natgillin/translations-raw huggingface dataset:
Why is Trumenba approved?
Zakaj je bilo zdravilo Trumenba odobreno?
When the person is then exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.
Ko je oseba izpostavljena bakteriji, ta protitelesa skupaj z drugimi deli imunskega sistema uničijo bakterije in pomagajo pri obrambi proti bolezni.
Supportive studies were also carried out, which showed that 2 doses of the vaccine achieved a broadly similar antibody response to 3 doses, and that even though protective antibody levels declined over time they could be improved by an additional booster dose after both 2- and 3-dose treatments.
Izvedli so tudi podporne študije, ki so pokazale, da se z dvema odmerkoma cepiva doseže na splošno podoben odziv protiteles kot pri treh odmerkih, in da ravni zaščitnih protiteles sicer sčasoma upadejo, vendar se lahko izboljšajo z dodatnim obnovitvenim odmerkom po cepljenju z dvema odmerkoma in tudi po cepljenju s tremi odmerki.
For the full list of all side effects and restrictions with Trumenba, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Trumenba glejte navodilo za uporabo.
It is not intended to provide practical advice on how to use Trumenba.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Trumenba is a vaccine used to protect individuals from 10 years old against invasive meningococcal disease caused by a group of bacteria called Neisseria meningitidis group B.
Zdravilo Trumenba je cepivo, ki se uporablja za zaščito posameznikov od 10. leta dalje pred invazivno meningokokno boleznijo, ki jo povzroča skupina bakterij, imenovane Neisseria meningitidis skupine B.
For practical information about using Trumenba, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Trumenba naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
The available data indicated that Trumenba should provide broad protection against the strains of Neisseria meningitidis group B that are currently found in Europe, whether given in a 3-dose or a 2dose schedule.
Razpoložljivi podatki so pokazali, da naj bi zdravilo Trumenba zagotovilo široko zaščito proti sevom Neisseria meningitidis skupine B, ki so trenutno prisotni v Evropi, ne glede na to, ali se daje po shemi z dvema ali tremi odmerki.
When a person is given the vaccine, the immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign' and makes antibodies against them.
Ko oseba prejme cepivo, imunski sistem prepozna dele bakterije v cepivu kot tujek in proti njim razvije protitelesa.
How does Trumenba work?
Kako zdravilo Trumenba deluje?
The first study involved around 3,600 participants aged 10 to 18 years, and the second study involved around 3,300 young adults between 18 and 25 years of age; none of the participants had previously been vaccinated against N. meningitidis group B. Those taking part were given 3 doses of the vaccine and antibody response against 4 main test strains of the bacteria (the ones usually responsible for disease in Europe) was measured one month after the last injection.
Nihče od udeležencev predhodno ni bil cepljen proti N. meningitidis skupine B. Udeleženci so prejeli tri odmerke cepiva, nato pa so jim en mesec po zadnji injekciji izmerili odziv protiteles proti štirim glavnim testnim sevom bakterije (sevom, ki so običajno odgovorni za bolezen v Evropi).
How is Trumenba used?
Kako se zdravilo Trumenba uporablja?
These proteins are fixed onto a compound containing aluminium (adsorbed), which helps to stabilise them, allowing the immune system to respond to them.
Zdravilo Trumenba vsebuje dve sestavini, in sicer beljakovini zunanje ovojnice bakterij Neisseria meningitidis skupine B. Ti beljakovini sta pritrjeni (adsorbirani) na spojino, ki vsebuje aluminij, kar ju stabilizira in omogoči, da se imunski sistem odzove nanju.
Antibodies were produced in sufficient quantities to provide protection against the 4 main test strains in between 80 and 90% of those in the first study, depending on the strain; 84% of those given the vaccine had protective antibodies against all 4 strains when tested.
V prvi študiji so protitelesa nastala v zadostnih količinah, da so zagotovila zaščito proti štirim glavnim testnim sevom, pri 80 do 90 % cepljenih, odvisno od seva.
This may take up to 60 minutes.
To lahko traja do 60 minut.
Participation in the registry is voluntary.
Sodelovanje v registru je prostovoljno.
These reactions usually go away within a few days.
Te reakcije običajno izzvenijo v nekaj dneh.
Wash your hands thoroughly.
Roke si temeljito umijte.
Potential complications can often be avoided by:
Možnim zapletom se lahko pogosto izognemo tako, da:
Currently available data are described in sections 4.8, 5.1 and 5.2.
Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2.
Prepare a clean work area.
Pripravite čisto delovno površino.
National unique code included.
Vključena je edinstvena nacionalna koda.
