natgillin/translations-raw huggingface dataset:
The requirements for submission of periodic safety update reports for this medicinal product 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
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
This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01).
To ustreza 28-odstotnemu zmanjšanju tveganja za umrljivost iz katerega koli vzroka (p=0,01).
- you are taking medicines called corticosteroids (such as prednisolone or dexamethasone) - you have cancer.
- prejemate zdravila, ki jih imenujemo kortikosteroidi (kot sta prednizolon ali deksametazon), - imate raka.
• Key signs and symptoms of serious adverse events • When to seek attention from the health care provider
• ključne znake in simptome resnih neželenih dogodkov, • navodila o tem, kdaj je treba poiskati zdravniško pomoč.
A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
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 ZVZI Z VARNO IN UČINKOVITO UPORABO
Class effects:
Učinki po skupinah:
Contents of the pack and other information
Vsebina pakiranja in dodatne infomacije
• Contraindication in pregnancy and in breast-feeding women due to potential teratogenicity
• kontraindikacije med nosečnostjo in dojenjem zaradi možne teratogenosti,
Therefore, interactions resulting from displacement of highly protein-bound drugs are unlikely.
Zato interakcije, ki se kažejo kot izrivanje zdravil pretežno vezanih na beljakovine, niso verjetne.
Zoledronic acid Teva Pharma may also cause other side effects Very common: may affect more than 1 in 10 people Fever.
Zdravilo Zoledronska kislina Teva Pharma lahko povzroča tudi druge neželene učinke Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov Vročina.
Zoledronic acid demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%).
Zoledronska kislina je pokazala stalen učinek v obdobju 3 let, kar je omogočilo 41-odstotno znižanje tveganja za zlom kolkov (95 % IZ: 17 % do 58 %).
It is important for your doctor to know all the medicines you are taking, especially if you are taking any medicines known to be harmful to your kidneys (e.g. aminoglycosides) or diuretics (“waterpills”) that may cause dehydration.
Pomembno je, da vaš zdravnik ve, katera zdravila jemljete, zlasti če jemljete zdravila, za katera je znano, da lahko škodujejo ledvicam (na primer aminoglikozide) ali diuretike (zdravila za odvajanje vode), ki lahko povzročajo dehidracijo.
• in adult men at increased risk of fracture, including those with a recent low-trauma hip fracture.
• pri odraslih moških s povečanim tveganjem za zlome, vključno s tistimi z nedavnim zlomom kolka po lažji poškodbi.
It must not be mixed or given intravenously with any other medicinal products.
Ne smete ga mešati ali dajati intravensko skupaj z drugimi zdravili.
• Need to ensure appropriate hydration of the patient especially those at an advanced age and those receiving diurectic therapy
• potrebo po zagotovitvi primerne hidriranosti bolnika, zlasti v primeru starejših bolnikov in bolnikov, ki prejemajo diuretično terapijo,
The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Varnost in učinkovitost zoledronske kisline pri otrocih in mladostnikih starih do 18 let nista bili dokazani.
Treatment of osteoporosis
Zdravljenje osteoporoze
Incidence of individual adverse reactions following the first infusion was: pyrexia (17.1%), myalgia (7.8%), influenza-like illness (6.7%), arthralgia (4.8%) and headache (5.1%).
Po prvi infuziji so bile incidence posameznih neželenih učinkov naslednje: pireksija (17,1 %), mialgija (7,8 %), gripi podobna bolezen (6,7 %), artralgija (4,8 %) in glavobol (5,1 %).
• A single dose of Zoledronic acid Teva Pharma should not exceed 5 mg and the duration of infusion should be at least 15 minutes (see section 4.2).
• Posamezen odmerek zdravila Zoledronska kislina Teva Pharma ne sme presegati 5 mg, infuzija pa mora trajati najmanj 15 minut (glejte poglavje 4.2).
- you do not receive routine dental care or have not had a dental check-up for a long time; - you are a smoker (as this may increase the risk of dental problems); - you have previously been treated with a bisphosphonate (used to treat or prevent bone
- nimate urejene redne oskrbe zob oziroma že dolgo niste bili na zobozdravstvenem pregledu, - ste kadilec (saj to lahko povečuje tveganje za težave z zobmi), - ste že kdaj prej prejemali katerega od difosfonatov (ki jih uporabljamo za zdravljenje ali
- Do not use this medicine if you notice any discolouration or particles in the solution.
- Ne uporabljajte tega zdravila, če opazite, da je raztopina drugačne barve ali so v njej majhni delci.
