FrancophonIA/ELRC3.0 huggingface dataset:
English: Janssen-Cilag NV Antwerpseweg 15-17, 2340 Beerse, Belgium
Slovenian: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgium
English: Turnhoutseweg 30, Beerse, Belgium
Slovenian: Janssen-Cilag International N.V Turnhoutseweg 30, Beerse, Belgium
English: Do not touch the dropper.
Slovenian: Ne dotikajte se kapalke.
English: If necessary, they can be diluted in water (see above).
Slovenian: Po potrebi jih je mogoče razredčiti v vodi (glejte zgoraj).
English: Available data are described in sections 4.8 and 5.1.
Slovenian: Podatki, ki so na voljo, so opisani v poglavjih 4.8 in 5.1.
English: [To be filled in nationally]
Slovenian: [Izpolni država članica]
English: These reactions usually disappear within a few days even if treatment is continued.
Slovenian: Te reakcije običajno po nekaj dneh izginejo, tudi če se zdravljenje ne prekine.
English: If and to what extend these results are applicable for the use in patients is not yet known.
Slovenian: Ni še znano, če in v kakšnem obsegu so ti rezultati pomembni za uporabo pri bolnikih.
English: Please interrupt treatment, temporarily.
Slovenian: Zdravljenje morate začasno prekiniti.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Slovenian: Informacije o zdravilu lahko pristojni organi države članice v sodelovanju z referenčno državo članico naknadno dopolnijo, kot je primerno, po postopkih iz Poglavja 4 Naslova III Direktive 2001/83/ES.
English: However, based on these limited data the safety profile for children and adolescents is considered to be comparable to that of adults.
Slovenian: Vendar pa lahko na podlagi teh omejenih podatkov sklepamo, da je varnostni profil za otroke in mladostnike podoben tistemu pri odraslih.
English: By reporting side effects, you can help provide more information on the safety of this medicine.
Slovenian: S tem ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: In a non-interventional study with 203 children aged 4-18 years no undesirable effects were reported.
Slovenian: V neintervencijski študiji, ki so jo opravili pri 203 otrocih, starih od 4 do 18 let, niso poročali o neželenih učinkih.
English: Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete/uporabljate, ste pred kratkim jemali/uporabljali ali pa boste morda začeli jemati/uporabljati katero koli drugo zdravilo.
English: Efficacy and safety beyond 8 weeks have not been studied.
Slovenian: Učinkovitosti in varnosti zdravila po osmih tednih uporabe niso proučevali.
English: Antibiotics may inhibit the Escherichia coli bacteria and thus reduce the efficacy of this medicine.
Slovenian: Antibiotiki lahko zavirajo delovanje bakterije Escherichia coli in tako zmanjšajo učinkovitost tega zdravila.
English: Overall, there is a shift in activity in favour of Th1 helper cells, accompanied by inhibition of the Th2 helper cells.
Slovenian: V splošnem je opaziti spremembo dejavnosti v korist celic pomagalk Th1, ki jo spremlja zaviranje celic pomagalk Th2.
English: The existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below] Summary of product characteristics
Slovenian: [Obstoječe informacije o zdravilu je treba spremeniti (vstaviti, zamenjati ali izbrisati besedilo, kot je primerno), tako da bodo odražale odobreno besedilo, ki je navedeno spodaj] Povzetek glavnih značilnosti zdravila
English: Duration of use of 8 weeks is recommended.
Slovenian: Priporočljivo trajanje uporabe zdravila je osem tednov.
English: This can be prevented by opening the bottle for a short time only when using this product, and by dispensing the drops carefully.
Slovenian: To lahko preprečite tako, da stekleničko odprete za kratek čas in le, ko uporabljate zdravilo, kapljice pa previdno odmerite.
English: You can also report side effects directly via the national reporting system: [to be filled in nationally]
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje: [Izpolni država članica].
