natgillin/translations-raw huggingface dataset:
Not to be sold separately.
Ni namenjena ločeni prodaji.
(There will be water remaining in the vial.)
(V viali bo ostalo nekaj vode.)
1 In SJIA
1 pri SJIA
This additional dose could be provided as early as 7 days after the first treatment dose.
Ta dodatni odmerek so lahko prejeli že 7 dni po prvem odmerku zdravila.
If you feel a spinning sensation or feel tired, do not drive or use any tools or machines until you are feeling normal again.
Če čutite vrtoglavico ali se počutite utrujeni, ne vozite avtomobila in ne uporabljajte nobenih naprav in strojev, dokler se ne počutite spet normalno.
Particularly in adult patients, this evaluation should include a detailed medical history.
Zlasti pri odraslih bolnikih mora tak pregled vključevati podrobno zdravstveno anamnezo.
Physician Global Assessment < 2
Zdravnikova splošna ocena < 2
More information on each of these diseases is given below.
Več podatkov o posamezni bolezni lahko najdete spodaj.
Two open-label, uncontrolled, long-term phase III studies were performed.
Izvedli so dve odprti nekontrolirani dolgoročni študiji faze III.
Centre de Biotechnologie 8, rue de l'Industrie 68330 Huningue France
Centre de Biotechnologie 8, rue de l'Industrie 68330 Huningue Francija
The total treatment duration ranged from 6 months to 2 years.
V celoti je zdravljenje trajalo od 6 mesecev do 2 let.
The clinical significance of this observation is unknown.
Klinični pomen te ugotovitve ni znan.
Your doctor may decide to delay or interrupt your treatment, but only if necessary.
Zdravnik bo morda odločil, da je treba zdravljenje odložiti ali prekiniti, vendar samo kadar bo to res potrebno.
The mean terminal half-life was 26 days.
Povprečni končni razpolovni čas je znašal 26 dni.
Steady state was reached after 110 days.
Do stanja dinamičnega ravnovesja je prišlo po 110 dneh.
It is important to tell your doctor if you are pregnant, if you think you may be pregnant or are planning to have a baby.
Pomembno je, da zdravniku poveste, če ste noseči, če mislite, da bi lahko bili noseči, ali če načrtujete zanositev.
Neutropenia and leukopenia
Nevtropenija in levkopenija
Do not stop taking Ilaris unless your doctor tells you to.
Zdravila Ilaris ne prenehajte jemati, razen če vam to naroči vaš zdravnik.
Frequency categories are defined 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 the available data).
Skupine pogostnosti so opredeljene 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 (ni mogoče oceniti iz razpoložljivih podatkov).
The mean number of gouty arthritis attacks in the previous 12 months was 6.5.
Povprečno število napadov uričnega artritisa v predhodnih 12 mesecih je bilo 6,5.
The studies were 12 weeks followed by 12-week double-blind extension.
Študiji sta trajali po 12 tednov, vsaka pa se je nadaljevala z 12-tedenskim dvojno slepim podaljšanjem študije.
Of the patients who had achieved a complete response, 89.3% maintained response without relapsing.
Med bolniki, pri katerih je prišlo do popolnega odziva, jih je 89,3 % ohranilo odziv brez ponovitve bolezni.
The terminal half-life ranged from 22.9 to 25.7 days, similar to the pharmacokinetic properties observed in adults.
Končni razpolovni čas je znašal od 22,9 do 25,7 dni, kar je podobno farmakokinetičnim lastnostim zdravila pri odraslih.
The efficacy observed in the studies G2305 and G2301 was maintained in the ongoing, open-label long-term extension study (data available through median of 49 weeks of follow-up).
Učinkovitost, ki so jo opažali v študijah G2305 in G2301, se ohranja v dolgoročnem odprtem podaljšanju študije, ki še poteka (na voljo so podatki po mediano 49 tednih spremljanja bolnikov).
Subcutaneous absorption rate was estimated to decrease with age and appeared to be fastest in the youngest patients.
Ocenjena hitrost absorpcije pri subkutani uporabi se s starostjo zmanjšuje in kaže, da je največja pri najmlajših bolnikih.