Before receiving Zoledronic acid Teva Pharma treatment, tell your doctor, pharmacist or nurse if - you have any problems with your mouth or teeth such as poor dental health, gum disease, or a
Preden prejmete zdravilo Zoledronska kislina Teva Pharma, povejte zdravniku, farmacevtu ali medicinski sestri, če: - imate težave v ustih oziroma z zobmi, kot so slabo zdravstveno stanje zob, bolezni dlesni ali
For information on the infusion of Zoledronic acid Teva Pharma, see section 6.6.
Za informacije o infundiranju zdravila Zoledronska kislina Teva Pharma glejte poglavje 6.6.
Zoledronic acid significantly decreased the incidence of one or more new vertebral fractures over three years and as early as the one year timepoint (see Table 2).
Zoledronska kislina je statistično značilno znižalo incidenco enega ali več novih zlomov vretenc tako v obdobju treh let kot tudi že po enem letu opazovanja (glejte preglednico 2).
Ask your doctor, pharmacist or nurse for advice before using this medicine.
Posvetujte se z zdravnikom, farmacevtom ali medicinsko sestro, preden uporabite to zdravilo.
• Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non
• potrebnost zadostnega nadomeščanja kalcija in vitamina D, ustrezne telesne dejavnosti in zdrave
The incidence rates of key clinical fracture variables are presented in Table 4.
Stopnje incidenc ključnih kliničnih zlomov so prikazane v preglednici 4.
The majority of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first three days following the dose of Zoledronic acid Teva Pharma.
Večina neželenih učinkov, kot so vročina z mrzlico, bolečine v mišicah in sklepih in glavobol, nastopi v prvih treh dneh po odmerku zdravila Zoledronska kislina Teva Pharma.
The incidence of post-dose symptoms occuring within the first three days after administration of Zoledronic acid Teva Pharma can be reduced with the administration of paracetamol or ibuprofen shortly following Zoledronic acid Teva Pharma administration.
Incidenco simptomov po odmerjanju, ki nastopijo v prvih treh dneh po aplikaciji zdravila Zoledronska kislina Teva Pharma, je mogoče znižati z jemanjem paracetamola ali ibuprofena kmalu po aplikaciji zdravila Zoledronska kislina Teva Pharma.
Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic acid Teva Pharma.
Skrbno se ravnajte po vseh navodilih zdravnika, farmacevta ali medicinske sestre, preden vam dajo zdravilo Zoledronska kislina Teva Pharma.
• Contraindication in patients with creatinine clearance < 35 ml/min
• kontraindikacija pri bolnikih z očistkom kreatinina < 35 ml/min,
For the treatment of Paget's disease, Zoledronic acid Teva Pharma should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone.
Za zdravljenje Pagetove bolezni smejo zdravilo Zoledronska kislina Teva Pharma predpisovati samo zdravniki, ki imajo izkušnje z zdravljenjem Pagetove bolezni kosti.
In another study in men (study CZOL446M2308) an annual infusion of zoledronic acid was noninferior to weekly alendronate for the percentage change in lumbar spine BMD at month 24 relative to baseline.
V drugi študiji z moškimi (študija CZOL446M2308) letna infuzija zoledronske kisline ni bila slabša od tedenske uporabe alendronata glede odstotka spremembe mineralne gostote kosti ledvene hrbtenice po 24 mesecih v primerjavi z izhodiščem.
The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Zoledronic acid Teva Pharma on an individual patient basis, particularly after 5 or more years of use.
Potrebo po nadaljevanju zdravljenja z zdravilom Zoledronska kislina Teva Pharma je treba periodično ponovno oceniti glede na koristi in tveganja za posameznega bolnika, še posebno po 5 letih ali več uporabe.
After initiation of the zoledronic acid infusion, plasma concentrations of the active substance increased rapidly, achieving their peak at the end of the infusion period, followed by a rapid decline to < 10% of peak after 4 hours and < 1% of peak after 24 hours, with a subsequent prolonged period of very low concentrations not exceeding 0.1% of peak levels.
Po začetku infundiranja zoledronske kisline so se koncentracije zdravilne učinkovine v plazmi hitro zvišale, dosegle ob koncu infundiranja vrh, ki mu je sledilo hitro znižanje na < 10 % najvišje dosežene vrednosti po 4 urah in na < 1 % najvišje dosežene vrednosti po 24 urah, čemur je sledilo dolgotrajno obdobje zelo nizkih koncentracij, ki niso presegle 0,1 % najvišje vrednosti.
