natgillin/translations-raw huggingface dataset:
Equilis StrepE is a vaccine which contains the active substance live deletion mutant Streptococcus equi bacteria.
Zdravilo Equilis StrepE je cepivo, ki vsebuje zdravilno učinkovino živi delecijski mutant bakterije Streptococcus equi.
What benefit has Equilis StrepE shown during the studies?
Kakšne koristi je zdravilo Equilis StrepE izkazalo med raziskavami?
Equilis StrepE is used to vaccinate horses against the respiratory disease caused by the bacteria Streptococcus equi.
Zdravilo Equilis StrepE se uporablja za cepljenje konjev proti dihalnih obolenjem, ki jih povzroča bakterija Streptococcus equi.
In very rare cases an abscess and discharge may develop at the injection site, and the lymph nodes in the head may enlarge, which may be painful for a short while.
V zelo redkih primerih se lahko na mestu injiciranja pojavi absces in izcedek, lahko pa se tudi povečajo bezgavke v glavi, kar utegne povzročiti kratkotrajno bolečino.
What is the risk associated with Equilis StrepE?
Kakšna tveganja so povezana z zdravilom Equilis StrepE?
Equilis StrepE reduces the clinical signs of disease and the occurrence of lymph node abscesses (collections of pus).
Zdravilo Equilis StrepE zmanjšuje klinične znake bolezni in nastanek abscesov (ognojkov) na bezgavkah.
The reaction is greatest at two to three days after injection, but the area affected should not be larger than 3 by 8 cm.
Reakcija je najhujša dva do tri dni po injiciranju, vendar pa prizadeto območje običajno ni večje od 3 krat 8 cm. Oteklina običajno izgine v treh tednih in ne vpliva na apetit cepljenega konja, niti mu ne povzroča nelagodja.
Why has Equilis StrepE been approved?
Zakaj je bilo zdravilo Equilis StrepE odobreno?
Fewer of the horses receiving Equilis StrepE had symptoms of strangles.
Po prejemu zdravila Equilis StrepE je imelo manj konjev simptome smolike.
How has Equilis StrepE been studied?
Kako je bilo zdravilo Equilis StrepE raziskano?
They also had fewer abscesses and fewer lymph nodes affected.
Prav tako se je zmanjšal delež abscesov in obolelih bezgavk.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis StrepE exceed the risks for immunisation of horses against S. equi to reduce clinical signs and occurrence of lymph node abscesses, and recommended that Equilis StrepE be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je sklenil, da so koristi zdravila Equilis StrepE pri imunizaciji konj proti S. equi za zmanjšanje kliničnih znakov in nastanka abscesov na bezgavkah večje od z njim povezanih tveganj.
How does Equilis StrepE work?
Kako zdravilo Equilis StrepE deluje?
What is Equilis StrepE used for?
Za kaj se zdravilo Equilis StrepE uporablja?
What is Equilis StrepE?
Kaj je zdravilo Equilis StrepE?
* Antibody micro agglutination-lytic reaction
*reakcija mikroaglutinacije-lize protiteles.
EU (MA) number
EU (MA) številka Izmišljeno ime Jakost Farmacevtska oblika
Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089
--1 Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae, sev MSLB 1089
Packag e size
Pakiranje Vsebina Velikost pakiranja
Strengt h
Način uporabe
The company presented results of studies on the quality, safety and effectiveness of the medicine.
Družba je predložila rezultate študij o kakovosti, varnosti in učinkovitosti zdravila.
The study measured the number of patients who responded to treatment.
Merilo učinkovitosti študije je bilo število bolnikov, ki so se odzvali na zdravljenje.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom structure (called an antigen) that is found on certain cells in the body.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom antigen), ki je prisotna na določenih celicah v telesu, in se veže nanjo.
This means that it was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union called Herceptin.
To pomeni, da naj bi bilo podobno biološkemu zdravilu („referenčnemu zdravilu“), ki je v Evropski uniji že odobreno, in sicer zdravilu Herceptin.
