FrancophonIA/ELRC3.0 huggingface dataset:
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific
Slovenian: To je protitelo (vrsta beljakovine), ki je zasnovano tako, da prepozna posebno strukturo (imenovano
English: Ogivri was developed as a ‘biosimilar' medicine.
Slovenian: Zdravilo Ogivri je bilo razvito kot „podobno biološko zdravilo“.
English: What was Ogivri expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Ogivri uporabljalo?
English: The CHMP's main concern was the lack of a valid certificate confirming that the manufacturing facility of the product complies with good manufacturing practice (GMP) requirements.
Slovenian: Glavni zadržek odbora CHMP je bil odsotnost veljavnega potrdila o tem, da proizvodni obrat, v katerem proizvajajo zdravilo, deluje v skladu z zahtevami dobre proizvodne prakse.
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ogivri could not have been approved for the treatment of breast cancer and gastric cancer.
Slovenian: Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Ogivri ni mogoče odobriti za zdravljenje raka dojk in raka želodca.
English: Withdrawal of the marketing authorisation application for Ogivri (trastuzumab)
Slovenian: Umik vloge za pridobitev dovoljenja za promet z zdravilom Ogivri (trastuzumab)
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough documentation to support the application for Ogivri.
Slovenian: Zato je ob umiku vloge menil, da družba ni predložila zadostne dokumentacije v podporo vlogi za zdravilo Ogivri.
English: The company informed the CHMP that the withdrawal does not impact ongoing clinical trials with Ogivri.
Slovenian: Družba je odbor CHMP obvestila, da zavrnitev nima vpliva na klinična preskušanja, ki trenutno potekajo z zdravilom Ogivri.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because a GMP certificate for the manufacturing site of the product could not be obtained in the time available.
Slovenian: Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umika vlogo, ker potrdila o dobri proizvodni praksi za proizvodni obrat, v katerem proizvajajo zdravilo Ogivri, ne more pridobiti v razpoložljivem času.
English: How does Ogivri work?
Slovenian: Kako zdravilo Ogivri deluje?
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ogivri, for the treatment of breast cancer and gastric cancer.
Slovenian: je 3. avgusta 2017 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Ogivri, namenjenim zdravljenju raka dojk in raka želodca.
English: What is Ogivri?
Slovenian: Kaj je zdravilo Ogivri?
English: Ogivri was to be used only when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly.
Slovenian: To pomeni, da na površini tumorskih celic v večjih količinah nastaja beljakovina, imenovana HER2, zato tumorske celice hitreje rastejo.
English: Trastuzumab also stops HER2 producing signals that cause the tumour cells to grow.
Slovenian: S tem prepreči, da bi beljakovina HER2 tvorila signale, ki spodbujajo rast tumorskih celic.
English: On 23 June 2005, the CHMP concluded that:
Slovenian: Dne 23. junija je CHMP zaključil da:
English: - recommended follow up measures to further investigate the safety of celecoxib.
Slovenian: - priporočil nadaljnje ukrepe za dodatno raziskovanje varnosti celekoksiba.
English: SCIENTIFIC CONCLUSIONS FOR AMENDMENT OF THE PRODUCT INFORMATION
Slovenian: ZNANSTVENI ZAKLJUČKI ZA DOPOLNILO DOVOLJENJA ZA PROMET
English: The CHMP confirmed changes to the Product Information already introduced through the annual reassessment adopted in April 2005 further to the February USR and requested further changes.
Slovenian: CHMP je potrdil spremembe informacij o zdravilu, že vnešene med rednim letnim ponovnim vrednotenjem, sprejete aprila 2005 po februarskem nujnem varnostnem ukrepu in zahteval še nadaljnje
English: On 20 April 2005, Pfizer presented data on serious skin reactions for valdecoxib during a hearing.
Slovenian: Dne 20. aprila 2005 je Pfizer med zaslišanjem predstavil podatke o hudih kožnih reakcijah pri uporabi
English: - Addition of a more detailed description of the first signs of skin reactions leading to
Slovenian: - dodan je podrobnejši opis začetnih znakov kožnih reakcij, zaradi katerih se zdravljenje
English: The CHMP agreed that an Urgent Safety Restriction (USR) on cardiovascular safety was needed to introduce new contraindications and strengthen warnings and information on side effects in the SPC and the Package Leaflet (PL).
