natgillin/translations-raw huggingface dataset:
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega mora posodobljen načrt za obvladovanje tveganja predložiti: • kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki lahko vplivajo na trenutne specifikacije varnosti zdravila, načrt farmakovigilance ali na dejavnosti za zmanjšanje tveganja. • V obdobju 60 dni po pomembnem mejniku (farmakološkem ali povezanem z zmanjševanjem tveganja). • Na zahtevo EMEA.
Each vial contains doripenem monohydrate equivalent to 500 mg doripenem
Ena viala vsebuje doripenem monohidrat v količini, ki ustreza 500 mg doripenema
Read the package leaflet before use Intravenous use
Intravenska uporaba
Turnhoutseweg 30 B-2340 Beerse Belgium
Turnhoutseweg 30 B- 2340 Beerse Belgija
17 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
17 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Doribax 500 mg powder for infusion doripenem Intravenous use
Doribax 500 mg prašek za infundiranje doripenem Intravenska uporaba
What Doribax is and what it is used for 2.
Kaj je zdravilo Doribax in za kaj ga uporabljamo 2.
Before you use Doribax 3.
Kaj morate vedeti, preden boste uporabili zdravilo Doribax 3.
How to use Doribax 4.
Kako uporabljati zdravilo Doribax 4.
How to store Doribax 6.
Shranjevanje zdravila Doribax 6.
WHAT DORIBAX IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO DORIBAX IN ZA KAJ GA UPORABLJAMO
Doribax works by killing different types of bacteria (germs) that cause infections in various parts of the body.
Zdravilo Doribax deluje tako, da ubije različne vrste bakterij (mikrobov), ki povzročajo okužbe na različnih delih telesa.
Doribax is used for the following infections:
Zdravilo Doribax uporabljamo pri naslednjih okužbah:
- Pneumonia (a serious type of chest or lung infection) that you catch in a hospital or similar setting.
- pljučnica (huda okužba prsnega koša ali pljuč), ki jo bolnik lahko dobi v bolnišnici ali v podobnih
This includes pneumonia that you catch when on a machine that helps you breathe
okoljih; sem sodi tudi pljučnica, ki se pojavi med uporabo naprave za umetno dihanje,
- Complicated infections of the area around your stomach (abdominal infections)
- zapletene okužbe v predelu trebuha (abdominalne okužbe),
- Complicated urinary tract infections, including kidney infections and cases that have spread to the
- zapletene okužbe sečil, vključno z okužbami ledvic in primeri, ko se je okužba razširila v krvni
bloodstream.
obtok.
BEFORE YOU USE DORIBAX
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO DORIBAX
Do not use Doribax
Ne uporabljajte zdravila Doribax
- If you are allergic (hypersensitive) to doripenem
- če ste alergični na (preobčutljivi za) doripenem,
- If you are allergic to other antibiotics such as penicillins, cephalosporins or carbapenems (which
- če ste alergični na druge antibiotike, na primer na peniciline, cefalosporine ali karbapeneme (ki
are used to treat various infections) as you may also be allergic to Doribax.
se uporabljajo za zdravljenje različnih okužb), ker ste v tem primeru morda alergični tudi na zdravilo Doribax.
Do not use Doribax if any of the above applies to you.
Če se karkoli od zgoraj navedenega nanaša na vas, ne smete uporabljati zdravila Doribax.
If you are not sure, talk to your doctor or pharmacist before being given Doribax.
Če niste prepričani, se posvetujte s svojim zdravnikom ali farmacevtom, preden prejmete zdravilo Doribax.
Take special care with Doribax If you have:
Bodite posebno pozorni pri uporabi zdravila Doribax Če imate:
Your doctor may need to lower your dose of Doribax
- ledvične težave, vam bo zdravnik morda zmanjšal odmerek zdravila Doribax,
It is important that you tell your doctor if you have bloody diarrhoea before, during or
- drisko; pomembno je, da zdravniku poveste, če se vam pojavi krvava driska pred, med ali po
after your treatment with Doribax.
zdravljenju z zdravilom Doribax, ker bi lahko imeli kolitis (vnetje črevesja).
