natgillin/translations-raw huggingface dataset:
Spray application of EVICEL should not be used in endoscopic procedures.
Zdravila EVICEL pri endoskopskih posegih ne smete nanašati s pršenjem.
EVICEL must not be applied intravascularly.
Zdravila EVICEL ne smete uporabiti intravaskularno.
• To avoid the risk of potentially fatal air or gas embolism EVICEL should be sprayed using pressurised CO2 gas only.
• Da bi se izognili tveganju za potencialno življenjsko nevarno zračno ali plinsko embolijo, se sme zdravilo EVICEL pršiti samo s plinom CO2 pod tlakom.
Component 1: 1 vial containing 5 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 5 ml of human thrombin (800 - 1200 IU/ml).
Raztopina 1: 1 viala vsebuje 5 ml humane koagulacijske beljakovine (50-90 mg/ml) Raztopina 2: 1 viala vsebuje 5 ml humanega trombina (800-1200 i.e./ml)
Solutions for sealant
Raztopini za lepilo
Component 1: 1 vial containing 1 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 1 ml of human thrombin (800 - 1200 IU/ml).
Raztopina 1: 1 viala vsebuje 1 ml humane koagulacijske beljakovine (50-90 mg/ml) Raztopina 2: 1 viala vsebuje 1 ml humanega trombina (800-1200 i.e./ml)
EVICEL forms a clear film over the area of application.
Zdravilo EVICEL po področju nanosa napravi prozoren film.
* Total quantity of protein is 80 - 120 mg/ml
* Skupna količina beljakovin je 80-120 mg/ml Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Component 1: Human clottable protein containing mainly fibrinogen and fibronectin (50 - 90 mg/ml) Component 2: Human thrombin (800 - 1,200 IU/ml)
Raztopina 1: humana koagulacijska beljakovina, ki vsebuje predvsem fibrinogen in fibronektin (5090 mg/ml)
Component 1: 1 vial containing 2 ml of human clottable protein (50 - 90 mg/ml) Component 2: 1 vial containing 2 ml of human thrombin (800 - 1200 IU/ml).
Raztopina 1: 1 viala vsebuje 2 ml humane koagulacijske beljakovine (50-90 mg/ml) Raztopina 2: 1 viala vsebuje 2 ml humanega trombina (800-1200 i.e./ml)
To avoid the risk of potentially life-threatening air or gas embolism EVICEL should be sprayed using pressurised CO2 gas only.
Da bi se izognili tveganju za potencialno življenjsko nevarno zračno ali plinsko embolijo, pršite zdravilo EVICEL samo s plinom CO2 pod tlakom.
• The bleeding should be controlled before EVICEL is used to seal the dural suture line.
• Preden se zdravilo EVICEL uporabi za lepljenje duralnih šivov, mora biti krvavitev nadzorovana.
Signs of allergic reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure, and breathing difficulties.
stiskanje v prsih, sopenje, padec krvnega tlaka in oteženo dihanje.
Thus, when the two components are mixed together they clot instantly.
To pomeni, da sestavini pri mešanju v hipu tvorita strdek.
CLINICAL PARTICULARS
Žilne bolezni
Using
Način uporabe
MedDRA System Organ Class
Organski sistem po MedDRA Priporočeni izraz
Sodium chloride Sodium citrate Calcium chloride Water for injections
Viala s humanim fibrinogenom argininijev klorid glicin natrijev klorid natrijev citrat kalcijev klorid voda za injekcije
• EVICEL will be applied as a thin layer.
• Zdravilo EVICEL se nanaša v tankem sloju.
EVICEL should be applied as a thin layer.
Zdravilo EVICEL je treba nanesti v tankem sloju.
o Healthcare professionals training material
SEZNAM POMOŽNIH SNOVI
45 cm Flexible Tip
Prožni nastavek dolžine 45 cm20 psi bara)
Device assembly
Sestavljanje pripomočka
Date of first authorisation: 28 April 2004 Date of latest renewal: 25 March 2009
Datum prve odobritve: 28. april 2004 Datum zadnjega podaljšanja: 25. marec 2009
Do not use any other liquid.
Ne uporabite nobene druge tekočine.
