natgillin/translations-raw huggingface dataset:
2 Disinfect each stopper with a separate sterile alcohol swab (or other suitable sterile solution suggested by your doctor or haemophilia treatment center) by wiping the stopper for several seconds.
2 Dezinficirajte svaki čep zasebnim sterilnim alkoholnim tupferima (ili drugom odgovarajućom sterilnom otopinom koju preporučuje
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER VIAL LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PRAŠKOM
1 Remove the caps from the VEYVONDI powder and solvent vials to expose the center of the rubber stoppers.
1 Skinite zatvarače s bočica VEYVONDI praška i otapala kako biste oslobodili središnji dio gumenih čepova.
Please refer to Table 2 for FVIII:C recommended target levels.
Pogledajte Tablicu 2 za preporučene ciljne doze FVIII:C.
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.
U bolesnika s neodgovarajućim razinama FVIII, doza od 40 do 60 IU/kg lijeka VEYVONDI treba se primijeniti 12 do 24 sata prije početka elektivnog kirurškog zahvata (predoperativna doza) kako bi se osigurale preoperativne razine endogenog FVIII ili barem 0,4 IU/ml za manji i najmanje 0,8 IU/ml za veći kirurški zahvat.
General Instructions - Check the expiry date, and ensure that the VEYVONDI powder and water for injections (solvent) are at room temperature prior to preparation.
Opće upute - Provjerite rok valjanosti i osigurajte da su VEYVONDI prašak i voda za injekciju (otapalo) na sobnoj temperaturi prije pripreme.
Patients and/or their caregivers should be informed of the early signs of hypersensitivity reactions, which may include but are not limited to tachycardia, tightness of the chest, wheezing and/or acute respiratory distress, hypotension, generalised urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, vomiting, paresthesia, restlessness, and may progress to anaphylactic shock.
Bolesnike i/ili njihove skrbnike treba informirati o ranim znakovima reakcija preosjetljivosti koje uključuju, između ostalog, tahikardiju, stezanje u prsima, piskanje pri disanju i/ili akutni respiratorni distres, hipotenziju, generaliziranu urtikariju, pruritus, rinokonjunktivitis, angioedem, letargiju, mučninu, povraćanje, paresteziju, nemir, a mogu napredovati u anafilaktički šok.
Store in the original package in order to protect from light
Čuvati u originalnom pakiranju radi zaštite od svjetlosti
Prevention of bleeding in case of elective surgery
Sprečavanje krvarenja u slučaju elektivnog kirurškog zahvata:
VEYVONDI 1300 IU powder and solvent for solution for injection.
VEYVONDI 1300 IU prašak i otapalo za otopinu za injekciju.
After the initiation of the surgical procedure, the VWF:RCo and FVIII:C plasma levels should be monitored and the intra- and post-operative substitution regimen should be individualized according to the PK results, intensity and duration of the haemostatic challenge, and the institution's standard of care.
Nakon započinjanja kirurškog zahvata, razine VWF:RCo i FVIII:C u plazmi trebaju se nadzirati, potrebno je individualizirati intraoperativni i postoperativni režim nadoknade u skladu s PK rezultatima, intenzitetom i trajanjem hemostatskog izazova i standardnom skrbi ustanove.
The dose depends on VWF and FVIII levels of the patient, the type and severity of the bleeding.
Doza ovisi o razinama VWF i FVIII u pacijenta, vrsti i ozbiljnosti krvarenja.
aIf rFVIII is administered, see rFVIII package insert for reconstitution and administration instructions.
Ako se primjenjuje rFVIII, pogledati rFVIII uputu o rekonstituciji i primjeni lijeka.
Name and address of the manufacturers responsible for batch release
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Baxter AG
This is to be taken into consideration by patients on a controlled sodium diet.
To je potrebno uzeti u obzir kod bolesnika na prehrani s ograničenjem unosa natrija.
The dose depends on VWF and FVIII levels of the patient, the type and severity of the expected bleeding.
Doza ovisi o VWF i FVIII razinama pacijenta, vrsti i ozbiljnosti očekivanog krvarenja.
Administer a subsequent dose of 40 IU to 60 IU/kg of VEYVONDI infused every 8 to 24 hours as per the dosing ranges in Table 1, as long as clinically required.
