natgillin/translations-raw huggingface dataset:
Each dose of vaccine is supplied as one vial of suspension together with one sachet of effervescent granules.
Vsak odmerek cepiva je na voljo kot ena viala suspenzije z eno vrečico šumečih zrnc.
Duration of vaccine protection differed by age, lasting for 6 months in children and for 2 years in adults (see table below).
Trajanje zaščite cepiva se je razlikovalo med starostnimi skupinami in je bilo 6 mesecev pri otrocih ter 2 leti pri odraslih (glejte preglednico spodaj).
The effervescent granules should be dissolved in a glass of cool water, and the resulting buffer solution should be mixed with the suspension.
Šumeča zrnca je treba raztopiti v kozarcu hladne vode in dobljeno pufrsko raztopino zmešati s suspenzijo.
The vaccine induced intestinal antitoxin IgA responses in 70-100% of vaccinated subjects.
Cepivo je pri 70-100 % cepljenih osebah sprožilo odziv črevesnih protitoksinskih protiteles IgA.
The standard primary course of vaccination with Dukoral against cholera consists of 2 doses for adults and children from 6 years of age.
Standardno primarno cepljenje proti koleri s cepivom Dukoral je za odrasle in otroke nad 6 let sestavljeno iz 2 odmerkov.
For continuous protection against cholera a single booster dose is recommended within 2 years for adults and children from 6 years of age, and within 6 months for children aged 2 to below 6 years.
Za dolgotrajno zaščito proti koleri je priporočen enojni poživitveni odmerek v 2 letih za odrasle in otroke, starejše od 6 let, ter v 6 mesecih za otroke, stare od 2 do 6 let.
DUKORAL suspension Oral use.
DUKORAL suspenzija peroralna uporaba
The sodium hydrogen carbonate is supplied as effervescent granules, which should be dissolved in a glass of cool water (approx. 150 ml).
Natrijev hidrogenkarbonat je na voljo v obliki šumečih zrnc, ki jih je treba raztopiti v kozarcu hladne vode (približno 150 ml).
• The other ingredients in the vaccine suspension are sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and water for injections.
• Pomožne snovi v suspenziji za cepljenje so natrijev dihidrogenfosfat, dinatrijev hidrogenfosfat, natrijev klorid in voda za injekcije.
It is important to use the buffer solution, as it protects the vaccine from the gastric acid.
Uporaba pufrske raztopine je pomembna, ker ščiti cepivo pred želodčno kislino.
The suspension should then be mixed with the buffer solution and drunk within 2 hours.
Suspenzijo je treba nato premešati s pufrsko raztopino in spiti v najkasneje 2 urah.
The most frequently reported adverse reactions, such as gastrointestinal symptoms including abdominal pain, diarrhoea, loose stools, nausea and vomiting, occurred at similar frequencies in vaccine and placebo groups.
Najpogostejši neželeni učinki, kot so prebavne težave, vključno z bolečinami v trebuhu, drisko, redkim blatom, slabostjo in bruhanjem, so bili podobno pogosti v skupini, ki je prejemala cepivo, in v skupini, ki je prejemala placebo.
Dukoral may not induce protective antibody levels in subjects with advanced HIV disease.
Cepivo Dukoral morda ne bo sprožilo zaščitnih ravni protiteles pri bolnikih, pri katerih je bolezen HIV že napredovala.
It takes about 1 week after the last dose for protection to begin.
Zaščita začne delovati približno 1 teden po zadnjem odmerku.
Bacterial strains of both Inaba and Ogawa serotypes and of El Tor and Classical biotypes are included in the vaccine.
Cepivo vsebuje bakterijske seve obeh serotipov, Inaba in Ogawa, ter biotipov El Tor in klasičnega biotipa.
Pack sizes: 1x1 dose, 2x1 dose, 20x1 dose Not all pack sizes may be marketed.
Velikosti pakiranj: 1 x 1 odmerek, 2 x 1 odmerek, 20 x 1 odmerek Na trgu morda ni vseh navedenih pakiranj.
