natgillin/translations-raw huggingface dataset:
Actraphane 30 vial (40 international units/ml)/Actraphane 30 vial (100 international units/ml) Vial (type 1 glass) closed with a disc (bromobutyl/polyisoprene rubber) and a protective tamper-proof plastic cap containing 10 ml of suspension.
Viala (steklo tipa 1), zaprta z zamaškom (bromobutil/poliizoprenska guma) in zaščitena z varnostno plastično zaporko, ki vsebuje 10 ml suspenzije.
Actraphane 50 Penfill 100 international units/ml suspension for injection in cartridge.
IME ZDRAVILA Actraphane 50 Penfill 100 mednarodnih enot/ml suspenzija za injiciranje v vložku
1 ml suspension contains 40 international units soluble insulin human*/isophane (NPH) insulin human* in the ratio 30/70 (equivalent to 1.4 mg).
En ml suspenzije vsebuje 40 mednarodnih enot topnega humanega insulina*/humanega insulina izofan (NPH)* v razmerju
Package leaflet: Information for the user Actraphane 30 FlexPen 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
Navodilo za uporabo Actraphane 30 FlexPen 100 mednarodnih enot/ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku humani insulin
Package leaflet: Information for the user Actraphane 30 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Navodilo za uporabo Actraphane 30 Penfill 100 mednarodnih enot/ml suspenzija za injiciranje v vložku humani insulin
Package leaflet: Information for the user Actraphane 50 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Navodilo za uporabo Actraphane 50 Penfill 100 mednarodnih enot/ml suspenzija za injiciranje v vložku humani insulin
Package leaflet: Information for the user Actraphane 40 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Navodilo za uporabo Actraphane 40 Penfill 100 mednarodnih enot/ml suspenzija za injiciranje v vložku humani insulin
Actraphane 30 100 international units/ml suspension for injection in vial.
Actraphane 30 40 mednarodnih enot/ml suspenzija za injiciranje v viali Actraphane 30 100 mednarodnih enot/ml suspenzija za injiciranje v viali
Actraphane 30 40 IU/ml Suspension for injection Insulin human SC
Actraphane 30 InnoLet 100 mednarodnih enot/ml suspenzija za injiciranje humani insulin za s.c. uporabo
Package leaflet: Information for the user Actraphane 30 40 IU/ml (international units/ml) suspension for injection in vial human insulin
Navodilo za uporabo Actraphane 30 40 mednarodnih enot/ml suspenzija za injiciranje v viali humani insulin
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN LABEL (PRE-FILLED PEN.
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (CARTRIDGE.
PODATKI NA ZUNANJI OVOJNINI ŠKATLA (NAPOLNJEN INJEKCIJSKI PERESNIK InnoLet)
Actraphane 40 Penfill 100 international units/ml suspension for injection in cartridge.
IME ZDRAVILA Actraphane 40 Penfill 100 mednarodnih enot/ml suspenzija za injiciranje v vložku
Package leaflet: Information for the user Actraphane 30 100 IU/ml (international units/ml) suspension for injection in vial human insulin
Navodilo za uporabo Actraphane 30 100 mednarodnih enot/ml suspenzija za injiciranje v viali humani insulin
Package leaflet: Information for the user Actraphane 30 InnoLet 100 IU/ml (international units/ml) suspension for injection in pre-filled pen human insulin
Navodilo za uporabo Actraphane 30 InnoLet 100 mednarodnih enot/ml suspenzija za injiciranje v napolnjenem injekcijskem peresniku humani insulin
The first infusion lasts 15 minutes.
Prva infuzija traja 15 minut.
The European Commission granted a marketing authorisation valid throughout the EU for ATryn on 28 July 2006.
Evropska komisija je dovoljenje za promet z zdravilom ATryn, veljavno po vsej Evropski uniji, izdala 28. julija 2006.
ATryn has been authorised under ‘exceptional circumstances'.
Zdravilo ATryn je bilo odobreno „v izjemnih okoliščinah“.
However, there was not enough information to identify the most appropriate dose to use during childbirth.
Vendar pa ni bilo zadostnih podatkov, na podlagi katerih bi bilo mogoče določiti najustreznejši odmerek, ki bi se lahko uporabil med porodom.
What measures are being taken to ensure the safe and effective use of Atryn?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila ATryn?
