natgillin/translations-raw huggingface dataset:
A further study was carried out to show that Dukoral could produce antibodies in people who do not come from areas where cholera is found.
Izvedli so še eno študijo, s katero so želeli pokazati, da lahko zdravilo Dukoral izzove tvorjenje protiteles tudi pri ljudeh, ki ne izhajajo iz področij, kjer je kolera prisotna.
The company also presented information on the use of Dukoral for the prevention of a severe type of traveller’ s diarrhoea caused by a bacterium called ‘ enterotoxigenic Escherichia coli’.
Družba je prav tako predstavila podatke o uporabi zdravila Dukoral za preprečevanje hude popotniške driske, ki jo povzroča bakterija, imenovana „ enterotoksigena Escherichia coli “.
In the study in Bangladesh, the protective effectiveness of Dukoral was 85% over the first six months of follow-up.
V študiji, ki so jo izvedli v Bangladešu, je bila učinkovitost zaščite z zdravilom Dukoral v prvih šestih mesecih sledenja 85- odstotna.
The length of vaccine protection was different for adults and children, lasting for six months in children and for two years in adults.
Trajanje zaščite s cepivom je bilo različno pri odraslih in otrocih ter je trajalo šest mesecev pri otrocih in dve leti pri odraslih.
In adults, two vaccine doses were shown to be as effective as three.
Odkrili so, da sta pri odraslih dva odmerka tako učinkovita kot trije.
In the first of the two studies in Peru, the protective effectiveness of Dukoral was 85% for the first five months of follow-up.
V prvi od dveh študij, ki so ju izvedli v Peruju, je bila učinkovitost zaščite z zdravilom Dukoral 85- odstotna v prvih petih mesecih sledenja.
The other study in Peru showed that after a booster dose, the protective effectiveness of Dukoral during the second year of follow-up was 61%.
Druga študija, izvedena v Peruju, je pokazala, da je bila učinkovitost zaščite z zdravilom Dukoral med drugim letom sledenja 61- odstotna.
The information presented was not sufficient to support the use of Dukoral in traveller’ s diarrhoea.
Predstavljeni podatki niso bili zadostni, da bi bilo mogoče podpreti uporabo zdravila Dukoral za popotniško drisko.
However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, diarrhoea, and abdominal (tummy) pain, cramps, gurgling (gas) or discomfort.
Najpogostejši neželeni učinki zdravila Dukoral (opaženi pri 1 do 10 bolnikih izmed 1 000) so: glavobol, driska in bolečine v trebuhu, krči v trebuhu, klokotanje (vetrovi) v trebuhu ali splošen neprijeten občutek v trebuhu.
For the full list of side effects reported with Dukoral, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Dukoral, glejte navodilo za uporabo.
Dukoral should not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to formaldehyde.
Zdravila Dukoral ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) katero koli zdravilno učinkovino, katero koli drugo sestavino zdravila ali formaldehid.
Its use should be postponed in patients with a short-lived illness affecting the stomach or gut, or with a fever.
Uporabo zdravila je treba prestaviti pri bolnikih s kratkotrajnimi boleznimi, ki prizadenejo želodec ali črevo, ali pri bolnikih s povišano telesno temperaturo.
The Committee for Medicinal Products for Human Use (CHMP) noted that the risk of cholera for regular tourists is minor, but that Dukoral could be important for certain groups, such as healthcare workers in cholera epidemics.
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je tveganje okužbe s kolero za redne turiste zelo majhno, vendar bi lahko bilo zdravilo Dukoral zelo pomembno za nekatere skupine, kot so zdravstveni delavci na področjih z epidemijo kolere.
The Committee decided that Dukoral’ s benefits are greater than its risks for active immunisation against disease caused by V. cholerae serogroup O1.
Odbor je zaključil, da so koristi cepiva Dukoral pri aktivni imunizaciji proti V. cholerae serološke skupine O1, večje od z njim povezanih tveganj.
The Committee recommended that Dukoral be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Dukoral odobri dovoljenje za promet.
Other information about Dukoral:
2/ 3 Druge informacije o zdravilu Dukoral:
The European Commission granted a marketing authorisation valid throughout the European Union for Dukoral to SBL Vaccin AB on 28 April 2004.
Evropska komisija je dovoljenje za promet z zdravilom Dukoral, veljavno po vsej Evropski uniji, odobrila družbi SBL Vaccin AB dne 28. aprila 2004.