English: The most common undesirable effects observed in the clinical trial, predominantly observed within the first 4 weeks of treatment, were abdominal pain and urticaria.
Slovenian: Najpogostejši neželeni učinki, ki so jih opazili v kliničnem preskušanju predvsem v prvih štirih tednih zdravljenja, so bili bolečine v trebuhu in urtikarija.
English: The efficacy and safety in children and adolescents have not been established.
Slovenian: Učinkovitost in varnost zdravila pri otrocih in mladostnikih nista bili dokazani.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system (details see below).
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neželenem učinku zdravila na nacionalni center za poročanje (podrobnosti v nadaljevanju).
English: The following undesirable effects may occur: Common (may affect up to 1 in 10 patients): - Abdominal pain (including upper abdominal pain and abdominal discomfort) - Hives These reactions usually occur within the first 4 weeks of treatment and disappear within a few days even if treatment is continued.
Slovenian: Pojavijo se lahko naslednji neželeni učinki: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov) - bolečine v trebuhu (vključno z bolečinami v zgornjem delu trebuha in neprijetnim občutkom v trebuhu) - izpuščaj (koprivnica) Te reakcije se običajno pojavijo v prvih štirih tednih zdravljenja in izginejo v nekaj dneh, tudi če z zdravljenjem nadaljujete.
English: - if you have very severe abnormal weight loss or extreme weight loss due to malnutrition (cachexia, marasmus).
Slovenian: - če imate zelo hudo nenormalno izgubo telesne mase ali izgubo telesne mase zaradi podhranjenosti (kaheksija, marazmus).
English: Because of the high surface tension of Symbioflor E. coli, problems with starting and stopping release of the drops of solution cannot be completely avoided.
Slovenian: Zaradi visoke površinske napetosti zdravila Symbioflor E. coli se težavam pri začetku in prekinitvi sproščanja kapljic raztopine ni mogoče povsem izogniti.
English: Prior to a diagnosis of 'irritable bowel syndrome', your doctor should exclude organic causes of the gastrointestinal disorders.
Slovenian: Pred diagnozo „sindroma razdražljivega črevesja“ mora vaš zdravnik izključiti organske vzroke za bolezni prebavil.
English: Section 2 What you need to know before you take Symbioflor E. coli The text below should be inserted by replacing the existing text of this section:
Slovenian: Poglavje 2 Kaj morate vedeti, preden boste vzeli zdravilo Symbioflor E. coli Besedilo v nadaljevanju je treba vstaviti namesto obstoječega besedila v tem poglavju:
English: If appropriate, speak to your doctor.
Slovenian: Po potrebi se posvetujte z zdravnikom.
English: In a non-interventional post-marketing high-dose safety study in healthy volunteers, two of five subjects experienced side effects.
Slovenian: V neintervencijski študiji o varnosti zdravila po pridobitvi dovoljenja za promet, v kateri so uporabili velike odmerke zdravila pri zdravih prostovoljcih, so se neželeni učinki pojavili pri dveh od petih prostovoljcev.
English: E. coli bacteria are not absorbed but act locally at the intestinal immune system.
Slovenian: Bakterije E. coli se ne absorbirajo, temveč delujejo lokalno na imunski sistem črevesja.
English: Do not take Symbioflor E. coli: - if you are allergic to Escherichia coli bacteria or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Symbioflor E. coli: - če ste alergični na bakterijo Escherichia coli ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: The speed at which the drops come out can be changed by varying the angle at which the bottle is held.
Slovenian: Hitrost kapljanja lahko spremenite s spreminjanjem kota, pod katerim držite stekleničko.
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare not known (cannot be estimated from the available data) The following undesirable effects may occur: Immune system disorders Common: urticaria
Slovenian: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1000 do < 1/100), redki (≥ 1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: The qualitative effect on the gene expression in the mucosal epithelial cells, the key control elements of immune function in the human intestine, is similar to that exerted by the natural, physiological intestinal flora.
