natgillin/translations-raw huggingface dataset:
A decrease in the GMTs against all 4 serotypes was observed one year after the third injection.
Zmanjšanje GMT proti vsem 4 serotipom so opažali eno leto po tretji injekciji.
This increased risk may mainly begin during the third year following the first injection.
To povečano tveganje se večinoma lahko začne v tretjem letu po prvi injekciji.
• have a weak immune system (the body's natural defences).
• Imate šibek imunski sistem (naravno telesno obrambo).
After reconstitution, one dose (0.5 mL) contains:
Po rekonstituciji en odmerek (0,5 ml) vsebuje:
Then, GMTs stabilize over the next 2 to 4 years and remain superior to pre-vaccination GMTs.
GMT se stabilizirajo v naslednjih 2 do 4 letih in ostanejo višji od GMT pred cepljenjem.
• Individuals with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function.
• Osebe s simptomatsko okužbo s HIV ali z asimptomatsko okužbo s HIV, ki jo spremljajo dokazi prizadetega imunskega delovanja.
The adverse reactions were usually mild to moderate in severity and of short duration (0 to 3 days).
Neželeni učinki so bili ponavadi blagi do zmerni in kratkotrajni (od 0 do 3 dni).
Tell your doctor or pharmacist if you or your child are using, have recently used or might use any other vaccines or medicines.
Obvestite svojega zdravnika ali farmacevta, če vi ali vaš otrok uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo cepivo ali zdravilo.
Dengue is not transmitted directly from personto-person.
Denga se ne prenaša neposredno s človeka na človeka.
How the vaccine works
Kako cepivo deluje
Most of the subjects were 9 to 17 years of age (n= 2810).
Večina preiskovancev je bila starih od 9 do 17 let (n = 2.810).
Dengvaxia is available in packs of 1 or 10.
Cepivo Dengvaxia je na voljo v pakiranjih po 1 ali 10.
You can also have dengue but show no symptoms (called "asymptomatic").
Dengo lahko imate tudi, ne da bi se vam pojavili kakšni simptomi (temu pravimo "asimptomatska bolezen").
CYD15: Brazil, Colombia, Honduras, Mexico, Puerto Rico.
CYD15: Brazilija, Kolumbija, Honduras, Mehika, Portoriko.
• Pregnant women (see section 4.6).
• Nosečnice (glejte poglavje 4.6).
No specific studies have been performed on fertility.
Specifičnih študij o vplivu na plodnost niso izvedli.
• medicines called “immunoglobulins” or blood products containing immuno globulins, such as blood or plasma.
• zdravila, imenovana "imunoglobulini", ali krvni izdelki, ki vsebujejo imunoglobuline, npr. kri ali plazma.
†The efficacy against hospitalised and severe VCD was not a primary objective and cut-off thresholds to define statistical significance were not pre-specified.
†Učinkovitost proti hospitaliziranim in hudim primerom VPD ni bila primarni cilj in mejne vrednosti statistične značilnosti niso bile vnaprej določene.
Therefore, protection is expected in adults in endemics areas although the actual magnitude of efficacy relative to that observed in children and adolescents is unknown.
Zato se na endemičnih področjih pri odraslih pričakuje zaščitno delovanje, čeprav dejanski obseg učinkovitosti v primerjavi s tistim, ki so ga opazili na otrocih in mladostnikih, ni znan.
Vaccination should be preceded by a review of the individual's medical history (in particular, previous vaccinations and possible adverse reactions which occurred after vaccination).
Pred cepljenjem je treba preveriti posameznikovo zdravstveno anamnezo (še zlasti predhodna cepljenja in možne neželene reakcije po cepljenjih).
You should take precautions to prevent mosquito bites.
Upoštevati morate previdnostne ukrepe za preprečitev pikov komarjev.
Person-years: sum of time-at-risk (in years) for the subjects during the study period.
Oseba-leta: vsota časa izpostavljenosti tveganju (v letih) pri preiskovancih med obdobjem študije.
• Sterile dose withdrawal has not been fully observed.
• ni bil v celoti upoštevan sterilen odvzem odmerka.