The marketing authorisation was renewed on 28 April 2009.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 28. aprila 2009.
The full EPAR for Dukoral can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Dukoral je na voljo tukaj.
DUKORAL suspension and effervescent granules for oral suspension Cholera vaccine (inactivated, oral)
DUKORAL suspenzija in šumeča zrnca za peroralno suspenzijo Cepivo proti koleri (inaktivirano, peroralno)
Each dose of vaccine suspension (3 ml) contains: − A total of 1x1011 bacteria of the following strains:
Vsak odmerek suspenzije za cepljenje (3 ml) vsebuje:
Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated)
skupaj 1x1011 bakterij naslednjih sevov: − 25x109 bakterij * Vibrio cholerae O1 Inaba, klasični biotip (inaktiviran s toploto) 25x109 bakterij * Vibrio cholerae O1 Inaba, biotip El Tor (inaktiviran s formalinom) 25x109 bakterij * Vibrio cholerae O1 Ogawa, klasični biotip (inaktiviran s toploto) 25x109 bakterij * Vibrio cholerae O1 Ogawa, klasični biotip (inaktiviran s formalinom) −
25x109 bacteria* 25x109 bacteria* 25x109 bacteria*
rekombinantno podenoto toksina kolera B (rCTB)
− Recombinant cholera toxin B subunit (rCTB) 1 mg (produced in V. cholerae O1 Inaba, classical biotype strain 213.)
(pridobljen s pomočjo bakterije V. cholerae O1 Inaba, klasičnem biotipu, sev 213)
Sodium dihydrogen phosphate monohydrate 1.7 mg, disodium 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 monohidrat 1, 7 mg, dinatrijev fosfat 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.
One dose contains approximately 1.1 g sodium.
En odmerek vsebuje približno 1, 1 g natrija.
Suspension and effervescent granules for oral suspension.
Suspenzija in šumeča zrnca za peroralno suspenzijo.
The suspension, supplied in a vial is whitish.
Suspenzija, ki je na voljo v vialah, je belkaste barve.
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.
DUKORAL je indiciran 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.
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 DUKORALA 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.
DUKORAL should not replace standard protective measures.
DUKORAL ne sme nadomestiti standardnih zaščitnih ukrepov.
Primary vaccination schedule
2 4. 2 Odmerjanje in način uporabe
2 The standard primary course of vaccination with DUKORAL against cholera consists of 2 doses for adults and children from 6 years of age.
Načrt primarnega cepljenja Standardno primarno cepljenje proti koleri s cepivom DUKORAL je za odrasle in otroke nad 6 let sestavljeno iz 2 odmerkov.
Children 2 to 6 years of age should receive 3 doses.
Otroci od 2 do 6 let naj prejmejo 3 odmerke.
Booster dose For continuous protection against cholera a single booster dose is recommended within 2 years for adults and children from 6 years of age, and after 6 months for children aged 2 to 6 years.
Poživitveni odmerek Za dolgotrajno zaščito proti koleri je priporočen enojni poživitveni odmerek v 2 letih za odrasle in otroke, starejše od 6 let, ter po 6 mesecih za otroke, stare od 2 do 6 let.
However, immunological data suggest that if up to 2 years have elapsed since the last vaccination a single booster dose should be given.
Vendar imunološki podatki kažejo, da je poživitveni odmerek treba dati po dveh letih od zadnjega cepljenja.
If more than 2 years have elapsed since the last vaccination the primary course should be repeated.
Če je od zadnjega cepljenja preteklo več kot 2 leti, je treba ponoviti primarno cepljenje.
Children less than 2 years 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 DUKORAL, vendar učinkovitosti zaščite v tej starostni skupini niso raziskovali.
Therefore, DUKORAL is not recommended to be used in children less than 2 years of age.
Zato uporaba DUKORALA ni priporočena pri otrocih, mlajših od 2 let.
Elderly There are only very limited data on protective efficacy of the vaccine in subjects aged 65 years and more.
Starejši bolniki Obstaja zelo malo podatkov o učinkovitosti zaščite tega cepiva pri bolnikih, starih 65 let ali več.
Method of administration The vaccine is intended for oral use.
Način uporabe Cepivo je namenjeno peroralni uporabi.
Before ingestion, the vaccine suspension should be mixed with a sodium hydrogen carbonate solution.
Suspenzijo za cepljenje morate pred zaužitjem zmešati z raztopino natrijevega hidrogenkarbonata.
