natgillin/translations-raw huggingface dataset:
To avoid irritation of the oesophagus (gullet), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet.
Da bi preprečili draženje požiralnika (cevke, ki vodi od ust do želodca), bolnik ne sme leči, dokler ne zaužije prvega dnevnega obroka hrane, kar pa ne sme biti prej kot 30 minut po zaužitju tablete.
Why has Adrovance been approved?
Zakaj je bilo zdravilo Adrovance odobreno?
This study was extended in 652 patients for a further 24 weeks to compare the effects on continuing with Adrovance 70 mg/2,800 IU on its own or adding another 2,800 IU vitamin D3 (equivalent to using Adrovance 70 mg/5,600 IU).
Ta študija je bila pri 652 bolnikih podaljšana za nadaljnjih 24 tednov, da bi primerjali učinke nadaljevanja zdravljenja samo z zdravilom Adrovance 70 mg/2 800 i.e. z učinki dodajanja 2 800 i.e. vitamina D3 (kar je enakovredno uporabi zdravila Adrovance 70 mg/5 600 i.e.).
Patients received either Adrovance 70 mg/2,800 IU or alendronic acid only once a week.
Bolniki so enkrat tedensko prejemali bodisi zdravilo Adrovance 70 mg/2 800 i.e. bodisi le alendronsko kislino.
To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Adrovance's ability to increase vitamin D levels.
V podporo uporabi kombinacije alendronske kisline in vitamina D3 v isti tableti in za pridobitev dokazov, da zdravilo Adrovance lahko poveča ravni vitamina D, je družba izvedla študijo s 717 bolniki z osteoporozo, ki je vključevala 682 žensk, ki so že prestale menopavzo.
Adrovance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Adrovance je zdravilo, ki vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol (vitamin D3).
Patients should also take calcium supplements if they are not getting enough calcium from their diet. For more information, see the package leaflet.
Bolniki morajo jemati tudi dodatke kalcija, če njegov vnos s prehrano ni zadosten.
In the extension study, similar numbers of patients taking Adrovance 70 mg/2,800 IU and Adrovance 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Adrovance 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.
V podaljšani študiji je bilo število bolnikov z nizkimi ravnmi vitamina D (pod 6 %) v skupini bolnikov, ki so jemali zdravilo Adrovance 70 mg/2 800 i.e., podobno številu bolnikov v skupini, ki je prejemala zdravilo Adrovance 70 mg/5 600 i.e., vendar pa so se pri bolnikih, ki so jemali zdravilo Adrovance 70 mg/5 600 i.e., v 24 tednih študije ravni vitamina D bolj povečale.
What is Adrovance used for?
Za kaj se zdravilo Adrovance uporablja?
Adrovance contains two active substances: alendronic acid and colecalciferol (vitamin D3).
Zdravilo Adrovance vsebuje dve zdravilni učinkovini: alendronsko kislino in holekalciferol (vitamin D3).
How has Adrovance been studied?
Kako je bilo zdravilo Adrovance raziskano?
Adrovance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels.
Zdravilo Adrovance (ki vsebuje 2 800 ali 5 600 i.e. holekalciferola) se uporablja za zdravljenje osteoporoze (bolezni, ki povzroča krhkost kosti) pri ženskah po menopavzi, pri katerih obstaja tveganje za pomanjkanje vitamina D. Zdravilo Adrovance 70 mg/5 600 i.e. se uporablja pri bolnikih, ki ne jemljejo dodatkov vitamina D. Zdravilo Adrovance zmanjšuje tveganje za zlome kosti v hrbtenici in kolkih.
How does Adrovance work?
Kako zdravilo Adrovance deluje?
How is Adrovance used?
Kako se zdravilo Adrovance uporablja?
After 15 weeks, fewer patients had low vitamin D levels when they took Adrovance 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%).