Special populations Patients with renal impairment
Posebne skupine bolnikov Bolniki z ledvično okvaro
While being treated with Zoledronic acid Teva Pharma, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.
V času zdravljenja z zdravilom Zoledronska kislina Teva Pharma morate skrbeti za dobro ustno higieno (kar vključuje redno čiščenje zob) in redno hoditi na rutinske preglede k zobozdravniku.
Patients being treated with Zoledronic acid Teva Pharma should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Bolniki, ki prejemajo zdravilo Zoledronska kislina Teva Pharma, ne smejo istočasno prejemati teh zdravil ali kateri koli druge difosfonate, saj skupni učinki teh zdravil niso znani.
For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg Zoledronic acid Teva Pharma administered once a year.
Za zdravljenje postmenopavzalne osteoporoze, osteoporoze pri moških in osteoporoze zaradi dolgotrajnega zdravljenja s sistemskimi glukokortikoidi je priporočeni odmerek ena intravenska infuzija s 5 mg zdravila Zoledronska kislina Teva Pharma enkrat na leto.
In both women and men, Zoledronic acid Teva Pharma strengthens the bone and therefore makes it less likely to break.
Tako pri ženskah kot pri moških zdravilo Zoledronska kislina Teva Pharma okrepi kosti in tako zmanjša verjetnost zlomov.
Your doctor will advise you and decide how long you should be treated with Zoledronic acid Teva Pharma.
Zdravnik vam bo svetoval in presodil, kako dolgo bi se morali zdraviti z zdravilom Zoledronska kislina Teva Pharma.
All cause mortality was 10% (101 patients) in the zoledronic acid-treated group compared to 13% (141 patients) in the placebo group.
Umrljivost iz katerega koli vzroka je bila 10 % v skupini, zdravljeni z zoledronsko kislino (101 bolnik), v primerjavi s 13 % v skupini s placebom (141 bolnikov).
Other products containing zoledronic acid as an active substance are available for oncology indications.
Obstajajo druga zdravila, ki vsebujejo zdravilno učinkovino zoledronska kislina in se uporabljajo za onkološke indikacije.
If you are under dental treatment or are due to undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Zoledronic acid Teva Pharma.
Če ste v postopku zdravljenja zoba ali ste v kratkem dogovorjeni za zobozdravstveni kirurški poseg (na primer puljenje zoba), zdravnika obvestite o zdravljenju zob, zobozdravniku pa povejte, da prejemate zdravilo Zoledronska kislina Teva Pharma.
Due to the rapid onset of effect of zoledronic acid on bone turnover, transient hypocalcaemia, sometimes symptomatic, may develop and is usually maximal within the first 10 days after infusion of Zoledronic acid Teva Pharma (see section 4.8).
Zaradi hitrega začetka delovanja zoledronske kisline na pregradnjo kosti se utegne razviti prehodna hipokalciemija, ki je včasih simptomatska in ki je navadno najbolj izražena v prvih 10 dneh po infuziji zdravila Zoledronska kislina Teva Pharma (glejte poglavje 4.8).
The physician educational material should contain the following key messages:
Izobraževalni material za zdravnika mora vsebovati naslednje ključne sestavine:
Your doctor, pharmacist or nurse knows how to store Zoledronic acid Teva Pharma properly.
Vaš zdravnik, farmacevt in medicinska sestra vedo, kako je treba zdravilo Zoledronska kislina Teva Pharma pravilno shranjevati.
Re-treatment of Paget's disease: After initial treatment with zoledronic acid in Paget's disease, an extended remission period is observed in responding patients.
Ponovno zdravljenje Pagetove bolezni: Po začetnem zdravljenju Pagetove bolezni z zoledronsko kislino opažajo pri bolnikih, ki se odzovejo na zdravljenje, obdobje dolgotrajne remisije.
oesophagitis, toothache, gastritis#
zobobol, gastritis#
The use of Zoledronic acid Teva Pharma in children and adolescents has not been studied.
Uporabe zdravila Zoledronska kislina Teva Pharma pri otrocih in mladostnikih niso proučevali.
This is especially important for the elderly (≥ 65 years) and for patients receiving diuretic therapy.
To je posebno pomembno za starejše (stare 65 let ali več) in za bolnike, ki jemljejo tudi diuretike.
It is currently unclear whether Zoledronic acid Teva Pharma causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic acid Teva Pharma.
