or has completed a course of treatment with these drugs.
Slovenian: Na zanesljivost testnih rezultatov lahko vpliva, če se bolnik trenutno zdravi z antibiotiki ali zaviralcem protonske črpalke oz. če je pravkar zaključil zdravljenje s tovrstnimi zdravili.
English: Drink the recommended test meal.
Slovenian: Testni obrok: popijte priporočen testni obrok.
English: If no test meal has been supplied, the most suitable test meal is 200 ml of pure undiluted orange juice.
Slovenian: Če testni obrok ni bil dostavljen, je najprimernejši testni obrok 200 ml čistega in nerazredčenega pomarančnega soka.
English: C in these samples will be compared to your normal level.
Slovenian: Količina 13C v teh vzorcih se primerja z običajno količino.
English: Following the meal, 3 samples of your breath will be taken.
Slovenian: Po testnem obroku bodo vzeli 3 vzorce vašega izdihanega zraka.
English: The results may be affected in general by all treatments interfering with H.pylori status or urease activity.
Slovenian: Na splošno pa lahko na rezultate vplivajo vse vrste zdravljenja, ki ovirajo stanje H. pylori ali aktivnost ureaze.
English: The Pylobactell breath test procedure includes the administering of a suitable test meal.
Slovenian: Postopek dihalnega testa Pylobactell vključuje tudi dajanje ustreznega testnega obroka.
English: The IRMS must possess a triple collector to allow the simultaneous detection of the ions at mass/charge ratio 44, 45 and 46 fluctuations in the oxygen isotope content.
Slovenian: IRMS mora biti opremljen s takim trojnim zbiralcem, da omogoča hkratno zaznavanje ionov z razmerji masa/naboj 44, 45 in 46 fluktuacij vsebnosti izotopov kisika.
English: C and urea are harmless naturally occurring substances which are found in your body.
Slovenian: 13C in sečnina sta nenevarni, naravno dani snovi, ki se nahajata tudi v vašem telesu.
English: The optimal test meal recommended is 200 ml pure undiluted orange juice.
Slovenian: Priporočeni optimalni testni obrok je 200 ml čistega in nerazredčenega pomarančnega soka.
English: Navarra,
Slovenian: Navarra, Španija
English: Taking Pylobactell with food and drink
Slovenian: Zdravilo Pylobactell skupaj s hrano in pijačo
English: It is reported to cross the placenta and penetrate the eye.
Slovenian: Poročali so, da prehaja skozi placento in penetrira v oči.
English: Do not store above 25°C.
Slovenian: Set shranjujte pri temperaturi do 25 °C.
English: The tablet must be taken when dissolved.
Slovenian: Tableto morate zaužiti, ko je raztopljena.
English: Each Pylobactell Breath Test kit contains:
Slovenian: Vsak set dihalnega testa Pylobactell vsebuje:
English: IRMS instruments may be of continuous flow or dual inlet configuration.
Slovenian: Pri instrumentih za IRMS lahko gre za pretočne instrumente ali za instrumente z dvojnim dovodom.
English: If so, please indicate type and when last taken.
Slovenian: Če da, prosimo navedite katere in čas zadnjega jemanja.
English: In the case of infection with H.pylori, orally ingested 13C-urea is metabolised by the enzyme urease which is present in H.pylori.
Slovenian: V primeru infekcije s H. pylori peroralno zaužito 13C-sečnino presnavlja encim ureaza, ki je prisoten v H. pylori.
English: Laboratory use only Date received:
Slovenian: Namenjeno samo laboratoriju: Datum prejema:
English: Satisfactory specificity and sensitivity have been demonstrated in clinical studies where breath was analysed using isotope ratio mass spectrometry (IRMS).
Slovenian: Zadovoljiva specifičnost in občutljivost sta bili dokazani v kliničnih raziskavah, ko so analizirale izdihani zrak s pomočjo masne spektrometrije za določanje razmerja izotopov (IRMS).
English: • you have long term stomach problems (atrophic gastritis) as the breath test may give the wrong result and other tests may be required to confirm the presence of H. pylori.
Slovenian: • če imate dolgotrajne želodčne težave (atrofični gastritis), ker lahko dihalni test pokaže napačen rezultat, zaradi česa bodo potrebni drugi testi za potrditev prisotnosti H. pylori.
English: The kit contains:
Slovenian: Set vsebuje:
English: Try to avoid getting saliva in the tubes.
Slovenian: Poskusite se izogniti temu, da bi slina prišla v epruvete.
English: Open the tablet sachet and empty the tablet into the mixer vial.
Slovenian: Odprite vrečko ter dajte tableto v vialo za mešanje.
English: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Ireland Tel. +44 (0)1953 607856
Slovenian: Torbet Laboratories Ireland Limited, 20 Holles Street, Dublin 2, Irska Tel :+44 (0)1953 607856
English: 07 May 2008
Slovenian: Datum prve odobritve: 07. maj 1998 Datum zadnjega podaljšanja: 07.maj 2008
English: The carbon dioxide which is liberated diffuses into the blood vessels and is transported as bicarbonate to the lungs where it is then liberated as
Slovenian: Sproščen ogljikov dioksid difundira v krvne žile in se prenese kot bikarbonat v pljuča, kjer se sprosti kot 13CO2 v izdihanem zraku.
English: The test must not be used in patients with documented or suspected gastric infection that might interfere with the urea breath test.
Slovenian: Testa se ne sme uporabljati pri bolnikih z dokazano gastrično infekcijo ali če obstaja sum gastrične infekcije, ki bi lahko neugodno vplivala na dihalni test s sečnino.
English: - suffer from any medical condition that you think may affect, or be affected by, the test.
Slovenian: - če trpite za boleznijo, ki bi lahko po vašem mnenju imela vpliv na test in/ali obratno.
English: Drink the solution.
Slovenian: Popijte raztopino.
English: TEST CHECK LIST
Slovenian: Seznam za testno preverjanje
English: WHAT PYLOBACTELL IS AND WHAT IT IS USED FOR
Slovenian: KAJ JE ZDRAVILO PYLOBACTELL IN ZA KAJ GA UPORABLJAMO
English: What Pylobactell is and what it is used for What you need to know before you use Pylobactell How to use Pylobactell
Slovenian: Kaj je zdravilo Pylobactell in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Pylobactell Kako uporabljati zdravilo Pylobactell Možni neželeni učinki