Dodatne študije so pokazale, da lahko vključitev vitamina D3 in alendronske kisline v isto tableto poveča ravni vitamina D. Po 15 tednih zdravljenja je bil delež bolnikov z nizko ravnjo vitamina D med bolniki, zdravljenimi z zdravilom Adrovance 70 mg/2 800 i.e., nižji (11 %) kot pri tistih, ki so prejemali le alendronsko kislino (32 %).
What is Adrovance?
Kaj je zdravilo Adrovance?
Vial 2 years.
Viala 2 leti.
Most ISRs lasted for one to two days.
Večina ISR je trajala en dan do dva dni.
• tuberculosis or you have been in close contact with someone who has had tuberculosis;
• tuberkulozo ali ste bili v tesnem stiku z nekom, ki je imel/ima tuberkulozo;
The steady state appeared to be reached by 6 weeks.
Zdi se, da je bilo stanje ravnovesja doseženo v 6 tednih.
These will be monitored by your doctor.
Te bo spremljal vaš zdravnik.
Combinations not recommended
Kombinacije, ki jih ne priporočajo
Part A of the trial was initiated in the winter months, while Part B was predominantly performed in the summer months.
Del A preskušanja se je začel v zimskih mesecih, del B pa je bil pretežno opravljen v poletnih mesecih.
The next dose should be injected at the next regularly scheduled time.
Naslednji odmerek si injicirajte ob naslednjem redno načrtovanem času.
The patients should be included in the Registry until both following conditions are met: 5 years recruitment period and 200 patients included.
Bolniki morajo biti vključeni v register dokler ne bosta izpolnjena oba naslednja pogoja: 5-letno obdobje vključevanja in 200 vključenih bolnikov.
Figure 13a (Adults)
Slika 13a (odrasli)
Proceed with the injection as described in Step 6 below.
Nadaljujte z injiciranjem, kot je opisano spodaj v koraku 6.
If you feel a spinning sensation, do not drive or operate any tools or machines until you are feeling normal again.
Če začutite vrtoglavico, ne vozite in ne upravljajte kakšnih orodij ali strojev, dokler se ne počutite spet normalno.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2009
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve pridobitve dovoljenja za promet: 23. oktober 2009 Datum zadnjega podaljšanja:
• The possibility to include patients in the registry study to facilitate the collection of long term efficacy and safety data;
• o možnosti vključitve bolnikov v študijo registra, s čimer bo olajšano zbiranje dolgoročnih podatkov o varnosti in učinkovitosti;
Let the alcohol air dry completely.
Počakajte, da se alkohol popolnoma posuši.
Your doctor may need to perform some tests and adjust the dose of such medicines.
Vaš zdravnik bo moral mogoče opraviti nekatere preiskave in prilagoditi odmerek takih zdravil.
The physician information should contain the following key messages:
Izobraževalno gradivo mora vsebovati naslednja ključna sporočila:
The maximum amount of product that can be safely administered has not been determined.
Največje količine zdravila, ki jo lahko varno uporabimo, niso določili.
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet z zdravilom v spodaj navedenem časovnem okviru izvesti naslednje ukrepe:
Active, severe infections (see section 4.4).
Aktivne, težke okužbe (glejte poglavje 4.4).
In particular, you should tell your doctor if you are using any of the below medicines:
Zdravniku še zlasti povejte, če uporabljate katero koli izmed spodaj navedenih zdravil:
Animal studies were conducted to assess reproductive toxicity.
Študije na živalih so opravili, da bi ocenili toksičnost za razmnoževanje.
None of these patients had serious infections associated with the neutropenia.
Nobeden od teh bolnikov ni imel resnih okužb, povezanih z nevtropenijo.
In both cases your doctor will calculate the corresponding volume to inject.
V obeh primerih bo vaš zdravnik izračunal ustrezni volumen, ki ga je treba injicirati.
The dose will depend on the body weight of the patient and will be different for each patient.
Odmerek bo odvisen od telesne mase bolnika in bo pri vsakem bolniku drugačen.