Slovenian: CHMP je soglasno ugotovil, da je potreben nujen varnostni ukrep (Urgent Safety Restriction, USR) v zvezi s kardiovaskularno varnostjo, da se dodajo nove kontraindikacije in okrepijo opozorila in podatki o neželenih učinkih v Povzetku glavnih značilnosti zdravila (SPC).
English: Further to a request from the European Commission, the scope of the ongoing class review was broadened to include the assessment of serious skin reactions in addition to the cardiovascular safety
Slovenian: Na zahtevo Evropske komisije se je obseg revizije skupine zdravil v teku še razširil, tako da poleg vidikov kardiovaskularne varnosti zajema tudi vrednotenje hudih kožnih reakcij.
English: These data resulted in the worldwide withdrawal of Vioxx (rofecoxib) from the market on 30 September 2004 by the MAH and raised questions regarding the cardiovascular safety of other Cox-2 inhibitors.
Slovenian: Zaradi teh podatkov je imetnik dovoljenja za promet dne 30. septembra 2004 z vseh svetovnih tržišč umaknil zdravilo Vioxx (rofekoksib), pojavila pa so se tudi vprašanja glede kardiovaskularne varnosti drugih zaviralcev Cox-2.
English: Further to the assessment of the data on serious skin reactions, celecoxib is associated with very rare occurrence of serious skin reactions, as evidenced in clinical studies and postmarketing surveillance, which analysis revealed several risk factors for the occurrence of these serious skin reactions with celecoxib.
Slovenian: Po vrednotenju podatkov o hudih kožnih reakcijah je celekoksib povezan z zelo redkimi pojavi hudih kožnih reakcij, kot je razvidno iz kliničnih študij in postmarketinškega nadzora, katerih analiza je pokazala več dejavnikov tveganja za pojav hudih kožnih reakcij s celekoksibom.
English: Between November 2004 and June 2005, the MAH made oral explanations to the CHMP on cardiovascular and skin safety aspects for Onsenal on 18 January, 15 February, and 25 May 2005.
Slovenian: Med novembrom 2004 in junijem 2005 je imetnik dovoljenja za promet 18. januarja, 15. februarja in 25 maja 2005 pred CHMP ustno obrazložil kardiovaskularne in kožne varnostne vidike za celekoksib.
English: During the CHMP meeting of February 2005, discussions on cardiovascular safety took place.
Slovenian: CHMP je o kardiovaskularni varnosti razpravljal na svoji seji februarja 2005.
English: In September 2004, the Marketing Authorisation Holder (MAH) of rofecoxib (a selective Cox-2inhibitor) informed the EMEA that new clinical trial (APPROVe) data for rofecoxib have revealed a risk of thrombotic cardiovascular (CV) events.
Slovenian: Septembra 2004 je imetnik dovoljenja za promet z rofekoksibom (selektivnim zaviralcem Cox-2) obvestil Evropsko agencijo za zdravila, da so podatki iz novega kliničnega preizkušanja (APPROVe) rofekoksiba pokazali tveganje za trombotične kardiovaskularne dogodke.
English: Further to discussions at the CHMP October 2004 plenary meeting, the European Commission recommended that this public health issue on all aspects of cardiovascular safety including thrombotic events and cardio-renal events is the subject of Community referrals under Article 31 of Directive 2001/83/EC, as amended regarding decentrally authorised products containing celecoxib, etoricoxib and lumiracoxib and subject to a review procedure under Article 18 of Council Regulation (EEC) No 2309/93, as amended regarding the centrally authorised products containing celecoxib (Onsenal), parecoxib (Dynastat/Rayzon) and valdecoxib (Bextra/Valdyn), which were started in November 2004.
