natgillin/translations-raw huggingface dataset:
EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tablets
EU/1/13/900/003 Xigduo 5 mg/850 mg 56 tablet
• changes in taste
• spremembe okusa • omotica
EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tablets
EU/1/13/900/001 Xigduo 5 mg/850 mg 14 tablet
MARKETING AUTHORISATION HOLDER AstraZeneca AB
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM AstraZeneca AB
For the add-on to metformin study, HbA1c reductions were sustained through Week 102 (-0.78% and 0.02% adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively).
10 mg dapagliflozina -0,78 % in s placebom 0,02 %).
Add-on combination Sulphonylurea + Metformin1
Razlika v primerjavi s kombinacijo glipizid + metforminc
EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tableta (enkratni odmerek) EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablet (skupno pakiranje)
Package leaflet: Information for the patient Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Navodilo za uporabo Xigduo 5 mg/850 mg filmsko obložene tablete Xigduo 5 mg/1000 mg filmsko obložene tablete dapagliflozin/metforminijev klorid Za to zdravilo se izvaja dodatno spremljanje varnosti.
At Week 208, adjusted mean change from baseline in HbA1c was -0.10% for dapagliflozin and 0.20% for glipizide, respectively.
HbA1c od izhodišča z dapagliflozinom -0,10 % in z glipizidom 0,20 %.
Dysuria Polyuria*,f
Bolezni sečil dizurija* poliurija
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje dapagliflozin-propandiol monohidrat v količini, ki ustreza 5 mg dapagliflozina, in 850
(95% CI) LOCF: Last observation carried forward bRandomised and treated subjects with baseline and at least 1 post-baseline efficacy measurement Least squares mean adjusted for baseline value dNon-inferior to glipizide + metformin p-value < 0.0001
Randomizirani in zdravljeni preiskovanci z izhodiščno in vsaj še eno poizhodiščno meritvijo učinkovitosti cPovprečje najmanjših kvadratov, korigirano za izhodiščno vrednost
Metformin (immediate- or extended-release formulations) ≥1500 mg/day plus maximum tolerated dose,
Metformin ≥ 1500 mg/dan,
LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period cLeast squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product **p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product
(95 % IZ) 1Metformin ≥ 1500 mg/dan, 2Sitagliptin 100 mg/dan LOCF: prenos zadnjega opažanja (pred rešilnim zdravljenjem za preiskovance s takšnim zdravljenjem) [Last observation carried forward] S placebom kontrolirana 16-tedenska študija cVsi randomizirani preiskovanci, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem Povprečje najmanjših kvadratov, korigirano za izhodiščno vrednost
During clinical trials, the overall proportion of subjects with malignant or unspecified tumours was similar between those treated with dapagliflozin (1.50%) and placebo/comparator (1.50%), and there was no carcinogenicity or mutagenicity signal in animal data (see section 5.3).
ki so prejemali dapagliflozin (1,50 %), in tistimi, ki so prejemali placebo/primerjalno zdravilo (1,50 %), podoben.
Malignancies
omotica
Signs of ‘lactic acidosis' are: - feeling or being very sick - vomiting, stomach ache - muscular cramps - severe tiredness - difficulty breathing.
- občutek slabosti ali huda slabost - bruhanje, bolečine v trebuhu - mišični krči
Invented name/ Name
Izmišljeno ime Ime
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/ MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV / IMETNIKOV DOVOLJENJA ZA
Content (concentratio n)
Vsebina (koncentracija)
Strength Pharmaceutic al form
Farmacevtska oblika
It is available as tablets (1 mg).
Na voljo je v obliki tablet (1 mg).
The European Commission granted a marketing authorisation valid throughout the European Union for Azilect on 21 February 2005.
Evropska komisija je dovoljenje za promet z zdravilom Azilect, veljavno po vsej Evropski uniji, izdala 21. februarja 2005.
The studies lasted 26 and 18 weeks, respectively.
Študije so trajale 26 oziroma 18 tednov.
Other information about Azilect
Druge informacije o zdravilu Azilect
The standard dose of Azilect is one tablet once a day.
Priporočeni odmerek zdravila Azilect je ena tableta enkrat na dan.
The full EPAR for Azilect 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 Azilect je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What benefit has Azilect shown during the studies?
Kakšne koristi je zdravilo Azilect izkazalo med študijami?
This is a summary of the European public assessment report (EPAR) for Azilect.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Azilect.