Suspension and effervescent granules for oral suspension: - Suspension for oral suspension
suspenzija in šumeča zrnca za peroralno suspenzijo: - suspenzija za peroralno suspenzijo
Dukoral is taken orally with bicarbonate buffer, which protects the antigens from the gastric acid.
Dukoral se uporablja peroralno, z bikarbonatnim pufrom, ki ščiti antigene pred želodčno kislino.
Adults and children from 6 years of age: The primary vaccination is 2 doses taken orally (by mouth) at least 1 week (up to 6 weeks) apart.
Odrasli in otroci, starejši od 6 let: Primarno cepljenje obsega 2 odmerka, ki se vzameta peroralno (skozi usta) s presledkom najmanj 1 tedna (do 6 tednov).
If more than 2 years have elapsed since the last vaccination (more than 6 months for children aged 2 to below 6 years) the primary course should be repeated.
Če sta od zadnjega cepljenja pretekli več kot 2 leti (oz. več kot 6 mesecev pri otrocih, starih od 2 do 6 let), je treba ponoviti primarno cepljenje.
See the package leaflet for further information.
Za dodatne informacije glejte navodila za uporabo.
If more than 6 weeks have elapsed between doses, the primary immunisation course should be re-started.
Če je med odmerkoma preteklo več kot 6 tednov, morate ponovno začeti primarno imunizacijo.
Sodium dihydrogen phosphate dihydrate Disodium hydrogen phosphate dihydrate Sodium chloride
natrijev dihidrogenfosfat dihidrat dinatrijev hidrogenfosfat dihidrat natrijev klorid voda za injekcije
Only half of the amount of the buffer solution should be mixed with the vaccine.
S cepivom je treba zmešati samo pol pufrske raztopine.
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 cepivo Dukoral ter niso opazili interakcij pri imunskem odzivu na cepivo proti rumeni mrzlici.
5 How to store Dukoral Contents of the pack and other information
Shranjevanje zdravila Dukoral Vsebina pakiranja in dodatne informacije
Dukoral is an oral vaccine against cholera that stimulates the immunological defence in the gut.
Dukoral je peroralno cepivo proti koleri, ki spodbuja imunski odziv v črevesu.
You can take the 2nd dose of Dukoral up to 6 weeks after the 1st dose (children of 2 to below 6 years have to take 3 doses).
Drugi odmerek zdravila Dukoral lahko vzamete do 6 tednov po prvem odmerku (otroci, stari od 2 do
Following a booster dose 10-12 months after primary immunisation, the protective efficacy during the second year was 60.5% (95%CI: 28,79).
Po poživitvenem odmerku, danem 10-12 mesecev po primarni imunizaciji, je bila učinkovitost zaščite v drugem letu 60,5-odstotna (interval zaupanja 95 %:
How to use Dukoral
Kako uporabljati zdravilo Dukoral
After the effervescent granules have been dissolved in water and the vaccine suspension has been added, the mixture should be drunk within 2 hours.
Po raztapljanju šumečih zrnc in dodajanju suspenzije za cepljenje morate mešanico spiti najkasneje v 2 urah.
Dukoral contains approximately 1.1 g sodium per dose.
Zdravilo Dukoral vsebuje približno 1,1 g natrija na odmerek.
Administration of Dukoral should be postponed for subjects suffering from acute gastrointestinal illness or acute febrile illness.
Uporabo cepiva Dukoral je treba prestaviti pri bolnikih z akutno boleznijo prebavnega trakta ali akutno povišano telesno temperaturo.
The suspension is a whitish suspension supplied in a vial.
Suspenzija je belkasta suspenzija, ki je na voljo v viali.
Children of 2 to below 6 years of age: The primary vaccination is 3 doses taken orally (by mouth) at least 1 week (up to 6 weeks) apart.
Otroci, stari od 2 do 6 let: Primarno cepljenje obsega 3 odmerke, ki se vzamejo peroralno (skozi usta) s presledkom najmanj 1 tedna (do 6 tednov).
In the longitudinal cohort-analysis conducted during the mass-vaccination campaign in Zanzibar, protective effectiveness after 2 doses of Dukoral was 79% (95% CI, 47, 92) for a follow-up period of 15 months.