Trastuzumab has been designed to attach to HER2.
Trastuzumab je bil zasnovan za vezavo na HER2.
Two studies were carried out in healthy volunteers to investigate whether Ogivri produces the same levels of the active substance in the body as the reference medicine Herceptin and therefore has the same effect.
Opravljeni sta bili dve študiji na zdravih prostovoljcih, da bi proučili, ali zdravilo Ogivri tvori enake ravni zdravilne učinkovine v telesu kot referenčno zdravilo Herceptin in ima tako enak učinek.
Withdrawal of the marketing authorisation application for Ogivri (trastuzumab) EMA/564631/2017
Umik vloge za pridobitev dovoljenja za promet z zdravilom Ogivri (trastuzumab) EMA/564631/2017
In a third study, Ogivri in combination with a taxane was compared with Herceptin used in combination with a taxane in 500 patients with metastatic breast cancer whose tumour cells overexpressed HER2.
V tretji študiji so zdravilo Ogivri v kombinaciji s taksanom primerjali z zdravilom Herceptin v kombinaciji s taksanom pri 500 bolnikih z metastatskim rakom dojk, pri katerih so tumorske celice čezmerno izražale HER2.
On 3 August 2017, Mylan S.A.S.
Družba Mylan S.A.S.
Ogivri is a medicine that contains the active substance trastuzumab.
Ogivri je zdravilo, ki vsebuje zdravilno učinkovino trastuzumab.
HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
HER2 je čezmerno izražen pri približno četrtini rakov dojk in petini rakov želodca.
It was to be available as a powder to be made up into a solution for infusion (drip) into a vein.
Na voljo naj bi bilo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Ogivri was expected to be used to treat early and metastatic breast cancer and metastatic gastric (stomach) cancer.
Pričakovalo se je, da se bo zdravilo Ogivri uporabljalo za zdravljenje zgodnjega metastatskega raka dojk in metastatskega raka želodca.
By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells.
Ob vezavi na HER2 aktivira celice imunskega sistema, ki nato uničijo tumorske celice.
The active substance in Ogivri and Herceptin, trastuzumab, is a monoclonal antibody.
Zdravilna učinkovina v zdravilih Ogivri in Herceptin, trastuzumab, je monoklonsko protitelo.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific
To je protitelo (vrsta beljakovine), ki je zasnovano tako, da prepozna posebno strukturo (imenovano
Ogivri was developed as a ‘biosimilar' medicine.
Zdravilo Ogivri je bilo razvito kot „podobno biološko zdravilo“.
What was Ogivri expected to be used for?
Za kaj naj bi se zdravilo Ogivri uporabljalo?
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.
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.
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.
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.
Withdrawal of the marketing authorisation application for Ogivri (trastuzumab)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Ogivri (trastuzumab)
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.
Zato je ob umiku vloge menil, da družba ni predložila zadostne dokumentacije v podporo vlogi za zdravilo Ogivri.
The company informed the CHMP that the withdrawal does not impact ongoing clinical trials with Ogivri.
Družba je odbor CHMP obvestila, da zavrnitev nima vpliva na klinična preskušanja, ki trenutno potekajo z zdravilom Ogivri.
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.
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.
How does Ogivri work?
Kako zdravilo Ogivri deluje?
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.
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.
What is Ogivri?
Kaj je zdravilo Ogivri?
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.
To pomeni, da na površini tumorskih celic v večjih količinah nastaja beljakovina, imenovana HER2, zato tumorske celice hitreje rastejo.
Trastuzumab also stops HER2 producing signals that cause the tumour cells to grow.
S tem prepreči, da bi beljakovina HER2 tvorila signale, ki spodbujajo rast tumorskih celic.
On 23 June 2005, the CHMP concluded that:
Dne 23. junija je CHMP zaključil da:
- recommended follow up measures to further investigate the safety of celecoxib.
