FrancophonIA/ELRC3.0 huggingface dataset:
English: Section 4.4 - Special warnings and precautions for use The wording of the core safety profile (CSP), currently approved in the context of the PSUR worksharing procedure number GR/H/PSUR/0001/001, was proposed by the MAH for the harmonised SmPC.
Slovenian: Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi Za usklajeni povzetek glavnih značilnosti zdravila je imetnik dovoljenja za promet z zdravilom predlagal besedilo osnovnega varnostnega profila (CSP), ki je trenutno odobreno v okviru postopka delitve dela PSUR številka GR/H/PSUR/0001/001.
English: A statement regarding the absence of specific interaction studies has been added to the SmPC by the MAH and agreed by the CHMP.
Slovenian: V povzetek glavnih značilnosti zdravila je bila dodana izjava o odsotnosti posebnih študij medsebojnega delovanja, s čimer se je odbor CHMP strinjal.
English: 3 Lucas JC, Karikas G, Gazouli M, et al. Pharmacokinetics of teicoplanin in an ICU population of children and infants.
Slovenian: 3 Lucas JC, Karikas G, Gazouli M, in sod.
English: In keeping with the adult studies, the clinical cure was > 80%.
Slovenian: Pri študijah z odraslimi bolniki je bila klinična ozdravitev
English: In the paediatric population, an adverse reaction was not reported most cases of teicoplanin overdose;
Slovenian: Pri pediatrični populaciji pri večini primerov prevelikega odmerka niso poročali o neželenem učinku teikoplanina; k agitaciji in bruhanju so lahko prispevala sočasna zdravljenja ali klinični primeri.
English: Following all the changes in the SPC there are several corresponding changes to the Package Leaflet.
Slovenian: Po spremembah povzetka glavnih značilnosti zdravila so uvedli več ustreznih sprememb še v navodilo za uporabo.
English: A warning has been included in sections 4.4 and 4.8 of the SmPC that patients should be especially monitored for adverse reactions when the higher dosage of 12mg/kg bid is administered.
Slovenian: V poglavjih 4.4 in 4.8 povzetka glavnih značilnosti zdravila je bilo vključeno opozorilo, da je treba pri odmerku, višjem od 12 mg/kg dvakrat na dan, bolnike skrbno nadzorovati zaradi možnega pojava neželenih učinkov.
English: Since safety data for the loading dose of12mg/kg bid (24mg/kg/day) is limited, the MAH has been requested by the CHMP to conduct a post-authorisation safety study (PASS) to evaluate the safety of the higher loading dose of 12mg/kg bid.
Slovenian: Študija o varnosti zdravila po pridobitvi dovoljenja za promet Ker so varnostni podatki za polnilni odmerek 12 mg/kg dvakrat na dan (24 mg/kg/dan) omejeni, je odbor CHMP imetnika dovoljenja za promet z zdravilom pozval, da izvede študijo o varnosti zdravila po pridobitvi dovoljenja za promet, da oceni varnost polnilnega odmerka, višjega od 12 mg/kg dvakrat na dan.
English: Regarding Enterococcus spp., the resistance breakpoint for teicoplanin has been reduced to >2 mg/ml to avoid erroneous reporting of isolates with Van-A-mediated resistance.
Slovenian: je bila mejna vrednost odpornosti za teikoplanin znižana na > 2 mg/ml, da bi se izognili napačnemu poročanju o izolatih odpornosti, posredovane z genom van-A. Za koagulaza-negativne stafilokoke (CoNS) je mejna vrednost odpornosti > 4 mg/ml.
English: In accordance with the CHMP guideline and the SmPC Guideline, the applicant has also inserted information with regard to fertility.
Slovenian: Predlagatelj je skladno s smernicami odbora CHMP in smernicami za povzetek glavnih značilnosti zdravila vključil tudi informacije o plodnosti.
English: the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Targocid and associated names (see Annex I).
Slovenian: • Odbor se je strinjal s predlagano uskladitvijo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo, kot jih je predlagal imetnik dovoljenja za promet z zdravilom, je Odbor CHMP priporočil spremembo pogojev dovoljenj za promet z zdravilom, za katera so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo določeni v Prilogi III za zdravilo Targocid in povezana imena (glejte Prilogo I).
English: monograph for teicoplanin.
Slovenian: za teikoplanin.
English: monograph for microbiological assay of antibiotics.
Slovenian: Učinkovitost zdravilne učinkovine teikoplanin je bila preskušena v skladu z monografijo Evropske farmakopeje za mikrobiološko določanje antibiotikov.
English: Other studies were also discussed by the MAH.