V vzdolžni kohortni analizi, opravljeni med kampanjo množičnega cepljenja v Zanzibarju, je bila učinkovitost zaščite po 2 odmerkih cepiva Dukoral 79 % (95 % interval zaupanja, 47, 92) v 15 mesecih spremljanja.
Study location
Kraj raziskave
Children 2 to below 6 years of age: half of the buffer solution is poured away and the remaining part (approx. 75 ml) is mixed with the entire contents of the vaccine vial.
Otroci, stari od 2 do 6 let: polovico pufrske raztopine zlijte stran in preostanek (približno 75 ml) premešajte s celotno vsebino viale s cepivom.
Children 2 to below 6 years of age: half of the buffer solution is poured away and the remaining part (approx. 75 ml) is mixed with the entire contents of the vial.
Otroci, stari od 2 do 6 let: polovico pufrske raztopine zlijte stran in preostanek (približno 75 ml) premešajte s celotno vsebino viale.
Skin and subcutaneous tissue disorders: Urticaria, angioedema, pruritus General disorders and administration site conditions: Pain, flu-like syndrome, asthenia, chills
Bolezni kože in podkožja: urtikarija, angioedem, pruritus Splošne težave in spremembe na mestu aplikacije: bolečine, gripi podoben sindrom, astenija, mrzlica
Follow up
Sledenje
Shake the Dukoral® suspension vial (1 vial = 1 dose).
Pretresite vialo z zdravilom Dukoral® suspenzija (1 viala = 1 odmerek).
The effervescent granules are white with a raspberry flavour and are supplied in a sachet.
Šumeča zrnca so bela, z okusom po malinah in pakirana v vrečici.
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 cepiva Dukoral 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
No established immunological correlates of protection against cholera after oral vaccination have been identified.
Imunološke korelacije zaščite proti koleri po peroralnem cepljenju niso opredelili.
If more than 6 months have passed since the last vaccination, the primary vaccination (3 doses) should be repeated.
Če je od zadnjega cepljenja preteklo več kot 6 mesecev, je treba ponoviti primarno cepljenje (3 odmerki).
What Dukoral looks like and contents of the pack
Izgled zdravila Dukoral in vsebina pakiranja
If less than 6 months have passed since the last vaccination a single dose will renew the protection.
Če je od zadnjega cepljenja preteklo manj kot 6 mesecev, bo en odmerek zadostoval za obnovo zaščite.
• The effervescent granules contain sodium hydrogen carbonate, citric acid, sodium carbonate, saccharin sodium, sodium citrate and raspberry flavour.
• Šumeča zrnca vsebujejo natrijev hidrogenkarbonat, citronsko kislino, natrijev karbonat, natrij saharinat, natrijev citrat in aromo maline.
If you had your last dose of vaccine less than 2 years ago a single dose will renew your protection.
Če je od zadnjega odmerka cepiva preteklo manj kot 2 leti, vam bo en odmerek zadostoval za obnovo zaščite.
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 vialah (steklo tipa I) z gumijastim zamaškom
However, immunological and duration of protection data suggest that if up to 2 years have elapsed since the last vaccination for adults and up to 6 months for children aged 2 to below 6 years a single booster dose should be given.
Vendar imunološki podatki in podatki o trajanju zaščite kažejo, da je treba odraslim, če sta od zadnjega cepljenja pretekli do 2 leti, in otrokom, starim od 2 do
Very rare side effects (may affect up to 1 in a 10,000 people)
Zelo redki neželeni učinki (ki se lahko pojavijo pri največ 1 osebi od 10.000):
Dukoral is presented as a suspension and effervescent granules for oral suspension.
Zdravilo Dukoral je na voljo kot suspenzija in šumeča zrnca za peroralno suspenzijo.
For children of 2 to below6 years: pour away half of the buffer solution.
Za otroke od 2 do 6 let: odlijte stran pol pufrske raztopine 2.
The anti-toxin intestinal antibodies prevent the cholera toxin from binding to the intestinal mucosal surface thereby preventing the toxin-mediated diarrhoeal symptoms.
Protitelesa proti toksinu preprečujejo toksinu kolere, da bi se vezal na sluznico črevesa, in tako preprečijo simptome driske, ki jih ta toksin povzroča.