Date of first authorisation: 16 May 2013 Date of renewal: 8 Jan 2018
Datum prve odobritve: 16. maj 2013 Datum podaljšanja: 8. januar 2018
Allow to dry (at least 30 seconds).
Počakajte, da se mesto posuši (vsaj 30 sekund).
Thrombosis may also occur in the absence of known risk factors.
Tromboza se lahko pojavi tudi v odsotnosti znanih dejavnikov tveganja.
Signs or symptoms of these rare allergic reactions include:
Znaki ali simptomi teh redkih alergijskih reakcij so med drugim:
Frequency not known (cannot be estimated from the available data):
Pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov):
Protein (grams)
Beljakovine (grami)
Partially used vials should be discarded.
Delno uporabljene viale morate zavreči.
Consequences of an overdose are not known.
Posledice prekomernega odmerjanja niso znane.
Higher incidences of AMS were seen in women.
Višjo pojavnost AMS so ugotovili pri ženskah.
Push the air into the vial.
Ves zrak potisnite v vialo.
AUC per week [g*days/l]
AUC na teden [g*dni/l]
Direct Coombs' test positive
Preiskave pozitiven direkten Coombsov test
Infusions of medicines like HyQvia can occasionally result in serious, but rare, allergic reactions.
Infuzije zdravil, kot je HyQvia, lahko občasno privedejo do resnih, vendar redkih alergijskih reakcij.
This medicinal product does not contain sugars.
To zdravilo ne vsebuje sladkorjev.
See sections 4.2 and 4.8.
Glejte poglavji 4.2 in 4.8.
• This medicinal product is comprised of two vials.
• To zdravilo je sestavljeno iz dveh vial.
Replacement therapy in adults, children and adolescents (0-18 years) in:
Nadomestno zdravljenje odraslih, otrok in mladostnikov (0-18 let) pri:
• Pull the needle wings straight up and out.
• Metuljčka igle povlecite naravnost gor in ven.
Effects on blood tests
Učinek na krvne preiskave
IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
IgG in kompleksi IgG se razgrajujejo v celicah retikuloendotelijskega sistema.
Apparent clearance or clearance [ml/kg/day] 1.6 (1.4 to 1.79)
Navidezni očistek ali očistek [ml/kg/dan] 1,6 (1,4 do 1,79)
The majority of these ARs were mild to moderate.
Večina teh neželenih učinkov je bila blagih do zmernih.
The purpose of such registry is to collect and share data only with the public health authorities responsible for monitoring the safety of this product.
Namen registra je zbiranje in širjenje podatkov samo z javnozdravstvenimi organizacijami, ki so pristojne za spremljanje varnosti tega zdravila.
Consider using longer needles and/or more than one infusion site.
Razmislite o uporabi daljših igel in/ali več kot enem mestu infundiranja.
Produced from the plasma of human donors.
Izdelano iz darovane človeške plazme.
The contents of each vial are described below:
Vsebina posamezne viale je opisana v nadaljevanju:
It is usually prepared from pooled human plasma from not fewer than 1,000 donations.
Ponavadi se pripravlja iz združene človeške plazme od najmanj 1000 darovanih enot.
Antibodies are part of the immune system (the body's natural defences) and help your body to fight infections.
Protitelesa so del imunskega sistema (naravne telesne obrambe) in pomagajo telesu v boju proti okužbam.
Frequencies per infusion have been evaluated using the following convention: 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), not known (cannot be estimated from available data).
Pogostnosti na infuzijo so bile ocenjene po naslednjem dogovoru: 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), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
The effects of the hyaluronidase are reversible and permeability of the subcutaneous tissue is restored within 24 to 48 hours.
Učinki hialuronidaze so reverzibilni in permeabilnost subkutanega tkiva se povrne v 24 do 48 urah.
Unlike the stable structural components of the interstitial matrix, hyaluronan has a very fast turnover with half-life of approximately 0.5 days.
V nasprotju s stabilnimi strukturnimi komponentami intersticijskega matriksa se hialuronan zelo hitro pretvarja, z razpolovno dobo približno 0,5 dneva.
Spread of localised infections
Širjenje lokaliziranih okužb
Excipients with known effects:
Pomožne snovi z znanimi učinki:
Results of clinical studies indicate similar safety profiles in adults and paediatric population, including the nature, frequency, seriousness and reversibility of adverse reactions.
Rezultati kliničnih študij nakazujejo podoben varnostni profil pri odraslih in pediatrični populaciji, vključno z naravo, pogostnostjo, resnostjo in reverzibilnostjo neželenih učinkov.
If this happens, you should wait until the reactions have disappeared.
V takšnem primeru morate počakati, da učinki izzvenijo.