Adults who entered in Part A
Odrasli, ki so se vključili v del A
23.6 to 27.2 27.3 to 30.8 30.9 to 34.4 34.5 to 38.1 38.2 to 41.7 41.8 to 45.4 45.5 to 49.0 49.1 to 52.6 52.7 to 56.3 56.4 to 59.9 60.0 to 63.5 63.6 to 67.2 67.3 to 70.8 70.9 or greater
23,6 do 27,2 27,3 do 30,8 30,9 do 34,4 34,5 do 38,1 38,2 do 41,7 41,8 do 45,4 45,5 do 49,0 49,1 do 52,6 52,7 do 56,3 56,4 do 59,9 60,0 do 63,5 63,6 do 67,2 67,3 do 70,8
It is not intended for intravenous or intramuscular use.
Ni namenjeno za intravensko ali intramuskularno uporabo.
Read these instructions all the way through before beginning.
Pred začetkom v celoti preberite ta navodila.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Če ste noseči, mislite, da ste mogoče noseči, ali načrtujete nosečnost, se za nasvet obrnite na svojega zdravnika, preden začnete jemati to zdravilo.
The EMA will review any new information, which may become available every year, and this SPC will be updated as necessary.
EMA bo pregledala vse nove podatke, ki bodo postali dosegljivi vsako leto, in ta SPC bo po potrebi posodobljen.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/582/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/582/001
Hold the syringe in one hand like you would hold a pencil.
Držite brizgo v eni roki, kot bi držali svinčnik.
Your doctor will tell you how much medicine to inject.
Zdravnik vam bo povedal, koliko zdravila je treba injicirati.
Changing injection sites helps to prevent irritation and allows the medicine to be better absorbed.
Spreminjanje mest injiciranja pomaga preprečevati draženje in omogoča zdravilu, da se bolje absorbira.
• if you are allergic to rilonacept or any of the other ingredients of this medicine (listed in section 6).
• če ste alergični na rilonacept ali katero koli sestavino tega zdravila (sestavine so naštete v poglavju 6);
Women who are pregnant or who desire to become pregnant should therefore only be treated after a thorough benefit-risk evaluation.
Zato smemo ženske, ki so noseče ali želijo zanositi, zdraviti šele po temeljiti oceni koristi in nevarnosti.
For small children or persons with little fat under the skin, you may need to hold the syringe and needle at a 45° angle (see Figure 13b).
Pri majhnih otrocih ali osebah, ki imajo malo maščobe pod kožo, boste mogoče morali držati brizgo in iglo pod kotom 45° (glejte sliko 13b).
The continued collection of data should be maintained from the registry on safety and efficacy in children; particularly risk of infection and possible impairment of immune reactions such as response to vaccinations and growth.
Nadaljnje zbiranje podatkov je treba vzdrževati iz registra o varnosti in učinkovitosti pri otrocih, predvsem tveganje za okužbo in morebitno poslabšanje imunskih reakcij, kot sta odziv na cepljenje in rast.
Where to inject Inject in a different place each time in order to keep your skin healthy.
Kam injicirati Vsakič morate injicirati na drugo mesto, da bo vaša koža ostala zdrava.
Contains:
Vsebuje:
Changes in lipid parameters
Spremembe lipidnih parametrov
However, clinical experience in such patients is limited.
Vendar so klinične izkušnje pri takih bolnikih omejene.
Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of CAPS.
Zdravljenje mora uvesti in nadzirati zdravnik specialist, izkušen v diagnostiki in zdravljenju CAPS.
If the powder has not completely dissolved, shake the vial quickly back and forth for 30 seconds more.
Če se prašek ni popolnoma raztopil, hitro stresajte vialo naprej in nazaj še 30 sekund.
• The proper patient management as regards the interaction with vaccination;
• o pravilnem vodenju bolnikov glede medsebojnega delovanja s cepljenjem;
Do not inject a double dose to make up for the forgotten dose.
