natgillin/translations-raw huggingface dataset:
Stevens - Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal cases, have been reported in patients who were receiving or had recently been treated with clofarabine.
Pri bolnikih, ki so prejemali ali so bili pred kratkim zdravljeni s klofarabinom, so poročali o StevensJohnsonovem sindromu (SJS) in toksični epidermalni nekrolizi (TEN) vključno s smrtnimi primeri.
Increases in postimplantation loss, reduced foetal body weights and decreased litter sizes together with increases in the number of malformations (gross external, soft tissue) and skeletal alterations (including retarded ossification) were reported in rats receiving doses which produced approximately 2 to 3 fold the clinical exposure (54 mg/m2/day) and in rabbits receiving 12 mg/m2/day clofarabine.
12 mg klofarabina/m2/dan, so poročali o povečanju postimplantacijske izgube, zmanjšanju telesne mase ploda in zmanjšanju velikosti mladičev, skupaj s povečanjem števila malformacij (zunanje, mehka tkiva) ter spremembami na skeletu (vključno z zaostalo osifikacijo).
Very common (may affect more than 1 in 10 people): - anxiety, headache, fever, tiredness; - feeling and being sick, diarrhoea (loose bowels); - flushing, itching and inflamed skin, inflammation of mucus (moist) linings such as the mouth and other areas; - you may have more infections than normal because Ivozall can lower the number of certain types of blood cells in your body; - skin rashes which may be itchy, red, painful or peeling skin including palms of the hands and soles of the feet, or small reddish or purple spots underneath the skin.
morda boste imeli več okužb kot navadno, ker zdravilo Ivozall lahko zmanjša število določenih vrst krvnih celic v telesu; kožni izpuščaji, ki so lahko srbeči, rdeči, boleči, ali luščenje kože na dlaneh in podplatih ali majhne rdečkaste ali vijolične pike pod kožo.
Capillary leak syndrome cases reported during the post-marketing period have been associated with a fatal outcome (See section 4.4).
Primeri sindroma kapilarne krvavitve med spremljanjem zdravila po dajanju le tega v promet so bili povezani s smrtnim izidom (glejte poglavje 4.4).
Cases of hepatitis and hepatic failure, including fatal outcomes, have been reported with clofarabine treatment (see section 4.8).
Med zdravljenjem s klofarabinom so bili opisani primeri hepatitisa in odpovedi jeter, vključno s smrtnimi izidi (glejte poglavje 4.8).
Common: Hyperbilirubinaemia, jaundice, veno-occlusive disease, increases in alanine (ALT)* and aspartate (AST)* aminotransferases, hepatic failure Uncommon: Hepatitis
tiflitis Bolezni jeter, žolčnika in žolčevodov Pogosti: hiperbilirubinemija, zlatenica, venookluzivna bolezen, povečanje vrednosti alanin- (ALT)* in aspartat
Hepatic effects were observed in rats following chronic administration of clofarabine.
Pri podganah so po kroničnem odmerjanju klofarabina opazili učinke na jetra.
How to store Ivozall
Shranjevanje zdravila Ivozall
Overall remission (OR) Rate
Stopnja skupne remisije (SR)
Do not use Ivozall - - if you are allergic to clofarabine or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding (please read the section “Pregnancy and breast-feeding” below); - if you have severe kidney or liver problems.
- če dojite (prosimo, preberite poglavje Nosečnost in dojenje spodaj); - če imate hude težave z ledvicami ali jetri.
Adverse reactions considered to be related to clofarabine reported at frequencies ≥ 1/1,000 (i.e. in > 1/115 patients) in clinical trials and post-marketing
Neželeni učinki, za katere so v kliničnih preskušanjih in v obdobju trženja ocenili, da so povezani z uporabo klofarabina in so o njih poročali s pogostnostjo ≥ 1/1.000
There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity.
Ni izkušenj z uporabo pri bolnikih z okvaro jeter (serumski bilirubin > 1,5 x ULN plus AST in ALT
Clofarabine is contraindicated in patients with severe renal insufficiency (see section 4.3) and should be used with caution in patients with mild to moderate renal insufficiency (see section 4.4).
Uporaba klofarabina pri bolnikih s hudo okvarjenim ledvičnim delovanjem je kontraindicirana (glejte poglavje 4.3), pri bolnikih z blago do zmerno okvarjenim ledvičnim delovanjem pa ga je treba uporabljati previdno (glejte poglavje 4.4).