Other information about ATryn:
Druge informacije o zdravilu ATryn:
The full EPAR for ATryn 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 ATryn je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atryn have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila ATryn, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
For more information about treatment with ATryn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom ATryn preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Evropska agencija za zdravila bo vsako leto ponovno pregledala vse nove podatke, ki bodo na voljo, in posodobila povzetek glavnih značilnosti zdravila, če bo potrebno.
In addition, ATryn was used in five patients who received the medicine during surgery in a ‘compassionate-use programme' (a programme through which doctors can request a medicine for one of their patients before it is authorised).
Poleg tega so zdravilo ATryn uporabili pri petih bolnikih, ki so zdravilo prejeli med kirurškim posegom v okviru „programa sočutne uporabe zdravila“ (programa, ki zdravnikom omogoča, da za katerega od svojih bolnikov zahtevajo zdravilo, preden je to v celoti odobreno).
This document is a summary of the European Public Assessment Report (EPAR) for ATryn.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo ATryn.
This means that because the disease is rare, it has not been possible to obtain complete information about ATryn.
To pomeni, da zaradi redkosti bolezni o zdravilu ATryn še ni bilo mogoče pridobiti vseh podatkov.
This is followed by a continuous infusion at a lower dose, during which the patients should be continually monitored and the infusion rate adjusted, so that the antithrombin activity is at least 80% of the normal level for the duration of treatment.
Sledi ji neprekinjena infuzija v nizkem odmerku, med katero je treba bolnike stalno spremljati in prilagajati hitrost infundiranja tako, da aktivnost antitrombina med zdravljenjem znaša najmanj 80 % normalne ravni.
The Committee decided that ATryn's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je zaključil, da so koristi zdravila ATryn večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Few patients were treated during the study because congenital antithrombin deficiency is rare - it is estimated that only about one person in 3,000 to 5,000 has the condition.
V študiji je bilo zdravljenih malo bolnikov, ker je prirojeno pomanjkanje antitrombina redko: ocenjuje se, da ima to bolezen ena oseba izmed 3 000 do 5 000.
However, this has not yet been seen in patients treated with ATryn.
Vendar do zdaj tega pri bolnikih, zdravljenih z zdravilom ATryn, niso opazili.
What information is still awaited for ATryn?
Katere informacije o zdravilu ATryn še pričakujemo?
The company will also put in place, before launch in any European Union (EU) Member State, programmes to ensure that doctors can report information on the patients they treat and monitor the development of antibodies against ATryn.
Preden bo družba zdravilo dala na trg v kateri koli državi članici Evropske unije (EU), bodo vzpostavljeni programi, ki bodo zdravnikom omogočali, da poročajo o bolnikih, ki jih zdravijo, in da zlasti spremljajo nastajanje protiteles proti zdravilu ATryn.
What benefit has ATryn shown during the studies?
Kakšne koristi je zdravilo ATryn izkazalo med študijami?
One study of ATryn was carried out in 14 patients aged between 21 and 74 years who had congenital antithrombin deficiency and were at risk of blood clot formation either during surgery (five patients) or during childbirth (nine patients).
Ena študija z zdravilom ATryn je bila opravljena pri 14 bolnikih, starih med 21 in 74 let, s prirojenim pomanjkanjem antitrombina, pri katerih je obstajala nevarnost nastanka krvnih strdkov med kirurškim posegom (pet bolnikov) ali med porodom (devet bolnic).
What is the risk associated with ATryn?
Kakšna tveganja so povezana z zdravilom ATryn?
The active substance in ATryn, antithrombin alfa, is a copy of the natural blood protein antithrombin, which is produced by ‘recombinant DNA technology': it is extracted from the milk of goats that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Zdravilna učinkovina zdravila ATryn, antitrombin alfa, je kopija naravne beljakovine v krvi, ki je proizvedena s tehnologijo rekombinantne DNK: pridobljena je iz mleka koz, ki so jim vstavili gen (DNK), s katerim lahko v svojem mleku tvorijo človeško beljakovino.
See the package leaflet for full instructions.
Za podrobnejše informacije glejte navodilo za uporabo.
ATryn is normally given with heparin (another medicine that helps to prevent blood clots).
Zdravilo ATryn se običajno daje s heparinom (drugim zdravilom za preprečevanje nastajanja krvnih strdkov).