Ne injicirajte dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
• The need to instruct patients on proper techniques for self-administration when the patient is willing and capable to do so, and guidance for Health Care Professionals on how to report administration errors;
• o potrebi, da bolnike poučijo o pravilnih tehnikah za samodajanje, kadar je bolnik voljan in sposoben za to, in smernice za zdravstvene delavce za poročanje o administrativnih napakah;
When the container is about twothirds full, dispose of it as instructed by your doctor or pharmacist.
Ko je vsebnik poln do približno dveh tretjin, ga zavrzite, kot vam je naročil vaš zdravnik ali farmacevt.
The efficacy portion of the study included 47 patients, 44 of whom had a diagnosis of FCAS and 3 with a diagnosis of MWS.
V učinkovitostnem delu študije je bilo vključenih 47 bolnikov, od katerih jih je imelo 44 diagnozo FCAS, 3 pa so imeli diagnozo MWS.
• The role and use of patient alert card.
• o vlogi in uporabi opozorilne kartice bolnika.
In the clinical program for CAPS, 8 adolescents aged 12-17 were treated for up to 18 months.
V kliničnem programu za CAPS so zdravili 8 mladostnikov, starih 12-17 let, do 18 mesecev.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
V skladu s smernicami CHMP za sisteme za obvladovanje tveganja za zdravila za uporabo v humani medicini mora biti posodobljeni RMP predložen hkrati z naslednjim rednim posodobljenim poročilom o varnosti zdravila (PSUR).
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached
• v 60 dneh po doseženem pomembnem mejniku (farmakovigilančnem ali povezanem z zmanjševanjem tveganja);
• The identified or potential risk of immunogenicity that might lead to immune-mediated symptoms;
• o dejanski ali možni nevarnosti imunogenosti, ki bi lahko povzročila imunsko posredovane simptome;
Do not use the solution if it is discoloured or cloudy, or if it contains small particles (see Figure 8).
Ne uporabite raztopine, če je drugačne barve ali je motna ali vsebuje majhne delce (glejte sliko 8).
The changes in mean symptom scores for the randomised parallel-group period (Part A) and the randomised withdrawal period (Part B) of the study are shown in Table 3.
Spremembe povprečnih izidov simptomov za obdobje randomiziranih paralelnih skupin (del A) in randomizirano obdobje odtegnitve (del B) študije kaže preglednica 3.
• The need for Health Care Professionals to perform an annual clinical assessment of patients regarding a potential increased risk for the development of malignancies;
• o potrebi, da zdravstveni delavci opravijo vsakoletni klinični pregled bolnikov zaradi možnega zvečanega tveganja razvoja malignih bolezni;
Age (26-78 years old) and body weight (50-120 kg) did not appear to have a significant effect on trough rilonacept concentrations.
Ni bilo videti, da bi starost (26-78 let) in telesna masa (50-120 kg) pomembno vplivali na minimalne koncentracije rilonacepta.
It may take up to 30 seconds to inject the entire dose.
Injiciranje celotnega odmerka lahko traja do 30 sekund.
Available data indicate that dose modification is not required based on advanced age.
Podatki, ki so na voljo, kažejo, da prilagajanje odmerka zaradi višje starosti ni potrebno.
Mutation in NLRP3 gene
Mutacija gena NLRP3
These changes were not deemed as clinically significant and were potentially due to a decrease in the chronic inflammatory state present in CAPS with an attendant decrease in acute-phase response.
Teh sprememb niso imeli za klinično pomembne in je možno, da so posledica zmanjšanja kroničnega vnetnega stanja, prisotnega pri CAPS, s spremljajočim upadom odziva akutne faze.
Patients or their caregivers should be instructed on the appropriate procedure for disposal of the vials, needles, and syringes.
Bolnike ali njihove negovalce je treba poučiti o ustreznem postopku odstranjevanja vial, igel in brizg.
Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted (see section 4.8).
Bolnike je treba spremljati glede sprememb v njihovem lipidnem profilu in jih zdraviti, če je to upravičeno (glejte poglavje 4.8).