• Flu -like symptoms, chestiness, chills, general pain, weakness
• gripi podobni simptomi, respiratorni simptomi, mrazenje, splošne bolečine, oslabelost,
• Diarrhoea, stomach pain, stomach cramps, gurgling stomach, bloated stomach, stomach gas and general stomach discomfort
• driska, bolečine v trebuhu, krči v trebuhu, klokotanje v trebuhu, napenjanje v trebuhu, vetrovi in splošen neprijeten občutek v trebuhu,
No animal data on reproduction toxicity are available.
Na voljo ni podatkov o vplivu zdravila na sposobnost razmoževanja pri živalih.
• Give the 2nd dose to the child at least 1 week after the 1st dose.
• Otroku dajte drugi odmerek najmanj 1 teden po prvem odmerku.
In the case-control study conducted during the mass vaccination campaign in Mozambique, protective effectiveness of 2 doses of Dukoral was 84% (95% CI: 43, 95, per-protocol analysis; p=0.005) for the initial 5 months of follow-up.
V študiji primerov, opravljeni med kampanjo množičnega cepljenja v Mozambiku, je bila učinkovitost zaščite 2 odmerkov cepiva Dukoral v prvih 5 mesecih spremljanja 84 % (95 % interval zaupanja: 43, 95, analiza po protokolih, p = 0,005).
To be used with DUKORAL.
Za uporabo s cepivom DUKORAL.
− Recombinant cholera toxin B subunit (rCTB) 1 mg
− rekombinantno podenoto toksina kolera B (rCTB) 1 mg
Protective efficacy of Dukoral against cholera has not been studied following repeated booster vaccination.
Učinkovitosti zaščite cepiva Dukoral po večkratnih poživitvenih cepljenjih niso raziskovali.
- granules for oral suspension in a sachet ::
- zrnca za peroralno suspenzijo v vrečici:
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: 36, 97, per-protocol analysis).
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,
In subjects infected with HIV, limited data are available on immunogenicity and safety of the vaccine.
Na voljo je le malo podatkov o imunogenosti in varnosti cepiva pri bolnikih, okuženih z virusom HIV.
• Give the 1st dose to the child no later than 3 weeks before you leave for your trip.
• Otroku dajte prvi odmerek najpozneje 3 tedne pred odhodom na potovanje.
The vaccine acts by inducing antibodies against both the bacterial components and CTB.
Cepivo deluje tako, da sproži nastanek protiteles proti bakterijski komponenti in podenoti B toksina kolere (CTB).
Additional adverse reactions reported during post-marketing surveillance are listed below.
Neželeni učinki iz nadzora po prihodu cepiva na trg Drugi neželeni učinki, o katerih so poročali med nadzorom po prihodu cepiva na trg, so našteti spodaj:
The vaccine is acid labile.
Cepivo je nestabilno v kislinah.
Active substances: 1 dose contains
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Učinkovine: 1 odmerek vsebuje
Dukoral contains sodium
Zdravilo Dukoral vsebuje natrij
(produced in V. cholerae O1 Inaba, classical biotype strain 213.)
(pridobljen s pomočjo bakterije V. cholerae O1 Inaba, klasičnem biotipu, sev 213)
• Take the 2nd dose at least 1 week after the 1st dose and at least 1 week before your trip.
• Vzemite drugi odmerek najmanj 1 teden po prvem in najmanj 1 teden pred potovanjem.
2x1 dose
2 x 1 odmerek
Vibrio cholerae O1 Inaba, classical biotype (heat inactivated)
Vibrio cholerae O1 Inaba, klasični biotip (inaktiviran s toploto)
Do not use Dukoral after the expiry date which is stated on the carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
No clinical data on protective efficacy of Dukoral against cholera after administration of booster doses are available.
Na voljo ni nobenih kliničnih podatkov o učinkovitosti zaščite cepiva Dukoral proti koleri po dajanju poživitvenega odmerka.
20x1 dose
20 x 1 odmerek
• Take the 1st dose no later than 2 weeks before you leave for your trip.
• Vzemite prvi odmerek najpozneje 2 tedna pred odhodom na potovanje.