Number (Age groups)
Število (starostne skupine)
At the end of this period the product should be used or discarded.
Ob koncu tega obdobja je treba zdravilo uporabiti ali zavreči.
Efficacy against cholera
Učinkovitost proti koleri
Chlorinated water can be used.
Lahko uporabite klorirano vodo.
Primary vaccination schedule
Načrt primarnega cepljenja
Other side effects (frequency cannot be estimated from the available data)
Drugi neželeni učinki (pogostosti ni mogoče oceniti iz razpoložljivih podatkov):
However, an effectiveness study in a population with high HIV prevalence showed similar protection as in other populations.
Vendar je študija učinkovitosti v populaciji z veliko razširjenostjo okužbe z virusom HIV pokazala podobno stopnjo zaščite kot v drugih populacijah.
1994 2 doses 7-11 days apart
1994 2 odmerka 7-11 dni narazen
Do not give this vaccine to children younger than 2 years since the protection has not been studied in this group.
Ne dajajte tega cepiva otrokom, mlajšim od 2 let, saj zaščita ni raziskana v tej skupini.
6 months 1st year 2nd year
6 mesecev 1. leto 2. leto
• if you have a disease of the immune system (including HIV infection).
• če imate bolezen imunskega sistema (vključno z okužbo z virusom HIV).
During a mass-vaccination campaign conducted in Zanzibar, 196 pregnant women had received at least one dose of Dukoral.
Med kampanjo množičnega cepljenja v Zanzibarju je 196 nosečnic prejelo vsaj en odmerek cepiva Dukoral.
In the majority of studies adverse events were assessed by passive surveillance.
V večini raziskav so neželene učinke ocenili s pasivnim nadzorom.
Please tell your doctor if you are taking or have recently taken any other medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Because each vial of Dukoral contains only one dose, overdosage is unlikely.
Ker vsaka viala zdravila Dukoral vsebuje samo en odmerek, je preveliko odmerjanje malo verjetno.
Read all of this leaflet carefully before you start using this vaccine because it contains important information for you.
Pred začetkom uporabe cepiva natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Dukoral should not replace standard protective measures.
Cepivo Dukoral ne sme nadomestiti standardnih zaščitnih ukrepov.
• if you take a medical treatment that affects the immune system
• če ste deležni zdravljenja, ki vpliva na imunski sistem,
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose
V skladu s členom 114 Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
Formaldehyde is used during the manufacturing process and trace amounts may be present in the final product.
Med proizvodnim postopkom se uporablja formaldehid in v končnem zdravilu se lahko nahajajo količine v sledovih.
• severe diarrhoea with loss of water from the body
• huda driska z izgubo vode iz telesa,
The third study, a field trial conducted in Peru, failed to show any protective efficacy against cholera during the first year.
Tretja raziskava, terensko preskušanje v Peruju, ni pokazala nikakršne učinkovitosti zaščite proti koleri v prvem letu.
Food and/or drink will increase acid production in the stomach and the effect of the vaccine may be impaired.
Hrana in/ali pijača poveča izločanje kisline v želodcu in to lahko zmanjša učinek cepiva.
1 dose (3 ml)
1 odmerek (3 ml)
The use of Dukoral should be determined on the basis of official recommendations taking into consideration the variability of epidemiology and the risk of contracting disease in different geographical areas and travelling conditions.
Uporabo cepiva Dukoral morate določiti na osnovi uradnih priporočil in pri tem upoštevati epidemiološko variabilnost ter tveganje za okužbo v različnih geografskih območjih in pri različnih potovalnih pogojih.
Using Dukoral with food and drink
Zdravilo Dukoral skupaj s hrano in pijačo
Protective effectiveness against cholera was evaluated during two mass-vaccination campaigns conducted in Mozambique (December 2003 - January 2004) and Zanzibar (February 2009 - May
Učinkovitost zaščite proti koleri so ocenili v dveh kampanjah množičnega cepljenja, ki sta potekali v Mozambiku (december 2003 - januar 2004) in Zanzibarju (februar 2009 - maj 2010).
If you are pregnant, think you may be pregnant or are planning to have a baby or are breast-feeding, ask your doctor before taking the vaccine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to cepivo.