The CHMP concluded that the information provided by the company had shown that ATryn can bring the antithrombin activity up to an acceptable level when used at the recommended dose during surgery.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da informacije, ki jih je predložila družba, kažejo, da lahko zdravilo ATryn poveča aktivnost antitrombina na sprejemljivo raven, kadar se uporabi v priporočenem odmerku med kirurškim posegom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ATryn.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
In studies, the most common side effects with ATryn (seen in between 1 and 10 patients in 100) were dizziness, headache, haemorrhage (bleeding, including bleeding at the site of the injection or after surgery), nausea (feeling sick) and wound secretion (discharge from the surgical wound).
V študijah zdravila ATryn so bili najpogostejši neželeni učinki (opaženi pri 1 do 10 bolnikih od 100) omotica, glavobol, hemoragija (krvavitev, vključno s krvavitvijo na mestu injiciranja ali krvavitev po kirurškem posegu), navzeja (slabost) in izcedek iz rane (izločki na mestu kirurškega reza).
Because ATryn is a protein given by injection, patients could develop antibodies (proteins produced in response to the medicine), with a risk of an allergic reaction at the time of injection.
Ker je zdravilo ATryn beljakovina, ki se daje z injekcijo, lahko bolniki razvijejo protitelesa (v telesu začnejo nastajati posebne beljakovine proti zdravilu), zaradi česar se pojavi tveganje za alergijsko reakcijo v času injiciranja.
In the study, among the 13 patients in whom the effectiveness of the treatment could be assessed, two had an episode of DVT, of which only one needed treatment.
V študiji so lahko učinkovitost zdravljenja ocenili pri 13 bolnikih, od katerih sta dva imela epizodo globoke venske tromboze, le eden izmed njiju pa je potreboval zdravljenje.
It is used when the patients are having surgery, to prevent problems due to the formation of blood clots.
Uporablja se pri kirurških posegih bolnikov za preprečitev težav zaradi nastajanja krvnih strdkov.
In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting.
V telesu antitrombin zavira trombin, snov, ki ima osrednjo vlogo pri strjevanju krvi.
Patients who have congenital antithrombin deficiency have low blood antithrombin levels and are therefore at increased risk of having blood clots.
Pri bolnikih, ki imajo prirojeno pomanjkanje antitrombina, so ravni antitrombina v krvi nizke, zato so izpostavljeni večjemu tveganju za nastanek krvnih strdkov.
ATryn must not be used in people who may be hypersensitive (allergic) to goat proteins or goat milk.
Zdravila ATryn ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) kozje beljakovine oziroma kozje mleko.
Treatment with ATryn should only be started by doctors who are experienced in treating patients with congenital antithrombin deficiency.
Zdravljenje z zdravilom ATryn lahko uvedejo le zdravniki, ki imajo izkušnje z zdravljenjem bolnikov s prirojenim pomanjkanjem antitrombina.
The doctor needs to calculate the doses to use, based both on the patient's weight and on the level of antithrombin activity.
Zdravnik mora izračunati uporabljeni odmerek na podlagi telesne mase bolnika in ravni aktivnosti antitrombina pri bolniku.
Why has ATryn been approved?
Zakaj je bilo zdravilo ATryn odobreno?
For the full list of side effects and restrictions with ATryn, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila ATryn glejte navodilo za uporabo.
Taken together, the results support the effectiveness of ATryn in preventing blood clot development in patients having surgery.
Vsi rezultati skupaj potrjujejo učinkovitost zdravila ATryn za preprečevanje nastanka krvnih strdkov pri bolnikih, ki so prestali kirurški poseg.
ATryn is used in adults who have ‘congenital antithrombin deficiency' (inherited low levels of the protein antithrombin).
Zdravilo ATryn se uporablja pri odraslih s prirojenim pomanjkanjem antitrombina (prirojenimi nizkimi ravnmi beljakovine antitrombin).
The studies measured how many patients developed deep vein thrombosis (DVT, formation of a blood clot in a deep vein, usually in the leg) during the 30 days after treatment.
V študiji so merili, pri koliko bolnikih se je v 30 dneh po zdravljenju pojavila globoka venska tromboza (DVT, tvorba strdkov v globokih venah, običajno v nogah).
It contains the active substance antithrombin alfa.
Vsebuje zdravilno učinkovino antitrombin alfa.
ATryn corrects the antithrombin deficiency, and gives temporary control of the clotting disorder.
Zdravilo ATryn odpravi pomanjkanje antitrombina in zagotavlja začasni nadzor nad motnjo strjevanja krvi.
ATryn is a powder that is made up into a solution for infusion (drip) into a vein.
Zdravilo ATryn je prašek za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
In the compassionate-use programme, no blood clots were seen in the patients receiving ATryn.
