FrancophonIA/ELRC3.0 huggingface dataset:
English: Each ml of oral suspension contains 40 mg of voriconazole when reconstituted with water.
Slovenian: 1 mililiter peroralne suspenzije po pripravi z vodo vsebuje 40 mg/ml vorikonazola.
English: Package Size
Slovenian: velikost pakiranja
English: EU Number
Slovenian: Vsebina (koncentracija)
English: EU/1/97/045/003 Helicobacter Test INFAI for children of the age 3-11
Slovenian: EU/1/97/045/003 Test Helicobacter INFAI za otroke v starosti 3-11 let
English: 50 jars
Slovenian: 50 plastenkami
English: 50 jars, as part of a multicomponent kit with breath bags
Slovenian: 50 plastenkami, 50 vrečke za vzorce izdihanega zraka
English: Invented name Strength Pharmaceutical form Route of administration
Slovenian: Številka EU Izmišljeno ime Jakost
English: 1 jar, as part of a multicomponent kit with breath bags
Slovenian: 1plastenka, 2 vrečke za vzorce izdihanega zraka
English: 12 x (1 vial + 1 prefilled syringe + 1 vial adapter with needle + 2 alcohol wipes) (Titration pack)
Slovenian: 12 x (1 viala + 1 napolnjena injekcijska brizga + 1 adapter za vialo z iglo + 2 alkoholni blazinici) (set za titriranje)
English: MA (EU) number (Invented) name
Slovenian: (Izmišlje no) ime
English: Ifirmasta irbesartan
Slovenian: irbesartan
English: Other information about Ifirmasta:
Slovenian: Druge informacije o zdravilu Ifirmasta:
English: The name of the medicine was changed to Ifirmasta on 24 September
Slovenian: Ime zdravila je bilo 24. septembra 2009 spremenjeno v Ifirmasta.
English: What are the benefit and risk of Ifirmasta?
Slovenian: Kakšne so koristi in tveganja, povezana z zdravilom Ifirmasta?
English: The full EPAR for Ifirmasta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ifirmasta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This means that Ifirmasta is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Aprovel.
English: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Krka on 1 December 2008.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Irbesartan Krka, veljavno po vsej Evropski uniji, izdala 1. decembra 2008.
English: For more information about treatment with Ifirmasta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ifirmasta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Ifirmasta is a ‘generic medicine'.
Slovenian: Zdravilo Ifirmasta je „generično zdravilo“.
English: Treatment is started at 150 mg once a day and is usually increased to 300 mg once a day.
Slovenian: Zdravljenje se začne z odmerkom 150 mg enkrat dnevno, ki se običajno poveča na 300 mg enkrat dnevno.
English: This document is a summary of the European public assessment report (EPAR) for Ifirmasta.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ifirmasta.
English: The usual recommended dose of Ifirmasta is 150 mg once a day.
Slovenian: Običajni priporočeni odmerek zdravila Ifirmasta znaša 150 mg enkrat dnevno.
English: 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 Ifirmasta.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: This allows the blood pressure to drop, reducing the risk caused by high blood pressure, such as having a stroke.
Slovenian: Zaradi tega se krvni tlak zniža, kar posledično zmanjša tveganje, ki ga povzroča visok krvni tlak, kot je denimo kap.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Slovenian: Dve zdravili sta biološko enakovredni, ko dosegata enake ravni zdravilne učinkovine v telesu.
English: Why has Ifirmasta been approved?
Slovenian: Zakaj je bilo zdravilo Ifirmasta odobreno?
English: Ifirmasta is used in adults who have essential hypertension (high blood pressure).
Slovenian: Zdravilo Ifirmasta se uporablja pri odraslih bolnikih z esencialno hipertenzijo (visokim krvnim tlakom).
English: Because Ifirmasta is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Slovenian: Ker je zdravilo Ifirmasta generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Ifirmasta is a medicine that contains the active substance irbesartan.
Slovenian: Ifirmasta je zdravilo, ki vsebuje zdravilno učinkovino irbesartan.