Slovenian: V zvezi z razpravo Odbora za zdravila za uporabo v humani medicini (CHMP) na plenarni seji oktobra 2004 je Evropska komisija priporočila, da se za to javno zdravstveno vprašanje o vseh vidikih kardiovaskularne varnosti, vključno s trombotičnimi dogodki in kardiorenalnimi dogodki, sproži napotitveni postopek Skupnosti v skladu z 31. členom Direktive 2001/83/ES z vsemi dodatki za zdravila, odobrena po decentraliziranem postopku, in vsebujejo celekoksib, etorikoksib in lumirakoksib ter revizijski postopek v skladu z 18. členom Uredbe Sveta (EGS) št. 2309/93 z vsemi dodatki za zdravila, odobrena po centraliziranem postopku, in vsebujejo celekoksib (Onsenal), parekoksib (Dynastat/Rayzon) in valdekoksib (Bextra/Valdyn).
English: - is of the Opinion that the benefit/risk balance of Onsenal in Familial Adenomatous Polyposis (FAP) remains favourable and the Marketing Authorisations should be maintained according to revised Summaries of Product Characteristics and Package Leaflet (attached in Annex I and IIIB, respectively of the CHMP Opinion), - concluded that the cardiovascular safety and serious skin reactions should be continuously and
Slovenian: - mnenja, da razmerje med koristjo in tveganjem za zdravilo Onsenal pri familiarni adenomatozni polipozi (FAP) ostaja ugodno in da se dovoljenja za promet ohranijo v skladu s popravljenimi Povzetki glavnih značilnosti zdravil (priloženih mnenju CHMP v Dodatku III), - zaključil, da je treba kardiovaskularno varnost in hude kožne reakcije neprekinjeno in
English: GROUNDS FOR AMENDMENT OF PRODUCT INFORMATION
Slovenian: PODLAGA ZA DOPOLNILO DOVOLJENJA ZA PROMET
English: - Addition of a warning for patients with a history of any drug allergy, - Strengthening of a warning to highlight that fatal serious skin reactions have now occurred
Slovenian: - dodano je opozorilo za bolnike z anamnezo alergije na katerokoli zdravilo, - okrepljeno je opozorilo, ki poudarja, da so se pri uporabi celekoksiba pojavile hude kožne
English: This USR was initiated on 16 February 2005 and finalised on
Slovenian: Nujen varnostni ukrep se je začel 16. februarja 2005 in zaključil 17. februarja 2005.
English: On 7 April 2005, the FDA (Food and Drug Administration) and the EMEA requested that Pfizer voluntarily withdraw Bextra (valdecoxib) from the market and Pfizer agreed to suspend sale and marketing of Bextra worldwide pending further discussions on the unfavorable risk versus benefit due
Slovenian: Dne 7. aprila 2005 sta FDA (Food and Drug Administration) in EMEA zaradi podatkov o hudih kožnih reakcijah zahtevali, da podjetje Pfizer prostovoljno umakne zdravilo Bextra (valdekoksib) iz prometa.
English: - Addition of a warning for patients with risk factors for heart disease, such as hypertension, hyperlipidaemia (high cholesterol levels), diabetes and smoking, - Addition of a warning for prescribers to consider discontinuation of therapy if during treatment, patients deteriorate in any of the organ system functions described, - Addition of a warning for prescribers to exercise caution when prescribing NSAIDs, including celecoxib, in combination with ACE inhibitors or angiotensin II receptor antagonists,
Slovenian: Spremembe informacij o zdravilu v zvezi s kardiovaskularnim sistemom lahko povzamemo kot sledi: - dodani sta kontraindikaciji Potrjena ishemična srčna bolezen in/ali cerebrovaskularno obolenje ter Periferna arterijska bolezen, - dodana je kratka informacija o kardiovaskularnih izsledkih v PreSAP (Učinkovitost in varnost celekoksiba (SC-58635) pri preprečevanju posameznih kolorektalnih adenomnih polipov) in APC (Preprečevanje posameznih kolorektalnih adenomov s celekoksibom); vključiti strožje besedilo v zvezi s skupinami za kardiovaskularna tveganja, - dodano je opozorilo za bolnike z dejavniki tveganja za srčne bolezni, kot so hipertenzija, hiperlipidemija (visoke ravni holesterola), sladkorna bolezen in kajenje, - dodano je opozorilo za predpisovalce zdravila, naj preučijo možnost prekinitve zdravljenja, če se med zdravljenjem bolniku poslabša katerakoli opisana funkcija organskih sistemov, - dodano je opozorilo za predpisovalce zdravila, naj bodo previdni pri predpisovanju neselektivnih nesteroidnih protivnetnih zdravil (non-steroidal anti-inflammatory drugs, NSAIDs), vključno s celekoksibom, v kombinaciji z zaviralci ACE ali antagonisti receptorjev
English: - the data on etoricoxib in the EDGE study and pooled analyses of other clinical trials, which suggested an association with a higher thrombotic risk than naproxen, - the data on lumiracoxib in the Target study, which suggested a small increase in thrombotic events (especially myocardial infarction) versus naproxen, all available data show an increased risk of CV adverse reactions for Cox-2 inhibitors as a class and agreed that there is an association between duration and dose of intake and the probability of suffering a CV reaction.
