FrancophonIA/ELRC3.0 huggingface dataset:
English: Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic/anaphylactoid reaction following the administration of the vaccine, as there is a possibility of hypersensitivity reactions, not only to the active substances, but also to the excipients and trace residuals (e.g. neomycin) present in the vaccine (see sections 4.3, 4.8 and 6.1).
Slovenian: Pri cepljenju obstaja možnost pojava preobčutljivostnih reakcij, ne le na učinkovino, temveč tudi na pomožne snovi in snovi, prisotne v sledeh (npr. neomicin) (glejte poglavja 4.3, 4.8 in 6.1).
English: Inject the entire content of the pre-filled syringe into the vial containing the powder.
Slovenian: Vso vsebino napolnjene injekcijske brizge iztisnite v vialo s praškom.
English: ZOSTAVAX contains sodium
Slovenian: Cepivo ZOSTAVAX vsebuje natrij
English: Discard if reconstituted vaccine is not used within 30 minutes.
Slovenian: Če cepiva ne uporabite v 30 minutah po rekonstituciji, ga zavrzite.
English: ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with 2 unattached needles - Pack of 1, 10, 20
Slovenian: ZOSTAVAX - prašek v viali in vehikel v napolnjeni injekcijski brizgi z 2 nepritrjenima iglama - pakiranje po 1, 10, 20
English: Transmission
Slovenian: Odmerjanje
English: Incidence rate of zoster per person years
Slovenian: Delež pojavnosti herpesa zostra na oseb-let
English: Transmission of vaccine virus from varicella vaccine recipients who do not develop a varicella-like rash has also been reported.
Slovenian: Poročali so tudi o prenosu cepilnega virusa z oseb, ki so bile cepljene s cepivom proti noricam in pri katerih se ni pojavil noricam podoben izpuščaj.
English: The need for, or timing of, a booster dose with ZOSTAVAX has not yet been determined.
Slovenian: Odrasli, ki so prejeli dodatne odmerke/ponovno cepljenje Potreba po obnovitvenem odmerku cepiva ZOSTAVAX ali čas njegove uporabe še nista bila določena.
English: If you have experienced any of the following, talk to your doctor or pharmacist before receiving ZOSTAVAX:
Slovenian: Pred cepljenjem s cepivom ZOSTAVAX se posvetujte z zdravnikom ali farmacevtom, če za vas velja kar koli od naštetega:
English: Powder and solvent for suspension for injection 1 vial (powder) + 1 vial (solvent) 10 vials (powder) + 10 vials (solvent)
Slovenian: prašek in vehikel za suspenzijo za injiciranje 1 viala (prašek) + 1 viala (vehikel) 10 vial (prašek) + 10 vial (vehikel)
English: Before mixing with the solvent, the powder is a white to off-white compact crystalline plug.
Slovenian: Pred dodajanjem vehikla je prašek bel do sivo-bel v grudo stisnjen kristalni prašek.
English: Administration of a higher than recommended dose of ZOSTAVAX was reported rarely and the adverse reaction profile was comparable to that observed with the recommended dose of ZOSTAVAX.
Slovenian: Profil neželenih učinkov je bil primerljiv s tistim, ki so ga opazili pri priporočenih odmerkih cepiva ZOSTAVAX.
English: There are no data on the use of ZOSTAVAX in pregnant women.
Slovenian: Cepiva ZOSTAVAX ne uporabljajte pri nosečnicah.
English: Number of zoster cases
Slovenian: Št. oseb Št. primerov herpesa zostra
English: Withdraw the entire content of the reconstituted vaccine using the same syringe.
Slovenian: Celotno vsebino rekonstituiranega cepiva povlecite v isto injekcijsko brizgo.
English: The ZEST study was a placebo-controlled, double-blind clinical trial in which 22,439 subjects were randomised to receive a single dose of either ZOSTAVAX or placebo and were followed for the development of zoster for a median of 1.3 years (range 0 to 2 years).
Slovenian: Študija ZEST je bila s placebom nadzorovano, dvojno slepo klinično preskušanje pri 22.439 osebah, randomiziranih na prejetje enega odmerka cepiva ZOSTAVAX ali placeba.
English: Compared with placebo, ZOSTAVAX induced a higher VZV-specific immune response at 6 weeks post-vaccination.
Slovenian: V primerjavi s placebom je cepivo ZOSTAVAX 6 tednov po cepljenju sprožilo pomembno večji imunski odziv, specifičen za VZV.
English: What ZOSTAVAX contains
Slovenian: Kaj vsebuje cepivo ZOSTAVAX
English: Headache and pain in the extremity were the most common systemic adverse reactions.