Remove HyQvia from the box:
Vzemite zdravilo HyQvia iz škatle:
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
Like all medicines, this medicine can have side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
It is unknown whether these antibodies may have any clinical significance in humans.
Ni znano, ali so ta protitelesa pri ljudeh klinično pomembna.
In the beginning you will receive one quarter of this dose at 1 week intervals.
Na začetku boste prejeli četrtino tega odmerka v enotedenskih presledkih.
The treatment required depends on the nature and severity of the adverse reaction.
Potrebno zdravljenje je odvisno od narave in resnosti neželenega učinka.
The following warnings and precautions should be taken into consideration before you receive or use HyQvia.
Naslednja opozorila in previdnostne ukrepe upoštevajte, preden prejmete ali uporabite zdravilo HyQvia.
Wash hands:
Umijte si roke:
o Select sites on the opposite sides of the body if instructed to infuse in two sites for doses above 600 ml.
 Izberite mesta na nasprotnih straneh telesa, če ste prejeli navodilo za infundiranje v dve mesti za odmerke nad 600 ml.
The overall combined exposure of PID patients in both studies was 187.69 patient-years; the longest exposure for adults was 3.8 years and 3.3 years for paediatric patients.
V obeh študijah je bila celotna skupna izpostavljenost bolnikov s PID 187,69 bolnikovih let; najdaljša izpostavljenost odraslih je bila 3,8 let, pri pediatričnih bolnikih pa 3,3 leta.
Gather all supplies: Collect all items for your infusion.
Zberite vse pripomočke: Zberite vse pripomočke za infundiranje.
In replacement therapy the dose may need to be individualized for each patient dependent on the pharmacokinetic and clinical response.
Pri nadomestnem zdravljenju boste odmerek morda morali prilagoditi vsakemu bolniku na podlagi farmakokinetičnega in kliničnega odziva.
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers.
Varnost tega zdravila za uporabo med nosečnostjo pri človeku ni bila ugotovljena v nadzorovanih kliničnih preskušanjih, zato se sme nosečnicam in doječim materam dajati samo s previdnostjo.
Hypertension, blood pressure increase
Žilne bolezni hipertenzija zvišan krvni tlak
For instructions on how to use the medicinal product, see section 6.6.
Za navodila o uporabi zdravila glejte poglavje 6.6.
To reduce the rate of infection, it may be necessary to increase the dosage and aim for higher trough levels (> 6 g/l).
Za zmanjšanje stopnje okužb boste morda morali povečati odmerek in doseči višje najnižje koncentracije zdravila v krvi (> 6 g/l).
Long-term animal studies to evaluate the carcinogenic or mutagenic potential of recombinant human hyaluronidase have not been conducted.
Dolgoročne študije na živalih za vrednotenje kancerogenega ali mutagenega potenciala rekombinantne humane hialuronidaze niso bile opravljene.
• Repeat this step if you have a second infusion site.
• Ponovite ta korak, če uporabljate še eno mesto infundiranja.
• initially infusing the product slowly (see section 4.2).
• zdravilo najprej infundiramo počasi (glejte poglavje 4.2).
Slowly and carefully push the plunger to remove any remaining air.
Počasi in previdno potisnite bat, da odstranite morebitno prisoten zrak.
Do not mix the components of this medicinal product.
Komponent tega zdravila ne mešajte.
HyQvia contains many different antibodies, some of which can affect blood tests (serological tests).
Zdravilo HyQvia vsebuje številna različna protiteles in nekatera od njih lahko vplivajo na krvne preiskave (serološke preiskave).
Firmly grasp and pinch at least 2 to 2.5 cm of skin between two fingers.
Z dvema prstoma odločno primite in stisnite vsaj 2 do 2,5 cm kože.
3, predominantly from the granulocytic series, and elevated protein levels up to several hundred mg/dL.
3, predvsem iz granulocitne vrste, in zvišanimi ravnmi beljakovin do nekaj sto mg/dL.
The rHuPH20 may be hand-pushed or infused by a pump.
Komponento rHuPH20 lahko potisnete ročno ali infundirate s črpalko.
• Expiration date: Do not use beyond expiration date.
• Datum izteka roka uporabnosti: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti.
The IG 10% component provides the therapeutic effect of this medicinal product.
Komponenta IG 10 % zagotavlja terapevtski učinek tega zdravila.
Your doctor may also adjust your dose depending on your response to treatment.
Zdravnik vam lahko tudi spremeni odmerek glede na vaš odziv na zdravljenje.
These include:
Sem sodijo:
If patients were previously on a 3-week dosing regimen, increasing the interval to 4-weeks can be accomplished by administering the same weekly equivalents.