Pharmacokinetics in patients aged between 2 to 19 years old with relapsed or refractory ALL or AML following administration of multiple doses of clofarabine by intravenous infusion
Farmakokinetika pri bolnikih, starih od 2 do 19 let s ponovljeno ali neodzivno ALL ali AML
Plasma protein binding Serum albumin Elimination: β half-life of clofarabine
Vezava na beljakovine v plazmi Serumski albumin
Intravenous use after dilution.
Pred uporabo razredčite.
Common: Septic shock*, sepsis, bacteraemia, pneumonia, herpes zoster, herpes simplex, oral candidiasis
Pogosti: septični šok*, sepsa, bakteremija, pljučnica,
The liver is a potential target organ for clofarabine toxicity and 25.2% of patients experienced at least one hepato-biliary disorders adverse reaction (see sections 4.3 and 4.4).
Pri 25,2 % bolnikov je prišlo do vsaj enega neželenega učinka bolezni jeter, žolčnika in žolčevodov (glejte poglavji 4.3 in 4.4).
Common (may affect up to 1 in 10 people): - infections of the blood, pneumonia, shingles, implant infections, infections of the mouth such as thrush and cold sores; - changes in blood chemistry, changes in white blood cells; - allergic reactions; - feeling thirsty and producing darker or less urine than normal, decreased or loss of appetite,
- okužbe krvi, pljučnica, pasovec, okužbe vsadkov, okužbe v ustih, kot sta kandidoza in mehurčki na ustnicah; - spremembe v krvni sliki, spremembe v belih krvnih celicah; - alergijske reakcije;
Common: Maculo-papular rash, petechiae, erythema, pruritic rash, skin exfoliation, generalised rash, alopecia, skin hyperpigmentation, generalised erythema, erythematous rash, dry skin, hyperhidrosis Frequency not known: Stevens Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)
Pogosti: makulo-papularni izpuščaj, petehije, eritem, srbeči izpuščaji, luščenje kože, generalizirani osip,
Occurrences of enterocolitis, including neutropaenic colitis, caecitis, and C. difficile colitis have been reported during treatment with clofarabine.
Med zdravljenjem s klofarabinom so poročali o pojavih enterokolitisa, vključno z nevtropeničnim kolitisom, tiflitisom in kolitisom zaradi C. difficile.
Clofarabine should be discontinued immediately if substantial increases in creatinine, liver enzymes and/or bilirubin are observed.
Če opazite znatno povečanje kreatinina, jetrnih encimov in/ali bilirubina, morate zdravljenje s klofarabinom takoj prekiniti;
Sodium chloride Water for injections
6.1 Seznam pomožnih snovi natrijev klorid voda za injekcije
Tell your doctor or carer immediately if you experience any of the following as you may need to stop treatment: - if you get a fever or high temperature - because clofarabine reduces the number of blood cells made in the bone marrow, you may be more likely to catch infections; - if you have breathing difficulties, rapid breathing, or breathlessness; - if you feel a change in your heart rate; - if you suffer from dizziness (light-headedness) or fainting - it may be a symptom of low blood pressure; - if you feel sick or have diarrhoea (loose bowels); - if your urine is darker than usual - it is important to drink plenty of water to avoid dehydration; - if you get a rash with blisters or mouth ulcers; - if you lose your appetite, have nausea (feeling sick), vomiting, diarrhea, dark-colored urine and light-coloured stools, stomach pain, jaundice (yellowing of the skin and eyes), or if you feel generally unwell, these could be symptoms of an inflammation of the liver (hepatitis), or liver damage (hepatic failure); - if you pass little or no urine, or experience drowsiness, nausea, vomiting, breathlessness, loss of appetite and / or weakness (these may be signs of acute kidney failure / kidney failure).
- če se pojavi izpuščaj z mehurji ali razjede ustne sluznice; - če izgubite apetit, občutite slabost v želodcu (siljenje na bruhanje), bruhate, imate drisko, temen urin in svetlo blato, bolečine v trebuhu, zlatenico (porumenelost kože in očesnih beločnic), ali če se na splošno slabo počutite, so to lahko simptomi vnetja jeter (hepatitisa) ali okvare jeter
6.4 Special precautions for storage
6.4 Posebna navodila za shranjevanje Ne zamrzujte.
There is no experience in patients with hepatic impairment (serum bilirubin > 1.5 x ULN plus AST and ALT > 5 x ULN) and the liver is a potential target organ for toxicity (see sections 4.3 and 4.4).
plus AST in ALT > 5 x ULN) in jetra so potencialna tarča za toksične učinke (glejte poglavji 4.3 in 4.4).
Each ml contains 1 mg of clofarabine.
En ml koncentrata vsebuje 1 mg klofarabina.