English: The active substance in Ifirmasta, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina zdravila Ifirmasta, irbesartan, je antagonist receptorjev angiotenzina II, kar pomeni, da v telesu prepreči delovanje hormona, imenovanega angiotenzin II.
English: The Committee recommended that Ifirmasta be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Ifirmasta izda dovoljenje za promet.
English: Because Ifirmasta is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine.
Slovenian: Ker je zdravilo Ifirmasta generično zdravilo, so bile študije omejene na preskuse, s katerimi se dokazuje, da je biološko enakovredno referenčnemu zdravilu.
English: By blocking the receptors to which angiotensin II normally attaches, irbesartan stops the hormone having an effect, allowing the blood vessels to widen.
Slovenian: Irbesartan z blokiranjem receptorjev, na katere se angiotenzin II običajno veže, zavira delovanje tega hormona, kar omogoči razširitev krvnih žil.
English: The CHMP concluded that, in accordance with EU requirements, Ifirmasta has been shown to have comparable quality and to be bioequivalent to Aprovel.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Ifirmasta primerljivo raven kakovosti kot zdravilo Aprovel ter da mu je biološko enakovredno.
English: In patients with hypertension and type 2 diabetes, Ifirmasta is added to some other treatments for hypertension.
Slovenian: Pri bolnikih z visokim krvnim tlakom in sladkorno boleznijo tipa 2 se zdravilo Ifirmasta uvede poleg drugih načinov zdravljenja hipertenzije.
English: Therefore, the CHMP's view was that, as for Aprovel, the benefit outweighs the identified risk.
Slovenian: Zato je menil, da koristi, tako kot pri zdravilu Aprovel, odtehtajo znana tveganja.
English: Ifirmasta is also used to treat kidney disease in adults with hypertension and type 2 diabetes.
Slovenian: Zdravilo Ifirmasta se uporablja tudi za zdravljenje ledvičnega obolenja pri odraslih z visokim krvnim tlakom in sladkorno boleznijo tipa 2.
English: How has Ifirmasta been studied?
Slovenian: Kako je bilo zdravilo Ifirmasta raziskano?
English: What is Ifirmasta used for?
Slovenian: Za kaj se zdravilo Ifirmasta uporablja?
English: What is Ifirmasta?
Slovenian: Kaj je zdravilo Ifirmasta?
English: How is Ifirmasta used?
Slovenian: Kako se zdravilo Ifirmasta uporablja?
English: How does Ifirmasta work?
Slovenian: Kako zdravilo Ifirmasta deluje?
English: Previously known as Irbesartan Krka.
Slovenian: Prej znano kot zdravilo Irbesartan Krka.
English: The current annual reporting cycle for periodic safety update reports (PSURs) should be maintained.
Slovenian: Potrebno je ohraniti letni cikel rednih posodobljenih poročil o varnosti zdravila (PSUR).
English: Date of first authorisation: 14/04/2011 Date of last renewal: 15/03/2016
Slovenian: Datum pridobitve: 14/04/2011 Datum podaljšanja dovoljenja za promet: 15/03/2016
English: Each ml of vaccine contains:
Slovenian: En ml cepiva vsebuje:
English: a) the administration of the product to animals will interfere with the implementation of a national programmes for the diagnosis, control and/or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Slovenian: a) bi uporaba zdravila ovirala izvajanje nacionalnih programov za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
English: 1 dose per year.
Slovenian: 1 odmerek letno.
English: Occasionally, the presence of maternally derived antibodies in ovines of minimum recommended age might interfere with the protection induced by the vaccine.
Slovenian: Občasno lahko prisotnost maternalnih protiteles pri ovcah minimalne priporočene starosti vpliva na zaščito, ki jo zagotavlja cepivo.
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Slovenian: Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu/).
English: Any revaccination scheme should be agreed by the competent authority or by the responsible veterinarian, taking into account the local epidemiological situation.