Če so bili bolniki predhodno na tritedenski shemi odmerjanja, lahko podaljšanje presledka na štiri tedne opravite z dajanjem enakih tedenskih ekvivalentov.
The listed warnings and precautions apply both to adults and children.
Našteta opozorila in previdnostni ukrepi veljajo tako za odrasle kot za otroke.
Record the infusion:
Zabeležite infuzijo:
66 patients who completed the pivotal phase 3 study participated in an extension study (160902) for the evaluation of long-term safety, tolerability and efficacy of HyQvia in PID.
66 bolnikov, ki so zaključili ključno študijo 3. faze, je sodelovalo v podaljšani študiji (160902) za oceno dolgoročne varnosti, prenašanja in učinkovitosti zdravila HyQvia pri PID.
► Tell your doctor about your treatment with HyQvia before any blood test.
► Zdravnika obvestite o zdravljenju z zdravilom HyQvia pred vsako krvno preiskavo.
Glycine, water for injections.
glicin, voda za injekcije.
Ask your doctor or pharmacist or nurse if another needle size would be more appropriate for you.
Zdravnika, farmacevta ali medicinsko sestro vprašajte, ali bi bila za vas primernejša igla druge velikosti.
Any change of needle size would have to be supervised by the treating physician.
Vsako spremembo velikosti igle mora nadzorovati lečeči zdravnik.
It is very important to infuse the medicine at the correct speed.
Zelo pomembna je ustrezna hitrost infundiranja tega zdravila.
Your treatment will be started by a doctor or nurse experienced in treating patients with a weak immune system and in guiding patients for home treatment.
Zdravljenje bosta uvedla zdravnik ali medicinska sestra z izkušnjami pri zdravljenju bolnikov z oslabljenim imunskim sistemom in pri usmerjanju bolnikov pri zdravljenju doma.
The potential exists for such antibodies to cross-react with endogenous PH20, which is known to be expressed in the adult male testes, epididymis, and sperm.
Ta protitelesa imajo potencial, da navzkrižno reagirajo z endogenim PH20, za katerega je znano, da je izražen v testisih, epididmisu in spermi odraslih.
HyQvia is prescribed as replacement therapy to patients who do not have sufficient antibodies, including the following groups:
Zdravilo HyQvia predpišemo kot nadomestno zdravljenje bolnikom, ki nimajo dovolj protiteles, vključno z naslednjimi skupinami:
The medicine works in exactly the same way as the immunoglobulins naturally present in the blood.
Zdravilo deluje povsem enako kakor imunoglobulini, ki so naravno prisotni v krvi.
• When treatment is given at home, support from another responsible person should be available for treating adverse reactions or to summon help should a serious adverse reaction occur.
• Če se zdravljenje izvaja doma, mora biti na voljo druga odgovorna oseba za zdravljenje neželenih reakcij ali klicanje pomoči, če bi prišlo do hudega neželenega učinka.
Live attenuated virus vaccines
Živa oslabljena virusna cepiva
HyQvia was evaluated in 24 paediatric patients, including 13 patients between 4 and < 12 years and 11 between 12 and < 18 years, who were treated for up to 3.3 years with an overall safety experience equivalent to 48.66 patient-years (as described in section Clinical efficacy and safety).
Zdravilo HyQvia je bilo ocenjeno pri 24 pediatričnih bolnikih, vključno s 13 bolniki, starimi od 4 do <12 let, in 11 bolniki, starimi od 12 do <18 let, ki so bili zdravljeni do 3,3 leta, s splošno izkušnjo glede varnosti enakovredni 48,66 bolnikovih let (kakor je opisano v poglavju Klinična učinkovitost in varnost).
The most frequently reported systemic ARs were headache, fatigue and pyrexia.
Najpogosteje navedeni sistemski neželeni učinki so bili glavobol, utrujenost in pireksija.
The table presented below is according to the MedDRA System Organ Classification (SOC and Preferred Term Level).
Spodnja tabela prikazuje razvrstitev glede na organske sisteme po MedDRA (SOC-System Organ Class in raven prednostnega profila).
During the infusion you must look out for first signs of side effects (for further details see section 4, “Possible side effects”).
Med infundiranjem morate biti pozorni na zgodnje znake neželenih učinkov (za podroben opis glejte poglavje 4, ”Možni neželeni učinki”).
They can particularly occur in patients with anti-IgA antibodies who should be treated with particular caution.
Zlasti se lahko pojavijo pri bolnikih s protitelesi proti IgA, ki jih morate zdraviti še posebej previdno.
