natgillin/translations-raw huggingface dataset:
During a pandemic, the virus strain in the vaccine will have to be replaced by the strain causing the pandemic before the vaccine can be used.
Med pandemijo bo sev virusa v cepivu nadomeščen s sevom, ki povzroča pandemijo, preden bo cepivo mogoče uporabljati.
This vaccine contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1.
To cepivo vsebuje majhno količino hemaglutininov (beljakovin s površine) virusa, imenovanega H5N1.
Other information about Pumarix
Druge informacije o zdravilu Pumarix :
One main study involving 680 adults compared Pumarix given as two doses three weeks apart with Pandemrix H5N1 (another pandemic influenza vaccine) and also compared Pumarix given with and without an adjuvant.
V eni glavni študiji, v kateri je sodelovalo 680 odraslih, so cepivo Pumarix v dveh odmerkih v tritedenskem razmiku primerjali s cepivom Pandemrix H5N1 (drugo cepivo proti pandemski gripi), pa tudi uporabo z adjuvansom ali brez njega.
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Pumarix cepivo proti pandemski gripi (H5N1) (z delci virionov, inaktivirano, z adjuvansom)
What information is still awaited for Pumarix?
Katere informacije o zdravilu Pumarix še pričakujemo?
However, it may be appropriate to give the vaccine to these patients during a pandemic, as long as facilities for resuscitation are available.
Med pandemijo je cepljenje teh oseb morda vseeno upravičeno, vendar mora biti na voljo oprema za oživljanje.
The second study showed that Pumarix was able to trigger the production of antibodies to a level high enough to meet CHMP criteria.
Druga študija je pokazala, da je cepivo Pumarix sposobno sprožiti nastanek protiteles na ravni, ki ustreza merilom CHMP.
The study also showed that Pumarix triggered the production of more antibodies when given with an adjuvant than when given without.
Študija je pokazala tudi, da cepivo Pumarix spodbudi nastanek več protiteles, kadar je uporabljeno z adjuvansom kot brez njega.
What is the risk associated with Pumarix?
Kakšna tveganja so povezana z zdravilom Pumarix?
In the first study, the immunogenicity of Pumarix was shown to be comparable to that of the comparator vaccine.
Prva študija je pokazala, da cepivo Pumarix sproži primerljivo imunogenost kot primerjalno cepivo.
A flu pandemic happens when a new strain of flu virus appears that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Do pandemije pride, ko se pojavi nov sev virusa gripe, ki se med ljudmi hitro širi, ker proti njemu niso imuni (oziroma pred njim niso zaščiteni).
Pumarix is a vaccine to protect against ‘pandemic' flu.
Zdravilo Pumarix je cepivo za zaščito pred pandemsko gripo.
Why has Pumarix been approved?
Zakaj je bilo zdravilo Pumarix odobreno?
Pumarix is a ‘mock-up' vaccine.
Zdravilo Pumarix je „modelno“ cepivo.
How has Pumarix been studied?
Kako je bilo zdravilo Pumarix raziskano?
Pumarix is a vaccine that is given by injection.
Zdravilo Pumarix je cepivo za injiciranje.
How does Pumarix work?
Kako zdravilo Pumarix deluje?
How is Pumarix used?
Kako se zdravilo Pumarix uporablja?
What is Pumarix used for?
Za kaj se zdravilo Pumarix uporablja?
What is Pumarix?
Kaj je zdravilo Pumarix?
Adopted at the 2-5 September 2019 PRAC
Sprejeto na seji odbora PRAC med 2. in 5. septembrom 2019
2 Canagliflozin; canagliflozin, metformin; dapagliflozin; dapagliflozin, metformin; empagliflozin; empagliflozin, metformin; empagliflozin, linagliptin; ertugliflozin, metformin; ertugliflozin, sitagliptin; saxagliptin, dapagliflozin
4 Kanagliflozin; kanagliflozin, metformin; dapagliflozin; dapagliflozin, metformin; empagliflozin; empagliflozin, metformin; empagliflozin, linagliptin; ertugliflozin, metformin; ertugliflozin, sitagliptin; saksagliptin, dapagliflozin
In both cases, tTreatment with <product name> may be restarted once when the ketone values are normal and the patient's condition has stabilised.
V obeh primerih je mogoče dapagliflozinZdravljenje z zdravilom <ime zdravila> je mogoče znova uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
EMA/PRAC/474668/2019
EMA/PRAC/501726/2019 Corr2
Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment.
