FrancophonIA/ELRC3.0 huggingface dataset:
English: Fever > 39 °C rectally (age < 2 years), injection site reactions like injection site induration Uncommon Injection site reactions like injection site haematoma, haemorrhage and nodule Adverse reactions additionally reported after booster vaccination of primary series and/or catch-up vaccination: Nervous system disorders
Slovenian: (starost < 2 leti), bolečina, pordelost, oteklost na mestu injiciranja pogosti zvišana telesna temperatura > 39 °C rektalno (starost < 2 leti), reakcije na mestu injiciranja, kot je induracija na mestu injiciranja občasni reakcije na mestu injiciranja, kot so hematom,
English: Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Slovenian: Redki (pojavi se lahko pri največ 1 od 1.000 odmerkov cepiva)
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in multidose container (4 doses) Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Slovenian: Navodilo za uporabo Synflorix suspenzija za injiciranje v večodmernem vsebniku (4 odmerki) konjugirano, adsorbirano cepivo s pnevmokoknimi polisaharidi
English: How to store Synflorix
Slovenian: Kako uporabljati cepivo Synflorix
English: IPD due to individual serotypes(4) - 6B
Slovenian: Invazivna pnevmokokna bolezen zaradi posameznih serotipov(4)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses (0.5 ml/dose)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2 odmerka (0,5 ml/odmerek)
English: Impact on nasopharyngeal carriage (NPC)
Slovenian: Vpliv na nazofaringealno nosilstvo
English: If your child gets any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: The clinical relevance of the above observations is unknown.
Slovenian: Klinični pomen teh ugotovitev ni znan.
English: Angioedema
Slovenian: - Meningitis
English: schedule schedule
Slovenian: POSTOPEK UPORABE
English: The proportion of subjects with an ELISA antibody concentration ≥ 0.20 µg/ml or an
Slovenian: Delež preiskovancev s koncentracijo protiteles z ELISA
English: Urticaria
Slovenian: Protitelo
English: Synflorix was shown to be immunogenic and no new safety concerns were observed in this study.
Slovenian: V tej študiji se je cepivo Synflorix izkazalo za imunogeno.
English: However, in TVC
Slovenian: Po NPC
English: The primary infant series consists of three doses with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Slovenian: Priporočeno zaporedje cepljenja za zagotovitev optimalne zaščite obsega štiri odmerke po 0,5 ml. Primarno zaporedje za dojenčke obsega tri odmerke, pri čemer je prvi odmerek po navadi uporabljen pri 2 mesecih starosti, presledek med odmerki pa je vsaj 1 mesec.
English: In Finland, Synflorix was introduced into NIP with a 2+1 schedule in infants (3, 5 months of age and a booster dose at 12 months) without catch-up campaign.
Slovenian: Na Finskem je bilo cepivo Synflorix vključeno v NPC po shemi 2+1 pri dojenčkih (v starosti 3 in 5
English: No increase in the incidence or severity of the adverse reactions was seen with subsequent doses of the primary vaccination series.
Slovenian: Po nadaljnjih odmerkih primarnega zaporedja cepljenja niso opazili večje incidence ali izrazitosti neželenih reakcij.
English: Infants from 6 weeks to 6 months of age:
Slovenian: Uporabljamo ga za zaščito otrok od 6. tedna do 5. leta starosti pred:
English: Table 4: Summary of effectiveness of Synflorix for IPD in Brazil Types of IPD(1)
Slovenian: Preglednica 4: Povzetek učinkovitosti cepiva Synflorix za invazivno pnevmokokno bolezen v
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine)
Slovenian: Občasni (pojavi se lahko pri največ 1 od 100 odmerkov cepiva)
English: Vaccine effectiveness was 6.1% (95% CI: -2.7; 14.1) for the 3+1 schedule and 7.4% (95% CI -2.8; 16.6) for 2+1 schedule for this AOM endpoint in the infant vaccinated cohort.
Slovenian: za shemo 3+1 in 7,4 % (95 % IZ: -2,8, 16,6) za shemo 2+1.
English: Synflorix is a pneumococcal conjugate vaccine.
Slovenian: Kaj je cepivo Synflorix in za kaj ga uporabljamo Synflorix je konjugirano pnevmokokno cepivo.
English: Instructions for administration of the vaccine presented in pre-filled syringe 1.
Slovenian: Navodila za injiciranje cepiva v napolnjeni injekcijski brizgi
English: Vaccine serotype
Slovenian: Povzročena s serotipom
English: Preterm infants (born after 27 weeks and less than 37 weeks of pregnancy): Your child (from 2 months to 6 months of age) will receive 3 injections with an interval of at least one month between each dose.