Slovenian: Najpogostejša sistemska neželena učinka sta bila glavobol in bolečina v okončini.
English: ZOSTAVAX significantly decreased the incidence of zoster compared to placebo (see Table 2).
Slovenian: Cepivo ZOSTAVAX je pomembno zmanjšalo pojavnost herpesa zostra v primerjavi s placebom (glejte preglednico 2).
English: The vaccine can be injected subcutaneously (SC) or intramuscularly (IM), preferably in the deltoid region (see sections 4.8 and 5.1).
Slovenian: ), po možnosti v deltoidni predel (glejte poglavji 4.8 in 5.1).
English: ZOSTAVAX induced a significantly higher VZV-specific immune response at 4 weeks post-vaccination, compared with placebo.
Slovenian: Cepivo ZOSTAVAX je v 6 tednih po cepljenju sprožilo pomembno večji imunski odziv, specifičen za VZV, v primerjavi s placebom.
English: Withdraw the entire content of the reconstituted vaccine vial using the same syringe.
Slovenian: Celotno vsebino viale z rekonstituiranim cepivom povlecite v isto injekcijsko brizgo.
English: Discard reconstituted vaccine if it is not used within 30 minutes.
Slovenian: Če cepiva niste aplicirali v 30 minutah po rekonstituciji, ga zavrzite.
English: What is PHN?
Slovenian: Kaj je postherpetična nevralgija (PHN)?
English: Shingles Prevention Study (SPS) in Subjects 60 years of age and older:
Slovenian: SPS pri osebah, starih 60 let ali več
English: Mean BOI score
Slovenian: Povprečna ocena BOI
English: EU/1/06/341/005 - pack of 1 EU/1/06/341/006 - pack of 10 EU/1/06/341/007 - pack of 20
Slovenian: EU/1/06/341/005 - pakiranje po 1 EU/1/06/341/006 - pakiranje po 10 EU/1/06/341/007 - pakiranje po 20
English: ZOSTAVAX powder and solvent for suspension for injection ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe shingles (herpes zoster) vaccine (live)
Slovenian: ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti pasovcu (herpesu zostru) (živo)
English: Your doctor will decide if ZOSTAVAX should be given.
Slovenian: O upravičenosti cepljenja s cepivom ZOSTAVAX bo presodil zdravnik.
English: ZOSTAVAX significantly decreased the incidence of zoster compared with placebo (see Table 3).
Slovenian: Cepivo ZOSTAVAX je pomembno zmanjšalo pojavnost herpesa zostra v primerjavi s placebom (glejte preglednico 3).
English: EU/1/06/341/008 - pack of 1 EU/1/06/341/009 - pack of 10 EU/1/06/341/010 - pack of 20
Slovenian: EU/1/06/341/008 - pakiranje po 1 EU/1/06/341/009 - pakiranje po 10 EU/1/06/341/010 - pakiranje po 20
English: Anyone who has been infected with VZV, including those without a clinical history of varicella, is at risk for developing zoster.
Slovenian: Tveganje za pojav herpesa zostra obstaja pri vseh osebah, ki so bile okužene z VZV, tudi tistih brez klinične oblike noric v anamnezi.
English: Immunogenicity of ZOSTAVAX
Slovenian: Imunogenost cepiva ZOSTAVAX
English: Varicella, Herpes zoster (vaccine strain)
Slovenian: Infekcijske in parazitske bolezni norice, herpes zoster (cepilni sev)
English: Monosodium L-glutamate monohydrate Disodium phosphate Sodium hydroxide (to adjust pH) Urea
Slovenian: Prašek: saharoza hidrolizirana želatina natrijev klorid kalijev dihidrogenfosfat kalijev klorid natrijev L-glutamat monohidrat natrijev hidrogenfosfat natrijev hidroksid (za uravnavo pH) sečnina
English: b. Tabulated summary of adverse events
Slovenian: b. Seznam neželenih učinkov v preglednici
English: Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe (solvent) + 2 needles 10 vials (powder) + 10 pre-filled syringes (solvent) + 20 needles 20 vials (powder) + 20 pre-filled syringes (solvent) + 40 needles
Slovenian: prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 viala (prašek) + 1 napolnjena injekcijska brizga (vehikel) + 2 igli 10 vial (prašek) + 10 napolnjenih injekcijskih brizg (vehikel) + 20 igel 20 vial (prašek) + 20 napolnjenih injekcijskih brizg (vehikel) + 40 igel
English: EU/1/06/341/003 - pack of 1 EU/1/06/341/004 - pack of 10
Slovenian: EU/1/06/341/003 - pakiranje po 1 EU/1/06/341/004 - pakiranje po 10
English: Rare
Slovenian: občasni
English: EU/1/06/341/001 - pack of 1 EU/1/06/341/002 - pack of 10
Slovenian: EU/1/06/341/001 - pakiranje po 1 EU/1/06/341/002 - pakiranje po 10