This is because you may have a condition known as colitis (an inflammation of the bowel).
Ne jemljite nobenega zdravila za zdravljenje driske, ne da bi se prej posvetovali s svojim zdravnikom.
Convulsions have infrequently been reported during treatment with closely related antibiotics.
Čeprav antibiotiki, vključno z zdravilom Doribax, ubijajo nekatere bakterije, pa se lahko druge bakterije in glivice še naprej razmnožujejo bolj kot je normalno - to imenujemo razrast
21 While antibiotics including Doribax kill certain bacteria, other bacteria and fungi may continue to grow more than normal.
21 mikroorganizmov.
Taking other medicines Always tell your doctor or pharmacist if you are taking or have recently taken any other medicines, This includes medicines you get without a prescription or herbal medicines.
Sem sodijo tudi zeliščni pripravki.
Tell your doctor if you are taking medicines called valproic acid (used to treat epilepsy, bipolar disorder, migraines or schizophrenia) or probenecid (used to treat gout or high levels of uric acid in the blood) as these medicines may affect Doribax.
Zdravniku morate tudi povedati, če jemljete valprojsko kislino (uporablja se za zdravljenje epilepsije, bipolarne motnje, migren ali shizofrenije) ali probenecid (uporablja se za zdravljenje putike ali visokih koncentracij sečne kisline v krvi), saj tudi ti dve zdravili lahko vplivata na zdravilo Doribax.
Pregnancy and breast -feeding Tell your doctor or pharmacist before using Doribax if:
Nosečnost in dojenje Posvetujte se z zdravnikom ali s farmacevtom, preden vzamete zdravilo Doribax:
Your doctor will decide whether you should use
- če ste noseči ali mislite, da bi lahko bili noseči; zdravnik bo presodil, ali smete jemati zdravilo
Doribax
Doribax,
Small amounts of this medicine may pass into
- če dojite ali nameravate dojiti svojega otroka, ker bi lahko majhne količine tega zdravila prehajale
Therefore, your doctor will decide whether you should use Doribax while breastfeeding.
v materino mleko in vplivale na dojenčka; zdravnik bo presodil, ali smete jemati zdravilo Doribax med dojenjem.
Driving and using machines Doribax is not likely to affect your ability to drive or operate machinery.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Doribax verjetno ne vpliva na sposobnost za vožnjo in upravljanje s stroji.
HOW TO USE DORIBAX
KAKO UPORABLJATI ZDRAVILO DORIBAX
- Doribax will be prepared and given to you by a doctor or nurse over one or four hours as an
- Zdravilo Doribax bosta pripravila in vam ga dala zdravnik ali medicinska sestra v eno od ven v
intravenous infusion into one of your veins (this is sometimes known as a “drip”)
obliki intravenske infuzije (poznane tudi kot » kapalna infuzija «), ki bo trajala eno ali štiri ure.
How much Doribax is given
Koliko zdravila Doribax uporabimo
- Your doctor will decide how much Doribax you need and for how long
- Vaš zdravnik bo presodil, koliko zdravila Doribax potrebujete in koliko časa bo trajalo zdravljenje.
- The usual dose is 500 mg every eight hours.
- Običajen odmerek zdravila je 500 mg na vsakih osem ur.
Each dose is given over a period of one or four hours
Dajanje vsakega odmerka traja eno ali
- The course usually lasts 5 to 14 days
- Zdravljenje običajno traja od 5 do 14 dni.
- If you have kidney problems, your doctor may lower your dose of Doribax to 250 mg given over
- Če imate ledvične težave, vam bo zdravnik odmerek zdravila Doribax lahko zmanjšal na 250 mg,
one or four hours every eight or 12 hours
dan v obdobju ene ali štirih ur, vsakih osem ali dvanajst ur.