Zdi se, da te reakcije bolnike najbolj ogrožajo v zgodnjem obdobju zdravljenja, saj se reakcija večinoma pojavi v prvem mesecu zdravljenja.
Latency from the initiation of treatment with ibrutinib to the onset of ischemic central nervous vascular conditions was in the most cases after several months (more than 1 month in 78% and more than 6 months in 44% of cases) emphasizing the need for regular monitoring of patients (please see section 4.4 Cardiac arrhythmia and Hypertension and section 4.8).
Latenca od začetka zdravljenja z ibrutinibom do pojava ishemičnih žilnih bolezni osrednjega živčevja je večinoma znašala nekaj mesecev (več kot 1 mesec v 78 % in več kot 6 mesecev v 44 % primerov), kar poudarja potrebo po rednem spremljanju bolnikov (glejte poglavje 4.4, Srčne aritmije in Hipertenzija, ter poglavje 4.8).
Frequency “Not known”
Neznana pogostnost
Tell a doctor straight away if you notice any of the following side effects: Uncommon (may affect up to 1 in 100 people): temporary episode of neurologic dysfunction caused by loss of blood flow, stroke.
Nemudoma obvestite svojega zdravnika, če opazite katerega od naslednjih neželenih učinkov: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov): začasna epizoda nevrološke disfunkcije, ki jo povzroči izguba pretoka krvi, možganska kap.
Footnotes:
Opombe:
Stop using <product name> if you develop these symptoms and seek medical attention immediately.
Če se pri vas pojavijo ti simptomi, prenehajte uporabljati zdravilo <ime zdravila> in takoj poiščite zdravniško pomoč.
A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis).
Rdeč, luskast razširjen izpuščaj s podkožnimi bulicami in mehurji, predvsem v kožnih gubah, na trupu in zgornjih okončinah, ki ga spremlja povišana telesna temperatura, na začetku zdravljenja (akutna generalizirana eksantemska pustuloza).
2 The following text should replace any current information regarding serious skin reactions in section Warnings and precautions.
2 Naslednje besedilo mora v poglavju „Opozorila in previdnostni ukrepi“ nadomestiti vsako trenutno obstoječo informacijo o resnih kožnih reakcijah.
Special warnings and precautions for use Diabetic ketoacidosis
Posebna opozorila in previdnostni ukrepi Diabetična ketoacidoza
Sodium-glucose co-transporter 2 (SGLT2) inhibitors2New information on the known association between SGLT2 inhibitors and diabetic ketoacidosis in surgical patients (EPITT no 19355)
Zaviralci natrij-glukoznega soprenašalca 2 (SGLT2)4nove informacije o znani povezavi med zaviralci SGLT2 in diabetično ketoacidozo pri kirurških bolnikih (št. EPITT
Ibuprofen should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.
Ibuprofen je treba ukiniti ob prvem pojavu znakov in simptomov hudih kožnih reakcij, kot so kožni izpuščaj in lezije na sluznicah, ali drugih znakih preobčutljivosti.
Teriflunomide - Psoriasis (EPITT no 19366)
Teriflunomid - psoriaza (št. EPITT 19366)
Ibuprofen - Acute generalised exanthematous pustulosis (AGEP) (EPITT no 19409)
Ibuprofen - akutna generalizirana eksantemska pustuloza (AGEP)(št. EPITT 19409)
1 Only if the already existing AGEP ADR in section 4.8 is listed specifically for pseudoephedrine.
1 Samo če je že obstoječi neželeni učinek, tj. akutna generalizirana eksantemska pustuloza, v poglavju 4.8 že naveden posebej za psevdoefedrin.
For ibuprofen and pseudoephedrine combinations 4.4.
Za ibuprofen v kombinacijah s psevdoefedrinom 4.4.
Serious skin reactions have been reported in association with <product name> treatment.
V povezavi z zdravilom <ime zdravila> so poročali o resnih kožnih reakcijah.
Tabulated list of adverse reactions Skin and subcutaneous tissue disorders Frequency not known: Psoriasis (including pustular psoriasis)b b: see section 4.4
Neznana pogostnost: Psoriaza (vključno s pustulozno psoriazo)b b: Glejte poglavje 4.4
For ibuprofen monotherapy or ibuprofen in combinations excluding combinations with pseudoephedrine
Za monoterapijo z ibuprofenom ali ibuprofen v kombinacijah, razen kombinacij s psevdoefedrinom 4.4.
New onset of psoriasis (including pustular psoriasis) and worsening of pre-existing psoriasis have been reported during the use of teriflunomide.