English: ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with one unattached needle - Pack of 1, 10, 20
Slovenian: ZOSTAVAX - prašek v viali in vehikel v napolnjeni injekcijski brizgi z eno nepritrjeno iglopakiranje po 1, 10, 20
English: Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe (solvent) + 1 needle 10 vials (powder) + 10 pre-filled syringes (solvent) + 10 needles 20 vials (powder) + 20 pre-filled syringes (solvent) + 20 needles
Slovenian: prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 viala (prašek) + 1 napolnjena injekcijska brizga (vehikel) + 1 igla 10 vial (prašek) + 10 napolnjenih injekcijskih brizg (vehikel) + 10 igel 20 vial (prašek) + 20 napolnjenih injekcijskih brizg (vehikel) + 20 igel
English: EU/1/06/341/012 - pack of 10 EU/1/06/341/013- pack of 20
Slovenian: EU/1/06/341/011 - pakiranje po 1 EU/1/06/341/012 - pakiranje po 10 EU/1/06/341/013 - pakiranje po 20
English: Withdraw the entire volume of solvent into a syringe.
Slovenian: Celoten volumen vehikla povlecite v injekcijsko brizgo.
English: One or 2 separate needles may be available in the packaging of the presentation containing the pre-filled syringe without attached needle.
Slovenian: V pakiranju z napolnjeno injekcijsko brizgo brez pritrjene igle sta lahko posebej priloženi ena ali 2 igli.
English: The VZV specific immune responses to ZOSTAVAX at Week 4 post-vaccination were comparable whether administered by SC or IM route.
Slovenian: Za VZV specifični imunski odziv na cepivo ZOSTAVAX je bil 4 tedne po cepljenju podoben po subkutani in po intramuskularni uporabi.
English: Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe without needle (solvent) 10 vials (powder) + 10 pre-filled syringes without needle (solvent) 20 vials (powder) + 20 pre-filled syringes without needle (solvent)
Slovenian: prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 enoodmerna viala (prašek) + 1 napolnjena injekcijska brizga brez igle (vehikel) 10 enoodmernih vial (prašek) + 10 napolnjenih injekcijskih brizg brez igle (vehikel) 20 enoodmernih vial (prašek) + 20 napolnjenih injekcijskih brizg brez igle (vehikel)
English: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) with one or two unattached needles in a pack size of 1, 10 or 20.
Slovenian: Cepivo ZOSTAVAX z vehiklom za rekonstitucijo v napolnjeni injekcijski brizgi Prašek v viali (steklo) z zamaškom (butilna guma) in s prekrivno zaporko (aluminij) ter vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in pokrovčkom (stiren-butadienska guma) z eno ali dvema nepritrjenima iglama.
English: Arthralgia, Myalgia, Pain in extremity
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija, mialgija, bolečina v okončini pogosti
English: VIAL OF SOLVENT
Slovenian: VIALA Z VEHIKLOM
English: The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Slovenian: Če opazite prisotnost tujih delcev in/ali neobičajen izgled cepiva pred injiciranjem, je treba cepivo zavreči.
English: Powder and solvent for suspension for injection in a pre-filled syringe 1 vial (powder) + 1 pre-filled syringe with needle (solvent) 10 vials (powder) + 10 pre-filled syringes with needle (solvent)
Slovenian: prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi 1 viala (prašek) + 1 napolnjena injekcijska brizga z iglo (vehikel) 10 vial (prašek) + 10 napolnjenih injekcijskih brizg z iglo (vehikel)
English: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and needle shield (natural rubber), in a pack size of 1 or 10.
Slovenian: Prašek v viali (steklo) z zamaškom (butilna guma) in prekrivno zaporko (aluminij) ter vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in z iglo z zaščito (naravna guma).
English: ZOSTAVAX - Powder in vial and solvent in pre-filled syringe with attached needle Pack of 1,
Slovenian: ZOSTAVAX - prašek v viali in vehikel v napolnjeni injekcijski brizgi brez igle - pakiranje po 1,
English: The SPS study was a placebo-controlled, double-blind clinical trial in which 38,546 subjects were randomised to receive a single dose of either ZOSTAVAX or placebo and were followed for the development of zoster for a median of 3.1 years (range 31 days to 4.9 years).