V okviru programa sočutne uporabe zdravila pri bolnikih, ki so prejemali zdravilo ATryn, niso opazili nobenih krvnih strdkov.
How has ATryn been studied?
Kako je bilo zdravilo ATryn raziskano?
What is ATryn used for?
Za kaj se zdravilo ATryn uporablja?
What is ATryn?
Kaj je zdravilo ATryn?
The company that makes ATryn has provided the results of a study looking at the use of ATryn during childbirth in women with congenital antithrombin deficiency to the Agency, and will submit an application with the aim of adding treatment during childbirth to the medicine's marketing authorisation.
Družba, ki izdeluje zdravilo ATryn, je agenciji posredovala rezultate študije, s katero so proučevali uporabo zdravila Atryn med porodom pri nosečnicah s prirojenim pomanjkanjem antitrombina.
How is ATryn used?
Kako se zdravilo ATryn uporablja?
How does ATryn work?
Kako zdravilo ATryn deluje?
ATryn is an anticlotting agent.
Zdravilo ATryn je sredstvo proti strjevanju krvi.
It contains important information about how to take these two medicines.
Vsebujejo pomembne informacije o tem, kako se jemljeta ti dve zdravili.
The potential relevance of these findings in humans is unknown.
Možni pomen teh ugotovitev za ljudi ni znan.
Date of first authorisation: 23 July 2012 Date of latest renewal: 28 April 2017
Datum prve odobritve: 23. julij 2012 Datum zadnjega podaljšanja: 28. april 2017
Juvenile animal studies
Študije na juvenilnih živalih
Currently available data are described in sections 4.4, 4.8 and 5.1, but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki so opisani v poglavjih 4.4, 4.8 in 5.1, vendar priporočil o odmerjanju ni mogoče dati.
Similar results to part 1 were seen in part 2 of the study.
Podobne rezultate kot v prvem delu so ugotovili v drugem delu študije.
Take the tablets approximately 12 hours apart.
Tablete jemljite približno 12 ur narazen.
However, increased liver enzymes in the blood are more frequently seen in young children.
Vendar pa zvišane jetrne encime v krvi pogosteje vidimo pri majhnih otrocih.
* Values based on data from a single patient; standard deviation not reported.
* Vrednosti na podlagi podatkov enega samega bolnika; o standardni deviaciji niso poročali.
Interim analysis 1: December 2017 Interim analysis 2: December 2019 Interim analysis 3: December 2021 Final report: December 2023
Vmesna analiza 1: december 2017 Vmesna analiza 2: december 2019 Vmesna analiza 3: december 2021 Končno poročilo: december 2023
Lift here to open
Tu privzdignite in odprite
See the end of section 2 - Important information about the contents of Kalydeco.
Glejte konec poglavja 2 - Pomembne informacije o vsebini zdravila Kalydeco.
For patients who rolled over from study 2 the number of events was, overall, low.
Za bolnike, ki so prešli iz študije 2, je bilo število dogodkov na splošno majhno.
Use all 7 days' doses before starting a new wallet.
Porabite vse odmerke za 7 dni, preden odprete novo zgibanko.
Ivacaftor does not bind to human red blood cells.
Ivakaftor se ne veže na humane rdeče krvničke.
In such cases, the starting dose should be as above recommended, but administered every other day.
V takih primerih naj bo začetni odmerek tak, kot je priporočen zgoraj, a uporabljen vsak drugi dan.
If this is not possible, give it within the following hour after mixing.
Če to ni možno, mu jo dajte znotraj ene ure po pripravi mešanice.
As such, a risk to the newborns/infants cannot be excluded.
Tveganja za dojenega novorojenca/dojenčka ne moremo izključiti.
Once mixed, the mixture has been shown to be stable for one hour.
Po pripravi mešanice je mešanica stabilna eno uro.
Patients after organ transplantation
Bolniki po presaditvi organov
25 kg or more
25 kg ali več
Study 4: open-label extension study
Študija 4: odprta podaljšana študija
Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to treatment cannot be excluded.
Čeprav so bili v nekaterih primerih prisotni drugi dejavniki tveganja (na primer uporaba kortikosteroidov in izpostavljenost sevanju), ni mogoče izključiti možnega tveganja, ki bi ga lahko pripisali zdravljenju.
It may be better to avoid using Kalydeco during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
Če je mogoče, se je uporabi zdravila Kalydeco med nosečnostjo morda bolje izogniti, zdravnik pa vam bo pomagal pri odločitvi, kaj je najboljše za vas in vašega otroka.