The most common side effect with Azilect (seen in more than 1 patient in 10) is headache.
Najpogostejši neželeni učinek zdravila Azilect (opažen pri več kot 1 bolniku od 10) je glavobol.
Azilect has been studied in three main studies involving a total of 1,563 patients with Parkinson's disease.
Zdravilo Azilect so raziskovali v treh glavnih študijah, ki so vključevale skupaj 1 563 bolnikov s Parkinsonovo boleznijo.
For more information about treatment with Azilect, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Azilect preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The CHMP decided that Azilect's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Azilect večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
The main measure of effectiveness was the change in symptoms over 26 weeks, as assessed on a standard scale (Unified Parkinson's Disease Rating Scale, UPDRS).
Glavno merilo učinkovitosti je bila sprememba simptomov po 26 tednih, ki je bila ocenjena s standardno lestvico (Enotno ocenjevalno lestvico Parkinsonove bolezni - Unified Parkinson's Disease Rating Scale, UPDRS).
Azilect is a medicine that contains the active substance rasagiline.
Azilect je zdravilo, ki vsebuje zdravilno učinkovino razagilin.
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 Azilect.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The main measure of effectiveness was the time spent in the ‘off' state during the day, as recorded in patients' diaries.
Glavno merilo učinkovitosti je bil čas preživet v stanju „off“ v teku dneva, kot je bilo zabeleženo v bolnikovem dnevniku.
It was compared with placebo or entacapone (another medicine for Parkinson's disease).
Primerjali so ga s placebom ali entakaponom (drugim zdravilom za zdravljenje Parkinsonove bolezni).
The other two studies involved a total of 1,159 patients with later stage disease, where Azilect was added to the patients' existing treatment including levodopa.
V drugi dve študiji je bilo vključenih skupno 1 159 bolnikov z boleznijo v kasnejši fazi, pri katerih je bilo zdravilo Azilect dodano k bolnikovemu obstoječemu zdravljenju, ki je vključevalo levodopo.
Azilect must not be used in patients who have severe problems with their liver.
Prav tako ga ne smejo uporabljati bolniki s hudimi težavami z jetri.
Azilect was more effective than placebo in all of the studies.
V vseh študijah je bilo zdravilo Azilect učinkovitejše od placeba.
In the study where Azilect was used alone, patients taking 1 mg of the medicine once a day had an average fall in UPDRS score of 0.13 points over the 26-week study from a starting value of 24.69.
V študiji, v kateri je bilo zdravilo Azilect uporabljeno samostojno, je bilo pri bolnikih, ki so prejemali 1 mg zdravila enkrat dnevno, po 26-tedenski študiji ugotovljeno povprečno zmanjšanje po lestvici UPDRS za 0,13 točke glede na začetno vrednost 24,69 točke.
Azilect is used to treat Parkinson's disease.
Zdravilo Azilect se uporablja za zdravljenje bolnikov s Parkinsonovo boleznijo.
This was compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54.
To so primerjali s povečanjem za 4,07 točke glede na začetno vrednost 24,54 točke pri bolnikih, ki so jemali placebo.
Why has Azilect been approved?
Zakaj je bilo zdravilo Azilect odobreno?
Neurotransmitters are chemicals that nerve cells use to communicate with neighbouring cells.
Živčni prenašalci so kemične snovi, ki omogočajo medsebojno sporazumevanje živčnih celic.
What is the risk associated with Azilect?
Kakšna tveganja so povezana z zdravilom Azilect?
Azilect can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having ‘fluctuations' towards the end of the period between levodopa doses.
Zdravilo Azilect se lahko uporablja samostojno ali kot dodatek levodopi (drugemu zdravilu, ki se uporablja pri Parkinsonovi bolezni) pri bolnikih z nihanji proti koncu obdobja med dvema odmerkoma levodope.
Fluctuations are linked to a reduction in the effects of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and immobile.
Nihanja so povezana z zmanjšanim učinkom levodope, ko bolnik doživlja nenadne preskoke med stanjem, ko se lahko giblje (stanje „on“), in med stanjem, ko se ne more premikati (stanje „off“).
Azilect can only be obtained with a prescription.
Izdaja zdravila je le na recept.
In both studies, patients adding Azilect spent an average of around one hour less in the ‘off' state than those adding placebo.