There are no safety, immunogenicity or efficacy data to support vaccination of individuals living in non-endemic areas and travelling to endemic areas, therefore vaccination of these individuals is not recommended.
Podatkov o varnosti, imunogenosti ali učinkovitosti, ki bi podpirali cepljenje oseb z neendemičnih območij, ki potujejo na endemična območja, ni, zato cepljenje takšnih oseb ni priporočljivo.
In particular, tell your doctor or pharmacist if you are taking any of the following:
Še zlasti morate zdravnika ali farmacevta obvestiti, če jemljete katera od naslednjih zdravil:
The same information is also available on the following URL: http://qr.sanofi.com/dengvaxia
Iste informacije so na voljo tudi na naslednjem URL: http://qr.sanofi.com/dengvaxia
• ever fainted from an injection.
• ste kdaj omedleli zaradi injekcije.
o That healthcare professionals should be aware of dengue early warning signs.
o zdravstveni delavci morajo poznati zgodnje opozorilne znake denge.
3.3 Long-term persistence of antibodies
3.3 Dolgoročna persistenca protiteles
Occasionally dengue can be severe enough for you to have to go to hospital and in rare cases it can cause death.
Občasno je lahko denga tako huda, da je potrebno zdravljenje v bolnišnici, v redkih primerih lahko celo povzroči smrt.
These signs or symptoms (anaphylactic reactions) usually develop soon after the injection is given and while you or your child are still in the clinic or doctor's surgery.
Ti znaki in simptomi (anafilaktična reakcija) se po navadi pojavijo kmalu po injekciji in medtem, ko ste vi ali vaš otrok še v ambulanti.
• blueness of the tongue or lips
• pomodrelost jezika ali ustnic
Cases: number of subjects with at least one symptomatic virologically-confirmed dengue episode in the considered period.
Primeri: število preiskovancev z vsaj eno simptomatsko, virološko potrjeno epizodo denge v obravnavanem obdobju.
The efficacy was assessed during an Active Phase of 25 months, in which surveillance was designed to maximize the detection of all symptomatic virologically-confirmed dengue (VCD) cases regardless of the severity.
Učinkovitost so ocenili med aktivno 25-mesečno fazo, v kateri je bil nadzor načrtovan tako, da je zajel kar največje število vseh primerov simptomatske, virološko potrjene denge (VPD), ne glede na to, kako huda je bila.
Clinically severe VCD cases†
Klinično hudi primeri VPD†
The Control Group in dengue studies was defined as subjects who received at least one injection of placebo or comparator vaccine.
Kontrolna skupina v študijah denge so bili preiskovanci, ki so prejeli vsaj eno injekcijo placeba ali primerjalnega cepiva.
Available data are not sufficient to confirm the safety and efficacy in individuals previously infected by any dengue virus and younger than 9 years.
Podatki, ki so na voljo, ne zadoščajo za potrditev varnosti in učinkovitosti cepiva pri otrocih, predhodno okuženih s katerim koli virusom denge, ki so mlajši od 9 let.
CYD14: Indonesia, Malaysia, the Philippines, Thailand, Vietnam.
CYD14: Indonezija, Malezija, Filipini, Tajska, Vietnam.
• low blood pressure causing dizziness or fainting
• nizek krvni tlak, ki povzroči omotico ali omedlevico
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov proizvajalca , odgovornega za sprostitev zadevne serije.
Dengvaxia should not be used in children less than 9 years of age (see sections 4.8).
Cepiva Dengvaxia se ne sme uporabljati pri otrocih, mlajših od 9 let (glejte poglavje 4.8).
• sudden and serious feeling of illness or unease with drop in blood pressure causing dizziness and loss of consciousness, rapid heartbeat linked with breathing difficulty.
• nenaden in resen občutek bolezni ali nelagodje s padcem krvnega tlaka, ki povzroči vrtoglavico in izgubo zavesti, hitro bitje srca in težko dihanje.
These data are not sufficient to conclude on the absence of potential effects of Dengvaxia on pregnancy, embryo-foetal development, parturition and post-natal development.