Slovenian: Imetnik dovoljenja za promet z zdravilom je razpravljal tudi o drugih študijah.
English: This information has been proposed by the MAH in the harmonised SmPC and was considered to be acceptable by the CHMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal vključitev teh informacij v usklajen povzetek glavnih značilnosti zdravila, kar je bilo za odbor CHMP sprejemljivo.
English: Section 4.2 - Posology and method of administration Posology
Slovenian: Poglavje 4.2 - Odmerjanje in način uporabe
English: EU/1/14/937/001 Gazyvaro
Slovenian: EU/1/14/937/001
English: (Invented) name Strength Pharmaceutical Form
Slovenian: Številka postopka EMA (Izmišljeno) ime Jakost Farmacevtska oblika
English: 1000 mg Concentrate for solution for infusion
Slovenian: 1000 mg koncentrat za raztopino za infundiranje intravenska uporaba viala (steklo) 40 ml
English: Date of first authorisation: 25 June 2007 Date of latest renewal: 14 May 2012
Slovenian: Datum prve odobritve: 25. junij 2007 Datum zadnjega podaljšanja: 14. maj 2012
English: Tell your doctor immediately if you:
Slovenian: Takoj obvestite zdravnika če:
English: • problems with speech
Slovenian: • težave z govorom
English: Not known: frequency cannot be estimated from the available data
Slovenian: Neznana: pogostnosti neželenih učinkov ni mogoče oceniti iz razpoložljivih podatkov
English: All tablets are available in the following pack sizes:
Slovenian: Vse tablete so na voljo v naslednjih velikostih pakiranj:
English: - if you have Parkinson's disease or Dementia.
Slovenian: - Če imate Parkinsonovo bolezen ali demenco.
English: - if you have epilepsy.
Slovenian: - Če imate epilepsijo.
English: Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.
Slovenian: Trenutno dostopni podatki so opisani v poglavjih 4.8 in 5.1, vendar priporočil za odmerjanje ne moremo podati.
English: Initial dose titration is not required.
Slovenian: Titracija začetnega odmerka ni potrebna.
English: The difference is unlikely to be of clinical relevance, though.
Slovenian: Vendar ni verjetno, da bi imela razlika kliničen pomen.
English: It should be noted that a broader spectrum of symptoms are included that do not necessarily have an extrapyramidal origin.
Slovenian: Treba je opozoriti, da je vključen širši spekter simptomov, ki niso nujno ekstrapiramidnega izvora.
English: Establish and maintain a clear airway and ensure adequate oxygenation and ventilation.
Slovenian: Zagotovite in ohranjajte proste dihalne poti ter zagotovite zadostno oksigenacijo in ventilacijo.
English: There was no clear dose relationship.
Slovenian: Jasne povezave z odmerkom ni bilo.
English: Note: Negative change in score indicates improvement.
Slovenian: Opomba: Negativna sprememba rezultata pomeni izboljšanje.
English: Close supervision and monitoring should continue until the patient recovers.
Slovenian: Strog nadzor in spremljanje bolnika naj trajata vse do okrevanja.
English: - if you have prolonged and/or painful erection.
Slovenian: - Če imate podaljšano ali bolečo erekcijo.
English: The terminal elimination half-life of paliperidone is about 23 hours.
Slovenian: Končna razpolovna doba izločanja paliperidona je približno 23 ur.
English: An examination of population subgroups did not reveal any evidence of differential responsiveness on the basis of gender, age, or geographic region.
Slovenian: Pri raziskavi podskupin populacij niso opazili nikakršnih dokazov za različno odzivnost glede na spol, starost ali geografsko območje.
English: This difference is largely explained by differences in lean body mass and creatinine clearance between men and women.
Slovenian: To razliko v veliki meri pojasnijo razlike v pusti telesni masi in očistku kreatinina med ženskami in moškimi.
English: It takes 2-3 weeks for full induction to be achieved and upon discontinuation of the inducer the effect wears off over a similar time period.
Slovenian: Polna indukcija se doseže v 2-3 tednih in po ukinitvi indukcijski učinek izzveni v podobnem časovnem obdobju.
English: Paediatric population Interaction studies have only been performed in adults.
Slovenian: Pediatrična populacija Študije medsebojnega delovanja so izvedli samo pri odraslih.
English: Subjects were 12-17 years of age and met DSM-IV criteria for schizophrenia.
Slovenian: Preiskovanci so bili stari od 12-17 let in so izpolnjevali kriterije DSM-IV za shizofrenijo.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: For all 3 studies, an active control (olanzapine at a dose of 10 mg) was included.
