natgillin/translations-raw huggingface dataset:
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial, 1 vial with solvent (5 mL), 1 Mix2Vial device
FARMACEVTSKA OBLIKA IN VSEBINA prašek in vehikel za raztopino za injiciranje Vsebina: 1 viala s praškom, 1 viala z vehiklom (5 ml), 1 pripomoček Mix2Vial
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial , 1 vial with solvent (10ml), 1 Mix2Vial device
FARMACEVTSKA OBLIKA IN VSEBINA prašek in vehikel za raztopino za injiciranje Vsebina: 1 viala s praškom, 1 viala z vehiklom (10 ml), 1 pripomoček Mix2Vial
c a Additional rFVIII may be required to attain the recommended FVIII:C target peak plasma levels.
c a Dodatni odmerki rFVIII bodo morda potrebni za doseganje priporočene ciljne najvišje ravni FVIII:C v plazmi.
Excipients: Sodium citrate, glycine, trehalose dihydrate, mannitol, polysorbate 80, and water for injections.
Pomožne snovi: natrijev citrat, glicin, trehaloza dihidrat, manitol, polisorbat 80 in voda za injekcije.
1 Remove the caps from the VEYVONDI powder and solvent vials to expose the center of the rubber stoppers.
1 Snemite pokrovček s praška VEYVONDI in viale z vehiklom, da razkrijete osrednji del gumijastih zamaškov.
11 Flip connected syringe and VEYVONDI vial so the vial is on top.
11 Nameščeno brizgo in vialo zdravila VEYVONDI obrnite tako, da je viala na vrhu.
1 IU/mL
1 i.e./ml
During and After Surgery
Med kirurškim posegom in po njem
In patients with inadequate levels of FVIII, a dose of 40-60 IU/kg VEYVONDI should be administered 12-24 hours prior to initiating elective surgery (pre-operative dose), to ensure preoperative endogenous FVIII levels of at least 0.4 IU/mL for minor and at least 0.8 IU/mL for major surgery.
Bolnikom z nezadostnimi ravnmi FVIII je treba dati odmerek zdravila VEYVONDI 40-60 i.e./kg 1224 ur pred začetkom izbirnega kirurškega posega (predoperativni odmerek), da se zagotovi predoperativne ravni endogenega FVIII (vsaj 0,4 i.e./ml pri manjših kirurških posegih in 0,8 i.e./ml pri večjih kirurških posegih).
If the patient's baseline plasma FVIII:C level is < 40% or is unknown and in all situations where a rapid correction of haemostasis should be achieved, such as treatment of an acute haemorrhage, severe trauma or emergency surgery, it is necessary to administer a recombinant factor VIII product with the first infusion of VEYVONDI, in order to achieve a haemostatic plasma level of FVIII:C.
Odmerek in trajanje zdravljenja sta odvisna od kliničnega stanja bolnika, vrste in resnosti krvavitve ter ravni VWF:RCo in FVIII:C. Če je bolnikova izhodiščna raven FVIII:C v plazmi < 40 % ali neznana in v vseh primerih, v katerih je treba hitro popraviti hemostazo, kot je zdravljenje akutne krvavitve ali hude poškodbe ali nujen kirurški poseg, je treba s prvo infuzijo zdravila VEYVONDI uporabiti zdravilo z rekombinantnim faktorjem VIII, da se doseže hemostatska raven FVIII:C v plazmi.
Turn the blue plastic side counterclockwise and gently pull the two vials apart.
Modri plastični del zavrtite v nasprotni smeri vrtenja urnega kazalca in previdno povlecite viali narazen.
5 To connect the solvent vial to the VEYVONDI vial, turn the solvent vial over and place it on top of the vial containing VEYVONDI powder.
5 Če želite vialo z vehiklom povezati z vialo zdravila VEYVONDI, obrnite vialo vehikla in jo namestite na vrh viale, ki vsebuje prašek VEYVONDI.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (650 IU)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (650 i.e.)
Reconstituted product should not be refrigerated.
Rekonstituiranega zdravila ne shranjujte v hladilniku.
Ensure that the VEYVONDI powder vial and the Sterilised Water for Injections (solvent) are at room temperature prior to preparation.