If you use more Dorib ax than you should If you are concerned that you may have been given too much Doribax, talk to your doctor or pharmacist straight away.
Če ste uporabili večji odmerek zdravila Doribax, kot bi smeli Če vas skrbi, da ste morda prejeli preveč zdravila Doribax, se nemudoma posvetujte s svojim zdravnikom ali farmacevtom.
If a Doribax dose has been missed If you are concerned that you may have missed a dose of Doribax, talk to your doctor or pharmacist straight away.
Če ste izpustili odmerek zdravila Doribax Če vas skrbi, da ste morda izpustili odmerek zdravila Doribax, se nemudoma posvetujte s svojim zdravnikom ali farmacevtom.
If you have any further questions on the use of Doribax, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila Doribax, se posvetujte z zdravnikom ali s farmacevtom.
Like all medicines, Doribax can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Doribax neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Pogostnost pojava neželenih učinkov je določena z naslednjim dogovorom: zelo pogosti (pojavijo se pri več kot 1 na 10 bolnikov) pogosti (pojavijo se pri 1 do 10 na 100 bolnikov) občasni (pojavijo se pri 1 do 10 na 1. 000 bolnikov) redki (pojavijo se pri 1 do 10 na 10. 000 bolnikov) zelo redki (pojavijo se pri manj kot 1 na 10. 000 bolnikov) neznana (ni mogoče oceniti iz razpoložljivih podatkov).
- Rash, itching or hives
- izpuščaj, srbenje ali koprivnica,
Tell your doctor straight away if you get bloody diarrhoea before, during or after your
- driska; če dobite krvavo drisko pred, med ali po zdravljenju z zdravilom Doribax, morate to
treatment with Doribax
nemudoma povedati svojemu zdravniku,
- Feeling sick (nausea)
- občutek slabosti (navzea),
- Vein wall inflammation where the intravenous infusion (or “drip”) goes into your vein (phlebitis)
- vnetje stene vene na mestu infundiranja zdravila v vašo veno (flebitis),
- Fungal infections (thrush) in your mouth or vagina
- glivične okužbe (soor) v ustih ali v nožnici,
- Increase in the level of some liver enzymes in your blood
- povečanje vrednosti nekaterih jetrnih encimov v krvi.
- Inflammation of the bowel with diarrhoea (Clostridium difficile colitis)
- vnetje črevesa z drisko (kolitis zaradi razrasta Clostridium difficile),
- Sudden swelling of your lips, face, throat or tongue, a rash, swallowing or breathing problems.
- nenadno otekanje ustnic, obraza, žrela ali jezika, izpuščaj in težave s požiranjem ali dihanjem.
These
To so
may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening.
lahko znaki hude alergijske (anafilaktične) reakcije in so lahko smrtno nevarni.
Tell your doctor straight away if you get these as you may need urgent medical treatment.
Če se pri vas pojavi kateri od omenjenih neželenih učinkov, morate to nemudoma povedati svojemu zdravniku, ker boste lahko potrebovali nujno medicinsko zdravljenje.
The following side effect was also seen in a small number of patients:
Pri majhnem številu bolnikov so opazili tudi naslednje neželene učinke:
- Decrease of white blood cells which may increase your risk of infections.
- zmanjšanje števila belih krvničk, ki lahko poveča nagnjenost k okužbam.
HOW TO STORE DORIBAX
SHRANJEVANJE ZDRAVILA DORIBAX
Do not use this medicine after the expiry date stated on the container.
Zdravila Doribax ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali.
What Doribax contains
Kaj vsebuje zdravilo Doribax
- The active substance is doripenem.
- Zdravilna učinkovina je doripenem.
Each vial contains doripenem monohydrate equivalent to
Ena viala vsebuje doripenem monohidrat v količini, ki ustreza
500 mg doripenem
500 mg doripenema.