• serious allergic reactions causing swelling of the face or throat and breathlessness
• hude alergijske reakcije, ki povzročajo otekanje obraza ali grla in zadihanost.
• High blood pressure
• povišan krvni tlak.
(18-65 years)
(18-65 let)
- Make sure to mix the vaccine with buffer solution as described in this leaflet.
- Ne pozabite zmešati cepiva s pufrsko raztopino, kot je opisano v tem navodilu.
Antibody response in vaccinees with endogenous or iatrogenic immunosuppression may be insufficient.
Odziv protiteles pri cepljenih osebah z endogeno ali iatrogeno imunosupresijo morda ne bo zadosten.
In the event of diarrhoea measures of rehydration should be instituted.
V primeru driske morate uporabiti ukrepe za rehidracijo.
• Fatigue/feeling tired
• utrujenost/občutek utrujenosti,
There is a poor correlation between serum antibody responses, including vibriocidal antibody response, and protection.
Obstaja nizka korelacija med odzivom serumskih protiteles, vključno z odzivom vibriocidnih protiteles in zaščito.
(≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Razvrstitev po pogostosti: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Serum vibriocidal antibodies against the bacterial components were seen in 35-55% of vaccinated subjects and antitoxic antibodies in 78-87% of vaccinated subjects.
Serumska vibriocidna protitelesa proti bakterijski komponenti so opazili pri 35-55 %, protititoksinska protitelesa pa pri 78-87 % cepljenih oseb.
Contact a doctor immediately if you experience the following serious side effects:
Takoj poiščite zdravniško pomoč, če se pri vas pojavijo naslednji resni neželeni učinki:
Immunisation should be completed at least 1 week prior to potential exposure to V. cholerae O1.
Imunizacijo morate končati vsaj en teden pred morebitno izpostavitvijo bakteriji V. cholerae O1.
There are only very limited data on protective efficacy of the vaccine in subjects aged 65 years and more.
Obstaja zelo malo podatkov o učinkovitosti zaščite tega cepiva pri bolnikih, starih 65 let ali več.
* Bacterial count before inactivation.
* Število bakterij pred inaktivacijo.
1993-95 2 doses 2 weeks apart with a booster dose 1 year later
1993-95 2 odmerka 2 tedna narazen s poživitvenim odmerkom po 1 letu
(2-65 years)
(2-65 let)
Please take this into consideration if you are on a controlled sodium diet.
To morate upoštevati, če ste na dieti z malo natrija.
• if you have an acute stomach disorder or infection with fever (vaccination should be delayed).
• če imate akutno trebušno bolezen ali okužbo z vročino (cepljenje morate prestaviti).
Children 2-6 years
Otroci 2-6 let
EU/1/03/263/001 1 dose EU/1/03/263/002 2x1 dose EU/1/03/263/003 20x1 dose
EU/1/03/263/001 1 odmerek EU/1/03/263/002 2 x 1 odmerek EU/1/03/263/003 20 x 1 odmerek
Evaluation of safety varied between trials with respect to mode of surveillance, definition of symptoms and time of follow-up.
Ocena varnosti se je, zaradi načina nadzora, opredelitve simptomov in časa sledenja, med posameznimi preskušanji razlikovala.
What Dukoral is and what it is used for What you need to know before you use Dukoral How to use Dukoral
Kaj je zdravilo Dukoral in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Dukoral Kako uporabljati zdravilo Dukoral
Like all medicines, Dukoral can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Dukoral neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Infections and infestations: Gastroenteritis
Infekcijske in parazitske bolezni: gastroenteritis
31.25x109 bacteria*
31,25 x 109 bakterij*
Children 2 to below 6 years of age should receive 3 doses.
Otroci od 2 do manj kot 6 let naj prejmejo 3 odmerke.
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to formaldehyde.
Preobčutljivost na učinkovine ali katero koli pomožno snov, navedeno v poglavju 6.1, ali formaldehid.
If you forget to take Dukoral.
Če ste pozabili vzeti zdravilo Dukoral
Drink the entire mixture within 2 hours.
Celotno zmes spijte najpozneje v 2 urah.