Poskrbite, da se viala s praškom VEYVONDI in sterilizirana voda za injekcije (vehikel) pred pripravo ogrejeta na sobno temperaturo.
40 to 50 IU/kg every 8 to 24 hours (or as long as deemed clinically necessary)
od 40 do 50 i.e./kg od 40 do 50 i.e/kg vsakih 8 do 24 ur (ali dokler je klinično primerno)
Place the needle, syringe, and empty VEYVONDI and solvent vial(s) in a hard-walled sharps container for proper disposal.
Iglo, brizgo in prazne viale zdravila VEYVONDI in vehikla pravilno odstranite tako, da jih odložite v posodo za ostre predmete s trdno steno.
If you stop using VEYVONDI
Če ste pozabili uporabiti zdravilo VEYVONDI
The solvent will flow into the VEYVONDI vial by vacuum.
Vakuum bo posesal vehikel v vialo zdravila VEYVONDI.
Thromboembolic events may occur in case of major overdose.
V primeru skrajno visokega odmerjanja se lahko pojavijo tromboembolični dogodki.
There may be a risk of developing blood clots (thrombosis) in case of an accidental high dose.
V primeru nenamernega velikega odmerka se lahko pojavi tveganje za nastanek krvnih strdkov (tromboze).
VEYVONDI 650 IU powder and solvent for solution for injection Each vial of powder contains nominally 650 International Units (IU) vonicog alfa.
VEYVONDI 650 i.e. prašek in vehikel za raztopino za injiciranje Vsaka viala praška vsebuje nominalno 650 mednarodnih enot (i.e.) vonikoga alfa.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja generaliziran pruritus pogosti
• Use the reconstitution steps above (2 to 8) to prepare the additional vial of VEYVONDI using a fresh Mix2Vial device for each vial.
• Z uporabo drugega pripomočka Mix2Vial za vsako vialo pripravite dodatno vialo zdravila VEYVONDI po zgornjih korakih rekonstitucije (2 do 8).
VWF:RCo Target Peak Plasma Level
VWF:RCo v plazmi
VEYVONDI 650 IU powder and solvent for solution for injection VEYVONDI 1300 IU powder and solvent for solution for injection vonicog alfa
VEYVONDI 650 i.e. prašek in vehikel za raztopino za injiciranje VEYVONDI 1300 i.e. prašek in vehikel za raztopino za injiciranje vonikog alfa
Patients developing inhibitors
Bolniki, pri katerih se pojavijo zaviralci
The product contains only trace amounts of human recombinant coagulation factor VIII (≤ 0.01 IU FVIII / IU VWF: RCo) as determined using the European Pharmacopoeia chromogenic assay for factor VIII (FVIII).
Zdravilo vsebuje le sledi humanega rekombinantnega koagulacijskega faktorja VIII (≤ 0,01 i.e. FVIII/i.e.
Firmly insert the blue plastic spike of the device into the center of the solvent vial stopper by pushing straight down.
Uvedite modro plastično konico pripomočka v sredino zamaška viale z vehiklom tako, da jo odločno potisnete naravnost navzdol.
Dosing guidance should be done based on the IR. b Δ = Target peak plasma VWF:RCo - baseline plasma VWF:RCo IR = Incremental Recovery as measured in the subject.
Navodila za odmerjanje morajo temeljiti na IR. b Δ = Ciljna najvišja raven VWF:RCo v plazmi - izhodiščna raven VWF:RCo v plazmi c
For prevention of excessive bleeding your doctor will assess the FVIII:C levels within 3 hours before surgery.
Preprečevanje krvavitev pri izbirnih kirurških posegih Za preprečevanje čezmerne krvavitve bo zdravnik ocenil vrednosti FVIII:C v 3 urah pred kirurškim posegom.
VEYVONDI 1300 IU powder and solvent for solution for injection Each vial of powder contains nominally 1300 International Units (IU) vonicog alfa.
VEYVONDI 1300 i.e. prašek in vehikel za raztopino za injiciranje Vsaka viala praška vsebuje nominalno 1300 mednarodnih enot (i.e.) vonikoga alfa.
It is unknown whether VEYVONDI is excreted in human milk.Therefore, VEYVONDI should be administered to lactating von Willebrand factor deficient women only if clearly indicated.