Ti podatki ne zadoščajo za sklep, da cepivo Dengvaxia nima možnih učinkov na nosečnost, embrio-fetalni razvoj, porod in poporodni razvoj.
Before each injection, the reconstituted suspension should be gently swirled once again.
Pred vsakim injiciranjem je treba rekonstituirano suspenzijo znova zavrteti.
Vaccination is not recommended if you live in area where dengue infections do not regularly occur and if you plan to travel to an area where dengue infections regularly occur.
Cepljenje ni priporočljivo, če živite na območju, kjer se okužba z dengo ne pojavlja redno in nameravate potovati na območje, kjer se ta okužba pojavlja redno.
1541 avenue Marcel Mérieux 69280 Marcy l'Etoile France
1541 avenue Marcel Mérieux 69280 Marcy l'Etoile Francija
If you or your child miss an injection of Dengvaxia
Če vi ali vaš otrok izpustite injekcijo cepiva Dengvaxia
A neurovirulence study shows that CYD dengue vaccine is not neurotoxic.
Študija nevrovirulence kaže, da cepivo CYD proti dengi ni nevrotoksično.
Allergic including anaphylactic reactions*
Alergijske reakcije, vključno z anafilaktičnimi reakcijami*
Procedures should be in place to prevent injury from falling and to manage syncopal reactions.
Vpeljani morajo biti postopki za preprečitev poškodb zaradi padcev in za obvladovanje reakcij s sinkopo.
N: number of subjects per study
N: število preiskovancev na študijo
• If you or your child miss a scheduled injection, your doctor will decide when to give the missed injection.
• Če vi ali vaš otrok izpustite načrtovano injekcijo, bo zdravnik odločil, kdaj jo morate dobiti.
Serious allergic (anaphylactic) reactions
Resne alergijske (anafilaktične) reakcije
The active detection of symptomatic dengue cases started on the day of the first injection and lasted until each subject had been followed for at least 13 months after the third injection.
Aktivno odkrivanje simptomatskih primerov denge se je začelo na dan prve injekcije in je trajalo, dokler ni bil posameznik spremljan vsaj 13 mesecev po tretji injekciji.
Prior to launch of Dengvaxia in each Member State the Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Pred prihodom cepiva Dengvaxia na trg v posamezni državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi drugimi vidiki programa.
* Adverse reactions from spontaneous reporting.
* Neželeni učinki iz spontanih poročil.
This phase includes therefore the primary endpoint observation period from 28 days after the third injection up to the end of the Active Phase.
Ta faza torej obsega obdobje opazovanja primarnega opazovanega dogodka od 28. dni po tretji injekciji do konca aktivne faze.
Symptomatic VCD Any serotype
Simptomatska VPD Kateri koli serotip
Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you.
Preden vas ali vašega otroka cepijo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Higher titres post-injection 3 are associated with a lower risk of dengue disease and higher vaccine efficacy, although an immunological correlate of protection has not been established.
Višji titri po 3. injekciji so povezani z manjšim tveganjem za dengo in z večjo učinkovitostjo cepiva, čeprav niso ugotovili imunološkega korelata zaščite.
6.6 Special precautions for disposal and other handling Contact with disinfectants is to be avoided since they may inactivate the vaccine viruses.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Izogibati se je treba stiku z razkužili, ker lahko inaktivirajo viruse v cepivu.
• had an allergic reaction after using Dengvaxia before.
• Ste kdaj v preteklosti imeli alergijsko reakcijo po uporabi cepiva Dengvaxia.
During clinical development, immunogenicity data were collected in a total of approximately 5700 subjects 9 months to 60 years of age that received at least one injection of the vaccine.
Med programom kliničnega razvoja so podatke o imunogenosti zbrali pri skupaj približno 5.700 osebah v starosti od 9 mesecev do 60 let, ki so prejele vsaj eno injekcijo cepiva.
Read the package leaflet before use and for reconstitution instructions.
Pred uporabo in za navodila za rekonstitucijo preberite navodilo za uporabo.