V obeh študijah je bil pri bolnikih, ki so dodatno prejemali zdravilo Azilect, čas stanja „off“ v povprečju približno eno uro krajši kot pri bolnikih, ki so kot dodatek prejemali placebo.
Azilect must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations obtained without prescription such as St John's wort.
Zdravilo Azilect se ne sme uporabljati skupaj z drugimi zaviralci monoaminooksidaz, vključno z zdravili ali rastlinskimi pripravki, ki se dobijo brez recepta, kot je šentjanževka.
A similar decrease in time spent in the ‘off' state was seen in patients taking entacapone.
Podobno skrajšanje časa, preživetega v stanju „off“ je bilo opaženo pri bolnikih, ki so prejemali entakapon.
There should be at least 14 days between stopping treatment with Azilect and starting treatment with another monoamine oxidase inhibitor or with pethidine.
Med prenehanjem zdravljenja z zdravilom Azilect in začetkom zdravljenja z drugim zaviralcem monoaminooksidaz ali petidinom mora preteči najmanj 14 dni.
It must also not be used with pethidine (a painkiller).
Ne sme se uporabljati skupaj s petidinom (zdravilom proti bolečinam).
By increasing levels of dopamine in the parts of the brain that control movement and co-ordination, Azilect improves the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Zdravilo Azilect s povečevanjem ravni dopamina v delih možganov, ki nadzorujejo gibe in koordinacijo, lajša znake in simptome Parkinsonove bolezni, kot sta okornost in počasnost gibov.
In the first study, two different doses of Azilect taken alone were compared with placebo (a dummy treatment) in 404 patients with early-stage disease.
V prvi študiji so učinke dveh različnih odmerkov zdravila Azilect, dajanega samostojno, primerjali z učinki placeba (zdravila brez zdravilne učinkovine) pri 404 bolnikih z boleznijo v zgodnji fazi.
When used as an add-on to levodopa, 1 mg Azilect reduced the time in the ‘off' state more than placebo did.
Zdravilo Azilect 1 mg, uporabljeno kot dodatek levodopi, je skrajšalo čas stanja „off“ bolj kot placebo.
In patients with Parkinson's disease, the cells that produce dopamine begin to die and the amount of dopamine in the brain decreases.
Parkinsonovo boleznijo začnejo celice, ki proizvajajo dopamin, odmirati, zato se količina dopamina v možganih zmanjša.
For the full list of all side effects reported with Azilect, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Azilect, glejte navodilo za uporabo.
The active substance in Azilect, rasagiline, is a ‘monoamine oxidase-B inhibitor'.
Zdravilna učinkovina zdravila Azilect je razagilin, zaviralec „monoaminooksidaze tipa B“.
How has Azilect been studied?
Kako je bilo zdravilo Azilect raziskano?
What is Azilect used for?
Za kaj se zdravilo Azilect uporablja?
How is Azilect used?
Kako se zdravilo Azilect uporablja?
What is Azilect?
Kaj je zdravilo Azilect?
How does Azilect work?
Kako zdravilo Azilect deluje?
Further information on VeraSeal can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/veraseal
Dodatne informacije o zdravilu VeraSeal so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/veraseal
VeraSeal received a marketing authorisation valid throughout the EU on 10 November 2017.
Za zdravilo VeraSeal je bilo 10. novembra 2017 izdano dovoljenje za promet, veljavno po vsej EU.
What measures are being taken to ensure the safe and effective use of VeraSeal?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila VeraSeal?
VeraSeal is used when standard surgery techniques do not work well enough.
Zdravilo VeraSeal se uporablja, kadar standardne kirurške tehnike niso dovolj učinkovite.
Other information about VeraSeal
Druge informacije o zdravilu VeraSeal
The European Medicines Agency therefore decided that VeraSeal's benefits are greater than its risks and recommended that it be approved for use in the EU.
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila VeraSeal večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
Rarely, VeraSeal may cause an allergic reaction which can be severe especially when the medicine is used repeatedly.
Redko lahko zdravilo VeraSeal povzroči alergijsko reakcijo, ki je lahko resna, zlasti ob večkratni uporabi zdravila.
As for all medicines, data on the use of VeraSeal are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila VeraSeal stalno spremljajo.
What benefits of VeraSeal have been shown in studies?
Kakšne koristi zdravila VeraSeal so se pokazale v študijah?
Although patients could develop antibodies against the medicine, which might reduce its effectiveness, this has not been seen in the studies.