Therefore, Dukoral is not recommended to be used in children less than 2 years of age.
Zato uporaba cepiva Dukoral ni priporočena pri otrocih, mlajših od 2 let.
6 months-5 years
6 mesecev-5 let
Dukoral causes your body to produce its own protection against cholera.
Cepivo Dukoral povzroči, da začne vaše telo proizvajati lastno zaščito proti koleri.
The vaccine is intended for oral use.
Cepivo je namenjeno peroralni uporabi.
Other medicines and Dukoral
Druga zdravila in zdravilo Dukoral
If you take more Dukoral than you should
Če ste vzeli večji odmerek zdravila Dukoral, kot bi smeli
A booster dose elicited an anamnestic response indicative of an immune memory.
Poživitveni odmerek je sprožil anamnezni odziv, ki kaže na imunski spomin.
The duration of the immunological memory was estimated to last for at least 2 years in adults.
Trajanje imunskega spomina pri odraslih je bilo ocenjeno na najmanj 2 leti.
The vaccine may provide you with a lower level of protection than it does for people with healthy immune systems.
Pri vas bo cepivo morda manj učinkovito kot pri osebah z zdravim imunskim sistemom.
Sodium dihydrogen phosphate dihydrate 2.0 mg, disodium hydrogen phosphate dihydrate 9.4 mg, sodium chloride 26 mg, sodium hydrogen carbonate 3600 mg, sodium carbonate anhydrous 400 mg, saccharin sodium 30 mg, sodium citrate 6 mg.
Natrijev dihidrogenfosfat dihidrat 2,0 mg, dinatrijev hidrogenfosfat dihidrat 9,4 mg, natrijev klorid 26 mg, natrijev hidrogenkarbonat 3.600 mg, brezvodni natrijev karbonat 400 mg, natrijev saharinat 30 mg, natrijev citrat 6 mg.
There is no evidence of an effect on the ability to drive and use machines.
Ni dokazov za učinke na sposobnost vožnje in upravljanja strojev.
What Dukoral is and what it is used for
Kaj je zdravilo Dukoral in za kaj ga uporabljamo
The effervescent granules are filled in an amount of 5.6 g in sachets with an inner layer of polyester/LD-polyethylene and an outer layer of aluminium/LD-polyethylene.
Šumeča zrnca so pakirana po 5,6 g v vrečice z notranjo plastjo iz poliestra/LD-polietilena in zunanjo plastjo iz aluminija/LD-polietilena.
The immune response to live typhoid vaccine was not investigated in this study.
Imunskega odziva na živo cepivo proti tifusu v tej študiji niso raziskovali.
The two toxins cross-react immunologically.
Ta dva toksina povzročita navzkrižno imunološko reakcijo.
Dukoral is available in packs of 1, 2 and 20 doses.
Zdravilo Dukoral je na voljo v pakiranjih po 1, 2 in 20 odmerkov.
Data on overdose are limited.
Podatkov o prevelikem odmerjanju je malo.
3 ml of suspension in a vial and 5.6 g of effervescent granules in a sachet.
3 ml suspenzije v viali in 5,6 g šumečih zrnc v vrečici.
Dizziness Very rare Drowsiness, insomnia, fainting, reduced sense of taste
Zelo redki omotica, nespečnost, omedlevanje, zmanjšan čut okusa
Immunisation of HIV infected subjects could result in transient increases of viral load.
Imunizacija bolnikov, okuženih z virusom HIV, bi lahko povzročila prehodno naraščanje količine virusa.
There was no statistically significant evidence of a harmful effect of Dukoral exposure during pregnancy.
Statistično pomembnih dokazov o škodljivih učinkih cepiva Dukoral pri izpostavljenosti med nosečnostjo ni bilo.
See Section 3.
Glejte poglavje 3.
3 ml of suspension in a vial.
3 ml suspenzije v viali.
The vaccine does not provide complete protection and it is important to adhere to dietary and hygiene advice to avoid diarrhoeal diseases.
Cepivo ne zagotavlja popolne zaščite in pomembno se je držati nasvetov o prehrani in higieni, s katerimi se lahko izognete boleznim z drisko.