- priporočil nadaljnje ukrepe za dodatno raziskovanje varnosti celekoksiba.
SCIENTIFIC CONCLUSIONS FOR AMENDMENT OF THE PRODUCT INFORMATION
ZNANSTVENI ZAKLJUČKI ZA DOPOLNILO DOVOLJENJA ZA PROMET
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.
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
On 20 April 2005, Pfizer presented data on serious skin reactions for valdecoxib during a hearing.
Dne 20. aprila 2005 je Pfizer med zaslišanjem predstavil podatke o hudih kožnih reakcijah pri uporabi
- Addition of a more detailed description of the first signs of skin reactions leading to
- dodan je podrobnejši opis začetnih znakov kožnih reakcij, zaradi katerih se zdravljenje
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).
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).
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
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.
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.
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.
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.
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.
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.
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.
During the CHMP meeting of February 2005, discussions on cardiovascular safety took place.
CHMP je o kardiovaskularni varnosti razpravljal na svoji seji februarja 2005.
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.
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.
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.
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).
- 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
- 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
GROUNDS FOR AMENDMENT OF PRODUCT INFORMATION
PODLAGA ZA DOPOLNILO DOVOLJENJA ZA PROMET
- 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
- 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
This USR was initiated on 16 February 2005 and finalised on
Nujen varnostni ukrep se je začel 16. februarja 2005 in zaključil 17. februarja 2005.
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
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.
- 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,
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
- 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.
- 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,
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
Spremembe informacij o zdravilu, povezanih s hudimi kožnimi neželenimi reakcijami (Severe Cutaneous Adverse Reaction, SCAR), lahko povzamemo, kot sledi:
EU/1/06/335/001 Valtropin 15 mg/1.5 ml Powder and solvent for solution for injection (multi-use)
EU/1/06/335/001 Valtropin 5 mg/1,5 ml Prašek in vehikel za raztopino za injiciranje (večkratna uporaba)
Powder: 5 mg Solvent: 1.5 ml
Prašek: 5 mg Vehikel: 1,5 ml
Powder: vial (glass) Solvent: pre-filled syringe (glass)
Prašek: viala (steklo) Vehikel: napolnjena injekcijska brizga (steklo)
1 vial + 1 pre-filled syringe l t o r
1 viala + 1 napolnjena injekcijska brizga o ā
Strength Pharmaceutical Form Route of administration
Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
Gastro-Resistant Tablet
Gastrorezistentna tableta
Suspension For Injection
Raztopina za injiciranje
Granules In Sachet
Granule v vrečici
Powder For Oral Suspension
Prašek za peroralno suspenzijo
Oral Drops, Suspension
Kapljice za nos, suspenzija
Tablet
Podjezična tableta
Streptococcus Agalactiae 1000 Mega Units Tablet, Haemophilus Influenzae 1500 Mega Units Tablet, Staphylococcus Aureus 1000 Mega Units Tablet, Streptococcus Pneumoniae 1000 Mega Units Tablet
Streptococcus Agalactiae 1000 mega enot/tableto, Haemophilus Influenzae 1500 mega enot/tableto, Staphylococcus Aureus 1000 mega enot/tableto, Streptococcus Pneumoniae 1000 mega enot/tableto
Lysatum Bacteriale Mixtum 3mg Tablet
Lysatum bacteriale mixtum 3 mg tableta
Granules For Oral Suspension
Granule za peroralno suspenzijo
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
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
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
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
Nasal Use
Nazalna uporaba
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
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
Lysatum Bacteriale Mixtum 3.5mg Capsule
Lysatum bacteriale mixtum 3,5 mg kapsula
Lysatum Bacteriale Mixtum 7mg Capsule
Lysatum bacteriale mixtum 7 mg kapsula
Lyophilized Bacterial Lysates 7mg Tablet
Liofilizirani bakterijski lizati 7 mg tableta