Zato je treba zdravilo VEYVONDI dajati doječim materam s pomanjkanjem von Willebrandovega faktorja le, če je jasno indicirano.
Vonicog alfa is a purified recombinant human von Willebrand factor (rVWF).
Vonikog alfa je prečiščen rekombinantni humani von Willebrandov faktor (rVWF).
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for VEYVONDI
IME ZDRAVILA IN POT(I) UPORABE Vehikel za zdravilo VEYVONDI voda za injekcije
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEYVONDI 650 IU powder vonicog alfa
IME ZDRAVILA IN POT(I) UPORABE VEYVONDI 650 i.e. prašek vonikog alfa i.v.
40 to 60 IU/kg every 8 to 24 hours for approximately 23 days (or as long as deemed clinically necessary)
od 50 do 80 i.e./kg od 40 do 60 i.e/kg vsakih 8 do 24 ur približno 2-3 dni (ali dokler je klinično primerno)
1 vial contains1300 IU vonicog alfa, approx. 130 IU/mL after reconstitution with 10 mL Water for Injections
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala vsebuje 1300 i.e. vonikoga alfa, približno 130 i.e./ml po rekonstituciji z 10 ml vode za injekcije
NOTE: When pushing air into a second vial of VEYVONDI to be pooled into a syringe, position the vial and connected syringe so that the vial is on top.
OPOMBA: Ko potisnete zrak v drugo vialo zdravila VEYVONDI, ki jo želite združiti v brizgo, namestite vialo in nameščeno brizgo tako, da je viala na vrhu.
Do not refrigerate after reconstitution.
Zdravila po rekonstituciji ne shranjujte v hladilniku.
If the FVIII:C levels are not at the recommended target levels, rFVIII should be administered in addition to vonicog alfa to raise VWF:RCo and FVIII:C, within 1 hour prior to the procedure.
Če ravni FVIII:C niso v priporočljivem ciljnem območju, moramo v 1 uri pred posegom vonikog alfa dati skupaj z rFVIII, da zvišamo ravni VWF:RCo in FVIII:C. Glejte priporočljive ciljne ravni FVIII:C v preglednici 2.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEYVONDI 1300 IU powder vonicog alfa
IME ZDRAVILA IN POT(I) UPORABE VEYVONDI 1300 i.e. prašek vonikog alfa i.v.
It is not uncommon for a few flakes or particles to remain in the product vial after reconstitution.
Občasno v viali z zdravilom po rekonstituciji ostane nekaj kosmičev ali delcev.
Table 2 VWF:RCo and FVIII:C Target Levels Recommended Target Peak Plasma Levels of VWF:RCo and FVIII:C be Achieved Prior to Surgery for the Prevention of Excessive Bleeding During and After Surgery
Ciljne ravni VWF:RCo in FVIII:C Priporočene ciljne najvišje ravni VWF:RCo in FVIII:C v plazmi, ki jih je treba doseči pred kirurškim posegom, da se prepreči čezmerno krvavitev med posegom in po njem
Trehalose dihydrate Mannitol
Prašek natrijev citrat glicin trehaloza dihidrat manitol polisorbat 80
You must stop the infusion and contact your doctor immediately if you have any of the following early symptoms of severe allergic reactions: - rash or hives, itching all over the body, - tightness of the throat, chest pain or chest tightness, - difficulty breathing, light headedness, fast heartbeat, - dizziness, nausea or fainting.
Če opazite katerega koli izmed naslednjih zgodnjih simptomov hudih alergijskih reakcij, prekinite infundiranje in se nemudoma posvetujte z zdravnikom: - izpuščaj ali koprivnica, srbenje po celem telesu, - tiščanje v grlu, bolečine v prsnem košu ali tiščanje v prsnem košu, - težave z dihanjem, omotica, pospešen srčni utrip, - omotica, siljenje na bruhanje ali omedlevica.
NAME OF THE MEDICINAL PRODUCT VEYVONDI 650 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
VEYVONDI 650 i.e. prašek in vehikel za raztopino za injiciranje vonikog alfa (rekombinantni humani von Willebrandov faktor)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER VIAL LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
VEYVONDI is a recombinant human von Willebrand factor (rVWF).
Zdravilo VEYVONDI je rekombinantni humani von Willebrandov faktor (rVWF).