Slovenian: - novih podatkov, ki jih je za rofekoksib prispevala klinična raziskava APPROVe in ki kažejo tveganje za trombotične kardiovaskularne dogodke, - podatkov za celekoksib iz raziskave APC, ki so nakazali povečanje tveganja hudih kardiovaskularnih dogodkov, ki so odvisni od odmerka, - podatkov za valdekoksib in parekoksib iz raziskav CABG (Coronary Artery Bypass Graft) in CABG II, ki kažejo višjo stopnjo hudih kardiovaskularnih tromboembolijskih dogodkov v skupinah bolnikov, ki so se zdravili s parekoksibom/valdekoksibom, v primerjavi s skupino bolnikov, ki je prejemala placebo, - podatkov za etorikoksib iz raziskave EDGE ter analiz združenih podatkov iz drugih kliničnih preizkušanj, ki nakazujejo povezavo z večjim tveganjem za trombotične dogodke v primerjavi z naproksenom, - podatkov za lumirakoksib iz raziskave Target, ki nakazujejo majhno povečanje trombotičnih dogodkov (zlasti miokardnega infarkta) v primerjavi z naproksenom,
English: The changes of the Product Information related to the SCAR can be summarised as follows: - Addition of a warning to report that the onset of skin reactions occur in the majority of cases
Slovenian: Spremembe informacij o zdravilu, povezanih s hudimi kožnimi neželenimi reakcijami (Severe Cutaneous Adverse Reaction, SCAR), lahko povzamemo, kot sledi:
English: EU/1/06/335/001 Valtropin 15 mg/1.5 ml Powder and solvent for solution for injection (multi-use)
Slovenian: EU/1/06/335/001 Valtropin 5 mg/1,5 ml Prašek in vehikel za raztopino za injiciranje (večkratna uporaba)
English: Powder: 5 mg Solvent: 1.5 ml
Slovenian: Prašek: 5 mg Vehikel: 1,5 ml
English: Powder: vial (glass) Solvent: pre-filled syringe (glass)
Slovenian: Prašek: viala (steklo) Vehikel: napolnjena injekcijska brizga (steklo)
English: 1 vial + 1 pre-filled syringe l t o r
Slovenian: 1 viala + 1 napolnjena injekcijska brizga o ā
English: Strength Pharmaceutical Form Route of administration
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
English: Gastro-Resistant Tablet
Slovenian: Gastrorezistentna tableta
English: Suspension For Injection
Slovenian: Raztopina za injiciranje
English: Luxembourg Om Pharma S.A.
Slovenian: Luksemburg Om Pharma S.A.