Delayed ovarian atrophy or degeneration and uterine mucosal apoptosis were observed in female mice at the only dose used of 225 mg/m2/day clofarabine.
Pri mišjih samicah so pri edinem uporabljenem odmerku, 225 mg klofarabina/m2/dan, opazili zapoznelo atrofijo jajčnikov ali degeneracijo in apoptozo maternične sluznice.
Further treatment with clofarabine, generally at a lower dose, can be considered when patients are stabilised and organ function has returned to baseline.
Ko so bolniki stabilizirani in se delovanje organov vrne na izhodiščno vrednost, se lahko razmisli o nadaljevanju zdravljenja s klofarabinom, ponavadi z manjšimi odmerki.
Severe bone marrow suppression, including neutropaenia, anaemia and thrombocytopaenia have been observed in patients treated with clofarabine.
vključno z nevtropenijo, anemijo in trombocitopenijo.
Thus, the concomitant use of medicinal products that have been associated with hepatic toxicity should be avoided wherever possible (see sections 4.4 and
Jetra so potencialni tarčni organ za toksičnost, zato se je treba izogibati sočasni uporabi zdravil, ki so povezana s toksičnimi učinki na jetra, kadar koli je to mogoče (glejte poglavji 4.4 in 4.8).
If a patient experiences a hematologic toxicity of Grade 4 neutropaenia (ANC < 0.5 x 10
Če se pri bolniku pojavi hematološka toksičnost v obliki 4. stopnje nevtropenije (ANC <0,5 x 109/l), ki traja ≥ 4 tedne, potem zmanjšajte odmerek za 25 % pri naslednjem ciklu.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of concentrate contains 1 mg of clofarabine.
200 ml * En ml koncentrata vsebuje 1 mg klofarabina.
Dose related toxicities on male reproductive organs were observed in mice, rats and dogs.
Pri miših, podganah in psih so opazili toksične učinke na moške reproduktivne organe, ki so bili odvisni od odmerka.
The active substance is clofarabine.
Učinkovina je klofarabin.
Sixty-eight patients (59%) experienced at least one serious clofarabine-related adverse event.
Vsaj en resen, s klofarabinom povezan neželeni dogodek, se je pojavil pri oseminšestdesetih bolnikih (59 %).
Very common: Vomiting, nausea, diarrhoea Common: Mouth haemorrhage, gingival bleeding, haematemesis, abdominal pain, stomatitis, upper abdominal pain, proctalgia, mouth ulceration Frequency not known: Pancreatitis elevations in serum amylase and lipase, enterocolitis, neutropenic colitis, caecitis
Pogostnost neznana: pankreatitis, povečanje amilaze in lipaze v serumu, enterokolitis, nevtropenični kolitis,
STATEMENT OF ACTIVE SUBSTANCE(S) Each 20 ml vial contains 20 mg of clofarabine
Ena 20 ml viala vsebuje 20 mg klofarabina
Treatment failure
Neuspešno zdravljenje ni na voljo
weight loss; - agitation, irritability, or restlessness;
občutek slabosti in slabost, driska;
Your doctor will carry out regular blood tests to check whether your body is working properly; - liver damage (liver failure).
Zdravnik bo opravljal redne krvne preiskave, da bo preveril, ali telo deluje normalno; - okvara jeter (odpoved jeter); - malo ali nič urina, zaspanost, slabost, bruhanje, zasoplost, izguba apetita in/ali oslabelost (možni znaki akutne odpovedi ledvic ali odpovedi ledvic).
The recommended dose in monotherapy is 52 mg/m2 of body surface area administered by intravenous infusion over 2 hours daily for 5 consecutive days.
Otroci in mladostniki (≥ 1 leto) Priporočeni odmerek za monoterapijo je 52 mg/m2 telesne površine, dane v obliki intravenske infuzije;
- Keep this leaflet.
* = glejte spodaj
Ivozall contains the active substance clofarabine.
Kaj je zdravilo Ivozall in za kaj ga uporabljamo Zdravilo Ivozall vsebuje učinkovino klofarabin.
It should be visually inspected for particulate matter and discolouration prior to administration.
Raztopino pred uporabo vizualno preglejte in preverite, ali so v njej delci in ali je barva spremenjena.
Renal impairment
Žilne bolezni
What information is still awaited?
Kakšne informacije še lahko pričakujemo?
It should only be used once a flu pandemic has been officially declared by the World Health Organization (WHO) or European Union (EU).
Uporablja se samo, če je pandemijo gripe uradno razglasila Svetovna zdravstvena organizacija ali Evropska unija (EU).