Primijenite naknadnu dozu od 40 IU do 60 IU/kg lijeka VEYVONDI infuzijom svakih 8 do 24 sata prema rasponima doze iz Tablice 1, dok god je to klinički potrebno.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1298/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1298/001
A subsequent dose of 40 IU to 60 IU/kg of VEYVONDI should be infused every 8 to 24 hours as per the dosing ranges in Table 1, or as long as clinically appropriate.
Naknadnu dozu od 40 IU do 60 IU/kg lijeka VEYVONDI treba infuzijom primijeniti svakih 8 do 24 sata prema rasponima doze iz Tablice 1 ili dok god je to klinički primjereno.
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.
Stoga VEYVONDI treba primijeniti u dojilja s nedostatkom von Willebrandova faktora samo ako je to jasno indicirano.
- Keep the vial in the outer carton in order to protect from light.
- Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
How to use VEYVONDI
Kako primjenjivati VEYVONDI
Be sure to keep the syringe plunger pressed in.
Klip štrcaljke trebate držati pritisnutim.
Any FVIII that would be administered along with VEYVONDI should be a pure FVIII product.
Svaki lijek koji sadrži FVIII, a koji se primjenjuje u kombinaciji s lijekom VEYVONDI treba biti čist FVIII lijek.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEYVONDI 650 IU powder vonicog alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA VEYVONDI 650 IU prašak vonikog alfa
VEYVONDI is a recombinant human von Willebrand factor (rVWF).
VEYVONDI je rekombinantni ljudski von Willebrandov faktor (rVWF).
VWF:RCo Target Peak Plasma Level
VWF:RCo Ciljna najniža razina u plazmi
What VEYVONDI looks like and contents of the pack VEYVONDI is a white to off-white powder.
VEYVONDI je prašak bijele do bjelkaste boje.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL (10 mL)
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICU NA BOČICI S OTAPALOM (10 ml)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEYVONDI 1300 IU powder vonicog alfa
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA VEYVONDI 1300 IU prašak vonikog alfa
Inspect the prepared solution in the syringe for particulate matter and discoloration prior to administration (the solution should be clear, colourless and free from particles).
Pripremljenu otopinu u štrcaljki pregledajte prije primjene kako biste isključili prisutnost bilo kakvih stranih čestica ili promjenu boje (otopina treba biti bistra, bezbojna i bez vidljivih čestica).
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1298/002
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1298/002
Because of this, administration of VEYVONDI restores the FVIII:C level to normal as a secondary effect after the first infusion Administration of the FVIII:C rises above 40% within 6 hours and peaks within 24 hours in a majority of patients, depending on the baseline FVIII:C level.
Primjena FVIII:C diže razinu iznad 40% u roku od 6 sati i doseže vršnu vrijednost u roku od 24 sata u većine bolesnika, ovisno o početnoj razini FVIII:C.
VEYVONDI 1300 IU powder and solvent for solution for injection Each vial of powder contains nominally 1300 International Units (IU) vonicog alfa.
VEYVONDI 1300 IU prašak i otapalo za otopinu za injekciju Svaka bočica praška nominalno sadrži 1300 međunarodnih jedinica (IU) vonikoga alfa.
The patient should be observed for any immediate reaction.
Bolesnika treba pratiti kako bi se uočila pojava svake rane reakcije.
What you need to know before you use VEYVONDI 3.
Što je VEYVONDI i za što se koristi Što morate znati prije nego počnete primjenjivati VEYVONDI Kako primjenjivati VEYVONDI Moguće nuspojave
9 Leaving the VEYVONDI vial (containing the dissolved product) on your flat work surface, connect the syringe to the clear plastic connector by attaching and turning the syringe clockwise.
9 Bočicu s lijekom VEYVONDI (koja sadrži otopljeni lijek) ostavite na ravnoj radnoj površini, a štrcaljku spojite na prozirni plastični priključak spajanjem i okretanjem štrcaljke u smjeru kazaljke na satu.
Excipients: Sodium citrate, glycine, trehalose dihydrate, mannitol, polysorbate 80 and water for injections.
Pomoćne tvari: natrijev citrat, glicin, trehaloza dihidrat, manitol, polisorbat 80 i voda za injekcije.
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial, 1 vial with solvent (5 mL), 1 Mix2Vial device
OBLIK I SADRŽAJ Prašak i otapalo za otopinu za injekciju Sadržaj: 1 bočica s praškom, 1 bočica s otapalom (5 ml), 1 Mix2Vial uređaj
VEYVONDI 650 IU powder and solvent for solution for injection Each vial of powder contains nominally 650 International Units (IU) vonicog alfa.