Dosing in children must be adjusted as the child grows.
Odmerjanje pri otrocih je treba prilagajati otrokovi rasti.
There are no adequate data from use of rilonacept in pregnant women.
Ni zadostnih podatkov o uporabi rilonacepta pri nosečnicah.
• Inflammation of the eye (iritis)
• vnetje očesa (iritis).
Repeat step 7 until the powder is completely dissolved and the solution is clear.
Ponavljajte korak 7, dokler se prašek popolnoma ne raztopi in je raztopina bistra.
HR3 5PG Hereford United Kingdom
HR3 5PG Hereford Velika Britanija
Regeneron UK Limited 40 Bank Street E14 5DS London United Kingdom
Regeneron UK Limited 40 Bank Street E14 5DS London Velika Britanija
It is unknown whether rilonacept is excreted in human or animal breast milk.
Ni znano, ali se rilonacept izloča v ženskem ali živalskem mleku.
No study was conducted to evaluate the effect of age, gender, or body weight on rilonacept exposure.
Opravljena ni bila nobena študija za vrednotenje učinka starosti, spola ali telesne mase na izpostavljenost rilonaceptu.
This medicinal product has been authorised under “Exceptional Circumstances”.
Zdravilo je pridobilo dovoljenje za promet v “izjemnih okoliščinah”.
Physicians should monitor the lipid profiles of their patients (for example after 2-3 months) and consider lipid-lowering therapies as needed based upon cardiovascular risk factors and current guidelines.
Zdravniki naj spremljajo lipidne profile svojih bolnikov (na primer po 2-3 mesecih) in po potrebi uvedejo zdravila za zniževanje ravni lipidov na podlagi dejavnikov srčno-žilnega tveganja in trenutno veljavnih smernic.
In patients with CAPS, the body produces excessive amounts of IL-1 beta.
Pri bolnikih s CAPS telo izdeluje čezmerne količine IL-1 beta.
• Other medicines that block interleukin-1, such as anakinra or canakinumab.
• druga zdravila, ki zavirajo interlevkin-1, kot je anakinra ali kanakinumab;
The following information is intended for medical or healthcare professionals only and is provided as a tear-off leaflet:
Naslednje informacije so namenjene samo zdravstvenemu osebju in so na voljo kot brošura, ki se odtrga:
• The need to monitor patients for changes in their lipid profiles;
• o potrebi, da spremljajo spremembe lipidnega profila bolnikov;
Check if the vial contains any particles or clumps of powder that have not dissolved.
Preverite, ali viala vsebuje delce ali kepice praška, ki so niso raztopili.
Figure 13b (Small Children, Thin Patients)
Slika 13b (majhni otroci, suhi bolniki) 6.
No patients withdrew from the study due to ISRs.
Noben bolnik ni zaradi ISR izstopil iz študije.
The results for the adults who entered the study in Part A are provided separately from the results of the adults who entered directly into the open label extension; the results for the four adolescents who entered directly into the open label extension are provided individually.
Rezultati za odrasle, ki so se vključili v del A študije, so prikazani ločeno od rezultatov odraslih, ki so se vključili neposredno v odprto podaljšanje; rezultati štirih mladostnikov, ki so se vključili v odprto podaljšanje, so prikazani individualno.
Each pack contains:
Eno pakiranje vsebuje:
In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted immediately.
V primeru prevelikega odmerka priporočajo spremljanje bolnika glede kakršnih koli znakov ali simptomov neželenih reakcij in takojšnjo uvedbo ustreznega simptomatskega zdravljenja.
Genotoxicity or long term animal studies have not been performed to evaluate the mutagenic or carcinogenic potential of rilonacept.
Študij genotoksičnosti ali dolgoročnih študij na živalih za ovrednotenje mutagenega ali kancerogenega potenciala rilonacepta niso opravili.
