FrancophonIA/ELRC3.0 huggingface dataset:
English: Pelzont in terms of number of days per week with moderate or greater flushing, p< 0.001, Figure 2.
Slovenian: 20 tednih zdravljenja z zdravilom Pelzont prenehali jemati laropiprant, bistveno več zardevanja kot pri bolnikih, ki so nadaljevali z jemanjem zdravila Pelzont, kar je bilo izraženo s številom dni v tednu z zmernim ali izrazitejšim zardevanjem, p < 0,001, Slika 2.
English: 28 modified-release tablets
Slovenian: 14 tablet s prirejenim sproščanjem28 tablet s prirejenim sproščanjem
English: The European Commission granted a marketing authorisation valid throughout the European Union for Actraphane on 7 October 2002.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Actraphane, veljavno po vsej Evropski uniji, odobrila 7. oktobra 2002.
English: The full EPAR for Actraphane 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 Actraphane je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What measures are being taken to ensure the safe and effective use of Actraphane?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Actraphane?
English: Actraphane is given 30 minutes before a meal.
Slovenian: Zdravilo Actraphane se daje 30 minut pred obrokom.
English: This is a summary of the European public assessment report (EPAR) for Actraphane.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Actraphane.
English: For more information about treatment with Actraphane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Actraphane preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: A risk management plan has been developed to ensure that Actraphane is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Actraphane je bil pripravljen načrt obvladovanja tveganj.
English: Other information about Actraphane
Slovenian: Druge informacije o zdravilu Actraphane
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Actraphane, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Actraphane in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Actraphane contains insulin in two forms: a soluble form, which acts quickly (within 30 minutes of injection) and an isophane form, which is absorbed much more slowly during the day.
Slovenian: Zdravilo Actraphane vsebuje insulin v dveh oblikah: v topni obliki, ki začne učinkovati hitro (v 30 minutah po injiciranju), ter v obliki izofan, ki se čez dan absorbira veliko počasneje.
English: The most common side effect with Actraphane (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Slovenian: Najpogostejši neželeni učinek zdravila Actraphane (opažen pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven glukoze v krvi).
English: The CHMP decided that Actraphane's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Actraphane večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: What benefit has Actraphane shown during the studies?
Slovenian: Kakšne koristi je zdravilo Actraphane izkazalo med študijami?
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 Actraphane.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Actraphane, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Actraphane has been studied in a total of 294 patients with type 1 diabetes, when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively.
Slovenian: Zdravilo Actraphane so preučili pri skupno 294 bolnikih s sladkorno boleznijo tipa 1, pri kateri trebušna slinavka ne more tvoriti insulina, in s sladkorno boleznijo tipa 2, pri kateri telo ne more učinkovito izrabiti insulina.
English: The active substance in Actraphane, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Slovenian: Zdravilna učinkovina v zdravilu Actraphane, humani insulin, se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri se v celice kvasovk vstavi gen (DNK), ki jim daje sposobnost tvorjenja insulina.
English: What is the risk associated with Actraphane?
Slovenian: Kakšna tveganja so povezana z zdravilom Actraphane?
English: Actraphane was effective for both type 1 and type 2 diabetes.
Slovenian: Zdravilo Actraphane se je izkazalo kot učinkovito tako pri sladkorni bolezni tipa 1 kot tudi tipa 2.
English: It is available as vials, cartridges (Penfill) or prefilled pens (InnoLet or FlexPen).
Slovenian: Na voljo je v vialah, injekcijskih vložkih (Penfill) ali napolnjenih injekcijskih peresnikih (InnoLet ali FlexPen).
English: Actraphane is a suspension for injection that contains the active substance human insulin.
Slovenian: Zdravilo Actraphane je suspenzija za injiciranje, ki vsebuje zdravilno učinkovino humani insulin.
English: Actraphane led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin.
Slovenian: Zdravilo Actraphane je privedlo do znižanja ravni HbA1c, kar kaže, da so bile ravni glukoze v krvi uravnane na podobno raven kot pri drugih humanih insulinih.
English: The study compared Actraphane 30 to a similar mix, but made up using an insulin analogue (insulin aspart).
Slovenian: V študiji so zdravilo Actraphane 30 primerjali s podobno mešanico, ki pa je vsebovala analog insulina (insulin aspart).
