natgillin/translations-raw huggingface dataset:
In this study, ellaOne was as effective as levonorgestrel at preventing pregnancies.
V tej študiji je bilo zdravilo ellaOne pri preprečevanju nosečnosti enako učinkovito kot levonorgestrel.
EllaOne is a female emergency contraceptive to be taken within 120 hours (five days) of unprotected sex or contraceptive failure (such as a tear in a condom during sex).
Zdravilo ellaOne je nujno kontracepcijsko sredstvo za ženske, ki ga je treba vzeti najkasneje 120 ur (pet dni) po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji (na primer, če med spolnim odnosom kondom poči).
EllaOne was effective as an emergency contraceptive, reducing the number of unintended pregnancies.
Zdravilo ellaOne je bilo pri zmanjšanju števila nenačrtovanih nosečnosti enako učinkovito kot nujno kontracepcijsko sredstvo.
This study included women who took the medicine within two days of unprotected sex or contraceptive failure.
V tej študiji so sodelovale ženske, ki so zdravilo vzele najkasneje dva dni po nezaščitenem spolnem odnosu ali neučinkoviti kontracepciji.
What is ellaOne used for?
Za kaj se zdravilo ellaOne uporablja?
How does ellaOne work?
Kako zdravilo ellaOne deluje?
How has ellaOne been studied?
Kako je bilo zdravilo ellaOne raziskano?
What is ellaOne?
Kaj je zdravilo ellaOne?
How is ellaOne used?
Kako se zdravilo ellaOne uporablja?
# at risk months months
# ob tveganju mesecev mesecev
The potential risk for humans is unknown.
Možno tveganje za ljudi ni znano.
This “treatment cycle” will be repeated every 4 weeks.
Ta „cikel zdravljenja“ se ponovi vsake 4 tedne.
(% of recommended starting dose)
(% priporočenega začetnega odmerka)
The following information is intended for healthcare professionals only:
Naslednje informacije so namenjene samo zdravstvenemu osebju:
After reconstitution:
Po rekonstituciji:
Your doctor will check your progress and may change your dose if necessary.
Vaš zdravnik bo preveril napredek in lahko po potrebi spremeni odmerek.
• Loss of appetite.
• izguba apetita
Response was assessed by the investigator or by the Independent Review Committee (IRC).
Odziv je ocenil raziskovalec ali neodvisni odbor za pregled (Independent Review Committee - IRC).
The primary endpoint of the study was overall survival.
Primarni cilj študije je bilo celokupno preživetje.
Unopened powder vial: 4 years
Neodprta viala s praškom: 4 leta
From a microbiological point of view, the reconstituted product should be used immediately.
Z mikrobiološkega vidika je treba rekonstituirano zdravilo uporabiti takoj.
Patients with secondary MDS were excluded from the study.
Bolniki s sekundarno MDS so bili izključeni iz študije.
Treatment should be continued as long as the patient continues to benefit or until disease progression.
Zdravljenje je treba nadaljevati tako dolgo, dokler bolniku koristi ali dokler bolezen ne napreduje.
Other side effects include:
Med druge neželene učinke spadajo:
HRQoL data could be analysed for a subset of the full trial population.
Podatke HRQoL je mogoče analizirati po podskupinah celotne populacije preskušanja.
Tell your doctor straight away if you notice any of the following side effects:
Takoj obvestite svojega zdravnika, če opazite kateregakoli od naslednjih neželenih učinkov:
This is to check that you have enough blood cells and that your liver and kidneys are working properly.
Na tak način se preveri, ali imate dovolj krvnih celic in ali vaša jetra in ledvice pravilno delujejo.
Total volume of reconstituted suspension required
Celotni volumen potrebne rekonstituirane suspenzije
The differences between the IRC and investigator assessments of response were a consequence of the International Working Group (IWG) criteria requiring improvement in peripheral blood counts and maintenance of these improvements for a minimum of 56 days.
Razlike med ocenami odziva IRC in raziskovalca so bile posledica kriterijev Mednarodne delovne skupine (IWGInternational Working Group), ki so zahtevali izboljšanje vrednosti periferne krvi in vzdrževanje teh izboljšanj vsaj 56 dni.
Based on results from animal studies and its mechanism of action, azacitidine should not be used during pregnancy, especially during the first trimester, unless clearly necessary.
Na podlagi rezultatov študij na živalih in mehanizma delovanja se azacitidina ne sme uporabljati med nosečnostjo, še zlasti ne v prvem trimesečju, razen če je to nujno.