• Increased blood pressure
• zvišan krvni tlak;
The data reflect the percentage of patients whose test results were positive for antibodies to rilonacept in specific assays, and are highly dependent on the sensitivity and specificity of the assays.
Podatki zrcalijo odstotni delež bolnikov, katerih testni rezultati so bili pozitivni na protitelesa proti rilonaceptu pri specifičnih testih, in so močno odvisni od občutljivosti in specifičnosti testov.
The MAH is requested to provide regular safety and efficacy data from the Global Registry for both adults and children.
Imetnik dovoljenja za promet z zdravilom mora posredovati redne podatke o varnosti in učinkovitosti iz globalnega registra tako za odrasle kot za otroke.
• if you have an active, severe infection.
• če imate težko aktivno okužbo.
This means that it is injected through a short needle into the fatty tissue just under the skin.
To pomeni, da se injicira skozi kratko iglo v maščobno tkivo tik pod kožo.
Used alcohol wipes can be thrown away in the household rubbish.
Rabljene alkoholne zložence lahko zavržete z gospodinjskimi odpadki.
• one used for injection
• ena se uporabi za injiciranje
Begin at the centre of the site and move outward.
Začnite sredi mesta injiciranja in se pomikajte navzven.
*p< 0.0001, comparison of rilonacept vs. placebo **p< 0.001, comparison of rilonacept vs. placebo, NS = not significant
*p< 0,0001, primerjava rilonacepta s placebom **p< 0,001, primerjava rilonacepta s placebom NS = nesignifikantno
There was no correlation of antibody activity and either clinical efficacy or safety.
Korelacije med aktivnostjo protiteles in bodisi klinično učinkovitostjo bodisi varnostjo ni bilo.
However, clinical experience in patients above 65 years is limited, therefore caution is recommended (see section 5.1).
Vendar so klinične izkušnje pri bolnikih, starejših od 65 let, omejene, zato priporočamo previdnost (glejte poglavje 5.1).
• The risk of acute injection-related reactions;
• o tveganju akutnih reakcij, povezanih z okužbami;
Pharmacotherapeutic group: Interleukin inhibitors, ATC code: L04AC04.
Farmakoterapevtska skupina: Zaviralci interlevkinov, oznaka ATC: L04AC04.
Each vial should be used for a single dose only.
Vsaka viala se sme uporabiti samo za enkraten odmerek.
Do not touch this area again before injecting.
Pred injiciranjem se tega predela ne dotikajte več.
Therefore, live vaccines should not be given concurrently with Rilonacept Regeneron, unless the benefits clearly outweigh the risks.
Zato živih cepiv ne smemo dajati sočasno z zdravilom Rilonacept Regeneron, razen če koristi očitno odtehtajo nevarnosti.
Table 4: Key symptom scores by age and diagnosis following 24-week open label extension Group
Preglednica 4: Izidi ključnih simptomov po starosti in diagnozi po 24-tedenskem odprtem podaljšanju
If you have any questions about how Rilonacept Regeneron works or why this medicine has been prescribed for you, ask your doctor.
Če imate kakšna vprašanja o tem, kako zdravilo Rilonacept Regeneron deluje ali zakaj so vam predpisali to zdravilo, vprašajte svojega zdravnika.
• Any other medicines for chronic disorders, as Rilonacept Regeneron can affect how the liver processes some medicines, such as warfarin (a blood thinner).
• katerakoli druga zdravila za kronične bolezni, ker lahko zdravilo Rilonacept Regeneron vpliva na način, na katerega jetra predelujejo nekatera zdravila, na primer varfarin (zdravilo za redčenje krvi).
In studies of patients with CAPS, no ISRs were assessed as severe, and no patient discontinued study participation due to an ISR.
V študijah bolnikov s CAPS nobene ISR niso bile ocenjene kot težke in noben bolnik ni izstopil iz študije zaradi ISR.
Endpoint Period (Weeks 22 to 24)
Obdobje končnega stanja (tedni 22 do 24)