Čeprav se pri bolnikih lahko pojavijo protitelesa proti zdravilu, kar lahko zmanjša njegovo učinkovitost, tega v študijah niso opazili.
What is VeraSeal and what is it used for?
Kaj je zdravilo VeraSeal in za kaj se uporablja?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of VeraSeal have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila VeraSeal upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
An overview of VeraSeal and why it is authorised in the EU
Pregled zdravila VeraSeal in zakaj je odobreno v EU
It is available as two prefilled syringes in a syringe holder, one containing a solution of human fibrinogen (80 mg/ml), and the other containing a solution of human thrombin (500 international units/ml).
Na voljo je v dveh napolnjenih injekcijskih brizgah v držalu za injekcijske brizge, pri čemer ena brizga vsebuje raztopino s humanim fibrinogenom (80 mg/ml), druga pa raztopino s humanim trombinom (500 mednarodnih enot/ml).
VeraSeal (human fibrinogen / human thrombin)
VeraSeal (humani fibrinogen/humani trombin)
As for all medicines obtained from blood, infections could be transmitted with the medicine; however, the medicine is manufactured using filtration and a process to inactivate viruses that minimise this risk.
Kot velja za vsa zdravila, pridobljena iz krvi, se z zdravilom lahko prenašajo okužbe, vendar je to izdelano s filtracijo in postopkom inaktivacije virusov, kar to tveganje zmanjšuje.
Why is VeraSeal authorised in the EU?
Zakaj je bilo zdravilo VeraSeal odobreno v EU?
VeraSeal should only be used by an experienced surgeon who has been trained in its use.
Zdravilo VeraSeal sme uporabljati samo izkušeni kirurg, ki je bil usposobljen za njegovo uporabo.
The amount of VeraSeal to be used depends on a number of factors, including the type of surgery, the size of the wound and the number of applications.
Količina zdravila VeraSeal, ki jo je treba uporabiti, je odvisna od številnih dejavnikov, vključno z vrsto kirurškega posega, velikostjo rane in številom nanosov.
The active substances in VeraSeal, fibrinogen and thrombin, are substances present in human plasma (the liquid part of the blood), which are involved in the normal blood clotting process.
Učinkovini v zdravilu VeraSeal, fibrinogen in trombin, sta snovi, prisotni v človeški plazmi (tekočem delu krvi), ki sodelujeta pri običajnem strjevanju krvi.
What are the risks associated with VeraSeal?
Kakšna tveganja so povezana z zdravilom VeraSeal?
Side effects reported with VeraSeal are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu VeraSeal, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
The observed side effects were as expected with major surgeries or the patient's condition.
Opaženi neželeni učinki so bili takšni, kot se pričakujejo pri večjih kirurških posegih oziroma glede na bolnikovo stanje.
The most common side effects with VeraSeal (which may affect up to 1 in 10 people) are nausea (feeling sick), pruritus (itchiness) and procedural pain (pain from the surgery).
Najpogostejši neželeni učinki zdravila VeraSeal (ki se lahko pojavijo pri največ 1 od 10 bolnikov) so navzeja (siljenje na bruhanje), pruritus (srbenje) in bolečina pri posegu (bolečina zaradi kirurškega posega).
VeraSeal has been shown to effectively stop bleeding during surgery, which can be expected to reduce blood loss, reduce time in the operating theatre and possibly shorten hospital stays.
Dokazano je bilo, da zdravilo VeraSeal učinkovito ustavi krvavitev med kirurškim posegom, kar po pričakovanju zmanjša izgubo krvi, skrajša čas v operacijski dvorani in morda skrajša ležalno dobo.
When the two active substances are mixed, thrombin cuts fibrinogen up into fibrin.
Ko se učinkovini zmešata, trombin razreže fibrinogen v fibrin.
VeraSeal must not be used intravascularly (inside blood vessels) or to treat heavy bleeding of the arteries.
Zdravilo VeraSeal se ne sme uporabljati intravaskularno (znotraj žil) ali za zdravljenje obilnih krvavitev iz arterij.
In rare cases, patients have developed antibodies to the proteins in VeraSeal, which could interfere with blood clotting.
V redkih primerih so se pri bolnikih pojavila protitelesa proti beljakovinam v zdravilu VeraSeal, ki lahko ovirajo strjevanje krvi.