Proportion Surviving
Sorazmerno preživetje
The safety and efficacy of Vidaza in children aged 0-17 years have not yet been established.
Varnost in učinkovitost zdravila Vidaza pri otrocih, starih 0 do 17 let, še nista bili dokazani.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v poglavju 6.6.
Non-proliferating cells are relatively insensitive to azacitidine.
Neproliferativne celice so relativno neobčutljive na azacitidin.
Calculation of an individual dose The total dose, according to the body surface area (BSA) can be calculated as follows:
Izračun individualnega odmerka Celotni odmerek glede na površino telesa (BSA - body surface area) se izračuna tako:
Following dose modifications, the cycle duration should return to 28 days.
Po spremembi odmerka mora biti dolžina cikla ponovno 28 dni.
Do not use this medicine after the expiry date which is stated on the vial label and the carton.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki viale in na škatli.
Children and adolescents Vidaza is not recommended for use in children and adolescents below the age of 18.
Otroci in mladostniki Uporaba zdravila Vidaza ni priporočljiva pri otrocih in mladostnikih, mlajših od 18 let.
Your doctor will decide your dose of this medicine, depending on your general condition, height and weight.
Zdravnik bo določil odmerek tega zdravila glede na vaše splošno počutje, vašo višino in telesno maso.
When more than 1 vial is needed all the above steps for preparation of the suspension should be repeated.
Kadar je potrebna več kot 1 viala, ponovite vse zgornje korake za pripravo suspenzije.
However, exposure was within the same general range of exposures observed for subjects with normal renal function.
Vendar pa je bila izpostavljenost znotraj istega splošnega razpona izpostavljenosti, ki so jih opažali pri osebah z normalno ledvično funkcijo.
These patients should be monitored closely and appropriate precautions taken.
Te bolnike je treba skrbno spremljati in pri njih uvesti ustrezne previdnostne ukrepe.
ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
PRILOGA II A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
• if you are allergic to azacitidine or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na azacitidin ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
It is not known if this medicine passes into human milk.
Ni znano, ali to zdravilo prehaja v materino mleko.
The following table is provided only as an example of how to calculate individual azacitidine doses based on an average BSA value of 1.8 m2.
Naslednja preglednica je prikazana samo kot primer izračuna za pripravo individualnih odmerkov azacitidina na podlagi povprečne vrednosti BSA, ki je 1,8 m2.
They are also responsible for preparing and disposing of any unused Vidaza correctly.
Odgovoren je tudi za pravilno pripravo in odstranitev neuporabljenega zdravila Vidaza.
No specific dose adjustments are recommended for the elderly.
Ni priporočil o posebnih prilagajanjih odmerka za starejše ljudi.
Date of latest renewal: 13 November 2013
Datum prve odobritve: 17. december 2008 Datum zadnjega podaljšanja: 13. november 2013
Haematologic and cytogenetic responses were assessed by the investigator and by the IRC with similar results.
Hematološke in citogenetske odzive so ocenjevali raziskovalec in IRC s podobnimi rezultati.
Necrotising fasciitis
Nekrotizantni fasciitis
Bleeding may occur with patients receiving azacitidine.
Krvavitev se lahko pojavi pri bolnikih, ki prejemajo azacitidin.
You should not use Vidaza during pregnancy as it may be harmful to the baby.
Med nosečnostjo ne uporabljajte zdravila Vidaza, ker lahko škodi otroku.
Talk to your doctor if you wish to conserve your sperm before starting this treatment.
Pogovorite se z zdravnikom, če želite pred začetkom zdravljenja shraniti svojo spermo.
Therefore, caution is recommended when driving or operating machines.
Zato se pri vožnji ali upravljanju strojev priporoča previdnost.
It must be taken into account that filters are present in some adaptors, spikes and closed systems; therefore such systems should not be used for administration of the medicinal product after reconstitution.
Upoštevati morate, da so filtri nameščeni v nekaterih adapterjih, konicah in zaprtih sistemih; zato se taki sistemi ne smejo uporabljati za dajanje zdravila po rekonstituciji.
2 vials
2 viali
• Vidaza is given every day for one week, followed by a rest period of 3 weeks.
• Zdravilo Vidaza boste en teden prejemali vsak dan, nato sledi tritedensko obdobje mirovanja.
This medicinal product must not be mixed with other medicinal products except those mentioned below (see “Reconstitution Procedure”).