Estimates from the long-term analysis suggest the onset of increased risk was mainly during the 3rd year following the first injection.
Ocene na podlagi dolgoročnih analiz kažejo, da se večje tveganje pojavi predvsem v 3. letu po prvi injekciji.
The estimations described above for a 6 year period are derived from data obtained in the pivotal clinical trials in countries with a particular dengue seroprevalence and epidemiological context.
Omenjene ocene za 6-letno obdobje temeljijo na podatkih ključnih kliničnih preskušanj v državah s specifično seroprevalenco denge in epidemiološkim okvirom.
Signs of an allergic reaction may include an itchy rash, shortness of breath and swelling of the face and tongue.
Med znaki alergijske reakcije so lahko srbeč izpuščaj, težko dihanje in otekanje obraza in jezika.
Dengvaxia contains live attenuated viruses.
Cepivo Dengvaxia vsebuje žive oslabljene viruse.
Very rare: (may affect up to 1 in 10 000 people) • allergic reactions.
Zelo redki: (pojavijo se lahko pri največ 1 od 10.000 oseb) • alergijske reakcije.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem cepivu se lahko obrnete na predstavništvo imetnika dovoljenja za promet:
The marketing authorisation holder (MAH) shall submit the first PSURs for this product within 6 months following authorisation.
Imetnik dovoljenja za promet z zdravilom mora prvo PSUR za to zdravilo predložiti v 6 mesecih po pridobitvi dovoljenja za promet.
Dengvaxia stimulates the body's natural defences (immune system), to produces antibodies that will help protect against the viruses that cause dengue disease if the body is exposed to them in the future.
Cepivo Dengvaxia spodbuja naravno telesno obrambo (imunski sistem) k tvorbi protiteles, ki pomagajo zaščititi pred virusi, ki povzročajo vročico denga, če jim bo morda telo izpostavljeno kdaj v prihodnosti.
No cases of overdose have been reported.
Poročil o primerih prevelikega odmerjanja ni.
CYD28: Low endemic country
CYD28: nizkoendemične države
Travellers
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4.7 Effects on ability to drive and use machines Dengvaxia has minor influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Cepivo Dengvaxia ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Among these 5700 subjects, a total of 3104 subjects 9 to 45 years of age from endemic areas received at least one injection of Dengvaxia.
Med temi 5.700 osebami so skupaj 3.104 osebe v starosti od 9 do 45 let z endemičnih območij prejele vsaj eno injekcijo cepiva Dengvaxia.
Administration of Dengvaxia must be postponed in individuals suffering from moderate to severe febrile or acute disease.
Uporabo cepiva Dengvaxia je treba odložiti pri osebah, ki imajo kakšno zmerno do hudo febrilno ali akutno bolezen.
The clinical efficacy of Dengvaxia was assessed in 3 studies: one supportive Phase IIb efficacy study (CYD23) in Thailand, and 2 pivotal large-scale Phase III efficacy studies, CYD14 in Asia (Indonesia, Malaysia, the Philippines, Thailand, Vietnam) and CYD15 in Latin America (Brazil, Colombia, Honduras, Mexico, Puerto Rico).
Klinično učinkovitost cepiva Dengvaxia so ocenili v 3 študijah: eni podporni študiji učinkovitosti faze IIb (CYD23) na Tajskem in 2 ključnih obsežnih študijah učinkovitosti III. faze CYD14 v Aziji (Indonezija, Malezija, Filipini, Tajska, Vietnam) in CYD15 v Latinski Ameriki (Brazilija, Kolumbija, Honduras, Mehika, Portoriko).
As there are no data on co-administration of Dengvaxia vaccine with other vaccines for the population from 9 years and above, the concomitant use of Dengvaxia with other vaccines is not recommended.
Ker za populacijo v starosti od 9 let naprej ni podatkov o sočasni uporabi cepiva Dengvaxia z drugimi cepivi, se sočasne uporabe cepiva Dengvaxia z drugimi cepivi ne priporoča.