For continuous protection, re-vaccination is recommended within 2 years.
Za dolgotrajno zaščito je priporočeno ponovno cepljenje v roku 2 let.
Dukoral contains approximately 1.1 g sodium per dose, which should be taken into consideration by patients on a controlled sodium diet.
Cepivo Dukoral vsebuje približno 1,1 g natrija na odmerek, kar morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
Immunisation does not protect against V. cholerae serogroup O139 or other species of Vibrio.
Imunizacija ne ščiti pred okužbo z bakterijo V. cholerae serološke skupine O139 ali drugimi vrstami rodu Vibrio.
Following careful benefit/risk assessment the vaccine may be administered during pregnancy and to breast-feeding women although no specific clinical studies have been performed to address this issue.
Po previdni oceni morebitnega tveganja in koristi lahko cepivo dajemo tudi nosečnicam in ženskam, ki dojijo, čeprav niso bile opravljene študije, ki bi raziskovale to vprašanje.
The vaccine does not provide complete protection and it is important to adhere additionally to standard protective measures to avoid cholera.
Cepivo ne zagotavlja popolne zaščite in pomembno se je držati tudi standardnih zaščitnih ukrepov proti koleri.
In addition to the direct protection, it was shown that Dukoral provides significant indirect (herd) protection in the studied setting.
Izkazalo se je, da cepivo Dukoral poleg neposredne zaščite zagotavlja tudi pomembno posredno (skupinsko) zaščito v obravnavanem okolju.
- suspension for oral suspension:
- suspenzija za peroralno suspenzijo:
Caution should be taken in subjects with known hypersensitivity to formaldehyde.
Bodite previdni pri osebah z znano preobčutljivostjo za formaldehid.
One dose contains approximately 1.1 g sodium.
En odmerek vsebuje približno 1,1 g natrija.
Dukoral is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children from 2 years of age who will be visiting endemic/epidemic areas.
Cepivo Dukoral je indicirano za aktivno imunizacijo proti bolezni, ki jo povzroča Vibrio cholerae serološke skupine O1 pri odraslih in otrocih od dveh let starosti dalje, ki bodo obiskali epidemična ali endemična območja.
Product in the unopened vial and sachet, stored in the outer carton, is stable at temperatures up to 25oC for a period of 14 days.
Zdravilo v neodprti viali in vrečici, shranjeni v kartonski škatli, je pri temperaturi do 25 °C stabilno 14 dni.
Dukoral has been given to children between 1 and 2 years of age in safety and immunogenicity studies, but the protective efficacy has not been studied in this age group.
Otroci, mlajši od 2 let Otroci, stari od 1 do 2 leti, so v raziskavah varnosti in imugenosti prejemali cepivo Dukoral, vendar učinkovitosti zaščite v tej starostni skupini niso raziskovali.
The number of patients enrolled, dosage regimens and follow-up periods are shown in the following table.
Število bolnikov, ki so sodelovali v preskušanju, odmerjanje in čas sledenja so prikazani v preglednici spodaj.
Pharmacotherapeutic group: Bacterial vaccines, ATC-code: J07AE01
Farmakoterapevtska skupina: Bakterijska cepiva, oznaka ATC: J07A E01 Mehanizem delovanja
The vaccine vial should be shaken gently and the vaccine suspension should then be added to the buffer solution and mixed well to get the colourless slightly opalescent oral suspension.
Vialo s cepivom je treba stresati previdno, suspenzijo cepiva pa je treba dodati pufrski raztopini in dobro premešati, da bi dobili brezbarvno, rahlo opalescentno peroralno suspenzijo.
Contents of the pack and other information What Dukoral contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Dukoral
After getting the vaccine, your body will make substances called antibodies, which fight the cholera bacteria and toxin that cause diarrhoea.
Po prejemu cepiva bodo v vašem telesu nastale snovi, imenovane protitelesa, ki se borijo proti bakterijam kolere in toksinu, ki povzroča drisko.
Drink the entire mixture within 2 hours after mixing with the buffer solution.
Celotno zmes spijte najpozneje v 2 urah po mešanju s pufrsko raztopino.