Slovenian: Kvalitativni učinek na gensko ekspresijo v epitelijskih celicah sluznice, ki je ključni element nadziranja imunskega delovanja v človeškem črevesju, je podoben, kot ga izkazuje naravna, fiziološka črevesna flora.
English: The drops are taken orally during the meals.
Slovenian: Način uporabe Kapljice se jemljejo peroralno med obroki.
English: The text below should be inserted by replacing the existing text of this section: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Besedilo v nadaljevanju je treba vstaviti namesto obstoječega besedila v tem poglavju: Preobčutljivost za učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: In this model enough bacteria of the E. coli strain survived the acid stomach passage so that their number increased again when they reached the small intestine conditions.
Slovenian: V tem modelu je dovolj bakterij seva E. coli preživelo prehod skozi želodčno kislino, da se je njihovo število znova povečalo, ko so dosegle pogoje tankega črevesa.
English: The investigator's global assessment of tolerability was predominantly good to very good and balanced between Symbioflor E. coli and placebo.
Slovenian: Skupna ocena prenašanja, ki jo je izvedel raziskovalec, je bila pretežno dobra do zelo dobra ter uravnotežena med zdravilom Symbioflor E. coli in placebom.
English: Although there are no known harmful effects of Symbioflor E. coli on the unborn child, the drops should be used during pregnancy and when breast-feeding only after a careful benefit-risk assessment by the doctor.
Slovenian: Čeprav ni znanih škodljivih učinkov zdravila Symbioflor E. coli na nerojenega otroka, se sme kapljice med nosečnostjo in dojenjem jemati le po zdravnikovi skrbni oceni razmerja med koristmi in tveganji zdravila.
English: The overall assessment of tolerability was good to very good in more than 98 % of the children for both, the physician's and the patient/parent's assessment (see also section 4.8).
Slovenian: Skupna ocena prenašanja zdravila je bila dobra do zelo dobra pri več kot 98 % otrok, tako po oceni zdravnika kot tudi po oceni staršev/bolnika (glejte tudi poglavje 4.8).
English: The high dose study (see section 4.9) demonstrated that the specific E. coli strain cultivates the human gut at least for days but also for up to months after a single dose.
Slovenian: Študija z velikimi odmerki (glejte poglavje 4.9) je pokazala, da specifični sev E. coli po enkratnem odmerjanju živi v človeških prebavilih najmanj nekaj dni, lahko pa tudi več mesecev.
English: Escherichia coli, the active substance in Symbioflor E. coli, is a living bacterium that is present in the healthy intestinal flora of humans.
Slovenian: Escherichia coli, učinkovina zdravila Symbioflor E. coli, je živa bakterija, ki je prisotna pri ljudeh v zdravi črevesni flori.
English: In a human whole-blood culture model, Symbioflor E. coli exerts strong modulating effects on the physiologically induced synthesis and release of cytokines and chemokines.
Slovenian: V modelu s človeškimi kulturami iz polne krvi je zdravilo Symbioflor E. coli pokazalo močne modulacijske učinke na fiziološko sproženo sintezo in sproščanje citokinov in kemokinov.
English: Symbioflor E. coli contains no preservatives and is therefore susceptible to contamination in the event of improper use.
Slovenian: Zdravilo Symbioflor E. coli ne vsebuje konzervansov, zato je v primeru nepravilne uporabe občutljivo za kontaminacijo.
English: Only limited experience of adverse reactions in children from pharmacovigilance data is available.
Slovenian: V podatkih o farmakovigilanci so na voljo le omejene izkušnje z neželenimi učinki pri otrocih.
English: Efficacy was confirmed when using two post-hoc defined patient assessed endpoints, i.e. patient's assessment of symptoms and abdominal discomfort/pain comprising each of 8 or respectively 5 IBS relevant symptoms.