Slovenian: Pri vseh treh študijah so uporabili tudi aktivno kontrolo (olanzapin v odmerku 10 mg).
English: In some cases, a prior increase in body weight has been reported which may be a predisposing factor.
Slovenian: V nekaterih primerih so poročali o predhodnem povečanju telesne mase kot o možnem dejavniku tveganja.
English: This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.
Slovenian: To je treba upoštevati v primerih, ko je potrebna popolna pozornost (npr. pri upravljanju vozil in strojev).
English: People with this disorder may also feel depressed, anxious, guilty, or tense.
Slovenian: Osebe s to motnjo se lahko počutijo tudi depresivne, zaskrbljene ali napete in imajo občutek krivde.
English: What INVEGA is and what it is used for
Slovenian: Kaj je zdravilo INVEGA in za kaj ga uporabljamo
English: No in vivo data are available and the clinical relevance is unknown.
Slovenian: In vivo podatki ne obstajajo, klinični pomen pa ni znan.
English: LOCF = last observation carried forward.
Slovenian: LOCF (last observation carried forward) = zadnje opazovanje, preneseno naprej.
English: This depends on how well the medicine works for you.
Slovenian: To je odvisno od tega, kako dobro bo zdravilo pri vas delovalo.
English: Pregnancy There are no adequate data from the use of paliperidone during pregnancy.
Slovenian: Nosečnost Ni zadostnih podatkov o uporabi paliperidona med nosečnostjo.
English: The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from the available data).
Slovenian: Pri navajanju pogostnosti neželenih učinkov so uporabljeni naslednji izrazi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: What you need to know before you take INVEGA
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo INVEGA
English: All tested doses of INVEGA separated from placebo on day 4 (p < 0.05).
Slovenian: Vsi preizkušeni odmerki zdravila INVEGA so se ločili od placeba na 4. dan (p < 0,05).
English: You should not take this medicine during pregnancy unless this has been discussed with your doctor.
Slovenian: V času nosečnosti ne smete jemati tega zdravila, razen če ste se o tem posvetovali s svojim zdravnikom.
English: If you miss one dose, take your next dose on the day following the missed dose.
Slovenian: Če izpustite en odmerek, vzemite naslednji odmerek dan po izpuščenem odmerku.
English: Association with ketoacidosis has been reported very rarely and rarely with diabetic coma.
Slovenian: O povezavi s ketoacidozo so poročali zelo redko in redko o povezavi z diabetično komo.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite da bi lahko bili noseči ali načrtujete zanositev, se posvetujte s svojim zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: A 15 mg dose was also included in Study R076477-SCH-305, but results are not presented since this is above the maximum recommended daily dose of 12 mg.
Slovenian: V študiji R076477-SCH-305 so uporabili tudi 15 mg odmerek, vendar ti rezultati niso vključeni zgoraj, ker ta odmerek presega največji priporočeni dnevni odmerek 12 mg.
English: Paliperidone was not teratogenic in animal studies, but other types of reproductive toxicity were observed (see section 5.3).
Slovenian: V študijah na živalih paliperidon ni bil teratogen, vendar so opazili druge vrste reprodukcijske toksičnosti (glejte poglavje 5.3).
English: How and when to take INVEGA
Slovenian: Kako in kdaj jemati zdravilo INVEGA
English: Appropriate clinical monitoring is advisable in accordance with utilised antipsychotic guidelines.
Slovenian: Priporoča se ustrezno klinično spremljanje v skladu z znanimi priporočili za antipsihotike.
English: Patients with severe neutropenia (absolute neutrophil count < 1 x 10
Slovenian: Pri bolnikih s hudo nevtropenijo (absolutno število nevtrofilcev < 1, 0 x 10
English: If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.
Slovenian: Če menite, da je kombiniranje teh zdravil kljub temu potrebno, še posebej v končnem stadiju Parkinsonove bolezni, pa lahko bolniku predpišete najmanjši še učinkovit odmerek vsakega od teh zdravil.
English: This is because it is not known if INVEGA is safe or effective in these age groups.
Slovenian: Ni znano ali je uporaba zdravila INVEGA v teh starostnih skupinah varna ali učinkovita.
English: INVEGA can help alleviate the symptoms of your disease and stop your symptoms from coming back.
Slovenian: Zdravilo INVEGA pomaga ublažiti simptome vaše bolezni in prepreči njihovo ponovitev.
English: Aripiprazole 5-15 mg N=114
Slovenian: aripiprazol 5-15 mg N=114
English: - if you have diseases associated with diarrhoea.
Slovenian: - Če imate bolezni, ki so povezane z drisko.
English: - if you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.