Treatment of overdose consists of general supportive measures including monitoring of vital signs, liver function tests and observation of the clinical status of the patient.
Zdravljenje prevelikega odmerka sestavljajo splošni podporni ukrepi, vključno s spremljanjem vitalnih znakov, testi funkcije jeter in opazovanjem kliničnega stanja bolnika.
12- to 17-year-olds n = 97
12- do 17-letni n = 97
P value
vrednost P
The frequency of adverse reactions is defined as follows: 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 the available data).
Pogostost neželenih učinkov je opredeljena kot: 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 (ni mogoče oceniti iz razpoložljivih podatkov).
* Treatment occurred during blinded, controlled, 48-week Phase 3 study.
* Zdravljenje med slepo, kontrolirano 48-tedensko študijo 3. faze.
Each sachet is for single use only.
Vsaka vrečica je samo za enkratno uporabo.
Relative risk of pulmonary exacerbation
Relativno tveganje pljučne eksacerbacije
Absolute change at week 24
Absolutna sprememba v 24. tednu
Patients continued on their prescribed standard-of-care CF therapies.
Bolniki so se še naprej zdravili s svojimi predpisanimi standardnimi terapijami CF.
Tertiary endpoints included efficacy measures such as Faecal Elastase-1 and growth parameters.
Terciarni cilji so vključevali merila učinkovitosti, na primer fekalno elastazo-1 in parametre rasti.
Meals or snacks that contain fat include those prepared with butter or oils or those containing eggs.
Obroki ali prigrizki, ki vsebujejo maščobe, vključujejo tiste, ki so pripravljeni z maslom ali olji, in tiste, ki vsebujejo jajca.
†† n = 3 for the analysis of absolute change in sweat chloride.
†† n = 3 za analizo absolutne spremembe kloridov v znoju.
If you feel dizzy, do not drive, cycle or use machines.
Če ste omotični, ne vozite, ne kolesarite in ne uporabljajte strojev.
An open-label, rollover, 96 week study is on-going to evaluate the long-term safety and efficacy of the combination regimen in both patient populations.
Odprta obnovitvena 96-tedenska študija za ocenjevanje dolgoročne varnosti in učinkovitosti kombinirane sheme v obeh populacijah bolnikov je v teku.
Other medicinal products for which exposure may be increased include glimepiride and glipizide; these medicinal products should be used with caution.
Druga zdravila, katerih izpostavljenost se lahko zveča, vključujejo glimepirid in glipizid; ta zdravila je treba uporabljati previdno.
A total of 36 patients continued into part 2 (18 per treatment sequence).
Vsega skupaj 36 bolnikov je nadaljevalo v drugi del (18 na posamezno zaporedje zdravljenja).
At the start of the study, patients in the placebo group used some medicinal products at a higher frequency than the ivacaftor group.
V začetku študije so bolniki v skupini s placebom uporabljali nekatera zdravila pogosteje kot v skupini z ivakaftorjem.
* Statistical testing was not performed due to small numbers for individual mutations.
* Zaradi majhnega števila posameznih mutacij statistično testiranje ni bilo opravljeno.
Study 1
Študija 1
Digoxin and other P-gp substrates
Digoksin in drugi substrati P-gp
Kalydeco should only be prescribed by physicians with experience in the treatment of cystic fibrosis.
Zdravilo Kalydeco naj predpisujejo le zdravniki, ki imajo izkušnje z zdravljenjem cistične fibroze.
In both studies, improvements in FEV1 were rapid in onset (day 15) and durable through 48 weeks.
V obeh študijah so izboljšanja FEV1 nastopila hitro (15. dne) in so trajala vseh 48 tednov.
Exposures in 6- to 11-year-olds are predictions based on simulations from the population PK model using data obtained for this age group.
Izpostavljenosti pri 6 do 11 let starih otrocih so napovedi na podlagi simulacij iz populacijskega FK modela z uporabo podatkov, dobljenih pri tej starostni skupini.
Adults (≥ 18 years old)
Odrasli (stari ≥ 18 let)
Open
Odprite.
Ensure that the mixture is completely and immediately consumed.
Zagotovite, da bo otrok mešanico zaužil v celoti in takoj.
Patients in study 7 were aged 2 to less than 6 years (mean age 3 years).
Bolniki v študiji 7 so bili stari 2 leti do manj kot 6 let (povprečna starost 3 leta).