There are some data supporting the use of half-doses (0.25 ml) in children three to nine years of age.
Nekateri podatki podpirajo uporabo polovičnih odmerkov (0,25 ml) pri otrocih, starih od tri do devet let.
The full EPAR for Adjupanrix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Adjupanrix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The European Commission granted a marketing authorisation valid throughout the European Union for Adjupanrix on 19 October 2009.
Evropska komisija je dovoljenje za promet z zdravilom Adjupanrix, veljavno po vsej Evropski uniji, odobrila dne 19. oktobra 2009.
For more information about treatment with this vaccine, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju s tem cepivom preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefit has this vaccine shown during the studies?
Kakšne koristi je to cepivo izkazalo med študijami?
The vaccine contains a flu strain called ‘A/VietNam/1194/2004 NIBRG 14' (H5N1).
Cepivo vsebuje sev gripe, imenovan „A/VietNam/1194/2004 NIBRG 14“ (H5N1).
It contains parts of influenza (flu) viruses that have been inactivated (killed).
Vsebuje delce virusov influence (gripe), ki so bili inaktivirani (uničeni).
This is a summary of the European public assessment report (EPAR) for Adjupanrix.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Adjupanrix.
The main measures of effectiveness were the levels of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Glavna merila učinkovitosti so bile ravni protiteles proti virusu gripe v krvi v treh različnih obdobjih: pred cepljenjem, na dan drugega cepljenja (21. dan) in 21 dni kasneje (42. dan).
The CHMP decided that the vaccine's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi cepiva večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
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 very low levels in the vaccine, such as eggs, chicken protein, ovalbumin (a protein in egg white), formaldehyde, gentamicin sulphate (an antibiotic) and sodium deoxycholate.
Cepivo se ne sme dajati osebam, ki so imele anafilaktično reakcijo (resno alergijsko reakcijo) na katero koli sestavino cepiva ali na katero koli od snovi, ki jih v zelo nizkih količinah najdemo v cepivu, kot so jajca, piščančje beljakovine, ovalbumin (beljakovina v beljaku), formaldehid, gentamicinijev sulfat (antibiotik) in natrijev deoksiholat.
Why has Adjupanrix been approved?
Zakaj je bilo zdravilo Adjupanrix odobreno?
What is the risk associated with this vaccine?
Kakšna tveganja so povezana s tem cepivom?
The resulting ‘emulsion' will then be injected.
Tako dobljena „emulzija“ se nato injicira.
The vaccine is given by injection into the shoulder or thigh muscle.
Cepivo se injicira v ramensko ali stegensko mišico.
The solvent contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Emulzija vsebuje tudi „adjuvans“ (spojino, ki vsebuje olje) za povečanje imunskega odziva.
When the company that makes the vaccine includes the flu strain responsible for a pandemic in the vaccine, it will collect information on the safety and effectiveness of the final pandemic vaccine, and submit this to the CHMP for evaluation.
Ko bo družba, ki izdeluje cepivo, vanj vključila sev gripe, odgovoren za pandemijo, bo zbrala informacije o varnosti in učinkovitosti končnega pandemičnega cepiva in jih predložila CHMP v oceno.
The company that made the Pandemrix H5N1 mock-up vaccine has agreed that its scientific data can be used for this vaccine.
Družba, ki izdeluje modelno cepivo Pandemrix H5N1, je privolila, da se znanstveni podatki tega zdravila uporabljajo tudi za to cepivo.
This vaccine is the same as the Pandemrix H5N1 mock-up vaccine, which was previously authorised in the European Union (EU).
To cepivo je enako modelnemu cepivu Pandemrix H5N1, ki je že bilo odobreno v Evropski uniji (EU).
Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because very few people have been exposed to it, and to which very few people are immune.
Lahko pa pripravijo cepivo, ki vsebuje posebej izbrani sev virusa gripe, kateremu je bilo izpostavljenih zelo malo ljudi oziroma so proti njemu imuni.
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 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.
People who have not previously been vaccinated against the pandemic flu with a ‘prepandemic' vaccine should receive two single 0.5 ml doses of the vaccine at least three weeks apart.
Osebe, ki predhodno niso bile cepljene proti pandemični gripi s „prepandemičnim“ cepivom, bi morale prejeti dva enojna 0,5-mililitrska odmerka cepiva v najmanj tritedenskem razmiku.
At 21 days after the second injection, 84% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
21 dni po drugem injiciranju je imelo 84 % oseb, ki so prejele cepivo, koncentracijo protiteles, ki bi jih zaščitila pred virusom H5N1.