English: Actraphane is used to treat diabetes.
Slovenian: Zdravilo Actraphane se uporablja za zdravljenje sladkorne bolezni.
English: Actraphane is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Slovenian: Zdravilo Actraphane se injicira v podkožje stegna, trebušne stene (sprednjega dela trebuha), glutealnega predela (zadnjice) ali deltoidnega predela (ramena).
English: Actraphane is a replacement insulin which is very similar to the insulin made by the pancreas.
Slovenian: Zdravilo Actraphane je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna slinavka.
English: Why has Actraphane been approved?
Slovenian: Zakaj je bilo zdravilo Actraphane odobreno?
English: How has Actraphane been studied?
Slovenian: Kako je bilo zdravilo Actraphane raziskano?
English: What is Actraphane used for?
Slovenian: Za kaj se zdravilo Actraphane uporablja?
English: Actraphane contains both fast-acting (soluble) and long-acting (isophane) insulin:
Slovenian: Zdravilo Actraphane vsebuje tako hitrodelujoči (topni) kot tudi dolgodelujoči (izofan) insulin.
English: How is Actraphane used?
Slovenian: Kako se zdravilo Actraphane uporablja?
English: What is Actraphane?
Slovenian: Kaj je zdravilo Actraphane?
English: This gives Actraphane a longer duration of action.
Slovenian: To podaljša čas delovanja zdravila Actraphane.
English: How does Actraphane work?
Slovenian: Kako zdravilo Actraphane deluje?
English: Shake well and use immediately.
Slovenian: Dobro pretresite in uporabite takoj.
English: Provide enough space so that all pigs can drink the required amount.
Slovenian: Omogočite dovolj prostora, da bodo lahko vsi prašiči zaužili potrebno količino.
English: ATCvet code: QI09AE03.
Slovenian: Oznaka ATC vet: QI09AE03.
English: The actual amount of water consumed may however vary considerably depending on several factors.
Slovenian: Dejanska količina popite vode je lahko zelo različna, kar je odvisno od več dejavnikov.
English: The active substance being a principle of biological origin intended to produce a state of immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: Učinkovina, ki je v osnovi biološkega izvora namenjena vzbujanju aktivne imunosti, ne spada v področje uporabe Uredbe (ES) št. 470/2009.
English: Each dose of vaccine contains:
Slovenian: En odmerek cepiva vsebuje:
English: Withhold drinking water supply for 1 to 2 hours prior to the planned vaccination to stimulate drinking of the vaccine suspension.
Slovenian: Dovajanje pitne vode prekinite od 1 do 2 uri pred načrtovanim cepljenjem, da spodbudite pitje suspenzije cepiva.
English: The excipients 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 dovoljenje 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: Duration of immunity: 21 days after vaccination.
Slovenian: Trajanje imunosti: 21 dni po cepljenju.
English: The suspension should be administered within 4 hours after preparation.
Slovenian: Suspenzijo je treba uporabiti v 4 urah po pripravi.
English: Cardboard box
Slovenian: kartonasta škatla
English: Vials (50 or 200 doses)
Slovenian: viale (50 ali 200 odmerkov)
English: Poligono La Relva, Torneiros s/n 36410 Porriño (Pontevedra) SPAIN
Slovenian: Poligono La Relva, Torneiros s/n 36410 Porriño (Pontevedra) ŠPANIJA
English: The drinking water systems have to be cleaned and intensively rinsed with untreated water to avoid any residues of antimicrobials, detergents or disinfectants.
Slovenian: Vodne sisteme za pitje je treba očistiti in temeljito sprati s čisto vodo, da se izognete kakršnim koli ostankom antibiotikov, detergentov ali dezinfekcijskih sredstev.
English: All materials used in preparing and administering the vaccine must be free of antimicrobials, detergent or disinfectant residues to prevent inactivation.
Slovenian: Vsi materiali, ki se uporabljajo pri pripravi in uporabi cepiva, morajo biti brez ostankov antibiotikov, detergentov ali dezinfekcijskih sredstev, da preprečite inaktivacijo.
English: Manufacturer responsible for batch release: CZ Veterinaria S.A.
Slovenian: Proizvajalec odgovoren za sproščanje serij: CZ Veterinaria S.A.