Slovenian: Študija preprečevanja pasovca (SPS - Shingles Prevention Study) pri osebah, starih 60 let ali več: Študija SPS je bila s placebom nadzorovano, dvojno slepo klinično preskušanje, v katerem so 38.546 oseb randomizirali na prejetje enega odmerka cepiva ZOSTAVAX ali placeba.
English: OTHER
Slovenian: ZDA
English: ZOSTAVAX Powder and solvent for suspension for injection shingles (herpes zoster) vaccine (live)
Slovenian: ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje cepivo proti pasovcu (herpesu zostru) (živo)
English: The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be reconstituted with the solvent provided with the vial of powder.
Slovenian: Cepivo v obliki praška za suspenzijo za injiciranje se nahaja v enoodmerni viali.
English: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber) without needle in pack size of 1, 10 or 20.
Slovenian: Prašek v viali (steklo) z zamaškom (butilna guma) in prekrivno zaporko (aluminij) ter vehikel v napolnjeni injekcijski brizgi (steklo) z batnim zamaškom (klorobutilna guma) in s pokrovčkom (stiren-butadienska guma) brez igle.
English: It usually occurs in one part of the body and can last for several weeks.
Slovenian: Lahko traja več tednov.
English: ZOSTAVAX powder and solvent for suspension for injection in a pre-filled syringe shingles (herpes zoster) vaccine (live)
Slovenian: ZOSTAVAX prašek in vehikel za suspenzijo za injiciranje v napolnjeni injekcijski brizgi cepivo proti pasovcu (herpesu zostru) (živo)
English: Powder in a vial (glass) with a stopper (butyl rubber) and flip off cap (aluminium) and solvent in a vial (glass) with a stopper (chlorobutyl rubber) and flip off cap (aluminium) in a pack size of 1 or 10.
Slovenian: Cepivo ZOSTAVAX z vehiklom za rekonstitucijo v viali Prašek v viali (steklo) z zamaškom (butilna guma) in prekrivno zaporko (aluminij) ter vehikel v viali (steklo) z zamaškom (klorobutilna guma) in s prekrivno zaporko (aluminij).
English: At four weeks post-vaccination, the VZV-specific immune responses following concomitant use were not similar to the VZV-specific immune responses following nonconcomitant administration.
Slovenian: Imunski odziv, specifičen za VZV, štiri tedne po cepljenju v skupini, ki je prejela obe cepivi sočasno, ni bil podoben kot v skupini, ki cepiv ni prejela sočasno.
English: ZOSTAVAX was administered either subcutaneously (SC) or intramuscularly (IM) in subjects 50 years of age or older (see section 5.1).
Slovenian: Cepivo ZOSTAVAX so osebam, starim 50 let ali več, injicirali subkutano (s.c.) ali intramuskularno (i.m.)
English: Subjects who received ZOSTAVAX by SC (subcutaneous) or IM (intramuscular) route In an open-label, randomised, controlled clinical trial, ZOSTAVAX was administered either by SC route or by IM route to 353 subjects 50 years of age or older.
Slovenian: V odprtem, randomiziranem nadzorovanem kliničnem preskušanju so 353 osebam, starim 50 let ali več, cepivo ZOSTAVAX dali subkutano ali intramuskularno.
English: Number of subjects
Slovenian: Št. oseb
English: All patients were receiving standard treatment.
Slovenian: Vsi bolniki so prejemali standardno zdravljenje.
English: Cablivi (caplacizumab)
Slovenian: Cablivi (kaplacizumab)
English: Treatment with Cablivi may continue for longer if necessary.
Slovenian: Zdravljenje z zdravilom Cablivi se lahko po potrebi nadaljuje tudi dalj časa.
English: Patients also receive treatments to reduce the immune system's activity.
Slovenian: Bolniki prejmejo tudi zdravilo za zmanjšanje dejavnosti imunskega sistema.
English: The most important side effect of treatment is bleeding but it is considered manageable.
Slovenian: Najpomembnejši neželeni učinek zdravljenja je krvavitev, vendar velja za obvladljivega.
English: The European Medicines Agency decided that Cablivi's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Cablivi večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Cablivi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Cablivi?
English: Further information on Cablivi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Cablivi so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients or their carers may be able to inject Cablivi themselves after appropriate training.
Slovenian: Bolniki ali njihovi negovalci si lahko po ustreznem usposabljanju zdravilo Cablivi injicirajo sami.
English: As for all medicines, data on the use of Cablivi are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Cablivi stalno spremljajo.
English: What benefits of Cablivi have been shown in studies?