Zdravila ne smemo mešati z drugimi zdravili, razen s tistimi, ki so omenjena v nadaljevanju (glejte „Postopek rekonstitucije“).
Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function.
Ker je pri starejših bolnikih večja verjetnost zmanjšane ledvične funkcije, je morda koristno spremljati delovanje ledvic.
Frequencies are defined as: 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).
Pogostnosti so opredeljene 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 pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
Azacitidine has minor or moderate influence on the ability to drive and use machines.
Azacitidin ima blag ali zmeren vpliv na sposobnost vožnje in upravljanja strojev.
Adverse reactions are presented in the table below according to the highest frequency observed in any of the main clinical studies.
Neželeni učinki so predstavljeni v spodnji preglednici v skladu z največjo pogostnostjo, ki so jo opazili v kateri koli od glavnih kliničnih študij.
• High or low blood pressure (hypertension or hypotension).
• visok ali nizek krvni tlak (hipertenzija ali hipotenzija)
The potential carcinogenicity of azacitidine was evaluated in mice and rats.
Potencialno karcinogenost azacitidina so ocenili pri miših in podganah.
• Tumour lysis syndrome - Metabolic complications that can occur during treatment of cancer and sometimes even without treatment.
• sindrom tumorske lize - presnovni zapleti, ki se lahko pojavijo med zdravljenjem raka in včasih celo brez zdravljenja.
Myelosuppression may lead to neutropenia and an increased risk of infection.
Mielosupresija lahko povzroči nevtropenijo in poveča tveganje za okužbe.
Adverse reactions considered to be possibly or probably related to the administration of Vidaza have occurred in 97 % of patients.
Neželeni učinki, ki so morda ali verjetno povezani z zdravljenjem z zdravilom Vidaza, so se pojavili pri 97 % bolnikov.
On analyses of age subgroups, an increase in median overall survival was observed for all groups (< 65 years, ≥ 65 years and ≥ 75 years).
V analizah starostnih podskupin so v vseh skupinah opazili podaljšanje mediane celokupnega preživetja (< 65 let, ≥ 65 let in ≥ 75 let).
This may be due to an allergic (hypersensitivity) reaction.
Vzrok je lahko alergijska (preobčutljivostna) reakcija.
These cutaneous reactions have to be distinguished from soft tissue infections, sometimes occurring at injection site.
Te kožne reakcije je treba razlikovati od okužb mehkih tkiv, ki se včasih pojavijo na mestu injiciranja.
The product should be discarded if it contains large particles or agglomerates.
Zdravilo zavrzite, če vsebuje večje delce ali aglomerate.
While there are limitations in the analysis, the available data suggest that patients do not experience meaningful deterioration in quality of life during treatment with Vidaza.
Čeprav so v analizi nekatere omejitve, podatki, ki so na voljo, kažejo, da pri bolnikih med zdravljenjem z zdravilom Vidaza ne pride do pomembnega poslabšanja kakovosti življenja.
The requirements for submission of periodic safety update reports for this medicinal are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih
Details on storage of the reconstituted product are provided below.
Podrobnosti o shranjevanju rekonstituiranega zdravila so navedene spodaj.
The results presented below represent the intent-to-treat population studied in AZA-AML-001 (see section 4.1 for the approved indication).
Rezultati, predstavljeni v nadaljevanju, predstavljajo populacijo, namenjeno za zdravljenje, ki so jo proučili v študiji AZA-AML-001 (glejte poglavje 4.1 za odobreno indikacijo).
Doses greater than 4 mL should be injected into two separate sites.
Odmerke, večje kot 4 ml, injicirajte na dve različni mesti.
Procedures for proper handling and disposal of anticancer medicinal products should be applied.
Upoštevati je treba postopke za pravilno ravnanje z zdravili proti raku in njihovo odstranjevanje.
It is therefore advised to exercise caution when prescribing azacitidine to these patients.
Zato se pri predpisovanju azacitidina tem bolnikom priporoča previdnost.
Cardiopulmonary assessment before and during the treatment should be considered.
Razmisliti je treba o kardiopulmonarni oceni pred zdravljenjem in med njim.
Prognostic Scoring System (IPSS),
Mednarodnem prognostičnem sistemu ocenjevanja (IPSS - International Prognostic Scoring
Pack size: 1 vial
Pakiranje: 1 viala.
Following intravenous administration, the mean volume of distribution was 76 ± 26 L, and systemic clearance was 147 ± 47 L/h.