150 ml).
Natrijev hidrogenkarbonat je na voljo v obliki šumečih zrnc, ki jih je treba raztopiti v kozarcu hladne vode (približno 150 ml).
The vaccine suspension should then be mixed with the sodium hydrogen carbonate solution and drunk within 2 hours.
Suspenzijo za cepljenje je treba premešati z raztopino natrijevega hidrogenkarbonata in spiti v najkasneje 2 urah.
Oral administration of other medicinal products should be avoided within 1 hour before and after administration of DUKORAL.
Uro pred jemanjem DUKORALA in po njem se je treba izogibati peroralnemu jemanju drugih zdravil.
75 ml) is mixed with the entire contents of the vaccine vial.
Otroci, stari od 2 do 6 let: polovico raztopine natrijevega hidrogenkarbonata zlijte stran in preostanek (približno 75 ml) premešajte s celotno vsebino viale s cepivom.
Hypersensitivity to the active substances, to any of the excipients or to formaldehyde.
Preobčutljivost za zdravilne učinkovine, katerokoli pomožno snov ali formaldehid.
Administration of DUKORAL should be postponed for subjects suffering from acute gastrointestinal illness or acute febrile illness.
Uporabo DUKORALA je treba prestaviti pri bolnikih z akutno boleznijo prebavnega trakta ali akutno povišano telesno temperaturo.
No clinical data on protective efficacy of DUKORAL against cholera after administration of booster doses are available.
DUKORAL Ni na voljo podatkov o učinkovitosti zaščite DUKORALA proti koleri po dajanju poživitvenega odmerka.
DUKORAL confers protection specific to Vibrio cholerae serogroup O1.
DUKORAL ponuja zaščito, specifično za Vibrio cholerae serološke skupine O1.
DUKORAL may not induce protective antibody levels in subjects with advanced HIV disease.
DUKORAL morda ne bo sprožil zaščitnih ravni protiteles pri bolnikih, pri katerih je bolezen HIV že napredovala.
However, an effectiveness study in a population with high HIV prevalence showed similar protection as in other populations.
Vendar je študija učinkovitosti v
3 Antibody response in vaccinees with endogenous or iatrogenic immunosuppression may be insufficient.
3 populaciji z veliko razširjenostjo okužbe z virusom HIV pokazala podobno stopnjo zaščite kot v drugih populacijah.
DUKORAL contains approximately 1.1 g sodium per dose, which should be taken into consideration by patients on a controlled sodium diet.
Zdravilo DUKORAL vsebuje približno 1, 1 g natrija na odmerek, kar morajo upoštevati bolniki, ki so na dieti z nadzorovanim vnosom natrija.
The vaccine does not provide complete protection and it is important to adhere to standard protective measures to avoid cholera.
Cepivo ne zagotavlja popolne zaščite in pomembno se je držati standardnih zaščitnih ukrepov proti koleri.
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.
Oral administration of other vaccines and medicinal products should be avoided 1 hour before and 1 hour after vaccination.
Uro pred cepljenjem in uro po njem se je treba izogibati tudi peroralnemu jemanju drugih cepiv in zdravil.
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 DUKORAL pri sočasni uporabi živega peroralnega cepiva (enterokapsul) proti tifusu in DUKORALA.
Similarly, a yellow fever vaccine was given concomitantly with DUKORAL, and there was no interaction observed with the immune response to the yellow fever vaccine.
V podobni raziskavi so sočasno dajali cepivo proti rumeni mrzlici in DUKORAL in niso opazili interakcij pri imunskem odzivu na cepivo proti rumeni mrzlici.
The immune responses to DUKORAL were not studied.
Imunskega odziva na DUKORAL niso raziskovali.
No other vaccines/ medicinal products, including oral polio vaccine and antimalarials, have been given simultaneously with DUKORAL in clinical studies.
V kliničnih študijah niso skupaj z DUKORALom dajali nobenega drugega cepiva ali zdravila, vključno s cepivom proti otroški paralizi in antimalariki.
No animal data on reproduction toxicity are available.
Na voljo ni podatkov o reproduktivni toksičnosti pri živalih.
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 safety of DUKORAL was assessed in clinical trials, including both adults and children from 2 years of age, conducted in endemic and non-endemic countries for cholera and enterotoxigenic Escherichia coli (ETEC) producing heat-labile enterotoxin (LT).