Slovenian: Učinkovitost so potrdili z dvema opazovanima dogodkoma, ki so ju ocenili bolniki naknadno, tj. bolnikova ocena simptomov in neprijetnega občutka/bolečine v trebuhu, pri čemer je ocena vsebovala osem oziroma pet simptomov sindroma razdražljivega črevesja.
English: Adults take 10 drops orally three-times daily during meals at the beginning of treatment.
Slovenian: Odrasli na začetku zdravljenja jemljejo 10 kapljic peroralno (skozi usta) trikrat na dan, med obroki.
English: Release of the drops is started by holding the bottle at an angle and tapping lightly on the bottom.
Slovenian: Sproščanje kapljic omogočite tako, da stekleničko držite pod kotom in nežno udarjate po njenem dnu.
English: In a non-interventional study with 203 children aged 4 - 18 years, that were diagnosed for having IBS based on the ROM III criteria for children, the overall assessment of efficacy for all 4 IBS subtypes was very good to good in more than 80 % of the children for both, the physician's and the patient/parent's assessment.
Slovenian: V neintervencijski študiji, ki so jo opravili pri 203 otrocih, starih od 4 do 18 let, ki so prejeli diagnozo sindroma razdražljivega črevesja na podlagi meril ROM III za otroke, je bila skupna ocena učinkovitosti za vse štiri podtipe sindroma razdražljivega črevesja zelo dobra do dobra pri več kot 80 % otrok, in sicer pri ocenjevanju, ki ga je opravil zdravnik, in ocenjevanju, ki so ga opravili starši/bolnik.
English: An in-vitro study carried out using polymerase chain reaction (PCR) to investigate the effects of Symbioflor E. coli on epithelial cells (SW 480) from the human intestinal mucosa showed an upregulation of the cytokines IL-1β, TNF-α, GM-CSF and the chemokine IL-8.
Slovenian: V študiji in vitro, v kateri so uporabili metodo verižne reakcije s polimerazo (PCR) za proučevanje učinkov zdravila Symbioflor E. coli na epitelijske celice (SW 480) črevesne sluznice ljudi, so dokazali povišanje števila citokinov IL-1β, TNF-α, GM-CSF in kemokina IL-8.
English: Severe organic diseases of the gastrointestinal tract such as acute cholecystitis, acute pancreatitis, ileus, as well as cachexia and marasmus.
Slovenian: Hude organske bolezni prebavil, kot so akutni holecistitis, akutni pankreatitis, ileus, kaheksija in marazmus.
English: Common: abdominal pain (including upper abdominal pain and abdominal discomfort).
Slovenian: Pogosti: bolečine v trebuhu (vključno z bolečinami v zgornjem delu trebuha in neprijetnim občutkom v trebuhu)
English: At the beginning of the treatment: 10 drops three-times daily.
Slovenian: Na začetku zdravljenja: 10 kapljic trikrat na dan.
English: In the group of children aged 12 - 18 years with the IBS subtype “pain + alternating diarrhoea and constipation” the physician's and patient/parent's assessment of efficacy was lowest (55 % or 66 %, respectively).
Slovenian: V skupini otrok, starih od 12 do 18 let, s podtipom sindroma razdražljivega črevesja „bolečina in izmenična diareja in zaprtje“, je bila učinkovitost glede na oceno, ki jo je podal zdravnik, in oceno, ki so jo podali starši/bolnik, najnižja (55 % oziroma 66 %).
English: These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Slovenian: Spremembe zadevnih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo so rezultat napotitvenega postopka.