Do not increase the total dose of VEYVONDI to control your bleeding without consulting your doctor.
Brez posveta z zdravnikom ne povečujte skupnega odmerka zdravila VEYVONDI za obvladovanje krvavitev.
Minimum Duration of treatment
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Each pack of VEYVONDI 650 IU contains: - powder in a glass vial with a rubber stopper - 5 mL of solvent in a glass vial with a rubber stopper - one reconstitution device (Mix2Vial)
Vsako pakiranje zdravila VEYVONDI 650 i.e. vsebuje: - prašek v stekleni viali z zamaškom iz gume - 5 ml vehikla v stekleni viali z zamaškom iz gume - en pripomoček za rekonstrukcijo (Mix2Vial)
After reconstitution with the 10 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.
Po rekonstituciji z 10 ml vehikla zdravilo VEYVONDI vsebuje približno 130 i.e./ ml vonikoga alfa.
VEYVONDI contains the active substance vonicog alfa, which is a recombinant human von Willebrand factor (rVWF).
Zdravilo VEYVONDI vsebuje zdravilno učinkovino vonikog alfa, ki je rekombinantni humani von Willebrandov faktor (rVWF).
NAME OF THE MEDICINAL PRODUCT VEYVONDI 1300 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
VEYVONDI 1300 i.e. prašek in vehikel za raztopino za injiciranje vonikog alfa (rekombinantni humani von Willebrandov faktor)
Each pack of VEYVONDI 1300 IU contains: - powder in a vial (type I glass), with a butyl rubber stopper - 10 mL of solvent in a vial (type I glass), with a rubber stopper (bromobutyl) - one reconstitution device (Mix2Vial)
Vsako pakiranje zdravila VEYVONDI 1300 IU vsebuje: - prašek v viali (steklo tipa I) z zamaškom iz butilne gume - 10 ml vehikla v viali (steklo tipa I) z zamaškom iz gume (bromobutilne) - en pripomoček za rekonstrukcijo (Mix2Vial)
Heart rate increased
Ciljna najvišja raven
- Do not store above 30°C.
- Vialo shranjujte pri temperaturah do 30 °C.
PHARMACEUTICAL FORM Powder and solvent for solution for injection.
FARMACEVTSKA OBLIKA prašek in vehikel za raztopino za injiciranje Prašek je bel do sivobel liofiliziran prašek.
How to store VEYVONDI
Shranjevanje zdravila VEYVONDI
After reconstitution with the 5 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.
Po rekonstituciji s 5 ml vehikla zdravilo VEYVONDI vsebuje približno 130 i.e./ ml vonikoga alfa.
What you need to know before you use VEYVONDI 3.
Kaj je zdravilo VEYVONDI in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo VEYVONDI Kako uporabljati zdravilo VEYVONDI Možni neželeni učinki
If you forget to use VEYVONDI - Do not infuse a double dose to make up for a forgotten dose.
• Ne infundirajte dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
VEYVONDI 650 IU powder and solvent for solution for injection Each pack contains: - powder in a vial (type I glass), with a butyl rubber stopper - 5 mL of solvent in a vial (type I glass), with a rubber stopper (chlorobutyl) - one reconstitution device (Mix2Vial)
VEYVONDI 650 i.e. prašek in vehikel za raztopino za injiciranje Vsako pakiranje vsebuje: - prašek v viali (steklo tipa I) z zamaškom iz butilne gume, - 5 ml vehikla v viali (steklo tipa I) z zamaškom iz (klorobutilne) gume, - en pripomoček za rekonstrukcijo (Mix2Vial).
0.80 - 1 IU/mL Δ
0,80-1 i.e./ml b
0.60 IU/mL
0,60 i.e./ml
Talk to your doctor before using VEYVONDI.
Pred začetkom uporabe zdravila VEYVONDI se posvetujte z zdravnikom.
0.40 IU/mL
0,40 i.e./ml
Inspect the syringe visually for particulate matter; the solution in the syringe should be clear.
Raztopina v brizgi mora biti bistra.