Ob uporabi teriflunomida so poročali o novem pojavu psoriaze (vključno s pustulozno psoriazo) in poslabšanju že obstoječe psoriaze.
Uncommon: cerebrovascular accident, transient ischaemic attack, ischaemic stroke
Občasni: cerebrovaskularni insult, prehodni ishemični napad, ishemična možganska kap
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely in association with the use of NSAIDSs (see section 4.8).
V zvezi z uporabo nesteroidnih protivnetnih zdravil (NSAID) so zelo redko3 poročali o resnih kožnih reakcijah, pri čemer so bile nekatere od njih smrtne, vključno z eksfoliativnim dermatitisom, StevensJohnsonovim sindromom in toksično epidermalno nekrolizo (glejte poglavje 4.8).
You should stop taking <product name> and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction.
Če se pri vas pojavijo kakršni koli kožni izpuščaji, lezije na sluznicah, mehurji ali drugi znaki alergije, morate zdravilo <ime zdravila> nemudoma prenehati jemati in poiskati zdravniško pomoč, saj so to lahko prvi znaki zelo resne kožne reakcije.
Ibrutinib - Ischaemic stroke (EPITT no 19369)
Ibrutinib - ishemična možganska kap (št. EPITT 19369)
Warnings and precautions - Take special care with <product name> Skin reactions2
Kaj morate vedeti, preden boste uporabili zdravilo <ime zdravila> Opozorila in previdnostni ukrepi - Pri uporabi zdravila <ime zdravila> bodite posebej previdni: Kožne reakcije2
Treatment withdrawal and initiation of an accelerated elimination procedure may be considered taking into account patient's disease and medical history.
Ob upoštevanju bolnikove bolezni in anamneze je smiselno razmisliti o ukinitvi zdravljenja in začetku postopka pospešenega izločanja.
Special warnings and precautions for use Severe skin reactions
Posebna opozorila in previdnostni ukrepi Kožne reakcije
Severe skin reactions such as acute generalised exanthematous pustulosis (AGEP) may occur with ibuprofen and pseudoephedrine-containing products.
Pri zdravljenju z ibuprofenom in zdravili, ki vsebujejo psevdoefedrin, se lahko pojavijo hude kožne reakcije, npr. akutna generalizirana eksantemska pustuloza (AGEP).
Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products.
V povezavi z zdravili, ki vsebujejo ibuprofen, so poročali o akutni generalizirani eksantemski pustulozi (AGEP).
Severe skin reactions
Bolezni živčevja
The majority of these reactions were of mild to moderate severity and were not long lasting.
Večina teh reakcij je bila blagih do zmernih in niso bile dolgoročne.
The children were followed up until the end of their second year of life.
Otroke so spremljali do konca drugega leta življenja.
The children were followed up for an average of around 2 years.
V povprečju so otroke spremljali približno dve leti.
Additional studies looked at the effects of booster vaccinations and vaccinations in older infants and children.
V dodatnih študijah so proučevali učinke obnovitvenih cepljenj in cepljenj pri starejših dojenčkih in otrocih.
The vaccine is given by injection into the thigh muscle in infants or into the shoulder muscle in young children.
Cepivo se daje z injekcijo v stegensko mišico pri dojenčkih ali v ramensko mišico pri majhnih otrocih.
The full EPAR for Synflorix 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 Synflorix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The vaccine is also adsorbed (fixed) onto an aluminium compound to stimulate a better response.
Cepivo je tudi „adsorbirano“ (vezano) na površino aluminijeve spojine, kar spodbudi boljši odziv.
This is a summary of the European public assessment report (EPAR) for Synflorix.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Synflorix.
In Europe, it is estimated that these are responsible for 56 to 90% of the cases of invasive disease caused by S. pneumoniae in children under the age of 5 years.
V Evropi se ocenjuje, da ti vplivajo na 56 do 90 % primerov invazivne bolezni, ki jih povzroča bakterija S. pneumoniae pri otrocih, mlajših od pet let.
The vaccination schedule for Synflorix depends on the age of the child and should be based on official recommendations.
Shema cepljenja za zdravilo Synflorix je odvisna od starosti otroka in mora temeljiti na uradnih priporočilih.
The European Commission granted a marketing authorisation valid throughout the European Union for Synflorix on 30 March 2009.
Evropska komisija je dovoljenje za promet z zdravilom Synflorix, veljavno po vsej Evropski uniji, izdala 30. marca 2009.
What measures are being taken to ensure the safe and effective use of Synflorix?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Synflorix?
For the three additional polysaccharides (1, 5, 7F), Synflorix was effective in triggering the production of antibodies.