English: Date of first authorisation:16/03/2015 Date of latest renewal: dd/mm/yyyy
Slovenian: Datum pridobitve dovoljenja za promet: 16/03/2015 Datum zadnjega podaljšanja dovoljenja za promet: 07/11/2019
English: Vaccination by drench application:
Slovenian: Cepljenje z drenažno aplikacijo:
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 (European Medicines Agency) (http://www.ema.europa.eu/).
English: The final concentration of the skimmed milk powder should be 5 g/litre.
Slovenian: Končna koncentracija posnetega mleka v prahu mora biti 5 g/liter.
English: As an example, for a 4-hour consumption of 22 l and a dosing pump rate of 1%, the volume of the stock solution should be 22 l x 0.01 = 220 ml.
Slovenian: Na primer pri 4-urni porabi 22 l in hitrosti črpalke 1 % bo volumen osnovne raztopine 22 l x 0,01 = 220 ml.
English: to 9.0 x10
Slovenian: do 9,0 x 10
English: Onset of immunity: 7 days after vaccination.
Slovenian: Začetek imunosti: 7 dni po cepljenju.
English: Pregnancy and lactation: The use is not recommended during pregnancy.
Slovenian: Brejost in laktacija: Uporaba med brejostjo ni priporočljiva.
English: 80689 München GERMANY
Slovenian: 80689 München
English: Type I glass vial of 6 ml containing 50 doses and of 11 ml containing 200 doses with a chlorobutyl rubber stopper sealed with an aluminum cap.
Slovenian: Viala (steklo tipa I) s 6 ml, ki vsebuje 50 odmerkov, in 11 ml, ki vsebuje 200 odmerkov, z zamaškom iz klorobutilne gume, zatesnjenim z aluminijasto zaporko.
English: In case of concerns about the presence of disinfectant residues in the drinking water, it is recommended to add skimmed milk powder as a stabilizer into the drinking water prior to adding the vaccine.
Slovenian: Če sumite, da so v vodi za pitje ostanki dezinfekcijskih sredstev, je priporočljivo, da vodi za pitje pred dodajanjem cepiva kot stabilizator dodate posneto mleko v prahu.
English: The final concentration of the skimmed milk powder should be 5 g/l.
Slovenian: Končna koncentracija posnetega mleka v prahu mora biti 5 g/l.
English: 50 doses 4 x 50 doses 200 doses
Slovenian: 50 odmerkov 4 x 50 odmerkov 200 odmerkov
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal.
Slovenian: Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: Shelf life of the veterinary medicinal product as packaged for sale : 18 months.
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo: 18 mesecev.
English: The vaccine strain may be excreted by vaccinated piglets for at least 14 days following vaccination.
Slovenian: Cepljeni prašički lahko ta vakcinalni sev izločajo vsaj 14 dni po cepljenju.
English: Marketing authorisation holder: Prevtec Microbia GmbH Geyerspergerstr.
Slovenian: Imetnik dovoljenja za promet z zdravilom: Prevtec Microbia GmbH Geyerspergerstr.
English: During this time, the contact of immunosuppressed pigs with vaccinated pigs should be avoided.
Slovenian: V tem času se je treba izogibati stiku imunsko oslabljenih prašičev s cepljenimi prašiči.
English: The vaccine strain readily spreads to other pigs in contact to vaccinated pigs.
Slovenian: Sev cepiva se hitro razširi na druge prašiče, ki so v stiku s cepljenimi prašiči.
English: Vaccination via the drinking water:
Slovenian: Cepljenje prek vode za pitje:
English: Store and transport refrigerated (2 C - 8 C).
Slovenian: Shranjujte in prevažajte v hladilniku (2 °C-8 °C).
English: Vaccination schedule: administer a single dose orally from 18 days of age.
Slovenian: Razpored cepljenja: uporabite enkratni peroralni odmerek od 18. dneva starosti.
English: • For administration using bowls or tanks, dilute the reconstituted vaccine in the volume of water that the pigs will drink during a 4-hour time period.
Slovenian: • Če uporabljate sklede ali cisterne, rekonstituirano cepivo razredčite v količini vode, ki jo bodo prašiči popili v 4-urnem obdobju.
English: Therefore, it is recommended to assess the actual water intake during a 4-hour time period the day before vaccination.
Slovenian: Zato je priporočljivo, da dan pred cepljenjem ocenite dejansko količino popite vode v 4-urnem obdobju.