Slovenian: Otrok (od 2 do 6 mesecev starosti) bo dobil 3 injekcije; med posameznimi odmerki bo presledek vsaj enega meseca.
English: At the end of this IA or end-of-study ATP follow-up period, the mean age was 29 months (range from 4 to 41 months) and 36 months (range from 4 to 50 months), respectively.
Slovenian: Ob koncu obdobja spremljanja kohorte po protokolu je bila povprečna starost 29 mesecev (razpon od
English: In clinical studies the immunogenicity of Synflorix was evaluated after a 3-dose primary vaccination series (6941 subjects) according to different schedules (including 6-10-14 weeks, 2-3-4, 3-4-5 or 2-4-6 months of age) and after a fourth (booster) dose (5645 subjects) given at least 6 months after the last primary dose and from the age of 9 months onwards.
Slovenian: V kliničnih študijah so ocenili imunogenost cepiva Synflorix po primarnem zaporedju cepljenja s 3 odmerki (6941 preiskovancev) po različnih razporedih cepljenja (vključujoč pri 6-10-14 tednih ali pa
English: The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Slovenian: zlasti tistih z anamnezo respiratorne nezrelosti, je treba upoštevati možnost apneje in potrebo po 48do 72-urnem respiratornem nadzoru.
English: Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Slovenian: konjugirano, adsorbirano cepivo s pnevmokoknimi polisaharidi
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja občasni izpuščaj redki urtikarija
English: 10 doses (0.5 ml)
Slovenian: 10 napolnjenih injekcijskih brizg 10 odmerkov (0,5 ml)
English: Store in the original package in order to protect from light After first use, the product may be stored in a refrigerator for a maximum of 28 days
Slovenian: Po prvi uporabi lahko cepivo shranjujete v hladilniku največ 28 dni.
English: Two-dose primary series
Slovenian: Primarno zaporedje cepljenja z 2 odmerkoma
English: 96.5% CI
Slovenian: Synflorix) N % N % % 96,5 % IZ
English: Following catch-up vaccination in children 12 to 23 months of age, urticaria was reported more frequently (uncommon) compared to the rates observed in infants during primary and booster vaccination.
Slovenian: Po naknadnem cepljenju otrok v starosti od 12 do 23 mesecev so urtikarijo zabeležili pogosteje
English: Store in a refrigerator (2 °C - 8 °C).
Slovenian: 6.4 Posebna navodila za shranjevanje Shranjujte v hladilniku (2 °C - 8 °C).
English: However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Slovenian: Vendar pa naj cepljenja ne bi odložili zaradi blagih okužb, npr.
English: PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in multidose container (2 doses) 100 MULTIDOSE vials (2 doses per vial - 0.5 ml per dose)
Slovenian: 100 VEČODMERNIH vial (2 odmerka na vialo - 0,5 ml na odmerek)
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Slovenian: Navodilo za uporabo Synflorix suspenzija za injiciranje konjugirano, adsorbirano cepivo s pnevmokoknimi polisaharidi
English: NAME OF THE MEDICINAL PRODUCT Synflorix suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Slovenian: Navodilo za uporabo Synflorix suspenzija za injiciranje v napolnjeni injekcijski brizgi konjugirano, adsorbirano cepivo s pnevmokoknimi polisaharidi
English: 10 pneumococcal vaccine serotypes
Slovenian: Invazivna pnevmokokna bolezen zaradi katerega koli serotipa v cepivu
English: Syringe barrel
Slovenian: krvavitev in vozlič
English: Any vaccine serotype IPD(3) - Invasive pneumonia or bacteraemia - Meningitis
Slovenian: - 19A (1) Invazivna pnevmokokna bolezen, potrjena s kulturo ali PCR
English: In FinIP the overall observed VE against culture-confirmed IPD was 100% (95% CI: 85.6; 100; 0 versus 14 cases) for the 3+1 schedule, 85.8% (95% CI: 49.1; 97.8; 2 versus 14 cases) for the 2+1 schedule and 93.0% (95% CI: 74.9; 98.9; 2 versus 14 cases) regardless of the primary vaccination schedule.
Slovenian: V FinIP je bila celotna opažena UC proti IPB, potrjeni s kulturo, za shemo 3+1 100 % (95 % IZ: 85,6; 100; 0 v prim.
English: Pneumococcal polysaccharide serotype 11,2
Slovenian: En 0,5-ml odmerek vsebuje: Pnevmokokni polisaharid serotip 11,2
English: (1) Culture or PCR confirmed IPD (2) The adjusted effectiveness represents the percent reduction in IPD in the Synflorix vaccinated group compared to the unvaccinated group, controlling for confounding factors.