Po intravenskem dajanju je bil povprečni porazdelitveni volumen 76 ± 26 l in sistemski očistek 147 ± 47 l/h.
• Red or purple spots under your skin.
• rdeče ali vijolične lise pod kožo
Do not use Vidaza
Ne uporabljajte zdravila Vidaza
What you need to know before you use Vidaza
Kaj morate vedeti, preden boste uporabili zdravilo Vidaza
In the event of overdose, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary.
V primeru prevelikega odmerjanja je treba bolnika spremljati z ustreznimi pregledi krvne slike in mu po potrebi nuditi podporno zdravljenje.
Health- Related Quality of Life (HRQoL) was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30).
Z zdravjem povezano kakovost življenja (HRQoL - Health-Related Quality of Life) so ocenjevali z osnovnim vprašalnikom o kakovosti življenja Evropske organizacije za raziskovanje in zdravljenje raka (EORTC QLQ-C30 - European Organization for Research and Treatment of Cancer Core
It is recommended that patients be treated for a minimum of 6 cycles.
Priporočeno je, da se bolnike zdravi vsaj 6 ciklov.
You will usually receive at least 6 treatment cycles.
Običajno je ciklov zdravljenja vsaj 6.
• The recommended dose is 75 mg per m2 body surface area.
• Priporočeni odmerek je 75 mg/m2 površine telesa.
For immediate use
Za takojšnjo uporabo
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
There are no adequate data from the use of azacitidine in pregnant women.
Ni zadostnih podatkov o uporabi azacitidina pri nosečnicah.
Other medicines and Vidaza
Druga zdravila in zdravilo Vidaza
The effects of hepatic impairment (see section 4.2), gender, age, or race on the pharmacokinetics of azacitidine have not been formally studied.
Učinkov motenj v delovanju jeter (glejte poglavje 4.2), spola, starosti ali rase na farmakokinetiko azacitidina niso formalno preučili.
A tumorigenicity study in rats revealed an increased incidence of testicular tumours.
Študija tumorogenosti pri podganah je razkrila povečano pojavnost testikularnih tumorjev.
Any unused medicinal product or waste material should be disposed of in accordance with the local requirements.
Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
These are diseases which affect the bone marrow and can cause problems with normal blood cell production.
To so bolezni, ki prizadenejo kostni mozeg in lahko povzročijo težave pri normalnem nastajanju krvnih celic.
The majority of adverse reactions occurred during the first 2 cycles and tended to decrease with subsequent cycles.
Večina neželenih učinkov se je pojavila v prvih 2 ciklih in se je v naslednjih ciklih manjšala.
Patients and physicians are also advised to be observant for signs and symptoms of bleeding.
Bolnike in zdravnike je treba opozoriti, da naj bodo pozorni na znake in simptome krvavenja.
Within the Intent to Treat population (ITT), the median age was 69 years (range 38 to 88 years).
V populaciji bolnikov, ki so jih nameravali zdraviti (ITT - Intent to Treat), je bila mediana starosti 69 let (razpon 38 do 88 let).
Also, some other medicines may affect the way Vidaza works.
Prav tako lahko nekatera druga zdravila vplivajo na način delovanja zdravila Vidaza.
Time (months) from Randomization
Čas (meseci) od naključne razvrstitve
Patients with a history of severe congestive heart failure, clinically unstable cardiac disease or pulmonary disease were excluded from the pivotal registration studies (AZA PH GL 2003 CL 001 and AZA-AML-001) and therefore the safety and efficacy of azacitidine in these patients has not been established.
Bolniki z anamnezo hude kongestivne srčne odpovedi, klinično nestabilne bolezni srca ali bolezni pljuč so bili iz osrednjih registracijskih študij (AZA PH GL 2003 CL 001 in AZA-AML-001) izločeni, zato varnost in učinkovitost azacitidina pri teh bolnikih nista bili ugotovljeni.
Early embryotoxicity studies in mice revealed a 44 % frequency of intrauterine embryonal death (increased resorption) after a single intraperitoneal injection of azacitidine during organogenesis.
Študije zgodnje embriotoksičnosti pri miših so pokazale 44 % pogostnost smrti zarodka v maternici (povečana resorpcija) po enkratnem intraperitonealnem injiciranju azacitidina med organogenezo.
There is a greater risk of these events occurring during the first 2 cycles, after which they occur with less frequency in patients with restoration of haematological function.