Slovenian: Kakšne koristi zdravila Cablivi so se pokazale v študijah?
English: The most common side effects with Cablivi (which may affect more than 1 in 10 people) are nosebleeds, headache and bleeding from gums.
Slovenian: Najpogostejši neželeni učinki zdravila Cablivi (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so krvavitev iz nosu, glavobol in krvavitev iz dlesni.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cablivi have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Cablivi upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Other information about Cablivi
Slovenian: Druge informacije o zdravilu Cablivi
English: The company is expected to provide results of a study on Cablivi's safety and effectiveness over a longer period.
Slovenian: Pričakuje se, da bo podjetje priskrbelo rezultate študije glede dolgoročne varnosti in učinkovitosti zdravila Cablivi.
English: Why is Cablivi authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Cablivi odobreno v EU?
English: An overview of Cablivi and why it is authorised in the EU
Slovenian: Pregled zdravila Cablivi in zakaj je odobreno v EU
English: What are the risks associated with Cablivi?
Slovenian: Kakšna tveganja so povezana z zdravilom Cablivi?
English: For more information about using Cablivi, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Cablivi glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Side effects reported with Cablivi are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Cablivi, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: Treatment should be started and supervised by doctors experienced in managing patients who have clotting disorders affecting small blood vessels.
Slovenian: Zdravljenje mora začeti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z motnjami strjevanja krvi, ki prizadenejo majhne krvne žile.
English: The company that markets Cablivi will provide materials, including a patient alert card, on the risk of serious bleeding and how the risk should be managed.
Slovenian: Podjetje, ki trži zdravilo Cablivi, bo priskrbelo gradivo, vključno z opozorilno kartico za bolnika, o tveganju za resno krvavitev in njegovem obvladovanju.
English: What is Cablivi and what is it used for?
Slovenian: Kaj je zdravilo Cablivi in za kaj se uporablja?
English: In patients with aTTP, levels of a substance called von Willebrand factor are increased.
Slovenian: Pri bolnikih s pridobljeno trombotično trombocitopenično purpuro se zvišajo ravni snovi, imenovane von Willebrandov faktor.
English: Cablivi is used together with plasma exchange (in which certain antibodies are removed from the blood) and treatments to reduce the activity of the immune system (the body's defences).
Slovenian: Zdravilo Cablivi se uporablja skupaj z izmenjavo plazme (pri tej se iz krvi odstranijo določena protitelesa) in zdravili za zmanjševanje dejavnosti imunskega sistema (naravnega obrambnega mehanizma telesa).
English: This reduces platelets sticking together and forming clots in blood vessels and, as a result, platelet levels in the blood rise because they are no longer taken up to form clots.
Slovenian: To zmanjšuje zlepljenje krvnih ploščic in nastanek strdkov v krvnih žilah, to pa posledično zviša raven krvnih ploščic v krvi, ker ne tvorijo več strdkov.
English: aTTP is rare, and Cablivi was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 April 2009.
Slovenian: Pridobljena trombotična trombocitopenična purpura je redka, zato je bilo zdravilo Cablivi 30. aprila 2009 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Treatment is continued with 10 mg daily given by injection under the skin in the belly after daily plasma exchange and continued for 30 days after daily plasma exchange is stopped.
Slovenian: Zdravljenje se nadaljuje z odmerkom 10 mg enkrat na dan s podkožno injekcijo v trebuh po dnevni izmenjavi plazme in se nadaljuje 30 dni po tem, ko je izmenjava plazme zaključena.
English: The Agency considered that, in patients with aTTP, Cablivi combined with plasma exchange and immunosuppression can reduce the time it takes for platelet counts to return to the normal range, which is associated with shorter duration of plasma exchange treatment and shorter stay in intensive care facility.
Slovenian: Agencija je menila, da pri bolnikih s pridobljeno trombotično trombocitopenično purpuro zdravilo Cablivi v kombinaciji z izmenjavo plazme in imunosupresijo lahko zmanjša čas, potreben za vrnitev števila krvnih ploščic na normalno raven, to pa je povezano s krajšim časom zdravljenja z izmenjavo plazme in bivanja na oddelku za intenzivno nego.
English: The second study, involving 145 patients, measured how long it took for the platelet count to return to the normal range and for sufficient improvement in the condition to allow daily plasma exchange to be stopped within 5 days.
Slovenian: Druga študija je vključevala 145 bolnikov, v njej pa so proučevali, po koliko časa se je število krvnih ploščic vrnilo na normalno raven in se je stanje ustrezno izboljšalo, da se je izmenjava plazme lahko zaključila v petih dneh.