Slovenian: (2) Korigirana učinkovitost pomeni odstotek zmanjšanja invazivne pnevmokokne bolezni v skupini,
English: Uncommon (these may occur with up to 1 in 100 doses of the vaccine) • itching, blood clot, bleeding or a small lump where the injection is given
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 odmerkov cepiva) • Kawasakijeva bolezen (pomembnejši znaki bolezni so npr.: povišana telesna temperatura,
English: The reduction in B-CAP and C-CAP was greatest in children < 36 months of age (vaccine efficacy of 20.6% (95% CI: 6.5; 32.6) and 24.2% (95% CI: 7.4; 38.0) respectively).
Slovenian: 20,6 % (95 % IZ: 6,5; 32,6) in 24,2 % (95% IZ: 7,4; 38,0)).
English: Check with your doctor or pharmacist before this vaccine is given if: • your child has a bleeding problem or bruises easily.
Slovenian: • če ima vaš otrok kakšne težave s strjevanjem krvi (krvavitve) ali se mu zlahka pojavijo podplutbe.
English: Pneumonia
Slovenian: • zaspanost
English: Further information on Azacitidine Celgene can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/azacitidine-celgene.
Slovenian: Nadaljnje informacije o zdravilu Azacitidine Celgene so na voljo na spletni strani agencije: www.ema.europa.eu/medicines/human/EPAR/azacitidine-celgene.
English: This medicine is the same as Vidaza, which is already authorised in the EU.
Slovenian: To zdravilo je enako zdravilu Vidaza, ki je že odobreno v EU.
English: The European Medicines Agency decided that Azacitidine Celgene's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Azacitidine Celgene večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The recommended dose of Azacitidine Celgene is 75 mg per square metre body surface area (calculated using the patient's height and weight).
Slovenian: Priporočeni odmerek zdravila Azacitidine Celgene je 75 mg na kvadratni meter površine telesa (izračunano na podlagi bolnikove telesne mase in višine).
English: What measures are being taken to ensure the safe and effective use of Azacitidine Celgene?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Azacitidine Celgene?
English: It can only be obtained with a prescription and treatment should be started and monitored under the supervision of a doctor experienced in the use of cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, zdravljenje pa mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: In this study, patients receiving Azacitidine Celgene survived for an average of 24.5 months, compared with 15.0 months in patients receiving conventional care.
Slovenian: V tej študiji so bolniki, ki so prejeli zdravilo Azacitidine Celgene, v povprečju preživeli 24,5 meseca v primerjavi s 15,0 meseca pri bolnikih, ki so bili deležni običajne oskrbe.
English: The effect of Azacitidine Celgene was similar in all three diseases.
Slovenian: Učinek zdravila Azacitidine Celgene je bil podoben pri vseh treh obolenjih.
English: Azacitidine Celgene (azacitidine)
Slovenian: Azacitidine Celgene (azacitidin)
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Azacitidine Celgene have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Azacitidine Celgene upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Azacitidine Celgene are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Azacitidine Celgene, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: For more information about using Azacitidine Celgene, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij o uporabi zdravila Azacitidine Celgene glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: As for all medicines, data on the use of Azacitidine Celgene are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Azacitidine Celgene stalno spremljajo.
English: The active substance in Azacitidine Celgene, azacitidine, belongs to the group ‘antimetabolites' and can be incorporated into the genetic material of cells (RNA and DNA) instead of their natural building-block, cytidine.
Slovenian: Učinkovina v zdravilu Azacitidine Celgene, azacitidin, spada v skupino „antimetabolitov“ in se lahko vgradi v dedni material celic (RNK in DNK) namesto njihovega naravnega gradnika, citadina.
English: Azacitidine Celgene must not be used in patients with advanced liver cancer or in women who are breastfeeding.
Slovenian: Zdravila Azacitidine Celgene ne smejo uporabljati bolniki z napredovalim rakom jeter ali ženske, ki dojijo.
English: The most common side effects of Azacitidine Celgene, which may affect more than 60% of patients with myelodysplastic syndromes, CMML or AML (20 to 30% abnormal cells), are blood reactions including thrombocytopenia (low platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell) and leucopenia (low white blood cell counts), side effects affecting the stomach and gut including nausea and vomiting, and injection site reactions.