English: Other medicines and Symbioflor E. coli
Slovenian: Druga zdravila in zdravilo Symbioflor E. coli
English: A clinical trial including 298 patients with irritable bowel syndrome recruited in primary care centres showed a good or very good treatment success on Symbioflor E. coli in 62.9 % of the patients and in 39.4 % of the patients treated with placebo based on the investigator's global assessment of efficacy on a 4-point rating scale
Slovenian: V kliničnem preskušanju, ki je vključevalo 298 bolnikov s sindromom razdražljivega črevesja, vključenih v zavodih osnovnega zdravstvenega varstva, so na podlagi skupne ocene učinkovitosti, ki jo je izvedel raziskovalec s pomočjo štiritočkovne ocenjevale lestvice, dokazali dobro ali zelo dobro uspešnost zdravljenja pri 62,9 % bolnikov, zdravljenih z zdravilom Symbioflor E. coli, in pri 39,4 % bolnikov, ki so prejemali placebo.
English: When the same volume was tested in the SHIME model (Simulation of the Human Intestinal Microbial Ecosystem) under conditions simulating food intake fewer bacteria were killed in the stomach while their numbers were relatively stable in the conditions simulating the upper gastrointestinal tract.
Slovenian: Ko so enako prostornino bakterij testirali v modelu SHIME (Simulation of the Human Intestinal Microbial Ecosystem - simulacija človeškega mikrobnega ekosistema v črevesju) pod pogoji, ki posnemajo zaužitje hrane, je v želodcu propadlo manj bakterij, njihovo število pa je ostalo sorazmerno stabilno v pogojih, ki posnemajo zgornji del prebavil.
English: Not known (cannot be estimated from the available data): - Flatulence - Nausea - Diarrhoea
Slovenian: Neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov) - napenjanje - siljenje na bruhanje - driska
English: In an in-vitro gastric exposure model mimicking the human stomach and ileus under fasting conditions 1 ml (less than a single dose) of Symbioflor E. coli was tested for the survivability of the E. coli production strain.
Slovenian: V človeškem modelu želodčne izpostavljenosti in vitro, ki posnema človeški želodec in ileus na tešče, so testirali 1 ml (manj kot enkratni odmerek) zdravila Symbioflor E. coli za sposobnost preživetja proizvodnega seva E. coli.
English: The wording of the indication should be deleted and the text below should be inserted in its place: Irritable bowel syndrome
Slovenian: Besedilo indikacije je treba izbrisati in ga nadomestiti z besedilom, ki je navedeno spodaj: Sindrom razdražljivega črevesja
English: During acute febrile diseases, Symbioflor E. coli should be temporarily discontinued.
Slovenian: Med akutnimi vročinskimi obolenji je treba jemanje zdravila Symbioflor E. coli začasno prekiniti.
English: Do not take a double dose to make up for a forgotten dose, but continue taking the dosage prescribed.
Slovenian: Če ste pozabili vzeti zdravilo Symbioflor E. coli Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek, ampak nadaljujte z jemanjem predpisanega odmerka.
English: Symbioflor E. coli with food and drink Take the drops during meals (see section 3 How to take Symbioflor E. coli)
Slovenian: Zdravilo Symbioflor E. coli skupaj s hrano in pijačo Kapljice jemljite med obroki (glejte poglavje 3 Kako jemati zdravilo Symbioflor E. coli).
English: After one week, the dose is increased to 20 drops three-times daily.
Slovenian: Po enem tednu se odmerek poveča na 20 kapljic trikrat na dan.
English: Symbioflor E. coli has no or negligible influence on the ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Symbioflor E. coli nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Not known: flatulence, nausea, diarrhoea.
Slovenian: Neznana pogostnost: flatulenca, navzea, driska.
English: This will cause slight turbidity.
Slovenian: Zdravilo bo postalo nekoliko motno.