Varnost DUKORALA so ocenili v kliničnih preskušanjih, v katerih so sodelovali odrasli in otroci, starejši od 2 let, opravljenih v državah, endemičnih in neendemičnih za kolero in enterotoksigeno Escherichio coli (ETEC), ki proizvaja termolabilni enteroroksin (LT).
Over 94,000 doses of DUKORAL were administered during the clinical trials.
V teh kliničnih preskušanjih so dali več kot 94. 000 odmerkov DUKORALA.
Very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to ≤ 1/ 100); rare (≥ 1/ 10,000 to ≤ 1/ 1,000); very rare (≤ 1/ 10,000), not known (cannot be estimated form 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).
4 Metabolism and nutrition disorder Rare Loss of / or poor appetite Very rare Dehydration
4 V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Nervous system disorders Uncommon Headache Rare Dizziness Very rare Drowsiness, insomnia, fainting, reduced sense of taste
Zelo redki Omotica, nespečnost, omedlevanje, zmanjšan čut okusa
Respiratory, thoracic and mediastinal disorders Rare Respiratory symptoms (including rhinitis and cough)
Bolezni dihal, prsnega koša in mediastinalnega prostora Redki Dihalni simptomi (vključno z rinitisom in kašljem)
Gastrointestinal disorders Uncommon Diarrhoea, abdominal cramps, abdominal pain, stomach/ abdominal gurgling (gas), abdominal discomfort Rare Vomiting, nausea Very rare Sore throat, dyspepsia
Driska, krči v trebuhu, bolečine v trebuhu, klokotanje v trebuhu ali želodcu (vetrovi), neprijeten občutek v trebuhu
Skin and subcutaneous tissue disorders Very rare Sweating, rash
Zelo redki Bolečine v grlu, dispepsija
Musculoskeletal and connective tissue disorders Very rare Joint pain
Bolezni kože in podkožja Zelo redki Potenje, izpuščaji
General disorders and administration site conditions Rare Fever, malaise Very rare Fatigue, shivers
Splošne težave in spremembe na mestu aplikacije Redki Povišana telesna temperatura, občutek nelagodja Zelo redki Utrujenost, drhtenje
Adverse reactions from post-marketing surveillance Additional adverse reactions reported during post-marketing surveillance are listed below.
Neželeni učinki iz postmarketinškega nadzora Drugi neželeni učinki, o katerih so poročali med postmarketinškim nadzorom, so našteti spodaj:
Gastroenteritis Blood and lymphatic system disorders:
Gastroenteritis Bolezni krvi in limfatičnega sistema:
Lymphadenitis Nervous system disorders:
Limfadenitis Bolezni živčevja:
Paraesthesia Vascular disorders:
Parestezija Žilne bolezni:
Hypertension Respiratory, thoracic and mediastinal disorders:
Povišan krvni tlak Bolezni dihal, prsnega koša in mediastinalnega prostora:
Dyspnoea, increased sputum Gastrointestinal disorders:
Dispneja, povečano izločanje sluzi Bolezni prebavil:
Flatulence Skin and subcutaneous tissue disorders:
Vetrovi Bolezni kože in podkožja:
Urticaria, angioedema, pruritus General disorders and administration site conditions:
Urtikarija, angioedem, pruritus Splošne težave in spremembe na mestu aplikacije:
Pain, flu-syndrome, asthenia, chills
Bolečine, sindrom gripe, astenija, mrzlica
Data on overdose are extremely limited.
Podatki o prevelikem odmerjanju so zelo redki.
Bacterial vaccines, ATC-code:
Bakterijska cepiva, Oznaka ATC:
Bacterial strains of both Inaba and Ogawa serotypes and of El Tor and 5 Classical biotypes are included in the vaccine.
Cepivo vsebuje mrtve cele bakterije V. cholerae O1 in rekombinantno netoksično podenoto B toksina kolere (CTB).
DUKORAL is taken orally with bicarbonate buffer, which protects the antigens from the gastric acid.
Cepivo vsebuje bakterijske seve obeh serotipov, Inaba in Ogawa, ter biotipov El Tor in klasičnega biotipa.
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.
6 Efficacy against cholera 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 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).