English: Granules In Sachet
Slovenian: Granule v vrečici
English: Powder For Oral Suspension
Slovenian: Prašek za peroralno suspenzijo
English: Oral Drops, Suspension
Slovenian: Kapljice za nos, suspenzija
English: Tablet
Slovenian: Podjezična tableta
English: Streptococcus Agalactiae 1000 Mega Units Tablet, Haemophilus Influenzae 1500 Mega Units Tablet, Staphylococcus Aureus 1000 Mega Units Tablet, Streptococcus Pneumoniae 1000 Mega Units Tablet
Slovenian: Streptococcus Agalactiae 1000 mega enot/tableto, Haemophilus Influenzae 1500 mega enot/tableto, Staphylococcus Aureus 1000 mega enot/tableto, Streptococcus Pneumoniae 1000 mega enot/tableto
English: Lysatum Bacteriale Mixtum 3mg Tablet
Slovenian: Lysatum bacteriale mixtum 3 mg tableta
English: Granules For Oral Suspension
Slovenian: Granule za peroralno suspenzijo
English: Streptococcus Agalactiae 1 Giga Units Tablet, Haemophilus Influenzae 1.5 Giga Units Tablet, Staphylococcus Aureus 1 Giga Units Tablet, Streptococcus Pneumoniae 1 Giga Units Tablet
Slovenian: Streptococcus Agalactiae 1 giga enot/tableto, Haemophilus Influenzae 1,5 giga enot/tableto, Staphylococcus Aureus 1 giga enot/tableto, Streptococcus Pneumoniae 1 giga enot/tableto
English: Haemophilus Influenzae Type B (Hib) 1.25 Giga Cells / 50mg, Branhamella Catarrhalis Lysate 1.25 Giga Cells / 50mg, Klebsiella Pneumoniae (Inactivated) 1.25 Giga Cells / 50mg, Staphylococcus Aureus Inactivated Bacteria 1.25 Giga Cells / 50mg, Streptococcus Pneumoniae Inactivated Bacteria 1.25 Giga Cells / 50mg, Streptococcus Pyogenes Inactivated Bacteria 1.25 Giga Cells / 50mg
Slovenian: Haemophilus Influenzae tip B (Hib) 1,25 giga celic/50 mg, lizat bakterije Branhamella Catarrhalis 1,25 giga celic/50 mg, Klebsiella Pneumoniae (inaktivirana) 1,25 giga celic/50 mg, inaktivirana bakterija Staphylococcus Aureus 1,25 giga celic/50 mg, inaktivirana bakterija Streptococcus Pneumoniae 1,25 giga celic/50 mg, inaktivirana bakterija Streptococcus Pyogenes 1,25 giga celic/50 mg
English: Nasal Use
Slovenian: Nazalna uporaba
English: Haemophilus Influenzae Type B (Hib) 0.625 Giga Cells / 25mg, Branhamella Catarrhalis Lysate 0.625 Giga Cells / 25mg, Klebsiella Pneumoniae (Inactivated) 0.625 Giga Cells / 25mg, Staphylococcus Aureus Inactivated Bacteria 0.625 Giga Cells / 25mg, Streptococcus Pneumoniae Inactivated Bacteria 0.625 Giga Cells / 25mg, Streptococcus Pyogenes Inactivated Bacteria 0.625 Giga Cells / 25mg
Slovenian: Haemophilus Influenzae tip B (Hib) 0,625 giga celic/25 mg, lizat bakterije Branhamella Catarrhalis 0,625 giga celic/25 mg, Klebsiella Pneumoniae (inaktivirana) 0,625 giga celic/25 mg, inaktivirana bakterija Staphylococcus Aureus 0,625 giga celic/25 mg, inaktivirana bakterija Streptococcus Pneumoniae 0,625 giga celic/25 mg, inaktivirana bakterija Streptococcus Pyogenes 0,625 giga celic/25 mg
English: Lysatum Bacteriale Mixtum 3.5mg Capsule
Slovenian: Lysatum bacteriale mixtum 3,5 mg kapsula
English: Lysatum Bacteriale Mixtum 7mg Capsule
Slovenian: Lysatum bacteriale mixtum 7 mg kapsula
English: Lyophilized Bacterial Lysates 7mg Tablet
Slovenian: Liofilizirani bakterijski lizati 7 mg tableta
English: Haemophilus Influenzae Type B (Hib) 50.2agu/Ml, Klebsiella Pneumoniae 39.8agu/Ml, Staphylococcus Aureus 79.6agu/Ml, Streptococcus Pneumoniae 63.2agu/Ml, Streptococcus Pyogenes 126.2agu/Ml, Moraxella Catarrhalis 39.9agu/Ml
Slovenian: Haemophilus Influenzae tip B (Hib) 50,2 AGU/ml, Klebsiella Pneumoniae 39,8 AGU/ml, Staphylococcus Aureus 79,6 AGU/ml, Streptococcus Pneumoniae 63,2 AGU/ml, Streptococcus Pyogenes 126,2 AGU/ml, Moraxella Catarrhalis 39,9 AGU/ml
English: Luxembourg Daiichi Sankyo Europe Gmbh
Slovenian: Luksemburg Daiichi Sankyo Europe Gmbh
English: Broncho-Vaxom Lysatum Bacteriale Mixtum 7mg Capsule