Adjust the frequency and number of infusion sites taking into consideration volume, total infusion time, and tolerability so that the patient receives the same weekly equivalent dose.
Pogostnost in število infuzijskih mest prilagodite glede na volumen, skupni čas infundiranja in prenašanje, tako da bolnik prejme enak tedenski enakovredni odmerek.
The pharmacokinetics of HyQvia were evaluated in a clinical study in patients with PID aged 12 years and older.
Farmakokinetika zdravila HyQvia je bila ocenjena v klinični študiji pri bolnikih s PID, ki so bili stari 12 let in več.
Aseptic meningitis syndrome (AMS)
Sindrom aseptičnega meningitisa (AMS)
• The medicinal product is for subcutaneous use only, do not administer intravenously.
• Zdravilo je namenjeno samo za subkutano uporabo, ne dajajte ga intravensko.
The safety of HyQvia was evaluated in 4 clinical studies (160602, 160603, 160902, and 161101) in 124 unique patients with PID receiving 3,202 infusions.
Varnost zdravila HyQvia je bila ocenjena v kliničnih študijah (160602, 160603, 160902 in 161101) pri 124 edinstvenih bolnikih s PID, ki so prejeli 3.202 infuziji.
Prepare the pump: Follow the manufacturer's instructions for preparing the pump.
Pripravite črpalko: Pri pripravi črpalke upoštevajte navodila izdelovalca.
The European Medicines Agency has deferred the obligation to submit the results of studies with HyQvia in one or more subsets of the paediatric population in treatment of primary immunodeficiency as model for replacement therapy.
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom HyQvia za eno ali več podskupin pediatrične populacije za zdravljenje primarne imunske pomanjkljivosti kot modela za nadomestno zdravljenje.
In addition to the adverse reactions noted in clinical trials, the following adverse reactions have been reported in the post-marketing experience (frequency of these reactions is not known (cannot be estimated from the available data)):
Poleg neželenih učinkov, ki so jih opazili v kliničnih preskušanjih, so v obdobju trženja zdravila poročali o naslednjih neželenih učinkih (pogostnost teh učinkov ni znana (je ni mogoče oceniti iz razpoložljivih podatkov)):
Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Bolniki, pri katerih se med zdravljenjem pojavijo neželeni učinki, morajo pred vožnjo ali upravljanjem strojev počakati, da ti izzvenijo.
Your doctor or nurse will advise you on the appropriate infusion speed to use when you are infusing HyQvia at home (see section 3, “How to use HyQvia”).
Zdravnik ali medicinska sestra vam bosta svetovala glede ustrezne hitrosti infundiranja, ko si boste zdravilo HyQvia infundirali doma (glejte poglavje 3, ”Kako uporabljati zdravilo HyQvia”).
Monitoring during infusion
Spremljanje med infundiranjem
AMS may occur more frequently in association with high-dose (2 g/kg) intravenous immunoglobulin treatment.
AMS se lahko pojavlja pogosteje v povezavi z velikimi odmerki (2 g/kg) intravenskih imunoglobulinskih zdravil.
Name and address of the manufacturers of the biological active substance(s)
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
If a woman becomes pregnant, the treating physician should encourage her to participate in the pregnancy registry.
Če bolnica zanosi, naj jo lečeči zdravnik spodbudi k vključitvi v register nosečnosti.
• ensuring that patients are carefully monitored for any symptoms throughout the infusion period.
• poskrbimo, da se bolniki skrbno spremljajo glede pojava morebitnih simptomov ves čas trajanja infuzij.
Home treatment
Zdravljenje doma
• Check each vial of HyQvia before using:
• Pred uporabo na vsaki viali zdravila HyQvia preverite naslednje:
The other ingredients of this vial are glycine and water for injections.
Drugi sestavini v tej viali sta glicin in voda za injekcije.
There were two instances of transient genital oedema, one considered severe, that resulted from diffusion of the medicinal product from the infusion site in the abdomen.
Ugotovili so dva primera prehodnega genitalnega edema (eden se je štel za resnega), ki sta bila posledica difuzije zdravila iz mesta infundiranja v abdomen.
MedDRA System Organ Class (SOC)
Organski sistem, MedDRA (SOC)
Your doctor will calculate the correct dose for you based on your body weight, any previous treatment you may have received and your response to treatment.
Zdravnik bo preračunal pravilni odmerek za vas na osnovi vaše telesne mase, predhodno prejetih zdravljenj in vašega odziva na zdravljenje.
The following pack sizes are available:
Na voljo so naslednja pakiranja:
This guardian should help you keep an eye on potential side effects.
Skrbnik vam bo pomagal paziti na možne neželene učinke.