VEYVONDI 650 IU prašak i otapalo za otopinu za injekciju Jedna bočica praška nominalno sadrži 650 međunarodnih jedinica (IU) vonikoga alfa.
VEYVONDI contains the active substance vonicog alfa, which is a recombinant human von Willebrand factor (rVWF).
VEYVONDI sadrži djelatnu tvar vonikog alfa, a to je rekombinantni ljudski von Willebrandov faktor (rVWF).
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 concentrate.
Da biste spojili bočicu otapala na bočicu s lijekom VEYVONDI, okrenite bočicu otapala i postavite je na vrh bočice koja sadrži VEYVONDI koncentrat.
Inspect the syringe visually for particulate matter; the solution should be clear and colourless.
Štrcaljku treba pregledati kako biste provjerili sadrži li strane čestice; otopina treba biti bistra i bezbojna.
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
Tablica 2: Ciljne razine VWF:RCo i FVIII:C Preporučene ciljne vršne plazmatske razine VWF:RCo i FVIII:C koje treba postići prije kirurškog zahvata za sprečavanje prekomjernog krvarenja tijekom i nakon kirurškog zahvata
PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial , 1 vial with solvent (10ml), 1 Mix2Vial device
OBLIK I SADRŽAJ Prašak i otapalo za otopinu za injekciju Sadržaj: 1 bočica s praškom, 1 bočica s otapalom (10 ml),, 1 Mix2Vial uređaj
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 Bočicu s lijekom VEYVONDI (koja sadrži rekonstituirani lijek) ostavite na ravnoj radnoj površini, a štrcaljku spojite na prozirni plastični priključak i okrenite štrcaljku u smjeru kazaljke na satu.
Vonicog alfa is a purified recombinant human von Willebrand factor (rVWF).
Vonikog alfa je pročišćen rekombinantni ljudski von Willebrandov faktor (rVWF).
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.
Inhibitori (antitijela) koji djeluju protiv VWF-a mogu se javiti u nekih bolesnika koji primaju lijek.
NAME OF THE MEDICINAL PRODUCT VEYVONDI 1300 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
VEYVONDI 1300 IU prašak i otapalo za otopinu za injekciju vonikog alfa (rekombinantni ljudski von Willebrandov faktor)
Always use this medicine exactly as your doctor has told you.
Ako primijenite više lijeka VEYVONDI nego što ste trebali Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik.
NAME OF THE MEDICINAL PRODUCT VEYVONDI 650 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
VEYVONDI 650 IU prašak i otapalo za otopinu za injekciju vonikog alfa (rekombinantni ljudski von Willebrandov faktor)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL (5mL)
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S OTAPALOM (5 ml)
Cardiac disorders
Srčani poremećaji Tahikardija
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.
Da biste spojili bočicu otapala na bočicu s lijekom VEYVONDI, okrenite bočicu otapala i postavite je na vrh bočice koja sadrži VEYVONDI prašak.
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. Please refer to (Table 2) for FVIII:C recommended target levels.
Ako razine FVIII:C nisu pri preporučenim ciljnim razinama, rFVIII treba primijeniti kao dodatak vonikogu alfa kako bi se povisile razine VWF:RCo i FVIII:C.
Check the expiry date, and ensure that the VEYVONDI powder and water for injections (solvent) are at room temperature prior to preparation.
Provjerite rok valjanosti i osigurajte da su VEYVONDI prašak i voda za injekciju (otapalo) na sobnoj temperaturi prije pripreme.
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
Tablica 3: Preporučene najniže ciljne razine VWF:RCo i FVIII:C u plazmi i minimalno trajanje liječenja za naknadne doze održavanja za prevenciju prekomjernog krvarenja nakon kirurškog zahvata
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 IU prašak i otapalo za otopinu za injekciju Jedno pakiranje sadrži: - prašak u bočici (staklo tip I), s čepom od butilne gume - 5 ml otapala u bočici (staklo tipa I), s gumenim čepom (klorobutil) - jedan uređaj za rekonstituciju (Mix2Vial)
0.80 - 1 IU/mL Δ
0,80 - 1 IU/ml b
FVIII:C Target Peak Plasma
FVIII:C Ciljna najniža razina u plazmi
FVIII:C Target Peak Plasma Level a
Ciljna vršna razina FVIII:C u plazmi a
The solvent will flow into the VEYVONDI vial by vacuum.