Canakinumab also reduced the risk of subsequent attacks (see Table 5).
Kanakinumab je zmanjšal tudi tveganje za nadaljnje napade (glejte preglednico 5).
Allow the area to dry.
Pustite, da se posuši.
The reconstituted solution should ideally be used immediately, but can still be used for up to 24 hours if stored in a refrigerator.
Rekonstituirano raztopino je najbolje porabiti takoj, vendar jo je mogoče uporabiti tudi v roku 24 ur, če je shranjena v hladilniku.
The absolute bioavailability of subcutaneously administered canakinumab was estimated to be 66%.
Absolutna biološka uporabnost subkutano vnešenega kanakinumaba je ocenjena na 66 %.
Reported experience with overdose is limited.
Podatki o izkušnjah s prevelikim odmerjanjem so omejeni.
Mutation in NLRP3 gene in CAPS patients
Mutacija gena NLRP3 pri bolnikih s CAPS
Results for the components of the adapted paediatric ACR which included systemic and arthritic components, were consistent with the overall ACR response results.
Rezultati pri posameznih postavkah prirejenih pediatričnih kriterijev ACR, ki vključujejo sistemske in sklepne komponente, so se ujemali z rezultati celotnega odziva po kriterijih ACR.
- It is important not to try to inject yourself until you have been trained by your healthcare professional.
Pomembno je, da si zdravila ne poskušate injicirati sami, dokler vas za to ni usposobil zdravstveni strokovnjak.
Health-related and quality of life outcomes in studies G2305 and G2301
Z zdravjem in kakovostjo življenja povezani izidi v študijah G2305 in G2301
9/l were also observed (see section 4.4).
9/l (glejte poglavje 4.4).
Bioavailability (AUCss) was not affected.
Starost ni vplivala na biološko uporabnost (AUCss) učinkovine.
Within each system organ class, the adverse reactions are ranked by frequency category with the most common first.
V okviru vsakega organskega sistema so neželeni učinki razvrščeni po kategorijah pogostnosti, pri čemer so najbolj pogosti navedeni najprej.
If you need to be given a live vaccine after starting treatment with Ilaris, discuss this with your doctor.
Če morate biti cepljeni z živim cepivom po začetku zdravljenja z zdravilom Ilaris, se o tem pogovorite s svojim zdravnikom.
Wash your hands with soap and water, then dry them on a clean towel.
Z milom in vodo si umijte roke in si jih nato obrišite s čisto brisačo.
Before initiation of therapy, all patients must be evaluated for both active and latent tuberculosis infection.
Pred začetkom zdravljenja je treba vse bolnike pregledati glede prisotnosti tako aktivne kot latentne oblike tuberkuloze.
Table 4 Paediatric ACR response and disease status at days 15 and 29
Preglednica 4 Odziv po pediatričnih kriterijih ACR in status bolezni na 15. in 29. dan
C-reactive protein ≤ 10 mg/l
C-reaktivni protein ≤ 10 mg/l
No
NE
The study included 243 CAPS patients (including 85 patients less than 18 years of age).
Študija je zajemala 243 bolnikov s CAPS (vključno s 85 bolniki, ki so bili stari manj kot 18 let).
Interactions between canakinumab and other medicinal products have not been investigated in formal studies.
Medsebojnega delovanja kanakinumaba in drugih zdravil niso raziskovali s formalnimi študijami.
Gouty arthritis: Ilaris is not recommended for children or adolescents under 18 years of age.
Urični artritis: Uporaba zdravila Ilaris ni priporočena za otroke ali mladostnike, ki so stari manj kot 18 let.
Do not try to administer an injection yourself if you have not been properly trained or if you are not sure how to do it.
Zdravila ne poskušajte injicirati sami, če se tega niste naučili ali če ne veste, kako je treba to izvesti.
After removing the vial from the refrigerator, check the expiry date on the vial.
Ko boste vzeli vialo iz hladilnika, preverite datum izteka roka uporabnosti zdravila na viali.