Slovenian: Najpogostejši neželeni učinki zdravila Azacitidine Celgene, ki se lahko pojavijo pri več kot 60 % bolnikov z mielodisplastičnimi sindromi, kronično mielomonocitno levkemijo ali akutno mieloično levkemijo (pri katerih je bilo od 20 % do 30 % celic nenormalnih), so krvne reakcije, ki vključujejo trombocitopenijo (nizko število trombocitov), nevtropenijo (nizko število nevtrofilcev, vrste belih krvničk) in levkopenijo (nizko število belih krvnih celic), neželeni učinki v želodcu in črevesju, ki vključujejo navzejo (slabost) in bruhanje, ter reakcije na mestu injiciranja.
English: Azacitidine Celgene is used for the treatment of adults with the following diseases, if they cannot have haematopoietic stem cell transplantation (when the patient receives stem cells to restore the bone marrow's ability to produce healthy blood cells):
Slovenian: Zdravilo Azacitidine Celgene se uporablja za zdravljenje odraslih z naslednjimi boleznimi, če jim ni mogoče presaditi hematopoetskih (krvotvornih) matičnih celic (pri čemer bolnik prejme matične celice, ki pomagajo obnoviti sposobnost kostnega mozga, da proizvaja zdrave krvne celice):
English: Azacitidine Celgene is available as a powder to be made up into a suspension for injection.
Slovenian: Zdravilo Azacitidine Celgene je na voljo v obliki praška za pripravo suspenzije za injiciranje.
English: In the second study, which involved 488 patients with AML who could not have haematopoietic stem cell transplantation and whose bone marrow contained more than 30% abnormal cells, patients receiving Azacitidine Celgene survived for an average of 10.4 months, compared with 6.5 months in patients receiving conventional care.
Slovenian: V drugi študiji, v katero je bilo vključenih 488 bolnikov z akutno mieloično levkemijo, pri katerih ni bilo mogoče opraviti presaditve krvotvornih matičnih celic in katerih krvni mozeg je vseboval več kot 30 % nenormalnih celic, so bolniki, ki so prejemali zdravilo Azacitidine Celgene, preživeli v povprečju 10,4 meseca v primerjavi s 6,5 meseca pri bolnikih, ki so bili deležni običajne oskrbe.
English: An overview of Azacitidine Celgene and why it is authorised in the EU
Slovenian: Pregled zdravila Azacitidine Celgene in zakaj je odobreno v EU
English: Why is Azacitidine Celgene authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Azacitidine Celgene odobreno v EU?
English: What is Azacitidine Celgene and what is it used for?
Slovenian: Kaj je zdravilo Azacitidine Celgene in za kaj se uporablja?
English: The company that makes Vidaza has agreed that its scientific data can be used for Azacitidine Celgene (‘informed consent').
Slovenian: Podjetje, ki proizvaja zdravilo Vidaza, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Azacitidine Celgene („uporaba dokumentacije s soglasjem“).
English: This helps to correct the problems with the maturation and growth of young blood cells in the bone marrow that cause myelodysplastic disorders, and to kill cancerous cells in leukaemia.
Slovenian: Tako se odpravijo težave, ki se pojavijo pri zorenju in rasti mladih krvnih celic v kostnem mozgu, kar povzroča mielodisplastične motnje, ter uničijo rakave celice pri levkemiji.
English: Azacitidine Celgene is used when the bone marrow consists of 10 to 29% abnormal cells and the bone marrow is not producing large numbers of white blood cells;
Slovenian: Zdravilo Azacitidine Celgene se uporablja, kadar je od 10 % do 29 % celic kostnega mozga nenormalnih, kostni mozeg pa ne proizvaja zadostnega števila belih krvničk;
English: What benefits of Azacitidine Celgene have been shown in studies?
Slovenian: Kakšne koristi zdravila Azacitidine Celgene so se pokazale v študijah?
English: Other information about Azacitidine Celgene
Slovenian: Druge informacije o zdravilu Azacitidine Celgene
English: • chronic myelomonocytic leukaemia (CMML, a cancer affecting white blood cells called monocytes).
Slovenian: • kronično mielomonocitno levkemijo (KMML, tj. rakom, ki prizadene bele krvničke, imenovane monociti).
English: Azacitidine Celgene is used in patients with an intermediate to high risk of progressing to AML or death;
Slovenian: Zdravilo Azacitidine Celgene se uporablja pri bolnikih s srednjo in visoko stopnjo tveganja za napredovanje bolezni do akutne mieloične levkemije ali smrti;
English: What are the risks associated with Azacitidine Celgene?
Slovenian: Kakšna tveganja so povezana z zdravilom Azacitidine Celgene?