23 What Doribax looks like and contents of the pack Doribax is a white to slightly yellowish off-white crystalline powder in a glass vial.
Izgled zdravila Doribax in vsebina pakiranja Doribax je bel do rahlo rumenkast kristalni prašek v steklenih vialah.
Doribax is supplied in packs of 10 vials.
Doribax je na voljo v pakiranjih po 10 vial.
Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium
Imetnik dovoljenja za promet z zdravilom Janssen- Cilag International NV Turnhoutseweg 30 B- 2340 Beerse Belgija
Manufacturer Janssen Pharmaceutica Turnhoutseweg 30 B-2340 Beerse Belgium
Izdelovalec Janssen Pharmaceutica Turnhoutseweg 30 B- 2340 Beerse Belgija
This leaflet was last approved in MM/YYYY
Navodilo je bilo odobreno MM/ LLLL.
Detailed information on this medicine is available on the European Medicines Evaluation Agency (EMEA) website: http://www.emea.europa.eu/
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http: // www. emea. europa. eu /.
Preparation of 500 mg dose of solution for infusion
Priprava 500 mg odmerka raztopine za infundiranje
Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 100 ml of either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection and mix to complete dissolution.
Suspenzijo posesajte v brizgo z iglo in jo injicirajte v infuzijsko vrečko, ki vsebuje bodisi 100 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali 100 ml 50 mg/ ml (5%) raztopine dekstroze za injiciranje in zmešajte, da se zaključi proces raztapljanja.
Preparation of 250 mg dose of solution for infusion for patients with moderate or severe renal impairment
Priprava 250 mg odmerka raztopine za infundiranje za bolnike z zmerno do hudo ledvično okvaro
Withdraw the suspension using a syringe and needle and add it to an infusion bag containing 100 ml either sodium chloride 9 mg/ml (0.9%) solution for injection or dextrose 50 mg/ml (5%) solution for injection and mix to complete dissolution.
Suspenzijo potegnite v brizgo z iglo in jo injicirajte v infuzijsko vrečko, ki vsebuje bodisi 100 ml 9 mg/ ml (0, 9%) raztopine natrijevega klorida za injiciranje ali pa 100 ml 50 mg/ ml (5%) raztopine dekstroze za injiciranje in zmešajte, da se zaključi proces raztapljanja.
25 Doribax solutions for infusion range from clear, colourless solutions to solutions that are clear and slightly yellow.
Zdravilo Doribax raztopina za infundiranje je lahko bistra in brezbarvna do bistra in rahlo rumenkasta.
Time by which reconstitution, dilution and infusion must complete for Doribax infusions solutions
Čas, v katerem je treba končati rekonstitucijo, redčenje in infundiranje infuzijskih raztopin zdravila Doribax
24 hours*
24 ur *
*Once removed from the refrigerator, infusions should be completed within the room temperature stability time, provided the total refrigeration time, time to reach room temperature and infusion time does not exceed refrigeration stability time. + Dextrose 50 mg/ml (5%) solution for injection should not be used for infusion durations greater than 1 hour.
* Ko jih enkrat vzamete iz hladilnika, je treba infuzijske raztopine uporabiti v času stabilnosti pri sobni temperaturi, tako da seštevek časa shranjevanja v hladilniku, časa do doseganja sobne temperature in časa infundiranja zdravila ne bo presegel časa stabilnosti zdravila v hladilniku. + Če infundiranje traja dlje kot 1 uro se 50 mg/ ml (5%) raztopine dekstroze za injiciranje ne sme uporabljati.