* Denotes significant p-value ≤ 0.025
* označuje statistično značilno vrednost p ≤0,025
Do not inject air into the liquid.
Zraka ne iztiskajte v tekočino.
Your baby should not receive live vaccines until at least 16 weeks after you received your last dose of canakinumab before giving birth.
Vaš otrok ne sme prejeti živih cepiv najmanj 16 tednov po tem, ko ste prejeli zadnji odmerek kanakinumaba pred porodom.
Fewer patients aged 2 to < 4 years achieved complete response (57.1%) than older paediatric and adult patients.
Med bolniki, ki so bili stari od 2 do < 4 leta, je do popolnega odziva prišlo pri manjšem deležu bolnikov (57,1 %) kot med starejšimi pediatričnimi in odraslimi bolniki.
Women who are pregnant or who desire to become pregnant should therefore only be treated after a thorough benefit-risk evaluation.
Ženske, ki so noseče ali želijo zanositi, je zato smiselno zdraviti šele po temeljitem razmisleku o razmerju med tveganji in koristmi.
Treatment with canakinumab resulted in clinically relevant improvements in patients' physical function and quality of life.
Zdravljenje s kanakinumabom je omogočilo klinično pomembno izboljšanje telesnih funkcij in kakovosti življenja bolnikov.
Use immediately after first opening.
Zdravilo uporabite takoj po odprtju.
It is unknown whether the use of interleukin-1 (IL-1) inhibitors such as canakinumab increases the risk of reactivation of tuberculosis.
Ni znano, ali uporaba zaviralcev interlevkina-1 (zaviralcev IL-1), kot je kanakinumab, povečuje tveganje za reaktivacijo tuberkuloze.
Canakinumab is associated with an increased incidence of serious infections.
Kanakinumab je povezan s povečano pojavnostjo resnih okužb.
The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Ilaris are provided with a physician information pack containing the following:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo pred prihodom zdravila na trg vsi zdravniki, za katere se pričakuje, da bodo predpisovali/uporabljali zdravilo Ilaris, prejeli komplet podatkov za zdravnika, ki bo vseboval sledeče:
Always use new, unopened needles and syringes.
Vedno uporabite nove igle in brizge, ki še niso bile odprte.
Clinical experience in CAPS patients without a confirmed mutation in the NLRP3 gene is limited.
Kliničnih izkušenj pri bolnikih s CAPS brez potrjene mutacije gena NLRP3 je malo.
The study consisted of two parts with two independent primary endpoints (successful steroid taper and time to flare).
Študija je obsegala dve obdobji in dva neodvisna primarna cilja opazovanja (uspešno postopno zniževanje odmerkov steroidnih zdravil in čas do zagona).
In case of overdose, it is recommended for the patient to be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
V primeru prevelikega odmerjanja je priporočljivo bolnika opazovati glede morebitnih znakov in simptomov neželenih učinkov in takoj uvesti ustrezno simptomatsko zdravljenje.
The European Medicines Agency has waived the obligation to submit the results of studies with Ilaris in all subsets of the paediatric population in gouty arthritis (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Ilaris za vse podskupine pediatrične populacije z uričnim artritisom (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
This means that it is injected through a short needle into the fatty tissue just under the skin.
To pomeni, da je zdravilo treba s kratko iglo injicirati v maščobno tkivo pod kožo.
A live vaccine should normally be given 3 months after your last injection of Ilaris and 3 months before the next one.
Živo cepivo je običajno mogoče dati 3 mesece po zadnji injekciji zdravila Ilaris in 3 mesece pred naslednjo injekcijo zdravila.
These symptoms could be due to a serious infection, an unusual infection (opportunistic infection) or be related to low levels of white blood cells (called leukopenia or neutropenia).
To so lahko simptomi resne okužbe, neobičajne (oportunistične) okužbe ali pa so povezani z znižanim številom belih krvnih celic (kar imenujemo levkopenija ali nevtropenija).
Periodic fever syndromes
Periodični vročinski sindromi
Ilaris is available in packs containing one vial or multipacks comprising four intermediate packs, each containing one vial.