English: 50 doses 200 doses
Slovenian: 50 odmerkov 200 odmerkov
English: Shelf-life after dilution according to directions: 4 hours.
Slovenian: Rok uporabnosti po razredčenju v skladu z navodili: 4 ure.
English: Unvaccinated pigs in contact with vaccinated pigs will harbour and shed the vaccine strain similarly to vaccinated pigs.
Slovenian: Necepljeni prašiči, ki pridejo v stik s cepljenimi prašiči, bodo cepivo kolonizirali in razsejali na podoben način kot cepljeni prašiči.
English: A transient reduced weight gain was observed during the first week after vaccination in studies.
Slovenian: V študijah so v prvem tednu po cepljenju opazili prehodno zmanjšanje pridobivanja telesne mase.
English: The volume of stock solution is calculated using the volume of water that the pigs will drink during a 4-hour time period multiplied by the dosing pump rate (in decimal).
Slovenian: Količino osnovne raztopine se izračuna tako, da se količina vode, ki jo bodo prašiči popili v 4-urnem obdobju, pomnoži s hitrostjo črpalke za odmerjanje (v decimalkah).
English: Pharmacotherapeutic group: immunologicals for Suidae live bacterial vaccines for pigs.
Slovenian: Farmakoterapevtska skupina: imunološka zdravila za prašiče, živa bakterijska cepiva za prašiče.
English: Administer a single 2 ml dose orally to pigs (from 18 days of age), irrespective of body weight.
Slovenian: Prašičem dajte enkratni 2-mililitrski peroralni odmerek (od starosti 18 dni), ne glede na telesno maso.
English: The final suspension containing the vaccine should be consumed within 4 hours after preparation.
Slovenian: Končno suspenzijo, ki vsebuje cepivo, morajo prašiči zaužiti v 4 urah po pripravi.
English: Shelf life after reconstitution and dilution according to directions: 4 hours.
Slovenian: Rok uporabnosti po rekonstituciji in razredčenju v skladu z navodili: 4 ure.
English: In case of spillage onto skin, rinse with water and seek medical advice immediately and show the package leaflet or the label to the physician.
Slovenian: V primeru razlitja po koži sperite z vodo ter se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: Do not vaccinate animals undergoing antibacterial treatment effective against Escherichia coli.
Slovenian: Ne cepite živali, ki se zdravijo z antibiotiki, učinkovitimi proti Escherichia coli.
English: Special precautions for use in animals Apply the usual aseptic precautions to all administration procedures.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Pri vseh postopkih cepljenja upoštevajte običajne aseptične previdnostne ukrepe.
English: Shivering was very commonly observed after vaccination in studies.
Slovenian: V študijah so po cepljenju zelo pogosto opazili tresenje.
English: Do not vaccinate animals undergoing immunosuppressive treatment.
Slovenian: Ne cepite živali, ki se zdravijo z imunosupresivi.
English: Reconstitute the lyophilisate by adding 5 ml (50-dose presentation) or 10 ml (200-dose presentation) of tap water to the vial.
Slovenian: Rekonstituirajte liofilizat, tako da viali dodate 5 ml (50 odmerkov) ali 10 ml (200 odmerkov) vode iz pipe.
English: Prevtec Microbia GmbH 80689 München GERMANY
Slovenian: Prevtec Microbia GmbH 80689 München NEMČIJA
English: • For administration through water lines using a dosing pump (proportioner), dilute the reconstituted vaccine in the needed volume of the dosing pump stock solution.
Slovenian: • Če uporabljate vodne cevi in črpalko za odmerjanje (dozirnik), rekonstituirano cepivo razredčite v potrebni količini osnovne raztopine v črpalki za odmerjanje.
English: Apply the usual aseptic precautions to all administration procedures.
Slovenian: Pri vseh postopkih cepljenja upoštevajte običajne aseptične previdnostne ukrepe.
English: CFU - colony forming units For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Name and address of the manufacturer of the biological active substance and the manufacturer responsible for batch release:
Slovenian: Ime in naslov proizvajalca biološke učinkovine in proizvajalca zdravila, odgovornega za sproščanje serij:
English: Water consumption in a 4-hour time period of number of pig(s)
Slovenian: Popita voda v 4-urnem obdobju glede na število prašičev
English: Shake well and transfer the suspension into a graduated container, mix again with tap water to complete to a total volume of 100 ml.