Table 3 Recommended Target Trough Plasma Levels of VWF:RCo and FVIII:C and Minimum Duration of Treatment for Subsequent Maintenance Doses for the Prevention of Excessive Bleeding During and After Surgery
Priporočene ciljne ravni VWF:RCo in FVIII:C v plazmi in najkrajše trajanje zdravljenja pri nadaljnjih vzdrževalnih odmerkih za preprečevanje čezmerne krvavitve po kirurškem posegu
For prevention of excessive bleeding in case of elective surgery, within 3 hours prior to initiation of any surgical procedure, the FVIII:C levels should be assessed.
Za preprečevanje čezmerne krvavitve moramo ravni FVIII:C določiti v 3 urah pred začetkom katerega koli kirurškega posega.
FVIII:C Target Peak Plasma
Ciljna najnižja raven FVIII:C v plazmi
0.50 IU/mL Δ
0,40-0,50 i.e./ml Δ
FVIII:C Target Peak Plasma Level a
Ciljna najvišja raven FVIII:C v plazmi a
The powder is a white to off-white lyophilized powder The solvent is a clear and colourless solution.
Vehikel je bistra in brezbarvna raztopina.
Vomiting
Trombogenost
Binding antibodies against impurities such as rFurin, CHO-protein or mouse IgG were not observed after treatment with VEYVONDI.
Po zdravljenju z zdravilom VEYVONDI niso ugotovili vezavnih protiteles proti nečistotam, kot so rFurin, beljakovine CHO ali mišji IgG.
Cardiac disorders
Srčne bolezni tahikardija pogosti
Table 2 Recommended Target Peak Plasma Levels of VWF:RCo and FVIII:C to be Achieved Prior to Surgery for the Prevention of Excessive Bleeding During and After Surgery
Priporočljive ciljne najvišje ravni VWF:RCo in FVIII:C v plazmi, ki jih je treba doseči pred kirurškim posegom, da preprečimo čezmerne krvavitve med kirurškim posegom in po njem
1 vial contains 650 IU vonicog alfa, approx. 130 IU/mL after reconstitution with 5 mL water for Injections
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala vsebuje 650 i.e. vonikoga alfa, približno 130 i.e./ml po rekonstituciji s 5 ml vode za injekcije Specifična aktivnost: približno 110 i.e. VWF:RCo/mg beljakovin
0.50 IU/mL
0,50 i.e./m l
VEYVONDI 1300 IU powder and solvent for solution for injection Each pack contains: - powder in a vial (type I glass), with a butyl rubber stopper
VEYVONDI 1300 i.e. prašek in vehikel za raztopino za injiciranje Vsako pakiranje vsebuje: - prašek v viali (steklo tipa I) z zamaškom iz butilne gume, - 10 ml vehikla v viali (steklo tipa I) z zamaškom iz (bromobutilne) gume, - en pripomoček za rekonstrukcijo (Mix2Vial).
Inspect the syringe visually for particulate matter; the solution should be clear and colourless.
Raztopina v brizgi mora biti bistra in brez barve.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PRILOGA II A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL (10 mL)
OZNAKA VIALE Z VEHIKLOM (10 ml)
Discard the empty solvent vial.
Zavrzite prazno vialo z vehiklom.
Inhibitors (antibodies) against the VWF may occur in some patients receiving the medicine.These inhibitors, especially at high levels, could cause the treatment to stop working properly.
Zaradi teh zaviralcev, zlasti če se pojavijo v visokih koncentracijah, zdravilo ne deluje več pravilno.
0.30 IU/mL
0,30 i.e./ml
VEYVONDI (Study 071001)
Faza 3 FK80 zdravilo VEYVONDI (študija 071001)
NA
SD
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL (5mL)
OZNAKA VIALE Z VEHIKLOM (5 ml)
9 Leaving the VEYVONDI vial (containing the reconsituted product) on your flat work surface, connect the syringe to the clear plastic connector and turning the syringe clockwise.
9 Vialo zdravila VEYVONDI (ki vsebuje rekonstituirano zdravilo) položite na ravno delovno površino.
Major > 0.50 IU/mL
0,50 i.e./ml
Check with your doctor if you are not sure.
Če o tem niste prepričani, se posvetujte z zdravnikom.
EU/1/18/1298/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/18/1298/001 EU/1/18/1298/002
The vaccine would be given according to official recommendations.
Cepivo je treba dajati v skladu z uradnimi priporočili.