Zaenkrat ni jasno, ali to nepravilno bitje srca povzroča zdravilo Zoledronska kislina Teva Pharma, kljub temu pa morate zdravniku sporočiti, če pri vas pride do takih simptomov po prejemu zdravila Zoledronska kislina Teva Pharma.
The incidence of clinical fractures, including vertebral, non-vertebral and hip fractures, was evaluated in 2,127 men and women aged 50-95 years (mean age 74.5 years) with a recent (within 90 days) lowtrauma hip fracture who were followed for an average of 2 years on study treatment.
Incidenco kliničnih zlomov, vključno z zlomi vretenc, nevretenčnimi zlomi in zlomi kolka, so vrednotili pri 2.127 moških in ženskah, starih 50-95 let (povprečna starost 74,5 let) z nedavnim (v okviru 90 dni) zlomom kolka po lažji poškodbi, ki so jih opazovali povprečno 2 leti med zdravljenjem s študijskim zdravilom.
What Zoledronic acid Teva Pharma is and what it is used for What you need to know before you are given Zoledronic acid Teva Pharma How Zoledronic acid Teva Pharma is given
Kaj je zdravilo Zoledronska kislina Teva Pharma in za kaj ga uporabljamo Kaj morate vedeti, preden vam dajo zdravilo Zoledronska kislina Teva Pharma Kako se daje zdravilo Zoledronska kislina Teva Pharma
Pre-existing hypocalcaemia must be treated by adequate intake of calcium and vitamin D before initiating therapy with Zoledronic acid Teva Pharma (see section 4.3).
Že obstoječo hipokalciemijo je treba zdraviti z zadostnim vnosom kalcija in vitamina D še pred uvedbo zdravljenja z zdravilom Zoledronska kislina Teva Pharma (glejte poglavje 4.3).
EXP After opening: 24 hours at 2°C - 8°C
EXP Po odprtju: 24 ur pri 2 °C - 8 °C.
Effect on morphometric vertebral fractures
Učinek na morfometrično opredeljene zlome vretenc
Not known** Hypersensitivity reactions including rare cases of bronchoconstriction, urticaria and angioedema, and very rare cases of anaphylactic reaction/shock
Bolezni imunskega sistema preobčutljivostne reakcije, vključno z redkimi primeri bronhospazma, urtikarije in angioedema in z zelo redkimi primeri anafilaktične reakcije/šoka
Zoledronic acid Teva Pharma is not recommended for anyone under 18 years of age.
Uporaba zdravila Zoledronska kislina Teva Pharma ni priporočljiva pri starosti pod 18 let.
The use of Zoledronic acid Teva Pharma in patients with severe renal impairment (creatinine clearance < 35 ml/min) is contraindicated due to an increased risk of renal failure in this population.
Uporaba zdravila Zoledronska kislina Teva Pharma pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 35 ml/min) je kontraindicirana zaradi povečanega tveganja za odpoved pri tej populaciji.
Suomi/Finland ratiopharm Oy
Ísland ratiopharm Oy, Finnland
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in Paget's disease of the bone, osteoporosis in post-menopausal women at an increased risk of fracture, osteoporosis in men at increased risk of fracture and prevention of clinical fractures after a hip fracture in men and women (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij referenčnega zdravila, ki vsebuje zoledronsko kislino za vse skupine pediatrične populacije s Pagetovo boleznijo kosti, za osteoporozo pri postmenopavzalnih ženskah s povečanim tveganjem za zlome, za osteoporozo pri moških s povečanim tveganjem za zlome in za preprečevanje kliničnih zlomov po zlomu kolka pri ženskah in moških (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
If you missed a dose of Zoledronic acid Teva Pharma Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Če ste izpustili odmerek zdravila Zoledronska kislina Teva Pharma Čimprej pokličite zdravnika oziroma v bolnišnico, da se dogovorite za nov datum.
Six patients who achieved therapeutic response 6 months after treatment with zoledronic acid and later experienced disease relapse during the extended follow-up period were re-treated with zoledronic acid after a mean time of 6.5 years from initial treatment to re-treatment.
Šest bolnikov, pri katerih je prišlo do terapevtskega odziva 6 mesecev po zdravljenju z zdravilom zoledronska kislina, kasneje v obdobju podaljšanega spremljanja pa do recidiva bolezni, je ponovno prejelo zdravilo zoledronska kislina, pri čemer je interval med začetnim in ponovnim zdravljenjem v povprečju znašal 6,5 let.