Zdravilo Ilaris je na voljo v pakiranjih, ki vsebujejo po eno vialo, ali v skupnih pakiranjih, ki obsegajo štiri vmesna pakiranja, od katerih vsako vsebuje po eno vialo.
Wash your hands with soap and water.
Z milom in vodo si umijte roke.
Make sure all of the solution is in the bottom of the vial.
Preglejte, če je vsa raztopina na dnu viale.
Of the patients treated with 600 mg or 8 mg/kg (or even higher), 43.8% achieved complete response.
Med bolniki, ki so prejemali 600 mg ali 8 mg/kg (ali celo več), je do popolnega odziva prišlo pri 43,8 %.
This may affect your ability to drive or use tools or machines.
To lahko zmanjša sposobnost za vožnjo ali za uporabo naprav in upravljanje strojev.
The safety profile of canakinumab observed following long-term treatment in this setting was consistent with what has been observed in interventional studies in CAPS patients.
Varnostni profil kanakinumaba, ki so ga opažali pri dolgotrajnem zdravljenju v navedenih pogojih, se je ujemal z opažanji v intervencijskih študijah pri bolnikih s CAPS.
Although approximately 22% of patients receiving canakinumab required dose adjustment, only a small percentage of patients (1.2%) discontinued canakinumab due to lack of therapeutic effect.
Čeprav je med bolniki, ki so prejemali kanakinumab, potrebovalo prilagajanje odmerjanja približno 22 % bolnikov, je le majhen odstotek bolnikov (1,2 %) prekinil zdravljenje s kanakinumabom zaradi nezadostnega terapevtskega učinka.
In early clinical trials, patients and healthy volunteers received doses as high as 10 mg/kg, administered intravenously or subcutaneously, without evidence of acute toxicity.
V zgodnjih kliničnih preskušanjih so bolniki in zdravi prostovoljci intravensko ali subkutano prejemali odmerke do 10 mg/kg brez znakov akutne toksičnosti.
Never re-use syringes or needles.
Brizg in igel nikoli ne uporabite ponovno.
Tuberculosis screening
Presejanje za tuberkulozo
The study also evaluated the effect of canakinumab on the development of antibodies to standard childhood vaccines.
V študiji so ocenjevali tudi vpliv kanakinumaba na razvoj protiteles po cepljenju v okviru standardnega programa cepljenja v otroški dobi.
ALT/AST
Vrednosti ALT/AST
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI S ŠTEVILOM ENOT
Swirl the vial slowly at an angle of about 45° for approximately 1 minute and allow to stand for about 5 minutes.
Vialo pod kotom približno 45° približno 1 minuto počasi vrtite, nato pa jo pustite, da stoji približno 5 minut.
If you experience a new attack, your doctor may consider giving you a new dose of Ilaris but not earlier than 12 weeks from the previous dose.
Če pride do novega napada, bo zdravnik razmislil o možnosti, da vam da nov odmerek zdravila Ilaris, vendar ne prej kot 12 tednov po predhodnem odmerku.
This is clinically relevant for CYP450 substrates with a narrow therapeutic index where the dose is individually adjusted.
To je klinično pomembno pri substratih CYP450 z ozkim terapevtskim oknom, katerih odmerjanje je treba prilagajati posameznemu bolniku.
No differences in safety or efficacy were observed in patients under the age of 2 years compared with patients aged 2 years and above.
Pri tem niso opažali nobenih razlik glede varnosti in učinkovitosti pri bolnikih, ki so bili stari manj kot 2 leti; v primerjavi z bolniki, ki so bili stari 2 leti ali več.
If the solution has a distinctly brown discolouration it should not be used.
Če ima raztopina izrazito rjavo barvo, je ne smete uporabiti.
Patients > 28 days but < 2 years of age were allowed to enter the study directly into an open-arm of Part II as nonrandomised patients (and were excluded from the primary efficacy analysis).
Bolnike, ki so bili stari > 28 dni, a manj kot 2 leti, so vključili v študijo neposredno v 2. obdobje, in sicer v skupino z odprtim zdravljenjem kot nerandomizirane bolnike (njihovi podatki niso bili vključeni v primarno analizo učinkovitosti).