Pri treh dodatnih polisaharidih (1, 5, 7F), je bilo zdravilo Synflorix učinkovito pri sprožanju tvorbe protiteles.
Synflorix contains the polysaccharides from ten different types of S. pneumoniae (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).
Zdravilo Synflorix vsebuje polisaharide iz desetih različnih vrst bakterije S. pneumoniae (serotipe 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F in 23F).
Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend the body against the infection.
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj brani telo pred okužbami.
The children received one dose of Synflorix in the first study and two doses in the second study.
Otroci so prejeli en odmerek zdravila Synflorix v prvi študiji in dva odmerka v drugi študiji.
However, children aged under 6 months with conditions that make them more likely to catch these invasive diseases, such as those with human immunodeficiency virus (HIV) infection, sickle cell disease or spleen problems, should be given three doses followed by a booster dose.
Vendar morajo otroci, mlajši od šest mesecev, z boleznimi, zaradi katerih so bolj dovzetni za okužbo s temi invazivnimi boleznimi, kot je na primer okužba z virusom humane imunske pomanjkljivosti (HIV), boleznijo srpastih celic ali težavami z vranico, prejeti tri odmerke, katerim sledi obnovitveni odmerek.
The most common side effects with Synflorix (which may affect more than 1 in 10 people) are pain, redness and swelling at the injection site, fever, drowsiness, irritability and loss of appetite.
Najpogostejši neželeni učinki zdravila Synflorix (ki se lahko pojavijo pri več kot 1 bolniku od 10) so bolečina, pordelost in oteklina na mestu injiciranja, vročina, zaspanost, razdražljivost in izguba teka.
Other information about Synflorix
Druge informacije o zdravilu Synflorix
Invasive disease results from the bacterium spreading through the body causing serious infections such as septicaemia (blood infection), meningitis (infection of the membranes around the brain and spine) and pneumonia.
Invazivna bolezen nastopi, ko se bakterija razširi po telesu, kar povzroči resne okužbe, kot sta septikemija (okužba krvi), meningitis (okužba membran, ki obdajajo možgane in hrbtenjačo) in pljučnica.
The percentage of children who had bacterial pneumonia was 2.3% (240 out of over 10,000) among those given Synflorix compared with 3% (304 out of over 10,000) among those given the comparator.
Odstotek otrok z bakterijsko pljučnico je bil 2,3 % (240 od več kot 10 000) med tistimi, ki so prejemali zdravilo Synflorix, v primerjavi s 3 % (304 od več kot 10 000) med tistimi, ki so prejemali primerjalno cepivo.
Synflorix is available as a suspension for injection.
Zdravilo Synflorix je na voljo v obliki suspenzije za injiciranje.
These polysaccharides have been purified, then conjugated (attached) to a carrier to help them to be recognised by the immune system.
Ti polisaharidi se prečistijo in nato „konjugirajo“ (vežejo) na nosilec, zaradi česar jih imunski sistem lahko prepozna.
The response to Synflorix in 2 to 5 year olds was similar to the younger age group, with better results in children who received two doses.
Odziv na zdravilo Synflorix pri skupini od dveh do pet let je bil podoben kot pri mlajši starostni skupini, pri čemer so bili boljši rezultati pri otrocih, ki so prejeli dva odmerka.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Synflorix have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Synflorix upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
In particular, two clinical studies in children aged 2 to 5 years investigated the ability of Synflorix to produce antibodies in this age group compared with other age groups.
Zlasti so v dveh kliničnih študijah z otroki, starih od 2 do 5 let, proučevali zmožnost zdravila Synflorix, da tvori protitelesa v tej starostni skupini, v primerjavi z drugimi starostnimi skupinami.
• When Synflorix is given as part of a routine infant immunisation programme (when all infants in an area are vaccinated at around the same time), a course of two doses may be given 2 months apart, from the age of 6 weeks, followed by a booster dose at least 6 months later.
• Kadar se zdravilo Synflorix daje kot del rutinskega programa cepljenja dojenčkov (kadar se vsi dojenčki na območju cepijo približno isti čas), se lahko daje sklop dveh odmerkov v razmaku dveh mesecev, od starosti šest tednov dalje, temu pa sledi obnovitveni odmerek najmanj šest mesecev pozneje.
For more information about treatment with Synflorix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Synflorix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The ability of Synflorix to trigger the production of antibodies (immunogenicity) was assessed in one main study involving 1,650 healthy infants aged between 6 and 12 weeks.