4.8 Undesirable effects a.
4.8 Neželeni učinki a. Povzetek varnostnih značilnosti
The MAH shall ensure that in each Member State where Dengvaxia is marketed, all healthcare professionals who are expected to use Dengvaxia have access to/are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, kjer bo cepivo Dengvaxia na trgu, vsi zdravstveni delavci, za katere se pričakuje, da bodo uporabljali cepivo Dengvaxia, imeli dostop oziroma prejeli naslednji paket izobraževalnih gradiv:
• The second injection, 6 months after the first injection.
• Drugo injekcijo boste prejeli 6 mesecev po prvi injekciji.
They can also happen very rarely after receiving any vaccine (may affect up to 1 in 10 000 people).
Pojavijo se zelo redko po cepljenju s katerim koli cepivom (pojavijo se lahko pri največ 1 od 10.000 oseb).
Following administration, the viruses replicate locally and elicit neutralizing antibodies and cell-mediated immune responses against the four dengue virus serotypes (see detailed data below, subsection 3).
Po uporabi se virusi replicirajo lokalno in sprožijo nastanek nevtralizirajočih protiteles in celične imunske odzive proti štirim serotipom virusa denge (glejte podrobne podatke spodaj, podpoglavje 3).
• skin eruption over the whole body (rash generalized)
• kožni izbruh po celem telesu (generalizirani izpuščaj)
There was no shedding of Dengvaxia RNA in a distribution and shedding study, hence no risk of dissemination to the environment or transmission from vaccinees.
V študiji porazdelitve in izločanja niso ugotovili izločanja RNA iz cepiva Dengvaxia; to pomeni, da ni tveganja za širjenje v okolje ali za prenos s cepljenih oseb.
Hospitalised VCD†
V bolnišnico sprejeti z VPD†
A new sterile syringe and needle should be used for withdrawal of each of the 5 doses.
Za odvzem vsakega od 5 odmerkov je treba uporabiti novo sterilno brizgo in iglo.
Contact with disinfectants is to be avoided since they may inactivate the vaccine viruses.
Izogibati se je treba stiku z razkužili, ker lahko inaktivirajo viruse v cepivu.
• A new sterile syringe and needle were not used for reconstitution or withdrawal of each of the previous doses.
• za rekonstitucijo ali odvzem vsakega od prejšnjih odmerkov nista bili uporabljeni nova sterilna brizga in igla.
Allergic including anaphylactic reactions have been reported very rarely.
Zelo redko so poročali o alergijskih reakcijah, vključno z anafilaktičnimi reakcijami.
The virus from an infected person can spread to other people through mosquito bites for about 4 to 5 days (maximum 12 days) after the first symptoms appear.
Virus se lahko z okužene osebe prenaša na druge ljudi s piki komarjev, in sicer približno 4 do 5 dni (in največ 12 dni) potem, ko se pojavijo prvi simptomi.
Urticaria (uncommon) was only reported in subjects 9 to 17 years of age (none in adults).
O urtikariji (občasno) so poročali le pri preiskovancih v starosti od 9 do 17 let (nobenega primera pri odraslih).
• think you or your daughter may be pregnant or are planning to have a baby, ask your doctor,
• menite, da ste vi (ali vaša hči) noseči, ali načrtujete zanositev, se posvetujte z zdravnikom,
Most of the side effects occurred within 3 days of having the injection of Dengvaxia.
Večina neželenih učinkov se je pojavila v 3 dneh po injiciranju cepiva Dengvaxia.
• are pregnant or breast-feeding.
• Ste noseči ali dojite.
Efficacy in subjects 9 to 11 years of age was assessed in 1554 subjects (1032 in vaccine group and 522 in Control Group).
Učinkovitost v starostni skupini od 9 do 11 let so ocenili pri 1.554 osebah (1.032 v skupini s cepivom in 522 v kontrolni skupini).
The vaccination schedule consists of 3 injections of one reconstituted dose (0.5 mL) to be administered at 6-month intervals.
Shema cepljenja obsega 3 injekcije enega rekonstituiranega odmerka (0,5 ml), uporabljene v 6-mesečnih presledkih.
• Physician educational material
• Izobraževalno gradivo za zdravnike.