Slovenian: - Če ste imeli vi ali kdo drug v vaši družini krvne strdke, ker je jemanje antipsihotikov lahko povezano z nastankom krvnih strdkov.
English: - if you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
Slovenian: - Če ste že imeli majhno število belih krvnih celic (ki bi jo lahko ali ne povzročilo drugo zdravilo).
English: You should be aware that both of these conditions may be caused by this type of medicine.
Slovenian: se morate zavedati, da ta skupina zdravil lahko povzroči obe opisani stanji.
English: • inappropriate secretion of a hormone that controls urine volume
Slovenian: • nepravilno izločanje hormona, ki uravnava količino urina
English: In addition, the difference in the percentage of patients demonstrating ≥ 20% improvement in PANSS total score at week 26 between the two treatment groups was numerically similar.
Slovenian: Tudi sprememba v odstotku bolnikov z ≥ 20% izboljšanjem v vrednosti PANSS v 26. tednu je bila pri obeh zdravljenih skupinah številčno podobna.
English: If discontinuation during pregnancy is necessary, it should not be done abruptly.
Slovenian: Če je potrebna ukinitev zdravila med nosečnostjo, le-ta ne sme biti nagla.
English: The European Medicines Agency has waived the obligation to submit the results of studies with INVEGA in all subsets of the paediatric population in the treatment of schizoaffective disorders.
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom INVEGA za vse skupine pediatrične populacije pri zdravljenju shizoafektivnih motenj.
English: The absolute oral bioavailability of paliperidone following INVEGA administration is 28% (90% CI of 23%-33%).
Slovenian: Absolutna peroralna biološka uporabnost paliperidona po jemanju zdravila INVEGA znaša 28% (90% CI od 23%-33%).
English: The PANSS is a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement, and anxiety/depression.
Slovenian: PANSS je validiran vprašalnik, sestavljen iz petih delov za ocenjevanje pozitivnih simptomov, negativnih simptomov, neorganiziranih misli, nenadzorovane sovražnosti/razburjenja in tesnobe/depresije.
English: If you miss two or more doses, contact your doctor.
Slovenian: Če pa izpustite dva ali več odmerkov, se posvetujte z zdravnikom.
English: • loss of menstrual periods
Slovenian: • izostanek menstruacije
English: • loss of consciousness, balance disorder, abnormal coordination
Slovenian: • izguba zavesti, motnje ravnotežja, nenormalna koordinacija
English: Elimination of paliperidone decreased with decreasing renal function.
Slovenian: Izločanje paliperidona se zmanjšuje z zmanjševanjem delovanja ledvic.
English: Since this medicine can lower blood pressure, care should be taken when this medicine is taken with other medicines that lower blood pressure.
Slovenian: To zdravilo lahko zniža krvni tlak, zato morate biti previdni, če ga jemljete skupaj z drugimi zdravili, ki tudi znižujejo krvni tlak.
English: INVEGA contains a racemic mixture of (+)- and (-)-paliperidone.
Slovenian: Zdravilo INVEGA vsebuje racemsko mešanico (+) in (-) paliperidona.
English: Parkinson's disease and dementia with Lewy bodies Physicians should weigh the risks versus the benefits when prescribing INVEGA to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotics.
Slovenian: Parkinsonova bolezen in demenca z Lewyevimi telesci Zdravnik mora pretehtati tveganja in koristi predpisovanja zdravila INVEGA bolnikom s Parkinsonovo boleznijo ali demenco z Lewyevimi telesci (DLB), ker imata obe skupini lahko povečano tveganje za pojav nevroleptičnega malignega sindroma in tudi povečano občutljivost na antipsihotike.
English: This medicine should be taken every morning with breakfast or without breakfast, but in the same way every day.
Slovenian: To zdravilo jemljite vsako jutro z zajtrkom ali vsako jutro brez zajtrka, pomembno je le, da ga vzamete na enak način vsak dan.
English: This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.
Slovenian: To znižanje je, v veliki meri, povzročeno s 35 % zvišanjem ledvičnega očistka paliperidona, verjetno zaradi indukcije ledvičnega P-gp s karbamazepinom.
English: • serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing
Slovenian: • resna alergijska reakcija z otekanjem, vključno z grlom, ki lahko vodi v oteženo dihanje
English: Predefined secondary endpoints included the Personal and Social Performance (PSP) scale and the Clinical Global Impression - Severity (CGI-S) scale.
Slovenian: Vnaprej opredeljena sekundarna končna rezultata sta bila: ocena po lestvici osebnega in socialnega delovanja (Personal and Social Performance-PSP) in ocena po lestvici globalnega kliničnega vtisa glede resnosti (Clinical Global Impression for Severity-CGI-S).