Slovenian: Vsak program ponovnega cepljenja mora odobriti pristojni organ ali odgovorni veterinar ob upoštevanju lokalnih epidemioloških razmer.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št. 37/2010 določa, da MRL ni potreben ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle).
Slovenian: Oznake ATC vet: QI04AA02 (ovce) in QI02AA08 (govedo).
English: Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Slovenian: Vsako neuporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo pri teh zdravilih, je treba odstraniti v skladu z lokalnimi zahtevami.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: Ni podatkov o varnosti ter učinkovitosti uporabe tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label/carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na plastenki/kartonski škatli.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (http://www.ema.europa.eu/).
English: OTHER INFORMATION Immunological properties
Slovenian: DRUGE INFORMACIJE Imunološke lastnosti
English: The safety and efficacy of the vaccine has not been established in breeding males (sheep and cattle).
Slovenian: Varnost in učinkovitost cepiva nista bili ugotovljeni pri plemenskih samcih (ovce in govedo).
English: In this category of animals the vaccine should be used only according to the benefit-risk assessment by the responsible veterinarian and/or National competent authorities on the current vaccination policies against bluetongue virus (BTV).
Slovenian: Pri tej kategoriji živali lahko cepivo uporabimo le na podlagi ocene razmerja korist-tveganje odgovornega veterinarja in/ali pristojnega nacionalnega organa, odvisno od veljavne politike cepljenja proti virusu bolezni modrikastega jezika (BTV).
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Slovenian: Ob uporabi cepiva pri drugih domačih in divjih vrstah prežvekovalcev, ki jih ogroža okužba, je potrebna previdnost; pred množičnim cepljenjem je priporočljivo testno cepljenje manjšega števila živali.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Slovenian: - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali)
English: Special warnings for each target species: Vaccinate healthy animals only.
Slovenian: Posebna opozorila za vsako živalsko vrsto Cepite samo zdrave živali.
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome) Onset of immunity:
Slovenian: *(ciklična vrednost (Ct) ≥ 36 pri potrjeni metodi RT-PCR, kar kaže, da virusni genom ni prisoten) Nastop imunosti:
English: Intervet Nederland B.V. Wim de Körverstraat 35 5831 AN Boxmeer Tel: +31.485.587652
Slovenian: Wim de Körverstraat 35 5831 AN Boxmeer Tel: +31.485.587652
English: It lasts not longer than 24 to 48 hours.
Slovenian: Povišana telesna temperatura traja od 24 do 48 ur.
English: Temporary local reactions can occur very rarely at the injection site in the form of a nodule of 0.5 to 1 cm in sheep and of 0.5 to 3 cm in cattle which disappears within 14 days, at the latest and which may be painful.
Slovenian: Zelo redko se pojavijo začasne lokalne reakcije na mestu injiciranja v obliki bule premera 0,5 do 1 cm pri ovcah in 0,5 do 3 cm pri govedu, ki pa izgine najkasneje v 14 dneh in ki je lahko boleča.
English: Tel.: + 34 986 33 04 00 Fax: + 34 986 33 65 77 czv@czveterinaria.com
Slovenian: Tel: + 34 986 33 04 00 Faks: + 34 986 33 65 77 czv@czveterinaria.com
English: *(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome)
Slovenian: *(ciklična vrednost (Ct) ≥ 36 pri potrjeni metodi RT-PCR, kar kaže, da virusni genom ni prisoten)
English: EU/2/11/122/001 bottle of 52 ml EU/2/11/122/002 bottle of 100 ml EU/2/11/122/003 bottle of 252 ml
Slovenian: EU/2/11/122/001 plastenka z 52 ml EU/2/11/122/002 plastenka s 100 ml EU/2/11/122/003 plastenka z 252 ml
English: Occasionally a slight increase of the temperature (0.5 ºC - 1.0 ºC) is observed for 24-48 hours after the administration of a double dose of the vaccine.
Slovenian: Občasno je mogoče opaziti blago povišanje telesne temperature (0,5 ºC-1,0 ºC), ki traja 24-48 ur po dajanju dvojnega odmerka cepiva.