It should only be used once a flu pandemic has been officially declared by the World Health Organization or European Union (EU).
Uporablja se samo, če je pandemijo gripe uradno razglasila Svetovna zdravstvena organizacija ali Evropska unija (EU).
One main study in adults included 561 healthy volunteers, 281 of whom were over the age of 60 years.
V eni glavni študiji z odraslimi je sodelovalo 561 zdravih prostovoljcev, od katerih jih je bilo 281 starejših od 60 let.
Every year, the European Medicines Agency (EMA) will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila (EMA) bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
The vaccine contains a flu strain called A/VietNam/1203/2004 (H5N1).
Cepivo vsebuje sev gripe, imenovan A/VietNam/1203/2004 (H5N1).
The vaccine must not be given to people who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any of the substances found at trace (very low) levels in the vaccine, such as formaldehyde, benzonase or sucrose.
Cepivo se ne sme dajati osebam, ki so imele anafilaktično reakcijo (hudo alergijsko reakcijo) na katero koli sestavino cepiva ali na katero koli izmed snovi v sledeh (v zelo nizkih koncentracijah) cepiva, npr. formaldehid, benzonazo ali saharozo.
They can then test this vaccine to see how people react to it, allowing them to predict how people will react when the flu strain causing the pandemic is included.
To cepivo lahko nato preizkusijo, da bi preverili odziv ljudi nanj, na podlagi česar lahko predvidijo, kako se bodo ti odzvali, ko se bo pojavil sev gripe, ki povzroča pandemijo.
The study also looked at the effect of a booster dose given after twelve months in some of the children.
V študiji so proučevali tudi učinek poživitvenega odmerka, injiciranega po 12 mesecih, pri nekaterih otrocih.
This is a special type of vaccine that is designed to help with the management of a future pandemic.
To je posebna vrsta cepiva, ki je izdelana za pomoč pri nadzorovanju morebitne pandemije.
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance.
Pred začetkom pandemije ni znano, kateri sev virusa gripe se bo razvil, zato farmacevtske družbe ne morejo vnaprej pripraviti ustreznega cepiva.
It contains influenza (flu) viruses that have been inactivated (killed).
Vsebuje viruse gripe, ki so bili inaktivirani (uničeni).
Although levels of antibodies slowly fell over the year after vaccination, a booster dose after 12 months resulted in protective levels of antibodies in 93 to 100% of children who received it.
Čeprav so ravni protiteles v letu po cepljenju počasi padle, je poživitveni odmerek, injiciran po 12 mesecih, zagotovil zaščitne ravni protiteles pri 93 do 100 % otrok, ki so ga prejeli.
When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign' and makes antibodies against it.
Ko oseba prejme cepivo, imunski sistem prepozna inaktivirani virus kot „tujek“ in proti njemu tvori protitelesa.
The main measure of effectiveness was the production of protective levels of antibodies 21 days after the second vaccination.
Glavno merilo učinkovitosti je bilo tvorjenje zaščitnih ravni protiteles 21 dni po drugem cepljenju.
If a pandemic has started, however, it may be appropriate to give the vaccine to these patients, as long as facilities for resuscitation are available.
Ob pojavu pandemije pa bo cepljenje teh bolnikov morda vseeno upravičeno, vendar mora biti na voljo oprema za oživljanje.
This means that, because the vaccine is a mock up and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine.
Do tega je prišlo, ker gre za modelno cepivo, ki še ne vsebuje seva virusa gripe, ki utegne povzročiti pandemijo, zato ni bilo mogoče pridobiti vseh informacij o končnem pandemičnem cepivu.
whole virion influenza virus, propagated in vero cells (continuous cell line of mammalian origin), inactivated, containing antigen of pandemic strain
celoten viron virusa gripe, razmnožen v celicah Vero (neprekinjena celična linija sesalskega izvora), inaktiviran, vsebuje antigen pandemičnega seva
According to criteria laid down by the Committee for Medicinal Products for Human Use (CHMP), a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of adults for it to be considered suitable.
V skladu z merili, ki jih je določil Odbor za zdravila za uporabo v humani medicini (CHMP), je modelno cepivo ustrezno učinkovito le, če zagotovi zaščitno raven protiteles pri vsaj 70 % odraslih.