Učinkovitost cepiva Synflorix pri sprožanju nastanka protiteles (imunogenosti) so ocenjevali v eni glavni študiji, v kateri je sodelovalo 1 650 zdravih dojenčkov, starih od šest do 12 tednov.
It is used to protect infants and children aged between 6 weeks and 5 years against invasive disease, pneumonia (infection of the lungs) and acute otitis media (infection of the middle ear) caused by S. pneumoniae.
Uporablja se za zaščito dojenčkov in otrok, starih od šest tednov do pet let, pred invazivno boleznijo, pljučnico (okužbo pljuč) in akutnim vnetjem srednjega ušesa, ki ga povzroča bakterija S. pneumoniae.
In studies in infants and older children, although Synflorix produced a lower antibody response than the comparator vaccine, it fulfilled pre-defined criteria and was considered acceptable in this group.
V študijah z dojenčki in starejšimi otroki so bila, čeprav je bil pri zdravilu Synflorix manjši odziv na protitelesa kot pri primerjalnem cepivu, izpolnjena vnaprej določena merila, zato je zdravilo veljalo za sprejemljivo v tej skupini.
The Agency also noted that Synflorix contains additional polysaccharides from the types of S. pneumoniae that are responsible for disease in Europe and therefore decided that Synflorix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Ugotovila je tudi, da vsebuje zdravilo Synflorix dodatne polisaharide iz vrst bakterije S. pneumoniae, ki povzročajo bolezen v Evropi, zato je sklenila, da so koristi zdravila Synflorix večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
For practical information about using Synflorix, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Synflorix naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Synflorix was effective in protecting against invasive disease: no cases were seen among the 10,000 children given three doses of Synflorix and a booster dose, one case occurred among the 10,000 children given two doses of Synflorix and a booster dose and 12 cases occurred in 10,000 children given the comparator vaccine.
Zdravilo Synflorix je bilo učinkovito pri zaščiti pred invazivno boleznijo: med 10 000 otroki, ki so prejeli tri odmerke zdravila Synflorix in obnovitveni odmerek, ni bilo primerov; en primer se je pojavil pri 10 000 otrocih, ki so prejeli dva odmerka zdravila Synflorix in obnovitveni odmerek; in 12 primerov se je pojavilo pri 10 000 otrocih, ki so prejeli primerjalno cepivo.
Synflorix was as effective as the comparator in triggering the production of antibodies against five of the polysaccharides that the two vaccines shared in common (4, 9V, 14, 18C and 19F), but it was less effective than the comparator for two (6B and 23F).
Zdravilo Synflorix je bilo enako učinkovito kot primerjalno cepivo pri sprožanju tvorbe protiteles proti petim polisaharidom (4, 9V, 14, 18C in 19F), ki so skupni obema cepivoma, vendar je bilo pri dveh (6B in 23F) manj učinkovito od primerjalnega cepiva.
The studies showed that Synflorix led to an increase in antibody production following booster vaccinations.
Tri študije so pokazale, da je zdravilo Synflorix povzročilo povečano tvorb protiteles po obnovitvenih cepljenjih.
What benefits of Synflorix have been shown in studies?
Kakšne koristi je zdravilo Synflorix izkazalo v študijah?
A fourth (‘booster') dose is recommended at least 6 months after the third dose, preferably when the child is between 12 and 15 months of age.
Četrti (obnovitveni) odmerek se priporoča najmanj šest mesecev po tretjem odmerku, po možnosti pri starosti otroka med 12 in 15 mesecev.
What is Synflorix and what is it used for?
Kaj je zdravilo Synflorix in za kaj se uporablja?
Synflorix was also investigated in a large study involving around 24,000 children aged between 6 and 16 weeks that focussed mainly on the vaccine's benefit in preventing community acquired pneumonia.
Zdravilo Synflorix so proučevali tudi v večji študiji s približno 24 000 otroki, starih od šest do 16 tednov, katere cilj je bil predvsem ugotoviti koristi cepiva pri preprečevanju zunajbolnišnične pljučnice.
The occurrence of the first episode of acute otitis media caused by S. pneumoniae was approximately halved among children who were given the investigational vaccine compared with those given the comparator.
Pojavitev prve epizode akutnega vnetja srednjega ušesa, ki ga povzroča bakterija S. pneumoniae, je bila približno dvakrat manjša pri otrocih, ki so prejeli cepivo v preskušanju, v primerjavi z otroki, ki so prejeli primerjalno cepivo.
What are the risks associated with Synflorix?
Kakšna tveganja so povezana z zdravilom Synflorix?