English: No information is available on the use of the vaccine in seropositive bovines, including those with maternally derived antibodies.
Slovenian: Na voljo ni nobenih informacij o uporabi cepiva pri seropozitivnem govedu niti pri govedu z maternalnimi protitelesi.
English: BLUEVAC BTV8 suspension for injection for cattle and sheep
Slovenian: BLUEVAC BTV8 suspenzija za injiciranje za ovce in govedo
English: Phosphate buffered saline (sodium chloride, disodium phosphate and potassium phosphate, water for injections)
Slovenian: tiomersal fosfatna pufrska fiziološka raztopina (natrijev klorid, dinatrijev fosfat in kalijev fosfat, voda za injekcije)
English: Each ml of vaccine contains: BTV8 antigen 106.5 CCID50
Slovenian: En ml cepiva vsebuje: antigen BTV8 106,5 CCID50
English: 4.2 Indications for use, specifying the target species Sheep
Slovenian: 4.2 Indikacije za uporabo pri ciljnih živalskih vrstah Ovce
English: (*) equivalent to titre prior to inactivation (log10)
Slovenian: (*)enakovredno titru pred inaktivacijo (log 10)
English: (*)equivalent to titre prior to inactivation (log10)
Slovenian: (*) enakovredno titru pred inaktivacijo (log 10)
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Slovenian: Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove proizvajanje, uvoz/vnos,
English: An average increase in body temperature varying between 0.5 and 1.0 ºC is a common reaction observed in sheep and cattle.
Slovenian: NEŽELENI UČINKI Povprečno povišanje telesne temperature, ki variira med 0,5 in 1,0 °C, je pogosta reakcija pri ovcah in govedu.
English: 1 year after the second dose.
Slovenian: 1 leto po drugem odmerku.
English: Suspension for injection White or pinkish-white.
Slovenian: Bela ali rožnato-bela.
English: 31 days after the second dose.
Slovenian: 31 dni po drugem odmerku.
English: Loss of appetite can occur in very rare cases.
Slovenian: V zelo redkih primerih lahko pride tudi do izgube teka.
English: 20 days after the second dose.
Slovenian: 20 dni po drugem odmerku.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Slovenian: BESEDILO „SAMO ZA ŽIVALI“ IN POGOJI ALI OMEJITVE GLEDE OSKRBE IN
English: BLUEVAC BTV8 stimulates active immunity against bluetongue virus, serotype 8.
Slovenian: BLUEVAC BTV8 spodbuja aktivno imunost proti serotipu 8 virusa bolezni modrikastega jezika.
English: QUANTITY OF THE ACTIVE SUBSTANCE
Slovenian: KOLIČINA ZDRAVILNE UČINKOVINE
English: Bluetongue virus inactivated, serotype 8:
Slovenian: inaktiviran virus bolezni modrikastega jezika, serotip 8:
English: Sheep from 2.5 months of age: Administer two doses of 2 ml subcutaneously with a 3 week interval.
Slovenian: Ovce od starosti 2,5 meseca dalje: dva odmerka po 2 ml subkutano s 3-tedenskim presledkom.
English: Cattle from 2.5 months of age: Administer two doses of 4 ml subcutaneously with a 3 week interval.
Slovenian: Govedo od starosti 2,5 meseca dalje: dva odmerka po 4 ml subkutano s 3-tedenskim presledkom.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalc, odgovornega za sproščanje serij
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box (52 ml, 100 ml and 252 ml)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla (52 ml, 100ml, 252 ml)
English: For the active immunisation of sheep from 2.5 months of age to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotype 8.
Slovenian: Za aktivno imunizacijo ovac od starosti 2,5 meseca dalje za preprečitev viremije* in za zmanjševanje kliničnih znakov, ki jih povzroča serotip 8 virusa bolezni modrikastega jezika.
English: Pregnancy: Can be used during pregnancy in ewes and cows.