Adjupanrix is a vaccine for use in adults to protect against ‘pandemic' flu.
Zdravilo Adjupanrix je cepivo za uporabo pri odraslih za zaščito pred „pandemično“ gripo.
In elderly people, single doses also met the CHMP's criteria, except for in the small number of patients aged over 80 years who did not have any protection against the virus at the start of the study.
Pri starejših osebah so enojni odmerki cepiva prav tako izpolnili merila odbora CHMP, razen pri manjšem številu bolnikov, starejših od 80 let, ki na začetku študije niso imeli razvite zaščite pred virusom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adjupanrix.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Adjupanrix, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Other information about Adjupanrix
Druge informacije o zdravilu Adjupanrix:
People who have previously been vaccinated with a prepandemic vaccine that contains a similar flu strain to the one causing the pandemic will only need one single dose.
Pri osebah, ki so bile predhodno cepljene s prepandemičnim cepivom, ki vsebuje sev gripe, podoben tistemu, ki povzroča pandemijo, bo potreben zgolj en enojni odmerek.
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.
To pomeni, da gre za modelno cepivo, ki še ne vsebuje seva virusa gripe, ki utegne povzročiti pandemijo, zato ni bilo mogoče pridobiti vseh podatkov o končnem pandemičnem cepivu.
The most common side effects with the vaccine (seen with more than 1 in 10 doses of the vaccine) are headache, arthralgia (joint pain), myalgia (muscle pain), reactions at the site of the injection (hardening, swelling, pain and redness), fever and fatigue (tiredness).
Najpogostejši neželeni učinki cepiva (opaženi pri več kot 1 odmerku cepiva od 10) so glavobol, artralgija (bolečine v sklepih), mialgija (bolečine v mišicah), reakcije na mestu injiciranja (zatrdlina, oteklina, bolečina in rdečina), povišana telesna temperatura in utrujenost.
Before use, the vaccine will be made up by mixing together a suspension that contains the virus particles with a solvent.
Pred uporabo se cepivo pripravi z mešanjem suspenzije, ki vsebuje delce virusa, in vehikla.
For the full list of all side effects reported with this vaccine, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi tega cepiva, glejte navodilo za uporabo.
The main study showed that the 3.75 microgram dose of the adjuvanted vaccine produced an antibody response that met these criteria.
Glavna študija je pokazala, da je cepivo z adjuvansom v odmerku 3,75 mikrograma povzročilo odziv protiteles, in izpolnjuje ta merila.
A further study looked at the immunogenicity of single or double doses in 437 people aged over 60 years, and two studies looked at the effect of giving a single injection of the vaccine to adults who had previously been vaccinated with a prepandemic vaccine containing a related virus strain.
Nadaljnja študija je proučevala imunogenost enojnih ali dvojnih odmerkov pri 437 osebah, starih nad 60 let, dve študiji pa sta proučevali učinek cepljenja z enojnim odmerkom odraslih, ki so bili predhodno cepljeni s prepandemičnim cepivom, ki vsebuje soroden sev virusa.
The participants received two injections of the vaccine containing one of four different doses of haemagglutinin.
Osebe, ki so sodelovale v študiji, so prejele dve injekciji cepiva, ki sta vsebovali enega od štirih različnih odmerkov hemaglutinina.
The main study of the vaccine included 400 healthy adults aged between 18 and 60 years and compared the ability of different doses of the vaccine, with or without the adjuvant, to trigger the production of antibodies (‘immunogenicity').
V glavno študijo cepiva je bilo vključenih 400 zdravih odraslih oseb, starih od 18 do 60 let, v njej pa so primerjali učinkovitost različnih odmerkov virusa, z adjuvansom ali brez njega, pri sprožanju nastajanja protiteles („imunogenosti“).
What is Adjupanrix?
Kaj je zdravilo Adjupanrix?
The final two studies in adults showed that a single dose of the vaccine was sufficient to bring about protective levels of antibodies in people who had previously been vaccinated with a prepandemic vaccine containing a related flu strain.
Zadnji dve študiji pri odraslih sta pokazali, da je enojni odmerek cepiva učinkovito zagotavljal zaščitne ravni protiteles pri osebah, ki so bile predhodno cepljene s prepandemičnim cepivom, ki vsebuje soroden sev virusa gripe.
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Povzetek EPAR za javnost cepivo proti pandemični gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom)
According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
V skladu z merili, ki jih je določil CHMP, je modelno cepivo ustrezno učinkovito le, če zagotovi zaščitno raven protiteles pri vsaj 70 % ljudi.