Essential preparation
Obvezna predpriprava
There is a limited amount of data from the use of canakinumab in pregnant women.
Obseg podatkov o uporabi kanakinumaba pri nosečnicah je omejen.
The efficacy of canakinumab for the treatment of active SJIA was assessed in two pivotal studies (G2305 and G2301).
Učinkovitost kanakinumaba pri zdravljenju aktivnega SJIA so ocenjevali v dveh ključnih študijah (G2305 in G2301).
The primary objective was the proportion of patients at day 15 who achieved a minimum 30% improvement in the paediatric American College of Rheumatology (ACR) response criterion adapted to include absence of fever.
Primarni cilj opazovanja v študiji je bil delež bolnikov, pri katerih je 15. dan v študiji prišlo do najmanj 30-odstotnega izboljšanja po pediatričnih kriterijih Ameriškega združenja za revmatologijo (ACRAmerican College of Rheumatology) ki so jih priredili tako, da so vključevali še odsotnost zvišane telesne temperature.
Ilaris has minor influence on the ability to drive and use machines.
Zdravilo Ilaris ima blag vpliv na sposobnost vožnje in upravljanja strojev.
Gouty arthritis is caused by the formation of urate crystals.
Urični artritis povzroča nastajanje uratnih kristalov.
Packs containing 1 vial.
Pakiranja vsebujejo 1 vialo.
Turn the vial and syringe upside down and bring to eye level.
Obrnite vialo in brizgo na glavo in ju dvignite do višine svojih oči.
Formal studies of the potential effect of canakinumab on human fertility have not been conducted.
Formalnih študij možnega vpliva kanakinumaba na plodnost pri ljudeh niso izvajali.
The apparent volume of distribution (V/F) was 4.96 l at body weight of 55 kg.
Navidezni volumen porazdelitve (V/F) je pri telesni masi 55 kg znašal 4,96 l.
Gouty arthritis: If you have a gouty arthritis attack, you will be given a single dose of Ilaris.
Urični artritis: Če imate napad uričnega artritisa, boste prejeli en sam odmerek zdravila Ilaris.
If you have gouty arthritis, your treatment will be overseen by a doctor with specialist training.
Če imate urični artritis, bo vaše zdravljenje nadzoroval zdravnik specialist, ki bo za to posebej usposobljen.
At week 12, the adapted paediatric ACR30, 50, 70, 90 and 100 responses were: 70%, 69%, 61%, 49% and 30%, respectively and 28% of patients had inactive disease (N=178).
Po 12 tednih zdravljenja so odzivi po prirejenih pediatričnih kriterijih odziva ACR30, 50, 70, 90 in 100 znašali: 70 %, 69 %, 61 %, 49 % oziroma 30 %, pri 28 % bolnikov pa je bila bolezen neaktivna (N=178).
This product information has been updated to include the results of studies with Ilaris in the paediatric population.
Te informacije o zdravilu so že dopolnjene z rezultati študij zdravila Ilaris pri pediatrični populaciji.
The primary objective was to assess the proportion of patients who were free of relapse at week 24, including those patients whose dose was increased.
Primarni cilj študije je bil oceniti delež bolnikov, pri katerih v 24 tednih ni prišlo do ponovitve bolezni, pri čemer so upoštevali tudi tiste bolnike, ki so jim odmerke zvišali.
The results of a study in healthy adult subjects demonstrated that a single dose of Ilaris 300 mg did not affect the induction and persistence of antibody responses after vaccination with influenza or glycosylated protein based meningococcus vaccines.
Rezultati študije pri zdravih odraslih so pokazali, da enkratni odmerek 300 mg zdravila Ilaris ni vplival na indukcijo in trajnost protitelesnih odzivov po cepljenju s cepivom proti gripi oziroma s cepivom proti meningokoku, ki vsebuje glikozilirane proteine.
Over 85% of patients had comorbidity, including hypertension (60%), diabetes (15%), ischaemic heart disease (12%), and stage ≥ 3 chronic kidney disease (25%).