Slovenian: Dobro pretresite in suspenzijo prenesite v vsebnik z merilnimi oznakami; ponovno premešajte z vodo iz pipe, da vsebino dopolnite do skupne prostornine 100 ml.
English: Cardboard box of four vials of 50 doses.
Slovenian: Kartonasta škatla s štirimi vialami s 50 odmerki.
English: Shake well and transfer the suspension into a graduated container, mix again with tap water to complete to a total volume of 400 ml.
Slovenian: Dobro pretresite in suspenzijo prenesite v vsebnik z merilnimi oznakami; ponovno premešajte z vodo iz pipe, da vsebino dopolnite do skupne prostornine 400 ml.
English: Shake well.
Slovenian: Dobro pretresite.
English: The reconstituted vaccine is transparent to opaque white-yellowish suspension depending on the volume of water used for dilution.
Slovenian: Rekonstituirano cepivo je prozorna do motna belo-rumenkasta suspenzija, odvisno od prostornine vode, ki se uporabi za redčenje.
English: Alternatively, refer to the following table:
Slovenian: Poleg tega lahko upoštevate spodnjo preglednico:
English: No adverse reactions other than those stated for single dose use have been observed after administration of 10 times the recommended dose
Slovenian: Pri uporabi odmerka, ki je 10-krat večji od priporočenega, niso opazili nobenih neželenih učinkov, razen tistih, navedenih za enkratni odmerek.
English: Prevtec Microbia GmbH Geyerspergerstr 27
Slovenian: Prevtec Microbia GmbH
English: For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive Escherichia coli in order to:
Slovenian: Za aktivno imunizacijo prašičev od starosti 18 dni proti enterotoksigeni, za F4 pozitivni okužbi z Escherichia coli za:
English: Cardboard box of one vial of 200 doses.
Slovenian: Kartonasta škatla z eno vialo z 200 odmerki.
English: No adverse reactions other than those stated under section 4.6 have been observed after administration of 10 times the recommended dose.
Slovenian: Pri uporabi odmerka, ki je 10-krat večji od priporočenega, niso opazili nobenih neželenih učinkov, razen tistih, opisanih v poglavju 4.6.
English: In drinking water use.
Slovenian: Dajanje v vodo za pitje.
English: Oral use and in drinking water use.
Slovenian: peroralna uporaba in dajanje v vodo za pitje.
English: For active immunisation of pigs against enterotoxigenic F4-positive Escherichia coli in order to: - reduce the incidence of moderate to severe post-weaning Escherichia coli diarrhoea (PWD) in pigs - reduce the colonisation of the ileum and faecal shedding of enterotoxigenic F4-positive Escherichia coli from infected pigs.
Slovenian: Za aktivno imunizacijo prašičev proti enterotoksigeni, za F4 pozitivni okužbi z Escherichia coli za: - zmanjšanje incidence zmerne do hude driske zaradi Escherichia coli po odstavitvi pri prašičih; - zmanjšanje kolonizacije spodnjega tankega črevesa in fekalnega razsejanja enterotoksigene, za F4 pozitivne okužbe z Escherichia coli pri okuženih prašičih.
English: • 200-dose presentation: Reconstitute the lyophilisate by adding 10 ml of tap water to the vial.
Slovenian: • primer za 200 odmerkov: rekonstituirajte liofilizat, tako da viali dodate 10 ml vode iz pipe.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po EXP. Rok uporabnosti zdravila se se nanaša na zadnji dan v navedenem mesecu.
English: The reconstituted vaccine is a transparent to opaque white-yellowish suspension depending on the volume of water used for dilution.
Slovenian: Rekonstituirano cepivo je prozorna do motna belorumena suspenzija, ki je odvisna od prostornine vode, ki se uporabi za redčenje.
English: • 50-dose presentation: Reconstitute the lyophilisate by adding 5 ml of tap water to the vial.
Slovenian: • primer za 50 odmerkov: rekonstituirajte liofilizat, tako da viali dodate 5 ml vode iz pipe.
English: White or whitish lyophilisate.
Slovenian: - kolonijske enote Bel ali belkast liofilizat.
English: Live E.coli, O8:K87 (F4ac).
Slovenian: živi sev E. coli, O8:K87 (F4ac).