Strength Pharmaceutical Form 1
Jakost 1
Package size
Velikost pakiranja:
Suspension of vaccine and effervescent granules for oral solution
Suspenzija cepiva in šumečih zrnc za peroralno raztopino
Vaccine: vial (glass); granules: sachet (PE/ alu)
Cepivo: viala (steklena) zrnca: blazinica (PE/ alu)
Vaccine:
Cepivo:
3 ml; Sachet:
3 ml; Blazinica:
2 x 1 dose
2 x 1 odmerek
Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 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) Recombinant cholera toxin B subunit (rCTB) 1 mg
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 25x109 bacteria
− Rekombinantna podenota toksina kolera B (rCTB)
Dukoral is a vaccine, which is available as a suspension in a vial.
Dukoral je cepivo, ki je na voljo v obliki suspenzije v viali.
It contains four different inactivated (killed) strains (types) of the bacterium Vibrio cholerae (V. cholerae) serotype O1, and part of a toxin from one of these strains as active substances.
Kot zdravilne učinkovine vsebuje štiri različne inaktivirane (uničene) seve (tipe) bakterije Vibrio cholerae (V. cholerae) serotipa O1 in del toksina iz enega od teh sevov.
Dukoral is supplied with granules in a sachet to help make it up into an oral suspension.
Zdravilo Dukoral se dobavlja v zrncih, ki so na voljo v blazinici in s pomočjo katerih se zdravilo zmeša v peroralno suspenzijo.
Dukoral is used to protect against cholera (a very serious disease caused by V. cholerae, which is caught from contaminated food or water and causes severe diarrhoea).
Zdravilo Dukoral se uporablja za zaščito proti koleri (zelo resni bolezni, ki jo povzroča bakterija V. cholerae, s katero se bolnik okuži z onesnaženo hrano ali vodo, posledica pa je huda driska).
Dukoral is used in adults, adolescents and children from two years of age who will be visiting high-risk areas.
Zdravilo Dukoral se uporablja pri odraslih, mladostnikih in otrocih, starih vsaj dve leti, ki nameravajo obiskali zelo tvegana področja.
Dukoral should be given according to official recommendations, taking into account where cholera is found and the risk of contracting the disease.
Uporabo zdravila Dukoral je treba določiti na osnovi uradnih priporočil in pri tem upoštevati področja pojavljanja kolere in stopnjo tveganja za okužbo z boleznijo.
Dukoral should not replace standard protective measures against cholera, including paying attention to advice on diet and hygiene.
Zdravilo Dukoral ne sme nadomestiti standardnih zaščitnih ukrepov proti koleri, ki vključujejo upoštevanje nasvetov glede prehrane in higiene.
Dukoral is taken by mouth.
Zdravilo Dukoral se zaužije peroralno.
In adults and children from six years of age, Dukoral is given as two doses, one to six weeks apart.
Pri odraslih in otrocih, starih nad šest let, se zdravilo Dukoral daje v dveh odmerkih, med katerima mora biti eno - do šesttedenski presledek.
Children aged between two and six years should receive three doses, with an interval of one to six weeks between each dose.
Otroci, stari od dve do šest let, morajo prejeti tri odmerke, med katerimi mora biti eno - do šesttedenski presledek.
For continuous protection against cholera, a single booster dose is recommended after two years for adults and children from six years of age, and after six months for children aged between two and six years.
Za dolgotrajno zaščito proti koleri je priporočen enojni poživitveni odmerek, ki se odraslim in otrokom, starejšim od šest let, da po dveh letih, otrokom, starim od dveh do šest let, pa po šestih mesecih.
The vaccine is made up by dissolving the granules in a glass of water to prepare an effervescent (sparkling) solution, and adding the contents of the vial.
Cepivo se pripravi z raztapljanjem zrnc v kozarcu vode, pri čemer nastane šumeča raztopina, ki ji dodamo vsebino viale.
Once prepared, the suspension should be drunk within two hours.
Ko je zdravilo pripravljeno, je treba raztopino popiti v dveh urah.
Food, drink and other medicines taken by mouth should be avoided for one hour before and one hour after each dose of Dukoral.