Več kot 85 % bolnikov je imelo sočasno še katero od drugih bolezni, med drugim hipertenzijo (60 %), sladkorno bolezen (15 %), ishemično bolezen srca (12 %) in kronično ledvično bolezen 3. ali višje stopnje (25 %).
If possible, avoid touching the rubber stopper with your fingers.
Če se le da, se s prstom ne dotikajte gumijastega zamaška.
Approximately one-third of the patients enrolled (76 [33.8%] in the canakinumab group and 84 [36.7%] in the triamcinolone acetonide group) had documented inability (intolerance, contraindication or lack of response) to use both NSAIDs and colchicine.
Približno ena tretjina vključenih bolnikov (76 [33,8 %] v skupini s kanakinumabom in 84 [36,7 %] v skupini s triamcinolon acetonidom) je imela dokumentirano nezmožnost (neprenašanje, kontraindikacije ali nezadosten učinek) uporabe tako nesteroidnih protivnetnih zdravil kot kolhicina.
From a microbiological point of view, the product should be used immediately after first opening.
S stališča mikrobiološke varnosti je treba zdravilo uporabiti takoj po odprtju.
All patients who received non-live, standard of care childhood vaccinations (N=7) developed protective antibody levels.
Pri vseh bolnikih, ki so prejeli neživa cepiva po standardnem programu cepljenja v otroški dobi (N=7), se je razvila zaščitna raven protiteles.
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC08
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci interlevkinov, oznaka ATC: L04AC08
* human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology
* humano monoklonsko protitelo, pridobljeno iz celic mišjega mieloma Sp2/0 s tehnologijo rekombinantne DNA
What Ilaris is and what it is used for
Kaj je zdravilo Ilaris in za kaj ga uporabljamo
Patients who do not respond to initial treatment should not be re-treated with canakinumab.
Bolniki, ki se ne odzovejo na začetno zdravljenje, kanakinumaba ne smejo ponovno prejeti.
The co-primary endpoints were: (i) gouty arthritis pain intensity (visual analogue scale, VAS) at 72 hours post-dose, and (ii) time to first new gouty arthritis attack.
Enakovredna primarna cilja opazovanja sta bila: (1) intenzivnost bolečine pri uričnem artritisu (ocena na vizualni analogni lestvici - VAS) 72 ur po odmerjanju in (2) čas do prvega novega napada uričnega artritisa.
If you received canakinumab while you were pregnant, it is important that you inform the baby's doctor or nurse before any vaccinations are given to your baby.
Če ste v času nosečnosti prejemali kanakinumab, je pomembno, da o tem obvestite otrokovega zdravnika ali medicinsko sestro, preden vaš otrok prejme katerokoli cepivo.
9/l) and leukopenia have been observed with medicinal products that inhibit IL-1, including canakinumab.
9/l) in levkopenijo so pogosto opažali pri uporabi zdravil, ki zavirajo IL-1, med katere sodi tudi kanakinumab.
The distribution volume (Vss) of canakinumab varied according to body weight.
Volumen porazdelitve (Vss) kanakinumaba je odvisen od telesne mase.
A total of 324 SJIA patients aged 2 to < 20 years have received Ilaris in interventional clinical trials, including 293 patients aged 2 to < 16 years old, 21 patients aged 16 to < 18 years old and 10 patients aged 18 to < 20 years old.
Skupno je v intervencijskih kliničnih študijah prejemalo zdravilo Ilaris 324 bolnikov s SJIA, ki so bili stari od 2 do <20 let, vključno z 293 bolniki, ki so bili stari od 2 do <16 let, 21 bolniki, ki so bili stari od 16 do <18 let, in 10 bolniki, ki so bili stari od 18 do <20 let.
Let the vial stand unopened for 10 minutes to bring the contents to room temperature.
Vialo pustite zaprto stati 10 minut, da se njena vsebina ogreje na sobno temperaturo.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Če zdravila ne uporabi takoj, je uporabnik sam odgovoren za čas in pogoje shranjevanja pred uporabo, ki naj praviloma ne presegajo 24 ur pri 2 °C - 8 °C.