If more than 2 years have passed since you had the last vaccine dose, the primary vaccination (2 doses) should be repeated.
Če je od zadnjega odmerka cepiva preteklo več kot 2 leti, morate ponoviti primarno cepljenje (2 odmerka).
Valneva Sweden AB, 105 21 Stockholm, Sweden.
Valneva Sweden AB, 105 21 Stockholm, Švedska.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING DUKORAL - 1 dose package, 2x1 dose package, 20x1 dose package (outer sleeve)
DUKORAL - pakiranje po 1 odmerek, pakiranje 2 x 1 odmerek, pakiranje 20 x 1 odmerek (zunanji ovoj)
Do not take other medicine starting 1 hour before until 1 hour after taking the vaccine.
Eno uro pred jemanjem cepiva in eno uro po tem ne jemljite drugih zdravil.
Vomiting, nausea Very rare Sore throat, dyspepsia
Zelo redki bolečine v grlu, dispepsija
Other side effects: Uncommon side effects (may affect up to 1 in a 100 people)
Občasni neželeni učinki (ki se lahko pojavijo pri največ 1 osebi od 100):
An exploratory analysis suggested that 2 vaccine doses seemed as effective as 3 doses in adults.
odmerka cepiva enako učinkovita kot 3 odmerki.
Nervous system disorders Uncommon Headache Rare
Bolezni živčevja Občasni glavobol
Mix suspension with buffer solution before drinking.
Pred pitjem suspenzijo zmešajte s pufrsko raztopino.
- Granules for oral suspension in a sachet.
- zrnca za peroralno suspenzijo v vrečici
In the Bangladesh field trial, protective efficacy of Dukoral in the overall population was 85% (95%CI: 56, 95, per-protocol analysis) for the initial 6 months of follow-up.
Dukoral v celotni populaciji 85-odstotna (interval zaupanja 95 %: 56, 95, analiza po protokolih).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING DUKORAL - 20x1 dose package (inner carton for 20 sodium hydrogen carbonate sachets)
DUKORAL - pakiranje 20 x 1 odmerek (stična ovojnina za 20 vrečic z natrijevim hidrogenkarbonatom)
If you have taken more than one dose at one time, please contact your doctor, pharmacist or nurse.
Če ste vzeli več kot en odmerek naenkrat, se obrnite na svojega zdravnika, farmacevta ali medicinsko sestro.
Pour the content of the Dukoral® suspension vial into the glass of buffer solution (see 1).
Prelijte vsebino viale z zdravilom Dukoral® suspenzija v kozarec pufrske raztopine (glejte
If you take the doses less than one week apart, contact your doctor, pharmacist or nurse.
Če ste vzeli odmerke z manj kot enim tednom presledka, se obrnite na svojega zdravnika, farmacevta ali medicinsko sestro.
The suspensionsupplied in a single-dose glass vial is a whitish suspension.. Each vial comes with one sachet package that contains white effervescent granules of sodium hydrogen carbonate.
Vsaki viali je priložena ena vrečica z belimi šumečimi zrnci natrijevega hidrogenkarbonata.
The immune responses to Dukoral were not studied.
Imunskega odziva na cepivo 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 s cepivom Dukoral dajali nobenega drugega cepiva ali zdravila, vključno s cepivom proti otroški paralizi in z antimalariki.
Sodium hydrogen carbonate
Natrijev hidrogenkarbonat šumeča zrnca
Consequently, food and drink should be avoided 1 hour before and 1 hour after vaccination.
Zato se je uro pred cepljenjem in uro po njem treba izogibati hrani in pijači.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING DUKORAL - 20x1 dose package (inner carton for 20 vaccine vials)
PODATKI NA PRIMARNI OVOJNINI DUKORAL - pakiranje 20 x 1 odmerek (stična ovojnina za 20 vial s cepivom)
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)
• Generally feeling unwell, feeling dizzy
• splošno slabo počutje, omotica,
• Nausea (feeling sick), vomiting, loss of /or poor appetite
• navzea (siljenje na bruhanje), bruhanje, izguba ali poslabšanje apetita, • otekla in razdražena notranjost nosu, kašelj.