Slovenian: Broncho-Vaxom Lysatum bacteriale mixtum 7 mg kapsula
English: Granules
Slovenian: Granule
English: Escherichia Coli (Inactivated) 20 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 10 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 50 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 50 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 10 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 10 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 20 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 10 Mega Cells / Ml
Slovenian: Escherichia Coli (inaktivirana) 20 mega celic/ml, Klebsiella Pneumoniae (inaktivirana) 10 mega celic/ml, inaktivirana bakterija Staphylococcus Aureus 50 mega celic/ml, inaktivirana bakterija Staphylococcus Epidermidis 50 mega celic/ml, inaktivirana bakterija Streptococcus Salivarius 10 mega celic/ml, inaktivirana bakterija Streptococcus Pneumoniae 10 mega celic/ml, inaktivirana bakterija Streptococcus Pyogenes 10 mega celic/ml, inaktivirana bakterija Haemophilus Influenzae 10 mega celic/ml, inaktivirana bakterija Corynebacterium Pseudodiphtheriticum 20 mega celic/ml, inaktivirana bakterija Moraxella Catarrhalis 10 mega celic/ml
English: Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Capsule
Slovenian: Broncho-Vaxom Liofilizirani bakterijski lizati 3,5 mg kapsula
English: Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Sachet
Slovenian: Broncho-Vaxom Liofilizirani bakterijski lizati 3,5 mg vrečica
English: Escherichia Coli (Inactivated) 2 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 1 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 5 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 5 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 1 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 1 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 1 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 1 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 2 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 1 Mega Cells / Ml
Slovenian: Escherichia Coli (inaktivirana) 2 mega celic/ml, Klebsiella Pneumoniae (inaktivirana) 1 mega celic/ml, inaktivirana bakterija Staphylococcus Aureus 5 mega celic/ml, inaktivirana bakterija Staphylococcus Epidermidis 5 mega celic/ml, inaktivirana bakterija Streptococcus Salivarius 1 mega celic/ml, inaktivirana bakterija Streptococcus Pneumoniae 1 mega celic/ml, inaktivirana bakterija Streptococcus Pyogenes 1 mega celic/ml, inaktivirana bakterija Haemophilus Influenzae 1 mega celic/ml, inaktivirana bakterija Corynebacterium Pseudodiphtheriticum 2 mega celic/ml, inaktivirana bakterija Moraxella Catarrhalis 1 mega celic/ml
English: Escherichia Coli (Inactivated) 200 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 100 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 500 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 500 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 100 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 100 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 200 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 100 Mega Cells / Ml
Slovenian: Escherichia Coli (inaktivirana) 200 mega celic/ml, Klebsiella Pneumoniae (inaktivirana) 100 mega celic/ml, inaktivirana bakterija Staphylococcus Aureus 500 mega celic/ml, inaktivirana bakterija Staphylococcus Epidermidis 500 mega celic/ml, inaktivirana bakterija Streptococcus Salivarius 100 mega celic/ml, inaktivirana bakterija Streptococcus Pneumoniae 100 mega celic/ml, inaktivirana bakterija Streptococcus Pyogenes 100 mega celic/ml, inaktivirana bakterija Haemophilus Influenzae 100 mega celic/ml, inaktivirana bakterija Corynebacterium Pseudodiphtheriticum 200 mega celic/ml, inaktivirana bakterija Moraxella Catarrhalis 100 mega celic/ml