Preliminary results from a clinical study including a limited number of volunteers showed no interaction with the antibody response to Dukoral when a live oral vaccine (enterocapsules) against typhoid was given simultaneously with Dukoral.
Preliminarni rezultati klinične raziskave, v kateri je sodelovalo omejeno število prostovoljcev, niso pokazali interakcij v odzivu protiteles na cepivo Dukoral pri sočasni uporabi živega peroralnega cepiva (enterokapsul) proti tifusu in cepiva Dukoral.
There are no reasons to suspect that Dukoral will affect your ability to drive or handle machines
Ni razlogov za sum, da zdravilo Dukoral vpliva na sposobnost vožnje ali upravljanja s stroji.
For continuous protection, re-vaccination is recommended within 6 months.
Za dolgotrajno zaščito je priporočeno ponovno cepljenje v roku 6 mesecev.
Cholera Bangladesh 1985-88 3 doses at 6 week intervals
Kolera Bangladeš 1985-88 3 odmerki v presledkih po 6 tednov 89.152 (2-65 let)
Vaccine protective efficacy has not been studied.
Učinkovitosti zaščite cepiva niso raziskovali.
What you need to know before you use Dukoral Do not use Dukoral
Kaj morate vedeti, preden boste uporabili zdravilo Dukoral Ne uporabljajte zdravila Dukoral:
Efficacy against cholera was assessed in three randomised double-blind placebo-controlled clinical trials conducted in Bangladesh (endemic region) and in Peru (non-endemic region).
Učinkovitost proti koleri so ocenili v treh naključnih, dvojno slepih kliničnih preskušanjih, nadzorovanih s placebom, ki so jih opravili v Bangladešu (endemsko področje) in Peruju (neendemsko področje).
• Sore throat, reduced sense of taste
• boleče grlo, zmanjšan čut okusa,
Doses are to be administered at intervals of at least one week.
Odmerke uporabite v presledkih od vsaj enega tedna.
The vaccine contains killed whole V. cholerae O1 bacteria and the recombinant non-toxic B-subunit of the cholera toxin (CTB).
Cepivo vsebuje mrtve cele bakterije V. cholerae O1 in rekombinantno netoksično podenoto B toksina kolere (CTB).
The vaccine protects adults and children from 2 years of age against cholera.
Cepivo ščiti odrasle in otroke, starejše od 2 let, proti koleri.
• if you are allergic to any ingredient of the vaccine or to formaldehyde.
• če ste alergični na katero koli sestavino tega cepiva (navedeno v poglavju 6) ali na formaldehid,
Dukoral confers protection specific to Vibrio cholerae serogroup O1.
Cepivo Dukoral ponuja zaščito, specifično za Vibrio cholerae serološke skupine O1.
The heat-labile toxin (LT) of enterotoxigenic E. coli (ETEC ) is structurally, functionally and immunologically similar to CTB.
Termolabilni toksin (LT) enterotoksigene E. coli (ETEC ) je po zgradbi, delovanju in imunoloških lastnostih podoben toksinu CTB.
The effervescent granules should be dissolved in approximately 150 ml of cool water to get the buffer solution.
Šumeča zrnca je treba raztopiti v približno 150 ml hladne vode, da bi dobili pufrsko raztopino.
Blood and lymphatic system disorders: Lymphadenitis Nervous system disorders: Paraesthesia
Bolezni krvi in limfatičnega sistema: limfadenitis Bolezni živčevja: parestezija
Over 94,000 doses of Dukoral were administered during the clinical trials.
V teh kliničnih preskušanjih so dali več kot 94.000 odmerkov cepiva Dukoral.
Loss of /or poor appetite Very rare Dehydration
Presnovne in prehranske motnje Redki izguba ali poslabšanje apetita Zelo redki dehidracija
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKIH UČINKOVIN IN IZDELOVALEC, ODGOVOREN ZA
The antibacterial intestinal antibodies prevent the bacteria from attaching to the intestinal wall thereby impeding colonisation of V. cholerae O1.
Protitelesa proti bakterijam v črevesu preprečujejo bakterijam, da bi se vezale na steno črevesa, in tako onemogočijo kolonizacijo bakterije V. cholerae O1.