Slovenian: Brejost: Lahko se uporablja v obdobju brejosti ovc in krav.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Slovenian: NAČIN IN POT(I) UPORABE ZDRAVILA
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 52 ml
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH Plastenka z 52 ml
English: Pharmacotherapeutic group: Bluetongue virus vaccines, inactivated.
Slovenian: Farmakoterapevtska skupina: Cepiva proti virusu bolezni modrikastega jezika, inaktivirana.
English: For the active immunisation of cattle from 2.5 months of age to prevent viraemia* caused by bluetongue virus serotype 8.
Slovenian: Za aktivno imunizacijo goveda od starosti 2,5 meseca dalje za preprečitev viremije* ki jo povzroča serotip 8 virusa bolezni modrikastega jezika.
English: EXP {month/year} Once opened, use within 10 hours.
Slovenian: Načeto zdravilo uporabite v 10 urah.
English: Lactation: There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.
Slovenian: Uporaba cepiva nima nobenih negativnih posledic na mlečnost ovc in krav v obdobju laktacije.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aluminijev hidroksid prečiščen saponin (Quil A)
English: Box of 1 bottle of 52 ml Box of 1 bottle of 100 ml Box of 1 bottle of 252 ml.
Slovenian: 1 plastenka z 52 ml 1 plastenka s 100 ml 1 plastenka z 252 ml
English: CZ Veterinaria, S.A. 36400 Porriño SPAIN
Slovenian: CZ Veterinaria, S.A. 36400 Porriño ŠPANIJA
English: Can be used during pregnancy in ewes and cows.
Slovenian: Brejosti in laktacija Lahko se uporablja v obdobju brejosti ovc in krav.
English: Painless swellings occur occasionally with a size up to 2 cm in sheep and up to 4.5 cm in cattle after a double dose.
Slovenian: 2 cm pri ovcah in do 4,5 cm pri govedu.
English: ANNEX II A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs D. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Slovenian: PRILOGA II A. PROIZVAJALEC BIOLOŠKE UČINKOVINE IN PROIZVAJALEC ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Each ml of vaccine contains: Bluetongue virus inactivated, serotype 8
Slovenian: En ml cepiva vsebuje: inaktiviran virus bolezni modrikastega jezika, serotip 8 106,5 CCID50* aluminijev hidroksid
English: SC
Slovenian: KARENCA
English: 1 bottle + 1 syringe
Slovenian: 1 plastenka + 1 brizga
English: Oral solution bottle (HDPE) 180 ml
Slovenian: Peroralna uporaba plastenka (HDPE) 180 ml
English: Invented name
Slovenian: Številka EU Izmišljeno ime Jakost
English: 30 mg/ml
Slovenian: 30 mg/ml Peroralna raztopina
English: Package size
Slovenian: Stična ovojnina Vsebina Velikost pakiranja
English: Source data are, however, no longer available.
Slovenian: Izvorni podatki niso več na voljo.
English: Jatros Gastroenterol, 1993” (Study S2)”, and
Slovenian: Jatros Gastroenterol, 1993“ (Študija S2), in
English: Data, however, were not controlled.
Slovenian: Vendar pa rezultati niso bili nadzorovani.
English: It is not life threatening but can significantly impact the quality of life of patients.
Slovenian: Ni življenjsko nevarno, vendar lahko močno vpliva na kakovost življenja bolnikov.
English: Symbioflor 2 is currently used for the indications:
Slovenian: Zdravilo Symbioflor 2 se trenutno uporablja za naslednje indikacije:
English: This relatively benign safety profile was confirmed by post-marketing data.
Slovenian: Ta sorazmerno benigen varnostni profil so potrdili tudi podatki iz obdobja trženja.
English: The marketing authorisations were granted in Austria in 2000 (renewed on 12 February 2014) and in 2003 in Hungary (HU) respectively.
Slovenian: Dovoljenje za promet z zdravilom je bilo v Avstriji izdano leta 2000 (in podaljšano 12. februarja 2014), na Madžarskem pa leta 2003.