Tveganje, da se ti dogodki pojavijo v prvih 2 ciklih, je večje, nato se pri bolnikih pojavijo manj pogosto, krvotvorna funkcija pa se ponovno vzpostavi.
When IPSS cytogenetic subgroups were analysed, similar findings in terms of median overall survival were observed in all groups (good, intermediate, poor cytogenetics, including monosomy 7).
Pri analiziranju citogenetskih podskupin IPSS so bili izsledki v smislu mediane celokupnega preživetja v vseh skupinah podobni (dobra, srednja, slaba citogenetika, vključno z monosomijo 7).
RAEB-T patients (21-30 % blasts) are now considered to be AML patients under the current WHO classification system.
Bolniki z RAEB-T (21-30 % blastov) se sedaj obravnavajo kot bolniki z AML po sedanjem razvrstitvenem sistemu SZO.
• Skin infection (cellulitis).
• kožna okužba (celulitis)
A survival benefit was also demonstrated in patients that had not achieved a complete response for Vidaza compared to CCR.
Korist za preživetje so dokazali tudi pri bolnikih, ki niso dosegli popolnega odziva na zdravilo Vidaza v primerjavi s CCR.
This is because Vidaza may affect the way some other medicines work.
Zdravilo Vidaza lahko vpliva na način delovanja nekaterih drugih zdravil.
Vidaza treatment was also associated with a reduction in cytopenias, and their related symptoms.
Zdravljenje z zdravilom Vidaza je bilo povezano tudi z zmanjšanjem citopenij in z njimi povezanih simptomov.
• Blood in your urine.
• kri v urinu
If bone marrow cellularity is ≤ 50 %, treatment should be delayed and the dose reduced according to the following table:
Če je celularnost kostnega mozga ≤ 50 %, je treba zdravljenje preložiti in odmerek zmanjšati v skladu z naslednjo tabelo:
Azacitidine plus best supportive care (BSC) (n = 179) was compared to conventional care regimens (CCR).
Azacitidin z najboljšo podporno oskrbo (BSC - best supportive care (n = 179) je bil primerjan z običajnimi režimi oskrbe (CCR - conventional care regimens).
Patients should be monitored for signs and symptoms of bleeding, particularly those with pre-existing or treatmentrelated thrombocytopenia.
Pri bolnikih je treba spremljati znake in simptome krvavitev, še zlasti pri tistih, ki imajo obstoječo ali z zdravljenjem povezano trombocitopenijo.
For doses requiring more than 1 vial, the dose should be equally divided e.g., dose 150 mg = 6 mL, 2 syringes with 3 mL in each syringe.
Za odmerke, pri katerih je potrebna več kot 1 viala, morate odmerek enakomerno razdeliti, npr. odmerek 150 mg = 6 ml, 2 brizgi s po 3 ml v vsaki brizgi.
Patients should be monitored for haematologic response/toxicity and renal toxicities (see section 4.4); a delay in starting the next cycle or a dose reduction as described below may be necessary.
Pri bolnikih je treba spremljati hematološki odziv/toksičnost in toksičnost za ledvice (glejte poglavje 4.4); morda bo treba začetek naslednjega cikla prestaviti ali odmerek zmanjšati, kot je opisano spodaj.
• The other ingredient is mannitol (E421).
• Druga sestavina zdravila (pomožna snov) je manitol (E421).
Dose adjustment due to haematological toxicity
Prilagoditev odmerka zaradi hematološke toksičnosti
• Having trouble sleeping (insomnia).
• težave s spanjem (nespečnost)
If the bone marrow cellularity is > 50 %, no dose adjustments should be made.
Če je celularnost kostnega mozga > 50 %, ni treba prilagajati odmerka.
Cumulatively, the safety database includes 51 cases with 56 events of pericarditis, myocarditis, and/or endocarditis reported with the use of Vidaza.
Zbirka podatkov o varnosti skupno vključuje 51 primerov s 56 pojavi perikarditisa, miokarditisa in/ali endokarditisa, o katerih so poročali pri uporabi zdravila Vidaza.
For clinical management of infectious adverse reactions, see section 4.8 Infections.
Za klinično obravnavo neželenih učinkov, povezanih z okužbami, glejte poglavje 4.8 Okužbe.
• Pain in your belly (abdominal pain).
• bolečine v trebuhu (abdominalne bolečine)
However, if recovery has not been achieved within 14 days, the dose should be reduced according to the following table.
Če v 14 dneh ne pride do obnovitve, je treba odmerek zmanjšati v skladu z naslednjo tabelo.