English: Four metabolic pathways have been identified in vivo, none of which accounted for more than 6.5% of the dose: dealkylation, hydroxylation, dehydrogenation, and benzisoxazole scission.
Slovenian: In vivo so sicer ugotovili štiri presnovne poti, vendar se po nobeni od njih ne presnovi več kot 6,5% zaužitega odmerka: dealkilacija, hidroksilacija, dehidrogenacija in benzizoksazolska cepitev.
English: Even though paliperidone is a strong D2-antagonist, which is believed to relieve the positive symptoms of schizophrenia, it causes less catalepsy and decreases motor functions to a lesser extent than traditional neuroleptics.
Slovenian: Čeprav je močan antagonist D2 in menijo, da tako ublaži pozitivne simptome shizofrenije, povzroča manj katalepsije in oslabi motorične funkcije v manjši meri kot tradicionalni nevroleptiki.
English: A change in the time of administration of INVEGA may improve the impact of sedation on the patient.
Slovenian: Sprememba v času jemanja zdravila INVEGA lahko izboljša učinek sedacije na bolnika.
English: • leaking milk from the breasts in girls
Slovenian: • izločanje mleka iz prsi pri dekletih
English: • sensation of spinning (vertigo).
Slovenian: • občutek vrtenja (vertigo)
English: Patients should be informed to seek urgent medical care in case that priapism has not been resolved within 3-4 hours.
Slovenian: Bolnike je treba poučiti, da poiščejo zravniško pomoč, če priapizem ne izveni v 2-3 urah.
English: The 1-7 version of the PANSS was used.
Slovenian: Uporabljali so PANSS lestvico (verzije 1-7).
English: In clinical trials with some other atypical antipsychotics, increased risks of death and cerebrovascular accidents have been reported (see section 4.4).
Slovenian: V kliničnih preskušanjih z nekaterimi drugimi atipičnimi antipsihotiki so poročali o povečanem tveganju za smrt in cerebrovaskularne dogodke (glejte poglavje 4.4).
English: A population pharmacokinetic analysis showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Slovenian: Analiza populacijske farmakokinetike je pri kadilcih pokazala malo manjšo izpostavljenost paliperidonu v primerjavi z ne-kadilci.
English: Efficacy was evaluated using the PANSS.
Slovenian: Učinkovitost so ocenili z vprašalnikom PANSS.
English: This effect was not observed after discontinuation of treatment.
Slovenian: Po prenehanju zdravljenja učinka niso opažali.
English: • very low body temperature, a decrease in body temperature
Slovenian: • zelo nizka telesna temperatura, zvečana telesna temperatura
English: No data are available in patients with severe hepatic impairment (Child-Pugh class C).
Slovenian: Ni podatkov o bolnikih s hudo okvaro jeter (razreda C po Child-Pughu).
English: The apparent clearance of paliperidone following INVEGA administration is approximately 19% lower in women than men.
Slovenian: Navidezni očistek paliperidona po jemanju zdravila INVEGA je pri ženskah za približno 19% manjši kot pri moških.
English: The population included subjects with schizoaffective bipolar and depressive types.
Slovenian: V populacijo so bili vključeni preiskovanci s shizoafektivno bipolarno in depresivno motnjo.
English: • decreased oxygen in parts of your body (because of decreased blood flow), flushing
Slovenian: • zmanjšanje kisika v delih telesa (zaradi zmanjšanega pretoka krvi), rdečica
English: Among those treated with risperidone, the mortality was 4% compared with 3.1% for placebo.
Slovenian: Smrtnost pri bolnikih, zdravljenih z risperidonom, je bila 4%, v primerjavi s 3,1% pri placebu.
English: Paliperidone systemic exposure in adolescent subjects (15 years and older) was comparable to that in adults.
Slovenian: Sistemska izpostavljenost paliperidonu pri mladostnikih (starih 15 let in več) je bila primerljiva izpostavljenosti pri odraslih.
English: - if you have heart disease or heart disease treatment that makes you prone to low blood pressure.
Slovenian: - Če imate srčno bolezen ali se zdravite z zdravili za srčne bolezni in ste zato nagnjeni k nizkemu krvnemu tlaku.
English: Fertility There were no relevant effects observed in the non-clinical studies.
Slovenian: Plodnost V nekliničnih študijah niso opazili pomembnih učinkov.
English: • dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood
Slovenian: • nevarno majhno število določenih tipov belih krvnih celic, ki jih potrebujete za obrambo pred okužbo v krvi