Eno uro pred zaužitjem odmerka zdravila Dukoral in eno uro po njem ni priporočljivo uživati hrane, pijače in drugih zdravil, ki se jemljejo peroralno.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to protect itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „ naučijo “, kako naj se brani pred boleznimi.
Dukoral contains small amounts of killed cholera bacteria and a part of the cholera toxin called the ‘ B subunit’.
Zdravilo Dukoral vsebuje majhne količine uničenih bakterij kolere in del toksina kolere, ki se imenuje podenota B.
This subunit is not toxic by itself.
Ko
Reproduction is authorised provided the source is acknowledged. it is exposed to cholera bacteria.
Reproduction is authorised provided the source is acknowledged. oseba prejme cepivo, njen imunski sistem prepozna bakterije in toksin ter začne proti njim tvoriti protitelesa.
These antibodies will help to protect against cholera by preventing the bacteria and the toxins from attaching to the walls of the gut and entering the body’ s cells.
Ta protitelesa bodo pomagala ščititi osebo pred kolero tako, da bodo preprečevala vezanje bakterij in toksinov na steno črevesja in njihov vstop v celice telesa.
In Dukoral, the cholera toxin is produced by a method known as ‘ recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce the toxin.
Toksin kolere v zdravilu Dukoral se proizvaja z metodo, znano kot „ tehnologija rekombinantne DNK “, pri kateri bakterija prejeme gen (DNK), s katerim lahko tvori toksin.
As Dukoral has been in use in Sweden since 1991, the company presented the results of three main studies that had already been carried out in order to support the use of Dukoral.
Ker je zdravilo Dukoral na Švedskem v uporabi že od leta 1991, je družba predstavila rezultate treh glavnih študij, ki so bile že izvedene v podporo uporabi zdravila Dukoral.
The three main studies involved a total of almost 113,000 people.
Tri glavne študije so vključevale skupaj skoraj 113 000 oseb.
In all three studies, the effectiveness of Dukoral, given as either two or three doses, was compared with that of placebo (a dummy vaccine).
V vseh treh študijah so učinkovitost zdravila Dukoral, ki so ga osebam dajali bodisi v dveh ali treh odmerkih, primerjali s placebom (cepivom brez zdravilne učinkovine).
The studies took place in areas where cholera is found.
Študije so izvajali na področjih, kjer se kolera pojavlja.
The first study involved over 89,000 people in Bangladesh and compared the effects of Dukoral with the effects of the vaccine without the toxin and with the effects of placebo.
Prva študija je vključevala več kot 89 000 oseb iz Bangladeša, pri katerih so učinke zdravila Dukoral primerjali z učinki cepiva brez toksina in z učinki placeba.
In this study, Dukoral was made using cholera toxin extracted from cholera bacteria in place of the newer recombinant toxin.
V tej študiji je bilo zdravilo Dukoral izdelano z uporabo toksina kolere, pridobljenega iz bakterije kolere, namesto novejšega rekombinantnega toksina.
The other two studies compared Dukoral (containing recombinant cholera toxin) with placebo in over 22,000 people in Peru.
V drugih dveh študijah so zdravilo Dukoral (ki je vsebovalo rekombinantni toksin kolere) primerjali s placebom pri več kot 22 000 osebah v Peruju.
The people in the final study also received a booster dose 10 to 12 months later.
Osebe iz zadnje študije so po 10 do 12 mesecih prejele tudi poživitveni odmerek.
In all three studies, the main measure of effectiveness was the ‘ protective effectiveness ’ of the vaccine, calculated by comparing the number of people in the studies who developed cholera after receiving Dukoral and after receiving placebo.
Glavno merilo učinkovitosti v vseh treh študijah je bila „ učinkovitost zaščite “, ki jo zagotavlja cepivo in je izračunana na podlagi primerjave števila oseb iz študij, ki so po cepljenju z zdravilom Dukoral obolele za kolero, s številom tistih, ki so oboleli za kolero po prejemanju placeba.