Study
Kraj
location
raziskave
(Age groups)
Kolera
Cholera
(starostne skupine)
89,152 (2-65 years)
89. 152 (2- 65 let)
6 months-5 years
6 mesecev- 5 let
2 doses 7-11 days apart
2 odmerka 7- 11 dni narazen
1,563 (18-65 years)
1. 563
2 doses 2 weeks apart with a booster dose 1 year later
2 odmerka 2 tedna narazen s
21,924 (2-65 years)
21. 924
In the Bangladesh field trial, protective efficacy of DUKORAL in the overall population was 85% (95%CI:
V terenskem preskušanju v Bangladešu je bila v prvih 6 mesecih sledenja učinkovitost zaščite DUKORALA v celotni populaciji 85- odstotna (interval zaupanja 95%:
56, 95, per-protocol analysis) for the initial 6 months of follow-up.
56, 95, analiza po protokolih).
Protective efficacy against cholera in the Bangladesh study (per-protocol analysis) Protective efficacy,% (95% CI)
Učinkovitost zaščite proti koleri v raziskavi v Bangladešu (analiza po protokolih) Učinkovitost zaščite,% (interval zaupanja 95%)
Adults and children > 6 year
Odrasli in otroci > 6 let
6 months st
Otroci 2- 6 let
1 year 2nd year
6 mesecev 1. leto 2. leto
In the second trial, conducted in Peru and enrolling military recruits, the short-term protective efficacy against cholera after 2 vaccine doses was 85% (95%CI:
V drugem preskušanju, ki so ga opravili pri vojaških nabornikih v Peruju, je bila kratkoročna učinkovitost zaščite proti koleri po dveh odmerkih cepiva 85- odstotna (interval zaupanja 95%:
36, 97, per-protocol analysis).
36, 97, analiza po protokolih).
Following a booster dose 10-12 months after primary immunisation, the protective efficacy during the second year was 60.5% (95%CI:
Po poživitvenem odmerku, danem 10- 12 mesecev po primarni imunizaciji, je bila učinkovitost zaščite v drugem letu 60, 5- odstotna (interval zaupanja 95%:
Protective efficacy of DUKORAL against cholera has not been studied following repeated booster vaccination.
Učinkovitosti zaščite DUKORALA po večkratnih poživitvenih cepljenjih niso raziskovali.
Immunogenicity No established immunological correlates of protection against cholera after oral vaccination have been identified.
Imunogenost Imunološke korelacije zaščite proti koleri po peroralnem cepljenju niso opredelili.
The vaccine induced intestinal antitoxin IgA responses in 70-100% of vaccinated subjects.
6 Cepivo je pri 70- 100% cepljenih osebah sprožilo odziv črevesnih protitoksinskih protiteles IgA.
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.
The duration of the immunological memory was estimated to last for at least 2 years in adults.
5. 2 Farmakokinetične lastnosti
5.2 Pharmacokinetic properties
Navedba smiselno ni potrebna.
7 5.3 Preclinical safety data
5. 3 Predklinični podatki o varnosti
No preclinical safety testing with the vaccine has been conducted.
S tem cepivom niso opravili nikakršnih predkliničnih raziskav varnosti.
Sodium dihydrogen phosphate monohydrate Disodium phosphate dihydrate Sodium chloride Water for injections
Natrijev dihidrogenfosfat monohidrat Dinatrijev fosfat dihidrat Natrijev klorid Voda za injekcije
Effervescent granules:
Šumeča zrnca:
Sodium hydrogen carbonate Citric acid Sodium carbonate, anhydrous Saccharin sodium Sodium citrate Raspberry flavour
Natrijev hidrogenkarbonat Citronska kislina Brezvodni natrijev karbonat Saharin natrij Natrijev citrat Aroma maline
DUKORAL should only be mixed with the supplied effervescent granules dissolved in water.
DUKORAL se sme mešati le s priloženimi šumečimi zrnci, raztopljenimi v vodi.
The vaccine suspension is filled in a volume of 3 ml in vials (type I glass) with a rubber stopper (bromobutyl rubber) and a screw cap.
Suspenzija za cepljenje je polnjena v 3- mililitrskih steklenih vialah (tipa I) z gumijastim zamaškom (bromobutilna guma) in pokrovčkom na navoj.
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.
7 Šumeča zrnca so pakirana po 5, 6 g v blazinice z notranjo plastjo iz poliestra/ LD- polietilena in zunanjo plastjo iz aluminija/ LD- polietilena.
1x1 dose, 2x1 dose, 20x1 dose Not all pack sizes may be marketed.
1 x 1 odmerek, 2 x 1 odmerek, 20 x 1 odmerek Na trgu ni vseh navedenih pakiranj.