Otapalo će se pomoću vakuuma uliti u bočicu s lijekom VEYVONDI.
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
Tablica 2: Preporučene ciljne vršne, plazmatske razine VWF:RCo i FVIII:C koje treba postići prije kirurškog zahvata za sprečavanje prekomjernog krvarenja tijekom i nakon kirurškog zahvata
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)
Jedno pakiranje lijeka VEYVONDI 650 IU sadrži: - prašak u staklenoj bočici s gumenim čepom - 5 ml otapala u staklenoj bočici s gumenim čepom - jedan uređaj za rekonstituciju (Mix2Vial)
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)
Jedno pakiranje lijeka VEYVONDI 1300 IU sadrži: - prašak u bočici (staklo tip I), s čepom od butilne gume - 10 ml otapala u staklenoj bočici (staklo tip I), s gumenim čepom (bromobutil) - jedan uređaj za rekonstituciju (Mix2Vial)
MedDRA System Organ Class (SOC)
MedDRA klasifikacija organskih sustava
NAME OF THE MEDICINAL PRODUCT VEYVONDI 650 IU powder and solvent for solution for injection.
VEYVONDI 650 IU prašak i otapalo za otopinu za injekciju.
Ensure that the VEYVONDI powder vial and the Sterilised Water for Injections (solvent) are at room temperature prior to preparation.
Bočica s praškom VEYVONDI i sterilizirana voda za injekcije (otapalo) moraju biti na sobnoj temperaturi prije pripreme.
Investigations
(Ispitivanje
Immunogenicity
Hipertenzija
- Ensure that the VEYVONDI powder vial and the sterilised water for injections (solvent) are at room temperature prior to preparation.
- Bočica s praškom VEYVONDI i sterilizirana voda za injekcije (otapalo) moraju biti na sobnoj temperaturi prije pripreme.
Adverse Reaction by Preferred Term (PT)
Nuspojava po preporučenom pojmu
Phase 3 PK50 VEYVONDI (Study 071001)
PK50 Faze 3 VEYVONDI (Ispitivanje
Clinical and compatibility studies were conducted to administer vonicog alfa (human von Willebrand factor) with octocog alfa (human coagulation factor) in the same syringe.
Provedena su klinička ispitivanja i ispitivanja kompatibilnosti za primjenu vonikoga alfa (ljudskog von Willebrandovog faktora) s oktokogom alfa (ljudskim koagulacijskim faktorom) u istoj štrcaljki. rVWF i rFVIII mogu se prethodno pomiješati u istoj štrcaljki kako bi se dobila odgovarajuća doza (vidjeti dio 4.2 za način primjene).
Δ = Target peak plasma VWF:RCo - baseline plasma VWF:RCo cIR = Incremental Recovery as measured in the subject.
= Ciljna vršna razina VWF:RCo u plazmi - početna razina VWF:RCo u plazmi IR = prirast po jedinici doze (engl.
Excipients: Sodium citrate, glycine, trehalose dihydrate, mannitol, polysorbate 80, and water for injections.
Pomoćne tvari: natrijev citrat, glicin, trehaloza dihidrat, manitol, polisorbat 80 te voda za injekcije, Vidjeti uputu o lijeku za više informacija.
After reconstitution with the 5 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.
Nakon rekonstitucije s 5 ml priloženog otapala, VEYVONDI sadrži približno 130 IU/mL vonikoga alfa.
After reconstitution with the 10 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.
Nakon rekonstitucije s 10 ml priloženog otapala, VEYVONDI sadrži približno 130 IU/mL vonikoga alfa.
1 vial contains 650 IU vonicog alfa, approx. 130 IU/mL after reconstitution with 5 mL water for Injections
1 bočica sadrži 650 IU vonikoga alfa, otprilike 130 IU/ml nakon rekonstitucije s 5 ml vode za injekcije Specifična aktivnost: približno 110 IU VWF:RCo/mg proteina
IV
Δ
Vertigo
Trombogenost
There is a risk of occurrence of thrombotic events if you have known clinical or laboratory risk factors.Therefore your doctor will monitor you for early signs of thrombosis.
Postoji opasnost od pojave trombotskih događaja ako imate poznate kliničke ili laboratorijske čimbenike rizika.
Shaking will adversely affect the product.
Trešnja štetno djeluje na lijek.