English: The text below should be inserted by replacing the existing text of this section:
Slovenian: Besedilo v nadaljevanju je treba vstaviti namesto obstoječega besedila v tem poglavju:
English: Pharmacotherapeutic group: Other immunostimulants, Antidiarrheal microorganisms ATC code: L03AX, A07FA
Slovenian: Besedilo v nadaljevanju je treba vstaviti namesto obstoječega besedila v tem poglavju: Farmakoterapevtska skupina: Druga zdravila za spodbujanje imunske odzivnosti, mikroorganizmi z antidiaroičnim delovanjem, oznaka ATC: L03AX, A07FA
English: The number of patients free of all the assessed IBS relevant symptoms after the treatment period of 8 weeks was significantly higher for Symbioflor E. coli treatment compared to placebo
Slovenian: Število bolnikov brez vseh ocenjevanih simptomov sindroma razdražljivega črevesja je bilo po osemtedenskem obdobju zdravljenja v skupini, zdravljeni z zdravilom Symbioflor E. coli, bistveno višje kot v skupini, ki je prejemala placebo.
English: If symptoms worsen during treatment or persist after 8 weeks of treatment, the patient should seek medical advice.
Slovenian: Če se simptomi med zdravljenjem poslabšajo ali če so po osmih tednih zdravljenja še vedno prisotni, se mora bolnik posvetovati z zdravnikom.
English: Shake Symbioflor E. coli well before use.
Slovenian: Zdravilo Symbioflor E. coli pred uporabo dobro pretresite.
English: After one week, increase the dose to 20 drops three-times daily.
Slovenian: Po enem tednu odmerek povečajte na 20 kapljic trikrat na dan.
English: Consult a doctor and stop treatment if symptoms are more severe, e.g. acute diarrhoea with high fever or blood in stool, or the diarrhoea lasts longer than 2 days, or other, longer-lasting or unexplained gastrointestinal symptoms occur.
Slovenian: Posvetujte se z zdravnikom in prekinite zdravljenje, če simptomi postanejo hujši, npr. akutna driska z visoko telesno temperaturo ali krvjo v blatu ali driska, ki traja več kot dva dneva, oziroma če se pojavijo drugi dolgotrajni ali nepojasnjeni simptomi bolezni prebavil.
English: If symptoms worsen during treatment or persist after 8 weeks of treatment, seek medical advice.
Slovenian: Če se simptomi med zdravljenjem poslabšajo ali če so po osmih tednih zdravljenja še vedno prisotni, se posvetujte z zdravnikom.
English: Only non-serious and already known side effects as described in section 4.8 were reported upon administration of single doses up to 20 times higher than the recommended daily dose.
Slovenian: Po dajanju enkratnih odmerkov, ki so bili do 20-krat večji od priporočenega dnevnega odmerka, so poročali le o neresnih in že znanih neželenih učinkih, opisanih v poglavju 4.8.
English: Symbioflor E. coli should not be taken during a treatment with antibiotics or within 5 days after the end of such a treatment (see also section 4.5).
Slovenian: Zdravila Symbioflor E. coli se ne sme jemati med zdravljenjem z antibiotiki ali v petih dneh po zaključku zdravljenja z antibiotiki (glejte tudi poglavje 4.5).
English: - if you have severe organic diseases of the gastrointestinal tract such as acute inflammation of the gallbladder or pancreas, or intestinal obstruction.
Slovenian: - če imate hude organske bolezni prebavil, kot so akutno vnetje žolčnika ali trebušne slinavke ali pa zaporo črevesja;
English: If symptoms are more severe, e.g. acute diarrhoea with high fever or with blood in stool or the diarrhoea lasts longer than 2 days, or if other, longer-lasting or unexplained gastrointestinal symptoms occur, treatment should be discontinued and a doctor should be consulted.
Slovenian: Če simptomi postanejo hujši, npr. akutna diareja z visoko telesno temperaturo ali krvjo v blatu, ali diareja, ki traja več kot dva dneva, oziroma če se pojavijo drugi dolgotrajni ali nepojasnjeni simptomi v prebavilih, je treba zdravljenje prekiniti in se posvetovati z zdravnikom.
English: Do not take Symbioflor E. coli during acute illnesses with fever.
Slovenian: Zdravila Symbioflor E. coli ne smete jemati med akutno boleznijo s povišano telesno temperaturo.