English: For the full list of side effects and restrictions of Azacitidine Celgene, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Azacitidine Celgene glejte navodilo za uporabo.
English: Azacitidine Celgene was shown to be more effective than conventional care in extending survival in two main studies.
Slovenian: V dveh glavnih študijah je bilo dokazano, da je zdravilo Azacitidine Celgene učinkovitejše pri podaljševanju prežitevja od običajne oskrbe.
English: In some cases, myelodysplastic syndromes can lead to acute myeloid leukaemia (AML, a cancer affecting white blood cells called myeloid cells).
Slovenian: V nekaterih primerih lahko mielodisplastični sindromi povzročijo akutno mieloično levkemijo (AML, tj. raka, ki prizadene bele krvničke, imenovane mieloične celice).
English: The first study involved 358 adults with intermediate to high-risk myelodysplastic syndromes, CMML or AML who were unlikely to go on to have a stem cell transplant.
Slovenian: V prvo študijo je bilo vključenih 358 odraslih z mielodisplastičnimi sindromi s srednjo in visoko stopnjo tveganja, kronično mielomonocitno levkemijo ali akutno mieloično levkemijo, pri katerih je zelo majhna verjetnost presaditve matičnih celic.
English: • AML, when the bone marrow has more than 30% abnormal cells.
Slovenian: • akutno mieloično levkemijo, kadar kostni mozeg vsebuje več kot 30 % nenormalnih celic.
English: • myelodysplastic syndromes, a group of conditions where too few blood cells are produced by the bone marrow.
Slovenian: • mielodisplastičnimi sindromi, tj. skupino obolenj, pri katerih kostni mozeg ne proizvaja dovolj velikega števila krvnih celic.
English: Azacitidine Celgene contains the active substance azacitidine.
Slovenian: Zdravilo Azacitidine Celgene vsebuje učinkovino azacitidin.
English: Patients should be given medicines to prevent nausea (feeling sick) and vomiting before receiving Azacitidine Celgene.
Slovenian: Bolniki morajo pred zdravljenjem z zdravilom Azacitidine Celgene prejeti zdravila za preprečevanje navzeje (slabosti) in bruhanja.
English: How is Azacitidine Celgene used?
Slovenian: Kako se zdravilo Azacitidine Celgene uporablja?
English: How does Azacitidine Celgene work?
Slovenian: Kako zdravilo Azacitidine Celgene deluje?
English: • AML that has developed from a myelodysplastic syndrome and the bone marrow consists of 20 to 30% abnormal cells;
Slovenian: • akutno mieloično levkemijo, ki se je razvila iz mielodisplastičnega sindroma, kostni mozeg pa tvori
English: The results obtained were compared to see if they agreed.
Slovenian: Dobljene rezultate so primerjali, da bi ugotovili, ali se skladajo.
English: The marketing authorisation was renewed on 7 May 2003 and on 7 May 2008.
Slovenian: Dovoljenje za promet z zdravilom je bilo obnovljeno dne 7. maja 2003 in 7. maja 2008.
English: These samples are then sent for analysis at a specialised laboratory.
Slovenian: Ti se nato pošljejo na analizo v specializiran laboratorij.
English: The carbon dioxide is then removed from the body in the breath.
Slovenian: Ogljikov dioksid se nato iz telesa izloči z dihanjem.
English: First, the patient takes a ‘test meal' (such as 200 ml of pure undiluted orange juice).
Slovenian: Bolnik najprej vzame „testni obrok“ (npr. 200 ml čistega nerazredčenega pomarančnega soka).
English: The marketing authorisation holder is Torbet Laboratories Limited.
Slovenian: Imetnik dovoljenja za promet je družba Torbet Laboratories Limited.
English: The patient should fast for four hours before the test so that it is done on an empty stomach.
Slovenian: Bolnik se mora pred izvedbo testa štiri ure postiti, tako da se test izvede na prazen želodec.
English: Pylobactell is not recommended for use in patients below 18 years of age because there is insufficient information on its effectiveness in this group.
Slovenian: Uporaba zdravila Pylobactell ni priporočena pri bolnikih, starih pod 18 let, saj ni na voljo zadosti informacij o učinkovitosti zdravila v tej starostni skupini.
English: This 13C-labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry.
Slovenian: Ta ogljikov dioksid, označen s 13C, lahko izmerimo v specializiranih laboratorijih s tehniko, imenovano masna spektrometrija.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PYLOBACTELL EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) PYLOBACTELL Povzetek EPAR za javnost
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pylobactell on 7 May 1998.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Pylobactell, veljavno po vsej Evropski uniji, odobrila dne 7. maja 1998.