The clinical efficacy of the vaccine is based on bridging of immunogenicity data (see below section 3.2).
Podatki o klinični učinkovitosti cepiva temeljijo na premostitvi podatkov o imunogenosti (glejte spodaj, v tem poglavju 3.2).
• are of child-bearing age, you must use an effective method of contraception to avoid pregnancy for at least one month after each Dengvaxia dose.
• v rodni dobi, mora(te) uporabljati učinkovit način kontracepcije za preprečitev nosečnosti vsaj en mesec po vsakem odmerku cepiva Dengvaxia.
For severe VCD cases, two types of endpoints were considered: clinically severe VCD cases and VCD cases that met the 1997 WHO criteria for Dengue Haemorrhagic Fever (DHF).
Pri hudih primerih VPD sta bili upoštevani dve vrsti opazovanih dogodkov: klinično hudi primeri VPD in primeri VPD, ki so izpolnjevali merila SZO 1997 za hemoragično vročico denga (HMD).
• Individuals with congenital or acquired cell-mediated immune deficiency, including immunosuppressive therapies such as chemotherapy or high doses of systemic corticosteroids (e.g. 20mg or 2mg/kg of prednisone for 2 weeks or more) within 4 weeks prior to vaccination.
• Osebe s prirojeno ali pridobljeno celično imunsko pomanjkljivostjo, vključno z uporabo imunosupresivnih zdravil, npr. kemoterapije ali velikih odmerkov sistemskih kortikosteroidov (npr. 20 mg ali 2 mg/kg prednizona 2 tedna ali več) v 4 tednih pred cepljenjem.
The GMTs levels depend on age and dengue serostatus at baseline.
Ravni GMT so odvisni od starosti in izhodiščnega serološkega stanja glede denge.
• Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, or after prior administration of Dengvaxia or a vaccine containing the same components.
• Preobčutljivost na zdravilno učinkovino, katero koli pomožno snov, navedeno v poglavju 6.1, ali preobčutljivost po predhodni uporabi cepiva Dengvaxia ali kakšnega drugega cepiva z enakimi sestavinami.
It is used to help protect you or your child against "dengue disease" caused by dengue virus serotypes 1, 2, 3 and 4.
Dengvaxia je cepivo, ki se uporablja za zaščito vas ali vašega otroka pred boleznijo, imenovano vročica denga, ki jo povzroča virus denge serotipov 1, 2, 3 in 4.
• The third injection, 6 months after the second injection.
• Tretjo injekcijo boste prejeli 6 mesecev po drugi injekciji.
There is limited amount of data from the use of Dengvaxia in pregnant women.
Podatki o uporabi cepiva Dengvaxia pri nosečnicah so omejeni.
Any remaining vaccine doses should be discarded at the end of the immunization session or within 6 hours after reconstitution, whichever comes first.
Vse morebiti neuporabljene odmerke cepiva je treba zavreči po končanem cepljenju ali v 6 urah po rekonstituciji, kar nastopi prej.
The vaccine efficacy against symptomatic VCD is moderate for serotypes 1 and 2 and higher for serotypes 3 and 4 (see Table 4).
Učinkovitost cepiva proti simptomatski VPD je zmerna za serotipa 1 in 2 in večja za serotipa 3 in 4 (glejte preglednico 4).
Keep the vaccine in the outer carton in order to protect it from light.
Cepivo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
• ever had any health problems when given a vaccine.
• ste kdaj po kakšnem cepljenju imeli kakšne zdravstvene težave.
Systemic adverse reactions tended to be less frequent after the second and third injections of Dengvaxia as compared to the first injection.
Sistemski neželeni učinki so bili po drugi in tretji injekciji cepiva Dengvaxia praviloma manj pogosti kot po prvi injekciji.
The use of Dengvaxia should be in accordance with official recommendations.
Cepivo Dengvaxia je treba uporabljati v skladu z uradnimi priporočili.
After reconstitution, use within 6 hours if stored between 2°C and 8°C.
Po rekonstituciji uporabite v 6 urah, če je shranjeno na temperaturi od 2 do 8 °C.