Of the 153 zoledronic acid-treated patients and 115 risedronate-treated patients who entered an extended observation study, after a mean duration of follow-up of 3.8 years from time of dosing, the proportion of patients ending the Extended Observation Period due to the need for re-treatment (clinical judgment) was higher for risedronate (48 patients, or 41.7%) compared with zoledronic acid (11 patients, or 7.2%).
Od 1543 bolnikov, zdravljenih z zoledronsko kislino, in 115 bolnikov, zdravljenih z risedronatom, ki so bili vključeni v študijo podaljšanega opazovanja, je bil po povprečnem trajanju spremljanja 3,8 let od časa odmerjanja delež bolnikov, ki so zaključili svoje sodelovanje v podaljšanem obdobju opazovanja, ker so potrebovali ponovno zdravljenje (po presoji zdravnika), večji v skupini bolnikov, ki so prejemali risedronat, (48 bolnikov oziroma 41,7 %) kot v skupini bolnikov, ki so prejemali zoledronsko kislino (11 bolnikov oziroma 7,2 %).
Uncommon (may affect up to 1 in 100 people) Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov) Otekanje, rdečina, bolečina in srbenje v očeh ali povečana občutljivost oči za svetlobo.
The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 patients studied.
Ledvični očistek je znašal 75 ± 33 % očistka kreatinina, ki je pri 64 proučevanih bolnikih pokazal srednjo vrednost 84 ± 29 ml/min (obseg 22 do 143 ml/min).
Zoledronic acid Teva Pharma is also used in patients who have recently broken their hip in a minor trauma such as a fall and therefore are at risk of subsequent bone breaks.
Zdravilo Zoledronska kislina Teva Pharma uporabljamo tudi pri bolnikih, ki so si pred kratkim zlomili kolk ob lažji poškodbi, na primer pri padcu, in je zato tveganje za nadaljnje zlome pri njih povečano.
In patients with Paget's disease: symptoms due to low blood calcium, such as muscle spasms, or numbness, or a tingling sensation especially in the area around the mouth have been reported.
Pri bolnikih s Pagetovo boleznijo so poročali o simptomih zaradi nizke koncentracije kalcija v krvi, kot so mišični krči, odrevenelost ali občutek zbadanja, posebno v predelu okrog ust.
In patients with a recent low-trauma hip fracture, it is recommended to give the zoledronic acid infusion at least two weeks after hip fracture repair (see section 5.1).
Pri bolnikih z nedavnim zlomom kolka po lažji poškodbi je priporočeno dati infuzijo zoledronsko kislino najmanj dva tedna po oskrbi zloma kolka (glejte poglavje 5.1).
Zoledronic acid Teva Pharma works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Zoledronska kislina Teva Pharma deluje tako, da normalizira proces kostne pregradnje, omogoči tvorbo normalne kostnine in tako kostem povrne čvrstost.
Zoledronic acid Teva Pharma is contraindicated in patients with creatinine clearance < 35 ml/min (see sections 4.3 and 4.4).
Zdravilo Zoledronska kislina Teva Pharma je kontraindicirano pri bolnikih z očistkom kreatinina < 35 ml/min (glejte poglavji 4.3 in 4.4).
• Need to calculate creatinine clearance based on actual body weight using the Cockcroft-Gault formula before each treatment with Zoledronic acid Teva Pharma
• potreba izračuna očistka kreatinina glede na dejansko telesno maso po Cockcroft-Gaultovi formuli pred vsakim zdravljenjem z zdravilom Zoledronska kislina Teva Pharma,
Zoledronic acid Teva Pharma must not be mixed or given intravenously with any other medicinal product and must be given through a separate vented infusion line at a constant infusion rate.
Zdravila Zoledronska kislina Teva Pharma ne smete mešati ali dajati intravensko z drugim zdravilom, dajati ga morate po ločenem prezračevanem infuzijskem sistemu s stalno hitrostjo infundiranja.
If you feel dizzy while taking Zoledronic acid Teva Pharma, do not drive or use machines until you feel better.
Vpliv na sposobnost upravljanja vozil in strojev Če ste v obdobju zdravljenja z zdravilom Zoledronska kislina Teva Pharma omotični, ne vozite in ne upravljajte strojev, dokler se vaše počutje ne izboljša.
Zoledronic acid significantly increased BMD at the lumbar spine, hip, and distal radius relative to treatment with placebo at all timepoints (6, 12, 24 and 36 months).
Zoledronska kislina je statistično značilno povečala mineralno gostoto kosti ledvene hrbtenice, kolka in distalnega dela koželjnice v primerjavi s placebom po vseh obdobjih opazovanja (po 6, 12, 24 in 36 mesecih).