It contains the active substances human fibrinogen and human thrombin.
Vsebuje učinkovini humani fibrinogen in humani trombin.
Three main studies in 614 patients found that VeraSeal is effective at stopping bleeding within 4 minutes of applying it during surgery.
V treh glavnih študijah pri 614 bolnikih so ugotovili, da je zdravilo VeraSeal med kirurškim posegom učinkovito pri ustavitvi krvavitve v štirih minutah po nanosu.
For the full list of all side effects and restrictions with VeraSeal, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila VeraSeal glejte navodilo za uporabo.
Before use, the syringes are attached to a device supplied with the medicine that allows their contents to mix as they are dripped or sprayed on the wound.
Pred uporabo se injekcijski brizgi pritrdita na pripomoček, priložen zdravilu, ki omogoča, da se njuni vsebini zmešata med nanosom na rano s kapljanjem ali pršenjem.
How is VeraSeal used?
Kako se zdravilo VeraSeal uporablja?
In a second study of organ surgery, VeraSeal was as effective as another product Surgicel: 93% of the patients had no bleeding 4 minutes after treatment with VeraSeal (103 out of 111), while 81% of the patients had no bleeding with Surgicel (91 out of 113).
V drugi študiji pri kirurškem posegu na organih je bilo zdravilo VeraSeal enako učinkovito kot drugo zdravilo, zdravilo Surgicel: po štirih minutah ni več krvavelo 93 % (103 od 111) bolnikov , zdravljenih z zdravilom VeraSeal, in 81 % (91 od 113) bolnikov, zdravljenih z zdravilom Surgicel.
How does VeraSeal work?
Kako zdravilo VeraSeal deluje?
In one study of blood vessel surgery, VeraSeal worked better than manual compression, with 76% of patients having no bleeding 4 minutes after treatment with VeraSeal (83 out of 109), compared with 23% after manual compression (13 out of 57).
V študiji pri kirurškem posegu na žilah je zdravilo VeraSeal delovalo bolje kot ročna kompresija, pri čemer 76 % (83 od 109) bolnikov, zdravljenih z zdravilom VeraSeal, po štirih minutah ni več krvavelo, delež takšnih bolnikov, zdravljenih z ročno kompresijo, pa je bil 23 % (13 od 57 bolnikov).
Finally, in a third study of soft tissue surgery, VeraSeal was as effective as Surgicel: 83% of the patients had no bleeding 4 minutes after treatment with VeraSeal (96 out of 116), compared with 78% of the patients after treatment with Surgicel (84 out of 108).
V tretji študiji pri kirurškem posegu na mehkih tkivih je bilo zdravilo VeraSeal enako učinkovito kot zdravilo Surgicel: po štirih minutah ni več krvavelo 83 % (96 od 116) bolnikov, zdravljenih z zdravilom VeraSeal, in 78 % (84 od 108) bolnikov, zdravljenih z zdravilom Surgicel.
VeraSeal is a sealant (glue) used to stop bleeding during surgery or to support stitches during surgery on blood vessels.
Zdravilo VeraSeal je lepilo za tkiva, ki se uporablja za ustavitev krvavitve med kirurškim posegom ali kot opora šivom med kirurškim posegom na žilah.
Thromboembolic complications (blood clots) may occur if VeraSeal is accidentally injected into a blood vessel.
Če se zdravilo VeraSeal nenamerno injicira v žilo, lahko nastanejo trombembolični zapleti (krvni strdki).
18 weeks.
18 tednov.
MN HAI MN HAI MN HAI MN HAI
Preiskovanci s 4-kratnim porastom protiteles (odstotek) MN HAI MN HAI MN HAI MN HAI
The safety and efficacy of the vaccine in this population has not been established.
Varnost in učinkovitost tega cepiva v tej populaciji nista ugotovljeni.
Small white particles may be present.
Vsebuje lahko majhne bele delce.
Age range as described in the protocol for the study.
Razpon starosti, kot je opisan v protokolu študije.
Two doses are recommended for all children and adolescents.
Za vse otroke in mladostnike sta priporočena dva odmerka.
See section 5 for advice on storage and disposal.
Glejte 5. poglavje za nasvet o shranjevanju in odstranjevanju.
.......................................................................................................per 0.2 ml dose
.......................................................................................................na 0,2-ml odmerek
It spreads rapidly around the world.
Pandemska gripa se hitro širi po vsem svetu.