• Numbness or pins and needles
• otrplost ali mravljinčenje,
Adverse reactions reported are consistent with those seen after the recommended dosing.
Neželeni učinki, o katerih so poročali, so skladni s tistimi,
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Sodium hydrogen carbonate 5.6 g, sachet
OVOJNINAH natrijev hidrogenkarbonat 5,6 g, vrečica
Sodium carbonate, anhydrous Saccharin sodium Sodium citrate
natrijev hidrogenkarbonat citronska kislina brezvodni natrijev karbonat natrijev saharinat natrijev citrat aroma maline
Oral administration of other vaccines and medicinal products should be avoided 1 hour before and 1 hour after administration of Dukoral.
Uro pred uporabo cepiva Dukoral in uro po njej se je treba izogibati tudi peroralnemu jemanju drugih cepiv in zdravil.
Locally produced secretory IgA antibodies in the intestine probably mediate protective immunity.
Zaščitno imunost verjetno povzročajo lokalno nastala sekretorna protitelesa IgA v črevesu.
Fever, malaise Very rare Fatigue, shivers
Zelo redki utrujenost, drhtenje
Respiratory, thoracic and mediastinal disorders: Dyspnoea, increased sputum Gastrointestinal disorders: Flatulence
Bolezni dihal, prsnega koša in mediastinalnega prostora: dispneja, povečano izločanje sluzi Bolezni prebavil: vetrovi
• Give the 3rd dose at least one week after the 2nd dose and at least one week before your trip.
• Dajte otroku tretji odmerek najmanj 1 teden po drugem in najmanj 1 teden pred potovanjem.
Food and drink should be avoided 1 hour before and 1 hour after vaccination.
Uro pred cepljenjem in uro po njem se je treba izogibati hrani in pijači.
How to store Dukoral
Shranjevanje zdravila Dukoral
DUKORAL suspension Cholera vaccine (inactivated, oral)
DUKORAL supenzija cepivo proti koleri (inaktivirano, peroralno)
− A total of 1.25x1011 bacteria of the following strains:
Vsak odmerek suspenzije za cepljenje (3 ml) vsebuje: − skupaj 1,25 x 1011 bakterij naslednjih sevov:
Oral administration of other medicinal products should be avoided within 1 hour before and 1 hour after administration of Dukoral.
Uro pred jemanjem Dukorala in uro po njem se je treba izogibati peroralnemu jemanju drugih zdravil.
Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x109 bacteria*
31,25 x 109 bakterij* Vibrio cholerae O1 Inaba, biotip El Tor (inaktiviran s formalinom) 31,25 x 109 bakterij*
To prepare the buffer solution,dissolve the effervescent granules in a glass of cool water (approx. 150 ml) by gently stirring.
Pripravite pufrsko raztopino tako, da raztopite šumeča zrnca v kozarcu hladne vode (približno
Talk to your doctor before taking Dukoral
Pred začetkom uporabe zdravila Dukoral se posvetujte z zdravnikom:
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalcev bioloških zdravilnih učinkovin Valneva Sweden AB
Booster dose
Poživitveni odmerek
Sodium hydrogen carbonate effervescent granules Oral use.
Šumeča zrnca natrijevega hidrogenkarbonata peroralna uporaba
No preclinical safety testing with the vaccine has been conducted.
5.3 Predklinični podatki o varnosti S tem cepivom niso opravili nikakršnih predkliničnih študij varnosti.
Vascular disorders: Hypertension
Žilne bolezni: povišan krvni tlak
Musculoskeletal and connective tissue disorders Very rare Joint pain
Bolezni mišično-skeletnega sistema in vezivnega tkiva
If more than 6 weeks have passed, contact your doctor, pharmacist or nurse.
Če je preteklo več kot 6 tednov, se obrnite na svojega zdravnika,
Rare side effects (may affect up to 1 in a 1,000 people)
Redki neželeni učinki (ki se lahko pojavijo pri največ 1 osebi od 1.000): • povišana telesna temperatura,
• Sweating, shivering
• koprivnica, srbenje,
No clinical efficacy data has been generated on repeat booster dosing.
O učinkovitosti večkratnih poživitvenih odmerkov ni kliničnih podatkov.