Phase 3 PK80
PK80 faze 3 VEYVONDI (Ispitivanje
Pruritus generalized
Prijavljivanje nuspojava
Haemorrhage
Vrtoglavica
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 IU prašak i otapalo za otopinu za injekciju Jedno pakiranje sadrži: - prašak u bočici (staklo tip I), s čepom od butilne gume - 10 ml otapala u bočici (staklo tip I), s gumenim čepom (bromobutil) - jedan uređaj za rekonstituciju (Mix2Vial)
Tachycardia
Omaglica
Prevention of bleeding/haemorrhage and treatment in case of elective surgery Assess FVIII:C levels prior to initiation of any surgical procedure.
Procijenite razine FVIII:C prije započinjanja bilo kojeg kirurškog zahvata.
How VEYVONDI is given
Što VEYVONDI sadrži
Gastrointestinal disorders
Duboka venska tromboza
Side effects are similar in children.
Nuspojave su slične i u djece.
This summary was last updated in 11-2013.
Sažetak je posljednji put ažuriran u 11.2013.
The vaccine would be given according to official recommendations.
Cjepivo se treba primjenjivati u skladu sa službenim preporukama.
This is a special type of vaccine that is designed to help with the management of a future pandemic.
Ovo je poseban tip cjepiva koji je dizajniran kao pomoć pri upravljanju budućim pandemijama.
It contains influenza (flu) viruses that have been inactivated (killed).
Sadrži viruse influence (gripe) koji su inaktivirani (ubijeni).
One main study in adults included 561 healthy volunteers, 281 of whom were over the age of 60 years.
Jedno glavno ispitivanje provedeno u odraslih bolesnika obuhvatilo je 561 zdravog dobrovoljca, od kojih je 281 dobrovoljac bio stariji od 60 godina.
It should only be used once a flu pandemic has been officially declared by the World Health Organization or European Union (EU).
Treba se koristiti tek nakon što Svjetska zdravstvena organizacija ili Europska unija (EU) službeno proglasi pandemiju gripe.
The immune system will then be able to produce antibodies more quickly when it is exposed to the virus again.
Imunološki sustav može zatim brže proizvoditi protutijela nakon što je ponovno izložen virusu.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Cjepiva djeluju „učeći” imunološki sustav (prirodnu obranu tijela) kako da se brani protiv bolesti.
Every year, the European Medicines Agency (EMA) will review any new information that may become available and this summary will be updated as necessary.
Svake godine Europska agencija za lijekove procjenjuje sve nove dostupne informacije te se ovaj sažetak po potrebi ažurira.
The vaccine contains a flu strain called A/VietNam/1203/2004 (H5N1).
Cjepivo sadrži soj gripe naziva A/VietNam/1203/2004 (H5N1).
Before a pandemic starts, nobody knows which strain of flu virus will be involved, so pharmaceutical companies cannot prepare the correct vaccine in advance.
Prije početka pandemije nitko ne zna koji soj virusa će biti uključen u cjepivo, tako da farmaceutske tvrtke ne mogu unaprijed pripremiti ispravno cjepivo.
The study also looked at the effect of a booster dose given after twelve months in some of the children.
Ispitivanje je također istražilo djelovanje dodatne doze primijenjene nakon dvanaest mjeseci u pojedine djece.
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.
Cjepivo se ne smije primjenjivati u osoba koje imaju anafilaktičku reakciju (ozbiljnu alergijsku reakciju) na bilo koju komponentu cjepiva ili na bilo koju pomoćnu tvar koja je prisutna u tragovima (vrlo malo) u cjepivu, poput formaldehida, benzonasa ili sukroze.
This helps to protect against the disease.
Ovo može pomoći pri zaštiti od bolesti uzrokovanom virusom.
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Umjesto toga mogu pripremiti cjepivo koje sadrži soj virusa gripe koji je posebno odabran zato što niti jedna osoba nije izložena tom soju, i nitko nije imun na njega.
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.
Sukladno kriterijima utvrđenima od strane Povjerenstva za lijekove za primjenu kod ljudi (CHMP), „mock-up” cjepivo mora stvoriti zaštitne razine protutijela u najmanje 70% odraslih bolesnika da bi se smatralo primjerenim.
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.
Farmaceutske tvrtke mogu samo testirati ovo cjepivo i vidjeti kako osobe reagiraju na njega, što im omogućuje da predvide kako će osobe reagirati nakon što se soj gripe koji uzrokuje pandemiju uključi u cjepivo.